Press Release Details
Cogent Biosciences Reports Fourth Quarter 2020 and Full Year 2020 Financial Results
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Recent Program and Corporate Highlights
- Encouraging data from CGT9486 + sunitinib in Phase 1/2 combination study in heavily pre-treated patients with GIST support a randomized trial in 2H21
- Data presented at the
Connective Tissue Oncology Society (CTOS) 2020 virtual meeting demonstrated that treatment with a combination of CGT9486, a KIT inhibitor with activity against exon 17 mutations, and sunitinib, a KIT inhibitor with activity against exon 13 mutations, is associated with encouraging clinical activity in heavily pre-treated patients with GIST. - Data showed median progression free survival (PFS) of 12 months in a heavily pre-treated population of advanced GIST patients and an objective response rate (ORR) of 20%.
- The combination was well-tolerated across three dose levels with no maximum tolerated dose level reached. The most common minor adverse events were anemia, hypophosphatemia, diarrhea, and lymphopenia.
- Based on these encouraging data, Cogent plans to initiate a randomized trial in patients with imatinib-resistant GIST during the second half of 2021.
- Upsized Public Offering with gross proceeds of approximately
$115 million support advancement of CGT9486 into three clinical trials in 2021 - On
December 4, 2020 ,Cogent Biosciences announced the closing of its upsized underwritten public offering; net proceeds from which will be used for the continued clinical development of CGT9486 to treat patients with systemic mastocytosis and GIST. - Appointed new individuals to several key leadership positions
Todd E. Shegog to Board of DirectorsMr. Shegog currently serves as the Chief Financial Officer for Forma Therapeutics and brings more than 25 years of financial, operations, corporate strategy, and compliance expertise in the biotechnology and pharmaceutical industries toCogent Biosciences' Board. Todd has past experience as CFO at Synlogic, FORUM, and Millennium and received degrees in electrical engineering fromLafayette College and an MBA from theTepper School of Management atCarnegie Mellon University .Sara Saltzman as Senior Vice President, Regulatory AffairsMs. Saltzman has built extensive experience in Regulatory Affairs working for top-tier life sciences companies such asGenzyme , Takeda, and Alexion; most recently serving as the Vice President of Regulatory Affairs forUnum Therapeutics . Sara holds a degree in Biology fromColby College .Ben Exter as Vice President, Pharmacovigilance and Risk ManagementDr. Exter spent several years in clinical development at Biogen and Takeda, culminating with his role as Global Head of Risk Management at Takeda. Most recently he was VP of Pharmacovigilance atUnum Therapeutics . Ben received his Doctorate of Pharmacy degree fromNortheastern University .Mark Lohman as Vice President, CGT9486 Program Team LeaderMr. Lohman has spent over 20 years in program and alliance management and leadership roles at Array BioPharma and most recently at Pfizer as Executive Director, Alliance and Program Management for Oncology. Mark holds a degree in Chemistry fromKent State University and an MBA from theUniversity of Colorado Denver .
Fourth Quarter and Year End 2020 Summarized Financial Results
- R&D Expenses: Research and development expenses were
$6.1 million for the fourth quarter of 2020 and$25.7 million for the year endedDecember 31, 2020 , as compared to$10.4 million for the fourth quarter of 2019 and$43.7 million for the year endedDecember 31, 2019 . This decrease is primarily related to the reduction in clinical activity of legacy cell therapy clinical trials. - G&A Expenses: General and administrative expenses were
$5.3 million for the fourth quarter of 2020 and$17.4 million for the year endedDecember 31, 2020 , as compared to$2.7 million for the fourth quarter of 2019 and$11.0 million for the year endedDecember 31, 2019 . The increase is primarily related to higher professional fees and stock compensation. - Net Loss: Net loss was
$11.3 million for the fourth quarter of 2020 and$74.8 million for the year endedDecember 31, 2020 as compared to a net income of$2.3 million for the fourth quarter of 2019 and a net loss of$31.8 million for the year endedDecember 31, 2019 . - Cash and Cash Equivalents: As of
December 31, 2020 ,Cogent Biosciences had cash and cash equivalents of$242.2 million . We believe our cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into 2024.
About
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; upcoming results from clinical trials including from its lead program, CGT9486. 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 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 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
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CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||
(in thousands, except share and per share amounts) |
||||||||||||||||
(unaudited) |
||||||||||||||||
Year Ended |
Three Months Ended |
|||||||||||||||
2020 |
2019 |
2020 |
2019 |
|||||||||||||
Collaboration revenue |
$ |
7,871 |
$ |
22,499 |
$ |
— |
$ |
15,288 |
||||||||
Operating expenses: |
||||||||||||||||
Research and development |
25,738 |
43,709 |
6,107 |
10,354 |
||||||||||||
General and administrative |
17,422 |
10,968 |
5,348 |
2,694 |
||||||||||||
Acquired in-process research and development |
46,910 |
— |
— |
— |
||||||||||||
Total operating expenses |
90,070 |
54,677 |
11,455 |
13,048 |
||||||||||||
Loss from operations |
(82,199) |
(32,178) |
(11,455) |
2,240 |
||||||||||||
Other income (expense): |
||||||||||||||||
Interest income |
144 |
267 |
70 |
61 |
||||||||||||
Gain on disposal of long-lived assets |
7,493 |
78 |
31 |
— |
||||||||||||
Other income |
779 |
— |
531 |
(4) |
||||||||||||
Change in fair value of CVR liability |
(1,025) |
— |
(516) |
— |
||||||||||||
Total other income (expense), net |
7,391 |
345 |
116 |
57 |
||||||||||||
Net income (loss) |
$ |
(74,808) |
$ |
(31,833) |
$ |
(11,339) |
$ |
2,297 |
||||||||
Net income (loss) attributable to common shareholders |
$ |
(179,208) |
$ |
(31,833) |
$ |
(115,739) |
$ |
2,297 |
||||||||
Net loss per common share, basic and diluted |
$ |
(16.17) |
$ |
(4.18) |
$ |
(6.06) |
$ |
0.28 |
||||||||
Weighted average common shares outstanding, basic and diluted |
11,081,257 |
7,620,082 |
19,088,362 |
7,798,905 |
|
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CONSOLIDATED BALANCE SHEETS |
||||||||
(in thousands, except share and per share amounts) |
||||||||
(unaudited) |
||||||||
|
|
|||||||
Cash, cash equivalents and marketable securities |
$ |
242,190 |
$ |
37,424 |
||||
Working capital |
$ |
231,818 |
$ |
27,343 |
||||
Total assets |
$ |
250,916 |
$ |
49,423 |
||||
Total liabilities |
$ |
16,249 |
$ |
17,661 |
||||
Total stockholders' equity |
$ |
234,667 |
$ |
31,762 |
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SOURCE
Amanda Sellers, asellers@vergescientific.com, 301.332.5574