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Lykos Major Reorganization Is Underway

The What - Lykos Therapeutics, a company at the forefront of mental healthcare innovation, has announced a significant reorganization to enhance its efforts in resubmitting the new drug application (NDA) for midomafetamine capsules, aimed at treating post-traumatic stress disorder (PTSD) in adults. This strategic move underscores Lykos’ unwavering commitment to bringing this groundbreaking therapy to market despite the challenges posed by recent FDA feedback.

Jeff George, Chairman of Lykos’ Board, emphasized the company’s dedication to addressing the FDA’s concerns and the additional work required to ensure the approval of midomafetamine. As part of the reorganization, Dr. David Hough has been appointed to lead the clinical development program and engage with the FDA. Dr. Hough brings a wealth of experience from his tenure at Johnson & Johnson, where he played a pivotal role in the development of several key psychiatric drugs, including SPRAVATO® (esketamine nasal spray). His expertise is expected to be instrumental in navigating the complex regulatory landscape and advancing midomafetamine toward approval.

In addition to leadership changes, Lykos will be reducing its workforce by approximately 75%, focusing its remaining resources on critical clinical development and regulatory engagement. CEO Amy Emerson acknowledged the pioneering efforts of the Lykos team in advancing midomafetamine through clinical trials and highlighted the importance of delivering robust clinical data to support the NDA resubmission.

To support this effort, Lykos has established an Independent Advisory Board that will provide guidance throughout the resubmission process. This board will ensure continued engagement with key stakeholders, including behavioral health facilities, the mental health community, and patient groups such as veterans and survivors of sexual violence.

Notably, Dr. Rick Doblin, Founder and President of MAPS, has resigned from the Lykos board to focus on his advocacy work following the FDA’s decision. Dr. Doblin expressed disappointment over the FDA’s stance but remains committed to advancing the global accessibility of MDMA and other psychedelics through MAPS’ multidisciplinary research and policy reform efforts. His departure marks the end of an era, but his legacy continues to inspire the ongoing work in psychedelic research and development.

Lykos’ reorganization reflects a strategic shift to ensure the successful resubmission of midomafetamine’s NDA. With Dr. Hough at the helm and a leaner, more focused team, Lykos is well-positioned to address the FDA’s requirements and ultimately bring this much-needed therapy to the millions suffering from PTSD.

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Rubicon Organics Shines

For the quarter ended June 30, 2024, the company reported a record net revenue of $12.1 million, reflecting a 7% year-over-year increase, and $21.0 million for the first half of 2024, up 5%. Adjusted EBITDA stood at $0.9 million for the quarter, while operating cash flow reached $1.1 million and free cash flow was $0.7 million. The company maintained its position as the top premium licensed producer across all categories, with a 2.0% national market share in flower and pre-rolls, and a dominant 28% share in the topical market through its Wildflower™ brand. Additionally, it achieved a 29.9% market share in premium edibles and launched new full-spectrum extract vapes in key provinces.

Georgia Is Starting To Hit Its Stride

Despite Georgia's stringent 5% THC cap on medical marijuana products, the state's program is gaining traction, with approximately 1,000 residents registering each month. Currently, the program supports 21,368 registered medical cannabis patients, 1,542 caregivers, and 712 physicians authorized to recommend treatment. Around 75% of patients use medical cannabis to address intractable pain or PTSD. Recent reforms have made access easier by extending patient card validity to five years and allowing home delivery of ID cards. However, Georgia’s program remains limited, with only a dozen operational dispensaries and restrictions on product types. In contrast, neighboring Florida has nearly 885,000 registered patients and 661 dispensaries, with the potential legalization of recreational marijuana in November further highlighting Georgia's limitations.

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Auxly Reports Q2 Numbers

In Q2 2024, the company delivered exceptional financial performance, with net revenues reaching $29.2 million, up 33% year-over-year and 16% quarter-over-quarter. The gross margin on finished cannabis inventory sold hit a record 41%, improving by 14% year-over-year. Adjusted EBITDA surged by over 580% to $5.2 million, while SG&A expenses decreased by $0.2 million despite $0.7 million in restructuring costs. Net income stood at $2.0 million, with positive operating cash flow of $2.9 million. The company also reduced its debt by 48% and maintained market leadership in the all-in-one vape category, with significant success in dried flower and pre-roll sales.

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Cannabis Stock Glass House Brands Continues to Surge

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✅ Trade To Black coming at you today for a special Thursday livestream as we dive into Glass House Brands (OTC: GLASF) latest earrnings.

The California cannabis cultivator reported record second-quarter revenue on Tuesday, driven by expanded greenhouse production despite price pressures in the wholesale market.

Revenue came in at $53.9 million for the quarter, up 21% from the previous year and 79% from the previous quarter. Income was $10 million, compared to $25 million in the same period last year. Revenue from Glasshouse's wholesale biomass business increased by 28% year-over-year to $39.1 million. The company produced approximately 150,000 pounds of cannabis biomass in the quarter, exceeding its previous guidance.