WALTHAM, Mass., July 25, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it will report its second quarter 2024 financial results and provide a business update on Thursday, August 1, 2024. In connection with the earnings release, Syndax's management will host a conference call and live audio webcast at 4:30 p.m. ET on Thursday, August 1, 2024 to discuss the Company's financial r ...

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"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]

Financial Performance - For the three months ended March 31, 2024, the net loss was $72.4 million, compared to a net loss of $41.1 million for the same period in 2023, representing a 76% increase in losses[59]. - The company has not generated any product revenues to date, with no revenue recognized under the Incyte Agreements for the three months ended March 31, 2024[66]. - The company has an accumulated deficit of $974.8 million as of March 31, 2024, and anticipates continued significant losses in the coming years[96]. Research and Development - Research and development expenses increased by 66% to $56.5 million for the three months ended March 31, 2024, compared to $34.1 million in the same period in 2023[80]. - Total research and development expenses for Q1 2024 increased by $22.4 million, or 66%, to $56.5 million compared to Q1 2023[81]. - Revumenib-related costs rose by $16.5 million, primarily due to increased clinical trial expenses and pre-commercial manufacturing activities[81]. - Enrollment in the pivotal AUGMENT-101 trial for revumenib has been completed, with topline data expected in Q4 2024[61]. - The company plans to initiate a pivotal trial of revumenib in combination with venetoclax and azacitidine by year-end 2024[61]. Expenses - Selling, general and administrative expenses rose by 92% to $23.0 million for the three months ended March 31, 2024, compared to $12.0 million in the same period in 2023[80]. - Selling, general and administrative expenses increased by $11.1 million, or 92%, to $23.0 million in Q1 2024 compared to Q1 2023[84]. Cash and Investments - As of March 31, 2024, the company had cash, cash equivalents, and investments totaling $522.0 million, sufficient to fund operations for at least the next 12 months[89]. - As of March 31, 2024, the company had cash and cash equivalents of $114.6 million and short and long-term investments totaling $407.4 million[105]. - Net cash used in operating activities for Q1 2024 was $83.5 million, compared to $39.2 million in Q1 2023, reflecting increased clinical trial activities[98]. - Net cash used in investing activities for Q1 2024 was $99.4 million, primarily due to the purchase of $167.4 million in available-for-sale securities[101]. Income and Interest - Interest income increased by 43% to $7.3 million for the three months ended March 31, 2024, compared to $5.1 million in the same period in 2023[80]. - Interest income for Q1 2024 increased by $2.2 million, or 43%, due to higher interest rates and increased average balances on cash equivalents and investments[85]. Regulatory Developments - The FDA granted Priority Review for the New Drug Application (NDA) for revumenib, with a target action date of September 26, 2024[61]. - The Biologics License Application (BLA) for axatilimab was accepted by the FDA, with a PDUFA action date of August 28, 2024[68]. Market Risk and Economic Factors - The primary exposure to market risk is interest rate sensitivity, which is influenced by changes in U.S. interest rates[105]. - An immediate 100 basis point change in interest rates would not have a material effect on the fair market value of cash equivalents and investments due to their short-term maturities and low risk profile[105]. - The company does not believe that inflation and changing prices significantly impacted its results of operations for the periods presented[106]. Other Financial Activities - The company entered into a sales agreement for an at-the-market offering program with potential proceeds of up to $200.0 million[90]. - Total other income (expense), net decreased in Q1 2024 primarily due to a reduction in foreign currency losses on investments[87]. - The company has established guidelines for approved investments and maturities to maintain safety and liquidity[105].

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]