Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on advancing innovative cancer therapies [3] - The company's pipeline includes FDA-approved therapies such as Revuforj (revumenib), a menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody targeting the CSF-1 receptor [3] Upcoming Financial Results - Syndax Pharmaceuticals will report its second quarter 2025 financial results and provide a business update on August 4, 2025 [1] - A conference call and live audio webcast will be hosted by the management at 4:30 p.m. ET on the same day [1] Accessing the Conference Call - The live audio webcast and accompanying slides can be accessed through the Events & Presentations page on the company's website [2] - Domestic and international dial-in numbers are provided for the conference call, with a specific Conference ID: Syndax2Q25 [2] - A replay of the conference call will be available approximately 24 hours after the event and will remain accessible for 90 days [2]

Group 1 - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies [2] - The company's pipeline includes FDA-approved therapies such as Revuforj (revumenib), a menin inhibitor, and Niktimvo™ (axatilimab-csfr), a monoclonal antibody targeting the CSF-1 receptor [2] - Syndax is committed to advancing cancer care and is conducting several clinical trials across various treatment stages [2] Group 2 - Michael A. Metzger, CEO of Syndax, and the management team will participate in investor conferences, including the Jefferies Global Healthcare Conference on June 5, 2025, and the Goldman Sachs 46th Annual Global Healthcare Conference on June 11, 2025 [1][3] - A live webcast of the fireside chats will be available on the company's website, with replays accessible for a limited time [1]

Company Overview - BeyondSpring Inc. is a clinical-stage global biopharmaceutical company focused on developing cancer therapies, particularly its lead asset Plinabulin, which is in late-stage clinical development for non-small cell lung cancer (NSCLC) and other cancer indications [3] Study Announcement - BeyondSpring announced a poster presentation on the 303 Study, an investigator-initiated study supported by Merck, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled from May 30 to June 3 in Chicago, IL [1] 303 Study Details - The 303 Study is an open-label, single-arm Phase 2 study evaluating the efficacy and safety of Plinabulin in combination with docetaxel and pembrolizumab for previously treated patients with metastatic NSCLC who have progressed after anti-PD-(L)1 inhibitor therapy [4] - The study involves 47 enrolled patients and is conducted at Peking Union Medical College Hospital in Beijing, China, with Dr. Mengzhao Wang as the principal investigator [4] - The primary endpoint is the investigator-based overall response rate (ORR), while secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety [4] Presentation Details - The presentation will take place on May 31, 2025, from 1:30 PM to 4:30 PM CDT at McCormick Place Convention Center, focusing on initial efficacy and safety results related to immune re-sensitization [5]

Company Overview - VERAXA Biotech AG is an emerging leader in designing novel cancer therapies and is the proposed de-SPAC acquisition target of Voyager Acquisition Corp [1][4] - The company focuses on next-generation antibody-based therapeutics, including bispecific antibody-drug conjugates (ADCs) and T-cell engagers, utilizing transformative technologies [3] Leadership Appointment - Rick Austin, Ph.D., has been appointed as Chief Scientific Officer, effective May 1st, bringing over 25 years of experience in oncology discovery and early development [1][2] - Dr. Austin's previous roles include Vice President of Research at Harpoon Therapeutics and various positions at Amgen, where he led tumor immunology projects [2] Strategic Goals - The appointment of Dr. Austin is seen as pivotal for advancing VERAXA's BiTAC platform and clinical-stage pipeline, aiming to enhance the therapeutic window of cancer treatments while minimizing off-tumor toxicity [2][3] - The company is committed to tapping into the U.S. biopharma talent pool and expanding its scientific footprint [2] Business Combination - On April 22, 2025, VERAXA entered into a definitive business combination agreement with Voyager Acquisition Corp, which will lead to VERAXA becoming a publicly traded company on NASDAQ upon closing [4]

Core Insights - SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [2] - The company’s lead product candidate, GPS, targets the WT1 protein and has potential applications as both a monotherapy and in combination with other therapies for hematologic malignancies and solid tumors [2] - SELLAS is also developing SLS009, a differentiated small molecule CDK9 inhibitor, which shows promise in treating AML patients with unfavorable prognostic factors [2] Event Participation - Dr. Angelos Stergiou, President and CEO of SELLAS, will participate in a fireside chat at the A.G.P. Virtual Healthcare Company Showcase on May 21, 2025, at 8:20 am ET [1][2] Company Overview - SELLAS Life Sciences Group, Inc. is dedicated to the development of innovative therapeutics for a wide range of cancer types [2] - The company’s lead candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets a protein present in various tumor types [2] - SLS009 is positioned as potentially the first and best-in-class CDK9 inhibitor with reduced toxicity and increased potency compared to existing options [2]

Core Insights - Syndax Pharmaceuticals announced the acceptance of multiple abstracts for clinical data presentations of Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr) at the 30th European Hematology Association (EHA) Annual Congress Meeting scheduled for June 12-15, 2025, in Milan, Italy [1][2] Group 1: Revuforj® (revumenib) - Revuforj is a first-in-class selective menin inhibitor approved for treating relapsed or refractory acute leukemia with KMT2A translocation in patients aged one year and older [10][11] - The BEAT AML frontline trial data will be presented, showcasing the combination of revumenib with venetoclax and azacitidine in patients with mNPM1 and KMT2Ar AML [2][6] - Compelling results in acute leukemia across various genetic populations, including mNPM1 and KMT2Ar, will be highlighted [5][6] Group 2: Niktimvo™ (axatilimab-csfr) - Niktimvo is a first-in-class CSF-1R-blocking antibody approved for chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy [12][35] - The AGAVE-201 trial data will be presented, demonstrating robust responses in different organs and patient subgroups with chronic GVHD [5][8] - Ongoing studies include a Phase 2 combination trial with ruxolitinib and a Phase 3 trial with steroids for chronic GVHD [14][35]

Core Insights - Syndax Pharmaceuticals has appointed Dr. Nicholas Botwood as the new Head of Research and Development and Chief Medical Officer, bringing over 25 years of experience in oncology drug development [1][2] - Dr. Botwood previously held senior roles at Bristol Myers Squibb, where he led medical oncology and was responsible for the medical strategy in the U.S. [2][3] - The company aims to leverage Dr. Botwood's expertise to accelerate the growth of its oncology franchises and enhance its R&D strategy [2][3] Company Overview - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies [4] - The company's pipeline includes FDA-approved products such as Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr) [4] - Syndax is committed to advancing cancer care through ongoing clinical trials and aims to unlock the full potential of its product pipeline [4]

Core Insights - Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on innovative cancer therapies [2] - The company has FDA-approved products in its pipeline, including Revuforj® (revumenib) and Niktimvo™ (axatilimab-csfr) [2] - Syndax is actively conducting clinical trials to maximize the potential of its pipeline [2] Upcoming Events - Michael A. Metzger, CEO of Syndax, and the management team will participate in investor conferences [1] - A fireside chat at the Bank of America Merrill Lynch Vegas Health Care Conference is scheduled for May 15, 2025, at 9:20 a.m. PT/12:20 p.m. ET [3] - A virtual fireside chat at the TD Cowen 6th Annual Oncology Innovation Summit will take place on May 28, 2025, at 10:30 a.m. ET [3]

Financial Performance - Syndax Pharmaceuticals reported $20.0 million in net revenue from Revuforj® (revumenib) in the first full quarter of its launch [1][4] - Niktimvo™ (axatilimab-csfr) generated $13.6 million in net revenue in its first partial quarter of launch, as reported by Incyte [1][8] - The company had cash, cash equivalents, and investments totaling $602.1 million as of March 31, 2025, which is expected to fund operations until profitability [1][7] Business Developments - The company submitted a supplemental New Drug Application (sNDA) for revumenib for the treatment of relapsed or refractory (R/R) mutant NPM1 acute myeloid leukemia (AML) [1][4] - A pivotal frontline trial of revumenib in combination with venetoclax and azacitidine for mNPM1 and KMT2Ar AML has been initiated [1][4] - Multiple ongoing trials are evaluating revumenib in various combinations and settings, including a Phase 1 trial showing a 100% overall response rate in newly diagnosed mNPM1 or KMT2Ar AML patients [4][5] Research and Development - Research and development expenses for the first quarter of 2025 increased to $61.6 million from $56.5 million in the prior year, driven by costs related to axatilimab and ongoing clinical trials [10] - Selling, general, and administrative expenses rose to $41.0 million from $23.0 million, primarily due to increased employee-related expenses and marketing efforts for Revuforj [11] - The company plans to initiate multiple trials of revumenib in combination with standard care regimens for newly diagnosed acute leukemia patients starting in the second half of 2025 [5][10] Future Outlook - For the second quarter of 2025, the company expects research and development expenses to be between $70 million and $75 million, with total operating expenses projected to be between $110 million and $115 million [13] - The company anticipates that its current cash position, along with expected product revenue, will enable it to reach profitability [14]

Financial Data and Key Metrics Changes - Revenues associated with the BARDA contract were approximately $4 million in 2024 compared to zero in 2023, as the contract began in June 2023 [27] - Research and development expenses increased to $23.7 million in 2024 from $20.7 million in 2023, representing a 14% increase [28] - Net loss for 2024 was approximately $25 million, or $4.82 per share, compared to $26 million, or $14.29 per share in 2023 [30] Business Line Data and Key Metrics Changes - The BARDA contract is a cost reimbursement contract, with total contract value to GeoVax at $26 million, potentially increasing to $45 million [27] - General and administrative expenses decreased to $5.4 million in 2024 from $6 million in 2023, an 11% decrease [29] Market Data and Key Metrics Changes - The WHO declared Mpox a public health emergency of international concern, emphasizing the need for expanded vaccine supply [19] - There is significant government interest in U.S.-based supply chains, reflecting a shift towards onshoring initiatives [21] Company Strategy and Development Direction - The company aims to establish business partnerships and collaborations for worldwide development, commercialization, and distribution of its vaccines [11] - The focus for 2025 includes advancing the GEO-CM04S1 vaccine, particularly in relation to the Project NextGen initiative [11] Management's Comments on Operating Environment and Future Outlook - Management highlighted the critical need for additional vaccine supply options for Mpox, with Africa needing 20 to 25 million doses [38] - The company remains in close contact with BARDA, with indications that operations will continue as planned despite uncertainties in Washington [70] Other Important Information - The company is actively progressing with the advanced MVA manufacturing process to produce vaccines more efficiently [22] - The anticipated clinical evaluation for the GEO-MVA vaccine is expected to begin in the second half of the year [9] Q&A Session Summary Question: Could GeoVax sell product without clinical testing given the urgency of the Mpox threat? - Management indicated that while there is a major need for vaccines, the ability to sell without clinical testing is uncertain and would depend on emergency use licensing [38] Question: How is GeoVax working with international partners for equitable vaccine access? - Management has been in discussions with African health ministries and European regulatory agencies to ensure equitable access and manufacturing [41] Question: What is needed to start the next Gedeptin trial? - Management stated that sufficient product supply is being manufactured, and the trial is likely to initiate in the mid to latter part of next year [45] Question: How will efficacy and safety be tested for the MVA vaccine? - Management explained that animal studies may run in parallel with clinical trials, focusing on immunological endpoints [52][54] Question: What are the timelines for data readouts for the Phase 2 trials? - Management expects readouts for the blood cancer patient study in early to mid-2026 and for the CLL study to be fully enrolled by the end of the year [64][66] Question: How might changes in COVID-19 funding affect the company? - Management reported ongoing positive communication with BARDA, with no current indications to slow down operations [70]