On September 16, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its financial results for the six-month period ended June 30, 2025, and provides an update on the myvac platform, its lead asset TG4050, and upcoming plans (Press release, Transgene, SEP 16, 2025, View Source [SID1234656003]).

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Dr. Alessandro Riva, MD, Chairman and CEO of Transgene, commented: "We are extremely proud that all patients treated with TG4050 in our Phase I trial remained disease-free after a median follow-up of 30 months. These results, selected for oral presentation at ASCO (Free ASCO Whitepaper) 2025, represent a pivotal milestone for Transgene and underscore the potential of our viral vector-based individualized therapeutic cancer vaccine platform. The durable clinical benefit and robust immune responses we have observed, together with the strong enthusiasm from clinicians, reinforce our vision to deliver transformative therapies to people living with operable head and neck cancer. TG4050 continues to progress through Phase II and we look forward to sharing first data from his trial in 2026. We will also present further immunological data from our Phase I study later this year."

TG4050: Individualized Neoantigen Therapeutic Cancer Vaccine (INTV)

ASCO 2025: TG4050, the first candidate from Transgene’s myvac platform, achieves all Phase I endpoints, with 100% disease-free survival (DFS) after more than 2-years

Transgene presented positive data from the randomized Phase I part of the ongoing multicenter Phase I/II trial (NCT04183166) in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2025) Annual Meeting (see press release). TG4050 was administered as a single agent in the adjuvant treatment of HPV-negative operable head and neck squamous cell carcinoma (HNSCC).

– All patients who received TG4050 remained disease-free for at least two years (median follow-up: 30 months), providing strong clinical proof of principle. TG4050 also induced durable and specific T cell responses persisting 24 months after the start of treatment.

-> In addition, the results successfully met all trial endpoints (including safety and feasibility). Additional immunological data from Phase I patients will be presented at an upcoming congress in Q4 2025. These data will provide further insight into the phenotyping of patients’ immune responses against selected epitopes. In addition, Transgene expects to communicate on the 3-year follow-up of Phase I patients in H1 2026.

Based on the positive Phase I data presented at ASCO (Free ASCO Whitepaper) and further immunological data (that will be communicated in Q4 2025), Transgene is currently evaluating the most efficient regulatory pathway to accelerate the development of TG4050 and bring it to patients with operable HNSCC as quickly as possible.

Ongoing Phase II part: critical milestones in 2026 and 2027

Initial patient screening has been completed in the randomized Phase II part of the Phase I/II clinical trial with TG4050 (see press release).

Randomization of all patients in the Phase II part is expected to be completed by the end of 2025.

First immunogenicity data and preliminary efficacy data from the Phase II part of the trial are expected in H2 2026 and Q4 2027, respectively.

Expanding the myvac potential in operable solid tumors

Transgene’s INTV platform myvac could be applied across a range of solid tumors where in many cases a significant unmet medical need remains.

In parallel with the development plan in HNSCC, Transgene is setting up a new Phase I trial in a second indication in an early treatment setting, with the aim to initiate it as soon as all conditions are met.

Other viral vector-based assets

BT-001 (oncolytic virus – intratumoral administration): Updated data on Phase I/II trial to be presented at ESMO (Free ESMO Whitepaper) 2025

Transgene and BioInvent will present a poster on updated data from the ongoing Phase I trial (NCT04725331) evaluating BT-001, an armed oncolytic virus expressing an anti-CTLA4 monoclonal antibody, in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab)[1], at the European Society for Medical Oncology Annual Meeting (ESMO 2025 — see press release). The abstract will be available on the ESMO (Free ESMO Whitepaper) website on October 13, 2025, at 0:05 am CEST.

In previously reported data (ESMO 2024), BT-001 was well tolerated with limited adverse events and no dose-limiting toxicities. BT-001 in monotherapy was shown to shrink injected lesions in patients with advanced solid tumors.

In combination with pembrolizumab, BT-001 showed promising efficacy data with partial responses in patients with relapsed and refractory advanced melanoma and leiomyosarcoma.

Transgene and BioInvent are pursuing clinical development opportunities with clinicians for BT-001 administered intratumorally.

TG4001 (HPV16 therapeutic vaccine)

Transgene presented a poster (available here) on randomized Phase II data of TG4001 in combination with avelumab in a cervical cancer subgroup at the 2025 ASCO (Free ASCO Whitepaper) conference.

Transgene is currently evaluating potential partnership opportunities to determine the best path forward for the program.

TG6050 (oncolytic virus — intravenous administration)

The Phase I dose-escalation Delivir trial (NCT05788926), evaluating TG6050 administered by intravenous infusion, has enrolled 22 patients with advanced non-small cell lung cancer who have failed standard therapeutic options.

TG6050 has demonstrated good tolerability as monotherapy, with no new safety signals identified. However, the analysis of preliminary efficacy and translational data did not demonstrate a clear efficacy signal in the context of intravenous administration in this indication. Patient recruitment of the Phase I trial is completed, and the Company is evaluating the best way forward for this candidate.

On September 16, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), a leading artificial intelligence (AI)-driven oncology company leveraging its proprietary RADR platform to accelerate targeted cancer therapies, reported the successful completion of its Phase 1a clinical trial (NCT05933265) for LP-184 (Press release, Lantern Pharma, SEP 16, 2025, View Source [SID1234656004]). The trial met all primary endpoints, demonstrating a favorable safety and pharmacokinetic (PK) profile, and early signs of antitumor activity. Enrollment is complete, with several patients continuing treatment due to ongoing clinical benefit.

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The open-label, multicenter, non-randomized study evaluated LP-184 in 63 patients with advanced relapsed or refractory solid tumors, including GBM. Primary objectives focused on safety, tolerability, PK, and determining a recommended Phase 2 dose (RP2D) when administered on Days 1 and 8 of a 21-day cycle.

Summary of Preliminary Phase 1a Safety and Pharmacokinetic Observations

LP-184 exhibited a robust safety profile, with no dose-limiting toxicities in the majority of cohorts and low incidence of discontinuations, interruptions, or delays due to drug-related adverse events. Adverse events were predominantly Grade 1 or 2, including manageable nausea and vomiting—consistent with alkylating agents—that resolved without significant intervention. The low rate of Grade 3+ events (minimal across the study) underscores LP-184’s tolerability, making it well-suited for potential monotherapy or combinations with agents like PARP inhibitors and immunotherapies, where preclinical synergies have been observed.

PK data confirmed that therapeutic concentrations were achieved at dose levels 8 (0.25 mg/kg) and above, aligning with preclinical models and supporting dose optimization for future trials. These observations will help further de-risk LP-184, enabling efficient advancement in biomarker-enriched populations identified via our RADR AI platform.

Summary of Preliminary Phase 1a Antitumor Observations

Promising antitumor activity emerged, particularly at dose levels 8 (0.25 mg/kg) and above, where therapeutic exposures were attained. Disease control was achieved in 48% (10/21) of evaluable patients after two cycles, including in heavily pre-treated cases. The median number of prior lines of therapy was 3; some patients had up to 8 prior lines of therapy.

Notable highlights from the overall study include:

Clinical benefit observed in 4 of 16 recurrent GBM patients previously exposed to temozolomide, lomustine, and/or radiation.
Marked reductions in target cancer lesions among patients with CHK2, ATM, BRCA1 and STK11/KEAP1 mutations, spanning colon cancer, thymic carcinoma, gastrointestinal stromal tumor (GIST), and NSCLC.
A NSCLC patient with DNA damage response (DDR) mutations, refractory to immunotherapy, achieved nearly two years of clinical benefit and remained on treatment.
Two patients at dose level 10 (0.39 mg/kg) maintain disease control beyond six months and continue on therapy.
These signals in DDR-deficient tumors further support LP-184’s synthetic lethal mechanism and highlight its potential in precision oncology.

"On behalf of our dedicated team, we extend our sincere gratitude to the patients, families, investigators, and clinical staff whose commitment drove the success of our Phase 1a LP-184 trial, establishing a robust safety profile with encouraging signals of activity at therapeutic doses," said Panna Sharma, Chief Executive Officer of Lantern Pharma. "Leveraging our RADR AI platform, we’re now positioning LP-184 for targeted Phase 1b and Phase 2 studies. Our goals are to position LP-184 to address critical unmet needs in TNBC, NSCLC, and other DDR-deficient cancers, which can unlock significant value for patients and investors alike."

Recommended Phase 2 Dose and LP-184 Future Development Plan

The Safety Review Committee supported an RP2D of 0.39 mg/kg in this regimen, with provisions for intra-patient escalation, based on the trial’s evaluation of safety, tolerability, and PK data. Building on these results, Lantern is developing plans to advance multiple Phase 1b/2 trials, prioritizing the following disease indications:

TNBC in combination with Olaparib (a PARP inhibitor), with potential for ctDNA as an early response biomarker to support accelerated approval pathways.
NSCLC with STK11/KEAP1 co-mutations, with or without immunotherapy.
Bladder cancer in a trial to be conducted as an investigator-led study in Denmark with patients harboring DNA damage repair genetic alterations.
These initiatives target high-value indications with substantial market potential and high clinical need.

Data Cutoff Date and Future Publications and Presentations

The data cutoff for the observations described in this release is August 26, 2025. Comprehensive results from the LP-184 Phase 1a trial are being prepared for peer-reviewed publications and presentations at upcoming oncology conferences.

On September 16, 2025 On September 16, 2025 (the "Amendment Effective Date"), Carisma Therapeutics Inc. (the "Company") and ModernaTX, Inc. ("Moderna") reported to have entered into a First Amendment to the Collaboration and License Agreement (the "Amendment"), which amends that certain Collaboration and License Agreement, dated as of January 7, 2022, by and between the Company and Moderna (the "Moderna Agreement") (Filing, Carisma Therapeutics, SEP 16, 2025, View Source [SID1234656075]).

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Effective as of the Amendment Effective Date, in exchange for a one-time cash payment of $4.0 million payable to the Company within ten (10) business days following the Amendment Effective Date, Moderna has no further obligation to make any financial payments to the Company under or in connection with the Agreement, subject to certain specified exceptions. Specifically, Moderna is no longer required to pay to the Company any development target designation, development, regulatory and commercial milestone payments, any royalties on net sales of any products that are commercialized under the Moderna Agreement or any research costs, regardless of whether such applicable milestone event, sale of product or research cost occurs on or after the Amendment Effective Date. Effective as of the Amendment Effective Date, the royalty term for all products expired and the licenses granted to Moderna under the Agreement became fully paid-up, perpetual, irrevocable and royalty-free.

The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the complete text of such agreement, a copy of which is expected to be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2025.

On September 15, 2025 Champions Oncology, Inc. (Nasdaq: CSBR), a leading translational oncology research organization, reported its financial results for its first quarter of fiscal 2026, ended July 31, 2025 (Press release, Champions Oncology, SEP 15, 2025, View Source [SID1234655973]).

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First Quarter and Recent Highlights:

•Total revenue of $14 million
•Adjusted EBITDA of $60,000
•Appointment of Rob Brainin as Chief Executive Officer to lead the next phase of growth

Rob Brainin, newly appointed CEO of Champions, commented, "It is great to be joining Champions at such an exciting inflection point. Our core services business—the backbone of our company—is strengthening and well positioned for sustained growth. At the same time, we are scaling our emerging data platform, which has already shown encouraging traction with leading biopharma partners. These complementary growth engines give us the opportunity to deepen our scientific impact, deliver innovative solutions to patients and customers, and create durable long-term value for shareholders. In parallel, our Corellia team continues to generate data demonstrating the potential of the compounds in our pipeline. Over the coming quarters, I look forward to working closely with our talented team to sharpen our strategy, invest in key capabilities, and build on Champions’ culture of collaboration and scientific excellence."

David Miller, CFO of Champions, added, "We opened the fiscal year with $14 million in revenue and adjusted EBITDA of $60,000. While revenue was slightly lower than the first quarter of last year, we achieved solid sequential growth that met our expectations and provides a strong foundation for the year. As we move forward, we anticipate continued topline expansion and margin improvement driven by a healthy services pipeline and growing demand for our proprietary data offerings. Our financial discipline and focus on profitable growth give us the flexibility to invest in strategic initiatives that will position Champions for long-term success."

First Fiscal Quarter Financial Results

Total oncology revenue for the first quarter of fiscal 2026 was $14.0 million compared to $14.1 million for the same period last year, consisting of a $400,000, or 3% decline in service revenue and a $300,000 increase in data license revenue. Total costs and operating expenses for the first quarter of fiscal 2026 were $14.5 million compared to $12.7 million for the first quarter of fiscal 2025, an increase of $1.8 million or 14.1%.

For the first quarter of fiscal 2026, Champions reported a loss from operations of $527,000, including $208,000 in stock-based compensation, $358,000 in depreciation and amortization expenses, and a $20,000 charge for the disposal of lab equipment, compared to income from operations of $1.3 million, inclusive of $258,000 in stock-based compensation and $448,500 in depreciation and amortization expenses, in the first quarter of fiscal 2025. Adjusted EBITDA, which is defined as income from operations excluding stock-based compensation, depreciation and amortization expenses, and equipment disposal charges, was $59,000 for the first quarter of fiscal 2026 compared to adjusted EBITDA of $2.0 million in the first quarter of fiscal 2025.

Cost of oncology revenue was $8.0 million, up $923,000, or 13.1%, from $7.1 million in the same period last year. The increase primarily reflects higher outsourced lab services for radiolabeling work, which will vary from quarter to quarter. Importantly, as we migrate this work into our own labs in the coming quarters, we anticipate a reduction in cost of sales and improvement in gross margins. Gross margin for the quarter was 43% compared to 50% in the prior year.

Research and development expense for the three-months ended July 31, 2025 was $2.1 million, an increase of $628,000 or 43.2%, compared to $1.5 million for the three-months ended July 31, 2024. The increase reflected greater investment in sequencing and related costs to develop our data licensing platform. Sales and marketing expense for the three-months ended July 31, 2025 was $1.9 million, an increase of $176,000, or 10.5%, compared to $1.7 million for the three-months ended July 31, 2024. The increase was related to compensation expense to support the growth of our data license business. General and administrative expense for the three-months ended July 31, 2025 was $2.6 million, an increase of $43,000, or 1.7%, compared to $2.5 million for the three-months ended July 31, 2024 driven primarily from an increase in IT related costs.

Net cash provided by operating activities was approximately $600,000 for the quarter, supported by receivables conversion and normal working capital activity, partially offset by a quarterly net loss. Net cash used in investing activities for the three-months ended July 31, 2025 was approximately $46,000 for lab and computer equipment. Net cash used in financing activities for the three-months ended July 31, 2025 was $14,000 resulting from financing lease payments slightly offset by proceeds from options exercises.

The Company ended the quarter with cash on hand of approximately 10.3 million and no debt, providing us with a strong balance sheet and financial flexibility.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its third quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 261008, or provide the verbal reference "Champions Oncology".

On September 15, 2025, BullFrog AI Holdings, Inc. (the "Company") reported to have entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement"), with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which Lincoln Park committed to purchase up to $10.0 million of the Company’s common stock, par value $0.00001 per share (the "Common Stock"), subject to certain limitations and satisfaction of the conditions set forth in the Purchase Agreement (Filing, 8-K, Bullfrog AI, SEP 15, 2025, View Source [SID1234655993]).

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Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $10.0 million of the Company’s Common Stock (the "Purchase Shares"). Such sales of Common Stock by the Company, if any, will be subject to certain limitations set forth in the Purchase Agreement, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the date that the conditions to Lincoln Park’s purchase obligation set forth in the Purchase Agreement are satisfied, including that a registration statement covering the resale by Lincoln Park of shares of Common Stock that have been and may be issued to Lincoln Park under the Purchase Agreement, which the Company agreed to file with the U.S. Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC (the date on which all of such conditions are satisfied, the "Commencement Date").

From and after the Commencement Date, provided the last closing sale price of Common Stock is not below $0.50 at or immediately prior to the time of sale, the Company may, by written notice, direct Lincoln Park to purchase up to 30,000 shares of our Common Stock, which amount may be increased depending on the last closing sale price of Common Stock at or immediately prior to the time of sale, subject to a maximum commitment of $500,000 on such business day (or the purchase date) at a purchase price per share that will be determined in accordance with the Purchase Agreement at the time the Company delivers such written notice to Lincoln Park (a "Regular Purchase"). The purchase price per share for each Regular Purchase will be based on prevailing market prices of the Common Stock at or prior to the time of sale as computed in accordance with the terms set forth in the Purchase Agreement. There are no upper limits on the price per share that Lincoln Park must pay for shares of Common Stock under the Purchase Agreement.

If the Company directs Lincoln Park to purchase the maximum number of shares of Common Stock that the Company may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, the Company may direct Lincoln Park to purchase additional shares of Common Stock in an "accelerated purchase" (each, an "Accelerated Purchase") and an "additional accelerated purchase" (each, an "Additional Accelerated Purchase") (including multiple Additional Accelerated Purchases on the same trading day) as provided in the Purchase Agreement. The purchase price per share for each Accelerated Purchase and Additional Accelerated Purchase will be based on market prices of the Common Stock on the applicable purchase date for such Accelerated Purchases and such Additional Accelerated Purchases.

The Company will control the timing and amount of any sales of Common Stock to Lincoln Park pursuant to the Purchase Agreement. Lincoln Park has no right to require the Company to sell any shares of Common Stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to certain conditions set forth in the Purchase Agreement.

Actual sales of shares of Common Stock to Lincoln Park will depend on a variety of factors to be determined by the Company from time to time, including, among others, general market conditions, the trading price of the Company’s Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park. The Company expects that any proceeds received by the Company from such sales to Lincoln Park will be used for working capital, capital expenditures and general corporate purposes.

In the case of Regular Purchases, Accelerated Purchases and Additional Accelerated Purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute the purchase price.

The aggregate number of shares that the Company can sell to Lincoln Park under the Purchase Agreement may in no case exceed 2,048,936 shares (subject to adjustment as described above) of the Common Stock (which is equal to 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the Purchase Agreement) (the "Exchange Cap"), unless (i) stockholder approval is obtained to issue Purchase Shares above the Exchange Cap, or (ii) at the time the Company has issued shares of Common Stock equal to the Exchange Cap and at all times thereafter, the average price per share of Common Stock for all shares of Common Stock sold by the Company to Lincoln Park under the Purchase Agreement equals or exceeds $1.4053 per share (which represents the lower of (A) the official closing price of our Common Stock on Nasdaq on the trading day immediately preceding the date of the Purchase Agreement and (B) the average official closing price of our Common Stock on Nasdaq for the five consecutive trading days ending on the trading day immediately preceding the date of the Purchase Agreement, in each case as adjusted under applicable Nasdaq rules to take into account the issuance of shares of Common Stock to Lincoln Park for non-cash consideration as payment of the commitment fee described below so that the Exchange Cap limitation would not apply to issuances and sales of Common Stock under the Purchase Agreement pursuant to the rules and regulations of Nasdaq).

In all cases, the Purchase Agreement also prohibits the Company from directing Lincoln Park to purchase any shares of Common Stock if those shares, when aggregated with all other shares of Common Stock then beneficially owned by Lincoln Park (as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder), would result in Lincoln Park beneficially owning more than 4.99% of the then total outstanding shares of Common Stock.

There are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or Registration Rights Agreement, except the Company is prohibited (with certain specified exceptions set forth in the Purchase Agreement) from effecting or entering into an agreement to effect an "equity line of credit" or other substantially similar offering whereby an investor is irrevocably bound to purchase securities over a period of time from the Company at a price based on the market price of the Common Stock at the time of each such purchase. Lincoln Park has agreed not to engage in or effect, directly or indirectly, for its own principal account or for the principal account of any of its affiliates, any short sales of the Common Stock or hedging transaction that establishes a net short position in the Common Stock during the term of the Purchase Agreement.

Pursuant to the terms of the Purchase Agreement, the Company will issue 147,682 shares of Common Stock (the "Commitment Shares") to Lincoln Park as consideration for its commitment to purchase shares of Common Stock under the Purchase Agreement.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time with one business day notice, at no cost or penalty. Following the Commencement Date, if any "Suspension Event", as defined in the Purchase Agreement, occurs, Lincoln Park does not have the right to terminate the Purchase Agreement; however, the Company may not initiate any regular or other purchase of shares by Lincoln Park, until such Suspension Event is cured.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are summaries and are qualified in their entirety by reference to the full texts of the Purchase Agreement and Registration Rights Agreement, which are filed as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K and incorporated herein by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

This current report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of common stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.