On May 15, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that an abstract regarding IPH6501, its ANKET targeting CD20 B cells currently developed in relapsed and/or refractory Non-Hodgkin Lymphoma, has been selected for the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2025, taking place June 12-15 in Milan, Italy (Press release, Innate Pharma, MAY 15, 2025, View Source [SID1234653170]).

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!

Abstract details
Antitumor characterization of IPH6501, a novel il2v-armed tetraspecific NK cell engager targeting CD20 B cells, in DLBCL and FL patient samples, and in preclinical combination with R-CHOP
•Abstract Code: PS2004
•Session: Poster session 2
•Session Date/Time: Saturday, June 14, 2025, 18:30 – 19:30 CEST
•More information can be found on the EHA (Free EHA Whitepaper) website.

In addition, an abstract related to SAR’514/IPH6401 (developed by Sanofi) was accepted for online publication.

The BCMA NK Cell Engager SAR’514 Induces Macrophage-Mediated Phagocytosis which is improved by combination with Evorpacept, a CD47 Blocker, in Multiple Myeloma
•Abstract Code: PB2850

About ANKET
ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About IPH6501
IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not the alpha subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells.

IPH6501 has shown better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models (Demaria, EHA (Free EHA Whitepaper) 2023, Carrette, SITC (Free SITC Whitepaper) 2024, Demaria et al, Science Immunology 2024).

IPH6501 is currently being evaluated in a Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with relapsed and/or refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma.

On May 15, 2025 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported financial results for the three months ended March 31, 2025, and highlighted recent pipeline progress and business updates (Press release, I-Mab Biopharma, MAY 15, 2025, View Source [SID1234653169]).

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!

"2025 is off to a strong start for I-Mab. Designation of givastomig as our lead program has enabled us to unlock significant value for the Company by considerably accelerating our Phase 1b program, as we work to improve the care of patients with gastric cancers, which impact more than 250,000 people globally," said Sean Fu, PhD, Chief Executive Officer of I-Mab. "Driven by study momentum and investigator interest, we have completed patient enrollment in the first of two Phase 1b dose expansion cohorts ahead of schedule. We expect to share data on both cohorts in 1H 2026. We believe the combination of significant progress in our givastomig program, substantial cash balance, streamlined operations, and new U.S.-based business model positions I-Mab to deliver for both patients and our investors."

Pipeline Overview and Anticipated Upcoming Milestones

Upcoming anticipated milestones for givastomig (CLDN18.2 x 4-1BB bispecific), prioritized to be I-Mab’s lead program in January 2025:

•
July 2025: Presentation of new givastomig dose escalation combination data on U.S. patients at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) ("ESMO") Gastrointestinal ("GI") Cancers Congress 2025, being held July 2-5 in Barcelona, Spain
Details of the ESMO (Free ESMO Whitepaper) GI Mini Oral Presentation:

Title: Preliminary Safety and Efficacy of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in Metastatic Gastroesophageal Carcinoma (mGEC)

Speaker: Samuel J. Klempner, MD, Associate Professor of Medicine, Massachusetts General Hospital

Presentation Number: 388MO

Date and Time: Wednesday, July 2nd at 16:50 CEST (10:50am EST)

•
1H 2026: Presentation of data from givastomig dose expansion cohorts (n=40)
Enrollment in the ongoing dose expansion study for givastomig is progressing ahead of schedule. In addition, the Company anticipates updates in 2026 for two programs being developed with its partners: uliledlimab (monoclonal antibody targeting CD73); and ragistomig (PD-L1 x 4-1BB bispecific).

First Quarter 2025 Financial Results – In connection with the divestiture of its Greater China assets and business operations, I-Mab’s first quarter 2024 amounts have been recast to conform to the discontinued operations presentation. Additionally, certain non-recurring costs occurred during the first quarter of 2024 that impact quarter-over-quarter comparisons.

Cash Position

As of March 31, 2025, the Company had cash and cash equivalents, and short-term investments of $168.6 million. The Company’s current cash position is expected to fund the givastomig Phase 1b study through anticipated dose expansion data readouts and further development initiatives into 2027.

Shares Outstanding

As of March 31, 2025, the Company had 187,818,796 ordinary shares issued and outstanding, representing the equivalent of 81,660,346 ADSs, assuming the conversion of all ordinary shares into ADSs.

Research and Development Expenses

Research and development expenses were $0.8 million for the three months ended March 31, 2025, compared to $6.1 million for the three months ended March 31, 2024. The decrease was primarily driven by reimbursements recognized under an existing collaboration agreement and lower contract research organization costs during the three months ended March 31, 2025.

Administrative Expenses

Administrative expenses were $4.5 million for the three months ended March 31, 2025, compared to $2.4 million for the three months ended March 31, 2024. Employee share-based compensation expenses during the three months ended March 31, 2024 were $4.8 million lower, primarily driven by forfeitures in connection with the divestiture of the Greater China assets and business operations. Additionally, legal expenses were $2.5 million lower during the three months ended March 31, 2025.

Interest Income

Interest income was $1.9 million for the three months ended March 31, 2025, compared to $0.7 million for the three months ended March 31, 2024. The increase was primarily attributable to higher interest rates earned on cash balances in 2025.

Other Income (Expenses), Net

Other income (expenses), net were $0.2 million for the three months ended March 31, 2025, compared to $(0.6) million for the three months ended March 31, 2024.

Equity in Loss of Affiliates

Equity in loss of affiliates was $1.0 million for the three months ended March 31, 2024 due to recognition of the employee stock ownership plan expenses from the Company’s unconsolidated investee as a result of the divestiture of the Greater China assets and business operations. There was no equity in loss of affiliates for the three months ended March 31, 2025.

Net Loss from Continuing Operations

Net loss from continuing operations was $(3.2) million for the three months ended March 31, 2025, compared to $(9.4) million for the three months ended March 31, 2024. Net loss from continuing operations per share attributable to ordinary shareholders was $(0.02) for the three months ended March 31, 2025, compared to $(0.05) for the three months ended March 31, 2024.

Net Loss from Discontinued Operations

On April 2, 2024, the Company closed the China divestiture announced on February 7, 2024 (the "Transaction"). In accordance with ASC 205-20, the Company determined that the Transaction represented a strategic shift that had a major effect on the business and therefore, met the criteria for classification as discontinued operations. As a result, the Company recognized a loss from discontinued operations of $6.9 million for the three months ended March 31, 2024.

Net Loss

Net loss was $(3.2) million for the three months ended March 31, 2025, compared to $(16.3) million for the three months ended March 31, 2024. Net loss per share attributable to ordinary shareholders was $(0.02) for the three months ended March 31, 2025, compared to $(0.09) for the three months ended March 31, 2024.

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 ("CLDN18.2")-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line ("1L") metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

The ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). The study builds on positive Phase 1 monotherapy data.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

On May 15, 2025 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, reported financial results and recent business highlights for its first quarter ended March 31, 2025 (Press release, HCW Biologics, MAY 15, 2025, View Source [SID1234653168]).

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!

On May 15, 2025, the Company closed an equity offering with gross proceeds of $5.0 million with a single institutional investor. Dr. Hing Wong, Founder and CEO, stated, "We are pleased to have completed a successful $5.0 million equity offering in a difficult market without using a highly structured deal. This funding will be used to open clinical sites for our Phase 1 clinical trial to evaluate HCW9302 in an autoimmune disorder." Dr. Wong continued, "Our new round of financing will provide funding for critical studies to complete the research package for our business development campaign to identify a licensing partner to commercialize our Immune-Cell Engagers, including T-Cell Engagers, which we created using our TRBC drug discovery and development platform."

Dr. Wong explained the Company’s financing strategy, stating, "We have over 50 compounds that we have created and own. We are continually assessing our portfolio of molecules to identify strong candidates to develop and commercialize through licensing or other business development transactions. We plan to ramp up our business development efforts in the second half of 2025. One of our compounds that is ready to commercialize is HCW9206, a clinical-stage molecule. It is a promising revolutionary reagent to replace anti-CD3/anti-CD28/IL-2-based approaches to streamline and lower the costs of CAR-T manufacturing. Equally important, we believe that HCW9206 can improve the functional activities and persistence of CAR-Ts following adoptive transfer, a goal that has not been achieved for the last decade."

Business Highlights

Business Development Transactions

•
On May 13, 2025, the Company delivered its technology report to WY Biotech in accordance with the terms of the WY Biotech exclusive worldwide licensing agreement to use and apply HCW11-006 for in vivo applications. HCW11-006 is a preclinical drug built with our second-generation discovery and development platform — the TRBC platform. WY Biotech has 30-days due diligence to study this report, after which the Company expects to recognize revenue for a $7.0 million upfront licensing fee.

Financing Transactions

•
On May 15, 2025, the Company completed a $5.0 million offering of an aggregate of 671,140 units at a purchase price of $7.45 per unit priced at-the-market under Nasdaq rules. Each unit consisted of one share of Common Stock or one Pre-Funded Warrants to purchase one share of Common Stock, with two warrants, each of which can be exercised for one share of Common Stock for $7.45 per share. In addition, the Company entered into a privately negotiated agreement with the holder of certain existing outstanding warrants to purchase up to 167,925 shares of common stock (the "Existing Warrants") to reduce the exercise price of such Existing Warrants from $41.20 per share to $7.45 per share.
•
On May 13, 2025, the Company received a compliance letter from the Nasdaq Panel to confirm that the Company has regained compliance with the bid price requirement in Listing Rule 5550(a)(2), the public float requirement in Listing Rule 5550(a)(4), and the market value of publicly held shares requirement in Listing Rule 5550(a)(5), as required by the Nasdaq Panel decision of April 8, 2025, as amended. The Company remains subject to the remaining terms of the Panel’s April 8, 2025, decision to provide an extension to the compliance period for other Listing Rules. The Company must be in compliance with all Listing Rules by June 16, 2025.

Clinical Development Results

•
On January 28, 2025, the Company received clearance of its IND from the FDA to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments. This will be a multi-site, Company-sponsored trial that is expected to be initiated in the third quarter of 2025.
•
The Company is launching the commercialization its clinical-stage molecule, HCW9206. Positive results of studies presented by the Company’s research collaborator Dr. Harris Goldstein’s laboratory at the Albert Einstein College of Medicine, Bronx, New York, at the 2025 Annual Meeting of American Association of Immunologists (AAI 2025), Honolulu, HI. The results of these studies represent an alternative novel strategy for CAR-T cell production with the advantage of generating a large population of CAR-Ts with a stem cell-like memory T cell phenotype, which should enhance the persistence of CAR-Ts in patients. We believe that this strategy will likely improve long-term survival of disease-specific CAR-Ts following adoptive transfer and enable sustained suppression of malignancies, chronic infections and autoimmune diseases, and lower the cost of CAR-T manufacturing. Also, we believe that it provides the Company with an in-road opportunity to participate in the development of "in-vivo CAR-T manufacturing technology," a highly promising emergent field.

First Quarter 2025 Financial Results

•
Revenues: Revenues for the first quarters ended March 31, 2024 and 2025 were $1.1 million and $5,065, respectively. Revenues in both periods were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. The licensed molecules are one of the components used by Wugen in manufacturing their immunotherapeutic products.
•
Research and development (R&D) expenses: R&D expenses for the first quarters ended March 31, 2024 and 2025 were $2.1 million and $1.5 million, respectively, a decrease of $644,573, or 30%. R&D expenses were comparatively lower in the reporting period of the first quarter of 2025 primarily due to a decline in manufacturing and material and preclinical expenses, but all expense categories were comparatively lower in the first quarter of 2025 when compared to the first quarter of 2024.
•
General and administrative (G&A) expenses: G&A expenses for the first quarters ended March 31, 2024 and 2025 were $1.6 million and $2.2 million, respectively, an increase of $661,505, or 42%. The increase was primarily due to the waiver of performance bonuses of $293,159 in the aggregate in the first quarter of 2024, which were earned by officers of the Company in prior periods. Expenses increased by $273,059 as a result of accretion of a fixed bonus that will be due if the Secured Notes are repaid on the Maturity Date. Subsequent to the end of the first quarter of 2025, $6.6 million of the outstanding principal for these Secured Notes elected to convert to equity and a portion of the Company’s shares in Wugen common stock. Other increases in expenses were related to insurance costs and professional services, such as auditing services as well as tax and accounting advisors.
•
Legal expenses: Legal expenses, net represent the legal fees that the Company incurred for an Arbitration. On July 13, 2024, the parties entered into a Settlement Agreement and General Release, and the Arbitration and related Complaint were dismissed on December 24, 2024. In the first quarter of 2024, while the Company was preparing for the hearings which took place in May 2024, the Company incurred $4.4 million of legal fees. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company is engaged in discussions with the law firms involved with this matter to arrange a reasonable payment plan with respect to those legal fees.
•
Net loss: Net loss for the first quarters ended March 31, 2024 and 2025 was $7.5 million and $2.2 million, respectively.

Financial Guidance

As of March 31, 2025, the Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months from the issuance date of the audited financial statements, without additional funding or financial support. We considered future elements of our financing plan that were probable and likely to be implemented within the next year to determine if financing activities currently underway are sufficient to mitigate the substantial doubt in our going concern analysis. We have had some early success in completing key elements of our multi-step financing plan, however, we cannot be assured that we will continue to have success with all of the elements of our plan.

On May 15, 2025 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, reported financial results and recent corporate highlights for the first quarter ended March 31, 2025 (Press release, Fortress Biotech, MAY 15, 2025, View Source [SID1234653167]).

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!

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "Fortress entered 2025 with strong momentum following a transformational fourth quarter marked by the U.S. Food and Drug Administration ("FDA") approvals of Emrosi and UNLOXCYT, and the acceptance of the New Drug Application ("NDA") for CUTX-101. In the first quarter 2025, our Fortress-founded partner company, Checkpoint Therapeutics, Inc., ("Checkpoint"), signed a merger agreement with Sun Pharma providing for Checkpoint’s acquisition by Sun Pharma, which we believe will enable broader patient access for Checkpoint’s UNLOXCYT (cosibelimab-ipdl) product and trigger a significant monetization event for Fortress — including an expected ~$28 million at closing, future potential royalties, and a potential CVR payment. These outcomes continue to validate Fortress’ business model — identifying, developing, and advancing innovative therapies with strategic optionality for value creation."

Dr. Rosenwald continued, "Looking ahead, we are focused on key value drivers, including the September 30, 2025 Prescription Drug User Fee Act ("PDUFA") action date for CUTX-101, which may also result in a Priority Review Voucher for our subsidiary, Cyprium Therapeutics, upon approval. Commercial launch of Emrosi is also underway with initial prescriptions filled at the end of March. Fortress’ robust pipeline — including multiple late-stage programs and newly approved products — positions us for continued revenue growth, value-driving milestones, and additional monetization opportunities. We remain committed to delivering innovative therapies to patients while building long-term shareholder value."

Recent Corporate Highlights1:

Monetization Updates

● In March 2025, our subsidiary Checkpoint entered into an agreement to be acquired by Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, "Sun Pharma"). Fortress owns approximately 6.9 million shares (including Class A Common on an as-converted basis) of Checkpoint’s common stock and is eligible to receive a 2.5% royalty on future sales of UNLOXCYT, pursuant to a royalty agreement between Checkpoint, Sun Pharma and Fortress. Upon completion of the transaction, Sun Pharma will acquire all outstanding shares of Checkpoint, and Checkpoint stockholders will receive, for each share of common stock they hold, an upfront cash payment of $4.10, without interest, and a non-transferable contingent value right ("CVR") entitling the stockholder to receive up to an additional $0.70 in cash if cosibelimab is approved prior to certain deadlines in the European Union pursuant to the centralized approval procedure or in Germany, France, Italy, Spain or the United Kingdom, subject to the terms and conditions in the CVR agreement. The closing of the transaction is subject to various conditions including the approval by requisite majorities of holders of Checkpoint’s shares at a special meeting of Checkpoint’s stockholders on May 28, 2025. We expect the transaction to close shortly after the stockholder meeting, assuming the requisite votes are received, although there can be no assurance that the transaction closes in a timely manner, or at all.

Regulatory Updates

● In November 2024, the FDA approved Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg), also known as DFD-29. Emrosi has the potential to be the new treatment paradigm for the millions of patients suffering from inflammatory lesions of rosacea. In March 2025, we announced the launch of Emrosi by our partner company, Journey Medical Corporation ("Journey Medical") (Nasdaq: DERM).
● In December 2024, the FDA approved UNLOXCYT, also known as cosibelimab, our anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or radiation. UNLOXCYT was developed at our partner company, Checkpoint (Nasdaq: CKPT).
● The FDA accepted the NDA submission for CUTX-101 (copper histidinate for Menkes disease) for priority review with a PDUFA goal date of September 30, 2025. In December 2023, we completed the asset transfer of CUTX-101 to Sentynl Therapeutics ("Sentynl"), a wholly owned subsidiary of Zydus Lifesciences Ltd. Sentynl completed the rolling submission of the NDA for CUTX-101 in the fourth quarter of 2024. Cyprium Therapeutics, our subsidiary company that developed CUTX-101, will retain 100% ownership over any FDA Priority Review Voucher that may be issued at NDA approval.

Commercial Product Updates

● Journey Medical’s net product revenues for the first quarter ended March 31, 2025, were $13.1 million, compared to net product revenues of $13.0 million for the first quarter ended March 31, 2024.
● At the end of March 2025, Journey Medical announced the launch of, and the first prescriptions filled for, Emrosi for the treatment of inflammatory lesions of rosacea in adults. Emrosi is available by prescription at specialty pharmacy chains.

Clinical Updates

● In March 2025, we announced that full results from two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea in Rosacea-1 ("MVOR-1") and Minocycline Versus Oracea in Rosacea-2 ("MVOR-2"), evaluating Emrosi for the treatment of moderate-to-severe papulopustular rosacea in adults, were published in the Journal of the American Medical Association – Dermatology. The results demonstrated the efficacy, safety and tolerability of oral DFD-29 in rosacea. The full publication is available at View Source Information on such website is not a part of this release.
● In January 2025, we announced that the first patient was dosed in a multicenter, placebo-controlled and randomized Phase 2 clinical trial to evaluate Triplex, a cytomegalovirus ("CMV") vaccine, when administered to human leukocyte antigen matched related stem cell donors to reduce CMV events in patients undergoing hematopoietic stem cell transplantation. Triplex is currently in development at our subsidiary company, Helocyte, Inc.

General Corporate:

● In March 2025, Fortress entered into a strategic collaboration with Partex NV to identify and evaluate biopharmaceutical compounds using artificial intelligence for potential acquisition or licensing by Fortress.
● In February 2025, our partner company Mustang Bio, Inc. ("Mustang") raised net proceeds of $6.8 million in a public offering.
● Also in February 2025, Mustang announced the exit of the lease for its manufacturing facility in Worcester, Massachusetts and concurrent divestment of certain fixed assets including furniture and equipment to AbbVie Bioresearch Center Inc. for $1.0 million.

Financial Results:

● As of March 31, 2025, Fortress’ consolidated cash and cash equivalents totaled $91.3 million, compared to $57.3 million as of December 31, 2024, an increase of $34.0 million during the quarter.
● Fortress’ consolidated cash and cash equivalents totaling $91.3 million as of March 31, 2025, includes $19.5 million attributable to Fortress and the private subsidiaries, $3.5 million attributable to Avenue, $33.0 million attributable to Checkpoint, $14.2 million attributable to Mustang Bio and $21.1 million attributable to Journey Medical.
o Fortress’ consolidated cash and cash equivalents totaled $57.3 million as of December 31, 2024, and included $20.9 million attributable to Fortress and private subsidiaries, $2.6 million attributable to Avenue, $6.6 million attributable to Checkpoint, $6.8 million attributable to Mustang and $20.3 million attributable to Journey Medical.
● Fortress’ consolidated net product revenue totaled $13.1 million for the first quarter ended March 31, 2025, which is generated from Journey Medical’s marketed dermatology products. This compares to consolidated revenue totaling $13.0 million for the first quarter of 2024.
● Consolidated research and development expenses totaled $3.9 million for the first quarter ended March 31, 2025, compared to $24.8 million for the first quarter ended March 31, 2024.
● Consolidated selling, general and administrative costs were $25.7 million for the first quarter ended March 31, 2025, compared to $17.9 million for the first quarter ended March 31, 2024.
● Consolidated net loss attributable to common stockholders was $(12.7) million, or $(0.48) per share, for the first quarter ended March 31, 2025, compared to net loss attributable to common stockholders of $(17.9) million, or $(1.04) per share for the first quarter ended March 31, 2024.

On May 15, 2025 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported financial results for the quarter ended March 31, 2025, and provided recent business updates (Press release, Elevation Oncology, MAY 15, 2025, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-first-quarter-2025-financial-results-and-provides-business-updates [SID1234653166]).

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 recently presented preclinical proof-of-concept data for EO-1022, reaffirming its potential as a differentiated HER3 ADC, and supporting our goal of providing a safer and more effective option for patients with HER3-expressing solid tumors," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "In parallel, we are engaged in efforts to explore a range of strategic alternatives, with the objective of identifying and capitalizing on the opportunity that is in the best interest of our shareholders. We look forward to providing an update at the appropriate time."

Recent Business Updates

Pipeline

Elevation Oncology is developing EO-1022, a HER3 antibody-drug conjugate (ADC) for the treatment of patients with HER3-expressing solid tumors, including breast cancer and non-small cell lung cancer. The Company expects to file an Investigational New Drug (IND) application for EO-1022 in 2026.

In April 2025, Elevation Oncology presented new preclinical proof-of-concept data supporting the development of EO-1022 in a late-breaking poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The in vitro and in vivo data indicate EO-1022 may offer reduced payload-associated toxicity and an improved safety profile, as well as improved anti-tumor activity, for patients living with solid tumors that express HER3. Specifically, data show:
EO-1022 is highly stable in human serum, with a homogenous drug-to-antibody ratio (DAR) of 4 and minimal free payload compared to seribantumab-vcMMAE and patritumab-DXd, two benchmark HER3 ADCs, both of which use stochastic conjugation. These findings illustrate that a key feature of EO-1022 is minimal systemic exposure to free payload, potentially resulting in reduced payload-associated toxicity in patients and an improved safety profile.
EO-1022 exhibits potent in vitro cytotoxicity that is dependent on HER3 expression levels.
EO-1022 elicits anti-tumor activity in in vivo models of low, medium and high HER3 expression levels, including in a patient derived xenograft (PDX) model of low HER3-expressing EGFR-mutant lung cancer.
Corporate

In March 2025, Elevation Oncology elected to discontinue development of EO-3021. In parallel, the Company implemented a workforce reduction of approximately 70%. Elevation Oncology is in the process of evaluating strategic options with a commitment to maximizing shareholder value. There is currently no timetable set for completion of the strategic alternatives review process.
Financial Outlook

Elevation Oncology ended the first quarter of 2025 with $80.7 million in cash, cash equivalents and marketable securities. Subsequent to the first quarter, on May 2, 2025, Elevation Oncology voluntarily prepaid the $32.3 million aggregate principal, interest, fees and expenses due under its loan agreement with K2 HealthVentures LLC. Elevation Oncology expects that a significant majority of expenses incurred in relation to its workforce reduction and EO-3021 program closure will be paid in the second quarter of 2025.

Elevation Oncology estimates that it will have cash, cash equivalents and marketable securities in a range of approximately $30 million to $35 million as of June 30, 2025, which is expected to fund its current operations into the second half of 2026.

First Quarter 2025 Financial Results

Research and development expenses for the first quarter of 2025 were $6.9 million, compared to $6.0 million for the first quarter of 2024. The increase of $0.9 million was primarily due to $1.3 million of increased costs associated with the preclinical development of EO-1022 and a $0.6 million increase in clinical trial expenses for EO-3021, partially offset by a $1.0 million decrease in clinical trial expenses for seribantumab.

General and administrative expenses for the first quarter of 2025 were $4.0 million, compared to $3.9 million for the first quarter of 2024. The increase of $0.1 million was mainly due to increased personnel costs, including stock-based compensation.

Restructuring charges were $3.4 million for the first quarter of 2025 and consisted primarily of charges related to the workforce reduction in connection with the discontinuation of development of EO-3021. No such charges were incurred during the first quarter of 2024.

Net loss for the first quarter of 2025 was $14.2 million, compared to $10.7 million for the first quarter of 2024.

About EO-1022

Elevation Oncology is developing EO-1022, a potentially differentiated HER3 ADC for the treatment of HER3-expressing solid tumors, including breast cancer and non-small cell lung cancer. EO-1022 consists of seribantumab, a fully human IgG2 anti-HER3 antibody, site-specifically conjugated at glycan to the MMAE payload with a DAR of 4. It leverages seribantumab’s desirable internalization properties and advanced site-specific ADC technology which makes possible the use of the potent cytotoxic MMAE payload. Elevation Oncology expects to file an IND application in 2026.