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MIRA says ketamine-based drug beats current pain treatments in study

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MIRA Pharmaceuticals Inc. (NASDAQ: MIRA) said its experimental ketamine-based drug outperformed currently available pain treatments in preclinical studies, building on months of research that show why the compound might succeed where other treatments have failed.

The drug, known as Ketamir-2, demonstrated up to 112% more effective results than pregabalin (Lyrica) and 70% greater relief than gabapentin (Neurontin) at higher doses, the Miami-based company said Monday. The findings follow an August breakthrough where the compound achieved complete reversal of neuropathic pain in animal studies.

“Ketamir-2, a non-opioid, offers tremendous promise for patients seeking better solutions for neuropathic pain without the habit-forming risks or debilitating side effects associated with existing medications,” Erez Aminov, chairman and CEO of MIRA Pharmaceuticals, said in Monday’s statement.

The comparative results cap several months of scientific developments for MIRA. In July, researchers discovered the compound isn’t affected by a key protein that typically pumps drugs out of the brain, potentially allowing for better absorption than traditional ketamine. The following month, the company identified that the drug’s principal metabolite, called Nor-Ketamir-2, achieves nearly 100% oral bioavailability with an extended therapeutic window.

“Traditional ketamine’s limitations, including its low oral bioavailability and extensive receptor interactions, have hindered its widespread use,” Dr. Itzchak Angel, MIRA’s chief scientific advisor, said in an August statement. The company’s findings at the time suggested “a potentially safer and more effective treatment that could be administered at home.”

The research will be presented at the Annual Pain Therapeutics Summit in Boston later this month.

The development push comes as MIRA tries to stay afloat. The company reported using approximately $1.9 million in operating activities during the first half of 2024, leaving it with $2.8 million in cash as of June 30, according to SEC filings. In August, MIRA entered into an At The Market offering agreement to sell up to $19.3 million in common stock.

MIRA is targeting a neuropathic pain treatment market that’s projected to reach $5.2 billion across the U.S., Canada and Mexico by 2030. Within that space, gabapentin alone is expected to reach $4.95 billion by 2033.

Current treatments often come with significant drawbacks. Gabapentin can cause drowsiness and cognitive impairment, while pregabalin carries risks of dependence and withdrawal symptoms, according to company statements.

The U.S. Drug Enforcement Administration also previously determined that the compound would not be classified as a controlled substance, which could simplify its path to market.

“What sets Ketamir-2 apart from other current neuropathic pain treatments is its unique profile: It is not an opioid, does not share the dependency risks associated with opioids, and is classified as a non-controlled substance,” the company noted in a previous statement.

MIRA plans to file an Investigational New Drug application with the FDA by December, with human trials expected to begin in early 2025.

Beyond pain management, MIRA is also exploring Ketamir-2’s potential use in treating post-traumatic stress disorder (PTSD) and is pursuing government grants to speed development for additional neuropsychiatric conditions.

MIRA is also advancing MIRA-55, a pharmaceutical marijuana analog, for treating anxiety and cognitive decline. In July, the company reported that MIRA-55 demonstrated “higher efficacy at both the CB1 and CB2 cannabinoid receptors compared to THC” in preclinical studies.

The company went public in August 2023, raising $9 million through an IPO priced at $7 per share. The stock has since fallen to around $1.05, giving MIRA a market value of approximately $17 million.



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Nebraska medical cannabis regulations stall in legislative committee

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A Nebraska legislative committee voted 5-3 against advancing a bill designed to implement and regulate the state’s medical cannabis program, leaving legislators and advocates searching for alternative paths forward, according to the Nebraska Examiner.

The General Affairs Committee rejected Legislative Bill 677, sponsored by State Sen. Ben Hansen of Blair, during a Thursday vote where committee members declined to offer amendments to the legislation, the publication reported.

“I don’t want to shut all the doors right now, but some doors are closing, and they’re closing fast, and so we have to act,” Hansen told reporters after the vote, according to the Examiner.

Nebraska voters approved medical cannabis in November 2024, with residents legally permitted to possess up to 5 ounces with a healthcare practitioner’s recommendation since mid-December. However, the regulatory commission created by the ballot initiative lacks effective power and funding to regulate the industry.

Hansen described his legislation as “a must” for 2025 to prevent a “Wild West” scenario in the state’s cannabis market. The bill would have expanded regulatory structure through the Nebraska Medical Cannabis Commission and extended deadlines for regulations and licensing to allow more time for implementation, the Examiner noted.

Committee disagreements centered on proposed restrictions. A committee amendment would have prohibited smoking cannabis and the sale of flower or bud products while limiting qualified healthcare practitioners to physicians, osteopathic physicians, physician assistants or nurse practitioners who had treated patients for at least six months.

The amendment also would have limited qualifying conditions to 15 specific ailments including cancer, epilepsy, HIV/AIDS, and chronic pain lasting longer than six months.

State Sen. Bob Andersen of Sarpy County opposed allowing vaping due to concerns about youth drug use, while committee chair Rick Holdcroft suggested selling cannabis flower would be “a gateway toward recreational marijuana,” a claim Hansen “heavily disputed,” according to the Examiner.

Hansen now faces a difficult path forward, requiring at least 25 votes to pull the bill from committee and then needing 33 senators to advance it across three rounds of debate, regardless of filibuster attempts.

Crista Eggers, executive director of Nebraskans for Medical Marijuana, remained optimistic despite the setback.

“This will not be the end,” Eggers said, according to the outlet. “Giving up has never been an option. Being silenced has never been an option. It’s not over. It’s not done.”

The legislative impasse is further complicated by ongoing litigation. Former state senator John Kuehn has filed two lawsuits challenging the voter-approved provisions, with one appeal pending before the Nebraska Supreme Court. The state’s Attorney General is also trying to do something about the hemp question, akin to other states across the country.



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One of Las Vegas’ cannabis lounges closes its doors

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Nevada’s cannabis lounge experiment faces some expected growing pains, with one of just two state-licensed venues closing its doors after barely a year in business, according to the Las Vegas Weekly.

“The regulatory framework, compliance costs and product limitations just don’t support a sustainable business model,” said Thrive Cannabis managing partner Mitch Britten, who plans to convert the space into an event venue until regulations loosen up.

The closure leaves Planet 13’s Dazed Consumption Lounge as the only operational state-regulated cannabis lounge in Nevada. Dazed manager Blake Anderson estimates the venue attracts around 250 customers daily, primarily tourists. One other establishment, Sky High Lounge, has operated since 2019 on sovereign Las Vegas Paiute Tribe land exempt from state regulations.

Even with Nevada regulators conditionally approving 21 more lounge licenses, potential owners are struggling to meet the $200,000 liquid assets requirement – particularly social equity applicants from communities hit hardest by prohibition.

Recreational marijuana has been legal statewide since 2017, but public consumption remains prohibited. That’s created an obvious disconnect for the millions of tourists who visit Las Vegas annually but have nowhere legal to use the products they purchase. The state recorded roughly $829 million in taxable sales during the 2024 fiscal year.

“It always comes down to money, and it’s difficult to get a space if you can’t afford to buy a building. On top of that, getting insurance and finding a landowner who’s willing to lease to a cannabis business is a challenge in and of itself,” said Christopher LaPorte, whose consulting firm Reset Las Vegas helped launch Smoke and Mirrors, told Las Vegas Weekly.

Many think the key to future success lies in legislative changes that would allow lounges to integrate with food service and entertainment – playing to Las Vegas’s strengths as a hospitality innovator. In the meantime, the industry will continue to adapt and push forward.

“Things take time,” LaPorte said. “There’s a culture that we have to continue to embrace and a lot of education that we still have to do. But at the end of the day, tourists need a place to smoke, and that’s what these places are.”



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Psyence Group consolidates its shares

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Psyence Group Inc. (CSE: PSYG) told investors that it will be consolidating all of its issued and outstanding share capital on the basis of every 15 existing common shares into one new common share effective April 23, 2025 with a record date of April 23, 2025. As a result of the consolidation, the issued and outstanding shares will be reduced to approximately 9,387,695 on the effective date.

This is the second time a Psyence company has consolidated shares recently. In November, its Nasdaq-listed associate, Psyence Biomedical Ltd. (Nasdaq: PBM), implemented a 1-for-75 share consolidation as the psychedelics company worked to maintain its Nasdaq listing.

Psyence Group reported earnings in February when the company delivered a net loss of C$3 million and was reporting as a going concern. At the end of 2024, the company said it had not yet achieved profitable operations, has accumulated losses of C$48,982,320 since its inception.

Total assets at the end of 2024 were C$11,944,478 and comprised predominantly of: cash and cash equivalents of C$10,611,113, other receivables of C$159,808, investment in PsyLabs of C$1,071,981 and prepaids of C$68,243.

Still, the company is pushing ahead. Psyence told investors that it has historically secured financing through share issuances and convertible debentures, and it continues to explore funding opportunities to support its operations and strategic initiatives. “Based on these actions and
management’s expectations regarding future funding and operational developments, the company believes it will have sufficient resources to meet its obligations as they become due for at least the next twelve months,” it said in its last financial filing.

The company said it believes that the consolidation will position it with greater flexibility for the development of its business and the growth of the company.

 



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