UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of November, 2024.
Commission File Number: 001-40673
Cybin Inc.
(Exact Name of Registrant as Specified in Charter)
100 King Street West, Suite 5600, Toronto, Ontario, M5X 1C9
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F □ Form 40-F ⊠
INCORPORATION BY REFERENCE
Exhibits 99.1 - 99.2 of this Form 6-K of Cybin Inc. (the "Company") are hereby incorporated by reference into the Registration Statement on Form F-10 (File No. 333-272706) of the Company, as amended or supplemented.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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| | CYBIN INC. | |
| | (Registrant) | |
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Date: | November 13, 2024 | By: | /s/ Doug Drysdale | |
| | Name: | Doug Drysdale | |
| | Title: | Chief Executive Officer | |
EXHIBIT INDEX
CYBIN INC.
CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED)
TO OUR SHAREHOLDERS
The accompanying unaudited condensed interim consolidated financial statements of Cybin Inc. ("Cybin") have been prepared by and are the responsibility of Cybin's management in accordance with International Accounting Standards (“IAS”) 34, Interim Financial Reporting as issued by the International Accounting Standards Board ("IASB''). These unaudited condensed interim consolidated financial statements do not include all the information and notes required by International Financial Reporting Standards ("IFRS'') for annual financial statements and should be read in conjunction with Cybin’s annual financial statements and notes for the year ended March 31, 2024, which are available on SEDAR+ at www.sedarplus.com.
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CYBIN INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (All amounts expressed in thousands of Canadian dollars) (Unaudited) |
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As at | Notes | September 30, 2024 | March 31, 2024 |
| | | |
ASSETS | | | |
Current | | | |
Cash | | 154,318 | | 208,992 | |
Accounts receivable | | 5,505 | | 4,476 | |
Prepaid expenses | | 17,301 | | 2,891 | |
Other current assets | | 1,605 | | 2,177 | |
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Total Current Assets | | 178,729 | | 218,536 | |
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Non-current | | | |
Equipment | 3 | 216 | | 266 | |
Intangible assets | 4 | 35,937 | | 35,465 | |
Right-of-use asset | 5 | 127 | | 281 | |
Goodwill | 6 | 47,382 | | 47,475 | |
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Total Non-Current Assets | | 83,662 | | 83,487 | |
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TOTAL ASSETS | | 262,391 | | 302,023 | |
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LIABILITIES | | | |
Current | | | |
Accounts payable and accrued liabilities | | 7,240 | | 9,805 | |
Lease liabilities | 5 | 133 | | 291 | |
| | | |
Total Liabilities | | 7,373 | | 10,096 | |
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SHAREHOLDERS' EQUITY | | | |
Share capital | 7 | 443,448 | | 443,877 | |
Contributed surplus | | 43,791 | | 11,750 | |
Options reserve | 7 | 42,615 | | 39,177 | |
Warrants reserve | 7 | 27,594 | | 25,639 | |
Accumulated other comprehensive loss | | (4,183) | | (2,285) | |
Deficit | | (298,247) | | (226,231) | |
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TOTAL SHAREHOLDERS' EQUITY | | 255,018 | | 291,927 | |
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TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | | 262,391 | | 302,023 | |
Corporate information (note 1); Contracts, commitments and contingencies (note 11)The accompanying notes are an integral part of these condensed interim consolidated financial statements.
These condensed interim consolidated financial statements were approved for issue on November 12, 2024 by the board of directors and signed on its behalf by:
/s/ Paul Glavine Director /s/ Eric So Director
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CYBIN INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (All amounts expressed in thousands of Canadian dollars, except share and per share amounts) (Unaudited) |
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| | Three months ended September 30 | | Six months ended September 30 |
| Notes | 2024 | 2023 | | 2024 | 2023 |
| | | | | | |
EXPENSES | | | | | | |
Research | 9 | 9,115 | | 6,696 | | | 17,156 | | 13,080 |
General and administrative costs | 10 | 15,678 | | 5,800 | | | 23,981 | | 10,848 |
Share-based compensation | 7 | 33,461 | | 1,414 | | | 37,434 | | 2,689 |
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TOTAL EXPENSES | | 58,254 | | 13,910 | | | 78,571 | | 26,617 | |
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OTHER INCOME (EXPENSES) | | | | | | |
Foreign currency translation gain (loss) | | (2,016) | | 1,968 | | | 1,336 | | 77 |
Interest income | | 3,078 | | 52 | | | 5,219 | | 136 |
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TOTAL OTHER INCOME | | 1,062 | | 2,020 | | | 6,555 | | 213 | |
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NET LOSS FOR THE PERIOD | | (57,192) | | (11,890) | | | (72,016) | | (26,404) | |
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OTHER COMPREHENSIVE LOSS | | | | | | |
Foreign currency translation differences for foreign operations | | (803) | | (1,216) | | | (1,898) | | (39) |
COMPREHENSIVE LOSS FOR THE PERIOD | | (57,995) | | (13,106) | | | (73,914) | | (26,443) | |
| | | | | | |
Basic loss per share for the period | | (2.86) | | (1.93) | | | (3.60) | | (4.55) | |
Weighted average number of common shares outstanding - basic | | 20,001,406 | | 6,173,270 | | | 20,001,406 | | 5,801,282 | |
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
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CYBIN INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY For the six-month periods ended September 30, 2024 and 2023 (All amounts expressed in thousands of Canadian dollars, except share amounts) (Unaudited) |
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| | | Share capital | | Reserves | | | | | | |
| Note | | Number of shares | Amount | | Warrants | Options | Contributed surplus | | Deficit | | Accumulated other comprehensive loss | | Total |
| | | # | $ | | $ | $ | $ | | $ | | $ | $ |
Balance at March 31, 2023 | | | 5,279,846 | 158,162 | | 10,873 | 27,283 | 2,102 | | (148,151) | | (2,035) | | 48,234 |
At-the-market offering - net of share issuance costs | 7 | | 855,691 | 13,722 | | — | — | — | | — | | — | | 13,722 |
Shares issued through common share purchase agreement - net of share issuance costs | 7 | | 638,545 | 5,349 | | 4,599 | — | — | | — | | — | | 9,948 |
Issuance of common share as commitment fee for future financing | 7 | | 66,812 | — | | — | — | — | | — | | — | | — |
Shares issued through LPC purchase agreement - net of share issuance costs | 7 | | 50,658 | 234 | | — | — | — | | — | | — | | 234 |
Options expired | 7 | | — | — | | — | (467) | 467 | | — | | — | | — |
Warrants expired | 7 | | — | — | | (1,156) | — | 1,156 | | — | | — | | — |
Share-based compensation | 7 | | — | — | | — | 2,689 | — | | — | | — | | 2,689 |
Unrealized loss on translation of foreign operations | 7 | | — | — | | — | — | — | | — | | (39) | | (39) |
Net loss for the period | 7 | | — | — | | — | — | — | | (26,404) | | — | | (26,404) |
Balance at September 30, 2023 | | | 6,891,552 | 177,467 | | 14,316 | 29,505 | 3,725 | | (174,555) | | (2,074) | | 48,384 |
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Balance as at March 31, 2024 | | | 20,001,403 | | 443,877 | | | 25,639 | | 39,177 | | 11,750 | | | (226,231) | | | (2,285) | | | 291,927 | |
Adjustment for fractional shares upon share consolidation | 7 | | 3 | | — | | | — | | — | | — | | | — | | | — | | | — | |
Share issuance costs | 7 | | — | | (429) | | | — | | — | | — | | | — | | | — | | | (429) | |
Options cancelled | 7 | | — | | — | | | — | | (32,041) | | 32,041 | | | — | | | — | | | — | |
Share-based compensation | 7 | | — | | — | | | 1,955 | | 35,479 | | — | | | — | | | — | | | 37,434 | |
Unrealized loss on translation of foreign operations | 7 | | — | | — | | | — | | — | | — | | | — | | | (1,898) | | | (1,898) | |
Net loss for the period | 7 | | — | | — | | | — | | — | | — | | | (72,016) | | | — | | | (72,016) | |
Balance as at September 30, 2024 | | | 20,001,406 | | 443,448 | | | 27,594 | | 42,615 | | 43,791 | | | (298,247) | | | (4,183) | | | 255,018 | |
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
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CYBIN INC. CONDENSED INTERIM CONSOLIDATED STATEMENT OF CASH FLOWS (All amounts expressed in thousands of Canadian dollars) (Unaudited) |
| | | | | | | | | | | |
| | For the six months ended September 30, |
| Notes | 2024 | 2023 |
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OPERATING ACTIVITIES | | | |
Net loss for the period | | (72,016) | | (26,404) | |
Adjustments for items not affecting cash: | | | |
Depreciation and amortization | 3, 4, 5 | 281 | | 140 | |
Share-based compensation | 7 | 37,434 | | 2,689 | |
Lease interest | 5 | 6 | | — | |
Unrealized foreign currency translation gain | | (1,336) | | (95) | |
| | (35,631) | | (23,670) | |
Net changes in non-cash working capital items: | | | |
Accounts receivable | | (1,029) | | (632) | |
Prepaid expenses | | (14,410) | | (1,332) | |
Other current assets | | 572 | | (105) | |
Accounts payable and accrued liabilities | | (2,565) | | 3,580 | |
Net cash flows used in operating activities | | (53,063) | | (22,159) | |
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INVESTING ACTIVITIES | | | |
Purchase of equipment and intangible assets | 3, 4 | (579) | | (323) | |
Net cash flows used in investing activities | | (579) | | (323) | |
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FINANCING ACTIVITIES | | | |
Proceeds on issuance of common shares, net | | — | | 23,904 | |
Share issuance costs | 7 | (429) | | — | |
Lease payments | 5 | (176) | | — | |
Net cash flows used in financing activities | | (605) | | 23,904 | |
Effects of exchange rate changes on cash | | (427) | | 63 | |
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Net decrease in cash | | (54,674) | | 1,485 | |
Cash, beginning of period | | 208,992 | | 16,633 | |
Cash, end of period | | 154,318 | | 18,118 | |
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
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CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
1. CORPORATE INFORMATION
Cybin Inc. (“Cybin”), was incorporated under the Business Corporations Act (British Columbia) on October 13, 2016. These consolidated financial statements include the accounts of Cybin’s seven subsidiaries (together with Cybin, the “Company”): Cybin Corp., Natures Journey Inc. (“Journey”), Serenity Life Sciences Inc. (“Serenity”), Cybin US Holdings Inc. (“Cybin US”), Adelia Therapeutics Inc. (“Adelia”) Cybin IRL Limited (“Cybin IRL”) and Cybin UK Ltd. Cybin’s head office, principal address and registered address and records office is 100 King Street West, Suite 5600, Toronto, Ontario M5X 1C9.
The Company is a clinical-stage neuropsychiatric company focused on advancing therapies, delivery mechanisms, novel compounds and protocols as potential treatments for various psychiatric and neurological conditions. The Company is developing technologies and delivery systems aimed at improving the pharmacokinetics of its proprietary molecules while retaining the therapeutic benefit. These new molecules and delivery systems are expected to be studied through clinical trials to confirm safety and efficacy.
These condensed interim consolidated financial statements as at, and for the three and six months ended, September 30, 2024 were approved and authorized for issue by the board of directors on November 12, 2024.
Stock exchange listings
Cybin’s common shares (the “Common Shares”) are listed for trading on Cboe Canada Inc.(“Cboe") and NYSE American LLC under the symbol “CYBN” and on the Frankfurt Stock Exchange under the symbol “R7E1”.
Share consolidation
On September 19, 2024, the Company consolidated its outstanding Common Shares on the basis of one new Common Share for every 38 existing Common Shares. As a result, the number of Common Shares, warrants, options and earnings per share presented in these condensed interim consolidated financial statements have been restated retrospectively for all the periods to reflect this consolidation.
2. MATERIAL ACCOUNTING POLICY INFORMATION AND BASIS OF PREPARATION
Statement of compliance
These condensed interim consolidated financial statements for the three and six months ended September 30, 2024 have been prepared in accordance with International Accounting Standard 34 “Interim Financial Reporting”. Accordingly, certain information and footnote disclosure normally included in annual financial statements prepared in accordance with International Financial Reporting Standards (“IFRS”) have been omitted or condensed.
The accounting policies adopted in the preparation of the condensed interim consolidated financial statements are consistent with those set out in note 2 “Significant accounting policies and basis of preparation” of the Company’s annual consolidated financial statements for the year ended March 31, 2024.
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CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
These condensed interim consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended March 31, 2024.
Basis of measurement
These condensed interim consolidated financial statements have been prepared on a going concern basis, under the historical cost convention, except for certain financial instruments classified at fair value upon initial recognition.
Functional and presentation currency
The functional currency of a company is the currency of the primary economic environment in which the company operates. The presentation currency for a company is the currency in which the company chooses to present its financial statements.
These condensed interim consolidated financial statements are presented in Canadian dollars, the Company’s presentation currency. The subsidiaries’ functional currencies are as follows:
| | | | | | | | |
Entity | Currency | Ownership |
Cybin Corp. | Canadian dollars | 100% |
Journey | Canadian dollars | 100% |
Serenity | Canadian dollars | 100% |
Cybin US1 | Canadian dollars | 100% |
Adelia | U.S. dollars | 100% |
Cybin IRL | U.S. dollars | 100% |
Cybin UK Ltd. | Great Britain pounds | 100% |
1 For accounting purposes, Cybin US is a wholly-owned subsidiary of Cybin. Certain former Adelia Shareholders hold Class B Shares (defined below) in Cybin US.
The Company acquired Small Pharma Inc. and its subsidiary Small Pharma Ltd. on October 23, 2023. On April 1, 2024, Small Pharma Inc. was amalgamated with Cybin Corp. and continued as Cybin Corp. and effective on December 16, 2023, Small Pharma Ltd.'s name was changed to Cybin UK Ltd.
Share Consolidation
On September 19, 2024, the Company consolidated its outstanding Common Shares on the basis of one new Common Share for every 38 existing Common Shares. IAS 33 Earnings Per Share requires retrospective adjustment to the number of shares and earnings per share in such cases even if such a transaction occurred after the reporting period. As a result, the number of Common Shares, warrants, options and earnings per share presented in these condensed interim consolidated financial statements have been restated retrospectively for all the periods to reflect this consolidation.
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CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
Material accounting policy information
These condensed interim consolidated financial statements have been prepared using the same accounting policies and methods as those used in the Company’s annual consolidated financial statements for the year ended March 31, 2024.
Use of significant estimates and assumptions
The preparation of financial statements in accordance with IAS 34 requires the use of certain significant estimates and assumptions. It also requires management to exercise judgment when applying the Company’s accounting policies. The critical accounting estimates and judgments have been set out in note 3 of the Company’s annual consolidated financial statements for the year ended March 31, 2024.
New standards and interpretations not yet adopted
A number of new standards, amendments to standards and interpretations are not yet effective as at September 30, 2024, and have not been applied in preparing these condensed interim consolidated financial statements. Management has determined that none of these will have a significant effect on the condensed interim consolidated financial statements of the Company.
3. EQUIPMENT
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| Lab Equipment | Computer Equipment | Total |
Cost | $ | $ | $ |
Balance March 31, 2024 | 664 | 266 | 930 |
Additions | — | | 35 | | 35 |
Effect of foreign exchange | (2) | | — | | (2) | |
Balance, September 30, 2024 | 662 | | 301 | | 963 |
| | | |
Accumulated Depreciation | | | |
Balance, March 31, 2024 | 430 | 234 | 664 |
Depreciation charge | 70 | | 15 | | 85 |
Effect of foreign exchange | (2) | | — | | (2) | |
Balance, September 30, 2024 | 498 | | 249 | | 747 |
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Net book value as at March 31, 2024 | 234 | 32 | 266 |
Net book value as at September 30, 2024 | 164 | | 52 | | 216 |
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CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS June 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
4. INTANGIBLE ASSETS
| | | | | | | | | | | | | | | | | |
| IP Research & Development | Patents | License | Software | Total |
Cost | $ | $ | $ | $ | $ |
Balance, March 31, 2024 | 32,440 | | 1,668 | | 1,381 | | 74 | | 35,563 | |
Additions | — | | 544 | | — | | — | | 544 | |
Effect of foreign exchange | (31) | | (7) | | (3) | | — | | (41) | |
Balance, September 30, 2024 | 32,409 | | 2,205 | | 1,378 | | 74 | | 36,066 | |
| | | | | |
Accumulated Amortization | | | | | |
Balance, March 31, 2024 | — | | — | | 56 | | 42 | | 98 | |
Amortization | — | | — | | 19 | | 12 | | 31 | |
Balance, September 30, 2024 | — | — | 75 | | 54 | | 129 | |
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Net book value as at March 31, 2024 | 32,440 | | 1,668 | | 1,325 | | 32 | | 35,465 | |
Net book value as at September 30, 2024 | 32,409 | | 2,205 | | 1,303 | | 20 | | 35,937 | |
5. RIGHT-OF-USE ASSETS AND LEASE LIABILITIES
a)Right-of-use assets
| | | | | |
Cost | $ |
Balance as at March 31, 2024 | 424 | |
Additions | — | |
Effect of foreign exchange | 13 | |
Balance as at September 30, 2024 | 437 | |
| |
Accumulated amortization | |
Balance as at March 31, 2024 | 143 | |
Amortization | 165 | |
Effect of foreign exchange | 2 | |
Balance as at September 30, 2024 | 310 | |
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Net book value as at March 31, 2024 | 281 | |
Net book value as at September 30, 2024 | 127 | |
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CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
b)Lease Liabilities
| | | | | |
| $ |
Balance as at March 31, 2024 | 291 | |
Interest accretion | 6 |
Effect of foreign exchange | 12 |
Payments | (176) | |
Balance as at September 30, 2024 | 133 |
| |
Current lease liabilities | 133 | |
6. GOODWILL
Goodwill is recognized at the acquisition date when total consideration exceeds the net identifiable assets acquired.
| | | | | |
Cost | $ |
Balance as at March 31, 2024 | 47,475 |
Effect of foreign exchange | (93) | |
Balance as at September 30, 2024 | 47,382 | |
7. SHARE CAPITAL
a)Authorized share capital
On September 19, 2024, the Company consolidated its outstanding Common Shares on the basis of one new Common Share for every 38 existing Common Shares. As a result, the number of Common Shares, warrants, options and earnings per share presented in these condensed interim consolidated financial statements have been restated retrospectively for all the periods to reflect this consolidation.
The authorized share capital of Cybin consists of an unlimited number of Common Shares and an unlimited number of preferred shares without par value. The board of directors of Cybin would determine the designation, rights, privileges, and conditions attached to any preferred shares prior to issuance.
b)Issued share capital
Common Shares
As at September 30, 2024 the Company had no Common Shares subject to transfer restrictions (March 31, 2024: 415,985).
During the three and six month periods ended September 30, 2024 no Common Shares were issued.
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CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
Preferred Shares
As at September 30, 2024 the Company had no preferred shares outstanding (March 31, 2024- nil).
Cybin US Class B Shares
As at September 30, 2024, 36,084.7 class B common shares of Cybin US (“Class B Shares”) were outstanding, and are exchangeable for a total of 9,496 Common Shares. These condensed interim consolidated financial statements reflect issued Class B Shares on an as-converted basis.
During the three and six month periods ended September 30, 2024, no Class B Shares were issued.
c)Warrants
The continuity of the outstanding warrants for the six-month period ended September 30, 2024, is as follows:
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| Number of Warrants | Weighted average exercise price1 |
| | $ |
Common Share Purchase Warrants | | |
As at March 31, 2024 | 2,796,197 | | 22.74 | |
Exercised | — | — | |
Outstanding as at September 30, 2024 | 2,796,197 | | 22.66 | |
Exercisable as at September 30, 2024 | 2,796,197 | | 22.66 | |
1Certain warrants were issued in USD, the weighted average exercise price is calculated using the closing exchange rate in effect as at the respective dates.
The following summarizes information about warrants outstanding as at September 30, 2024:
| | | | | | | | | | | | | | | | | |
Date of Expiry | Warrants outstanding | Warrants exercisable | Weighted average of exercisable price | Estimated grant date fair value | Weighted average remaining contractual life |
| | | $ | $000’s | Years |
August 4, 2028 | 635,887 | | 635,887 | | US$15.20 | 4,578 | 3.84 | |
May 14, 2029 | 1,754,386 | | 1,754,386 | | US$19.38 | 17,842 | 4.62 |
June 15, 2030 | 336,843 | | 336,843 | | 9.50 | 3,891 | 5.71 |
August 20, 2030 | 38,818 | | 38,818 | | 24.32 | 936 | 5.89 |
November 15, 2030 | 30,263 | | 30,263 | | 9.50 | 347 | 6.12 |
| 2,796,197 | | 2,796,197 | | 22.66 | 27,594 | 4.61 |
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CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
On August 27, 2024, the Company, upon receiving shareholder approval, extended the expiry dates of the warrants originally expiring on June 15, 2025, August 20 , 2025, and November 15, 2025 to June 15, 2030, August 20, 2030, and November 15, 2030, respectively. The Company extended the expiry date of 405,924 warrants, of which 260,527 related to officers and directors of the Company. No other changes to the terms of the warrants were made. As a result of the modification, the Company recorded an additional expense, related to the incremental fair value, of $1,955 in the statement of income as "Share-based compensation ".
As at September 30, 2024, the Company has no Common Share purchase warrants subject to transfer restrictions (2023 - nil).
d) Stock options
On November 5, 2020, Cybin adopted an equity incentive plan. Under the plan, the board of directors may grant share-based awards to acquire such number of Common Shares as is equal to up to 20% of the total number of issued and outstanding Common Shares at the time such awards are granted. Options granted under the plan vest over a period of time at the discretion of the board of directors. On August 27, 2024, the board of directors and the shareholders re-approved the equity incentive plan and approved certain amendments to the plan, including an increase to the fixed number of Incentive Stock Options (as defined in the plan), certain changes to the board of director's authority to amend existing awards, and certain other housekeeping amendments.
The changes in options for the six-month period ended September 30, 2024 are as follows:
| | | | | | | | |
| Number of Options | Weighted average exercise price |
| | $ |
As at March 31, 2024 | 1,742,139 | | 35.17 |
Granted | 3,369,526 | | 13.92 |
Exercised | — | | — | |
Forfeited/Expired | — | | — | |
Cancelled | (1,199,655) | | 39.65 | |
Outstanding as at September 30, 2024 | 3,912,010 | | 15.31 |
Exercisable as at September 30, 2024 | 3,174,626 | | 15.21 |
On April 5, 2024, the Company granted options to purchase up to 308,294 Common Shares, of which 111,188 were granted to employees, 171,054 were granted to officers of the Company and 26,052 were granted to consultants. The granted options have an exercise price of $21.28 per Common Share and expire on April 5, 2029. The granted options vest over two years. The aggregate estimated grant date fair value was determined to be $4,619 calculated using the Black-Scholes option pricing model with the following assumptions:
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CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
| | | | | |
Risk-free interest rate | 3.62% |
Expected annual volatility, based on historical share price of the Company | 88.13% |
Expected life (in years) | 5.00 |
Expected dividend yield | 0.00% |
Unvested forfeiture rate | 0% to 3.4% |
Share price | $ | 21.28 |
Exercise price | $ | 21.28 |
On May 5, 2024, the Company cancelled options to purchase up to 1,199,655 Common Shares (exercise prices ranged from $27.17 to $119.70). The unvested options were vested based on an accelerated cancellation criteria which resulted in $2,060 share based compensation expense.
On August 15, 2024, the Company granted options to purchase up to 3,061,232 Common Shares, of which 940,168 were granted to employees, 1,980,888 were granted to officers and directors and 140,176 were granted to consultants. The granted options have an exercise price of $13.11 per Common Share and expire on August 15, 2034. Certain options vested immediately, while others vest over periods of up to two years. The aggregate estimated grant date fair value was determined to be $34,822 calculated using the Black-Scholes option pricing model with the following assumptions:
| | | | | |
Risk-free interest rate | 3.07% |
Expected annual volatility, based on historical share price of the Company | 86.69% |
Expected life (in years) | 10.00 |
Expected dividend yield | 0.00% |
Unvested forfeiture rate | 0% to 3.4% |
Share price | $ | 13.30 |
Exercise price | $ | 13.11 |
| | |
CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
The following summarizes information about stock options outstanding on September 30, 2024:
| | | | | | | | | | | | | | | | | |
| Exercise Price | Number of options outstanding | Number of options exercisable | Weighted average remaining life | Estimated grant date fair value |
Expiry date | $ | | | Years | $000’s |
June 15, 2025 | 9.50 | 61,842 | | 61,842 | | 0.71 | 420 | |
June 30, 2025 | 34.20 | 13,158 | | 13,158 | | 0.75 | 183 | |
August 14, 2025 | 38.00 | 6,250 | | 6,250 | | 0.87 | 127 | |
September 30, 2025 | 28.50 | 7,106 | | 7,106 | | 1.00 | 97 | |
November 4, 2025 | 28.50 | 25,000 | | 25,000 | | 1.10 | 509 | |
November 15, 2025 | 28.50 | 9,869 | | 9,869 | | 1.13 | 110 | |
November 15, 2025 | 34.58 | 5,263 | | 5,263 | | 1.13 | 53 | |
December 11, 2025 | 56.24 | 5,263 | | 5,263 | | 1.20 | 212 | |
December 14, 2025 | 66.12 | 3,990 | | 3,990 | | 1.20 | 186 | |
February 15, 2026 | 77.14 | 1,974 | | 1,974 | | 1.38 | 109 | |
March 10, 2026 | 52.82 | 5,725 | | 5,725 | | 1.44 | 217 | |
March 15, 2026 | 58.90 | 7,895 | | 7,895 | | 1.45 | 360 | |
March 29, 2026 | 50.16 | 987 | | 987 | | 1.49 | 36 | |
June 28, 2026 | 110.20 | 4,475 | | 4,475 | | 1.74 | 354 | |
September 26, 2026 | 30.02 | 25,657 | | 25,657 | | 1.99 | 439 | |
November 16, 2026 | 27.17 | 13,158 | | 6,578 | | 2.13 | 127 | |
December 31, 2026 | 57.00 | 32,896 | | 32,896 | | 2.25 | 1,352 | |
March 4, 2027 | 42.94 | 526 | | 526 | | 2.42 | 16 | |
March 8, 2027 | 38.76 | 10,526 | | 10,526 | | 2.43 | 295 | |
September 30, 2027 | 38.00 | 132 | | 132 | | 3.00 | 2 | |
June 30, 2028 | 16.72 | 297,634 | | 238,331 | | 3.75 | 3,795 | |
September 26, 2028 | 30.02 | 2,632 | | 1,645 | | 3.99 | 54 | |
March 20, 2029 | 21.28 | 526 | | 262 | | 4.47 | 6 | |
April 5, 2029 | 21.28 | 308,294 | | 115,548 | | 4.51 | 2,970 | |
August 15, 2034 | 13.11 | 3,061,232 | | 2,583,728 | | 9.87 | 30,586 | |
| | 3,912,010 | | 3,174,626 | | 8.45 | | 42,615 | |
The Company recognized share-based payments expense related to the issuance of stock options for the three and six months ended September 30, 2024 of $31,506 and $35,479 (2023 - $1,414 and $2,689), respectively.
The outstanding options and warrants disclosed above were anti-dilutive for the three and six months ended September 30, 2024 and 2023 and did not impact the calculation of the loss per share.
| | |
CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
8. RELATED PARTY TRANSACTIONS AND BALANCES
Key management personnel include persons having the authority and responsibility for planning, directing, and controlling the activities of the Company as a whole. The Company has determined its key management personnel to be certain executive officers and directors of the Company.
The remuneration of key management personnel for the three and six month periods ended September 30, 2024 and 2023 are as follows:
| | | | | | | | | | | | | | | | | |
| Three month period ended September 30, | | Six month period ended September 30, |
| 2024 | 2023 | | 2024 | 2023 |
| $ | $ | | $ | $ |
Payroll, consulting and benefits(1) | 1,441 | | 885 | | | 4,036 | | 1,846 | |
Share-based compensation | | | | | |
Options | 20,726 | | 444 | | | 22,702 | | 663 | |
Warrants | 1,239 | | — | | | 1,239 | | — | |
Total | 23,406 | | 1,329 | | | 27,977 | | 2,509 | |
(1)For the three months ended on September 30, 2024, includes $1,277 presented in the consolidated statement of loss and comprehensive loss as a part of “General and administrative costs” and $164 presented in the consolidated statement of loss and comprehensive loss as a part of “Research”. For the six months ended on September 30, 2024, includes $3,243 presented in the consolidated statement of loss and comprehensive loss as a part of “General and administrative costs” and $793 presented in the consolidated statement of loss and comprehensive loss as a part of “Research”.
9. RESEARCH EXPENSES
| | | | | | | | | | | | | | | | | |
| Three month period ended September 30, | | Six month period ended September 30, |
| 2024 | 2023 | | 2024 | 2023 |
| $ | $ | | $ | $ |
Advancement of development programs | 5,774 | | 4,952 | | | 10,406 | | 9,358 | |
Payroll and benefits | 2,221 | | 1,530 | | | 5,170 | | 3,209 | |
Lab and administration | 695 | | 197 | | | 863 | | 405 | |
Professional and consulting fees | 425 | | 17 | | | 717 | | 108 | |
Total | 9,115 | | 6,696 | | | 17,156 | | 13,080 | |
| | |
CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
10. GENERAL AND ADMINISTRATIVE EXPENSES
| | | | | | | | | | | | | | | | | |
| Three month period ended September 30, | | Six month period ended September 30, |
| 2024 | 2023 | | 2024 | 2023 |
| $ | $ | | $ | $ |
Capital market | 9,608 | | 2,062 | | | 12,215 | | 4,224 | |
Payroll, consulting and benefits | 3,085 | | 1,342 | | | 6,107 | | 2,790 | |
Investor relations | 874 | | 315 | | | 1,385 | | 442 | |
Office and administration | 848 | | 611 | | | 1,615 | | 1,219 | |
Professional and consulting fees | 812 | | 1,088 | | | 1,441 | | 1,506 | |
Business development | 323 | | 286 | | | 958 | | 489 | |
Listing fees | 79 | | 81 | | | 180 | | 151 | |
Marketing media | 49 | | 15 | | | 80 | | 27 | |
Total | 15,678 | | 5,800 | | | 23,981 | | 10,848 | |
11. CONTRACTS, COMMITMENTS AND CONTINGENCIES
As at September 30, 2024, the Company had entered into agreements for various studies which may require the Company to spend up to an additional $60,262. The Company expects to pay this amount within the 18 months ending March 31, 2026, however the timing and certainty of the payments are contingent on availability of materials and successful completion of certain milestones. The Company has the right to cancel the studies at its discretion, in which case a cancellation fee may apply, however the Company is not liable to pay the full amount of the studies.
In addition to the above, during the year ended March 31, 2022, the Company entered into an exclusive license agreement with Mindset Pharma Inc. to acquire access to a number of classes of tryptamine-based molecules to support Company’s early-stage research programs and a fully-paid, perpetual non-exclusive license to a separate class of tryptamine-based molecules. Upon the successful completion of certain milestones contemplated in the exclusive license, the Company may have to pay additional consideration of up to $12,824 (US$9,500). At the sole discretion of Cybin, the milestones may be paid in cash or in Common Shares, or a combination thereof, subject to the approval of Cboe. Due to the nature of the arrangement, the timing and probability of future potential payments cannot be determined at this time, and no accrual has been recorded. Further, there is no assurance that the aforementioned milestones will be met at all. The agreement also contemplates a sales royalty of approximately 2% for all commercialized licensed products within the scope of the agreement.
The Company is party to certain employee and management contracts that contain severance obligations. These contracts contain clauses requiring additional payments to be made upon the occurrence of involuntary termination. As the likelihood of these events taking place is not determinable, no contingent liabilities have been recorded in the consolidated financial statements.
| | |
CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
In the normal course of business, the Company may be subject to legal proceedings and claims. As at September 30, 2024, there was no ongoing litigation and therefore no contingent liabilities have been recorded.
12. CAPITAL MANAGEMENT
The Company’s objectives when managing capital are to safeguard the Company’s ability to continue as a going concern in order to pursue business opportunities and to maintain a flexible capital structure that optimizes the costs of capital at an acceptable risk. The Company’s intentions are to (i) provide financial capacity and flexibility in order to preserve its ability to meet its strategic objectives and financial obligations; (ii) maintain a capital structure which allows the Company to respond to changes in economic and marketplace conditions and affords the Company the ability to participate in new investments; (iii) optimize the use of its capital to provide an appropriate investment return to its shareholders equal with the level of risk; and (iv) maintain a flexible capital structure which optimizes the cost of capital at acceptable levels of risk.
The Company’s financial strategy is formulated and adapted according to market conditions in order to maintain a flexible capital structure that is consistent with its objectives and the risk characteristics of its underlying assets. The Company manages its capital structure and makes adjustments to it in light of changes in economic conditions and the risk characteristics of its underlying assets. The Company maintains or adjusts its capital level to enable it to meet its objectives by raising capital through the issuance of securities.
The Company’s capital management objectives, policies and processes generally remained unchanged during the three and six month periods ended September 30, 2024.
The Company requires capital to fund existing and future operations and meet regulatory capital requirements. The Company’s policy is to maintain adequate levels of capital at all times.
The Company’s capital structure includes the following:
| | | | | | | | |
As at | September 30, 2024 | March 31, 2024 |
| $ | $ |
Shareholders’ equity comprised of: | | |
Share capital | 443,448 | | 443,877 | |
Contributed surplus | 43,791 | | 11,750 | |
Options reserve | 42,615 | | 39,177 | |
Warrants reserve | 27,594 | | 25,639 | |
Accumulated other comprehensive loss | (4,183) | | (2,285) | |
Deficit | (298,247) | | (226,231) | |
Total | 255,018 | 291,927 |
| | |
CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
13. FINANCIAL INSTRUMENTS
The Company’s financial instruments are exposed to certain financial risks, which include currency risk, credit risk, liquidity risk and interest rate risk.
The Company has classified its financial instruments as follows:
| | | | | | | | |
As at | September 30, 2024 | March 31, 2024 |
| $ | $ |
Financial assets, measured at fair value: | | |
Cash | 154,318 | | 208,992 |
Financial assets, measured at amortized cost: | | |
Accounts receivable | 678 | | 254 |
Financial liabilities, measured at amortized cost: | | |
Accounts payable and accrued liabilities | 7,240 | | 9,805 |
Lease liabilities | 133 | | 291 |
The carrying value of the Company’s financial instruments approximate their fair value.
Fair value hierarchy of financial instruments
The Company has categorized its financial instruments that are carried at fair value, based on the priority of the inputs to the valuation techniques used to measure fair value, into a three-level fair value hierarchy as follows:
Level 1: Fair value is based on unadjusted quoted prices for identical assets or liabilities in an active market. The types of assets and liabilities classified as Level 1 generally included cash.
Level 2: Fair value is based on quoted prices for similar assets or liabilities in active markets, valuation that is based on significant observable inputs, or inputs that are derived principally from or corroborated with observable market data through correlation or other means. Currently, the Company has no financial instruments that would be classified as Level 2.
Level 3: Fair value is based on valuation techniques that require one or more significant inputs that are not based on observable market inputs. These unobservable inputs reflect the Company’s assumptions about the assumptions market participants would use in pricing the asset or liability. Investments are classified as Level 3.
There were no transfers between levels of the fair value hierarchy for the three and six month periods ended September 30, 2024.
| | |
CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
Financial risk management
Credit risk
Credit risk is the risk that one party to a financial instrument will cause a financial loss for the other party by failing to discharge an obligation. The Company’s cash is exposed to credit risk. The Company reduces its credit risk on cash by placing these instruments with institutions of high creditworthiness. As at September 30, 2024 the Company’s maximum exposure to credit risk is the carrying value of its financial assets.
Liquidity risk
Liquidity risk is the risk that an entity will encounter difficulty in raising funds to meet commitments associated with financial instruments. The Company manages liquidity by maintaining adequate cash balances to meet liabilities as they become due.
As at September 30, 2024, the Company had cash of $154,318 (March 31, 2024 - $208,992) in order to meet current liabilities. Current liabilities include accounts payable and accrued liabilities of $7,240 (March 31, 2024 - $9,805) and lease liabilities of $133 (March 31, 2024 - $291). All amounts are due within the next 12 months.
Market risk
The significant market risks to which the Company is exposed are interest rate risk and currency risk.
Interest rate risk
Interest rate risk is the risk that the fair value or the future cash flows of a financial instrument will fluctuate because of changes in market interest rates. In seeking to minimize the risks from interest rate fluctuations, the Company manages exposure through its normal operating and financing activities. Assuming that all other variables remain constant, as at September 30, 2024, a 1% decline on the interest rate generated on cash would have resulted in a reduction of interest income of $1,475 over a one-year period.
Currency risk
The Company is exposed to currency risk to the extent that monetary operational expenses are denominated in both CAD and USD while the functional currency of CAD is used for reporting. The Company has not entered into any foreign currency contracts to mitigate this risk.
| | |
CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
At September 30, 2024 the Company had the following balances in monetary assets and monetary liabilities which are subject to fluctuation against CAD:
| | | | | | | | | | | |
Denominated in: | US$000’s | GBP 000’s | EUR 000’s |
Cash | 110,302 | | 22 | | 343 | |
Accounts payable and accrued liabilities | (218) | | (475) | | (211) | |
Lease liability | — | | (74) | | — | |
| 110,084 | | (527) | | 132 | |
Foreign currency rate | 1.3499 | 1.8080 | 1.5076 |
Equivalent in Canadian dollars | 148,602 | | (953) | | 199 | |
Impact of 10% change in exchange | 14,860 | | (95) | | 20 | |
| | | |
Such analysis excludes any indirect economic or geo-political effects of such currency fluctuations.
14. INCOME TAX
Major items causing the Company’s income tax rate to differ from the Canadian statutory rate of approximately 26.5% are as follows:
| | | | | | | | | | | | | | |
| Three month period ended September 30, | Six month period ended September 30, |
| 2024 | 2023 | 2024 | 2023 |
| $ | $ | $ | $ |
Net loss before income taxes | (57,192) | | (11,890) | | (72,016) | | (26,404) |
| | | | |
Expected recovery at statutory rate | (15,157) | | (3,151) | | (19,085) | (6,997) |
Share-based compensation | 8,867 | | 375 | | 9,920 | 713 |
Share issuance costs | (35) | | (459) | | (74) | (545) |
Difference between Canadian and foreign tax rates | 2,109 | | 941 | | 3,069 | 1,893 |
Effect of exchange on unbooked deferred tax assets | (23) | | (193) | | 53 | (444) |
Adjustment to prior year loss carryforwards | — | | — | | — | (239) |
Non-deductible expenses | 68 | | 29 | | 87 | 34 |
Other | 40 | | — | | 5 | — |
Change in unrecognized deferred tax assets | 4,131 | | 2,458 | | 6,025 | 5,585 |
Income tax recovery | — | — | — | — |
| | |
CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
The significant components of the Company’s temporary differences, unused tax credits and unused tax losses, that have not been included on the consolidated statements of financial position, are as follows:
| | | | | | | | |
As at | September 30, 2024 | March 31, 2024 |
| $ | $ |
Non-capital loss carryforwards | 49,534 | 43,185 |
Deferred compensation | 1,505 | 1,474 |
R&D expenditures | 1,937 | 1,681 |
Share issuance costs | 3,748 | 4,361 |
Depreciation/CCA differences | 9 | 7 |
| 56,733 | 50,708 |
Valuation allowance | (56,733) | (50,708) |
| — | — |
Non-capital loss balance
As at September 30, 2024, the Company has non-capital losses in Canada, which under certain circumstances can be used to reduce taxable income of future years. The non-capital losses expire as follows:
| | | | | |
Year of expiry | $ |
2036 | 1 |
2037 | 62 |
2038 | 32 |
2039 | 115 |
2040 | 863 |
2041 | 21,856 |
2042 | 16,019 |
2043 | 10,704 |
2044 | 24,397 |
2045 | 14,394 |
| 88,443 |
As at September 30, 2024, the Company has non-capital losses in the United States, which under certain circumstances can be used to reduce the taxable income of future years. The non-capital losses, stated in Canadian dollars that will expire as follows:
| | |
CYBIN INC. NOTES TO THE CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS September 30, 2024 (All amounts expressed in thousands of Canadian dollars, except share and per share amounts, and those otherwise stated in US dollars, Euros and Great Britain pounds which are in thousands.) (Unaudited) |
| | | | | |
| $ |
Pre-acquisition loss generated in the period ended December 4, 2020 | 989 |
Post-acquisition loss generated in the period ending March 31, 2021 | 1,320 |
Loss generated in the year ending March 31, 2022 | 5,849 |
Loss generated in the year ending March 31, 2023 | 5,311 |
Loss generated in the year ending March 31, 2024 | 2,792 |
Loss generated in the three-month period ended September 30, 2024 | 3,010 |
| 19,271 |
Although the US federal losses carryforward indefinitely, they are subject to restrictions on their deductibility. The deductibility of the pre-acquisition loss and the post-acquisition loss is restricted to 80% of taxable income in the year of deduction. The pre-acquisition loss is further restricted to an annual limitation under Section 382. As at September 30, 2024, the annual limitation was $144.
Massachusetts allows for a 20-year carryforward period for restricted and unrestricted losses without limitation.
As at September 30, 2024, the Company has non-capital losses in Ireland, which under certain circumstances can be used to reduce taxable income of future years. The non-capital losses in Ireland , stated in Canadian Dollars, expire as follows:
| | | | | |
Year of expiry | $ |
2042 | 22,965 |
2043 | 23,017 |
2044 | 33,857 |
2045 | 18,572 |
| 98,411 |
As at September 30, 2024 the Company had $41,640 of non-capital losses in UK which under certain circumstances can be used to reduce the taxable income of future years. These losses do not expire.
Cybin Inc.
Management’s Discussion and Analysis
of Financial Condition and Operating Performance
For the three and six months ended September 30, 2024
Date: November 12, 2024
CYBIN INC.
MANAGEMENT’S DISCUSSION AND ANALYSIS
This Management’s Discussion and Analysis (“MD&A”) has been prepared by management of Cybin Inc. (“Cybin” or the “Company”) and should be read in conjunction with Cybin’s unaudited condensed interim consolidated financial statements and notes for the three and six months ended September 30, 2024 (the “ Financial Statements”). This MD&A does not address all of the changes to the Company and its business, such changes are addressed in the Company’s most recently filed annual information form (the “AIF”) on SEDAR+. The Financial Statements have been prepared using International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board. All amounts are in Canadian dollars unless otherwise indicated. The Financial Statements may be viewed on the SEDAR+ profile of Cybin at www.sedarplus.ca.
This MD&A contains disclosure related to Cybin occurring up to and including November 12, 2024. Unless otherwise indicated, all amounts in this MD&A are in thousands of Canadian dollars.
Cybin was incorporated under the laws of the Province of British Columbia. Its wholly owned subsidiary, Cybin Corp. was incorporated under the laws of the Province of Ontario. Prior to November 5, 2020, the Company’s operations were conducted through Cybin Corp. On November 5, 2020, the Company completed a reverse takeover transaction pursuant to the terms of an amalgamation agreement dated June 26, 2020, as amended on October 21, 2020, among the Company, Cybin Corp. and 2762898 Ontario Inc. (“SubCo”), a wholly-owned subsidiary of the Company (the “Reverse Takeover”). The Reverse Takeover was completed by way of a “three-cornered” amalgamation pursuant to the provisions of the Business Corporations Act (Ontario) whereby Cybin Corp. amalgamated with SubCo to form an amalgamated corporation and a wholly owned subsidiary of the Company. Cybin Corp. is deemed to be the acquirer in the Reverse Takeover. As a result, the consolidated statements of financial position are presented as a continuance of Cybin Corp. and the comparative figures presented are those of Cybin Corp.
FORWARD-LOOKING STATEMENTS
Certain statements contained in this MD&A constitute “forward-looking information” and “forward-looking statements”. All statements, other than statements of historical fact, contained in this MD&A are forward-looking statements, including, without limitation, statements regarding future financial position, business strategy, budgets, research and development and plans and objectives of management for future operations. Such statements can, in some cases, be identified by the use of forward-looking terminology such as “expect,” “likely”, “may,” “will,” “should,” “intend,” or “anticipate,” “potential,” “proposed,” “estimate” and other similar words, including negative and grammatical variations thereof, or statements that certain events or conditions “may” or “will” happen, or by discussions of strategy. The forward-looking statements included in this MD&A are made only as of the date of this MD&A and the Company assumes no obligation to update or revise them to reflect subsequent information, events or circumstances or otherwise, except as required by applicable securities laws.
Forward-looking statements in this MD&A are not guarantees of future performance and involve assumptions, risks and uncertainties that are difficult to predict. Therefore, actual results may differ
materially from what is expressed, implied or forecasted in such forward-looking statements. Management provides forward-looking statements because it believes they provide useful information to readers when considering their investment objectives and cautions readers that the information may not be appropriate for other purposes.
Some of the risks which could affect future results and could cause results to differ materially from those expressed in the forward-looking statements contained herein include:
•limited operating history;
•achieving publicly announced milestones;
•speculative nature of investment risk;
•early stage of the industry and product development;
•regulatory risks and uncertainties
•risks of operating in European countries;
•“foreign private issuer” status under U.S. Securities Laws;
•plans for growth;
•limited products;
•limited marketing and sales capabilities;
•no assurance of commercial success;
•no profits or significant revenues;
•reliance on third parties for clinical development activities;
•risks related to third party relationships;
•reliance on contract manufacturers;
•safety and efficacy of products;
•clinical testing and commercializing products;
•completion of clinical trials;
•commercial grade product manufacturing;
•nature of regulatory approvals;
•market access and acceptance;
•unfavourable publicity or consumer perception;
•social media;
•biotechnology and pharmaceutical market competition;
•reliance on key executives and scientists;
•employee misconduct;
•business expansion and growth;
•negative results of external clinical trials or studies;
•product liability;
•enforcing contracts;
•product and material recalls;
•distribution and supply chain interruption;
•difficulty to forecast;
•promoting the brand;
•product viability;
•success of quality control systems;
•reliance on key inputs;
•liability arising from fraudulent or illegal activity;
•operating risk and insurance coverage;
•costs of operating as public company;
•management of growth;
•conflicts of interest;
•foreign operations;
•exchange rate fluctuations;
•cybersecurity and privacy risk;
•environmental regulation and risks;
•decriminalization of psychedelics;
•forward-looking statements may prove to be inaccurate;
•effects of inflation;
•political and economic conditions;
•application and interpretation of tax laws;
•enforcement of civil liabilities;
•pandemics;
Risks Related to Intellectual Property:
•trademark protection;
•trade secrets;
•patent law reform;
•patent litigation and intellectual property;
•protection of intellectual property;
•third-party licences;
Financial and Accounting Risks:
•substantial number of authorized but unissued Common Shares (as defined herein);
•dilution;
•negative cash flow from operating activities;
•additional capital requirements;
•lack of significant product revenue;
•estimates or judgments relating to critical accounting policies;
•inadequate internal controls;
Risks related to the Common Shares:
•market for the Common Shares;
•significant sales of Common Shares;
•volatile market price for the Common Shares;
•tax issues; and
•no dividends.
Although the forward-looking statements contained in this MD&A are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors
that actual results, performance or achievements will be consistent with these forward-looking statements. In particular, the Company has made assumptions regarding, among other things:
•substantial fluctuation of losses from quarter to quarter and year to year due to numerous external risk factors, and anticipation that we will continue to incur significant losses in the future;
•uncertainty as to the Company’s ability to raise additional funding to support operations;
•the Company’s ability to access additional funding;
•the fluctuation of foreign exchange rates;
•the risks associated with pandemics;
•the risks associated with the development of the Company’s product candidates which are at early stages of development;
•reliance upon industry publications as the Company’s primary sources for third-party industry data and forecasts;
•reliance on third parties to plan, conduct and monitor the Company’s preclinical studies and clinical trials;
•reliance on third party contract manufacturers to deliver quality clinical and preclinical materials;
•the Company’s product candidates may fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or may not otherwise produce positive results;
•risks related to filing investigational new drug applications to commence clinical trials and to continue clinical trials if approved;
•the risks of delays and inability to complete clinical trials due to difficulties enrolling patients;
•competition from other biotechnology and pharmaceutical companies;
•the Company’s reliance on the capabilities and experience of the Company’s key executives and scientists and the resulting loss of any of these individuals;
•the Company’s ability to fully realize the benefits of acquisitions;
•the Company’s ability to adequately protect the Company’s intellectual property and trade secrets;
•the risk of patent-related or other litigation; and
•the risk of unforeseen changes to the laws or regulations in the United States (the “United States” or the “U.S.”), the United Kingdom (the “United Kingdom” or the “UK”), Canada, the Netherlands, Ireland and other jurisdictions in which the Company operates.
Drug development involves long lead times, is very expensive and involves many variables of uncertainty. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. Every patient treated on future studies can change those assumptions either positively (to indicate a faster timeline to new drug applications and other approvals) or negatively (to indicate a slower timeline to new drug applications and other approvals). This MD&A contains certain forward-looking statements regarding anticipated or possible drug development timelines. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company’s development efforts to date.
In addition to the factors set out above and those identified in this MD&A under “Risk Factors”, other factors not currently viewed as material could cause actual results to differ materially from those described in the forward-looking statements. Although Cybin has attempted to identify important risks and factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors and risks that cause actions, events or results not to be anticipated, estimated or intended. Accordingly, readers should not place any undue reliance on forward-looking statements.
CORPORATE STRUCTURE OVERVIEW
The Company is a clinical-stage breakthrough neuropsychiatry company focused on advancing next-generation therapies, delivery mechanisms, novel compounds and protocols as potential treatments for various psychiatric and neurological conditions. The Company is developing technologies and delivery systems aimed at improving the pharmacokinetics of its proprietary molecules while retaining the therapeutic benefit. These new molecules and delivery systems are expected to be studied through clinical trials to confirm safety and efficacy.
On November 5, 2020, the Company completed a reverse takeover transaction pursuant to the terms of an amalgamation agreement dated June 26, 2020, as amended on October 21, 2020, among the Company, Cybin Corp. and SubCo, a wholly-owned subsidiary of the Company. The Reverse Takeover was completed by way of a “three-cornered” amalgamation pursuant to the provisions of the Business Corporations Act (Ontario) whereby Cybin Corp. amalgamated with SubCo to form an amalgamated corporation and a wholly owned subsidiary of the Company.
In connection with the Reverse Takeover, Clarmin Explorations Inc. (“Clarmin”) changed its name to “Cybin Inc.” and the common shares (“Common Shares”) became listed for trading on Cboe Canada Inc. (the “Exchange”) under the trading symbol “CYBN”.
On July 8, 2021, the Company announced the scale-up of its European operations and research activities with various academic and clinical research organizations, including the transfer of its intellectual property assets to its wholly owned Ireland subsidiary, Cybin IRL Limited (“Cybin Ireland”).
On August 5, 2021, the Common Shares commenced trading on the NYSE American LLC stock exchange (the “NYSE American”) under the symbol “CYBN”. Concurrent with the commencement of trading on the NYSE American, the Common Shares ceased to be quoted on the OTCQB® Venture Market.
On October 23, 2023, the Company announced the completion of the acquisition by Cybin of Small Pharma Inc. (“Small Pharma”) by way of a statutory plan of arrangement under the provisions of the Business Corporations Act (British Columbia) (the “Arrangement”). The Arrangement was completed pursuant to the terms of an arrangement agreement entered into between the Company and Small Pharma dated August 28, 2023 (the “Arrangement Agreement”). As a result of the Arrangement, Small Pharma is now a wholly-owned subsidiary of Cybin.
On September 19, 2024, the Company consolidated its outstanding Common Shares on the basis of one new Common Share for every 38 existing Common Shares (the “Consolidation”). As a result, all figures related to shares, warrants, options and earnings per share presented in this MD&A have been restated retrospectively for all periods to reflect the Consolidation.
Please refer to “General Development of the Business” in the AIF for additional information on the background and operational highlights of Cybin. The AIF may be viewed under the SEDAR+ profile of Cybin at www.sedarplus.ca.
BUSINESS OVERVIEW
Cybin is a clinical-stage breakthrough neuropsychiatry company on a mission to create safe and effective next-generation therapeutics to address the unmet need for new and innovative treatment options for people who suffer from mental health conditions. Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens.1
Cybin’s research and development work focuses on a three-pillar strategy that leverages the Company’s core competencies in preclinical innovation and clinical development. This strategy supports the creation of intellectual property (“IP”) focused on developing the Company’s platform technology, the progression of clinical development programs including CYB003, a deuterated psilocin molecule, CYB004, a deuterated version of N, N-dimethyltryptamine (“DMT”), CYB005, phenethylamine derivatives, and an expansive list of preclinical molecules to facilitate future drug development opportunities.
On October 23, 2023, the Company completed the acquisition of Small Pharma by way of the Arrangement pursuant to which Small Pharma became a wholly-owned subsidiary of Cybin. Small Pharma is a biotechnology company focused on developing short-duration therapies for the treatment of mental health conditions. Small Pharma initiated programs across its “First-generation” and “Second-generation” psychedelics portfolio. First-generation psychedelics refer to the well-known classic psychedelics which includes psilocybin, DMT, and Lysergic acid diethylamide (“LSD”). Second-generation psychedelics refer to those that have been chemically modified with the aim to optimize their therapeutic benefit.
With a common goal to create novel, optimized psychedelic-based therapeutics, the combination of Cybin and Small Pharma creates a leading international, clinical-stage company with potential to transform the treatment paradigm for mental health conditions. The companies’ combined development portfolios are highly complementary and provide multiple opportunities to create operational and cost synergies.
1 This is a forward-looking statement that involves material assumptions by the Company. Drug development involves long lead times, is very expensive and involves many variables of uncertainty. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company’s development efforts to date.
As a result of the acquisition of Small Pharma by way of the Arrangement, Cybin currently now has over 70 granted patents and over 220 pending applications. See “Intellectual Property”.
Advancement of Mental Healthcare
The Company is conducting research and development of next-generation neuropsychiatry therapeutics that aim to address unmet needs in the treatment of mental health conditions. This comprehensive development work is predicated on structural modifications of known tryptamine and phenethylamine derivatives to improve their pharmacokinetic properties while maintaining their respective pharmacology.
Across its extensive research and development programs, Cybin is evaluating a wide array of novel, synthetic active pharmaceutical ingredients (“API”) intended to be delivered through innovative drug delivery systems including via inhalation, via intravenous (“IV”), and intramuscular, or subcutaneous administration.2
The Company intends to apply for regulatory approval for therapies targeting indications such as major depressive disorder (“MDD”), alcohol use disorder (“AUD”), generalized anxiety disorder (“GAD”) and potentially other various mental health conditions.3 The Company is also developing compounds that may have the potential to address neuroinflammation, central nervous system (“CNS”) disorders, and psychiatric disorders.4
Further, over the next 12-month period, the Company will continue to seek to establish strategic partnerships that advance the Company’s scientific research and IP for novel compounds and delivery mechanisms.5 The Company will also continue to sponsor select internal and partner-related clinical trials that advance the understanding of safety and efficacy for various psychedelic agents that target mental health conditions.6
Stage of Development
Like most life sciences and pharmaceutical companies, the Company’s neuropsychiatry business is focused on research and development and any future revenue will be dependent on a number of factors, including the outcome of the Company’s clinical trials and the receipt of all necessary regulatory approvals.
In order to establish its business operations, Cybin intends to leverage the extensive professional network of its management to build working partnerships with (i) existing producers of products based in Canada, the United States, the European Union (the “EU”) and the UK to source the
2 See footnote 1.
3 See footnote 1.
4 See footnote 1.
5 A material factor and assumption underlying this forward-looking statement is that the Company will be able to successfully negotiate strategic partnerships.
6 The material factors and assumptions underlying this forward-looking statement are: (a) that the Company will be able to successfully negotiate strategic partnerships; and (b) all necessary approvals for the studies will be obtained. As of the date hereof, the Company and the University of Washington are co-sponsoring a randomized, placebo-controlled clinical trial of psychedelic-assisted psychotherapy with psilocybin for frontline clinicians experiencing Covid-related distress.
pharmaceutical products the Company intends to develop and distribute under its specific brand, and (ii) to explore options to facilitate the development and distribution and sale of its specific brand of pharmaceutical products.7
Prescription drugs are classified and regulated under the federal Food and Drugs Act (Canada) (the “Canadian FDA”). Labeling, marketing and selling of any prescription drug must comply with the Canadian FDA, including by ensuring that the Company’s products are not packaged or marketed in a manner that is misleading or deceptive to a consumer.
In the United States, foods, drugs and dietary supplements are subject to extensive regulation. The Federal Food, Drug, and Cosmetic Act (the “FFDCA”) and other federal and state statutes and regulations govern, among other things, the research, development, testing, manufacturing, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. The Company must ensure that all promotion and marketing, distribution, and labeling of any pharmaceutical products comply with the U.S. regulations, including the FFDCA and the U.S. Food and Drug Administration (the “FDA”).
On November 4, 2021, the Company announced that it had been granted a Schedule I manufacturing license from the U.S. Drug Enforcement Administration (“DEA”). The DEA license is for the Company’s research lab in the Boston area. The license allows the Company to further become a hub for innovation and drug discovery. Previously, the Company conducted much of its R&D work through globally licensed research organizations in the U.S., Canada, and the UK, and through certain in-house capabilities. With the DEA license, the Company has expanded its internal R&D capabilities to support innovative drug discovery and delivery involving Schedule I compounds.
On March 13, 2024, the Company announced that it had been granted Breakthrough Therapy Designation (the “BTD”) by the FDA in respect of CYB003. The BTD provides an expedited review pathway, as well as increased access to FDA guidance on trial design, which has the potential to significantly reduce drug development timelines. The designation includes all “fast track” program features, as well as more intensive FDA guidance and discussion of the CYB003 development program, including planned clinical trials and plans for expediting the manufacturing development strategy.
Non-Revenue Generating Projects8
The Company currently has four significant projects, which have not yet generated revenue:
1.Deuterated Psilocin Program (CYB003)
2.Deuterated Dimethyltryptamine Program (CYB004)
3.Phenethylamine Derivatives Program (CYB005)
4.Technology Programs
7 At this time the Company has not entered into commercial supply agreements and has no control over price or conditions. The Company’s assumption is that it will be able to enter into agreements at such a time when there will be sufficient competition in the market which will render prices reasonable.
8 All quarter references in this section are based on calendar year-end.
The Company has developed EMBARK, a psychological support model that integrates leading clinical approaches to promote supportive healing with pharmacological interventions for neurosychiatry. EMBARK’s six clinical domains (Existential-Spiritual, Mindfulness, Body Aware, Affective-Cognitive, Relational, Keeping Momentum) represent the broad spectrum of ways in which therapeutic benefits may arise in treatment and the equally broad training needed to prepare therapists to support them all. The Company launched its EMBARK training program in June 2021, which prepares facilitators to work within all of these domains, while inviting facilitators to bring in their own therapeutic training and expertise in a flexible, yet structured way. The EMBARK curriculum additionally emphasizes trauma-informed, culturally competent, and ethically rigorous care. On April 12, 2023, the Company announced the launch of EMBARK Open Access (“EMBARK OA”), a free online foundational training course for facilitation. EMBARK Open Access is the first and only free massive open online course that offers foundational facilitation training for healthcare professionals and people interested in offering psychological support. On July 12, 2023, the Company announced that it has commenced the development of a streamlined, scalable version of its EMBARK Training Program, known as EMBARKCT, which is designed for individuals with existing knowledge, skills, and experience in facilitation. The EMBARKCT training program is expected to enable the Company to effectively screen, qualify, and train facilitators on a multi-site, international level, to provide support and in-person monitoring for study participants receiving the Company’s investigational therapeutics in larger pivotal trials.
The Company is continuing to assess the research and development programs of Small Pharma acquired through the acquisition of Small Pharma by way of the Arrangement and will provide further information and updates upon completion of the integration of Small Pharma’s business, including the anticipated spend associated with any programs.
Deuterated Psilocin Program (CYB003)
The Company has been investigating the development of short-acting tryptamines with the aim of creating clinical development candidates, utilizing (i) the chemical modification of tryptamine derivatives through the selective substitution of hydrogen atoms with deuterium (i.e. deuteration); and (ii) the combination of such deuterated tryptamine derivative molecules with selected drug delivery methods, including but not limited to oral, inhalation methods, IV and intramuscular delivery.
The Company’s lead program, CYB003, is an orally delivered deuterated psilocin molecule that has been granted FDA BTD for the adjunctive treatment of MDD. CYB003 aims to address the limitations of oral psilocin, including side effects, scalability and accessibility of treatment.
The Company completed its CYB003 Investigational New Drug (“IND”)-enabling preclinical studies and Chemistry, Manufacturing and Control (“CMC”) development, including the production of clinical materials required for clinical trials, in the second quarter of calendar 2022. In the same period, the Company submitted an IND application to the FDA and received a “may proceed letter” and IND application clearance from the FDA as well as Institutional Review Board (the “IRB”) approval in the U.S. to commence its first-in-human Phase 1/2a study of CYB003 in participants with moderate to severe MDD. The Company has engaged Clinilabs Drug Development Corporation (“Clinilabs”), a full-service contract research organization with deep expertise in central nervous
system drug development, to carry out the Phase 1/2a clinical trial of CYB003. On August 30, 2022, the Company announced that the first two participants had been dosed in the Phase 1/2a study.
About the CYB003 Phase 1/2a Clinical Trial
The Phase 1/2a trial was a randomized, double-blind, placebo-controlled study evaluating CYB003 in participants with moderate to severe MDD and in healthy volunteers. Per a protocol amendment to the initial Phase 1/2a study design that was announced on February 28, 2023, the study introduced healthy volunteers for the lower (sub-therapeutic) dose cohorts and added a bioequivalence cohort to facilitate the transition to pivotal studies. Healthy volunteers received two administrations (placebo/active and active/active) one week apart, and measures of pharmacological effect were assessed after each dose. Participants with MDD received two administrations (placebo/active and active/active) three weeks apart and response/remission were assessed three weeks after each dose. MDD participants in the trial that were being treated with antidepressants were allowed to remain on their antidepressant medication.
The study investigated the safety, tolerability, pharmacokinetics (“PK”) and pharmacodynamics (“PD”), and pharmacological effect of ascending oral doses of CYB003. In participants with MDD, the trial evaluated rapid onset of antidepressant effect on the day of dosing, using the Montgomery-Asberg Depression Rating Scale (“MADRS”), and evaluated the incremental benefit of a second dose of CYB003 when administered at Week 3. An optional period of assessment will help determine the durability of treatment effect out to 12 months. The study is listed on ClinicalTrials.gov under Identifier: NCT05385783.
On February 28, 2023, the Company announced positive interim safety and pharmacokinetics and pharmacodynamics data from the Phase 1/2a study of CYB003. Interim findings showed that CYB003 exhibited rapid, short-acting effects, low variability in plasma levels, and achieved a psychedelic effect at low doses. At the 8mg and 10mg dose levels, most of the participants reported robust and meaningful psychedelic effects, confirming a complete mystical experience was achieved. All doses evaluated (single oral doses of CYB003 up to 10mg) were well-tolerated with no serious adverse events reported.
On July 24, 2023, the Company announced that it had completed dosing in Cohort 5 of the Phase 2a portion of the study with no serious adverse events or other adverse events that may preclude continued dosing, with recruitment underway for Cohort 6. The Phase 2a trial, consisting of completed Cohorts 4 and 5 as of the date of the announcement, evaluated two 12mg doses of CYB003. On August 2, 2023, the Company announced that it had initiated dosing in Cohort 6, the final cohort of the CYB003 Phase 2a study.
On September 21, 2023, the Company announced that it had completed enrollment in its Phase 2a study of CYB003, its proprietary deuterated psilocin analog program being developed for the potential treatment of MDD. All participants in the sixth, and final, cohort received at least one dose (placebo or 16mg of CYB003) with several second doses already administered, and no serious adverse events observed in participants. As of that date, CYB003 demonstrated a favorable safety and tolerability profile at all doses evaluated in the five completed cohorts (1mg, 3mg, 8mg, 10mg, and 12mg).
On October 3, 2023, the Company announced that it had completed dosing in Cohort 6 of its Phase 2a study of CYB003. The following doses were evaluated in the six cohorts that comprised the Phase 2a study: 1mg, 3mg, 8mg, 10mg, 12mg, and 16mg. As of that date, CYB003 has been shown to be safe and tolerable at all doses evaluated with no serious adverse events or discontinuations due to adverse events having been observed in the final dose cohort.
On October 31, 2023, the Company announced Phase 2a interim results for CYB003, its proprietary deuterated psilocin analog, demonstrating a rapid, robust and statistically significant reduction in symptoms of depression three weeks following a single 12mg dose compared to placebo, in participants with moderate to severe MDD. At the 3-week primary efficacy endpoint, the reduction in MDD symptoms, defined as change from baseline in the MADRS total score, was superior in participants assigned to CYB003 compared to the participants who received placebo by 14.08 points (p=0.0005, Cohen’s d=2.15).
On November 30, 2023, the Company announced positive Phase 2a topline results for CYB003, showing rapid and robust improvements in symptoms of depression after single doses of CYB003, with an average 13.75 point difference in MADRS score reduction between CYB003 and placebo which was statistically significant at 3 weeks (p<0.0001). The study also demonstrated a clear incremental benefit of a second dose, with a further 5.8 point improvement on the MADRS total score with a second dose of CYB003 (12mg) at 6 weeks, and 79% of patients were in remission from depression at 6 weeks after two doses of CYB003 (12mg). CYB003 exhibited a favorable safety and tolerability profile with no treatment-related serious adverse events at 12mg and 16mg doses.
On March 13, 2024, the Company announced that the FDA had granted BTD to its CYB003 program for the adjunctive treatment of MDD. The BTD provides an expedited review pathway, as well as increased access to FDA guidance on trial design, with the potential to reduce drug development timelines. On March 13, 2024, the Company also reported positive four-month durability data from the Phase 2a study of CYB003 in MDD. These results showed robust, sustained and statistically significant improvements in depression symptoms at four months with two doses of CYB003 (12mg or 16mg):
•Average mean reduction from baseline in the MADRS total score across 2 cohorts was approximately 22 points from baseline in both dosing cohorts.
•60% of patients on 12 mg and 75% on 16 mg were in remission from depression following 2 doses (MADRS score </= 10).
On August 13, 2024, the Company announced that it held a Type B Initial Comprehensive Breakthrough Therapy Meeting with the FDA. Further to recent industry discussions around the subject of functional unblinding, the Company plans to implement multiple measures to attempt to mitigate the risk of functional unblinding in its pivotal study program, as follows:
•the pivotal study program will include one study with a three-arm design with a high dose, mid-dose, and placebo arm. Patients will not know if they received the therapeutic high dose or the sub therapeutic mid-dose, mitigating the unblinding to an extent and addressing potential expectancy bias;
•the study will utilize remote, independent, blinded raters who will not have any information on the dose received or the participant’s dosing experience;
•the reporting of effects during the dosing session will be fire-walled to ensure that the study team stays blinded;
•the studies will recruit participants who are largely psychedelic naïve to reduce the impact of expectancy bias; and
•the studies will assess long-term efficacy data points up to one year, to outlast any potential expectancy effects.
In addition, the study will include manual and real time artificial intelligence screening of monitoring sessions to ensure monitor fidelity and patient safety.
On September 19, 2024, the Company announced the appointment of Dr. Atul R. Mahableshwarkar, and Dr. Tom Macek to lead the Company’s CYB003 and CYB004 programs, respectively.
The Company anticipates to initiate a multinational Phase 3 study evaluating CYB003 in participants with MDD in November 2024.9
The Company spent approximately $11,312 on the Deuterated Psilocin Program during the six months ended September 30, 2024.
As the Company continues to progress through the CYB003 program, additional milestones related its clinical development have been identified. The Company intends to:
•Provide 12-month efficacy data from the Phase 2 MDD study in Q4 2024.10
The Company has spent approximately $10,669 to initiate a Phase 3 study of CYB003 in MDD to the end of November 2024, of which approximately $6,889 was spent during the six months ended September 30, 2024 and approximately $2,978 was spent during the twelve months ended March 31, 2024, resulting in an approximate remaining spend as of September 30, 2024 of $80211. The Company expects to spend approximately $750 to provide 12-month efficacy data from the Phase 2 MDD study in Q4 2024 of which approximately $631 was spent during the six months ended September 30, 2024, resulting
9 The Company has updated this milestone. The Company had previously expected it would complete this milestone by late summer 2024. The Company completed initiation of a Phase 3 study of CYB003 in MDD in November 2024. Minor change in anticipated timing due to updates to the study. Anticipated spending and timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. Also see footnote 10.
10 There is no assurance that the aforementioned timeline will be met or that the program will advance to clinical trials, at all. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company’s development efforts to date.
11 The Company had previously estimated that its spending to complete this milestone would be $13,276. Anticipated timing and spending regarding drug development is based on reasonable assumptions informed by current knowledge and information available to the Company. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company’s development efforts to date. See footnotes 9 and 10.
in an approximate remaining spend as of September 30, 2024 of $119.12 The Company intends to continue funding the Deuterated Psilocin (CYB003) Program.
The Company intends to complete future clinical trials for this program in the U.S., Canada, and/or Europe.
The Phase 3 CYB003 study will include thirty sites in the United States and Europe with deep clinical expertise in depression studies. Clinical site selection has been completed for the Phase 3 study, and the Company is on track to commence enrollment in Q4 2024.13
Deuterated Dimethyltryptamine Program
The Company’s proprietary deuterated dimethyltryptamine (“dDMT”) program CYB004 is being developed as an intermittent treatment with the potential for less invasive, more convenient and patient-friendly dosing methods for the potential treatment of GAD with or without MDD. A single intramuscular (“IM”) dose is expected to result in acute psychedelic effects lasting an average of 90 minutes.
Cybin has leveraged clinical data from its completed DMT and dDMT trials, which collectively form one of the most advanced and extensive DMT/dDMT data portfolio in the psychedelic drug development sector, to inform and optimize the development of the CYB004 program. To date, Cybin has completed five clinical trials across four molecules: CYB004 (IV dDMT), SPL028 (IV/IM dDMT), SPL026 (IV/IM DMT), and DMT, demonstrating proof-of-concept in potentially treating depression, supporting the development of dDMT for the potential treatment of anxiety disorders, and providing important dosing insights.
Key findings from these completed studies are as follows:
•Phase 2a safety and efficacy data for SPL026 (IV DMT) in 34 participants with MDD, demonstrating a clinically relevant and statistically significant reduction in depression symptoms at two weeks after dosing (-7.4 point difference in MADRS between SPL026 and placebo). Durable antidepressant response and remission rates were observed at six months. Among participants who had achieved remission within three months with SPL026, 64% sustained remission to six months.
•Phase 1 study evaluating IM SPL026 supporting IM administration for patient-friendly dosing. The study demonstrated that IM DMT is well-tolerated and generates a breakthrough psychedelic experience lasting approximately 45 minutes.
•Phase 1 study evaluating IM SPL028 supporting IM administration for patient-friendly dosing. The completed Phase 1 study of IV/IM SPL028 in healthy volunteers showed that SPL028 is safe and well-tolerated, and demonstrated that IM dosing of SPL028 produced
12 The Company had previously estimated that its spending to complete this milestone would be $664. Anticipated timing and spending regarding drug development is based on reasonable assumptions informed by current knowledge and information available to the Company. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company’s development efforts to date. See footnote 10.
13 See footnote 10.
robust psychedelic effects lasting a short duration (average approximately 90 minutes) in the majority of subjects.
•Phase 1b study evaluating the safety and efficacy of SPL026 in conjunction with selective serotonin reuptake inhibitors (“SSRIs”) in 17 participants with MDD, demonstrating no relevant drug-drug interactions, a favorable safety profile and enhanced efficacy when SPL026 was administered with SSRIs, and a 92% remission rate at 4 weeks in the DMT + SSRI combination cohort (n=12).
•Phase 1 results for IV CYB004 demonstrated robust and rapid-onset psychedelic effects at lower doses compared to native DMT, suggesting potential as a short-acting, scalable treatment.
Exploratory analysis of the Phase 2a and Phase 1b data for SPL026 also shows significant improvements in symptoms of anxiety, as measured using the State Trait Anxiety Inventory – Trait version (STAI-T), with a 23 point improvement from baseline at the two week endpoint, in the DMT+ SSRI combination group.
The Company is currently advancing CYB004, a deuterated version of DMT, for the potential treatment of GAD. DMT activates the serotonin 5-HT2A receptor, which is believed to mediate the potential therapeutic effects of DMT. In its regular form, DMT is an unstable molecule rapidly metabolized in the body, which significantly reduces its bioavailability. CYB004, as a deuterated molecule, has the potential to overcome the therapeutic limitations of native DMT. To date, CYB004 has demonstrated robust and rapid-onset psychedelic effects at lower doses compared to native DMT, suggesting potential as a short-acting, scalable treatment. Additionally, learnings from Phase 1 studies of IM SPL028 have supported IM administration as a viable dosing method for deuterated DMT, suggesting the potential for CYB004 to offer more convenient and patient-friendly dosing methods.
CYB004 is secured by a U.S. composition of matter patent with protection through 2041. The patent covers a range of deuteration forms of DMT and protects CYB004 as a putative new chemical entity.
On June 7, 2022, the Company announced it had entered into an agreement to acquire a Phase 1 DMT study (the “Asset Acquisition”) from Entheon Biomedical Corp. (“Entheon”) to accelerate the clinical development path for CYB004. On July 11, 2022, the Company announced that the Asset Acquisition was completed. The Phase 1 study, previously identified as EBRX-101 and now named CYB004-E, was conducted in the Netherlands. Entheon acted as external consultants to the Company for approximately 10 months after the Asset Acquisition.
On January 12, 2023, the Company announced that it has selected GAD as the target indication for its proprietary deuterated DMT molecule, CYB004.
About the Phase 1 CYB004-E DMT Study
The Phase 1 trial was a three-part study evaluating the safety, pharmacokinetics, and pharmacodynamics of escalating doses of DMT and CYB004 in healthy volunteers. The three-part study design was established in a protocol amendment to the initial study design, allowing the
Company to commence first-in-human dosing of CYB004 sooner than initially planned. The study provided essential safety and dosing optimization data informing the clinical path forward for CYB004. The CYB004-E study was conducted at the Centre for Human Drug Research in the Netherlands and is one of the largest Phase 1 DMT clinical trials to date.
On November 10, 2022, the Company announced that its CYB004-E Phase 1 trial evaluating IV DMT completed dosing for four out of five cohorts and that the Safety Review Committee had confirmed no safety issues.
On February 1, 2023, the Company announced that it had received approval from an independent ethics committee in the Netherlands to initiate first-in-human dosing of CYB004 through a protocol amendment to its ongoing Phase 1 CYB004-E study.
On February 28, 2023, the Company announced a protocol amendment to the initial Phase 1 study design that would allow the Company to initiate first-in-human dosing of CYB004 sooner than initially planned. Per the protocol amendment, Cybin established a three-part study to include Part A (IV DMT infusion), Part B (IV DMT bolus + infusion) and Part C (IV CYB004 bolus + infusion) in healthy volunteers. The Company was able to rely upon completed preclinical data to gain regulatory authorization to add CYB004 to the CYB004-E DMT Study. The Company also announced confirmatory data from Part A, the single ascending dose portion of the CYB004-E study, which assessed a continuous IV DMT infusion. The Part A data showed a dose-proportional increase in exposure and dose-related increase in behavioral measures of subjective psychedelic experience with IV DMT. IV DMT was also well-tolerated with no safety issues and no serious adverse events within the dose range evaluated.
On May 9, 2023, the Company announced that it had completed dosing for the last subject in Part B of the Phase 1 CYB004-E trial.
On May 24, 2023, the Company announced that it had initiated first-in-human dosing of CYB004 in Part C of the Phase 1 CYB004-E trial.
On January 8, 2024, the Company announced positive topline results from its Phase 1 studies of its proprietary deuterated DMT molecules, CYB004 and SPL028.
•The Phase 1 CYB004 study results showed that IV CYB004 demonstrated robust and rapid-onset psychedelic effects at lower doses compared to native DMT. These psychedelic effects were rapid in onset when administered as an IV bolus over five minutes and persisted for about 40 minutes after the bolus without the need for an extended infusion.
•The Phase 1 SPL028 study identified an IM dose of SPL028 that resulted in a breakthrough psychedelic experience, with a total duration ranging from 55 to 120 minutes.
•Both CYB004 (IV) and SPL028 (IM and IV) were well-tolerated with no serious adverse events, and the majority of adverse events were mild to moderate and self-limiting.
On January 23, 2024, the Company announced that it had received FDA clearance to initiate a Phase 2 study of CYB004 in GAD.
On March 15, 2024, the Company announced that it had initiated a Phase 2 study of IM CYB004 in participants with moderate to severe GAD.
About the Phase 2 CYB004 Study in GAD
The CYB004-002 Phase 2 study is a randomized, double-blind study which will evaluate the safety and efficacy of CYB004 in participants with moderate to severe GAD (GAD-7 score ≥10), with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed. The study will recruit approximately 36 participants, who will be randomized in a double-blind manner, into two groups. The first group will receive two IM doses of CYB004, three weeks apart, while the second group will receive two low-dose control administrations of sub-therapeutic doses of CYB004. The primary endpoint is a change in the Hamilton Anxiety Rating Scale score from baseline at six weeks following the second dose. Other endpoints include the HAM-D (Hamilton Depression Rating Scale), safety assessments, MEQ30 (psychedelic experience assessment) and EQ-5D-5L (quality of life assessment). Participants will be followed for up to a year. Results from this study are expected to provide proof of concept for CYB004’s efficacy in GAD, the time to onset of effects, as well as durability of effects to one year.
The Company spent approximately $4,511 on its Deuterated Dimethyltryptamine Program during the six months ended September 30, 2024 related to the milestones detailed below.
As the Company continues to progress its Deuterated Dimethyltryptamine Program, additional milestones related to its clinical development have been identified. The Company intends to:
•provide topline safety and efficacy data from Phase 2 GAD study around year end 2024 or early Q1 2025. Dosing is underway in the Phase 2 GAD study.14
The Company expects to spend approximately $5,720 to provide topline safety and efficacy data from Phase 2 GAD study around year end 2024 or early Q1 2025 of which approximately $2,205 was spent during the six months ended September 30, 2024 and approximately $58 was spent during the financial year ended March 31, 2024, resulting in an approximate remaining spend as of September 30, 2024 of $3,457 by Q4 2024.15
The Company intends to continue funding the Deuterated Dimethyltryptamine (CYB004) Program.
14 See footnote 10.
15 The Company had previously estimated that its spending to complete this milestone would be $5,521. Anticipated timing and spending regarding drug development is based on reasonable assumptions informed by current knowledge and information available to the Company. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company’s development efforts to date. See footnote 10.
In addition, following the acquisition of Small Pharma, the Company is continuing to assess and will provide further information and updates upon completion of the integration of Small Pharma’s business, including the anticipated spend associated with the SPL028 study.16
Phenethylamine Derivatives Program (CYB005)
The Company’s Phenethylamine Derivatives Program (CYB005) is focused on the development of therapeutic phenethylamine derivatives. Multiple phenethylamines have been shown to have psychedelic properties and several, such as MDMA, have shown promise as therapeutics. Cybin’s proprietary approach to phenethylamines modification with novel chemistry, proprietary formulations and directed delivery systems has yielded a number of novel, IP-protected leads with significant therapeutic potential. Several compounds are now being further studied both in vitro and in vivo for selection of the best development candidates, including evaluating the benefits of sub-psychedelic, chronic dosing. The Company is investigating the effects of phenethylamine derivatives on neuroplasticity, and for the potential treatment of CNS disorders, neuroinflammation and other neurological conditions.17 The Company is investigating novel molecules within the CYB005 program at non-hallucinogenic doses for a range of CNS disorders. In addition, the Company is continuing to explore non-hallucinogenic neuroplastogens within its broader discovery pipeline, as well as targeted serotonin 5-HT1A and 5-HT2C receptor agonists18.
In order to assess the feasibility and viability of these phenethylamine derivatives entering clinical studies, the Company has and will continue to contract with reputable and licensed third-party vendors to undertake extensive preclinical characterization of target molecules on the Company’s behalf. These activities include, but are not limited to: the synthesis of such molecules as API at laboratory scale, the development and optimization of production processes for such APIs, the development of stable formulations utilizing these APIs, the development and validation of analytical methods for such formulations, the scale up of API production processes beyond laboratory scale to deliver GLP and GMP material suitable for entry into animal and human studies, studies of the stability of such formulations suitable for human studies, the development of Chemistry, Manufacturing and Controls to meet cGMP.
In addition, utilizing the expertise of selected third parties, the Company intends to oversee the study of the pharmacokinetic profiles of its formulations in a number of animal models and the completion of Absorption, Distribution, Metabolism, and Excretion (“ADME”) profiles. Further, the Company’s
16 See footnote 10.
17 This statement is based on the following material factors and assumptions: (a) the Company assumes it will enter into a contract with a licensed third-party vendor to undertake extensive preclinical characterization of target molecules on the Company’s behalf; (b) the Company anticipates to complete a number of animal models and the completion of ADME profiles; (c) the Company assumes to enter into third party agreements in order to complete a range of additional preclinical programs including but not limited to dose-ranging studies in multiple animal species, toxicity studies in multiple animal species, genotoxicity studies, teratogenicity studies, along with neuropharmacological, pulmonary, and cardiovascular profiling before the final selection of drug candidates for entry into human trials; and (d) obtain an IND and/or a CTA to enter into clinical trials. As of the date hereof, it has not yet completed the aforementioned items. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company’s development efforts to date.
18 See footnotes 10 and 17.
licensed third party vendors will be responsible for completing a range of additional preclinical programs including, but not limited to, dose-ranging studies in multiple animal species, toxicity studies in multiple animal species, genotoxicity studies, along with neuropharmacological, pulmonary, and cardiovascular profiling, before the final selection of drug candidates for entry into human trials.
The Company intends to complete these studies, and collect further relevant safety and toxicity data, prior to the filing for any IND application with the FDA, a CTA with Health Canada, or other similar application with regulatory bodies in other jurisdictions.
On October 24, 2024, the Company announced that the United States Patent and Trademark Office granted U.S. patent 12,122,741 with claims to the composition of matter of lead preclinical candidates in the Company's CYB005 phenethylamines program.
The Company spent approximately $14 on its preclinical Phenethylamine Derivatives Program during the six months ended September 30, 2024.
The Company is currently identifying a viable drug candidate and completing its assessment of the potential path forward for this candidate, including whether it will be developed internally or by way of potential third party partners. The Company anticipates that its phenethylamine program may deliver a drug candidate suitable for entry into clinical studies by the end of calendar 2024.19
The Company expects to spend approximately $90020 to complete preclinical development of a phenethylamine drug candidate by 2024,21 of which approximately $14 was spent in six months ended September 30, 2024, approximately $83 was spent during the twelve months ended March 31, 2024, and approximately $782 was spent during the financial year ended March 31, 2023 resulting in an approximate remaining spend as of September 30, 2024 of $21. The Company intends to continue funding the Phenethylamine Derivatives Program (CYB005) Program.
19 See footnote 10.
20 Reflects actual spend during the financial year ended March 31, 2024, the six months ended September 30, 2024, and expected spend during the period from July 1, 2024 until the achievement of preclinical development of a phenethylamine drug candidate by December 31, 2024. Anticipated timing and spending regarding drug development is based on reasonable assumptions informed by current knowledge and information available to the Company. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company’s development efforts to date.
21 The Company has updated this milestone. The Company had previously expected it would complete this milestone by Q3 2023. The Company now expects to complete preclinical development of phenethylamine drug candidate by the end of Q4 2024.Change in anticipated timing due to the prioritization of the CYB003 Program. Anticipated spending and timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. See also footnote 10.
Technology Programs
Digital Therapy Platform
The Company has been working on the creation of a patient digital therapy platform (the “Digital Platform”). The Digital Platform is envisioned to help patients undergoing psychedelic therapies to memorialize the learning from their treatment sessions and to assist with the integration of such learnings into the patient’s psychotherapy program.
The Company’s digital therapy platform technology is designed to better enable the evaluation of patient outcomes through a highly secure, patient-centered data analytics platform for better pre- and post-psychedelic treatments. The digital therapy platform is proprietary to Cybin and the subject of one of the Company’s patent applications.
Proof-of-concept testing for the Company’s Digital Platform was completed in Q2 2022. The Company is currently evaluating paths forward for its Digital Platform program.
Kernel Collaboration
On January 11, 2021, the Company announced that it entered into an agreement with HI, LLC dba Kernel (“Kernel”) that will enable the Company to use the Kernel Flow technology (“Flow”) to potentially measure neural activity during psychedelic therapy.
On October 26, 2021, the Company announced that the FDA had authorized an IND application to proceed with a Cybin-sponsored feasibility study using Flow to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics. On January 11, 2022, the Company announced that the IRB had approved the feasibility study. On May 9, 2022, the Company and Kernel announced results from the piloting of the feasibility study. The preliminary data confirmed Flow’s ability to successfully measure neuro-effect of ketamine over 10 days.22 The Company completed its feasibility study sponsorship utilizing Flow in Q3 2022.
On January 18, 2023, the Company announced promising results from the completed feasibility study, evaluating Flow’s wearable technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics. Key findings from the study provided proof-of-principle for Flow as a portable functional system that provides real-time measurements of changes in blood oxygenation in the brain associated with neural activity. The study demonstrated ketamine-induced changes to functional brain biomarkers associated with potential therapeutic effects, including changes in cortical function associated with psychedelic experiences. Additionally, Flow demonstrated reliable measurements of pulse rate (“PR”) and pulse rate variability (“PRV”), therefore eliminating the need for external cardiac activity sensors in future studies. The study also observed physiological measures of the
22 Preliminary data from the piloting suggested that ketamine-induced changes in functional connectivity persisted for several days after administration. Flow successfully measured the neuro-effect of ketamine over 11 days (baseline at Days 1-5, dosing at Day 6, follow-up at Days 7-11), and confirmed changes in functional connectivity that are consistent with current scientific research (Scheidegger et al 2012; Zacharias et al 2019; Li et al 2022). The piloting was conducted to ensure the efficiency of the feasibility study design. Participants in the pilot received either a low dose of ketamine and/or a placebo while wearing the Flow headset.
effects of ketamine, including increased PR, decreased PRV, increased absolute concentrations of oxy-hemoglobin and decreased deoxyhemoglobin, and elevated electrodermal activity.
On July 20, 2023, the Company commended Kernel on their publication titled “Measuring acute effects of subanesthetic ketamine on cerebrovascular hemodynamics in humans using TD-fNIRS” in the journal Scientific Reports from the Nature Portfolio of Journals. The publication highlights the results of the Cybin-sponsored Kernel Flow1 feasibility study demonstrating the capabilities of the Flow1 system to capture and analyze brain changes resulting from the administration of a psychoactive substance. The feasibility study is the largest functional near-infrared spectroscopy (“fNIRS”) study to measure the acute effect of a psychedelic and is the first ever fNIRS neuroimaging study evaluating ketamine in humans. In this single-blind, placebo-controlled study, employing a non-randomized design, the Flow1 system, built with time-domain functional near-infrared spectroscopy (TD-fNIRS) was utilized to measure acute brain dynamics following intramuscular subanesthetic ketamine (0.75 mg/kg) and placebo (saline) administration in a clinical setting. Results from the study are intended to inform the next steps forward for this program.
Results from the study are intended to inform the next steps forward for this program.
About the Phase 1 Kernel Flow Feasibility Study
The feasibility study was a single-blind, placebo-controlled, non-randomized design with participants completing study visits roughly once a week for four weeks. The four study visits were always conducted in the same order: a screening visit, two dosing visits, and a follow-up phone call. Dosing visits were always placebo (saline, 0.9% NaCl) first and ketamine second, with the ketamine visit occurring one week (7.1±0.5 days, mean ±standard deviation) after the saline visit. Ketamine and saline were administered via bolus intramuscular injection (deltoid muscle). Ketamine dosing was based on participant weight with a target of 0.75 mg/kg, up to the maximum dose of 60 mg. Two participants were administered the maximum dose. Participants included 15 healthy individuals who met eligibility criteria and consented to participation in the study. There were eight females and seven males, all 24-48 years old.
The main objective of the feasibility study was to evaluate a participant’s experience wearing Flow while in an altered state of consciousness following the administration of ketamine.
As part of the Company’s sponsorship of the feasibility study, the Company will retain an exclusive interest in any innovations that are discovered or developed through its independent analysis of the study findings.
Update on Use of Proceeds
August Prospectus Supplement
The table below covers the period beginning July 1, 2023 until September 30, 2024. There were no differences between the Company’s anticipated use of proceeds of $10,018 as previously disclosed in the Company’s prospectus supplement dated August 1, 2023 (the “August Prospectus Supplement”)
to the Company’s short form base shelf prospectus dated July 5, 2021 (the “2021 Base Shelf Prospectus”) and the actual use of proceeds.
| | | | | | | | | | | |
Use of Available Funds ($000’s)(1)(2) | Previous Disclosure Regarding Use of Proceeds in the August Prospectus Supplement (July 1, 2023 to June 30 2024) | Actual Use of Proceeds as at September 30, 2024 | Revised Estimated Use of Proceeds |
Deuterated Psilocin Program |
Complete FDA submission of Phase 1/2a data | $2,500 | $2,500 | N/A |
Deuterated Dimethyltryptamine Program |
Provide topline data from Phase 1 CYB004-E trial | $1,269 | $1,269 | N/A |
Complete FDA IND submission | $1,373 | $1,373 | N/A |
Phenethylamine Development Program |
Progression of phenethylamine candidate to clinical studies | Nil | Nil | N/A |
Other |
Working Capital, and General Corporate Purposes(3) | $4,876 | $4,876 | N/A |
TOTAL: | $10,018 | $10,018 | N/A |
Notes:
(1)Certain amounts have been converted from USD to CAD at an exchange rate of 1.35:1.
(2)Such amounts do not reflect the entire anticipated expenditures or budget related to the listed programs. For further information see “Non-Revenue Generating Projects”.
(3)Includes personnel costs, professional services, overhead expenses and general expenses to be incurred by the Company in the normal course of business. In addition, the Company intends to use a portion of these proceeds to continue funding both its Deuterated Psilocin and Deuterated Dimethyltryptamine programs. The allocation between these programs and specific milestones within the programs have not yet been determined.
November Prospectus Supplement
The table below covers the period beginning November 1, 2023 until October 31, 2024, and describes the differences between the Company’s anticipated use of proceeds of $28,070 as previously disclosed in the Company’s prospectus supplement dated November 10, 2023 (the “November Prospectus Supplement”) to the Company’s base shelf prospectus dated August 17, 2023 (the “2023 Base Shelf Prospectus”), the revised estimated costs as at September 30, 2024, for the same period, and the actual use of proceeds as at December 31, 2023.
| | | | | | | | | | | |
Use of Available Funds (USD $000’s)(1)(2) | Previous Disclosure Regarding Use of Proceeds in the November Prospectus Supplement (November 1, 2023, to October 31, 2024) | Actual Use of Proceeds as at September 30, 2024 | Revised Estimated Use of Proceeds |
Deuterated Psilocin Program |
Initiate a Phase 3 Study of CYB003 in MDD | $6,393 | $6,216 | $6,393 |
Deuterated Dimethyltryptamine Program |
Initiate a Phase 2 Proof-Of-Concept Study(3) | $597 | $597 | $597 |
Initiate a Subcutaneous Formulation Study | $780 | Nil | Nil |
Phenethylamine Development Program |
Progression of phenethylamine candidate to clinical studies | Nil | Nil | Nil |
Other |
Working Capital, and General Corporate Purposes(4) | $20,300 | $20,300 | $21,080 |
TOTAL: | $28,070 | $27,113 | $28,070 |
Notes:
(1)Amounts in the chart are in USD. Certain amounts have been converted from USD to CAD at an exchange rate of 1:0.74.
(2)Such amounts do not reflect the entire anticipated expenditures or budget related to the listed programs. For further information see “Non-Revenue Generating Projects”.
(3)This milestone is now denoted as ‘initiate a Phase 2a GAD study’. For further information see “Deuterated Dimethyltryptamine Program”.
(4)Includes personnel costs, professional services, overhead expenses and general expenses to be incurred by the Company in the normal course of business. In addition, the Company intends to use a portion of these proceeds to continue funding both its Deuterated Psilocin and Deuterated Dimethyltryptamine programs. The allocation between these programs and specific milestones within the programs have not yet been determined.
The Company has negative cash flow from operating activities and has historically incurred net losses. To the extent that the Company has negative operating cash flows in future periods, it may need to deploy a portion of its existing working capital to fund such negative cash flows. The Company will be required to raise additional funds through the issuance of additional equity securities, through loan financing, or other means, such as through partnerships with other companies and research and development reimbursements. There is no assurance that additional capital or other types of financing will be available if needed or that these financings will be on terms at least as favourable to the Company as those previously obtained.
The expected use of net proceeds from the Company’s financing activities, as presented above, represents the Company’s current intentions based upon its present plans and business condition, which could change in the future as its plans and business conditions evolve. The amounts and timing of the actual use of the net proceeds will depend on multiple factors and there may be circumstances where, for sound business reasons, a reallocation of funds may be necessary in order for the Company to achieve its stated business objectives. The Company may also require additional funds in order to fulfill its expenditure requirements to meet existing and any new business objectives, and the Company expects to either issue additional securities or incur debt to do so.
Relationships with Third Parties
The Company’s research and development of its psychedelic pharmaceutical products is conducted by way of licensed partners. The Company also intends to sponsor clinical and other studies at various clinical trial sites.
Clinilabs Drug Development Corporation
On April 21, 2022, the Company announced that it had partnered with Clinilabs, a global, full-service contract research organization with deep expertise in central nervous system drug development, to carry out the Company’s Phase 1/2a clinical trial of CYB003, its proprietary deuterated psilocin program.
Entheon Biomedical Corp.
On July 11, 2022, the Company completed the acquisition of a Phase 1 DMT study from Entheon. As part of the Asset Acquisition, Entheon assigned its rights under the Master Services Agreement between Entheon and Centre For Human Drug Research (“CHDR”) to the Company. The Company now maintains a direct contractual relationship with CHDR to conduct the CYB004-E trial. CHDR is an independent institute in the Netherlands specializing in innovative early-stage clinical drug research.
Mindset Pharma Inc.
On September 27, 2022, the Company entered into an agreement, as amended, with Mindset Pharma Inc. (“Mindset”) to acquire an exclusive license to an extensive targeted class of tryptamine-based molecules. The agreement includes an initial license fee payment by Cybin to Mindset of US$500 as well as additional clinical development milestone payments of up to US$9,500, with the first milestone payment, in the amount of US$500, payable upon completion of a Phase 1 clinical trial. At the sole discretion of Cybin, the milestones may be paid in cash or in Common Shares, or a combination thereof, subject to the approval of the Exchange. There is no assurance that the aforementioned milestones will be met. The agreement also contemplates a sales royalty of approximately 2% for all commercialized licensed products within the scope of the agreement, which is customary for drug licensing agreements of this nature.
Worldwide Clinical Trials
On July 26, 2023, the Company announced that it has partnered with Worldwide Clinical Trials, a global, full-service contract research organization with deep expertise managing clinical trials for mental health conditions, including MDD.
Other Third-Party Partners
The Company has established contractual sources of synthetic GMP (as defined below) and non-GMP raw materials to support its development operations through licensed third-party suppliers located in
Canada, the United States, the UK and Europe. Such raw materials are expected to be, in general, readily available and in adequate supply to meet the Company’s need for development quantities, or custom manufactured on the Company’s behalf.23 The prices of research quantities of novel tryptamine compounds are generally higher than commercial supply prices at significantly larger scale and the Company, therefore, expects its supply prices to reduce over time. Development and production of the Company’s proprietary novel compounds is performed under confidential contractual agreements.
The Company has conducted due diligence on each such third party, including but not limited to the review of necessary licences and the regulatory framework enacted in the jurisdiction of operation.
The allocation of capital towards the Company’s ongoing projects and programs is largely dependent on the success, or difficulties encountered, in any particular portion of the process and therefore the time involved in completing it; in turn the time and costs associated with completing each step are highly dependent on the incremental results of each step and the results of other programs, and the Company’s need to be flexible to rapidly reallocate capital to projects whose results show the greatest potential. As such, it is difficult for the Company to anticipate the timing and costs associated with taking the projects to their next planned stage, and the Company cannot make assurances that the foregoing estimates will prove to be accurate, as actual results and future events could differ materially from those anticipated. Accordingly, investors are cautioned not to put undue reliance on the foregoing estimates.
Moreover, identifying the timing and costs of such projects beyond their immediate next steps go to the core differentiating factors with respect to the Company and its competitors. The disclosure of prospective costs and timing other than as already disclosed by the Company would negatively impact shareholder value and undermine the Company’s proprietary technology. In keeping with pharmaceutical industry practice, it is the Company’s policy to disclose these details in conjunction with its financial statements, and to publicly disclose published patent applications, published scientific papers, scientific symposia and the attainment of key milestones only. In addition, the premature disclosure of proprietary data would have a material and adverse effect on the Company’s patent and other intellectual property rights and could result in the breach of confidentiality obligations.
The material factors or assumptions used to develop the estimated costs disclosed above are included in the “Cautionary Note Regarding Forward-Looking Information” section above. The actual amount that the Company spends in connection with each of the intended uses of proceeds will depend on a number of factors, including those listed under “Risk Factors” in this MD&A or unforeseen events.
Other than as described in the AIF and herein, to the knowledge of management, there are no other particular significant events or milestones that must occur for the Company’s business objectives in the next 12 months to be accomplished. However, there is no guarantee that the Company will meet its business objectives or milestones described above within the specific time periods, within the
23 At this time the Company has not entered into commercial supply agreements and has no control over price or conditions. The Company has assumed that it will be able to enter into commercial supply agreements at such a time when there will be sufficient competition in the market which will render prices reasonable.
estimated costs or at all. The Company may, for sound business reasons, reallocate its time or capital resources, or both, differently than as described above.
The Company has negative cash flow from operating activities and has historically incurred net losses. To the extent that the Company has negative operating cash flows in future periods, it may need to deploy a portion of its existing working capital to fund such negative cash flows. The Company will be required to raise additional funds through the issuance of additional equity securities, through loan financing, or other means, such as through partnerships with other companies and research and development reimbursements. There is no assurance that additional capital or other types of financing will be available if needed or that these financings will be on terms at least as favourable to the Company as those previously obtained.
Intellectual Property
Cybin has title to nineteen granted US patents and fifty eight granted national (non-US) patents, including claims directed to compositions of matter and methods of use in support of its research and development and preclinical and clinical trial programs. Granted European patents are counted as a single granted patent (as opposed to multiple patents in each European territory in which the patent is in force).
| | | | | | | | |
Patent Number | Jurisdiction of Filing | Description |
11,242,318 | United States | Deuterated Tryptamine Derivatives And Methods Of Use |
11,724,985 | United States | Deuterated Tryptamine Derivatives And Methods Of Use |
11,746,088 | United States | Deuterated Tryptamine Derivatives And Methods Of Use |
11,834,410 | United States | Deuterated Tryptamine Derivatives And Methods Of Use |
11,958,807 | United States | Deuterated Tryptamine Derivatives And Methods of Use |
12,110,272 | United States | Deuterated Tryptamine Derivatives And Methods of Use |
12,122,741 | United States | Therapeutic Phenethylamine Compositions and Methods of Use |
2018311307 | Australia | Crystalline Forms of Hydroxynorketamine |
2020378647 | Australia | Method of Synthesis |
2020381103 | Australia | Compounds |
2021334933 | Australia | Injectable Formulation |
2021204158 | Australia | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
2020286709 | Australia | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
1120220221983 | Brazil | Injectable Formulation |
3104072 | Canada | Drug Substance Compositions Comprising N,N-Dimethyltryptamine |
3160337 | Canada | Method of Synthesis |
3179161 | Canada | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
3160334 | Canada | Compounds |
3179335 | Canada | Injectable Formulation |
ZL202080087091.0 | China | Compounds |
ZL202080087092.5 | China | Method of Synthesis |
ZL202180044031.5 | China | Injectable Formulation |
ZL202180046463.X | China | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
046951 | Eurasian Patent Office | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
| | | | | | | | |
Patent Number | Jurisdiction of Filing | Description |
3463323 | European Patent Office | Solid Oral Dosage Forms of 2R,6R-Hydroxynorketamine or Derivatives Thereof |
3687515 | European Patent Office | Solid Oral Dosage Forms of Ketamine Derivatives |
3532457 | European Patent Office | Crystalline Forms of Hydroxynorketamine |
3826632 | European Patent Office | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
3844147 | European Patent Office | Compounds |
3873883 | European Patent Office | Method of Synthesis |
3902541 | European Patent Office | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
4031529 | European Patent Office | Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
4138818 | European Patent Office | Injectable Formulations |
40042383 | Hong Kong | Therapeutic Compositions |
40035970 | Hong Kong | Solid Oral Dosage Forms of Ketamine Derivatives |
40056359 | Hong Kong | Compounds |
40060666 | Hong Kong | Method of Synthesis |
40065709 | Hong Kong | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
40064531 | Hong Kong | Therapeutic Solid Dosage Forms |
40045846 | Hong Kong | Therapeutic Compositions |
40060891 | Hong Kong | Therapeutic Compositions |
40078818 | Hong Kong | Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
507114 | India | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
528813 | India | Injectable Formulation |
292753 | Israel | Compounds |
7288154 | Japan | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
7422474 | Japan | Method of Synthesis |
7423131 | Japan | Compounds |
7422474 | Japan | Injectable Formulations |
7523474 | Japan | A therapeutic composition comprising a deuterated or partially deuterated N,N-dimethyltryptamine compounds |
ZL202180044031.5 | Macao | Injectable Formulations |
ZL202080087092.5 | Macao | Method of Synthesis |
ZL202180046463.X | Macao | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
404310 | Mexico | Compounds |
411316 | Mexico | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
412331 | Mexico | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
788543 | New Zealand | Dimethyltryptamine derivatives and their use in psychedelic-assisted psychotherapy |
794833 | New Zealand | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
2589605 | Republic of Korea | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
2636385 | Republic of Korea | Injectable Formulation |
2023/01086 | South Africa | Injectable Formulation |
2585978 | United Kingdom | Therapeutic Compositions |
| | | | | | | | |
Patent Number | Jurisdiction of Filing | Description |
2586940 | United Kingdom | Therapeutic Compositions |
2592822 | United Kingdom | Therapeutic Compositions |
2595776 | United Kingdom | Therapeutic Solid Dosage Forms |
11,377,416 | United States | Crystalline Forms of Hydroxynorketamine |
11,771,681 | United States | Therapeutic Compositions |
11,773,062 | United States | Deuterated Compounds |
11,643,390 | United States | Synthesis of N,N-Dimethyltryptamine-Type Compounds, Methods, and Uses |
11,471,417 | United States | Deuterated N,N-Dimethyltryptamine Compounds |
11,406,619 | United States | Injectable Formulations |
11,697,638 | United States | 5-Methoxy-N,N-Dimethyltryptamine Crystalline Forms |
11,660,289 | United States | Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
11,578,039 | United States | Compounds |
12,042,564 | United States | Therapeutic Solid Dosage Forms |
12,076,311 | United States | Therapeutic Compositions Comprising Deuterated or Partially Deuterated N,N-Dimethyltryptamine Compounds |
12,084,417 | United States | Synthesis of N,N-Dimethyltryptamine-Type Compounds, Methods, and Uses |
In addition, Cybin has title to seven provisional patent applications, thirty US non-provisional patent applications, one hundred and ninety two national (non-US) patent applications, and thirteen Patent Cooperation Treaty (“PCT”) applications, including claims directed to compositions of matter and methods of use in support of its research and development and preclinical and clinical trial programs.
| | | | | | | | | | | |
Patent Application Number | Jurisdiction of Filing | Status | Description |
18/056,958 | United States | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
17/999,310 | United States | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
18/041,728 | United States | Pending | Phenethylamine Derivatives, Compositions, and Methods of Use |
18/027,810 | United States | Pending | Methods For Delivery of Psychedelic Medications By Inhalation and Systems For Performing the Methods |
PCT/EP2023/057939 | WIPO | Pending | Methods For Delivery of Psychedelic Medications By Inhalation and Systems For Performing the Methods |
PCT/EP2023/058107 | WIPO | Pending | Combination Drug Therapies |
PCT/EP2023/066900 | WIPO | Pending | Formulations of Psilocybin |
18/547,100 | United States | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
PCT/EP2023/073122 | WIPO | Pending | Tryptamine Compounds, Compositions, and Methods of Use |
PCT/EP2023/080027 | WIPO | Pending | Phenethylamine Compounds, Compositions, and Methods of Use |
63/599,483 | United States | Pending | Injectable Pharmaceutical Formulations |
18/561,152 | United States | Pending | Formulations of Psilocybin |
63/600,179 | United States | Pending | Companion Animal Treatments |
63/602,888 | United States | Pending | Methods of Treating Disorders with a Psilocybin Analog |
63/603,262 | United States | Pending | Methods of Treating Disorders with a Psilocybin Analog |
63/603,886 | United States | Pending | Methods of Treating Disorders with a Psilocybin Analog |
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Patent Application Number | Jurisdiction of Filing | Status | Description |
18/576,487 | United States | Pending | Integrated Data Collection Devices for Use in Various Therapeutic and Wellness Applications |
63/553,321 | United States | Pending | Methods of Treating Disorders with a Psilocybin Analog |
18/588,132 | United States | Pending | Methods of Treating Disorders with a Psilocybin Analog |
PCT/EP2024/054897 | WIPO | Pending | Methods of Treating Disorders with a Psilocybin Analog |
18/688,125 | United States | Pending | Combination Drug Therapies |
18/600,018 | United States | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
PCT/EP2024/062406 | WIPO | Pending | Injectable Pharmaceutical Formulations |
18/707,825 | United States | Pending | Formulations Of Psilocybin Analogs and Methods of Use |
PCT/EP2024/065453 | WIPO | Pending | Companion Animal Treatments |
18/720,922 | United States | Pending | Tryptamine Compositions and Methods |
PCT/EP2024/067458 | WIPO | Pending | Processes For Preparing Phenethylamine Compounds |
18/730,397 | United States | Pending | Therapeutic Phenethylamine Compositions and Methods of Use |
18/730,423 | United States | Pending | Phenethylamine Derivatives, Compositions, and Methods of Use |
18/825,122 | United States | Pending | Therapeutic Phenethylamine Compositions and Methods of Use |
18/883,262 | United States | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
18/850,356 | United States | Pending | Methods For Delivery of Psychedelic Medications By Inhalation and Systems For Performing the Methods |
18/852,115 | United States | Pending | Combination of Nitrous Oxide and 5-HT2A Receptor Agonists |
793553 | New Zealand | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
812214 | New Zealand | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
297492 | Israel | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
312785 | Israel | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
3177454 | Canada | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
NC2022/0016662 | Colombia | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
MX/a/2022/014605 | Mexico | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
MX/a/2024/006467 | Mexico | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
202203191 | Chile | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
10-2022-7040243 | Republic of Korea | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
10-2024-7019118 | Republic of Korea | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
EP21808464.8 | European Patent Office | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
24175524.8 | European Patent Office | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
202180036163.3 | China | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
202410728550.9 | China | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
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Patent Application Number | Jurisdiction of Filing | Status | Description |
1120220235658 | Brazil | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
2021276656 | Australia | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
2024203974 | Australia | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
11202254530T | Singapore | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
10202401521X | Singapore | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
202213256 | South Africa | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
2201007493 | Thailand | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
1-2022-553135 | Philippines | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
1-2024-551326 | Philippines | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
202227065770 | India | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
2022-571175 | Japan | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
2024-080101 | Japan | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
62023078320.6 | Hong Kong | Pending | Deuterated Tryptamine Derivatives and Methods of Use |
3186357 | Canada | Pending | Therapeutic Phenethylamine Compositions and Methods of Use |
10-2023-7003815 | Korea | Pending | Therapeutic Phenethylamine Compositions and Methods of Use |
2021327136 | Australia | Pending | Therapeutic Phenethylamine Compositions and Methods of Use |
2023-512063 | Japan | Pending | Therapeutic Phenethylamine Compositions and Methods of Use |
21766581.9 | European Patent Office | Pending | Therapeutic Phenethylamine Compositions and Methods of Use |
62023079716.4 | Hong Kong | Pending | Therapeutic Phenethylamine Compositions and Methods of Use |
3186359 | Canada | Pending | Phenethylamine Derivatives, Compositions, and Methods of Use |
10-2023-7006128 | Korea | Pending | Phenethylamine Derivatives, Compositions, and Methods of Use |
2021328671 | Australia | Pending | Phenethylamine Derivatives, Compositions, and Methods of Use |
2023-512107 | Japan | Pending | Phenethylamine Derivatives, Compositions, and Methods of Use |
21763068.0 | European Patent Office | Pending | Phenethylamine Derivatives, Compositions, and Methods of Use |
62023079718.0 | Hong Kong | Pending | Phenethylamine Derivatives, Compositions, and Methods of Use |
21786852.0 | European Patent Office | Pending | Methods For Delivery of Psychedelic Medications By Inhalation and Systems For Performing the Methods |
10-2023-7007858 | Korea | Pending | Methods For Delivery of Psychedelic Medications By Inhalation and Systems For Performing the Methods |
2021354006 | Australia | Pending | Methods For Delivery of Psychedelic Medications By Inhalation and Systems For Performing the Methods |
2023-519831 | Japan | Pending | Methods For Delivery of Psychedelic Medications By Inhalation and Systems For Performing the Methods |
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Patent Application Number | Jurisdiction of Filing | Status | Description |
3194558 | Canada | Pending | Methods For Delivery of Psychedelic Medications By Inhalation and Systems For Performing the Methods |
62023079720.6 | Hong Kong | Pending | Methods For Delivery of Psychedelic Medications By Inhalation and Systems For Performing the Methods |
802136 | New Zealand | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
305457 | Israel | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
3212563 | Canada | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
NC2023/0013714 | Columbia | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
MX/a/2023/010843 | Mexico | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
202302731 | Chile | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
10-2023-7032581 | Korea | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
22716857.2 | European Patent Office | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
202280022029.2 | China | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
1120230188946 | Brazil | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
2022239825 | Australia | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
11202305618U | Singapore | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
202309486 | South Africa | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
2301005753 | Thailand | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
1-2023-552572 | Philippines | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
202327063524 | India | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
2023-556906 | Japan | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
62024086011.9 | Hong Kong | Pending | Psilocybin Analogs, Salts, Compositions, and Methods of Use |
2022277515 | Australia | Pending | Formulations of Psilocybin |
3216799 | Canada | Pending | Formulations of Psilocybin |
22729558.1 | European Patent Office | Pending | Formulations of Psilocybin |
202327074210 | India | Pending | Formulations of Psilocybin |
2023-571283 | Japan | Pending | Formulations of Psilocybin |
10-2023-7041239 | Korea | Pending | Formulations of Psilocybin |
62024089505.7 | Hong Kong | Pending | Formulations of Psilocybin |
2022342266 | Australia | Pending | Combination Drug Therapies |
3231021 | Canada | Pending | Combination Drug Therapies |
22716971.1 | European Patent Office | Pending | Combination Drug Therapies |
2024-515026 | Japan | Pending | Combination Drug Therapies |
10-2024-7008355 | Korea | Pending | Combination Drug Therapies |
62024094405.3 | Hong Kong | Pending | Combination Drug Therapies |
2022381220 | Australia | Pending | Formulations Of Psilocybin Analogs and Methods of Use |
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Patent Application Number | Jurisdiction of Filing | Status | Description |
1120240088332 | Brazil | Pending | Formulations Of Psilocybin Analogs and Methods of Use |
3236624 | Canada | Pending | Formulations Of Psilocybin Analogs and Methods of Use |
202280073355.6 | China | Pending | Formulations Of Psilocybin Analogs and Methods of Use |
22783493.4 | European Patent Office | Pending | Formulations Of Psilocybin Analogs and Methods of Use |
202417038272 | India | Pending | Formulations Of Psilocybin Analogs and Methods of Use |
312175 | Israel | Pending | Formulations Of Psilocybin Analogs and Methods of Use |
2024-526529 | Japan | Pending | Formulations Of Psilocybin Analogs and Methods of Use |
10-2024-7017594 | Korea | Pending | Formulations Of Psilocybin Analogs and Methods of Use |
810005 | New Zealand | |