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Disc Medicine Reports Second Quarter 2025 Financial Results and Provides Business Update

On August 7, 2025 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the second quarter ended June 30, 2025, and provided a recap of recent program and corporate developments (Press release, Disc Medicine, AUG 7, 2025, View Source [SID1234654973]).

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"We are pleased with the continued momentum this past quarter, highlighted by clinical data presentations that support further advancement across our programs and continued progress toward our first NDA submission. Following positive feedback from our pre-NDA meeting, we are on track to submit an NDA for bitopertin in EPP under the accelerated approval pathway in October," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "We have also made great progress across the rest of our pipeline, initiating a Phase 2 study of DISC-3405 in polycythemia vera, and looking ahead to data from the Phase 2 trial of DISC-0974 in MF anemia and Phase 1b trial in NDD-CKD anemia in the second half of the year. Our team’s commitment to execution, supported by a strong balance sheet that provides cash runway into 2028, has positioned Disc to prepare for the potential commercialization of bitopertin and advance pipeline development as we enter the next phase of growth."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyTI Inhibitor (Heme Synthesis Modulator)

Presented data from HELIOS, an ongoing open-label extension study of bitopertin in EPP, which showed favorable long-term efficacy and safety with sustained protoporphyrin IX (PPIX) reductions, improvement in quality of life, and improved liver biomarkers
Progressing confirmatory Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP
Completed positive pre-NDA meeting with FDA, confirming alignment with the agency on the expected timing, format, and content of planned NDA submission for bitopertin in EPP
Expect to submit an NDA in October 2025 under the FDA’s accelerated approval pathway based on Disc’s existing data package
Publication of the results from a preclinical study conducted in collaboration with Boston Children’s Hospital showing that, in mice, bitopertin may help prevent liver disease in EPP, in addition to ameliorating blood PPIX levels. The paper, "The GLYT1 inhibitor bitopertin mitigates erythroid PPIX production and liver disease in erythroid protoporphyria," was published in the Journal of Clinical Investigation (corresponding authors Sarah Ducamp and Paul Schmidt)
DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)

Hosted a virtual MF Anemia KOL event on May 9, 2025, discussing DISC-0974 and its potential to play a significant role in the treatment of anemia in patients with MF
A replay of the webcast is available on the Events & Presentations page on the investor relations portion of the Company website
Presented clinical data from the continuation phase of the Phase 1b trial of DISC-0974 in MF anemia demonstrating durable hematologic response at EHA (Free EHA Whitepaper) 2025
Progressing RALLY-MF Phase 2 study of DISC-0974 in patients with anemia of MF with initial data expected in Q4 2025
Exploratory cohort for patients on concomitant momelotinib or pacritinib fully enrolled, and trial protocol updated to allow patients on these therapies into the main study cohorts
Progressing Phase 1b study of DISC-0974 in patients with anemia of NDD-CKD with multiple-dose data expected in Q4 2025
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Presented updated SAD/MAD data from the Phase 1 trial of DISC-3405 in healthy volunteers providing proof of mechanism to support advancement of the program at EHA (Free EHA Whitepaper) 2025
Initiated a Phase 2 study of DISC-3405 in patients with PV with initial data expected in 2026
Corporate:

Appointed Nadim Ahmed, President and CEO of Cullinan Therapeutics, to the Company’s Board of Directors in July, bringing to the Company over 25 years of development and commercial leadership experience including multiple product launches in the hematology space
Second Quarter 2025 Financial Results:

Cash Position: Cash, cash equivalents, and marketable securities were $650.0 million as of June 30, 2025, which are expected to fund operational plans into 2028.
Research and Development Expenses: R&D expenses were $46.3 million for the three months ended June 30, 2025, as compared to $23.5 million for the three months ended June 30, 2024. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including bitopertin’s clinical studies and drug manufacturing, the advancement of the DISC-0974 program, and increased headcount, as well as a payment of a $10 million milestone upon initiation of the APOLLO study.
Selling, General and Administrative Expenses: SG&A expenses were $15.1 million for the three months ended June 30, 2025, as compared to $7.4 million for the three months ended June 30, 2024. The increase in SG&A expenses was primarily due to increased headcount including establishing infrastructure to support potential commercialization.
Net Loss: Net loss was $55.2 million for the three months ended June 30, 2025, as compared to $26.4 million for the three months ended June 30, 2024. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

CytomX Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update

On August 7, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported second quarter 2025 financial results and provided a business update (Press release, CytomX Therapeutics, AUG 7, 2025, View Source [SID1234654972]).

"Q2 2025 was an exciting quarter for CytomX as we announced positive initial clinical results for CX-2051 in advanced colorectal cancer, a very challenging disease to treat. Our data highlight CX-2051’s intentional design as a first-in-class, masked EpCAM-directed ADC with potential to improve upon the standard of care in late-line CRC. We are also delighted to have completed a financing with top-tier investors that enables CytomX to rapidly advance the CX-2051 development program. Looking ahead, we remain highly focused on our next anticipated CX-2051 clinical data update in Q1 2026 and to potentially launching a Phase 2 study in the first half of 2026," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

Q2 2025 Pipeline Program Updates:

CX-2051 (EpCAM PROBODY Topo-1 ADC)

Announced positive interim data from ongoing Phase 1 dose escalation study of first-in-class EpCAM Antibody Drug Conjugate (CX-2051) in patients with advanced colorectal cancer (CRC).
Initiated CX-2051 dose expansions at the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks (Q3W).
Phase 1 data update in advanced CRC in approximately 70 patients is expected by Q1 2026.
Planning underway for CX-2051 Phase 2 study initiation in advanced, late-line CRC in 1H 2026.
Potential to initiate CX-2051 combination studies in earlier lines of CRC therapy in 2026.
Evaluation ongoing of multiple non-CRC, EpCAM-expressing tumor indications for potential future CX-2051 development.
CX-801 (PROBODY Interferon alpha-2b)

Phase 1 dose escalation of CX-801 monotherapy continues. Preliminary tumor biomarker, pharmacodynamic (PD) and pharmacokinetic (PK) data evaluating the initial molecular performance of CX-801 monotherapy in the ongoing Phase 1 study are expected in the fourth quarter of 2025.
In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA was initiated. Initial clinical data for the combination therapy in advanced melanoma is anticipated in 2026.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Corporate and Financial:

Financial:
Completed $100 million ($93.4 million net proceeds) underwritten offering of common stock.
CytomX ended the second quarter of 2025 with $158.1 million of cash, cash equivalents and investments with expected cash runway to the second quarter of 2027.
Research collaborations:
Presented preclinical data for mRNA encoded masked IL-12 molecule in collaboration with Moderna at AACR (Free AACR Whitepaper) Annual Meeting showing potent anti-tumor activity with significantly enhanced tolerability vs. unmasked IL-12 molecule.
Multiple drug discovery programs continue across our research collaborations with a focus on bispecific immunotherapies, including T-cell engagers. CytomX has research collaborations with Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna.
Second Quarter 2025 Financial Results:

Cash, cash equivalents and investments totaled $158.1 million as of June 30, 2025, compared to $79.9 million as of March 31, 2025.

Total revenue was $18.7 million for the quarter ended June 30, 2025, compared to $25.1 million for the quarter ended June 30, 2024. The decrease in revenue was driven primarily by the completion of our performance obligations in the Bristol Myers Squibb collaboration, the decision not to further develop the CX-904 program in the Amgen agreement, and a decrease in Moderna activities due to Moderna budget considerations.

Total operating expense in the second quarter of 2025 was $19.9 million compared to $33.6 million in the second quarter of 2024, a decrease of $13.7 million.

Research and development expenses were $13.3 million for the three months ended June 30, 2025, a decrease of $11.9 million compared to the corresponding period of 2024. Reduced research and development expenses were primarily due to a one-time milestone payment of $5M to Immunogen for the first patient dosed in Phase 1 with CX-2051 in Q2 2024, a reduction in CX-904 spend due to program de-prioritization in 2025, and reduced research expenses following the Q1 2025 restructuring.

General and administrative expenses were $6.6 million for the three months ended June 30, 2025, a decrease of $1.8 million compared to the corresponding period of 2024. The decrease in general and administrative expenses was primarily driven by personnel costs as well as patent and legal expenses.

Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2025 Financial Results

On August 7, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported an update on recent and anticipated business highlights and announced its financial results for the second quarter ended June 30, 2025 (Press release, Cullinan Oncology, AUG 7, 2025, View Source [SID1234654971]).

"I am proud of the team’s strong execution throughout the first half of the year as we continue to advance the CLN-978 program across three active studies in SLE, RA, and Sjögren’s disease. With the addition of velinotamig, we further solidified our leadership position in the development of T cell engagers for autoimmune diseases. With these two programs, our portfolio covers the entire breadth of the B cell compartment. Recent data presented at the European Alliance of Associations for Rheumatology (EULAR) meeting reinforced the potential of T cell engagers as disease-modifying therapies across a wide spectrum of autoimmune diseases," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics.

"We also continue making important progress across our oncology portfolio, recently sharing results from the pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, and we look forward to sharing multiple new data sets at upcoming medical conferences. Pending discussions with the U.S. FDA, our partner Taiho plans to submit an NDA in relapsed EGFR ex20ins NSCLC later this year and expects to complete enrollment of the frontline study REZILIENT3 in the first half of 2026. We also plan to share clinical data for CLN-049, our FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory AML and MDS later this year. With $510.9 million in cash and investments and runway into 2028, we have the resources to generate multiple value-driving catalysts near term and beyond across both our immunology and oncology programs. Lastly, I am pleased to welcome Drs. Mittie Doyle and Andrew Allen to our Board of Directors. They are proven leaders with deep strategic and development expertise in immunology and oncology, respectively, and I believe their contributions will be invaluable as we continue to advance our programs. I would also like to thank Drs. Anne-Marie Martin and David Ryan for their contributions to our progress and success over the last several years."

Portfolio Highlights

Immunology

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CLN-978 (CD19xCD3 bispecific T cell engager): Systemic lupus erythematosus, rheumatoid arthritis, and Sjögren’s disease
o
The global Phase 1 study in patients with moderate to severe SLE is enrolling in the United States, Europe, and Australia, and the Company plans to share initial safety data and B cell depletion data from Part A of the study in Q4 2025.
o
The Phase 1 study in patients with active, difficult-to-treat rheumatoid arthritis is enrolling in Europe. This company-sponsored study is being led by sites at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Italy. The Company plans to share initial data from this study during the first half of 2026.
o
The global Phase 1 study in patients with active, moderate to severe Sjögren’s disease is enrolling in the U.S. and is now also active in Europe following recent regulatory approval.

•
Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
o
In June 2025, the Company entered into an agreement with Genrix Bio for an exclusive global (ex-Greater China) license to velinotamig. Under the agreement, Cullinan paid Genrix Bio an upfront license fee of $20 million. In the future, Genrix Bio will also be eligible to receive up to $292 million in development and regulatory milestones plus up to an additional $400 million in sales-based milestones, as well as tiered royalties on potential ex-Greater China net sales.
o
Genrix Bio plans to initiate a Phase 1 study in patients with autoimmune diseases in China by the end of 2025. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.
Oncology

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Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
In June 2025, results from the pivotal Phase 2b portion of REZILIENT1 in patients with EGFR ex20ins NSCLC who have received prior therapy were shared at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting and published simultaneously in the Journal of Clinical Oncology. Cullinan plans to share updated efficacy and safety data in patients previously treated with amivantamab during a mini oral abstract session at the IASLC 2025 WCLC.
o
Pending discussions with the U.S. Food and Drug Administration, Taiho plans to submit an NDA in relapsed EGFR ex20ins NSCLC by the end of 2025. Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in the first half of 2026.
o
Taiho plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC. Taiho also plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with active brain metastases at the ESMO (Free ESMO Whitepaper) Congress 2025.

•
CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
o
Enrollment continues in the Phase 1 study in patients with relapsed/refractory AML or MDS and the company plans to share clinical data from this study in Q4 2025.
o
Enrollment also continues in the Phase 1 study in patients with measurable minimal residual disease in AML.
•
CLN-619 (Anti-MICA/MICB monoclonal antibody): NSCLC and multiple myeloma
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Enrollment continues in the Phase 1 expansion cohorts in patients with NSCLC and the Phase 1 study in patients with relapsed/refractory multiple myeloma.
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CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
o
Enrollment continues in the Phase 1 study in patients with advanced solid tumors.
Corporate Updates

•
Mittie Doyle, M.D., and Andrew Allen, M.D., Ph.D., were appointed to the Board of Directors, effective August 7, 2025. Both board directors bring significant leadership experience, with Dr. Doyle having extensive immunology clinical development expertise, and Dr. Allen with extensive oncology clinical development experience. Anne-Marie Martin, Ph.D., and David Ryan, M.D., will resign from Cullinan’s Board of Directors effective August 7, 2025.
Second Quarter 2025 Financial Results

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Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $510.9 million as of June 30, 2025. Cullinan continues to expect its cash resources to provide runway into 2028 based on its current operating plan.
•
R&D Expenses: Research and development expenses were $61.0 million for the second quarter of 2025, compared to $36.3 million for the same period in 2024.
•
G&A Expenses: General and administrative expenses were $14.8 million for the second quarter of 2025, compared to $13.8 million for the same period in 2024.
•
Net Loss: Net loss attributable to Cullinan was $70.1 million for the second quarter of 2025, compared to $42.0 million for the same period in 2024.

Crinetics Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Business Update

On August 7, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the second quarter ended June 30, 2025 (Press release, Crinetics Pharmaceuticals, AUG 7, 2025, View Source [SID1234654970]).

"We continue to make significant progress towards our goal of becoming a fully-integrated, commercial-stage company and delivering on our commitment to help people living with acromegaly," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "As we approach our PDUFA date, our interactions with the FDA remain on track. In addition to our world-class drug discovery and development capabilities, we have now nearly completed the build-out of a premier commercial organization. We are committed to rapidly making PALSONIFY available as the new level of care for patients upon approval. At the same time, we remain dedicated to the execution of early- and late-stage trials across our pipeline. I am excited to see the ramp of our late-stage trials in carcinoid syndrome and CAH (both adult and pediatric), as well as initiation of the Phase 1/2 trial of our first nonpeptide drug-conjugate, CRN09682, for SST2-expressing solid tumors. Overall, Crinetics is in the strongest position in its history, with unprecedented momentum across our clinical programs, multiple new candidates approaching the clinic, a solid financial foundation, and a clear path toward delivering transformative therapies to patients."

Second Quarter 2025 and Recent Highlights:

The review process for paltusotine’s New Drug Application (NDA) for acromegaly remains on track with consistent and productive engagement with the Food & Drug Administration (FDA).
Marketing Authorization Application (MAA) validated by the European Medicines Agency (EMA) for paltusotine for the treatment of acromegaly, consistent with a timeline for potential EMA decision in the first half of 2026.
Continued progress on the global development program for atumelnant across multiple trials, including enrollment completion of Cohort 4 of the adult Phase 2 study with data expected early in 2026.
The Phase 2/3 BALANCE-CAH pediatric study is seamlessly designed to expedite development with the goal of demonstrating atumelnant’s potential ability to normalize androstenedione (A4) levels with physiological glucocorticoid (GC) replacement.
Presented two abstracts at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2025 which showed treatment with investigational PALSONIFY resulted in rapid and durable IGF-1 control in surgically naïve acromegaly patients and additional research on symptom burden and standard-of-care discontinuation rates.
Eight abstracts from Crinetics’ novel clinical development programs, including oral presentations featuring lead investigational drug candidate, paltusotine, investigational candidate atumelnant, and CRN12755, the early-stage development program in Graves’ hyperthyroidism and orbitopathy, were presented at the Endocrine Society’s Annual Meeting, ENDO 2025.
Key Upcoming Milestones:
FDA PDUFA target action date of September 25, 2025 for paltusotine NDA for the treatment of acromegaly.
Crinetics expects to initiate the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in the second half of 2025.
Crinetics expects to initiate the CALM-CAH Phase 3 study in adults with CAH and the BALANCE-CAH Phase 2/3 study in pediatrics in the second half of 2025.
Planning, including regulatory interactions, for the next study of atumelnant in ACTH-dependent Cushing’s syndrome is underway. Initiation of the Phase 2/3 study is expected to begin in the first half of 2026.
Crinetics expects to initiate a Phase 1/2 dose escalation study for CRN09682, the first candidate from the nonpeptide drug conjugate (NDC) platform with an expansion phase for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors (NETs) and other SST2-expressing solid tumors.
IND-enabling activities for the TSH antagonist continue as expected, and development of the SST3 agonist and PTH antagonist is ongoing.
Second Quarter 2025 Financial Results:
Revenues were $1.0 million for the quarter ended June 30, 2025, compared to $0.4 million for the same period in 2024. Revenues were derived from the paltusotine licensing and supply agreements with Sanwa Kagaku Kenkyusho Co., Ltd.

Research and development expenses were $80.3 million for the three months ended June 30, 2025, compared to $58.3 million for the same period in 2024. The increases were primarily attributable to an increase in personnel costs of $9.6 million and increased clinical and manufacturing activities costs of $7.9 million for the quarter ended June 30, 2025, respectively, driven by the advancement of our clinical programs and the expansion of our preclinical portfolio.
Selling, general and administrative expenses were $49.8 million for the three months ended June 30, 2025, compared to $24.8 million for the same period in 2024. The increases were primarily driven by an increase in personnel costs of $12.0 million primarily due to the increase in headcount and an increase in outside services costs of $10.3 million primarily for commercial planning for the quarter ended June 30, 2025, respectively, to support our overall growth and the planned commercial launch of PALSONIFY
Net loss for the three months ended June 30, 2025, was $115.6 million, compared to a net loss of $74.1 million for the same period in 2024.

Cash, cash equivalents, and investments totaled $1.2 billion as of June 30, 2025, compared to $1.4 billion as of December 31, 2024. Based on current projections, Crinetics expects that its cash, cash equivalents and investments will be sufficient to fund its current operating plan into 2029. For 2025, we now anticipate our cash used in operations to be between $340 and $370 million.

Conference Call and Webcast Details

Management will hold a live conference call and webcast today, Thursday, August 7 at 4:30 p.m. ET. To participate, please dial 1-833-470-1428 (domestic) or 1-404-975-4839 (international) and refer to Access Code 899803. To access the webcast, the direct link (here) or visit the Events page of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.

Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2025 Financial Results

On August 7, 2025 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the second quarter ended June 30, 2025 (Press release, Corvus Pharmaceuticals, AUG 7, 2025, View Source [SID1234654969]).

"We are excited by the data reported from our Phase 1 trial of soquelitinib for atopic dermatitis and are advancing its development for this indication on multiple fronts," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "This includes patient enrollment in the extension cohort 4 of the Phase 1 trial, which is exploring an 8-week treatment period and is on track to report data in the fourth quarter 2025, along with near-final plans for a Phase 2 trial that we expect to initiate before year-end. In China, our partner Angel Pharmaceuticals plans to initiate a separate Phase 1b/2 trial, which will further expand the clinical experience with soquelitinib, including a 12-week treatment period and a 400 mg once-daily dose. In addition, enrollment continues in our Phase 3 registration clinical trial in PTCL and the Phase 2 trial in autoimmune lymphoproliferative syndrome (ALPS), reflecting the broader opportunity for ITK inhibition across a range of immune diseases."

Business Update and Strategy

Soquelitinib (Corvus’ selective ITK inhibitor) for Immune Diseases

On June 4, 2025, Corvus reported interim results (data cutoff date of May 28, 2025) from the first three cohorts of its randomized, placebo-controlled Phase 1 clinical trial of soquelitinib in patients with moderate to severe atopic dermatitis that continued to demonstrate a favorable safety profile and efficacy profile. Patients in cohort 3 had more advanced disease with a higher mean baseline EASI (Eczema Area and Severity Index) score compared to patients in cohorts 1 and 2. At 28 days, the mean reduction in EASI for cohort 3 (n=12) was 64.8%, compared to 54.6% for cohort 1 and 2 combined (n=24) and 34.4% for placebo (n=12). Cohort 3 patients experienced earlier responses and deeper separation from placebo compared to cohorts 1 and 2 starting by day 8. EASI scores continue to improve further in treated patients from all cohorts out to day 58.
In cohort 3, of the patients for whom adequate PP-NRS (Peak Pruritus Numerical Rating Scale) data was available, 4 of 8 (50%) had a ≥4 point reduction in PP-NRS score from baseline at day 28, with a reduction in itch seen as early as day 8. Of the remaining patients, two had baseline PP-NRS of less than 4 and two had incomplete PP-NRS data. One of 10 evaluable placebo patients (10%) experienced a ≥4 point reduction in PP-NRS score at Day 28.
As of the data cutoff, soquelitinib was well tolerated in the Phase 1 clinical trial, with no dose limiting toxicities (DLTs) and no clinically significant laboratory abnormalities observed in any of the cohorts.
Corvus initiated enrollment in extension cohort 4 of the Phase 1 clinical trial, which is planned to study 24 patients randomized 1:1 between active (soquelitinib 200 mg twice per day, the same dose as cohort 3) and placebo. The treatment period for this group is 8 weeks, compared to 4 weeks in cohorts 1-3, with the same additional 30-day follow-up period with no treatment.
Angel Pharmaceuticals, Corvus’ partner in China, has been approved by the Center for Drug Evaluation of the China National Medical Products Administration to initiate a Phase 1b/2 clinical trial of soquelitinib for the treatment of patients with moderate-to-severe atopic dermatitis in China. The trial, which is planned to enroll 48 patients and will study four soquelitinib doses and placebo, will further expand the clinical experience with soquelitinib in atopic dermatitis, including a 12-week treatment period and a 400 mg once-daily dose.
Preclinical data highlighting the potential of soquelitinib to treat systemic sclerosis was presented in a poster session at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress, where it was selected as a top 10 abstract by the Emerging EULAR Network (EMEUNET), a network of young rheumatologists and researchers in the field of rheumatology in Europe and beyond.
Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation that is optimized for specific immunology indications.
Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)

Patient enrollment continues in the ALPS Phase 2 clinical trial, which is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial (NCT06730126) is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing.
Soquelitinib for T Cell Lymphoma

Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy.
Collaboration with Kidney Cancer Research Consortium: Ciforadenant (adenosine A2a receptor inhibitor)

Corvus is collaborating with the Kidney Cancer Research Consortium (KCRC) in a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The trial is fully enrolled and patients are being followed.
Partner Led Program: Mupadolimab (anti-CD73)

Angel Pharmaceuticals continues to evaluate data from its Phase 1/1b clinical trial of mupadolimab in patients with relapsed non-small cell lung cancer (NSCLC).
Financial Results
As of June 30, 2025, Corvus had cash, cash equivalents and marketable securities of $74.4 million as compared to $52.0 million as of December 31, 2024. During the three months ended June 30, 2025, all of the remaining outstanding common stock warrants were exercised, resulting in proceeds of $35.7 million which included $2.0 million from warrants exercised by Corvus’ CEO, Dr. Miller. Based on its current plans, Corvus expects its cash to fund operations into the fourth quarter of 2026.

Research and development expenses for the three months ended June 30, 2025 totaled $7.9 million compared to $4.1 million for the same period in 2024. The increase of approximately $3.8 million was primarily due to higher clinical trial and manufacturing costs associated with the development of soquelitinib as well as an increase in personnel related costs.

Net loss for the three months ended June 30, 2025 was $8.0 million compared to a net loss of $4.3 million for the same period in 2024. Included in net loss for the three months ended June 30, 2024 and 2025 was a gain of $2.0 million and $1.8 million, respectively, associated with a change in fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended June 30, 2025 was $1.3 million compared to $0.8 million for the same period in 2024, and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $0.4 million for the three months ended June 30, 2025 compared to non-cash income of $0.6 million for the same period in 2024.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, August 7, 2025, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2025 financial results. The conference call can be accessed by dialing 1-800-717-1738 (toll-free domestic) or 1-646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.