On April 3, 2023 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported a corporate update and reported financial results for the fourth quarter and year ended December 31, 2022 (Press release, Enveric Biosciences, APR 3, 2023, View Source [SID1234629794]).

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"Enveric is a transformed company; 2022 was a year of considerable accomplishments, and we are now poised for an active, productive and exciting 2023 as we strive to bring a new approach to solving the mental health challenges that face our society," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "In early 2023, we announced the establishment of our Australia-based subsidiary, Enveric Therapeutics Pty. Ltd, and we are rapidly preparing to initiate the planned Phase 1 trial of EB-373. Additionally, we are pleased to be working with Avance Clinical and are eager to benefit from the CRO’s proven expertise and experience managing early-stage clinical programs in Australia."

Dr. Tucker continued: "Conducting the initial development of EB-373 in Australia enables us to leverage key clinical, regulatory and financial opportunities that the Australian government and the Therapeutic Goods Administration (TGA) have implemented to empower biotechnology companies to execute robust yet highly efficient clinical studies, particularly those advancing psychedelic-derived compounds. We now look forward to expeditiously advancing the Phase 1 clinical trial of EB-373 towards a potential topline data readout by early 2024. Our Australian subsidiary also gives Enveric an operational foothold in Australia, which we see as an ideal location to advance the development of additional future pipeline candidates generated from our EVM201 and EVM301 Series."

Dr. Tucker concluded: "2023 will be a year of substantial progress for Enveric, with acceleration of the pipeline milestones to enable us to rapidly grow into a leading, innovative CNS company. Mental health treatments have seen little innovation for decades; stigmatization has abetted a global epidemic in depression and anxiety, which continued to worsen as a result of the COVID-19 pandemic. At Enveric, we believe it’s time for bold innovation and investment to conquer the monumental challenge of tackling mental health disorders."

FOURTH QUARTER AND RECENT PROGRAM UPDATES

A Pipeline Targeting Unmet Needs in Mental Health

EB-373 nominated as lead development candidate from EVM201 Series targeting the treatment of anxiety disorders
Phase 1 clinical trial for EB-373 planned to initiate in the fourth quarter of 2023. The trial will be conducted in Australia via Enveric’s newly established subsidiary, Enveric Therapeutics.
Avance Clinical identified as CRO to conduct Phase 1 trial
Enveric continues to advance its EVM301 Series targeting mood, anxiety and addiction disorders with unmet needs.
Enveric expects to identify optimal molecular candidates to advance into in vitro and in vivo testing by the third quarter of 2023
Dr. Tucker explained: "With EVM201 Series, we are seeking to address a major gap in innovation with rationally designed, next generation molecules that are prodrugs of the active psychedelic metabolite, psilocin. Through our advanced discovery platform, we’ve been able to design products with altered metabolic and pharmacokinetic properties with the goal of achieving improved risk/benefit profiles. Meanwhile, our EVM301 Series aims at minimizing or eliminating the hallucinatory effect, to enable administration without the compulsory presence of a healthcare professional to observe dosing. We believe this could offer a significant commercial opportunity, as current treatment standards with psychedelics necessitate costly, prolonged sessions with health care providers in attendance."

Positioned Financially and Operationally to be a Leading Developer of Novel Small-Molecule Therapeutics for the Treatment of Anxiety, Depression and Addiction Disorders

Raised approximately $10 million in gross proceeds via public offering in February 2022
An additional $8 million gross aggregate proceeds raised with registered direct and private placement offerings, which closed July 2022
Anticipated spin-off of Akos Biosciences, Inc. (formerly Acanna Therapeutics, Inc.) announced
Kevin Coveney named as Chief Financial Officer and Lynn Gallant as Vice President, Clinical Operations
Dr. Tucker commented: "The aggressive pace of pipeline developments that we expect in 2023 has been made possible by the execution of several key structural and business development transactions in 2022. This includes our February 2022 public offering, the planned spin-off of our cannabinoid clinical development pipeline assets, which we announced in May, and our registered direct and private placement offerings, which closed July 26, 2022."

FOURTH QUARTER AND YEAR END 2022 FINANCIAL RESULTS

Comprehensive net loss was $19.3 million for the year ended December 31, 2022, including $2.4 million in net non-cash expenses, with a basic and diluted loss per share of $13.00, as compared to a comprehensive net loss of $48.8 million with basic and diluted loss per share of $103.69 per share for the year ended December 31, 2021.

Net cash used in operations for the year ended December 31, 2022, was $17.1 million consisting of a $18.5M net loss, adjusted by a net of $1.5 million in non-cash expenses and changes in asset and liability balances of $0.2 million.

As of December 31, 2022, the Company had cash and cash equivalents of $17.7 million and working capital of $14.4 million.

On April 3, 2023 Covis Finco Sarl (together with its subsidiaries "Covis" or the "Company"), reported that the Company entered into the Support Agreement with its Equity Sponsors, approximately 95% of its First Lien Lenders (including Revolving Facility Lenders) and 100% of its Second Lien Lenders regarding the terms of a comprehensive financial recapitalization that will reduce its debt by ~$450 million (the "Recapitalization") (Press release, Covis Pharmaceuticals, APR 3, 2023, View Source [SID1234629793]). The Recapitalization leads to a material strengthening of Covis’ balance sheet as well as its liquidity position. Upon consummation of the Recapitalization, funds managed by an affiliate of Apollo Global Management (the "Equity Sponsors") will remain majority owners of the Company, while the First Lien Lenders will receive a significant minority stake.

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Pro forma for the Recapitalization, the Company will be operationally and financially in a position to scale its business, including through commercial and life cycle management initiatives in order to grow its existing portfolio as well as geographic expansion that leverages its commercial infrastructure and network. Covis will also pursue inorganic growth opportunities, which have historically been a key value lever for the Company.

"We are grateful to have the support from our Equity Sponsors as well as substantially all of our lenders to complete this transaction, which keeps us on track to scale Covis profitably and sustainably. At Covis, our paramount focus continues to be patient outcomes and improving the health of people with serious medical conditions," said Michael Porter, CEO of Covis.

To implement the Recapitalization, the Company is soliciting approval from its lenders of the transactions contemplated by the Support Agreement. Covis expects to complete this process quickly and efficiently and, with the strong support of its Equity Sponsors and lenders, anticipates a near-term closing of the Recapitalization.

Covis’ advisors include Paul, Weiss, Rifkind, Wharton & Garrison LLP and Slaughter and May as legal counsel and PJT Partners as financial advisor.

The First Lien Term Lenders are advised by Weil, Gotshal & Manges LLP as legal counsel and Houlihan Lokey Capital, Inc. as financial advisor and the Administrative Agent for the Revolving Facility Lenders and Second Lien Lenders are advised by Freshfields Bruckhaus Deringer LLP as legal counsel and Berkeley Research Group, LLC as financial advisor.

On April 3, 2023 BostonGene reported that it will participate and present at the hubXchange’s East Coast Genomics in Precision Oncology 2023, taking place April 5 in Boston, Massachusetts (Press release, BostonGene, APR 3, 2023, View Source [SID1234629783]). The event brings together executives from pharma and biotech to address and find solutions to the key issues that currently need to be addressed in genomics-led oncology precision medicine strategies.

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Presentation details:

Elucidation of the Cellular and Molecular Features of the TME Underlying Immune Escape and IO Failure
Wednesday, April 5 | 1:20 PM ET
Speaker: Alexander Bagaev, PhD, VP, Product Development, BostonGene

This session will highlight BostonGene’s comprehensive profile of a patient’s disease for therapy selection and stratification for IO clinical trials to improve outcomes by using CLIA-certified advanced whole exome and whole transcriptome sequencing paired with deep immunoprofiling and best-in-class analytics.

"I am excited to participate in the East Coast Genomics in Precision Oncology 2023 and to present how BostonGene’s transcriptional profiling and advanced analytics can reveal detailed characteristics of functional immune programs in the tumor microenvironment," said Alexander Bagaev, PhD, VP, Product Development at BostonGene. "Our comprehensive molecular profiling approach and innovative bioinformatics platform stratifies patients based on IO response and identifies the most effective therapy, ultimately improving patient outcomes."

On April 3, 2023 Novocure (NASDAQ: NVCR) reported that it will report financial results for the first quarter 2023 on Thursday, May 4, 2023, before the U.S. financial markets open (Press release, NovoCure, APR 3, 2023, View Source [SID1234629782]). Novocure management will host a conference call and webcast to discuss the company’s financial results for the three months ended March 31, 2023, at 8:00 a.m. ET on Thursday, May 4, 2023. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

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The slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On April 3, 2023 Scorpion Therapeutics, Inc. ("Scorpion"), a clinical-stage biotechnology company redefining the frontier of precision medicine through its Precision Oncology 2.0 strategy, reported that it has named STX-241 as its next development candidate (Press release, Scorpion Therapeutics, APR 3, 2023, View Source [SID1234629781]). STX-241 is the third development candidate nominated by Scorpion in less than three years, and the second highly selective epidermal growth factor receptor ("EGFR") development candidate from the Company’s franchise of next-generation mutant EGFR inhibitors for the treatment of non-small cell lung cancer ("NSCLC"). STX-241 is an orally bioavailable, highly selective, central nervous system ("CNS")-penetrant, and potentially best-in-class fourth generation EGFR tyrosine kinase inhibitor ("TKI") designed to inhibit C797S mutations with a co-occurring EGFR exon 19 deletion or exon 21 mutation ("double mutant") in NSCLC.

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NSCLC is the most common form of lung cancer and EGFR mutations are one of its most common disease drivers. The current standard-of-care therapy for NSCLC patients with EGFR exon 19 or 21 mutations is osimertinib; however, up to 12.5 percent of treated patients, or approximately 3,000 people each year in the United States, acquire resistance mutations at C797S, for which there are currently no approved therapies.1 As osimertinib use in first line EGFR-mutated NSCLC increases, mutations at C797S are expected to increase in parallel, creating a growing need for a fourth-generation EGFR TKI that can be used to treat this patient population.

"We are excited to name STX-241 as our next development candidate, as we believe it holds immense potential to improve the lives of a growing group of patients who invariably develop resistance to the standard-of-care," said Axel Hoos, M.D., Ph.D., Chief Executive Officer of Scorpion Therapeutics. "We are particularly proud to introduce our third internally discovered development candidate in less than three years after the founding of Scorpion. This is a testament to the expertise of our scientific team, the capabilities of our platform, and the resulting speed and quality of our Precision Oncology 2.0 strategy. We look forward to sharing preclinical data for STX-241 later this year, and to submitting an IND application to the U.S. Food and Drug Administration ("FDA") in the first half of 2024."

Scorpion Therapeutics is developing STX-241 as an orally bioavailable, highly selective, potent inhibitor of double mutant NSCLC with the potential to deliver promising safety, tolerability, and efficacy, while exhibiting excellent CNS penetrance. In preclinical studies, STX-241 demonstrated potential best-in-class mutant vs. wild-type selectivity for the EGFR exon 19/C797S and EGFR exon 21/C797S double mutations when compared to key reference benchmarks, including approved first- and third-generation EGFR TKIs, gefitinib and osimertinib, which could translate into a wide therapeutic index. In addition, treatment with STX-241 demonstrated tumor regressions in animal models and favorable CNS penetration. Scorpion expects to present these data in the second half of 2023 and to submit an IND filing in the first half of 2024.

"Despite recent progress in the treatment of NSCLC, there is a need for new options that can address the resistance mutations that arise following front-line therapies," said Darrin Stuart, Ph.D., Chief Scientific Officer of Scorpion Therapeutics. "While osimertinib has delivered tremendous benefit for people living with EGFR mutation driven NSCLC, we are hopeful that STX-241 can fill the treatment gap for the growing number of patients that develop ‘double mutant’ disease."

STX-241 is the second highly selective EGFR product candidate to emerge from Scorpion’s franchise of next-generation mutant EGFR inhibitors for the treatment of NSCLC. Scorpion is also developing STX-721, a potentially best-in-class exon 20 mutant EGFR inhibitor, for which an IND application is expected in 2023.