Grow Life 420

Gilgamesh Pharmaceuticals announced the successful completion of its Phase 1 single ascending dose (SAD) trial of GM-2505. In the Phase 1 study, Gilgamesh reported that the GM-2505 patients reached a peak intensity consistent with a full psychedelic experience, while the duration of those effects was limited to 60-90 minutes.

According to the company, GM-2505 is a novel, patented small molecule, short-acting 5-HT2A receptor agonist/5-HT releaser that is expected to have a rapid and durable antidepressant effect. It is expected to produce dramatic changes in human consciousness, perception, emotion, and cognition.

Given the limited number of trained therapists, Gilgamesh believes it will be able to treat more patients than those that only have multi-hour psychedelic treatment options.

“We were thrilled to obtain clinical confirmation of the short half-life and strong psychedelic effects of GM-2505 that were suggested by preclinical data and look forward to advancing this promising therapeutic candidate into patients,” said Andrew Kruegel, PhD, CSO and co-founder of Gilgamesh.

The company believes that GM-2505’s short duration of action will harness the impressive clinical efficacy of other 5-HT2A receptor agonists while better aligning with existing health care infrastructure and clinical workflow, which will broaden patient access in contrast to longer-acting agents such as psilocybin.

“In the Gilgamesh Phase 1 study, a full range of GM-2505 doses have been tested with the highest doses of 15 and 20 milligrams manifesting a full psychedelic effect with minimal effects below 10 milligrams. This provides a basis to move confidently into initial Phase 2a testing in patients with GM-2505,”  Dr. Matthias Liechti said.

Following the successful completion of the Phase 1 SAD trial, Gilgamesh said it will initiate a Phase 2a study in major depressive disorder (MDD) patients during the first quarter of 2024. The Phase 2a study will aim to refine the dosing regimen, confirm safety, and demonstrate an early efficacy signal of GM-2505.

The company said that additional details will be presented at the American College of Neuropsychopharmacology meeting in December.

The post Gilgamesh Pharmaceuticals Gets Positive Results on Fast-Acting Psychedelic appeared first on Green Market Report.

A state commission charged with studying how to legalize marijuana in New Hampshire has issued its final report, capping off months of meetings at which members failed to agree on a way forward for cannabis policy in the state.

“Ultimately, the Commission voted not to recommend legislation for the 2024 Session,” the new report says. “The Commission was unable to reach a consensus because of a large number of unresolved issues.”

As the new legislative session kicks off next month, says the report, submitted by commission chair Sen. Daryl Abbas (R), the commission “expects legislation to be introduced but with no recommendation.”

Among the issues the group failed to craft agreements on, Abbas said, were the allowable THC levels in legal cannabis products, penalties for public consumption, rules around the operation of motor vehicles, the creation of an oversight body to approve Liquor Commission rulemaking, measures to prevent access by minors, the number of allowed retail stores statewide and whether to allow or prohibit home cultivation.

During the bulk of its hearings, the Commission to Study With the Purpose of Proposing Legalization, State Controlled Sales of Cannabis and Cannabis Products conducted a line-by-line review of draft legislation submitted by Abbas in October, which his staff emphasized was intended as a starting point. But after weeks of sometimes testy debate among members, the body voted against recommending the bill to lawmakers.

“The first motion of recommending draft legislation that the Commission worked on be introduced next session was defeated by a vote of 5-4,” Abbas wrote in his report to Gov. Chris Sununu (R), leaders of the House and Senate and other state officials. “A subsequent motion to make no recommendation was made and passed by a vote of 7-2.”

The panel was initially formed this summer to consider state-run cannabis stores, a model supported by Sununu that would mirror how the state handles liquor sales. But in September, members turned to consideration of an alternative, franchise-style system, under which the state would regulate the marijuana industry and oversee its look and feel while private licensees would handle cultivation and day-to-day retail sales.

While the body was already at loggerheads going into its final meeting, a list of last-minute demands by Sununu was a dealbreaker for some of the committee. The governor said he would support no more than 15 licensed marijuana retailers statewide and wanted to include provisions specifying that cannabis businesses be barred from lobbying or making political contributions.

Included in the commission’s December 1 filing are four additional reports submitted on behalf of certain members of the group. Abbas’s note says explicitly that those reports represent the views of the members who signed them, not the commission as a whole.

Notably, the so-called “majority report” included in the commission’s filings represents just four of the body’s 19 members. Several of those members—including Rep. Tim Cahill (R) and Debra Naro, executive director of Communities for Alcohol- and Drug-Free Youth (CADY)—seemed to broadly oppose legalization during commission meetings.

Naro, for example, at one point called the emerging legalization proposal “the most irresponsible, dangerous legislation that I have ever participated in,” while Cahill openly relished establishing harsh penalties for illegal use.

The four-member faction wrote in its report that “the majority concludes the proposed legislation proffered by the Commission is insufficient to protect the citizens of NH from the harmful public health and public safety effects arising from the legalization and commercialization of marijuana or cannabis in NH.”

Moreover, the four said, “the majority concludes there are no set of comprehensive safeguards, laws, policies or procedures that will adequately protect the health, safety and quality of life NH currently enjoys if marijuana was legalized.”

The group of four, which also included John Bryfonski of the New Hampshire Association of Chiefs of Police and Sen. William Gannon (R), said it “strongly rejects the proposition that legalization is inevitable but rather cites the fact that use of harmful controlled substances is a choice, not a foregone conclusion.”

In comments to local news station WMUR this week, two bipartisan lawmakers on the New Hampshire panel—Sens. Becky Whitley (D) and Timothy Lang (R)—disagreed.

I sat down with @AdamSextonWMUR to discuss why I support legalization. Failure to legalize cannabis in NH means we will continue to miss out on substantial revenues going to our neighboring states AND see continued harms caused by prohibition. #NHPoliticshttps://t.co/g6TqKxVAdq

— Becky Whitley (@BeckyWhitleyNH) December 4, 2023

Lang said while he personally has “almost…no position” on legalization, he agrees with Sununu that the policy shift is inevitable.

“I think I agree with the governor. It’s inevitable,” Lang said. “And so under that condition, being inevitable, I want to make sure that we have a good strong regulatory environment that will keep it away from children and keep our public safe.”

Whitley, the elected official on the commission who appeared most supportive of legalization, said that 74 percent of New Hampshire residents want to see marijuana made legal, “and so I think we have an imperative from our constituents to work towards that.”

Both Lang and Whitley doubted whether Sununu’s proposed ban on marijuana businesses lobbying or engaging in political advocacy would survive a court challenge.

Lang said he understood Sununu’s goal in restricting political activity, but he worried the proposal would raise First Amendment concerns.

Another of the included reports, from CADY’s Naro alone, consists of 18 pages of “substance misuse prevention guardrails” such as criminalizing public consumption of marijuana and setting a “presumptive level of marijuana impairment” at a blood THC level of 2 nanograms of THC per milliliter of blood.

Naro attempted to raise some of those issues during the commission’s meetings, but the suggestions were not incorporated into the group’s draft bill.

A third included report comes from ACLU of New Hampshire, which was represented on the commission by Frank Knaack. It opposes increased fines or criminal penalties for public cannabis consumption, saying they would “further the harms created by marijuana prohibition without any evidence to support the stated claim to curb public smoking.”

Knaack argued in commission meetings that there is no evidence to suggest that stiffer penalties effectively reduce public consumption, but Abbas and Cahill argued that with harsh enough penalties, people would get the message.

The ACLU report also recommends the establishment of a justice reinvestment fund that would reinvest in communities that have been disproportionately harmed by the drug war. That fund, which was recommended by the nonprofit New Futures, was left out of the commission’s final draft legislation despite Abbas saying he intended to include it.

ACLU also supported annulling past cannabis arrests and convictions and explicitly stating that the smell of marijuana alone does not constitute probable cause for purposes of a search. Abbas had said such a provision was unnecessary due to a state precedent involving alcohol, but some members of the commission pushed to include the provision in statute.

Yet another report, from the New Hampshire Medical Society, which was represented on the committee by Kimberly Youngren, encourages “increased research” on the impact of adult-use marijuana legalization as well as “the biologic actions and interactions of active constituents in cannabis and the development of U.S. Food and Drug Administration (FDA) approved cannabis medications.”

So far no legislative member of the commission has indicated they will introduce the body’s draft bill in the new session, though many nevertheless expect another push for legalization.

Already a number of proposals have been pre-filed or requested by lawmakers for the 2024 session. Among them include measures to legalize home cultivation of cannabis among medical patients and add eating disorders to the state’s list of qualifying conditions for medical marijuana.

Another requested bill, sponsored by Rep. Erica Layon (R) and eight lawmakers others, would legalize and regulate cannabis for adults. Other lawmakers are expected to introduce competing proposals.

Meanwhile another Republican-requested bill, from Rep. Kevin Verville, relates to “the use of psychedelics for therapeutic purposes.”

Under the legislation that created the legalization study group that issued the new report, commissioners were tasked with studying the feasibility of a state-run cannabis model and specifically drafting legislation that:

1.  Allows the state to control distribution and access
2. Keeps marijuana away from kids and out of schools
3. Controls the marketing and messaging of the sale of marijuana
4. Prohibits “marijuana miles” or the over-saturation of marijuana retail establishments
5. Empowers municipalities to choose to limit or prohibit marijuana retail establishments
6. Reduces instances of multi-drug use
7. Does not impose an additional tax so as to remain competitive

Rep. John Hunt (R), a commissioner who chaired the House Commerce and Consumer Affairs Committee this year, worked extensively on marijuana reform issues during the session and attempted to reach a compromise to enact legalization through a multi-tiered system that would include state-controlled shops, dual licensing for existing medical cannabis dispensaries and businesses privately licensed to individuals by state agencies.

Hunt’s House panel, however, reached an impasse on the complex legislation, which was being considered following Sununu’s surprise announcement that he backed state-run legalization. Meanwhile the Senate defeated a more conventional legalization bill, HB 639, despite its bipartisan support.

In May, the House separately defeated a different marijuana legalization amendment that was being proposed as part of a Medicaid expansion bill.

Also, the Senate moved to table another piece of legislation that month that would have allowed patients and designated caregivers to cultivate up to three mature plants, three immature plants and 12 seedlings for personal therapeutic use.

After the Senate rejected reform bills in 2022, the House included legalization language as an amendment to separate criminal justice-related legislation—but that was also struck down in the opposite chamber.

States Where Marijuana Is Illegal Typically See Higher Rates Of Treatment Admissions, Federal Study Says

Photo courtesy of Philip Steffan.

The post New Hampshire Marijuana Legalization Commission Issues Final Report After Failing To Reach Consensus appeared first on Marijuana Moment.

Hawthorne, the hydroponic subsidiary of fertilizer company The Scotts Miracle-Gro Co. (NYSE: SMG), is looking to strike out on its own – a move that Scotts CEO Jim Hagedorn hinted at on the company’s earnings call in November.

“We’ve made progress on a range of potential solutions that should benefit shareholders and create opportunities for that business to grow,” Hagedorn said about Hawthorne at the time. “We’re in active discussions to create a leading vertically integrated cannabis company. I can’t share more at this time, but we will provide an update as soon as we can.”

Just a few years ago, Hawthorne was riding high as the cannabis industry’s mantra was bigger is better. Multistate operators were competing with each other over who could build the biggest grow facilities – and that meant lots and lots of lights.

However, the cannabis bubble burst and the business wilted. Hawthorne President Chris Hagedorn made difficult decisions to adjust to the new reality and eliminated almost a thousand jobs. He restructured debt and cut expenses.

Now the company is positioning itself to become profitable again.

Options

Green Market Report spoke with Jim and Chris Hagedorn at the MJBiz Conference last week, where the two opened up about the options being considered. Essentially, there appear to be two roads out of Scotts:

• Spinning out into a separate public company
• Joining forces with Riv Capital (TSX: RIV) (OTC: CNPOF), which has an investment connection with Hawthorne

“We’ve said as much publicly, but I think the interesting part of the conversation is why?” Jim Hagedorn said. “(Scotts will) keep the debt. You move it without any debt at all. So completely clean. Hundreds of millions of inventory and upward capital.”

New PubCo

Scotts could spin Hawthorne out into its own public company where it would compete with the likes of Ubi-grow, Agrify, and Grow Generation. However, these companies receive little analyst coverage, and there is concern that Hawthorne’s assets wouldn’t be recognized.

Hawthorne has engaged in considerable research, and Chris Hagedorn doesn’t want that to get lost by being lumped in with other hydroponic companies.

Riv Capital Option

Riv Capital and Hawthorne are already associated with each other. In 2021, RIV Capital Inc. signed a deal with The Hawthorne Collective, a  cannabis-focused subsidiary of Scotts for the purchase of a $150 million unsecured convertible note from RIV Capital.

However, Riv Capital is best known for paying top dollar to buy New York medical operator Etain. The Hagedorns acknowledged the criticism that the deal received but maintain that the New York market still holds great promise.

Jim Hagedorn pointed out that Riv Capital is currently sitting on almost $90 million in cash, but it only has a market cap of roughly $10 million.

In Talks

“So the audience of people who we’re talking to, we haven’t had anybody yet say no. The question is how do we do this so that we create a company that you would look at and say, holy f*ck,” Jim Hagedorn said. “I sat with those guys and they were giving me big time hints that there is going to be a consolidation here that’s sort of across the board that creates the best pot company in the United States.

“There are different permutations on how to get there. And these are conversations that are live right now,” he added.

Chris Hagedorn noted that in those conversations, they’ve been told, “We see the R&D you guys do. They look at it as there’s the tax-yielding, which is exciting because everyone’s looking for tax mitigation. Hawthorne has the highest possible quality produced at the lowest possible cost.”

The pair believe that cannabis will be rescheduled next year, which will release a lot of capital into the market. And with that there’s a lot of opportunity ahead for Hawthorne.

The post Hawthorne Looks to Strike Out on Its Own appeared first on Green Market Report.

10% – Percentage of cannabis consumers who prefer strains with 6%-10% THC content

A common theme resonating through many recreational cannabis markets is: How high can we get the THC level? But low-THC strains may be gaining in popularity. This year, more consumers have said they prefer this range of THC percentage than ever before. But these products can be hard to come by. With 1-in-10 flower users preferring this range, there’s a solid opportunity for sales.

Source: Brightfield Group, U.S. Cannabis Consumer Insights, Q3 2023

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