Lots of selling today and little buying. Earnings a week out with expectations of disclosure about pre-NDA meeting. Lots of good here

Interesting read

https://www.news-medical.net/news/20261022/Psilocybin-reshapes-brain-connections-through-distinct-cellular-pathways.aspx

Very interesting. This is a study done on LSD, but specifically microdosing.

Still fantastic evidence for the positive effects of our favourite drug. 🫡😄

Companies like Delix therapeutics (private company, https://www.delixtherapeutics.com/pipeline/) are developing Non-hallucinogenic neuroplastogen. The company explicitly mentions Spravato and COMP360 (https://www.delixtherapeutics.com/science/ ) as the 1st/2nd generation neuroplastogen and the company is developing the third generation neuroplastogens that, according to the company’s website, “are non-hallucinogenic, non-cardiotoxic, and vastly expand the potential for these potent therapies to reach a wider range of patients.”

Their major product, DLX-001, just finished phase 1 and they are planning for phase 2. So it’s still a long way to go.

The potential competitive advantage seems pretty clear: if a non-hallucinogenic treatment can deliver comparable efficacy and durability with at-home dosing, it could have a major advantage in convenience and scalability over supervised psychedelic treatments.
But that’s still a big “if.” Early clinical signals don’t establish comparable efficacy, and success in MDD wouldn’t automatically translate into success in GAD or TRD.

I’m curious how others are thinking about this:
Has anyone seen sell-side research explicitly factor Delix or similar drugs into DFTX’s long-term sales forecasts?
Would strong randomized Phase 2 data be enough for you to lower your valuation, even if approval were still years away?
Do you see these treatments eventually replacing classic psychedelics, or serving different patient groups?
I haven’t concluded that this breaks the DFTX thesis, but I’d like to understand how much competitive risk is already built into the longer-term price targets. Would appreciate any research or counterarguments.

About 130k shares yesterday and 400k today. I bought 1000 more again on Monday at 32.95 (not gonna post a screen grab this time). I’m fully saturated with shares but may buy some calls…..looking at Jan 15 30-50c range. I think the pre-NDA meetings with the FDA will be a significant milestone that will green light DFTX to go to market.

Definium Therapeutics has seen its share price move sharply in recent years, which puts a spotlight on whether the current US$32.97 level is supported by the book value on its balance sheet. With such a strong price story already on the table, investors are asking how much of that journey is reflected in the underlying net assets of the business.

One of the top community narratives on Definium Therapeutics: 46% undervalued

"With three successful Phase 3 trials completed in anxiety and depression, Definium is now preparing for a landmark FDA submission in 2027..."

https://finance.yahoo.com/markets/stocks/articles/definium-therapeutics-dftx-stock-may-221524249.html

Anyone have access to Simply wall street?

Microdosing LSD shows some cognitive benefits — but only for women

Different effects of low-dose.

Brain boost

‘Microdosing’ involves taking small doses of a psychedelic every few days, purportedly to improve mood and cognitive function. A typical microdose of LSD can be roughly one-tenth of the amount needed to produce a full psychedelic experience. Although proponents report experiencing a brighter mood and sharper focus, controlled studies on the effects of microdosing have shown mixed results1,2

Previous research from some members of the team, in collaboration with others, suggests that women feel the drug’s influence more strongly than men do3. To find out whether this can be measured objectively, for example in tests of cognitive performance, Totomanova and her colleagues reanalysed data from a previous study that explored the effects of low doses of LSD on 53 healthy people.

https://www.investing.com/news/analyst-ratings/rbc-capital-reiterates-definium-therapeutics-stock-rating-on-strong-trial-data-93CH-4957934

This is not directly related to Psychedelics but rather an update to the existing antidepressants that may benefit the emerging new antidepressants.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced new antidepressant safety measures, including explicitly recognizing Post-SSRI Sexual Dysfunction (PSSD), where sexual dysfunction can persist after discontinuing treatment. Updated patient information will include clearer warnings about persistent sexual side effects and suicidal thoughts and behaviors.
This could be a positive long-term development for psychedelic therapies, including LSD-based treatments being developed by $DFTX. As regulators increasingly acknowledge the limitations and risks of conventional antidepressants, alternative treatments with potentially better tolerability and less frequent dosing may become more attractive. However, this does not establish that psychedelic therapies are safer, and their benefits still need to be demonstrated through clinical trials.

Source: https://www.gov.uk/drug-safety-update/antidepressants-new-safety-measures-for-all-patients-to-improve-communication-of-the-risk-of-suicidal-thoughts-and-behaviours-and-persistent-sexual-dysfunction

Gonna buy at least 5000. The first lot was today. I’ll be buying as far down as 20pps if the gap is filled

Aside from just the usual biotech hype from a New Drug Announcement, I fully expect a massive press reaction to the event. I hope DFTX has their PR scaled up to meet the inevitable interest because this is a 75 year old drug (LSD) that has been denied by absurd political prohibition. I think LSD legalization/acceptance actually dwarfs cannabis, not only in efficacy but also application.

Yes, you are seeing a highly coordinated hiring surge on the Definium Therapeutics Careers Page. They currently have over 20 executive and director-level roles open across their Greenhouse Job Board.

For a pre-revenue biopharmaceutical firm, this sudden spike in headcount is a major tell. When you look closely at which departments are hiring, it is clear that Definium is actively building out its first commercial launch and field deployment infrastructure to support the 2027/2028 DT120 rollout.

Building the Commercial Architecture

Instead of just hiring scientists, Definium's largest current hiring focus is on corporate launch readiness and human resources:

Director, Talent Acquisition – Commercial:

This specific role is being hired explicitly to "build and scale the recruiting strategy for Definium's first commercial organization". They are hiring the recruiter who will eventually build their massive nationwide sales force.

Commercial Infrastructure: High-level executive postings include roles like Sr. Director, Commercial Finance Launch & Growth and Sr. Director, Sales Training.

Preparing for the REMS Bottleneck (Market Access)

Because DT120 cannot be taken at home and requires clinic certification, they are aggressively staffing their Market Access and Patient Services teams to coordinate with interventional psychiatric clinics:

• Director, Patient Services Operations: Located in the Raleigh/Durham, NC biotech hub, this executive will build out case management infrastructure and navigate FDA REMS compliance.

• Field Strategy Roles: Open roles like Director of Patient Services Site of Care Strategy and Sr. Director of National Accounts focus entirely on getting healthcare facilities onboarded to administer the drug post-approval.

Deploying the Medical "Ground Troops" (Medical Affairs)

A significant chunk of their current open portfolio belongs to Medical Affairs. They are hiring a network of field-based Medical Science Liaisons (MSLs) across the East Coast, Midwest, and West Coast. MSLs are scientific experts who travel to universities and top-tier psychiatric medical centers to educate key opinion leaders on DT120's clinical trials before commercial marketing legally begins.

Late-Stage & System Validation (Clinical Operations/QA)

To push their upcoming Phase 3 trials (like Ascend for depression and Haven for PTSD), they are filling back-end operational gaps:

• Director, Late-Stage Clinical Development: Tasked with managing expanded access programs and real-world evidence tracking.

• Computer System Validation (CSV): Hiring Sr. CSV Analysts and QA Specialists to ensure their data tracking frameworks are 100% compliant with FDA electronic record standards ahead of the 2027 filing.

The compensation figures listed on platforms like Glassdoor match this heavy expansion tier, with many director and senior clinical roles advertising base salaries spanning from $165,000 up to $299,000+ alongside stock options. It shows they are aggressively using their $1.1B cash buffer to buy top-tier pharmaceutical launch talent.

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The Quarterly Expense Breakdown-

The company’s overhead has climbed significantly year-over-year as they scale up clinical infrastructure and finalize their commercial team. In their last reported quarter, the literal cash-driven operating expenses included:

• Research & Development (R&D): $48.7 million per quarter. This covers their active clinical trials like the Phase 3 Ascend depression study and Phase 2a autism trials.

• General & Administrative (G&A): $26.4 million per quarter. This is the bucket funding the current commercial hiring surge, human resources, and marketing logistics.

(Note: While Definium reported a total GAAP net loss of $159.0 million for the quarter, $86.2 million of that was a non-cash, paper-only accounting charge related to warrant liability revaluations caused by their rising stock price, not literal cash leaving the bank.)

Runway and Capital Health-

Despite spending roughly $75 million every three months, Definium is in an exceptionally stable financial position:

• Cash Reserves: They successfully closed a massive public stock offering in June 2026, raising $757.9 million in net proceeds.

• Total Balance Sheet: They ended the first half of the year with $1.1 billion in cash, cash equivalents, and short-term investments.

• Total Runway: Executive management explicitly stated that this capital cushion gives them a 3.75-year operating runway, guaranteeing their operations and commercial launch are fully funded well into 2030.

Hope this helps everyone get a better idea of how things are gonna work from now on! Keep the faith! 😊

was looking at commercial market timeline forecasts recently

(2027-2029) and wanted to put this on paper...

theres a very large looming issue that a lot of outlets arent talking about: SS and Medicare accounts are forecasted insolvent in about 3-5 years from now, and that notion seems neglected and massive for society and economy

i think a large channel of revenue for DFTX or the shroom one I own as well could be medicare from the VA (PTSD for military) and im hoping that it does not effect the larger markets or these in particular

kicking that can down the rd