UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): November 20, 2020
KINDRED BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
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| Delaware | | 001-36225 | | 46-1160142 |
(State or other jurisdiction of
incorporation or organization) | | (Commission
File Number) | | (I.R.S. Employer
Identification No.) |
1555 Bayshore Highway, Suite 200, Burlingame, California 94010
(Address of principal executive offices) (Zip Code)
(650) 701-7901
(Registrant’s telephone number, including area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class | | Trading Symbol | | Name of each exchange on which registered |
| Common Stock, $0.0001 par value | | KIN | | The NASDAQ Stock Market LLC |
| Preferred Stock Purchase Rights | | KIN | | The NASDAQ Stock Market LLC |
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| Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). |
| | Emerging growth company | ☐ |
| 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. | o |
Item 8.01 Other Events.
Kindred Biosciences, Inc. (“KindredBio”) is providing notice that due to a delay in receiving appropriate vendor reagent material, completion of the upcoming pivotal efficacy study for KIND-030, a monoclonal antibody targeting canine parvovirus, is now expected in the first quarter of 2021. Completion of the pivotal efficacy study for the treatment of established parvovirus infection had previously been anticipated by year-end 2020. As previously stated, approval of KIND-030 is subject to regulatory risk and timelines, and there is no set review timeline at the United States Department of Agriculture 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. On September 16, 2020, KindredBio reported positive results from its pivotal efficacy study for the prophylactic indication.
The foregoing paragraphs contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements 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. 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 Current Report on Form 8-K. Forward-looking statements contained in this Current Report on Form 8-K speak only as of the date of this Form 8-K and we undertake no obligation to update or revise these statements, except as may be required by law.
The results stated in this filing have not been reviewed by the Food and Drug Administration or the United States Department of Agriculture Center for Veterinary Biologics, as applicable.
Item 9.01 Financial Statements and Exhibits.
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| Exhibit No. | | Description |
| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| KINDRED BIOSCIENCES, INC. |
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| Date: November 20, 2020 | By: /s/ Richard Chin |
| Richard Chin, M.D. |
| Chief Executive Officer |
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