As filed with the U.S. Securities and Exchange Commission on February 13, 2020

Registration No. 333-235683

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Amendment No. 2 to

FORM S-4

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

Organovo Holdings, Inc.

(Exact name of registrant as specified in its charter)

440 Stevens Avenue, Suite 200

Solana Beach, California 92075

(858) 224-1000

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Craig Kussman

Chief Financial Officer

Organovo Holdings, Inc.

440 Stevens Avenue, Suite 200

Solana Beach, California 92075

(858) 224-1000

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effectiveness of this registration statement and the satisfaction or waiver of all other conditions under the Merger Agreement described herein.

If the securities being registered on this Form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, please check the following box.  ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act  ☐

If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:

Exchange Act Rule 13(e)-4(i) (Cross-Border Issuer Tender Offer)  ☐

Exchange Act Rule 14d-1(d) (Cross-Border Third-Party Tender Offer)  ☐

CALCULATION OF REGISTRATION FEE

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this proxy statement/prospectus/information statement is not complete and may be changed. Organovo may not sell its securities pursuant to the proposed transactions until the Registration Statement filed with the Securities and Exchange Commission is effective. This proxy statement/prospectus/information statement is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.

Subject to completion, dated February 13, 2020

PROPOSED MERGER

YOUR VOTE IS VERY IMPORTANT

To the Stockholders of Organovo Holdings, Inc. and Tarveda Therapeutics, Inc.:

Organovo Holdings, Inc. (“Organovo”) and Tarveda Therapeutics, Inc. (“Tarveda”) have entered into an Agreement and Plan of Merger and Reorganization, dated as of December 13, 2019, as amended by the First Amendment to Merger Agreement (the “Amendment to Merger Agreement”), dated January 26, 2020, and as may be amended from time to time (the “Merger Agreement”), pursuant to which a wholly owned subsidiary of Organovo will merge with and into Tarveda, with Tarveda surviving as a wholly owned subsidiary of Organovo (the “Merger”). Organovo and Tarveda believe that the Merger will result in a clinical stage biopharmaceutical company discovering and developing a new class of potent and selective precision oncology medicines for the treatment of patients with a wide range of solid tumor malignancies.

At the effective time of the Merger (the “Effective Time”), each share of Tarveda common stock outstanding immediately prior to the Effective Time (excluding certain shares of Tarveda common stock that may be cancelled pursuant to the Merger Agreement and shares held by stockholders who have exercised and perfected appraisal rights or dissenters’ rights as more fully described in the section titled “The Merger — Appraisal Rights and Dissenters’ Rights” in this proxy statement/prospectus/information statement) will be converted into the right to receive a number of shares of Organovo common stock. The final exchange ratio (the “Exchange Ratio”) will be determined pursuant to a formula described in more detail in the Merger Agreement and in this proxy statement/prospectus/information statement. Immediately after the consummation of the Merger, based solely on the estimated Exchange Ratio as described in this proxy statement/prospectus/information statement, Tarveda securityholders would own approximately 75% of the Organovo common stock on a fully diluted basis as defined in the Merger Agreement, and Organovo securityholders would own approximately 25% of the Organovo common stock on a fully diluted basis as defined in the Merger Agreement, subject to adjustment of the Exchange Ratio as set forth in the Merger Agreement.

Shares of Organovo common stock are currently listed on The Nasdaq Capital Market under the symbol “ONVO.” After completion of the Merger, Organovo will be renamed “Tarveda Therapeutics, Inc.” and is expected to trade on The Nasdaq Capital Market under the symbol “TVDA”. On February 12, 2020, the last trading day before the date of this proxy statement/prospectus/information statement, the closing sale price of Organovo common stock was $0.33 per share.

Organovo is holding a special meeting of stockholders in order to obtain the stockholder approvals necessary to complete the Merger and related matters. At the Organovo special meeting, which will be held at                a.m., Pacific Time, on                , 2020 at                , unless postponed or adjourned to a later date, Organovo will ask its stockholders to:

Tarveda stockholders are being asked to approve the Merger Agreement, and vote in favor of any other matter necessary to consummate the transactions contemplated by the Merger Agreement.

As described in the accompanying proxy statement/prospectus/information statement, certain Tarveda stockholders, including certain directors and executive officers of Tarveda, and 5% or greater stockholders, who in the aggregate own approximately 95% of the outstanding shares of Tarveda common stock on an as-converted to common stock basis are parties to support agreements with Organovo and Tarveda. Following the registration statement on Form S-4, of which this proxy statement/prospectus/information statement is a part, being declared effective by the U.S. Securities and Exchange Commission and pursuant to the conditions of the Merger Agreement, the Tarveda stockholders who are party to the support agreements have each agreed to execute an action by written consent of the Tarveda stockholders, referred to as the written consent, (a) in favor of (i) adoption of the Merger Agreement and approval of the transactions contemplated by the Merger Agreement, (ii) approval of any proposal to adjourn or postpone a meeting of the holders of Tarveda capital stock to a later date, if there are not sufficient votes for the adoption of the Merger Agreement and the transactions contemplated thereby on the date such meeting is held, and (iii) any other matter necessary to consummate the transactions contemplated by the Merger Agreement that are considered and voted upon by Tarveda stockholders and (b) against any “acquisition proposal,” as defined in the Merger Agreement. Therefore, absent termination of the Merger Agreement, holders of a sufficient number of shares of Tarveda capital stock required to adopt the Merger Agreement have agreed to adopt the Merger Agreement, and no meeting of Tarveda stockholders to adopt the Merger Agreement and approve the Merger will be held. Nevertheless, all Tarveda stockholders will have the opportunity to elect to adopt the Merger Agreement, thereby approving the Merger and related transactions, by signing and returning to Tarveda a written consent.

After careful consideration, the Organovo and Tarveda boards of directors have approved the Merger Agreement and the Merger and the respective proposals referred to above, and each of the Organovo and Tarveda boards of directors has determined that it is advisable to enter into the Merger Agreement and related transactions. The Organovo board of directors recommends that its stockholders vote “FOR” the proposals described in the accompanying proxy statement/prospectus/information statement, and the board of directors of Tarveda recommends that its stockholders sign and return the written consent indicating their approval of the Merger and adoption of the Merger Agreement and related transactions to Tarveda described in the accompanying proxy statement/prospectus/information statement.

More information about Organovo, Tarveda and the proposed transaction is contained in this proxy statement/prospectus/information statement. Organovo and Tarveda urge you to read the accompanying proxy statement/prospectus/information statement, including the documents incorporated by reference herein, carefully and in its entirety. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER “RISK FACTORS” BEGINNING ON PAGE 30.

Organovo and Tarveda are excited about the opportunities the Merger brings to both Organovo and Tarveda stockholders, and thank you for your consideration and continued support.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this proxy statement/prospectus/information statement. Any representation to the contrary is a criminal offense.

The accompanying proxy statement/prospectus/information statement is dated                    , 2020, and is first being mailed to Organovo and Tarveda stockholders on or about                    , 2020.

ORGANOVO HOLDINGS, INC.

NOTICE OF SPECIAL MEETING OF STOCKHOLDERS

TO BE HELD ON

Dear Stockholders of Organovo:

On behalf of the board of directors of Organovo Holdings, Inc., a Delaware corporation (“Organovo”), we are pleased to deliver this proxy statement/prospectus/information statement for the proposed Merger between Organovo and Tarveda Therapeutics, Inc., a Delaware corporation (“Tarveda”), pursuant to which Opal Merger Sub, Inc., a wholly owned subsidiary of Organovo (“Merger Sub”), will merge with and into Tarveda, with Tarveda surviving as a wholly owned subsidiary of Organovo (the “Merger”). The special meeting of stockholders of Organovo will be held on                     , 2020 at                  a.m., Pacific Time, at                 , for the following purposes:

The Organovo board of directors has fixed                    , 2020 as the record date for the determination of stockholders entitled to notice of, and to vote at, the Organovo special meeting and any adjournment or postponement thereof. Only holders of record of shares of Organovo common stock at the close of business on the record date are entitled to notice of, and to vote at, the Organovo special meeting. At the close of business on the record date, Organovo had                shares of common stock outstanding and entitled to vote.

Your vote is important. The affirmative vote of a majority of the voting power of the votes cast at the Organovo special meeting, whether present in person or represented by proxy at the Organovo special meeting, is required for approval of Organovo Proposal Nos. 1, 3, 4 and 5. The affirmative vote of the holders of a majority of shares of Organovo common stock having voting power outstanding on the record

date for the Organovo special meeting is required for approval of Organovo Proposal No. 2. Proposal No. 1 is conditioned upon Proposal No. 2. Therefore, the Merger cannot be consummated without the approval of Proposal Nos. 1 and 2.

Even if you plan to attend the Organovo special meeting in person, Organovo requests that you sign and return the enclosed proxy to ensure that your shares will be represented at the Organovo special meeting if you are unable to attend.

By Order of the Organovo Board of Directors,

Taylor Crouch

Chief Executive Officer

Solana Beach, California

                    , 2020

THE ORGANOVO BOARD OF DIRECTORS HAS DETERMINED AND BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS ADVISABLE TO, AND IN THE BEST INTERESTS OF, ORGANOVO AND ITS STOCKHOLDERS AND HAS APPROVED EACH SUCH PROPOSAL. THE ORGANOVO BOARD OF DIRECTORS RECOMMENDS THAT ORGANOVO STOCKHOLDERS VOTE “FOR” EACH SUCH PROPOSAL.

REFERENCES TO ADDITIONAL INFORMATION

This proxy statement/prospectus/information statement incorporates important business and financial information about Organovo that is not included in or delivered with this document. You may obtain this information without charge through the SEC’s website (http://www.sec.gov) or upon your written or oral request by contacting the Secretary of Organovo Holdings, Inc., 440 Stevens Avenue, Suite 200, Solana Beach, California 92075 or by calling (858) 224-1000.

To ensure timely delivery of these documents, any request should be made no later than                    , 2020 to receive them before the Organovo special meeting.

For additional details about where you can find information about Organovo, please see the sections entitled “Where You Can Find More Information” and “Incorporation of Certain Documents By Reference” in this proxy statement/prospectus/information statement.

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QUESTIONS AND ANSWERS ABOUT THE MERGER

Except where specifically noted, the following information and all other information contained in this proxy statement/prospectus/information statement or incorporated by reference herein does not give effect to the proposed reverse stock split at a ratio of one (1) new share for every 20 to 40 shares of outstanding Organovo common stock described in Organovo Proposal No. 2 (the “Organovo Reverse Stock Split”) in this proxy statement/prospectus/information statement. If the Merger and the Organovo Reverse Stock Split are approved, the Organovo Reverse Stock Split will be effected immediately prior to the closing of the Merger (the “Closing”).

The following section provides answers to frequently asked questions about the Merger (as defined below). This section, however, provides only summary information. For a more complete response to these questions and for additional information, please refer to the cross-referenced sections.

At the effective time of the Merger (the “Effective Time”), the shares of Tarveda common stock outstanding immediately prior to the Effective Time (excluding certain shares of Tarveda common stock that may be cancelled pursuant to the Merger Agreement and shares held by stockholders who have exercised and perfected appraisal rights or dissenters’ rights as more fully described in “The Merger — Appraisal Rights and Dissenters’ Rights” below) will be converted into the right to receive an estimated aggregate 432.0 million shares of Organovo common stock, without taking into account the proposed Organovo Reverse Stock Split but including shares of Organovo common stock reserved for issuance upon exercise of Tarveda options and warrants assumed in the Merger, to be implemented prior to the consummation of the Merger and which is the subject of Proposal No. 2. The estimated exchange ratio contained herein (the “Exchange Ratio”) is based upon Organovo’s and Tarveda’s capitalization immediately prior to the date of this proxy statement/prospectus/information statement, and will be adjusted based on the amount of Organovo net cash, Organovo and Tarveda debt and changes in the capitalization of Organovo and Tarveda prior to the consummation of the Merger. As a result of the Merger, holders of Tarveda stock, options and warrants are expected to own in the aggregate approximately 75% of Organovo and the Organovo stockholders, optionholders, holders of restricted stock units (“RSUs”) and warrantholders are expected to own in the aggregate approximately 25% of Organovo on a fully-diluted basis as defined in the Merger Agreement and subject to adjustment as described herein. Simultaneously with the completion of the Merger, Organovo will change its corporate name to “Tarveda Therapeutics, Inc.” as required by the Merger Agreement.

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The approval by the stockholders of the issuance of Organovo common stock in the Merger in accordance with the terms of the Merger Agreement requires the affirmative vote of a majority of the voting power of the votes cast at the Organovo special meeting. The approval of the Organovo Reverse Stock Split requires the affirmative vote of the holders of a majority of the outstanding shares of Organovo common stock having voting power on the record date for the Organovo special meeting. The approval of the Organovo Reverse Stock Split is required in order to authorize Organovo’s issuance of the shares of its common stock pursuant to the Merger Agreement and/or to avoid a delisting of Organovo common stock from The Nasdaq Stock Market. Therefore, if the requisite stockholders of Organovo approve the issuance of Organovo common stock in the Merger to the Tarveda securityholders in accordance with the terms of the Merger Agreement but do not approve the Organovo Reverse Stock Split, the Merger will not be consummated.

The approval of the Merger and the adoption of the Merger Agreement and related transactions by the stockholders of Tarveda requires the affirmative vote of the holders of at least a majority of the outstanding shares of Tarveda’s Series 1 redeemable convertible preferred stock (the “Series 1 Preferred Stock”) and the holders of at least a majority of the outstanding capital stock of Tarveda (voting on an as-converted-to-common stock basis). In addition to the requirement of obtaining such stockholder approvals and appropriate regulatory approvals, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived.

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Certain Tarveda stockholders, including certain directors and executive officers of Tarveda and 5% or greater stockholders, who in the aggregate own approximately 95% of the outstanding shares of Tarveda common stock on an as-converted to common stock basis, and certain Organovo stockholders, including certain directors and executive officers, of Organovo who in the aggregate own approximately less than 1% of the outstanding shares of Organovo common stock, are parties to support agreements with Organovo and Tarveda. The Organovo stockholders who are party to such support agreements have agreed to vote (a) in favor of (i) the Organovo Stockholder Proposals and (ii) any other matter necessary to consummate the transactions contemplated by the Merger Agreement, and (b) against any “acquisition proposal,” as defined in the Merger Agreement. Following the registration statement on Form S-4, of which this proxy statement/prospectus/information statement is a part, being declared effective by the U.S. Securities and Exchange Commission and pursuant to the conditions of the Merger Agreement, the Tarveda stockholders who are party to the support agreements have each agreed to execute an action by written consent of the Tarveda stockholders, referred to as the written consent, (a) in favor of (i) adoption of the Merger Agreement and approval of the transactions contemplated by the Merger Agreement, (ii) approval of any proposal to adjourn or postpone a meeting of the holders of Tarveda capital stock to a later date, if there are not sufficient votes for the adoption of the Merger Agreement and the transactions contemplated thereby on the date such meeting is held, and (iii) any other matter necessary to consummate the transactions contemplated by the Merger Agreement that are considered and voted upon by Tarveda stockholders and (b) against any “acquisition proposal,” as defined in the Merger Agreement. Therefore, holders of a sufficient number of shares of Tarveda capital stock required to adopt the Merger Agreement, thereby approving the Merger, have agreed to adopt the Merger Agreement via written consent. Stockholders of Tarveda, including those who are parties to support agreements, will be requested to execute written consents providing such approvals.

For a more complete description of the closing conditions under the Merger Agreement, Organovo and Tarveda urge you to read the section titled “The Merger Agreement — Conditions to the Completion of the Merger” in this proxy statement/prospectus/information statement.

For a more complete description of what Tarveda stockholders, warrantholders and optionholders will receive in the Merger, please see the sections titled “Market Price and Dividend Information” and “The Merger Agreement — Merger Consideration” in this proxy statement/prospectus/information statement.

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Tax matters are very complicated, and the tax consequences of the Merger to a particular Tarveda stockholder will depend on such stockholder’s circumstances. Accordingly, each Tarveda stockholder is strongly urged to consult with his, her or its tax advisor for a full understanding of the tax consequences of the Merger to that stockholder, including the applicability and effect of federal, state, local and non-U.S. income and other tax laws. For more information, please see the section titled “The Merger — Certain Material U.S. Federal Income Tax Consequences of the Merger” in this proxy statement/prospectus/information statement.

For example, Organovo is party to Severance and Change in Control Plan Participation Agreements with each of its executive officers pursuant to Organovo’s Severance and Change in Control Plan (the “Organovo Severance Plan”) approved by Organovo’s compensation committee. The Organovo Severance Plan establishes the amount of severance payments and benefits available in the event of a (i) termination of employment by Organovo for reasons other than cause, death or disability or by the participant for good reason and (ii) termination of employment by Organovo for reasons other than cause, death or disability or by the participant for good reason within six months before or within 12 months after a change in control. Organovo’s executive officers, including Taylor Crouch, Organovo’s Chief Executive Officer, who also serves on Organovo’s board of directors, Craig Kussman, Organovo’s Chief Financial Officer and Jennifer Bush, Organovo’s general counsel and corporate secretary, are each parties to a participation agreement under the Organovo Severance Plan and are contractually entitled to severance payments, including a cash severance payment equal to a multiple of each person’s base salary (2.0 times the base salary for Messrs. Crouch and Kussman and 1.0 times the base salary for Ms. Bush) paid in a lump sum, plus a target bonus for the fiscal year in which the termination occurs, health benefit continuation (up to 18 months for Messrs. Crouch and Kussman, and 12 months for Ms. Bush), and outplacement assistance. In addition, Organovo’s executive officers are also entitled to full accelerated vesting of all outstanding equity grants and a one-year time period to exercise any stock options or stock appreciation rights.

Based on the terms of their respective participation agreements, Organovo’s current executive officers will be entitled to receive a total value of approximately $3.06 million (collectively, not individually) in connection with the consummation of the Merger and the associated termination of their employment from Organovo, not including the value associated with the acceleration of their outstanding equity awards. Such compensation is the subject of Proposal No. 3.

Additionally, pursuant to the terms of the Merger Agreement, Carolyn Beaver and Mark Kessel, who are currently directors of Organovo, will continue as directors of the combined organization after the Closing and will be due certain compensation as non-employee directors.

As of December 31, 2019, the directors and executive officers of Organovo owned, in the aggregate, less than 1% of the outstanding voting shares of Organovo common stock. Each of Organovo’s officers and

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directors have entered into support agreements and lock-up agreements in connection with the Merger. The support agreements and lock-up agreements are discussed in greater detail in the section titled “Agreements Related to the Merger” in this proxy statement/prospectus/information statement.

The Organovo board of directors and special committee were aware of these interests and considered them, among other matters, in the decision to approve the Merger Agreement. For more information, please see the section titled “The Merger — Interests of the Organovo Directors and Executive Officers in the Merger” in this proxy statement/prospectus/information statement.

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Abstentions will be counted towards the quorum requirement. If there is no quorum, the chair of the meeting or the holders of a majority of shares present and entitled to vote at the meeting in person or represented by proxy may adjourn the Organovo special meeting to another date.

If you are an Organovo stockholder, you may provide your proxy instructions in one of two different ways. First, you can mail your signed proxy card in the enclosed return envelope. You may also provide your proxy instructions via the Internet by following the instructions on your proxy card or voting instruction

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form. Please provide your proxy instructions only once, unless you are revoking a previously delivered proxy instruction, and as soon as possible so that your shares can be voted at the special meeting of Organovo stockholders.

If you are a Tarveda stockholder, you may execute and return your written consent to Tarveda in accordance with the instructions provided.

If your shares of Organovo common stock are held in a brokerage account or by another nominee, you are considered the beneficial owner of shares held in “street name,” and the proxy materials are being forwarded to you by your broker or other nominee together with a voting instruction card. As the beneficial owner, you are also invited to attend the Organovo special meeting. Because a beneficial owner is not the stockholder of record, you may not vote these shares in person at the Organovo special meeting unless you obtain a proxy from the broker, trustee or nominee that holds your shares, giving you the right to vote the shares at the meeting.

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Organovo has engaged D.F. King & Co., Inc. to assist in the solicitation of proxies and provide related advice and informational support, for a services fee and the reimbursement of customary disbursements, which are not expected to exceed $0.2 million in total.

If you are a Tarveda stockholder, and would like additional copies, without charge, of this proxy statement/prospectus/information statement or if you have questions about the Merger, including the procedures for voting your shares, you should contact:

Tarveda Therapeutics, Inc.

134 Coolidge Avenue

Watertown, MA 02472

Tel: (617) 923-4100

Fax: (617) 923-4101

Attn: Secretary

Secretary@tarvedatx.com

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SELECTED HISTORICAL AND UNAUDITED PRO FORMA

COMBINED FINANCIAL DATA

The following tables present summary historical financial data for Organovo and Tarveda, summary unaudited pro forma combined financial data for Organovo and Tarveda, and comparative historical and unaudited pro forma per share data for Organovo and Tarveda. The following information does not give effect to the proposed Organovo Reverse Stock Split. See “Incorporation of Certain Information by Reference” for instructions on how to obtain the information that has been incorporated by reference.

Selected Historical Consolidated Financial Data of Organovo

The following tables summarize Organovo’s consolidated financial data. The information set forth below is only a summary that you should read together with the historical audited consolidated statements of Organovo for the fiscal years ended March 31, 2019 and 2018 and the unaudited interim condensed consolidated financial statements for the nine months period ended December 31, 2019 and 2018 and the related notes, as well as the sections titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Organovo’s annual report on Form 10-K for the year ended March 31, 2019 and quarterly report on Form 10-Q for the nine months ended December 31, 2019 that Organovo previously filed with the SEC and that are incorporated by reference into this proxy statement/prospectus/information statement. In the opinion of Organovo’s management, the unaudited consolidated interim financial data reflects all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of the financial information in those statements. Organovo’s historical results are not necessarily indicative of results that should be expected in any future period.

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Selected Historical Financial Data of Tarveda

The following tables summarize Tarveda’s financial data. The statements of operations and comprehensive loss data for the year ended March 31, 2019 and the balance sheet data as of March 31, 2019 have been derived from Tarveda’s audited financial statements appearing elsewhere in this proxy statement/prospectus/information statement. The statement of operations and comprehensive loss data for the nine months ended December 31, 2019 and the balance sheet data as of December 31, 2019 have been derived from Tarveda’s unaudited financial statements appearing elsewhere in this proxy statement/prospectus/information statement. The unaudited financial statements of Tarveda have been prepared on the same basis as the audited financial statements of Tarveda. In the opinion of Tarveda’s management, the unaudited interim financial data reflects all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of the financial information in those statements. The following selected financial data should be read together with “Tarveda Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Tarveda’s financial statements and the related notes appearing elsewhere in this proxy statement/prospectus/information statement. Tarveda’s historical results are not necessarily indicative of results that should be expected in any future period.

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Selected Unaudited Pro Forma Combined Financial Data of Organovo and Tarveda

The following unaudited pro forma combined financial information gives effect to the Merger but does not give effect to the proposed Organovo Reverse Stock Split because the proposed reverse stock split is a range and is not final.

In the unaudited pro forma combined financial statements, the Merger has been accounted for as a reverse recapitalization under U.S. GAAP because the primary assets of Organovo at the Effective Date are expected to be primarily cash and short-term investments. Tarveda was determined to be the accounting acquirer based upon the terms of the Merger and other factors including: (1) Tarveda stockholders will own a substantial majority of the voting rights of the combined organization; (2) Tarveda will designate a majority (six of eight) of the initial members of the board of directors of the combined organization; and (3) Tarveda’s senior management will hold all key positions in senior management of the combined organization.

The unaudited pro forma combined balance sheet data as of December 31, 2019 gives effect to the Merger as if it took place on December 31, 2019. The unaudited pro forma combined statements of operations and comprehensive loss data for the year ended March 31, 2019 and the nine months ended December 31, 2019 gives effect to the Merger as if it took place on April 1, 2018. The historical financial statements of Organovo and Tarveda have been adjusted to give pro forma effect to events that are (1) directly attributable to the Merger, (2) factually supportable, and (3) with respect to the unaudited pro forma combined statements of operations, expected to have a continuing impact on the combined results of operations of the combined organization. The adjustments presented on the unaudited pro forma condensed combined financial statements have been identified and presented to provide relevant information necessary for an accurate understanding of the combined organization upon consummation of the Merger.

The unaudited pro forma condensed combined financial information is based on assumptions and adjustments that are described in the accompanying notes. The unaudited pro forma condensed combined financial information is for illustrative purposes only. The financial results may have been different had the companies always been combined. The unaudited pro forma condensed combined financial information should not be relied upon as being indicative of the historical results that would have been achieved had the companies always been combined or the future results that the combined organization will experience. The actual amounts recorded as of the completion of the Merger may differ materially from the information presented in these unaudited pro forma combined financial statements as a result of the amount of cash used by Organovo’s operations between the signing of the Merger Agreement and the Closing, the timing of Closing of the Merger, and other changes in Organovo’s assets and liabilities that occur prior to the completion of the Merger.

The unaudited pro forma combined financial statements, including the notes thereto, should be read in conjunction with the separate historical consolidated financial statements of Organovo and Tarveda and the sections titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the

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documents that are incorporated by reference in this proxy statement/prospectus/information statement and the section of this proxy statement/prospectus/information statement titled “Tarveda Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Organovo’s historical audited consolidated financial statements for the year ended March 31, 2019 and unaudited condensed consolidated financial statements for the nine months ended December 31, 2019 are incorporated by reference in this proxy statement/prospectus/information statement. Tarveda’s historical audited financial statements for the year ended March 31, 2019 and unaudited financial statements for the nine months ended December 31, 2019 appear elsewhere in this proxy statement/prospectus/information statement.

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Comparative Historical and Unaudited Pro Forma Per Share Data

The information below reflects the historical per share information for Organovo and Tarveda and the unaudited pro forma per share information of the combined organization as if Organovo and Tarveda had been combined as of or for the periods presented.

The pro forma amounts in the tables below have been derived from the unaudited pro forma combined financial information included in the section titled “Unaudited Pro Forma Combined Financial Statements” of this proxy statement/prospectus/information statement. The pro forma amounts are presented for illustrative purposes only and are not necessarily indicative of what the financial position, results of operations or per share information of the combined organization would have been had Organovo and Tarveda been combined as of or for the periods presented.

The tables below should be read in conjunction with the consolidated financial statements and the related notes of Organovo incorporated by reference in this proxy statement/prospectus/information statement and the financial statements and the related notes of Tarveda appearing elsewhere in this proxy statement/prospectus/information statement.

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MARKET PRICE AND DIVIDEND INFORMATION

Organovo Common Stock

Organovo common stock is listed on The Nasdaq Capital Market under the symbol “ONVO.” The closing price of Organovo common stock on                , 2020, as reported on The Nasdaq Capital Market, was $                per share.

Because the market price of Organovo common stock is subject to fluctuation, the market value of the shares of Organovo common stock that Tarveda stockholders will be entitled to receive in the Merger may increase or decrease.

Assuming approval of Organovo Proposal Nos. 1 and 2 and successful application for initial listing with The Nasdaq Capital Market, following the consummation of the Merger, Organovo common stock will be listed on The Nasdaq Capital Market and will trade under Organovo’s new name, “Tarveda Therapeutics, Inc.” and new trading symbol, “TVDA.”                

As of                , 2020, the record date for the Organovo special meeting, Organovo had approximately                  holders of record of its common stock. As of                , 2020, Tarveda had                holders of record of its common stock and preferred stock. For detailed information regarding the beneficial ownership of certain stockholders of Organovo upon consummation of the Merger, see the section titled “Principal Stockholders of Combined Organization” in this proxy statement/prospectus/information statement.

Dividends

Organovo

Organovo has never declared or paid any cash dividends on its capital stock, and it does not currently anticipate declaring or paying cash dividends on its capital stock in the foreseeable future. Organovo intends to retain all future earnings, if any, to finance the operation and expansion of Organovo’s business. Any future determination relating to Organovo’s dividend policy will be made at the discretion of Organovo’s board of directors and will depend on a number of factors, including future earnings, capital requirements, financial conditions, future prospects, contractual restrictions and covenants and other factors that Organovo’s board of directors may deem relevant.

Tarveda

Tarveda has never paid or declared any cash dividends on its common stock. Regardless of whether the Merger occurs or does not occur, Tarveda does not anticipate paying any cash dividends on its common stock in the foreseeable future, and Tarveda intends to retain all available funds and any future earnings to fund the development and expansion of its business. In addition, Tarveda’s ability to pay dividends is limited by covenants in Tarveda’s loan agreement. Following the Merger, Tarveda will be a holding company, and its ability to pay dividends will be dependent upon its subsidiaries’ ability to make distributions, which may be restricted by covenants in Tarveda’s loan agreement or any future contractual obligations. Any future determination to pay dividends will be at the discretion of Tarveda board of directors and will depend upon a number of factors, including its results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors the board of directors of Tarveda deems relevant.

Holders of Tarveda’s outstanding Series 1 Preferred Stock are entitled to receive cumulative, non-compounding dividends from the date of issuance thereof at an annual rate of $0.06606 per share of Series 1 Preferred Stock. Such dividends, as accrued and accumulated, increase the ratio into which shares of Tarveda’s preferred stock convert into Tarveda common stock upon conversion immediately prior to the Merger. Dividends payable to holders of Tarveda’s Series 1 Preferred Stock will continue to accrue until the Series 1 Preferred Stock is converted into Tarveda common stock immediately prior to the Merger.

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RISK FACTORS

The combined organization will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained in this proxy statement/prospectus/information statement, you should carefully consider the material risks described below and those described in the section of this proxy statement/prospectus/information statement titled “Forward-Looking Statements” before deciding how to vote your shares of stock. In addition, you should read and consider the risks associated with the business of Organovo because these risks may also affect the combined organization — these risks can be found in Organovo’s Annual Report on Form 10-K, as updated by subsequent Quarterly Reports on Form 10-Q, all of which are filed with the SEC and incorporated by reference into this proxy statement/prospectus/information statement. You should also read and consider the other information in this proxy statement/prospectus/information statement and the other documents incorporated by reference into this proxy statement/prospectus/information statement. Please see the sections titled “Where You Can Find More Information” and “Incorporation of Certain Documents By Reference” in this proxy statement/prospectus/information statement.

Risks Related to the Merger

The Exchange Ratio is not adjustable based on the market price of Organovo common stock so the Merger consideration at the Closing may have a greater or lesser value than at the time the Merger Agreement was signed.

The estimated Exchange Ratio calculation contained herein is based upon Organovo’s and Tarveda’s capitalization immediately prior to the date of this proxy statement/prospectus/information statement, and will be adjusted based on the amount of Organovo net cash, Organovo and Tarveda debt and changes in the capitalization of Organovo or Tarveda prior to the Closing, not taking into account the Organovo Reverse Stock Split, as described in the section titled “The Merger — Merger Consideration and Adjustment” of this proxy statement/prospectus/information statement. Any changes in the market price of Organovo common stock before the completion of the Merger will not affect the number of shares Tarveda securityholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the Merger the market price of Organovo common stock declines from the market price on the date of the Merger Agreement, then Tarveda securityholders could receive merger consideration with substantially lower value. Similarly, if before the completion of the Merger the market price of Organovo common stock increases from the market price on the date of the Merger Agreement, then, Tarveda securityholders could receive merger consideration with considerably more value for their shares of Tarveda capital stock than the parties had negotiated for in the establishment of the Exchange Ratio. The Merger Agreement does not include a price-based termination right. Because the Exchange Ratio does not adjust as a result of changes in the value of Organovo common stock, for each one percentage point that the market value of Organovo common stock rises or declines, there is a corresponding one percentage point rise or decline, respectively, in the value of the total merger consideration issued to Tarveda securityholders.

Failure to complete the Merger may result in Organovo or Tarveda paying a termination fee or reimbursing expenses to the other party and could harm the common stock price of Organovo and future business and operations of each company.

If the Merger is not completed, Organovo and Tarveda are subject to the following risks:

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In addition, if the Merger Agreement is terminated and the Organovo board of directors or the Tarveda board of directors determines to seek another business combination, there can be no assurance that either Organovo or Tarveda will be able to find a partner willing to provide equivalent or more attractive consideration than the consideration to be provided by each party in the Merger on a timely basis, or at all.

The Merger may be completed even though material adverse changes may result from the announcement of the Merger, industry-wide changes and other causes.

In general, either Organovo or Tarveda can refuse to complete the Merger if there is a material adverse change affecting the other party between December 13, 2019, the date of the Merger Agreement, and the Closing. However, certain types of changes do not permit either party to refuse to complete the Merger, even if such change could be said to have a material adverse effect on Organovo or Tarveda, including:

If adverse changes occur and Organovo and Tarveda still complete the Merger, the combined organization stock price may suffer. This in turn may reduce the value of the Merger to the stockholders of Organovo, Tarveda or both.

Some Organovo and Tarveda officers and directors have interests in the Merger that are different from yours and that may influence them to support or approve the Merger without regard to your interests.

Certain officers and directors of Organovo and Tarveda participate in arrangements that provide them with interests in the Merger that are different from yours, including, among others, the continued service as an officer or director of the combined organization, severance benefits, the acceleration of stock option vesting, continued indemnification and the potential ability to sell an increased number of shares of common stock of the combined organization in accordance with Rule 144 under the Securities Act of 1933, as amended (the “Securities Act”). For example, in November 2015 Organovo entered into a Severance and Change in Control Plan Participation Agreement with each of its executive officers and certain key employees pursuant to the Organovo Severance Plan, which was approved by Organovo’s compensation committee. The Organovo Severance Plan establishes the amount of severance payments and benefits available in the event of a (i) termination of employment by

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Organovo for reasons other than cause, death or disability or by the participant for good reason and (ii) termination of employment by Organovo for reasons other than cause, death or disability or by the participant for good reason within six months before or within 12 months after a change in control. Organovo’s executive officers, including Taylor Crouch, Organovo’s Chief Executive Officer, who also serves on Organovo’s board of directors, are each parties to a participation agreement under the Organovo Severance Plan and are contractually entitled to severance payments, including a cash severance payment equal to a multiple of the employee’s base salary, paid in a lump sum, plus a target bonus for the fiscal year in which the termination occurs, health benefit continuation for up to 18 months, and outplacement assistance. In addition, Organovo’s executive officers are also entitled to full accelerated vesting of all outstanding equity grants and a one-year time period to exercise any stock options or stock appreciation rights.

Based on the terms of their respective participation agreements, Organovo’s executive officers will be entitled to receive a total value of approximately $3.06 million (collectively, not individually) in connection with the consummation of the Merger and the associated termination of their employment from Organovo, not including the value associated with the acceleration of their outstanding equity awards.

Additionally, the directors and officers of Organovo are parties to the Organovo support agreements and lock-up agreements with Organovo and Tarveda.

The Organovo board of directors and special committee was aware of these interests and considered them, among other matters, in the decision to approve the Merger Agreement. For more information, please see the section titled “The Merger — Interests of the Organovo Directors and Executive Officers in the Merger” of this proxy statement/prospectus/information statement.

All of Tarveda’s executive officers and certain of its directors have options, subject to vesting, to purchase shares of Tarveda common stock which shall be converted into and become options to purchase shares of Organovo common stock, Tarveda’s directors and executive officers are expected to become directors and executive officers of Organovo upon the consummation of the Merger and all of Tarveda’s directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement. In addition, certain of Tarveda’s executive officers and directors and affiliates of Tarveda’s directors currently hold shares of Tarveda common stock and preferred stock. The shares of Tarveda preferred stock will be converted into shares of Tarveda common stock prior to the consummation of the Merger. In addition and for example, certain of Tarveda’s officers received grants of shares of Tarveda common stock prior to the execution of the Merger Agreement, certain of Tarveda’s directors and executive officers have options, subject to vesting, to purchase shares of Tarveda common stock, which shall be converted into and become options to purchase shares of Organovo common stock, certain of Tarveda’s directors and executive officers are expected to become directors and executive officers of Organovo upon the closing of the merger and all of Tarveda’s directors and executive officers are entitled to certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement.

These interests, among others, may influence the officers and directors of Organovo and Tarveda to support or approve the Merger. For more information concerning the interests of Organovo and Tarveda executive officers and directors, see the sections titled “The Merger — Interests of the Organovo Directors and Executive Officers in the Merger” and “The Merger — Interests of the Tarveda Directors and Executive Officers in the Merger” in this proxy statement/prospectus/information statement.

The market price of the combined organization’s common stock following the Merger may decline as a result of the Merger.

The market price of Organovo common stock may decline as a result of the Merger for a number of reasons including if:

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Organovo and Tarveda stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger.

If the combined organization is unable to realize the full strategic and financial benefits currently anticipated from the Merger, Organovo and Tarveda stockholders will have experienced substantial dilution of their ownership interests in their respective companies without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the combined organization is able to realize only part of the strategic and financial benefits currently anticipated from the Merger.

During the pendency of the Merger, Organovo and Tarveda may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect their respective businesses.

Covenants in the Merger Agreement impede the ability of Organovo and Tarveda to make acquisitions, subject to certain exceptions relating to fiduciaries duties, as set forth below, or complete other transactions that are not in the ordinary course of business, subject to certain exceptions, pending completion of the Merger. As a result, if the Merger is not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Merger Agreement is in effect, each party is generally prohibited from, among other things, soliciting, initiating, knowingly encouraging or entering into certain extraordinary transactions, such as a merger, sale of assets or other business combination outside the ordinary course of business, with any third party. Any such transactions could be favorable to such party’s stockholders.

Certain provisions of the Merger Agreement may discourage third parties from submitting alternative takeover proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement.

The terms of the Merger Agreement prohibit each of Organovo and Tarveda from soliciting alternative takeover proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances when, among other things, such party’s board of directors determines in good faith that an unsolicited alternative takeover proposal is or is reasonably likely to result in a superior takeover proposal and that failure to cooperate with the proponent of the proposal is a breach of the board’s fiduciary duties. In addition, if Organovo or Tarveda terminate the Merger Agreement under certain circumstances, including terminating because of a decision of a board of directors to recommend a superior proposal, Organovo or Tarveda would be required to pay to the other party a termination fee equal to $1.0 million (or $2.0 million in certain circumstances) and the third-party expenses incurred by the other party, up to a maximum of $0.3 million (or $0.5 million in certain circumstances). This termination fee may discourage third parties from submitting alternative takeover proposals to Organovo or Tarveda or their stockholders, and may cause the respective boards of directors to be less inclined to recommend an alternative proposal.

Because the lack of a public market for Tarveda shares makes it difficult to evaluate the fairness of the Merger, the stockholders of Tarveda may receive consideration in the Merger that is less than the fair market value of the Tarveda shares.

The outstanding capital stock of Tarveda is privately held and is not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair market value of Tarveda. Because the percentage of Organovo equity to be issued to Tarveda stockholders was determined based on negotiations

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between the parties, it is possible that the value of the Organovo common stock to be received by Tarveda stockholders will be less than the fair market value of Tarveda, or Organovo may pay more than the aggregate fair market value for Tarveda.

Because the lack of a public market for Tarveda shares makes it difficult to evaluate the fairness of the Merger, the stockholders of Tarveda may receive consideration in the Merger that is less than the fair market value of the Tarveda shares.

The outstanding capital stock of Tarveda is privately held and is not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair market value of Tarveda. Because the percentage of Organovo equity to be issued to Tarveda stockholders was determined based on negotiations between the parties, it is possible that the value of the Organovo common stock to be received by Tarveda stockholders will be less than the fair market value of Tarveda, or Organovo may pay more than the aggregate fair market value for Tarveda.

If the conditions to the Merger are not met, the Merger will not occur.

Even if the Merger is approved by the stockholders of Organovo and Tarveda, specified conditions must be satisfied or waived to complete the Merger. These conditions are set forth in the Merger Agreement and described in the section titled “The Merger Agreement — Conditions to the Completion of the Merger” in this proxy statement/prospectus/information statement. Organovo and Tarveda cannot assure you that all of the conditions will be satisfied. If the conditions are not satisfied or waived, the Merger will not occur or will be delayed, and Organovo and Tarveda each may lose some or all of the intended benefits of the Merger.

If the Merger does not qualify as a “reorganization” for U.S. federal income tax purposes, U.S. Holders of Tarveda common stock will be required to recognize gain or loss for U.S. federal income tax purposes upon the exchange of their Tarveda common stock for Organovo common stock in the Merger.

The U.S. federal income tax consequences of the Merger to U.S. Holders (as defined in the section titled “The Merger — Certain Material U.S. Federal Income Tax Consequences of the Merger”) will depend on whether the Merger qualifies as a “reorganization” for U.S. federal income tax purposes. Organovo’s and Tarveda’s obligations to effect the Merger are subject to the satisfaction, or waiver, at or prior to the effective time of the Merger, of the condition that each company receive an opinion of counsel (or Organovo’s Replacement Counsel or Tarveda’s Replacement Counsel, in each case, if applicable), dated as of the closing date of the Merger, to the effect that the Merger will qualify as a “reorganization” within the meaning of Section 368(a) of the Code. If, contrary to the opinions from counsel, the Merger fails to qualify as a reorganization within the meaning of Section 368(a) of the Code, a U.S. Holder of Tarveda common stock would recognize gain or loss for U.S. federal income tax purposes on each share of Tarveda common stock surrendered in the Merger for Organovo common stock and any cash received in lieu of a fractional share. For a more complete discussion of the material U.S. federal income tax consequences of the Merger, please carefully review the information set forth in the section titled “The Merger —Certain Material U.S. Federal Income Tax Consequences of the Merger” in this proxy statement/prospectus/information statement.

Risks Related to the Proposed Organovo Reverse Stock Split

The proposed Organovo Reverse Stock Split may not increase the combined organization’s stock price over the long-term.

The principal purpose of the proposed Organovo Reverse Stock Split is to increase the per-share market price of Organovo common stock and provide for sufficient authorized shares of Organovo common stock to issue shares of Organovo common stock in the Merger. It cannot be assured, however, that the proposed Organovo Reverse Stock Split will accomplish the objective of increasing the per-share market price of Organovo common stock for any meaningful period of time. While it is expected that the reduction in the number

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of outstanding shares of Organovo common stock will proportionally increase the market price of Organovo common stock, it cannot be assured that the proposed Organovo Reverse Stock Split will increase the market price of Organovo common stock by a multiple of the proposed Organovo Reverse Stock Split ratio, or result in any permanent or sustained increase in the market price of Organovo common stock, which is dependent upon many factors, including the combined organization’s business and financial performance, general market conditions and prospects for future success. Therefore, while the stock price of the combined organization might meet the continued listing requirements for The Nasdaq Capital Market initially, it cannot be assured that it will continue to do so.

The proposed Organovo Reverse Stock Split may decrease the liquidity of the combined organization’s common stock.

Although the Organovo board of directors believes that the anticipated increase in the market price of the combined organization’s common stock could encourage interest in its common stock and possibly promote greater liquidity for its stockholders, such liquidity could also be adversely affected by the reduced number of shares outstanding after the proposed Organovo Reverse Stock Split. The reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for Organovo common stock.

The proposed Organovo Reverse Stock Split may lead to a decrease in the combined organization’s overall market capitalization.

Should the market price of the combined organization’s common stock decline after the proposed Organovo Reverse Stock Split, the percentage decline may be greater, due to the smaller number of shares outstanding, than it would have been prior to the proposed Organovo Reverse Stock Split. A reverse stock split may be viewed negatively by the market and, consequently, can lead to a decrease in the combined organization’s overall market capitalization. If the per share market price does not increase in proportion to the proposed Organovo Reverse Stock Split ratio, then the value of the combined organization, as measured by its stock capitalization, will be reduced. In some cases, the per-share stock price of companies that have effected reverse stock splits subsequently declined back to pre-reverse split levels, and accordingly, it cannot be assured that the total market value of Organovo common stock will remain the same after the proposed Organovo Reverse Stock Split is effected, or that the proposed Organovo Reverse Stock Split will not have an adverse effect on the stock price of Organovo common stock due to the reduced number of shares outstanding after the proposed Organovo Reverse Stock Split.

Risks Related to Organovo’s Capital Requirements, Finances and Operations if the Merger is not Completed

There is no assurance that the proposed Merger between Organovo and Tarveda will be completed in a timely manner or at all. If the Merger with Tarveda is not consummated, Organovo’s business could suffer materially and its stock price could decline.

The consummation of the Merger between Organovo and Tarveda is subject to a number of closing conditions, including approval by Organovo’s and Tarveda’s respective stockholders and other customary closing conditions. The parties are targeting a Closing of the transaction in the first calendar quarter of 2020, however, there can be no assurance that the Merger will be consummated within this desired timeframe, or at all.

If the Merger between Organovo and Tarveda is not consummated, Organovo may be subject to a number of material risks, and its business and stock price could be adversely affected, as follows:

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If the Merger is not completed, Organovo may be unsuccessful in completing an alternative strategic transaction on terms that are as favorable as the terms of the proposed transaction with Tarveda, or at all, and Organovo may be unable to reestablish a viable operating business.

To date, Organovo has not generated significant revenue from product sales, and its assets currently consist primarily of cash, cash equivalents and marketable securities, its intellectual property portfolio, license and collaboration agreements, its remaining assets, its listing on The Nasdaq Capital Market and the Merger Agreement with Tarveda. While Organovo has entered into the Merger Agreement with Tarveda, the consummation of the Merger with Tarveda may be delayed or may not occur at all. If the Merger is not completed, the Organovo board of directors may elect to pursue an alternative strategic transaction similar to the proposed Merger with Tarveda. Attempting to complete an alternative transaction will be costly and time consuming. If the Merger with Tarveda is not completed and the Organovo board of directors determines to pursue an alternative transaction, the terms of any such alternative transaction may not be as favorable to Organovo and its stockholders as the terms of the Merger with Tarveda, and Organovo can make no assurances that such an alternative transaction would occur at all. Further, if the Merger with Tarveda is not completed, given the level of investment and time that would be required to redesign its liver tissue product or pursue the development of products and services pursuant to its collaboration agreements, it is unlikely that Organovo would be able to obtain the funding required to recommence its product development activities on terms favorable to its stockholders, or at all.

If the Merger is not completed, Organovo’s board of directors may decide to pursue a dissolution and liquidation of Organovo. In such an event, the amount of cash available for distribution to its stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.

There can be no assurance that the Merger will be completed. If the Merger is not completed, the Organovo board of directors may decide to pursue a dissolution and liquidation of Organovo. In such an event, the amount of cash available for distribution to its stockholders will depend heavily on the timing of such decision, as with the passage of time the amount of cash available for distribution will be reduced as Organovo continues to fund its operations. In addition, if Organovo’s board of directors were to approve and recommend, and its stockholders were to approve, a dissolution and liquidation of Organovo, Organovo would be required under Delaware corporate law to pay its outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to its stockholders. As a result of this requirement, a portion of Organovo’s remaining cash assets may need to be reserved pending the resolution of such obligations. In addition, Organovo may be subject to litigation or other claims related to a dissolution and liquidation of Organovo. If a dissolution and liquidation were pursued, Organovo’s board of directors, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of Organovo common stock could lose all or a significant portion of their investment in the event of Organovo’s liquidation, dissolution or winding up.

Organovo may be unable to continue as a going concern if the Merger is not completed.

Organovo has had recurring losses from operations since inception and will likely not generate meaningful revenue for the foreseeable future. Organovo believes that its existing cash, cash equivalents and marketable securities and interest thereon will be sufficient to fund its projected operating requirements under its current operating plan. However, if the Merger is not completed and Organovo’s operating plans change and its

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projected operating requirements increase, Organovo may be unable to continue as a going concern. In this event, the perception that Organovo may not be able to continue as a going concern may have an adverse impact on its business due to concerns about its ability to meet its future contractual obligations or pursue additional strategic transactions. Further, if Organovo is unable to continue as a going concern, Organovo may have to liquidate its assets, and the values it receives for its assets in liquidation and dissolution could be significantly lower than the values reflected in its financial statements and an investor could lose all or part of its investment in Organovo.

If Organovo were to continue to advance its research and development activities and pursue development of any of its pipeline products, it would require substantial additional funding. Raising additional capital would cause dilution to its existing stockholders, and may restrict its operations or require it to relinquish rights to its technologies or to a product candidate.

Organovo currently does not have any committed external source of funds and does not expect to generate any meaningful revenue in the foreseeable future. Organovo believes that its existing cash, cash equivalents and marketable securities and interest thereon will be sufficient to fund its projected operating requirements under its current operating plan. Organovo has based its estimates on assumptions that may prove to be wrong, and it may use its available capital resources sooner than it currently expects if its operating plans change. If the Merger is not completed and Organovo’s current operating plans change and it determines to pursue further research and development activities, it will require substantial additional funding to operate, and would expect to finance these cash needs through a combination of equity offerings, debt financings, government or other third-party funding and licensing or collaboration arrangements.

To the extent that Organovo raises additional capital through the sale of equity or convertible debt, the ownership interests of its stockholders will be diluted. In addition, the terms of any equity or convertible debt it agrees to issue may include liquidation or other preferences that adversely affect the rights of Organovo’s stockholders. Convertible debt financing, if available, may involve agreements that include covenants limiting or restricting Organovo’s ability to take specific actions, such as incurring additional debt, making capital expenditures, and declaring dividends, and may impose limitations on its ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact its ability to conduct its business.

Additional funds may not be available when Organovo needs them on terms that are acceptable to Organovo, or at all. If adequate funds are not available to Organovo on a timely basis, it may be required to curtail or cease its operations.

If the Merger is not completed, raising additional funding through debt or equity financing would be difficult or not successful at all, would be dilutive and may cause the market price of Orgnanovo’s common stock to decline further.

If the Merger is not completed, raising additional funding through debt or equity financing is likely to be difficult or unavailable altogether given the early stage of Organovo’s therapeutic candidates. To the extent that Organovo raises additional capital through the sale of equity or convertible debt securities, the issuance of those securities would result in substantial dilution for Organovo’s current stockholders and the terms may include liquidation or other preferences that adversely affect the rights of its current stockholders. Furthermore, the issuance of additional securities, whether equity or debt, by Organovo, or the possibility of such issuance, may cause the market price of its common stock to decline further and existing stockholders may not agree with its financing plans or the terms of such financings.

The issuance of shares of Organovo’s common stock to Tarveda’s stockholders in the Merger will dilute substantially the voting power of Organovo’s current stockholders.

If the Merger is completed, each outstanding share of Tarveda capital stock will be converted into the right to receive approximately 0.1311 shares of Organovo common stock, subject to adjustment to account for the

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proposed Organovo Reverse Stock Split. Immediately following the Merger, Organovo’s stockholders and optionholders are expected to own, or hold rights to acquire, approximately 25% of the common stock of Organovo on a fully diluted basis as defined in the Merger Agreement, and Tarveda’s stockholders, optionholders and warrantholders are expected to own, or hold rights to acquire, approximately 75% of the common stock of Organovo on a fully diluted basis as defined in the Merger Agreement. Accordingly, the issuance of shares of Organovo’s common stock to Tarveda’s stockholders in the Merger will reduce significantly the relative voting power of each share of Organovo’s common stock held by its current stockholders. Consequently, Organovo’s stockholders as a group will have significantly less influence over the management and polices of the combined organization after the Merger than prior to the Merger.

Organovo has incurred and will continue to incur significant transaction costs in connection with the Merger.

Organovo has incurred and will continue to incur significant transaction costs in connection with the Merger. Organovo estimates that it will incur aggregate direct transaction costs of approximately $3.9 million associated with the Merger and approximately $0.3 million for its portion of shared transaction expenses, as well as additional costs associated with the commencement of the combined organization’s operation as a public company, which cannot be estimated accurately at this time.

Organovo’s ability to use net operating loss (“NOL”) carryforwards and other tax attributes may be limited in connection with the Merger and other ownership changes.

Organovo has incurred substantial losses during its history and does not expect to become profitable in the near future, and Organovo may never achieve profitability. To the extent that Organovo continues to generate taxable losses, unused losses will carry forward to offset future taxable income, if any, until such unused losses expire (if at all). At March 31, 2019, Organovo had federal and state NOL carryforwards of approximately $170.3 million and $49.2 million, respectively. Such federal and state NOL carryforwards will begin to expire in 2028, unless previously utilized. At March 31, 2019, Organovo had federal and state research and development credit carryforwards of approximately $4.0 million and $3.6 million, respectively. The federal research and development credit carryforwards will begin expiring in 2028, unless previously utilized.

Under the Tax Act, federal NOLs generated in taxable years ending after December 31, 2017, may be carried forward indefinitely but federal NOLs generated in taxable years beginning after December 31, 2017 may only be used to offset 80% of Organovo’s taxable income annually. Organovo’s NOL carryforwards are subject to review and possible adjustment by the U.S. Internal Revenue Service (the “IRS”), and state tax authorities. Under Sections 382 and 383 of the Code, Organovo’s federal NOL and research and development tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50 percentage points. Organovo’s ability to utilize its NOL carryforwards and other tax attributes to offset future taxable income or tax liabilities may be limited as a result of ownership changes, including in connection with the Merger. Similar rules may apply under state tax laws. Organovo has not yet determined the amount of the cumulative change in its ownership resulting from the Merger or other transactions, or any resulting limitations on its ability to utilize its NOL carryforwards and other tax attributes. If Organovo earns taxable income, such limitations could result in increased future tax liability to Organovo and its future cash flows could be adversely affected. Organovo has recorded a full valuation allowance related to its NOLs and other deferred tax assets due to the uncertainty of the ultimate realization of the future benefits of those assets.

Risks Related to Tarveda

Tarveda has incurred significant net losses since inception and anticipates that it will continue to incur substantial net losses for the foreseeable future and may never achieve or maintain profitability.

Since inception in 2016, Tarveda has incurred significant net losses and has never generated any revenue from product sales. Tarveda’s net loss was $16.3 million and $16.5 million for the nine months ended

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December 31, 2019 and 2018, and $22.1 million and $19.0 million for years ended March 31, 2019 and 2018, respectively. As of December 31, 2019, Tarveda had an accumulated deficit of $121.5 million. Although Tarveda completed a private placement of its securities and recapitalization in December 2019 raising gross proceeds of $13.6 million before deducting estimated offering expenses, Tarveda expects to continue to incur significant expenses and increasing net losses for the foreseeable future. Since inception, Tarveda has devoted substantially all of its efforts to identifying, researching and conducting preclinical and clinical activities for its product candidates, acquiring and developing its Pentarin, including its Heat Shock Protein 90 (“HSP90”) binding miniature drug conjugate platforms and know-how to develop miniature drug conjugates, organizing and staffing the company, business planning, raising capital and establishing its intellectual property portfolio. To date, Tarveda has never obtained regulatory approval for, or commercialized, any products. It could be several years, if ever, before Tarveda has a commercialized product. The net losses Tarveda incurs may fluctuate significantly from quarter to quarter and year to year. Tarveda anticipates that its expenses will increase substantially if, and as, it:

To become and remain profitable, Tarveda must succeed in developing and eventually commercializing products that generate significant revenue. This will require Tarveda to be successful in a range of challenging activities, including completing preclinical studies and clinical trials of its current and future product candidates, obtaining regulatory approval, procuring commercial-scale manufacturing, marketing and selling any products for which it obtains regulatory approval (including through third parties), as well as discovering or acquiring and developing additional product candidates. Tarveda is only in the preliminary stages of most of these activities. Tarveda may never succeed in these activities and, even if it does, may never generate revenue that is sufficient to offset its expenses and achieve profitability.

Because of the numerous risks and uncertainties associated with biopharmaceutical product development, Tarveda is unable to accurately predict the timing or amount of expenses or when, or if, it will be able to achieve profitability. If Tarveda is required by regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in the initiation and completion of its clinical trials or the development of any of its product candidates, its expenses could increase.

Even if Tarveda does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis. Tarveda’s failure to become and remain profitable would decrease the value of the

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company and could impair its ability to raise capital, maintain its research and development efforts, expand its business or continue its operations.

There is substantial doubt about Tarveda’s ability to continue as a going concern.

Tarveda has incurred recurring losses since inception, including net losses of $22.1 million and $19.0 million for the years ended March 31, 2019 and 2018, respectively. In addition, as of March 31, 2019, Tarveda had an accumulated deficit of $105.2 million. Tarveda expects to continue to generate operating losses for the foreseeable future and will need to raise additional capital to finance its future operations. Tarveda’s management has concluded that these matters raise substantial doubt about its ability to continue as a going concern. Tarveda’s financial statements do not include any adjustments that might result from the outcome of this uncertainty. Tarveda’s auditors have included an explanatory paragraph in their audit report for this uncertainty. If Tarveda cannot continue as a viable entity, its securityholders may lose some or all of their investment in Tarveda.

Even after completion of the Merger, Tarveda will require substantial additional funding to finance its operations. If Tarveda is unable to raise capital when needed, it could be forced to delay, reduce or terminate certain of its development programs or other operations.

As of December 31, 2019, Tarveda had cash and cash equivalents of $15.5 million. Tarveda believes that its existing cash and cash equivalents as of December 31, 2019, will be sufficient to fund its operating expenses, capital expenditure requirements and debt service payments through September 2020 as a stand-alone private company. Upon completion of the Merger, and after taking into account the expected cash that Organovo will have on its balance sheet at the effective time of the Merger, Tarveda expects to have sufficient cash to fund the combined organization’s current operating plans through at least the 18 months following the anticipated effective time of the Merger. However, the combined organization’s operating plans may change as a result of many factors currently unknown to Tarveda, and the combined organization may need to seek additional funds sooner than planned. Tarveda expects to finance its cash needs through public or private equity or debt financings, third-party (including government) funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches. The combined organization’s future capital requirements will depend on many factors, including:

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Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and Tarveda may never generate the necessary data or results required to obtain regulatory approval and achieve product sales. In addition, Tarveda’s product candidates, if approved, may not achieve commercial success. Tarveda’s commercial revenue, if any, will be derived from sales of products that it does not expect to be commercially available for several years, if at all. Accordingly, Tarveda will need to continue to rely on additional financing to achieve its business objectives. Adequate additional financing may not be available to Tarveda on acceptable terms, or at all. If Tarveda is unable to raise capital when needed or on attractive terms, it could be forced to delay, reduce or altogether terminate its research and development programs or future commercialization efforts, which may adversely affect its business, financial condition, results of operations and prospects. In addition, Tarveda may seek additional capital due to favorable market conditions or strategic considerations even if Tarveda believes it has sufficient funds for its current or future operating plans.

The incurrence of debt may impact Tarveda’s financial position and subject it to additional financial and operating restrictions.

In March 2019, Tarveda entered into a $10.0 million senior secured term loan credit facility with Oxford. Tarveda’s overall leverage and certain covenants and obligations contained in the related documentation could adversely affect its financial health and business and future operations by, among other things:

Furthermore, substantially all of Tarveda’s assets, including its intellectual property, secure the Oxford loan. If an event of default under the Oxford loan occurs and is continuing, Oxford may request the acceleration of the related debt and foreclose on the underlying security interests. While Oxford consented to the entry into the Merger Agreement, Tarveda does not yet have Oxford’s consent to the consummation of the Merger. Oxford may request additional covenants or other concessions from Tarveda in order to consent to the Merger.

The LIBOR calculation method may change and LIBOR is expected to be phased out after 2021.

Interest on the outstanding principal balance of the loans under the Oxford loan is calculated based on one-month LIBOR, plus an applicable margin. On July 27, 2017, the U.K. Financial Conduct Authority (the “FCA”) announced that it will no longer require banks to submit rates for the calculation of LIBOR after 2021. In the meantime, actions by the FCA, other regulators or law enforcement agencies may result in changes to the method by which LIBOR is calculated. At this time, it is not possible to predict the effect of any such changes or any other reforms to LIBOR that may be enacted in the United Kingdom or elsewhere.

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Raising additional capital may cause dilution to Tarveda’s stockholders, restrict its operations or require it to relinquish rights to its product candidates.

Until such time, if ever, as Tarveda can generate substantial product revenue, it expects to finance its cash needs through public or private equity or debt financings, third-party (including government) funding and collaborations and strategic alliances, or any combination of these approaches. To the extent that Tarveda raises additional capital through the sale of equity or convertible debt securities, your ownership interest may be diluted and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Debt and equity financings, if available, may involve agreements that include covenants limiting or restricting Tarveda’s ability to take specific actions, such as redeeming its shares, making investments, incurring additional debt, making capital expenditures, declaring dividends or placing limitations on its ability to acquire, sell or license intellectual property rights. For example, Tarveda’s existing loan with Oxford is secured by a first priority lien on Tarveda’s assets and intellectual property, and requires compliance with certain affirmative and negative covenants.

If Tarveda raises additional capital through future collaborations or strategic alliances, it may have to relinquish valuable rights to its intellectual property, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to Tarveda. If Tarveda is unable to raise additional capital when needed, it may be required to delay, limit, reduce or terminate its product development or future commercialization efforts or grant rights to develop and market product candidates that it would otherwise develop and market ourselves.

Tarveda’s limited operating history may make it difficult for you to evaluate the success of its business to date and to assess its future viability.

Tarveda is a clinical-stage company that spun out its legacy business and renamed itself Tarveda Therapeutics, Inc. in 2016. Since the spinout, Tarveda’s operations have been largely focused on identifying, researching and conducting preclinical and clinical activities of its product candidates, PEN-866 and PEN-221, acquiring and developing its HSP90 binding miniature drug conjugate platform and know-how to develop miniature drug conjugates, organizing and staffing the company, business planning, raising capital and establishing its intellectual property portfolio. As an organization, Tarveda has not yet demonstrated an ability to successfully complete clinical development, obtain regulatory approvals, manufacture a commercial-scale product or conduct sales and marketing activities necessary for successful commercialization or arrange for a third party to conduct these activities on its behalf. Consequently, any predictions about Tarveda’s future success or viability may not be as accurate as they could be if it had a longer operating history.

Tarveda currently has two product candidates in its development pipeline. Tarveda may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving its business objectives, including with respect to its Pentarin platform including its HSP90 binding miniature drug conjugate platform, and product candidates. Tarveda will need to transition at some point from a company with a research and development focus to a company capable of supporting commercial activities. Tarveda may not be successful in such a transition.

Risks Related to the Design and Development of Tarveda’s Drug Candidates

Tarveda is early in its development efforts and its lead drug candidates, PEN-866 and PEN-221 are still in early stage clinical development. Tarveda has not successfully completed late-stage clinical trials or obtained regulatory approval for any drug candidate. Tarveda may never obtain approval for any of its drug candidates or achieve or sustain profitability.

Tarveda currently has no products that are approved for sale. Tarveda is early in its development efforts and has only recently completed enrollment in the Phase 1 portion of the Phase 1/2a trial evaluating PEN-866 in patients with advanced solid tumors. Tarveda’s only other drug candidate in clinical trials, PEN-221 is currently

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being investigated in an ongoing Phase 2a clinical trial in patients with neuroendocrine cancers, including gastrointestinal, neuroendocrine tumors (“GI NET”), pancreatic neuroendocrine tumors and small cell lung cancer. There can be no assurance that PEN-866, PEN-221 or any future drug candidates in development will achieve success in their clinical trials or obtain regulatory approval.

Tarveda’s ability to generate product revenues, which it does not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of PEN-866, PEN-221 or any other future drug candidates in development. The success of its drug candidates, including PEN-886 and PEN-221, will depend on several factors, including the following:

Many of these factors are beyond Tarveda’s control, and it is possible that none of its drug candidates will ever obtain regulatory approval even if Tarveda expends substantial time and resources seeking such approval. If Tarveda does not achieve one or more of these factors in a timely manner or at all, it could experience significant delays or an inability to successfully commercialize its drug candidates, which would materially harm its business. For example, Tarveda’s business could be harmed if results of the clinical trials of PEN-866, PEN-221 or any other drug candidates vary adversely from its expectations.

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Tarveda’s approach to the discovery and development of Pentarin miniature drug conjugates, including using its HSP90 binding miniature drug conjugate platform, is based on novel technologies that are unproven and may not result in marketable products.

The scientific research that forms the basis of Tarveda’s efforts to discover and develop Pentarin miniature drug conjugates, including based on its HSP90 binding miniature drug conjugate platform, is ongoing. Further, the scientific evidence to support the feasibility of developing therapeutic miniature drug conjugates, which it refers to as Pentarin miniature drug conjugates, based on Tarveda’s HSP90 binding miniature drug conjugate platform and other know-how is both preliminary and limited. Tarveda may not be correct in its assumptions about the superiority of its HSP90 binding miniature drug conjugate platform to develop effective therapeutics that bind to HSP90 to deliver anti-cancer payloads. If its HSP90 binding miniature drug conjugate platform is not able to develop Pentarin miniature drug conjugates that are successful in delivering an anti-cancer payload while minimizing toxicity outside the tumor environment, it could have a material and adverse effect on Tarveda’s business, financial condition, results of operations and prospects. Further, if PEN-866, as Tarveda’s first Pentarin developed using the HSP90 binding miniature drug conjugate platform is not successful in achieving its clinical objectives, it would materially and adversely effect Tarveda’s ability to leverage its HSP90 binding miniature drug conjugate platform to develop other Pentarin miniature drug conjugates to deliver other payloads, which would have a material and adverse effect on Tarveda’s business, financial condition, results of operations and prospects.

Drug development involves a lengthy and expensive process. Tarveda may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of PEN-866, PEN-221 or any other drug candidates.

Tarveda currently has only two drug candidates in clinical development, and the risk of failure is high. Tarveda is unable to predict when or if its drug candidates will prove effective or safe in humans or will obtain marketing approval. Before obtaining marketing approval from regulatory authorities for the sale of any drug candidate, Tarveda must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of its drug candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to the outcome. A failure of one or more clinical trials can occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim or preliminary results of a clinical trial do not necessarily predict final results. In particular, the small number of patients in Tarveda’s early clinical trials may make the results of these trials less predictive of the outcome of later clinical trials. For example, the Phase 1 trial for PEN-866 consists of approximately 30 patients of various tumor types and the various cohorts of Phase 2a for PEN-221 range from 10 to 25 patients in each cohort.

Tarveda may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent its ability to obtain marketing approval or commercialize its drug candidates, including:

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Tarveda’s product development costs will increase if it experiences delays in preclinical studies or clinical trials or in obtaining marketing approvals. Tarveda does not know whether any of its planned preclinical studies or clinical trials will begin on a timely basis or at all, will need to be restructured or will be completed on schedule, or at all. For example, the FDA may place a partial or full clinical hold on, any of Tarveda’s clinical trials for a variety of reasons. For example, early in the development of PEN-866 the Phase 1 clinical trial was delayed to resolve a solubility issue. Although rectified, additional issues could arise in the future that could further delay Tarveda’s development of PEN-866.

Significant preclinical or clinical trial delays also could shorten any periods during which Tarveda may have the exclusive right to commercialize its drug candidates or allow Tarveda’s competitors to bring products to market before it does and impair Tarveda’s ability to successfully commercialize its drug candidates and may harm its business and results of operations.

Any delays in the commencement or completion, or termination or suspension, of Tarveda’s ongoing, planned or future clinical trials could result in increased costs to Tarveda, delay or limit its ability to generate revenue and adversely affect its commercial prospects.

Before Tarveda can initiate clinical trials of a drug candidate in any indication, Tarveda must submit the results of preclinical studies to the FDA along with other information, including information about the drug candidate’s chemistry, manufacturing and controls and its proposed clinical trial protocol, as part of an IND or similar regulatory filing.

Before obtaining marketing approval from the FDA for the sale of PEN-866, PEN-221 or any other drug candidate in any indication, Tarveda must conduct extensive clinical studies to demonstrate safety and efficacy. Clinical testing is expensive, time consuming and uncertain as to outcome. In addition, Tarveda expects to rely in part on preclinical, clinical and quality data generated by its contract research organizations (“CROs”) and other third parties for regulatory submissions for its drug candidates. While Tarveda has or will have agreements governing these third parties’ services, Tarveda has limited influence over their actual performance. If these third parties do not make data available to Tarveda, or, if the quality or completeness of the data is not appropriate, or if applicable, make regulatory submissions in a timely manner, in each case pursuant to Tarveda’s agreements with them, its development programs may be significantly delayed and it may need to conduct additional studies or collect additional data independently. In either case, Tarveda’s development costs would increase. To date, Tarveda has submitted two INDs to the FDA: Phase 1/2a clinical trials for both PEN-866 and PEN-221 to evaluate safety and tolerability and one clinical trial authorization (“CTA”) to conduct a Phase 1/2a clinical trial

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of PEN-221 in the United Kingdom. The FDA may require Tarveda to conduct additional preclinical studies for any drug candidate before it allows Tarveda to initiate clinical trials under any IND, which may lead to additional delays and increase the costs of its preclinical development programs.

Any delays in the commencement or completion of Tarveda’s ongoing, planned or future clinical trials could significantly affect its product development costs. Tarveda does not know whether its planned trials will begin on time or at all, or be completed on schedule, if at all. The commencement and completion of clinical trials can be delayed for a number of reasons, including delays related to:

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Tarveda could also encounter delays if a clinical trial is suspended or terminated by it, by the IRBs/ECs of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or its clinical protocols, inspection of the clinical trial operations or trial site by the FDA resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a pharmaceutical, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. In addition, changes in regulatory requirements and policies may occur, and Tarveda may need to amend clinical trial protocols to comply with these changes. Amendments may require Tarveda to resubmit its clinical trial protocols to IRBs/ECs for reexamination, which may impact the costs, timing or successful completion of a clinical trial.

If Tarveda experiences delays in the completion of, or termination of, any clinical trial of PEN-866 or PEN-221 or any other drug candidate, the commercial prospects of such drug candidate will be harmed, and Tarveda’s ability to generate product revenues will be delayed. Moreover, any delays in completing its clinical trials will increase its costs, slow down its development and approval process and jeopardize Tarveda’s ability to commence product sales and generate revenues, which may harm its business, financial condition, results of operations and prospects significantly.

If Tarveda experiences delays or difficulties in enrolling patients in its ongoing or planned clinical trials, its receipt of necessary regulatory approval could be delayed or prevented.

Tarveda may not be able to initiate or continue its ongoing or planned clinical trials for its drug candidates if it is unable to identify and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA. In addition, some of Tarveda’s competitors may have ongoing clinical trials for drug candidates that would treat the same patients as PEN-866 or PEN-221 or any other drug candidates, and patients who would otherwise be eligible for Tarveda’s clinical trials may instead enroll in clinical trials of its competitors’ drug candidates. For example, this is relevant for Tarveda’s development of PEN-866 for the treatment of small cell lung cancer, an indication for which investigational drugs are competing for clinical trial participants. In addition, introduction of new drugs to the market place may have an effect on the number of patients available or timing of the availability of the patients. For example, the introduction of Lutathera has changed the treatment paradigm for neuroendocrine patients in the United States and has an impact on the availability of patients for inclusion in the PEN-221 trial. Patient enrollment is also affected by other factors, including:

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Tarveda’s inability to enroll a sufficient number of patients for its clinical trials would result in significant delays or may require it to abandon one or more clinical trials altogether. Enrollment delays in its clinical trials may result in increased development costs, which would cause the value of the company to decline and limit its ability to obtain additional financing.

Adverse side effects or other safety risks associated with PEN-866, PEN-221 or any other drug candidates could delay or preclude approval, cause Tarveda to suspend or discontinue clinical trials or abandon further development, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.

As is the case with pharmaceuticals generally, and with oncology drugs in particular, Tarveda has observed side effects and adverse events associated with PEN-866 and PEN-221, including but not limited to toxicities consistent with the anti-cancer payloads, including but not limited to fatigue, diarrhea, and neutropenia. While Tarveda has not experienced any serious adverse events to date, they could occur in the future.

Results of Tarveda’s ongoing and planned clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by Tarveda’s drug candidates could result in the delay, suspension or termination of clinical trials by Tarveda or the FDA for a number of reasons. Additionally, due to the high mortality rates of the cancers for which Tarveda is pursuing development and the pretreated nature of many patients in its ongoing and planned clinical trials of PEN-866 and PEN-221 and future drug candidates, a material percentage of patients in these clinical trials may die during a trial. The percentage of patient death, timing of patient death, or cause thereof could impact development of PEN-866, PEN-221 or future drug candidates. If Tarveda elects or is required to delay, suspend or terminate any clinical trial, the commercial prospects of its drug candidates will be harmed and its ability to generate product revenues from its drug candidates will be delayed or eliminated. Serious adverse events observed in clinical trials could hinder or prevent market acceptance of Tarveda’s drug candidates. Any of these occurrences may harm Tarveda’s business, prospects, financial condition and results of operations significantly.

Moreover, if Tarveda’s drug candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, Tarveda may elect to abandon or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial expectations for its drug candidates, if approved. Tarveda may also be required to modify its study plans based on findings in its clinical trials. Many drugs that initially showed promise in early stage testing have later been found to cause side effects that prevented further development. In addition, regulatory authorities may draw different conclusions or require additional testing to confirm these determinations.

It is possible that as Tarveda tests its drug candidates in larger, longer and more extensive clinical trials, including with different dosing regimens, or as the use of its drug candidates becomes more widespread

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following any regulatory approval, illnesses, injuries, discomforts and other adverse events that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by patients. If such side effects become known later in development or upon approval, if any, such findings may harm Tarveda’s business, financial condition, results of operations and prospects significantly.

In addition, if any of Tarveda’s drug candidates receive marketing approval, and it or others later identify undesirable side effects caused by treatment with such drug, a number of potentially significant negative consequences could result, including:

Any of these events could prevent Tarveda from achieving or maintaining market acceptance of its drug candidates, if approved, and could significantly harm its business, financial condition, results of operations and prospects.

Interim, topline and preliminary data from Tarveda’s clinical trials that it announces or publishes from time to time may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, Tarveda may publicly disclose preliminary, interim or topline data from its clinical trials such as Phase 1 dose escalation data for PEN-866 presented at the European Society for Medical Oncology Congress held in Barcelona, Spain in September 2019, or the PEN-221 Phase 1 clinical data presented at the American Society of Clinical Oncology Annual Meeting held in Chicago, Illinois in June, 2018. These interim updates are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. Tarveda also makes assumptions, estimations, calculations and conclusions as part of its analyses of data, and Tarveda may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the topline results that it reports may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data it previously published. As a result, topline data should be viewed with caution until the final data are available. In addition, Tarveda may report interim analyses of only certain endpoints rather than all endpoints. Interim data from clinical trials that Tarveda may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Adverse changes between interim data and final data could significantly harm its business and prospects. Further, additional disclosure of interim data by Tarveda or by its competitors in the future could result in stock price volatility.

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Further, others, including regulatory agencies, may not accept or agree with Tarveda’s assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular drug candidate or product and the company in general. In addition, the information Tarveda chooses to publicly disclose regarding a particular study or clinical trial is typically selected from a more extensive amount of available information. You or others may not agree with what Tarveda determines is the material or otherwise appropriate information to include in its disclosure, and any information Tarveda determines not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular drug, drug candidate or its business. If the preliminary or topline data that Tarveda reports differs from late, final or actual results, or if others, including regulatory authorities, disagree with the conclusions reached, Tarveda’s ability to obtain approval for, and commercialize, PEN-866, PEN-221 or any other drug candidates may be harmed, which could harm its business, financial condition, results of operations and prospects.

The continued development and future commercial success of PEN-221 depends in part on the continued availability of FDA-approved screening diagnostic tests that detect SSTR2 expression; the failure to have a readily available FDA-approved screening diagnostic would negatively impact the commercial success of PEN-221 if the continued availability of such screening tests is not assured.

PEN-221 is being developed to treat tumors that express SSTR2. SSTR2 expression is an indicator of many neuroendocrine tumors, and there are currently available FDA-approved screening diagnostic tests that are used to detect such SSTR2 expression and diagnose the existence of neuroendocrine tumors. Because PEN-221 is being developed for tumors that express SSTR2, the inability to detect or differentiate among various types of cancers, and detect SSTR2 expression, would negatively impact both the continued development of PEN-221, as well as future commercial success. Although there are currently approved screening diagnostics on the market, if the owners of such tests fail to maintain FDA-approval, it could prevent or delay approval of PEN-221. In addition, the commercial success of PEN-221 will be tied to and dependent upon the continued availability of an approved screening diagnostic to detect SSTR2 expression begin available to doctors and patients on reasonable terms in the relevant geographies.

Tarveda may expend its limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Because Tarveda has limited financial and managerial resources, it focuses on research programs and drug candidates that it identifies for specific indications or on specific paradigms including specific payloads. As a result, Tarveda may forego or delay pursuit of opportunities with other drug candidates or for other indications that later prove to have greater commercial potential. Tarveda’s resource allocation decisions may cause it to fail to capitalize on viable commercial products or profitable market opportunities. Tarveda’s spending on current and future research and development programs and drug candidates for specific indications may not yield any commercially viable products. If Tarveda does not accurately evaluate the commercial potential or target market for a particular drug candidate, it may relinquish valuable rights to that drug candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for Tarveda to retain sole development and commercialization rights to such drug candidate.

Tarveda may not be successful in its efforts to design additional potential drug candidates, nor move any that are designed into the clinic.

A key element of Tarveda’s strategy is to apply its knowledge and understanding of conjugating HSP90 binders to appropriate payloads to design miniature drug conjugates that maintain therapeutic properties while remaining miniature in size to enable rapid penetration into solid tumors. The therapeutic design and development activities that Tarveda is conducting may not be successful in developing drug candidates that are

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useful in treating cancer or other diseases. Tarveda’s research programs may initially show promise in identifying potential drug candidates, yet fail to yield drug candidates for clinical development for a number of reasons, including:

Research programs to identify and design new drug candidates require substantial technical, financial and human resources. Tarveda may choose to focus its efforts and resources on a potential drug candidate that ultimately prove to be unsuccessful. If Tarveda is unable to identify and design suitable drug candidates for preclinical and clinical development, it will not be able to obtain revenues from the sale of products in future periods, which likely would result in significant harm to its financial position and adversely impact your investment.

Tarveda may not be able to obtain or maintain orphan drug designation or exclusivity for its drug candidates.

Regulatory authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as “orphan drugs.” Under the Orphan Drug Act, the FDA may designate a drug candidate as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States, or if the disease or condition affects more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making a drug product available in the United States for the type of disease or condition will be recovered from sales of the product.

Orphan drug designation entitles a party to financial incentives, such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. Additionally, if a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity. This means that the FDA may not approve any other applications to market the same drug or biological product for the same indication for seven years, except in certain circumstances, including proving clinical superiority (i.e., another product is safer, more effective or makes a major contribution to patient care) to the product with orphan exclusivity. Competitors, however, may receive approval of different products for the indication for which the orphan product has exclusivity, or obtain approval for the same product but for a different indication than that for which the orphan product has exclusivity. In addition, exclusive marketing rights in the United States may be limited if Tarveda seeks approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective.

Tarveda has obtained orphan drug designation in the United States for use of PEN-866 for treatment of pancreatic cancer, and for use of PEN-221 in treatment of neuroendocrine cancers and separately for the treatment of small cell lung cancer. Tarveda may apply for similar designations in other geographies or for its other drug candidates in the future. Orphan drug status does not ensure that Tarveda will receive marketing exclusivity in a particular market, and Tarveda cannot assure you that any future application for orphan drug designation in any other geography or with respect to any other drug candidate will be granted. Orphan drug designation neither shortens the development time or regulatory review time of a drug, nor gives the drug any advantage in the regulatory review or approval process.

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Risks Related to Tarveda’s Dependence on Third Parties

Tarveda relies, and intends to continue to rely, on third parties to conduct its clinical trials and perform some of its research and preclinical studies. If these third parties do not satisfactorily carry out their contractual duties, fail to comply with applicable regulatory requirements or do not meet expected deadlines, Tarveda’s development programs may be delayed or subject to increased costs or it may be unable to obtain regulatory approval, each of which may have an adverse effect on its business, financial condition, results of operations and prospects.

Tarveda does not have the ability to independently conduct all aspects of its preclinical testing or clinical trials itself. As a result, Tarveda is dependent on third parties to conduct its ongoing and planned clinical trials of PEN-866 and PEN-221 and preclinical studies, and any preclinical studies and clinical trials of any other drug candidates. The timing of the initiation and completion of these trials will therefore be partially controlled by such third parties and may result in delays to its development programs. Specifically, Tarveda expects CROs, clinical investigators and consultants to play a significant role in the conduct of these trials and the subsequent collection and analysis of data. However, Tarveda will not be able to control all aspects of their activities. Nevertheless, Tarveda is responsible for ensuring that each clinical trial is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and its reliance on the CROs and other third parties does not relieve it of its regulatory responsibilities. Tarveda and its CROs are required to comply with GCP requirements, which are regulations and guidelines enforced by the FDA for drug candidates in clinical development. Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, clinical trial investigators and clinical trial sites. If Tarveda or any of its CROs or clinical trial sites fail to comply with applicable GCP requirements, the data generated in its clinical trials may be deemed unreliable, and the FDA may require Tarveda to perform additional clinical trials before approving its marketing applications. Tarveda cannot assure you that, upon inspection, the FDA will determine that its clinical trials comply with GCPs. In addition, Tarveda’s clinical trials must be conducted with product produced under cGMP regulations. Tarveda’s failure or the failure of third parties on whom it relies to comply with these regulations may require it to stop and/or repeat clinical trials, which would delay the marketing approval process.

There is no guarantee that any such CROs, clinical trial investigators or other third parties on which Tarveda relies will devote adequate time and resources to Tarveda’s development activities or perform as contractually required. If any of these third parties fail to meet expected deadlines, adhere to Tarveda’s clinical protocols or meet regulatory requirements, otherwise perform in a substandard manner, or terminate their engagements with Tarveda, the timelines for its development programs may be extended or delayed or its development activities may be suspended or terminated. If Tarveda’s clinical trial site terminates for any reason, it may experience the loss of follow-up information on subjects enrolled in such clinical trial unless it is able to transfer those subjects to another qualified clinical trial site, which may be difficult or impossible.

Furthermore, these third parties may also have relationships with other entities, some of which may be Tarveda’s competitors for whom they may also be conducting clinical trials or other pharmaceutical product development activities that could harm its competitive position. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct its clinical trials in accordance with regulatory requirements or Tarveda’s stated protocols, Tarveda will not be able to obtain, or may be delayed in obtaining, marketing approvals for PEN-866, PEN-221 or any other drug candidates and will not be able to, or may be delayed in its efforts to, successfully commercialize its products.

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Manufacturing pharmaceutical products is complex and subject to product loss for a variety of reasons. Tarveda contracts with third parties for the manufacture of its drug candidates for preclinical testing and clinical trials and expects to continue to do so for commercialization. This reliance on third parties increases the risk that Tarveda will not have sufficient quantities of its drug candidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair its development or commercialization efforts.

Tarveda does not have any manufacturing facilities. Tarveda produces in its laboratory very small quantities of PEN-866 and PEN-221 and other drug candidates for evaluation in its research programs. Tarveda relies, and expects to continue to rely, on third parties for the manufacture of its drug candidates for preclinical and clinical testing, as well as for commercial manufacture if any of its drug candidates obtain marketing approval. Some of Tarveda’s manufacturers represent its sole source of supply, including PEN-866 and PEN-221. This reliance on third parties increases the risk that Tarveda will not have sufficient quantities of its drug candidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair its development or commercialization efforts.

Tarveda may be unable to establish any agreements with third-party manufacturers or to do so on favorable terms. Even if Tarveda is able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

Tarveda has only limited arrangements in place with respect to acquiring and manufacturing necessary for clinical trials, and these arrangements do not extend to commercial supply. Tarveda acquires many key materials on a purchase order basis. As a result, it does not have long-term committed arrangements with respect to its drug candidates and other materials. If Tarveda obtains marketing approval for any of its drug candidates, it will need to establish an agreement for commercial manufacture with a third party.

Third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside of the United States. Tarveda’s failure, or the failure of its third-party manufacturers and suppliers, to comply with applicable regulations could result in sanctions being imposed on Tarveda, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of drug candidates or products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of its products. In addition, Tarveda’s third-party manufacturers and suppliers are subject to numerous environmental, health and safety laws and regulations, including those governing the handling, use, storage, treatment and disposal of waste products, and failure to comply with such laws and regulations could result in significant costs associated with civil or criminal fines and penalties for such third parties. Based on the severity of regulatory actions that may be brought against these third parties in the future, Tarveda’s clinical or commercial supply of drug and packaging and other services could be interrupted or limited, which could harm its business.

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Tarveda’s drug candidates and any products that it may develop may compete with other drug candidates and products for access to manufacturing facilities. As a result, Tarveda may not obtain access to these facilities on a priority basis or at all. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for Tarveda.

As Tarveda prepares for later-stage clinical trials and potential commercialization, Tarveda will need to take steps to increase the scale of production of its drug candidates. Tarveda has not yet scaled up the manufacturing process for any of its drug candidates. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If microbial, viral or other contaminations are discovered in its drug candidates or in the manufacturing facilities in which its drug candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.

Any performance failure on the part of Tarveda’s existing or future manufacturers could delay clinical development or marketing approval. Tarveda does not currently have arrangements in place for redundant supply or a second source for bulk drug substance for PEN-866 or PEN-221. If Tarveda’s current contract manufacturers for preclinical and clinical testing cannot perform as agreed, Tarveda may be required to replace such manufacturers. Although Tarveda believes that there are several potential alternative manufacturers who could manufacture its drug candidates, Tarveda may incur added costs and delays in identifying and qualifying any such replacement manufacturer or be able to reach agreement with any alternative manufacturer.

Tarveda’s current and anticipated future dependence upon others for the manufacture of its drug candidates or products may adversely affect its future profit margins and ability to commercialize any products that obtain marketing approval on a timely and competitive basis.

Tarveda may enter into collaborations with third parties for the development and commercialization of its drug candidates. If those collaborations are not successful, it may not be able to capitalize on the market potential of these drug candidates.

Tarveda may in the future seek third-party collaborators for the development and commercialization of some of its drug candidates on a selected basis. Tarveda’s likely collaborators for any collaboration arrangements include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies and biotechnology companies. Tarveda faces significant competition in seeking appropriate collaborators. Its ability to reach a definitive agreement for a collaboration will depend, among other things, upon its assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors.

If Tarveda does enter into any such arrangements with any third parties, it will likely have limited control over the amount and timing of resources that such collaborators dedicate to the development or commercialization of its drug candidates. Tarveda’s ability to generate revenues from these arrangements will depend on its collaborators’ abilities and efforts to successfully perform the functions assigned to them in these arrangements. Collaborations involving Tarveda’s drug candidates would pose numerous risks, including the following:

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Risks Related to Regulatory Approval and Marketing of Tarveda’s Drug Candidates and Other Legal Compliance Matters

The development and commercialization of pharmaceutical products are subject to extensive regulation, and Tarveda may not obtain regulatory approvals for PEN-866, PEN-221 or any other drug candidates, on a timely basis or at all.

The clinical development, manufacturing, labeling, packaging, storage, recordkeeping, advertising, promotion, export, import, marketing, distribution, adverse event reporting, including the submission of safety and other post-marketing information and reports, and other possible activities relating to PEN-866 and PEN-221, currently Tarveda’s only drug candidates in clinical trials, as well as any other drug candidate that Tarveda may develop in the future, are subject to extensive regulation. Marketing approval of drugs in the United States requires the submission of a new drug application (“NDA”) to the FDA and Tarveda is not permitted to market any drug candidate in the United States until it obtains approval from the FDA of the NDA for that product. An NDA must be supported by extensive clinical and preclinical data, as well as extensive information regarding pharmacology, chemistry, manufacturing and controls.

FDA approval of an NDA is not guaranteed, and the review and approval process is an expensive and uncertain process that may take several years. The FDA also has substantial discretion in the approval process. The number and types of preclinical studies and clinical trials that will be required for NDA approval varies depending on the drug candidate, the disease or the condition that the drug candidate is designed to treat and the regulations applicable to any particular drug candidate. Despite the time and expense associated with preclinical studies and clinical trials, failure can occur at any stage. The results of preclinical and early clinical trials of PEN-866, PEN-221or any other drug candidate may not be predictive of the results of Tarveda’s later-stage clinical trials.

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Clinical trial failure may result from a multitude of factors including flaws in trial design, dose selection, placebo effect, patient enrollment criteria and failure to demonstrate favorable safety or efficacy traits, and failure in clinical trials can occur at any stage. Companies in the pharmaceutical industry frequently suffer setbacks in the advancement of clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials. Based upon negative or inconclusive results, Tarveda may decide, or regulators may require it, to conduct additional clinical trials or preclinical studies. In addition, data obtained from clinical trials are susceptible to varying interpretations, and regulators may not interpret Tarveda’s data as favorably as it does, which may further delay, limit or prevent marketing approval.

The FDA could delay, limit or deny approval of a drug candidate for many reasons, including because they:

Generally, public concern regarding the safety of pharmaceutical products could delay or limit Tarveda’s ability to obtain regulatory approval, result in the inclusion of unfavorable information in its labeling, or require it to undertake other activities that may entail additional costs. Tarveda has not obtained FDA approval for any product. This lack of experience may impede its ability to obtain FDA approval in a timely manner, if at all, for PEN-866 and PEN-221.

If Tarveda experiences delays in obtaining approval or if it fails to obtain approval of PEN-866, PEN-221 or its other drug candidates, its commercial prospects will be harmed and its ability to generate revenues will be materially impaired which would adversely affect its business, prospects, financial condition and results of operations.

Tarveda’s failure to obtain marketing approval in foreign jurisdictions would prevent its drug candidates from being marketed abroad, and any approval it is granted for its drug candidates in the United States would not assure approval of drug candidates in foreign jurisdictions.

In order to market and sell its products in any jurisdiction outside the United States, Tarveda must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the

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product can be approved for sale in that country. Tarveda may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. Tarveda may not be able to submit for marketing approvals and may not receive necessary approvals to commercialize its products in any market.

Even if Tarveda obtains marketing approval for its drug candidates, the terms of approvals and ongoing regulation of its products may limit how it manufactures and markets its products and compliance with such requirements may involve substantial resources, which could materially impair its ability to generate revenue.

Even if marketing approval of a drug candidate is granted, an approved product and its manufacturer and marketer are subject to ongoing review and extensive regulation, which may include the requirement to implement a REMS or to conduct costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of the product. Tarveda must also comply with requirements concerning advertising and promotion for any of its drug candidates for which it obtains marketing approval. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved labeling. Thus, Tarveda will not be able to promote any products it develops for indications or uses for which they are not approved. In addition, manufacturers of approved products and those manufacturers’ facilities are required to ensure that quality control and manufacturing procedures conform to cGMPs, which include requirements relating to quality control and quality assurance as well as the corresponding maintenance of records and documentation and reporting requirements. Tarveda and its contract manufacturers could be subject to periodic unannounced inspections by the FDA to monitor and ensure compliance with cGMPs.

Accordingly, assuming Tarveda obtains marketing approval for one or more of its drug candidates, it and its contract manufacturers will continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance and quality control. If Tarveda is not able to comply with post-approval regulatory requirements, it could have the marketing approvals for its products withdrawn by regulatory authorities and its ability to market any future products could be limited, which could adversely affect Tarveda’s ability to achieve or sustain profitability. As a result, the cost of compliance with post-approval regulations may have a negative effect on Tarveda’s operating results and financial condition.

Any drug candidate for which Tarveda obtains marketing approval will be subject to ongoing enforcement of post-marketing requirements and Tarveda could be subject to substantial penalties, including withdrawal of its product from the market, if Tarveda fails to comply with all regulatory requirements or if it experiences unanticipated problems with its products, when and if any of them are approved.

Any drug candidate for which Tarveda obtains marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements include, but are not limited to, restrictions governing promotion of an approved product, submissions of safety and other post-marketing information and reports, registration and listing requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, and requirements regarding drug distribution and the distribution of samples to physicians and recordkeeping.

The FDA and other federal and state agencies, including the Department of Justice, closely regulate compliance with all requirements governing prescription drug products, including requirements pertaining to marketing and promotion of drugs in accordance with the provisions of the approved labeling and manufacturing of products in accordance with cGMP requirements. Violations of such requirements may lead to investigations alleging violations of the Food, Drug, and Cosmetic Act (“FDCA”), and other statutes, including the False Claims Act and other federal and state healthcare fraud and abuse laws as well as state consumer protection laws.

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Tarveda’s failure to comply with all regulatory requirements, and later discovery of previously unknown adverse events or other problems with its products, manufacturers or manufacturing processes, may yield various results, including:

Non-compliance by Tarveda or any future collaborator with regulatory requirements, including safety monitoring or pharmacovigilance, can also result in significant financial penalties.

Tarveda’s relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose it to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Healthcare providers, physicians and third-party payors will play a primary role in the recommendation and prescription of any drug candidates for which Tarveda obtains marketing approval. Tarveda’s current and future arrangements with healthcare providers, third-party payors and customers may expose it to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which it conducts research, markets, sells and distributes any products for which it obtains marketing approval. Restrictions under applicable federal and state healthcare laws and regulations, include the following:

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Efforts to ensure that Tarveda’s business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that its business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If Tarveda’s operations are found to be in violation of any of these laws or any other governmental regulations that may apply to it, Tarveda may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional integrity reporting and oversight obligations, and the curtailment or restructuring of its operations, any of which could adversely affect its ability to operate its business and its results of operations. If any of the physicians or other healthcare providers or entities with whom Tarveda expects to do business is found to be not in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs, which could have a material adverse effect on Tarveda’s business, results of operations, financial condition and prospects.

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Recently enacted and future legislation may increase the difficulty and cost for Tarveda to obtain marketing approval of and commercialize its drug candidates and decrease the prices it may obtain.

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of Tarveda’s drug candidates, restrict or regulate post-approval activities and affect its ability to profitably sell any drug candidates for which it obtains marketing approval.

In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) changed the way Medicare covers and pays for pharmaceutical products. The legislation expanded Medicare coverage for drug purchases by the elderly and introduced a new reimbursement methodology based on average sales prices for physician- administered drugs. In addition, this legislation provided authority for limiting the number of drugs that will be covered in any therapeutic class. Cost reduction initiatives and other provisions of this legislation could decrease the coverage and price that Tarveda receives for any approved products. While the MMA applies only to drug benefits for Medicare beneficiaries, private third-party payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates. Therefore, any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private third-party payors.

In March 2010, the ACA was signed into law and substantially changed the way healthcare is financed by both governmental and private insurers, and continues to significantly impact the U.S. pharmaceutical industry. The ACA is a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.

Among the provisions of the ACA of importance to Tarveda’s potential drug candidates are the following:

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Some of the provisions of the ACA have yet to be fully implemented, while certain provisions have been subject to judicial and Congressional challenges as well as recent efforts by the current U.S. President’s administration to repeal or replace certain aspects of the ACA. Since January 2017, the current U.S. President has signed two Executive Orders and other directives designed to delay the implementation of certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the ACA. While Congress has not passed comprehensive repeal legislation, it has enacted laws that modify certain provisions of the ACA such as removing penalties, starting January 1, 2019, for not complying with the ACA’s individual mandate to carry health insurance, delaying the implementation of certain ACA-mandated fees, and increasing the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D. On December 14, 2018, a U.S. District Court Judge in the Northern District of Texas ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because it was repealed as part of the Tax Cuts and Jobs Act (the “Tax Act”) the remaining provisions of the ACA are invalid as well. While the Texas district court judge, as well as the current U.S. President’s administration and CMS, have stated that the ruling will have no immediate effect, it is unclear how this decision, subsequent appeals, and other efforts to repeal and replace the ACA will impact the ACA and Tarveda’s business.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals for spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction, triggering the legislation’s automatic reduction to several government programs. These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, starting in 2013, and due to subsequent legislative amendments to the statute, will remain in effect through 2029 unless additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012 (the “ATRA”) was signed into law, which, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These laws may result in additional reductions in Medicare and other healthcare funding.

Further, there has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. For example, the current U.S. President’s administration released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers. In addition, the current U.S. President’s administration’s budget proposal for fiscal year 2020 contains further drug price control measures that could be enacted during the budget process or in other future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B, to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients. For example, in May 2019, CMS issued a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020. This final rule codified CMS’s policy change that was effective January 1, 2019. Although some of these and other measures may require additional authorization to become effective, Congress and the current U.S. President’s administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs. In addition, at the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and

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marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Additionally, on May 30, 2018, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (the Right to Try Act) was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase I clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act.

Tarveda expects that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that it receives for any approved product. The implementation of cost containment measures or other healthcare reforms may prevent Tarveda from being able to generate revenue, attain profitability, or commercialize its products.

Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. Tarveda cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of its drug candidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject Tarveda to more stringent product labeling and post-marketing testing and other requirements.

Governments outside of the United States tend to impose strict price controls, which may adversely affect Tarveda’s revenues, if any.

In some countries, particularly the countries of the European Union (the “EU”), the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, Tarveda may be required to conduct a clinical trial that compares the cost-effectiveness of its drug candidate to other available therapies. If reimbursement of Tarveda’s products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, its business could be harmed. In addition, the recent United Kingdom referendum on its membership in the European Union resulted in a majority of United Kingdom voters voting to exit the European Union, often referred to as Brexit. Brexit could lead to legal uncertainty and potentially divergent national laws and regulations, including those related to the pricing of prescription pharmaceuticals, as the United Kingdom determines which EU laws to replicate or replace. If the United Kingdom were to significantly alter its regulations affecting the pricing of prescription pharmaceuticals, Tarveda could face significant new costs. In addition, Tarveda has filed a CTA to conduct a Phase 1 clinical trial of PEN-221 in the United Kingdom. It is unclear what the effects of Brexit will be on the successful conduct of such clinical trial, and how Brexit may affect the acceptability and use of the results of such clinical trial in the European Union. As a result, Brexit could impair Tarveda’s ability to transact business in the European Union and the United Kingdom, as well as its conduct of its Phase 1/2a clinical trial of PEN-221.

Laws and regulations governing any international operations Tarveda may have in the future may preclude it from developing, manufacturing and selling certain drug candidates and products outside of the United States and require Tarveda to develop and implement costly compliance programs.

If Tarveda expands its operations outside of the United States, it must dedicate additional resources to comply with numerous laws and regulations in each jurisdiction in which it plans to operate. The Foreign Corrupt Practices Act (the “FCPA”) prohibits any U.S. individual or business from paying, offering, authorizing payment or offering anything of value, directly or indirectly, to any foreign official, political party or candidate for the

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purpose of influencing any act or decision of such third party in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the company, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.

Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data relating to those products. If Tarveda expands its presence outside of the United States, it will require Tarveda to dedicate additional resources to comply with these laws, and these laws may preclude it from developing, manufacturing or selling certain drug candidates and products outside of the United States, which could limit its growth potential and increase its development costs.

The failure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension or debarment from government contracting. The Securities and Exchange Commission also may suspend or bar issuers from trading securities on U.S. exchanges for violations of the FCPA’s accounting provisions.

If Tarveda fails to comply with environmental, health and safety laws and regulations, it could become subject to fines or penalties or incur costs that could harm its business.

Tarveda is subject to numerous foreign, federal, state and local environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Tarveda’s operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Tarveda’s operations also produce hazardous waste products. Tarveda generally contracts with third parties for the disposal of these materials and wastes. Tarveda cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from its use of hazardous materials, Tarveda could be held liable for any resulting damages, and any liability could exceed its resources, including any available insurance.

In addition, Tarveda’s leasing and operation of real property may subject it to liability pursuant to certain of these laws or regulations. Under existing U.S. environmental laws and regulations, current or previous owners or operators of real property and entities that disposed or arranged for the disposal of hazardous substances may be held strictly, jointly and severally liable for the cost of investigating or remediating contamination caused by hazardous substance releases, even if they did not know of and were not responsible for the releases.

Tarveda could incur significant costs and liabilities which may adversely affect its financial condition and operating results for failure to comply with such laws and regulations, including, among other things, civil or criminal fines and penalties, property damage and personal injury claims, costs associated with upgrades to its facilities or changes to its operating procedures, or injunctions limiting or altering its operations.

Although Tarveda maintains workers’ compensation insurance to cover it for costs and expenses it may incur due to injuries to its employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. Tarveda does not maintain insurance for environmental liability or toxic tort claims that may be asserted against it in connection with its storage or disposal of biological, hazardous or radioactive materials.

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In addition, Tarveda may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations, which are becoming increasingly more stringent, may impair its research, development or production efforts. Tarveda’s failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Tarveda is subject to certain U.S. and certain foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. Tarveda can face serious consequences for violations.

U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations prohibit, among other things, companies and their employees, agents, CROs, legal counsel, accountants, consultants, contractors and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of these laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences. Tarveda has direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities and other organizations. Tarveda also expects its non-U.S. activities to increase over time. Tarveda expects to rely on third parties for research, preclinical studies and clinical trials and/or to obtain necessary permits, licenses, patent registrations and other marketing approvals. Tarveda can be held liable for the corrupt or other illegal activities of its personnel, agents, or partners, even if it does not explicitly authorize or have prior knowledge of such activities.

Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.

Risks Related to Tarveda’s Intellectual Property

If Tarveda is unable to obtain and maintain sufficient patent protection for its drug candidates and platform technologies, or if the scope of the patent protection is not sufficiently broad, third parties, including its competitors, could develop and commercialize products similar or identical to Tarveda’s, and its ability to commercialize its drug candidates successfully may be adversely affected.

Tarveda’s commercial success depends significantly on its ability to protect its proprietary technologies that it believes are important to Tarveda’s business, including pursuing, obtaining and maintaining patent protection in the United States and other countries intended to cover the composition of matter of its drug candidates, for example, PEN-866 and PEN-221, the methods of use, related technologies, for example, its HSP90 binding miniature drug conjugate platform and Pentarin development technologies, and other inventions that are important to its business. In addition to patent protection, Tarveda also relies on trade secrets to protect aspects of its business that are not amenable to, or that it does not consider appropriate for, patent protection. If Tarveda does not adequately pursue, obtain, maintain, protect or enforce its intellectual property, third parties, including its competitors and/or collaborators, may be able to erode or negate any competitive advantage Tarveda may have, which could harm its business and ability to achieve profitability.

To protect its proprietary position, Tarveda files patent applications in the United States and abroad related to its drug candidates, their methods of manufacture and use. Tarveda also seeks to protect its HSP90 binding miniature drug conjugate platform and Pentarin discovery efforts that it considers important to its business. The patent application and approval process is expensive, time-consuming and complex. Tarveda may not be able to prepare, file, prosecute and maintain all necessary or desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions. It is also possible that Tarveda will fail to identify patentable aspects of its research and development output before it is too late to obtain patent protection. Moreover, depending on the terms of any future license agreements to which it may become a party, Tarveda may not have the right to control the preparation, filing, and prosecution of patent applications, or to maintain or defend the patents, covering technology licensed from third parties. Therefore, these patents and patent applications may not be prosecuted and enforced in a manner consistent with the best interests of its business.

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Furthermore, the patent position of biotechnology and pharmaceutical companies generally is highly uncertain. No consistent policy regarding the breadth of claims allowed in biotechnology and pharmaceutical patents has emerged to date in the United States or in many foreign jurisdictions. The standards applied by the USPTO and foreign patent offices in granting patents are not always applied uniformly or predictably. In addition, the determination of patent rights with respect to biological and pharmaceutical products commonly involves complex legal and factual questions, which have in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of Tarveda’s patent rights are highly uncertain. Thus, it cannot offer any assurances about which, if any, patents will issue, the breadth of any such patents, whether any issued patents will be found invalid and unenforceable or will be threatened by third parties or whether any issued patents will effectively prevent others from commercializing competing technologies and drug candidates. While Tarveda has filed many patent applications covering aspects of its drug candidates and platform technologies, it currently has or has in-licensed 26 issued patents and six soon-to-be-issued patents. Tarveda has not filed its patent applications in every jurisdiction, and some filings are only pending in the United States.

Tarveda’s pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until at least one patent issues from such applications. Assuming the other requirements for patentability are met, currently, the first to file a patent application is generally entitled to the patent. However, prior to March 16, 2013, in the United States, the first to invent was entitled to the patent. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Because patent applications in the United States and most other countries are confidential for a period of time after filing, and some remain so until issued, Tarveda cannot be certain that it was the first to file or invent (prior to March 16, 2013) any patent application related to its drug candidates and HSP90 binding miniature drug conjugate platform and Pentarin know-how. In addition, Tarveda enters into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of its research and development output, such as its employees, collaborators, CROs, contract manufacturers, hospitals, independent treatment centers, consultants, independent contractors, suppliers, advisors and other third parties; however, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing Tarveda’s ability to seek patent protection. Furthermore, if third parties have filed patent applications related to Tarveda’s drug candidates or technology, it may not be able to obtain its own patent rights to those drug candidates or technology.

Moreover, because the issuance of a patent, although presumptive, is not conclusive as to its inventorship, scope, validity or enforceability, Tarveda’s patents or pending patent applications may be challenged in the courts or patent offices in the United States and abroad. For example, Tarveda may be subject to a third-party pre-issuance submission of prior art to the USPTO or become involved in post-grant review procedures, oppositions, derivations, revocation, reexaminations, inter partes review or interference proceedings, in the United States or elsewhere, challenging its patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, Tarveda’s patent rights, allow third parties to commercialize its technology or products and compete directly with Tarveda, without payment to Tarveda, or result in an inability to manufacture or commercialize products without infringing third-party rights. Moreover, Tarveda may have to participate in interference proceedings declared by the USPTO to determine priority of invention or in post-grant challenge proceedings, such as oppositions in a foreign patent office, that challenge priority of invention or other features of patentability. Such challenges may result in loss of exclusivity or in Tarveda’s patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit its ability to stop others from using or commercializing similar or identical technology and products or limit the duration of the patent protection of its technology and products. Such challenges also may result in substantial cost and require significant time from Tarveda’s scientists and management, even if the eventual outcome is favorable to it. Any of the foregoing could have a material adverse effect on Tarveda’s business, financial condition, results of operations, and prospects.

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In addition, given the amount of time required for the development, testing and regulatory review of new drug candidates, Tarveda’s patents protecting such drug candidates might expire before or shortly after such drug candidates are commercialized. As a result, Tarveda’s intellectual property may not provide it with sufficient rights to exclude others from commercializing products similar or identical to its products. Moreover, some of Tarveda’s patents and patent applications may in the future be co-owned with third parties. If Tarveda is unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including Tarveda’s competitors, and its competitors could market competing products and technology. In addition, Tarveda may need the cooperation of any such co-owners of its patents in order to enforce such patents against third parties, and such cooperation may not be provided to Tarveda. Any of the foregoing could have a material adverse effect on Tarveda’s competitive position, business, financial conditions, results of operations, and prospects.

Tarveda’s pending and future patent applications may not result in patents being issued that protect its drug candidates, in whole or in part, or that effectively prevent others from commercializing competitive products. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of Tarveda’s patents or narrow the scope of its patent protection. In addition, the laws of foreign countries may not protect its rights to the same extent or in the same manner as the laws of the United States. For example, European patent law restricts the patentability of methods of treatment of the human body more than U.S. law does.

Even if Tarveda’s patent applications issue as patents, they may not issue in a form that will provide it with any meaningful protection, prevent competitors or other third parties from competing with it or otherwise provide Tarveda with any competitive advantage. Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued and its scope can be reinterpreted after issuance. Consequently, Tarveda does not know whether any of its drug candidates or platform technologies will be protectable or remain protected by valid and enforceable patents. Tarveda’s competitors and other third parties may be able to circumvent its patents by developing similar or alternative technologies or products in a non-infringing manner. Tarveda’s competitors and other third parties may also seek approval to market their own products similar to or otherwise competitive with its products. Alternatively, Tarveda’s competitors or other third parties may seek to market generic versions of any approved products by submitting abbreviated NDAs to the FDA during which process they may claim that patents owned by Tarveda are invalid, unenforceable or not infringed. In these circumstances, Tarveda may need to defend or assert its patents, or both, including by filing lawsuits alleging patent infringement. In any of these types of proceedings, a court or other agency with jurisdiction may find Tarveda’s patents invalid or unenforceable, or that its competitors are competing in a non-infringing manner. Thus, even if Tarveda has valid and enforceable patents, these patents still may not provide protection against competing products or processes sufficient to achieve its business objectives. Any of the foregoing could have a material adverse effect on Tarveda’s competitive position, business, financial conditions, results of operations, and prospects.

Furthermore, future patents may be subject to a reservation of rights by one or more third parties. For example, to the extent the research resulting in future patent rights or technologies is funded in the future in part by the U.S. government, the government could have certain rights in any resulting patents and technology, including a non-exclusive license authorizing the government to use the invention or to have others use the invention on its behalf for non-commercial purposes. If the U.S. government then decides to exercise these rights, it is not required to engage Tarveda as its contractor in connection with doing so. These rights may also permit the government to disclose Tarveda’s confidential information to third parties and to exercise march-in rights to use or allow third parties to use its licensed technology. The government may also exercise its march-in rights if it determines that action is necessary because Tarveda failed to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to U.S. industry. In addition, Tarveda’s rights in such government-funded inventions may be subject to certain requirements to manufacture products embodying such

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inventions in the United States. Any exercise by the government of aforementioned proprietary rights could harm Tarveda’s competitive position, business, financial condition, results of operations, and prospects.

Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing Tarveda’s ability to protect its products.

As is the case with other pharmaceutical companies, Tarveda’s success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the pharmaceutical industry involves both technological and legal complexity and is therefore costly, time consuming and inherently uncertain. Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Recent patent reform legislation in the United States and other countries, including the Leahy-Smith America Invents Act (the Leahy-Smith Act) signed into law in September 2011, could increase those uncertainties and costs. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art and provide more efficient and cost-effective avenues for competitors to challenge the validity of patents. For example, the Leahy-Smith Act allows third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. In addition, the Leahy-Smith Act has transformed the U.S. patent system from a “first-to-invent” system to a “first-to-file” system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. The first-to-file provisions, however, only became effective on March 16, 2013. Accordingly, it is not yet clear what, if any, impact the Leahy-Smith Act will have on the operation of Tarveda’s business. However, the Leahy-Smith Act and its implementation could make it more difficult to obtain patent protection for Tarveda’s inventions and increase the uncertainties and costs surrounding the prosecution of its or its collaboration partners’ patent applications and the enforcement or defense of or collaboration partners’ issued patents, all of which could harm Tarveda’s business, results of operations, financial condition and prospects.

In addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly uncertain. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained. Additionally, there have been recent proposals for additional changes to the patent laws of the United States and other countries that, if adopted, could impact Tarveda’s ability to enforce its proprietary technology. Depending on future actions by the U.S. Congress, the U.S. courts, the USPTO and the relevant law-making bodies in other countries, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on Tarveda’s existing patent portfolio and weaken its ability to obtain new patents or to enforce its existing patents and patents that it might obtain in the future.

Tarveda may become involved in lawsuits or administrative disputes to protect or enforce its patents or other intellectual property, which could be expensive, time consuming and unsuccessful.

Competitors and other third parties may infringe, misappropriate or otherwise violate Tarveda’s patents, trademarks, copyrights, trade secrets or other intellectual property. To counter infringement, misappropriation or other violations, Tarveda may be required to file infringement, misappropriation or other violation claims, which can be expensive and time consuming and divert the time and attention of its management and business and scientific personnel. In addition, many of Tarveda’s adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than it can.

Any claims Tarveda asserts against perceived infringers could provoke these parties to assert counterclaims against Tarveda alleging that it infringes, misappropriates or otherwise violates their patents or their other

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intellectual property, in addition to counterclaims asserting that Tarveda’s patents are invalid or unenforceable, or both. In patent litigation in the United States, counterclaims challenging the validity, enforceability or scope of asserted patents are commonplace. Similarly, third parties may initiate or threaten legal proceedings against Tarveda seeking a declaration that certain of its intellectual property is non-infringed, invalid or unenforceable. The outcome of any such proceeding is generally unpredictable. Given the costs involved to litigate, Tarveda may decide to settle rather than dispute such claims if it is more economical to do so. For example, in 2017, Tarveda received a demand letter allenging potential trademark infringement. Rather than engage in a costly dispute, Tarveda agreed to certain modifications of how it uses its corporate name to resolve the issue.

In any patent infringement proceeding, there is a risk that a court will decide that a patent is invalid or unenforceable, in whole or in part, and that Tarveda does not have the right to stop the other party from using the invention at issue. There is also a risk that, even if the validity of such patents is upheld, the court will construe the patent’s claims narrowly or decide that Tarveda does not have the right to stop the other party from using the invention at issue on the grounds that its patent claims do not cover the invention. An adverse outcome in a litigation or proceeding involving Tarveda’s patents could limit its ability to assert its patents against those parties or other competitors, and may curtail or preclude its ability to exclude third parties from making and selling similar or competitive products. If a defendant were to prevail on a legal assertion of invalidity or unenforceability of Tarveda’s patents covering one of its drug candidates, Tarveda could lose at least a part, and perhaps all, of the patent protection covering such a drug candidate. Competing drugs may also be sold in other countries in which its patent coverage might not exist or be as strong. If Tarveda loses a foreign patent lawsuit alleging its infringement of a competitor’s patents, Tarveda could be prevented from marketing its drugs in one or more foreign countries. Any of these occurrences could adversely affect its competitive business position, business prospects and financial condition. Similarly, if Tarveda asserts trademark infringement claims, a court may determine that the marks Tarveda has asserted are invalid or unenforceable, or that the party against whom it has asserted trademark infringement has superior rights to the marks in question. In this case, Tarveda could ultimately be forced to cease use of such trademarks.

Even if Tarveda establishes infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of Tarveda’s confidential information could be compromised by disclosure during litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If these results are perceived to be negative, it could have a material adverse effect on your investement. Moreover, there can be no assurance that Tarveda will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are concluded. Even if Tarveda ultimately prevails in such claims, the monetary cost of such litigation and the diversion of the attention of management and scientific personnel could outweigh any benefit it receives as a result of the proceedings.

Furthermore, third parties may also raise invalidity or unenforceability claims before administrative bodies in the United States or foreign authorities, even outside the context of litigation. Such mechanisms include re-examination, inter partes review, post-grant review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in revocation, cancellation or amendment to Tarveda’s patents in such a way that they no longer cover and protect its drug candidates or platform technologies. The outcome following legal assertions of invalidity and unenforceability is unpredictable. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or written description. Grounds for an unenforceability assertion could be an allegation that someone connected with the prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution of the patent. With respect to the validity of Tarveda’s patents, for example, it cannot be certain that there is no invalidating prior art of which Tarveda, its licensors, patent counsel and the patent examiner were unaware during prosecution. Moreover, it is possible that prior art may exist that it is aware of but does not believe is

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relevant to its current or future patents, but that could nevertheless be determined to render its patents invalid. If a third party were to prevail on a legal assertion of invalidity or unenforceability, Tarveda could lose at least part, and perhaps all, of the patent protection on one or more of its drug candidates. Any such loss of patent protection could have a material adverse impact on Tarveda’s business, financial condition, results of operations and prospects.

Tarveda may not be able to effectively enforce its intellectual property and proprietary rights throughout the world.

Filing, prosecuting and defending patents with respect to its drug candidates in all countries throughout the world would be prohibitively expensive, and the laws of foreign countries may not protect Tarveda’s rights to the same extent as the laws of the United States. The requirements for patentability may differ in certain countries, particularly in developing countries. In addition, any future intellectual property license agreements may not always include worldwide rights. Consequently, competitors and other third parties may use Tarveda’s technologies in jurisdictions where it has not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where Tarveda may obtain patent protection, but where patent enforcement is not as strong as that in the United States and where its ability to enforce patents to stop infringing activities may be inadequate. These products may compete with Tarveda’s products in such territories and in jurisdictions where it does not have any patent rights or where any future patent claims or other intellectual property or proprietary rights may not be effective or sufficient to prevent them from competing with Tarveda, which could have a material adverse effect on its business, financial condition, results of operations and prospects.

Moreover, Tarveda’s ability to protect and enforce its intellectual property and proprietary rights may be adversely affected by unforeseen changes in foreign intellectual property laws. Additionally, the laws of some countries outside of the United States and Europe do not afford intellectual property protection to the same extent as the laws of the United States and Europe. Many companies have encountered significant problems in protecting and defending intellectual property and proprietary rights in certain foreign jurisdictions. The legal systems of some countries, including, for example, India, China and other developing countries, do not favor the enforcement of patents and other intellectual property or proprietary rights, particularly those relating to biotechnology products, which could make it difficult for Tarveda to stop the infringement, misappropriation or other violation of its patents or other intellectual property or proprietary rights. For example, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. Consequently, Tarveda may not be able to prevent third parties from practicing its inventions in certain countries outside the United States and Europe. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If Tarveda is forced to grant a license to third parties with respect to any patents relevant to its business, its competitive position may be impaired, and its business, financial condition, results of operations, and prospects may be adversely affected. Proceedings to enforce Tarveda’s intellectual property and proprietary rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert efforts and resources from other aspects of its business, could put its patents, trademarks or other intellectual property and proprietary rights at risk of being invalidated or interpreted narrowly, could put its patent applications at risk of not issuing, and could provoke third parties to assert claims against it. Tarveda may not prevail in any lawsuits that it initiates, and the damages or other remedies awarded, if any, may not be commercially meaningful. Furthermore, while Tarveda intends to protect its intellectual property and proprietary rights in major markets for its products, it cannot ensure that it will be able to initiate or maintain similar efforts in all jurisdictions in which it may wish to market its products. Accordingly, Tarveda’s efforts to protect its intellectual property and proprietary rights in such countries may be inadequate.

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If Tarveda is sued for infringing, misappropriating or otherwise violating intellectual property or proprietary rights of third parties, such litigation or disputes could be costly and time consuming and could prevent or delay it from developing or commercializing its drug candidates.

Tarveda’s commercial success depends, in part, on its ability to develop, manufacture, market and sell its drug candidates and use its proprietary platform and other technologies without infringing, misappropriating or otherwise violating the intellectual property and other proprietary rights of third parties. If any third-party patents, patent applications or other proprietary rights are found to cover Tarveda’s drug candidates or their compositions, methods of use or manufacturing, Tarveda may be required to pay damages, which could be substantial, and Tarveda would not be free to manufacture or market its drug candidates or to do so without obtaining a license, which may not be available on commercially reasonable terms, or at all.

Tarveda may in the future become party to, or threatened with, adversarial proceedings or litigation regarding intellectual property or proprietary rights with respect to its drug candidates and platform and other technologies it uses in its business. Tarveda’s competitors or other third parties may assert infringement claims, alleging that Tarveda’s drug candidates or platform or other technologies are covered by their patents. Tarveda cannot be certain that it does not infringe existing patents or that it will not infringe patents that may be granted in the future. Furthermore, because patent applications can take many years to issue and may be confidential for 18 months or more after filing, and because patent claims can be revised before issuance, there may be applications now pending that may later result in issued patents that may be infringed by the manufacture, use or sale of its drug candidates. If a patent holder believes Tarveda’s drug candidate or technology infringes its patent rights, the patent holder may sue even if Tarveda has received patent protection for its technology. Moreover, Tarveda may face patent infringement claims from non-practicing entities that have no relevant drug revenue and against whom its own patent portfolio may thus have no deterrent effect.

There is a substantial amount of intellectual property litigation in the biotechnology and pharmaceutical industries, and Tarveda may become party to, or threatened with, litigation or other adversarial proceedings regarding intellectual property or proprietary rights with respect to its drug candidates and platform technologies, including interference proceedings before the USPTO. Third parties may assert infringement, misappropriation or other claims against Tarveda based on existing or future intellectual property or proprietary rights. The outcome of intellectual property litigation and other disputes is subject to uncertainties that cannot be adequately quantified in advance. The pharmaceutical and biotechnology industries have produced a significant number of patents, and it may not always be clear to industry participants, including Tarveda, which patents cover various types of products or methods of using or manufacturing products. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform. If Tarveda were sued for patent infringement, Tarveda would need to demonstrate that its drug candidates, products or methods of use, manufacturing or other applicable activities either do not infringe the patent claims of the relevant patent or that the patent claims are invalid or unenforceable, and Tarveda may not be successful in doing so. However, proving invalidity or unenforceability is difficult. For example, in the United States, proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if Tarveda believes third-party intellectual property claims are without merit, there is no assurance that a court would find in Tarveda’s favor on questions of infringement, validity, or enforceability. Even if Tarveda is successful in these proceedings, it may incur substantial costs and the time and attention of management and business and scientific personnel could be diverted in pursuing these proceedings, which could significantly harm its business and operating results. In addition, Tarveda may not have sufficient resources to bring these actions to a successful conclusion.

If Tarveda is found to infringe, misappropriate or otherwise violate a third party’s intellectual property or proprietary rights and is unsuccessful in demonstrating that such intellectual property or proprietary rights are invalid or unenforceable, Tarveda could be forced, including by court order, to cease developing, manufacturing or commercializing the infringing drug candidate or product. Alternatively, Tarveda may be required to obtain a license from such third party in order to use the infringing technology and continue developing, manufacturing or

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marketing the infringing drug candidate. However, Tarveda may not be able to obtain any required license on commercially reasonable terms or at all. Even if Tarveda were able to obtain such a license, it could be granted on non-exclusive terms, thereby giving its competitors and other third parties access to the same technologies licensed to it. In addition, Tarveda could be found liable for significant monetary damages, including treble damages and attorneys’ fees if it is found to have willfully infringed such third-party patent rights. A finding of infringement could prevent Tarveda from commercializing its drug candidates or force it to cease some of its business operations, which could materially harm its business. Claims that Tarveda has misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on its business, financial condition, results of operations and prospects.

Tarveda may be subject to claims by third parties asserting that its employees or consultants or it has misappropriated their intellectual property, or claiming ownership of what Tarveda regards as its own intellectual property.

Some of Tarveda’s employees and consultants are currently or have been previously employed at universities or at other biotechnology or pharmaceutical companies, including its competitors or potential competitors. These employees and consultants may have executed proprietary rights, non-disclosure and non-competition agreements, or similar agreements, in connection with such other current or previous employment. Although Tarveda tries to ensure that its employees and consultants do not use the proprietary information or know-how of others in their work for it, Tarveda may be subject to claims that it or these individuals have used or disclosed intellectual property, including trade secrets or other proprietary information, of third parties. Litigation may be necessary to defend against such claims. If Tarveda fails in defending any such claims, in addition to paying monetary damages, Tarveda may lose valuable intellectual property or personnel or sustain damages. Such intellectual property could be awarded to a third party, and Tarveda could be required to obtain a license from such third party to commercialize its technology or products. Such a license may not be available on commercially reasonable terms or at all. Even if Tarveda is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management. Any of the foregoing would have a material adverse effect on Tarveda’s business, financial condition, results of operations and prospects.

In addition, while it is Tarveda’s policy to require its employees, consultants and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to it, Tarveda may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that it regards as its own, which may result in claims by or against Tarveda related to the ownership of such intellectual property. In addition, such agreements may not be self-executing such that the intellectual property subject to such agreements may not be assigned to Tarveda without additional assignments being executed, and Tarveda may fail to obtain such assignments. In addition, such agreements may be breached. Accordingly, Tarveda may be forced to bring claims against third parties, or defend claims that they may bring against it to determine the ownership of what it regards as its intellectual property. If Tarveda fails in prosecuting or defending any such claims, in addition to paying monetary damages, Tarveda may lose valuable intellectual property. Even if Tarveda is successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to its senior management and scientific personnel, which would have a material adverse effect on its business, financial condition, results of operations and prospects.

Rights to improvements to Tarveda’s drug candidates may be held by third parties.

In the course of testing its drug candidates, Tarveda has entered into agreements with third parties to conduct preclinical and clinical testing, which provide that improvements to its drug candidates may be owned solely by a party or jointly between the parties. If Tarveda determines that rights to such improvements owned solely by a third party are necessary to commercialize its drug candidates or maintain its competitive advantage, Tarveda may need to obtain a license from such third party in order to use the improvements and continue

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developing, manufacturing or marketing the drug candidates. However, Tarveda may not be able to obtain any required license on commercially reasonable terms or at all. Even if Tarveda were able to obtain such a license, it could be granted on non-exclusive terms, thereby giving its competitors and other third parties access to the same technologies licensed to it. Failure to obtain a license on commercially reasonable terms or at all, or to obtain an exclusive license, could prevent Tarveda from commercializing its drug candidates or force it to cease some of its business operations, which could materially harm its business. If Tarveda determines that rights to improvements jointly owned between Tarveda and a third party are necessary to commercialize its drug candidates or maintain its competitive advantage, Tarveda may need to obtain an exclusive license from such third party. If Tarveda ise unable to obtain an exclusive license to any such third-party co-owners’ interest in such improvements, such co-owners may be able to license their rights to other third parties, including its competitors, and Tarveda’s competitors could market competing products and technology. In addition, Tarveda may need the cooperation of any such co-owners of its intellectual property in order to enforce such intellectual property against third parties, and such cooperation may not be provided. Any of the foregoing could have a material adverse effect on Tarveda’s competitive position, business, financial conditions, results of operations, and prospects.

The term of Tarveda’s patents may be inadequate to protect its competitive position on its products.

Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. Depending upon the timing, duration and other factors relating to any FDA marketing approval Tarveda receives for any of its drug candidates, one or more of its U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984 (commonly referred to as the Hatch-Waxman Amendments). Tarveda expects to seek extensions of patent terms in the United States and, if available, in other countries where it is prosecuting patents. In the United States, the Hatch-Waxman Amendments permit a patent term extension of up to five years beyond the normal expiration of the patent, limited to the approved indication (or any additional indications approved during the period of extension), as compensation for patent term lost during the regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent applicable to an approved drug is eligible for the extension and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended, and the application for the extension must be submitted prior to the expiration of the patent. However, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with Tarveda’s assessment of whether such extensions are available for its patents, may refuse to grant extensions to its patents, or may grant more limited extensions than Tarveda requests. Tarveda may not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy applicable requirements. If Tarveda is unable to obtain patent term extension or the term of any such extension is less than it requests, its competitors and other third parties may be able to obtain approval of competing products following patent expiration and take advantage of Tarveda’s investment in development and clinical trials by referencing its clinical and preclinical data and launch their product earlier than might otherwise be the case. Any of the foregoing would have a material adverse effect on Tarveda’s business, financial condition, results of operations and prospects.

Obtaining and maintaining patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent offices, and Tarveda’s patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees and various other government fees on any issued patent are due to be paid to the USPTO and patent offices in foreign countries in several stages over the lifetime of the patent. The USPTO and patent offices in foreign countries require compliance with a number of procedural, documentary, fee payment and other requirements during the patent application process. In the future, Tarveda may rely on licensing partners to pay these fees due to U.S. and non-U.S. patent agencies and to

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comply with these other requirements with respect to any future licensed patents and patent applications. While an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of a patent or patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an event, Tarveda’s competitors and other third parties might be able to enter the market with similar or identical products of technology, which would have a material adverse effect on its business, financial condition, results of operations and prospects.

If Tarveda is unable to protect the confidentiality of its trade secrets, the value of its technology could be materially adversely affected and its business would be harmed.

While Tarveda has obtained composition of matter patents with respect to both of its clinical Pentarin miniature drug conjugates PEN-866 and PEN-221, it also relies on proprietary know-how and trade secret protection and confidentiality agreements to protect proprietary know-how or trade secrets that are not patentable or that it elects not to patent. Tarveda seeks to protect its proprietary know-how in part by entering into non-disclosure and confidentiality agreements with parties who have access to such knowledge, such as its employees, consultants, independent contractors, advisors, contract manufacturers, CROs, hospitals, independent treatment centers, suppliers, collaborators and other third parties. Tarveda also enters into confidentiality and invention or patent assignment agreements with employees and certain consultants. However, Tarveda cannot guarantee that it has entered into such agreements with each party that may have or have had access to its trade secrets or proprietary know-how. Additionally, Tarveda’s confidentiality agreements and other contractual protections may not be adequate to protect its intellectual property from unauthorized disclosure, third-party infringement or misappropriation. Any party with whom it has executed such an agreement may breach that agreement and disclose Tarveda’s proprietary information, including its trade secrets, and Tarveda may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts in the United States and certain foreign jurisdictions are less willing or unwilling to protect trade secrets. If any of Tarveda’s trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, Tarveda would have no right to prevent such third party, or those to whom they communicate such technology or information, from using that technology or information to compete with Tarveda. If any of Tarveda’s trade secrets were to be disclosed to or independently developed by a competitor or other third party, its business, financial condition, results of operations and prospects and competitive position could be materially harmed.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by Tarveda’s intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect its business or permit it to maintain its competitive advantage. For example: