On February 28, 2023 Enveric Biosciences (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 the appointment of Kevin Coveney, CPA, to the position of Chief Financial Officer, effective March 13, 2023 (Press release, Enveric Biosciences, FEB 28, 2023, View Source [SID1234627840]). Mr. Coveney brings 30+ years of accounting, finance, and operations experience to Enveric, having previously served as Chief Financial Officer for multiple biotechnology companies.

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As CFO, Mr. Coveney will be responsible for leading Enveric’s financial and capital markets activities as the Company targets multiple anticipated growth drivers resulting from the advancement of its EVM201 Series and EVM301 Series programs. Mr. Coveney joins Enveric’s leadership team alongside Joseph Tucker, Ph.D., CEO, Avani Kanubaddi, President and COO, Bob Dagher, M.D., Chief Medical Officer, Peter Facchini, Ph.D., Chief Innovation Officer, and Lynn Gallant, who was recently hired as Vice President, Clinical Operations.

"We are extremely pleased to add Kevin to the leadership team at Enveric Biosciences. He is ideally suited for this role given his prior executive experience at multiple life sciences companies and track record executing growth strategies that translate to shareholder value," said Joseph Tucker, Ph.D., Director and CEO of Enveric Biosciences. "We believe that as CFO, Kevin will strive to ensure Enveric has the proper financial structures and discipline in place to enable our near-term and longer-range growth objectives, including the development of our EVM201 and EVM301 product platforms."

Mr. Coveney joins Enveric after serving as a fractional CFO to emerging life science and digital health companies to support the development of the companies’ finance and accounting departments as well as venture capital fundraising strategy. Companies that Mr. Coveney provided CFO services to include Progressive Therapeutics, Power of Patients, and VSI.

Previously, Mr. Coveney was CFO of Memgen, Inc., a clinical-stage immune-oncology company focused on developing cancer immunotherapies that can safely activate the immune system and be combined with other drugs to eradicate cancer. Prior to Memgen, Mr. Coveney was CFO of Q-State Biosciences, a biotech company focused on CNS disorders, where he was responsible for all investor financial due diligence inquiries and financial reporting requirements to investors and strategic collaboration partners. Before Q-State, Mr. Coveney was Senior Vice President of Finance, HR & IT at Vedanta Biosciences, a private microbiome company developing a therapy for Clostridium difficile infection. Prior to Vedanta, Mr. Coveney served roles of increasing responsibility at Berg Health, a family office/VC-backed clinical-stage biotech focused on oncology with a machine learning/AI platform to improve drug discovery and development. Mr. Coveney has also held senior positions at several global accounting firms, including Grant Thornton, Marcum, Deloitte & Touche, BDO Seidman, and Ernst & Young. Mr. Coveney earned his BS in management from the University of Massachusetts and served as a non-commission officer in the United States Coast Guard.

"I am excited to join the team at Enveric at such a crucial time for the Company," said Mr. Coveney. "With multiple milestones on the horizon, I look forward to working with Joe and the leadership team to strengthen Enveric’s financial and capital markets activities so that we are optimally positioned to pursue our goal of developing ‘next generation’ drug technologies for the treatment of underserved mental health conditions, including anxiety disorders and depression, and by doing so, generate value for both patients and shareholders."

The Company has agreed to grant, on March 13, 2023 upon the effective date of Mr. Coveney as Chief Financial Officer of the Company, an award of restricted stock units ("RSUs") convertible into an aggregate of 26,500 shares of the Company’s common stock to Mr. Coveney, to serve as the Company’s Chief Financial Officer, as an inducement award outside of the Company’s 2020 Long-Term Incentive Plan. Subject to certain exceptions including change in control or termination of employment, the awarded RSUs shall vest in four equal installments on each of the first four anniversaries of the date of grant. The grant was approved by the board of directors of the Company and will be made as an inducement material to Mr. Coveney entering into employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).

On February 28, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will participate in the following investor conferences in March (Press release, CytomX Therapeutics, FEB 28, 2023, View Source [SID1234627839]).

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Cowen 43rd Annual Health Care Conference
Date: Tuesday, March 7, 2023
Panel Discussion: 9:10 a.m. ET
Location: Boston, MA

Barclays Global Healthcare Conference
Date: Tuesday, March 14, 2023
Fireside Chat: 4:05 p.m. ET
Location: Miami, FL

Live webcasts of the Cowen panel discussion and Barclays fireside chat will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.

On February 28, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) reported financial results for the fourth quarter and year ended December 31, 2022 (Press release, Crinetics Pharmaceuticals, FEB 28, 2023, View Source [SID1234627838]).

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"We continue to make great progress in our vision to build a premier fully integrated endocrine company that can sustainably innovate pioneering therapies for our patients around the world," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "In 2022, we demonstrated pharmacologic proof-of-concept for CRN04894 and CRN04777, established global clinical study capabilities with our Phase 3 PATHFNDR program for paltusotine in acromegaly, and began laying groundwork for a potential commercial launch."

Dr. Struthers continued, "Looking forward, we believe our efforts in acromegaly position us for success not only in this program, but also in additional indications with our multiple oral small molecule drug candidates. Going into 2023, I am especially proud of our discovery team who continues to bring innovative opportunities forward in the areas of hyperparathyroidism, polycystic kidney disease, Graves’ disease, including thyroid eye disease, and metabolic diseases including diabetes and obesity."

Key Corporate Updates:

•
Phase 3 PATHFNDR-1 study enrollment complete. PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 clinical studies of oral paltusotine in participants with acromegaly. The study enrolled participants with acromegaly who were biochemically controlled (IGF-1 ≤ 1.0x upper limit of normal) on octreotide or lanreotide depot monotherapy. Topline data from PATHFNDR-1 are expected in the third quarter of 2023.
•
Phase 3 PATHFNDR-2 study enrollment ongoing. PATHFNDR-2 is the second placebo-controlled Phase 3 clinical study of oral paltusotine in participants with acromegaly. The study is enrolling participants with acromegaly with elevated IGF-1 levels who are either medication naïve or who are not being treated with pharmacotherapy. Enrollment is ongoing in the study and the company is aggressively navigating prolonged pandemic-related and geopolitical disruptions in certain key study regions. Momentum and interest in the study continue to build despite these disruptions, however, based on current enrollment projections, the company’s anticipated timeline for topline results from the study now extends into the first quarter of 2024.
•
Paltusotine NDA Submission. Pending a successful outcome from the PATHFNDR studies, Crinetics plans to seek regulatory approval for paltusotine for the treatment of acromegaly in the United States with an anticipated submission of a new drug application (NDA) in 2024.
•
Phase 2 open-label study of paltusotine in carcinoid syndrome ongoing. Paltusotine is also being studied in a Phase 2 open-label study in carcinoid syndrome associated with neuroendocrine tumors. Enrollment is ongoing and data from the study are expected in the second half of 2023.

EXHIBIT 99.1

•
CRN04894 studies in Cushing’s disease and congenital adrenal hyperplasia. Based on successful Phase 1 studies demonstrating pharmacologic proof-of-concept, Crinetics is advancing CRN04894 into clinical studies in Cushing’s disease and congenital adrenal hyperplasia. Start-up activities for studies in each of these indications began in the first quarter of 2023.
•
CRN04777 progress. In November 2022, the U.S. Food and Drug Administration (FDA) informed Crinetics that the company’s planned Phase 2 study of CRN04777 in a pediatric population was not yet permitted to proceed. Crinetics is in the process of collecting additional information and data to submit to the FDA, with the goal of gaining allowance to proceed with the Phase 2 study. The planned Phase 2 study is supported by pharmacologic proof-of-concept results from a successful Phase 1 study in healthy adult volunteers conducted under a Clinical Trial Application in Germany.

Full Year 2022 Highlights:

•
Reported long-term safety and efficacy data from ACROBAT Advance open-label extension study of paltusotine in acromegaly. Once-daily oral paltusotine was shown to lower and maintain IGF-1 at levels comparable to prior injected somatostatin receptor ligand (SRL) therapy for up to 103 weeks. In addition, paltusotine was well tolerated and 89% of study participants surveyed selected paltusotine as their preferred treatment option over injected SRLs.
•
Reported positive topline results from multiple-ascending dose (MAD) cohorts of the CRN04894 Phase 1 study in healthy adult volunteers. Pharmacodynamic data from the Phase 1 study’s MAD cohorts demonstrated pharmacologic proof-of-concept for CRN04894, an adrenocorticotropic hormone (ACTH) antagonist being developed as a treatment for conditions of ACTH-excess. Pharmacokinetic data demonstrated CRN04894’s oral bioavailability. No serious adverse events nor study drug discontinuations due to treatment-related adverse events were observed.
•
Reported positive topline results from MAD cohorts of the CRN04777 Phase 1 study in healthy adult volunteers. Pharmacodynamic data from the Phase 1 study’s MAD cohorts demonstrated pharmacologic proof-of-concept for CRN04777, a somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism. Pharmacokinetic data indicated CRN04777 was orally bioavailable and support a once daily dosing schedule. No serious adverse events nor discontinuations due to adverse events were reported in the Phase 1 study, which was conducted under a Clinical Trial Application in Germany.
•
Received UK Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Passport for CRN04777 for the treatment of congenital hyperinsulinism. The Innovation Passport enables sponsors to access the Innovative Licensing and Access Pathway (ILAP), which was launched in 2021 with the goal of reducing the time to market for designated medicines. The ILAP is designed to achieve this goal by enabling enhanced coordination between sponsors and the MHRA leading up to Marketing Authorization Application (MAA) submissions and by providing the opportunity for accelerated MAA reviews.
•
Entered into strategic licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd. (Sanwa) for the development and commercialization of paltusotine in Japan. Per the agreement, Crinetics received $13 million upfront and is also eligible to receive development, regulatory and commercial milestones, as well as tiered royalties on net product sales should paltusotine receive marketing approval in Japan. In exchange, Sanwa was granted an exclusive right to develop and commercialize paltusotine in Japan. Sanwa will assume all costs associated with clinical studies and regulatory applications in Japan. Crinetics retains all rights to develop and commercialize paltusotine in territories other than Japan.
•
Strengthened balance sheet with successful $125 million common stock offering. In April 2022, Crinetics successfully completed an underwritten follow-on offering of its common stock, raising gross proceeds of approximately $125 million.

EXHIBIT 99.1

•
Made key additions to management team and Board of Directors. Crinetics strengthened the company’s leadership throughout 2022 by appointing James Hassard to the role of chief commercial officer, Chris Robillard to the role of chief business officer, Dana Pizzuti, M.D., to the role of chief development officer, and Rogério Vivaldi Coelho, M.D., M.B.A., and Caren Deardorf to the Board of Directors.

Fourth Quarter and Full Year 2022 Financial Results

•
Research and development expenses were $37.0 million and $130.2 million for the three months and full year ended December 31, 2022, respectively, compared to $24.6 million and $84.3 million for the same periods in 2021. The increases were primarily attributable to an increase in supplies and spending on manufacturing and development activities of $5.6 million for the quarter ended December 31, 2022 and $25.3 million for the year ended December 31, 2022 associated with our clinical and nonclinical activities for paltusotine, CRN04777, CRN04894 and our preclinical programs and an increase in personnel costs of $5.0 million for the quarter ended December 31, 2022 and $16.2 million for the year ended December 31, 2022.
•
General and administrative expenses were $11.3 million and $42.4 million for the three months and full year ended December 31, 2022, respectively, compared to $7.4 million and $24.5 million for the same periods in 2021. The increases were primarily attributable to an increase in personnel costs of $2.7 million for the quarter ended December 31, 2022 and $10.8 million for the year ended December 31, 2022.
•
Net loss for the three months ended December 31, 2022, was $45.0 million, compared to a net loss of $30.8 million for the same period in 2021. For the year ended December 31, 2022, the company’s net loss was $163.9 million compared to a net loss of $107.6 million for the year ended December 31, 2021.
•
Revenues were $0.7 million and $4.7 million for the three months and full year ended December 31, 2022, respectively, primarily consisting of license revenue recognized from the license agreement entered into with Sanwa in February 2022.
•
Unrestricted cash, cash equivalents, and investments totaled $334.4 million as of December 31, 2022, compared to $368.4 million as of September 30, 2022, and $333.7 million as of December 31, 2021. Based on its current projections, the company expects that current cash, cash equivalents and short-term investments will fund its current operating plan through 2024.
•
The company had 53,908,865 common shares outstanding as of February 24, 2023.

On February 28, 2023 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, reported its results for the quarter and year ended December 31, 2022 (Press release, Corcept Therapeutics, FEB 28, 2023, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-2022 [SID1234627837]).

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Financial Results

Fourth quarter revenue of $103.1 million, compared to $98.8 million in fourth quarter 2021
2022 revenue of $401.9 million, compared to $366.0 million in 2021
2023 revenue guidance of $430 – $450 million
Fourth quarter diluted net income per common share of $0.14, compared to $0.26 in fourth quarter 2021
2022 diluted net income per common share of $0.87, compared to $0.89 in 2021
Cash and investments of $436.6 million, compared to $335.8 million at December 31, 2021
Corcept’s fourth quarter 2022 revenue was $103.1 million, compared to $98.8 million in the fourth quarter of 2021. Revenue for the full year was $401.9 million, compared to $366.0 million in 2021. The company expects 2023 revenue of $430 – $450 million.

Net income was $16.6 million in the fourth quarter of 2022, compared to $32.1 million in the fourth quarter of 2021. For the full year, it was $101.4 million compared to $112.5 million in 2021.

Cash and investments of $436.6 million at December 31, 2022 compared to $335.8 million at December 31, 2021.

"We remain extremely optimistic about the growth potential of our Cushing’s syndrome business. Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it. We are making substantial investments to improve the screening and treatment of these patients. We are providing 2023 revenue guidance of $430 – $450 million," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer.

Clinical Development

"We significantly advanced our clinical development programs, with three of our proprietary selective cortisol modulators – relacorilant, dazucorilant and miricorilant – now in the clinic," added Dr. Belanoff. "We expect to make further progress in the next twelve months with submission of the NDA for relacorilant in Cushing’s syndrome, enrollment of our confirmatory Phase 3 trial of relacorilant in platinum-resistant ovarian cancer and Phase 2 trial of dazucorilant in ALS, and advancement to Phase 2 of miricorilant as a potential treatment for NASH."

Cushing’s Syndrome

Enrollment to close in the coming weeks in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome – new drug application (NDA) submission expected in the first quarter of 2024
Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome caused by adrenal adenomas
CATALYST – 1,000-patient randomized, double-blind, placebo-controlled Phase 4 trial to examine the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes and treat the patients determined to have hypercortisolism with Korlym – to begin this quarter
"We are pleased to announce that we believe that we have enough patients in screening in our GRACE trial to complete enrollment in the coming weeks. We expect GRACE to serve as the basis for relacorilant’s NDA in Cushing’s syndrome, which we plan to submit in the first quarter of 2024," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "The Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that affects many patients but has not been subject to rigorous, controlled study."

"Our randomized, double-blind, placebo-controlled, Phase 4 CATALYST study will examine the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes and treat the patients determined to have hypercortisolism with Korlym. Planned enrollment is 1,000 patients, which we expect to complete by the end of this year. The most prominent diabetologists in the country helped design and are participating in this study. We expect CATALYST to produce data that will improve the screening and treatment of these patients," added Dr. Guyer.

Oncology

Enrollment continues in ROSELLA – 360-patient pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer
Enrollment continues in open-label, Phase 1b trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess
Randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer expected to begin by mid-year in collaboration with the University of Chicago
"We and our investigators are extremely excited to advance relacorilant in platinum-resistant ovarian cancer. The 40,000 women in the United States and Europe with this disease do not have good treatment options and relacorilant plus nab-paclitaxel has the potential to become a new standard of care," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

Enrollment continues in DAZALS – 198-patient, randomized, double-blind, placebo-controlled Phase 2 trial of dazucorilant in patients with ALS
"The 55,000 patients in the United States and Europe with ALS have an urgent need for better treatment. Dazucorilant showed great promise in animal models of ALS – improving motor performance and reducing neuroinflammation and muscular atrophy. We are conducting this important study in collaboration with TRICALS, the leading ALS academic consortium in Europe, to investigate dazucorilant’s potential to significantly improve the lives of patients with ALS," said Dr. Guyer.

Non-alcoholic Steatohepatitis (NASH)

Screening closed in Phase 1b dose-finding trial of miricorilant in patients with presumed NASH – data expected by mid-year
"Miricorilant, an oral medication, continues to demonstrate great promise as a treatment for NASH. Our Phase 1b study has identified a range of doses, all substantially lower than our originally tested doses, that significantly reduces liver fat without causing excessive liver irritation," said Dr. Guyer. "We expect to share results from this study by mid-year and plan to start a Phase 2 trial later this year."

Conference Call

We will hold a conference call on February 28, 2023, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To access the conference call, please dial 877-407-8029 from the United States or +1-201-689-8029 internationally. A replay of the call will be available on the Investors / Events tab of www.corcept.com.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

On February 28, 2023 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported that its fourth quarter and full year 2022 financial results will be released after market close on Monday, March 6, 2023 (Press release, Coherus Biosciences, FEB 28, 2023, View Source/news-releases/news-release-details/coherus-biosciences-report-fourth-quarter-and-full-year-2022" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-fourth-quarter-and-full-year-2022" rel="nofollow">View Source [SID1234627836]). Starting at 5:00 pm ET on March 6, 2023, Coherus’ management team will host a conference call and webcast to discuss financial results and provide a general business update.

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A replay of the webcast will be available on View Source following the conclusion of the live conference call.

Conference Call Information
When: Monday, March 6th, 2023, starting at 5:00 p.m. Eastern Time
To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BI8a3cc318d81c4ebaa9d8f6e635f9731c

Webcast: View Source

The press release with the fourth quarter and full year 2022 financial results and related materials will be available at View Source prior to the start of the conference call.

A live and archived webcast will be available on the "Investors" section of the Coherus website at View Source.

Please dial-in 15 minutes early to ensure a timely connection to the call.