Full Press Release Details
Cogent Biosciences Provides Corporate Updates and
Reports Third Quarter 2021 Financial Results
Initiated SUMMIT, a Phase 2 clinical trial of bezuclastinib for Nonadvanced Systemic Mastocytosis (NonAdvSM) patients
PEAK, a Phase 3 clinical trial of bezuclastinib and sunitinib for Gastrointestinal Stromal Tumor (GIST) patients, remains on track for 2021 start following positive FDA discussions
Presented new preclinical data demonstrating bezuclastinib as a differentiated KIT inhibitor with minimal brain penetration
Ended Q3 2021 with $202.9 million in cash, sufficient to fund operations into 2024
CAMBRIDGE, Mass. and BOULDER, Colo., November 10, 2021 - Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced financial results for the third quarter ended September 30, 2021 and provided corporate updates.
"We are pleased to announce that we have started the SUMMIT trial, a Phase 2 study of bezuclastinib in patients with nonadvanced systemic mastocytosis," said Andrew Robbins, President and CEO of Cogent Biosciences. "Based on recently presented preclinical data, we believe that bezuclastinib has best-in-class potential as a highly potent and selective KIT mutant inhibitor and look forward to initiating the PEAK trial for GIST patients in the coming weeks."
Recent Program and Corporate Highlights
Third Quarter 2021 Summarized Financial Results
About Cogent Biosciences, Inc.
Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition to bezuclastinib, the newly formed Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases. Cogent Biosciences is based in Cambridge, MA and Boulder, CO. Visit our website for more information at
www.cogentbio.com. Follow Cogent Biosciences on social media: Twitter and LinkedIn. Information that may be important to investors will be routinely posted on our website and Twitter.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: discussion of the company's business and operations; projected cash runways; future product development plans; clinical
development plans and timelines for its lead program, bezuclastinib, including the expectation to initiate the PEAK trial before the end of 2021, as well as the anticipated timeline for reporting clinical data from the APEX trial in 2022; the potential for bezuclastinib to be a best-in-class KIT mutant inhibitor; and the expected benefits of the updated bezuclastinib formulation planned for use in the PEAK trial. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogents' most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
COGENT BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Collaboration revenue | $ | - | $ | 312 | $ | - | $ | 7,871 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 14,798 | 5,003 | 35,399 | 19,630 | ||||||||||||
| General and administrative | 5,021 | 5,598 | 14,512 | 12,074 | ||||||||||||
| Acquired in-process research and development | - | 46,910 | - | 46,910 | ||||||||||||
| Total operating expenses | 19,819 | 57,511 | 49,911 | 78,614 | ||||||||||||
| Loss from operations | (19,819 | ) | (57,199 | ) | (49,911 | ) | (70,743 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 115 | 23 | 360 | 73 | ||||||||||||
| Gain on disposal of long-lived assets | - | 7,463 | - | 7,470 | ||||||||||||
| Other income | 620 | 239 | 1,847 | 239 | ||||||||||||
| Change in fair value of CVR liability | - | (509 | ) | 343 | (509 | ) | ||||||||||
| Total other income | 735 | 7,216 | 2,550 | 7,273 | ||||||||||||
| Net loss and comprehensive loss | $ | (19,084 | ) | $ | (49,983 | ) | $ | (47,361 | ) | $ | (63,470 | ) |
COGENT BIOSCIENCES, INC.
CONSOLIDATED SELECTED BALANCE SHEET DATA
(in thousands, except share and per share amounts)
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Cash and cash equivalents | $ | 202,888 | $ | 242,190 | ||||
| Working capital | $ | 190,795 | $ | 231,818 | ||||
| Total assets | $ | 215,385 | $ | 250,916 | ||||
| Total liabilities | $ | 18,147 | $ | 16,249 | ||||
| Total stockholders' equity | $ | 197,238 | $ | 234,667 |