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]).

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"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
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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.
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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.
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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.

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Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
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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.
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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
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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.

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CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
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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.
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Enrollment also continues in the Phase 1 study in patients with measurable minimal residual disease in AML.
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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
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Enrollment continues in the Phase 1 study in patients with advanced solid tumors.
Corporate Updates

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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.
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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.
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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.
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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.

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]).

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"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.

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]).

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"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.

On August 7, 2025 CorMedix Inc. (Nasdaq: CRMD) reported financial results for the second quarter and six months ended June 30, 2025 and provided an update on its business announcing the acquisition of Melinta Therapeutics LLC, with a target closing date as early as September 1, 2025 (Press release, CorMedix, AUG 7, 2025, View Source [SID1234654968]).

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Second Quarter and Six Months 2025 Financial Highlights

For the second quarter of 2025, CorMedix recorded $39.7 million in net revenue from sales of DefenCath, compared to $0.8 million for the same period last year, and recorded net income of $19.8 million, or $0.29 per share, compared with a net loss of $14.2 million, or $0.25 per share, in the second quarter of 2024, driven primarily by net sales of DefenCath during the period.

Operating expenses in the second quarter of 2025 were $18.3 million, compared with $15.6 million in the second quarter of 2024, an increase of approximately 18%. The increase was driven primarily by an increase in G&A expense and R&D expense for the period. R&D expense in the second quarter of 2025 was $2.4 million, compared with $0.7 million for the same period in 2024, due to an increase in personnel and clinical trial services in support of the ongoing clinical programs. Selling and Marketing expense for the second quarter of 2025 amounted to $6.4 million, compared with $7.4 million in the second quarter of 2024, a decrease of 14% which was primarily due to increased marketing costs in the prior period related to the launch of DefenCath. General and administrative expense in the second quarter of 2025 amounted to $9.5 million, compared with $7.6 million in the second quarter of 2024, an increase of 25%. The increase was primarily driven by non-cash charges for stock-based compensation and costs related to business development.

For the six months ended June 30, 2025, the Company recorded $78.8 million in net revenue from the sales of DefenCath, compared to $0.8 million in net revenue for the same period last year, and recorded net income of $40.5 million, or $0.60 per share, during the first half of 2025, compared to a net loss of $28.6 million, or $0.50 per share, for the same period in 2024.

Operating expenses in the first half of 2025 were $35.7 million, compared to $31.5 million in the same period in 2024, an increase of approximately $4.2 million or 13%. This increase was primarily due to an increase in R&D expense and G&A expense, partially offset by a decrease in S&M expense related to the commercial launch activities of DefenCath.

The Company reported cash and short-term investments of $190.7 million as of June 30, 2025, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, August 7, 2025, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

Thursday, August 7th @ 8:30am ET
Domestic: 1-844-676-2922
International: 1-412-634-6840
Webcast: Webcast Link

On August 7, 2025 Coherus Oncology, Inc. (Nasdaq: CHRS), reported financial results for the second quarter ended June 30, 2025 and provided an overview of recent business highlights (Press release, Coherus Oncology, AUG 7, 2025, View Source [SID1234654967]).

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"Coherus Oncology is dedicated to significantly extending survival for people with cancer," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "We are executing well commercially, and our focus on maximizing LOQTORZI’s potential in nasopharyngeal carcinoma has resulted in a 36% net revenue increase over Q1 2025 to $10.0 million. With a cash runway through 2026, beyond key data readouts, continued strong clinical execution will derisk the pipeline, unlocking large U.S. market potential and creating Ex-U.S. licensing opportunities as the clinical data further evolve."

"Our pipeline clinical programs with CHS-114 and casdozkitug in solid tumors are progressing and on track for data readouts in 2026," said Theresa LaVallee, Ph.D., Coherus Chief Scientific and Development Officer. "Data on CHS-114, our cytolytic CCR8 antibody, in combination with toripalimab, provide compelling evidence of their potential in remodeling the tumor microenvironment by depleting immunosuppressive Treg cells with CHS-114 and boosting immune activation with toripalimab. We believe that in 2026, anti-CCR8s may start to realize their therapeutic promise and become a new treatment backbone, used broadly across solid tumor types."

RECENT BUSINESS HIGHLIGHTS

LOQTORZI (toripalimab-tpzi) COMMERCIAL UPDATES

LOQTORZI is the only FDA-approved and available treatment in the U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), in all patient subsets and across all lines of therapy.
LOQTORZI net revenue for Q2 2025 was $10.0 million, a 36% growth over LOQTORZI net revenue of $7.3 million in Q1 2025. This growth was driven largely by higher patient demand and some inventory restocking. LOQTORZI net revenue was $3.8 million in Q2 2024.
Following a recent revision in the National Comprehensive Cancer Network (NCCN) guidelines granting LOQTORZI preferred status for NPC indication, the Company has seen strong demand growth among Head & Neck cancer specialists. The Company’s focus remains on deepening adoption within the community oncologist setting.
ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE

LOQTORZI is a next-generation, differentiated PD-1 marketed in the U.S. in two indications.

Coherus plans to maximize the value of this medicine by combining LOQTORZI with internal pipeline candidates, CHS-114 and casdozokitug, for additional solid tumor indications and entering into capital-efficient external partnerships for label expansions.
CHS-114 is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding.

Phase 1b CHS-114/toripalimab combination dose optimization studies in 2L head and neck (HNSCC) and 2L gastric cancers are underway, with initial data readouts expected in 1H 2026.
A Phase 1b study evaluating the CHS-114/toripalimab combination, with and without chemotherapy, in 1L and 2L esophageal squamous cell carcinoma (ESCC), respectively, is underway with a first data readout expected in 1H 2026.
Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory non-small cell lung cancer (NSCLC) and clear cell renal cell carcinoma (ccRCC) and combination activity in hepatocellular carcinoma (HCC).

Enrollment is ongoing in the Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in 1L HCC, with the first data readout expected in 1H 2026.
UDENYCA DIVESTITURE COMPLETED AND CERTAIN FINANCIAL OBLIGATIONS PAID OFF

On April 11, 2025, Coherus completed the UDENYCA divestiture and received $483.4 million in cash, inclusive of $118.4 million for UDENYCA product inventory. In addition, the Company is eligible to receive potential milestone payments of up to $75 million.

During Q2 2025, the Company used a portion of the proceeds from the UDENYCA sale to: (1) repay substantially all of the $230 million aggregate principal amount of the outstanding 2026 Convertible Notes, and (2) buy out the royalty rights on the net revenues of UDENYCA, in accordance with the Revenue Purchase and Sale Agreement, resulting in a $47.7 million payment.

SECOND QUARTER 2025 FINANCIAL RESULTS

Net revenue from continuing operations was approximately $10.3 million for each of the quarters ended June 30, 2025 and 2024. LOQTORZI net product revenue increased $6.2 million compared to Q2 in the prior year primarily due to volume growth, offset by a $6.2 million decrease in other revenue primarily due to the upfront fee recognized in the prior year period for the outlicense of rights to commercialize toripalimab within Canada. Net revenue was $17.9 million and $12.6 million for the six months ended June 30, 2025 and 2024, respectively, with the increase primarily driven by volume growth of LOQTORZI, which launched in December 2023.

Cost of goods sold (COGS) from continuing operations was $3.4 million and $1.8 million during the three months ended June 30, 2025 and 2024, respectively, and $6.0 million and $3.2 million during the six months ended June 30, 2025 and 2024, respectively. The increases were primarily due to volume growth of LOQTORZI.

Research and development (R&D) expenses from continuing operations were $26.3 million and $20.6 million for the three months ended June 30, 2025 and 2024, respectively, and $50.7 million and $49.0 million during the six months ended June 30, 2025 and 2024, respectively. The increases were primarily due to increased costs for development of casdozokitug and CHS-114, partially offset by reductions in co-development costs for toripalimab, termination of the TIGIT Program, savings from reduced headcount, and lower infrastructure costs.

Selling, general and administrative (SG&A) expenses from continuing operations were $26.0 million and $27.5 million during the three months ended June 30, 2025 and 2024, respectively, and $52.1 million and $67.7 million during the six months ended June 30, 2025 and 2024, respectively. The decreases were driven primarily by lower headcount and decreased operating costs following Coherus’ recent divestitures. The decrease in the six-month period was also due to a net $6.8 million charge in the first quarter of 2024 for the write-off of an intangible asset and associated contingent value right liability related to NZV930, which was acquired in the Surface Oncology, Inc. acquisition.

Interest expense from continuing operations was $2.3 million and $4.1 million during the three months ended June 30, 2025 and 2024, respectively, and $4.4 million and $7.2 million during the six months ended June 30, 2025 and 2024, respectively. The decreases were primarily due to the prepayment of the remaining $75.0 million of the principal amount due under the 2027 Term Loans on May 8, 2024, partially offset by interest on the $38.7 million senior secured term loan facility and the LOQTORZI portion of the Revenue Participation Right Purchase and Sale Agreement, each commencing May 8, 2024.

Net loss from continuing operations for the second quarter of 2025 was $44.9 million, or $(0.39) per share on a diluted basis, compared to a net loss of $54.9 million, or $(0.48) per share on a diluted basis, for the same period in 2024. Net loss for the first half of 2025 was $92.3 million, or $(0.80) per share on a diluted basis, compared to a net loss of $122.9 million, or $(1.08) per share on a diluted basis for the first half of 2024.

Non-GAAP net loss from continuing operations for the second quarter of 2025 was $39.0 million, or $(0.34) per share on a diluted basis, compared to $34.7 million, or $(0.30) per share for the same period in 2024. Non-GAAP net loss for the first half of 2025 was $79.9 million, or $(0.69) per share on a diluted basis, compared to $88.3 million, or $(0.78) per share for the first half of 2024. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss from continuing operations and a reconciliation to the most directly comparable GAAP measures.

Net income from discontinued operations, net of tax was $342.6 million, or $2.95 per share on a diluted basis, for the second quarter of 2025 compared to $41.9 million, or $0.37 per share on a diluted basis, for the same period in 2024. Net income from discontinued operations, net of tax for the first half of 2025 was $333.5 million, or $2.88 per share on a diluted basis, compared to $212.8 million, or $1.87 per share on a diluted basis for the same period in 2024.

The increases compared to the prior year periods were primarily due to the $339.1 million net gain on the UDENYCA divestiture in April 2025, partially offset by the $22.9 million net gain on the YUSIMRY Sale in June 2024, the $10.3 million charge for loss on debt extinguishment, and lower net revenue driven by the 2024 divestitures. Total net revenues attributable to the Company’s divested products, UDENYCA, CIMERLI and YUSIMRY, which are reflected in discontinued operations, were $23.1 million and $54.7 million for the three months ended June 30, 2025 and 2024, respectively, and $55.2 million and $129.4 million during the six months ended June 30, 2025 and 2024, respectively.

The increase in the six-month period was partially offset by $153.6 million gain on sale of the CIMERLI divestiture in the first quarter of 2024 and an $11.8 million charge in the first quarter of 2025 for the change in fair value of the Royalty Fee Derivative Liability related to UDENYCA.

Cash, cash equivalents and marketable securities totaled $237.6 million as of June 30, 2025, compared to $126.0 million as of December 31, 2024. A majority of the $96.8 million in accrued rebates, fees and reserves reflected on the June 30, 2025 balance sheet were UDENYCA-related obligations that did not transfer in the divestiture and are expected to be settled in a front-loaded fashion over the remainder of the year and into 2026.

Conference Call Information
When: Thursday, August 7, 2025, starting at 5:00 p.m. Eastern Daylight Time

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