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FENNEC PHARMACEUTICALS ANNOUNCES PROPOSED OFFERING OF COMMON SHARES

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])

Translational Data and Significant Pathologic Response Rates from EFTISARC-NEO Phase II Highlighted in Oral Presentation at CTOS 2025

On November 13, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported positive data from the EFTISARC-NEO trial that were detailed in an oral presentation by Paweł Sobczuk, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting held in Boca Raton, Florida.

The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) significantly exceeded the study’s prespecified level of pathologic response rates. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001), meeting the study’s primary endpoint.1

These promising results were achieved in patients with ten different STS subtypes including rare and/or highly aggressive tumours with poor prognosis such as myxofibrosarcoma (N=16), undifferentiated pleomorphic sarcoma (N=10) and malignant peripheral nerve sheath tumor (N=2).

Early translational data from the initial twenty patients who underwent surgery in the trial show a strong immune system activation in line with efti’s mode of action, with statistically significant increases in the expression of key cytokines and chemokines in peripheral blood — specifically CXCL9, CXCL10, IL-23, and IFN-g.

Immune Response Biomarkers (fold change from week 1 through pre-surgery)

Serum Biomarker Fold change (p-value)
C-X-C motif chemokine ligand 9 (CXCL9)

2.5x (p<0.01)
C-X-C motif chemokine ligand 10 (CXCL10)

1.8x (p<0.0001)
Interleukin-23 (IL-23)

2.2x (p<0.05)
Interferon-gamma (IFN-g)

2.5x (p<0.05)
The increase on treatment of immune response biomarkers like IFN-gamma correlated with pathologic responses in this study, meaning patients with a biomarker increase during treatment also had a higher probability of a good clinical response at surgery.

The promising tumour hylanization/fibrosis rate achieved (over 3X greater than standard-of-care radiotherapy based on historical data)1 may hold significance in terms of future outcomes as it serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients.2,3 Disease-free survival and overall survival data are immature at this stage and will be presented in the future. Further correlative translational studies are also ongoing.

Dr. Paweł Sobczuk, one of the trial’s principal investigators, stated: "We are excited to share these strong results in resectable soft tissue sarcoma, a challenging indication with a high unmet medical need. This level of efficacy, observed across ten different STS subtypes including rare, highly aggressive tumours with poor prognosis, further supports the hypothesis that efti’s distinctive activation of antigen-presenting cells—and consequent induction of both adaptive and innate immunity—plays a key role in driving a coordinated immune response to fight cancer. This novel combination with neoadjuvant efti warrants further investigation in registrational settings."

"Our team was delighted to have recently been awarded the distinguished Golden Scalpel Award (Złoty Skalpel)* for EFTISARC-NEO. This honour is reserved for projects that demonstrate exceptional innovation and impact in medical research and clinical practice," added Dr. Sobczuk.

Dr. Frédéric Triebel, CSO of Immutep, said: "We are pleased to see a confirmation of earlier promising data on now 38 patients in this difficult-to-treat cancer. The prolonged increase in serum immune response biomarkers, observed two weeks after efti subcutaneous injection, is indicative of a robust adaptive and innate immune response. This enhanced immune activity is crucial because it means the body’s own defences are being mobilised to target and destroy cancer cells more effectively, further supporting the positive impact of the observed pathologic responses. The recent results suggest that efti may have potential applications beyond advanced or metastatic cancer, extending into earlier-stage disease."

As neoadjuvant immunotherapy becomes more established in the treatment of early-stage cancers, the findings from EFTISARC-NEO highlight the possibility for efti to be used in patients who have a lower tumor burden at diagnosis. This could expand the range of patients who might benefit from efti, potentially increasing its role in the treatment landscape for cancers that are still localized and resectable.

STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.4

For more information on EFTISARC-NEO, visit clinicaltrials.gov (NCT06128863). The CTOS 2025 oral presentation slides can be found on the Posters & Publications page of Immutep’s website.

*About the Golden Scalpel Award in Poland

The Golden Scalpel Award in Poland is recognized as a benchmark of excellence within the medical community. It is presented by independent experts to initiatives that set new standards in advancing healthcare. This year, EFTISARC NEO was the only oncology project to receive this accolade, underscoring its leadership and breakthrough potential in cancer treatment.

About Eftilagimod Alfa (Efti)

Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, NOV 13, 2025, View Source [SID1234659971])

JSR Life Sciences Enters Definitive Agreement to Transfer Crown Bioscience to Adicon Holdings Limited

On November 13, 2025 JSR Life Sciences LLC ("JSR Life Sciences"), a global leader in life sciences materials and services, reported it has entered into a definitive agreement to transfer Crown Bioscience Inc. ("Crown Bioscience") to Adicon Holdings Limited ("Adicon"), a premier independent clinical laboratory provider in China and a portfolio company of The Carlyle Group. The transaction, subject to customary closing conditions, is expected to close in 2026.

This strategic move will enable Crown Bioscience to operate as a standalone entity under Adicon’s ownership. Crown Bioscience’s comprehensive portfolio of translational oncology services, including its world-leading patient-derived xenograft (PDX) models, tumor organoid platforms, immuno-oncology assays, and bioinformatics solutions, will transition to Adicon, positioning the company to accelerate advancements in precision medicine and drug discovery for oncology.

Crown Bioscience’s Global Biospecimens business, headquartered in Hamburg, Germany, with facilities in Frederick, MD, will remain fully integrated within JSR Life Sciences. The Biospecimens team will continue to benefit from JSR’s robust global resources, innovation ecosystem, and focus on ethical sourcing, custom procurement, and advanced sample processing and storage capabilities.

"After careful strategic review, we believe this transaction represents an optimal path forward for both Crown Bioscience and JSR Life Sciences," said Tim Lowery, President and CEO of JSR Life Sciences. "Adicon’s deep domain expertise and financial backing from The Carlyle Group will empower Crown to scale its groundbreaking oncology services to new heights. As part of our long-standing onshore strategy, Crown remains firmly committed to serving clients through its global network of facilities, including its headquarters in San Diego and recent investments in the US and Europe. Initiatives like the launch of new Model Development Center in North Carolina and the expansion of biomarker and imaging capabilities in the UK ensure that customers have access to the same exceptional Crown experience, no matter where they choose to conduct their study."

Adicon, recognized as one of China’s largest independent clinical laboratory service providers, brings complementary strengths in high-throughput testing and data analytics to the partnership. Backed by global investment firm Carlyle’s extensive network and resources in healthcare and life sciences industry, Adicon is well-positioned to support Crown Bioscience’s growth trajectory.

Ms. Yang Ling, Chairwoman of Adicon and Head of Asia Healthcare at Carlyle, commented, "This acquisition represents an important milestone in Adicon’s growth journey. With Crown Bioscience’s world-class CRO capabilities, Adicon is expanding its reach across the global healthcare value chain– from clinical diagnostics to drug discovery and translational research. This transaction reinforces Adicon’s vision to become a trusted partner for biopharma innovation and precision diagnostics."

Until the transaction closes, Crown Bioscience will continue to operate as a wholly owned subsidiary of JSR Life Sciences, with no anticipated disruptions to ongoing services, projects, or customer relationships. JSR and Adicon are committed to a smooth transition, maintaining the highest standards of quality, compliance, and innovation across all operations.

(Press release, Crown Bioscience, NOV 13, 2025, View Source [SID1234659945])

First Patient Dosed in SYNERGY-101, a Global, Randomized Phase 2 Clinical Trial of STK-012 in First-Line, PD-L1 Negative Nonsquamous Non-Small Cell Lung Cancer

On November 13, 2025 Synthekine Inc., an engineered cytokine therapeutics company, reported that the company has dosed the first patient in the SYNERGY-101 study. SYNERGY-101 is a global, randomized Phase 2 clinical trial evaluating STK-012 combined with pembrolizumab and chemotherapy (PCT) vs. PCT in first-line, PD-L1 negative nonsquamous non-small cell lung cancer (NSCLC).

"This marks a key milestone for Synthekine as we advance STK-012 into a randomized Phase 2 trial," said Debanjan Ray, Chief Executive Officer of Synthekine. "Our promising Phase 1b data suggest that STK-012 may lead to a meaningful improvement in outcomes in PD-L1 negative NSCLC, a population with limited benefit from current therapies."

Positive Phase 1b results presented at SITC (Free SITC Whitepaper) 2025 showed a 50% response rate in PD-L1 negative nonsquamous NSCLC patients treated with STK-012 in combination with PCT, substantially higher than the 23–32% response typically seen with standard of care alone. Notably, similarly high response rates were observed in patients with immune-resistant tumor profiles, such as those patients with STK11 or KEAP1 mutations, which have a high prevalence in PD-L1 negative NSCLC.

"PD-L1 negative patients represent 30-40% of new nonsquamous NSCLC diagnoses and typically face poor prognosis on standard-of-care therapy, highlighting the need for new treatment options in this setting," said Naiyer Rizvi, M.D., Chief Medical Officer of Synthekine. "SYNERGY-101 will help determine whether STK-012 can offer a new standard of care for this underserved population."

For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT05098132.

About SYNERGY-101

SYNERGY-101 is a global, randomized Phase 2 study designed to evaluate the safety and efficacy of STK-012 in combination with PCT in first line, PD-L1 negative nonsquamous NSCLC patients. This trial aims to enroll approximately 105 patients, with a primary endpoint of overall response rate based on RECIST v1.1. Secondary endpoints include progression-free survival and safety.

About PD-L1 Negative Nonsquamous Non-Small Cell Lung Cancer

Lung cancer is the third-most common cancer in the United States and is a serious and life-threatening disease, which is expected to account for 20% of cancer deaths in 2025.1 Nonsquamous NSCLC is the most common form of lung cancer and PD-L1 negative patients account for 30 – 40% of these patients, who have a poor prognosis despite currently available standard-of-care therapies.

1Cancer Facts & Figures 2025, American Cancer Society (ACS), Atlanta, Georgia, 2025

About STK-012

STK-012 is a first-in-class α/β-IL-2 receptor biased partial agonist engineered to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, while minimizing activation of other lymphocytes, such as natural killer (NK) cells or naïve T cells, which are associated with IL-2 related toxicity.

(Press release, Synthekine, NOV 13, 2025, View Source [SID1234659944])

Virometix AG Announces Completion of $15 Million Financing Round to Advance Development of V-212 and Next-Generation Synthetic Vaccines

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.

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])