GeoVax Labs, Inc. (NASDAQ:GOVX) is a great speculative biotech play to look into. That's because it only trades at $3 per share, but it has potential advancement for its vaccine technology in two key areas. These key areas are a Covid-19 vaccine which is ongoing in two phase 2 studies. One study is using GEO-CM04S1 as a Covid-19 vaccine and then another study using it as a booster.
One key thing to note is that in terms of it being used as a Covid-19 vaccine, the phase 2 study is exploring it in immunocompromised cancer patients. This means that the biotech is specifically going after a subpopulation who may need stronger immunity against the virus. In addition, it has another shot on goal with a pan-corona virus vaccine it is working on, known as GEO-CM02. The other key area for which it is exploring the use of GEO-CM04S1 in is Monkeypox. That is, it is being explored as a prevention of Monkeypox.
This vaccine technology of GEO-CM04S1 is what it is being used against other target indications such as HIV, Zika and Hemorrhagic fever viruses. The company is even expanding to cancer immunotherapy as well with its vaccine technology to develop additional shots on goal. It remains to be seen if the vaccine products ultimately work out, but I believe these two key indications could be huge value adding events.
The other shots on goal in the pipeline are in early-stage testing but provide other opportunities. These are the reasons why I believe GeoVax is a great speculative biotech play to look into.
There are many Covid-19 vaccines out there and so the market is being overwhelmed with them. If that is the case, then how does GeoVax Labs hope to capitalize on advancing GEO-CM04S1 for Covid-19? There are three possibilities here.
The first being that it is able to get this vaccine developed for those who are immunocompromised, especially those with cancer. The thing is that those who have cancer can't develop the antibodies necessary to fend off Covid-19. As such, they rely on T-cells only which is likely not enough. The point here is that there is an opportunity to target a specific sub-population of Covid-19 patients. This is how GeoVax can still capitalize on this market indication, without being overwhelmed.
The use of GEO-CM04S1 is being explored in a phase 2 study as a primary vaccine for immunocompromised cancer patients. However, why I think this study is well powered is because it is being compared to a Pfizer (PFE)/BioNTech (BNTX) authorized messenger RNA ((mRNA)) vaccine named COMIRNATY. The primary endpoint of this phase 2 study is immune response over a 28 day period. Again, I think the opportunity here is to target-specific immunocompromised patients, especially those with cancer.
The second opportunity lies in using GEO-CM04S1 as a vaccine booster in a phase 2 study. This vaccine is a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of Covid-19 infection. It was developed by GeoVax by putting in small pieces of SARS-CoV-2 DNA into synthetic MVA. The belief is that may be able to induce an immune response to recognize and kill off the virus. However, this study will compare the use of GEO-CM04S1 to placebo administration.
The reason why I think this vaccine holds so much potential is because it's a dual approach. What do I mean by that? Well, all currently approved mRNA vaccines target the Spike protein in particular. On the other hand, GEO-CM04S1 targets two proteins. It targets both the Spike and nucleocapsid proteins. It remains to be seen if this dual targeting approach is much more adequate compared to only targeting the Spike protein alone, but there is huge potential for advancement here.
Thus far, it has reported some pretty good data. For instance, back in March of 2022 is posted some results from a phase 1 study using GEO-CM04S1 in a peer-reviewed journal. The takeaway is that it was able to produce robust neutralizing antibodies and T cells against SARS-CoV-2 with no significant side effects. I think the huge promise here is that even if there eventually are additional mutations in the Spike protein, the company's dual targeting approach (targeting both Spike and nucleocapsid proteins) may still provide substantial immunity compared to those currently approved mRNA vaccines. This remains to be seen until the phase 2 results are posted, but this potential would be huge, especially for cancer patients who are really immunocompromised.
The third opportunity lies with the use of GeoVax's pan-coronavirus vaccine, which is being developed as a universal vaccine for the virus. This is a good idea, because just in case the dual protein targeting approach doesn't pan out in phase 2 studies, it still has an opportunity to advance a single-dose vaccine. This single-dose vaccine being developed is known as GEO-CM02. The only problem with this program is that it is still in early development. Matter of fact, it is still being explored in preclinical studies. The purpose is to eventually get this pan-coronavirus vaccine ready for an IND filing and then subsequent human studies.
The thing is that GeoVax is doing pretty well in advancing its vaccine GEO-CM04S1 for Covid-19. However, it also has a great shot at developing a vaccine for Monkeypox as well. Why is that so? That's because the vaccine used and stockpiled for immunization against Monkeypox is MVA. As I noted above, modified vaccinia Ankara (MVA) is a vector also being used in all of GeoVax's vaccines targeting multiple indications such as HV, Zika, Hemorrhagic fever viruses and others.
It is not quite yet a pandemic, but cases are starting to rise. As of this past Friday, there have been about 7,510 cases of Monkeypox in the United States. The majority of cases are coming from California, Florida, and New York. Globally, there has been more than 28,000 cases reported since January of this year. It's important to watch the spread of this, because it's possible that the spread could increase.
There is a notion that it is not an STI and that it can be spread through close skin contact. Regardless, the rise in cases if anything should be monitored closely. Monkeypox DNA has been detected in feces and other bodily fluids. However, it is under investigation whether or not the mere presence of virus DNA found can cause a spread in these instances.
The use of GeoVax's MVA-based HIV vaccine has shown to be successful in the prevention of Monkeypox in non-human primate models in a peer-reviewed publication. Preclinical studies are being done, and if the results are successful, then further studies could come about later on. The key thing is that this could open the scope for the GEO-CM04S1 MVA to be used for multiple indications. Even better, there is potential to prevent both hemorrhagic fever virus and the Monkeypox virus in a single vaccine. This has not yet been validated yet, but if it is in the coming months/year it would be a huge finding.
According to the 10-Q SEC Filing, GeoVax Labs Inc. had $30.9 million in cash as of June 30, 2022. The reason why it has so much cash on hand is because of a follow-on offering and private placement of common stock and warrants it had done in May of 2022. This was a registered direct and PIPE offering in which it was able to raise approximately $20 million. This is on top of the cash it had already raised back in January of 2022, which was $9.2 million. This financial transaction was a private placement of common stock and warrants.
I believe that going forward the biotech will likely need to raise additional cash. It hopes to provide updates on its programs throughout 2022. If positive news is released in this 2nd half of 2022 (program/trial updates), then I expect it to raise cash immediately. Why I do believe this will be the case? That's because GeoVax notes in its 10-Q SEC filing that it believes it has enough cash to fund its operations for at least the next 12 months. It will not wait until the very end to raise cash. As such, it will likely take advantage of an immediate rise in stock price. However, such a rise will only occur if one of the ongoing studies have positive results reported.
There are several risks that investors should be aware of before investing in GeoVax. The first risk being the Covid-1 vaccine program. That's because both the use of GEO-CM04S1 as a Covid-19 vaccine for the immunocompromised and as a booster are being evaluated in two ongoing phase 2 studies. There is no guarantee that either of these mid-stage studies will end up being successful.
Even if they are successful, plus the company is able to obtain EUA for GEO-CMS04S1, there is no assurance that the vaccine will do well on the global stage. As I noted directly above in the beginning, there are many other regulatory approved vaccines, especially the most popular ones being Pfizer/BioNTech COMIRNATY and Moderna (MRNA) Spikevax. Pfizer believes that it could earn as much as $32 billion in revenue for COMIRNATY. Moderna did well for itself back in 2021, where it earned full year revenue of $18.5 billion. It already has in place the ability to earn $21 billion from Advance Purchase Agreements in 2022.
It's important to note that GeoVax holds potential of being successful in clinical development depending upon what is achieved. If it can obtain impressive results for use with GEO-CM04S1 as a Covid-19 vaccine for everyone that would be amazing. However, even if it only obtains its goal of specifically targeting immunocompromised patients, then it could still do well. The booster vaccine study being successful would only serve to help it expand to a larger pool of patients. Even then, it is expanding the use of GEO-CM04S1 as a preventative vaccine for Monkeypox. The risk is that it is still only in early pre-clinical testing for this product and there is no guarantee that it will ultimately succeed in human testing.
A final risk would be as it relates to the financials of the biotech. It predicts that it only has enough cash on hand to fund its operations for at least the next 12 months. Having said that, I don't believe it will wait until the very end to raise cash. Not only that, but it is building its pipeline developing other vaccines for additional indications. These new studies will need funding and as such it may be pressed to raise cash earlier than anticipated.
I believe that GeoVax has developed a pipeline that holds a lot of potential for success. The ability to use GEO-CM04S1 vaccine for multiple indications is huge. I noted that the biotech is already advancing it in two key areas. These are for patients with Covid-19 and for Monkeypox. Whether or not it is ultimately successful for either or both of these indications remains to be seen. However, the company is not just relying on the use of its technology towards only targeting Covid-19, Monkeypox and other viruses. It also wants to focus on advancing the MVA for use in oncology. This is a product known as MVA-VLP-MUC01 for treatment of patients with solid tumors, which is in IND-enabling studies.
There is another product in the pipeline which is different and this is known as Gedeptin. This is a replication-deficient adenoviral vector, which is used in existing vaccines. An example would be Johnson & Johnson's (JNJ) single shot Covid-19 vaccine. However, Gedeptin is being coded for an enzyme derived from E-coli called purine nucleoside phosphorylase (PNP). How can such an enzyme do well against cancer? Alone, it honestly can't. However, when this PNP enzyme is used in combination with a purine nucleoside prodrug then it can possibly become a strong active chemotherapeutic agent within tumor cells. The first target for use with Gedeptin is advanced head and neck cancer.
Based on the most recent advancements, plus the ability to expand its vaccine technologies against virus and cancers, I believe that GeoVax is a great speculative biotech play to look into.
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33.50% discount price of $399 per year.
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