Genelux Corp 2025年度报告

HOPE CULTURE CONNECTION Ouris to build a pre-eminent immuno-oncologycompany that addresses seriousunmet medical needs.VISION Ouris to developimmunotherapeutics that deliverthe full complement of tumor(neo)antigens with the power tostimulate a personalized immuneresponse to fight cancer,individual by individual.MISSION INTRODUCTION01. CONTENTS 2025
YEAR
IN
REVIEW02. 03.LOOKING
AHEAD
TO
2026
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BEYOND 04.CORPORATE
VALUES

10-K05. INTRODUCTION Dear Stockholders, As we reflect on 2025, it was a year in which Geneluxcontinuedits disciplined execution across clinicaldevelopment, operations, and corporate governance. Theprogress achieved this year underscores ourcommitmenttodevelopingapractice-changingoncolytic immunotherapy that addresses some of thegreatest unmet needs in oncology. 2025 YEAR IN REVIEW The beginning of 2025 was highly productive, and we carried themomentumthroughouttheyear.Westrengthenedtheorganizationby welcoming accomplished biopharmaceuticalexecutivesto our management team and by completing anunderwritten public offering to bolster our balance sheet. Enrollment continued in our clinical trials, which are designed tobuild on prior pre-clinical and clinical studies. These include (i) theOnPrime/GOG-3076 Phase 3 registrational trial in ovarian cancer;and (ii) in our systemic administration program, two registration-path trials in lung cancer. In anticipation of clinical success, we progressed operational andfacilityreadiness activities to support the filing of a BiologicsLicense Application (BLA), as well as the commercial manufactureand launch of Olvi-Vec. “Platinum-resistant/refractory ovariancancer remains one of the most challengingareas in oncology. We believe Olvi-Vec hasthe potential to redefine the treatmentparadigm for these patients.”“PP” Our focus is to establish Olvi-Vec as a differentiated immunotherapeuticthatfavorably modifies the tumor microenvironment and resensitizestumors to standard-of-care regimens, including frontline platinum-basedchemotherapy.The advancements made in 2025 generate momentumtoward delivering meaningful data catalysts in 2026 across multiple solidtumorindications that,together,represent a multi-billion-dollar marketopportunity. CLINICALDEVELOPMENTPROGRESS Geneluxcontinued to advance three sponsored clinical trials in athoughtfully integrated strategy around its most advanced clinical data: OnPrime / GOG-3076 (U.S.-based trial):OnPrime / GOG-3076 (U.S.-based trial): Phase 3 registrational trial in platinum-resistant/refractory ovarian cancer (PRROC)Phase3registrationaltrial in platinum-resistant/refractory ovarian cancer (PRROC) Olvi-Vec-SCLC-202 (Greater China-based trial):Olvi-Vec-SCLC-202(GreaterChina-basedtrial): Phase 1b/2 trial in recurrent small cell lung cancer(SCLC)Phase 1b/2//trial in recurrent small cell lung cancer(SCLC) Phase 2 trial in recurrent non-small cell lung cancer(NSCLC)Phase2trialinrecurrentnon-smallcelllungcancer(NSCLC) OnPrime/GOG-3076 Ourhighest clinical priority remained the OnPrime/GOG-3076 Phase 3registrational trial in women diagnosed with PRROC. OnPrime is designedbased on the positive results achieved in our completed VIRO-15 Phase 2trial and is being conducted in collaboration with the GOG Foundation (anon-profit gynecologic cancer research group). It is a U.S.-based, multi-center, randomized, open-label study evaluating thesafety and efficacy of intraperitoneally administered Olvi-Vec followed bysystemicadministrationofplatinum-doubletchemotherapyandbevacizumab, compared to the active comparator arm of physician's choicechemotherapy and bevacizumab. The trial will enroll a sufficient number ofpatientsto achieve 127 PFS events,with the primary endpoint ofprogression-freesurvival(PFS)and with secondary endpoints includingoverall survival (OS). Throughout 2025, patient enrollment remained active across our clinicalsites.We are pleased to see strong engagement from investigators and siteteams, and from patient advocacy groups. Notable achievements includedthe following: The Independent Data Monitoring Committee regularly reviewed safetydata and recommended continuation of the trial without modification. Geneluxachieved alignment with the FDA on key elements of theapproval pathway for Olvi-Vec in platinum-resistant/refractory ovariancancer. Specifically, the agency guided that if a clinically meaningful PFSadvantage is demonstrated in the absence of a decrement in OS, thiscouldpotentially support traditional approval without the need toconduct a separate confirmatory trial powered to demonstrate an OSbenefit. Additionally, the FDA encouraged us to request a meeting priorto filing a BLA upon study completion to discuss next steps. Systemic Administration Program Inparallel,we are advancing two ongoing registration-path trials inrecurrent lung cancer designed to further demonstrate the ability of Olvi-Vec to resensitize multiple solid tumor types after failing frontline platinum-basedtherapy.Each