Kindred Biosciences Announces Submission of Parvovirus Monoclonal Antibody Data for Prophylactic Indication
Kindred Biosciences, Inc. (NASDAQ: KIN) announced its submission of efficacy data for the monoclonal antibody KIND-030 to the USDA for review, targeting canine parvovirus. This marks a significant step towards obtaining approval for its prophylactic indication. CEO Richard Chin emphasized the importance of this data in transforming how parvovirus is treated. However, the company warns of regulatory risks and potential delays due to COVID-19. The completion of clinical studies is now expected in Q2 2021, though it doesn't affect the agreement with Elanco Animal Health.
- Submission of efficacy data for KIND-030 to USDA, moving closer to potential approval.
- Positive results reported from pivotal efficacy study for KIND-030.
- Approval timelines are uncertain due to regulatory risks and potential delays from COVID-19.
- Completion of pivotal efficacy study for treatment indication expected to extend into Q2 2021.
SAN FRANCISCO, Feb. 25, 2021 /PRNewswire/ -- Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that it has submitted efficacy data to support the prophylactic indication for KIND-030 to the United States Department of Agriculture (USDA) Center for Veterinary Biologics for review. This submission is part of the overall project data package that will be submitted and evaluated for full approval. KIND-030 is a monoclonal antibody targeting canine parvovirus.
"This data submission brings us a step closer to approval for this tragic disease," said Chief Executive Officer, Richard Chin, M.D. "We are committed to transforming how parvovirus is treated and prevented, and look forward to commencement of the pivotal efficacy study for the treatment indication."
On September 16, 2020, KindredBio reported positive results from its pivotal efficacy study for the prophylactic indication. As previously stated, approval of KIND-030 is subject to regulatory risk and timelines, and there is no set review timeline at the USDA Center for Veterinary Biologics. Regulatory consultants to KindredBio anticipate possible delays to the regulatory review process due to COVID-19. KindredBio will provide an update on the timing of KIND-030's expected approval at the time of announcing the company's fourth quarter 2020 results. Regulatory approval and review timeline are subject to the typical risks inherent in such a process.
KIND-030 is being pursued for two indications in dogs: prophylactic therapy to prevent clinical signs of canine parvovirus infection, and treatment of established parvovirus infection. Completion of the upcoming pivotal efficacy study for the treatment indication for KIND-030 is now expected to extend into the second quarter of 2021.
KindredBio does not expect the updated timing of completion of the pivotal efficacy study for the treatment indication to impact achievement of the terms contained in the parvovirus license agreement with Elanco Animal Health Incorporated.
About Kindred Biosciences
Kindred Biosciences is a biopharmaceutical company developing innovative biologics focused on saving and improving the lives of pets. Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy. The Company's strategy is to identify targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated targets for dogs and cats. KindredBio has a deep pipeline of novel biologics in development across many therapeutic classes, alongside state-of-the-art biologics manufacturing capabilities and a broad intellectual property portfolio.
For more information, visit: www.kindredbio.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash.
These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: our limited operating history and expectations of losses for the foreseeable future; the absence of significant revenue from our products and our product candidates for the foreseeable future; the likelihood that our revenue will vary from quarter to quarter; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our products and our lead product candidates which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies related to our products and our product candidates and the potential inability of these manufacturers to deliver a sufficient amount of supplies on a timely basis; the uncertain effect of the COVID-19 pandemic on our business, results of operations and financial condition; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to enter into satisfactory agreements with third-party licensees of our biologic products and uncertainty about the amount of revenue that we will receive from such agreements; our significant costs of operating as a public company; potential cyber-attacks on our information technology systems or on our third-party providers' information technology systems, which could disrupt our operations; our potential inability to repay the secured indebtedness that we have incurred from third-party lenders, and the restrictions on our business activities that are contained in our loan agreement with these lenders; the risk that our 2020 strategic realignment and restructuring plans will result in unanticipated costs or revenue shortfalls; uncertainty about the amount of royalties that we will receive from the sale of Mirataz® to Dechra Pharmaceuticals PLC; the risk that the revenue from our delivery of services or products under any contract may be less than we anticipate if the other party to the contract exercises its right to terminate the contract prior to the completion of the contract; our potential inability to obtain and maintain patent protection and other intellectual property protection for our products and our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.
For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC. As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release. Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law.
The results stated in this press release have not been reviewed by the Food and Drug Administration or the United States Department of Agriculture Center for Veterinary Biologics, as applicable.
Contacts
For investor inquiries:
Katja Buhrer
Katja.buhrer@kindredbio.com
(917) 969-3438
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SOURCE Kindred Biosciences, Inc.
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