NEW YORK, April 14, 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: Veru Inc. (NASDAQ: VERU), Nova Mentis Life Sciences (OTC: NMLSF) (CSE: NOVA), Clarus Therapeutics (NASDAQ: CRXT) and PharmaDrug (OTC: LMLLF) (CSE: PHRX).

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:

Veru Inc. (NASDAQ: VERU) CEO Mitchell Steiner, M.D: “Sabizabulin Delivers Significant Milestone in COVID-19”
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, today announced positive efficacy and safety results from a planned interim analysis of the double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial evaluating oral sabizabulin 9 mg versus placebo in 150 hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS). The Independent Data Safety Monitoring Committee unanimously recommended that the Phase 3 study be halted early due to efficacy, and they further remarked that no safety concerns were identified.
CEO Mitchell Steiner, M.D, commented: “This study represents a significant milestone in the global fight against COVID-19 as sabizabulin is the first drug to demonstrate a clinically and statistically meaningful reduction in deaths in hospitalized patients with moderate to severe COVID-19. We strongly believe that sabizabulin, with its dual anti-viral and anti-inflammatory properties which demonstrated positive efficacy and safety results in the Phase 3 COVID-19 study, can be that greatly needed oral therapy for hospitalized moderate to severe COVID-19 patients.”
Veru Inc. (NASDAQ: VERU) News: https://www.wallstreetreporter.com/2022/04/11/verus-novel-covid-19-drug-candidate-reduces-deaths-by-55/

PharmaDrug (OTC: LMLLF) (CSE: PHRX) CEO Dan Cohen: “Advancing Drug Pipeline Addressing Billion Dollar Markets”
PharmaDrug (OTC: LMLLF) (CSE: PHRX) CEO Dan Cohen, a featured presenter at Wall Street Reporter’s NEXT SUPER STOCK investors conference is advancing a pipeline of natural based drugs, addressing multi-billion dollar market opportunities in cancers, anti-viral and glaucoma indications. LMLLF now has four drug candidates advancing towards clinical trials, with key milestones in the weeks ahead.
Watch NEXT SUPER STOCK PharmaDrug (OTC: LMLLF) (CSE: PHRX) Video: https://www.wallstreetreporter.com/2022/03/31/next-super-stock-pharmadrug-otc-lmllf-cse-phrx-advancing-biopharm-assets-w-billion-dollar-markets/

LMLLF’s flagship platform is PD-001 – a reformulated and patented version of cepharanthine, with lab data demonstrating potential therapies for a number of anti-cancer and anti-viral indications. Cepharanthine is a natural based drug already approved in Japan, with a 70 year history of use. Cepharanthine has shown in studies to both stop the spread and kill cancer cells, and reduce resistance to chemotherapy.
LMLLF’s PD-001 is a reformulation of the traditional treatment in pill form used in Japan, but with 10X the bioavailability. LMLLF sees its PD-001 as a platform for potentially treating a wider array of cancer indications.

LMLLF is now advancing studies for PD-001 for treating esophageal, and prostate cancers. LMLLF has just received FDA Orphan Drug Designation for PD-001 for esophageal cancer a $1.5 billion market opportunity. Orphan Drug Designation allows for potentially fast track FDA approval, lower development costs and increased market protection. LMLLF is also advancing PD-001 for prostate cancer, filing a provisional patent for cepharanthine combined with chemo for prostate cancer.

LMLLF is also developing a treatment for glaucoma, based on a re-formulation of DMT (N-Dimethyltryptamine) to reduce intraocular pressure. Tryptamines, including DMT, have been shown in clinical studies to reduce intraocular pressure. LMLLF is collaborating with the Terasaki Institute for Biomedical Innovation, a world class leader in development of novel drug delivery technologies to optimize DMT formulation with a controlled release device. LMLLF’s clinical research has developed two potential drug formulations, which have have tested well for low toxicity, and show promising potency and efficacy, and expects to initiate FDA clinical trials in coming months. In his interview, CEO Dan Cophen also shares that LMLLF’s pipeline assets have significant upside potential as biotech valuations recover from current cyclical lows.

April 7 - LMLLF advances DMT-analogue program for glaucoma with production of medical device designed to provide sustained control of elevated intraocular pressure, in collaboration with the Terasaki Institute for Biomedical Innovation

March 9 - LMLLF reports positive interim findings for combination of Cepharanthine and frontline chemotherapy for IND-enabling prostate cancer study. The study demonstrated improved tumor growth inhibition by 73% compared to cabazitaxel-alone.

Feb 23 - LMLLF receives encouraging potency data for candidate DMT-analogue molecules designed to treat primary open angle glaucoma. LMLLF successfully completed a head-to-head potency comparator study of its two undisclosed DMT-analogue candidates for the treatment of primary open angle glaucoma (POAG). LMLLF intends to use the current results in combination with several planned upcoming in vitro studies to elect its final development candidate. Future in vivo efficacy testing in an accepted model of POAG is currently being planned with the goal of providing all necessary support to file an investigative new drug (IND) application with the FDA to conduct clinical studies.
Watch NEXT SUPER STOCK PharmaDrug (OTC: LMLLF) (CSE: PHRX) Video: https://www.wallstreetreporter.com/2022/03/31/next-super-stock-pharmadrug-otc-lmllf-cse-phrx-advancing-biopharm-assets-w-billion-dollar-markets/

Nova Mentis Life Sciences (OTC: NMLSF) (CSE: NOVA) CMO Marvin Hausman, M.D.: “Nova’s Psilocybin-based Therapeutics Showing Vast Promise for Autism and Other 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: https://www.wallstreetreporter.com/2022/03/25/next-super-stock-nova-mentis-life-sciences-otc-nmlsf-billions-opportunity-w-autism-psilocybin/

"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: https://www.wallstreetreporter.com/2022/03/25/next-super-stock-nova-mentis-life-sciences-otc-nmlsf-billions-opportunity-w-autism-psilocybin/

Clarus Therapeutics (NASDAQ: CRXT) CEO Dr. Robert Dudley: “Advancing Androgen and Metabolic Therapies”
Clarus Therapeutics (NASDAQ: CRXT), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, announced the initiation of screening for the first patient in an investigator-initiated Phase 4 clinical trial designed to evaluate the efficacy and safety of JATENZO (testosterone undecanoate) oral softgel capsules for the treatment of adult hypogonadal men with chronic kidney disease (CKD). Clarus expects to announce results from the trial in the first half of 2023.

CEO Dr. Robert Dudley commented, “We are excited screening has begun for the first patient in this trial of hypogonadal men with CKD. Patients with CKD suffer from a myriad of comorbidities, which often include profound reductions in circulating T. Epidemiological data indicate that an estimated two million men with CKD are clinically hypogonadal and thus may benefit from T replacement therapy. This will be the first of several life cycle management studies for JATENZO designed to maximize the potential for treatment of specific patient populations where T deficiency is a component of their compromised health. Because JATENZO increases T levels and has a positive impact on hemoglobin levels, our hypothesis is that JATENZO, with its flexible oral dosing options, could become an important treatment option for hypogonadal adult men with CKD. These men also may prefer JATENZO over other T treatment modalities because it is administered orally as a softgel capsule.”
Clarus Therapeutics (NASDAQ: CRXT) News: https://www.wallstreetreporter.com/2022/03/16/clarus-nasdaq-crxt-announces-initiation-of-phase-4-clinical-trial/

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