Psychedelic: NRx Pharmaceuticals reports Q2 earnings

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, completion of a trial’s SAD portion and study results.

NRX PHARMACEUTICALS REPORTS Q2 EARNINGS: On Monday, NRx Pharmaceuticals (NRXP) reported a second quarter loss per share of (98c), which compared to a loss per share of (75c) for the same period last year. As of June 30, NRx had approximately $2.9M in cash and cash equivalents. The company believes that its current cash position will support operations into 2026 and provide sufficient capital to reach expected regulatory inflection points.

“NRx has made remarkable progress with all three of our lead programs in recent months,” said CEO Jonathan Javitts. “Additionally, we have now attracted our first group of fundamental biotechnology investors who have joined us to partner in building a successful commercial enterprise and contributed sufficient capital to reach expected regulatory inflection points. The investor group has aligned its interests in the future growth of our enterprise by purchasing restricted common stock that is subject to a one-year lockup agreement and is devoid of warrants, repricing mechanisms, or other mechanisms that are likely to cause future dilution. Furthermore, the B Group Capital led consortium of investors is strategic as it relates to our efforts to scale-up and develop our HOPE Therapeutics business with the potential to bring future partnerships and operational infrastructure to more quickly realize the potential of our HOPE clinic strategy. Last week, we received a markedly expanded Fast Track designation from FDA that establishes the unmet medical need associated with using NRX-100 to treat suicidal depression in more than 13M Americans each year. Over the past quarter and in subsequent events, we filed an application under the Commissioner’s National Priority Voucher Program, filed a patent with the USPTO, filed an ANDA for existing indications, and a Citizen’s Petition to remove Benzethonium Chloride from IV ketamine products. The Fast Track determination just received qualifies NRX-100 for the stated requirements of the CNPV. We have continued to advance NRX-100, initiated filing of an NDA for Accelerated Approval in bipolar depression and akathisia, and advanced our development of the HOPE clinic network.”

MIRA COMPLETES SAD PORTION FOR PHASE 1 KETAMIR-2 TRIAL: MIRA Pharmaceuticals (MIRA) announced Tuesday the completion of the Single Ascending Dose portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2. The study, conducted at the Hadassah Clinical Research Center in Israel under the direction of Principal Investigator Prof. Yoseph Caraco, demonstrated a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed to date. The study is designed to establish the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adult volunteers. To date, no severe or clinically significant adverse effects have been observed at any dose level in the SAD portion of the study. The company is advancing to the Multiple Ascending Dose portion, which will evaluate three cohorts receiving daily oral doses of 150 mg, 300 mg, or 600 mg for five consecutive days in up to 24 participants.

“Completion of the SAD portion with a favorable safety and tolerability profile is an important milestone in the clinical development of Ketamir-2,” said Caraco. “Importantly, no severe or clinically significant adverse effects have been observed to date, which supports continued progression into the Multiple Ascending Dose stage of the trial.”

SILO REPORTS RESULTS FROM SPC-15 LARGE ANIMAL SAFETY STUDY: Silo Pharma (SILO) announced Tuesday bioanalytical and safety/toxicology results for its U.S. Food and Drug Administration-requested 7-day large animal safety study of its lead asset SPC-15. The preclinical study compared the safety and overall exposure of the SPC-15 intranasal spray formulation to oral drug administration. Data showed that SPC-15, administered at clinical-representative doses, demonstrated local and systemic safety with no toxicities identified. The study also showed that systemic exposure of intranasal SPC-15 administered at the anticipated therapeutic range is comparable to standard oral administration, which the company believes validates the drug’s potential as a targeted intranasal therapeutic for PTSD and stress-induced anxiety that has a potentially greater safety profile.
Silo CEO Eric Weisblum commented,

“Overall, we believe the positive results of this study confirm that SPC-15’s formulation and spray profile meets the safety standards for clinical trials. While the safety of the oral counterpart to SPC-15 is well documented, our challenge was to develop a viable intranasal therapeutic dose that meets the same safety standards while offering distinct advantages over oral delivery. So far, we believe our intranasal nose-to-brain formulation has met that challenge and supports our potential to bring a safe, easily administered, and rapidly absorbed PTSD therapeutic to market.”

REUNION ACHIEVES PRIMARY ENDPOINT IN RECONNECT TRIAL: On Monday, Reunion Neuroscience announced topline results from its RECONNECT Phase 2 clinical trial evaluating RE104 in adult female patients with moderate-to-severe postpartum depression. RECONNECT met its primary endpoint with a single 30mg subcutaneous dose of RE104 demonstrating a statistically significant reduction from baseline of 23.0 points in the Montgomery-Åsberg Depression Rating Scale total score on Day 7, as compared to a reduction of 17.2 points in patients treated in the active control arm with a 1.5mg dose of RE104. Clinically meaningful reductions in MADRS were observed for RE104 30mg on the first day following administration and maintained through the Day 28 follow-up. 77.1% of patients treated with RE104 30mg demonstrated a response to therapy at Day 7, defined as at least a 50% improvement from baseline MADRS total score, as compared to 61.6% of patients who received Active Control. 71.4% of patients treated with RE104 30mg were in remission at Day 7, defined as a total MADRS score of ≤10, as compared to 41.0% of patients who received Active Control. Both response and remission rates were maintained through the Day 28 follow-up. Other key secondary endpoints demonstrated improvements in symptoms that were supportive of the primary endpoint, including the Barkin Index of Maternal Functioning scale, a self-reported measure that assesses overall maternal functioning, providing a holistic view of the patient’s well-being and ability to manage life with a new baby. In RECONNECT, RE104 was observed to be generally well-tolerated, consistent with previously reported Phase 1 safety data with RE104 and other psychedelic agents. The most commonly reported treatment-emergent adverse events were nausea, occurring in 43.9% of patients, and headache, occurring in 34.1% of patients; these adverse events were generally mild to moderate, occurred primarily on the day of treatment, resolved spontaneously, and are consistent with those observed with other agents in the class. 

Reunion also announced initial data from its clinical lactation study. Preliminary results from the study suggest that the total amount of metabolites observed in the breastmilk represents less than 0.1% of the 30mg RE104 administered to the mother, an order of magnitude below the level that might potentially cause risk to the infant. While final data from the study will be reviewed by the FDA, Reunion believes these results suggest that mothers who wish to return to breastfeeding following RE104 treatment may be able to do so with limited interruption.

“We are encouraged by the results from our RECONNECT Phase 2 trial, which provide strong clinical validation for RE104 as a well-tolerated and effective treatment for PPD offering rapid relief with minimal interruption to daily activities,” said Mark Pollack, CMO. “These data support our proposed plan to advance RE104 into a pivotal Phase 3 trial in 2026.”

OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Bright Minds Biosciences (DRUG), Compass Pathways (CMPS), Clearmind (CMND), Cybin (CYBN), Enveric Biosciences (ENVB), Filament Health (FLHLF), GH Research (GHRS), Incannex (IXHL), Mind Medicine (MNMD), Numinus Wellness (NUMIF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC) and Seelos Therapeutics (SEEL).