Duyuru • Jan 28

Veru Announces Positive Topline Data from Phase 2b QUALITY Clinical Study

Veru Inc. announced positive topline results from the Phase 2b QUALITY clinical study. Phase 2b QUALITY clinical trial design - The Phase 2b QUALITY clinical study was a multicenter, double-blind, placebo-controlled, randomized, dose-finding study to evaluate the safety and efficacy of enobosarm 3mg, and enobosarm 6mg, compared to placebo in 168 older patients, greater than 60 years of age, who are overweight or have obesity and who are receiving WEGOVY (semaglutide), a GLP-1 receptor agonist (RA), for weight reduction. The primary endpoint was the change in total lean body mass from baseline to 16 weeks, and key secondary endpoints were the change from baseline to 16 weeks in total fat mass, total body weight, and physical function as measured by a stair climb test. Standard Deviation, ANCOVA model, least square means analysis using gender and BMI at baseline as covariates, Fisher’s exact test The Phase 2b QUALITY study is the first human study to report the effects of a muscle preservation agent on body composition in older patients who have obesity or are overweight and receiving a GLP-1 receptor agonist. In the topline efficacy analysis, the Phase 2b QUALITY clinical study met its primary endpoint with a statistically significant benefit in preservation of total lean body mass in all patients receiving enobosarm + semaglutide versus placebo + semaglutide at 16 weeks. Secondary endpoints showed: Enobosarm + semaglutide treatment resulted in a greater reduction in total fat mass compared to placebo + semaglutide at 16 weeks. There appears to be minor differences in total body weight changes between the enobosarm + semaglutide group and placebo + semaglutide group at 16 weeks. Therefore, enobosarm + semaglutide improved changes in body composition and resulted in more selective and greater loss of fat mass than in subjects receiving placebo + semaglutide. The proportion of subjects that lost =10% stair climb power was statistically significant and clinically meaningfully reduced in the enobosarm + semaglutide groups compared to placebo + semaglutide group. Therefore, enobosarm reduced the proportion of patients that lost clinically significant physical function versus subjects receiving semaglutide alone. The Company plans to present the full clinical efficacy and safety data set for the Phase 2b QUALITY clinical study in future scientific conferences and publications after the Phase 2b extension portion of study is completed and unblinded. Next regulatory steps: As a reminder, the 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 is ongoing. The blinded Phase 2b extension clinical trial is asking a different question than the Phase 2b QUALITY clinical study which evaluated the ability of enobosarm to improve body composition changes associated with GLP-1 RA weight loss induction. The Phase 2b extension study will evaluate maintenance of weight loss, meaning whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. If successful, this would provide another important obesity related indication for which enobosarm could be considered. The topline results for the separate blinded Phase 2b extension clinical study are expected in April of 2025. As the Phase 2b QUALITY study has positive topline clinical results, the company are planning to move forward to request an end of Phase 2 meeting with FDA. In the new weight reduction FDA guidance, FDA makes a regulatory path distinction between weight reduction drugs and drugs for body composition changes. FDA states that: “Sponsors seeking an efficacy claim related to changes in body composition would need to consult with FDA early in development to align on the clinical condition being treated. Trial design, including appropriate choice of population and selection of endpoints that measure how a patient feels, functions, or survives, to potentially support such a claim is beyond the scope of this weight reduction guidance.” Based on this updated FDA guidance, enobosarm is being developed as a body composition drug to selectively preserve lean body mass and physical function, and augment loss of fat in older patients who are overweight or have obesity receiving GLP-1 RA containing drug for chronic weight management. The company has previously met with FDA to discuss the company's regulatory path forward as an improvement in body composition drug, and FDA has provided general advice on Phase 3 design. Anticipated Phase 3 Trial Design: Based on the Phase 2b QUALITY clinical trial, the proposed Phase 3 clinical trial design is currently expected to be a double-blind, placebo-controlled study in older (> 60 years of age), patients who have obesity or who are overweight and who are eligible for treatment with GLP-1 RA. The GLP-1 RA may be either WEGOVY (semaglutide) and/or Zepbound® (tirzepatide). Patients will be randomized to oral daily enobosarm or matching placebo. All subjects will start and receive GLP-1 RA during the study. The proposed primary objective will be the effect of enobosarm on stair climb power, as measured by the proportion of subjects that lose =10% stair climb power from baseline. Proposed key secondary objectives will be to assess the effect of enobosarm on total lean mass, total body weight, total fat mass, bone mineral density, HOMA-IR, and hemoglobin A1c. The duration of treatment is expected to be 52 weeks which will allow the company to also capture the benefits of enobosarm improvements on body composition for greater loss of adiposity and weight reduction. Based on the responder rates of the stair climb power observed in this Phase 2b clinical study, the predicted trial sample size is expected to be approximately 470 total subjects with a 90% power and an alpha of 0.05.

Duyuru • Jan 24

Bragar Eagel & Squire, P.C. Announces Class Action Lawsuit Against Veru Inc

Bragar Eagel & Squire, P.C. announced class action lawsuit against Veru Inc. Veru is primarily an oncology-based biopharmaceutical company that develops drugs for the management of breast and prostate cancers. Veru also develops medicines for COVID-19 and other diseases related to viral and acute respiratory distress syndrome (“ARDS”), and has two FDA-approved products for sexual health. Veru “opportunistically” developed sabizabulin (VERU-111), an orally administered “microtubule disruptor” – a drug that inhibits a virus’ ability to replicate itself – for the treatment of COVID-19 in hospitalized patients at high risk for ARDS. Veru had originally developed sabizabulin with the intention of using it as a treatment for prostate cancer. In January 2022, however, the FDA granted Veru’s COVID-19 program Fast Track designation. At the time, there was no authorized or approved treatment for hospitalized patients with severe COVID-19 infections. Throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the data from the sabizabulin Phase 3 trial and the Company’s interactions with the FDA. Specifically, Veru misled its shareholders to believe that the data from the Phase 3 trial was sufficient to support Emergency Use Authorization (“EUA”) and even the submission of a New Drug Application (“NDA”) without any further studies. VERU’s filings therefore concealed the true risks faced by the Company in gaining approval for its EUA request. Veru conducted a randomized, double-blind Phase 3 trial of sabizabulin’s effectiveness in treating hospitalized adults with moderate to severe COVID-19 at high risk for ARDS. The Phase 3 study sought to enroll 210 patients and evaluate mortality after 60 days of treatment. On April 11, 2022, Veru issued a press release announcing that the company would be terminating sabizabulin’s Phase 3 trial early on the basis of positive interim data, after Veru’s Independent Data Safety Monitoring Committee conducted an interim analysis of the first 150 patients randomized into the study. Veru reported that sabizabulin “resulted in a clinically and statistically meaningful 55% relative reduction in deaths” relative to the placebo group (45% mortality at 60 days for the placebo group vs. 20% mortality for the sabizabulin-treated group). On an investor call held that same day, Veru’s Chairman, President, and Chief Executive Officer Mitchell Steiner, M.D. (“Steiner”) told investors that Veru had been in “constant dialogue with FDA” since receiving the Fast Track designation and that the Company “plan[ned] to meet with FDA to discuss the next steps” including submitting an application for Emergency Use Authorization (“EUA”) on the strength of the positive Phase 3 interim results. Steiner also addressed the placebo group’s 45% mortality rate, stating that this death rate “underscores how sick these patients really are.” During the call, an analyst from Cantor Fitzgerald asked Steiner to “elaborate” on any differences in the standard of care between the placebo group and the sabizabulin-treated group in the Phase 3 trial. Steiner responded: “So, there are no imbalances with males and females and with standard of care is exactly – I mean, the system works, so the randomization works. So, there are no imbalances.” Veru’s share price more than doubled on April 11, 2022, from an opening price of $5.99 per share to a closing price of $12.28. On May 2, 2022, Veru announced that the FDA had granted the Company a pre-EUA meeting to discuss sabizabulin’s Phase 3 results, to be held on May 10, 2022. On May 11, 2022, Veru issued a press release announcing that in the May 10, 2022, pre-EUA meeting, the FDA “agreed that the efficacy and safety data from the completed Phase 3 clinical study in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome are sufficient to support the submission of a request for Emergency Use Authorization (EUA).” The press release quoted Steiner as saying “The discussion with FDA in the Pre-EUA meeting has established a direct path forward to expedite the availability of sabizabulin to the high risk hospitalized patients with COVID-19 . . . In the Phase 3 COVID-19 clinical study, sabizabulin demonstrated a clear mortality benefit in hospitalized moderate to severe COVID-19 patients on current standard of care with no significant safety signals.” The May 11, 2022 press release further stated that the FDA had “agreed that the current safety data available for sabizabulin is sufficient to support the safety portion of a request for EUA submission,” and that “additional safety data that would be collected during the use of sabizabulin under the EUA, if granted, will be sufficient to support an NDA submission, and furthermore, that no additional safety clinical studies are required.” Veru’s stock price rose from its closing price of $7.79 per share on May 10, 2022, the day of the pre-EUA meeting with the FDA to close at $13 per share on May 13, 2022 the day after Veru filed its 2022 Second Quarter 10-Q in which it reported on the results of its pre-EUA meeting with the FDA. On June 7, 2022, Veru submitted an EUA request with the FDA for use of sabizabulin to treat COVID-19. On September 7, 2022, the FDA scheduled an October 6, 2022 meeting of the Pulmonary-Allergy Drugs Advisory Committee (“AdCom”) to vote on whether sabizabulin should be granted EUA. Although AdCom recommendations are not binding, the FDA ordinarily follows them. On September 19, 2022, it was announced that the FDA had postponed the AdCom meeting to November 9, 2022. On November 9, 2022, the AdCom voted against granting Veru’s EUA request by an 8-5 margin. One AdCom member who voted against approval explained that there was “no direct evidence to support [sabizabulin’s] antiviral activity.” Veru’s stock price plummeted on the news, falling from its closing price of $15.01 per share on November 8, 2022 to close at $6.97 per share on November 10, 2022, a 54% one-day drop, wiping out over $640 million in market capitalization.

Toplam Hissedar Getirisi	-63.0%
Gelecekteki Temettü Verimi	n/a
Temettü Büyümesi	n/a
Bir sonraki temettü ödeme tarihi	n/a
Eski temettü tarihi	n/a
Hisse başına temettü	n/a
Ödeme oranı	0%

Segment	Temettü Verimi
Şirket (VERU)	0%
Pazarın Alt %25'i (US)	1.4%
Pazarın En İyi %25'i (US)	4.2%
Sektör Ortalaması (Pharmaceuticals)	2.1%
Analist tahmini (VERU) (3 yıla kadar)	n/a

Veri	Son Güncelleme (UTC saati)
Şirket Analizi	2026/05/27 10:24
Gün Sonu Hisse Fiyatı	2026/05/27 00:00
Kazançlar	2026/03/31
Yıllık Kazançlar	2025/09/30

Paket	Veri	Zaman Çerçevesi	Örnek ABD Kaynağı ^*
Şirket Finansalları	10 yıl	Gelir tablosu Nakit akış tablosu Bilanço	SEC Form 10-K SEC Form 10-Q
Analist Konsensüs Tahminleri	+3 yıl	Finansal tahminler Analist fiyat hedefleri	Analist Araştırma Raporları Blue Matrix
Piyasa Fiyatları	30 yıl	Hisse senedi fiyatları Temettüler, Bölünmeler ve Eylemler	ICE Piyasa Verileri SEC Form S-1
Sahiplik	10 yıl	En büyük hissedarlar İçeriden öğrenenlerin ticareti	SEC Form 4 SEC Form 13D
Yönetim	10 yıl	Liderlik ekibi Yönetim Kurulu	SEC Form 10-K SEC Form DEF 14A
Önemli Gelişmeler	10 yıl	Şirket duyuruları	SEC Form 8-K

Analist	Kurum
Edward Nash	Canaccord Genuity
Yuchen Ding	Jefferies LLC
Leland Gershell	Oppenheimer & Co. Inc.

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Recent updates

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Chairman recently sold US$247k worth of stock

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High number of new and inexperienced directors

Veru Inc. to Report Q2, 2024 Results on May 08, 2024

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Veru Submits IND Application to FDA for the Development of Enobosarm to Prevent Muscle Loss While Augmenting Fat Loss in Combination with Glp-1 Drugs for Weight Loss

New major risk - Shareholder dilution

Veru Inc. has completed a Follow-on Equity Offering in the amount of $33 million.

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