Tectonic Therapeutic (TECX) 2025 Conference May 15, 2025 12:20 PM ET Speaker0 Hey, everyone. Good morning, and welcome to day three of the twenty twenty five Bank of America Healthcare Conference. And thanks for joining this session with Tectonic Therapeutics. My name is Alex Stranahan. I'm senior biotech analyst at Bank of America. And I'm pleased to introduce Elise Raisin, president and CEO of Tectonic. She'll be running through some slides and going over the company. So with that, Elise, over to you. Spe ...

Summary of Werewolf Therapeutics Conference Call Company Overview - Werewolf Therapeutics is a clinical stage biopharmaceutical company focused on developing conditionally activated biologics for cancer and other serious diseases. The company has engineered a pipeline of cytokine prodrugs, referred to as endokines, to address therapeutic index challenges associated with potent biologics [2][3] Core Programs - The lead endokine programs include: - WTX-124 (an interleukin-2 endokine) - WTX-330 (an interleukin-12 endokine) - The company has also developed T cell engagers called inducers, designed to address therapeutic index challenges of T cell engagers [3][19] Clinical Data and Efficacy - WTX-124 has completed dose escalation for both monotherapy and combination therapy with pembrolizumab, with a determined dose of 18 mg delivered IV every two weeks [5][6] - Expansion arms are open for indications including: - Cutaneous melanoma - Renal cell carcinoma - Cutaneous squamous cell carcinoma, where a patient achieved a complete response after failing standard treatment [6][7] - The company aims for an overall response rate above 20% for monotherapy and higher for combination therapy, with enrollment progressing well [11][12] Safety Profile - The safety profile of WTX-124 has shown no hallmark toxicities associated with high-dose IL-2, allowing for outpatient delivery to a broad patient population [9][10] Regulatory Pathway - The company plans to present data to the FDA in the coming quarters, seeking insights on both monotherapy and combination data for potential registration [13][14] Future Expectations - The company anticipates presenting updated interim data in Q4 2025, with a focus on both efficacy and safety metrics [9][22] - For WTX-330, the company has completed a first-in-human trial, showing a good safety profile and antitumor activity, with plans for further studies [16][17] Inducers Platform - The inducers platform aims to mask immune cell engagement to reduce cytokine release syndrome, enhancing the therapeutic index of T cell engagers [19][20] - The company plans to announce a development candidate for the inducers platform imminently [22] Conclusion - Werewolf Therapeutics is positioned for significant developments in the coming months, with a robust pipeline and promising clinical data that could lead to regulatory advancements and potential market opportunities [24][25]

Summary of T SCAN Therapeutics Conference Call Company Overview - The conference featured T SCAN Therapeutics, represented by CEO Gavin Macbeth, at BofA's 2025 health care conference [1] Core Insights and Arguments - T SCAN is developing a program called Orca 21, which aims to combine IL-23 and IL-17 therapies for psoriasis treatment. The strategy involves using IL-17 for rapid skin clearance followed by IL-23 for maintenance [3][4] - The company is currently in Phase 1 clinical trials for the Orca 1 program, with results expected in the second half of the year. A Phase 2 study will also commence in the same timeframe, with psoriasis data anticipated next year [5][6] - T SCAN has raised over $475 million last year, providing sufficient funding for ongoing clinical trials and a runway for an additional year without needing further capital [6] Key Upcoming Events - Key milestones include: - Phase 1 readout for Orca 1 in the second half of this year - Phase 2 study initiation for psoriasis in the second half of this year - Pharmacokinetic (PK) data expected in the first half of next year [5][6] Important Metrics - The company aims for a 50-day half-life for the molecule to enable six-month dosing and a 75-day half-life for annual dosing, which would be a significant advancement in treatment options [9][10] Additional Considerations - The combination therapy approach has garnered excitement from physicians, indicating potential market interest and acceptance [4] - The reproducibility of psoriasis data across trials is highlighted as a critical factor for the company's future success [5]

- Announced preclinical data demonstrating the bioequivalence of RT-114, a bispecific GLP-1/GLP-2 receptor agonist (PG-102), delivered orally via the RaniPill® capsule, to subcutaneous administration of PG-102 - - Phase 1 study for RT-114 for the treatment of obesity expected to initiate in mid-2025 - - Announced preclinical data demonstrating successful oral delivery of semaglutide via RaniPill® capsule - SAN JOSE, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutic ...

Core Insights - CytomX Therapeutics announced positive interim clinical results for CX-2051, an EpCAM-directed antibody-drug conjugate (ADC) for advanced colorectal cancer (CRC), highlighting its strategic importance for the company [3][7] - The company has initiated dose expansions for CX-2051 at 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg, with a Phase 2 study planned for the first half of 2026 [7][3] - Financial results for Q1 2025 show total revenue of $50.9 million, an increase from $41.5 million in Q1 2024, driven by collaborations with Bristol Myers Squibb and Amgen [9][10] Pipeline Program Updates - CX-2051 is currently in a Phase 1 dose escalation study, with an update on data from at least 70 patients expected by Q1 2026 [7] - CX-801, a PROBODY interferon alpha-2b, is also in development, with initial Phase 1a translational data expected in the second half of 2025 [7][5] - The company is focusing on combination therapy with CX-801 and KEYTRUDA, aiming to initiate this in 2025 [7] Financial Overview - As of March 31, 2025, the company reported cash, cash equivalents, and investments totaling $79.9 million, down from $100.6 million at the end of 2024 [8] - Total operating expenses for Q1 2025 were $28.3 million, a decrease from $29.8 million in Q1 2024, with R&D expenses at $18.9 million, down from $22.1 million [10][11] - The net income for Q1 2025 was $23.5 million, compared to $13.8 million in Q1 2024, reflecting improved operational efficiency [18]

AxoGen (AXGN) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Michael Dale - President, CEO & Board DirectorNir Naor - Chief Financial OfficerJens Schroeder Kemp - Chief Marketing OfficerCaitlin Cronin - DirectorChris Pasquale - Partner - Medical Devices & SuppliesBrett Gasaway - VP - Equity ResearchMatthew Park - Equity Research AssociateRick Ditto - VP, Global Health Economics, Reimbursement & PolicyJayson Bedford - Managing Director - Medical Technology Conference Call Participants Mi ...

AxoGen (AXGN) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Speaker0 Good morning, everyone. Joining me on today's call is Michael Dale, AxoGen's Chief Executive Officer and Director Nir Naor, Chief Financial Officer and Jens Kemp, Chief Marketing Officer. Michael will discuss first quarter twenty twenty five financial results and corporate highlights. Nir will then provide an analysis of our financial performance and guidance and discuss our outlook for the year, followed by a question and answer session. ...

Company Announcement Decision to submit based on a positive overall response rate (ORR) (p-value < 0.0001), one of the dual primary endpoints in the Phase 3 EPCORE® FL-1 trialFull results from the trial will be submitted for presentation at an upcoming medical conference in 2025 COPENHAGEN, Denmark; May 2, 2024 – Genmab A/S (Nasdaq: GMAB) announced today its intention to submit in the first half of 2025 a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for ...

SAN FRANCISCO and BOSTON, May 01, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), today announced that members of management will present at the Bank of America Health Care Conference on Tuesday, May 13, 2025, at 1:40 p.m. P.T. / 4:40 p.m. E.T. A live and archived webcast of the presentation will be available via the News & Events page in the Investors section of the Apogee Therapeutics website. About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel b ...

West Pharmaceutical Services, Inc. (NYSE:WST) Q1 2025 Earnings Conference Call April 24, 2025 9:00 AM ET Company Participants John Sweeney - Vice President of Investor Relations Eric Green - Chairman, President and Chief Executive Officer Bernard Birkett - Senior Vice President and Chief Financial Officer Conference Call Participants Paul Knight - KeyBanc Larry Solow - CJS Securities Justin Bowers - Deutsche Bank Michael Ryskin - Bank of America David Windley - Jefferies Daniel Markowitz - Evercore ISI Thom ...