Core Viewpoint - Cogent Biosciences, Inc. has successfully closed an upsized underwritten public offering of 25,555,556 shares of common stock at a price of $9.00 per share, raising approximately $230 million in gross proceeds [1][2]. Group 1: Offering Details - The offering included 3,333,333 shares from the underwriters' option to purchase additional shares [1] - The net proceeds will be utilized for the development and commercial preparation of bezuclastinib and other product candidates, as well as for working capital and general corporate purposes [2]. - J.P. Morgan, Leerink Partners, and Guggenheim Securities served as joint book-running managers for the offering [2]. Group 2: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with its leading clinical program being bezuclastinib, a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [6]. - The company is also conducting a Phase 1 study of a novel FGFR2 inhibitor and is developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [6].

[Introduction to the Underwriting Agreement](index=1&type=section&id=Introduction) This section outlines the proposed issuance and sale of common stock by Cogent Biosciences, Inc. and the roles of the underwriting representatives - Cogent Biosciences, Inc. proposes to issue and sell **22,222,223 shares** of common stock ('Firm Shares') and an additional **3,333,333 shares** ('Additional Shares') if the Underwriters exercise their option[1](index=1&type=chunk) - **J.P. Morgan Securities LLC, Leerink Partners LLC, and Guggenheim Securities, LLC** are acting as representatives for the Underwriters[1](index=1&type=chunk) - The Company has filed an **automatic shelf registration statement on Form S-3** with the SEC, including a prospectus for the securities[1](index=1&type=chunk) - Key terms like 'Registration Statement,' 'Prospectus,' 'Time of Sale Prospectus,' and 'free writing prospectus' are defined, including documents incorporated by reference[2](index=2&type=chunk)[3](index=3&type=chunk) [1. Representations and Warranties](index=2&type=section&id=1.%20Representations%20and%20Warranties) The Company provides assurances regarding its legal, financial, and operational status, including SEC filings, corporate authority, and regulatory compliance [1.1. Securities Filings and Disclosure Accuracy](index=2&type=section&id=1.1.%20Securities%20Filings%20and%20Disclosure%20Accuracy) The Company represents that its SEC filings, including the Registration Statement, Prospectus, Time of Sale Prospectus, and any free writing prospectuses, comply materially with applicable laws and regulations, are free from material misstatements or omissions, and that the Company is a 'well-known seasoned issuer' Statistical and forward-looking data are also affirmed for reliability and proper disclosure - The Registration Statement is an '**automatic shelf registration statement**' and became automatically effective upon filing; no stop order is in effect or threatened[4](index=4&type=chunk) - Each document incorporated by reference, the Registration Statement, the Prospectus, and the Time of Sale Prospectus, complied or will comply materially with the Securities Act and Exchange Act, and do not contain untrue statements or omissions of material fact[5](index=5&type=chunk)[6](index=6&type=chunk)[20](index=20&type=chunk)[60](index=60&type=chunk) - The Company is not an 'ineligible issuer' and is a '**well-known seasoned issuer**'; all required free writing prospectuses have been or will be filed and comply materially with the Securities Act[7](index=7&type=chunk) - All statistical, demographic, and market-related data in the filings are based on reliable and accurate sources Forward-looking statements are included in good faith with a reasonable basis and accompanied by meaningful cautionary statements[64](index=64&type=chunk)[66](index=66&type=chunk) [1.2. Corporate Status and Authority](index=3&type=section&id=1.2.%20Corporate%20Status%20and%20Authority) The Company and its subsidiaries are duly incorporated, validly existing, and in good standing, possessing the necessary corporate power and qualifications to conduct their business The Agreement is duly authorized, and all capital stock, including the Shares being offered, is properly authorized, validly issued, fully paid, and non-assessable - The Company is duly incorporated, validly existing, in good standing under Delaware law, and has the corporate power and authority to own its property and conduct its business[8](index=8&type=chunk) - Each subsidiary is duly incorporated, validly existing, in good standing, and its issued capital stock is duly authorized, validly issued, fully paid, non-assessable, and owned directly by the Company, free and clear of all liens[9](index=9&type=chunk) - This Agreement has been duly authorized, executed, and delivered by the Company[10](index=10&type=chunk) - The Shares have been duly authorized and, when issued and delivered, will be validly issued, fully paid, and non-assessable, without being subject to any preemptive or similar rights[13](index=13&type=chunk) [1.3. Compliance with Laws and Regulations](index=4&type=section&id=1.3.%20Compliance%20with%20Laws%20and%20Regulations) The Company asserts its material compliance with a wide array of laws and regulations, including those governing environmental protection, anti-corruption, anti-money laundering, sanctions, healthcare, and data privacy (HIPAA, GDPR) It also confirms that the offering will not contravene any applicable laws or corporate documents - The execution and delivery of the Agreement and the issuance of Shares will not contravene applicable law, the Company's organizational documents, or material agreements, and no governmental consents are required (except Blue Sky laws)[14](index=14&type=chunk) - The Company and its subsidiaries are in compliance with Environmental Laws, possess all required permits, and have no material environmental liabilities[22](index=22&type=chunk)[23](index=23&type=chunk) - The Company, its subsidiaries, and affiliates comply with applicable anti-corruption laws and Anti-Money Laundering Laws, and will not use offering proceeds in violation of such laws or Sanctions[25](index=25&type=chunk)[27](index=27&type=chunk)[29](index=29&type=chunk) - The Company and its subsidiaries are in material compliance with all Applicable Laws (including those related to product candidates), possess all material Authorizations, and have conducted preclinical and clinical trials in material compliance with accepted scientific standards and laws[37](index=37&type=chunk)[39](index=39&type=chunk) - The Company and its subsidiaries are in material compliance with all applicable state and federal data privacy and security laws and regulations, including HIPAA and GDPR, and have implemented commercially reasonable controls for IT Systems and Personal Data[67](index=67&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk) [1.4. Financial Information and Controls](index=11&type=section&id=1.4.%20Financial%20Information%20and%20Controls) The Company affirms that its consolidated financial statements fairly present its financial position in accordance with GAAP and SEC requirements It also confirms the maintenance of effective internal accounting controls and disclosure controls, and compliance with tax filing and payment obligations - **PricewaterhouseCoopers LLP** is an independent public accountant as required by the Securities Act and Commission rules[47](index=47&type=chunk) - The consolidated financial statements present fairly the financial position and results, comply materially with the Securities Act, and are prepared in conformity with GAAP (with exceptions for unaudited interim statements)[48](index=48&type=chunk)[50](index=50&type=chunk) - The Company and its subsidiaries maintain internal accounting controls sufficient to provide reasonable assurance over financial reporting and asset accountability, with no material weaknesses or changes since the most recent audited fiscal year (except as disclosed)[51](index=51&type=chunk) - The Company maintains effective disclosure controls and procedures designed to comply with Exchange Act requirements[52](index=52&type=chunk) - All required federal, state, local, and foreign tax returns have been filed or extended, and all taxes paid (except for good faith contests with GAAP reserves or non-material failures)[55](index=55&type=chunk)[56](index=56&type=chunk) [1.5. Business Operations and Assets](index=8&type=section&id=1.5.%20Business%20Operations%20and%20Assets) The Company represents that it holds good and marketable title to its material personal property and valid leases for real property It also confirms ownership or valid licenses for all material intellectual property, compliance with labor laws, adequate insurance coverage, and possession of necessary regulatory permits for its business operations - The Company does not own real property but has good and marketable title to all material personal property, free and clear of liens (except as described or non-material) Leased real property is held under valid, subsisting, and enforceable leases[33](index=33&type=chunk) - The Company and its subsidiaries own or have valid licenses for all material Intellectual Property used in their business, and such IP is valid, enforceable, and subsisting (except as disclosed) There are no material infringement claims or challenges to IP rights[34](index=34&type=chunk) - All patent and patent applications owned or licensed by the Company have been duly filed, prosecuted, and maintained in all material respects[36](index=36&type=chunk) - No material labor dispute exists or is imminent, and there are no threatened labor disturbances from principal suppliers, manufacturers, or contractors that would have a material adverse effect[42](index=42&type=chunk) - The Company and its subsidiaries are insured by financially responsible insurers against prudent and customary losses and risks, and possess all necessary regulatory certificates, authorizations, and permits[45](index=45&type=chunk)[46](index=46&type=chunk) [1.6. Other Representations](index=5&type=section&id=1.6.%20Other%20Representations) This section includes various other representations, such as the absence of material adverse changes since the Time of Sale Prospectus, no significant pending legal proceedings, no recent stock sales outside of employee plans, no securities ratings, and compliance with Nasdaq listing requirements It also confirms no market manipulation activities and proper disclosure of related-party transactions - There has been no material adverse change or development in the Company's condition, earnings, business, management, prospects, or operations since the Time of Sale Prospectus[18](index=18&type=chunk) - No material legal or governmental proceedings are pending or threatened against the Company or its subsidiaries (except as described or non-material)[19](index=19&type=chunk) - Subsequent to the dates of information in the filings, no material liabilities or transactions have occurred, no stock repurchases (except for employee/consultant departures), no non-ordinary dividends, and no material changes in capital stock or debt (except as described)[31](index=31&type=chunk) - The Company has not sold, issued, or distributed any Common Stock in the six-month period preceding the agreement, other than shares issued pursuant to employee benefit plans or outstanding options/warrants[53](index=53&type=chunk) - The Shares are listed on the **Nasdaq Global Select Market**, and the Company is in compliance with all applicable listing requirements[57](index=57&type=chunk) - The Company has not taken any action designed to stabilize or manipulate the price of the Shares or any reference security, or to violate Regulation M[61](index=61&type=chunk) [2. Agreements to Sell and Purchase](index=15&type=section&id=2.%20Agreements%20to%20Sell%20and%20Purchase) This section details the Company's agreement to sell Firm Shares to the Underwriters and the option for Additional Shares - The Company agrees to sell **22,222,223 Firm Shares** to the Underwriters at a Purchase Price of **$8.46 per share**[70](index=70&type=chunk) - The Underwriters have an option to purchase up to an additional **3,333,333 shares** ('Additional Shares') at the Purchase Price[71](index=71&type=chunk) - The option can be exercised in whole or in part by written notice within 30 days after the agreement date ('Option Period')[71](index=71&type=chunk) [3. Terms of Public Offering](index=16&type=section&id=3.%20Terms%20of%20Public%20Offering) This section specifies the initial public offering price per share and the concession offered to dealers - The Shares are to be offered to the public initially at a price of **$9.00 per Firm Share**[73](index=73&type=chunk) - A concession not exceeding **$0.324 per Firm Share** will be offered to certain dealers selected by the Representatives[73](index=73&type=chunk) [4. Payment and Delivery](index=16&type=section&id=4.%20Payment%20and%20Delivery) This section outlines the payment schedule and delivery procedures for the Firm Shares and any Additional Shares - Payment for Firm Shares will be made on **July 10, 2025** ('Closing Date'), or a designated date not later than **July 24, 2025**, in immediately available funds[74](index=74&type=chunk) - Payment for any Additional Shares will be made on the specified 'Option Closing Date,' not later than **August 8, 2025**[74](index=74&type=chunk) - Shares will be delivered to the Representatives, registered as requested, with transfer taxes paid, against payment of the Purchase Price[75](index=75&type=chunk) [5. Conditions to the Underwriters' Obligations](index=16&type=section&id=5.%20Conditions%20to%20the%20Underwriters'%20Obligations) The Underwriters' obligations are contingent upon the accuracy of the Company's representations, the absence of adverse changes, and receipt of legal and financial documentation - The Underwriters' obligations are subject to the accuracy of the Company's representations and warranties as of the agreement date and Closing Date, and the effectiveness of the Registration Statement[76](index=76&type=chunk) - No stop order suspending the Registration Statement's effectiveness shall be in effect, and no material adverse change in the Company's condition, earnings, business, prospects, or operations shall have occurred since the Time of Sale Prospectus that makes marketing impracticable[77](index=77&type=chunk)[78](index=78&type=chunk) - The Underwriters must receive various legal opinions and negative assurance letters from Company counsel (Gibson, Dunn & Crutcher LLP, Goodwin Procter LLP) and Underwriters' counsel (Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.)[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk) - Receipt of 'comfort letters' from **PricewaterhouseCoopers LLP** and certificates from the Company's executive officer and CFO confirming representations, compliance, and financial information accuracy is required[79](index=79&type=chunk)[86](index=86&type=chunk)[88](index=88&type=chunk) - Lock-up agreements with certain shareholders, officers, and directors must be in full force and effect[87](index=87&type=chunk) [6. Covenants of the Company](index=19&type=section&id=6.%20Covenants%20of%20the%20Company) The Company commits to various actions, including SEC filing updates, expense payments, and restrictions on stock sales during a lock-up period - The Company covenants to furnish copies of all SEC filings and amendments to the Representatives, and to promptly advise them of any significant developments related to the Registration Statement or Prospectus[91](index=91&type=chunk)[92](index=92&type=chunk)[99](index=99&type=chunk) - The Company will prepare and furnish amendments or supplements to the Time of Sale Prospectus or Prospectus if necessary to prevent misleading statements or ensure compliance with applicable law[95](index=95&type=chunk)[96](index=96&type=chunk) - The Company agrees to pay all expenses incident to the performance of its obligations under the Agreement, including legal, accounting, printing, transfer, listing, and road show costs (with specific limits for Underwriters' counsel fees)[102](index=102&type=chunk)[103](index=103&type=chunk) - During a **60-day 'Restricted Period'** after the Prospectus date, the Company will not offer, sell, or transfer Common Stock or convertible securities, or file related registration statements, without the Representatives' prior written consent[106](index=106&type=chunk) - Exceptions to the lock-up include sales under the agreement, exercise of existing options/warrants, S-8 filings, sales under existing 'at the market' programs (with conditions), and issuances for M&A or strategic transactions (up to **5% of outstanding shares**, with lock-up for recipients)[107](index=107&type=chunk) [7. Covenants of the Underwriters](index=23&type=section&id=7.%20Covenants%20of%20the%20Underwriters) Each Underwriter agrees not to take actions that would necessitate additional free writing prospectus filings by the Company - Each Underwriter covenants not to take any action that would require the Company to file a free writing prospectus under Rule 433(d) that would otherwise not be required[108](index=108&type=chunk) [8. Indemnity and Contribution](index=24&type=section&id=8.%20Indemnity%20and%20Contribution) This section establishes mutual indemnification obligations between the Company and Underwriters for offering document liabilities, with provisions for contribution - The Company agrees to indemnify the Underwriters (and their controlling persons, affiliates, directors, officers) against losses arising from untrue statements or omissions of material fact in the offering documents, except for information furnished by the Underwriters[109](index=109&type=chunk) - Each Underwriter severally agrees to indemnify the Company (and its directors, officers, controlling persons) for losses arising from untrue statements or omissions based on information specifically furnished by that Underwriter for use in the offering documents[110](index=110&type=chunk) - Procedures for notification, retention of counsel, payment of legal fees, and settlement of proceedings are outlined[111](index=111&type=chunk) - If indemnification is unavailable or insufficient, parties will contribute to losses based on relative benefits received from the offering or relative fault, considering factors like intent, knowledge, and opportunity to correct[112](index=112&type=chunk)[113](index=113&type=chunk) - The Underwriters' contribution obligations are several, not joint, and capped at the public offering price of the shares underwritten by them These provisions survive the termination of the agreement and any investigations[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk) [9. Termination](index=26&type=section&id=9.%20Termination) The Underwriters may terminate the agreement under specific adverse market, trading, or geopolitical conditions prior to the Closing Date - The Underwriters may terminate the Agreement if, prior to the Closing Date, certain adverse events occur, including: (i) suspension or material limitation of trading on major exchanges, (ii) suspension of Company securities trading, (iii) material disruption in securities settlement services, (iv) a moratorium on commercial banking activities, or (v) any outbreak of hostilities, change in financial markets, or calamity/crisis making the offering impracticable or inadvisable[116](index=116&type=chunk) [10. Effectiveness; Defaulting Underwriters](index=27&type=section&id=10.%20Effectiveness%3B%20Defaulting%20Underwriters) The agreement becomes effective upon execution, with provisions for handling defaulting Underwriters and Company reimbursement for termination due to non-compliance - The Agreement becomes effective upon execution and delivery by the parties[118](index=118&type=chunk) - If defaulting Underwriters fail to purchase shares, non-defaulting Underwriters may be obligated to purchase their proportional share if the default is not more than **one-tenth** of the total shares[119](index=119&type=chunk) - If the default exceeds **one-tenth** and no satisfactory arrangements are made within **36 hours**, the Agreement may terminate without liability for non-defaulting Underwriters or the Company[119](index=119&type=chunk) - The Company will reimburse Underwriters for out-of-pocket expenses if the Agreement is terminated due to the Company's non-compliance or inability to perform its obligations[120](index=120&type=chunk) [11. Entire Agreement](index=28&type=section&id=11.%20Entire%20Agreement) This agreement constitutes the complete understanding between the Company and Underwriters, clarifying their arm's-length relationship and absence of fiduciary duties - This Agreement, along with any contemporaneous and prior written agreements related to the offering, constitutes the entire agreement between the Company and the Underwriters[122](index=122&type=chunk) - The Company acknowledges that the Underwriters act at arm's length, are not agents, owe no fiduciary duties, and are not providing legal, tax, investment, accounting, or regulatory advice[123](index=123&type=chunk) - The Company waives any claims against the Underwriters arising from an alleged breach of fiduciary duty[123](index=123&type=chunk) [12. Counterparts](index=28&type=section&id=12.%20Counterparts) The agreement may be executed in multiple counterparts, with electronic delivery and signatures deemed valid - The Agreement may be signed in two or more counterparts, each considered an original[124](index=124&type=chunk) - Delivery of executed counterparts by facsimile or electronic mail (including electronic signatures) is deemed duly and validly delivered[124](index=124&type=chunk) [13. Applicable Law](index=28&type=section&id=13.%20Applicable%20Law) The agreement and related disputes are governed by the internal laws of the State of New York - This Agreement and any related claims or disputes shall be governed by and construed in accordance with the internal laws of the **State of New York**[125](index=125&type=chunk) [14. Waiver of Jury Trial](index=28&type=section&id=14.%20Waiver%20of%20Jury%20Trial) All parties irrevocably waive their right to a jury trial for any disputes arising from this agreement - Each of the parties irrevocably waives any right to trial by jury in any suit or proceeding arising out of or relating to this Agreement[125](index=125&type=chunk) [15. Consent to Jurisdiction](index=28&type=section&id=15.%20Consent%20to%20Jurisdiction) The parties agree to the exclusive jurisdiction of federal and New York State courts in Manhattan for any legal proceedings - Any legal suit, action, or proceeding arising from the Agreement shall be instituted in the federal courts of the United States or the courts of the **State of New York** located in the City and County of New York, Borough of Manhattan[126](index=126&type=chunk) - The parties irrevocably submit to the exclusive jurisdiction of these courts and waive any objection to venue or inconvenient forum[126](index=126&type=chunk) [16. Headings](index=29&type=section&id=16.%20Headings) Section headings are for reference only and do not form part of the agreement's substantive content - The headings of the sections of this Agreement are for convenience of reference only and shall not be deemed a part of this Agreement[128](index=128&type=chunk) [17. Persons Entitled to Benefit of Agreement](index=29&type=section&id=17.%20Persons%20Entitled%20to%20Benefit%20of%20Agreement) The agreement benefits the parties and their successors, but no other persons, including share purchasers, have rights under it - This Agreement shall inure to the benefit of and be binding upon the parties, their respective successors, and the officers, directors, controlling persons, and affiliates referred to herein[129](index=129&type=chunk) - No other person, including purchasers of Shares from any Underwriter, is intended to have any legal or equitable right, remedy, or claim under this Agreement[129](index=129&type=chunk) [18. Survival](index=29&type=section&id=18.%20Survival) Indemnities, contribution rights, representations, warranties, and agreements survive the delivery and payment for shares, remaining in effect despite termination or investigation - The respective indemnities, rights of contribution, representations, warranties, and agreements of the Company and the Underwriters shall survive the delivery of and payment for the Shares[130](index=130&type=chunk) - These provisions shall remain in full force and effect regardless of any termination of this Agreement or any investigation[130](index=130&type=chunk) [19. Compliance with USA Patriot Act](index=29&type=section&id=19.%20Compliance%20with%20USA%20Patriot%20Act) Underwriters are required to obtain and verify client identification information in accordance with the USA Patriot Act - In accordance with the **USA Patriot Act**, the Underwriters are required to obtain, verify, and record information that identifies their respective clients, including the Company[131](index=131&type=chunk) [20. Notices](index=29&type=section&id=20.%20Notices) All communications under the agreement must be in writing and are effective upon receipt, with specific contact details provided - All communications under the Agreement must be in writing and are effective only upon receipt[132](index=132&type=chunk) - Specific contact information, including addresses and attention lines, is provided for notices to the Underwriters (J.P. Morgan, Leerink, Guggenheim) and the Company (Cogent Biosciences, Inc.)[132](index=132&type=chunk) [21. Recognition of the U.S. Special Resolution Regimes](index=30&type=section&id=21.%20Recognition%20of%20the%20U.S.%20Special%20Resolution%20Regimes) This section addresses the applicability of U.S. Special Resolution Regimes to Underwriters, limiting default rights under such regimes - If an Underwriter (defined as a 'Covered Entity') becomes subject to a **U.S. Special Resolution Regime**, the transfer of this Agreement and any related interests/obligations will be effective as if governed by U.S. law[134](index=134&type=chunk) - Default Rights against a Covered Entity Underwriter or its BHC Act Affiliate are limited to the extent exercisable under the **U.S. Special Resolution Regime**[135](index=135&type=chunk) - Definitions for 'BHC Act Affiliate,' 'Covered Entity,' 'Default Right,' and '**U.S. Special Resolution Regime**' are provided[136](index=136&type=chunk) [Signatures](index=31&type=section&id=Signatures) This section contains the formal execution and acceptance of the Underwriting Agreement by the Company and the Underwriters - The Agreement is signed by **John Green, Chief Financial Officer of Cogent Biosciences, Inc.**[138](index=138&type=chunk) - The Agreement is accepted by **Benjamin Burdett (J.P. Morgan Securities LLC), Jon Civitarese (Leerink Partners LLC), and Shiv Taylor (Guggenheim Securities, LLC)** on behalf of themselves and the several Underwriters[138](index=138&type=chunk) [Schedule I: Underwriters and Firm Shares](index=32&type=section&id=Schedule%20I) This schedule details the specific allocation of Firm Shares to be purchased by each Underwriter Number of Firm Shares To Be Purchased by Each Underwriter | Underwriter | Number of Firm Shares | | :---------- | :-------------------- | | J.P. Morgan Securities LLC | 9,777,778 | | Leerink Partners LLC | 6,666,667 | | Guggenheim Securities, LLC | 4,444,445 | | LifeSci Capital LLC | 1,333,333 | | **Total** | **22,222,223** | [Schedule II: Time of Sale Prospectus Information](index=33&type=section&id=Schedule%20II) This schedule provides key offering parameters, including the preliminary prospectus date, public price, and share counts - The preliminary prospectus is dated **July 8, 2025**[142](index=142&type=chunk) - The price per Share to the public is **$9.00**[142](index=142&type=chunk) - The number of Firm Shares offered is **22,222,223**[142](index=142&type=chunk) - The Underwriters' option to purchase Additional Shares is **3,333,333**[142](index=142&type=chunk) [Exhibit A: Form of Lock-Up Letter](index=34&type=section&id=Exhibit%20A) This exhibit presents the form of the lock-up agreement restricting insiders from selling shares for a specified period post-offering - The lock-up letter is intended to induce the Underwriters to continue their efforts in connection with the Public Offering[144](index=144&type=chunk) - During a '**Restricted Period**' of **60 days** after the final prospectus supplement date, the undersigned agrees not to offer, sell, or transfer Common Stock or related securities, or enter into swaps that transfer economic consequences of ownership, without the Representatives' prior written consent[144](index=144&type=chunk) - Key exceptions to the lock-up include shares acquired in the Public Offering or open market, bona fide gifts, distributions to affiliates/family (with donee lock-up), transfers by will, exercise of existing options/warrants (underlying stock remains locked up), transfers by operation of law, repurchases by the Company upon employment termination, establishment of Rule 10b5-1 plans (no transfers during Restricted Period), cashless exercises for tax withholding, and transfers in connection with a Board-approved Change of Control transaction[145](index=145&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk) - The undersigned also agrees not to demand or exercise any registration rights during the Restricted Period and consents to stop transfer instructions[148](index=148&type=chunk) - The lock-up agreement is irrevocable and binding, but automatically terminates under specific conditions, such as the Public Offering not proceeding or the Underwriting Agreement not being executed by **July 31, 2025**[149](index=149&type=chunk)[150](index=150&type=chunk)

Group 1 - The article is authored by Terry Chrisomalis, who operates the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace, offering a two-week free trial for new subscribers [1] - Biotech Analysis Central provides a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and various analysis and news reports to assist healthcare investors [2] Group 2 - The service is priced at $49 per month, with a yearly plan available at a discounted rate of $399, representing a 33.50% discount [1] - The analyst has no current stock or derivative positions in any mentioned companies and does not plan to initiate any within the next 72 hours [3]

Core Viewpoint - Cogent Biosciences, Inc. has announced a public offering of 22,222,223 shares of common stock at a price of $9.00 per share, aiming to raise approximately $200 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 3,333,333 shares on the same terms [1]. - The expected closing date for the offering is around July 10, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the development, regulatory, and commercial preparation activities related to bezuclastinib and other product candidates [2]. - Funds will also support the planned commercial launch of bezuclastinib, along with working capital and general corporate purposes [2]. Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being the most advanced clinical program [5]. - Bezuclastinib is a selective tyrosine kinase inhibitor targeting the KIT D816V mutation, which is associated with systemic mastocytosis and advanced gastrointestinal stromal tumors [5]. - The company is also conducting a Phase 1 study of a novel FGFR2 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [5].

Core Viewpoint - Cogent Biosciences, Inc. has initiated an underwritten public offering of $150 million in common stock, with an additional option for underwriters to purchase up to $22.5 million more [1][2] Group 1: Offering Details - The offering is subject to market conditions and there is no assurance regarding its completion or the final terms [1] - The net proceeds will be used for the development and commercial preparation of bezuclastinib and other product candidates, as well as for working capital and general corporate purposes [2] - J.P. Morgan, Leerink Partners, and Guggenheim Securities are acting as joint book-running managers for the offering [2] Group 2: Regulatory Information - The securities will be offered under an automatic shelf registration statement filed with the SEC on February 10, 2023 [3] - A preliminary prospectus supplement will be filed with the SEC detailing the terms of the offering [4] Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being the most advanced clinical program [5] - Bezuclastinib is designed to inhibit the KIT D816V mutation, which is linked to systemic mastocytosis and advanced gastrointestinal stromal tumors [5] - The company is also developing a portfolio of targeted therapies for mutations in ErbB2, PI3Kα, and KRAS [5]

Core Insights - Shares of Cogent Biosciences (COGT) increased by 23.4% following the positive results from a late-stage study of bezuclastinib for treating non-advanced systemic mastocytosis (SM) patients [1][7]. Study Results - The phase III SUMMIT study met all primary and key secondary endpoints, showing significant improvements in the treatment of SM patients with bezuclastinib compared to placebo [2][9]. - Bezuclastinib treatment resulted in a mean total symptom score (TSS) reduction of 24.3 points at 24 weeks, compared to a 15.4-point reduction in the placebo group, leading to a placebo-adjusted improvement of 8.91 points [8]. - 87.4% of patients treated with bezuclastinib experienced a ≥50% reduction in serum tryptase levels, a key biomarker, while no patients in the placebo group achieved this [9]. Safety and Tolerability - Bezuclastinib was reported to be well-tolerated with a favorable safety profile, indicating its potential for chronic use in this patient population [10]. Future Plans - Cogent Biosciences plans to submit a new drug application to the FDA for bezuclastinib by the end of 2025, aiming to establish it as a new standard of care for non-advanced SM [11]. - The company is also evaluating bezuclastinib for advanced SM and gastrointestinal stromal tumors in separate pivotal studies, with top-line data expected in the second half of 2025 [12]. Market Performance - Year-to-date, Cogent Biosciences shares have increased by 19.9%, outperforming the industry, which saw a decline of 1.9% [4].

Core Insights - Cogent Biosciences, Inc.'s bezuclastinib demonstrated significant clinical benefits for patients with non-advanced systemic mastocytosis, supporting plans for FDA approval by the end of 2025 [1][4] Group 1: Clinical Trial Results - The SUMMIT trial achieved its primary endpoint with a statistically significant mean change in total symptom score (TSS) at 24 weeks, showing a mean reduction of 24.3 points in the bezuclastinib arm compared to 15.4 points in the placebo arm, resulting in a placebo-adjusted improvement of 8.91 points [5] - Statistically significant benefits were observed across all key secondary endpoints, including a reduction in serum tryptase, where 87.4% of bezuclastinib-treated patients had a ≥50% reduction compared to none in the control arm [6] Group 2: Future Plans and Financials - Cogent plans to submit its first new drug application (NDA) for bezuclastinib in NonAdvSM by the end of 2025 and will present detailed results from the SUMMIT trial at a medical meeting later this year [4][6] - The company is also on track to provide topline results from the PEAK and APEX trials in the second half of 2025, with a cash balance of $237 million and access to an additional $350 million through a debt facility [7] Group 3: Market Reaction - Following the positive trial results, COGT stock rose by 15.7% to $8.77 during the premarket session [8]

Bezuclastinib Program - Bezuclastinib is a potential best-in-class selective KIT mutant inhibitor, showing promise in pre-clinical studies and Phase 1/2 trials for GIST patients[10, 115] - KIT mutations drive up to 80% of GIST and over 90% of SM cases[27] - Bezuclastinib exhibits minimal brain penetration, with a brain to plasma ratio of 007, compared to 20 for avapritinib[37] - Cogent is conducting a Phase 2 clinical study (APEX) of Bezuclastinib in patients with Advanced Systemic Mastocytosis, with initial clinical results expected in 1H 2022[47, 48] FGFR2 Program - FGFR2 and FGFR3 are collectively altered in up to 41% of cancers[55] - Cogent is developing FGFR2 selective inhibitors with a target profile of <10 nM FGFR2 Cell IC50 and >200 nM FGFR1 Cell IC50[64] - CGT0292, a lead compound, demonstrates ~30x selectivity between FGFR1 and FGFR2 in cellular assays[80] - CGT0292 does not show serum phosphorus increase at a 5 mg/kg dose in the SD Rat Model of Hyperphosphatemia[84] ErbB2 Program - Significant unmet need remains for patients with non-exon 20 ErbB2 mutations[95] - Cogent is developing an ErbB2 mutant selective drug which covers key mutations while sparing wtEGFR, with a target Mutant Cell IC 50 of <10 nM and EGFR WT Cell IC 50 of >200 nM[104, 105] - Cogent has identified several novel series with promising enzyme selectivity for ErbB2 over EGFR WT[114] Financial Status - Cogent Biosciences had a cash balance of $2197 million as of December 31, 2021[12, 117]

Bezuclastinib Clinical Programs - Bezuclastinib combined with sunitinib demonstrated a 12-month median Progression-Free Survival (mPFS) in heavily pre-treated Gastrointestinal Stromal Tumors (GIST) patients[10] - In the APEX study, initial data in Advanced Systemic Mastocytosis (AdvSM) patients shows promising clinical activity with Bezuclastinib[10] - In Apex study, the Overall Response Rate (ORR) of CR + CRh + PR + CI was 73% (8 out of 11 patients) per CRRC assessment in TKI therapy-naïve AdvSM patients[27] - In Apex study, 88% of patients achieved a ≥ 50% reduction in serum tryptase levels[35] - In Apex study, 100% of patients with at least 2 cycles of treatment achieved a ≥ 50% reduction in bone marrow mast cell burden[35] - In Apex study, 92% of patients with at least 2 cycles of treatment achieved a ≥ 50% reduction in KIT D816V VAF[35] Market Opportunity - The global Total Addressable Market (TAM) potential for Bezuclastinib exceeds $3.5 billion, including $1.5 billion for NonAdvSM, $700 million for 2nd-line GIST, and $300 million for AdvSM[14] - Approximately 90% of Systemic Mastocytosis (SM) patients present with non-advanced systemic mastocytosis (NonAdvSM)[18] - Approximately 10% of patients present with advanced systemic mastocytosis (AdvSM)[18] Pipeline and Financials - The company's research pipeline includes novel, small-molecule targeted therapies for rare diseases, including an FGFR1-sparing, pan-mutant FGFR2 and a CNS-penetrant ErbB2[7] - The company's cash runway is expected to fund operations into 2025, with $289.1 million in cash as of September 30, 2022[7, 83]

Cogent Biosciences (COGT) Conference Call Summary Company Overview - **Company**: Cogent Biosciences - **Focus**: Development of bezuclastinib for the treatment of non-advanced systemic mastocytosis (SM) Key Industry Insights - **Industry**: Rare disease treatment, specifically systemic mastocytosis - **Current Treatment Landscape**: Limited options for patients with non-advanced SM, highlighting the unmet medical need for effective therapies Core Findings from the SUMMIT Trial - **Trial Results**: The SUMMIT trial demonstrated positive top-line results, meeting all primary and key secondary endpoints with statistically significant benefits compared to placebo [5][24][54] - **Patient Population**: The trial included 179 patients with moderate to severe symptoms of non-advanced SM, with a significant percentage being female [20][22] - **Primary Endpoint**: The mean change in total symptom score at week 24 was significantly better in the bezuclastinib group (24.32) compared to placebo (15.41), with a placebo-adjusted effect size of 8.91 [25] - **Secondary Endpoints**: Significant reductions in serum tryptase levels and other markers of mast cell burden were observed, with 87.4% of patients achieving at least a 50% reduction in serum tryptase [26][54] Safety Profile - **Adverse Events**: Bezuclastinib showed a favorable safety profile, with 98% of patients experiencing treatment-emergent adverse events (TEAEs) compared to 88% in the placebo group [29] - **Serious Adverse Events**: Serious AEs were low, with 5% in placebo versus 4.2% in the bezuclastinib cohort [29] - **Common AEs**: Hair color changes (69%), altered taste (23.7%), and nausea (22%) were among the most common TEAEs [30] Future Outlook - **Regulatory Submissions**: Cogent plans to submit a New Drug Application (NDA) for bezuclastinib later in 2025, aiming for commercial approval [6][54] - **Upcoming Trials**: Results from two additional pivotal trials (APeX and PEAK) are expected later in 2025, which could further establish bezuclastinib's role in treating advanced SM and gastrointestinal stromal tumors (GIST) [9][51] - **Market Potential**: The company is positioned to become a leader in the treatment of non-advanced SM, with a strong financial position to support its initiatives [54] Competitive Landscape - **Comparison with Avapritinib**: The conference highlighted the potential for bezuclastinib to outperform avapritinib in terms of efficacy and safety, with physicians expressing interest in switching patients who are not well-controlled on avapritinib [60][88] - **Patient Preferences**: Patients currently on avapritinib expressed satisfaction but showed a strong interest in switching to bezuclastinib based on the promising SUMMIT trial results [93] Additional Considerations - **Patient Quality of Life**: The trial results indicate not only symptomatic relief but also potential disease modification, which is crucial for improving patients' overall quality of life [96][98] - **Ongoing Research**: Further analysis of the SUMMIT trial data is anticipated, which may provide deeper insights into specific symptom domains and long-term outcomes [87][90] This summary encapsulates the key points from the Cogent Biosciences conference call, focusing on the promising results of the SUMMIT trial and the potential impact of bezuclastinib in the treatment landscape for systemic mastocytosis.