NEW YORK, April 13, 2022 (GLOBE NEWSWIRE) — Wall Street Reporter, the trusted name in financial news since 1843, has published reports on the latest comments and insights from CEOs of: PolarityTE, Inc. (NASDAQ: PTE), Nova Mentis Life Sciences (OTC: NMLSF) (CSE: NOVA), atai Life Sciences N.V. (NASDAQ: ATAI), and LIXTE Biotechnology (NASDAQ: LIXT).

As the global pharma market surpasses $1.3 trillion dollars (Statista), emerging technologies and healthcare research innovations are unleashing new exponential growth opportunities. As the biotech sector rebounds from cyclical lows, institutional investors are increasingly eyeing early-stage biotech stocks for upside potential delivering alpha. Wall Street Reporter highlights the latest comments from industry thought leaders shaping our world today, and in the decades ahead:

LIXTE Biotechnology (NASDAQ: LIXT) CEO John S. Kovach MD: “LB-100 Potential New Approach to Chemotherapy”


LIXTE Biotechnology Holdings (NASDAQ: LIXT), a clinical-stage pharmaceutical company focused on developing and commercializing cancer therapies reports that Professor René Bernards, of the Netherlands Cancer Institute, Amsterdam, presented new data from promising drug combinations of LIXTE’s lead clinical cancer compound, LB-100, at the Annual Meeting of American Association for Cancer Research in New Orleans, LA. LIXTE’s new data demonstrates its first-in-class lead clinical compound and protein phosphatase 2A (PP2A) inhibitor, LB-100, induces further activation of oncogenic signaling in a number of KRAS-mutant cancers, rendering them particularly vulnerable to anti-cancer therapy. CEO John S. Kovach MD, commented, “Professor Bernards’ insights and contributions enable us to take full advantage of the unique anti-cancer properties of LB-100. His creativity in developing new anti-cancer drug combinations has already had a significant impact on cancer care. His current observations of unexpected synergy of LB-100 with a variety of standard agents and with investigational compounds with only modest activity on their own are promising leads to a new approach to cancer chemotherapy.”


LIXTE Biotechnology (NASDAQ: LIXT) News:

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


CMO Marvin Hausman, M.D.: “Nova’s


Psilocybin-based Therapeutics Showing Vast Promise 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 its 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:

atai Life Sciences N.V. (NASDAQ: ATAI) CEO Florian Brand:


“..We enter 2022 with US$362 million in cash, putting us into a very, very strong position to work up towards our strategic goal, achieving clinically meaningful and sustained behavioral change in mental health patients. To achieve this goal, we will focus on three strategic pillars. One rapid acting intervention; two, ongoing digital support; and three, biomarker driven precision mental health…”

“Rapid acting intervention is really about developing our first, second and third generation compounds in the most effective and most efficient way. We anticipate these compounds to be highly differentiated to show rapid acting improvements in mental health disorders. We’re especially interested in compounds with strong neuroplastic properties that open a therapeutic window to initiate behavioral change in patients. To give you an example, in the context of depression, this first pillar is really about lifting a patient out of depression in a quick and meaningful way, but then we want this patient to stay out of depression. This leads me to our second pillar, ongoing digital support. This pillar is about keeping mental health patients in state of remission. And it is grounded in innovative digital care provided patients before, during and after treatment…Our third strategic pillar, biomarker driven precision mental health. When it comes to mental health, there is no one size fits all approach. So, this pillar is about identifying patient subtypes using biological and digital biomarkers to treat patients with a therapy that is right for them at the right moment in time. We believe this will reduce the need for trial and error and give each patient the best chance of receiving the treatment that works for her or him. Each of these pillars has a true disruptive potential on its own. But it’s by combining them that we can really unleash their full potential, allowing a true leap forward for mental health patients by achieving clinically meaningful and sustained behavioral change…”


atai Life Sciences N.V. (NASDAQ: ATAI) Earnings Highlights:

PolarityTE, Inc. (NASDAQ: PTE)


CEO


Richard Hague: “Expanding Regenerative Tissue Technology Patent Portfolio Increasing Shareholder Value”


PolarityTE, Inc. (NASDAQ: PTE), a biotechnology company developing regenerative tissue products and biomaterials, announced the U.S. Patent and Trademark Office (USPTO) recently issued a Notice of Allowance for U.S. Application No. 17/326,734 filed on May 21, 2021. This is the Company’s fourth patent allowance in the United States. The newly allowed claims are for compositions that relate to the Company’s minimally polarized functional unit (MPFU) technology in combination with a cryoprotectant. CEO, Richard Hague commented: “PolarityTE understands the importance of intellectual property and building a patent portfolio that protects our regenerative tissue technology embodied in SkinTE®. Protecting this technology goes hand in hand with our effort to advance regulatory approval of SkinTE® through the first of two Phase 3 clinical studies we are preparing to start, as we seek to drive shareholder value through our differentiated technology and intellectual property.”


PolarityTE, Inc. (NASDAQ: PTE) News:

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