On November 10, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), with no further comments, clearing the trial to proceed.

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The planned confirmatory Phase 3 trial, TELLOMAK 3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sézary syndrome post-mogamulizumab treatment randomized 1:1 to receive lacutamab or romidepsin, and one enrolling patients with Mycosis fungoides randomized 1:1 to receive lacutamab or mogamulizumab. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review.

Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. With this feedback from FDA, the Company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK 3 trial in H1 2026. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, once the Phase 3 trial is underway.

"This important regulatory milestone with the FDA marks a key step forward for the lacutamab program," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "Building on robust Phase 2 data from TELLOMAK, this milestone brings us one step closer to our next goal, submitting for accelerated approval in Sézary syndrome once the Phase 3 trial is underway. We remain deeply committed to advancing this differentiated therapy for patients with CTCL, while creating meaningful value for our shareholders."

"We are pleased to reach this important milestone for the lacutamab program as we prepare to initiate the confirmatory Phase 3 study, TELLOMAK 3," said Sonia Quaratino, Chief Medical Officer of Innate Pharma. "The efficacy and safety data from the TELLOMAK Phase 2 trial suggest that lacutamab has the potential to be a game changer in the treatment of CTCL, an orphan disease with a high unmet medical need. Our expert clinical team looks forward to collaborating with CTCL investigators and regulators to start the Phase 3 trial in due time."

About lacutamab

Lacutamab is a first-in-class anti-KIR3DL2 antibody, currently developed in cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). CTCL is a group of rare non-Hodgkin’s lymphomas that develop in the skin and severely affect patients’ quality of life. Sezary syndrome (SS) is a rare and aggressive leukemic form with poor survival, while mycosis fungoides (MF) is the most common subtype, with advanced stages associated with poor outcomes.

Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome.

(Press release, Innate Pharma, NOV 10, 2025, View Source [SID1234659717])

On November 10, 2025 Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported financial results for the third quarter ended September 30, 2025, and provided a review of recent accomplishments and anticipated upcoming developments.

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Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "Biohaven remains energized and focused on our mission to advance innovative medicines to patients who are waiting every day for new treatments. Our pipeline consists of multiple novel approaches for unmet medical needs and has the potential to deliver paradigm shifting treatments for conditions such as epilepsy, autoimmune disease, obesity, depression and cancer. We are particularly excited about the continued progress across our key programs and clinical-stage assets including: MoDE and TRAP degrader programs, where our two lead assets, BHV-1300 and BHV-1400, show compelling evidence to change the treatment paradigm in immune-mediated diseases; opakalim, a novel Kv7 ion channel activator, for the treatment of epilepsy and depression; and taldefgrobep alfa, myostatin-activin targeting therapy for obesity and SMA."

Dr. Coric continued, "Our late-stage clinical programs are poised to transform their respective treatment paradigms, given their novel mechanistic foundations and the body of clinical and non-clinical data generated to date. Our redirected approach to ‘right-sizing’ innovation is an important step we have undertaken to ultimately drive growth and resources to the most critical areas of our business. With this thoughtful approach to rebalancing our portfolio, we believe Biohaven remains well-positioned to execute on our commitment to transforming the treatment landscape for patients with serious and underserved diseases and we remain unwaveringly committed to delivering on our promise to advance our programs for patients, families, and shareholders in the balance of the year and in the years ahead. We will also continue to provide updates on any progress determining a path forward in SCA."

Third Quarter 2025 and Recent Business Updates

Initiated strategic cost optimization efforts across portfolio to focus forward-looking spend on three value-driving, late-stage clinical programs that will prioritize resources:
Opakalim, Kv7 ion channel activator, in pivotal studies for focal epilepsy and depression;
Lead TRAP and MoDE extracellular degraders for IgA nephropathy (BHV-1400) and Graves’ disease (BHV-1300);
Taldefgrobep alfa, myostatin-activin pathway inhibitor, for obesity and spinal muscular atrophy.
Restructuring of business priorities and optimizing resource allocation may result in either pause, delay or halting of non-priority programs.
The cost optimization efforts are expected to achieve an approximately 60% reduction in annual direct R&D spend (which excludes personnel and share-based compensation).
Expected Upcoming Milestones:

We believe Biohaven is well positioned to achieve significant, value-creating milestones in 2025 and 2026 across numerous programs:

Kv7 Activator (Opakalim):

Deliver top-line results from Phase 2 study in major depressive disorder study in 4Q 2025.
Continue two Phase 2/3 studies in focal epilepsy with initial top-line results expected in 1H 2026.
Lead TRAP and MoDE Extracellular Degraders (BHV-1400 and BHV-1300)

Continue enrollment of patients with IgAN and Graves’s disease in expanded Phase 1b and advance to pivotal studies in IgAN and Graves’ disease.
Myostatin-Activin Pathway Inhibitor (Taldefgrobep alfa):

Initiate Phase 2 clinical trial in obesity in 4Q 2025.Continue ongoing Health Authority interactions to discuss SMA registrational path in the US and Europe.
Glutamate Modulator (VYGLXIA):

We requested a Type A meeting with FDA as part of initiating an appeal process for the SCA CRL and plan to meet with the FDA to discuss potential next steps.
Capital Position:

Cash, cash equivalents, marketable securities and restricted cash as of September 30, 2025, totaled approximately $263.8 million.

Third Quarter 2024 Financial Highlights:

Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $141.2 million for the three months ended September 30, 2025, compared to $157.6 million for the three months ended September 30, 2024. The decrease of $16.4 million was primarily due to decreases in direct program spend, largely related to BHV-2000 and opakalim, which were partially offset by increased personnel costs including non-cash share-based compensation, as compared to the same period in the prior year. Non-cash share-based compensation expense was $13.9 million for the three months ended September 30, 2025, an increase of $6.8 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025.

General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $28.2 million for the three months ended September 30, 2025, compared to $20.6 million for the three months ended September 30, 2024. The increase of $7.7 million was primarily due to increased non-cash share-based compensation expense and increased legal costs. Non-cash share-based compensation expense was $7.6 million for the three months ended September 30, 2025, an increase of $2.6 million as compared to the same period in 2024. Non-cash share-based compensation expense was higher in 2025 primarily due to our annual equity incentive awards granted in the first quarter of 2025.

Other (Expense) Income, Net: Other (expense) income, net was other expense, net of $3.8 million for the three months ended September 30, 2025, compared to other income, net of $17.8 million for the three months ended September 30, 2024. The decrease of $21.6 million was primarily due to an increase in non-cash losses related to changes in fair value of our notes payable liability under the Note Purchase Agreement with Beetlejuice SA LLC, an affiliate of Oberland Capital Management LLC, entered into during the second quarter of 2025 (the Note Purchase Agreement), a decrease in gains recorded for the non-cash changes in the fair value of our forward contracts and derivative liabilities recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment), and decreased investment income.

Net Loss: Biohaven reported a net loss for the three months ended September 30, 2025 of $173.4 million, or $1.64 per share, compared to $160.3 million, or $1.70 per share, for the same period in 2024. Non-GAAP adjusted net loss for the three months ended September 30, 2025 was $155.9 million, or $1.47 per share, compared to $164.1 million, or $1.74 per share, for the same period in 2024. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.

(Press release, Biohaven Pharmaceutical, NOV 10, 2025, View Source [SID1234659737])

On November 10, 2025 Assertio Holdings reported financial results for the third quarter ended September 30, 2025.

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Mark Reisenauer, Chief Executive Officer, stated: "In the third quarter we achieved financial results that position us to achieve our full-year 2025 guidance. We also advanced key integration efforts to consolidate operations and align products – including Rolvedon – under a single commercial entity, Assertio Specialty Pharmaceuticals, which will enable greater efficiency, stronger company recognition, and ultimately cost savings. With our solid balance sheet and the potential of our key assets, we are well positioned for the future. I look forward to detailing additional elements of our strategy soon."

Third Quarter 2025 Financial and Operating Highlights

Rolvedon net product sales were $38.6 million for the third quarter of 2025, up from $15.0 million in the prior-year quarter. This reflects both normal demand and large purchases by several national distributors to help ensure consistent supply of Rolvedon over the next two quarters as we complete the integration. Assertio maintained a leading market share in its chosen segment and expects uninterrupted patient supply, with regular sales of the newly labeled Rolvedon beginning in the second quarter of 2026.
Sympazan net product sales grew to $2.8 million for the third quarter of 2025, up from $2.6 million in the prior-year quarter, driven by higher volume, partially offset by the impact of payor mix.
Indocin net product sales were $4.8 million for the third quarter of 2025, down from $5.7 million in the prior-year quarter, reflecting expected volume and pricing impacts from previously announced generic competition.
Gross margin1 was 72%, compared to 74% in the prior-year quarter, primarily due to a higher proportion of Rolvedon sales.
SG&A expenses were $16.9 million, up slightly from $16.7 million in the prior-year quarter, reflecting non-recurring costs related to the decommercialization of Otrexup, partially offset by lower legal expenses following completion of litigation-related initiatives.
Adjusted EBITDA2 was $20.9 million for the third quarter of 2025, up from $4.4 million in the prior-year quarter, driven primarily by higher Rolvedon net product sales.
Cash, cash equivalents, and short-term investments totaled $93.4 million as of September 30, 2025, compared to $98.2 million as of June 30, 2025, reflecting working capital impacts from the Rolvedon sell-in, including higher accounts receivable and gross-to-net liabilities. As these balances normalize over the next two quarters, the timing of related cash collections and payments is expected to result in a temporary decline in cash before increasing in the second quarter.

(Press release, Assertio Holdings, NOV 10, 2025, View Source [SID1234661831])

On November 10, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payloads for antibody drug conjugates (ADCs), reported the presentation of immune mechanism-of-action data for its novel ADC payload, PH1. The Company will host a live webcast to discuss the presented data on Tuesday, November 18th (details below).

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The abstract titled,A Novel Splicing-Targeted ADC Payload Drives Immune Activation, Synergy with Checkpoint Inhibitors, and Enhanced Therapeutic Potential Beyond Cytotoxicity was presented in oral and poster presentations at the recently held 40th Annual SITC (Free SITC Whitepaper) Meeting by Satyajit Mitra Ph.D., Executive Director, Head of Oncology at Akari Therapeutics.

Dr. Mitra commented, "We were excited to showcase the unique mechanism of action of our novel ADC payload PH1 at the annual meeting for SITC (Free SITC Whitepaper), a premier global immunotherapy conference. It’s not often that one gets to introduce a novel ADC payload class with the unique data we presented. I was thrilled to see our work being received extremely well and the excitement from colleagues to see further clinical development of the PH1 payload as Akari continues to advance its lead ADC molecule, a Trop2 PH1 ADC."

The presented data outlined Akari’s investigation of multiple mechanisms behind preclinical colon tumor regressions induced by a Trastuzumab PH1 ADC as a single agent or in combination with an anti-PD-1 therapy compared to a first-in-class ADC with a microtubule inhibitor payload, Kadcyla, tested also as a monotherapy or in combination with anti-PD1 therapy. A higher rate of complete tumor regressions was seen with Trastuzumab PH1 combined with anti-PD1 therapy (74%) when compared to Kadcyla, combined with anti-PD1 therapy (42%), with statistical significance of p < 0.05. These differentiated results are attributed to a multi-faceted immune response activated by neoantigens induced by the PH1 payload’s ability to disrupt normal RNA splicing. These neoantigens likely trigger the observed multi-modal immune response including a polarization of macrophages to the pro-inflammatory phenotype, an increase in the presence of neutrophils, and importantly, expansion of both B cell clones to produce polyclonal IgM antibodies, and gamma-delta T-cell clones. Notably, these immune system responses were not as prominent in the comparator test arm utilizing Kadcyla, in combination with anti-PD1 therapy. Importantly, these Trastuzumab PH1 results also highlight a synergy between the PH1 ADC payload and the anti-PD1 checkpoint inhibitor. The induction of gamma-delta T-cells by the combination of Trastuzumab PH1 and anti-PD1 is particularly interesting because this subpopulation of T-cells is known to attack cancer through a rapid response and has high cytotoxic activity.

Key Highlights:

Payload diversification is key in the current ADC landscape dominated by 2 ADC payload classes, microtubule inhibitors, and topoisomerase inhibitors.
A payload that disrupts the actions of the spliceosome demonstrates multiple modes of actions to attack cancer, including cytotoxicity and broad immuno-oncology effects.
An ADC of Trastuzumab PH1 induces RNA mis-splicing and subsequently increases neoantigen generation in cancer cells and a subsequent increase in anti-cancer immune cells in the tumor microenvironment.
Trasutuzmab-PH1 in combination with an anti-PD1 agent outperformed Kadcyla in combination with an anti-PD1 agent in complete tumor regressions with statistical significance (74% vs. 42%, p < 0.05) in an immune-competent, HER2-positive colon cancer model.
When combined with anti-PD1 therapy, the MOAs of the two agents complemented each other: Trastuzumab PH1 increased neoantigens, driving an increase in pro-inflammatory macrophages, an increase in pro-inflammatory neutrophils, and the expansion of B cells and resulting IgM antibodies. The anti-PD1 therapy specifically expanded alpha-beta T cell clones as expected, and together, the combination of both therapies drove the unique expansion of gamma-delta T cell clones. The synergy of the Trastuzumab PH1+ anti-PD-1 agent is likely due to each agent’s unique and complementary impact on the immune system.

These unique results seen with both the single agent ADC Trastuzumab-PH1 and the combination therapy with an anti-PD1 agent open up the possibility of creating a new paradigm of an ADC/checkpoint inhibitor therapy that goes beyond today’s regimens using ADCs with traditional payloads. This new potential combination of ADC’s using the PH1 payload with checkpoint inhibitors has the opportunity to set a new standard of care, and the chance to dramatically improve outcomes for cancer patients.

Utilizing its innovative ADC payload platform, Akari is advancing a new class of immuno-oncology ADCs built on the platform of a novel PH1 payload. This payload is designed specifically to target and disrupt the action of the spliceosome and has a unique preclinical efficacy and safety profile with the potential to address an unmet need for oncology patients as a monotherapy or used in combination with checkpoint inhibitors. Akari’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells with a proprietary linker and delivers its novel PH1 payload directly into the tumor. Akari is currently initiating IND-enabling studies with the plan to advance this lead ADC into clinical trials in the near future. For more information, visit www.akaritx.com.

Webcast Details

Members from the Akari management team will host a live webcast to discuss the presented data for investors, analysts and other interested parties on Tuesday, November 18, 2025 at 11:00 AM ET.

Interested participants can access the webcast here or on the Presentations page under the Investors section of the Company’s website, akaritx.com. A replay of the webcast will be accessible two hours after the live event and archived for 90 days.

(Press release, Akari Therapeutics, NOV 10, 2025, View Source [SID1234659702])

On November 10, 2025 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported its financial results for the third quarter of 2025 and provided an update on recent company developments.

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"I’m very pleased to report that we’ve completed the rolling submission of our BLA for lead candidate INO-3107. We believe every patient deserves a treatment that reduces exposure to surgery and INO-3107 has the potential to meet that significant need in the RRP community. The majority of patients in our Phase 1/2 trial needed fewer surgeries after treatment and showed continued improvement through Year 2 without additional doses, and without surgical interventions during the treatment window to maintain minimal residual disease as required by other treatment modalities," said Dr. Jacqueline Shea, INOVIO’s President and Chief Executive Officer. "As INOVIO works toward a potential approval for INO-3107 in mid-2026, we’re also working to advance our next generation DNA medicine candidates. Landmark proof-of-concept data on our DMAb technology was recently published in Nature Medicine and we are preparing for an upcoming presentation of promising pre-clinical data from our DNA-encoded protein technology (DPROT) at the World Federation of Hemophilia Global Forum. We look forward to sharing more on the company’s progress in the coming months."

Operational Highlights

INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
INOVIO completed the rolling submission of its BLA for DNA immunotherapy candidate INO-3107 for the treatment of RRP in adults. INOVIO submitted the BLA under the FDA’s accelerated approval program and has requested a priority review, which if granted, is expected to be completed within six months following file acceptance. Commercial preparations continue to advance for a potential launch in mid-2026. If approved, INO-3107 would be INOVIO’s first commercial product and the first DNA medicine available in the United States.

INOVIO plans to conduct a confirmatory trial and expects to begin enrolling patients during the BLA review period. The trial is expected to be conducted at approximately 20 sites across the United States.

Peer-reviewed data from a retrospective study (RRP-002) investigating the long-term clinical and safety response of patients treated with INO-3107 were published online in The Laryngoscope. The data demonstrate that a majority of patients experienced continued improvement beyond the initial 12-month study period of the previously published Phase 1/2 trial (RRP-001), as measured by the number of surgical procedures needed after treatment with INO-3107. Since our last report, INOVIO has also presented key data at several scientific conferences, including the American Academy of Otolaryngology – Head and Neck Surgery Annual Meeting, the European Society for Medical Oncology Annual Congress, and the 37th International Papillomavirus Society Conference. Highlights from the data include:
•81% (26/32) of patients experienced a reduction of one or more surgeries at Year 1 post-treatment
•By the end of Year 2, 91% (21/23) of evaluable patients continued to experience a reduction of one or more surgeries. Only two patients had not yet responded to treatment with INO-3107
•INO-3107 demonstrated continued clinical benefit, with a persistent decline in the mean number of surgeries through Year 2 post-therapy: A 78% reduction in mean annual surgeries was seen at Year 2 compared to the 1 year pre-treatment period (0.9, n=28 vs 4.1, n=32)
•Clinical response was not dependent upon low viral loads, molecular subtype or other elements of the papilloma microenvironment

Next Generation DNA Medicine Candidates
Results from a Phase 1 proof-of-concept trial evaluating next generation DMAbs for COVID-19 were published online in Nature Medicine, demonstrating the technology’s potential as a long-acting, scalable and tolerable alternative to traditional monoclonal antibody therapies. Interim pharmacokinetic results were previously available as a preprint on Research Square. The study is being led by The Wistar Institute in collaboration with INOVIO, AstraZeneca, and clinical investigators at the Perelman School of Medicine at the University of Pennsylvania.

This was the first demonstration that monoclonal antibodies, complex proteins, can be durably and tolerably expressed in humans. INOVIO is building on this research to evaluate in vivo therapeutic protein production and will be presenting promising preclinical data from its DPROT program at the upcoming World Federation of Hemophilia Global Forum. This technology aims to address some of the shortcomings of conventional therapeutic protein replacement treatments including gene therapy approaches.

General Corporate
INOVIO remains focused on financial discipline and directing resources to advance the INO-3107 program towards commercialization and a potential launch date in mid-2026.

Third Quarter 2025 Financial Results

•Research and Development (R&D) Expenses: R&D expenses for the three months ended September 30, 2025, decreased to $13.3 million from $18.7 million for the same period in 2024. The decrease was primarily the result of lower drug manufacturing, clinical study and other expenses related to INO-3107 and lower expensed inventory, among other variances.

•General and Administrative (G&A) Expenses: G&A expenses decreased to $7.9 million for the three months ended September 30, 2025, from $8.6 million for the same period in 2024. The decrease was primarily related to a decrease in employee and consultant compensation, including stock-based compensation, among other variances.

•Total Operating Expenses: Total operating expenses decreased to $21.2 million for the three months ended September 30, 2025, from $27.3 million for the same period in 2024.

•Net Loss: Net loss for the three months ended September 30, 2025, increased to $45.5 million, or $0.87 per basic and diluted share, from a net loss of $25.2 million, or $0.89 per basic and diluted share, for the three months ended September 30, 2024.

The increase in net loss for the period was primarily driven by a $22.5 million non-cash loss on fair value adjustment related to our warrant liabilities. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss.

The loss from operations prior to other income (expenses) for the quarter ended September 30, 2025, was $21.2 million, or $0.41 per share, as compared with $27.3 million, or $0.97 per share, for the quarter ended September 30, 2024.

•Shares Outstanding: As of September 30, 2025, INOVIO had 53.6 million common shares outstanding and 94.5 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting, and conversion, as applicable, of its outstanding common stock warrants, stock options, restricted stock units and convertible preferred stock.

•Cash, Cash Equivalents and Short-term Investments: As of September 30, 2025, cash, cash equivalents and short-term investments were $50.8 million, compared to $94.1 million as of December 31, 2024.

INOVIO’s balance sheet and statement of operations are provided below. Additional information is included in INOVIO’s quarterly report on Form 10-Q for the quarter ended September 30, 2025, which can be accessed at: View Source

Cash Guidance

INOVIO estimates its current cash, cash equivalents and short-term investments balances will support the company’s operations into the second quarter of 2026. This projection includes an operational net cash burn estimate of approximately $22 million for the fourth quarter of 2025. These projections do not include any further capital-raising activities that INOVIO may undertake.

Conference Call / Webcast Information
INOVIO’s management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source

(Press release, Inovio, NOV 10, 2025, View Source [SID1234659718])