Organovo Updates Key Clinical Development Goals; Company Reports Preliminary Fiscal Fourth-Quarter 2019 Results
- Pre-Investigational New Drug (“IND”) meeting with the
- Submit first IND in calendar 2021
“We have determined that we need to conduct additional preclinical studies, optimize our manufacturing processes, and most importantly to generate decisive scientific data regarding the prolonged functionality and therapeutic benefits of our liver tissue patch,” said
Crouch continued, “The most recent data we’ve generated from a much larger group of animal studies provides differing results from what we observed in our earlier pilot studies. We continue to see statistically meaningful reduction in toxic globules in the Alpha-1-antitrypsin animal models over a three-month period. However, in these and other animal models, we are also seeing evidence of shorter tissue duration than we observed in previous studies, as measured by human protein output and the quantity of hepatocytes. We’ll continue to examine all aspects of our manufacturing process, with the goal of improving the durability and optimizing the functionality of our tissues.”
Crouch concluded, “At the same time, we’ve had good progress in other critical elements of our development program. We’ve explored alternate placement and implantation strategies and have shown the ability to apply multiple tissue patches of varying sizes to the animals using different adhesion methods. In addition, we’ve initiated early work with larger NovoTissues® to focus on surgical approaches for human implantation. We’ve also successfully engrafted our therapeutic tissue onto a fibrotic animal liver, an important step in evaluating the patch’s versatility as we consider end-stage liver disease indications. From a safety perspective, although definitive IND-enabling toxicology studies have not been performed yet, no adverse effects have been detected to date on liver enzymes or histology in over 500 animals treated with our liver patches. Finally, we have reviewed our operational capabilities to prepare our Chemistry Manufacturing and Controls plan. Assuming successful outcomes of our additional preclinical studies, we plan to move forward with our objective to implement clinical scale manufacturing and quality processes in advance of our first-in-human trials. These achievements and challenges are natural parts of the innovation process for novel cell-based therapies.”
Key Clinical Development Goals & Outlook
- The Company believes its healthy therapeutic liver tissue patch has the potential to treat a broad range of liver disease indications. Its initial Phase I trial is expected to target patients with end-stage liver disease, and subject to favorable outcomes in that trial,
Organovointends to explore the benefits of its NovoTissues® in one or more inborn errors of metabolism disease areas such as Alpha-1 antitrypsin deficiency. The Company may also study its product as a bridge-to-transplant. All of these diseases represent high unmet need areas where Organovobelieves its liver patches may provide a meaningful benefit to patients. Organovoexpects to hold a pre-IND meeting with the FDAin calendar 2020 for its lead program with the intent to begin IND-enabling studies in the second half of calendar 2020. Organovoexpects to file for its first IND in calendar 2021.
- As of
March 31, 2019, the Company had a cash and cash equivalents balance of $36.5 million. Organovoexpects a net cash utilization(1) rate of $20.0 million to $22.0 millionin fiscal 2020, and believes it has sufficient funds, along with the continued usage of its at-the-market (“ATM”) facility, to meet its operating and capital requirements through its forecasted IND submission in calendar 2021.
Organovobegan its evaluation of surgical implantation techniques for its liver therapeutic tissue in large animals at a leading academic institution. Organovocommenced a collaboration with Professor Melissa Littleat the Murdoch Childrens Research Institute, The Royal Children’s Hospital, Melbourne, Australiaand Ton Rabelink at Universiteit Leiden, Leiden, Netherlandsto develop a 3D bioprinted stem cell-based therapeutic tissue for treating end-stage renal disease.
- The Company also continued to partner with leading academic institutions conducting proof-of-concept studies in 3D bioprinted tissue research areas including the retina, vasculature and musculoskeletal applications.
Preliminary Fiscal Fourth-Quarter 2019 Financial Results (Unaudited)
- Net loss was
$7.0 million, a $0.5 millionimprovement over the year-ago period, as total costs and expenses declined 10 percent to $7.8 million, primarily due to lower employee costs.
- Net cash utilization was
$5.1 million, an improvement from $5.7 millionin the prior-year quarter.
- Total revenue was
$0.7 million, a 38 percent decrease from the year-ago period, primarily driven by lower products and services revenue.
- During the fiscal fourth quarter, the Company generated net proceeds of approximately
$6.3 millionfrom the issuance of 6.1 million shares of common stock in ATM offerings at a weighted average price of $1.04per share.
Definitions & Supplemental Financial Measures
- In addition to disclosing financial results that are determined in accordance with U.S. GAAP, the Company provides net cash utilization as a supplemental measure to help investors evaluate the Company’s fundamental operational performance. The Company defines net cash utilization as the net decrease in cash and cash equivalents during the reporting period less proceeds from the sale of common stock and the exercise of warrants and stock options during the reporting period. Net cash utilization is an operational measure that should be considered as additional financial information regarding our operations. This operational measure should not be considered without also considering our results prepared in accordance with U.S. GAAP, and should not be considered as a substitute for, or superior to, our U.S. GAAP results. The Company believes net cash utilization is a relevant and useful operational measure because it provides information regarding our cash utilization rate. Management uses net cash utilization to manage the business, including in preparing its annual operating budget, financial projections and compensation plans. The Company believes that net cash utilization is also useful to investors because similar measures are frequently used by securities analysts, investors and other interested parties in their evaluation of companies in similar industries. However, there is no standardized measurement of net cash utilization, and net cash utilization as the Company presents it may not be comparable with similarly titled operational measures used by other companies. Due to these limitations, the Company’s management does not view net cash utilization in isolation but also uses other measurements, such as cash used in operating activities and revenues to measure operating performance.
Conference Call Information
As previously announced, the Company will host a conference call to discuss its results at
Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding the potential benefits and therapeutic uses of the Company’s therapeutic liver tissue, including the benefits of an orphan designation; the Company’s expectations regarding the
This press release contains certain unaudited financial results for the Company’s fiscal year and fourth quarter ended
Investor & Press Contact: Steve Kunszabo
Organovo Holdings, Inc.+1 (858) 224-1092 email@example.com
Source: Organovo, Inc.