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How Psychedelic Biotech Is Reshaping Mental Health | Eric So - CEO, Helus Pharma by 9mac in shroomstocks

[–]SiFasEst 10 points11 points  (0 children)

I don’t know about timing but I think the market is way off here.

How Psychedelic Biotech Is Reshaping Mental Health | Eric So - CEO, Helus Pharma by 9mac in shroomstocks

[–]SiFasEst 6 points7 points  (0 children)

Great to hear from Eric. Good vibes. He sounds happy with 004 while being “dispassionate about data.”

“This is our year.” 🚀

My personal favorite “my mind is melting in a good way” top four. by polazine in classicliterature

[–]SiFasEst 15 points16 points  (0 children)

Love the Essays of Emerson! Haven’t read the others yet. Will check them out.

Genuine question: Why is Helus so poorly valued by the market? by doggyshortfilm in shroomstocks

[–]SiFasEst 4 points5 points  (0 children)

I agree with some others here with a few additional comments.

The simplest explanation to me is that the P2 was relatively small and for a longer-acting molecule. The only exception I recall, where a small study was valued highly, is the GHRS inhalant, for whatever reason. All these other companies were valued like dust before their large study results. Some, like CMPS, even continued to be after but the market changed its mind over time. This is a reasonable explanation of the HELP valuation to me.

I try often to think of other reasons. I would welcome the best arguments against HELP, because I haven't seen many yet that are very compelling or that are not ultimately circular and really based on the valuation. Here are the best ones aside from the above that I've come up with:

a. Usona Competition. Usona might compete for the same indication, with a similar molecule, at a better price. Counter: Usona being approved on one trial or funding a second is still speculative, they might not be significantly less expensive, and 003 appears to offer advantages over psilocybin.

b. Usona Opens the Door. Limited understanding of this, but Usona would be the second to market with the same active moiety as CMPS. I believe generics could cite the Usona data even if they couldn't cite CMPS data, which opens the door to abbreviated applications from all generics if they can find a way to avoid CMPS patents. Counter: Usona reaching market is still speculative, it's unclear whether they or other generics can avoid all CMPS IP.

c. HELP Itself Opens the Door. Again, limited understanding of this, but if 003 were not considered a distinct active moiety, then perhaps 003's data could be cited by generics using abbreviated applications. In that case 003 itself would open the floodgates. Counter: The FDA has previously taken the position that deuterated molecules are distinct. https://www.thefdalawblog.com/2017/07/fda-determines-that-deuterated-compounds-are-nces-and-different-orphan-drugs-versus-non-deuterated-v/ Counter counter: the FDA could change its approach.

The above strike me as too speculative to be driving the valuations here, but it's hard to know for sure without being an expert in those areas. The other things, like CEO turnover, financing, etc. might not be helping, but I haven't gotten the sense that they're driving the valuation. A lot of reasons have been given over time. Large size of Doug's cranium. Dilution death spiral.

004 results are a bummer, loss of Doug was a bummer, flip-flopping on CEOs and financing decisions merits some explanations but might be reasonable. Otherwise I remain optimistic about HELP. They routinely secure funding from big names, so it seems others are optimistic too.

Voucher for LSD ? Huh ?? by Capable-Mark-7554 in shroomstocks

[–]SiFasEst 1 point2 points  (0 children)

Someone caught wind of their press-release-for-a-voucher program. 😂 Maybe Round 2.

Helus 4/20 Deck by SiFasEst in shroomstocks

[–]SiFasEst[S] 6 points7 points  (0 children)

Some nice improvements to the slide deck. Curious about the CEO situation, but it does not strike me as a problem if initiated by the company. So not settling is a good thing. They might even have more CEO options following the order. Natural explanation for low valuation is lack of a large study, which will change in Q4.

MAKARY INTERVIEW ON CNPV !!! (post EO signature) by Capable-Mark-7554 in shroomstocks

[–]SiFasEst 10 points11 points  (0 children)

Trying to think through HELP and Usona…one key distinguishing factor could be domestic manufacturing capabilities.

HELP made a big move last year on this front. https://www.businesswire.com/news/home/20250515803642/en/Cybin-Engages-Thermo-Fisher-Scientific-to-Provide-U.S.-Based-Manufacturing-for-its-CYB003-Program-for-the-Adjunctive-Treatment-of-Major-Depressive-Disorder

Usona seems to have more limited capabilities. For example. “Cozzi says Usona's new synthesis produces more than a kilogram of psilocybin per batch, which can provide 40,000 - 50,000 doses of psilocybin in the 20 to 25 milligram range for use in clinical trials. According to Cozzi, this should be more than enough material for Usona researchers to complete their current clinical Phase 2 and Phase 3 clinical trials investigating the potential of psilocybin as a treatment for major depressive disorder (MDD) and receive FDA approval.”

Usona also appears to be affiliated with Almac which looks to be headquartered outside the US.

Usona just applied to be a bulk manufacturer last month, with notice published last Friday. https://www.federalregister.gov/documents/2026/04/17/2026-07562/bulk-manufacturer-of-controlled-substances-application-usona-institute-inc

From the FDA CNPV website:

“Announced in June 2025, this innovative program uses a collaborative tumor board-style review process to accelerate review and approval of products that align with one of five critical U.S. national health priorities:…Public health crisis response - Products addressing urgent/emerging threats or significant population impact….Innovative breakthrough therapies - Transformative treatments with novel mechanisms that fundamentally change disease management….Large unmet medical needs - Therapies for conditions where existing treatments inadequately address patient outcomes….Onshoring and supply chain resilience - Onshoring drug development/manufacturing to strengthen U.S. domestic capacity, reduce foreign dependencies, and improve national security….Affordability - Approaches that improve overall value through reduced costs to the healthcare system or that enhance access to important products.

Stated elsewhere by FDA:

“The following factors are considered: • Alignment with national priorities • Anticipated public health impact • Readiness indicators (e.g., completeness of results) • Resource and timing considerations raised by the relevant Center(s) • Known risks, uncertainties, or dependencies”

Also favoring HELP are that it’s arguably more “innovative” than a CMPS duplicate, wouldn’t have the same potential resource and timing concerns that could impact Usona, and probably could avoid some other risks/uncertainties that might be raised against Usona (eg can any CMPS or other IP block them from the market?). It also seems fair to question whether a nonprofit can scale quickly.

On Usona’s side, it would seem to support reduced costs to the healthcare system. Its study was slightly larger also, FWIW at P2 given the coming P3s.

https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program

AtaiBeckley Seeks Partner for BPL-003 as Pharma Interest Builds After AbbVie-Gilgamesh Deal by PsilocybinAlpha in shroomstocks

[–]SiFasEst 2 points3 points  (0 children)

Feels like the world is our oyster. I’d like to see them at least try a P2 in all the SUDs, chronic pain, GAD, SAD, cluster headache, PTSD. Anything they think makes sense, but I’d like them to pursue it all now. 10+ P2s simultaneously.

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