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Relmada Therapeutics says it has enough cash to get through its milestones

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After markets closed on Wednesday, Relmada Therapeutics, Inc. (Nasdaq: RLMD) delivered its financial results for the second quarter ending June 30, 2024. The company does not have revenue to report at this time.

Relmada told investors that the net loss for the quarter was $17.8 million, or $0.59 per basic and diluted share, compared with a net loss of $25.3 million, or $0.84 per basic and diluted share, for the second quarter of 2023. This was better than the Yahoo Finance average analyst estimate for earnings of ($0.68).

Net cash used in operating activities was flat at $13.3 million. The company’s CFO Maged Shenoudawe said, “We believe our current cash position is adequate to support operations into 2025 through key milestones, including the top-line from the Reliance II study.” Relmada has $70 million in cash.

Expenses decline

Relmada told investors that research and development expenses in the quarter fell to $10.7 million from last year’s $13.7 million. The company attributed the drop to decreased study costs associated with completing two Phase 3 trials and the long-term, open-label, safety trial (Study 310).

“Relmada’s clinical programs have made meaningful progress this year. We believe that the portfolio, led by the Phase 3 program for REL-1017 as a potential adjunctive treatment for major depressive disorder (MDD), is poised to reach important milestones that could represent inflection points for Relmada,” said CEO Sergio Traversa. “We believe that our two ongoing Phase 3 trials, Reliance II and Relight, have been carefully designed to enhance the probability of success by appropriate patient adjudication in each study. We expect to complete enrollment in Reliance II by year-end 2024, to be followed by Relight
6-months after that.”

The general and administrative (G&A) expenses also dropped to $8.1 million versus last year’s $12.3 million, which was primarily driven by a decrease in stock-based compensation expense.

Milestones

The company said that completing the Phase 3 program of REL-1017 was its number-one objective, and it will complete the study package required to file the NDA.

The company said on its earnings call that it expects two important milestones from the Reliance II study before the end of the year, with the output of a pre-planned interim analysis, which includes both a futility analysis and a simple size re-estimation, if necessary, and the completion of enrollment of the Reliance II study.

It also expects the completion of enrollment of Reliance to follow approximately six months after that. Traversa said on the call, “Preparations are on track to begin the clinical program for REL-P11. Our appropriate data is silo-side formulation for metabolic disorder later this quarter or early next quarter. We believe our financial resources will support our planned operations into 2025 through key milestones including top-lay data from the Reliance II study.”

Dr. Traversa continued, “In addition, we are advancing preparations to begin the clinical program for REL-P11, our low-dose, modified-release psilocybin formulation for potential treatment of metabolic disorders, and intend to initiate a Phase 1 study in Canada before year-end 2024.”



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Massachusetts regulators order single-lab testing to combat cannabis lab shopping

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Massachusetts regulators will require cannabis businesses to use a single laboratory for all compliance testing in an effort to prevent companies from shopping around for favorable test results.

The state’s Cannabis Control Commission voted 3-0 to require licensed businesses submit testing samples to one independent laboratory starting April 1, 2025, according to an administrative order advanced Thursday. The new rule is meant to close loopholes that some say have allowed companies to shop around for labs to juice their numbers for market share.

“This administrative order continues our mission of being a strong regulator,” Acting Executive Director Debbie Hilton-Creek said in a statement.

Under current rules, companies can split testing among multiple labs. The practice has led some facilities to report suspiciously high THC levels or overlook contamination to attract business.

The commission’s enforcement team said the changes would reduce risks of noncompliant products reaching consumers and improve audit capabilities. The move follows a November listening session in which testing concerns were raised, according to the announcement.

If an original testing lab needs to subcontract work, they must first obtain commission approval and demonstrate they are “incapable of performing certain required tests due to a hardship.” Labs also can only subcontract with one other facility at a time.

“The commission shall only approve subcontracting agreements when the Originating Independent Testing Laboratory is incapable of performing certain required tests due to a hardship relative to its facilities, instrumentation, personnel, or required consumable materials or in the event of an actual or potential conflict of interest,” according to the order.

Results must be uploaded to the state’s tracking system within 72 hours, with all certificates of analysis containing the complete testing results, including any subcontracted work, it said.

The commission will also begin publishing THC test results on its public data platform and establishing regular meetings with licensed laboratories to improve oversight.

The commission thus far has struggled to implement effective testing oversight. Earlier this year, the agency contracted with a private lab for a “secret shopper” program to verify retail products’ test results, Green Market Report previously reported. Unlike other major cannabis markets such as California and Colorado, Massachusetts lacks a state reference lab to independently verify commercial lab results.

Analysis of testing data by MCR Labs found that across multiple states, laboratories reporting higher THC concentrations tend to increase their market share while those reporting average failure rates lose business, according to Chemical & Engineering News.



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Cansortium completes merger with RIV Capital, plans to scale up in New York

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Florida-based Cansortium (CSE: TIUM.U) (OTCQB: CNTMF), which does business as Fluent, has finalized its megamerger with New York-based RIV Capital, (CSE: RIV) (OTC: CNPOF), creating a new multistate operator that has a footprint in four states with 42 operational dispensaries.

The move gives Cansortium immediate access to New York, one of the fastest-growing legal marijuana markets in the nation, along with its existing portfolio of cannabis shops and grows in its home state, Pennsylvania and Texas. The company now owns eight total cultivation and processing facilities, which it said in a press release would allow it to bolster the Fluent brand even more going forward.

The company reportedly has $33 million in the bank with which to finance further acquisitions, it said in a Thursday announcement.

Another major winner in the deal is Scotts Miracle-Gro, which has a sizable stake in RIV Capital through its subsidiary The Hawthorne Collective. Existing shares will be converted into 1.245 shares of the newly formed Fluent, eliminating $160 million in company debt.

Shareholders of Cansortium will own 51.25% of the new Fluent, while shareholders of RIV Capital will own 48.75%, the company said. The company will continue trading under Cansortium’s existing ticker symbols on the Canadian Securities Exchange and the Over-The-Counter markets.

Cansortium CEO Robert Beasley will continue to lead the new company, and RIV Capital interim CEO David Vautrin will serve as the new company’s chief commercial officer.

Beasley said in the release that Fluent intends to scale up wholesale operations in New York to boost its Moods brand of marijuana products and “gain additional shelf space in dispensaries across the state,” which he said has “immense potential.”

The merger could prove key to the long-term prospects for both Cansortium and RIV Capital. Cansortium posted an $11.7 million net loss for the third quarter of 2024, and RIV Capital reported a $63.4 million net loss for the same period.

“Looking ahead, we remain focused on sustainable, long-term growth and will continue to drive efficiencies across all areas of the business to achieve our profitability and cash generation goals,” Beasley said.



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The Daily Hit: December 19, 2024

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News from: US Farm Bill, Fluent Cannabis, Massachusetts and more.

The Daily Hit is a recap of the top financial news stories for Thursday, December 19, 2024.

On the Site

Farm Bill extension leaves hemp industry rules intact for now, including intoxicating products

The farm bill extension would run through March 2025.

Read more here.

Cansortium completes merger with RIV Capital, plans to scale up in New York

Scotts Miracle-Gro, which is a major investor in RIV, also benefits from the deal.

Read more here.

Massachusetts regulators order single-lab testing to combat cannabis lab shopping

The rule change follows growing evidence of inconsistent testing practices in the state’s $7 billion cannabis industry.

Read more here.

Nine New York social equity retailers ask to join lawsuit halting cannabis licensing for 3rd time

A court filing argued that the group of CAURDs are in danger of bankruptcy if the injunction is not removed soon.

Read more here.

In Other News

Greenway Greenhouse Cannabis Corp.

Greenway Greenhouse Cannabis Corp. entered into an asset purchase agreement to acquire all of Choice Growers’ consumer packaged goods brands, SKUs and listings of the brands, trademarks, goodwill and other associated intellectual property. This acquisition encompasses all of Choice Growers’ brands, including Grapefruit God Bud (also known as Grape God), The Jeffrey, Watermelon Pebbles, Pink Lemonade, Duke Nukem, Tangerine Dream and Blackberry Cheesecake.

Read more here.

Innocan Pharma Corp.

Innocan Pharma Corp. intends to complete a non-brokered private placement of up to 3.5 million units of the company at a price of C$0.20 per unit for gross proceeds up to C$700,000 plus 15% overallotment options. The offering is expected to close on or around Dec. 31.

Read more here.



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