Genelux : Corporate Presentation - May (d7b15d)

Published: 2025-05-07 12:51:06 ET GNLX

Published on 05/07/2025 at 12:51

Redefining Immuno-Oncology

Corporate Presentation May 2025

Ongoing pivotal Phase 3 trial in late-stage platinum resistant/refractory ovarian cancer (PRROC) Ongoing Phase 2 trial via systemic administration in recurrent non-small cell lung cancer (NSCLC) Ongoing Phase 1b/2 trial via systemic administration in recurrent small cell lung cancer (SCLC)

Library with over 500 novel vaccinia strains and 110+ transgenes

Newsoara Biopharma (Greater China rights) has paid $11M to date and Genelux is eligible for additional development, regulatory

and sales milestone payments and up to mid-double-digit percentages royalties on net sales

US launch in Ovarian Cancer initially; strategic partnerships for ex-US rights

Potential well beyond ovarian and lung cancers in numerous settings via systemic administration

Next Generation Regional & Systemic Administration

Systemic Delivery Potential to be First-in-Class

Across multiple tumor types

Limitations of 1st Gen Viruses

Limited to local delivery and scope of addressable cancers

Phase 2 Ovarian Cancer Apparent tumor re-sensitization to platinum-based therapy

Phase 1b Solid Tumors

FDA/EMA Approval in Melanoma

Dose-dependent mOS in metastatic lung-diseased solid tumor patients after multiple IV doses

PMDA Approval in malignant glioma

Potential Clinical Advantages of Olvi-Vec

Potential FDA approval in July 2025 for anti-PD-1 failed melanoma

Phase 3 monotherapy trial in bladder cancer

Systemic Dosing and Redosing

Target & Treat Metastatic Diseases

Robust Immune Activation Profile

Broad spectrum of accessible tumor types

Multiple Routes of Delivery

Tumor Selectivity

Strong immune activator

Nonhuman Pathogen

mOS: median overall survival

Regional and Systemic Administration to preferentially locate, colonize and destroy tumor cells, including metastatic disease

IV therapy currently being used in small cell lung cancer Phase 1b/2 trial and in non-small cell lung cancer Phase 2 trial

In ovarian cancer Phase 3 trial, catheter placement is prior to chemotherapy, with removal no longer than 2 weeks after initial placement

Antitumor Effect and Well Tolerated

Strong ORR, mPFS & mOS* data in Phase 1b/2 trial in platinum-resistant/ refractory ovarian cancer

No Maximum Tolerated Dose (MTD)

observed

Potential utility in multiple cancers (demonstrated anti-tumor activity in

20 pre-clinical solid & liquid tumor models, e.g., ovarian, lung, breast, colon, lymphoma)

Turns tumors "hot" by localized inflammation and induction of the influx of tumor infiltrating lymphocytes (TILs)

Positively modulates anti-tumor pathways in tumor microenvironment

Potential use with various modalities such as chemotherapies (e.g., platinum-based), immune checkpoint inhibitors and bi-specifics - including rechallenging recurrent patients in multiple tumor types)

*ORR: overall response rate, mPFS: median progression-free survival, mOS: median overall survival.

Disclaimer

Genelux Corporation published this content on May 07, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 07, 2025 at 16:50 UTC.