"Pyxis Oncology's novel ADC approach and impressive pipeline comprised of next-generation therapeutics are aimed to target difficult-to-treat cancers and improve the quality of life of patients," said Mr. Metzger. "I look forward to working with the deeply experienced board and leadership team assembled at Pyxis Oncology to further advance the Company's mission of improving outcomes for patients with cancer." Pyxis Oncology, Inc. is a clinical stage company focused on defeating difficult-to-treat cancers. T ...

– IDMC recommendation to advance based on favorable safety profile observed in Phase 1a portion of trial – WALTHAM, Mass., June 6, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it has advanced into the Phase 1b portion of its Phase 1/2 proof-of-concept trial of revumenib, the Company's highly selective, oral menin inhibitor, as a monotherapy in patients with relapsed or refrac ...

Core Insights - Syndax Pharmaceuticals granted inducement awards to purchase up to 499,200 shares of common stock to fifty-three new employees under the Company's 2023 Inducement Plan [1] - The stock options will vest over four years, with 25% vesting on the one-year anniversary and the remaining shares vesting monthly thereafter [1] Company Overview - Syndax is a clinical-stage biopharmaceutical company focused on developing an innovative pipeline of cancer therapies [2] - Key products in the pipeline include revumenib, a selective menin inhibitor, and axatilimab, a monoclonal antibody targeting the CSF-1 receptor [2]

Financial Data and Key Metrics Changes - The company reported $522 million in cash equivalents and investments as of March 31, expected to provide runway through 2026 [53] - Operating expenses for Q1 were $79.5 million, with R&D expenses at $56.5 million and SG&A expenses at $23 million [82] - For Q2, the company expects R&D expenses to be $50 million to $55 million and total operating expenses to be $80 million to $85 million [54] Business Line Data and Key Metrics Changes - Revumenib received priority review from the FDA for the treatment of adult and pediatric relapsed or refractory KMT2A rearranged acute leukemia, with a PDUFA date of September 26, 2024 [39] - The company completed enrollment in the NPM1 AML cohort of the AUGMENT-101 pivotal trial, with data expected in Q4 2024 [37][68] - Axatilimab's BLA filing was granted priority review for chronic GVHD, with a PDUFA date of August 28, 2024 [71] Market Data and Key Metrics Changes - KMT2Ar and NPM1 acute leukemias represent up to 40% of all AML patients, with an addressable market opportunity of approximately $750 million in the US for relapsed or refractory KMT2Ar acute leukemia [49] - The total addressable market for both KMT2Ar and NPM1 in the relapsed or refractory setting is estimated to approach $2 billion in the US [50] Company Strategy and Development Direction - The company aims to launch two first-in-class products, revumenib and axatilimab, in Q3 2024, focusing on building relationships with healthcare providers and payers [45][46] - The strategy includes in-licensing and developing new molecules with differentiated profiles, emphasizing the importance of capital allocation for future business development [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming product launches and the potential market impact, highlighting the urgency of treatment for patients with acute leukemia [77][78] - The company is actively engaging with payers to ensure timely access and reimbursement for revumenib, anticipating coverage for 90% of lives prior to approval [48][104] Other Important Information - The company is preparing for a significant increase in operating expenses in the second half of the year due to R&D and commercial organization build-out [28] - The company has a robust publication plan to detail the clinical benefits of its products to the prescribing community [44] Q&A Session Summary Question: Importance of NCCN guidelines for new indications - Management plans to engage with the NCCN committee for inclusion in guidelines post-approval, leveraging data presentations at medical congresses [106] Question: Expectations around colorectal cancer data - The company is conducting a Phase 1 trial in metastatic colorectal cancer and plans to provide updates in Q2 [108] Question: Sales force size and overlap of providers - The sales force will be adequately sized to cover 95% of the opportunity, with significant overlap in providers treating both leukemia and chronic GVHD [22][24]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37708 Syndax Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 32-0162505 (State or Other J ...

Exhibit 99.1 Syndax Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Clinical and Business Update – NDA filing for revumenib in R/R KMT2Ar acute leukemia granted Priority Review under RTOR; PDUFA action date set for September 26, 2024 – – BLA filing for axatilimab in chronic GVHD granted Priority Review; PDUFA action date set for August 28, 2024 – – Enrollment completed in AUGMENT-101 mNPM1 cohort; topline data expected in 4Q24 to potentially support sNDA filing in 1H25 – – Company ...

Organ responses in 0.3 mg/kg Q2W 66% had improvement in skin and joint tightening severity 12 Ab535 is a mouse specific anti-CSF-1R antibody | --- | --- | --- | --- | |--------------------------|-----------------------------------|-----------|------------------------------------------------------------------------------------| | N=135 randomized 2:1 | Axatilimab 0.3 mg/kg Q2W (N=90) | | PRIMARY ENDPOINT ∆ FVC | | to axatilimab or placebo | Placebo Q2W (N=45) | Follow-up | SECONDARY ENDPOINTS Disease progres ...

Financial Data and Key Metrics Changes - In Q4 2023, the company strengthened its balance sheet with an additional $258 million in cash, bringing the total cash on hand to $600 million, which is expected to provide a cash runway through 2026 [12][71] - Operating expenses for Q4 were $77.9 million, consisting of $55.1 million in research and development and $22.8 million in selling, general, and administrative expenses [72] - For Q1 2024, the company expects research and development expenses to be between $56 million and $62 million, and total operating expenses to be between $82 million and $88 million [73] Business Line Data and Key Metrics Changes - The company is focused on pre-launch activities for revumenib and axatilimab, with plans to finalize go-to-market strategies [13] - Revumenib has shown a high overall response rate of 63% in KMT2A acute leukemia patients, with a complete response rate of 23% [23] - Axatilimab received priority review from the FDA, with a PDUFA action date set for August 28, 2024, for chronic graft versus host disease [19] Market Data and Key Metrics Changes - The annual incidence of KMT2A acute leukemia is approximately 2,600 patients, with the majority being refractory to frontline treatments, representing a market opportunity of $750 million in the U.S. [42] - The company estimates that the NPM1 acute leukemia population would be slightly larger than the KMT2A population, creating a total accessible population of 5,000 to 6,500 patients in the relapsed or refractory setting [45] Company Strategy and Development Direction - The company aims to distinguish itself as a commercial-stage biotechnology firm with opportunities to expand beyond initial indications for revumenib and axatilimab [9] - The strategy includes targeting both KMT2A and NPM1 acute leukemias, with plans to explore expansion into solid tumors [46][47] - The company is preparing for the commercialization of two first- and best-in-class products in 2024 [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving goals for 2024, highlighting the potential for broad franchise opportunities beyond initial registration indications [77] - The company anticipates a historical year in 2024 with the launch of two significant products, emphasizing the importance of first-mover advantage [14][20] Other Important Information - The company is actively recruiting for its sales force in preparation for the product launches, with plans to have representatives trained before the approvals [82] - The company has a disciplined approach to resource allocation, ensuring financial strength to support its pipeline and product launches [72] Q&A Session Summary Question: Can you comment on expectations for your launch of axatilimab and revumenib? - Management indicated that they will be ready with their sales force prior to the approval of either product, with ongoing recruitment for territory managers [81][82] Question: What are your pre-commercial plans and how do you expect SG&A expenses to grow in 2024? - The company is building out its commercial organization to accommodate both product launches, with SG&A expenses expected to grow to approximately $100 million in 2024 [84][91] Question: Can you address the neutropenia rates observed in the SAVE AML trial? - Management clarified that the observed cytopenia rates are consistent with expectations for the heavily pretreated population included in the trial [96] Question: How do you see the KMT2A launch playing out this year? - Management noted that KMT2A represents a compelling commercial opportunity, with a first-to-market product addressing a dire need in the patient population [115] Question: What are the key efficacy measures you are looking for in the frontline setting for revumenib? - Management emphasized the importance of MRD status, transplant rates, and durable responses as key efficacy measures in the frontline setting [121][126]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File Number: 001-37708 Syndax Pharmaceuticals, Inc. (Exact name of Registrant as specified in its charter) Delaware 2834 32-0162505 (State or Other J ...

Exhibit 99.1 Syndax Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Clinical and Business Update – BLA filing for axatilimab in chronic GVHD granted Priority Review; PDUFA action date set for August 28, 2024 – – NDA for revumenib in R/R KMT2Ar acute leukemia submitted under FDA's RTOR program; PDUFA date assignment expected in 1Q24 – – Enrollment in AUGMENT-101 mNPM1 patient cohort expected to complete in late 1Q/early 2Q; topline data in 4Q24 – – Initiated revumenib ...