Reunion Neuroscience Touts 'Transformative' Quarter, Reaffirms Postpartum Depression Treatment

Zinger Key Points
  • In January, Reunion completed its Phase 1 placebo-controlled study.
  • Reunion’s other pipeline program is the RE200 series, which are novel molecules structurally similar to classic psychedelics.

Clinical-stage psychedelics biotech Reunion Neuroscience Inc. REUN shared its unaudited financial results for the third quarter, as of Dec. 31, 2022.

Cash and investments totaled $24.3 (CA$32.4) million by December 31, 2022.

For the three and nine-month periods, R&D expenses were $2.6 and $6.5 million respectively, compared to $826,000 and $3.6 million for the same periods in 2021.

See Also: Health Canada Grants Exemption: Phase 2 Trial On Psilocybin For Genetic Disorder

Net loss from continuing operations was $9.4 million, or $0.8 per share, and $23.7 million — or $2.04 per share — for the three and nine-month periods ended Dec. 31, 2022, compared to $4.4 million and $8.9 million for the same periods the prior year.

Net loss from discontinued operations — see 2022’s clinic operations spinout — was only present during the nine-month period and totaled $7.8 million, compared to a $6.8 and $21.6 million loss for the three and nine months ended Dec. 31, 2021.

President and CEO Greg Mayes called it a “transformative quarter” for the company. 

“We enter 2023 well positioned, with both encouraging clinical data and a highly experienced executive leadership team in place to execute on our mission to rapidly and efficiently develop RE104 as a potential therapeutic option for the millions of patients underserved by today’s standard of care in depression and other mental health disorders,” commented Mayes. 

Pipeline And Business Update

Proprietary patented serotonergic psychedelic compound RE104 -reportedly the only 4-OH-DiPT prodrug in development- continues advancing through the clinical stage as a potential fast-acting, durable treatment for patients suffering from Postpartum Depression (PPD.)

This condition represents a priority clinical development opportunity: one in eight mothers experience PPD and there is only one FDA-approved treatment for the condition, which is administered via continuous infusion over a 60-hour inpatient hospital stay and has a black box safety warning due to excessive sedation and potential for sudden loss of consciousness.

RE104 could potentially provide mothers with both fast relief and return to mother-child bonding and breastfeeding (an estimated 24 to 48 hours) due to RE104’s limited-duration psychoactive experience (between three and four hours), durable efficacy and rapid washout period. 

In January, Reunion completed its Phase 1 placebo-controlled study’s interim data analysis showing RE104’s safety and tolerability with no serious or severe adverse events in the 32 healthy volunteers, together with a shorter duration of the psychedelic experience as compared to psilocybin.

After the readout, the company is continuing the study with dose escalation to seek additional safety, pharmacokinetic and pharmacodynamic data in two additional cohorts towards an upcoming multicenter Phase 2 trial.

Reunion’s other pipeline program is the RE200 series, which are novel molecules structurally similar to classic psychedelics but with enhanced receptor selectivity — targetting serotonin 2A receptor (5HT2A) and devoiding 5HT2B receptor agonism — to address further therapeutic applications.

Photo: Benzinga edit with photo by Marcos Mesa Sam Wordley and Zita on Shutterstock.

Posted In: CannabisEarningsNewsPenny StocksPsychedelicsGuidanceManagementGlobalMarketsfinancial resultsNext-Generation PsychedelicsPostpartum Depression
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