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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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

•
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

•
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
o
Enrollment continues in the Phase 1 expansion cohorts in patients with NSCLC and the Phase 1 study in patients with relapsed/refractory multiple myeloma.
•
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

•
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.

On August 7, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Janux Therapeutics, AUG 7, 2025, View Source [SID1234654987]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The recent expansion of our TRACTr, TRACIr, and ARM development programs displays our ability to enact a strategy that attempts to both maximize the benefit and value of our current clinical programs, including JANX007, while continuing to advance other differentiated candidates in oncology and autoimmune disease," said David Campbell, Ph.D., President and CEO of Janux. "We look forward to additional clinical data from JANX007 and JANX008 expected in the second half of 2025."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

•
R&D Day highlighted pipeline progress and novel bispecific platform in autoimmune disease.
In July 2025, Janux management presented multiple product candidates identified from its preclinical pipeline to move towards clinical trials.

•
A PSMA-TRACIr designed to be combined with potentially best-in-treatment asset, JANX007, and provide CD28 co-stimulation to further differentiate depth and durability of patient responses.
•
A TROP2-TRACTr added a first-in-class opportunity targeting multiple solid tumors with preclinical data supporting differentiated safety and efficacy potential.
•
A CD19-ARM displayed rapid, deep and durable B-cell depletion in periphery and tissues with a prolonged memory B cell reset while maintaining a large safety window in non-human primates.

•
JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).

•
JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).

•
Clinical milestone payment of $10 million from Merck recently triggered by first patient dosed in the lead collaboration program under the companies’ 2020 Research Collaboration and Exclusive License Agreement.

Additional data from JANX007 and JANX008 will be presented at future Janux events in the second half of 2025.

SECOND QUARTER 2025 FINANCIAL RESULTS:

•
Cash and cash equivalents and short-term investments: As of June 30, 2025, Janux reported cash and cash equivalents and short-term investments of $996.0 million, compared to $1.03 billion at December 31, 2024.

•
Research and development expenses: Research and development expenses for the quarter ended June 30, 2025 were $34.7 million, compared to $14.9 million for the comparable period in 2024.

•
General and administrative expenses: General and administrative expenses for the quarter ended June 30, 2025 were $10.5 million, compared to $7.8 million for the comparable period in 2024.

•
Net loss: For the quarter ended June 30, 2025, Janux reported a net loss of $33.9 million, compared to a net loss of $6.0 million for the comparable period in 2024.

Janux’s TRACTr, TRACIr and ARM Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development.

On August 7, 2025 aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported second quarter 2025 results and provided a corporate update (Press release, aTyr Pharma, AUG 7, 2025, View Source [SID1234655006]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"With the recent completion of the last patient visit in our Phase 3 EFZO-FIT study of efzofitimod in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), we are on track to report topline data in mid-September," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "This upcoming readout represents a major inflection point for aTyr, our clinical program for efzofitimod in ILD, and the broader sarcoidosis community, and we look forward to sharing the results."

Second Quarter 2025 and Subsequent Period Highlights

Completed the last patient visit in the global pivotal Phase 3 EFZO-FIT study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. Topline data from the study are expected in mid-September 2025. This is a randomized, double-blind, placebo-controlled, 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo administered intravenously monthly for a total of 12 doses. The study enrolled 268 patients with pulmonary sarcoidosis across 85 centers in nine countries. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction measured as the absolute change from baseline to week 48. Secondary endpoints include measures of sarcoidosis symptoms and lung function. Patients who complete the study and wish to receive treatment with efzofitimod outside of the clinical trial are eligible to participate in an Individual Patient Expanded Access Program.

Announced interim data from the ongoing Phase 2 EFZO-CONNECT study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related ILD (SSc-ILD). This proof-of-concept study is a randomized, double-blind, placebo-controlled, 28-week study consisting of three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo administered intravenously monthly for a total of six doses. Enrollment in the study is ongoing, and the study intends to enroll up to 25 patients at multiple centers in the United States. The interim analysis evaluated skin assessments and serum biomarkers at baseline and week 12 for efzofitimod and placebo patients. Eight patients were evaluated, including five with diffuse and three with limited SSc-ILD. Key findings for efzofitimod-treated patients to date included:

Stable or improved modified Rodnan Skin Score (mRSS), a key measure of skin fibrosis, for all patients and an improvement of 4 points or greater for three out of four efzofitimod-treated patients with diffuse SSc-ILD, where the minimal clinically important difference (MCID) is a 4 to 6 point improvement at 12 months

Preliminary signals of improvement for inflammatory biomarkers including interferon gamma (IFN-γ) and monocyte chemoattractant protein-1 (MCP-1) and disease biomarkers Krebs von den Lungen-6 (KL-6) and surfactant protein-D (SP-D)

Efzofitimod was generally safe and well tolerated at all doses, with no treatment related serious adverse events

Advanced ATYR0101 to investigational new drug (IND) candidate stage for pulmonary fibrosis. ATYR0101 is a fusion protein derived from a proprietary extracellular domain of aspartyl-tRNA synthetase (DARS) that binds to latent transforming growth factor beta binding protein 1 (LTBP-1) to induce cell death of myofibroblasts, which are key cells responsible for driving the progression of fibrosis. The Company anticipates filing an IND application in the second half of 2026.

Preclinical data generated to date demonstrating ATYR0101’s unique anti-fibrotic mechanism through LTBP-1 were presented in an oral presentation at the American Thoracic Society 2025 Respiratory Innovation Summit

Announced that the Company was added to the Russell 2000 Index and broad market Russell 3000 Index. These additions were a part of the 2025 Russell U.S. Indexes annual reconstitution.

Second Quarter 2025 Financial Highlights and Cash Position

Cash & Investment Position: Cash, cash equivalents, restricted cash and available-for-sale investments as of June 30, 2025, were $83.2 million. Subsequent to the end of the second quarter 2025, the Company raised approximately $30.7 million in gross proceeds from its at-the-market (ATM) offering with Jefferies LLC. The Company believes its cash runway will be sufficient to fund its operations for a period of one year following the Phase 3 EFZO-FIT readout.

R&D Expenses: Research and development expenses were $15.4 million for the second quarter 2025, which consisted primarily of clinical trial costs for the Phase 3 EFZO-FIT and Phase 2 EFZO-CONNECT studies, manufacturing costs for the efzofitimod program and research and development costs for the efzofitimod and discovery programs.

G&A Expenses: General and administrative expenses were $4.9 million for the second quarter 2025.

About Efzofitimod

Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

On August 6, 2025 Sana Biotechnology, Inc. (Nasdaq: SANA) ("Sana"), a company focused on changing the possible for patients through engineered cells, reported that it has commenced an underwritten public offering of $75.0 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock (Press release, Sana Biotechnology, AUG 6, 2025, View Source [SID1234654872]). In addition, Sana intends to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of shares of its common stock. All of the shares of common stock and pre-funded warrants to be sold in the proposed offering will be sold by Sana. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities, and TD Cowen are acting as joint book-running managers for the proposed offering.

The proposed offering is being made pursuant to a Registration Statement on Form S-3, including a base prospectus, previously filed with and declared effective by the SEC, and Sana will file a preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed offering, copies of which can be accessed for free through the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering may also be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014 or by email at [email protected]; Goldman Sachs & Co. LLC, Attn: Prospectus Department, at 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; BofA Securities, Attn: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001 or by email at [email protected]; or TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, by telephone at (855) 495-9846 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of any such state or jurisdiction.

On August 6, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a corporate update and provided financial results for the second quarter ended June 30, 2025 (Press release, Vir Biotechnology, AUG 6, 2025, View Source [SID1234654891]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We achieved several important milestones across our pipeline, reflecting our commitment to our mission of powering the immune system to transform lives," said Marianne De Backer, Chief Executive Officer, Vir Biotechnology. "The initiation of our Phase 1 study of PRO-XTEN dual-masked VIR-5525 positions us to potentially address the shortcomings of available treatment options across multiple EGFR-expressing solid tumors. The universal PRO-XTEN masking technology represents a next-generation approach to cancer treatment, designed to expand the therapeutic index of T-cell engagers. We now have three clinical trials of PRO-XTEN masked T-cell engagers ongoing, supported by promising early clinical data for VIR-5818 and VIR-5500, and we are leveraging insights from our ongoing programs to efficiently execute clinical trials and expand our oncology portfolio. Additionally, our ECLIPSE registrational program is now fully underway, and we are advancing toward a potentially highly effective, well-tolerated and convenient treatment option for patients with chronic hepatitis delta."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

ECLIPSE registrational program is fully underway following enrollment of the first patients in ECLIPSE 2 and ECLIPSE 3.
ECLIPSE 2 will compare the combination of tobevibart and elebsiran to continued bulevirtide monotherapy in participants with CHD who have not achieved undetectable hepatitis delta virus RNA despite bulevirtide treatment.
ECLIPSE 3 will compare the combination of tobevibart and elebsiran to bulevirtide monotherapy in participants with CHD who have not received bulevirtide before.
ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies, including agencies in the U.S. and Europe. ECLIPSE 3 is expected to provide important supportive data to help establish access and reimbursement in key markets.
Solid Tumors

First patient dosed in the Phase 1 clinical study of VIR-5525, the Company’s investigational PRO-XTEN dual-masked T-cell engager (TCE) targeting EGFR.
VIR-5525 will be evaluated for the treatment of a variety of EGFR-expressing solid tumors in areas of high unmet need such as non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma and cutaneous squamous cell carcinoma.
The Company’s Phase 1 clinical trial of PRO-XTEN masked VIR-5818 evaluates the TCE in multiple tumor types, including metastatic breast cancer and metastatic colorectal cancer.
VIR-5818 is the only dual-masked HER2-targeting TCE in clinical development.
The Company has completed monotherapy dose escalation and is analyzing the data while continuing to dose escalate VIR-5818 in combination with pembrolizumab.
VIR-5500, the only dual-masked PSMA-targeting TCE in clinical trials, continues to advance through dose escalation.
The Company received Investigational New Drug clearance from the U.S. Food and Drug Administration to evaluate VIR-5500 in combination with androgen receptor pathway inhibitors for earlier lines of metastatic castration-resistant prostate cancer treatment, unlocking new opportunities to transform patient lives.
Early Phase 1 data for VIR-5818 and VIR-5500 reported in January 2025 showed promising safety profiles for both clinical candidates, with maximum tolerated dose not yet reached, no dose-limiting cytokine release syndrome (CRS) observed and no CRS greater than grade 2 reported.
Initial clinical data demonstrate the PRO-XTEN masking technology’s potential to minimize systemic toxicity while enabling selective killing of cancer cells in the tumor microenvironment, minimizing CRS and expanding the therapeutic index compared to traditional therapeutic approaches.
Preclinical Pipeline Candidates

Leveraging its immune system expertise and platform strengths, the Company continues to progress multiple undisclosed PRO-XTEN dual-masked TCEs against clinically validated targets with potential applications across a number of solid tumors. These preclinical candidates integrate the PRO-XTEN masking technology with novel TCEs discovered and engineered using the Company’s antibody discovery platform and proprietary dAIsY (data AI structure and antibody) AI engine.
The Company is advancing its broadly neutralizing antibody development candidate for the treatment of HIV in collaboration with the Gates Foundation.
Second Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2025, the Company had $892.1 million in cash, cash equivalents and investments, representing a decrease of approximately $127.7 million during the second quarter of 2025. The current quarter decrease includes $50.5 million in milestone payments related to the initiation of the ECLIPSE Phase 3 registrational program, which were previously expensed in prior quarters.

In addition to the $892.1 million in cash, cash equivalents and investments, the Company had $95.2 million in restricted cash and cash equivalents as of June 30, 2025. This included a $75.0 million milestone payment due to the former shareholders of Amunix Pharmaceuticals, Inc., upon VIR-5525 achieving "first in human dosing," which occurred in July 2025.

Revenues: Total revenues for the second quarter of 2025 were $1.2 million compared to $3.1 million for the same period in 2024.

Cost of Revenue: The change in cost of revenue for the second quarter of 2025 compared to the same period in 2024 was nominal.

Research and Development Expenses (R&D): R&D expenses for the second quarter of 2025 were $97.5 million, which included $6.9 million of non-cash stock-based compensation expense, compared to $105.1 million for the same period in 2024, which included $13.1 million of non-cash stock-based compensation expense. The decrease was primarily driven by cost savings from previously announced restructuring initiatives, partially offset by higher clinical expenses from the initiation of our ECLIPSE registrational program for CHD, progression of our oncology programs and an increase in the fair value of contingent payment obligations for our CHD program.

Selling, General and Administrative Expenses (SG&A): SG&A expenses for the second quarter of 2025 were $22.3 million, which included $5.5 million of non-cash stock-based compensation expense, compared to $30.3 million for the same period in 2024, which included $9.1 million of non-cash stock-based compensation expense. The decrease was largely due to efficiencies and cost savings from previously announced restructuring initiatives.

Restructuring, Long-Lived Assets Impairment and Related Charges, Net: Restructuring, long-lived assets impairment and related charges, net for the second quarter of 2025 was $(0.2) million compared to $26.3 million for the same period in 2024. The decrease was due to the fact that our restructuring initiatives implemented in prior years were substantially completed by the end of 2024.

Other Income: Other income for the second quarter of 2025 was $7.6 million compared to $18.7 million for the same period in 2024. The decrease was primarily driven by lower interest income.

(Provision for) Benefit from Income Taxes: The provision for income taxes for the second quarter of 2025 was nominal.

Net Loss: Net loss for the second quarter of 2025 was $111.0 million, or $0.80 per share, basic and diluted, compared to a net loss of $138.4 million, or $1.02 per share, basic and diluted for the same period in 2024.

2025 Financial Guidance

Based on current operating plans, the Company expects its cash, cash equivalents and investments to fund operations into mid-2027.

Conference Call

Vir Biotechnology will host a conference call to discuss the second quarter results at 1:30 p.m. PT / 4:30 p.m. ET today. A live webcast will be available on View Source and will be archived for 30 days.

About VIR-5818, VIR-5500, VIR-5525

VIR-5818, VIR-5500 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the PRO-XTEN masking technology with three different T-cell engagers (TCEs) targeting HER2, PSMA and EGFR, respectively.

TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells. By driving the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians.

About Tobevibart and Elebsiran

Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.