Release Date: February 13, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Veru Inc (NASDAQ:VERU) reported positive top-line results from its Phase 2B clinical study for Novosarm, showing significant preservation of lean body mass in older patients.
• The company successfully sold its FC2 female condom business, allowing it to focus on its biopharmaceutical pipeline.
• Veru Inc (NASDAQ:VERU) has sufficient cash to fund operations until the end of the calendar year, providing financial stability for ongoing projects.
• The company's drug development strategy includes exploring Subisobulin as a treatment for inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need.
• Veru Inc (NASDAQ:VERU) plans to move forward with a Phase 3 study for Novosarm, aiming for a 52-week treatment duration to capture long-term benefits.

Negative Points

• Veru Inc (NASDAQ:VERU) reported a net loss of $1.8 million from continuing operations, indicating ongoing financial challenges.
• The sale of the FC2 female condom business resulted in a $4.2 million loss, impacting the company's financial position.
• The company has a negative cash flow from operations and will need additional capital to support its drug development candidates.
• There is a 13% dropout rate in the clinical study due to gastrointestinal side effects associated with GLP-1 receptor agonists.
• The safety data from the Phase 2B study remains blinded, and full safety results will only be available after the extension study is completed.

Q & A Highlights

• Warning! GuruFocus has detected 6 Warning Signs with VERU.

Q: Can you provide details on the dropout rate for the extension trial and the reasons for discontinuation? A: Dr. Gary Barnett, Chief Scientific Officer, explained that the dropout rate is about 13%, primarily due to gastrointestinal side effects associated with GLP-1 receptor agonists, which is expected.

Q: What are your expectations for the extension trial data, particularly regarding weight regain after GLP-1 discontinuation? A: Dr. Mitchell Steiner, CEO, stated that the focus is on preventing fat regain, as muscle preservation should help avoid rebound weight gain. The aim is to show that Enovasar can minimize fat regain while maintaining muscle mass.

Q: What kind of patient safety data did the safety monitoring committee review, and are there any notable findings? A: Dr. Gary Barnett mentioned that the committee reviewed individual patient safety data, including demographics and treatment assignments, up to December 20, 2024. No significant abnormalities were noted in the top-line data.

Q: Is there potential for combining the new oral formulation of Nobusar with oral GLP-1s as a fixed-dose combo? A: Dr. Mitchell Steiner confirmed that combining Nobusar with oral GLP-1s is feasible and has been discussed, as it could enhance the efficacy of GLP-1 therapies by making them more tissue-selective.

Q: How does Subisobulin compare to colchicine in terms of mechanism and safety for treating atherosclerotic cardiovascular disease? A: Dr. Mitchell Steiner explained that Subisobulin shares a similar mechanism with colchicine but has a better safety profile due to lower potential for drug-drug interactions, making it a promising candidate for reducing inflammation in cardiovascular disease.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.