2023-07-17 08:06:31 ET
Summary
- FPI-2265 is being explored in patients with metastatic castration-resistant prostate cancer in the ongoing phase 2 TATCIST trial; Results from this study are expected to be released Q1 of 2024.
- The global metastatic castrate resistant prostate cancer treatment market is expected to reach $17.71 billion by 2029.
- Two other targeted alpha therapies in the pipeline, known as FPI-1434 and FPI-2059, are being used to treat patients with solid tumors.
- The global solid tumor cancer treatment market size is estimated to reach $532.42 billion by 2032.
Fusion Pharmaceuticals ( FUSN ) is advancing a candidate which it acquired in February of 2023. It was acquired as an ongoing phase 2 study, known as the TATCIST trial. This is evaluating the use of FPI-2265 for the treatment of patients with metastatic castration resistant prostate cancer [mCRPC]. It is expected that results from this ongoing phase 2 study, using this therapy for the treatment of patients with mCRPC, will be released in Q1 of 2024. This is a large multi billion-dollar market opportunity and success with the phase 2 study would mean a huge boost to the value of this biotech. In addition, it is also advancing two clinical products to be developed for treating patients with solid tumors. These two clinical candidates are known as FPI-1434 and FPI-2059.
Acquired Alpha-Emitting Radiopharmaceutical To Target Large Market Opportunity
Fusion Pharmaceuticals is advancing a pipeline full of targeted alpha therapies or TATs. To such end, in February of 2023 it was able to acquire an alpha-emitting radiopharmaceutical , which was being evaluated in a phase 2 study known as the TATCIST trial. The use of FPI-2265 is being explored in this mid-stage study for the treatment of patients with metastatic castration resistant prostate cancer. Prostate cancer is a cancer that forms in a man's prostate, which is a small walnut-sized gland that produces seminal fluid. There are typically no symptoms found at all, but when a symptom is present it might be difficulty to urinate. Castration resistant prostate cancer is such a type whereby treatment with androgen deprivation therapy [ADT], doesn't prevent the prostate cancer from progressing.
ADT is used to block the production and signaling activity of hormones called androgens [such as testosterone]. The hope is that by blocking such advancement that would stop the cancer from growing further. Most CRPC are diagnosed as being metastatic and that is when the cancer has already spread beyond the prostate. Only about 16% of CRPC are caught prior to metastasis. It is a very large market opportunity, which is why I believe that such an acquisition might end up being the right move. The global metastatic castrate resistant prostate cancer treatment market is expected to reach $17.71 billion by 2029 . Therefore, if Fusion Pharmaceuticals can successfully advance FPI-2265 for the treatment of patients with mCRPC, then this alone will greatly boost value in the company.
With the acquisition of this clinical product, Fusion is advancing the use of FPI-2265 for the treatment of patients with metastatic castration-resistant prostate cancer [mCRPC], in a phase 2 study. Why I believe the advancement of this clinical product offers opportunity, is because it is expected that Fusion Pharmaceuticals will release results from this mid-stage study in Q1 of 2024. This will include about between 20 to 30 patients with mCRPC who have progressive disease. One thing to note is that this study will include patients who are naive to PSMA-targeted radiopharmaceuticals and those who have been pre-treated with Lu-based PSMA radiopharmaceuticals such as PLUVICTO.
Financials
According to the 10-Q SEC Filing , Fusion Pharmaceuticals had cash, cash equivalents and investments of $221.2 million. The reason for the cash on hand was because of the addition of $60 million in gross proceeds received from a private placement financing that was closed in February of 2023. Not only that, but it was able to complete a private placement agreement. That is, it agreed to sell approximately 4.8 million common shares to Federated Hermes Kaufmann Funds in a private placement in public equity financing. The offering is expected to result in gross proceeds of about $20 million, before deducting expenses. This newly raised cash should be enough to fund this biotech for quite some. I state that because with the cash on hand, plus the recent private placement agreement of $20 million, it believes that it has enough cash on hand to fund its operations into Q2 of 2025.
Risks To Business
There are several risks that investors should be aware of before investing in Fusion Pharmaceuticals. The first risk to consider would be with respect to the ongoing phase 2 TATCIST trial, which is using FPI-2265 for the treatment of patients with metastatic castration-resistant prostate cancer [mCRPC]. That's because results from this mid-stage study are expected to be released by Q1 of 2024. There is no guarantee that the primary endpoint of this study will be met or that it will be positive. A second risk to consider would be with respect to the FDA itself. Even if Fusion Pharmaceuticals is able to eventually pass phase 2 and phase 3 clinical testing, it still has to file a regulatory application for approval with the FDA. There is no assurance that the FDA will accept the regulatory application of FPI-2265, nor that it will be approved to treat patients with mCRPC. A third risk to consider would be with respect to the two clinical candidates of FPI-1434 and FPI-2059, which are being advanced for the treatment of patients with solid tumors. There is no guarantee that both will achieve positive results in phase 1 testing or that both will be brought forward into phase 2 clinical testing.
Conclusion
Fusion Pharmaceuticals is pushing along its clinical candidates which are Targeted Alpha Therapeutics [TATs]. Despite having an early-stage pipeline, it was able to acquire a phase 2 asset known as FPI-2265, which is being advanced for the treatment of patients with metastatic castration-resistant prostate cancer [mCRPC]. It is also targeting the very large solid tumor market, through the use of two other TATs in its pipeline, which are FPI-1434 and FPI-2059. The global solid tumor cancer treatment market size is estimated to reach $532.42 billion by 2032 . If this biotech can at least successfully get one of these two clinical candidates eventually approved, then it will be in good shape. With its data readout of its phase 2 TATCIST trial in patients with mCRPC in Q1 of 2024, plus the ability to target the large solid tumor market with FPI-1434 and FPI-2059, I believe that investors might be able to capitalize on any possible gains made here.
For further details see:
Fusion: Targeted Alpha Therapy FPI-2265 For Large Prostate Cancer Market