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Filament Health (OTCQB: FLHLF) (NEO: FH) received regulatory approval for its planned SPAC merger, which is expected to help its uplisting to Nasdaq.

The U.S. Securities and Exchange Commission approved the F-4 registration statement, which is a vital step in completing the joint venture proposal with Jupiter Acquisition Corporation (NASDAQ: JAQC). The new company will be called TopCo on the exchange.

Filament CEO and co-founder Benjamin Lightburn called it a “crucial” step towards getting the deal done, “which is expected to offer us access to a broader capital markets audience and advance our drug development platform.”

During the quarter, which ended Sept. 30, filings show the company recorded a net and comprehensive loss of $1.3 million, a slight increase from the loss of $1.25 million in the same period of the previous year. This includes $305,791 in non-cash expenditures.

Total expenses for the quarter were $1.7 million, up by $349,957 from the previous year, with rising insurance costs, professional and consulting fees, and sales and marketing expenses. However, wages and benefits showed a decrease compared to the prior period.

Filament had cash and cash equivalents of $2.2 million versus $2.8 million at the end of last year. The company has no unused lines of credit, borrowing arrangements, off-balance sheet arrangements, nor does it use hedges or other financial derivatives.

The firm also announced its intentions for a non-brokered private placement aiming to raise up to C$2 million, although management says the private placement hasn’t closed. This follows an upsized private placement financing in July, which raised gross proceeds of C$2.5 million.

Filament said it has been active in expanding its R&D efforts. In September, a joint venture with Jaguar Health successfully imported coca leaf to Filament’s research facility. The company also entered an Aug. 31 licensing agreement with Reset Pharmaceuticals Inc. to use PEX010 in a phase 2 clinical trial for demoralization syndrome.

Additionally, the FDA approved two Filament clinical trials using PEX010 for treating cancer-related anxiety and depression.

The post SEC Greenlights Filament Health SPAC Deal appeared first on Green Market Report.

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Lucy Scientific Discovery Inc. (NASDAQ: LSDI) released its quarterly financial earnings for the period ended Sept. 30. In just three months, the company has burned through $1.4 million in cash.

The company had a cash balance at the end of June, the end of its last fiscal year, of $1.6 million; at the end of September, it was just $237,614. The company also reported a working capital deficiency of $636,603 at the end of the quarter.

Lucy reported no revenue in the quarter, which the company in its filing attributed to “no product sales during the three months ended September 30, 2023, as the company was changing its payment processor. Sales commenced again in October 2023.”

Lucy Scientific reported $7,048 in sales for the past fiscal year, but that figure is also listed in the accounts receivable column, so the company hasn’t actually been paid for those sales. The operating loss for the quarter was $1.6 million and the net loss for the quarter was $1.9 million.

The company incurred net losses in recent periods and has accumulated a deficit of $46,413,848 as of Sept. 30.

Lucy Scientific summed up dire state of affairs in its latest regulatory filing: “We may be unable to raise additional funds or enter into such other arrangements when needed or on terms that are acceptable to us, or at all. To the extent that we raise additional capital by issuing our equity securities, our existing stockholders may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that could harm the rights of a common shareholder. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us.”

Still, the company said it believes it will have sufficient working capital to meet its liquidity needs through 12 months from the quarterly report.

The company mentioned its recent acquisition plans for High Times and Bluesky Biologics in the filing, but neither of the deals has actually closed.

The post Lucy Scientific Burns Cash with No Revenue Collected in Q1 appeared first on Green Market Report.

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Chicago-based Cresco Labs Inc. (CSE: CL) (OTCQX: CRLBF) (FSE: 6CQ) posted a $113.4 million loss for the third quarter this year as company revenue continued to trend downward, the multistate operator reported in its quarterly financials.

The financial hit was primarily due to a one-time impairment charge of $129 million, Cresco said in a statement, but net revenues were also down both sequentially and year-over-year. For Q3, Cresco pulled in $190.5 million, down from $197.8 million in Q2 and from $210.4 million a year prior.

The quarter brought losses for 2023 to $183 million thus far, following its $215.8 million in losses for 2022.

While Cresco also slashed operating expenses by $40 million and increased its retail transactions by 17%, the overall approach has not translated yet to profitability for shareholders.

Cresco noted that it will continue to streamline operations in U.S. markets that it has found to not be advantageous, such as Arizona, where it finished divesting in October. The company also suffered a setback in July when its blockbuster merger with Columbia Care was canceled.

Refocusing on Cresco’s “core” markets, which includes Florida, Illinois, Massachusetts and Pennsylvania, has been a strategy for several months now. Cresco also opened two more dispensaries in Florida, which brings its total of Sunnyside-branded cannabis shops to 70 nationwide.

CEO Charles Bachtell said the quarter demonstrated the company’s “ability to drive solid performance” through difficult times.

“Cresco Labs is leaner and more productive than ever,” Bachtell said, pointing to operating cash flow of $41 million in the most recent quarter, which he said was “almost double what we generated” in the first two quarters of 2023.

Bachtell also raised again the possibility of federal marijuana reform, which could have enormous financial benefits for companies such as Cresco – such as federal tax savings if rescheduling happens – and said that this month’s cannabis legalization vote in Ohio is another symbolic reminder that “change is inevitable.”

“Until that change comes, we’re improving every aspect of our business to best position ourselves for both today’s environment and for the future,” Bachtell said.

At the end of September, Cresco had $1.3 billion in total assets, including $113 million in cash, against $973.2 million in total liabilities.

The post Cresco Loses Another $113 Million in Q3 as Revenue Slides appeared first on Green Market Report.

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After the markets closed on Tuesday, Cybin Inc. (NYSE: CYBN) (NEO: CYBN)  reported unaudited financial results for its second quarter ending September 30, 2023. Cybin reported a net loss of C$11.9 million for the quarter versus last year’s net loss of C$10.0 million.

At present, Cybin’s operations do not generate cash flows and at the end of September, the company had an accumulated deficit of C$174 million, cash of C$18 million, and working capital of C$17 million. In the company’s filing, it was noted that it had accounts payable and accrued liabilities including trade payables and other obligations of $9 million, all amounts are due within the next 12 months

However, Cybin closed its previously announced underwritten offering for aggregate gross proceeds of $30 million (approximately C$40 million). The company said in a statement that with the recently completed Offering and a combination of the company’s current cash position, it has access to over C$138 million.

Cash flows received from financing activities were C$20.4 million for the quarter versus last year’s C$4.6 million in the same period last year, related to the net proceeds on the issuance of common shares through the company’s August 3, 2023 financing and its at-the-market equity program.

“Advancing our clinical programs with the goal of changing the treatment landscape in mental health has always been Cybin’s mission,” said Doug Drysdale, Chief Executive Officer of Cybin. “We have made enormous progress during the past quarter, with ample momentum to carry us through year-end and into 2024. We are actively gathering important data from CYB003, our deuterated psilocybin analog program, and CYB004 and SPL028, our deuterated DMT programs, with topline readouts expected before the end of 2023. As a company, we are proud of our consistent progress, robust patent portfolio, skilled and dedicated team of drug development experts, and believe we are well-positioned to progress our pipeline toward potential regulatory approval.”

Looking Ahead

As Cybin continues to progress through the CYB003 program, additional milestones related to the Phase 1/2a clinical trial have been identified. Cybin outlined them as such:

• provide topline data readout from the Phase 1/2a study in the fourth quarter of 2023
• complete FDA submission of CYB003 Phase 1/2a data for end of phase 2 meeting in the fourth quarter of 2023
• initiate a Phase 3 study of CYB003 in MDD in the first quarter of 2024

Cybin said it expects to spend approximately $7.7 million to provide topline data readout from the Phase 1/2a study by the fourth quarter, of which approximately $5 million was spent during the six months ending September 30, 2023, and approximately $1 million was spent in the financial year ended March 31, 2023. This means it will still need to spend $1 million by the end of 2023.

The company said it also expects to spend approximately $2.5 million to complete the FDA submission of CYB003 Phase 1/2a data by the fourth quarter of 2023, of which approximately nil was spent during the six months ended September 30, 2023. The company said it intends to continue funding the Deuterated Psilocybin Analog (CYB003) Program.

The post Cybin Expects Phase 3 Data on CYB003 in 2024 appeared first on Green Market Report.

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A Massachusetts company that bills itself as “the first and only licensed provider of psychedelic health plans” announced on Tuesday that it will cover psilocybin-assisted therapy in states where it’s legal.

“Given the evidence of effectiveness seen in clinical trials in the U.S. and elsewhere, we have decided to give our employers the option of including psilocybin-assisted therapy in their benefit plans,” said Sherry Rais, CEO and co-founder of Enthea, a third-party health insurance benefits administrator. “Oregon and Colorado have already legalized the use of psilocybin, and we expect others to do so next year.”

Enthea announced earlier this year that it would cover ketamine treatment nationwide. The nonprofit previously worked with soap company Dr. Bronner’s last year to offer psychedelic-assisted therapy to workers through their employee health plans.

Enthea said this week that it plans to expand its standards of care to include adult use of psilocybin “in combination with psychotherapeutic support.” The company expects to publish the change to its provider network sometime in the first quarter of next year.

The goal, Enthea said, is to be able to cover psilocybin-assisted treatment by mid-2024.

“We have had our eye on the potential benefits of psilocybin therapy since we founded our company,” Dan Rome, Enthea’s co-founder and chief medical officer, said in a press release. “We are very encouraged by published results as well as what we hear from practicing therapists, and are confident that this brings an important new option for combating mental illness.”

Enthea has said its services will expand further to include therapies with other substances, such as MDMA, “as they are approved.”

The Food and Drug Administration (FDA) designated MDMA as a “breakthrough therapy” in 2017, and the substance is now on track for FDA consideration next year following successful Phase 3 clinical trials published in September in the journal Nature that found that MDMA-facilitated talk therapy reduced symptoms in patients with moderate to severe PTSD.

Two other companies, Bennabis Health and CannaCoverage, also teamed up earlier this year to offer medical marijuana coverage as part of their workplace benefits packages, a perk meant to reduce out-of-pocket costs for employees who use cannabis therapeutically.

While Oregon and Colorado have already passed laws allowing therapeutic use of psilocybin, other states are considering similar reforms. In California, for example, a Democratic senator said this month that he’ll be filing a revised psychedelics bill next year alongside an Assembly Republican that will focus on providing regulated therapeutic access to certain psychedelics.

It’s a more limited bill than the one vetoed this year by Gov. Gavin Newsom (D), who has touted the “profound” therapeutic potential of certain psychedelics to treat severe mental health conditions but vetoed SB 58 because it would have removed criminal penalties for possession and cultivation without first implementing guidelines for regulated access.

In Massachusetts, Gov. Maura Healy (D) recently filed a bill to create a psychedelics working group to study and make recommendations about the potential therapeutic benefits of substances like psilocybin and MDMA for military veterans. Campaign organizers in the state recently said they believe they’ve collected enough valid signatures to force lawmakers to consider a psychedelics legalization initiative—the first option for the reform before activists move to put it on the state’s 2024 ballot.

Bipartisan lawmakers in Wisconsin, meanwhile have introduced a new bill to create a psilocybin research pilot program in the state.

At the federal level, lawmakers met Tuesday for the first-ever congressional hearing on psychedelics, with testimony focusing on how substances like psilocybin and MDMA can aid therapy for military veterans’ facing mental health challenges.

In a recent Harvard University-hosted panel featuring former Department of Veterans Affairs (VA) and Centers for Disease Control and Prevention (CDC) officials, speakers broadly agreed that psychedelic substances like MDMA and psilocybin hold powerful potential to help treat PTSD and curb suicide rates in service members, but they cautioned against hasty, unsupervised use of psychedelics given the possibility for further harms.

Earlier this month, the National Institutes of Health (NIH) announced it’s seeking proposals to develop psychedelics into treatments for substance use disorder (SUD), with plans to issue $2 million in grant money toward the research projects during fiscal year 2025.

Federal Health Agency Announces $2 Million In Funding To Develop Psychedelic Treatments For Substance Use Disorders

Photo courtesy of Wikimedia/Mushroom Observer.

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