On September 10, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported positive preclinical results evaluating pelareorep in combination with a pan-RAS inhibitor in a RAS-driven colorectal cancer model.

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During the initial treatment period, when pelareorep was administered every other day, pelareorep, the pan-RAS inhibitor and the combination each reduced tumor growth compared to the control. The greatest tumor reductions were observed in the RAS inhibitor and combination groups, demonstrating that pelareorep activity was maintained in the presence of RAS inhibition without evidence of antagonism between the two therapies.

Following the transition to less frequent weekly pelareorep dosing, the incremental activity associated with pelareorep became less evident. Together, these findings support further evaluation of optimized pelareorep dosing with RAS inhibitors and the hypothesis that sustained pelareorep activity could potentially deepen or prolong responses to RAS-targeted therapy and thereby delay the emergence of treatment resistance.

Importantly, the findings are consistent with previously published independent research demonstrating that RAS inhibitors do not interfere with the mechanism through which pelareorep selectively infects tumor cells. This biological compatibility provides a rationale for further evaluating whether pelareorep’s tumor-selective and immunologic activity can complement the direct antitumor effects of RAS inhibition and potentially delay the development of resistance.

"These results provide an encouraging first look at combining pelareorep with one of the most important emerging classes of targeted cancer therapies," said Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics. "We observed pelareorep activity during the initial intensive dosing period as well as biologic compatibility between pelareorep and RAS inhibition, supporting the continued evaluation of pelareorep/RAS inhibitor combination therapy. Because acquired resistance remains a major limitation of RAS-targeted therapies, we believe these findings provide a compelling rationale to investigate whether sustained pelareorep activity can deepen and prolong responses to RAS inhibition and potentially delay the emergence of resistance. Similarly, pelareorep, because of its unique mechanism of action, may offer a treatment option for patients who become resistant to RAS inhibitors."

Oncolytics plans to expand its preclinical evaluation of pelareorep with RAS inhibitors across additional dosing schedules and RAS-driven tumor models. These studies will be designed to further characterize pelareorep’s contribution to the combination, including its potential impact on the depth and durability of tumor response and the development of resistance to RAS-targeted therapy.

About Pelareorep

Pelareorep is an intravenously delivered, systemically active, investigational immunotherapy with a dual mechanism of action that selectively replicates in tumor cells while activating both innate and adaptive anti-tumor immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. It has been administered to over 1,200 patients, and clinical studies have demonstrated pelareorep’s potential to enhance the activity of checkpoint inhibitors and other anti-cancer therapies across multiple solid tumor types.

(Press release, Oncolytics Biotech, SEP 10, 2026, View Source [SID1234670723])

On September 10, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a precision guided, biotech/life sciences company focused on advancing novel and potentially disruptive therapeutic assets, reported that an abridged Clinical Study Report (CSR) for SKNJCT-003 (NCT06608238) has been posted on ClinicalTrials.gov, providing transparent public access to the efficacy, safety, drug-delivery and clinical findings from the completed Phase 2 study.

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Publication of the abridged CSR represents an important scientific milestone for SkinJect and provides a transparent public record of the completed Phase 2 findings. The Company believes the dataset provides the clinical foundation for its focused development strategy, prioritizing the FDA-authorized SKNJCT-005 program in Gorlin syndrome patients with multiple basal cell carcinoma lesions, while pursuing strategic partnership opportunities to advance SkinJect in nodular basal cell carcinoma (BCC).

The randomized, double-blind, multicenter Phase 2 study enrolled 90 patients across ten U.S. investigative sites and evaluated two dose levels of SkinJect compared with a device-only microneedle comparator. All 90 enrolled patients completed the study without treatment discontinuations or study withdrawals, providing a complete clinical dataset for efficacy and safety evaluation.

The completed SKNJCT-003 CSR represents the definitive analysis of the Phase 2 program and incorporates the full clinical, pathological, and translational dataset generated during SKNJCT-003. Final efficacy analyses were conducted in the modified intent-to-treat population representing patients with centrally confirmed nodular basal cell carcinoma, providing what the Company believes to be the most clinically relevant assessment of SkinJect’s therapeutic performance in its intended target population.

Dr. Faisal Mehmud, Chief Medical Officer of Medicus, commented:

"Publication of the SKNJCT-003 abridged Clinical Study Report is an important milestone in the development of SkinJect. We believe that the completed Phase 2 study has provided the clinical information needed to define the next stage of development, including selection of the 200-mcg dose, continued improvement in clinical and histological clearance with longer follow-up, a favorable safety profile and important learnings around study design and assessment timing. These findings directly informed our FDA-authorized SKNJCT-005 program in Gorlin syndrome and provide a defined development package that we believe can support discussions with potential strategic partners interested in advancing SkinJect in nodular basal cell carcinoma."

Phase 2 Results Support a Focused, Capital-Efficient Development Strategy

Beyond reporting the efficacy and safety findings from SKNJCT-003, the completed Phase 2 program has defined key scientific elements relevant to future SkinJect development, including dose selection, efficacy endpoints, assessment timing, comparator selection and statistical design. Medicus is applying these learnings to its FDA-authorized new drug application (NDA)-enabling development program in Gorlin syndrome patients and believes the same body of evidence can support a potential strategic partner in advancing a registrational program in nodular basal cell carcinoma.

The scientific conclusions documented in the CSR include:

Selection of the 200 µg SkinJect patch as the proposed pivotal dose.
Adoption of a composite complete response endpoint incorporating both clinical and histological clearance.
Selection of a later primary efficacy assessment, reflecting continued improvement in treatment response observed with longer follow-up.
Replacement of the biologically active device-only comparator with a non-penetrating sham comparator designed to better isolate the pharmacologic contribution of SkinJect.
A randomized, double-blinded, sham-controlled registrational study intended to generate a robust, decision-grade clinical dataset.
A statistical design providing approximately 90% power to detect a clinically meaningful treatment difference while supporting discussions with FDA regarding a potential single pivotal study approach.
Collectively, these findings provide a scientific bridge from the completed SKNJCT-003 study to the Company’s current SkinJect strategy, where the Company believes the platform has the potential for greater clinical differentiation, a more focused regulatory pathway and attractive rare-disease commercial economics in treating Gorlin syndrome patients with multiple BCC lesions, while preserving the broader opportunity in nodular BCC through potential strategic partnering.

Medicus intends to continue clinical development through SKNJCT-005, in Gorlin syndrome, a rare autosomal dominant disease in which patients can develop numerous BCC lesions throughout their lifetime, frequently requiring repeated surgical or other lesion directed procedures. Approximately 11,000 patients with Gorlin syndrome in the United States are estimated to have active BCC, representing approximately 50,000 Gorlin-associated BCC procedures annually. The U.S. Food and Drug Administration has issued a "Study May Proceed" letter authorizing initiation of the Company’s NDA-enabling registrational Phase 2b clinical study, SKNJCT-005, evaluating SkinJect 200 µg skin patch in patients with Gorlin syndrome presenting with multiple BCCs. The study is designed to enroll up to approximately 50 patients.

The Company believes concentrating SkinJect development on Gorlin syndrome could provide several potential strategic advantages beyond the more broadly competitive sporadic BCC market. Medicus has submitted applications to the FDA for Orphan Drug Designation ("ODD") and Rare Pediatric Disease ("RPD") designation. If granted and applicable statutory requirements are ultimately satisfied, these designations could provide important regulatory and economic benefits, including potential orphan-drug incentives and potential eligibility for a Rare Pediatric Disease Priority Review Voucher ("RPD PRV").

The Gorlin-focused strategy may also potentially support a differentiated reimbursement profile. A Company-commissioned 2026 independent commercial assessment incorporating interviews with physicians and payers modeled rare-disease-anchored net pricing of approximately $25,800 per treatment, an implied U.S. total addressable market of approximately $1.1 billion, and potential peak U.S. revenue of approximately $383 million. These estimates are non-risk-adjusted and dependent upon successful clinical development, regulatory approval, reimbursement and commercial adoption.

Scientific Dissemination

Publication of the abridged Clinical Study Report and public availability of the SKNJCT-003 results represent the first step in the Company’s broader scientific dissemination strategy. Medicus has submitted the complete Phase 2 dataset for presentation at a forthcoming major international scientific congress and for publication in a leading peer-reviewed medical journal, further supporting independent review of the study findings and continued engagement with the global dermatology and oncology communities; however, there is no guarantee that such dataset will be accepted for presentation or for publication.

(Press release, Medicus Pharma, SEP 10, 2026, View Source [SID1234670722])

On September 10, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported successful completion of the planned technology transfer for LYL273, a guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate, to its LyFE Manufacturing Center (LyFE) in Bothell, Washington, following review by the U.S. Food and Drug Administration (FDA). LyFE is implementing an improved manufacturing process and updated analytical methods to enhance manufacturing performance and increase capacity. The Phase 1/2 clinical trial of LYL273 in patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC) continues to enroll patients with the goal of determining the recommended Phase 2 dose and optimized safety management plan. Additional clinical data from the trial and a planned End-of-Phase 1 meeting with the FDA are now expected in 2027.

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"The LYL273 Phase 1/2 clinical trial continues to build momentum. We are activating additional clinical sites for the expansion phase of the trial, with strong interest in the study across our group of highly experienced investigators," said Lynn Seely, MD, President and Chief Executive Officer of Lyell. "LYL273 has already generated encouraging clinical activity data in patients with metastatic colorectal cancer. We are now focused on determining the recommended Phase 2 dose and optimizing the safety management plan, including with results from patients treated with LYL273 manufactured at LyFE. We look forward to sharing additional clinical data and bringing a more complete data package to the FDA as we plan for our End-of-Phase 1 meeting in 2027."

About LYL273

LYL273 is a guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release, designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. CARABiNER (NCT05319314) is an ongoing Phase 1/2 dose-escalation, dose-expansion trial of LYL273 in the United States in patients with R/R mCRC. Lyell announced in June 2026 safety data from the trial demonstrating that gastrointestinal prophylaxis consisting of infliximab, vedolizumab and budesonide reduced Grade ≥ 2 diarrhea/colitis from 55%

without prophylaxis to 10% with prophylaxis. Enrollment in the trial is continuing with dose escalation to determine the recommended Phase 2 dose, including with data from the improved LyFE manufacturing process and analytical methods, as well as to optimize the prophylaxis and safety management plan to calibrate immune suppression.

(Press release, Lyell Immunopharma, SEP 10, 2026, View Source [SID1234670721])

On September 10, 2026 Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company focused on the development of novel oral therapeutics, reported that Company management will present and meet with investors at the H.C. Wainwright 28th Annual Global Investment Conference, to be held in person and virtually September 14-16, 2026.

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Presentation Details

Date:

Wednesday, September 16, 2026

Time:

10am ET

Location:

New York, NY

Investors can register for the conference here. Those interested in arranging a one-on-one meeting with Lipocine should contact their H.C. Wainwright representative.

The live webcast and subsequent replay of the presentation can be accessed in the "Events" section of Lipocine’s website after the presentation. The webcast will be archived and available for 90 days following the live event.

(Press release, Lipocine, SEP 10, 2026, View Source [SID1234670720])

On September 10, 2026 Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company"), a CNS oncology company advancing an integrated platform of precision diagnostics, targeted therapeutics, and artificial intelligence, reported that it has entered into a financing agreement with 3i, LP ("3i Fund") for a senior secured facility of up to $20 million with royalty-based repayments. Under the agreement, the Company received initial funding at closing, with future tranches available upon achieving certain milestones.

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The financing is intended to support the scale-up of the Company’s proprietary laboratory-developed tests, particularly its CNSide cerebrospinal fluid ("CSF") assay platform.

"Cerenome is grateful for the support of the 3i Fund team, and we look forward to a long-term relationship," said Andrew Sims, Cerenome’s Chief Financial Officer. "This facility is designed to be minimally dilutive to stockholders while supporting the next stage of commercial scale-up and development of CNSide, specifically growing sales and broadening the pipeline. We forecast our cash runway is now well into 2028 when we consider, the 3i facility, other existing facilities along with current cash and forecasted CNSide related sales and cash flow."

Additional transaction details are included in a Current Report on Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission.

(Press release, Cerenome, SEP 10, 2026, View Source [SID1234670718])