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])

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 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported an update on recent progress with its IMNN-001 development program for the treatment of newly diagnosed advanced ovarian cancer, including a review of positive data from the Company’s Phase 2 OVATION 2 Study and the minimal residual disease (MRD) study conducted in partnership with Break Through Cancer. The program will also include updates on trial activation and patient enrollment in the Company’s ongoing Phase 3 OVATION 3 pivotal trial.

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"IMNN-001 represents a potential landmark breakthrough in the treatment of newly diagnosed ovarian cancer in combination with standard of care chemotherapy. Data thus far indicate that our novel immunotherapy has the potential to represent a major advance in treatment that can make a meaningful difference in the lives of thousands of women," said Stacy Lindborg, Ph.D., President and CEO of IMUNON. "No other frontline ovarian cancer treatment has shown improvement in overall survival, which of course is the ultimate goal. We are very encouraged to see results from our Ovation 2 Study demonstrate that IMNN-001 treatment plus chemotherapy is associated with a 13-month improvement in overall survival with a highly favorable benefit-risk profile. The results from this landmark trial strongly support the advancement of IMNN-001 into our Phase 3 trial. We are excited to share the latest updates in today’s event and to review what’s ahead for this program."

R&D Day Featured Speakers and Program Highlights:

Premal H. Thaker, M.D., Washington University School of Medicine, will discuss the significant continuing unmet needs in ovarian cancer, a devastating disease where patient outcomes and frontline standard of care treatment have not changed for about 30 years, and the promise IMNN-001 brings to these patients and clinicians. She will highlight the data from the Phase 2 OVATION 2 clinical trial, with results including:
Broad impact observed with IMNN-001 treatment on important cancer-fighting cytokines, effectively turning the tumor microenvironment from "cold" to "hot" by activating both innate and adaptive immune systems, renewing the elusive promise of an immunotherapy for ovarian cancer.
Data reinforcing the highly favorable benefit-risk and safety profile of IMMN 001.
The remarkable median 13-month overall survival (OS) benefit observed with IMNN-001 plus standard of care (SoC) chemotherapy, an increase that is considered clinically meaningful compared to SoC alone.
Amir Jazaeri, M.D., University of Texas MD Anderson Cancer Center, will discuss safety, tolerability and translational insights from the Phase 2 MRD study of IMNN-001, including:
Rationale for the trial and the importance of frontline therapy as the best opportunity to achieve a cure for ovarian cancer.
New translational data that clearly show IMNN-001 preferentially being taken up by macrophages within the peritoneal fluid and tumor tissue, which then induces a robust response and tumor microenvironment remodeling.
New data further supporting the highly favorable benefit-risk and tolerability profile of IMNN-001.
The positive tolerability profile of IMNN-001, including in combination with SoC chemotherapy plus bevacizumab and in the maintenance setting.
Giorgio Paulon, Ph.D., Berry Consultants, LLC, will review the Phase 2 and ongoing Phase 3 trial designs and the strength of evidence for IMNN-001 from a statistical perspective. He will highlight the well-precedented nature of the Phase 3 design with the FDA, which leverages an innovative, adaptive, event-driven approach aligned with prior successful oncology trials that resulted in full approval by FDA based on interim analyses of overall survival. This foundation, supported by conservative power assumptions drawn from Phase 2 data, strong simulation modeling and robust statistical properties, underpins the Phase 3 trial’s high probability for success.

Douglas V. Faller, M.D., Ph.D., IMUNON, will share new data further demonstrating that IMNN-001 shifted the balance in favor of immune stimulation, remodeling the tumor microenvironment in favor of anti-tumor responses, which is established to be associated with better prognosis. He will share the rapid progress to-date on the Phase 3 trial of IMNN-001, including expansion to additional sites and enrollment exceeding the Company’s expectations, strong levels of support and interest from investigators and the scientific community, and key clinical and other milestones for the company moving forward.
A live webcast of the event and presentation materials will be available on the "Scientific Presentations" page of the IMUNON website at View Source

(Press release, IMUNON, NOV 10, 2025, View Source [SID1234659716])

On November 10, 2025 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported management will participate at the following conferences in November.

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Guggenheim 2nd Annual Healthcare Innovation Conference
Fireside Chat: Tuesday, November 11, 2025, at 3:00 p.m. EST

Jefferies London Healthcare Conference
Fireside Chat: Wednesday, November 19, 2025, at 3:30 p.m. GMT

Where relevant, the presentations will be webcast live and can be accessed by visiting ‘Events & Presentations’, under ‘Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentations will be made available for a limited time.

(Press release, Immunocore, NOV 10, 2025, View Source [SID1234659715])

On November 10, 2025 Genmab A/S (Nasdaq: GMAB) ("Genmab") reported that it and its wholly owned subsidiary Genmab Finance LLC ("Genmab Finance") intend to offer, subject to market and other conditions, $1.5 billion of senior secured notes due 2032 (the "Secured Notes") and $1.0 billion of senior unsecured notes due 2033 (the "Unsecured Notes," and together with the Secured Notes, the "Notes").

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Genmab also launched the syndication of a new $2.0 billion senior secured term loan "B" facility, which term loan "B" facility is in addition to a $1.0 billion senior secured term loan "A" facility and $500 million senior secured revolving credit facility (collectively, the "New Credit Facilities") that Genmab previously syndicated to certain lenders as part of the financing for the pending acquisition (the "Acquisition") of Merus N.V. ("Merus").

Genmab intends to use the net proceeds from this offering of the Notes, together with borrowings under the New Credit Facilities and cash on hand, to fund the consideration payable in connection with the Acquisition of Merus and related fees and expenses in connection with the Acquisition, the borrowings under the New Credit Facilities and the issuance of the Notes.

Prior to the Acquisition closing, the Notes and the related guarantees from Genmab subsidiaries will be secured solely by segregated securities accounts of Genmab in which the gross proceeds of the Notes will be held. Following the purchase of all Merus common shares tendered in the previously announced tender offer by Genmab, the Secured Notes will be secured by a first priority security interest in certain assets of Genmab and its subsidiaries that will guarantee the obligations under the New Credit Facilities, in accordance with certain customary practices in the relevant jurisdictions, and subject to certain thresholds, exceptions and permitted liens. The Secured Notes will be unconditionally guaranteed on a senior secured basis and the Unsecured Notes will be unconditionally guaranteed on a senior unsecured basis by certain subsidiaries of Genmab that will guarantee the obligations under the New Credit Facilities.

The indentures governing the Notes are expected to contain customary covenants that, among other things, restrict, with certain exceptions, the ability of each of Genmab and its subsidiaries to incur additional debt, pay dividends, make certain other restricted payments, incur debt secured by liens, dispose of assets, engage in consolidations and mergers or sell or transfer all or substantially all of its assets.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other securities laws and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements of or in a transaction not subject to the Securities Act and any state or other applicable securities laws. Accordingly, the offering of the Notes is available only to persons who are either (1) reasonably believed to be "qualified institutional buyers" as defined in Rule 144A under the Securities Act or (2) non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act. The Notes will be subject to restrictions on transferability and resale and may not be transferred or resold except in compliance with the registration requirements of the Securities Act or pursuant to an exemption therefrom and in compliance with any state or other applicable securities laws.

This announcement shall not constitute an offer to sell or a solicitation of an offer to purchase any securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. The offering of the Notes may be made only by means of an offering memorandum.

(Press release, Genmab, NOV 10, 2025, View Source [SID1234659714])