Progress across the pipeline in multiple clinical trials, including
Phase 2 program of GEO-CM04S1, next-generation Covid-19 vaccine, and
multicenter Phase 1/2 study of Gedeptin®, targeting advanced head and neck cancer
Catalyst-rich 2024 with data readouts planned throughout the year
Company to host conference call and webcast today at
“2023 marked another year of advancement of our ongoing clinical programs for GEO-CM04S1, our next-generation Covid-19 vaccine, and for Gedeptin® in cancer therapy,” stated
“Results released during 2023 demonstrated the safety and efficacy of GEO-CM04S1 and emphasize the role it will play in protecting immunocompromised patients from greater risk of severe disease, hospitalization and death from SARS-CoV-2 infection,” Dodd continued. “Perhaps of most importance, the results to date have demonstrated potential protective immunity of GEO-CM04S1 against multiple strains of SARS-CoV-2, from the ancestral
Dodd concluded, “Relative to our oncology progress,
2023 Clinical Trial Progress and Operational Developments
GEO-CM04S1
- Enrollment completed for the Phase 2 clinical trial assessing GEO-CM04S1 as a potential universal booster for patients previously vaccinated with Pfizer or Moderna vaccines. The data presented during this period showcased promising results, indicating the potential of GEO-CM04S1 as a versatile Covid-19 vaccine capable of providing immunity against various strains, including the
Wuhan , Delta, and Omicron variants. The trial involves 63 healthy adults who previously received mRNA vaccines as their primary vaccine. The data showed no serious adverse events and significant increases in neutralizing antibody, as well as cellular immune responses against multiple SARS-CoV-2 variants. Final results from this trial are anticipated during the fourth quarter of 2024. - Initiation of a Phase 2 booster trial targeting immunocompromised patients with chronic lymphocytic leukemia (CLL), who typically have reduced immune responses to mRNA vaccines due to their medical condition. This investigator-initiated trial expects to enroll 80 patients and directly compare GEO-CM04S1 with the Pfizer/BioNTech Bivalent vaccine. Results from an interim analysis are anticipated during the first half of 2024.
- Data presentations from the immunocompromised/stem cell transplant patient Phase 2 trial of GEO-CM04S1 at the
World Vaccine Congress , as well as initial results published in the peer-reviewed journal, Vaccines. The findings demonstrated robust immunogenicity, illustrating the vaccine's ability to induce both antibody and T cell responses, essential for conferring protection, particularly in immunocompromised individuals. The article also highlighted the unique feature of GEO-CM04S1 providing protective immune levels from the ancestralWuhan strain through Delta and the highly virulent Omicron XBB.1.5 variant. This study has been expanded to a multi-site trial, with further results anticipated throughout 2024.
Gedeptin®
- Completion of patient enrollment for the Phase 1/2 clinical trial of Gedeptin among advanced head and neck cancer patients. The data presented at the
AACR-AHNS Head and Neck Cancer Conference emphasized the safety and feasibility of Gedeptin therapy, providing insights into its potential as a treatment option for patients with limited therapeutic alternatives. The initial Phase 1/2 trial aims to guide future studies, potentially expanding the application of Gedeptin in other solid tumor areas and in combination with immune checkpoint inhibitors. During 2024, we expect to announce plans relative to an expanded Phase 2 study among advanced head and cancer patients, following discussions with regulatory authorities. In addition, we plan to outline plans for further Gedeptin clinical development, both in additional monotherapy and in combination-therapy (e.g., Gedeptin + immune-checkpoint inhibitor) indications.
Advanced Vaccine Manufacturing Process
- Significant advancements made in MVA manufacturing capabilities focused on implementing a transformative manufacturing process in support of MVA-based vaccines and immunotherapies. The multi-product license with ProBioGen involving the AGE1.CR.PIX® suspension cell line enhances
GeoVax's capacity to produce MVA-based vaccines and immunotherapies at an unprecedented scale. Additionally, the agreement withAdvanced Bioscience Laboratories, Inc. (ABL) secures cGMP production capabilities in support ofGeoVax transitioning to worldwide commercialization capability. These developments signifyGeoVax's commitment to improving vaccine accessibility through cost-effective and scalable manufacturing processes. Our intent is to successfully develop our products for worldwide commercialization and distribution, in conjunction with partnering and collaborative relationships.
Corporate and Intellectual Property Developments
- Achieved notable milestones in intellectual property development, securing multiple patents covering a range of vaccine candidates. The expanded rights under the NIH Covid-19 license to include Mpox and smallpox further diversify
GeoVax's vaccine portfolio, potentially offering broader protection against infectious diseases. Additionally, the issuance of patents for Ebola, Marburg, Malaria, and HIV vaccines underscoresGeoVax's innovative approach to vaccine development and its dedication to advancing global health initiatives. As ofFebruary 2024 , the following actions were taken by global patent offices, further strengthening the Company’s intellectual property assets:
- The Japanese Patent Office issued a Decision of Grant notifying
GeoVax of the allowance of the Company’s Patent Application No. 2022-153352 titled “Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen.” The allowed claims are directed to recombinant MVA viral vectors comprising specific MUC-1 nucleic sequences used in GeoVax’s MUC-1 tumor-associated antigen immunotherapy program. Pharmaceutical compositions for inducing immune responses, preventing or reducing neoplasm growth, or treating cancer are also covered by the granted claims. - The
U.S. Patent and Trademark Office issued Patent No. 11,896,657 toGeoVax , pursuant to the Company’s patent application No. 17/584,231 titled “Replication-Deficient Modified Vaccinia Ankara (MVA) Expressing Marburg Virus Glycoprotein (GP) and Matrix Protein (VP40).” The allowed claims generally cover GeoVax’s vector platform for expressing Marburg virus antigens in virus-like particles (VLPs) utilizing an MVA viral vector. - The
U.S. Patent and Trademark Office issued Patent No. 11,897,919 pursuant to the Company’s patent application No. 17/409,574 titled “Multivalent HIV Vaccine Boost Compositions and Methods of Use.” The allowed claims generally cover a priming vaccination with a DNA vector encoding multiple HIV antigens in virus-like particles (VLPs), followed by a boost vaccination with GeoVax’s vector platform for expressing HIV-1 antigens in VLPs utilizing an MVA viral vector.
- The Japanese Patent Office issued a Decision of Grant notifying
- Appointed J. Marc Pipas, M.D., as Executive Medical Director, Oncology. Dr. Pipas has extensive clinical, research, and leadership expertise in oncology, built on a long and successful academic career at
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center , anNCI Comprehensive Cancer Center . He brings a deep understanding of oncologic therapeutics and clinical trial management, as well as a network of research contacts and leadership skills honed by many years of experience.
2023 Full Year Financial Results
Net Loss: Net loss for the year ended
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Cash Position:
Summarized financial information is attached. Further information is included in the Company’s Annual Report on Form 10-K filed with the
Conference Call Details
Management will host a conference call scheduled to begin at
Domestic: (800) 715-9871
International: +1 (646) 307-1963
Conference ID: 3926207
Webcast: https://edge.media-server.com/mmc/p/uo7z87mz
A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.
About
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether:
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the
Company Contact: | Investor Relations Contact: | Media Contact: | ||
info@geovax.com | paige.kelly@sternir.com | sr@roberts-communications.com | ||
678-384-7220 | 212-698-8699 | 202-779-0929 | ||
FINANCIAL TABLES FOLLOW
Condensed Consolidated Statements of Operations Information | ||||||||||||
(amounts in thousands, except common share information) | ||||||||||||
Year Ended | ||||||||||||
2023 | 2022 | |||||||||||
Grant revenue | $ | - | $ | 81 | ||||||||
Operating expenses: | ||||||||||||
Research and development | 20,721 | 9,123 | ||||||||||
General and administrative | 6,022 | 4,987 | ||||||||||
26,743 | 14,110 | |||||||||||
Loss from operations | (26,743 | ) | (14,029 | ) | ||||||||
Other income (expense), net | 776 | 7 | ||||||||||
Net loss | $ | (25,967 | ) | $ | (14,021 | ) | ||||||
Net loss per common share | $ | (14.29 | ) | $ | (12.39 | ) | ||||||
Weighted average shares outstanding | 1,817,282 | 1,131,546 |
Condensed Consolidated Balance Sheet Information | |||||||||
(amounts in thousands, except common share information) | |||||||||
2023 | 2022 | ||||||||
Assets: | |||||||||
Cash and cash equivalents | $ | 6,453 | $ | 27,613 | |||||
Other current assets | 1,433 | 1,326 | |||||||
Total current assets | 7,886 | 28,939 | |||||||
Property and other assets | 1,397 | 2,409 | |||||||
Total assets | $ | 9,283 | $ | 31,348 | |||||
Liabilities and stockholders’ equity | |||||||||
Total liabilities | $ | 3,520 | $ | 4,748 | |||||
Stockholders’ equity | 5,763 | 26,600 | |||||||
Total liabilities and stockholders’ equity | $ | 9,283 | $ | 31,348 | |||||
Common Shares Outstanding | 1,977,152 | 1,755,664 |
Source:
2024 GlobeNewswire, Inc., source