Twiggs333
6日前
DFTX - Updated Resources and Major Recent Events and Milestones
1. The raise is a major institutional signal, not just “more cash.”
Definium closed an upsized $805 million public offering at $34/share, with the underwriters exercising their option in full. All shares were sold by the company, and proceeds are earmarked for R&D, DT120 commercialization preparation, working capital, and general corporate purposes. The syndicate is serious: J.P. Morgan, Jefferies, Leerink, BofA, Evercore, Stifel, Oppenheimer, and LifeSci. That does not guarantee approval, but it shows major capital markets support after the Emerge data. ([Definium Therapeutics][1])
2. Sell-side coverage is now broad.
The company’s official analyst coverage list includes Baird, Canaccord, Cantor, Evercore, H.C. Wainwright, Jefferies, Jones, Leerink, LifeSci, Maxim, Needham, Oppenheimer, Piper Sandler, RBC, Roth, Stifel, and Wolfe. That is a lot of institutional attention for a psychiatry biotech and helps explain why data, hiring, and filing changes are being watched closely. ([Definium Therapeutics][2])
3. Emerge had deeper operational signals than just the MADRS result.
The Phase 3 Emerge study hit the primary endpoint with an 8.1-point placebo-adjusted MADRS improvement at Week 6 and showed a 14.2-point placebo-adjusted difference by Week 1 and 7.3 points at Week 12. Safety looked clean in the topline release: no serious adverse events or suicidality signal, 99% of TEAEs mild-to-moderate, and 100% of participants met end-of-session checklist criteria by Hour 8, with mean time 5.8 hours and median 5.1 hours. That last part matters commercially because it supports the “single-day clinic model” argument. ([Definium Therapeutics][3])
4. Ascend is the real confirmatory MDD lever.
Ascend, the second Phase 3 MDD study, has already dosed its first patient and is expected to read out in 2027. Unlike Emerge, Ascend includes a 50 µg control arm in a 2:1:2 randomization to DT120 100 µg, DT120 50 µg, or placebo. Definium explicitly says the 50 µg arm is intended to confound patients’ ability to identify dose assignment, which is directly aimed at the functional-unblinding criticism. ([Definium Therapeutics][4])
5. The GAD program has strong “execution” breadcrumbs.
The Analyst Day deck showed Voyage complete at n=214, Panorama screening closed with target updated to n=200, and SSRE/power estimates of >99% for Voyage and 99% for Panorama to detect a 5-point placebo-adjusted HAM-A change. That is a very important under-the-radar data point because it suggests the studies did not require a big sample-size rescue after interim blinded review.
6. Commercial hiring lines up almost exactly with launch infrastructure.
The current Greenhouse page shows 16 open roles across marketing, commercial, corporate affairs, clinical development, medical affairs, biometrics, VEOR, program management, and pharmaceutical development. The specific roles — VP Sales, HCP marketing, patient/digital marketing, MSL East/West, Field VEOR, commercial supply chain — are launch-build roles, not early R&D-only roles. ([Greenhouse][5])
7. The VP Sales posting is especially direct.
The VP Sales job says the role is to lead the field team and sales training efforts “in preparation for the potential commercial launch of DT120,” with experience in neuroscience/CNS, psychiatry, complex products, REMS, reimbursement specialists, and site readiness. That is about as clear as public hiring language gets. ([LinkedIn][6])
8. The commercial supply-chain role is also high-signal.
The commercial supply-chain posting talks about launch deliverables, commercial supplier oversight, demand planning, third-party logistics, DSCSA serialization, hub/wholesaler models, and experience with specialty pharmaceutical launches including Schedule II–V controlled drugs. That reads like a company building the infrastructure needed for a controlled-substance specialty launch, not simply maintaining trials. ([RemoteLeaf][7])
9. The deck shows the same launch model the jobs imply.
Their Analyst Day deck explicitly maps field infrastructure, medical support, access support, site-of-care support, field sales, HUB model, REMS, affordability support, case management, trade/distribution, benefits investigation, and prior authorization support. The hiring is not random — it matches the launch architecture they already showed investors.
10. Payer/reimbursement work is already being framed around Spravato.
The Analyst Day deck says payer engagement points to Spravato as the primary price analog, expectation that FDA-approved psychedelic treatments would be covered, and likely prior authorization management similar to other branded psych products. This is not approval evidence, but it is strong evidence they are building the payer story now.
11. Catalent/Zydis exclusivity is a real moat angle.
The 10-K says Definium/MindMed has an exclusive Catalent Zydis license for lysergide in major jurisdictions including the U.S., U.K., and EU. That matters because DT120 is not just “LSD”; it is an ODT formulation with delivery/IP claims around lysergide salts, polymorphs, and orally disintegrating technology. ([Definium Therapeutics][8])
12. The patent trail has useful details.
Google Patents shows applications/issued patents around lyophilized ODT LSD formulations, immediate-release LSD formulations, D-LSD D-tartrate, and Zydis ODT containing LSD. One patent-family page shows issued U.S. patents in 2026 including lyophilized ODT formulations, immediate-release formulations, and LSD salt crystal forms. ([Google Patents][9])
13. Europe/UK site expansion is another breadcrumb.
Panorama is not only U.S.-based; Definium’s own trial page lists it as U.S. and Europe. King’s College London has a public PANORAMA study page, and the National Centre for Mood Disorders describes PANORAMA as involving 36 centres in more than five countries. That gives you another OSINT trail: European trial sites, investigators, ethics approvals, recruitment pages, and conference mentions. ([Definium Therapeutics][10])
[1]: https://ir.definiumtx.com/news-events/press-releases/detail/235/definium-therapeutics-inc-announces-closing-of-805-million-upsized-public-offering-including-full-exercise-of-the-underwriters-option-to-purchase-additional-shares "Definium Therapeutics, Inc. Announces Closing of $805 Million Upsized Public Offering, Including Full Exercise of the Underwriters’ Option to Purchase Additional Shares :: Definium Therapeutics (DFTX)"
[2]: https://ir.definiumtx.com/analyst-coverage "Analyst Coverage :: Definium Therapeutics (DFTX)"
[3]: https://ir.definiumtx.com/news-events/press-releases/detail/232/definium-therapeutics-announces-positive-topline-results-from-phase-3-emerge-study-of-dt120-orally-disintegrating-tablet-odt-in-major-depressive-disorder "Definium Therapeutics Announces Positive Topline Results from Phase 3 Emerge Study of DT120 Orally Disintegrating Tablet (ODT) in Major Depressive Disorder :: Definium Therapeutics (DFTX)"
[4]: https://ir.definiumtx.com/news-events/press-releases/detail/227/definium-therapeutics-announces-first-patient-dosed-in-ascend-the-second-phase-3-pivotal-study-of-dt120-odt-in-major-depressive-disorder "Definium Therapeutics Announces First Patient Dosed in Ascend, the Second Phase 3 Pivotal Study of DT120 ODT in Major Depressive Disorder :: Definium Therapeutics (DFTX)"
[5]: https://job-boards.greenhouse.io/definiumtherapeutics "Jobs at Definium Therapeutics"
[6]: https://www.linkedin.com/jobs/view/vice-president-sales-at-definium-therapeutics-4412183416 "Definium Therapeutics hiring Vice President, Sales in Durham, NC | LinkedIn"
[7]: https://remoteleaf.com/company/definium-therapeutics/senior-director-commercial-supply-chain-anywhere/ "Senior Director, Commercial Supply Chain at Definium Therapeutics - Remote"
[8]: https://ir.definiumtx.com/sec-filings/all-sec-filings/content/0001193125-26-076742/dftx-20251231.htm?utm_source=chatgpt.com "10-K: Annual report [Section 13 and 15(d), not S-K Item 405]"
[9]: https://patents.google.com/patent/US20230218532A1/en "US20230218532A1 - LYOPHILIZED ORALLY DISINTEGRATING TABLET FORMULATIONS OF d-LYSERGIC ACID DIETHYLAMIDE FOR THERAPEUTIC APPLICATIONS
\- Google Patents"
[10]: https://definiumtx.com/clinical-trials/ "Enroll in a Clinical Trial | Definium Ongoing Clinical Trials"
Twiggs333
7日前
DFTX Current Job Listing Overview of Preparing for Commercial Success:
This hiring slate is bullish as a launch-readiness signal, having like a company that believes DT120 has moved from “clinical asset” to “potential commercial product.”
https://job-boards.greenhouse.io/definiumtherapeutics
The jobs are not just trial-support roles. They are weighted toward pre-commercial launch infrastructure: HCP marketing, patient/digital marketing, sales leadership, product communications, MSLs, field VEOR, biostatistics/statistical programming, drug product development, and commercial supply chain. That is the exact mix you would expect when a late-stage biotech is preparing for NDA filing, label strategy, payer engagement, REMS/site-of-care planning, and possible commercial launch**.
The company’s own decks already frame DT120 this way: a late-stage DT120 program in GAD/MDD with multiple Phase 3 studies, cash runway into 2028, and a stated commercial launch path around GAD and MDD. The May deck says DT120 is in five Phase 3 studies, with three 2026 readouts anticipated and cash of $373.4M as of March 31, 2026. The Analyst Day deck also specifically tells investors to watch the “evolution of commercial organization” alongside Emerge, Voyage, and Panorama readouts.
This is not random hiring. It breaks into a very clear late-stage biotech playbook.
1. Commercial launch buildout
These roles are the loudest signal:
Vice President, Sales
Senior Product Manager, HCP Marketing
Director, Patient & Digital Marketing
Associate Director, Medical Marketing
Director, Product Communications
That is classic pre-launch commercialization. A company does not usually build HCP marketing, patient digital, sales leadership, and product communications unless it is actively preparing the market. This does not mean approval is guaranteed, but it does mean management is preparing for the possibility that the clinical package supports filing and launch.
For DT120, this matters because the product is not a simple “ship pills to CVS” launch. It likely requires physician education, patient screening, dosing-session logistics, payer/reimbursement preparation, and potentially REMS-style controls. The Analyst Day deck already shows a support model with **field sales, medical support, access support, site-of-care support, HUB model, REMS, affordability support, benefits investigation, prior authorization support, case management, and trade/distribution.
So when you see DFTX hiring marketing, sales, communications, VEOR, MSLs, and supply chain, that lines up almost perfectly with the infrastructure shown in their commercial strategy.
2. Medical Affairs / MSL buildout
Senior MSL - East
Senior MSL - West
This is very important. Medical Science Liaisons are usually hired before launch to engage KOLs, educate investigators and treatment centers, handle scientific exchange, prepare congress strategy, and support evidence generation. In psychiatry — especially with a psychedelic-derived Schedule I compound — this is not optional. The field needs education.
MSLs also help bridge the gap between clinical data and real-world implementation. For DT120, they will need to explain:
DT120’s single-dose model, durability claims, safety/tolerability profile, absence of required psychotherapy in the trial design, dosing-session monitoring, potential REMS logistics, and how GAD/MDD populations were studied.
That is a strong launch-prep signal.
3. VEOR / payer strategy
Senior Director, Field VEOR
This might be one of the most bullish roles on the list.
VEOR means **Value, Evidence, and Outcomes Research**. This is where the company builds the payer-facing case: burden of disease, treatment failures, cost offsets, claims analyses, real-world outcomes, budget impact, and formulary value proposition.
The Analyst Day deck already shows that DFTX is thinking in payer terms: 4.2 million patients failed by 2+ prescriptions, potential revenue per 1% penetration, Spravato as a reimbursement analog, payer expectations of coverage for FDA-approved psychedelic treatments, and likely prior authorization management.
Hiring Field VEOR says: they are preparing for payer conversations, not just FDA conversations.
That is usually a later-stage move.
4. Biostatistics and statistical programming
Associate Director, Biostatistics
Senior Director, Biostatistics
Director, Statistical Programming
This is approval-path infrastructure. These are the people needed for Phase 3 readouts, integrated safety/efficacy analyses, FDA questions, NDA datasets, tables/listings/figures, subgroup analyses, label discussions, and post-hoc/pooled analyses.
For a company with multiple Phase 3 studies reading out close together, this is critical. DFTX’s decks show Emerge, Voyage, Panorama, Ascend, and future PTSD/Haven planning. They also emphasize SSRE, powering assumptions, minimum detectable differences, and integrated Phase 3 design logic.
This hiring tells me they are preparing for a heavy data package and possible regulatory submission work.
5. CMC / drug product / supply chain
Associate Director, Drug Product Development
Executive Director, Commercial Supply Chain
This is another major signal.
For DT120, commercial supply chain is not trivial. The asset is lysergide tartrate, a controlled substance. The company would need manufacturing, quality systems, controlled-substance handling, packaging, distribution, inventory controls, and potentially REMS-aligned logistics.
A commercial supply chain executive is not usually a “maybe someday” hire. It is a “we need to be ready if/when the product gets approved” hire.
This is especially relevant because DFTX is trying to create a scalable episodic-care model: single oral dose, 5–8 hour monitoring, end-of-session checklist, next-day return to normal activities, and treatment-site workflow. The May deck lays out that target product profile directly.
6. Clinical development and program management
Associate Director, Clinical Development
Senior Director, Clinical Development
Senior Project Manager
This supports ongoing trials, label expansion, extension studies, additional indications, FDA interactions, site oversight, and cross-functional execution. This is not as directly “commercial” as VP Sales or Field VEOR, but it supports the broader DT120 lifecycle.
The decks show DT120 is not just one trial in one indication. It is a platform-like clinical program across GAD, MDD, PTSD, and possible additional indications.
The biotech late-stage hiring playbook
A late-stage biotech usually evolves in stages:
Stage 1: Clinical proof-of-concept company
Mostly R&D, clinical operations, regulatory, CMC, finance. Commercial is small or nonexistent.
Stage 2: Pivotal-readout company
Adds biostatistics, statistical programming, regulatory ops, medical affairs planning, publication planning, market research, HEOR/VEOR, and early brand strategy.
Stage 3: Pre-NDA / pre-launch company
Adds HCP marketing, patient marketing, product communications, sales leadership, market access, field medical, commercial analytics, supply chain, patient services, HUB planning, distribution, and REMS planning.
Stage 4: Launch company
Adds field sales managers, reps, access/reimbursement teams, nurse educators/site support, patient services, pharmacovigilance expansion, trade/distribution, compliance, training, sales ops, and full medical affairs coverage.
DFTX’s job list looks like **Stage 3**. They are not merely keeping trials alive. They are building the bridge from Phase 3 data to market entry.
Why this is bullish
The bullish part is not “they know FDA will approve.” The bullish part is that the hiring is **coherent** with a company preparing to commercialize a high-value CNS product.
The most bullish pieces are:
VP Sales - field organization architecture is being planned.
HCP Marketing + Patient/Digital Marketing - brand launch messaging is being built.
MSLs East/West - scientific field infrastructure is starting.
Field VEOR - payer/reimbursement groundwork is being built.
Commercial Supply Chain - manufacturing/distribution readiness is being treated seriously.
Biostats + Statistical Programming - NDA-level data package support is being expanded.
Twiggs333
1週前
Definium Therapeutics’ Emerge Phase 3 readout looks like a major inflection point for DT120 ODT.
The headline is simple: one supervised 100 µg dose of DT120 ODT produced an 8.1-point placebo-adjusted MADRS benefit at Week 6, the primary endpoint, and a 7.3-point benefit at Week 12. That is not just statistically significant; it is clinically meaningful and above the bar Definium had previously framed as potentially best-in-class. The data also showed rapid onset, with separation by Week 1 and CGI-S improvement as early as Day 2.
The safety profile looked manageable in the controlled setting. There were no serious adverse events, no suicidality signal, no TEAEs leading to discontinuation, and most adverse events were mild to moderate and concentrated on dosing day. The session data also matter: average clearance from the End-of-Session Checklist was 5.8 hours, and all participants cleared by 8 hours. That supports a real-world model where DT120 could be delivered as a single-day interventional psychiatry treatment rather than a long multi-day therapy-heavy process.
On the TRD criticism: Emerge was not a dedicated TRD trial. It was a broad MDD trial. So I would not claim it “proved efficacy in a formal TRD pivotal population.” However, it is also wrong to say Definium avoided treatment-resistant patients. The study included a high-burden population, with severe baseline depression and a large treatment-experienced subgroup. Roughly 53% of patients had used two or more prior antidepressants. Management also said the treatment effect was maintained across subgroups, including those with two or more prior treatments. The balanced view is that Emerge supports efficacy in broad MDD, including a meaningful TRD-like subgroup, but it was not a pure TRD registration trial.
The financing is also important. Definium raised $805 million in an upsized public offering after the readout. Combined with its prior cash position, this gives the company substantial runway and negotiating leverage. It can continue building the program, fund commercial preparation, and negotiate from strength rather than desperation.
The next catalysts are the GAD Phase 3 readouts: Voyage expected in early 3Q 2026 and Panorama expected in late 3Q 2026. These are critical. If both are positive, Definium’s story becomes much larger than MDD alone. It would have positive Phase 3 evidence in MDD plus potentially confirmatory Phase 3 evidence in GAD, a massive indication with little innovation for years.
Big pharma is likely watching because DT120 checks several boxes: large market, strong efficacy, rapid onset, durable benefit after one dose, manageable session logistics, broad label strategy, IP around formulation/manufacturing/treatment, and a commercial model that can borrow from the Spravato/interventional psychiatry playbook.
The FDA/regulatory backdrop is also becoming more favorable. Operation TrialBlazer and the Commissioner’s National Priority Voucher program show that FDA/HHS are actively looking for ways to accelerate serious-mental-illness drug development and review timelines. There is no confirmed public voucher for Definium/DT120 yet, and I would treat any LSD/GAD voucher talk as speculative until official. But if GAD data are strong, DT120 clearly fits the spirit of the current policy environment: serious mental illness, large unmet need, and potentially transformative efficacy.
Bottom line: Emerge substantially de-risked DT120, but it did not eliminate all risk. The next leg depends on GAD readouts, Ascend confirmation in MDD, long-term retreatment data, FDA alignment, REMS/scheduling, and real-world commercial execution. But after this week, Definium is no longer just a psychedelic promise story. It has a positive Phase 3 dataset that looks highly competitive within depression and potentially practice-changing if replicated.
US Market News
2週前
A Breakthrough-Designated Depression Drug Is 86% Through Its Phase 3, With Topline Data Due This YearJune 26, 2026 9:30 AM
PR Newswire (US) Issued on behalf of Helus Pharma™Helus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP), the commercial operating name of Cybin Inc., says its APPROACH Phase 3 trial of HLP003 for adjunctive treatment of major depressive disorder has surpassed 86% enrollment, keeping the FDA Breakthrough-designated program on track for a topline data readout in Q4 2026.NEW YORK and TORONTO, June 26, 2026 /PRNewswire/ -- USA News Group News Commentary, In drug development, enrollment is the quiet variable that decides whether a promising therapy ever reaches a data readout on schedule. Late-stage psychiatric trials are notoriously hard to fill, which is why a clean enrollment update is meaningful. On June 24, 2026, Helus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP), the commercial operating name of Cybin Inc., reported that its APPROACH Phase 3 trial of HLP003 for the adjunctive treatment of major depressive disorder has surpassed 86% enrollment and is progressing as planned, keeping the program on course for a topline data readout in the fourth quarter of 2026. Key TakeawaysHelus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP) reported that its APPROACH Phase 3 trial of HLP003 for the adjunctive treatment of major depressive disorder (MDD) has surpassed 86% enrollment and is progressing as planned.HLP003 has previously been granted Breakthrough Therapy Designation by the U.S. FDA, and the Company says it remains on track for a topline data readout in Q4 2026.Company-reported Phase 2 results showed a ~23-point MADRS reduction from baseline at 12 months (after two 16 mg doses three weeks apart), with response/remission rates of 75% at week 18 improving to 100% response and 71% remission at 12 months — figures that have not been evaluated by the FDA.An Enrollment Milestone That Matters"We are pleased with the continued progress of the APPROACH study as we surpass 86% enrollment," said Eric So, Interim Chief Executive Officer of Helus Pharma. "This milestone underscores the execution of our clinical program and brings us closer to the anticipated topline data readout in the fourth quarter of 2026. We remain focused on advancing HLP003 as a potential transformative treatment option for patients living with MDD."APPROACH is one of the Company's Phase 3 studies evaluating HLP003, its lead proprietary novel serotonergic agonist (NSA). The trial sits within a broader Phase 3 program Helus calls PARADIGM, which also includes the EMBRACE study and the EXTEND long-term extension study — a multi-trial structure designed to build the efficacy and safety package required to advance HLP003 toward potential commercialization.What HLP003 Is, and Why 'Breakthrough' Status MattersHelus describes its proprietary NSAs as synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity — the brain's capacity to form new neural connections — with the aim of delivering durable improvements rather than the symptom-by-symptom maintenance of traditional antidepressants. HLP003 is the lead candidate, now in Phase 3 for the adjunctive treatment of MDD; the Company is also developing HLP004, an NSA in Phase 2 for generalized anxiety disorder, alongside a broader portfolio of investigational NSAs.The FDA's Breakthrough Therapy Designation, which HLP003 has received, is granted to investigational therapies intended to treat serious conditions where preliminary clinical evidence suggests a substantial improvement over available options. The designation is meant to expedite development and review through more intensive FDA guidance — it is a signal of regulatory engagement and perceived promise, not a guarantee of approval. For a clinical-stage company, it is among the more meaningful validations a program can carry into late-stage trials.The Phase 2 Data Behind the StoryThe reason HLP003 has drawn attention is the strength of its earlier-stage results. In previously reported Phase 2 data, the Company says HLP003 demonstrated long-term efficacy with an approximately 23-point reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared to baseline at 12 months, following two 16 mg doses administered three weeks apart. The MADRS is the standard clinician-rated instrument for measuring depression severity, and a reduction of that magnitude, if it holds up in a larger controlled trial, would be clinically substantial.The Company further reported that Phase 2 response and remission rates were 75% at week 18, and that by the 12-month mark response and remission rates improved to 100% and 71%, respectively. These are striking figures — but important caveats apply, and Helus Pharma itself flags them: Phase 2 studies are typically small and may lack the controls of a pivotal trial, results from a Phase 2 study may not be predictive of Phase 3 outcomes, and the FDA has not evaluated these results or confirmed any efficacy claims for HLP003. The APPROACH Phase 3 trial exists precisely to test whether the early signal can be reproduced rigorously at larger scale.A Market Hungry for Something NewThe opportunity backdrop is significant. Major depressive disorder affects hundreds of millions of people worldwide and remains a leading cause of disability, yet the workhorse treatments — SSRIs and SNRIs — are built on chemistry that is decades old, can take weeks to work, and leave a large share of patients with inadequate relief. That gap is why the depression field is, in the words of one 2026 industry analysis, undergoing its most significant therapeutic transformation in decades, as mechanistically novel drugs reach the market and late-stage pipeline at the same time.Helus is positioning HLP003 squarely in that opening: a fast-acting, durable, neuroplasticity-oriented option intended to work adjunctively for patients whose depression is not adequately controlled. The thesis is that an adjunctive treatment requiring only periodic dosing could reshape how MDD is managed — if the Phase 3 data deliver. The Company operates across Canada, the United States, the United Kingdom, and Ireland.The Closest ComparisonsA handful of clinical-stage developers are pursuing novel-mechanism therapies for depression using the same pivotal-trial yardstick Helus relies on — the MADRS. Three are worth watching as the most direct points of comparison, though each carries its own risk profile, targets its own patient population, and none is a proxy for Helus. Compass Pathways (NASDAQ: CMPS) is among the most advanced: its synthetic psilocybin candidate, COMP360, is in Phase 3 for treatment-resistant depression, and in early 2026 the company reported achieving the primary endpoint in both of its pivotal Phase 3 trials using the same MADRS-based measurement. It offers the clearest read on how regulators and markets are treating late-stage, novel-mechanism depression programs.Definium Therapeutics (NASDAQ: DFTX), the company formerly known as Mind Medicine (MindMed) and renamed in January 2026, is an especially timely comparison. In June 2026 it reported positive topline results from its Phase 3 Emerge study of DT120 (lysergide) orally disintegrating tablet in MDD: the study met its primary endpoint with a placebo-adjusted MADRS reduction of 8.1 points at week 6 (p
US Market News
2週前
Definium Therapeutics, Inc. Announces Closing of $805 Million Upsized Public Offering, Including Full Exercise of the Underwriters’ Option to Purchase Additional SharesJune 25, 2026 4:15 PM
Business Wire Definium Therapeutics, Inc. (Nasdaq: DFTX) (the “Company” or “Definium”), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today announced the closing of its previously announced underwritten public offering of 23,676,471 common shares, without par value, which includes the exercise in full by the underwriters of their option to purchase 3,088,235 additional common shares, at a public offering price of $34.00 per common share. All of the shares were offered by Definium. The gross proceeds from this offering were $805 million, before deducting underwriting discounts, commissions, and other offering-related expenses. Definium intends to use the net proceeds from this offering for the research and development of its product candidates, preparation activities for potential commercialization of DT120 ODT, if approved, and working capital and general corporate purposes. J.P. Morgan, Jefferies, Leerink Partners, and BofA Securities acted as the joint lead bookrunners for the offering, and Evercore ISI and Stifel acted as bookrunners for the offering. Oppenheimer & Co. and LifeSci Capital acted as co-lead managers for the offering. The offering closed on June 25, 2026. No distribution under the offering occurred in Canada or to a person resident in Canada. The securities in the offering were offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-280548) that was filed with the Securities and Exchange Commission (“SEC”) on June 28, 2024 and became effective upon filing. The offering was made by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the shelf registration statement. A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering were filed with the SEC and SEDAR+ on June 24, 2026, and are available on the SEC’s website at www.sec.gov and on SEDAR+’s website at www.sedarplus.ca. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by contacting the following: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Jefferies LLC by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525 ext. 6105 or by email at syndicate@leerink.com; BofA Securities, Attention: Prospectus Department, 201 North Tryon Street, NC1-022-02-25 Charlotte, NC 28255-0001 or by email at dg.prospectus_requests@bofa.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200 or by email at ecm.prospectus@evercore.com; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by emailing syndprospectus@stifel.com; Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055 or by email at EquityProspectus@opco.com and LifeSci Capital LLC, Attention: LifeSci Capital LLC at 1700 Broadway, 40th Floor, New York, New York 10019, or by email at compliance@lifescicapital.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Definium The mission of Definium Therapeutics is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Guided by a recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol “DFTX.” Forward-Looking Statements Certain statements in this press release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and is therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will,” “may,” “should,” “could,” “intend,” “estimate,” “plan,” “anticipate,” “expect,” “believe,” “potential” or “continue,” or the negative thereof or similar variations. Forward-looking information in this press release includes, but is not limited to, statements regarding the intended use of the net proceeds from the offering. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information. These forward-looking statements are based on the Company’s current expectations, estimates, forecasts and projections about the offering, the Company’s business and the industry in which it operates and management’s beliefs and assumptions, including the non-occurrence of the risks and uncertainties that are described in its filings made with the SEC and the applicable Canadian securities regulators or other events occurring outside of its normal course of business, and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond its control. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20260625937686/en/ Investors:
Gitanjali Jain
VP, Head of Investor Relations
ir@definiumtx.com Media:
media@definiumtx.com Original: Definium Therapeutics, Inc. Announces Closing of $805 Million Upsized Public Offering, Including Full Exercise of the Underwriters’ Option to Purchase Additional Shares
Twiggs333
2週前
Post Phase 3 Results and Raise Clarity
I think this week may end up being one of the most important moments the psychedelic medicine sector has had so far.
Definium just delivered positive Phase 3 data in major depressive disorder for DT120, and I don’t think people are fully appreciating what that means yet.
The Emerge study met the primary endpoint and all key secondary endpoints. The headline number was an 8.1-point placebo-adjusted improvement on MADRS at Week 6, with p<0.0001. They also showed a 7.3-point placebo-adjusted improvement at Week 12, again with p<0.0001. For a single-dose treatment in depression, that is a serious result.
This matters because the biggest question in this sector has always been whether the Phase 2 signals would survive Phase 3. It is one thing to believe in the mechanism. It is another thing to see a psychedelic-derived medicine actually clear a late-stage, randomized, placebo-controlled trial in a major psychiatric indication. Definium has now done that, at least once.
Before this, the bull case was mostly built around potential: strong GAD Phase 2b data, a differentiated LSD-based mechanism, and the possibility that DT120 could become a broader psychiatry platform. Now the company has a positive Phase 3 result in MDD. That does not guarantee FDA approval, and it does not eliminate the need for more data, but it materially de-risks the program.
The stock reaction reflected that. The market did not treat this like a minor update. The stock gapped up hard, traded with real volume, and even after the offering announcement, it has held up surprisingly well. That part is important. Biotech offerings after a big data move can easily crush momentum if investors think the raise is desperate or poorly timed. In this case, the offering priced at $34, and the stock has traded well above that level afterward. To me, that suggests the market is absorbing the dilution and treating the raise as a strategic financing rather than a rescue financing.
The $700M offering is dilution. There is no point pretending otherwise. But not all dilution is equal. Raising money after a failed trial or into a weak stock is bad dilution. Raising $700M after a major Phase 3 win, while demand is strong, is a completely different situation. That is how a biotech strengthens its balance sheet from a position of leverage.
Definium already had a few hundred million in cash before this raise. Adding another $700M gives them a serious war chest. That money can fund additional Phase 3 work, regulatory preparation, commercial planning, market access work, manufacturing, treatment-site readiness, payer studies, and launch infrastructure if DT120 is approved. It also gives the company negotiating power.
That last point is important. A large cash pile does not just fund commercialization. It also changes the strategic posture of the company. If a potential partner or acquirer comes knocking, Definium does not have to negotiate from weakness. They can credibly say, “We have the data, we have the cash, and we can continue alone.”
Could Definium be acquired before FDA approval? I think it is possible. Not guaranteed, but possible. CNS assets with large market potential can get acquired pre-approval if the data are strong enough. The obvious comparison is Karuna, which was acquired by Bristol Myers before FDA approval of KarXT.
That does not mean Definium gets the same outcome, but it does prove that big pharma will pay for de-risked psychiatry assets before approval when the commercial opportunity is large enough.
And that brings me to the broader industry.
I do not think this is a one-winner market. The “LSD versus psilocybin” debate is too simplistic. We are seeing a lot of this banter on r/shroomstocks - Psychiatry has never worked like that. SSRIs, SNRIs, atypical antidepressants, antipsychotic augmentation, ketamine/esketamine, TMS, ECT, talk therapy, and other approaches all coexist because depression and anxiety are not one disease with one solution. Different patients respond to different mechanisms. Different severity levels require different tools. Different providers and payors will prefer different models.
Compass can succeed with psilocybin. Definium can succeed with LSD. Atai can still have a role. Others may find specific niches. There does not need to be only one winner.
What matters is whether each treatment can prove efficacy, durability, safety, and a realistic commercial model. Definium just took a major step on the efficacy and durability side. The safety data, at least from the topline release, also look manageable. The big remaining debate is commercialization: monitoring time, reimbursement, provider logistics, REMS, and whether payors will support a longer interventional psychiatry session.
Those concerns are real, but I think some bears are looking at the issue too narrowly. A six-to-eight-hour treatment day sounds difficult if you compare it to a normal office visit. But that is not the right comparison. The right comparison is years of failed antidepressant cycling, chronic medication burden, disability, relapse, psychiatric visits, emergency care, and repeated treatments with other interventional options.
If a single supervised dose can produce meaningful improvement for weeks or months, payors will at least have to look at the health-economic argument. They may push back. They may restrict use. They may require prior authorizations. But if the clinical effect is strong enough and durable enough, the value proposition becomes very different than “expensive drug with inconvenient monitoring.”
Spravato already proved that monitored interventional psychiatry can exist commercially. It is not perfect, and DT120 would have a different treatment model, but the idea that payors and clinics will never support any monitored psychiatric treatment is already outdated. The question is not whether the model is easy. The question is whether the benefit is large enough to justify the friction. After this Phase 3 result, Definium has a much stronger argument that it may be.
The other major thing I like is the potential breadth of DT120. This is not just an MDD story. The company already had strong GAD Phase 2b results, and GAD is still a major upcoming catalyst. If GAD Phase 3 hits after this MDD result, the narrative changes again. Then DT120 starts looking less like a single-indication drug and more like a broad psychiatric platform: depression, anxiety, possibly PTSD, and maybe other neuropsychiatric conditions over time.
That is why I think this week matters for the entire sector. A clean Phase 3 win gives legitimacy not just to Definium, but to the broader idea that psychedelic-derived medicines can be developed through normal FDA pathways. The sector needed real late-stage validation. This is exactly the kind of validation investors, regulators, payors, and potential pharma partners needed to see.
There will still be volatility. There will be dilution debates. There will be people arguing over discharge timing, monitoring requirements, trial population, REMS, and whether MDD is the right initial market. That is fine. Those are fair debates. But none of that changes the fact that a Phase 3 trial just hit with a large placebo-adjusted effect and durability through Week 12. That is the kind of result that changes assumptions.
For me, the $700M raise is not a negative signal. It looks like a company taking advantage of a major de-risking event to fund the next stage of the business. That could mean preparing to commercialize. It could mean strengthening the balance sheet before partnership talks. It could mean making sure they are not forced into a cheap acquisition. It could mean all of the above.
I would much rather see a biotech raise from strength after positive Phase 3 data than wait until they are desperate. Definium is now in a much stronger position than it was before this readout. DT120 is no longer just a speculative psychedelic asset. It has late-stage data in a major psychiatric indication, a large cash position, multiple upcoming catalysts, and a realistic path toward becoming one of the first major psychedelic-derived psychiatric medicines to reach the market.
There is still risk. There is always risk in biotech. They still need more data, FDA alignment, and a workable commercial model. But the risk/reward changed meaningfully with this result.
I do not think the sector needed perfection this week. It needed proof that these drugs can work in Phase 3.
Definium just gave us that proof.
And with that... I wish all you luck. Mostly the believers in this sector and not those trying to nitpick the finer points. We are in the final stretch. Be glad you are here.
US Market News
2週前
Definium Therapeutics, Inc. Announces Pricing of $700 Million Upsized Public OfferingJune 23, 2026 9:57 PM
Business Wire Definium Therapeutics, Inc. (Nasdaq: DFTX) (the “Company” or “Definium”), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today announced the pricing of an underwritten public offering of 20,588,236 common shares, without par value, at a public offering price of $34.00 per common share. The gross proceeds to Definium from the offering, before deducting underwriting discounts, commissions, and other offering-related expenses, are expected to be approximately $700 million. In addition, Definium has granted the underwriters an option for a period of 30 days to purchase up to an additional 3,088,235 common shares at the public offering price, less underwriting discounts and commissions. All of the common shares are being offered by Definium. Definium intends to use the net proceeds from this offering for the research and development of its product candidates, preparation activities for potential commercialization of DT120 ODT, if approved, and working capital and general corporate purposes. J.P. Morgan, Jefferies, Leerink Partners, and BofA Securities are acting as the joint lead bookrunners for the offering, with Evercore ISI and Stifel also acting as bookrunners for the offering. Oppenheimer & Co. and LifeSci Capital are acting as co-lead managers for the offering. The offering is expected to close on or about June 25, 2026, subject to the satisfaction of customary closing conditions. No distribution under the offering shall occur in Canada or to a person resident in Canada. The securities in the offering are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-280548) that was filed with the Securities and Exchange Commission (“SEC”) on June 28, 2024 and became effective upon filing. The securities will be offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the shelf registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and SEDAR+ and are available on the SEC’s website at www.sec.gov and on SEDAR+’s website at www.sedarplus.ca. A final prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC and SEDAR+ and, when filed, will also be available on the SEC’s website and SEDAR+’s website. Alternatively, copies of the final prospectus and the accompanying prospectus relating to the offering may be obtained, when available, by contacting the following: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Jefferies LLC by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525 ext. 6105 or by email at syndicate@leerink.com; BofA Securities, Attention: Prospectus Department, 201 North Tryon Street, NC1-022-02-25 Charlotte, NC 28255-0001 or by email at dg.prospectus_requests@bofa.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200 or by email at ecm.prospectus@evercore.com; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by emailing syndprospectus@stifel.com; Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055 or by email at EquityProspectus@opco.com and LifeSci Capital LLC, Attention: LifeSci Capital LLC at 1700 Broadway, 40th Floor, New York, New York 10019, or by email at compliance@lifescicapital.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Definium The mission of Definium Therapeutics is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Guided by a recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol “DFTX.” Forward-Looking Statements Certain statements in this press release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and is therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will,” “may,” “should,” “could,” “intend,” “estimate,” “plan,” “anticipate,” “expect,” “believe,” “potential” or “continue,” or the negative thereof or similar variations. Forward-looking information in this press release includes, but is not limited to, statements regarding the filing of the final prospectus supplement and the accompanying prospectus relating to the offering; anticipated closing of the offering; gross proceeds; and intended use of proceeds. There can be no assurance that this offering will close and the Company will receive the net proceeds therefrom. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including satisfaction of the customary closing conditions for the offering. These forward-looking statements are based on the Company’s current expectations, estimates, forecasts and projections about the offering, the Company’s business and the industry in which it operates and management’s beliefs and assumptions, including the satisfaction of all customary closing conditions and the non-occurrence of the risks and uncertainties that are described in its filings made with the SEC and the applicable Canadian securities regulators or other events occurring outside of its normal course of business, and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond its control. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20260623369229/en/ Investors:
Gitanjali Jain
VP, Head of Investor Relations
ir@definiumtx.com Media:
media@definiumtx.com Original: Definium Therapeutics, Inc. Announces Pricing of $700 Million Upsized Public Offering
US Market News
2週前
Definium Therapeutics, Inc. Announces Proposed Public OfferingJune 22, 2026 4:01 PM
Business Wire Definium Therapeutics, Inc. (Nasdaq: DFTX) (the “Company” or “Definium”), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today announced that it intends to offer and sell, subject to market conditions, $500 million of its common shares and, to certain investors, pre-funded warrants to purchase common shares in an underwritten public offering. In addition, Definium intends to grant the underwriters an option for a period of 30 days to purchase up to $75 million of its common shares at the public offering price, less underwriting discounts and commissions. All of the common shares and pre-funded warrants are being offered by Definium. Definium intends to use the net proceeds from this offering for the research and development of its product candidates, preparation activities for potential commercialization of DT120 ODT, if approved, and working capital and general corporate purposes. J.P. Morgan, Jefferies, Leerink Partners, and BofA Securities are acting as the joint lead bookrunners for the offering, with Evercore ISI and Stifel also acting as bookrunners for the offering. Oppenheimer & Co. and LifeSci Capital are acting as co-lead managers for the offering. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. No distribution under the offering shall occur in Canada or to a person resident in Canada. The securities in the offering are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-280548) that was filed with the Securities and Exchange Commission (“SEC”) on June 28, 2024 and became effective upon filing. The securities will be offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the shelf registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and SEDAR+ and will be available on the SEC’s website at www.sec.gov and on SEDAR+’s website at www.sedarplus.ca. Copies of the preliminary prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained, when available, by contacting the following: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Jefferies LLC by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525 ext. 6105 or by email at syndicate@leerink.com; BofA Securities, Attention: Prospectus Department, 201 North Tryon Street, NC1-022-02-25 Charlotte, NC 28255-0001 or by email at dg.prospectus_requests@bofa.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200 or by email at ecm.prospectus@evercore.com; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by emailing syndprospectus@stifel.com; Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055 or by email at EquityProspectus@opco.com and LifeSci Capital LLC, Attention: LifeSci Capital LLC at 1700 Broadway, 40th Floor, New York, New York 10019, or by email at compliance@lifescicapital.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Definium The mission of Definium Therapeutics is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Guided by a recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol “DFTX.” Forward-Looking Statements Certain statements in this press release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and is therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will,” “may,” “should,” “could,” “intend,” “estimate,” “plan,” “anticipate,” “expect,” “believe,” “potential” or “continue,” or the negative thereof or similar variations. Forward-looking information in this press release includes, but is not limited to, the uncertainties related to market conditions, the intended use of proceeds, the filing of the preliminary prospectus supplement and the accompanying prospectus relating to the offering and the completion of the offering on the anticipated terms or at all. There can be no assurance that this offering will close and the Company will receive the net proceeds therefrom. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including market conditions and satisfaction of the customary closing conditions for the offering. These forward-looking statements are based on the Company’s current expectations, estimates, forecasts and projections about the offering, the Company’s business and the industry in which it operates and management’s beliefs and assumptions, including the satisfaction of all customary closing conditions and the non-occurrence of the risks and uncertainties that are described in its filings made with the SEC and the applicable Canadian securities regulators or other events occurring outside of its normal course of business, and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond its control. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20260622980137/en/ Investors:
Gitanjali Jain
VP, Head of Investor Relations
ir@definiumtx.com Media:
media@definiumtx.com Original: Definium Therapeutics, Inc. Announces Proposed Public Offering
US Market News
2週前
Definium Therapeutics to Discuss Topline Results from Phase 3 Emerge Study in Major Depressive Disorder on June 22, 2026June 21, 2026 5:00 PM
Business Wire Company to host webcast tomorrow at 8:00 a.m. EDT Definium Therapeutics, Inc. (“Definium” or the “Company”), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today announced that it will host a live webcast tomorrow at 8 a.m. EDT to discuss topline results from Emerge, its first randomized, double-blind, placebo-controlled Phase 3 study evaluating a single dose of DT120 ODT 100 µg in adults with major depressive disorder (MDD). Webcast Details Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Investor Relations section of the Definium Therapeutics website, ir.definiumtx.com, and archived for at least 30 days after the webcast. Those who plan on participating are advised to join 15 minutes prior to the start time. About Emerge Emerge is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of a single 100 µg dose of DT120 ODT versus placebo in participants with major depressive disorder (MDD). The study consists of a 12-week double-blind phase (Part A) followed by a 40-week open-label extension phase (Part B) during which participants may be eligible to receive DT120 ODT based on symptom severity. The study enrolled 149 participants aged 18 to 74 years across 20 sites with a DSM-5-confirmed diagnosis of MDD, a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of at least 26, and a Clinical Global Impression–Severity (CGI-S) score of at least 4 at screening and baseline. The primary endpoint is change from baseline in the MADRS total score at Week 6. Key secondary endpoints are change from baseline in CGI-S score at Week 6, Week 12 and Day 2, and change from baseline in MADRS total score at Week 12 and Week 1. Emerge is one of two pivotal Phase 3 studies in MDD. Ascend, the second Phase 3 study in MDD, is aligned with Emerge, but includes a low dose arm and is also conducted in two parts: Part A, a 12-week, randomized, double-blind, placebo-controlled, parallel-group period; and Part B, a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT based on symptom severity. Participants will be randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg, or placebo. The 50 µg arm is intended to confound participants’ ability to accurately assess the dose condition to which they have been randomized. This approach continues to build on the Company’s Phase 2b study of DT120 in generalized anxiety disorder (GAD), which the Company believes demonstrated that DT120's clinical activity is not attributable to functional unblinding and aligns with FDA guidance on the use of complementary designs across the Company’s DT120 clinical development program. The primary endpoint of Ascend is change from baseline in MADRS total score at Week 6 between DT120 ODT 100 µg and placebo. About Definium Therapeutics The mission of Definium Therapeutics is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Guided by a recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. Forward-Looking Statements Certain statements in this news release related to the Company constitute "forward-looking information" within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as "will", "may", "should", "could", "intend", "estimate", "plan", "anticipate", "expect", "believe", "potential" or "continue", or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, the Company’s plans to host a live webinar to discuss topline results from the Phase 3 Emerge Study; statements regarding the Company’s beliefs regarding potential benefits of DT120 ODT; and statements regarding the design of the Phase 3 Emerge Study and the Phase 3 Ascend Study. There are numerous risks and uncertainties that could cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; compliance with laws and regulations; legislative and regulatory developments, including decisions by the Drug Enforcement Administration and states to reschedule any of our product candidates, if approved, containing Schedule I controlled substances, before they may be legally marketed in the U.S.; difficulty associated with research and development; risks associated with clinical studies or studies; heightened regulatory scrutiny; early stage product development; clinical study risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; ability to maintain effective patent rights and other intellectual property protection; as well as those risk factors discussed or referred to herein and the risks, uncertainties and other factors described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2026 under headings such as "Special Note Regarding Forward-Looking Statements," and "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company's profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20260621839059/en/ Investors:
Gitanjali Jain
VP, Head of Investor Relations
ir@definiumtx.com Media:
media@definiumtx.com Original: Definium Therapeutics to Discuss Topline Results from Phase 3 Emerge Study in Major Depressive Disorder on June 22, 2026
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