ATLANTA, GA, Aug. 06, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced financial results for the second quarter ended June 30, 2024, and provided a business update.
“The first half of 2024 has been marked by significant progress across our company, underscored by our recent announcement of the receipt of the BARDA Project NextGen award to evaluate GEO-CM04S1, our next-generation, dual-antigen COVID-19 vaccine. Additionally, we are pleased to partner with Allucent, a global CRO, to commence the trial and advance GEO-CM04S1 into the BARDA-funded 10,000-patient Phase 2b clinical study. With greater than $350 million secured to conduct the trial, this recognition from the U.S. government not only validates our clinical strategy, but also provides the necessary resources to more rapidly advance our mission,” stated David Dodd, GeoVax’s Chairman and CEO.
“While first-generation COVID-19 vaccines were essential during the early days of the pandemic, they require frequent updates to combat waning efficacy and durability issues now that COVID-19 has proven to be endemic. GEO-CM04S1 has demonstrated potent, broadly reactive, and durable antibody and T cell immune responses in individuals with both healthy and compromised immune systems. Given the growing appreciation that strong T cell responses are critically important for both antibody recall and protection against severe disease and hospitalization, GEO-CM04S1 is particularly well-positioned as a next-generation COVID-19 vaccine with the potential to greatly improve patient care,” Dodd continued.
“In addition, with support from an oncology clinical advisory committee, following a detailed review of Gedeptin’s safety and efficacy data, we look forward to advancing an expanded Phase 2 clinical trial evaluating Gedeptin in first-recurrence head and neck cancer patients. With multiple key catalysts in the remainder of 2024, we are in a strong position to create long term value as we execute on our clinical strategy and advance our robust portfolio of assets,” Dodd concluded.
Second Quarter Business Achievements
GEO-CM04S1
GeoVax’s role in this project is being funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) number: 75A50123D00005. Allucent’s role in the project is being funded in whole or in part with federal funds from BARDA under contract 75A50120D00016/75A50123F33005.
Gedeptin®
Vaccine Manufacturing Process Development
Second Quarter 2024 Financial Results
Summarized financial information is attached. Further information is included in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.
Conference Call Details
Management will host a conference call, scheduled to begin at 4:30 p.m. ET today, August 6, 2024, to review financial results and provide an update on corporate developments. Following management’s formal remarks, there will be a question-and-answer session.
Domestic: (800) 715-9871
International: +1 (646) 307-1963
Conference ID: 3852178
Webcast: https://edge.media-server.com/mmc/p/qj3e68n8
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 GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.
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: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
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 SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
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FINANCIAL TABLES FOLLOW
GEOVAX LABS, INC. | ||||||||||||||||
Condensed Consolidated Statements of Operations Information | ||||||||||||||||
(amounts in thousands, except common share information) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Revenue from government contract | $ | 301 | $ | - | $ | 301 | $ | - | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 4,277 | 4,720 | 8,703 | 7,539 | ||||||||||||
General and administrative | 1,086 | 1,459 | 2,543 | 2,910 | ||||||||||||
5,363 | 6,179 | 11,246 | 10,449 | |||||||||||||
Loss from operations | (5,062 | ) | (6,179 | ) | (10,945 | ) | (10,449 | ) | ||||||||
Other income (expense) | (2 | ) | 251 | 31 | 484 | |||||||||||
Net loss | $ | (5,064 | ) | $ | (5,928 | ) | $ | (10,914 | ) | $ | (9,965 | ) | ||||
Loss per common share | $ | (1.99 | ) | $ | (3.79 | ) | $ | (4.68 | ) | $ | (5.66 | ) |
Condensed Consolidated Balance Sheet Information | ||||||||||
(amounts in thousands, except common share information) | ||||||||||
June 30, 2024 | Dec. 31, 2023 | |||||||||
Assets: | ||||||||||
Cash and cash equivalents | $ | 1,562 | $ | 6,453 | ||||||
Other current assets | 2,282 | 1,433 | ||||||||
Total current assets | 3,844 | 7,886 | ||||||||
Property and other assets, net | 251 | 1,397 | ||||||||
Total assets | $ | 4,095 | $ | 9,283 | ||||||
Liabilities and stockholders’ equity (deficit) | ||||||||||
Total liabilities | $ | 6,404 | $ | 3,520 | ||||||
Stockholders’ equity (deficit) | (2,309 | ) | 5,763 | |||||||
Total liabilities and stockholders’ equity (deficit) | $ | 4,095 | $ | 9,283 | ||||||
Common shares outstanding | 4,178,700 | 1,977,152 |
Last Trade: | US$2.60 |
Daily Change: | -0.31 -10.65 |
Daily Volume: | 1,243,242 |
Market Cap: | US$22.150M |
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