Press Release Details
Cogent Biosciences Provides Corporate Updates and Reports Third Quarter 2021 Financial Results
"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
Recent Program and Corporate Highlights
- SUMMIT trial initiated in NonAdvSM patients
- Cogent initiated SUMMIT, a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial. The study is designed to explore the safety and efficacy of bezuclastinib in patients with moderate to severe Indolent Systemic Mastocytosis (ISM) or Smoldering Systemic Mastocytosis (SSM).
- SUMMIT is designed in three parts. Part 1 will enroll approximately 48 patients across 3 dose cohorts, plus one placebo arm, and is designed to confirm the optimal bezuclastinib dose. In addition, Part 1 will serve to validate a patient-reported outcomes (PRO) tool for use in assessing efficacy during Part 2 of the trial. Part 2 of SUMMIT will be randomized, double-blind, and placebo-controlled at a single dose level and will include a primary endpoint of disease improvement using the PRO tool from Part 1. After participation in Part 1 or Part 2, all patients may receive bezuclastinib in a long-term extension.
- Learn more about the SUMMIT trial at cogentclinicaltrials.com
- APEX trial on track for preliminary clinical data readout in the first half of 2022
- Cogent is currently enrolling APEX, a Phase 2 clinical trial of bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM) and expects to report preliminary clinical data at a scientific conference during the first half of 2022, including levels of serum tryptase, a validated biomarker of mast cell activity.
- Learn more about the APEX trial at cogentclinicaltrials.com.
- PEAK trial of bezuclastinib and sunitinib for GIST patients to start in 2021
- Following recent positive interactions with the FDA, Cogent remains on track to initiate PEAK, a Phase 3 clinical trial of bezuclastinib in combination with sunitinib in imatinib-resistant GIST patients, during 2021.
- Announces updated bezuclastinib formulation in partnership with Serán Biosciences
- Leveraging Serán's expertise in formulation and process optimization, an updated formulation of bezuclastinib has been developed. This formulation is expected to reduce the number of daily tablets, improving the overall patient experience.
- Updated formulation will be used in PEAK trial beginning in 2021.
- Presented new preclinical data supporting bezuclastinib as potential best-in-class KIT inhibitor
- Preclinical data presented at the 2021
AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics showed further evidence of bezuclastinib as a differentiated, potent, and selective KIT inhibitor. - In head-to-head studies comparing several commercial and development-stage KIT mutant inhibitors, bezuclastinib demonstrated minimal activity against closely related kinases, including PDGFR.
- In a nonclinical safety pharmacology study in rodents, bezuclastinib demonstrated minimal brain penetration with a low brain-to-plasma ratio.
- Appointed
Dana Martin as ChiefPatient Officer & Senior Vice President, Medical Affairs Dr. Martin joins with over 20 years of experience in the biopharmaceutical industry. Prior to joining Cogent, he held several roles of increasing leadership responsibility in the areas of clinical pharmacy, medical affairs, and patient advocacy atGenzyme Corporation , Synageva BioPharma, Sarepta Therapeutics, and Kiniksa Pharmaceuticals.Dr. Martin has contributed to the clinical development and/or product launch of multiple rare disease therapeutics, including first-to-market treatments for Fabry disease, Pompe disease, lysosomal acid lipase deficiency, and Duchenne muscular dystrophy. He holds a Bachelor of Science in pharmacy and a Doctor of Pharmacy fromMassachusetts College of Pharmacy-Boston .- Appointed
Courtney Watson as Vice President of Clinical Development Operations Mrs. Watson joins Cogent with nearly 15 years of experience in the biopharmaceutical industry. Prior to joining Cogent,Mrs. Watson was the Head of Clinical Operations at Fusion Pharmaceuticals. Previously, she served in various Clinical Operations roles of increasing responsibility at Forma Therapeutics, Synageva BioPharma, and Ziopharm Oncology.Mrs. Watson holds a Bachelor of Arts from theUniversity of Southern Maine .
Third Quarter 2021 Summarized Financial Results
- R&D Expenses: Research and development expenses were
$14.8 million for the third quarter of 2021 as compared to$5.0 million for the third quarter of 2020. Research and development expenses include non-cash stock compensation expense of$1.4 million for the third quarter of 2021 compared to$1.9 million for the third quarter of 2020. - G&A Expenses: General and administrative expenses were
$5.0 million for the third quarter of 2021 as compared to$5.6 million for the third quarter of 2020. General and administrative expenses include non-cash stock compensation expense of$2.0 million for the third quarter of 2021 compared to$1.6 million for the third quarter of 2020. - Net Loss: Net loss was
$19.1 million for the third quarter of 2021 as compared to a net loss of$50.0 million for the third quarter of 2020, which included$46.9 million resulting from the accounting treatment related to the asset acquisition ofKiq LLC . During the third quarter of 2021, the company spent$15.2 million of its cash and cash equivalents. - Cash and Cash Equivalents: As of
September 30, 2021 , Cogent had cash and cash equivalents of$202.9 million . The company believes that its cash and cash equivalents will be sufficient to fund its 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; 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
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
||||||||||||||||
(in thousands, except share and per share amounts) |
||||||||||||||||
(unaudited) |
||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
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) |
|
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CONSOLIDATED SELECTED BALANCE SHEET DATA |
||||||
(in thousands, except share and per share amounts) |
||||||
(unaudited) |
||||||
|
|
|||||
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 |
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SOURCE
Media contact: Amanda Sellers, asellers@vergescientific.com, 301.332.5574