Psychedelics biopharma company Reunion Neuroscience Inc. (NASDAQ:REUN) reported its business update and fiscal results for the second quarter ended September 30, 2022.
Reunion’s president and CEO Greg Mayes stated that the company has consolidated as an independent company and is “well positioned to round out the year in preparation for what promises to be an exciting 2023.”
Mayes further announced that Reunion has dosed all subjects in the first four cohorts of its Phase 1 study for which a readout date has been set for some time within Q1 2023. The company is strengthening its leadership team with newly-appointed Edward Smith as CFO, Dr. Aviva Asnis-Alibozek VP of medical affairs and Curtis Weber general counsel to advance its next growth stage.
“Reunion’s strong composition of matter IP significantly differentiates us from other psychedelic therapeutic companies. Making Reunion even more exciting is the company’s development program, which targets a niche initial indication with high unmet therapeutic need –PPD [Post-Partum Depression],” the company’s CEO said.
Financial results: On September 30, 2022 Reunion held cash, cash equivalents and investments of almost $27.6 million (CA$36.7 million)
R&D expenses for the three and six-month periods ended September 30, 2022 were of $1.6 million (CA$2.2 million) and $3.8 million (CA$5.1 million) respectively, compared to $1.6 million (CA$2.2 million) and $2.7 million (CA$3.6 million) respectively for the same periods in 2021.
G&A expenses for the three and six-month periods totaled $2.8 million (CA$3.7 million) and $4.4 million (CA$5.9 million) respectively, compared to $1.4 million (CA$1.9 million) and $2.5 million (CA$3.3 million) for the same periods in 2021, partly due to costs associated with becoming a public company with increased scale of operations over novel clinical stage for lead asset RE104.
Net loss from discontinued operations -attributable to the spinout of clinic operations- for the three and six months ended September 30, 2022 was $1.6 million (CA$2.2 million) and $7.8 million (CA$10.4 million) respectively, compared to $7.9 million (CA$10.5 million) and almost $15 million (CA$19.6 million) for the same periods in 2021.
Net loss from continuing operations for the three and six months totaled $10.4 million (CA$13.9 million) and $14.4 million (CA$19.2 million) respectively, compared to a loss of almost $1.9 million (CA$2.5 million) and $4.4 million (CA$5.9 million) for the same periods of 2021.
Business Highlights
For the quarter ended September 30, 2022, Reunion’s clinical-stage candidate, patent-protected pro-drug of 4-OH-DIPT, RE104, aimed primarily at patients suffering from postpartum depression, was successfully dosed in Phase 1 clinical trials and its planned interim analysis is set for release in Q1 2023.
The study assesses the safety, tolerability, pharmacokinetics and pharmacodynamic effects of RE104 over a range of dosage levels, for which protocol up to two additional dosing cohorts may be evaluated.
Data generated from the interim analysis will be used to support pre-IND meetings with the FDA in early 2023 together with plans for a following Investigational New Drug (IND) application.
Reunion’s other development is the RE200 series, novel molecules that are structurally similar to classical psychedelics but have selective potency at the target serotonin 2A receptor (5HT2A) and are devoid of 5HT2B receptor agonism.
During this second quarter, the company advanced in its understanding of some of the structural features defining this class of new chemical entity (NCE) molecules, initiated preclinical work to identify potential candidates in the RE200 series, and strengthened its patent portfolio.
Photo by Artem Kovalev on Unsplash
