People's Liberation Army Air Force Military Medical University

Aside from questioning the "trustworthiness" of clinical data generated at medical centers and hospitals belonging to the People's Liberation Army, the military of China, the lawmakers warned that U.S. biopharmas have run clinical studies with hospitals in Xinjiang, where China has been accused of committing genocide against Uyghur Muslims. As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem.In a letter addressed (PDF) to FDA Commissioner Robert Califf, M.D., a bipartisan group of lawmakers from the House committee asked that the regulator “play an active role in ensuring the United States remains ahead of the [People’s Republic of China] in biotechnology.”The lawmakers, led by committee Chairman John Moolenaar, R-Michigan, and ranking member Raja Krishnamoorthi, D-Illinois, called out the practice of U.S. drugmakers conducting clinical trials at medical centers and hospitals belonging to the People's Liberation Army, the military of China. This practice has been going on for more than a decade, the committee members claim.Rep. Neal Dunn, R-Florida, and Rep. Anna Eshoo, D-California, also signed onto the letter. Aside from questioning the "trustworthiness" of clinical data generated at these institutions, the lawmakers warned that U.S. biopharmas have run clinical studies with hospitals in Xinjiang, where China has been accused of committing genocide against Uyghur Muslims.“Given the historical suppression and medical discrimination against ethnic minorities in this region, there are significant ethical concerns around conducting clinical trials in the [Xinjiang Uyghur Autonomous Region],” the lawmakers wrote.Ethics concerns aside, the group from the House committee further argued that collaborative research with China’s military puts U.S. intellectual property at risk.In their review of U.S. clinical trials that included sites at China’s military hospitals, the lawmakers specifically homed in on an ongoing trial of Eli Lilly’s Alzheimer’s disease drug donanemab—which was recently approved in the U.S. as Kisunla—and a former study of Pfizer’s Inlyta in liver cancer.The letter states that Lilly’s trial is being run at the PLA’s General Hospital and Medical School and the military’s Air Force Medical University. The study on Pfizer’s medicine was conducted with a hospital under the PLA’s Academy of Military Medical Sciences (AMMS), according to the lawmakers' letter.AMMS, according to the lawmakers, is on the U.S. Department of Commerce’s Entity List, which precludes U.S. companies from transferring data to the organization over potential national security threats.In light of the concerns, the lawmakers from the House Select Committee are asking the FDA to answer a slate of questions around U.S. inspections of PLA facilities, the agency’s oversight of IP and technology transfer risks, and other topics.The select committee issued its letter as the House gets ready to vote on the related BIOSECURE Act next month.The bill, which was introduced earlier this year by former Republican congressman Mike Gallagher, proposes halting federal contracts with certain Chinese biotech outfits that allegedly pose a national security risk to the U.S. The legislation would effectively prevent other drugmakers from doing business with these targeted firms, threatening a significant chunk of their business.The bill currently lists respective R&D and manufacturing contractors WuXi AppTec and WuXi Biologics by name, as well as a clutch of genomics sequencing firms, though more companies of concern could be added into the mix in the future.The House is now expected to vote on the bill next month, Axios has reported. Within the biopharma industry, BIOSECURE has raised concerns about the potential difficulty of Western drugmakers decoupling from Chinese service providers. The current version of the bill would require U.S. companies to sever ties with Chinese contractors by 2032 to maintain their spots Medicare and Medicaid.A recent survey by L.E.K. Consulting found that U.S.-based life science companies’ confidence in working with Chinese firms has plummeted since the bill’s introduction in January.

Reducing the methylation of a key messenger RNA can promote migration of macrophages into the brain and ameliorate symptoms of Alzheimer's disease in a mouse model, according to a new study. The results illuminate one pathway for entrance of peripheral immune cells into the brain, and may provide a new target for treatment of Alzheimer's disease. Reducing the methylation of a key messenger RNA can promote migration of macrophages into the brain and ameliorate symptoms of Alzheimer's disease in a mouse model, according to a new study publishing March 7 in the open access journal PLOS Biology by Rui Zhang of Air Force Medical University in Xian, Shaanxi, China. The results illuminate one pathway for entrance of peripheral immune cells into the brain, and may provide a new target for treatment of Alzheimer's disease. A presumed trigger for the development of Alzheimer's disease is the accumulation of proteinaceous, extracellular amyloid-beta plaques in the brain. High levels of amyloid-beta in mice leads to neurodegeneration and cognitive symptoms reminiscent of human Alzheimer's disease, and reduction of amyloid-beta is a major goal in development of new treatments. One potential pathway for getting rid of amyloid-beta is the migration of blood-derived myeloid cells into the brain, and their maturation into macrophages, which, along with resident microglia, can consume amyloid-beta. That migration is a complex phenomenon controlled by multiple interacting players, but a potentially important one is the methylation of messenger RNA within the myeloid cells. The most common type of mRNA methylation, called m6A, is carried out by the enzyme METTL3, so the authors first asked whether deficiency of METTL3 in myeloid cells had any effect on cognition in the Alzheimer's disease mouse model. They found that it did -- treated mice performed better on various cognitive tests, an effect that could be inhibited when they blocked the migration of myeloid cells into the brain. How did decreased mRNA methylation promote myeloid cell migration? The authors elucidated a complex mechanism. Through analysis of mRNA expression patterns and other techniques, they showed that depletion of METTL3 reduced the activity of a key m6A reader protein, which recognizes m6A-modified mRNAs and promotes their translation into protein. That led to a decline in another protein, and that inhibited the production of yet another protein, called ATAT1. Loss of ATAT1 reduced the attachment of acetyl groups to microtubules, and that reduction in turn promoted migration of the myeloid cells into the brain, followed by maturation into macrophages, increased clearance of amyloid-beta, and improved cognition in mice. "Our results suggest that m6A modifications are potential targets for the treatment of Alzheimer's disease," the authors concluded, while noting that much about this pathway in Alzheimer's disease remains to be explored. Because mRNA methylation has a fundamental effect on a wide variety of downstream targets, effective drug development within this pathway may require moving further downstream to avoid unwanted effects.

Q4 2022 revenues grew 643% year-over-year to $4.2 million Q4 2022 gross margin grew to 31.5%, generated $1.3 million of gross profit Completed acquisition of Novamind, positioning Numinus as a leading, integrated mental healthcare company providing psychedelic-assisted therapies Ended quarter with cash position of $33.0 million All financial results are reported in Canadian dollars unless otherwise stated. VANCOUVER, BC, Nov. 29, 2022 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its financial results for the three and twelve months ended August 31, 2022 ("Q4 2022" and "Fiscal 2022"). "Fiscal 2022 was a pivotal year for Numinus, as we entered the US market with the transformational acquisition of Novamind, expanded our Ketamine-assisted Therapy offering across Canada, launched a formal practitioner training program, and unveiled a global rebranding of our company. Combined, these efforts have provided a solid platform for our continued, measured growth – with scalable infrastructure and systems, and a growing pipeline of practitioners choosing Numinus for their psychedelics-assisted therapy training," said Payton Nyquvest, Founder and CEO. "We also see exceptional opportunity from our new Cedar Clinical Research (CCR) division – which was acquired with Novamind. Through CCR, Numinus is forging trusted working relationships with many leading third-party drug developers, who may someday need clinical facilities to provide their patient protocols. With our strong wellness clinic network and a growing clinical research division, Numinus is one of the best positioned companies in the sector – supported by diversified revenue streams, growing brand awareness, and a recognized pathway to profitability." Commenting on the quarter, Mr. Nyquvest continued: "Our fiscal fourth quarter was the first to demonstrate the real power of our larger, cross-border platform following the acquisition of Novamind on June 10, 2022 – and the impacts are evident in our performance. Compared to the previous quarter, fourth quarter revenues grew 464% to $4.2 million, gross margin improved by 710 basis points from 6.5% to 31.5%, and gross profit grew 628% to $1.3 million. We're excited about the momentum building across our business and the regulatory reform underway across the US and Canada, and will continue to evaluate complementary growth opportunities that will enhance our client experience and further support margin expansion." Fourth Quarter Financial Highlights Revenues grew 643% year-over-year to $4.2 million in Q4 2022, due primarily to the acquisition of Novamind. Sequentially, revenues grew 464% from the prior quarter. Gross margin grew to 31.5% during Q4 2022 compared to 6.5% in Q4 2021. Sequentially, gross margin grew 710 basis points from 24.4% in Q3 2022. The improvement in gross margin is due mostly to the completion of the Novamind acquisition between periods and the offering of higher-margin services. Gross profit was $1.3 million in Q4 2022, a significant increase in compared to gross profit of $32,000 in Q4 2021, and a 628% increase compared to $0.2 million in the prior quarter. Cash balance of $33.0 million as of August 31, 2022. Cash outflows were larger than usual during the fourth quarter due to severance, contract terminations and banking costs related to the completion of the Novamind acquisition during the quarter. Fiscal 2022 Financial Highlights Revenues during fiscal 2022 were $6.5 million, a 329% increase from $1.5 million in fiscal 2021, due primarily to acquisitions completed during the year. Gross margin during fiscal 2022 was 27.4%, compared to -5.4% in fiscal 2021. Gross profit during fiscal 2022 was $1.8 million, a significant improvement compared to a gross loss of $82,000 in fiscal 2021. Operational Highlights During and Subsequent to Q4 2022 Corporate Updates On June 10, 2022, following exemplary shareholder approval, Numinus completed the acquisition of Novamind Inc. – providing a strong US wellness clinic platform and a clinical research management division. On June 10, 2022, Numinus announced several executive appointments. Michael Tan was promoted to President and Chief Operating Officer, Reid Robison was appointed Chief Clinical Officer, and Paul Thielking has been appointed Chief Science Officer. On June 27, 2022, Numinus introduced its new logo and brand identity to unify Numinus' presence across North America. The rebranding activities will be accomplished in phases and completed by the end of 2022. As indicated on June 10, 2022, following 2.5 years with Numinus, Dr. Evan Wood will no longer continue in his role as Chief Medical Officer of the Company, to enable him to continue with his tenured teaching and leadership university career. Dr. Wood remains an active supporter of Numinus and will continue working with the Company as a highly engaged advisor. Numinus Wellness Clinic Network Q4 2022 clinic network revenue was $3.7 million, representing a 404% sequential increase from $0.7 million in Q3 2022, and an 821% increase from $400,306 during the same period last year. The increase in clinic network revenues is primarily due to acquisitions completed during the year and the expansion of clinic services. During Q4 2022, Numinus completed more than 17,000 client appointments (including one-on-one and group therapy sessions, neurology-related appointments, paid group programs, Ketamine-assisted psychotherapy, Transcranial Magnetic Stimulation (TMS) and Ketamine/Spravato medicine appointments, representing a 202% increase in clinic appointments compared to more than 5,600 appointments in Q3 2022, mostly due to the acquisition of Novamind at the beginning of the quarter. 12.5% of appointments during Q4 2022 were made by new clients. TMS continues to show strong demand, with 1,568 TMS appointments made during Q4 2022 and continued growth subsequent to the quarter end. At the end of Q4 2022, Numinus had 122 practitioners providing client treatments through its wellness clinics and virtual services, a 10% increase from the beginning of the quarter. As of August 31, 2022, Numinus had 13 wellness clinics offering services to clients (one in Vancouver, one in Toronto, three in Montreal, six in Utah and two in Arizona). In addition, the Company had four dedicated research clinics where psychedelic studies are being conducted (two in Salt Lake City, one in Vancouver and one in Montreal). Following a strategy to identify operating efficiencies, Numinus consolidated two clinic locations in the Salt Lake City area, to reduce leasehold expenses while still retaining all medical staff, practitioners, and area clients. As a result of this activity, today Numinus has 12 wellness clinics across North America. On June 23, 2022, Numinus launched a pilot mental health program for corporate clients: Corporate Ketamine-Assisted Psychotherapy ("Corporate KAP"). This Utah-based program is aimed at helping businesses improve employee mental health by offering ketamine-assisted psychotherapy as a health benefit for eligible employees. On September 13, 2022, Numinus launched a new financing option for clinic patients in Canada. This new payment option will increase the accessibility of its traditional therapy and Ketamine-assisted therapy to a wider client population. Offered through iFinance, a third-party financing partner, Numinus' new financing option will allow Canadian clients to apply for financing with interest rates based on the applicant's credit history. Once approved, Numinus will provide the requested therapy services and collect full payment from iFinance following the completion of the treatment plan. On September 19, 2022, Numinus expanded its Ketamine-assisted Therapy offering to its Toronto location (The Neurology Centre of Toronto), to provide KAT services to patients with neurologic conditions. On October 28, 2022, Numinus announced the launch of its Ketamine for Chronic and Serious Medical Illness Program. This new program will be introduced first in Numinus' clinics in Utah, British Columbia and Quebec. The Company intends to expand the program to other clinics in later months. Numinus Clinical Research Revenues from Cedar Clinical Research ("CCR") during Q4 2022 were $0.5 million. CCR revenue streams are generated through the management of third-party clinical trials that use CCR's two clinical research sites. The business division joined Numinus through the acquisition of Novamind in June 2022. On June 22, 2022, Numinus Bioscience filed a patent application to the World Intellectual Property Organization (WIPO), an agency of the United Nations, for a rapid production process for Psilocybe and other fungi species containing psilocybin and other compounds. A provisional patent application for the process was submitted to the United States Patent & Trademark Office (USPTO) on June 24, 2021. With this additional filing, international patent protection would extend to all WIPO member states that have signed the Patent Cooperation Treaty (PCT), including Australia, Germany, Netherlands, and the United Kingdom, where psychedelic research is currently active. On October 5, 2022, the Company announced that Numinus Bioscience has developed a psilocybin-containing tea bag for use in clinical research and, if appropriate regulatory approvals are granted, eventual treatment of clients in psychedelic-assisted therapy. Other Items: A non-cash impairment charge of $13.3 million and transaction costs of $1.9 million related to the acquisition of Novamind Inc. were incurred during the fourth quarter and are not considered to be recurring operating expenses. Excluding these expenses, adjusted net loss for the fourth quarter was $9.3 million, or $0.04 per share. Q4 2022 Key Performance Metrics Fiscal 2022 Key Performance Metrics Numinus' condensed consolidated financial statements for the twelve months ended August 31, 2022 and related management's discussion and analysis are available on Numinus' Investor Relations website at and under the Company's profile on SEDAR at . These documents were prepared in accordance with IFRS. Conference Call and Webcast Details Interested parties are invited to participate in the Company's fourth quarter and annual 2022 results conference call and webcast. On the call Numinus executives will review the Company's performance and recent initiatives, and answer questions from analysts. To participate in the live conference call, please use the following dial-in information: 1 (888) 330-3632 (Toll-free North America) 1 (646) 960-0837 (International) Please ask to participate in Numinus' Q4 and 2022 Results Call. To avoid any delays in joining the call, please dial in at least five minutes prior to the call start time. If prompted, please provide conference passcode 3547386. A replay of the conference call can also be accessed after 8:30 p.m. Eastern time / 5:30 p.m. Pacific time on November 29, 2022, at 1-800-770-2030 or 1-647-362-9199 (using passcode 3547386). The replay will be available until December 13, 2022. About Numinus Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model - including psychedelic production, research and clinic care - is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society. Learn more at and follow us on LinkedIn, Facebook, Twitter, and Instagram. Disclaimer Neither Numinus Wellness Inc., nor any of its subsidiaries is a professional corporation licensed to practice health services. In jurisdictions where health services may only be provided by a corporation if that corporation holds a valid permit to do so, Numinus and its subsidiaries operate in a management services function to affiliated professional corporations, who provide health services to patients. Numinus and its subsidiaries do provide health services directly to patients in those jurisdictions where authorized to do so. Forward-looking statements This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are "forward-looking statements". Forward-looking statements can be identified by the use of words such as "expects", "does not expect", "is expected", "believes", "intends", "anticipates", "does not anticipate", "believes" or variations of these words, expressions or statements, that certain actions, events or results "may", "could", "would", "might" or "will be" taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company's facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company's limited operating and profitability track record; dependence on management; the Company's need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the impact of the Russia-Ukraine conflict on the global economy; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company's efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws. SOURCE Numinus Wellness Inc.