On December 3, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, reported that Chief Medical Officer Gordon Downie, MD, PhD, will present a poster at the American Cancer Society National Lung Cancer Roundtable (NLCRT) showcasing three cases in which CyPath Lung, a noninvasive sputum-based flow cytometry test, successfully identified Stage 1A lung cancer in patients with atypical and diagnostically challenging presentations.

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"Indeterminate pulmonary nodules pose a significant and growing clinical burden, especially when clinicians are confronted with conflicting or inconclusive diagnostic data," Dr. Downie said. "Risk calculators, imaging, genetic testing, and biomarker tools can at times point in opposing directions, leaving clinicians and patients uncertain about next steps. This challenge is amplified in patients with unusual risk profiles, discordant imaging and advanced age."

Dr. Downie’s poster, "CyPath Lung in Practice: From Uncertainty to Clarity and Confidence," details three complex cases from his tenure as Director of the Titus Regional Hospital Lung Nodule Clinic and Interventional Pulmonology. CyPath Lung was used alongside other diagnostic tools, including standard low-dose CT (LDCT), PET imaging, risk calculators, bronchoscopy and blood serum marker tests. In each case, CyPath Lung provided clarity and actionable results which led to confirmed diagnoses at the earliest and most treatable stage.

"These three cases illustrate scenarios that are increasingly common in real-world lung nodule practice," Dr. Downie said. "Incorporating CyPath Lung into the diagnostic pathway can accelerate diagnosis, guide difficult conversations with anxious patients, and prevent unnecessary invasive procedures that carry their own risks."

The NLCRT is a coalition of 194 medical, public health, advocacy, government, and corporate organizations that work together to fight lung cancer by working collectively and collaboratively to reduce lung cancer mortality. This year’s annual meeting is December 8-9, 2025, at the Grand Hyatt Atlanta in Buckhead, Atlanta, Georgia.

Dr. Downie’s poster session is scheduled for Monday, December 8, 2025, from 2:35-3:15 p.m. ET. The poster can be viewed on the bioAffinity website.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

(Press release, BioAffinity Technologies, DEC 3, 2025, View Source [SID1234661094])

On December 3, 2025 TransThera Sciences Nanjing, Inc. (the "TransThera") reported that Tinengotinib tablets have been included in the List of Products for Priority Review by the Center for Drug Evaluation ("CDE") of the National Medical Products Administration ("NMPA") of the PRC, with the proposed indication for the treatment of adults with unresectable advanced or metastatic cholangiocarcinoma (CCA) who have received at least one prior systemic treatment and FGFR inhibitor treatment. Previously, Tinengotinib has been granted Breakthrough Therapy Designation by the NMPA for the treatment of CCA.

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Disclaimer: This article serves as a press release by TransThera to disclose the company’s latest developments. It is not intended as a product promotion advertisement and does not constitute the company’s investment advice.

About Tinengotinib

Tinengotinib is an internally discovered, registrational clinical stage, multi-kinase inhibitor that exerts antitumor effects by targeting FGFRs/VEGFRs, Aurora kinases and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of Tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by the NMPA in China, the Orphan Drug Designation (ODD) for the treatment of biliary tract cancer by the EMA.

(Press release, TransThera Biosciences, DEC 3, 2025, View Source [SID1234661112])

On December 3, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech") reported that 184,071,410 shares of CureVac N.V. (Nasdaq: CVAC, "CureVac"), representing approximately 81.74% of CureVac’s issued and outstanding shares, were validly tendered and not properly withdrawn prior to the expiration of the initial offering period at 9:00 a.m. Eastern Time on December 3, 2025. As a result, the minimum condition for the exchange offer (the "Offer") has been satisfied, and all validly tendered shares have been accepted. All closing conditions related to the completion of the post-offer reorganization have now been satisfied. BioNTech will now proceed to deliver BioNTech American Depositary Shares ("ADSs") (and/or cash in lieu of fractional BioNTech ADSs) to the holders of CureVac shares who have tendered their shares, to close the transaction, as set out in more detail in the offer documents (as referred to below).

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BioNTech also announced that the subsequent offering period has commenced. CureVac shareholders who have not yet tendered their shares may still tender during the subsequent offering period, which will expire at 12:01 a.m. Eastern Time on Thursday, December 18, 2025. No guaranteed delivery procedures apply.

The parties will initiate the post-offer reorganization as promptly as practicable following the expiration of the subsequent offering period. The post-offer reorganization will result in non-tendering holders of CureVac shares receiving BioNTech ADSs (and/or cash in lieu of fractional BioNTech ADSs) pursuant to the post-offer reorganization (rather than the Offer). Non-tendering holders of CureVac shares who receive BioNTech ADSs (and/or cash in lieu of fractional BioNTech ADSs) pursuant to the post-offer reorganization generally will be subject to a 15% Dutch dividend withholding tax.

Promptly after the completion of the post-offer reorganization, shares held by non-tendering CureVac shareholders will cease to be tradable on any national stock exchange and may be subject to additional transfer restrictions.

Please refer to the Exchange Offer Prospectus, the EU Prospectus, or the UK exemption document (each as referred below) for more information and a full description of the summaries above.

(Press release, BioNTech, DEC 3, 2025, View Source [SID1234661095])

On December 3, 2025 ImmVira Group ("ImmVira" or the "Company") reported a poster presentation at the 26th Annual Meeting of the Society of Urologic Oncology (SUO 2025). The presentation featured the latest interim clinical data (as of September 19, 2025) for its lead HSV-1 oncolytic virus product. MVR-T3011, in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients.

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The patients were enrolled and treated with intravesical MVR-T3011 at two dose levels: 2×109 PFU and 1×1010 PFU in this study. There were a total of 26 patients with papillary (16 patients at the dosage level of 2×109 PFU, 10 patients at the dosage level of 1×1010 PFU), and a total of 12 patients with carcinoma in situ (CIS) (7 patients at the dosage level of 2×109 PFU, 5 patients at the dosage level of 1×1010 PFU) enrolled in this trial. Data from the patients demonstrated a promising efficacy profile:

Among 16 evaluable patients with BCG-unresponsive papillary who received MVR-T3011 at a dose of 2×109 PFU, the 3-month, 6-month, 9-month and 12-month recurrence-free survival (RFS) rates were 87.1%, 80.4%, 80.4% and 71.4%, respectively. Among 6 evaluable patients who received MVR-T3011 at a dose of 1×1010 PFU, 100% of patients remained recurrence free at Month 3 and Month 6.
As of the same date, among 7 evaluable patients with BCG-unresponsive CIS (with or without Ta/T1) who received MVR-T3011 at doses of 2×109 PFU, the CR at any time, 3-month and 6-month CRR was 71.4%, and among 5 evaluable patients with BCG-unresponsive CIS (with or without Ta/T1) who received MVR-T3011 at doses of 1×1010 PFU, the CR at any time, 3-month and 6-month CRR was 100%.
Consistent with previous clinical findings, MVR-T3011 continued to demonstrate a favorable safety and tolerability profile in the latest study. Most treatment-emergent adverse events (TEAEs) were at Grades 1 or 2. Only five Grade 3 TEAEs were reported, two of which were treatment-related adverse events (TRAEs) and were consistent with reactions commonly associated with catheterization procedures. No Grade 3 or above TEAEs and no dose-limiting toxicities (DLT) occurred.

According to Frost & Sullivan, bladder cancer is one of the top 10 most common solid tumors globally by incidence and often requires prolonged treatment and surveillance spanning 5-10 years. NMIBC is a main type of bladder cancer, representing approximately 75% of all newly diagnosed bladder cancer cases. The current standard of care for high-risk NMIBC is Bacillus Calmette-Guerin (BCG). However, the availability of BCG is significantly limited by global supply shortages. In the U.S., BCG supply meets less than 30% of the total demand. These significant unmet medical needs highlight a clear opportunity for novel immunotherapies such as oncolytic viruses, which hold considerable potential as a new mechanism of action in this underserved market.

"We are highly encouraged by the interim efficacy data from the study, especially the high CR and RFS rate for both BCG-unresponsive CIS and papillary patients at 1×1010 PFU," said Dr. Grace Zhou, Chairwoman and CEO of ImmVira. "We have initiated a phase II trial for BCG-unresponsive high-risk NMIBC in the U.S. in June 2025 and are progressing a global multi-regional clinical trial (MRCT) inclusive of China. We believe MVR-T3011 could emerge as the new generation of therapy for patients with high-risk, BCG-unresponsive NMIBC."

About MVR-T3011

MVR-T3011, represents a breakthrough in HSV-1-based oncolytic immunotherapy. Its proprietary "3-in-1" design unites a replication-competent, tumor-lytic HSV-1 backbone with anti-PD-(L)1 antibody and IL-12, enabling it simultaneously to lyse tumor cells and stimulate innate and adaptive immunity. MVR-T3011 has demonstrated its adaptability and feasibility across multiple routes of administration including intratumoral, intracavitary and intravenous administrations. MVR-T3011 is the world’s first HSV-1-based oncolytic immunotherapy that has completed a phase I trial via systemic intravenous dosing under the FDA regulatory regime.

(Press release, Immvira, DEC 3, 2025, View Source [SID1234661113])

On December 3, 2025 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, reported that the previously disclosed 6-month follow-up data from the ongoing Phase 2 study of NDV-01, a sustained release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for non-muscle invasive bladder cancer (NMIBC) will be presented in a poster at the Society of Urologic Oncology 26th Annual Meeting (SUO 2025). The poster (#143) will be presented by Yair Lotan, MD, Chairman of Relmada’s Clinical Advisory Board, on Thursday, December 4th at 2:30 PM MT in Phoenix, AZ.

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Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics, noted, "We believe NDV-01 has the opportunity to transform the treatment of NMIBC by providing patients and physicians with a potential bladder-sparing, in-office, ready-to-use, safe, effective and durable, best-in-class therapy. We are on track to initiate the Phase 3 program in H1 2026, building on the encouraging, recently announced 9-month data, showing a 92% complete response (CR) rate at any time point, and encouraging recent FDA discussions, which provide us with a well-defined registrational strategy in two distinct indications in NMIBC with limited treatment options."

The Society of Urologic Oncology 26th Annual Meeting Information:

Title: Prospective Open-Label Study to Evaluate the Safety and Efficacy of Intravesical Sustained-Release Gemcitabine Docetaxel combination (NDV-01) in High-Risk NMIBC: Update with 6-month Complete Response Data
Poster Number: #143
Date and Time: Thursday, December 4th at 2:30 PM MT

A copy of the poster will be available on the Events section of the Relmada website after the session. To review the an overview of the 9-month data and FDA discussions, click here.

About NDV-01

NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. The NDV-01 formulation is a ready to use, convenient to administer in-office in less than 10 minutes, and does not require anesthesia or specialized equipment. It is protected by patents through 2038.

About the Phase 2 Study

The Phase 2 study (NCT06663137) is an open-label, single-arm, single-center study evaluating the safety and efficacy of NDV-01 in patients with HG-NMIBC. Patients are treated with NDV-01 in a biweekly induction phase, follow by monthly maintenance for up to one year, with regular assessments via cystoscopy, cytology, and biopsy, as indicated. The primary efficacy endpoints are safety and complete response rate (CRR) at 12 months, and secondary efficacy endpoints are duration of response (DOR) and event free survival (EFS).

About NMIBC

NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50–80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.

(Press release, Relmada Therapeutics, DEC 3, 2025, View Source [SID1234661917])