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.

On August 14, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported business update and announces second quarter 2025 financial results (Press release, Evaxion Biotech, AUG 14, 2025, View Source [SID1234655300]).

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!

Business highlights (since last quarterly update)
Evaxion continues to execute its strategy and plans with a number of significant achievements across the company in recent months. We remain on track to achieve the milestones set for 2025. Highlights include:

Continued strong execution of the phase 2 trial with personalized cancer vaccine EVX-01. All patients have now completed treatment and the full two-year clinical efficacy data from the trial will be presented at an oral session at the ESMO (Free ESMO Whitepaper) Congress in October 2025. This will provide a fantastic opportunity to announce the data to a large international audience, including potential partners.
Further, the recruitment for the one-year extension of the phase 2 trial is finalized, allowing us to present three-year EVX-01 data in 2026.
Massive recognition of our AI-Immunology platform through a grant from the Gates Foundation to explore design options for a new and unique sub-unit vaccine against polio. This validation further supports the strong external interest in AI-Immunology from potential partners and collaborators.
Expansion of our R&D pipeline with EVX-B4, a new vaccine program against Group A Streptococcus bacteria, underscoring the scalability of AI-Immunology to more than 100 different diseases.
Significant improvement in our financial position through an agreement with the European Investment Bank (EIB) to convert debt into equity on favorable terms for Evaxion and our shareholders. The agreement saw our equity immediately improved by $4.1 million. Current cash at hand is sufficient to fund our operating expenses and capital expenditure requirements until mid-2026.
The search for a new CEO is on-going following the stepping down of Christian Kanstrup and Birgitte Rønø taking the role of interim CEO. Our strategy, tactical plans and anticipated milestones are unchanged.
"We maintain a strong operational momentum as we track towards further potential value catalysts, most importantly presentation of the two-year EVX-01 clinical data and potential exercise by MSD of one or two of their options on EVX-B2 and EVX-B3. Business development discussions remain a key priority, both in terms of advancing ongoing discussions and entering new ones, as we pursue the remaining company milestones set for 2025," says Birgitte Rønø, CSO and interim CEO of Evaxion.

Conference call and webcast
Evaxion’s Executive Management will host a conference call and webcast today, presenting the business update and financial results as well as taking questions. This event is free, open to the public and encouraged.

To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event.

To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event.

Research & Development (R&D) update
Evaxion has a R&D pipeline of innovative development candidates for both cancer and infectious diseases.

Personalized cancer vaccine EVX-01, which is being evaluated as a treatment for advanced melanoma (skin cancer) in the ongoing phase 2 trial, is our most advanced asset. We continue to progress the trial according to plan and have completed the treatment of all patients. Thus, we are set to collect and present two-year clinical efficacy data from the trial.

We are excited that the data has been accepted for oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 on October 17, 2025. As one of the most important medical oncology conferences in the world, it will be a great venue for us to present the data to a large audience, including potential partners. The trial has already yielded very promising data, including convincing one-year clinical data and immune data, and we are looking forward to sharing the results observed after two years of treatment.

To further enhance EVX-01’s data package we decided earlier in the year to extend the trial by a further year. This might allow us to document even better effects of the treatment than what will be observed after one and two years. We have now finalized recruitment of patients for the trial extension with the three-year data expected next year.

Further to our clinical progress, we also maintain a high level of preclinical activity. We got another massive recognition of the potential of AI-Immunology through a grant from the Gates Foundation to explore design options for a new and unique vaccine against polio. On top of allowing further application and validation of the platform without adding to our operational expenditure, the grant has further supported the interest in collaborations and partnerships from other external parties.

Polio is not the only new disease against which we will be applying AI-Immunology. In June, we announced the expansion of our R&D pipeline with EVX-B4, a new vaccine program against Group A Streptococcus. This is again showcasing the scalability of AI-Immunology, which can be applied to more than 100 different diseases thanks to its unique architecture. This, in turn, creates numerous potential partnerships and out-licensing opportunities for us.

Business development update
The EVX-B2 and EVX-B3 programs, being conducted in collaboration with MSD, continue to track towards potential option exercise in the second half of 2025. Following potential option exercise, MSD would take over further development and commercialization with Evaxion entitled to significant milestone payments as development successfully progresses. Evaxion would also be entitled to royalties on future sales.

The MSD collaboration on EVX-B2 and EVX-B3 is a great example of the partnering strategy we are pursuing. Our long-term value creation rests on monetization of both our R&D pipeline assets and AI-Immunology platform through multiple partnerships. Our investments are aimed at creating and improving our opportunities to enter such partnerships.

As per our strategy, business development remains a high priority, and we continue to be engaged in multiple parallel partnership discussions based on a solid level of external interest in both our platform and pipeline. We maintain the ambition to enter at least two new partnership deals in 2025 while also reiterating that the current turmoil in the financial markets and increased regulatory uncertainty is having an impact on the decision processes with some potential partners.

EIB loan conversion
We have significantly bolstered our capital structure by agreeing with the European Investment Bank (EIB) to convert debt into equity on favorable terms for Evaxion and our shareholders.

EIB has converted €3.5 million of its €7 million loan to Evaxion into equity via a purchase of ordinary Evaxion warrants at a price of $4.87, corresponding to a premium of 89% to the share price the day before the agreement was announced.

The agreement saw our equity immediately improved by $4.1 million and substantially reduce our overall liabilities, simplifies our balance sheet and improves our financial flexibility and future cash flow.

Second quarter 2025 financial results
Our financial situation remains solid with our cash runway extending to mid-2026.

Cash and cash equivalents as of June 30, 2025, were $14.7 million, as compared to $6.0 million as of December 31, 2024. The significant improvement in our cash position is due to our successful capital markets initiatives in Q1 2025, and we expect our existing cash and cash equivalents to be sufficient to fund our operating expenses and capital expenditure requirements till mid-2026.

Revenue of $37 thousand was recorded in the three months ending June 30, 2025, primarily relating to revenue recorded from Gates Foundation, as compared to $154 thousand same period last year relating to revenue from the collaborative agreement with MSD.

Research and development (R&D) expenses were $2.2 million for the period ending June 30, 2025, compared to $2.8 million for the same period in 2024. The reduced spending relates to cost management and efficiencies, and project costs being more back-end loaded in 2025 compared to 2024.

General and administrative expenses were $2.2 million for the second quarter 2025, compared to $2.0 million for the second quarter 2024. The increase is primarily driven by capital market transaction costs and increased investor relations activities.

Net financial income in the second quarter of 2025 is driven by $0.3 million net expense from remeasurement of the derivative liability from investor warrants from our January 2025 public offering, compared to a net expense from remeasurement of derivative liability of $1.7 million in the second quarter 2024. The accounting is aligned with the required treatment according to IAS/IFRS, as further explained below.

For the three-month period ending June 30, 2025, we generated a net loss of $4.8 million, or $(0.02) per basic and diluted share, as compared to a net loss of $6.2 million, or $(0.12) per basic and diluted share for the same period 2024. The change is mainly due to a higher change in fair value of derivative liability in the same period in 2024.

Total equity amounts to $6.2 million as of June 30, 2025, which is a significant improvement compared to a negative equity of $(1.7) million as of December 31, 2024.

The equity is negatively impacted by $0.4 million as of June 30, 2025, arising from the net effect of the derivative liability from investor warrants issued as part of our January 2025 public offering. According to IAS/IFRS, the investor warrants are seen as derivative instruments, as the exercise price is denominated in USD while our company’s functional currency is DKK. Part of the proceeds from capital raises are consequently recognized as derivative liabilities. Reassessments are disclosed as financial income/expense and reverted to equity when warrants are exercised or lapse. The derivative liability from investor warrants has no impact on other items in the financial statement, hence Evaxion discloses the impact as a separate equity item.

During March 2025, an agreement has been made with approximately 50% of the participating investors from the January 2025 public offering to convert the exercise price from USD into DKK to eliminate the derivative liability, whereas approximately 50% of the liability was reversed in Q1 2025 and will thereby not impact the accounts going forward.

We will continue to focus and maintain our strict cost control and diligently prioritize and optimize our resource allocation. This enables us to absorb the general cost increase and inflation within the same cash spend as in 2024, e.g. we expect an operational cash burn of approximately $14 million in 2025.

Evaxion A/S
(Unaudited) Consolidated Statement of Financial Position Data
(USD in thousands)

June 30,
2025 Dec 31,
2024
Cash and cash equivalents 14,746 5,952
Total assets 22,449 12,485
Total liabilities 16,223 14,137
Share capital 11,823 10,516
Other reserves 121,778 106,369
Accumulated deficit (124,943) (118,537)
Total equity before derivative warrant liability 8,658 1,652
Effect from derivative liabilities from investor warrants (2,432) -
Total equity 6,226 1,652
Total liabilities and equity 22,449 12,485

Evaxion A/S
(Unaudited) Consolidated Statement of Comprehensive Loss Data
(USD in thousands, except per share data)

Three Months Ended
June 30, Six Months Ended
June 30,
2025 2024 2025 2024
Revenue 37 154 37 205
Research and development (2,165) (2,752) (4,321) (5,588)
General and administrative (2,212) (1,983) (3,924) (3,594)
Operating loss (4,340) (4,581) (8,208) (8,977)
Finance income 1,821 220 4,305 5,838
Finance expenses (2,498) (2,036) (2,895) (2,282)
Net loss before tax (5,026) (6,198) (6,798) (5,421)
Income tax benefit 195 199 387 417
Net loss for the period (4,831) (6,198) 6,411 (5,004)
Net loss attributable to shareholders of Evaxion A/S (4,831) (6,198) 6,411 (5,004)
Loss per share – basic and diluted (0.02) (0.12) (0.02) 0.10
Number of shares used for calculation (basic and diluted) 315,828,608 53,787,469 275,434,522 50,212,854

On August 14, 2025 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported financial and operating results for the second quarter ended June 30, 2025, and provided a corporate update (Press release, Chemomab, AUG 14, 2025, View Source [SID1234655299]).

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 of 2025 Chemomab continued to lay the groundwork for the nebokitug Phase 3 program in primary sclerosing cholangitis (PSC) and to progress discussions with potential strategic collaborators. Our goal is to secure the right partner to optimize development resources, accelerate the Phase 3 launch and maximize the commercial potential of nebokitug as the first approved disease-modifying therapy for this devastating disease with enormous unmet medical need." said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. "During the quarter, we submitted our nebokitug Phase 3 protocol to the FDA and look forward to receiving their response soon. We are also engaging in a similar process with the European Medicines Agency, as we plan for a global Phase 3 trial that will include many sites in the E.U. and anticipate that the Phase 3 protocol agreed with the FDA would also support regulatory approvals in Europe. During the quarter we also aligned with the FDA on two additional requirements for the eventual regulatory approval of nebokitug—the CMC standards needed for manufacturing of drug supply for the "to be marketed" formulation as well as the timing of required nonclinical toxicology testing. We look forward to continuing to work closely with the FDA as we finalize the details of the Phase 3 development program."

Dr. Mor added, "As disclosed previously, we are planning to advance the nebokitug PSC Phase 3 program in collaboration with a strategic partner and we continue in active discussions with a variety of potential partners on multiple possible paths forward. A number of developments during the quarter supported these discussions. Enlarging the scope of our patent protections is relevant for partnerships, and we were pleased to report adding to our existing large and comprehensive intellectual property portfolio with new nebokitug patents in China and Russia, two significant territories for future commercialization. We also presented SPRING trial data at a number of high profile scientific meetings, further raising awareness of nebokitug’s demonstrated potential as a groundbreaking treatment for PSC."

Dr. Mor concluded, "In parallel to the ongoing activities, we are assessing a number of near-term value-creating initiatives with the potential to accelerate the Phase 3 program and strengthen its probability of success. We anticipate sharing more information about these activities in the coming months."

Separately, Chemomab plans to change the ratio of its American Depositary Shares ("ADSs") to its ordinary shares (the "ADS Ratio"), from the current ADS Ratio of one ADS to 20 ordinary shares to a new ADS Ratio of one ADS to 80 ordinary shares, effective on August 26, 2025. Chemomab will continue to be traded on the Nasdaq Capital Market under the ticker "CMMB," with an updated CUSIP Number of 16385C104. This ratio adjustment will essentially serve as a one-for-four reverse split for ADS holders and requires no action on their part. The Bank of New York Mellon, the depositary bank for Chemomab’s ADS program, will arrange for the exchange on the effective date. There will be no issuance of new ADSs in connection with the adjustment.

Second Quarter 2025 and Recent Highlights:

On June 30, 2025, Chemomab reported that results of the Phase 2 SPRING trial assessing nebokitug for the treatment of PSC were presented in an oral session at BSG Live’25, the annual scientific meeting of the British Society for Gastroenterology. The SPRING trial data was presented by Douglas Thorburn, MD, Professor of Hepatology within the Institute for Liver and Digestive Health at UCL and Principal Investigator of the trial. Post-conference, it was announced that Professor Thorburn’s talk on the SPRING trial results was awarded the prize for the Best Oral Presentation in its respective category at BSG LIVE’25.
On June 11, 2025, Chemomab obtained confirmation from the FDA on two development milestones for the nebokitug Phase 3 program. These included agreement with the FDA on the Chemistry, Manufacturing, and Controls (CMC) strategy proposed by Chemomab and its contract manufacturing partner and agreement that additional animal toxicology testing routinely required by the FDA may be conducted in parallel with the nebokitug Phase 3 clinical trial and submitted as part of the planned Biologics Licensing Application. This represents a favorable outcome for Chemomab and supports the timely advancement of the program.
On June 3, 2025, Chemomab reported that two new patents covering the use of nebokitug for the treatment of liver diseases, including primary sclerosing cholangitis, were issued in China and Russia, providing coverage up to 2041. These new patents further expand the protections provided by nebokitug’s composition of matter and methods and use patents issued in the U.S., Europe, Japan and additional key territories.
On May 5, 2025, Chemomab announced that data from the company’s Phase 2 SPRING trial of nebokitug in PSC was presented in an oral Distinguished Abstract Plenary session at Digestive Disease Week (DDW 2025) in San Diego, California. The DDW 2025 session presented data from the double-blind, placebo-controlled 15-week treatment period and the 48-week open label extension portion of the study.
On April 28, 2025, Chemomab reported data from two study abstracts that were presented as posters at EASL 2025, the Annual Congress of the European Association for the Study of the Liver. In one study, proteomic analyses of 3,000 circulating proteins in patient samples from the SPRING trial showed that nebokitug-treated patients exhibited significant and dose-dependent changes in proteins playing a key role in fibrosis, immune cell recruitment and inflammation. These data highlight how nebokitug’s ability to neutralize CCL24 exerts a wide impact, including reductions in a broad array of inflammatory and fibrotic biomarkers in treated patients. The second study analyzed the pharmacodynamics and pharmacokinetics (PK) of nebokitug and CCL24 using data from the SPRING trial. PK analyses indicated effective antibody-target engagement and linear regression analyses found trends between increasing patient exposure to nebokitug and decreasing levels of PSC disease biomarkers.
On April 15, 2025, Chemomab announced new executive medical and clinical appointments. David M. Weiner, MD, rejoined Chemomab as Interim Chief Medical Officer, bringing extensive biotechnology and pharmaceutical industry R&D, drug development and strategic experience, and Jack Lawler, who oversaw the conduct of Chemomab’s successful Phase 2 SPRING Trial in PSC, was promoted to the position of Chief Development Officer.
Second Quarter 2025 Financial Highlights

Cash Position: Cash, cash equivalents and short-term bank deposits were $ 9.5 million as of June 30, 2025, compared to $10.6 million as of March 31, 2025. This cash is expected to fund the company through the second quarter of 2026. During the first half of 2025, the company issued 1,023,104 ADSs under its at-the-market (ATM) equity offering program, resulting in net proceeds of $1.3 million.
Research and Development (R&D) Expenses: R&D expenses were $1.3 million for the second quarter of 2025, compared to $2.9 million for the second quarter of 2024. The decrease in R&D expenses in the second quarter of 2025 compared to the second quarter of 2024 primarily resulted from the end of activities related to the Phase 2 SPRING trial.
General and Administrative (G&A) Expenses: G&A expenses were approximately $1.0 million for the second quarter of 2025, compared to $0.8 million for the second quarter of 2024. The increase in G&A expenses primarily reflects increases in noncash share-based expenses.
Net Loss: Net loss was $2.1 million, or a net loss of less than $0.01 per basic and diluted ordinary share for the second quarter of 2025, compared to $3.6 million, or a net loss of $0.01 per basic and diluted ordinary share for the second quarter of 2024. The weighted average number of ordinary shares outstanding, basic and diluted, was 463,508,519 (equal to approximately 23.2 million ADSs) for the second quarter of 2025.
Liquidity and Capital Resources: Chemomab believes its existing liquidity resources as of June 30th, 2025 will enable it to fund its operations through the second quarter of 2026.
Number of Issued and Outstanding Shares: As of June 30, 2025, the company had 413,851,140 Ordinary shares issued and outstanding (equal to 20,692,557 ADSs), compared to 377,132,220 Ordinary shares issued and outstanding (equal to 18,856,611 ADSs) as of December 31, 2024.