On November 13, 2025 Flashpoint Therapeutics, a biotechnology company pioneering a new class of structural nanomedicine, reported the publication of foundational research demonstrating the power of its proprietary Spherical Nucleic Acid (SNA) platform to create highly potent and targeted cancer therapies. The study, published in the journal ACS Nano by a team led by Flashpoint’s scientific co-founder Professor Chad A. Mirkin at the International Institute for Nanotechnology at Northwestern University, reports results of research with a new chemotherapeutic SNA that selectively targets and eliminates acute myeloid leukemia (AML) cells in preclinical models.

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The publication highlights a revolutionary approach to nanomedicine design which incorporates the chemotherapeutic agent into the shell of the nanoparticle. Unlike conventional nanocarriers that encapsulate drugs within a core, Flashpoint’s SNAs are built with oligonucleotides made from units of a chemotherapeutic drug, 5-fluorouracil (5-Fu), anchored to a nanoparticle core. This unique architecture, a key tenet of structural nanomedicine, drives the therapeutic’s biological activity, enabling preferential uptake by myeloid cells, the lineage from which AML originates.

The study reports exceptional efficacy and a promising safety profile. Key findings include:

Targeted Delivery: The SNAs were selectively taken up by myeloid cells, including AML cells, at rates up to 12.5 times higher than the free drug components.
Potent Efficacy: The SNA construct demonstrated up to a 10,000-fold enhancement in cancer cell killing in vitro compared to the free drug. In a human AML mouse model, the therapy exhibited 59-fold greater antitumor efficacy than 5-Fu.
Favorable Safety: The potent anti-leukemia activity was achieved without observable side effects in animal models, suggesting a wide therapeutic window and the potential to reduce the harsh toxicities associated with conventional chemotherapy.
"This groundbreaking research by Professor Mirkin’s laboratory validates the capability of Flashpoint Therapeutics’ technology platform to precisely control the structure of a medicine at the nanoscale, thereby unlocking unprecedented therapeutic properties," said Barry Labinger, Chief Executive Officer of Flashpoint Therapeutics. "The results in AML are a powerful demonstration of our platform’s ability to create targeted, highly potent drug candidates that overcome the limitations of conventional approaches. We are excited to advance this and other programs based on our structural nanomedicine platform to bring transformative new treatments to patients."

AML is a devastating blood cancer with low survival rates, particularly for older patients who cannot tolerate aggressive chemotherapy. Flashpoint’s approach offers the potential for a new precision medicine that can effectively eliminate cancer cells while minimizing collateral damage to the body.

"This is a new class of chemotherapeutic that is defined by its structure," said Professor Mirkin. "Today’s chemotherapeutics kill cancer cells but also a lot of healthy cells. Our structural nanomedicine preferentially seeks out the myeloid cells, where the AML resides. Instead of overwhelming the whole body with chemotherapy, it delivers a higher, more focused dose where it is needed."

The full article, titled "Chemotherapeutic Spherical Nucleic Acids," can be found in ACS Nano.

(Press release, Flashpoint Therapeutics, NOV 13, 2025, View Source [SID1234659942])

On November 13, 2025 Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX) ("Fennec" or the "Company"), a specialty pharmaceutical company, reported that it intends to offer and sell its common shares in an underwritten registered public offering. In addition, Fennec intends to grant the underwriters a 30-day option to purchase up to an additional 15% of its common shares sold in the public offering.

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Fennec intends to use the net proceeds of the proposed offering to repurchase and redeem certain indebtedness and the remaining net proceeds, if any, for working capital and general corporate purposes.

Piper Sandler & Co. and Craig-Hallum Capital Group LLC are acting as the joint book-running managers for the proposed public offering.

The common shares are being offered by the Company pursuant to a registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus, when filed with the SEC, may also be obtained from Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, by telephone at (800) 747-3924 or by email at [email protected] and Craig-Hallum Capital Group LLC, Attention: Equity Capital Markets, 323 North Washington Ave., Minneapolis, MN 55401, by telephone at (612) 334-6300 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy common shares, nor shall there be any sale of common shares, in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The common shares in the proposed offering will not be offered or sold, directly or indirectly, in Canada or to any resident of Canada.

(Press release, Fennec Pharmaceuticals, NOV 13, 2025, View Source [SID1234660017])

On November 13, 2025 Enterome, a clinical-stage company pioneering OncoMimics, a new class of off-the-shelf, multi-targeted in vivo immune therapies that induce a fast and potent expansion of memory T-cells to fight cancer, reported positive new interim data from two cohorts of patients with low tumor-burden follicular lymphoma in the ongoing Phase 2 study of its lead OncoMimics immunotherapy EO2463. In cohort 3, data from the SIDNEY study showed a benign safety profile for EO2463 in combination with rituximab as first-line treatment for previously untreated patients with low tumor-burden follicular lymphoma in need of treatment, adding only injection site reactions to the well-known safety profile of rituximab. In addition, all six patients in this feasibility assessment responded to the combination treatment.

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Data from cohort 2 continue to show that EO2463 monotherapy produces excellent response rates when offered to patients with newly diagnosed follicular lymphoma or marginal zone lymphoma as an alternative to standard watchful waiting, an unmet clinical need setting. Per the abstract, data from 19 evaluable patients as of July showed an overall response rate (ORR) of 47%, including 3 complete responses (CRs) and 6 partial responses (PRs). No treatment is given to patients who currently follow the standard watch and wait setting practice as long as they do not show troublesome symptoms, despite the fact that they can remain anxious about their disease, and have a decreased quality of life.

The company will present the next update on both sets of data at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in Orlando, Florida, in December.

"These encouraging data further strengthen our conviction in the broad potential of EO2463 as a novel active immunotherapy. The data from the "watch-and-wait" setting confirm our earlier positive findings, while those from cohort 3 – which we had not reported on before – point in the same direction," said Jan Fagerberg, Chief Medical Officer at Enterome.

"This is another exciting set of new data, ahead of our lead asset EO2463 entering Phase 3 testing in the "watch-and-wait" setting in 2026. The data come shortly after we received Fast Track designation for EO2463 from the U.S. FDA for the watch-and-wait setting, raising our confidence that Enterome’s OncoMimics platform has the potential to be applied across a broad range of cancers," said Pierre Belichard, Chief Executive Officer of Enterome.

Details of the poster presentations:

Abstract #5377

Title: EO2463 (EO) peptide immunotherapy in patients (pts) with newly diagnosed asymptomatic follicular lymphoma (FL) and marginal zone lymphoma (MZL): Study EONHL1-20/SIDNEY (NCT04669171) primary endpoint Lugano objective response analysis
Presenting Author: Jose Caetano (JC) Villasboas, MD Mayo Clinic
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
Session date: 7 December 2025
Presentation time: 06:00-08:00 PM
Location: Room OCCC, West Halls B3-B4

Abstract #3594

Title: EO2463 (EO) peptide immunotherapy combined with rituximab (R) for first-line treatment of low-tumor burden follicular lymphoma (FL): A feasibility evaluation in Study EONHL1-20/SIDNEY (NCT04669171)
Presenting Author: Stephen Smith, M.D., UW Medicine, Fred Hutchinson Cancer Research Center
Session: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological
Session date: 8 December 2025
Presentation time: 06:00-8:00 PM
Location: Room OCCC, West Halls B3-B4

Follicular Lymphoma, one of several types of indolent Non-Hodgkin Lymphoma, is a difficult to treat chronic condition with relapses, characterized by slow progression and few symptoms, and reduced life expectancy. It is usually diagnosed by the appearance of swollen lymph nodes, and the early stages of the disease can be characterized by a lack of troublesome symptoms such as night sweats, fever or weight loss. There is a widespread consensus among leading investigators on the need for a well-tolerated and effective monotherapy to stop or slow progression for patients in the watch-and-wait setting.

EO2463 is an innovative, off-the-shelf OncoMimics active immunotherapy that combines four synthetic peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). It also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2). The unique ability of EO2463 to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms such as antigen escape.

OncoMimics consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs). These antigens induce a fast and potent in vivo expansion

of cytotoxic memory CD8+ T cells that were primed by gut bacteria, and are cross-reactive with TAAs. Because the peptides are "non-self", OncoMimics avoid the self-tolerance that limits many cancer immunotherapies to enable rapid, potent, and durable responses to tumors. The synthetically produced peptides are designed in silico, mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple high-affinity peptides to broaden target coverage and mitigate tumor heterogeneity.

OncoMimics are easy to manufacture, store, distribute and administer as an "off-the-shelf" subcutaneous injection. OncoMimics have achieved rapid and potent responses in clinical testing in over 230 patients to date, with a benign safety profile.

(Press release, Enterome, NOV 13, 2025, View Source [SID1234659898])

On November 13, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company developing therapeutics using its proprietary INTASYL siRNA gene silencing technology to eliminate cancer, reported its financial results for the quarter ended September 30, 2025 and provided a business update.

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Recent Corporate Updates

PH-762 Clinical Progress

Phio’s ongoing Phase 1b dose escalation clinical trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma. Per the trial’s protocol, patients receive four injections of PH-762 at weekly intervals and pathologic response is assessed on day 36 after the initial injection of PH-762. To date, pathologic results for the fifth and final cohort were as follows: 100% tumor clearance in one of three patients, > 90% clearance in the second patient, and > 50% clearance in the third patient at Day 36.

To date, a total of 18 patients with cutaneous carcinomas have completed treatment across five dose escalating cohorts in the Phase 1b trial. The cumulative pathologic response in 16 patients with cSCC include six with a complete response (100% clearance), two with a near complete response (> 90% clearance) and two with a partial response (> 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response (> 50% clearance). Six patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance). No patients in the study, however, exhibited clinical progression of disease.

To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. Phio may continue to screen and treat additional patients as part of the fifth cohort.

In July 2025, the Company entered into a comprehensive drug substance development services agreement with a U.S. manufacturing company pursuant to which the manufacturer will provide analytical and process development and cGMP manufacture of Phio’s lead development compound, PH-762.

Scientific and Investor Presentations

In September 2025, Phio delivered podium presentations for its INTASYL self-delivering siRNA technology at the Wainwright Global Investment Conference and the Life Sciences PA Life Sciences Future Conference. The Company presented its Phase 1b clinical trial results to date. The Company also delivered virtual presentations on its INTASYL compounds PH-762 and PH-894 in October 2025 at the Renmark Video Non Deal Roadshow. A poster highlighting an update on the ongoing clinical study for PH-762 was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in National Harbor, MD. In addition, a podium presentation entitled "Synthesized INTASYL siRNA Technology Downregulating Gene Expression" will be held at the Advanced Therapies USA conference 2025 in Philadelphia, PA.

Warrant Inducements

On July 25, 2025, the Company entered into warrant inducement agreements with certain holders of certain of the Company’s existing common stock warrants to exercise such warrants for an aggregate of 928,596 shares of the Company’s common stock. In consideration for the exercise of such warrants and the payment of an additional $0.125 per new warrant, the Company agreed to issue to such holders new unregistered common stock warrants to purchase an aggregate of up to 1,857,192 shares of common stock with an exercise price of $2.485 per share. In connection with this financing, the Company raised approximately $2.1 million after expenses.

On November 3, 2025, the Company entered into warrant inducement agreements with certain holders of certain of the Company’s existing common stock warrants to exercise such warrants for an aggregate of 5,663,182 shares of the Company’s common stock. In consideration for the exercise of such warrants and the payment of an additional $0.125 per new warrant, the Company agreed to issue to such holders new unregistered common stock warrants to purchase an aggregate of up to 11,326,364 shares of common stock with an exercise price of $2.05 per share. In connection with this financing, the Company expects to raise approximately $12.1 million, of which $11.5 million has been received by the Company, with the remainder expected by November 18, 2025.

Third Quarter 2025 Financial Results

Cash Position

At September 30, 2025, the Company had cash and cash equivalents of approximately $10.7 million as compared with approximately $5.4 million at December 31, 2024.

As of the date of this release, the Company had estimated cash and cash equivalents of approximately $21.3 million, which is projected to sustain operations into the first half of 2027.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2025 were $1.2 million compared to $0.6 million for the same period in 2024. The increase in research and development expenses was primarily driven by higher clinical trial costs and chemistry, manufacturing and controls (CMC) costs in connection with advancing our PH-762 program, as well as an increase in R&D employee personnel-related costs.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2025 were $1.3 million compared to $0.9 million for the same period in 2024. The increase in general and administrative expenses was primarily driven by an increase in outsourced professional fees related to accounting and legal services as well as employee stock compensation expense.

Net Loss

Net loss was $2.4 million for the three months ended September 30, 2025 compared with $1.5 million for the same period in 2024. The increase in net loss was due to the changes in research and development and general and administrative expenses as described above.

(Press release, Phio Pharmaceuticals, NOV 13, 2025, View Source [SID1234659914])

On November 13, 2025 Virometix AG, a clinical-stage biotechnology company pioneering fully synthetic vaccines, reported the completion of a $15 million financing round from existing shareholders. The funds will support continued clinical and development activities for V-212, Virometix’s lead serotype-independent pneumococcal vaccine candidate, currently in Phase I clinical evaluation.

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Proceeds from the financing will be used to:

Advance the ongoing Phase I clinical trial of V-212, with topline results expected in Q1 2026.
Prepare for a planned Phase Ib combination trial evaluating V-212 with an approved pneumococcal conjugate vaccine (PCV).
Complete OPK assay validation to support immunogenicity and functional data read-outs.
Implement platform enhancements to the company’s proprietary Synthetic Virus-Like Particle (SVLP) technology.
Progress next-generation serotype-independent pneumococcal vaccine programs toward preclinical development.
"This financing demonstrates the continued confidence and commitment of our investors to Virometix’s mission and platform," said Anna Sumeray, Chief Executive Officer of Virometix. "Our fully synthetic SVLP technology enables the design of broad-spectrum, self-adjuvanted vaccines with highly scalable manufacturing. With V-212 in clinical development, we are well positioned to deliver a truly next-generation approach to pneumococcal prevention."

About V-212

V-212 is a fully synthetic, serotype-independent, peptide-based vaccine designed to prevent Streptococcus pneumoniaeinfections. The vaccine incorporates multiple conserved antigenic epitopes from key pneumococcal surface proteins conjugated to Virometix’s proprietary SVLP nanoparticles, which include built-in adjuvant elements such as T-helper epitopes and Toll-like receptor (TLR) ligands. This unique design eliminates dependence on biological carrier proteins and allows for a streamlined, fully synthetic manufacturing process.

Preclinical studies demonstrated robust and durable immunogenicity in mouse and rabbit models, protection against lethal sepsis, and cross-reactivity with multiple pneumococcal serotypes, including non-PCV-13 types—underscoring V-212’s potential for broad protection.

The ongoing Phase I clinical trial (NCT06975319) is a randomized, double-blind, placebo-controlled, first-in-human study being conducted at the Centre for Vaccinology (CEVAC), Ghent University Hospital. Sixty healthy volunteers aged 18–45 have been enrolled, and topline safety and immunogenicity data are anticipated in the first quarter of 2026.

(Press release, Virometix, NOV 13, 2025, View Source [SID1234659943])