NEW YORK, April 11, 2022 (GLOBE NEWSWIRE) — Wall Street Reporter, the trusted name in financial news since 1843, has published reports on the latest comments and insights from CEO’s of: Hoth Therapeutics (NASDAQ: HOTH), Nova Mentis Life Sciences (OTC: NMLSF) (CSE: NOVA), Tonix Pharmaceuticals (NASDAQ: TNXP), and MedAvail Holdings (NASDAQ: MDVL).

Today’s emerging technologies and healthcare research innovations are unleashing trillion dollar market opportunities. As the biotech sector rebounds from cyclical lows, early-stage biotech stocks offer compelling opportunities. Wall Street Reporter highlights the latest comments from industry thought leaders shaping our world today, and in the decades ahead:

Nova Mentis Life Sciences (OTC: NMLSF) (CSE: NOVA)


CMO Marvin Hausman, M.D.: “Nova’s


Psilocybin-based Therapeutics Showing Vast Potential for Autism and O


ther


Neuroinflammatory Disorders”


Nova Mentis Life Sciences (OTC: NMLSF) (CSE: NOVA) a featured presenter at Wall Street Reporter’s NEXT SUPER STOCK investor conference is advancing psilocybin-based novel therapeutics, targeting autism spectrum disorders, an unmet medical need with multi-billion dollar market potential. NMLSF Chief Medical Officer Dr. Marvin Hausman, M.D., has a decades-long track record of success advancing new drugs through the FDA regulatory pathways, into commercialization, generating billions of dollars in revenue. Dr. Hausman, is now bringing the “same playbook” to NMLSF for it’s psilocybin-based therapeutics targeting Fragile X, then potential expansion to treat other neuroinflammatory disorders, including Alzheimers, and Parkinsons. NMLSF plans to submit a clinical trial application to Health Canada for a Phase 2A study evaluating its psilocybin microdose therapy for Fragile X Syndrome, in the coming weeks.

NMLSF is a global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders. NMLSF is the first biotech company to achieve FDA “Orphan Drug Designation” in both the United States and European Union for the use of psilocybin in the treatment of FXS. In his interview, with Wall Street Reporter, Dr. Hausman explains his strategy for advancing NMLSF’s drug pipeline through commercialization, as he has successfully accomplished with other novel drugs during his decades-long career.

Watch NEXT SUPER STOCK Nova Mentis (OTC: NMLSF) (CSE: NOVA) Video:

“The recently completed preclinical study of repeat low doses of our psilocybin drug – every other day for 2 weeks, showed clinical responses that greatly exceeded our expectations. We significantly modulated behavioural and cognitive defects, such as recognition memory, in FXS.” NMLSF plans to submit a clinical trial application to Health Canada in the coming weeks for a Phase 2A study evaluating psilocybin microdose therapy for FXS. “Autism spectrum disorder (“ASD”) and especially FXS, the largest genetic cause of ASD, continue to have unmet medical needs. Scientists at NOVA, over the past two years, have laid the groundwork for development of potential novel psilocybin-based microdose treatment of ASD,” said NMLSF Chief Medical Officer, Dr. Marvin S. Hausman, MD.

April 8

– NMLSF contracts with Toronto Institute of Pharmaceutical Technology to formulate and manufacture psilocybin microdose capsules for its upcoming Canadian Phase 2A fragile X syndrome clinical study. NMLSF has already manufactured a large supply of >98% pure psilocybin for clinical studies and commercialization following drug approval.

March 23

– NMLSF begins patient enrollment process for its North American Observational study: Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome (FXS). NMLSF’s Observational Study will study the neuroinflammatory mRNA genetic profile contained within cheek cells from ASD and FXS patients, as well as measure serotonin levels in patient saliva. The research objective is to develop a genetic neuroinflammatory and serotonin data bank that will help establish a “Diagnostic Index” – an objective set of tools that helps to differentiate subtypes of ASD, as well as FXS, and to develop more accurate methods of diagnosis and treatment. Collected data will be analyzed using customized machine learning algorithms and used to guide design of upcoming clinical trials that will test the efficacy of psilocybin-based therapeutics in ASD and FXS. Patients enrolled in this Observational Study will have a high priority position to be enrolled in planned psilocybin microdose clinical trials in Canada and the United States. NOVA is aiming to recruit at least 300 qualifying participants; 200+ ASD/FSX patients and 100+ neurotypical controls. Patient enrollment information at:


novamentis.ca/autismstudy

“Families caring for patients with autism spectrum disorder (ASD) and fragile X syndrome (FXS) deserve new scientific and therapeutic options to improve diagnosis, quality of care and treatment outcomes. The goal of our North American ASD and FXS Observational Study is to uncover novel and meaningful ways to diagnose and treat ASD and FXS, which is particularly relevant for statistical separation between the multitude of ASD subtypes, currently differentiated rather crudely, based on behavioural analysis,” says NMLSF Chief Medical Officer, Dr. Marvin S. Hausman MD.

February 16 –

NMLSF successfully completes an oral microdose psilocybin preclinical study, in the laboratory of Dr. Viviana Trezza, Rome Tre University, Rome, Italy. The results exceeded all expectations with the findings that a very low dose of the Company’s proprietary psilocybin significantly modulated behavioural and cognitive defects, such as recognition memory, in a genetic model of fragile X syndrome (FXS). “The science team led by Dr. Hausman, together with Dr. Viviana Trezza from Roma Tre University, continues to deliver promising preclinical results. The recent oral microdose data set not only confirms but exceeds our original injectable formulation results,” says Will Rascan, CEO of NOVA. “The clear positive data is critical as we prepare to submit our clinical trial application to Health Canada for a Phase 2A study evaluating psilocybin microdose therapy for fragile X syndrome.”

Watch NEXT SUPER STOCK Nova Mentis (OTC: NMLSF) (CSE: NOVA) Video:

Hoth Therapeutics (NASDAQ: HOTH) CEO Robb Knie: “HT-KIT ‘Flips Off’ Key Cancer Signal”


Hoth Therapeutics (NASDAQ: HOTH) reports it’s mRNA frame-shifting therapeutic, HT-KIT, proves effective against aggressive cancer cells. Hoth’s innovative approach, which employs a chemically-stable antisense oligonucleotide to target the proto-oncogene KIT through by frameshifting KIT mRNA transcripts, has potential as a KIT-targeted therapeutic alone, or in combination with agents that target KIT signaling, in the treatment of KIT-associated malignancies. Through a sponsored scientific research agreement with North Carolina State University, the team used the HT-KIT mRNA frame-shifting approach on mast cell leukemia cells in vitro and found that KIT protein expression, signaling and function were reduced. Treatment with HT-KIT prevented cancer cell growth and induced cell death over 72 hours. In a humanized mast cell leukemia mouse model, tumor growth and infiltration of other organs were reduced and tumor cell death increased when HT-KIT induced frameshifted c-KIT mRNA .”With our HT-KIT drug, we are flipping off a key cancer signal that’s involved in multiple aggressive cancers, such as systemic mastocytosis, mast cell leukemia, gastrointestinal stromal tumors and acute myeloid leukemia. Our approach avoids pitfalls related to KIT mutations by targeting mRNA. Our next round of preclinical studies are underway and we are excited to utilize the results for our planned Pre-IND meeting with FDA later this year,” stated Hoth CEO Robb Knie.

Hoth Therapeutics (NASDAQ: HOTH) News:

Tonix Pharmaceuticals (NASDAQ: TNXP) CEO Seth Lederman, M.D.: “Tonix Dedicated to Improving Lives of Millions Suffering From Fibromyalgia”


Tonix Pharmaceuticals (NASDAQ: TNXP) a clinical-stage biopharmaceutical company, announced the first participant was enrolled in its Phase 3 RESILIENT study of TNX-102 SL1 (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia. RESILIENT is the Company’s potentially pivotal Phase 3 study of TNX-102 SL, a proprietary sublingual tablet formulation of cyclobenzaprine HCl taken daily at bedtime for the management of fibromyalgia.“Tonix remains dedicated to improving the lives of the millions suffering from fibromyalgia and we are pleased to have our confirmatory, potentially pivotal Phase 3 RESILIENT study getting underway,” said CEO Seth Lederman, M.D. “Fibromyalgia is a complex syndrome in which many patients remain unsatisfied by existing treatment options. Based on the positive results from RELIEF study, together with our general understanding of TNX-102 SL tolerability, we are excited to initiate our new RESILIENT Phase 3 study for fibromyalgia.”

Tonix Pharmaceuticals (NASDAQ: TNXP) News:

MedAvail Holdings, Inc. (NASDAQ: MDVL) CEO Mark Doerr:


“Clear Pathway to Deliver Profitable Growth”


“…While I’m still in the early weeks of leading our MedAvail team, we are enthusiastic about the differentiated value proposition and competitive advantage of our pharmacy solutions and the strong momentum we continue to deliver with our business….I was attracted to MedAvail for two reasons. First, I was impressed by MedAvail’s differentiated technology platform, our MedCenter and its supporting system that enables our on-site pharmacy at the point of care in a cost-effective way. Second, I believe in the opportunities that our solutions provide given how strongly positioned we are to solve a multifaceted problem that challenges pharmacy services today. There’s a clear need for solutions to address the gaps faced by both retail pharmacies and at-risk value-based medical providers… Since joining MedAvail, my confidence in our business and the opportunities for it has grown. There is a tremendous market opportunity to be realized with our solutions, and we have a definitive road map intended to meet this rising demand. I also believe that we have a clear pathway to deliver profitable growth in the business. We are heavily focused on the profitability of our business. We have programs underway in 4 areas to achieve improved margin, driving prescription volumes, optimizing our prescription mix, reducing cost of goods and improving reimbursement. We have set forth specific initiatives with respect to each of these areas…I am confident that we are strongly positioned with our expansion plans underway and more opportunities presenting themselves in our existing business areas while we focus on delivering profitable and sustainable growth in the future…”

MedAvail Holdings, Inc. (NASDAQ: MDVL) Earnings Highlights:

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