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(R) (*) ) for high quality weight loss is actively enrolling--
--Company assembles esteemed high quality weight loss Scientific Advisory Board -- five MDs with significant relevant medical, clinical and scientific expertise--
--Company to present this month at upcoming American Association of Clinical Endocrinology annual meeting and GLP-1 Based Therapeutics Summit--
--Company to host conference call and webcast today at 8:00 a.m. ET--
MIAMI, FL, May 08, 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 financial results for its fiscal 2024 second quarter and provided a business update.
"We are pleased to have initiated the Phase 2b enobosarm clinical trial, " said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. "There is a significant unmet medical need to have a drug that may effectively preserve muscle and augment fat loss in patients receiving GLP-1 drugs for weight loss." Dr. Steiner also added: "We are also very pleased to have assembled such an esteemed group of five medical experts for our high quality weight loss Scientific Advisory Board. All of these experts in obesity and muscle share our vision and goal to develop enobosarm as a drug candidate that may potentially enhance quality weight loss for obese or overweight patients by preferentially increasing fat loss while preserving muscle. We know that all of them will make valuable contributions to guide the enobosarm development program."
High Quality Weight Loss Program Update:
The Company's high quality weight loss program is focused on the clinical development of enobosarm, a novel oral selective androgen receptor modulator, to preserve muscle while augmenting fat loss in patients receiving a GLP-1 RA for weight loss.
About the Enobosarm Phase 2b clinical trial
The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial was designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in approximately 90 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy(R)). The primary endpoint is difference in total lean body mass measured by DEXA, and the key secondary endpoints are differences in total body fat mass measured by DEXA and physical function as measured by stair climb test at 16 weeks. The Phase 2b clinical trial is actively enrolling patients from up to 15 clinical sites in the United States. Topline clinical results from the trial are expected by the end of calendar year 2024.
After completing the efficacy dose-finding portion of the Phase 2b clinical trial, it is expected that participants will then continue in blinded fashion into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025.
Second Quarter Financial Summary: Fiscal 2024 vs Fiscal 2023
-- Net revenues decreased to $4.1 million from $6.6 million -- Gross profit decreased to $0.7 million from $4.1 million -- Research and development expenses decreased to $3.0 million from $17.9 million, as restated -- Selling, general and administrative expenses decreased to $7.6 million from $12.8 million -- Operating loss decreased to $9.9 million versus $34.4 million, as restated -- Net loss was $10.0 million, or $0.07 per share, compared to $33.8 million, or $0.42 per share, as restated
Year-to-Date Financial Summary: Fiscal 2024 vs Fiscal 2023
-- Net revenues decreased to $6.3 million from $9.1 million -- Gross profit decreased to $1.8 million from $4.8 million -- Research and development expenses decreased to $4.6 million from $38.5 million, as restated -- Selling, general and administrative expenses decreased to $15.9 million from $30.4 million -- Operating loss was $17.8 million versus $71.9 million, as restated -- Net loss was $18.3 million, or $0.15 per share, compared to $72.5 million, or $0.90 per share, as restated
Balance Sheet Information
-- Cash and cash equivalents were $34.7 million as of March 31, 2024 versus $9.6 million as of September 30, 2023 -- Net accounts receivable were $2.8 million as of March 31, 2024 versus $4.5 million as of September 30, 2023
Event Details
The audio webcast will be accessible under the Investors page of the Company's website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company's website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international), passcode 8861692, for one week.
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 medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty in older obese or overweight elderly patients.
About Enobosarm
Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a "starvation state" where there is significant unintentional loss or wasting of both muscle and fat mass which is similar to what is observed with in patients taking GLP-1 RA drugs. We believe the totality of the clinical data from these previous five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced starvation-like state provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass.
Importantly, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women, some of which included patients dosed for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increases in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.
About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company's drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.
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 enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting.
Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources.
The Company also has an FDA-approved commercial product, the FC2 Female Condom(R) (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.
Forward-Looking Statements |
