Official Headline is “GeoVax Announces JCO Oncology Advances Publication Highlighting Favorable Safety and Evidence of Disease Stability of Gedeptin(R) in Recurrent Head & Neck Cancer.”
Despite there being so many technical terms in today’s release (see below), enough investor’s in the “sophisticated at medical terms” camp quietly stepped up to the plate, or added to the previous positions after reading a positive progress review on GeoVax’s Gedeptin® in the American Society of Clinical Oncology Journal.
It bumped volume to up over one million shares, for the first time in a long while. The share price has inched up 8% for the day, to $0.40.
If we would have to guess, the trading pattern indicates a professional type investor is acquiring a position, rather than daytraders who can send a stock up 50% in a day and back to where it started the next day – with 10’s of millions of shares trading hands. The day traders are well aware of GeoVax’s existence as evidenced by when it traded 141 million shares on August 11th, 2024 and traded as high as $8.35.
To say GeoVax has ‘explosive’ potential, is an understatement. With ‘significant’ type news of a partnership or joint venture or joint trial funding (GeoVax has three shots on goal, Covid, Cancer and MonkeyPox) we can envision a share price too high to mention. We’ll just leave it at a multiple, well above last years high.
Keep in mind the huge run last year (post reverse-split) wasn’t propelled by GeoVax ‘specific’ news issued by GeoVax – but merely the widespread awareness, that GeoVax is working on a leading solution for MonkeyPox. The specific news, was that MPOX infected numbers were going up. That’s all it took for a 420% gain, in a matter of weeks.
So just imagine what could happen if GeoVax’s MPOX vaccine is actually approved, by the FDA! Oh, ya.
Total Adressable Markets / TAM (for GeoVax treatments):
-Covid Vaccine, for Immunocompromised: $11+ billion
-Cancer Gedeptin®, in Conjunction Immune Checkpoint Inhibitors: $15+ billion
-Mpox/Smallpox Vaccine: $30+ billion
Just so you don’t think were pulling numbers out of thin air, in an upcoming report we will break these numbers down more realistically. Using simple math and logic..
As example, there are 40 million immunocompromised individuals in the U.S. today, where it is widely reported – that mRNA is barely effective. If a patient takes the GeoVax Covid vaccine and the vaccine cost $200 (a number we did pull out of the air) that would represent a market opportunity of $8 billion per year. .
Do the math yourself, 40 million doses x $200. Would everyone who needs it take it? That rarely happens. But what if 10% do?
Be it a first time dose, or as a booster dose for someone who initially tried mRNA and learned it didn’t work as hoped. And as we all know, these vaccines aren’t a one time dose – like a one and done. They are multiple doses, in a year. And unless Covid vanishes from the face of the earth (higly unlikley) it could be multiple doses (aka: repeat revenues) for life! Oh, yeah.
So do the math on two doses a year..
Then if you agree, that if there is a loved one in the house who is immunocomprimised, that everyone else in the house must be vaccinated – do the math again. If every household has two members, the TAM dose number jumps to 80 million. If three members, 120 million doses. Then if you assume two doses per year, per household – our calculator melts..
Think about it. If someone in your house has cancer, are you going to pass on getting vaccinated because you’re scared of needles? Nope, don’t think so.
And finally ponder that GeoVax has a current market cap of $11.8 million.
Read below “COVID-19 Vaccination Guidance for People Who Are immunocompromised.”
As we said many times before, with regards to many other Biotech companies and other treatments or drugs, we NEVER bet on an approval outcome. It’s entirely unpredictable. What we bet on (yes, investing is betting) is what potential revenues could be generated, AFTER approval. So read the above paragraph again. How many billions?
Then ask yourself, “is it worth the risk watching from the sidelines – or hoping to take a tax-loss and get back in near the same price – when there is a chance of an out of the blue NEWS release about an a) expedited approval from European Medicines Agency, b) partnership c) joint venture or d) joint trial funding annoucement?”
We’re not purpose built to react to AFTER significant news. As the 420% gain in a couple weeks above depicts, we’d rather be ahead of potential real news, rather than after.
SOME OF OUR OTHER ‘OUT OF THE BLUE ANNOUCEMENT’ WATCHLIST COMPANIES.
Immunomedics. $3.50 to $88, acquired for $21 billion in cash. Nobody saw “early” FDA approval coming for Toldelvy. Jumped from $8.00 to $20 after approval (where many sold), and then to $26 the day after (where many more sold). The next out of blue news was an acquisition offer from Gilead, five months after the approval. Jumped 98% from $42 to $84 the day of the news. Surprise!
Dicerna. $3.30 to $38.25, acquired for $3.3 billion in cash. Acquired two years before Dicerna’s lead Phase III drug Nedosiran, was approved by the FDA. Novo Nordisk was reportedly after Dicerna’s RNAi platform, an overlooked asset that nobody saw coming. Jumped 80% on the buyout news.
Provention Bio. $4.60 to $25, acquired for $2.5 billion in cash. 16 months after getting a “complete response” letter FDA (no thanks, come again) they finally get approved in November of 2022. In the next four months after the approval the stock DROPS from $10 to $6.70 and then bam, Sanofi offers $25. Stressful and out of the blue as it gets, but fun. Jumped 243% on buyout news.
Note; none of these companies had any revenues and they were constantly raising money, during the pre-lightning rounds wait. We don’t even like the term “dilution” (we think of it as gas to stay in the race). Are you diluting your car when you add gas? So if you can’t handle dilution – DO NOT invest in revenueless Biotechs. Just saying.
Considering the risk to reward – let’s call the downside to zero (as with all Biotechs) and the upside 20X, we are willing to play in this wait-and-see game by investing first, and then hoping for the best later. Versus hoping we see the news, minutes after it is announced, and then jumping into the inevitable feeding frenzy.
Like all Biotech companies without revenues, who need to regularly raise funding to progress through expensive clinical trial work, it is difficult to concieve a per share price target.
That’s because we have no idea how many shares will be outstanding, if it takes a couple years before lightning type news strikes, from out of the blue.
We haven’t come up with an ‘upside’ formula yet, but goes something like this:
On a gross basis, putting aside on a per share basis for a moment. If GeoVax’s Covid vaccine can do $8 billion in a year, what would that be worth on a gross basis? $100 million, $500 million, $1 billion, $8 billion or 2-3 times sales?
We have no idea. But we will note (excluding warrants) that GeoVax recently reported 29.7 million shares outstanding. At $0.40 that would give it a gross value or market cap of $11.8 million.
And what about overseas patients, where there are over 300 million* immunocompromised people? Our calculator doesn’t go that high.
In our opinion, a current market cap of $118 million (as in today), or ten times higher – could still be considered as undervalued when looking at the “big picture” opportunity (TAM). Time will tell.
(*2020 study published in The Lancet estimated that around 349 million people (4% of the global population at the time) were at a high risk of severe COVID-19 due to specific underlying immunocompromising conditions and would likely require hospitalization if infected.)
Lancet (look under findings)
CNBC (1.7 billion at “high risk,” which would not only melt, but vaporize our calculator)
PRESS RELEASE
GeoVax Announces JCO Oncology – Highlighting Favorable Safety and Evidence
Since we have been following and reporting on GeoVax for over a decade, we actually know what many of the technical terms in today’s press release mean. But due to time restraints (or is it constraints) we won’t be able to translate until later tomorrow.
Here’s what we mean, and BTW this was HUGE news, and we promise we will break it down into ‘investor’ lingo versus medical expert lingo:
“A Phase 1/2 Study of Intratumoral Ad/PNP (Gedeptin) with Fludarabine Phosphate in Subjects with Recurrent Head and Neck Cancer“, (from American Society of Clinical Oncology) reports findings from a multi-center clinical trial evaluating repeated cycles of Gedeptin(R), a gene-directed enzyme prodrug therapy (GDEPT), administered via intratumoral injection followed by systemic fludarabine.
We know what “reports findings” and “multi-center clinical trial” mean. But Systemic Fludarabine? Alrighty then.
It’s good to know the favorable news report came from the American Society of Clinical Oncology (ASCO), a highly reputable organization. It is widely recognized as the world’s leading professional organization for physicians and oncology professionals dedicated to conquering cancer. Their Journal is written for and read by 50,000 oncology (cancer) professionals.
As an important ‘big picture’ reminder, if there are safety problems (like people are dying), trials are halted. If there is no significant evidence it is working (or inferior to the standard treatment), trials are usually halted. Like “stop wasting everyone’s time!”
It’s like the Indy 500. After interim data is reported, the green flag indicates that racing can proceed at full speed. The red flag is the universal stop signal (trial halted), commanding all drivers to stop immediately. The circumstances that dictate a red flag are those that make it unsafe to proceed at any speed, requiring all activity to cease until the issue is resolved.
So “no trial halt,” for GeoVax implicitly means, everything looks great – keep going. Green flag.
PRESS RELEASE BULLET POINTS
“These results support the continued development of Gedeptin in settings where tumor burden is lower, patients are less heavily pretreated, or where combination strategies, particularly with immune checkpoint inhibitors, may amplify therapeutic benefit.”
- Acceptable safety profile.
- Clinical evidence of disease stability.
- Study results suggest that earlier intervention, higher vector dosing, improved tumor transduction, or combination therapy (e.g., with immune checkpoint inhibitors) may further increase efficacy. Preclinical findings cited in the manuscript show that Gedeptin-mediated tumor destruction may sensitize tumors to checkpoint inhibitors, offering a promising path forward.
- “This publication reinforces the strong scientific rationale underpinning the Gedeptin platform. Even in a highly refractory patient population with extensive prior treatment, repeated intratumoral dosing of Gedeptin demonstrated a favorable safety profile and evidence of disease stability.”
- Building on robust preclinical data showing that Gedeptin enhances tumor sensitivity to immune checkpoint blockade, GeoVax is advancing plans to evaluate Gedeptin with agents such as Keytruda aiming to strengthen antitumor immune activation.
- “These results support the continued development of Gedeptin in settings where tumor burden is lower, patients are less heavily pretreated, or where combination strategies, particularly with immune checkpoint inhibitors, may amplify therapeutic benefit.”
FDA: COVID-19 Vaccination Guidance for People Who Are Immunocompromised
(Bottom line from CDC: If you are immunocompromised, you should receive a 3-dose initial COVID-19 vaccine series followed by two booster doses spaced 6 months apart, with brand choice depending on age. Combine vaccination with preventive therapies and household protection for maximum safety.)
We highlighted “household” because if there is someone in the house who is immunocomprimised – EVERYONE in that house should be vaccinated by GeoVax, if and when it is approved.
Who Are the Immunocompromised?
FDA/CDC List of Immunocompromised Categories
Here are the main groups considered immunocompromised in the context of COVID-19 vaccination:
- Solid organ transplant recipients (e.g., kidney, liver, heart, lung).
- Stem cell transplant recipients (within the last 2 years or still on immunosuppressive therapy).
- Active cancer treatment for solid tumors or hematologic malignancies (chemotherapy, radiation, immunotherapy).
- Primary immunodeficiency disorders (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome).
- Advanced or untreated HIV infection (low CD4 counts or uncontrolled viral load).
- Use of immunosuppressive medications, including:
- High-dose corticosteroids (≥20 mg prednisone daily for ≥2 weeks).
- Biologic agents (e.g., rituximab, infliximab, adalimumab).
- Other immunosuppressants (e.g., methotrexate, azathioprine, cyclophosphamide).
- Chronic conditions requiring immunosuppressive therapy, such as:
- Leukemia, lymphoma, or myeloma.
- Autoimmune diseases treated with immunosuppressants (e.g., lupus, rheumatoid arthritis).
Are The Obese at Special Risk?
We’ll add to the above list, the Obese. There are 140 million of them, or 45.8% of U.S. adults. The CDC and FDA states that Obesity is a double burden: it increases both COVID-19 severity and prevalence of comorbidities like diabetes and hypertension. It explains that obesity makes COVID-19 more dangerous because it impairs immune functions. Obesity is linked to chronic inflammation that disrupts normal immune responses.
That’s pretty clear and not to be Mr. Obvious, but the GeoVax vaccine is designed to BOOST their immune response.
In investor terms, that’s an additional potential pool of 140 million revenue generating patients, to dose and treat.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumors. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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 mRNA vaccines. In oncology, the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the 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. GeoVax is a client of Institutional Analyst, the publisher of the Biotech Stock Review and has been retained with a combination of cash and equity for ongoing progress, news coverge and research reporting for five thousand dollars per month.
Company Contact:
info@geovax.com
678-384-7220
Media Contact:
Jessica Starman
media@geovax.com
