On August 14, 2025 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the second quarter of 2025 (Press release, Leap Therapeutics, AUG 14, 2025, View Source [SID1234655306]).

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!

Leap Highlights:

· Board of Directors initiated process of exploring strategic alternatives to maximize shareholder value
· Strategic restructuring to prioritize corporate development resulting in a further 75% reduction in workforce
· Reported updated data from the randomized, controlled Part B of the Phase 2 DeFianCe study of sirexatamab (DKN-01) plus bevacizumab and chemotherapy in second-line colorectal cancer (CRC)

"This past quarter, we undertook a strategic realignment to focus our resources on corporate development opportunities for sirexatamab and FL-501," said Douglas E. Onsi, President and CEO of Leap Therapeutics. "As part of this effort, we completed patient treatment in the DeFianCe trial, further reduced internal expenses, and initiated a review of strategic alternatives to maximize value for our shareholders. We intend to provide a further update in the coming weeks. We are grateful to all of our team members, and we thank them for their important contributions to Leap and their commitment to developing new therapies for cancer patients."

DKN-01 Development Update

· Reported updated clinical data from Part B of the DeFianCe study of sirexatamab plus bevacizumab and chemotherapy in CRC patients. In the updated analysis as of May 22, 2025, sirexatamab demonstrated a statistically significant benefit on overall response rate (ORR), by investigator assessment and blinded independent central review, and progression-free survival (PFS) in patients with high levels of DKK1, no prior exposure to anti-VEGF therapy, or liver metastasis, along with a positive trend on ORR and PFS in the full intent-to-treat population. The final data from the study is being prepared for presentation at a future medical conference.

Business Updates

· Exploring strategic alternatives to preserve and maximize shareholder value. The Board of Directors initiated a process to explore strategic alternatives to preserve and maximize shareholder value, including leveraging its cash balance and exploring potential sale or partnership opportunities for sirexatamab and FL-501. The Company’s Board of Directors has approved the engagement of Raymond James & Associates, Inc. to serve as exclusive financial advisor to assist in the strategic evaluation process.

· Taking additional steps to reduce spending and preserve capital. The Company implemented an additional workforce reduction of approximately 75%. The total costs related to this reduction in force, including severance payments, are estimated to be approximately $4.5 million. The majority of these costs will be recognized in the third and fourth quarters of 2025.

Selected Second Quarter 2025 Financial Results

Net Loss was $16.6 million for the second quarter 2025, compared to $20.4 million for the second quarter 2024. The decrease was primarily due to a decrease in research and development and general and administrative expenses, offset in part by a restructuring charge associated with the reduction in force.

Research and development expenses were $10.5 million for the second quarter of 2025, compared to $17.9 million for the same period in 2024. The decrease of $7.4 million was primarily due to decreases of $3.9 million in clinical trial costs, $1.7 million in payroll and other headcount related expenses, $1.4 million in manufacturing costs, and $0.4 million in stock-based compensation expense.

General and administrative expenses were $1.8 million for the second quarter 2025, compared to $3.4 million for the same period in 2024. The decrease of $1.6 million was primarily due to decreases of $1.4 million in payroll and other incentive based compensation expense and a $0.2 million decrease in stock-based compensation expense.

During the second quarter of 2025, we incurred $4.5 million of restructuring charges associated with our workforce reduction, consisting primarily of one-time employee severance and benefit costs.

Cash and cash equivalents totaled $18.1 million on June 30, 2025.

On August 14, 2025 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, reported financial results and business highlights for the second quarter of 2025 (Press release, IO Biotech, AUG 14, 2025, View Source [SID1234655304]).

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!

"In the second quarter, we achieved a significant milestone advancing our pipeline of novel cancer therapies with the readout of the topline results of the Phase 3 trial for Cylembio, our potentially first-in-class, immune-modulatory, off-the-shelf therapeutic cancer vaccine, being investigated in advanced melanoma," said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. "With the notable safety profile and clinical improvement observed in this trial, we are focused on discussing the results with the FDA and determining the next steps for a potential submission of a Biologics License Application (BLA) for the treatment of advanced melanoma."

Recent Business Highlights

•
The company announced topline results of its Phase 3 pivotal trial (IOB-013/KN-D18) evaluating the company’s lead investigational vaccine, Cylembio (imsapepimut and etimupepimut, adjuvanted), in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of advanced melanoma. The trial evaluated Cylembio in combination with pembrolizumab vs. pembrolizumab alone as a first-line treatment in 407 patients with unresectable or metastatic (advanced) melanoma. In the study, Cylembio plus pembrolizumab demonstrated clinical improvement in progression free survival (PFS) compared to pembrolizumab alone, but statistical significance was narrowly missed on the PFS primary endpoint. Based on these results, IO Biotech plans to meet with the United States (US) Food and Drug Administration (FDA) this fall to discuss the totality of data and determine next steps for a potential submission of a Biologics License Application (BLA) for the treatment of advanced melanoma.

•
The company continues to expect initial data from the perioperative Phase 2 solid tumor basket trial (IOB-032/PN-E40), studying treatment with Cylembio in combination with pembrolizumab in patients with resectable squamous cell carcinoma of the head and neck (SCCHN) and melanoma that completed enrollment in January, as well as longer-term data from the company’s other ongoing Phase 2 basket trial, IOB-022/KN-D38, in patients with advanced SCCHN or non-small cell lung cancer (NSCLC), to be available in the second half of 2025 and presented at a medical meeting in 2026.

Upcoming Investor Conferences Participation

•
Morgan Stanley 23rd Annual Global Healthcare Conference: Mai-Britt Zocca, PhD, President and CEO, Amy Sullivan, CFO, and Qasim Ahmad, MD, CMO, will participate in a fireside chat beginning at 7:45 AM ET on September 9, 2025.

•
H.C. Wainwright 27th Annual Global Investment Conference: Mai-Britt Zocca, PhD, President and CEO, will give a company presentation beginning at 8:00 AM ET on September 10, 2025.

The webcasts for these two upcoming conferences will be available from the Investors section of the company’s website at View Source

Second Quarter 2025 Financial Results

•
Net loss for the three months ended June 30, 2025, was $26.2 million, compared to $20.7 million for the three months ended June 30, 2024.

•
Research and development expenses were $16.7 million for the three months ended June 30, 2025, compared to $15.8 million for the three months ended June 30, 2024. The company recognized $0.6 million in research and development equity-based compensation for the three months ended June 30, 2025, compared to $0.7 million for the three months ended June 30, 2024.

•
General and administrative expenses were $6.5 million for the three months ended June 30, 2025, compared to $5.7 million for the three months ended June 30, 2024. The company recognized $1.0 million in general and administrative equity-based compensation for the three months ended June 30, 2025 and 2024, respectively.

•
Cash and cash equivalents as of June 30, 2025 were $28.1 million, compared to $60.0 million at December 31, 2024. During the three months ended June 30, 2025, the company used cash, cash equivalents and restricted cash of $9.0 million. The company has drawn down on the Tranche A and Tranche B loan facility in principal amount of €10.0 million and €12.5 million, respectively, on May 6, 2025 and July 4, 2025, each before payment of certain fees and transaction related expense. With the funds received from the second tranche of the EIB loan facility on July 4th, the company expects that it will have sufficient cash to run the company into the first quarter of 2026.

About Cylembio

Cylembio (imsapepimut and etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase 1 (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating Cylembio in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the Phase 3 trial was completed rapidly by December 2023 with topline results from this trial reported in the third quarter of 2025. Enrollment in the two ongoing company-sponsored Phase 2 clinical trials is now complete.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to Cylembio.

Cylembio is a registered trademark of IO Biotech ApS, a subsidiary of IO Biotech.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the US and Canada).

About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial

IOB-013/KN-D18 (ClinicalTrials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Enrollment in the trial was completed by December 2023 with a total of 407 patients enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study was progression free survival. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. The company reported topline results from this trial in the third quarter of 2025. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.

About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial

IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) or metastatic squamous cell carcinoma of the head and neck (SCCHN) at sites in the United States, Spain, and the United Kingdom. IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.

About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial

IOB-032/PN-E40 (NCT05280314) is a multicenter Phase 2 basket trial investigating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) as neo-adjuvant/adjuvant treatment of patients with solid tumors at sites in Australia, the United States, France, Germany, Spain, and Denmark. The study completed enrollment in all cohorts: 18 patients with melanoma in cohort A and 16 patients with SCCHN in cohort B, both as single arm cohorts receiving combination of Cylembio with pembrolizumab. In cohort C, 61 melanoma patients were randomized 1:1 to either the combination of Cylembio with pembrolizumab or pembrolizumab alone. In the neo-adjuvant period, for all cohorts, treatment is every 3 weeks (Q3W) for 3 cycles (melanoma) or 2-3 cycles (SCCHN). Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 4-9 weeks prior. Surgery will be followed by adjuvant treatment with the same regimen for 15 cycles. Cohort C patients with poor pathological response to pembrolizumab alone in the neo-adjuvant phase (>10% residual viable tumor) may cross over to combination treatment post-surgery. The primary endpoint is major pathological response at surgery (≤10% residual viable tumor; central assessment). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.

On August 14, 2025 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension ("PAH"), reported financial results for the quarter ended June 30, 2025 and highlighted recent developments (Press release, Inhibikase Therapeutics, AUG 14, 2025, View Source [SID1234655303]).

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!

"During our second quarter of 2025, we continued to position the Company to advance IKT-001 toward a late-stage clinical trial in PAH," said Mark Iwicki, Chief Executive Officer of Inhibikase. "We have now finalized our study protocol, and we expect to initiate our Phase 2b clinical study of IKT-001, our re-engineered prodrug of imatinib mesylate, in PAH in the second half of 2025."

Multiple studies including both Phase 2 and the Phase 3 IMPRES study previously demonstrated that imatinib mesylate ("imatinib"), an anti-proliferative tyrosine kinase inhibitor, was highly efficacious in PAH. Notably in the IMPRES study, patients that maintained 400 mg of imatinib for greater than 50% of the treatment period showed a placebo adjusted 45-meter improvement in 6-minute walk distance ("6MWD") which represents best-in-class improvements for patients afflicted by PAH. More recently, a contemporary study in the American Journal of Respiratory and Critical Care Medicine demonstrated that higher exposures of imatinib were associated with a larger improvement in total pulmonary resistance ("TPR"). The 400 mg dose of imatinib exhibited the greatest impact on TPR and, even though the majority of patients completed the study at 200 mg or less, the magnitude of the hemodynamic change for the study was noted to compare favorably with recent studies of novel therapies added to background treatment. The Company believes this supports its thesis that IKT-001 has the potential to minimize GI side effects while maximizing the highly efficacious outcomes observed at 400 mg across multiple studies.

Recent Developments:

Advancement of IKT-001 as a therapy in PAH:
During the first half of 2025, the Company evaluated potential study designs and obtained feedback from various key opinion leaders before finalizing a clinical study protocol for its forthcoming Phase 2b study, known as IMPROVE-PAH.
IMPROVE-PAH is a multi-center, randomized, double-blind, placebo-controlled study of approximately 150 PAH participants. Participants under IMPROVE-PAH will be randomized 1:1:1 to receive 300 mg IKT-001, 500 mg IKT-001, or placebo once daily for 26 weeks, in addition to stable background PAH therapy. The Company’s bioequivalence studies previously confirmed that 500 mg of IKT-001 has comparable exposure in humans to 380 mg of imatinib. The primary efficacy endpoint is change in pulmonary vascular resistance at Week 26. Secondary endpoints include 6MWD, World Health Organization functional class, and pharmacokinetics. The study protocol also includes an interim safety review for study continuance by the Data Safety Monitoring Board with at least 50 patients at 12-weeks of follow-up.
The Company expects to initiate IMPROVE-PAH in the second half of 2025.
Financial Results

Cash Position: As of June 30, 2025, cash, cash equivalents and marketable securities were $87.7 million as compared to $97.5 million as of December 31, 2024.

Net Loss: Net loss for the quarter ended June 30, 2025, was $9.9 million, or $0.11 per share, compared to a net loss of $5.0 million, or $0.66 per share in the quarter ended June 30, 2024. Net loss for the six months ended June 30, 2025, was $23.6 million, or $0.26 per share, compared to a net loss of $9.6 million, or $1.38 per share, for the six months ended June 30, 2024.

R&D Expenses: Research and development expenses were $5.3 million for the quarter ended June 30, 2025, compared to $3.1 million for the quarter ended June 30, 2024. Research and development expenses were $15.8 million for the six months ended June 30, 2025, which includes a non-cash write-off of in-process research and development of $7.4 million and $1.0 million of stock-based compensation expense, both associated with the Company’s acquisition of CorHepta in February 2025, compared to $5.8 million for the six months ended June 30, 2024.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2025 were $5.9 million, compared to $2.0 million for the quarter ended June 30, 2024. Selling, general and administrative expenses for the six months ended June 30, 2025 were $11.2 million, which includes $1.0 million of severance expenses resulting from the transition of senior executives in the Company during the year, compared to $4.0 million for the six months ended June 30, 2024.

On August 14, 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 second quarter ended June 30, 2025 (Press release, HCW Biologics, AUG 14, 2025, View Source [SID1234655302]).

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 challenging 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 novel TRBC drug discovery and development platform."

On June 24, 2025, HCWB received formal notice from Nasdaq confirming that the Company has satisfied the requirements of the Equity Rule. On May 13, 2025, the Company received formal notice from Nasdaq that it 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). Therefore, the Company now meets all Nasdaq Capital Market listing requirements for continued listing, and these matters are closed.

Business Highlights

Business Development Transactions

•
On May 30, 2025, WY Biotech ended its due diligence period and formally accepted the technical report delivered by the Company on May 13, 2025. In order to accommodate WY Biotech’s timing in finalizing legally binding agreements with its CDMO and lead investor, the Company and WY Biotech agreed to extend the latest date for payment of the $7.0 million license fee to September 30, 2025.
•
On May 29, 2025, after recognizing over $16.0 million in revenue from the Wugen License Agreement signed in 2020, the Company agreed to a one-year suspension of the Wugen License Agreement, during which time the Company may seek alternative licensing programs for HCW9206. The Company is actively negotiating with several major biologics manufacturing companies interested in licensing the molecule as a reagent to use in the manufacture of CAR-T products. HCW9206 represents a 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.
•
The Company has launched a search for a strong commercial partner for the clinical development of its T-cell engager compounds. The Company believes that its T-cell engagers target cancer antigens and CD3 activation of effector T cells while simultaneously reducing the immunosuppression in tumor microenvironment. Such immunosuppression could play a pivotal role in reducing effector T-cell infiltration and anti-tumor efficacy in solid tumors.

Financing Transactions

•
On May 15, 2025, the Company completed a $5.0 million offering with a single institutional investor for an aggregate of 671,140 units at a purchase price of $7.45 per unit priced at-the-market under Nasdaq rules. Each unit includes two warrants, which may be exercised to purchase common stock at $7.45 per share.
•
On May 7, 2025, the Company extinguished $6.9 million of debt through restructuring the debt or conversion to equity. As a result, the Company strengthened its balance sheet and completed an important element of its compliance plan with all Nasdaq Listing Rules.

Clinical Development and Preclinical Results

•
The Company remains on track to initiate the HCW9302 clinical trial in the third quarter of 2025. This trial is a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments.
•
The Company identified compounds created with the Company’s novel TRBC platform for clinical development: Second-Generation T-Cell Engagers and Second-Generation Immune Checkpoint Inhibitors. The Company’s T-cell engager compounds target tissue factor, which is a proven solid tumor antigen. The second-generation immune checkpoint inhibitors are the Company’s candidates as a potential gateway to the multi-billion-dollar immune checkpoint inhibitors product market. The Company’ has identified its pembrolizumab-based fusion molecule as its lead candidate because in preclinical IND-enabling studies this compound exhibits potent anti-pancreatic cancer activities.

Second Quarter 2025 Financial Results

Revenues: Revenues for the first quarters ended June 30, 2024 and 2025 were $618,854 and $6,550, respectively. Revenues for the six months ended June 30, 2024 and 2025 were $1.7 million and $11,615 million, respectively. Revenues were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. In the second quarter of 2025, the Company agreed to a one-year suspension of the Wugen License Agreement, during which time, the Company plans to identify a new corporate partner who wishes to license HCW9206.

Research and development (R&D) expenses: R&D expenses for the first quarters ended June 30, 2024 and 2025 were $2.0 million and $1.2 million, respectively, a decrease of $802,362, or 40%. R&D expenses for the six months ended June 30, 2024 and 2025 were $4.2 million and $2.7 million, respectively, a decrease of $1.5 million, or 35%. R&D expenses were comparatively lower in 2025 primarily due to a decline in manufacturing and material and preclinical expenses.

General and administrative (G&A) expenses: G&A expenses for the first quarters ended June 30, 2024 and 2025 were $1.6 million and $2.1 million, respectively, an increase of $503,826, or 31%. G&A expenses for the six months ended June 30, 2024 and 2025 were $3.2 million and $4.3 million, respectively, an increase of $1.1 million, or 36%. The increase in G&A expenses in 2025 was primarily related to an increase in fees for professional services, accretion of a fixed bonus payable upon Maturity Date to Secured Noteholders and insurance costs. Professional services include legal fees in the ordinary course of business, accounting advisors, auditing and tax services, facilities administrative costs, expenses related to maintaining our listing on Nasdaq and remaining in compliance with SEC filings, and other expenses.

Legal expenses and recoveries, net: Legal expenses and recoveries, 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. For the three and six months ended June 30, 2024, preparations for the hearing and the hearing took place, along with subsequent negotiations for settlement, and the Company incurred legal fees of $10.4 million and $14.8 million, respectively. 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 $12.3 million legal fees which remain unpaid.

Net loss: Net loss for the second quarters ended June 30, 2024 and 2025 were $15.3 million and $1.9 million, respectively. Net loss earnings for the six months ended June 30, 2024 and 2025 were $22.7 million and $4.1 million, respectively.

Financial Guidance

As of June 30, 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, especially business development programs, 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 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 remaining elements of our plan.

On August 14, 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 second quarter ended June 30, 2025 (Press release, Fortress Biotech, AUG 14, 2025, View Source [SID1234655301]).

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, "We achieved several key milestones in the second quarter that underscore the strength of Fortress’s diversified business model and our ability to create value across our portfolio. The acquisition of our subsidiary Checkpoint Therapeutics by Sun Pharma marked a significant validation of our business model, delivering approximately $28 million upfront, plus the potential for an additional contingent value right (CVR) payment and ongoing royalties on future sales of UNLOXCYT (cosibelimab-ipdl). We also look forward to the PDUFA goal date for CUTX-101, which is rapidly approaching on September 30, 2025 and the potential Priority Review Voucher which may be issued upon approval."

Dr. Rosenwald continued, "In addition, Mustang Bio received Orphan Drug Designation for MB-101, reinforcing the promise of our combination strategy leveraging MB-101 and MB-108 to target high-grade gliomas. Journey Medical continues to execute well, with the launch of Emrosi and commercial uptake, including expanded payer coverage now reaching 65% of U.S. commercial lives. We remain focused on unlocking the value of our portfolio and delivering innovative treatments to patients in need."

Recent Corporate Highlights1:

Monetization Updates

●On May 30, 2025, Fortress’ subsidiary, Checkpoint Therapeutics, Inc. ("Checkpoint"), was acquired by Sun Pharmaceutical Industries, Inc. (together with its subsidiaries and/or associated companies, "Sun Pharma"). Fortress received ~$28 million shortly after closing and is eligible to receive up to an
1 The development programs depicted in this press release include product candidates in development at Fortress, at Fortress’ private or public subsidiaries (referred to herein as "subsidiaries" or "partner companies") and at entities with whom one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as "partners"). The words "we", "us" and "our" may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.

additional $4.8 million under a contingent value right (CVR), plus a 2.5% royalty on future net sales of UNLOXCYT (cosibelimab-ipdl).

Regulatory Updates

● The FDA accepted the NDA submission for CUTX-101 (copper histidinate for Menkes disease) for priority review with a Prescription Drug User Fee Act ("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. 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.
● In July 2025, the FDA granted Orphan Drug Designation to Mustang for MB-101 (IL13Ra2-targeted CAR T-cells) for the treatment of recurrent diffuse and anaplastic astrocytoma and glioblastoma. MB-101 received Orphan Drug Designation on time and with a designation that is broader than the indication proposed. We intend to advance MB-101, in combination with MB-108, as a potential treatment option. Our novel therapeutic strategy, combining our MB-101 CAR-T cell therapy with our MB-108 oncolytic virus, leverages MB-108 to reshape the tumor microenvironment ("TME") to make cold tumors "hot," thereby potentially improving the efficacy of MB-101 CAR-T cell therapy.

Commercial Product Updates

● Journey Medical’s net product revenues for the second quarter ended June 30, 2025, were $15.0 million, compared to net product revenues of $14.9 million for the second quarter ended June 30, 2024.
● At the end of March 2025, Journey Medical announced initial distribution to pharmacies and first prescriptions filled for Emrosi for the treatment of inflammatory lesions of rosacea in adults. The full commercial launch began on April 7, 2025. Emrosi is available by prescription at specialty pharmacy chains.
● In July 2025, Journey Medical announced expanded payer access with over 100 million commercial lives in the United States for Emrosi (40mg Minocycline Hydrochloride Modified-Release Capsules, 10mg immediate release and 30mg extended release), the Company’s recently launched treatment for the inflammatory lesions of rosacea in adults. This compares to 54 million commercial lives in May 2025.

Clinical Updates

● In June 2025, we announced that a data analysis from the two Phase 3 multicenter clinical trials evaluating Emrosi for the treatment of moderate-to-severe papulopustular rosacea in adults was presented at the Society of Dermatology Physician Associates 2025 Summer Dermatology Conference. The analysis determined that differences in body weight did not affect the efficacy of Emrosi in the two Phase 3 trials, which supported its November 2024 FDA approval.
● In July 2025, AstraZeneca announced that anselamimab (formerly known as CAEL-101) did not achieve statistical significance for the primary endpoint in its Phase III Cardiac Amyloid Reaching for Extended Survival ("CARES") clinical program for Mayo stages IIIa and IIIb AL amyloidosis patients. However, the drug showed clinically meaningful improvement in a prespecified subgroup and was well tolerated. AstraZeneca is continuing to evaluate the full results and plans to share the data with health authorities and at a medical meeting.

General Corporate:

● Journey Medical joined the small-cap Russell 2000 Index and the broad-market Russell 3000 Index, effective after the close of U.S. equity markets on June 27, 2025, as a result of the 2025 annual Russell Index reconstitution.

Financial Results:

● As of June 30, 2025, Fortress’ consolidated cash and cash equivalents totaled $74.4 million, compared to $57.3 million as of December 31, 2024, an increase of $17.1 million year-to-date.
● Fortress’ consolidated cash and cash equivalents, totaling $74.4 million as of June 30, 2025, includes $38.1 million attributable to Fortress and the private subsidiaries, $3.3 million attributable to Avenue, $12.7 million attributable to Mustang Bio and $20.3 million attributable to Journey Medical. Checkpoint was acquired by Sun Pharma in May 2025.
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 revenue totaled $16.4 million for the second quarter ended June 30, 2025, $15.0 million of which was generated from our marketed dermatology products. This compares to consolidated net revenue totaling $14.9 million for the second quarter of 2024, most of which was generated from our marketed dermatology products.
● Consolidated research and development expenses totaled $8.1 million for the second quarter ended June 30, 2025, compared to $12.7 million for the second quarter ended June 30, 2024.
● Consolidated selling, general and administrative costs were $38.8 million for the second quarter ended June 30, 2025, compared to $20.8 million for the second quarter ended June 30, 2024.
● Consolidated net income attributable to common stockholders was $13.4 million, or $0.50 per share basic, and $0.45 per share diluted, for the second quarter ended June 30, 2025, compared to net loss attributable to common stockholders of $(13.3) million, or $(0.73) per share basic and diluted, for the second quarter ended June 30, 2024.