On November 6, 2026 Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a precision guided, biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, reported financial results for the three and nine months ended September 30, 2026, and provided a business update highlighting capital efficient strategic, clinical and regulatory progress across its development portfolio.

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During the third quarter of 2026, Medicus entered into a co-development and license agreement with Pfizer Inc. ("Pfizer") for PF-08046031 (CD228V), a clinical-stage antibody-drug conjugate (ADC) targeting melanotransferrin, or CD228. The Company subsequently designated CD228V as its principal development priority, with an initial focus on establishing clinical proof-of-concept in melanoma.

During and after the quarter, the Company achieved several important milestones, including the announcement of an exclusive development focus for SkinJect in Gorlin syndrome and the submission of an optimized Teverelix registrational protocol to the FDA for advanced prostate cancer. On November 4, 2026, Medicus announced a non-binding LOI (as defined below) for a proposed Business Combination (as defined below) between SkinJect and an undisclosed special purpose acquisition company. In addition, following the Share Consolidation (as defined below), the Company regained compliance with Nasdaq’s minimum bid price requirement.

During the quarter and on an ongoing basis, the Company has highlighted a capital-efficient portfolio strategy, which combines focused development of CD228V with essential support for SkinJect and Teverelix as partner-ready therapeutic programs. The Company is allocating resources to maintain these programs and keep their development packages current while pursuing the proposed SkinJect Business Combination and strategic partnerships for Teverelix.

Management Commentary

"The third quarter saw the transformation of Medicus into a precision oncology-led biotech company with CD228V as our principal development priority," stated Dr. Raza Bokhari, Medicus Executive Chairman and CEO. "With capital-efficient allocation of resources, we remain focused on disciplined execution, regulatory excellence and strategic growth as we seek to build long-term shareholder value and advance therapies with the potential to improve patient outcomes."

Financial Highlights (Q3 2026)

As disclosed in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, financial results include:

Cash, cash equivalents and restricted cash: $13.1 million.
Cash and cash equivalents: $5.0 million (vs.$8.7 million as of December 31, 2025).
Total Operating expenses (loss from operations): $14.5 million (vs. $15.4 million in Q3 2025).
General and administrative expenses: $2.5 million (vs. $5.0 million in Q3 2025).
Research and development expenses: $2.0 million (vs. $1.7 million in Q3 2025).
Net loss: $15.2 million (vs. $16.0 million in Q3 2025).
Net loss per share*: $11.64 (vs. $56.18 in Q3 2025).
* Share and per share amounts for all periods have been retroactively adjusted to reflect the Company’s 50-to-1 share consolidation effective October 12, 2026 (the "Share Consolidation").

The Company’s complete unaudited financial statements and results of operations for the quarter ended September 30, 2026, are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 2026 (the "Form 10-Q").

Third Quarter 2026 and Subsequent Operational Highlights

During and after the third quarter, Medicus established its revised portfolio priorities. The following summarizes the key developments and current program status.

CD228V License and Co-Development:

Worldwide license. On September 2, 2026, the Company through its wholly owned subsidiary, Medicus Pharma Inc., entered into a co-development and licensing agreement with Pfizer providing an exclusive worldwide license to develop, manufacture and commercialize CD228V, subject to Pfizer’s retained rights and other contractual provisions. Under the agreement, the Company controls program execution under the co-development framework.
Clinical development focus. CD228V is a second-generation CD228-targeted ADC, utilizing Pfizer’s established vedotin linker-payload platform. Medicus intends to pursue initial proof-of-concept in relapsed, refractory or immunotherapy-resistant melanoma, supported by the existing U.S. investigational new drug application (IND) for CD228V and a first-in-human Phase 1 clinical study.
Pfizer participation. Pfizer provided $2.0 million in development funding and retains the right, without an obligation, to elect to fund all or part of development beginning with the first pivotal trial, subject to a further definitive agreement in respect of such arrangements.
SkinJect Proposed Business Combination and Gorlin Syndrome Development

On November 4, 2026, Medicus announced that its wholly owned subsidiary, SkinJect, Inc. ("SkinJect"), had entered a non-binding letter of intent ("LOI") with an undisclosed special purpose acquisition company ("SPAC") for a proposed business combination involving SkinJect(the "Business Combination").

Proposed valuation and financing. The LOI contemplates an approximate $135 million pre-money enterprise valuation for SkinJect as well as a concurrent equity financing at closing of the proposed Business Transaction to support the SKNJCT-005 study in Gorlin syndrome and preparation and submission of a potential New Drug Application ("NDA"). Clinical package and indication focus. In September, the Company announced an exclusive development focus on evaluating SkinJect in treating multiple basal cell carcinoma lesions in patients with Gorlin syndrome and concluded any further development in sporadic nodular BCC. The clinical study report for the completed SKNJCT-003 Phase 2 study was finalized that month, and, among other things, the Company believes that it provides a basis for potential partners to assess the next development program.
Study authorization. In July, the FDA issued a "Study May Proceed" letter for SKNJCT-005, the planned registrational Phase 2b study in Gorlin syndrome. The authorization permits initiation of the study under the existing IND. SkinJect remains investigational, and any NDA submission or approval would depend on clinical results and applicable regulatory requirements.
Designation applications. The FDA has held review of the Company’s Orphan Drug Designation and Rare Pediatric Disease Designation applications in abeyance pending receipt of additional information from the Company.
Teverelix Partner Ready Therapeutic Programs

The Company views Teverelix as a portfolio of partner-ready opportunities in urology, advanced prostate cancer and women’s health. Existing clinical work, regulatory engagement and proposed study designs provide defined programs for potential partners to evaluate. Medicus is allocating essential resources to maintain program readiness and keep development documentation current as it seeks partners with the capabilities and resources to advance these opportunities.

Advanced prostate cancer. On September 29, 2026, Medicus announced that it had submitted to the FDA a proposed seamless Phase 2b/3 registration-intent protocol for Teverelix for patients at increased cardiovascular risk. The design is expected to begin with approximately 80 randomized patients and, if predefined continuation criteria are met, enroll approximately 528 additional patients, for a total of approximately 608 patients. The proposal remains subject to FDA feedback and there can be no assurance that the FDA will agree with the proposed protocol. Medicus intends to seek an out-license or other strategic partnership rather than independently fund the proposed study; however, there can be no assurance that the Company will successfully enter into any such transaction.
Other Corporate Developments:

During and after the quarter, Medicus also advanced initiatives, aimed at fostering long-term growth and building shareholder value. Medicus and YA II PN, Ltd. ("Yorkville") mutually agreed to terminate the standby equity purchase agreement (the "SEPA") effective September 11, 2026. No borrowings, advance notices or shares to be issued remained outstanding under the SEPA at the time of its termination.

Following the Share Consolidation, Medicus announced on October 26, 2026, that it had received written notice from Nasdaq on October 23, 2026, confirming that the Company had regained compliance with the minimum bid price requirement.

Anticipated Clinical Development and Partnering Priorities

The Company intends to focus in the coming quarters on capital-efficiency and disciplined execution. Medicus is focused on concentrating incremental development investment on selected CD228V milestones. Essential resources will continue to support current clinical and regulatory documentation, manufacturing information and readiness activities as the Company pursues the proposed SkinJect Business Combination, including definitive agreements and concurrent financing, and strategic partnerships for Teverelix. There can be no assurance that definitive agreements will be signed, that the financing will be secured or that the Business Combination will be completed on favorable terms or at all.

(Press release, Medicus Pharma, NOV 6, 2026, View Source [SID1234674394])

On November 6, 2026 MaaT Pharma (EURONEXT: MAAT – the "Company"), a late-stage clinical biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported an update on the preliminary findings from the Phase 2a PICASSO clinical trial, an investigator-sponsored study conducted by AP-HP in collaboration with INRAe and Gustave Roussy evaluating MaaT013 (Xervyteg) in combination with immune checkpoint inhibitors (ipilimumab and nivolumab) in patients with advanced, unresectable or metastatic melanoma who had not previously received anti-CTLA-4, anti-PD-1 or anti-PD-L1 therapy.

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This communication follows the publication of study information in the EU Clinical Trials Information System (CTIS), as submitted by the PICASSO investigators. The findings reported here are derived exclusively from this CTIS disclosure and should not be considered a final scientific publication of the study results. Full results and analyses will be presented by the PICASSO investigators at a future scientific congress. Preliminary results are available here in CTIS.

Preliminary findings, based on currently available data extracted from the CTIS submission:

The study met its primary objective of assessing the safety and feasibility of adding MaaT013 (Xervyteg) to ipilimumab and nivolumab in treatment-naïve metastatic melanoma. No statistically significant difference was observed in the incidence of Grade 3 or higher adverse events between the two treatment arms.
Based on the currently available data, the safety profile observed with MaaT013 (Xervyteg) in combination with ipilimumab and nivolumab was generally consistent with the expected safety profile of the immunotherapy combination.
Response rates, a main secondary endpoint, were comparable in the MaaT013 (Xervyteg) and placebo arms and consistent with previously reported response rates for ipilimumab and nivolumab combination therapy.
Additional secondary endpoints were also assessed, including longitudinal microbiome and biomarker analyses.
Exploratory analyses suggest that baseline microbiome composition (i.e.: before treatment) may influence clinical response to MaaT013 (Xervyteg), warranting further investigation.
Treatment with MaaT013 (Xervyteg) was associated with significant increases in microbiome richness and diversity compared to placebo, confirming an effect of MaaT013 (Xervyteg).

"PICASSO provides important safety and feasibility-controlled data on the administration of a microbiome therapy in combination with immune checkpoint inhibitors," said Hervé Affagard, Chief Executive Officer and co-founder of MaaT Pharma. "These findings provide further insight into the importance of treatment setting and patient selection. Together with the planned microbiome analyses, they will help inform the immuno-oncology strategy as we continue to advance MaaT034 development in ICI-refractory patients."

A total of 70 patients were randomized across five centers in France. The analysis included 69 patients, with 34 patients in the MaaT013 (Xervyteg) arm and 35 patients in the placebo arm. The Company provided MaaT013 (Xervyteg) and placebo and generated shotgun metagenomic profiles of patients using its proprietary gutPrint research engine. The PICASSO trial (ClinicalTrials.gov: NCT04988841 and CTIS / EU Clinical Trial (EU CT) number: 2024-516100-42-00) is fully funded by the Directorate of Health Care Supply (DGOS: Direction Générale de l’Offre de Soins) and operated by the French National Cancer Institute (INCa: Institut National du Cancer) as part of a call for projects (project PHRC-K19-183).

(Press release, MaaT Pharma, NOV 6, 2026, View Source [SID1234674393])

On November 6, 2026 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 data from its Phase 1/2 trial evaluating brenetafusp alone and in combination with KIMMTRAK in HLA-A*02:01-positive patients with metastatic uveal melanoma (mUM), in a poster session at the 2026 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The data will also be presented in an oral session on Saturday, November 7, at 3:45 p.m. ET.

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KIMMTRAK and brenetafusp are ImmTAC molecules targeting gp100 and PRAME, respectively, with PRAME representing an established negative prognostic factor in mUM. KIMMTRAK is the first bispecific T cell receptor therapy to demonstrate survival benefit in a solid tumor and is the standard of care for HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma. Brenetafusp is an investigational candidate being evaluated in a range of tumors, including first-line cutaneous melanoma in the PRISM-MEL-301 Phase 3 trial. Adding brenetafusp to KIMMTRAK tests the hypothesis of whether the combination may improve outcomes in patients with HLA-A*02:01-positive mUM by increasing target engagement and enhancing T cell-mediated tumor killing.

"Immunocore continues to lead bispecific T cell engager innovation, having demonstrated the first overall survival benefit in metastatic uveal melanoma. We are now seeing the synergistic potential of combining two clinically active ImmTAC therapies. The 1- and 2-year overall survival data could be practice-changing, and I look forward to evaluating this combination in a randomized trial for patients with metastatic uveal melanoma," said Dr. Omid Hamid, Chief of Research & Immuno-Oncology, Co-Director, Cutaneous Malignancy Program at The Angeles Clinic & Research Institute.

"These encouraging Phase 1 data suggest combining brenetafusp with tebentafusp may offer a meaningful new option for HLA-A*02:01-positive patients with metastatic uveal melanoma," said Dr. Mohammed Dar, Executive Vice President, Clinical Development and Chief Medical Officer of Immunocore. "Building on our leadership with KIMMTRAK, we believe that targeting both gp100 and PRAME – a combined ImmTAC approach – offers the potential to deliver an even greater benefit for HLA-A*02:01-positive patients."

At the June 2026 data cut-off, 22 patients with mUM had received clinically active doses of brenetafusp monotherapy and 26 had received brenetafusp plus tebentafusp. The Company believes that this is the first data showing clinical activity and a manageable safety profile for a combination of two T cell engagers in a solid tumor.

Across the 17 evaluable first-line patients who received the combination, overall response rate (ORR) was 29% with a median duration of response (mDoR) of 24.1 months. The disease control rate (DCR) was 71% and median progression-free survival (mPFS) was 8.1 months. At the data cut-off, median overall survival (mOS) had not been reached at a median follow-up of 29 months. OS rates were 88% at one year and 70% at two years with 10 of the 17 patients remaining on study. The majority of patients with OS >2 years (64%; 7 out of 11) had received only the brenetafusp and tebentafusp combination.

In the 16 evaluable patients who received brenetafusp monotherapy in the second-line or later setting, ORR was 19%, mDoR 14.5 months, DCR 63%, mPFS 4.2 months, and mOS 20.3 months. OS rates were 63% at one year and 31% at two years.

The safety profile of brenetafusp as monotherapy and in combination with tebentafusp was generally well tolerated and consistent with that observed for the individual agents, with no new safety signals reported. The most frequent treatment-related adverse event (TRAE) was reversible and manageable cytokine release syndrome (CRS), observed in 77% of combination patients and 73% of monotherapy patients, with the majority being Grade 1 or 2 (no Grade 3/4 CRS for the combination and 5% Grade 3 CRS for brenetafusp monotherapy). Grade 3 or 4 TRAEs were reported in 38% of combination patients and 41% of monotherapy patients, with the most frequent being transient lymphocyte count decrease that resolved without intervention. No TRAE led to discontinuation or death in either group.

The data also demonstrated molecular responses for the combination. Out of the nine patients who were evaluable for ctDNA response, eight (89%) had a molecular response, and four (44%) achieved ctDNA clearance.

The Company is planning to start DUET-UVEAL, a randomized Phase 2/3 trial, to further evaluate the combination for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.

The data presented at SITC (Free SITC Whitepaper) come from an ongoing Phase 1/2 trial (NCT04262466; EudraCT 2019-004046-16) evaluating brenetafusp as monotherapy as well as in combination across a number of solid tumors, including HLA-A*02:01-positive patients with unresectable or metastatic uveal melanoma. Brenetafusp and tebentafusp were administered by weekly intravenous infusion with step-up dosing.

Presentation details

Title: Phase 1 evaluation of brenetafusp alone and in combination with tebentafusp in metastatic uveal melanoma (Abstract number: 1177)

Poster session: Poster Hall
Date and Time: Friday, November 6, 2026, 10:00 a.m. MST / 12:00 p.m. EST

Clinical oral abstract session: Session 2
Date and Time: Saturday, November 7, 2026, 1:45 p.m. MST / 3:45 p.m. EST

(Press release, Immunocore, NOV 6, 2026, View Source [SID1234674392])

On November 6, 2026 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 its financial results for the third quarter ended September 30, 2026, and provided a business update.

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"Nearly five years after launch, KIMMTRAK remains the proven standard of care in HLA-A*02:01+ metastatic uveal melanoma. With TEBE-AM fully enrolled and data expected in the second quarter of 2027, we are advancing our mission to bring this therapy to even more patients," said Bahija Jallal, CEO of Immunocore. "Recently, our platform delivered two significant firsts: what we believe is the first data demonstrating clinical activity and a manageable safety profile with the combination of two T cell engagers in a solid tumor, and the first patient dosed in our tissue-specific autoimmune program for type 1 diabetes."

Third Quarter Highlights (including post-period)

Financial Results

For the third quarter ended September 30, 2026, total net product revenue (or ‘net sales’) arising from the sales of KIMMTRAK was $102.2 million, compared to $103.7 million for the same period in 2025. Q3 2026 sales were $62.2 million in the United States, $34.9 million in Europe, and $5.1 million in international regions. Revenue from net product sales compared to Q3 of 2025 was impacted by (i) United States wholesaler stocking that occurred in Q2 of 2026 and (ii) one additional week of sales in the U.S. in Q3 2025. Normalizing for the two US-related items above, underlying revenue growth for this quarter was approximately 10%, as compared to Q3 2025.

For the nine months ended September 30, 2026, net sales of KIMMTRAK were $324.8 million, compared to $295.5 million for the same period in 2025. For the nine months ended September 30, 2026, sales were $204.6 million in the United States, $103.5 million in Europe and $16.7 million in international regions. The increase in net product sales was due to continued growth in the United States, Europe and international regions.

Research and development (R&D) expenses for Q3 2026 were $74.7 million, compared to $70.6 million for Q3 2025. This increase was primarily due to advancement of our clinical programs, including our three Phase 3 trials.

Selling, general and administrative (SG&A) expenses for Q3 2026 were $40.5 million, compared to $39.8 million for Q3 2025.

Net loss for Q3 2026 was $14.2 million ($0.28 loss per share) compared to $0.2 million ($0.00 loss per share) for Q3 2025. Net loss for the nine months ended September 30, 2026, was $2.1 million ($0.04 loss per share) compared to $5.5 million ($0.11 loss per share) for the nine months ended September 30, 2025.

Cash, cash equivalents and marketable securities were $901.3 million as of September 30, 2026, as compared to $864.2 million as of December 31, 2025. The Company expects to pay, in the fourth quarter of 2026, approximately $120 million in sales-related rebate accruals.

KIMMTRAK

The Company’s lead product, KIMMTRAK, is approved in 39 countries and has been launched in over 30 countries globally to date for HLA-A*02:01 positive people with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in all major markets where it is launched.

The Company sees three key growth areas for KIMMTRAK as it plans to expand patient reach, including continued US community and global market penetration in mUM, the potential expansion into 2L+ advanced cutaneous melanoma (CM), and the potential expansion into adjuvant uveal melanoma.

Metastatic uveal melanoma

The five-year overall survival (OS) data from the Phase 3 trial of KIMMTRAK in patients with unresectable or mUM, which were presented at the AACR (Free AACR Whitepaper) 2026 meeting, have been accepted by the European Medicines Agency for inclusion in the European SmPC (Summary of Product Characteristics). This addition to the SmPC will allow the Company to engage more broadly with healthcare professionals in the region about the data.
The Company received the International Prix Galien 2026 for KIMMTRAK in the orphan/rare diseases category. This is the fifth Prix Galien awarded to KIMMTRAK.

2L+ advanced cutaneous melanoma

The registrational Phase 3 TEBE-AM trial, evaluating tebentafusp as monotherapy and in combination with pembrolizumab, versus a control arm in patients with previously treated advanced CM, has achieved its target enrollment of 540 patients. The trial is event-driven and topline overall survival data is expected in the second quarter of 2027.
There is great unmet need in second- and later-line CM, with no therapy, to date, having shown an OS improvement following progression on checkpoint inhibitors in a randomized clinical trial. The Company estimates there are up to 4,000 HLA-A*02:01 positive, previously treated, advanced CM patients in the US and Europe.
Adjuvant uveal (or ocular) melanoma

The European Organisation for Research and Treatment of Cancer (EORTC) is enrolling patients in the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM) in Europe and the United States.
The Company estimates the HLA-A*02:01 positive, high-risk adjuvant uveal melanoma patient population could represent up to 1,200 patients in the US and Europe.
PRAME portfolio

Brenetafusp is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line, advanced cutaneous melanoma, and in a Phase 1/2 clinical trial as monotherapy and in combination across multiple solid tumors, including ovarian cancer, uveal melanoma, and non-small cell lung cancer (NSCLC).

PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma

The Company continues enrollment of HLA-A*02:01 positive, first-line, advanced or metastatic cutaneous melanoma patients with 1:1 randomization to brenetafusp 160 mcg + nivolumab or a control arm of either nivolumab or nivolumab + relatlimab.
Despite approved therapies, there remains an unmet need for improved progression-free survival and OS in the first-line setting, where there is the potential to address an estimated 10,000 HLA-A*02:01 positive patients across the US and Europe.
Phase 1/2 clinical trials of brenetafusp and IMC-P115C (PRAME-A02 Half-Life Extended) in multiple solid tumors

Combination of KIMMTRAK and brenetafusp in metastatic uveal melanoma

As of June 2026, 22 HLA-A*02:01 positive adult patients with mUM received brenetafusp monotherapy at clinically active doses and 26 received the combination of KIMMTRAK and brenetafusp.
Among the 16 evaluable patients who received brenetafusp monotherapy in the second-line or later setting, overall response rate (ORR) was 19%, median duration of response (mDoR) was 14.5 months, median progression-free survival (mPFS) was 4.2 months, and median OS was 20.3 months.
Across the 17 evaluable first-line patients who received the combination, ORR was 29%, mDoR was 24.1 months, mPFS was 8.1 months, and median OS was not yet reached with 29 months of follow-up and 10 patients still on study. The two-year OS rate was 70%.
The most common brenetafusp monotherapy treatment-related adverse events (TRAEs) were reversible and manageable cytokine release syndrome (CRS) (73%) and rash (50%) consistent with the molecule’s mechanism of action. Grade 3/4 TRAEs were primarily transient lymphocyte decrease which resolved without intervention.
Combination regimens were generally well-tolerated. The most common TRAEs were Grade 1/2 CRS and rash (77% each). These attenuated over time with no Grade ≥3 CRS reported. No TRAE led to discontinuation or death.
The Company will present these data in a poster today at 10:00 a.m. MST / 12:00 p.m. ET and in an oral session, Saturday, November 7 at 1:45 p.m. MST / 3:45 p.m. ET, at the 2026 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
The Company believes these are the first data showing clinical activity and a manageable safety profile for a combination of two T cell engagers in a solid tumor.
Based on these data, the Company is planning to start DUET-UVEAL, a randomized Phase 2/3 trial, to evaluate the combination for the treatment of HLA-A*02:01-positive patients with mUM.
Brenetafusp in other tumors and IMC-P115C

After observing an initial brenetafusp monotherapy signal in platinum-resistant ovarian cancer (PROC), the Company is evaluating, as part of an ongoing Phase 1/2 trial, combination therapy with bevacizumab in earlier lines, including platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection across multiple metastatic non-small cell lung cancer (NSCLC) cohorts, including combinations with standards of care in earlier-line NSCLC.
The Company expects to present clinical data for brenetafusp from the ovarian and lung cohorts in the Phase 1/2 trial at a medical conference later this year.
In parallel, the Company is continuing to enroll patients in the Phase 1 dose escalation trial evaluating IMC-P115C in patients with multiple solid tumors.

ImmTAV candidates for a functional cure in infectious diseases

The Company’s bispecific TCR technology platform has the potential to offer a new approach for the treatment of certain chronic infections by eliminating the remaining virus in circulation after the patients stop taking their antiviral medication – known as a ‘functional cure’. The Company is studying an investigational candidate for people living with human immunodeficiency virus (HIV).

Phase 1/2 trial of IMC-M113V (Gag-A02) for people living with HIV

In July 2026, at the International AIDS Society meeting in Rio de Janeiro, the Company presented translational data, from the first three cohorts of the multiple ascending dose (MAD) part of the Phase 1/2 trial, demonstrating that IMC-M113V induces robust type I and II interferon-associated immune programs, with stronger induction in participants who maintained viral control after treatment interruption.
The data also showed that, in addition to previously demonstrated direct killing of HIV-infected cells, IMC-M113V redirection of T cells results in induction of a robust interferon-associated immune program that may contribute to post-treatment viral control.
The Company completed enrollment of additional patients at higher dose cohorts, up to 1200 mcg, as part of the MAD portion of the Phase 1/2 trial. Analysis of the new data is ongoing with results planned to be shared early next year.

Tissue-specific down modulation of the immune system for autoimmune diseases
The key differentiator of the ImmTAAI platform is down modulation of the immune system in a tissue-specific manner. The candidates achieve this by suppressing pathogenic T cells via PD1 receptor agonism only when tethered to the target tissue.

The Company recently announced that the first person with type 1 diabetes has been dosed in the Phase 1 trial of IMC-S118AI, its first tissue-specific autoimmune candidate.
IMC-S118AI is designed to bind preproinsulin on beta cells of the pancreas and deliver a PD-1 agonist signal to nearby auto-reactive T cells, thereby protecting the pancreatic beta cells from T cell attack, preserving beta cell mass, and avoiding systemic immune suppression.
The Company plans to file a clinical trial application (CTA) or investigational new drug (IND) application before the end of the year for its second autoimmune program, IMC-U120AI (CD1a x PD1), which is designed to target a variety of dermatological diseases including atopic dermatitis.

(Press release, Immunocore, NOV 6, 2026, View Source [SID1234674391])

On November 6, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel immunotherapies with its pioneering AI-Immunology platform, reported new biomarker data from its phase 2 trial with personalized cancer vaccine EVX-01 in patients with advanced melanoma (skin cancer).

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The data demonstrate potent EVX-01 induced immune responses and further underline the strong predictive performance of Evaxion’s AI-Immunology platform. It will be presented in both an oral and a poster session today and tomorrow respectively at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting, taking place in Phoenix, Arizona.

"It is exciting to announce yet another set of new and promising data providing insights into the magnitude, quality and systemic impact of EVX-01-induced immunity in advanced melanoma. The data provide a clear demonstration of the very strong immune responses induced by EVX-01 and also validates our AI-Immunology platform further. We are looking forward to sharing and discussing this data with both scientific stakeholders and potential business partners at the important SITC (Free SITC Whitepaper) meeting", says Birgitte Rønø, CSO and COO of Evaxion.

Comprehensive data package
The new data adds to EVX-01’s already comprehensive data package which includes three-year clinical response and immune data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 held in October. These data showed 89% vaccine target precision and sustained T-cell and clinical responses at three-year follow-up in the phase 2 trial.

New findings include detection of EVX-01 induced neoantigen-specific T-cells directly ex vivo, which is a clear testament to the magnitude of the vaccine-induced immune responses. Ex vivo responses were dominated by CD4+ T-cells, while CD8+ T-cell responses were observed in half of patients.

The data also documents a significant association (p<0.001) between predictions by AI-Immunology and actual T-cell responses, confirming the strong predictive performance of the platform. Essentially, the platform predicts, with very high precision, which neoantigens will illicit the strongest immune responses allowing for selection of these as optimal vaccine targets.

SITC oral and poster presentation details:

Abstract title: EVX-01 personalized AI-designed vaccine plus pembrolizumab induce neoantigen-specific T-cell responses and systemic immune modulation in advanced melanoma
Abstract#: 502
Oral presentation:

Session: 105b: Rapid Oral – Clinical 1
Location: Phoenix Convention Center, West Building-300 Level – 301BC
Date/Time: Friday, November 6, 2026, 12:30-1:30pm MT / 20.30-21.30 CET
Presenter: Mads Lausen, Senior Scientist at Evaxion
Poster presentation:

Session: Poster Session
Location: Phoenix Convention Center, North Building-Lower Level – Exhibition Halls 4-6
Date/Time: Saturday, November 7, 2026, 12:30-1:30pm & 6:40-8:10pm MT / 20:30-21:30 CET & 02:40-04:10 CET (Sunday, November 8)
Presenter: Mads Lausen, Senior Scientist at Evaxion
About the phase 2 trial
The phase 2 trial investigated EVX-01 in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial received a unique vaccine designed with Evaxion’s AI-Immunology prediction platform and manufactured based on their individual biology.

At two-year follow-up, the trial demonstrated an Objective Response Rate (ORR) of 75% as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. Clinical and T-cell responses were sustained at three-year follow-up. 89% of the EVX-01 neoantigen targets triggered a tumor-specific immune response in the patients.

In the first two-years, patients received EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab). In the third year, a subset of patients received EVX-01 as stand-alone therapy. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancer tumors. It is currently being evaluated as a treatment of advanced melanoma and is Evaxion’s lead clinical asset.

Designed with our AI-Immunology platform, EVX-01 is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system by mounting a targeted response against tumor-specific neoantigens.

(Press release, Evaxion, NOV 6, 2026, View Source [SID1234674390])