KIN-2787 is the company’s RAF inhibitor candidate for patients with mutant BRAF-driven solid tumors
Planned initiation of Phase 1 clinical trial for KIN-2787 in mid-2021
Ended the quarter with cash and cash equivalents and investments of $383.1 million
Closed $35 million Series A financing of Chinese joint venture in May 2021
SAN FRANCISCO and SAN DIEGO, May 17, 2021 (GLOBE NEWSWIRE) -- Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate”), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, today announced that the U.S Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for KIN-2787 and also announced financial results for the quarter ended March 31, 2021. Kinnate expects to initiate a first-in-human Phase 1 clinical trial of KIN-2787 in patients with mutant BRAF-driven solid tumors in mid-2021.
“In the three years since our founding, Kinnate has consistently hit key milestones essential to our mission of delivering new therapies to patients with difficult-to-treat, genomically-defined cancers. The FDA's clearance of our KIN-2787 IND marks another major achievement for the company and demonstrates the important progress we are making in our transition to becoming a clinical-stage company,” said Nima Farzan, Chief Executive Officer of Kinnate. "As we prepare for our first-in-human trial of KIN-2787 later this year, we are also pleased with the rapid advance of our lead FGFR inhibitor candidate, KIN-3248, which we believe may offer a new option for certain patients with cancers like urothelial tumors or intrahepatic cholangiocarcinoma. We anticipate a first half of 2022 IND filing for KIN-3248."
The Phase 1 trial will evaluate the safety, tolerability, pharmacokinetics and anti-cancer activity of KIN-2787 in cancer patients with mutant BRAF-driven solid tumors. The dose escalation portion (Part A) of the trial will determine the recommended dose and schedule of KIN-2787 for further evaluation in patients with BRAF mutations. The dose expansion phase (Part B) of the trial will assess the safety and efficacy of KIN-2787 at the recommended dose and schedule in patients with cancers driven by BRAF Class II or III mutations, including lung cancer, melanoma and other selected adult solid tumors.
Recent Business Highlights and Corporate Update:
First Quarter 2021 Financial Results
About Kinnate
Kinnate is focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers. Kinnate’s mission is to expand the reach of targeted therapeutics by developing products for underserved populations. Kinnate utilizes its deep expertise in structure-based drug discovery, translational research, and patient-driven precision medicine, which it refers to as the Kinnate Discovery Engine, to develop targeted therapies. Based in San Francisco and San Diego, California, the Kinnate team is composed of drug discovery experts supported by a distinguished group of scientific advisors. For more information, please visit www.kinnate.com.
Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. These forward-looking statements include, without limitation, statements regarding the potential benefits of our drug discovery activities, the expected timing for our regulatory filings and initiation of our clinical trials and the potential benefits and treatment indications of our product candidates. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are also intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends. Such expectations and projections may never materialize or may prove to be incorrect. These forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors, including risks related to operating as a preclinical-stage biopharmaceutical company with a limited operating history; our ability to raise additional capital to finance our operations; our ability to discover, advance through the preclinical and clinical development of, obtain regulatory approval for and commercialize our product candidates; the novel approach we are taking to discover and develop drugs; our ability to timely file and obtain approval of investigational new drug applications for our planned clinical trials; the potential for any clinical trial results to differ from our preclinical trial results; negative impacts of the COVID-19 pandemic on our business, including planned clinical trials and ongoing and planned preclinical trials; competition in our industry; regulatory developments in the United States and other countries; our ability to attract, hire and retain highly skilled executive officers and employees; difficulties in managing our growth; our ability to protect our intellectual property; reliance on third parties to conduct our preclinical studies and any future clinical trials, and to manufacture our product candidates; general economic and market conditions; and other risks.
These and other risks, uncertainties, assumptions and other factors are further described under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2021 that we are concurrently filing with the Securities and Exchange Commission (the “SEC”), as well as in our subsequent filings we make with the SEC. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Investors should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Our forward-looking statements speak only as of the date of this release, and except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason in the future.
Contacts:
Investors:
Patti Bank
Westwicke, an ICR Company
415-513-1284
investors@kinnate.com
Media:
Colin Sanford
colin@bioscribe.com
Kinnate Biopharma Inc. | |||||||
Condensed Balance Sheets | |||||||
(in thousands, except share and par value amounts) | |||||||
(Unaudited) | |||||||
March 31, 2021 | December 31, 2020 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 182,389 | $ | 365,462 | |||
Short-term investments | 65,808 | 31,398 | |||||
Prepaid expenses and other current assets | 2,975 | 3,343 | |||||
Total current assets | 251,172 | 400,203 | |||||
Property and equipment, net | 283 | 368 | |||||
Long-term investments | 134,910 | - | |||||
Total assets | $ | 386,365 | $ | 400,571 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,212 | $ | 3,940 | |||
Accrued expenses | 4,581 | 3,364 | |||||
Total current liabilities | 7,793 | 7,304 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock, $0.0001 par value; 200,000,000 shares authorized | |||||||
at March 31, 2021 and December 31, 2020; 0 shares outstanding | |||||||
at March 31, 2021 and December 31, 2020 | - | - | |||||
Common stock, $0.0001 par value; 1,000,000,000 shares authorized | |||||||
at March 31, 2021 and December 31, 2020; 43,477,439 shares | |||||||
issued and outstanding at March 31, 2021 and December 31, 2020 | 4 | 4 | |||||
Additional paid-in capital | 449,394 | 446,601 | |||||
Accumulated other comprehensive loss | (40 | ) | (9 | ) | |||
Accumulated deficit | (70,786 | ) | (53,329 | ) | |||
Total stockholders’ equity | 378,572 | 393,267 | |||||
Total liabilities and stockholders’ equity | $ | 386,365 | $ | 400,571 | |||
Kinnate Biopharma Inc. | |||||||
Condensed Statements of Operations and Comprehensive Loss | |||||||
(Unaudited) | |||||||
(in thousands, except share and per share amounts) | |||||||
Three Months Ended March 31, | |||||||
2021 | 2020 | ||||||
Operating expenses: | |||||||
Research and development | $ | 12,666 | $ | 3,198 | |||
General and administrative (includes related party amounts of $0 and $92, respectively) | 4,815 | 955 | |||||
Total operating expenses | 17,481 | 4,153 | |||||
Loss from operations | (17,481 | ) | (4,153 | ) | |||
Other income: | |||||||
Interest income | 403 | 212 | |||||
Other (expense) income, net | (379 | ) | - | ||||
Total other income, net | 24 | 212 | |||||
Net loss | (17,457 | ) | (3,941 | ) | |||
Unrealized loss on investments | (31 | ) | - | ||||
Comprehensive loss | $ | (17,488 | ) | $ | (3,941 | ) | |
Weighted-average shares outstanding, basic and diluted | 43,477,439 | 3,672,446 | |||||
Net loss per share, basic and diluted | $ | (0.40 | ) | $ | (1.07 | ) |