Veru Inc. (NASDAQ:VERU) Q1 2024 Earnings Conference Call February 8, 2024 8:00 AM ET

Company Participants

Mitchell Steiner - CEO

Michele Greco - CFO

Dr. Gary Barnette - Chief Scientific Officer

Michael Purvis - EVP, General Counsel & Corporate Strategy

Sam Fisch - IR & Corporate Communications

Conference Call Participants

Dennis Ding - Jefferies

Leland Gershell - Oppenheimer

Yi Chen - H.C. Wainwright

Operator

Good morning, ladies and gentlemen, and welcome to the Veru Inc. Investor Conference Call. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference call over to Mr. Michael Purvis, Veru Inc.'s Executive Vice President, General Counsel, and Corporate Strategy. Please go ahead.

Michael Purvis

The statements made on this conference call may be forward-looking statements. Forward-looking statements may include, but are not necessarily limited to, statements of the company's plans, objectives, expectations or intentions regarding its business, operations, regulatory interactions, finances, and development, and product portfolio. Such forward-looking statements are subject to known and unknown risks and uncertainties, and our actual results may differ significantly from those projected, suggested, or included in any forward-looking statements. Risks that may cause actual results or developments to differ materially are contained in our 10-Q and 10-K SEC filings, as well as in our press releases from time to time.

I would now like to turn the conference call over to Mitchell Steiner, Veru Inc's, Chairman, CEO, and President.

Mitchell Steiner

Good morning. With me on this morning's call are Dr. Gary Barnette, Chief Scientific Officer, Michele Greco, the CFO and Chief Administrative Officer, Michael Purvis, the Executive Vice President, General Counsel and Corporate Strategy, and Sam Fisch, Executive Director of Investor relations and Corporate Communications. Thank you for joining our Q1 fiscal year 2024 earnings call. Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for high quality weight loss, oncology, and ARDS. The company's drug development program includes two late-stage novel orally administered small molecules, Enobosarm and Sabizabulin. Our weight loss pipeline leads off Enobosarm, also known as Ostarine MK-2866, GTx-024, S-22, and VERU-024. These are all the identical same molecule Enobosarm, which is an oral selective androgen receptor modulator. Enobosarm is being developed as a treatment in combination with weight loss drugs to augment fat loss and to avoid muscle loss in overweight or obese patients for chronic weight management. In our oncology pipeline, we're developing Enobosarm as a treatment for antigen receptor positive, estrogen receptor positive, and human epidermal growth factor two negative metastatic breast cancer in the second line set setting. In our infectious disease pipeline, which is pending additional external funding or pharma partnership is Sabizabulin, a microtubule disruptor, which is being developed as a Phase 3 in a Phase 3 clinical trial for the treatment of hospitalized patients with viral induced ARDS. The company also has an FDA-approved commercial product, the FC2 female condom internal condom for the dual protection against unplanned pregnancy and sexually transmitted infections.