On November 7, 2025 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended September 30, 2025.

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"We remain focused on multiple upcoming milestones before year-end, including top-line results from our Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) and an enrollment update for the confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Recently, we were pleased to announce that the first Data Monitoring Committee (DMC) meeting for the confirmatory Phase 3 study evaluating HyBryte in the treatment of CTCL had concluded that there were no safety concerns, with HyBryte demonstrating an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. Looking ahead to 2026, Phase 3 enrollment remains on track with top-line results anticipated in the second half of 2026."

Dr. Schaber continued, "With approximately $10.5 million in cash at September 30, 2025, we’re focused on carefully allocating resources to hit our strategic goals and upcoming milestones. While this cash balance provides sufficient operating runway through 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."

Soligenix Recent Accomplishments

On October 14, 2025, the Company announced the update of its United States (U.S.) Medical Advisory Board (MAB) for CTCL to provide medical/clinical strategic guidance to the Company as it advances the Phase 3 clinical development of HyBryte. To view this press release, please click here.
On October 7, 2025, the Company announced its first DMC meeting for its confirmatory Phase 3 study evaluating HyBryte in the treatment of CTCL had concluded that there were no safety concerns and that HyBryte has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. To view this press release, please click here.
On September 30, 2025, the Company announced the expansion of its European MAB to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 d study evaluating the safety and efficacy of HyBryte. To view this press release, please click here.
On September 29, 2025, the Company announced the closing of its previously announced public offering with participation from existing and certain healthcare focused institutional investors. To view this press release, please click here.
On September 23, 2025, the Company announced the appointment of Tomas J. Philipson, PhD as a Strategic Advisor, given his extensive experience and relationships at the highest levels of government, including with U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services. To view this press release, please click here.
On September 4, 2025, the Company announced a publication describing the extended stability of ebolavirus vaccines using its ThermoVax platform. To view this press release, please click here.
On August 18, 2025, the Company announced that the Office of Orphan Products Development of the FDA had granted orphan drug designation to dusquetide, the active ingredient in SGX945, for "treatment of Behçet’s Disease" following review of positive Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet’s Disease. To view this press release, please click here.
Financial Results – Quarter Ended September 30, 2025

Soligenix reported no revenue for the quarters ended September 30, 2025 and 2024.

Soligenix’s net loss was $2.5 million, or ($0.58) per share, for the quarter ended September 30, 2025, compared to $1.7 million, or ($0.78) per share, for the quarter ended September 30, 2024. This increase in net loss was primarily due to an increase in operating expenses related to ongoing clinical trials and a decrease in interest income and a CARES Act employee retention credit received during the three months ended September 30, 2024 with no corresponding employee retention credit received during the three months ended September 30, 2025.

Research and development expenses were $1.6 million for the quarter ended September 30, 2025 as compared to $1.0 million for the same period in 2024. The increase was primarily due to costs associated with the second confirmatory Phase 3 CTCL trial as well as increases in third party contract manufacturing.

General and administrative expenses were $1.0 million for the quarter ended September 30, 2025 as compared to $0.9 million for the same period in 2024. The decrease was primarily attributable to increases in professional expenses.

As of September 30, 2025, the Company’s cash position was approximately $10.5 million.

(Press release, Soligenix, NOV 7, 2025, View Source [SID1234659641])

On November 7, 2025 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies for solid tumors, reported the presentation of safety and early efficacy data from the EVEREST-2 study (NCT06051695) of its lead program, A2B694. The data was presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and was recognized as a Top 150 Abstract.

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The findings from EVEREST-2 include the first reported complete response (CR) in a patient with non-small cell lung cancer (NSCLC) following treatment with a CAR T-cell therapy. This patient had progressive, metastatic NSCLC with KRAS G12V/STK11 co-mutations, an aggressive subtype associated with resistance to chemoimmunotherapy and poor prognosis. The patient had also been refractory to first-line therapy. After a single infusion of A2B694, the patient achieved a CR (per RECIST 1.1) at day 90 that was confirmed by central review at day 180. Complete responses have rarely been observed in studies of CAR T-cell therapies for the treatment of solid tumors and none have been reported in patients with lung cancer.1

"It is exciting to share the first report of a complete response to CAR T-cell therapy in a patient with a hard-to-treat case of non-small cell lung cancer. Our findings from the ongoing EVEREST-2 study demonstrate that A2B694 holds promise as a new precision cell therapy targeting mesothelin-expressing solid tumors, such as NSCLC, mesothelioma, pancreatic, ovarian, and colorectal cancer, if future studies prove successful," said Salman R. Punekar, M.D., assistant professor of medicine, NYU Langone Health, Perlmutter Cancer Center and treating physician of this patient.

Evaluating A2B694

As of September 11, 2025, nine patients were enrolled in EVEREST-2, including three patients with ovarian cancer; two patients with pancreatic cancer; and one patient each with NSCLC, colorectal cancer, gastro-esophageal cancer, and mesothelioma. Three dose levels were administered: 1×10⁸ (n=3), 2×10⁸ (n=4), and 4×10⁸ (n=2) cells, of which one patient each at the 1×10⁸ and 2×10⁸ levels received half dose due to body weight, per clinical protocol. Maximum tolerated dose (MTD) has not been reached. Higher doses up to 14×10⁸ are planned to be evaluated in this dose-finding trial.

A2B694 Safety

A2B694 had manageable safety and was well tolerated with no dose-limiting toxicities. Lymphodepletion prior to A2B694 administration was well tolerated, with typical, transient cytopenias. There were no dose-limiting toxicities (DLTs) or cases of cytokine release syndrome (CRS). There was one case of grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS), which was successfully managed. No deaths were attributed to A2B694, and no patient has discontinued the study due to adverse events.

A2B694 Pharmacokinetics

A2B694 was detected post-infusion in peripheral blood and showed cell expansion in all treated patients, and was also detected in multiple tumor biopsies. In one patient, A2B694 was detected in a tumor biopsy collected on day 42, but not in the concurrently collected blood sample, demonstrating that A2B694 can infiltrate the tumor microenvironment and persist for weeks, even when undetectable in the peripheral blood.

Case Report of Complete Response in NSCLC patient

A patient with co-mutated (KRAS G12V/STK11) NSCLC, a subtype associated with resistance to chemoimmunotherapy and poor prognosis, had progressed on standard-of-care first-line treatment of carboplatin, pemetrexed, and pembrolizumab before enrolling in EVEREST-2. At day 90 post-infusion of A2B694, the patient achieved a complete response (CR) per RECIST 1.1 and had a confirmed CR by central review at day 180. PET-CT scan on day 190 showed no evidence of disease. Longitudinal ctDNA tests that detected tumor mutations at diagnosis showed no detections of those same mutations post-treatment at month 6 and again at month 8. On day 243, the patient had an isolated CNS relapse, with an ongoing non-CNS CR per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM). The patient was treated with dexamethasone and definitive gamma knife radiosurgery. Subsequent PET-CT demonstrated continued absence of disease on day 284. At month 12, the patient’s CT showed no new findings.

Poster Presentation Details

Title:

EVEREST-2: A phase 1/2 study of A2B694, a logic‑gated Tmod CAR T therapy to treat solid tumors expressing mesothelin (MSLN) with HLA-A*02 loss of heterozygosity: initial safety and efficacy results

Presenter:

Jeffrey Ward, M.D., Ph.D.

Assistant Professor of Medicine, Division of Oncology

Washington University School of Medicine

Date:

Friday, November 7, 2025

Location:

Prince George ABC Halls, Lower-Level Atrium

Gaylord National Resort and Convention Center

Poster No.:

535

Enabling Efficient Patient Identification for Precision Medicine Studies

The BASECAMP-1 (NCT04981119) master prescreening study enables efficient identification of patients for all A2 Bio precision medicine studies. Patients are enrolled in EVEREST-2 through BASECAMP-1, which identifies patients with HLA loss of heterozygosity (LOH) at any time in the course of their disease via next-generation sequencing. Upon disease progression, the participant may screen for enrollment in EVEREST-2. There is no time requirement between the studies, and patients may go directly from BASECAMP-1 to EVEREST-2 based on their own disease course. BASECAMP-1 utilizes artificial intelligence (AI)-enabled precision diagnostics as a cost-effective, high-yield approach to identify eligible patients for all A2 Bio clinical studies.2,3

A2 Bio continues to advance its clinical development of A2B694, A2B395, the BASECAMP-1 prescreening study, and other preclinical programs as the company pursues additional pipeline expansion opportunities using its proprietary Tmod technology platform. The TmodTM platform comprises a suite of technologies that can be used in isolation or in combination, and in both autologous and allogeneic settings, to create novel therapies for cancers and beyond.

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com

All of A2 Bio’s scientific posters and publications are available at www.a2bio.com/science/abstracts-and-publications/

About EVEREST-2

EVEREST-2 (NCT06051695) is a seamless Phase 1/2 study evaluating the safety and efficacy of A2B694, an autologous logic-gated investigational cell therapy developed from the A2 Bio proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets mesothelin (MSLN) and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. The study is recruiting participants with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression.

About the Tmod Platform

A2 Bio has pioneered a precision-targeting cellular system – the Tmod platform – that incorporates two receptors, an activator and a blocker, to aim the powerful armaments of immune cells directly at tumors to unequivocally differentiate tumors from normal tissues. The activator recognizes antigens on tumor cells that trigger their destruction, while the blocker recognizes antigens on normal cells that protect them. This novel blocker technology enables precise, personalized and effective T-cell targeting. The blocker component equips Tmod cells with the capacity to identify tumors as distinct from normal cells.

(Press release, A2 Biotherapeutics, NOV 7, 2025, View Source [SID1234659657])

On November 7, 2025 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported new data from its ongoing Phase 2 clinical trial evaluating vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab (Tecentriq) in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC). A 40% objective response rate (ORR) was demonstrated in heavily pre-treated patients with MSS mCRC without liver metastases and with high plasma TMB (≥10 mutations/Mb), as well as a statistically significant correlation between plasma TMB status and response. These new clinical data are being presented in a late-breaking poster presentation (Abstract # 1315) today at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, taking place from November 5-9, 2025, in National Harbor, Maryland.

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"These compelling new Phase 2 data for vilastobart in combination with atezolizumab demonstrated a 40% objective response rate in heavily pre-pretreated patients with MSS mCRC without liver metastases and with high plasma TMB, signifying an important advance in our understanding of response to novel immunotherapy in MSS mCRC," said Katarina Luptakova, M.D., chief medical officer of Xilio. "In addition, these data showed a statistically significant correlation between plasma-based TMB and response. We estimate that approximately 55% of patients with MSS CRC have high plasma TMB, representing a meaningful patient population who could ultimately benefit from combination treatment with vilastobart and a substantially greater prevalence of patients with high TMB than previously estimated using traditional tissue-based assays."

"These new data highlight the potential to use plasma TMB as a predictive biomarker and identify patients with MSS mCRC who may benefit from treatment with vilastobart, a tumor-activated anti-CTLA-4, in combination with a PD-(L)1," said Diwakar Davar, M.D., Associate Professor of Medicine, Clinical Director of the Melanoma Program and Medical Oncologist/Hematologist at the UPMC Hillman Cancer Center. "This biomarker guided approach, utilizing a feasible and reproducible biomarker, together with vilastobart’s differentiated safety profile, continue to support the promising opportunity for vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS mCRC, as well as other tumor types."

Promising Opportunity for Plasma-Based TMB as a Biomarker Predictive of Response to Combination Treatment with Vilastobart in Patients with MSS mCRC

Tissue-based TMB has demonstrated potential as a biomarker predictive of response to immune checkpoint inhibitors in many tumor types. However, tissue-based TMB assays have not shown predictive utility in MSS mCRC historically, and these tissue-based assays may underestimate the mutational burden in patients. In particular, tissue-based assays are limited to evaluating mutations in a single-site biopsy specimen, which is typically taken once at the time of diagnosis, and cannot account for tumor heterogeneity or changes in TMB over time.

Newer plasma-based assays show potential to better assess TMB status and be used as a biomarker predictive of response in patients with MSS mCRC. These plasma-based assays are more sensitive than traditional tissue-based assays in that plasma-based TMB assays provide a comprehensive assessment of mutational load and account for tumor heterogeneity. In addition, plasma can be readily obtained from blood samples throughout the course of treatment, accounting for changes in TMB over time without the need for invasive procedures.

Approximately 55% of non-MSI-H CRC patients were plasma TMB high (>10 mutations/Mb) based on an analysis of the GuardantINFORM real-world clinical-genomic database in approximately 8,000 patients who received the Guardant360 Liquid (Infinity) assay and who had non-MSI-H disease and a reportable TMB result. In contrast, historical data for tissue-based TMB assays have suggested <10% of patients with MSS mCRC were TMB-high.

These data support the meaningful opportunity to use plasma-based TMB as a biomarker predictive of response to combination treatment with vilastobart in patients with MSS mCRC.

New Data from Phase 2 Trial for Vilastobart in Combination with Atezolizumab in Patients with MSS mCRC Without Liver Metastases and with High Plasma TMB

As of a data cutoff date of May 12, 2025, 44 patients with MSS mCRC had been treated with the combination of vilastobart at 100 mg once every six weeks (Q6W) and atezolizumab at 1200 mg once every three weeks (Q3W), including 27 patients without liver metastases. Patients were heavily pre-treated, with 80% having previously received three or more prior lines of anti-cancer therapy.

In a retrospective analysis, 24 patients without liver metastases were evaluable for plasma TMB status. Baseline plasma TMB was assessed using the Guardant360 Liquid (Infinity) assay, and patients with TMB ≥10 mutations/Mb were defined as having high plasma TMB.

Clinical Efficacy Data

40% ORR in patients with MSS mCRC without liver metastases and high plasma TMB, with statistically significant correlation (p=0.05) between plasma TMB status and response.

•
40% ORR in plasma TMB-high patients, consisting of six partial responses (PRs), with five confirmed PRs (with one confirmed after the data cutoff date) and one unconfirmed PR.

•
In patients evaluable for plasma TMB status, 62.5% were TMB-high. All responders who were evaluable for plasma TMB status were TMB-high, and the correlation between plasma TMB status and response was statistically significant (p=0.05).

•
As previously reported, responses were deep and durable, with reductions in target lesions of up to 71% from baseline.

Safety Data

Vilastobart in combination with atezolizumab continued to demonstrate a differentiated and generally well-tolerated safety profile. Treatment-related adverse events (AEs) were primarily Grade 1 or 2, consistent with the tumor-activated design for vilastobart.

As previously reported, across all patients treated as of a data cutoff date of May 12, 2025 (n=44), the combination of vilastobart at 100 mg Q6W and atezolizumab at 1200 mg Q3W was generally well-tolerated. Treatment-related AEs were primarily Grade 1 or 2. Only two patients (5%) discontinued treatment for the combination of vilastobart and atezolizumab due to a treatment-related AE, and only three patients (7%) experienced colitis of any grade.

Clinical Development Plans for Vilastobart

Based on the promising clinical activity and safety profile demonstrated by vilastobart as a combination therapy, including in patients who had high plasma TMB, Xilio is actively seeking a partner to develop vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS CRC and other tumor types.

Investor Conference Call Information

Xilio will host a conference call and webcast on Monday, November 10, 2025, at 4:30 p.m. ET. The webcast will feature a discussion with expert clinicians Aparna Parikh, M.D., Associate Professor of Medicine, Harvard Medical School, Program Director, GI Medical Oncology, Colorectal, Anal, and Neuroendocrine, Director of the MGB Global Cancer Care Program, Mass General Brigham Cancer Institute, Boston, MA, and Diwakar Davar, M.D., Associate Professor of Medicine, Clinical Director of the Melanoma Program and Medical Oncologist/Hematologist at the UPMC Hillman Cancer Center, Pittsburgh, PA. During the webcast, Xilio will discuss the new Phase 2 combination data for vilastobart and the promising opportunity to use high plasma TMB as a predictive biomarker for response, as well as briefly highlight additional data updates presented at SITC (Free SITC Whitepaper) across the company’s portfolio of differentiated masked immunotherapies.

Viewers can access the webcast by using this link. Listeners are encouraged to join at least 15 minutes prior to the scheduled start time. The webcast will also be accessible under "Events & Presentations" in the "Investors & Media" section of the Xilio Therapeutics website at ir.xiliotx.com. A replay of the webcast will be archived on the website for 30 days following the presentation.

About Vilastobart and the Phase 1/2 Combination Clinical Trial

Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the efficacy and safety of the combination in Phase 2 in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

(Press release, Xilio Therapeutics, NOV 7, 2025, View Source [SID1234659642])

On November 7, 2025 Biomunex Pharmaceuticals, a French biopharmaceutical company specializing in the development of next generation immunotherapies based on the discovery and development of bispecific and multispecific antibodies, reported presentation of preclinical data from its MAIT engager platform at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s ("SITC") 40th Annual Meeting being held in National Harbor, USA, from November 5th-9th, 2025.

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MAIT engagers: a new class of bispecific antibodies for cancer treatment

Invited to present an oral communication on November 8th, Dr Simon Plyte, Biomunex CSO (Chief Scientific Officer), will make a presentation entitled: "The MAIT Engager platform : rapid generation of several MAIT T cell engagers with significantly improved safety profile and large therapeutic window (Abstract 1197)." He is also presenting a Poster regarding the topic on November 7th.

Biomunex is developing a large portfolio of MAIT engager drug candidates, a new therapeutic class in immuno-oncology, that is differentiated from classical TCEs ("T cell engagers"). MAIT engagers are bispecific antibodies that identify, mobilize and bridge MAIT cells (Mucosal-Associated Invariant T cells) to cancer cells resulting in MAIT activation and directed killing of tumors; MAIT engagers could become a breakthrough approach in the treatment of many cancers, particularly in solid tumors.

The presentation at SITC (Free SITC Whitepaper) Annual meeting will focus on the MAIT engager differentiation from classical CD3+ TCEs and highlight the superior safety of MAIT engagers. MAIT engagers are expected to overcome some of the limitations of current CD3+ TCE therapies, including activation of regulatory T cells (Tregs) and cytokine release syndrome, serious side effects that are difficult to manage for cancer patients.

The Biomunex platform enables rapid generation of several MAIT engagers, that are not only as potent at classical CD3+ T cell engagers but also bring significantly improved safety profile and have the potential to provide a larger therapeutic window in specific tumor types. Moreover, MAIT engagers can effectively induce the "SPARK effect", enabling long-term durable anti-cancer response.

Based on preclinical data, Biomunex expects the first MAIT engager to enter clinical trials soon. The MAIT engager platform paves the way for a series of innovative new immunotherapeutics targeting many cancers. "MAIT engagers are an attractive approach for the treatment of cancer with breakthrough potential for redefining the standard of care for solid tumors," comments Dr. Simon Plyte, Biomunex’s CSO. "Presenting those preclinical data as an oral communication and a poster during the 40th SITC (Free SITC Whitepaper) meeting is a unique opportunity in sharing the scientific and medical potential of this innovative approach with the scientific community".

Biomunex accelerates development of its disruptive immunotherapies pipeline

Biomunex is becoming a major innovative player in oncology. Bi- and multi-specific antibodies and T cell engagers are attracting considerable interest from pharmaceutical companies, with the recent signing of many licensing and partnership agreements, including for Biomunex. "The last few months have marked the beginning of a new chapter in Biomunex’s development with the signing of a major agreement with Ipsen, following other licensing or partnership deals, demonstrating the team’s ability to develop drugs and technologies of interest for the pharmaceutical industry, such as the MAIT engagers presented at 2025 SITC (Free SITC Whitepaper) Annual meeting, to treat cancer patients, but also to establish leading licensing agreements and partnerships with the industry," comments Dr. Pierre-Emmanuel Gerard, Biomunex’s founder and President.

In addition to BMX-502 licensed to Ipsen, Biomunex is developing a portfolio of MAIT engager drug candidates and innovative new therapeutic approaches with high potential, based on its proprietary "Plug-and-Play" BiXAb platform. This technology enables the generation of breakthrough immunotherapies faster than most other platforms in the field, with excellent drug-like properties and high industrial yield. Biomunex’s first BiXAb drug candidate is currently in Phase 1 clinical development in partnership, as a monotherapy or in combination, in patients with certain solid tumors or hematological malignancies.

(Press release, BIOMUNEX Pharmaceuticals, NOV 7, 2025, View Source [SID1234659658])

On November 7, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that it will present clinical data from its ongoing Phase 1b clinical trial at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), which will be held in National Harbor, Maryland from November 7-9, 2025.

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Phio’s poster presentation will highlight the clinical results from the ongoing Phase 1b dose escalation clinical trial. This clinical trial is designed to evaluate the safety and tolerability of intratumoral injection of PH-762 in patients with cutaneous squamous carcinoma, Merkel cell carcinoma, and melanoma.

Presentation Details are as follows:

Title: PD-1 Directed Intratumoral Immunotherapy for Cutaneous Carcinomas: A Clinical Study of INTASYL PH-762
Abstract Number: 610
Presenting Author: Mary Spellman, M.D.
Date: Saturday November 8, 2025
Location: Prince George ABC Exhibit Halls Gaylord National Resort and Convention Center

(Press release, Phio Pharmaceuticals, NOV 7, 2025, View Source [SID1234659643])