Full Press Release Details
Cogent Biosciences Provides Corporate Updates and
Reports Second Quarter 2021 Financial Results
Initiated Phase 2 open-label clinical study (APEX) for bezuclastinib (CGT9486) in patients with Advanced Systemic Mastocytosis (AdvSM)
SUMMIT study for patients with Non-Advanced Systemic Mastocytosis (NonAdvSM) on track to
start 2H 2021 following recent positive interactions with FDA
Formed Cogent Scientific Advisory Board, including several
world-class experts in targeted therapy
Ended Q2 2021 with $218.1 million in cash, sufficient to fund operations into 2024
CAMBRIDGE, Mass. and BOULDER, Colo., August 16, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company
focused on developing precision therapies for genetically defined diseases, today announced financial results for the second quarter ended June 30, 2021 and provided corporate updates.
People fighting advanced systemic mastocytosis live every day in need of additional treatment options. We initiated the Phase 2 APEX clinical study for
our lead program bezuclastinib, designed to specifically target the underlying genetic cause of advanced systemic mastocytosis with the goal of providing new therapeutic options for patients, said Andrew Robbins, President and CEO of Cogent
Biosciences. In addition, we look forward to advancing bezuclastinib into two new clinical studies by the end of 2021, including the SUMMIT study for patients with non-advanced systemic mastocytosis,
while actively progressing novel discovery programs with the recently formed Cogent Research Team.
Recent Program and Corporate Highlights
Second 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 including for its lead program, bezuclastinib, and the expectation to initiate two new clinical trials before the end of 2021; the anticipated contributions of the Cogent Research
Team; and the company s expectation to report preliminary data from its Apex study in the first half of 2022. 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 June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Collaboration revenue | $ | $ | 528 | $ | $ | 7,559 | ||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 12,388 | 5,129 | 20,601 | 14,627 | ||||||||||||
| General and administrative | 4,904 | 2,802 | 9,491 | 6,476 | ||||||||||||
| Total operating expenses | 17,292 | 7,931 | 30,092 | 21,103 | ||||||||||||
| Loss from operations | (17,292 | ) | (7,403 | ) | (30,092 | ) | (13,544 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 120 | 3 | 245 | 50 | ||||||||||||
| Other income | 623 | 7 | 1,227 | 7 | ||||||||||||
| Change in fair value of CVR liability | 343 | |||||||||||||||
| Total other income | 743 | 10 | 1,815 | 57 | ||||||||||||
| Net loss and comprehensive loss | $ | (16,549 | ) | $ | (7,393 | ) | $ | (28,277 | ) | $ | (13,487 | ) | ||||
| Net loss per share attributable to common shareholders, basic and diluted | $ | (0.43 | ) | $ | (0.95 | ) | $ | (0.77 | ) | $ | (1.76 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 38,441,729 | 7,777,487 | 36,670,353 | 7,655,837 |
COGENT BIOSCIENCES, INC.
CONSOLIDATED SELECTED BALANCE SHEET DATA
| June 30, 2021 | December 31, 2020 | |||||||
| Cash and cash equivalents | $ | 218,105 | $ | 242,190 | ||||
| Working capital | $ | 207,669 | $ | 231,818 | ||||
| Total assets | $ | 228,516 | $ | 250,916 | ||||
| Total liabilities | $ | 15,712 | $ | 16,249 | ||||
| Total stockholders equity | $ | 212,804 | $ | 234,667 |