PSYENCE BIOMEDICAL LTD. annual report, Q4 FY2024

Psyence Biomedical Ltd. — Form 20-F Summary

Reporting period: Fiscal year ended March 31, 2024, with fiscal 2023 comparatives. Although the request metadata says “2023 Q4,” this filing is an annual report, not a standalone quarterly report. Financial statements are prepared under IFRS in U.S. dollars; 2023 figures are carve-out comparatives and may not be directly comparable.

Business context

Psyence is a clinical-stage biotechnology company developing naturally derived psilocybin therapies, initially for adjustment disorder in palliative-care patients with incurable cancer. Its lead candidate, PEX010, is licensed from Filament for clinical research. The company has no approved products and has generated no revenue. It completed its Nasdaq business combination and listing on January 25, 2024.

Key financial results and position

MetricFY ended March 31, 2024FY ended March 31, 2023
Revenue$0$0
Research and development expense$0.95 million$1.61 million
Net loss$51.16 million$3.21 million
Comprehensive loss$50.96 million$3.30 million
Cash used in operating activities$2.95 million$1.59 million
Cash and cash equivalents at year-end$0.73 million$1.33 million
Cash including restricted cash$0.76 million$1.36 million

The 2024 net loss was dominated by a $41.48 million deemed listing expense related to the business combination. Other transaction costs were $2.46 million; fair-value losses included $5.16 million on convertible notes and $0.31 million on warrant liabilities. The company also recorded $0.88 million of Australian R&D rebate income. No operating margin is meaningful because the company had no revenue.

At March 31, 2024, total assets were $1.13 million and total liabilities were $12.10 million, including a $7.66 million convertible-note liability and $0.90 million of derivative warrant liabilities. Net deficit was $10.97 million; management reported negative working capital of $10.98 million. Operating cash use increased year over year. The filing reports no long-term debt or off-balance-sheet arrangements, but it does disclose current obligations and convertible financing.

Material changes and financing

  • The business combination caused the large, largely non-cash listing charge and a substantial increase in reported loss. The comparative 2023 financial statements were carve-out statements prepared while the business was part of Psyence Group.
  • The initial convertible-note financing provided $2.5 million in cash for $3.125 million of principal, with 8% annual interest, security interests and conversion-price reset provisions. The notes are marked to fair value; conversion terms can create significant dilution.
  • After year-end, the company disclosed $1.0 million of additional proceeds from second-tranche notes through July 2024. Investors were not obligated to fund further tranches, and additional financing was not assured.
  • Subsequent to year-end, noteholders converted principal at a reported $0.5361 VWAP, resulting in 2,130,572 shares, with additional shares issued for interest. The filing also reports other post-year-end share issuances and a warrant exchange.

Outlook, risks and unusual items

  • Clinical outlook: The Australian Phase IIb study of PEX010 received ethics approval in March 2024. It is designed as a randomized, double-blind study of 84 patients, comparing psilocybin-assisted psychotherapy with psychotherapy alone. Enrollment was estimated to begin in the second half of 2024. A Phase III program depends on results and regulatory advice; acceptance of foreign trial data by the FDA is not assured. Management has discussed a possible 2027 launch, but this is not financial guidance and depends on successful development and approvals.
  • Funding and going concern: The auditor highlighted a material uncertainty that raises significant doubt about the company’s ability to continue as a going concern. The company has recurring losses, no revenue, limited cash and substantial financing needs. Management’s expectation that available and planned financing could fund operations beyond 12 months is conditional; future funding is uncertain.
  • Development and commercial risks: Clinical failure or delay, regulatory rejection, patient-enrollment challenges, controlled-substance rules, dependence on third-party trial operators and suppliers, and the need to secure new product and intellectual-property licenses could materially affect prospects. Psyence does not currently own patents and relies on licensed IP for its lead study.
  • Financing and listing risks: The filing describes Nasdaq deficiencies concerning market value and bid price. It also discloses potential registration-rights penalties and note acceleration following registration delays; as of July 1, 2024, the company said it had not received a default notice. Convertible-note reset terms, potential share issuance and existing-holder sales could cause substantial dilution and share-price pressure.
  • Controls and contingencies: Management concluded disclosure controls and procedures were not effective at year-end. The auditor did not audit internal control over financial reporting. The Australian R&D rebate could be subject to denial or clawback, although management considered clawback highly unlikely. No formal financial guidance was provided.

Most important facts for investors to verify

  • Current cash, cash runway, working capital and the company’s ability to meet liabilities as they fall due; reconcile the year-end position with subsequent financing and spending.
  • Whether additional financing tranches are committed or funded, and the effective conversion prices, interest, reset and make-whole terms, and resulting fully diluted share count.
  • Current Phase IIb enrollment and trial status, expected costs and timing, and the FDA’s position on using Australian trial data and the Phase III pathway.
  • Execution of replacement supply and licensing agreements for Phase III and commercialization, including the scope and duration of rights to PEX010 and related IP.
  • Resolution of Nasdaq listing deficiencies and any registration-rights default, penalties or debt-acceleration exposure.
  • Remediation of ineffective disclosure controls and the conditions attached to the Australian R&D rebate.