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Relay Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Updates

On February 26, 2025 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported fourth quarter and full year 2024 financial results and corporate highlights (Press release, Relay Therapeutics, FEB 26, 2025, View Source [SID1234650638]).

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"Our RLY-2608 breast cancer program continued to advance and develop rapidly in 2024, driven by positive maturation of the RLY-2608 + fulvestrant doublet dataset, now with over 100 patients dosed and median PFS of 11.4 months in second-line patients. We also continue to make progress with our investigational triplet combinations, which we believe could potentially allow RLY-2608 to address patients in earlier settings," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "Looking forward into 2025, it is our top priority to continue advancing our clinical programs, including the initiation of the RLY-2608 + fulvestrant Phase 3 trial in breast cancer patients. With a strong capital position that supports the execution of that pivotal trial, and a team with proven development experience, I am confident in our abilities to meaningfully advance these programs towards patients in oncology and genetic disease areas."

Initiation of ReDiscover-2 Phase 3 trial of RLY-2608 + Fulvestrant in the Middle of 2025

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Relay Tx has conducted an end of Phase 2 meeting with the Food and Drug Administration (FDA) and announces the Phase 3 trial design, dose, and plans to initiate the trial in mid-2025
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Design
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Planned Phase 3 registrational study (ReDiscover-2) is a randomized, open-label, multicenter clinical trial that will evaluate the safety and efficacy of RLY-2608 + fulvestrant in PI3Kα-mutated, HR+/HER2- advanced breast cancer patients previously treated with a CDK4/6 inhibitor
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Comparator arm will be capivasertib + fulvestrant
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Key inclusion criteria include:
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Patients must be CDK4/6-experienced (either in the adjuvant or metastatic setting)
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Patients must have been on frontline endocrine therapy containing regimen for >6 months
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Patients may have seen up to 1 prior chemotherapy and no ADC in the metastatic setting

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Metabolic inclusion criteria: HbA1c <7% and fasting plasma glucose <140 mg/dL at baseline
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Target enrollment is 540 patients
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The primary endpoint is progression free survival (PFS), per RECIST 1.1 criteria, tested hierarchically in patients with PI3Kα mutations in the kinase domain only and in patients with any PI3Kα mutation (kinase + non-kinase mutations)
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Overall survival is a key secondary endpoint with overall response rate (ORR), duration of response and quality of life as additional secondary endpoints
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Dose
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Phase 3 dose of RLY-2608 is 400mg twice daily (BID) in the fed state (fed)
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A positive food effect has been observed when RLY-2608 was administered to patients in the fed state, which increased the exposure level of RLY-2608 compared to the fasted state (fasted)
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The RLY-2608 400mg BID fed dose has been shown to achieve exposures equivalent to 600mg BID fasted in cancer patients.
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600mg BID fasted was the dose used in our expansion cohorts

Additional Corporate Highlights

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RLY-2608:
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RLY-2608 doublet: Presented interim clinical data from the open-label Phase 1b study for RLY-2608 + fulvestrant at the San Antonio Breast Cancer Symposium (SABCS) 2024, showing:
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11.4-month median PFS in second line (2L) patients with PI3Kα-mutated, HR+/HER2- advanced breast cancer
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39% confirmed ORR across patients with measurable disease (n= 31)
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67% Clinical Benefit Rate (CBR) across all evaluable patients (32 of 48 CBR-evaluable patients; CBR defined as the proportion of patients with complete response, partial response or stable disease for at least 24 weeks)
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Safety profile (n= 118) remained differentiated with mostly low-grade treatment- related adverse events
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RLY-2608 triplet: Continued to advance two potential front-line triplet regimens in patients with PI3Kα- mutated, HR+, HER2- advanced breast cancer who had previously received at least one prior CDK4/6 inhibitor, including:
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Initiation of triplet cohort for RLY-2608 + fulvestrant + atirmociclib (Pfizer’s selective CDK4 inhibitor) combination
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Continued advancement of the ongoing RLY-2608 + fulvestrant + ribociclib combination cohort
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Planning underway for development of next-generation endocrine therapy combinations with RLY-2608
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Lirafugratinib:
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Entered exclusive global licensing agreement, granting Elevar Therapeutics worldwide rights to develop and commercialize lirafugratinib
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NRAS program:
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Nominated development candidate, RLY-8161
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Research:
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Continued to consolidate and focus the research platform and portfolio on a small number of high-value targets

Anticipated 2025 Milestones

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RLY-2608 in Breast Cancer:
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Initiation of Phase 3 trial in the middle of 2025
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Additional Phase 1b doublet data in 2025

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Vascular malformations: RLY-2608 clinical trial initiation in the first quarter of 2025
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NRAS and Fabry programs continue to advance towards IND and timing of clinical start for each program will be phased to optimize resources to ensure the execution of the ReDiscover-2 Phase 3 trial

Fourth Quarter and Full Year 2024 Financial Results

Cash, Cash Equivalents and Investments: As of December 31, 2024, cash, cash equivalents, and investments totaled $781.3 million compared to approximately $750.1 million as of December 31, 2023. The company expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into the second half of 2027.

Revenue: There was no revenue for the fourth quarters of 2024 and 2023. Revenue was $10.0 million for the full year 2024, as compared to $25.5 million for the full year 2023. The decrease was primarily due to the timing of milestones achieved, as well as revenue recognized thereon, under the company’s Collaboration and License Agreement with Genentech, Inc.

R&D Expenses: Research and development expenses were $68.1 million for the fourth quarter of 2024, as compared to $77.5 million for the fourth quarter of 2023. Research and development expenses were $319.1 million for the full year 2024, as compared to $330.0 million for the full year 2023. The decreases were primarily due to the impact of prioritization of certain programs in the company’s pipeline, as previously disclosed.

G&A Expenses: General and administrative expenses were $16.9 million for the fourth quarter of 2024, as compared to $16.8 million for the fourth quarter of 2023. General and administrative expenses were $76.6 million for the full year 2024, as compared to $75.0 million for the full year 2023.

Net Loss: Net loss was $76.0 million for the fourth quarter of 2024, or a net loss per share of $0.45, as compared to a net loss of $83.5 million for the fourth quarter of 2023, or a net loss per share of $0.67. Net loss was $337.7 million for the full year 2024, or a net loss per share of $2.36, as compared to a net loss of $342.0 million for the full year 2023, or a net loss per share of $2.79.

Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma

On February 26, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy (Press release, Regeneron, FEB 26, 2025, View Source [SID1234650637]). The target action date for the FDA decision is July 30, 2025 .

Acceptance of the BLA resubmission follows the achievement of an FDA-mandated enrollment target for the Phase 3 confirmatory trial in R/R FL ( OLYMPIA -1). This was the sole approvability issue identified by the FDA in the complete response letter associated with the previous submission. The BLA resubmission is supported by data from the Phase 1 and pivotal Phase 2 trials (ELM-1 and ELM-2), which demonstrated an overall response rate of 80% (n=103), with 74% (n=95) achieving a complete response. Serious adverse events occurred in 67% of patients; those occurring in ≥10% of patients included cytokine release syndrome, COVID-19 and pneumonia.

Odronextamab is approved as Ordspono in the European Union for the treatment of R/R FL or diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy although its safety and efficacy have not been fully evaluated by any other regulatory authority. For complete product information, please see the Summary of Product Characteristics that can be found on www.ema.europa.eu.

About FL
FL is one of the most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). While FL is a slow-growing subtype, it is an incurable disease, and most patients will relapse after initial treatment. It is estimated that approximately 122,000 FL cases are diagnosed globally every year with more than 13,600 FL cases anticipated in the U.S. in 2025.

About the Odronextamab Clinical Development Program
Odronextamab is a CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

ELM-1 is an ongoing, open-label, multicenter Phase 1 trial to investigate the safety and tolerability of odronextamab in patients with CD20+ B-cell malignancies previously treated with CD20-directed antibody therapy.

ELM-2 is an ongoing, open-label, multicenter Phase 2 trial investigating odronextamab across five independent disease-specific cohorts, including DLBCL, FL, mantle cell lymphoma, marginal zone lymphoma and other subtypes of B-NHL. The primary endpoint is objective response rate according to the Lugano Classification as assessed by independent review committee, and secondary endpoints include complete response, progression-free survival, overall survival and duration of response. The pivotal results in FL were published in the Annals of Oncology.

Odronextamab is being investigated in a broad clinical development program exploring its use as a monotherapy as well as in combination regimens in several types of B-NHLs in earlier lines of therapy. In FL, odronextamab is being evaluated as a monotherapy against rituximab plus standard-of-care chemotherapies in a Phase 3 confirmatory trial ( OLYMPIA -1) and in combination with chemotherapy against rituximab plus standard-of-care chemotherapies in a separate Phase 3 trial ( OLYMPIA -2). For more information on Regeneron’s clinical trials in blood cancer, visit the clinical trials website or contact via [email protected] or +1 844-734-6643.

Pyxis Oncology Granted FDA Fast Track Designation for PYX-201 Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer

On February 26, 2025 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PYX-201 for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody (Press release, Pyxis Oncology, FEB 26, 2025, View Source [SID1234650636]). PYX-201 is a first-in-concept antibody-drug conjugate (ADC) that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM), which is highly expressed in various tumor types.

"Receiving Fast Track designation for PYX-201 from the FDA marks a significant milestone for Pyxis Oncology, recognizing our potential to address the significant medical need in R/M HNSCC. This designation underscores the urgency of bringing differentiated treatment options to patients and will help accelerate the development of PYX-201 as we actively recruit patients for our trial," said Lara S. Sullivan, M.D., President and Chief Executive Officer. "We look forward to working with the FDA to advance this promising therapy as efficiently as possible."

Fast Track designation is an FDA program intended to facilitate and expedite the development and review of new drugs in the U.S. for the treatment of a serious or life-threatening condition. To qualify for this designation, there must be clear data demonstrating the drug has potential to address unmet medical need in the designated condition.

About Head and Neck Squamous Cell Carcinoma (HNSCC)

Head and Neck Cancer (HNC) is the sixth most common cancer in the world, with 1,464,550 new cases and 487,993 deaths from HNC globally1. Squamous Cell Carcinoma presents as the most common subtype and is derived from the mucosal lining of the oral cavity, pharynx and larynx. Almost 50% of cases progress to recurrent or metastatic cancer post-initial treatment, presenting patients with a median overall survival of less than a year. The overall incidence of HNSCC is expected to rise, with a predicted 30% increase annually by 20302. The increase has been associated with multiple factors, including but not limited to tobacco use, alcohol consumption, a rise in HPV infections, and other environmental catalysts. With limited development outside of immunotherapy in the last decade, HNSCC remains one of the most difficult to treat carcinomas, highlighting the unmet need.

About PYX-201

PYX-201, an antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM), is the company’s lead clinical drug candidate.

Two PYX-201 trials are now actively recruiting. One trial, PYX-201-101, is designed to evaluate PYX-201 as monotherapy in patients with R/M HNSCC. A second trial, PYX-201-102, is evaluating PYX-201 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors. The combination trial is part of a recently announced Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada).

KEYTRUDAis a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Protara Therapeutics to Present at the TD Cowen 45th Annual Health Care Conference

On February 26, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that management will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Wednesday, March 5, 2025, at 9:50 am ET in Boston (Press release, Protara Therapeutics, FEB 26, 2025, View Source [SID1234650635]).

A live webcast of the fireside chat can be accessed by visiting the Events and Presentations section of the Company’s website: View Source The webcast will be archived for a limited time following the presentation.

Microbiotica presented new data on the mechanism of action of MB097, a clinical-stage drug candidate being developed as a co-therapy in combination with KEYTRUDA® (pembrolizumab) in patients with advanced melanoma

On February 26, 2025 Microbiotica, a clinical-stage biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs), reported that it has presented new data on the mechanism of action of MB097 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) AACR (Free AACR Whitepaper) IO meeting held in Los Angeles, February 23-26 (Press release, Microbiotica, FEB 26, 2025, View Source [SID1234650634]). MB097 is an LBP in development as an adjunct to immune-oncology treatments such as MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

Dr Mat Robinson, Microbiotica’s Senior Vice-President of Research, presented data from new pre-clinical studies in a poster entitled "Clinical response to immune checkpoint inhibitors in melanoma is associated with distinct gut bacterial species that promote anti-tumor immunity by different mechanisms". The poster can be accessed here (View Source)

The bacteria comprising MB097 were found to be associated with response to immune-oncology treatments, such as KEYTRUDA (pembrolizumab), in multiple cohorts of melanoma patients. These new data demonstrate that the bacterial strains within MB097 can interact directly with dendritic cells to potently activate cytotoxic T lymphocytes (CTL). In addition, certain MB097 bacteria also produced metabolites that enhanced the tumor cell-killing potential of CTLs. One strain released metabolites that reversed the inhibitory effects of tumor-associated macrophages.

Mat Robinson, Microbiotica’s Senior VP of Research, said, "These data begin to identify the different mechanisms by which gut commensal bacteria drive immunotherapy response."

MB097 is being tested in an international Phase Ib clinical study, in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with cutaneous melanoma who have failed to respond to immunotherapies. Data readout expected by the end of 2025.