Braxia Scientific Reports Q1 2023 Financial Results; Launches KetaMD in U.S. Increasing Treatment Access for Mental Health Patients

TORONTO, Aug. 29, 2022 /PRNewswire/ - Braxia Scientific Corp. ("Braxia Scientific", or the "Company"), (CSE: BRAX) (OTC: BRAXF) (FWB: 4960), a medical research and telemedicine company with clinics providing innovative ketamine and psilocybin treatments for depression and related disorders, today announced the filing of its financial statements and management discussion and analysis for the first quarter ended June 30, 2022. Complete financial statements along with related management discussion and analysis can be found in the System for Electronic Document Analysis and Retrieval (SEDAR), the electronic filing system for the disclosure documents of issuers across Canada, at www.SEDAR.com.

"We are proud to have launched KetaMD in the U.S. so that we can begin addressing the needs of millions lacking access to innovative treatments for mental health disorders such as depression, anxiety, bipolar disorder and post-traumatic stress disorder (PTSD)," said Dr. Roger McIntyre, CEO, Braxia Scientific. "We have established the infrastructure and clinical best practices to ensure proven treatments, such as Ketamine, are affordable and delivered safely, securely, reliably, and quickly to achieve the best outcome for patients. As we continue to expand KetaMD across multiple U.S. states we are also committed to advancing new and innovative treatments via our clinical research trials leveraging both our digital and in-person clinics."

Providing Access to Mental Health Therapies in North America

KetaMD U.S. – Providing Ketamine for Depression, Anxiety, PTSD and Bipolar Disorder

Braxia Scientific completed the acquisition and launch of KetaMD, a new end-to-end telemedicine platform, that utilizes leading technology, provides access to safe, affordable, and potentially life-changing at-home ketamine treatments for people suffering from depression and related mental health conditions. Treatments are medically supervised, guided virtually by registered nurses with mental health expertise, and backed by the world's leading psychiatrists and researchers in depression. KetaMD's integration of ketamine and telemedicine is guided by best practices and treatment guidance.

KetaMD's innovative technology capabilities provides Braxia the opportunity to offer both patient-centric in-person and digital telehealth ketamine treatments, combined with established clinical research and development capabilities focused on the commercialization and real-world implementation of novel pharmaceuticals. Braxia plans to further augment tools and capabilities of the KetaMD platform, including planning new clinical trials in the U.S. and leveraging Braxia's growing proprietary patient dataset, with patient outcomes, to support potential future development of digital therapeutics in the management of depression and other related mental health conditions. 

KetaMD is currently available in the State of Florida with a roll-out to other key states to begin in 2022.

Braxia Health Canada – Providing Access to Ketamine and Psilocybin-Assisted Therapy

Braxia Health, the Company's group of clinics, continued to see steady growth during the quarter following the opening of its Kitchener-Waterloo clinic in a growing suburb near the Greater Toronto Area in Ontario. The Company has made progress on the buildout of its new upcoming clinic in Ottawa. In Toronto the Company is working to expand capacity to support increased volumes for in-person ketamine treatments, and as the research team prepares to launch new clinical trials before the end of 2022. 

Braxia Health clinics are comprised of a unique network of physicians, specialists and researchers delivering innovative, rapid acting treatments like intravenous (IV) and oral ketamine, and psilocybin for treatment resistant depression (TRD) and other mental health disorders. The high quality and timely access to innovative treatment is the differentiating factor allowing Braxia to expand its footprint rapidly and diversify its offering into experimental therapeutic clinical research programs.

To date, the Company has steadily grown its ketamine program referral network across 5 cities. 

Braxia Health's research team progressed the first Phase II randomized Health Canada approved multi-dose psilocybin trial, approved July 2021 and launched November 2021. The trial is expected to be completed by December 2022. Following the preliminary positive results reported earlier this year, which reported meaningful improvements in depression severity observed (as measured by the Montgomery-Åsberg depression rating scale, MADRS), the Company expects to launch additional psilocybin-assisted trials in the coming quarters across multiple diagnostic categories.

Braxia's clinical and research capabilities, combined with a leading research team, have enabled the Company to establish and carryout research studies focused on advancing novel treatments for depression and other mental health disorders.

Braxia Health received multiple approvals from Health Canada to the Special Access Program ("SAP") to provide psilocybin-assisted psychotherapy for patients with Major Depressive Disorder outside of clinical trials.

The SAP was amended January 5^th, 2022 to include access to psychedelic compounds on a case-by-case basis outside of clinical trials. Braxia Health has since received SAP approvals for additional patients.

The Company also successfully expanded its Braxia Institute training program, recruiting and training 30 medical and research staff to provide psilocybin-assisted therapy with high quality safety monitoring.

The Company's cash and cash equivalents as of June 30, 2022 was $7.68 million compared with March 31, 2022 at $8.6 million includes cash invested to fund launch of KetaMD and purchase of equipment related to build out of new clinics.

First quarter revenue increased to $0.42 million for the period ending June 30, 2022, up 13% sequentially from $0.37 million in Q4 2022 and up 2.5% from $0.41 million in the comparative prior period. The increase in revenue primarily reflects an increase in the number of treatments from the administering of ketamine at the Braxia Health clinics in Ontario.

Net loss was $0.97 million for the quarter ended June 30, 2022, compared to a net loss of $1.09 million for the three months ended June 30, 2021.

Dr. McIntyre continued, "We are executing against our strategic priorities centred on creating and increasing access to safe, affordable, ketamine treatments, and other innovative treatments, for millions impacted by mental health challenges, whether its in person through our clinics or at-home through KetaMD. Through our KetaMD platform, we plan to connect people who have inadequate access to mental healthcare services, trained specialists, physicians, and psychiatrists in their communities across the U.S. Our combined clinical and telemedical platform positions us to well to drive further innovation in clinical research and scaling of access to experimental therapeutics in this patient population."

The Company also announced it has granted stock options to certain of its directors, officers and employees to acquire an aggregate of 11,220,000 common shares of the Company. Each option is exercisable into one common share of the Company at an exercise price of $0.08 per Share, being the closing trading price of the shares on the Canadian Securities Exchange on August 26, 2022, for a five-year term expiring on August 29, 2027. Subject to certain accelerated vesting provisions and to longer vesting periods for recently hired employees, one-half of the options will vest immediately and the remaining one-half will vest 6 months after the date of the grant. For recently hired employees, one-third of the Options will vest after 6 months from their start date, one-third will vest after 12 months from their start date, and the remaining one-third will vest 18 months from their start date.

Braxia Scientific is a medical research and telemedicine company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Braxia also launched its U.S. based end-to-end telemedicine platform KetaMD, that utilizes leading technology to provide access to safe, affordable, and potentially life-changing at-home ketamine treatments for people living with depression and related mental health conditions. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based disorders, such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatments in-person and virtually for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia seeks to develop ketamine and derivatives and other psychedelic products from its IP development platform. Through its wholly owned subsidiary, Braxia Health (formerly the Canadian Rapid Treatment Center of Excellence Inc.), operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Kitchener-Waterloo, Ottawa, and Montreal.

ON BEHALF OF THE BOARD

"Dr. Roger S. McIntyre"
Dr. Roger S. McIntyre

Chairman & CEO

The CSE has not reviewed and does not accept responsibility for the accuracy or adequacy of this release.

This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are "forward-looking statements."

Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression, the potential for ketamine or other psychedelics to treat other mental health conditions, the integration plans for Braxia and KetaMD, the intention to conduct further clinical trials, the expected growth of at-home telemedicine, the expected benefit and synergies of Braxia and KetaMD and the expectation to expand to areas other than Florida. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events, or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the "CDSA") and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription.

These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements.

Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company's filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021 and its most recent MD&A, which are available at www.sedar.com. 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.

SOURCE Braxia Scientific Corp.