Annovis Bio (NYSE:ANVS) is a good speculative biotech play to look into. The reason why I state this is because it has a major catalyst expected by the end of this year. That is, at the end of 2023, it expects to release results from the phase 3 study using its drug buntanetap for the treatment of patients with Parkinson’s Disease [PD]. Trial progress for this specific program has been amazing because of two events. First of all, it reached full enrollment quickly. In only nine months of time since this trial began, it completed enrollment of this late-stage study at record pace. This shows that there was a huge demand for patients to get into this study. Secondly, the Data Safety Monitoring Board [DSMB] performed an interim analysis on safety.
It was noted that there was only a 6% drop out rate and that there were no drug-related serious adverse events [SAEs] for PD patients who took buntanetap. This drug holds great potential in being able to treat patients with PD, but is also being explored in a phase 2/3 study to treat patients with mild to moderate Alzheimer’s Disease [AD]. With the data readout from the phase 3 PD study expected by the end of 2023, plus the possibility of buntanetap also being used to treat patients with mild to moderate AD, these are the reasons why I believe that Annovis Bio is a good speculative biotech play to look into.
End Of 2023 Parkinson’s Disease Data Readout Could Boost Shareholder Value
As I stated above, Annovis Bio is gearing up to release results from its phase 3 study using buntanetap for the treatment of patients with Parkinson’s Disease [PD], by the end of 2023. Parkinson’s Disease is a type of brain disorder whereby a patient experience uncontrollable movements such as difficulty with coordination, shaking and stiffness. Why do these issues occur? It is because nerve cell damage in the brain causes dopamine levels to drop off considerably. The global Parkinson’s Disease drug market is expected to reach $10.4 billion by 2031. Medications can help with respect to symptoms that these PD patients experience, but there is no cure for it.
Things are coming along well for this program, because there have been two promising events to make note of during the past several months. The first positive development with respect to this program is that enrollment was completed in record pace over a nine-month period. The first patient for this phase 3 study was dosed in August of 2022 and since then about 640 patients were screened and a total of 520 patients were recruited into this study. As I explained before, there seemed to have been a huge demand to get into this study. This does make sense though, because a prior phase 2 study using buntanetap for the treatment of patients with PD had achieved positive results. It was shown that buntanetap compared to placebo at day 25 had achieved a dose-dependent average 2.43 (13.4%) improvement when looking at the Unified Parkinson’s Disease Rating Scale [UPDRS] compared with baseline. This endpoint was achieved with a statistically significant p-value of p<.01. This drug also achieved statistical significance compared to placebo with another scale used for PD patients, which is known as the Wechsler Assessment of Intelligence Scale [WAIS] coding subtest.
It’s hard to say for sure if the final phase 3 results are going to be good, but at least Annovis was able to get a positive safety review of this study by the Data and Safety Monitoring Board [DSMB]. It was noted by the DSMB that the trial can continue as originally planned. The safety of buntanetap was shown to be good, especially when you consider that there was a very low 6% dropout rate. Also, there were no drug-related Serious Adverse Events [SAEs] to make note of either. There were only less than 2% of adverse events noted for this study.
Financials
According to the 10-Q SEC Filing, Annovis Bio had cash and cash equivalents of $16.8 million as of March 31, 2023. This is a low amount of cash on hand and thus, it needed to find a way to raise additional capital. It did so on April 11, 2023 when it raised aggregate gross proceeds of approximately $8.7 million between its now-terminated at-the-market [ATM] program and a private placement to individual members of its Board of Directors and management. The company terminated its ATM Sales Agreement effective on April 9, 2023. This newly added cash will help it fund its phase 3 study in early Parkinson’s Disease and its phase 2/3 study treating patients with Alzheimer’s Disease [AD]. Based on this newly added cash, it believes that it has enough funds to operate its business until Q1 of 2024. This is not enough cash to move forward with in my opinion, thus why I believe it will need to find a way to raise additional cash again before the end of 2023.
Risks To Business
There are several risks that traders/investors should be aware of before investing in this biotech. The first risk to consider would be with respect to the ongoing phase 3 study, using buntanetap to treat patients with Parkinson’s Disease [PD]. Data from this late-stage study is expected to be released before the end of 2023, however, there is no guarantee that the primary endpoint will be met. A second risk to consider would be with respect to the ongoing phase 2/3 study, which is using buntanetap for the treatment of patients with Alzheimer’s Disease [AD]. There is no assurance that this biotech will receive positive results for this phase 2/3 study and as such, it may have to choose to terminate this program. A final risk to consider would be with respect to its financial position. That’s because as I noted above, it only has enough cash to fund its operations into Q1 of 2024. This means, it will need to find a way to raise additional cash in the coming months. Thus, it is likely going to have to dilute shareholders soon to keep both clinical trials going.
Conclusion
The final conclusion is that Annovis Bio is a good speculative biotech play to look into. That’s because it is gearing up to report results from its phase 3 study, using buntanetap for the treatment of patients with Parkinson’s Disease, before the end of 2023. It is already ahead by one step of the game, in that the Data Safety Monitoring Board [DSMB] already conducted an interim analysis of buntanetap for the treatment of patients with PD. It was stated that treatment was safe/tolerable. On top of that, the dropout rate wasn’t bad either. It was stated that there was only a 6% dropout rate. In addition, this phase 3 trial completed enrollment in record time as well.
Another expansion opportunity might lie with respect to advancing buntanetap for the treatment of patients with Alzheimer’s Disease. It is expected that this phase 2/3 study is going to enroll up to 320 patients with AD. Such patients are to receive one of the three doses of buntanetap [7.5 mg, 15 mg, 30 mg] or placebo, on top of their current standard of care for a total of 3 months. In a prior phase 2 study, Annovis stated that AD patients treated with buntanetap achieved a statistically significant 4.7 point or 30% improvement in ADAS-Cog11. This, compared to those who took placebo in this study who only saw a 1.1 point improvement in ADAS-Cog11. With the data readout from the phase 3 PD study expected by end of 2023, plus the possibility of buntanetap also being used to treat patients with mild to moderate AD, these are the reasons why I believe that Annovis Bio is a good speculative biotech play to look into.
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