Workflow
Cogent Biosciences(COGT)
icon
Search documents
Cogent Biosciences(COGT) - 2020 Q1 - Quarterly Report
2020-05-11 20:53
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 Par Value UMRX The Nasdaq Global Select Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commissio ...
Cogent Biosciences(COGT) - 2019 Q4 - Annual Report
2020-03-26 20:06
Financial Position - The company has cash and cash equivalents of $37.4 million and available borrowings of $15.0 million as of December 31, 2019, but expects these will not be sufficient to fund operations for at least 12 months [24]. - The company has raised a total of $77.3 million from preferred stock sales since its inception in March 2014 [35]. - The initial public offering (IPO) in April 2018 resulted in net proceeds of approximately $61.5 million from the sale of 5,770,000 shares at $12.00 per share [36]. - A shelf registration statement allows the company to sell up to $150 million of various securities, including common stock, preferred stock, and debt securities [37]. - As of December 31, 2019, the company received a total of $48.2 million under the Collaboration Agreement, including $25.0 million in upfront payments and $18.2 million in research and development funding [98]. Strategic Focus - The company plans to prioritize resources towards the BOXR1030 program, reducing its workforce by approximately 60% (43 employees) to focus on this initiative [18]. - The company plans to submit an investigational new drug (IND) application for BOXR1030 to the FDA in late 2020 [18]. - The company is focused on developing a pipeline of adoptive cell therapies to transform cancer treatment and deliver patient cures in solid tumors [20]. - The company plans to expand its pipeline with a focus on solid tumor product candidates using the BOXR platform [42]. - The company aims to leverage its process development capabilities to create a competitive advantage in T cell manufacturing [42]. Product Development - BOXR1030 is engineered to target tumor cells expressing GPC3 and incorporates the transgene GOT2 to enhance T cell function in the tumor microenvironment [25]. - In preclinical studies, BOXR1030 T cells showed improved proliferation under hypoxic and low glucose conditions compared to control CAR-T cells, demonstrating superior activity in vivo [25]. - The company anticipates concluding its ACTR707 clinical trials, including the Phase 1 trial in combination with rituximab for relapsed or refractory non-Hodgkin lymphoma [19]. - A complete response rate of 40% was achieved in the ATTCK-20-03 trial for ACTR707 in combination with rituximab, with no dose-limiting toxicities reported [29]. - The BOXR platform aims to improve T cell functionality and target solid tumors more effectively, addressing challenges faced by existing CAR-T therapies [22]. Collaborations and Partnerships - The company has terminated its collaboration with Seattle Genetics for the ACTR087 program, reallocating resources towards other programs [30]. - The company is collaborating with Seattle Genetics to develop novel antibody-coupled ACTR therapies, enhancing its product pipeline [95]. - The company has received $25.0 million in upfront payments and $18.2 million in R&D funding from Seattle Genetics as part of a strategic collaboration [35]. - The company has a license agreement with the National University of Singapore and St. Jude Children's Research Hospital, which includes tiered royalties based on annual net sales of licensed products [101][102]. Regulatory Environment - The company must comply with extensive government regulations regarding the research, development, and marketing of pharmaceutical products, which require significant time and financial resources [109][111]. - The company is required to conduct non-clinical testing and submit an Investigational New Drug application (IND) to the FDA before commencing human clinical trials [114][116]. - Clinical trials must adhere to Good Clinical Practice (GCP) requirements and are subject to FDA oversight, which may impose clinical holds if safety concerns arise [118]. - The FDA has 60 days to conduct an initial review of a BLA submission to determine if it is sufficient for filing [130]. - The FDA may designate a product for fast track review if it addresses an unmet medical need for a serious or life-threatening condition [137]. Competition and Market Challenges - The company faces substantial competition from various organizations developing advanced T cell therapies and other oncology therapies, including companies like Kite Pharma and Novartis AG [107]. - The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies and intense competition, with many competitors having greater financial resources and expertise [108]. - Coverage and reimbursement for product candidates depend on third-party payors, with significant uncertainty regarding their decisions impacting sales and financial condition [176]. - Companies may need to conduct pharmacoeconomic studies to demonstrate the cost-effectiveness of products to secure coverage and reimbursement [178]. Legal and Compliance Issues - The company is subject to various federal and state healthcare laws, which could result in significant monetary penalties and impact future operations [186]. - The company is impacted by the General Data Protection Regulation (GDPR), which may increase compliance costs and potential liabilities [188]. - The company is subject to federal transparency requirements under the Physician Payments Sunshine Act, which mandates annual reporting of payments to healthcare providers [190]. - The company has no current legal proceedings but acknowledges that litigation can have adverse impacts due to costs and resource diversion [200]. Risk Factors - The company emphasizes the importance of reviewing risk factors and uncertainties that may impact business operations, as outlined in the Annual Report on Form 10-K [208]. - The company faces potential legislative changes aimed at reducing healthcare costs, which could adversely affect anticipated revenues from product candidates [195].
Unum Therapeutics (UMRX) Investor Presentation - Slideshow
2020-03-05 11:57
| --- | --- | --- | --- | |------------------------------------------------|-------|-------|-------| | | | | | | | | | | | Delivering novel cell therapies to cure cancer | | | | | CORPORATE PRESENTATION MARCH 2020 | | | | Forward-Looking Statements and Risk Factors This presentation and the accompanying oral commentary contain forward-looking statements that involve risks, uncertainties and assumptions. If the risks or uncertainties ever materialize or the assumptions prove incorrect, our results may differ ...
Unum Therapeutics (UMRX) Investor Presentation - Slideshow
2019-12-06 16:37
UNUM THERAPEUTICS CORPORATE PRESENTATION DECEMBER 2019 FORWARD-LOOKING STATEMENTS AND RISK FACTORS This presentation and the accompanying oral commentary contain forward-looking statements that involve risks, uncertainties and assumptions. If the risks or uncertainties ever materialize or the assumptions prove incorrect, our results may differ materially from those expressed or implied by such forward looking statements. All statements other than statements of historical fact could be deemed forward-looking ...
Cogent Biosciences(COGT) - 2019 Q3 - Quarterly Report
2019-11-12 21:49
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | --- | --- | |------------------------------------------------------------------------------------------------------------------------------|----------- ...
Unum Therapeutics (UMRX) Investor Presentation - Slideshow
2019-09-16 17:31
UNUM THERAPEUTICS CORPORATE PRESENTATION SEPTEMBER 2019 FORWARD-LOOKING STATEMENTS AND RISK FACTORS This presentation and the accompanying oral commentary contain forward-looking statements that involve risks, uncertainties and assumptions. If the risks or uncertainties ever materialize or the assumptions prove incorrect, our results may differ materially from those expressed or implied by such forward looking statements. All statements other than statements of historical fact could be deemed forward-lookin ...
Unum Therapeutics (UMRX) Presents At Wedbush PacGrow Healthcare Conference - Slideshow
2019-08-15 18:30
UNUM THERAPEUTICS WEDBUSH PACGROW HEALTHCARE CONFERENCE AUGUST 2019 FORWARD-LOOKING STATEMENTS AND RISK FACTORS This presentation and the accompanying oral commentary contain forward-looking statements that involve risks, uncertainties and assumptions. If the risks or uncertainties ever materialize or the assumptions prove incorrect, our results may differ materially from those expressed or implied by such forward looking statements. All statements other than statements of historical fact could be deemed fo ...
Unum Therapeutics (UMRX) Investor Presentation - Slideshow
2019-08-13 16:23
UNUM THERAPEUTICS CORPORATE PRESENTATION AUGUST 2019 FORWARD-LOOKING STATEMENTS AND RISK FACTORS This presentation and the accompanying oral commentary contain forward-looking statements that involve risks, uncertainties and assumptions. If the risks or uncertainties ever materialize or the assumptions prove incorrect, our results may differ materially from those expressed or implied by such forward looking statements. All statements other than statements of historical fact could be deemed forward-looking, ...
Cogent Biosciences(COGT) - 2019 Q2 - Earnings Call Transcript
2019-08-13 02:41
Unum Therapeutics Inc. (UMRX) Q2 2019 Earnings Conference Call August 12, 2019 4:30 PM ET Corporate Participants Chuck Wilson - Chief Executive Officer Jessica Sachs - Chief Medical Officer Seth Ettenberg - Chief Scientific Officer Matt Osborne - Chief Financial Officer Conference Call Participants Vikram Purohit - Morgan Stanley Peter Lawson - SunTrust Robinson Leo Li - Cowen Operator Good afternoon, and welcome to the Unum Therapeutics' Quarterly Investor Conference Call. Today, we will be showing update ...
Cogent Biosciences(COGT) - 2019 Q2 - Quarterly Report
2019-08-12 20:19
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | |------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------- ...