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Definium Therapeutics

Psychedelic medicine biotech company

Definium Therapeutics, Inc., formerly known as MindMed, is a New York-based biotechnology company that is currently developing clinical and therapeutic applications for psychedelic and, more broadly, psychoplastogenic drugs.3 Its shares trade on Nasdaq under the symbol DFTX.1 Wikipedia text CC BY-SA 4.0

$34.31 up 0.07 (0.20%)Price as of Oct 15, 2026 at 17:33 UTC

Last updated Oct 21, 2026.

Overview

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  • TickerDFTX on Nasdaq1
  • Industrybiotechnology industry1
  • HeadquartersNew York City1
  • Websitedefiniumtx.com
  • Listed onCboe Canada (MMED), Frankfurt Stock Exchange (MMQ), Nasdaq (MNMD)1
  • Incorporated inBritish Columbia, Canada5
  • Business addressOne World Trade Center, Suite 8500, New York, Ny 100075
  • Filer category, Emerging growth company5
  • Legal formCorporation

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Definium Therapeutics, Inc., formerly known as MindMed, is a New York-based biotechnology company that is currently developing clinical and therapeutic applications for psychedelic and, more broadly, psychoplastogenic drugs.3

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Financial statements

Operating income89101112-$166.3M in 2025+404% since 2020
-$200.0M-$150.0M-$100.0M-$50.0M02020: -$33.0M-$33.0M20202021: -$93.9M-$93.9M2021+184%2022: -$66.3M-$66.3M2022−29%2023: -$93.9M-$93.9M2023+42%2024: -$103.9M-$103.9M2024+11%2025: -$166.3M-$166.3M2025+60%
Net income89101112-$183.8M in 2025+442% since 2020
-$200.0M-$150.0M-$100.0M-$50.0M02020: -$33.9M-$33.9M20202021: -$93.0M-$93.0M2021+174%2022: -$56.8M-$56.8M2022−39%2023: -$95.7M-$95.7M2023+69%2024: -$108.7M-$108.7M2024+14%2025: -$183.8M-$183.8M2025+69%

Every line of the income statement as filed: the last 2 fiscal years, latest first.12

Period ending2025-12-312024-12-31
Research and development$117.7M$65.3M
General and administrative$48.6M$38.6M
Total operating expenses$166.3M$103.9M
Loss from operations-$166.3M-$103.9M
Interest income$11.0M$11.6M
Interest expense-$5.5M-$2.3M
Foreign exchange loss, net-$131.0K-$638.0K
Change in fair value of 2022 USD Financing Warrants-$22.8M-$15.9M
Gain on extinguishment of contribution payable$0$2.5M
Total other expense, net-$17.5M-$4.8M
Net loss-$183.8M-$108.7M
Unrealized gain on investments$330.0K
Gain/(loss) on foreign currency translation-$64.0K$476.0K
Comprehensive loss-$183.5M-$108.2M
Net loss per common share, basic-$2.06-$1.54
Net loss per common share, diluted-$2.06-$1.54
Weighted-average common shares, basic89.3M shares70.5M shares
Weighted-average common shares, diluted89.3M shares70.5M shares

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Corporate structure

Definium Therapeutics sits at the top of its group. 3 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Definium Therapeutics

  • Commodore Capital LP Filed SCHEDULE 13G/A on Definium Therapeutics, latest Aug 14, 2026 (4 filings since Mar 21, 2024)
  • DRIEHAUS CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on Definium Therapeutics, latest Aug 14, 2026 (2 filings since Feb 17, 2026)
  • Deep Track Capital, LP Filed SCHEDULE 13G/A on Definium Therapeutics, latest May 15, 2026 (5 filings since Mar 15, 2024)
  • Avoro Capital Advisors LLC Filed SCHEDULE 13G on Definium Therapeutics, latest Feb 17, 2026
  • BlackRock Filed SCHEDULE 13G/A on Definium Therapeutics, latest Feb 5, 2025 (3 filings since Oct 22, 2024)
  • CVI Investments, Inc. Filed SC 13G/A on Definium Therapeutics, latest Feb 14, 2023 (2 filings since Oct 6, 2022)
  • Joseph D. Samberg Filed SC 13G on Definium Therapeutics, latest Oct 7, 2022
  • Definium Therapeutics New York City
    • Definium Therapeutics US, Inc. Subsidiary · Delaware, United States
    • Healthmode, Inc. Subsidiary · Delaware, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Definium Therapeutics reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$257.8M12 Dec 31, 2025$273.7M12 Dec 31, 2024−5.8%
Marketable securities, current$153.8M12 Dec 31, 2025$012 Dec 31, 2024
Debt securities available for sale$153.8M12 Dec 31, 2025$012 Dec 31, 2024

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$19.9M12 Dec 31, 2025$19.9M12 Dec 31, 20240%
Finite-lived intangibles, gross$9.5M11 Dec 31, 2024$9.5M11 Dec 31, 20230%
Accumulated amortization$9.5M11 Dec 31, 2024$9.0M11 Dec 31, 2023+5.9%
Finite-lived intangibles, net$011 Dec 31, 2024$527.0K11 Dec 31, 2023−100.0%

Properties, in its own words

Our U.S. corporate address is located at One World Trade Center Suite 8500, New York, New York 10007, where we lease office space as well as shared use of office services and facilities. The term of the lease automatically renews every six months.

We lease additional office space in San Diego, California, Durham, North Carolina and Madison, Wisconsin. The term of our North Carolina lease commenced in April 2022 and expires in February 2031. The term of our California lease commenced in September 2025 and expires in August 2026. The term of our Wisconsin lease commenced in February 2026 and expires in January 2029.

Item 2 of the 10-K filed Feb 26, 2026.15

The story

MindMed was founded in May 2019 by Stephen Hurst and Jamon Rahn.

MindMed initially focused on developing treatments for opioid withdrawal and opioid use disorder with 18-MC, a non-hallucinogenic molecule based on the psychoactive alkaloid ibogaine. In June 2019, it acquired the 18-MC drug development program, previously funded by the National Institute on Drug Abuse, and in September began to prepare 18-MC for a Phase I FDA clinical trial to enable further clinical trials targeting opioid withdrawal and opioid use disorder.

MindMed was the first psychedelic pharmaceutical company to go public, listing on the Canadian NEO Exchange in March of 2020 through a reverse takeover with the Canadian gold mining company Broadway Gold Mining. It began trading on the Nasdaq as MNMD in April 2021 after being approved for an uplisting from the OTC Markets.

In a press release on June 9, 2021 MindMed announced that Jamon Rahn was stepping down both as the CEO and as a director on the board, to be replaced by then CDO Robert Barrow.

On February 26, 2021, MindMed closed its acquisition of digital health startup HealthMode. In connection with the acquisition, Daniel Karlin MD, CEO of HealthMode, was appointed to the position of CMO of the company.

On August 25, 2022, the first patient was dosed in a phase 2b trial for treatment of MM120 (now DT120) in generalized anxiety disorder (GAD). The study would go on to recruit 198 participants. The majority of trial participants experienced statistically significant improvements in their GAD scores, leading to the approval of multiple phase three human trials.

On January 12, 2026, MindMed rebranded to Definium Therapeutics.

From Wikipedia’s article on Definium Therapeutics, shared under CC BY-SA 4.0.6

Leadership

Who has led Definium Therapeutics, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Robert Barrow2022–now

President

  1. Miri Halperin Wernli2022–2024

Chief financial officer

  1. Schond L. Greenway2022–2024
  2. Brandi Roberts2025–now
2025
Board members and other officers (16)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerMark R. Sullivan named Mar 18, 2024 to May 5, 202534

Products and brands

In March 2020, MindMed announced that it had partnered with NYU Langone to launch a clinical training program to train psychiatrists in psychedelic therapies and research to advance and deploy psychedelic medicines. The company committed $5 million to establish the center, which will also explore 18-MC and the use of drugs, including psilocybin-assisted therapy for alcohol use disorder.

In April 2020, the company entered into a long-term partnership with University Hospital Basel's Liechti Lab, gaining rights to more than ten years of the lab's data related to LSD, MDMA, and other psychedelic substances. The development of a novel compound designed to shorten the duration or stop an LSD experience that would allow LSD to be more widely used in a therapeutic environment was subsequently announced. Later that year a clinical trial studying the effects of DMT, the primary psychoactive ingredient in ayahuasca, and clinical trials combining MDMA and LSD were announced. A study to better understand and compare the altered states of consciousness induced by psilocybin and LSD began in August 2020,

and in October a Phase 1 study at the Liechti Lab on the acute dose dependent effects of LSD was completed. The results of the study were published by the American College of Neuropsychopharmacology in the journal Neuropsychopharmacology. In September 2021, further results were presented by Matthias Liechti, head of the Liechti Lab, at the INSIGHT Conference in Berlin. The results included the first clinical evidence on the comparative effects of LSD and psilocybin, stating 100mcg of LSD produced the same acute perceptual effects as a dose of 20 mg of psilocybin in healthy volunteers. Additionally, psilocybin taken after administering antidepressants for two weeks prior, was deemed safe, as well as reduced anxiety and blood pressure without hindering the psychedelic experience.

In December 2020, MindMed entered into an investigator-sponsored study agreement with Maastricht University in the Netherlands. The university provided facilities and personnel for a Phase 1 study to evaluate the effects of two low doses of LSD on mood, sleep and neuroplasticity.

Read the full text

In March 2024, the FDA granted breakthrough therapy designation to MindMed's form of LSD (MM120; now DT120) for the treatment of generalized anxiety disorder. This decision was influenced by a drug trial in which approximately half of the participants experienced significant relief from their symptoms. Positive results in clinical trials against general depression symptoms and generalized anxiety disorder were reported in 2026.

From Wikipedia’s article on Definium Therapeutics, shared under CC BY-SA 4.0.6

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Definium Therapeutics US, Inc. Delaware7
  • Healthmode, Inc. Delaware7

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • Mind Medicine (MindMed) Inc.Jun 8, 2020 to Jan 12, 20265

Timeline

  1. Sep 14, 20268-K Regulation FD disclosure; Other events35
  2. Sep 8, 20268-K Other events36
  3. Aug 12, 20268-K Regulation FD disclosure; Other events37
  4. Aug 6, 20268-K Results of operations38
  5. Jun 24, 20268-K Entered a material agreement; Other events39
  6. Jun 22, 20268-K Regulation FD disclosure; Other events40
  7. Jun 12, 20268-K Executive or director change; Shareholder vote41
  8. May 19, 20268-K Other events42
  9. May 12, 20268-K Other events43
  10. May 7, 20268-K Results of operations44
  11. Apr 22, 20268-K Other events45
  12. Feb 26, 20268-K Results of operations46
  13. Jan 10, 2022New chief executive Robert Barrow becomes CEO16

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.78) a share, on Nov 6, 2025.47

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results38
  2. May 7, 2026Reported quarterly or annual results44
  3. Feb 26, 2026Reported quarterly or annual results46
  4. Jan 12, 2026Reported quarterly or annual results48
  5. Nov 6, 2025Reported quarterly or annual results49
  6. Oct 29, 2025Reported quarterly or annual results50
  7. Jul 31, 2025Reported quarterly or annual results51
  8. May 8, 2025Reported quarterly or annual results52

Drug trials and FDA: coming up

  1. Aug 2027Phase 2 trial readout expected Phase 2 trial of DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA)) in Autism Spectrum Disorder: primary completion expected Aug 2027 (ClinicalTrials.gov NCT07303907).53
  2. Sep 2027Phase 3 trial readout expected Phase 3 trial of DT120 in Major Depressive Disorder: primary completion expected Sep 2027 (ClinicalTrials.gov NCT07592689).54

Drug trials and FDA: recently

  1. Aug 13, 2026Phase 3 trial completed Phase 3 trial of DT120 in Generalized Anxiety Disorder: primary completion Aug 13, 2026, no results posted yet (ClinicalTrials.gov NCT06809595).55
  2. Jul 15, 2026Phase 3 trial completed Phase 3 trial of DT120 in Generalized Anxiety Disorder: primary completion Jul 15, 2026, no results posted yet (ClinicalTrials.gov NCT06741228).56
  3. May 20, 2026Phase 3 trial completed Phase 3 trial of DT120 in Major Depressive Disorder: primary completion May 20, 2026, no results posted yet (ClinicalTrials.gov NCT06941844).57

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

463 filings to the SEC since October 2021: 5 annual reports, 14 quarterly reports, 81 major events, 186 insider forms, 18 large holders, 2 private raises, 157 other. The latest 20:

  1. Sep 29, 20264 OWNERSHIP DOCUMENT EDGAR
  2. Sep 29, 20264 OWNERSHIP DOCUMENT EDGAR
  3. Sep 29, 20264 OWNERSHIP DOCUMENT EDGAR
  4. Sep 29, 20264 OWNERSHIP DOCUMENT EDGAR
  5. Sep 29, 20264 OWNERSHIP DOCUMENT EDGAR
  6. Sep 25, 2026144 EDGAR
  7. Sep 25, 2026144 EDGAR
  8. Sep 25, 2026144 EDGAR
  9. Sep 25, 2026144 EDGAR
  10. Sep 25, 2026144 EDGAR
  11. Sep 18, 20264 EDGAR
  12. Sep 18, 20264 EDGAR
  13. Sep 14, 20264 EDGAR
  14. Sep 14, 20264 EDGAR
  15. Sep 14, 20264 EDGAR
  16. Sep 14, 20264 EDGAR
  17. Sep 14, 20264 EDGAR
  18. Sep 14, 20268-K EDGAR
  19. Sep 8, 20268-K EDGAR
  20. Sep 4, 20264 EDGAR

The 463 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

80 open-market trades by officers, directors and large owners since October 2021: 4 buys and 76 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 25, 2026Karlin DanielChief Medical OfficerSale10,853$36.57$396.9KForm 4
Sep 25, 2026Barrow RobertChief Executive OfficerSale31,550$36.57$1.2MForm 4
Sep 25, 2026Wiley Matthew T.Chief Commercial OfficerSale3,097$36.57$113.3KForm 4
Sep 25, 2026Sullivan MarkChief Legal OfficerSale14,051$36.57$513.8KForm 4
Sep 25, 2026Roberts BrandiChief Financial OfficerSale3,377$36.57$123.5KForm 4
Sep 3, 2026Barrow RobertChief Executive OfficerSale19,023$37.94$721.7KForm 4
Jun 25, 2026Sullivan MarkChief Legal OfficerSale13,008$45.03$585.8KForm 4
Jun 25, 2026Karlin DanielChief Medical OfficerSale10,035$45.03$451.9KForm 4
Jun 25, 2026Roberts BrandiChief Financial OfficerSale3,013$45.03$135.7KForm 4
Jun 25, 2026Barrow RobertChief Executive OfficerSale29,208$45.03$1.3MForm 4
Jun 25, 2026Wiley Matthew T.Chief Commercial OfficerSale2,867$45.03$129.1KForm 4
Mar 25, 2026Karlin DanielChief Medical OfficerSale8,018$18.47$148.1KForm 4
Mar 25, 2026Sullivan MarkChief Legal OfficerSale10,702$18.47$197.7KForm 4
Mar 25, 2026Barrow RobertChief Executive OfficerSale24,431$18.47$451.2KForm 4
Dec 26, 2025Karlin DanielChief Medical OfficerSale5,600$13.15$73.6KForm 4
Dec 26, 2025Barrow RobertChief Executive OfficerSale25,791$13.15$339.2KForm 4
Dec 26, 2025Sullivan MarkChief Legal OfficerSale11,276$13.15$148.3KForm 4
Sep 25, 2025Sullivan MarkChief Legal OfficerSale11,278$9.77$110.2KForm 4
Sep 25, 2025Barrow RobertChief Executive OfficerSale25,797$9.77$252.0KForm 4
Sep 25, 2025Karlin DanielChief Medical OfficerSale7,704$9.77$75.3KForm 4

All 80 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Robert Barrow37$655.0K$12.8M65
2025Brandi L. Roberts52$288.8K$5.1M65
2025Daniel KarlinM.D.46$510.0K$4.0M65
2024Chief Executive Officer$623.5K$2.7M65
2024Chief Medical Officer$485.5K$1.3M65

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$82.0M 2023–2024
Money received by yearMoney received by year, 2023–2024: $82.0M in all. Private raises (Form D) $82.0M.$0$20M$40M$60M$80M2023 · Private raises (Form D): $7.0M20232024 · Private raises (Form D): $75.0M2024
Figures by year
YearPrivate raises (Form D)Total
2024$75.0M$75.0M
2023$7.0M$7.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Mar 11, 2024Raised $75 million in a private offering of equity66 Form D: 2 investors so far Form D
  2. Aug 11, 2023Raised $7 million in a private offering of equity34 Form D: 1 investor so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.11,232,834$528.4M0.0%+2,752,604
Avoro Capital Advisors LLC7,188,888$338.2M3.0%+2,188,888
Driehaus Capital Management LLC6,845,276$322.0M1.9%+933,387
Jupiter Topco LLC5,615,645$264.0M0.1%New
Capital World Investors5,367,723$252.5M0.0%New
Fmr LLC4,752,921$223.6M0.0%+2,943,311
Geode Capital Management, LLC3,644,813$171.5M0.0%+1,149,414
State Street Corp3,065,390$144.2M0.0%+593,517
Capital International Investors2,963,410$139.4M0.0%New
Octagon Capital Advisors LP2,950,000$138.8M12.7%+510,000
Wellington Management Group Llp2,949,734$138.8M0.0%+1,644,985
Deep Track Capital, LP2,750,000$129.4M1.9%−250,000
Commodore Capital LP2,000,000$94.1M5.6%No change
Goldman Sachs Group Inc1,800,852$84.7M0.0%+125,441
Citadel Advisors LLC1,688,587$79.4M0.0%+355,145
Vanguard Portfolio Management LLC1,648,426$77.5M0.0%+775,761
Ra Capital Management, L.P.1,500,000$70.6M0.6%New
Vanguard Capital Management LLC1,486,454$69.9M0.0%+389,476
Siren, L.L.C.1,419,493$66.8M1.4%+500,000
Marshall Wace, Llp1,298,946$61.1M0.1%+98,121
Northern Trust Corp1,169,238$55.0M0.0%+370,251
Ameriprise Financial Inc1,148,363$54.0M0.0%+181,755
Nuveen, LLC1,105,314$52.0M0.0%+407,184
Charles Schwab Investment Management Inc1,083,576$51.0M0.0%+274,861
Woodline Partners LP1,003,641$47.2M0.1%+250,849

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Definium Therapeutics is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARDefinium Therapeutics, Inc.2
  • CIK0001813814
  • Employer ID (EIN)98-158243815
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company15
  • Incorporated inBritish Columbia15
  • Fiscal year endsDecember 312
  • Industry code (SIC)2833 Medicinal Chemicals & Botanical Products2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business addressOne World Trade Center, Suite 8500, New York, NY 100072
  • Phone212-220-66332
  • Shares outstanding134,366,950 as of Jul 30, 202614
  • Public float$487.7M as of Jun 30, 202515
  • AuditorKPMG LLP, San Diego, California PCAOB ID 185; no auditor attestation of internal control over financial reporting15
  • On EDGAR sinceJun 8, 20202
  • Filings503 in all: 4 (160), 8-K (78), 144 (48), 6-K (46), DEFA14A (30), 3 (18), DFAN14A (17), 10-Q (14)2
    All 39 form types

    424B5 (9), 4/A (8), SCHEDULE 13G/A (8), D (6), SC 13G (6), 10-K (5), S-8 (5), DEF 14A (4), UPLOAD (4), 424B3 (3), 8-K/A (3), ARS (3), CORRESP (3), EFFECT (3), DEFC14A (2), PREC14A (2), S-3 (2), SC 13G/A (2), SCHEDULE 13G (2), 424B7 (1), 8-A12B (1), CERT (1), F-10 (1), F-10/A (1), F-X (1), PRE 14A (1), PRER14A (1), PRRN14A (1), S-3ASR (1), S-3MEF (1), S-8 POS (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Sep 14, 2026

Securities registered for trading

ClassSymbolExchange
Common shares, no par value per shareDFTXThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).15

Risk factors and legal proceedings

The risks Definium Therapeutics names in Item 1A of its 10-K filed Feb 26, 2026: 75 risks under these headings, as written.15

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have a limited operating history, have not completed any pivotal clinical trials, and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and likelihood of success and viability.
  • We are a clinical-stage pharmaceutical company and have incurred significant net losses since our inception, and we expect to continue to incur significant net losses for the foreseeable future.
  • The terms of our loan agreement place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our operating and financial flexibility.
  • We have never generated revenue and may never be profitable.
  • We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts.
  • Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to our product candidates on unfavorable terms.
  • We may plan to grow and develop our business through in-license agreements, acquisitions of or investment in new or complementary businesses, product candidates or technologies, and the failure to manage these license agreements, acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us.
  • Risks Related to the Discovery, Development and Commercialization of our Product Candidates
  • We are dependent on the successful development of our product candidates. We cannot give any assurance that any of our product candidates will successfully complete clinical trials or receive regulatory approval, which is necessary before any product candidate can be commercialized.
  • Our focus is on product candidates that are subject to controlled substance laws and regulations in the territories where the products are being developed and intended to be marketed, if approved, and failure to comply with these laws and regulations, or the cost of compliance with these laws and regulations, may adversely affect the results of our business operations and our financial condition, both during clinical development and post approval, if any. In addition, the FDA and/or other regulatory
  • bodies may require additional data, including with respect to abuse potential of our product candidates, before allowing us to commence a clinical trial or before approving any future marketing application we may submit.
The other 64 risks
  • State-controlled substances laws.
  • Manufacture in the United States.
  • Distribution in the United States.
  • Our product candidates are controlled substances, the use of which may generate public controversy. Adverse publicity or public perception regarding controlled substances and psychedelics may negatively influence the success of our product candidates.
  • Drug development is a lengthy and expensive process with uncertain timelines and uncertain outcomes. If preclinical studies or clinical trials of our product candidates are prolonged or delayed, we or our current or future collaborators may be unable to obtain required regulatory approvals, which would mean that we would be unable to commercialize our product candidates on a timely basis or at all, which will adversely affect our business.
  • Our clinical trials may fail to demonstrate substantial evidence of the safety and effectiveness of DT120, DT402, or any other product candidates that we may identify and pursue, which would prevent, delay or limit the scope of regulatory approval and commercialization.
  • Changes in our formulation or components of our formulation of DT120 or DT402 could have a material adverse effect on our business, financial condition and results of operations.
  • Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data. These data may not be sufficient to support regulatory submissions or approvals.
  • We may not be able to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA or similar regulatory authorities may not permit us to proceed in a timely manner, or at all.
  • We may not achieve our publicly announced milestones according to schedule, or at all.
  • The regulatory approval process of the FDA and other comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for any product candidates, our business will be substantially harmed.
  • Even if DT120, DT402 or any other product candidates obtain regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, any such product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • Our product candidates may have serious adverse, undesirable or unacceptable side effects which may delay or prevent marketing approval. If such side effects are identified during the development of DT120, DT402 or any other product candidates or following approval, if any, we may need to abandon our development or commercialization of such product candidates, the commercial profile of any approved label may be limited, or we may be subject to other significant negative consequences.
  • Even if we obtain FDA approval for DT120, DT402 or any other product candidates, we may never obtain approval to commercialize any such product candidates outside of the United States, which would limit our ability to realize their full market potential.
  • There is a variety of risks associated with marketing our product candidates internationally, any of which could materially adversely affect our business.
  • Research and development of drugs targeting brain health disorders is particularly difficult, which makes it difficult to predict and understand why the drug has a positive effect on some patients but not others.
  • We depend on enrollment of patients in our clinical trials for our product candidates. If we are unable to enroll patients in our clinical trials, our research and development efforts and business, financial condition and results of operations could be materially adversely affected.
  • We have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize our product candidates on our own or with suitable collaborators.
  • The future commercial success of our product candidates will depend on the degree of market access and acceptance of our product candidates, if approved, among healthcare professionals, patients, healthcare payors, health technology assessment bodies and the medical community at large.
  • Our business and commercialization strategy depends on our ability to identify, qualify, prepare, certify and support third-party treatment sites offering any approved product candidate. If we are unable to do so, our commercialization prospects would be limited and our business, financial condition and results of operations would be harmed.
  • We currently rely on qualified HCPs working at third-party clinical trial sites to administer our product candidates in our clinical trials and we expect this to continue upon approval, if any, of DT120, DT402 or any other product candidates. If third-party sites fail to recruit and retain a sufficient number of HCPs or effectively oversee their HCPs, our business, financial condition and results of operations would be materially harmed.
  • We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims.
  • Risks Related to Regulatory Approval and other Legal Compliance Matters
  • Lysergide, MDMA and other compounds used in our product candidates are listed as Schedule I controlled substances under the CSA in the U.S., and similar controlled substance legislation in other countries and any significant breaches in our compliance with these laws and regulations, or changes in the laws and regulations may result in interruptions to our development activity or business continuity.
  • Disruptions at the FDA, including due to a reduction in the FDA’s workforce, inadequate funding for the FDA or a shutdown of the federal government, could prevent the FDA from performing normal functions on which our business relies, which could negatively impact our business.
  • Our business operations and our relationships with investigators, healthcare professionals, consultants, third-party payors and customers are currently or will be subject to U.S. federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, other healthcare laws and regulations and other foreign privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • We are subject to stringent and changing obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation, fines and penalties; disruptions of our business operations, reputational harm, loss of revenue or profits, loss of customers or sales, and other adverse business consequences.
  • The successful commercialization of our product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate reimbursement levels and pricing policies. Failure to obtain or maintain
  • adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market those product candidates and decrease our ability to generate revenue.
  • We intend to seek approval to market DT120, DT402 and other product candidates in both the United States and in selected foreign jurisdictions. If we obtain approval in one or more foreign jurisdictions for our product candidates, we will be subject to rules and regulations in those jurisdictions.
  • Enacted and future legislation may increase the difficulty of commercializing our product candidates and affect the prices we may charge for such product candidates.
  • If we do not obtain protection under the Hatch-Waxman Amendments and similar foreign legislation for extending the term of patents covering each of our investigational product candidates, our business may be materially harmed.
  • We could experience difficulty enforcing our contracts.
  • Investors in certain jurisdictions may have difficulty in enforcing judgments and effecting the service of process on us.
  • The increasing use of social media platforms presents new risks and challenges.
  • The production and sale of our product candidates may be considered illegal or may otherwise be restricted due to the use of controlled substances, which may also have consequences for the legality of investments from foreign jurisdictions.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.
  • Our business activities may be subject to the FCPA, CFPOA and similar anti-bribery and anti-corruption laws of other countries in which we operate, as well as U.S., Canadian and certain foreign export controls, trade sanctions, and import laws and regulations. Compliance with these legal requirements could limit our ability to compete in foreign markets and subject us to liability if we violate them.
  • Risks Related to Employee Matters, Managing our Growth and Other Risks Related to our Business
  • Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees.
  • We face competition from other biotechnology and pharmaceutical companies and our financial condition and operations will suffer if we fail to effectively compete.
  • If we are unable to establish sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to successfully sell or market our product candidates that obtain regulatory approval.
  • In order to successfully implement our plans and strategies, we will need to increase the size of our organization, and we may experience difficulties in managing this growth.
  • If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
  • Risks Related to our Intellectual Property
  • Third-party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate our patents or other proprietary rights, may delay or prevent our development and commercialization efforts.
  • We may not identify relevant patents or may incorrectly interpret the relevance, scope or expiration of a patent, which might adversely affect our ability to develop and market our products.
  • We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • If we are unable to obtain and maintain effective patent protection for our technology and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets
  • Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submissions, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not be able to protect our intellectual property rights throughout the world, which could impair our business.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • We may be subject to claims challenging the inventorship of our patent filings and other intellectual property.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • We may develop or license intellectual property for which development was funded or otherwise assisted by, the U.S. government and/or government agencies, such as the National Institutes of Health, for development of our technology and product candidates. Failure to meet our own obligations to future licensors or upstream licensors, including such government agencies, may result in the loss of our rights to such intellectual property, which could harm our business.
  • Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
  • Risks Related to our Dependence on Third Parties
  • We rely on third parties to supply and manufacture DT120 ODT, DT402 and our other product candidates, and we will rely on third parties to manufacture these substances for commercial supply, if approved. If any third-party provider fails to meet its obligations manufacturing our product candidates, or fails to maintain or achieve satisfactory regulatory compliance, the development of such substances and the commercialization of any product candidates, if approved, could be stopped, delayed or made commercially unviable, less profitable or may result in enforcement actions against us.
  • We rely, and expect to continue to rely, on third parties, including independent clinical investigators, academic collaborators and CROs, to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.
  • If we decide to establish collaborations, but are not able to establish those collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • We may enter into collaborations with third parties for the development and commercialization of product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • Risks Related to the Securities Markets and Ownership of our Common Shares
  • The price of our common shares is volatile.
  • Our operating results may fluctuate significantly, which would make our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.
  • Information that is published by third parties, including blogs, articles, message boards and social and other media, has in the past and may in the future include statements not attributable to us and may not be reliable or accurate.
  • Our business and operations could be negatively affected if we become subject to any securities litigation or shareholder activism, which could cause us to incur significant expense, hinder execution of business and growth strategies and impact our share price.

Legal proceedings

From time to time, we may become involved in litigation or other legal proceedings arising in the ordinary course of our business. We are not currently a party to any material litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business.

The opening of Item 3, Legal Proceedings.15

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