What’s Everyone’s Outlook on ATYR Pharma ($LIFE) After the FDA Type C Update?
Hi everyone! New account - I have been recently getting more involved in the biotech/pharma investing space and was curious as to what people think. I've been trying to use my background as a clinical pharmacist to supplement my financial analyses, and wanted to see how my analyses pan out and learn from it.
I've been following ATYR stock for quite some time now shortly after its prices plummeted late last year after the results of their Phase 3 trial. I had personally invested just a little bit when it hit $1 and recently when it was hovering around $0.80. My original thought process was that the company wasn't completely dead yet and had a decent chance for a rebound based on these factors:
- Novel drug to treat pulmonary sarcoidosis, where the first line treatment is steroids (comes with nasty side effects with long term use)
- Good secondary outcomes, although it failed to meet its primary endpoint in a mean reduction of corticosteroid use, it did improve FVC and KSQ Lung Scores. I think what we typically see in diseases that are harder to treat (like oncology/rheumatology), the FDA is more flexible with what metrics make a drug clinically viable (symptom improvement/quality of life). It surely was different from what they intended, in reducing steroid doses, but it sounded like it would still have a role in therapy as an adjunct agent?
- Ambiguity regarding it's lead asset sounds like a terrible thing, but it wasn't shut down for good, and the stock price was kinda tempting to me post crash (Sorry if you had invested). It looked like ATYR had a pretty high liquidity and somewhat decent sized runway to continue operating its other ongoing trials.
After combing through some posts related to ATYR it seemed like it was split on two extremes, your overenthusiastic, annoying, "to-the-moon" type posts and your "i would rather have a gun to my head rather than invest in ATYR again." To be honest, the latter made more sense to me as there were so many people who got burned, but my take was somewhere more in the middle, and it has stayed pretty constant since I made my initial investments months ago.
The outcome of the FDA type C meeting was more or less what I thought would happen (a complete redo of the phase 3 trial reframing their primary endpoints). People who were talking highly of this stock claimed that it's secondary endpoints would carry it to the finish line and get it approved despite failing primary endpoints, with some nonsense about "new" FDA standards, but realistically there are so few drugs that have ever had success with this. Secondary endpoints are generally considered exploratory and I felt like while they had merit and highlighted a potential role in therapy for Efzofitimod, that it would still require a redo of the Phase 3 trial to reframe their primary endpoints. The realistic best case scenario would have been maybe a narrower study group, but the fact that a redo is happening at all still gives it a chance.
My biggest concern for my continued investment is their funding. Their annual expenses rounded out to close to $60 million, and it seemed like they'd only have maybe a year, a little more over a year of runway left, so a complete re-do, and the time it takes to enroll patients and carry it out would likely exceed their funding. Although typical for biotech companies to have massive R&D spend with little revenue, the public sentiment, the pending lawsuits (add that to the expenses), and the risk of delisting from NASDAQ (potential reverse stock split and dilution incoming?) does make me skeptical. I noticed they had a milestone partnership with Kyorin, a mid-sized Japanese pharmaceutical company, but to what degree in the event of a redo of their Phase 3 trial?
Would love to have discussions about this from both ends of the spectrum. Please let me know if there are other factors i'm missing. In the best case scenario, they find the capability to fund a new phase 3 trial, would you invest? Sorry for the super long post!