On November 6, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT) ("RAPT" or the "Company"), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, reported financial results for the third quarter and nine months ended September 30, 2025.

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"We have considerable momentum heading into the end of the year. We see tremendous potential for ozureprubart in large IgE-driven indications such as food allergy and CSU, and our recent financing gives us additional capital to advance our programs," said Brian Wong, President and CEO of RAPT. "Looking ahead, we plan to report topline results from Jeyou’s Phase 2 trial of ozureprubart in asthma and to provide additional details from the recently reported Phase 2 clinical trial in CSU at a medical meeting next year. We also plan to meet with the FDA and other regulatory agencies to discuss the registrational pathway in CSU."

Recent Highlights

In September, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) Application to proceed to a Phase 2b clinical trial of ozureprubart (RPT904) in food allergy. In October, the Company initiated the prestIgE Phase 2b trial, a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of ozureprubart dosed every 8 weeks (Q8W) and every 12 weeks (Q12W) as a treatment for food allergy.

In October, together with Shanghai Jeyou Pharmaceutical Co., Ltd. (Jeyou), announced positive topline data from Jeyou’s Phase 2 trial of ozureprubart as monotherapy in chronic spontaneous urticaria (CSU). Results from this study, which was conducted in China, indicate that ozureprubart dosed Q8W or Q12W has comparable efficacy and safety to omalizumab dosed Q4W, and the companies believe these results warrant advancing ozureprubart to Phase 3 development in CSU. Although the study was not a formal non-inferiority study and no statistical hypothesis was tested, the data from both the ozureprubart Q8W and Q12W treatment arms showed numerically greater improvement on the UAS7 endpoint and numerically higher proportion of patients with UAS7=0 at all timepoints (Weeks 8, 12 and 16) compared to omalizumab Q4W.
In October, completed an underwritten public offering of 8,333,334 shares of common stock at a price of $30.00 per share for gross proceeds of $250 million. The Company’s current cash balance is projected to fund operations to mid-2028, which includes the planned initiation of Phase 3 studies of ozureprubart in CSU.
Financial Results for the Third Quarter and Nine Months Ended September 30, 2025

All share and per share amounts in this press release have been adjusted to reflect the 1-for-8 reverse split of the Company’s common stock effected on June 16, 2025.

Third Quarter Ended September 30, 2025

Net loss for the third quarter of 2025 was $17.6 million, compared to $18.4 million for the third quarter of 2024.

Research and development expenses for the third quarter of 2025 were $12.0 million, compared to $13.3 million for the third quarter of 2024. The decrease in research and development expenses was primarily due to decreases in costs related to development of zelnecirnon and tivumecirnon, personnel, lab supplies, non-cash stock-based compensation and facilities, partially offset by increases in consulting costs and costs related to development of ozureprubart and early-stage programs.

General and administrative expenses for the third quarter of 2025 were $7.3 million, compared to $6.4 million for the third quarter of 2024. The increase in general and administrative expenses was primarily due to increases in non-cash stock-based compensation, consulting costs and facilities costs.

Nine Months Ended September 30, 2025

Net loss for the nine months ended September 30, 2025 was $52.4 million, compared to $76.6 million for the same period in 2024.

Research and development expenses for the nine months ended September 30, 2025 were $36.4 million, compared to $60.8 million for the same period in 2024. The decrease in research and development expenses was primarily due to decreases in costs related to development of zelnecirnon and tivumecirnon, personnel, lab supplies, non-cash stock-based compensation and facilities, partially offset by increases in consulting costs and costs related to development of ozureprubart and early-stage programs.

General and administrative expenses for the nine months ended September 30, 2025 were $21.8 million, compared to $20.9 million for the same period of 2024. General and administrative expenses increased primarily due to increases in non-cash stock-based compensation, consulting costs and facilities costs, partially offset by a decrease in personnel costs.

As of September 30, 2025, the Company had cash and cash equivalents and marketable securities of $157.3 million. In October 2025, the Company completed an underwritten public offering of 8,333,334 shares of common stock at a price of $30.00 per share for net proceeds of approximately $234.4 million, after deducting underwriting discounts and commissions and offering-related expenses.

(Press release, RAPT Therapeutics, NOV 6, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-third-quarter-2025-financial-results [SID1234659587])

On November 6, 2025 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported financial results for the third quarter ended September 30, 2025, and provided recent corporate progress.

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"The third quarter was marked by executional focus, and we remain on track with our planned IND filings for HWK-007 and HWK-016 by the end of the year. We continue to deploy capital efficiently, maintaining strong financial discipline as we prepare to enter the clinic and deliver potentially value-creating milestones," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "I’m proud of our role in adding to the scientific understanding of PTK7 with the data we presented at AACR (Free AACR Whitepaper)-NCI-EORTC. Confirming PTK7 as the third most highly expressed tumor marker among clinically validated and emerging ADC targets, these data underscore the tremendous opportunity we have with our first ADC candidate, HWK-007, to make a difference for the nearly 750,000 patients in the US with PTK7-expressing cancers."

Recent Operational Highlights:

Presented real-world analysis at AACR (Free AACR Whitepaper)-NCI-EORTC confirming PTK7 as a broadly expressed, clinically relevant target across solid tumors. The analysis was part of a collaboration between Whitehawk and Tempus AI.

On track to bring all three assets to IND by mid-2026. IND submissions are planned by year-end 2025 for HWK-007 and HWK-016. An IND for HWK-206 is expected by mid-2026.

Focused execution and capital efficiency support anticipated runway into 2028. Based on current plans, cash position enables initial clinical data readouts across the portfolio.
Third Quarter 2025 Financial Results:

Cash, cash equivalents and short-term investments as of September 30, 2025, were $162.6 million as compared to $47.2 million as of December 31, 2024. Cash is anticipated to fund operations into 2028 based on current plans.

Net loss for the three months ended September 30, 2025, was $17.7 million as compared to $12.5 million for the three months ended September 30, 2024.

(Press release, Whitehawk Therapeutics, NOV 6, 2025, View Source [SID1234659615])

On November 6, 2025 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported financial results for the third quarter ended September 30, 2025, as well as business updates.

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"Recent months have been transformative for C4T, and we are in a strong position to rapidly advance cemsidomide registrational development and progress our discovery pipeline of degraders against non-oncology and oncology targets," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "We remain laser-focused on initiating cemsidomide’s next phase of development in early 2026, which includes a Phase 1b trial in combination with elranatamab as well as the Phase 2 MOMENTUM trial in combination with dexamethasone, which has potential for accelerated approval. With a successful raise of $125 million in upfront proceeds, we have extended our runway to the end of 2028, beyond important data from cemsidomide’s Phase 2 trial with dexamethasone and the Phase 1b in combination with elranatamab, strengthening our balance sheet to continue to deliver on the promise of targeted protein degradation to improve patients’ lives."

THIRD QUARTER 2025 HIGHLIGHTS AND RECENT ACHIEVEMENTS

Clinical:

Presented Phase 1 data of cemsidomide in combination with dexamethasone in multiple myeloma (MM) demonstrating a potential best-in-class profile in a heavily pre-treated patient population and supports cemsidomide’s advancement to a Phase 1b trial in combination with elranatamab and a Phase 2 MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) trial in combination with dexamethasone. C4T has completed enrollment and dose escalation for the Phase 1 trial.
In the Phase 1 trial, cemsidomide in combination with dexamethasone achieved a 40% and 53% overall response rate at the two highest dose levels, 75 µg and 100 µg, respectively. One patient at the 100 µg dose level achieved a minimal residual disease (MRD) negative complete response. Cemsidomide was well-tolerated and achieved a median duration of response of 9.3 months across all doses, supporting differentiation from other IKZF1/3 degraders.
Entered into a clinical trial collaboration and supply agreement with Pfizer for the combination of cemsidomide and elranatamab for the treatment of relapsed/refractory MM. Under the terms of the agreement, C4T will sponsor and conduct the Phase 1b trial while Pfizer will supply elranatamab (ELREXFIO), a B-cell maturation antigen CD3 targeted bispecific antibody (BCMAxCD3 bispecific), at no cost to C4T for the upcoming trial.
Continued to execute operational steps necessary for the initiation of the Phase 2 MOMENTUM trial of cemsidomide in combination with dexamethasone in the fourth line or later for the first quarter of 2026 and the Phase 1b trial of cemsidomide in combination with elranatamab in the second line or later for the second quarter of 2026.
Presented data analyzing population pharmacokinetic and exposure-response relationships for cemsidomide in MM and non-Hodgkin’s lymphoma (NHL) in a poster at the 2025 American Conference on Pharmacometrics (ACoP 2025). The analysis indicated an increased anti-myeloma effect at higher exposures and a clinically manageable exposure-safety relationship, supporting the risk-benefit analysis in heavily pre-treated MM patients.
Completed dose escalation for the Phase 1 trial of cemsidomide in NHL. Monotherapy cemsidomide demonstrated a well-tolerated profile, consistent with previous disclosures, and achieved compelling anti-lymphoma activity across all dose levels as assessed by investigators. In peripheral T-cell lymphoma (PTCL), 9 out of 22 patients achieved a partial response or better with a PET-CT-based assessment.
Partner Betta Pharmaceuticals continues to advance the CFT8919 Phase 1 dose escalation trial in Greater China.
Research and Discovery:

Highlighted leadership in designing targeted heterobivalent degraders, including CFT1946, that penetrate the blood brain barrier to achieve high central nervous system (CNS) exposures and compelling efficacy in CNS models in presentations delivered by C4T leadership at Fierce Biotech Week and the 8th Annual Targeted Protein Degradation Summit.
Earned a $2 million milestone payment from Biogen related to a patient dosing milestone for the Phase 1 trial of BIIB142, a degrader of IRAK4, which was designed by C4T.
Notified by Merck of their decision to conclude the research collaboration, which will end in late November 2025.
Financing:

Raised $125 million in gross proceeds through an underwritten offering that was led by RA Capital Management with participation from existing shareholders including OrbiMed, Soleus Capital, Lynx1 Capital Management, and Bain Capital Life Sciences. As part of the offering, there is the potential to earn up to $225 million in additional proceeds if the outstanding warrants are exercised.
KEY UPCOMING MILESTONES

Formally align with the U.S. Food & Drug Administration (FDA) on the recommended Phase 2 dose of cemsidomide for the registrational Phase 2 trial of cemsidomide in combination with dexamethasone by year-end 2025.
Initiate a Phase 2 single-arm registrational trial in the first quarter of 2026 to evaluate cemsidomide in combination with dexamethasone.
Initiate a Phase 1b trial in the second quarter of 2026 to evaluate the safety and tolerability of cemsidomide in combination with elranatamab.
UPCOMING INVESTOR EVENTS:

November 12, 2025, at 8:30 AM ET: Management will participate in a fireside chat at the Guggenheim Second Annual Healthcare Conference taking place in Boston, Massachusetts.
December 3, 2025, at 3:25 PM ET: Management will participate in a fireside chat at the 8th Evercore Healthcare Conference taking place in Coral Gables, Florida.
THIRD QUARTER 2025 FINANCIAL RESULTS

Revenue: Total revenue for the third quarter of 2025 was $11.2 million, compared to $15.4 million for the third quarter of 2024. The decrease in revenue was a result of an $8.0 million milestone from Biogen recognized in the third quarter 2024 offset by the recognition of all deferred revenue from our collaboration with Merck and the continued progress on our other collaboration programs during the third quarter of 2025.

Research and Development (R&D) Expense: R&D expense for the third quarter of 2025 was $26.0 million compared to $31.8 million for the third quarter of 2024. The decrease in R&D expense was primarily related to reduced clinical trial expense for CFT1946 as the Phase 1 trial neared completion.

General and Administrative (G&A) Expense: G&A expense for the third quarter of 2025 was $8.9 million compared to $11.8 million for the third quarter of 2024. The decrease was primarily related to lower stock-based compensation expense.

Net Loss and Net Loss per Share: Net loss for the third quarter of 2025 was $32.2 million, compared to $24.7 million for the third quarter of 2024. Net loss per share for the third quarter of 2025 was $0.44 compared to $0.35 for the third quarter of 2024.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of September 30, 2025 were $199.8 million, compared to $223.0 million as of June 30, 2025 and $267.3 million as of December 31, 2024. The decrease during the third quarter was primarily the result of cash used to fund operations and advance our programs, partially offset by $7.5 million of net proceeds from our at-the-market (ATM) equity program. Cash, cash equivalents and marketable securities as of September 30, 2025 does not include $125 million of gross proceeds raised through an equity offering in October 2025. The company expects that its current cash, cash equivalents and marketable securities will enable the company to fund its operating plan to the end of 2028.

About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm, multicenter study to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior lines of therapy will be enrolled in the trial.

About Cemsidomide
Cemsidomide is an investigational, orally bioavailable small-molecule degrader in clinical development for the treatment of relapsed/refractory multiple myeloma. Cemsidomide is a potent and selective degrader of IKZF1/3, transcription factors that drive multiple myeloma, with unique pharmacokinetic properties. Data from the Phase 1 trial of cemsidomide in combination with dexamethasone demonstrated a differentiated safety and tolerability profile and class-leading anti-myeloma activity with durable responses. Two clinical trials are planned to further evaluate cemsidomide in relapsed/refractory multiple myeloma: the registrational Phase 2 MOMENTUM trial to evaluate cemsidomide in combination with dexamethasone expected to initiate in the first quarter of 2026 and a Phase 1b trial to evaluate cemsidomide in combination with elranatamab expected to initiate the second quarter of 2026.

About CFT8919
CFT8919 is an orally bioavailable allosteric degrader that is designed to be potent and selective against EGFR bearing an oncogenic L858R mutation. In preclinical studies, CFT8919 is active in in vitro and in vivo models of L858R driven non-small cell lung cancer. Importantly, CFT8919 retains full activity against additional EGFR mutations that confer resistance against approved EGFR inhibitors including L858R-C797S, L858R-T790M and L858R-T790M-C797S. C4T and Betta Pharmaceuticals have established a strategic partnership to develop CFT8919 in Greater China, where the Phase 1 clinical trial is underway. C4T retains development and commercialization rights for CFT8919 in the United States, European Union and rest of the world.

(Press release, C4 Therapeutics, NOV 6, 2025, View Source [SID1234659556])

On November 6, 2025 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported its financial results for the third quarter ended September 30, 2025, and provided a business update.

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"Our commercial momentum continues with over $100 million in sales this quarter and enables sustained investment in innovation. We are executing to plan – advancing three Phase 3 melanoma trials and multiple mid-stage programs – to deliver transformative outcomes for patients and sustained value for shareholders," said Bahija Jallal, Chief Executive Officer of Immunocore.

Third Quarter 2025 Highlights (including post-period)

KIMMTRAK
The Company’s lead product, KIMMTRAK (tebentafusp), is approved in 39 countries and has been launched in 28 countries globally to date for HLA-A*02:01 positive people with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in most markets where it is launched.

The Company sees three key growth areas as it plans to expand patient reach for KIMMTRAK, including continued global expansion in mUM, the potential expansion into 2L+ advanced cutaneous melanoma (CM), and the potential expansion into adjuvant uveal melanoma.

Metastatic uveal melanoma

KIMMTRAK net product sales were $103.7 million and $295.5 million for the three and nine months ended September 30, 2025, respectively, representing increases of 29% and 31% respectively, as compared to the same periods in 2024.
18% year-over-year quarterly sales growth in the United States with mean duration of treatment increasing to 14 months.
58% year-over-year quarterly sales growth in Europe and in international regions combined, driven by increased demand and launches in additional markets.
2L+ advanced cutaneous melanoma

The Company is currently enrolling patients in the TEBE-AM registrational Phase 3 trial and expects to complete enrollment in the first half of 2026.
The Phase 3 trial is enrolling three arms: tebentafusp monotherapy, tebentafusp in combination with pembrolizumab, and a control (investigator’s choice of therapy including clinical trials, chemotherapy, or retreatment with anti-PD1 or BRAF therapy). The primary endpoint of the randomized Phase 3 trial is Overall Survival (OS).
There is great unmet need in second- and later-line cutaneous melanoma, with no therapy having shown, to date, an OS improvement post checkpoint inhibitors in a randomized clinical trial. The Company estimates that there is a potential to address up to 4,000 previously treated advanced CM patients.

Adjuvant uveal (or ocular) melanoma

The European Organisation for Research and Treatment of Cancer (EORTC) continues to expand the site footprint of the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM).
The Company estimates that the HLA-A*02:01 positive, high-risk adjuvant uveal melanoma patient population could be up to 1,200 patients in the US and Europe.
PRAME portfolio
Brenetafusp is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line, advanced cutaneous melanoma, and in a Phase 1/2 clinical trial as monotherapy and in combination across multiple tumor types, including ovarian cancer and non-small cell lung cancer (NSCLC).

PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma

The Independent Data Monitoring Committee (IDMC) has recommended the dose of 160 mcg as the go-forward dose in PRISM-MEL-301, the Company’s registrational Phase 3 trial in first-line, advanced cutaneous melanoma.
The IDMC made the decision following a pre-planned review of safety for all three arms and of efficacy for the two brenetafusp regimens (40 mcg and 160 mcg) in the first 90 patients randomized in the Phase 3 trial. (In 1Q 2025, the IDMC reviewed the safety of the first 30 patients randomized and recommended to continue the study with no changes.)
Patients treated with the dose of 160 mcg will be included in the intent-to-treat analysis for the primary endpoint.
Patients who are receiving 40 mcg have the option to dose-escalate to 160 mcg but will not be included in the intent-to-treat analysis for the primary endpoint.
The Company will now continue with a 1:1 randomization of HLA-A*02:01 positive patients with first-line, advanced or metastatic cutaneous melanoma to brenetafusp 160 mcg + nivolumab or a control arm of either nivolumab or nivolumab + relatlimab.
Despite approved therapies, there remains a need for improved progression-free survival and OS, and there is the potential to address an estimated 10,000 HLA-A*02:01 positive patients in the US and Europe.
Phase 1/2 clinical trial of brenetafusp in multiple solid tumors

The Company continues to evaluate brenetafusp in a Phase 1/2 trial in combination with non-platinum chemotherapies in platinum-resistant ovarian cancer (PROC) and with bevacizumab or with platinum chemotherapy in earlier lines of platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection in metastatic non-small cell lung cancer (NSCLC) cohorts, including brenetafusp in combination with docetaxel and with osimertinib in earlier-line NSCLC.

IMC-P115C (PRAME-A02 Half-Life Extended) & IMC-T119C (PRAME-A24)

The Company is enrolling patients in the Phase 1 dose escalation trial evaluating IMC-P115C in patients with multiple solid tumors.

IMC-R117C (PIWIL1) for colorectal and other gastrointestinal cancers

The Company is enrolling patients in the Phase 1/2 dose escalation trial evaluating IMC-R117C in HLA-A*02:01 positive patients with advanced solid tumors, including colorectal cancer, as a single agent and in combination with standards of care.

ImmTAV candidates for a functional cure in infectious diseases
The Company’s bispecific TCR technology platform has the potential to offer a new approach for the treatment of certain chronic infections and aims to eliminate evidence of remaining virus in circulation after the patient stops taking medication – known as a ‘functional cure’. Two investigational candidates are in Phase 1 or Phase 1/2 trials for people living with human immunodeficiency virus (HIV) and people with chronic hepatitis B infection (HBV).

Phase 1/2 trial of IMC-M113V (Gag-A02) for people living with HIV

Patient enrollment continues at higher doses in the multiple ascending dose part of the Phase 1/2 clinical trial to identify a safe and tolerable dose.

Phase 1 trial of IMC-I109V (Envelope-A02) for people living with HBV or HBV-positive hepatocellular carcinoma

The Company will present the following poster at the 2025 American Association for the Study of Liver Diseases’ Meeting on November 7, 2025:
Title: IMC-I109V, a soluble T cell receptor (TCR) bispecific targeting HBsAg (ENVxCD3), is tolerable and active against hepatitis B in a first-in-human (FIH) single ascending dose (SAD) study (Poster 1185)
Presenting author: Man-Fung Yuen, MD, PhD, DSc
Session: Poster Session Hepatitis B ("1118-1367")
Date and time: Friday November 7, 2025; 8:00 a.m.-5 p.m. ET

Tissue-specific down modulation of the immune system for autoimmune diseases
The key differentiator of the ImmTAAI platform is tissue-specific, down modulation of the immune system, as the candidates suppress pathogenic T cells via PD1 receptor agonism only when tethered to the target tissue.

IMC-S118AI (PPI-A02) for type 1 diabetes

The Company is on track to file a clinical trial application (CTA) or investigational new drug application (IND) for IMC-S118AI (PPI x PD1) in the second half of 2025.

IMC-U120AI (CD1a) for atopic dermatitis as the initial indication – first universal program

The Company plans to file a CTA/IND for IMC-U120AI (CD1a x PD1) in 2026.

Financial Results
For the third quarter ended September 30, 2025, the Company generated net product sales of $103.7 million compared to $80.2 million for the same period in 2024. Sales of KIMMTRAK were $67.3 million in the United States, $33.5 million in Europe, and $2.9 million in the international regions. The increase in net product sales was due to increased volumes in the United States and Europe as well as global country expansion.

For the quarter ended September 30, 2025, research and development (R&D) expenses were $70.6 million compared to $52.8 million for the same period in 2024. The increase was due to preclinical expenses related to the advancement of the Company’s autoimmune programs, including clinical material manufacturing for anticipated Phase 1 initiations, and clinical expenses related to the progression of the Company’s Phase 3 trials, primarily TEBE-AM and PRISM-MEL-301.

For the quarter ended September 30, 2025, SG&A expenses were $39.8 million compared to $35.5 million for the same period in 2024. The increase was primarily due to costs related to business support functions to support the Company’s growing pipeline and global commercial expansion.

Net (loss) for the quarter ended September 30, 2025, was ($0.2) million, as compared to a net profit of $8.7 million for the same period in 2024. Basic and diluted net loss per share was ($0.00) for the quarter ended September 30, 2025, as compared to a basic and diluted net income per share of $0.17 for the same period in 2024.

Cash, cash equivalents and marketable securities were $892.4 million as of September 30, 2025, as compared to $820.4 million as of December 31, 2024. The Company expects to pay approximately $65 million in sales-related rebate accruals in the fourth quarter of 2025.

(Press release, Immunocore, NOV 6, 2025, View Source [SID1234659572])

On November 6, 2025 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, reported third quarter 2025 financial results and corporate updates.

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"We are pleased with the clinical progress we’ve made across all three of our RLY-2608 trials in breast cancer and vascular malformations," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "In conjunction with our company’s focus on clinical execution, we are pleased to welcome to our Board, Mr. Coats and Mr. Dable, whose extensive experiences in late-stage development and commercialization will help to guide us as we advance our programs."

Board of Directors Updates

Effective November 4, 2025, Lonnel Coats and Habib Dable were appointed to Relay Therapeutics’ Board of Directors.

Lonnel Coats is the former Chief Executive Officer and director of Lexicon Pharmaceuticals, Inc., a biopharmaceutical company. Prior to his time at Lexicon, from 1996 to 2014, Mr. Coats served in a series of leadership positions at Eisai Inc. and Eisai Corporation of North America, U.S. subsidiaries of Tokyo-based Eisai Co., Ltd., a Japanese pharmaceutical company, including as Chief Executive Officer of Eisai Inc. from 2010 to 2014 and as President and Chief Operating Officer of Eisai Inc. from 2004 to 2010. As President and Chief Executive Officer of Eisai, Mr. Coats oversaw the commercialization of Eisai products in the therapeutic areas of oncology, neurology, gastro-intestinal, epilepsy and metabolic disorders. Prior to joining Eisai, Mr. Coats spent eight years with Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, where he held a variety of management and sales positions. Mr. Coats is a former member of the board of directors of Blueprint Medicines and Verve Therapeutics. Mr. Coats holds a B.S. in Public Administration from Oakland University.

Habib Dable has over 30 years of experience in the healthcare industry and is currently an advisor at RA Capital Management, L.P. Most recently, Mr. Dable was President and Chief Executive Officer of Acceleron Pharma Inc., a biopharmaceutical company targeting leading-edge therapies for patients with serious and rare diseases, until its acquisition by Merck in 2021. Prior to joining Acceleron in 2016, Mr. Dable spent 22 years at Bayer AG where he served as President of U.S. Pharmaceuticals; Executive Vice President, Global Head Specialty Medicine; Vice President, Ophthalmology; Global Launch Team Head, EYLEA; Global Head, Neurology and Ophthalmology; and Vice President, Regional Head, Hematology

and Cardiology. He also serves on the board of directors of Day One Biopharmaceuticals, PepGen Inc. and BioLink.org. Mr. Dable is also a former member of the board of directors of Blueprint Medicines, Millendo Therapeutics, Aerovate Therapeutics and Albireo Pharma. Mr. Dable received a B.B.A and M.B.A. from the University of New Brunswick.

RLY-2608 Highlights

•
Breast Cancer Clinical Trial Execution
o
Continued Phase 3 ReDiscover-2 trial of RLY-2608 + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer
o
Continued Phase 1/2 ReDiscover trial, advancing the ongoing triplet cohorts with RLY-2608 + fulvestrant + atirmociclib, palbociclib, or ribociclib
•
Vascular Malformations Clinical Trial
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Continued execution of ongoing Phase 1/2 ReInspire clinical trial in vascular malformations

Third Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2025, cash, cash equivalents and investments totaled $596.4 million, as compared to $781.3 million as of December 31, 2024. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.

R&D Expenses: Research and development expenses were $68.3 million for the third quarter of 2025, as compared to $76.6 million for the third quarter of 2024. The decrease of $8.4 million was primarily due to the series of strategic choices made to streamline the research organization throughout 2024 and 2025, as well as cost avoidance on continued development of lirafugratinib after execution of the license agreement with Elevar Therapeutics, Inc. in December 2024, offset by increases in costs for the ReDiscover-2 Trial and ReInspire Trial.

G&A Expenses: General and administrative expenses were $12.1 million for the third quarter of 2025, as compared to $19.8 million for the third quarter of 2024. The decrease of $7.6 million was primarily due to a decrease in stock compensation expense, as well as other employee compensation costs.

Net Loss: Net loss was $74.1 million for the third quarter of 2025, or a net loss per share of $0.43, as compared to a net loss of $88.1 million for the third quarter of 2024, or a net loss per share of $0.63.

(Press release, Relay Therapeutics, NOV 6, 2025, View Source [SID1234659588])