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Sensei Biotherapeutics Announces Initiation of Strategic Review to Maximize Shareholder Value
Globenewswire· 2025-10-30 13:00
Core Viewpoint - Sensei Biotherapeutics has decided to discontinue the development of solnerstotug and is initiating a strategic review to maximize shareholder value, which may include various options such as asset sales or mergers [1][3]. Company Overview - Sensei Biotherapeutics is a clinical-stage biotechnology company focused on developing next-generation therapeutics for cancer patients [4]. Strategic Review and Workforce Reduction - The company plans to implement a workforce reduction to preserve cash, retaining a small team to assist in exploring strategic alternatives and managing the cessation of development activities [2]. - The strategic review may lead to various outcomes, including a sale of assets, licensing arrangements, or a merger, but there is no definitive timeline for this process [1][3]. Clinical Development Status - Solnerstotug has shown clinical activity in a patient population with significant unmet needs, but the company has decided not to initiate new clinical studies due to funding needs and the current capital markets environment [3].
Morning Market Movers: ATMV, NEUP, BOF, RYOJ See Big Swings
RTTNews· 2025-10-21 11:45
Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - AlphaVest Acquisition Corp (ATMV) is up 71% at $14.24 [3] - BranchOut Food Inc. (BOF) is up 44% at $3.04 [3] - rYojbaba Co., Ltd. (RYOJ) is up 35% at $5.14 [3] - GSI Technology, Inc. (GSIT) is up 25% at $16.24 [3] - Jowell Global Ltd. (JWEL) is up 18% at $2.02 [3] - General Motors Company (GM) is up 9% at $63.68 [3] - Crown Holdings, Inc. (CCK) is up 8% at $103.00 [3] - Spero Therapeutics, Inc. (SPRO) is up 8% at $2.49 [3] - Sunrun Inc. (RUN) is up 6% at $21.90 [3] - Foxx Development Holdings Inc. (FOXX) is up 5% at $4.50 [3] Premarket Losers - Neuphoria Therapeutics Inc. (NEUP) is down 66% at $5.19 [4] - New Era Energy & Digital, Inc. (NUAI) is down 9% at $5.09 [4] - Odyssey Marine Exploration, Inc. (OMEX) is down 8% at $3.28 [4] - Carbon Revolution Public Limited Company (CREV) is down 7% at $4.86 [4] - Coeur Mining, Inc. (CDE) is down 7% at $20.38 [4] - Hecla Mining Company (HL) is down 6% at $13.50 [4] - Verrica Pharmaceuticals Inc. (VRCA) is down 6% at $4.12 [4] - Sensei Biotherapeutics, Inc. (SNSE) is down 5% at $10.06 [4] - Whitehawk Therapeutics, Inc. (WHWK) is down 5% at $2.52 [4] - Greenidge Generation Holdings Inc. (GREE) is down 5% at $2.07 [4]
Sensei Biotherapeutics (NasdaqGM:SNSE) Update / Briefing Transcript
2025-10-20 13:02
Summary of Sensei Biotherapeutics Conference Call Company Overview - **Company**: Sensei Biotherapeutics (NasdaqGM:SNSE) - **Event Date**: October 20, 2025 - **Focus**: Update on Solnestretug, a VISTA-targeting antibody in immuno-oncology Key Points Industry Context - **Immuno-Oncology**: The call marks a significant milestone for the field, particularly regarding VISTA-targeting therapies, which have not previously demonstrated progression-free survival data in PD1-resistant tumors [2][56] Clinical Data and Findings - **Solnestretug**: - Represents the first progression-free survival data for any VISTA-targeting antibody [2] - Demonstrated clinical activity, durability, and tolerability, suggesting a differentiated mechanism of action [2] - Designed to selectively reverse immunosuppression in the tumor microenvironment, avoiding systemic toxicity [4][6] - **Clinical Trials**: - Phase one dose escalation showed no dose-limiting toxicity, reaching a top dose of 15 mg/kg [7][8] - Combination therapy with cemiplimab was well tolerated, with a six-month progression-free survival rate of 37% for patients previously treated with immunotherapy [15][21] - Notably, 50% of patients receiving the 15 mg/kg dose had a six-month progression-free survival [16][21] Safety Profile - **Adverse Events**: - Low-grade cytokine release syndrome was the only notable class-related adverse event, with no grade 3 or 4 adverse events attributed to Solnestretug [12][48] - The safety profile was consistent with that of single-agent cemiplimab, indicating a well-tolerated regimen [48][56] Market Opportunity - **Commercial Potential**: - PD1-targeted therapies generate over $45 billion annually, with significant unmet needs in secondary resistance cases [4][5] - VISTA's expression across various cancer types presents a broad therapeutic potential [5] Future Plans - **Phase Two Studies**: - Planned initiation in early 2026, focusing on hot tumor settings and potentially leading to accelerated approval in the PD1-resistant population [25][29] - Two-study approach: one randomized study in non-small cell lung cancer and a single-arm study in Merkel cell carcinoma [26][27] Regulatory Considerations - **FDA Engagement**: - Ongoing discussions with the FDA regarding phase two study design and potential for breakthrough therapy designation [54] Conclusion - **Overall Impact**: - Solnestretug represents a significant advancement in immuno-oncology, offering a new therapeutic path for patients with secondary resistance to existing therapies [56][57] - **Future Outlook**: - The company is optimistic about the potential of Solnestretug to redefine treatment options in the immuno-oncology landscape [57]
Sensei Biotherapeutics (NasdaqGM:SNSE) Earnings Call Presentation
2025-10-20 12:00
Full Dose Expansion Data for Solnerstotug in PD-(L)1 Resistant Tumors October 20, 2025 Presenters: Dr. Kyriakos Papadopoulos Co-Director of Clinical Research START, San Antonio Principal Investigator for Ph1 trial of Solnerstotug John Celebi Chief Executive Officer Ron Weitzman Chief Medical Officer Disclaimer This presentation has been prepared by Sensei Biotherapeutics, Inc. (the "Company," "we," "us") and is made for informational purposes only. The information set forth herein does not purport to be com ...
Sensei Biotherapeutics Reports New Clinical Results Highlighting Durable Progression Free Survival Data for Solnerstotug in PD-(L)1 Resistant Tumors at the ESMO Congress 2025
Globenewswire· 2025-10-17 12:00
Core Insights - Sensei Biotherapeutics announced results from the dose expansion portion of its Phase 1/2 trial for solnerstotug, a monoclonal antibody targeting VISTA, at the ESMO Congress 2025 [1][2] Study Design and Patient Population - The Phase 1 dose expansion is a multi-center, open-label study evaluating solnerstotug as monotherapy and in combination with Libtayo, enrolling 44 patients with "hot" tumor types and 20 patients with "cold" tumor types [2] - Among the "hot tumor" patients, 41 had previously received PD-(L)1 therapy and progressed, indicating a challenging prognosis for these patients [3][4] Efficacy Results - In the higher 15 mg/kg dose cohort, the overall 6-month progression-free survival (PFS) rate was 50% among PD-(L)1 resistant patients, which is significantly higher than historical benchmarks [6][7] - Six clinical responses were observed at the 15 mg/kg dose, including five in patients with PD-(L)1 resistant tumors, while no responses were noted at the 3 mg/kg dose [5][6] Safety Profile - Solnerstotug was well tolerated, with only six mild (Grade 1) cytokine release syndrome (CRS) events reported, all manageable [8][9] - The safety profile remains consistent with prior data and compares favorably to other checkpoint inhibitor combinations [8] Future Development Plans - Sensei plans to initiate two Phase 2 studies in 2026, subject to FDA feedback and capital raising, focusing on NSCLC and Merkel Cell Carcinoma [11][12] - The first trial will be a randomized study comparing solnerstotug plus a PD-(L)1 inhibitor against chemotherapy in patients who failed anti-PD-(L)1 treatment [11] - The second trial will be a single-arm study in PD-(L)1 resistant Merkel Cell Carcinoma patients, with potential for accelerated approval [12] Unique Mechanism of Action - The combination of solnerstotug and cemiplimab may demonstrate a unique pattern of delayed, durable responses, indicating a complementary mechanism to PD-(L)1 therapies [10][9]
Sensei Biotherapeutics to Host Virtual KOL Event to Discuss Full Dose Expansion Data for Solnerstotug in PD-(L)1 Resistant Tumors on October 20, 2025
Globenewswire· 2025-09-23 11:30
Company Overview - Sensei Biotherapeutics, Inc. is a clinical stage biotechnology company focused on developing next-generation therapeutics for cancer patients [4] - The company utilizes its TMAb™ platform to create conditionally active therapeutics that target immunosuppressive signals in the tumor microenvironment [4] Upcoming Event - Sensei Biotherapeutics will host a virtual key opinion leader (KOL) event on October 20, 2025, featuring discussions on immunotherapy-resistant solid tumors [1] - The event will include updates on the company's Phase 2 studies and data from the full Phase 1/2 dose expansion cohort, including insights from an ESMO oral presentation on October 17 [2] Product Information - The lead product candidate, solnerstotug (formerly SNS-101), is a monoclonal antibody targeting VISTA in PD-(L)1 resistant tumors [2] - Solnerstotug is designed to block the VISTA checkpoint selectively within the low pH tumor microenvironment, enhancing T cell activation against tumors [4] Key Opinion Leader - Dr. Kyriakos Papadopoulos, Co-Director of Clinical Research at START, will participate in the KOL event, bringing expertise in drug development and oncology [3]
Sensei Biotherapeutics (SNSE) FY Conference Transcript
2025-09-05 12:00
Summary of Sensei Biotherapeutics (SNSE) FY Conference - September 05, 2025 Company Overview - **Company**: Sensei Biotherapeutics - **Industry**: Biotechnology - **Focus**: Developing conditionally active antibodies for cancer using the Tumor Microenvironment Activated Biologics (TMAb) platform [1] Core Points and Arguments 1. **Defining Year**: 2025 is highlighted as a pivotal year for Sensei Biotherapeutics, transitioning from early promise to more mature efficacy signals, with phase one to dose expansion results expected at the ESMO Congress in October [2] 2. **Lead Program - SylvesterTOG**: - Positioned as the first credible VISTA-targeted therapy, aiming to address issues that previously hindered VISTA-focused antibodies [2] - Designed to selectively bind in the acidic tumor microenvironment, minimizing toxicity and improving pharmacokinetics [3] 3. **Market Opportunity**: - The PD-L1 therapy market is valued at $50 billion, with VISTA expressed in most solid tumors, indicating a significant potential for SylvesterTOG [3] - The approach aims to open a new checkpoint pathway that could rival PD-L1 therapies [3] 4. **Collaboration with Regeneron**: Evaluating SylvesterTOG in combination with Regeneron's PD-1 inhibitor, Libtayo, across various tumors, showcasing the innovative approach and recognition of VISTA's role in immunotherapy resistance [4] 5. **Safety and Efficacy**: - SylvesterTOG has shown a favorable safety profile with no dose-limiting toxicities and manageable cytokine release events, contrasting with earlier VISTA programs that faced severe issues [5] - The trial focused on "hot tumors," with historical response rates for PD-1 rechallenge being in the single digits, yet SylvesterTOG demonstrated remarkable activity [6][7] 6. **Durability of Response**: - Emphasis on the importance of durable responses in immunotherapy, with several patients showing long-term benefits from SylvesterTOG [8][9] - Full phase one to dose expansion data, including six-month progression-free survival (PFS) metrics, will be presented at ESMO [10] 7. **Safety Profile in Expansion Cohort**: Most adverse events were grade one or two, with low-grade cytokine release, indicating a well-tolerated treatment [11] 8. **Future Plans**: - Plans to initiate phase two studies in 2026, with multiple trials aligned with unmet medical needs and commercial potential [11] - Financially positioned with a cash runway into 2026 to support upcoming milestones [12] Other Important Content - **Recognition at ESMO**: The data will be featured in a mini oral session at ESMO, marking a significant recognition of the work being done on VISTA as a therapeutic target [10] - **Investor Opportunity**: Sensei Biotherapeutics presents a unique investment opportunity in the first successful unlocking of VISTA's myeloid biology, which could reshape the immuno-oncology landscape [12]
Sensei Biotherapeutics to Participate in the H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-09-03 12:00
Company Overview - Sensei Biotherapeutics, Inc. is a clinical stage biotechnology company focused on developing next-generation therapeutics for cancer patients [3] - The company utilizes its TMAb™ platform to create conditionally active therapeutics that target immunosuppressive signals in the tumor microenvironment [3] - The lead product candidate is solnerstotug, an antibody designed to block the VISTA checkpoint selectively in low pH tumor environments [3] Upcoming Events - John Celebi, President and CEO of Sensei Biotherapeutics, will participate in 1x1 investor meetings at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025 [1] - An on-demand corporate presentation will be available on September 5, 2025, at 7:00 a.m. ET, with a replay accessible for approximately 90 days [2]
Sensei (SNSE) Q2 Loss Narrows 31%
The Motley Fool· 2025-08-06 04:47
Core Insights - Sensei Biotherapeutics reported a Q2 2025 loss per share of $(3.91), which was better than the expected $(5.60) loss, indicating improved financial performance [1][2] - The company achieved a net loss of $4.9 million in Q2 2025, down from a net loss of $7.1 million in Q2 2024, reflecting effective cost management [1][2] - Sensei Biotherapeutics remains in the early stages of development with no revenue reported, consistent with its status as a clinical-stage biotech company [1][8] Financial Performance - Q2 2025 EPS was $(3.91), compared to $(5.60) estimated and $(5.69) in Q2 2024, showing a year-over-year improvement of 31.3% [2] - Research and Development expenses decreased to $2.5 million in Q2 2025 from $4.6 million in Q2 2024, a reduction of 46.0% [2][7] - General and Administrative expenses fell to $2.7 million in Q2 2025 from $3.2 million in Q2 2024, a decrease of 15.6% [2][7] - Cash, cash equivalents, and marketable securities totaled $28.6 million as of June 30, 2025, down from $41.3 million in December 2024 [8] Business Overview - Sensei Biotherapeutics is focused on developing solnerstotug, a monoclonal antibody targeting the VISTA immune checkpoint in cancer [3][10] - The company aims to demonstrate the efficacy of solnerstotug in patients with cancers resistant to PD-(L)1 treatments, a significant challenge in cancer therapy [4][11] - The ongoing Phase 1/2 clinical trial has enrolled 64 patients, including those with "hot" tumors, which are known to initially respond to immunotherapy but later become resistant [5][10] Clinical Development - Preliminary safety and efficacy data for solnerstotug indicated favorable activity in PD-(L)1 resistant "hot" tumors, with no dose-limiting toxicities reported [6] - Full dose expansion data, including 6-month progression-free survival, are expected by year-end 2025, with a major presentation planned at the ESMO Congress in October 2025 [12] Future Outlook - Management expects current cash resources to fund operations into the second quarter of 2026, emphasizing the importance of ongoing clinical updates and funding strategies [12][13] - The success of solnerstotug is critical for the company's future growth, especially in a competitive immuno-oncology market [11]
sensei(SNSE) - 2025 Q2 - Quarterly Report
2025-08-05 20:30
PART I FINANCIAL INFORMATION This section covers unaudited financial statements, management's analysis, market risk disclosures, and internal controls [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Net loss improved to **$11.8 million** in H1 2025, assets decreased, and substantial doubt exists about the company's going concern [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance sheet shows total assets decreased to **$31.8 million** by June 30, 2025, mainly from reduced marketable securities Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $12,557 | $9,994 | | Marketable securities | $16,071 | $31,341 | | Total current assets | $29,572 | $41,929 | | Total assets | $31,783 | $45,361 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $3,873 | $5,448 | | Total liabilities | $4,469 | $6,975 | | Total stockholders' equity | $27,314 | $38,386 | | Total liabilities and stockholders' equity | $31,783 | $45,361 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss improved to **$11.8 million** for H1 2025 from **$15.1 million** in 2024, primarily due to reduced operating expenses Statement of Operations Highlights (in thousands, except per share data) | | **Three Months Ended June 30,** | | **Six Months Ended June 30,** | | | :--- | :--- | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Research and development | $2,533 | $4,584 | $6,258 | $9,501 | | General and administrative | $2,673 | $3,203 | $6,222 | $7,016 | | **Loss from operations** | **($5,206)** | **($7,787)** | **($12,480)** | **($16,517)** | | **Net loss** | **($4,936)** | **($7,142)** | **($11,800)** | **($15,134)** | | Net loss per common share | ($3.91) | ($5.69) | ($9.36) | ($12.07) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash increased by **$2.56 million** for H1 2025, driven by investing activities offsetting operating cash usage Cash Flow Summary for the Six Months Ended June 30 (in thousands) | | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($13,003) | ($13,408) | | Net cash provided by investing activities | $15,948 | $12,677 | | Net cash used in financing activities | ($382) | ($389) | | **Net increase (decrease) in cash** | **$2,563** | **($1,120)** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes highlight substantial doubt about going concern, a 1-for-20 reverse stock split, and a November 2024 restructuring - The company has concluded there is **substantial doubt about its ability to continue as a going concern**, as it will not have sufficient cash to fund operations beyond one year from the issuance of the financial statements without additional financing[24](index=24&type=chunk)[25](index=25&type=chunk) - On June 16, 2025, the company effected a **1-for-20 reverse stock split** of its common stock, with all historical share and per-share amounts adjusted to reflect this split[26](index=26&type=chunk) - In November 2024, the company initiated a **restructuring** to focus resources on its lead candidate, solnerstotug, involving closing a research site and reducing its workforce by approximately **46%**[76](index=76&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses solnerstotug, restructuring, decreased net loss, and critical liquidity concerns with going concern doubt [Overview](index=23&type=section&id=Overview) Overview details the company's clinical-stage biotech focus on solnerstotug and the impact of its November 2024 restructuring - The company is a clinical-stage biotechnology firm focused on its TMAb™ (Tumor Microenvironment Activated Biologics) platform to develop cancer therapeutics[81](index=81&type=chunk) - The lead product candidate, **solnerstotug**, is in a Phase 1/2 clinical trial, with updated data expected by the end of 2025 and Phase 2 studies planned for 2026, contingent on additional capital[82](index=82&type=chunk) - A November 2024 **restructuring** decreased operating expenses and focused resources on solnerstotug, involving a **46% workforce reduction** and pausing preclinical candidates[84](index=84&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Operating expenses significantly decreased in 2025 compared to 2024 for both periods, primarily due to the November 2024 restructuring Comparison of Operating Expenses (in thousands) | | **Three Months Ended June 30,** | | **Six Months Ended June 30,** | | | :--- | :--- | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Research and development | $2,533 | $4,584 | $6,258 | $9,501 | | General and administrative | $2,673 | $3,203 | $6,222 | $7,016 | | **Total operating expenses** | **$5,206** | **$7,787** | **$12,480** | **$16,517** | - The decrease in operating expenses for both the three and six-month periods of 2025 compared to 2024 was primarily driven by lower personnel costs (including stock-based compensation), reduced facilities and equipment costs, and lower manufacturing and research fees, all resulting from the November 2024 restructuring[102](index=102&type=chunk)[103](index=103&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is constrained with **$28.6 million** cash and **$273.9 million** accumulated deficit, raising substantial doubt about funding operations beyond Q2 2026 - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities of **$28.6 million** and an accumulated deficit of **$273.9 million**[109](index=109&type=chunk) - Based on current operating plans, the company expects its existing cash to fund operations and capital expenditures only into the **second quarter of 2026**[122](index=122&type=chunk) - Management has concluded that there is **substantial doubt about the company's ability to continue as a going concern** and will require additional financing to support its operations[122](index=122&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company, as a smaller reporting entity, is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, the company is not required to provide the information otherwise required under this item[136](index=136&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - Management, including the principal executive officer and principal financial officer, evaluated the effectiveness of disclosure controls and procedures and concluded they were **effective** at a reasonable assurance level as of June 30, 2025[139](index=139&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2025[140](index=140&type=chunk) PART II OTHER INFORMATION This section covers legal proceedings, significant risk factors, unregistered equity sales, and other miscellaneous information [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently a party to any material legal proceedings[143](index=143&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) Key risks include financial instability, funding needs, early-stage product development, third-party reliance, and regulatory hurdles [Risks Related to Our Financial Position](index=40&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position) Financial risks include urgent funding needs, a history of substantial losses, and material uncertainty about the company's going concern ability - The company requires **substantial additional funding** to continue operations; failure to obtain capital could force it to delay, reduce, or terminate development and commercialization efforts[150](index=150&type=chunk) - The company has a history of significant losses, with a net loss of **$11.8 million** for the first six months of 2025 and an accumulated deficit of **$273.9 million** as of June 30, 2025[162](index=162&type=chunk) - There is **substantial doubt about the company's ability to continue as a going concern**, as its current cash, cash equivalents, and marketable securities are only expected to fund operations into the second quarter of 2026[170](index=170&type=chunk) [Risks Related to the Development of our Product Candidates](index=46&type=section&id=Risks%20Related%20to%20the%20Development%20of%20our%20Product%20Candidates) Product development risks include early-stage candidates, high dependence on solnerstotug, lengthy regulatory processes, and potential changes in interim data - The company's development efforts are in early stages, and its business is highly dependent on the success of its product candidates, particularly **solnerstotug**, which requires significant additional development and regulatory approval[176](index=176&type=chunk)[190](index=190&type=chunk) - The regulatory approval process for product candidates is lengthy, expensive, and unpredictable, with no guarantee of success[183](index=183&type=chunk) - Interim and preliminary data from clinical trials may change as more patient data becomes available, and positive early results are not predictive of final outcomes[200](index=200&type=chunk)[202](index=202&type=chunk) [Risks Related to our Dependence on Third Parties](index=61&type=section&id=Risks%20Related%20to%20our%20Dependence%20on%20Third%20Parties) Risks arise from reliance on third-party CROs for clinical trials, CMOs for production, and supply agreements for combination therapies - The company relies on third-party Contract Research Organizations (CROs) to conduct its clinical trials, and poor performance by these CROs could delay or prevent regulatory approval[222](index=222&type=chunk)[223](index=223&type=chunk) - The company depends on Contract Manufacturing Organizations (CMOs) for the production of its product candidates, including solnerstotug, which creates risks related to supply sufficiency, cost, and quality control[236](index=236&type=chunk) - The clinical trial of solnerstotug in combination with cemiplimab is dependent on a supply agreement with Regeneron, and any disruption could delay development[232](index=232&type=chunk)[234](index=234&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=117&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - There were no recent sales of unregistered equity securities[407](index=407&type=chunk) [Item 3. Defaults Upon Senior Securities](index=117&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[410](index=410&type=chunk) [Item 4. Mine Safety Disclosures](index=117&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[411](index=411&type=chunk) [Item 5. Other Information](index=117&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted, modified, or terminated a Rule 10b5-1 trading plan during the quarter ended June 30, 2025 - No officers or directors adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the fiscal quarter[412](index=412&type=chunk) [Item 6. Exhibits](index=117&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the company's articles of incorporation, bylaws, and certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act - The exhibits filed with the report include certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sarbanes-Oxley Act Sections 302 and 906[415](index=415&type=chunk)