Genelux: H2 2025 PRROC Data Is A Major Inflection Point

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Topline results from the phase 3 OnPrime/GOG-3076 study using Olvi-Vec for the treatment of patients with platinum-resistant recurrent ovarian cancer are expected in the second half of 2025.Interim ...

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About 85% of patients with ovarian cancer will experience recurrence at some point.gorodenkoff  Genelux Corporation (NASDAQ:GNLX) is gearing up for a major inflection point next year, in that it is expected to release topline results from its phase 3 OnPrime/GOG-3076 registrational study using its oncolytic immunotherapy drug Olvi-Vec to treat patients with platinum-resistant recurrent ovarian cancer [PRROC]. It is expected that such data could be released at some point in the 2nd half of 2025. While this is a major inflection point that is not expected until the latter part of next year, this doesn't mean that investors can't benefit from any other possible catalysts to be released beforehand. Having said that, it is expected that it will release data from a few other studies before then. One release is going to deal with the U.S.-based phase 2 VIRO-25 trial evaluating the use of Olvi-Vec for the treatment of patients with recurrent non-small cell lung cancer [NSCLC, with interim data expected from it in mid-2025. An even earlier opportunity for investors to focus on would be the phase 1b/2 China study using Olvi-Vec for the treatment of patients with recurrent small cell lung cancer [SCLC]. An interim data readout from it is expected at some point during the 2nd half of 2024. With the continued development of Olvi-Vec for the treatment of patients with PRROC in late-stage development, plus several catalysts expected to happen in the coming year, I believe that investors could benefit from any potential gains made. The last time I wrote about Genelux was regarding a Seeking Alpha article entitled \"Genelux: Biotech To Watch With Oncolytic Virus Immunotherapy In Late-Stage Testing\". Recruitment has been continuing on the front to reach top-line results for the phase 3 OnPrime/GOG-3076 study, which is setting up for a major catalyst as I noted above. In my previous thesis, I noted that the company initiated the study only. Since then, it has come a long way with the continued advancement of this late-stage program. A new development since then is that the company was granted Fast Track Designation [FTD] of Olvi-Vec for the treatment of these patients with PRROC. This designation brings about more frequent interactions with the FDA for starters. Even more important than that, it gives the potential to have a Priority Review, which speeds up the pathway for approval. I believe that with continued traction on this front, plus several catalysts on the way, it could really boost shareholder value if everything turns out to be positive. Olvi-Vec For The Treatment Of Patients With Ovarian Cancer The first program to go over from Genelux's pipeline would be the development of Olvi-Vec in the ongoing phase 3 OnPrime/GOG-3076 registrational study targeting patients with platinum-resistant recurring ovarian cancer [PRROC]. Before going over this specific late-stage trial, plus any catalysts to be released from this program, it is first important to go over what platinum-resistant ovarian cancer is and what the possible market opportunity could end up being. Ovarian cancer is a type of disease characterized by malignant cells that form a tumor on the ovaries of a woman. The ovaries are an important part of a woman's body as they are almond-size shaped organs that produce eggs and two female hormones [progesterone and estrogen]. There definitely needs to be new treatment options for sure, that's because this type of cancer accounts for 1% of all U.S. cancer cases. Even worse, is that this cancer can even spread and may do so from the pelvic region of the patient to the stomach, lymph nodes, chest, and liver. Some symptoms that these patients with ovarian cancer experience are as follows:  Loss of appetite. Stomach pain. Change in bowel movements. Frequent urination. Vaginal discharge.  The global ovarian cancer treatment drugs market size is expected to reach $5.45 billion by 2033. This is a big market opportunity, but it is important to keep in mind that the goal is to target such patients who have platinum-resistant disease or platinum-resistant ovarian cancer [PROC]. That is, despite being given platinum-based chemotherapy, their cancer recurs within a 6-month period. Despite only having the focus on a subpopulation of these patients, it is still expected to be a big market opportunity. The reason why I state that is because it is said that approximately 85% of patients with ovarian cancer will experience recurrence at some point. In order to see if Olvi-Vec is going to be able to treat patients with platinum-resistant recurrent ovarian cancer, it is in the process of running the phase 3 OnPrime/GOG-3076 study. This multi-center randomized open-label trial is expected to recruit up to a total of 186 patients who will be randomized to one of the following treatment arms:  Treatment arm: Olvi-Vec + platinum double chemotherapy + Avastin [bevacizumab] followed by maintenance therapy. Comparator arm: Physician's choice of chemotherapy [single agent chemotherapy or doublet] + Avastin followed by maintenance therapy.  The primary endpoint of this phase 3 OnPrime/GOG-3076 study is going to be progression-free survival [PFS]. Secondary endpoints to be added to this study will be both in terms of safety and efficacy measures. In terms of safety, the secondary endpoint will entail treatment-emergent adverse events [AEs]. On the efficacy side of things, regarding the secondary endpoint, there are several measures expected such as Overall survival [OS], Overall response rate [ORR], and Duration of response [DOR]. The thing to note is that there is a major inflection point for this particular registrational type study. It is expected that topline results from this phase 3 OnPrime/GOG-3076 study will be released in the 2nd half of 2025. The hope is that Genelux's therapy Olvi-Vec is going to be able to achieve its intended mechanism of action [MOA]. That is, this oncolytic virus therapy establishes three modes of action to potentially achieve its ultimate goal. The first goal is to achieve tumor cell lysis [tumor cell death]. However, the key here is that the virus only replicates in cancerous cells and leaves healthy human cells alone as the first action. Secondly, it produces neo-antigens to present parts of the virus to the immune system. The immune system takes the bits and pieces and mounts its own immune response to drive deeper tumor cell lysis. The third and last item that this therapy does is to alter the tumor microenvironment [TME]. In essence, it removes the immunosuppressive nature of the tumor [cold tumor] and changes it to a \"hot\" state. In the case of the targeting of PRROC patients, it makes it so that the tumor is desensitized so that there is no tumor resistance when given alongside other therapies. It remains to be seen if the phase 3 OnPrime/GOG-3076 study is going to achieve the primary endpoint. However, there is already data released from a prior study that paints a picture of why success might be achieved. This would be regarding data from a prior phase 2 study, which used Olvi-Vec for the treatment of patients with recurrent or refractory ovarian cancer. Patients in this mid-stage study were given Olvi-Vec + chemotherapy with or without Avastin. A total of 27 patients were recruited into this mid-stage study. The final outcome was that an objective response rate [ORR] of 54% was obtained using RECIST1.1 criteria. Not only that, but the overall progression-free-survival [PFS] number ended up being 11 months. The PFS number increased slightly to 11.4 months for the 13 patients with platinum-refractory disease. For the approximately 14 platinum-resistant patients the PFS was 10 months. As you can see, this oncolytic immunotherapy was active in being able to treat these patients in a phase 2 study. All that remains now is to see if such a PFS number can be replicated in the ongoing phase 3 OnPrime/GOG-3076 study. Financials According to the 10-Q SEC Filing, Genelux Corporation had cash, cash equivalents, and short and long-term investments of $40.4 million as of June 30th of 2024. The reason for the cash on hand is that back in May 2024, it completed an underwritten public offering of common stock and warrants. This offering helped the biotech to raise approximately $27.7 million in net proceeds from this offering. There should be no risk of dilution in the near term, but I believe that it may have to likely raise additional cash at some point in 2025. What makes me believe this to be the case? It is because it states in its 10-Q SEC Filing that it believes it has enough cash on hand to fund its operations into Q1 of 2026. The company is set to release its next set of earnings soon. What investors should look out for regarding this is whether or not there are any timeline shifts or changes on when data is expected. A delay won't necessarily be a terribly bad thing, but it will mean that investors may have to wait longer to see clinical data from say, the phase 3 OnPrime/GOG-3076 study. What I'm watching out for really is to see if there is any update on the two other expected programs of Olvi-Vec in treating patients with NSCLC and SCLC. That's because positive data from these studies might possibly mean a successful outcome for the ongoing phase 3 study. In addition, it will be important to keep track of the updated cash burn in the financials. Just to see if there has been any shift in R&D and G&A expenses funding. The next earnings date is estimated to be around November 12th of 2024. However, it is possible that earnings could be released before or after this particular date. Risks To Business There are several risks that investors should be aware of before investing in Genelux Corporation. The first risk to consider would be regarding the development of Olvi-Vec for the treatment of PRROC patients in the ongoing phase 3 OnPrime/GOG-3076 registrational study. The risk here is that there is no assurance that the primary endpoint of this late-stage study is going to be met with statistical significance. In addition, even if this primary efficacy measure is met, there is no guarantee that the company will be able to file a regulatory application to seek marketing approval for this oncolytic immunotherapy for the treatment of these PRROC patients. The second risk to consider would be regarding the phase 2 U.S. study using Olvi-Vec for the treatment of patients with non-small cell lung cancer [NSCLC]. With interim data anticipated to be released in mid-2025, the risk here is that there is no guarantee that the data to be released from this study are going to be positive. Nor, that the efficacy produced from this mid-stage trial will be enough to warrant further investigation to the next stage of clinical testing. The third and final risk to consider would be in terms of the ongoing phase 1b/2 China study, which is evaluating the use of Olvi-Vec for the treatment of patients with small-cell lung cancer [SCLC]. Interim results from this mid-stage study are expected to be released in the 2nd half of 2024 any day now. The risk here is that there is no assurance that the data to end up being released from this study will turn out to be positive. Not only that, but since this study is being done with collaboration partner Newsoara in China, the continued partnership is likely dependent upon successful results. If this is not the case, then it is quite possible that such a collaboration between both companies could end up being terminated. Conclusion Genelux Corporation has done well to advance its oncolytic immunotherapy treatment Olvi-Vec for the treatment of patients with various cancer types. The most notable program from its pipeline would be the use of this drug to target patients with PRROC in the ongoing phase 3 OnPrime/GOG-3076 registrational study. The data is not that far off, as it is expected in the latter part of next year, but the point is that this will be a major inflection point. One other item to quickly point out is that this program, in targeting PRROC patients, is part of the ability to treat these patients via the peritoneal [regional] route. The reason why I bring that up is because Olvi-Vec in the targeting of NSCLC and SCLC patients involves treating such patients via a systemic route of administration.  Having said that, the goal is to start off with next-generation regional routes of administration for oncolytic immunotherapies and then branch off to systemic routes out of administration. For example, Amgen Inc. (AMGN) has been able to receive FDA approval for its drug IMLYGIC [talimogene laherparepvec] for the treatment of patients with advanced melanoma. It is the first and only FDA-approved viral therapy which is injected directly into melanoma tumors. The goal for Genelux is to take this first-generation concept of oncolytic virus and improve upon the efficacy regarding the regional route of administration. 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