Cybin Reports Access To $101M To Sustain Deuterated Psychedelics Programs, Q2 Numbers & 2024 Goals

Clinical-stage psychedelics biotech Cybin Inc. CYBN released its financial results for second quarter ended September 30, 2023.

• Cash totaled $13.25 (CA$18.1) million by Sept. 30, vs. $13.17 million by August 14, $6.81 million by June 30, and $12.17 million by March 31, 2023.

• Three and six-month R&D expenses of $4.9 million and $9.57 million, respectively 30.3% and 16.8% increases as per the numbers of the comparable 2022 periods ($3.76 million and $8.19 million.)

• Three and six-month G&A expenses of $4.24 million and $7.94 million, tuned down 5.1% and 4% as per the numbers of the comparable 2022 periods ($4.47 million and $8.27 million, respectively.)

• Three and six-month net loss of $8.7 million and $19.47 million, vs. $7.3 million and $16.85 million in the same periods in 2022.

See full Q1 results.

• Quarterly cash-based operating expenses totaled $9.2 million vs. $8.3 million in the comparable period in 2022.

• Quarterly cash flows used in operating activities were $8.4 million vs. $10.8 million in the same period in 2022.

• Quarterly cash flows received from financing activities of $14.9 million vs. $3.4 million in the same period in 2022.

• Accumulated deficit of $127.74 million by Sept. 30, a 17.8% six-month increase as compared to $108.42 million by March 31.

The quarterly cash flows are linked to the net proceeds on the common shares issuance through an August financing plus an ATM equity program. 

Together with the latest units’ offering completed Nov. 14 led by one of its largest institutional shareholders, Cybin’s current cash position, current ATM program and assuming exercise in full of the warrants issued as part of the units, the company reports having access to over $101 (CA$138) million.

‘Ample Momentum’ For Broadened Pipeline & Business

CEO Doug Drysdale reaffirms that Cybin’s mission has always been to advance its clinical programs “with the goal of changing the treatment landscape in mental health,” further highlighting the team’s “enormous progress” during Q3 and the company’s current “ample momentum” toward 2023 wrap-up and into 2024.

Quarterly efforts include:

• Positive Phase 2 interim data for CYB003 (novel deuterated psilocybin analog) in Major Depressive Disorder (MDD). 

• Completion of acquisition of Small Pharma Inc., now a wholly-owned subsidiary, enabling the DMT and deuterated DMT combined programs “the most advanced dataset” of systematic research on the short-duration psychedelic molecules.

• Positive topline data from Phase 1b SPL026 (DMT)-SSRI drug interaction study in MDD.

• Positive results earlier in 2023 from a Phase 2a trial on safety, tolerability and efficacy of intravenous SPL026 with supportive therapy in patients with moderate-severe MDD. The data reportedly demonstrates proof-of-concept for deuterated DMT and serves “to further de-risk” this development program.

• Added four new patents to IP portfolio, including three U.S. patents covering composition of matter of certain deuterated tryptamines around the CYB003 and CYB004 programs, methods of treating MDD and TRD, medical use and novel synthesis of certain DMT analogs; and one European patent covering composition of matter of certain deuterated tryptamines including deuterated psilocybin analogs within the CYB003 program and deuterated DMT analogs within Cybin’s DMT program, as well as their medical use.

Next-up milestones include:

• Complete Phase 2 topline safety and efficacy data readout for CYB003 in MDD (including 6-week data and results on incremental benefit of a second dose) expected in Q4 2023; additional data on effect durability (at 12 weeks) expected in Q1 2024. Consequent data submission to FDA for end-of-Phase 2 meeting, aiming Q1 2024.

• Progression to an international, multisite Phase 3 trial “in early 2024” to further evaluate safety and efficacy of CYB003 capsules in a larger MDD patient population, recruiting expected to begin by end of Q1 2024.

• Phase 1 study data on dosing, PK/PD and safety for CYB004, and Part A data for SPL028, expected around year-end 2023.

• Initiation of Phase 2 proof-of-concept study in participants with Generalized Anxiety Disorder (GAD) in Q1 2024.

• A CYB004 subcutaneous (SQ) formulation study in Q1 2024, plus the SPL028 formulation work.

• Photo: Benzinga edit with photo by RF._.studio on Pexels and Jynto on Wikimedia Commons.