Cybin Inc. Archives

Debra BorchardtNovember 15, 2023

After the markets closed on Tuesday, Cybin Inc. (NYSE: CYBN) (NEO: CYBN) reported unaudited financial results for its second quarter ended Sept. 30. Cybin reported a net loss of C$11.9 million for the quarter versus last year’s net loss of C$10 million.

At present, Cybin’s operations do not generate cash flows and at the end of September, the company had an accumulated deficit of C$174 million, cash of C$18 million, and working capital of C$17 million. In the company’s filing, it was noted that it had accounts payable and accrued liabilities including trade payables and other obligations of $9 million, all amounts are due within the next 12 months

However, Cybin closed its previously announced underwritten offering for aggregate gross proceeds of $30 million (approximately C$40 million). The company said in a statement that with the recently completed Offering and a combination of the company’s current cash position, it has access to over C$138 million.

Cash flows received from financing activities were C$20.4 million for the quarter versus last year’s C$4.6 million in the same period last year, related to the net proceeds on the issuance of common shares through the company’s August 3, 2023 financing and its at-the-market equity program.

“Advancing our clinical programs with the goal of changing the treatment landscape in mental health has always been Cybin’s mission,” said Doug Drysdale, Chief Executive Officer of Cybin. “We have made enormous progress during the past quarter, with ample momentum to carry us through year-end and into 2024. We are actively gathering important data from CYB003, our deuterated psilocybin analog program, and CYB004 and SPL028, our deuterated DMT programs, with topline readouts expected before the end of 2023. As a company, we are proud of our consistent progress, robust patent portfolio, skilled and dedicated team of drug development experts, and believe we are well-positioned to progress our pipeline toward potential regulatory approval.”

Looking Ahead

As Cybin continues to progress through the CYB003 program, additional milestones related to the Phase 1/2a clinical trial have been identified. Cybin outlined them as such:

• provide topline data readout from the Phase 1/2a study in the fourth quarter of 2023
• complete FDA submission of CYB003 Phase 1/2a data for end of phase 2 meeting in the fourth quarter of 2023
• initiate a Phase 3 study of CYB003 in MDD in the first quarter of 2024

Cybin said it expects to spend approximately $7.7 million to provide topline data readout from the Phase 1/2a study by the fourth quarter, of which approximately $5 million was spent during the six months ending September 30, 2023, and approximately $1 million was spent in the financial year ended March 31, 2023. This means it will still need to spend $1 million by the end of 2023.

The company said it also expects to spend approximately $2.5 million to complete the FDA submission of CYB003 Phase 1/2a data by the fourth quarter of 2023, of which approximately nil was spent during the six months ended September 30, 2023. The company said it intends to continue funding the Deuterated Psilocybin Analog (CYB003) Program.

Debra BorchardtOctober 25, 2023

Cybin Inc. (NYSE American: CYBN) (NEO: CYBN) announced that the United States Patent and Trademark Office has issued two patent grants that offer protection for its deuterated N, N-dimethyltryptamine (“DMT“) program.

“Following Cybin’s recent acquisition of Small Pharma Inc., our development programs are protected by 32 granted patents and over 170 pending applications, establishing our leadership position in developing novel tryptamine-based therapeutics in a key market. This multi-layered and robust IP protection includes composition of matter, medical use, synthesis and drug product protection, providing us with the latitude to advance our deuterated programs with confidence,” said Doug Drysdale, Cybin’s Chief Executive Officer.

The granted patents cover Cybin’s deuterated DMT program and are as follows:

United States patent no. 11,771,681, which provides a composition of matter protection for certain deuterated analogs of DMT; and

United States patent no. 11,773,062, which provides protection for medical use and the novel, efficient, and scalable synthesis of certain analogs of DMT.

Cybin said its proprietary novel deuterated DMT compounds, CYB004 and SPL028, are each currently in Phase I clinical trials. CYB004 and SPL028 target an extended DMT psychedelic experience while retaining a short-duration drug profile that could provide optimized dose formulations for different administration routes and distinct therapeutic benefits for patients. The company said that preliminary findings from the studies demonstrate that IV CYB004 and SPL028 elicit a psychedelic experience of less than 1 hour and are well-tolerated. Topline data readouts from both studies are expected in Q4 2023.

According to the National Library of Medicine, “Deuteration refers to the selective replacement of protium hydrogen isotope atoms in small-molecule drugs with deuterium hydrogen isotope atoms. Deuteration of a drug is most likely to affect pharmacokinetic properties, such as metabolism, rather than its pharmacodynamic effects. For this reason, the metabolism of certain drugs may be favorably influenced when deuterium is substituted for protium, resulting in improved safety, tolerability, or efficacy.”

In September, Cybin said it had successfully obtained a U.S. patent for the compounds it uses in pre-clinical deuterated tryptamine research. The patent, No. 11,746,088, is valid until 2041.