On September 9, 2026 Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported the publication of a case report from the ongoing Phase 1b dose escalation portion of its Phase 1b/2 OLVI-VEC-202-SCLC trial (NCT07136285). The report was published in Frontiers in Oncology, a peer-reviewed journal published by Frontiers Media S.A., available here.

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This is an open-label trial evaluating a single intravenous cycle with multiple doses of Olvi-Vec administered in combination with platinum and etoposide chemotherapy in patients with platinum-relapsed or platinum-refractory small cell lung cancer (SCLC) after failing previous first-line treatment with platinum and etoposide chemotherapy. The trial is being conducted by the Company’s licensing partner, Newsoara HYK Biopharmaceuticals Co. (Shanghai), Ltd. (Newsoara), in China.

"This compelling case published in Frontiers in Oncology provides clinically relevant evidence that strengthens our commitment to evaluating systemic (intravenous) administration of Olvi-Vec in combination with platinum-based chemotherapy and potentially other treatment regimens," said Thomas Zindrick, President, CEO, and Chairman of Genelux. "We are encouraged by the consistency between our preclinical and clinical data with Olvi-Vec-primed immunochemotherapy which supports a mechanism of action by which Olvi-Vec-mediated changes to the tumor microenvironment may enhance responsiveness to therapies in both first-line and recurrent settings."

In this case report, a 58-year-old woman was previously treated for extensive stage SCLC with four cycles of frontline standard treatment with platinum and etoposide, followed by radiotherapy to the lung and prophylactic brain radiotherapy resulting in a 14.3-month progression-free survival (PFS) and a duration of response (DOR) of 13.0 months.

After progressing from standard frontline therapy, the patient received a single course of systemically administered Olvi-Vec, which was well tolerated, and then was re-challenged with eight cycles of platinum and etoposide. The patient achieved a deep and durable partial objective response (84.6% reduction in target lesion size), a PFS of 16.7 months and a DOR of 14.3 months, exceeding those observed during her first-line platinum-based treatment. Moreover, the patient achieved a deeper tumor reduction after 4 cycles of platinum re-challenge as compared to after 4 cycles of first-line treatment (-78.9% vs -67.8%), representing an absolute reduction of 22.0 mm (from a 27.9 mm baseline before initiation of 2nd line therapy) versus 11.6 mm (from a 17.1 mm baseline before initiation of 1st line therapy).

This patient’s experience exceeds historical outcomes reported with platinum rechallenge and support the hypothesis that Olvi-Vec-mediated changes in the tumor microenvironment may contribute to renewed sensitivity to platinum-based therapy.

"Small cell lung cancer is known for its aggressive nature and poor prognosis once it recurs after initial chemotherapy," said Jason Litten, M.D., Chief Medical Officer of Genelux Corporation. "Although this case report reflects the outcome of a single patient and does not establish safety or efficacy or predict similar outcomes in other patients, the magnitude and duration of tumor regression are highly encouraging and align with our scientific rationale for combining Olvi-Vec with platinum-based therapy in various clinical settings."

Patient enrollment is ongoing in the dose-escalation cohorts of OLVI-VEC-202-SCLC and in the VIRO-25 trial, a Phase 2 trial evaluating a single intravenous cycle with multiple doses of Olvi-Vec in combination with platinum chemotherapy and an immune checkpoint inhibitor (ICI) in patients with advanced or metastatic recurrent non-small-cell lung cancer (NSCLC) who failed standard first-line treatment of platinum chemotherapy and an ICI. Additional dose‑finding updates from both the Phase 1b/2 SCLC trial and Phase 2 VIRO‑25 NSCLC trial are expected in 2026. Together, these dose‑finding studies are intended to inform the Company’s lung cancer development strategy and the potential for broader systemic use of Olvi-Vec across additional solid tumor types.

Pursuant to a license agreement entered into in September 2021, Genelux granted to Newsoara BioPharma Co. Ltd. an exclusive license to research, develop, commercialize or exploit Olvi-Vec in China, which includes mainland China, Taiwan, Hong Kong and Macau, for all human diagnostic, prophylactic and therapeutic uses. In October 2025, Newsoara BioPharma Co. Ltd. assigned all of its rights and obligations under the agreement to an affiliate, Newsoara HYK Biopharmaceuticals Co., Ltd. Genelux and Newsoara co-sponsor the Olvi-Vec-SCLC-202 Phase 1b/2 study, which Newsoara is conducting in China.

About Olvi-Vec

Olvi-Vec (olvimulogene nanivacirepvec), Genelux’s lead investigational asset, is a proprietary, modified vaccinia virus being evaluated as an oncolytic immunotherapy. Olvi-Vec’s differentiated mechanism of action (MoA) is designed to directly kill cancer cells, stimulate a tumor-specific immune response, remodel the tumor microenvironment, and re-sensitize tumors to platinum-based chemotherapy with or without ICIs. Genelux is developing Olvi-Vec immunotherapy for multiple cancer types in a strategically integrated program based on robust preclinical data and clinical evidence of its differentiated MoA, feasibility of repeat dosing and a dose-dependent overall survival benefit in cancer patients with primary or metastatic lung diseases. To date, Olvi-Vec has been administered to more than 150 patients across seven completed clinical trials, where Olvi-Vec has been generally well tolerated and demonstrated clinically meaningful benefits. Genelux has granted Newsoara an exclusive license to develop and commercialize Olvi-Vec in greater China (i.e., Mainland China, Hong Kong, Macau and Taiwan).

(Press release, Genelux, SEP 9, 2026, View Source [SID1234670680])

On September 9, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage biotechnology company developing DNA-mediated immunotherapies, reported the agenda and speaker lineup for its upcoming R&D Day highlighting IMNN-001, the Company’s investigational IL-12 immunotherapy. The event will be held at the Sofitel New York in New York City on Wednesday, September 23, 2026, beginning at 10:00 a.m. ET.

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To register to attend the event in person or virtually, please RSVP by clicking here.

"We look forward to gathering with investors and scientific leaders to showcase key progress across our IMNN-001 clinical program," said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. "With our Phase 3 OVATION 3 trial advancing and insightful data emerging from our Phase 2 MRD study, this event highlights our commitment to redefining treatment paradigms for women facing advanced ovarian cancer. A highlight of the event will be a conversation with an OVATION 1 clinical trial participant who received IMNN-001 in the study."

The event will feature a conversation with an OVATION 1 clinical trial participant offering a firsthand perspective on her experience in the study and in the years following the trial. Presentations will include leading experts in ovarian cancer and principal investigators involved in the Company’s Phase 3 OVATION 3 clinical trial and the Phase 2 minimal residual disease (MRD) clinical trial, conducted in partnership with the Break Through Cancer Foundation.

Members of IMUNON’s management team will join these experts to deliver updates on new IMNN-001 data and discuss the potential role of IMNN-001 in transforming the treatment landscape for women with advanced ovarian cancer. A live Q&A session and networking opportunities will follow the formal presentations.

Featured Presentations and Speakers:

Redefining Frontline Care — Unlocking the Potential of a First-in-Class IL-12 Immunotherapy in Ovarian Cancer
Presenter: Stacy R. Lindborg, Ph.D., President and Chief Executive Officer, IMUNON, Inc.
Resurrecting IL-12: Overcoming Historical Barriers with Targeted TheraPlas Delivery of IMNN-001
Presenter: Douglas V. Faller, M.D., Ph.D., Chief Medical Officer, IMUNON, Inc.
Unveiling Translational Insights — MRD Clearance, Microenvironment Remodeling, and Combination Strategies
Presenter: Amir Jazaeri, M.D., Vice Chair for Clinical Research, Director, Gynecologic Cancer Immunotherapy Program, Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center
Advancing Frontline Efficacy — Translating OVATION 2 Overall Survival Signals into Pivotal Phase 3 OVATION 3
Presenter: Premal H. Thaker, M.D., David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Chief of Gynecologic Oncology, Director of Gynecologic Oncology Clinical Research, Professor in Gynecologic Oncology, Washington University School of Medicine
Beyond the Data: Clinical Experience with IMNN-001 — A Conversation with an OVATION 1 Study Participant
Presenter: OVATION 1 clinical trial participant, with William Bradley, M.D., Professor and Vice Chair for Clinical Research, Division of Gynecologic Oncology, Medical College of Wisconsin
Building the Future — Strategic Milestones, Catalysts, and the Investment Horizon
Presenter: Stacy R. Lindborg, Ph.D., President and Chief Executive Officer, IMUNON, Inc.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local production of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m² administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

(Press release, IMUNON, SEP 9, 2026, View Source [SID1234670679])

On September 9, 2026 Aktis Oncology, Inc. ("Aktis"), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies, reported that Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology, will participate in the following investor conferences in September.

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Morgan Stanley 24th Annual Global Healthcare Conference
Date & Time: Wednesday, September 16, 2026, at 8:30 a.m. ET
Location: New York, NY

Oppenheimer 4th Annual Targeted Radiopharmaceutical Therapies in Oncology Summit
Date: Thursday, September 17, 2026
Location: New York, NY

A live webcast of the Morgan Stanley presentation may be accessed via the Investors section of the Aktis website at investors.aktisoncology.com. An archived replay of the event will be available on the website for approximately 90 days following the conference.

About Aktis’ Radioconjugate Platform

Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anticancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end clinical supply chain built for resiliency and scalability, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, SEP 9, 2026, View Source [SID1234670678])

On September 9, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that Dr. Christian Behrenbruch, Managing Director and Group CEO and Kevin Richardson, CEO, Precision Medicine will present at the upcoming Morgan Stanley 24th Annual Global Healthcare Conference and at the H.C. Wainwright 28th Annual Global Investment Conference, both in New York, NY.

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Presentation details:

Morgan Stanley 24th Annual Global Healthcare Conference
Date: September 14, 2026
Time: 9:15 a.m. EDT (11:15 p.m. AEST)

H.C. Wainwright 28th Annual Global Investment Conference
Date: September 15, 2026
Time: 10:30 a.m. EDT (12:30 a.m. AEST, Sep 16)

Both sessions will be webcast live, and accessible through Telix’s Investor Relations website.

For more information including how to register, please visit: View Source

(Press release, Telix Pharmaceuticals, SEP 9, 2026, View Source [SID1234670677])

On September 9, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported initial results from SURF302, its Phase 2 study evaluating oral dabogratinib in patients with FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer (LG IR NMIBC). The study provided clinical proof of concept for selective oral FGFR3 inhibition and identified 60 mg once-daily (QD) as the potential dose supporting TYRA’s planned registrational adjuvant development strategy.

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Approximately 70% of patients with LG IR NMIBC do not receive adjuvant therapy intended to reduce recurrence, despite evidence that intravesical treatment lowers recurrence risk. Instead, many patients choose surveillance, or "watch and wait", because existing therapies involve repeated catheterization and office-based procedures that can make the burden of treatment outweigh its perceived benefit. TYRA believes oral dabogratinib, if approved, has the potential to change that paradigm by offering patients a convenient, once-daily oral therapy.

"We are extremely excited to report initial results from SURF302 today as we work to advance what we believe could become the first once-daily oral therapy for patients with low-grade IR NMIBC," said Todd Harris, Ph.D., Chief Executive Officer of TYRA Biosciences. "These results belong first and foremost to the patients participating in SURF302 and the investigators and study teams who have made this research possible. We’re incredibly grateful for their partnership."

"SURF302 has effectively given us two studies in one, informing dual settings in which dabogratinib could potentially be used. Patients with a single marker lesion — whose minimal disease most closely mirrors the adjuvant setting (where no tumor is left behind) and historical marker lesion studies — achieved a 100% overall response rate (ORR) (8/8) with 60 mg QD, including a 75% complete response (CR) rate as best overall response (BOR), demonstrating the activity of this dose for our planned Phase 3 adjuvant study," said Doug Warner, M.D., Chief Medical Officer of TYRA. "Patients with multiple marker lesions carry a higher tumor burden, more representative of an ablative setting, and our preliminary exposure-response analyses suggest that higher drug exposure may be important there. Dabogratinib’s favorable safety results to date give us the opportunity to evaluate a higher dose in that setting. Taken together, these data have meaningfully expanded our understanding of dabogratinib as we look to continue to advance development into Phase 3 studies."

"As a community-based urologist, one of the greatest challenges isn’t identifying patients who could benefit from therapy—it’s that many choose surveillance because the burden of repeated catheterization and intravesical treatments outweighs the perceived benefit," said Mark Silva, M.D., Greater Boston Urology. "Too often, those patients are simply waiting to recur. A well-tolerated once-daily oral therapy could fundamentally change that conversation – giving patients an option they may be more willing to accept, and giving physicians the chance to intervene before the next recurrence rather than react after it occurs."

Initial safety and tolerability results. As of the August 31, 2026 data cutoff, initial safety and tolerability results for oral dabogratinib were favorable across the 60 mg QD (n=22) and 50 mg QD (n=22) dose cohorts. Most treatment-emergent adverse events (TEAEs) were Grade 1 or 2, with Grade 3 TEAEs in 3 participants (14%) at 60 mg and 2 participants (9%) at 50 mg. Grade 3 treatment-related AEs occurred in 2 of 44 participants (4.5%) across both cohorts, both at 50 mg QD, with none at 60 mg QD. There were no Grade 4 or 5 TEAEs. TYRA believes these results are consistent with the potential for chronic once-daily administration.

At 60 mg QD, there were no dose reductions or treatment-related discontinuations.
No clinically significant hyperphosphatemia, nail toxicity, or ocular toxicity was observed.
TEAEs were generally manageable.
Transaminase TEAEs were observed at low frequency (< 10%).
The most frequently reported TEAEs at 60 mg QD were fatigue, diarrhea and dry eye. Diarrhea was generally Grade 1, transient, and limited.
Initial efficacy results. As of the August 31, 2026 data cutoff, 26 participants were evaluable for efficacy across the 60 mg QD (n=14) and 50 mg QD (n=12) cohorts (participants who received study treatment and had undergone at least the month 3 disease assessment). All responses below are subject to change with continued treatment and follow-up.

Combined Single and Multiple Marker Lesion Response

60 mg QD Cohort (n=14)

50 mg QD Cohort (n=12)

3-Month
Assessment

BOR

3-Month Assessment and BOR

ORR

79% (11/14)

79% (11/14)

67% (8/12)

CR

57% (8/14)

64% (9/14)#

33% (4/12)

Partial
Response (PR)

21% (3/14)

14% (2/14)

33% (4/12)

#Best overall response CR includes the initial 60 mg participant with a 3-month PR who converted to CR at the 6-month assessment. No
 other 60 mg participant with a 3-month PR had reached the 6-month assessment at data cutoff.

Single Marker Lesion Response

60 mg QD Cohort

(n=8)

All Doses, 50 mg and 60 mg Pooled
(n=16)

3-Month
Assessment

BOR

3-Month
Assessment

BOR

ORR

100% (8/8)

100% (8/8)

94% (15/16)

94% (15/16)

CR

63% (5/8)

75% (6/8)#

50% (8/16)

56% (9/16)#

PR

38% (3/8)

25% (2/8)

44% (7/16)

38% (6/16)

#Best overall response CR includes the initial 60 mg participant with a 3-month PR who converted to CR at the 6-month assessment. No
  other 60 mg participant with a 3-month PR had reached the 6-month assessment at data cutoff.

All 3-month CRs with 6-month assessments remained in response at 6 months (n=5).
The first participant in the study remained in CR at 12 months and continued on study drug at 14 months.
Dose-optimization and registrational strategy.

Preliminary exposure-response analyses across the 50 mg QD and 60 mg QD cohorts showed an ORR of 86% (12/14) among participants with a target steady-state exposure above the AUC threshold of 2500 ng‧hr/mL, compared with 58% (7/12) among participants below the threshold. The exposure-response relationship was most apparent among participants with multiple marker lesions, while responses in participants with a single marker lesion occurred across the observed exposure range — supporting 60 mg QD in the planned adjuvant setting, where disease burden is minimal, and the evaluation of a higher dose in the ablative setting.
TYRA plans to complete enrollment in the 60 mg QD cohort and initiate a 70 mg QD cohort to explore dabogratinib in the ablative setting. TYRA also plans to engage health authorities on Phase 3 study design and dose selection and, subject to that feedback, to continue preparations for a planned registrational adjuvant study.
Initial observation from SURF303 in LG UTUC. In SURF303, TYRA’s Phase 2 study evaluating oral dabogratinib in patients with low-grade upper tract urothelial cancer (LG UTUC), the first patient treated achieved a complete response at the 3-month assessment with 60 mg QD, with no observed TEAEs and remained on study drug as of the August 31, 2026 data cutoff.

Conference Call and Webcast

TYRA is hosting a conference call and webcast today, September 9, 2026, at 8:00 am ET to discuss the initial SURF302 study results with oral dabogratinib. Participants may access a live webcast of the call and the associated slide presentation following the conclusion of the call on the "For Investors" page of the TYRA website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 90 days.

About SURF302

SURF302 (NCT06995677) is a Phase 2, multicenter, open-label clinical study evaluating the efficacy and safety of oral dabogratinib in adults with FGFR3-altered low-grade IR NMIBC. The study includes dose-optimization cohorts and is designed to support the potential development of dabogratinib as an adjuvant therapy. Key endpoints include best overall response, complete response at three months, time to recurrence, duration of response, recurrence-free survival, progression-free survival, safety and tolerability. For more information, please visit the Patients page of the Company’s website at View Source or View Source

About Intermediate-Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

Bladder cancer is one of the most common cancers in the United States, with more than 760,000 people living with the disease. Many patients are diagnosed with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC), a disease characterized by frequent tumor recurrence that often requires repeated surveillance and surgical intervention over many years. Current treatment typically includes transurethral resection of bladder tumor (TURBT) followed by intravesical chemotherapy administered through repeated bladder catheterization. Despite evidence that adjuvant intravesical therapy can reduce recurrence, approximately 70% of patients with LG IR NMIBC do not receive treatment intended to prevent recurrence, highlighting a significant unmet medical need for more accessible and better-tolerated treatment options. Dabogratinib is the only investigational oral FGFR3-selective therapy currently in clinical development for patients with FGFR3-altered IR NMIBC.

About Dabogratinib

Dabogratinib is TYRA’s lead precision medicine candidate stemming from its in-house SNÅP platform. Dabogratinib is an investigational, oral, FGFR3-selective inhibitor currently in Phase 2 development for the treatment of urologic cancers and skeletal dysplasias, specifically low-grade upper tract urothelial carcinoma (LG UTUC), IR NMIBC and achondroplasia (ACH). TYRA believes dabogratinib was the first orally available, FGFR3-selective inhibitor to enter clinical development, and it has been studied in more than 200 individuals to date across multiple clinical and healthy volunteer studies. Oral dabogratinib is currently advancing in three Phase 2 clinical trials: SURF303 in LG UTUC, SURF302 in IR NMIBC and BEACH301 in ACH. The FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to oral dabogratinib for the treatment of achondroplasia.

(Press release, Tyra Biosciences, SEP 9, 2026, View Source [SID1234670675])