2023-05-11 19:10:07 ET
Summary
- Results from the phase 2 BOLD study, using ATA188 for the treatment of patients with progressive multiple sclerosis, are expected in October of 2023.
- It is said that the global multiple sclerosis drug market size could reach $34.03 billion by 2031; About 10% of MS patients have PPMS.
- Update on Biologics Licensing Application of Tab-cel for treatment of patients with PTLD to be decided upon in Q3 of 2023 earnings release.
- Additional results from an open label expansion phase 2 multi-cohort 2 study, using Tab-cel towards other EBV diseases, are expected in Q4 of 2023.
Atara Biotherapeutics ( ATRA ) is a good speculative biotech play to look into. That's because it has a major catalyst which is coming in October of 2023, which will be the release of results from the phase 2 EMBOLD study, which is using ATA188 for the treatment of patients with progressive multiple sclerosis. Besides this, Atara has potential to file a Biologics Licensing Application [BLA] of Tab-cel for post-transplant lymphoproliferative disease [PTLD]. That's because it spoke with the FDA about chemistry, manufacturing, and controls [CMC] matters. At that time, it was stated that Atara won't meet with the FDA again until Q2 of 2023 to discuss what CMC will be necessary for a BLA filing. Thus, it is anticipated that Atara will update shareholders on plans of a BLA submission in the next earnings update, which won't happen until Q3 of 2023. Lastly, it is looking at advancing Tab-cel towards other EBV diseases. Having said that, it expects to release results from an open label expansion phase 2 multi-cohort 2 study using Tab-cel in Q4 of 2023. With European approval of Tab-cel for PTLD, plus two data readouts expected in the 2nd half of 2023, these are the reasons why I believe that Atara Biotherapeutics a good speculative biotech play to look into.
ATA188 For The Treatment Of Patients With Progressive Multiple Sclerosis
Atara is advancing the use of ATA188 for the treatment of patients with progressive multiple sclerosis in the phase 2 EMBOLD study . Multiple sclerosis [MS] is a neurodegenerative disease that disrupts the brain's ability to control a person's body. There are multiple types of MS, but Atara is specifically going Primary Progressive MS [PPMS]. Primary Progressive MS is a type of MS whereby neurological functions steadily decline from the get go. It is said that those who have this disease have neurological decline which progresses continuously. This is a large market opportunity, because it is said that the global multiple sclerosis drug market size could reach $34.03 billion by 2031 . Having said that, about 10% of people diagnosed with MS have PPMS. Even at this percentage, it would still be a large market for it to go after. There are several types of symptoms that these PPMS patients might experience, such as:
- Muscle weakness
- Vision issues
- Trouble walking
- Numbness
- Feeling dizzy
- Pain on many parts of the body
The thing about this biotech is that Atara Biotherapeutics has an opportunity to help shareholders in that there is the expected release of results from the phase 2 EMBOLD study in October of 2023. It's hard to say whether or not the results are going to end up being successful for this phase 2 EMBOLD study. The reason why is because an interim analysis update was not able to conclude whether or not treatment with ATA188 would result in an improvement for these PPMS patients at a 12-month time point. Having said that, this is huge make or break for this particular program. If the results to be released in October of 2023 fail to live up to expectations, then this program will be cut from the pipeline.
Financials
According to the 10-Q SEC Filing , Atara Biotherapeutics had cash, cash equivalents and short-term investments of $205.4 million as of March 31, 2023. It believes that it has enough cash to fund its operations into Q2 of 2024. Being that most biotechs tend not to wait to raise additional cash, it will likely need to raise cash in the coming months. It has already been diluting shareholders with the use of an ATM agreement it had made with Cowen and Company, LLC [Cowen], with the ability to sell an aggregate offering of up to $100 million. During Q1 of 2023, it sold an aggregate of 147,930 shares of common stock under this 2021 ATM facility, at an average price of $4.64 per share. It raised net proceeds of $0.6 million from it after deducting commission and other offering expenses. I believe that this is something that Atara will likely continue until it finds another means to raise additional cash.
Risks To Business
There are several risks that traders/investors should be aware of before investing in this biotech. The biggest risk of all would be the results to be released from the phase 2 EMBOLD study, which is using ATA188 for the treatment of patients with PPMS. That's because, as I noted above, an interim analysis done at 6 months was not able to conclude whether or not these PPMS patients had a benefit with this therapy. Thus, this makes this data a high risk/high reward. There is no assurance that the final results to be released from this study will be successful. A second risk to consider would be with respect to the release of expansion cohorts from the basket study using Tab-cel towards other EBV diseases. Data from this study is expected to be released in Q4 of 2023 and there is no guarantee that this study will also be successful. The third risk would be relating to the ongoing BLA dialog talk between Atara and the FDA. A talk with the agency to discuss the possibility of the BLA filing of Tab-cel for PTLD is expected in Q2 of 2023. However, the intention and/or plans of whether or not a BLA can be filed will be updated in the next earnings conference call, which likely won't happen until around August of 2023. The final risk to consider would be with respect to the financial position in which it is in. That's because it believes it only has enough cash to fund its operations until at least Q2 of 2024. This means not only will it have to dilute shareholders in the meantime through the use of the ATM, but it will have to find another way to raise cash in the coming months.
Conclusion
The final conclusion is that Atara Biotherapeutics is a good speculative biotech play to look into. That's because there are a few catalysts for investors to look forward to. The first catalyst would involve the release of results in October of 2023 from the phase 2 EMBOLD study, which is using ATA188 for the treatment of patients with primary progressive multiple sclerosis [PPMS]. A second catalyst would be the next earning update by Q3 of 2023. The reason why this will be important is because the biotech will know by then whether or not it plans/can file a BLA for Tab-cel for PTLD. Lastly, it is looking at advancing Tab-cel towards other EBV diseases. Which means it is exploring the use of this drug for such populations in a phase 2 multi-cohort study and expects to release additional results from it in Q4 of 2023. This will be important, because it will reveal if Tab-cel can be advanced towards other EBV diseases. With several catalysts expected in the 2nd half of 2023, plus having already received European approval of Tab-cel for PTLD, these are the reasons why I believe it is a good speculative biotech play to look into.
For further details see:
Atara: MS Study Data Release And Other Catalysts Make This A Must Watch