GeoVax Reports Second Quarter 2024 Financial Results and Provides Business Update
GeoVax Labs, Inc. (Nasdaq: GOVX) reported its Q2 2024 financial results and provided a business update. Key highlights include:
1. Awarded BARDA Project NextGen (PNG) contract worth over $350 million to advance GEO-CM04S1, their next-generation COVID-19 vaccine, into a 10,000-participant Phase 2b study.
2. Partnered with Allucent, a global CRO, to conduct the Phase 2b trial.
3. Advancing Gedeptin® into an expanded Phase 2 clinical trial for first-recurrence head and neck cancer, with activation expected in H1 2025.
4. Produced first lot of GEO-CM04S1 with a commercial manufacturing platform.
5. Q2 2024 net loss of $5,064,042 ($1.99 per share), compared to $5,927,620 ($3.79 per share) in Q2 2023.
6. Cash balance of $1,561,712 as of June 30, 2024.
GeoVax Labs, Inc. (Nasdaq: GOVX) ha riportato i risultati finanziari del secondo trimestre 2024 e fornito un aggiornamento sull'attività. I punti salienti includono:
1. Assegnazione del contratto BARDA Project NextGen (PNG) del valore di oltre 350 milioni di dollari per far avanzare GEO-CM04S1, il loro vaccino COVID-19 di nuova generazione, in uno studio di Fase 2b con 10.000 partecipanti.
2. Collaborazione con Allucent, un CRO globale, per condurre il trial di Fase 2b.
3. Avanzamento di Gedeptin® in un trial clinico di Fase 2 ampliato per il cancro testa-collo in prima ricorrenza, con attivazione prevista nel primo semestre del 2025.
4. Produzione del primo lotto di GEO-CM04S1 con una piattaforma di produzione commerciale.
5. Perdita netta nel secondo trimestre 2024 di 5.064.042 dollari (1,99 dollari per azione), rispetto a una perdita di 5.927.620 dollari (3,79 dollari per azione) nel secondo trimestre 2023.
6. Saldo di cassa di 1.561.712 dollari al 30 giugno 2024.
GeoVax Labs, Inc. (Nasdaq: GOVX) reportó sus resultados financieros del segundo trimestre de 2024 y proporcionó una actualización comercial. Los aspectos más destacados incluyen:
1. Adjudicación del contrato BARDA Project NextGen (PNG) por más de 350 millones de dólares para avanzar GEO-CM04S1, su vacuna de COVID-19 de nueva generación, a un estudio de Fase 2b con 10,000 participantes.
2. Asociación con Allucent, una CRO global, para llevar a cabo el ensayo de Fase 2b.
3. Avance de Gedeptin® a un ensayo clínico de Fase 2 ampliado para el cáncer de cabeza y cuello en primera recurrencia, con activación prevista para el primer semestre de 2025.
4. Producción del primer lote de GEO-CM04S1 con una plataforma de fabricación comercial.
5. Pérdida neta del segundo trimestre de 2024 de 5.064.042 dólares (1,99 dólares por acción), en comparación con una pérdida de 5.927.620 dólares (3,79 dólares por acción) en el segundo trimestre de 2023.
6. Saldo de caja de 1.561.712 dólares a fecha del 30 de junio de 2024.
GeoVax Labs, Inc. (Nasdaq: GOVX)는 2024년 2분기 재무 결과를 발표하고 사업 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:
1. 3억 5천만 달러 이상의 가치가 있는 BARDA Project NextGen (PNG) 계약이 GEO-CM04S1, 차세대 COVID-19 백신을 10,000명의 참가자를 대상으로 하는 2b 단계 연구로 진행하기 위해 수여되었습니다.
2. 글로벌 CRO인 Allucent와 협력하여 2b 단계 시험을 수행합니다.
3. Gedeptin®을 첫 재발 두경부 암을 위한 확대된 2상 임상 시험으로 진행 중이며, 2025년 상반기에 활성화될 예정입니다.
4. 상업적 제조 플랫폼을 사용하여 GEO-CM04S1의 첫批을 생산했습니다.
5. 2024년 2분기 순손실은 5,064,042달러(주당 1.99달러)로, 2023년 2분기 손실 5,927,620달러(주당 3.79달러) 대비 감소했습니다.
6. 2024년 6월 30일 기준 현금 잔액은 1,561,712달러입니다.
GeoVax Labs, Inc. (Nasdaq: GOVX) a annoncé ses résultats financiers pour le deuxième trimestre 2024 et a fourni une mise à jour de l'activité. Les faits marquants incluent :
1. Attribution d'un contrat BARDA Project NextGen (PNG) d'une valeur de plus de 350 millions de dollars pour faire avancer GEO-CM04S1, leur vaccin COVID-19 de nouvelle génération, vers une étude de Phase 2b avec 10 000 participants.
2. Partenariat avec Allucent, un CRO mondial, pour mener l'essai de Phase 2b.
3. Avancement de Gedeptin® dans un essai clinique de Phase 2 élargi pour le cancer de la tête et du cou lors de la première récidive, avec activation prévue au premier semestre 2025.
4. Production du premier lot de GEO-CM04S1 avec une plateforme de fabrication commerciale.
5. Perte nette de 5 064 042 dollars au deuxième trimestre 2024 (1,99 dollars par action), contre une perte de 5 927 620 dollars (3,79 dollars par action) au deuxième trimestre 2023.
6. Solde de trésorerie de 1 561 712 dollars au 30 juin 2024.
GeoVax Labs, Inc. (Nasdaq: GOVX) hat seine finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und ein Geschäftsupdate gegeben. Die wichtigsten Highlights umfassen:
1. Vergabe des BARDA Project NextGen (PNG) Vertrages im Wert von über 350 Millionen US-Dollar zur Weiterentwicklung von GEO-CM04S1, ihrem Impfstoff der nächsten Generation gegen COVID-19, in eine Phase-2b-Studie mit 10.000 Teilnehmern.
2. Partnerschaft mit Allucent, einem globalen CRO, zur Durchführung der Phase-2b-Studie.
3. Fortführung von Gedeptin® in einer erweiterten Phase-2-Studie zur ersten Rückfall-Hals-Nasen-Ohrenkrebserkrankung, mit Aktivierung, die für das erste Halbjahr 2025 erwartet wird.
4. Herstellung der ersten Charge von GEO-CM04S1 mit einer kommerziellen Produktionsplattform.
5. Nettoverlust im zweiten Quartal 2024 von 5.064.042 US-Dollar (1,99 US-Dollar pro Aktie), im Vergleich zu einem Verlust von 5.927.620 US-Dollar (3,79 US-Dollar pro Aktie) im zweiten Quartal 2023.
6. Barguthaben von 1.561.712 US-Dollar zum 30. Juni 2024.
- Secured BARDA Project NextGen contract worth over $350 million for GEO-CM04S1 Phase 2b study
- Partnership with Allucent CRO for conducting the Phase 2b trial of GEO-CM04S1
- Successful production of first GEO-CM04S1 lot with commercial manufacturing platform
- Advancing Gedeptin® to expanded Phase 2 trial for head and neck cancer
- Net loss of $5,064,042 in Q2 2024
- Decreased cash balance from $6,452,589 (Dec 31, 2023) to $1,561,712 (Jun 30, 2024)
GeoVax's Q2 2024 results reveal a mixed financial picture. The company's net loss narrowed to
The most impactful news is the
GeoVax's GEO-CM04S1 COVID-19 vaccine candidate shows promising potential as a next-generation solution. Its dual-antigen approach and ability to induce both antibody and T cell responses address key limitations of current vaccines, particularly against emerging variants. The 10,000-participant Phase 2b trial will be important in demonstrating its efficacy compared to existing mRNA vaccines.
The decision to advance Gedeptin into an expanded Phase 2 trial for first-recurrence head and neck cancer is also significant. Combining it with an immune checkpoint inhibitor could potentially enhance treatment efficacy in this difficult-to-treat patient population. However, with trial activation not expected until H1 2025, results are still a ways off.
The BARDA Project NextGen award represents a major vote of confidence in GeoVax's technology and strategy. This
However, investors should note that while the COVID-19 program is well-funded, the company's other pipeline projects may face resource constraints. The market will likely focus on upcoming data readouts for GEO-CM04S1 in H2 2024 as key catalysts. The advancement of Gedeptin, while promising, has a longer timeline to potential value creation. Overall, GeoVax's near-term prospects appear tied to the success of its COVID-19 vaccine program.
Awarded BARDA Project NextGen (PNG) contract to advance GeoVax’s multi-antigen vaccine candidate, GEO-CM04S1, into 10,000-participant randomized, comparative Phase 2b COVID-19 vaccine study
BARDA PNG award represents greater than
Multiple planned data readouts for GEO-CM04S1 throughout second half of 2024;
Gedeptin® to advance into expanded Phase 2 clinical trial with activation in the first half of 2025
Company to host conference call and webcast today at 4:30 p.m. ET
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
“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
- Received BARDA Project NextGen award through the Rapid Response Partnership Vehicle (RRPV) to advance development of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, in a Phase 2b clinical trial. The direct award to GeoVax of approximately
$24.3 million , which may increase to as much as$45 million , will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities.- Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of GEO-CM04S1 with a U.S. Food and Drug Administration (FDA) approved mRNA COVID-19 vaccine. Preparations for the study are underway, and execution of the study will be funded by BARDA under its Clinical Studies Network.
- The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).
- Funding for this award is provided under Project NextGen, a
$5 billion initiative by HHS to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19 than the first generation COVID vaccines and medicines.
- Under the agreement, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of GEO-CM04S1 with a U.S. Food and Drug Administration (FDA) approved mRNA COVID-19 vaccine. Preparations for the study are underway, and execution of the study will be funded by BARDA under its Clinical Studies Network.
- Announced Project NextGen CRO partnership with Allucent, a global clinical research organization (CRO), to conduct the Phase 2b clinical trial of GEO-CM04S1. The combined value of the awards to GeoVax and Allucent for the clinical evaluation of GEO-CM04S1 is
$367 -388 million.
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.
- Presented data on GEO-CM04S1, at the 24th Annual World Vaccine Congress in April 2024. The presentation, titled “Vaccine Induction of Broadly-Specific Antibody and T Cell Responses to Combat SARS-CoV-2 Variation”, focused on GEO-CM04S1’s unique immune system driven mechanism and how it can contribute to the broad efficacy. The presentation highlighted that vaccine induced immunity protects against infections, serious disease symptoms and death against the original Wuhan variant as well as the Omicron XBB.1.5 variant, which is the basis of the currently approved mRNA booster vaccines.
Gedeptin®
- Completed review of Gedeptin clinical results, and recently announced decision to advance Gedeptin into an expanded Phase 2 clinical trial among patients with first-recurrence head and neck cancer. The primary goal of this trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in squamous cell head and neck cancer. The Company has initiated the necessary planning activities, including protocol development, manufacturing and CRO selection, with the trial activation anticipated during the first half of 2025.
Vaccine Manufacturing Process Development
- Produced first lot of GEO-CM04S1 with a commercial manufacturing platform, a critical step toward implementation of a validated chicken embryonic fibroblast (CEF) based production system for the company’s MVA-based vaccines. This milestone marks the successful completion of the transfer and scale-up of manufacturing from the research-focused Center for Biomedicine & Genetics at City of Hope to Oxford Biomedica, the Company’s cGMP (current Good Manufacturing Procedures) manufacturing partner.
Second Quarter 2024 Financial Results
- Net Loss: Net loss for the three-month period ended June 30, 2024, was
$5,064,042 , or$1.99 per share, as compared to$5,927,620 , or$3.79 per share, for the comparable period in 2023. For the six-month period ended June 30, 2024, the Company’s net loss was$10,914,174 , or$4.68 per share, as compared to$9,965,536 , or$5.66 per share, in 2023. - R&D Expenses: Research and development expenses were
$4,276,868 and$8,702,596 for the three-month and six-month periods ended June 30, 2024, compared with$4,719,728 and$7,538,917 for the comparable period in 2023, with the changes primarily due to timing of costs related to manufacturing of materials for use in the clinical trials of GEO-CM04S1 and Gedeptin as well as costs of various contracted research activities. - G&A Expenses: General and administrative expenses were
$1,086,030 and$2,543,383 for the three-month and six-month periods ended June 30, 2024, compared to$1,459,093 and$2,910,518 for the comparable periods in 2023, with the overall decrease primarily due to lower stock-based compensation expense, consulting costs, legal and patent costs, and travel costs. - Cash Position: GeoVax reported cash balances of
$1,561,712 at June 30, 2024, as compared to$6,452,589 at December 31, 2023.
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.
| Company Contact: | Investor Relations Contact: | Media Contact: | ||
| info@geovax.com | austin.murtagh@precisionaq.com | sr@roberts-communications.com | ||
| 678-384-7220 | 212-698-8696 | 202-779-0929 | ||
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 | ||||||||
FAQ
What is the value of the BARDA Project NextGen contract awarded to GeoVax for GEO-CM04S1?
How many participants will be involved in the Phase 2b study of GEO-CM04S1?
When is Gedeptin® expected to enter the expanded Phase 2 clinical trial?
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What was GeoVax's (GOVX) cash balance as of June 30, 2024?
