MIAMI, FL, July 29, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced the company will be participating in one-on-one meetings with investors at the BTIG Virtual Biotechnology Conference on August 5th, 2024. The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-f ...

About the Enobosarm Phase 2b clinical trial About Enobosarm Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of * Wegovy® is a r ...

Investor and Media Contact: About Sarcopenic Obesity According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA m ...

Veru Inc. (NASDAQ:VERU) Q1 2024 Earnings Conference Call May 8, 2024 8:00 AM ET Company Participants Sam Fisch - Investor Relations & Corporate Communications Mitchell Steiner - Chief Executive Officer Michele Greco - Chief Financial Officer Gary Barnette - Chief Scientific Officer Conference Call Participants Dennis Ding - Jefferies William Wood - B. Riley Securities Rohan Mathur - Oppenheimer Operator Good morning ladies and gentlemen and welcome to Veru Inc.'s Investors Conference Call. [Operator Instruc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q 2916 N. Miami Avenue, Suite 1000, Miami, FL 33127 (Address of Principal Executive Offices) (Zip Code) 305-509-6897 (Registrant's Telephone Number, Including Area Code) N/A (Mark One) Commission File Number 1-13602 | | | (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 As of May 6, 2024, the registrant had 146,383,920 shares of $0.01 par value common stock outstanding. (Former Name, Former Address and ...

Exhibit 99.1 Investor and Media Contact: Samuel Fisch Executive Director, Investor Relations and Corporate Communications Email: veruinvestor@verupharma.com Veru Reports Fiscal 2024 Second Quarter Financial Results and Progress of its Enobosarm High Quality Weight Loss Clinical Program —Phase 2b clinical study of enobosarm in combination with semaglutide (Wegovy®*) for high quality weight loss is actively enrolling— High Quality Weight Loss Program Update: The Company's high quality weight loss program is f ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Commission File Number 1-13602 | | | (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 2916 N. Miami Avenue, Suite 1000, Miami, FL 33127 (Address of Principal Executive Offices) (Zip Code) 305-509-6897 (Registrant's Telephone Number, Including Area Code) N/A Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller r ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Commission file number 1-13602 Veru Inc. (Name of registrant as specified in its charter) | Wisconsin 39-1144397 | | | --- | --- | | (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) | | | 2916 N. Miami Avenue, Suite 1000, Miami, Florida 33127 | | | (Address of principal executive offices) (Zip Code) | | | Registrant's telephone number, including area code (305) 509-6897 | | | ...

Financial Data and Key Metrics Changes - For Q3 2023, net revenues were $3.3 million, down from $9.6 million in the prior year [63] - Prescription business net revenues decreased from $6.7 million to $863,000 due to the Chapter 11 bankruptcy of the pill club [63] - Gross profit was $1.2 million or 37% of net revenues, compared to $7.1 million or 74% in the prior year [64] - Operating income for the quarter was $4.9 million, a significant improvement from an operating loss of $21.8 million in the prior year [68] - Net income for Q3 2023 was $6.3 million or $0.07 per diluted share, compared to a net loss of $22.2 million or $0.28 per diluted share in the prior year [70] Business Line Data and Key Metrics Changes - The FC2 female condom business generated over $213 million in net revenue since 2017, with a 115% increase in new prescriptions during Q3 2023 [52][57] - Global public sector net revenues were $2.5 million, down from $2.9 million in the prior year [64] - The U.S. prescription business net revenues were $5.2 million, down from $29.9 million in the prior year [71] Market Data and Key Metrics Changes - The company is experiencing a significant market opportunity in the contraceptive market, with a potential market opportunity for FC2 exceeding $400 million [55] - The company has seen a 115% increase in volume in the U.S. public sector for Q3 2023 compared to Q3 2022 [58] Company Strategy and Development Direction - The company is focused on obtaining regulatory clarity for two major Phase 3 clinical trials for Enobosarm and Sabizabulin [90] - Plans to expand the evaluation of Sabizabulin beyond COVID-19 to include all types of viral-induced lung infections [92] - The company aims to leverage partnerships for Enobosarm and Sabizabulin as a source of non-dilutive capital [96] Management's Comments on Operating Environment and Future Outlook - The company has successfully reduced expenses following the FDA's declination of the EUA for Sabizabulin, with a cash burn of $7.3 million in Q3 2023 [94] - The current cash position is $16 million, with expectations of $14 million in gross promissory notes receivable [94] - The company is actively seeking partnerships to enhance financial flexibility and shareholder value [95] Other Important Information - The company sold its Entadfi product for $20 million, recording a pre-tax gain of $17.5 million [68] - The company is pursuing smallpox and Ebola virus treatments, with a scheduled pre-IND meeting with the FDA [50] Q&A Session Summary Question: How much flexibility does the company have on OpEx to potentially extend the runway beyond the guidance for 12 months? - The company is exploring options to manage cash burn and may slow down drug development or focus on one program at a time to match spending with available resources [88] Question: Can the company comment on the status of the dual test mono trial and if data will be available? - The company is focused on obtaining regulatory clarity for the Phase 3 clinical trials and will provide updates as they progress [90]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Commission File Number 1-13602 | | | (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 2916 N. Miami Avenue, Suite 1000, Miami, FL 33127 N/A (Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report) Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | --- | --- | --- | | ...