Core Viewpoint - Veru Inc. is expected to report a quarterly loss of 39 cents per share for its fourth quarter, an improvement from a loss of 52 cents per share in the same period last year [1]. Financial Performance - The anticipated loss of 39 cents per share is based on analyst expectations [1]. - The company had a public offering of 1.4 million shares priced at $3.00 per unit, totaling $25 million [1]. Stock Performance - Veru's shares fell by 1.2%, closing at $2.39 on Monday [1]. Analyst Ratings - Raymond James analyst Gary Nachman maintained an Outperform rating but reduced the price target from $30 to $20 [3]. - HC Wainwright & Co. analyst Yi Chen maintained a Buy rating with a price target of $3 [3]. - Oppenheimer analyst Leland Gershell maintained an Outperform rating with a price target of $5 [3].

Group 1 - Onconetix announced a private placement of Series D Convertible Preferred Stock and warrants, raising approximately $12.9 million [1] - The financing included $9.3 million in cash, with the remainder used to offset debts owed to certain investors [1] - The Series D Preferred Stock is convertible into 4,362,827 shares of Common Stock, with anti-dilution adjustments [1] Group 2 - The warrants have an initial exercise price of $3.6896 per share and are exercisable for three years from the issuance date [1] - Approximately $6.3 million of the proceeds were used to pay off a debt to Veru, Inc., while $2.5 million of debt was converted into Series D Preferred Stock and warrants [1] - Remaining net cash proceeds will be used for costs related to the termination of a business combination with Ocuvex, Inc., and for working capital [1]

Core Viewpoint - Cannabis stocks experienced a significant increase, driven by reports that former President Trump is considering reclassifying cannabis as a lower-risk substance [1] Group 1: Stock Performance - Tilray Brands (TLRY.US) surged over 15% [1] - Veru Inc (VERU.US) also rose more than 15% [1] - Harrow (HROW.US) increased by over 5% [1] - Canopy Growth (CGC.US) saw a rise of over 3% [1]

Core Viewpoint - Veru Inc. is advancing its late-stage clinical development of enobosarm, showing promising safety and efficacy data in combination with semaglutide for weight management in elderly patients [1][2][8]. Group 1: Safety and Efficacy of Enobosarm - The combination of enobosarm with semaglutide demonstrated good safety, with no increase in gastrointestinal adverse events or signs of drug-induced liver injury [2][3]. - No serious adverse events related to treatment were reported, with only four non-treatment-related serious adverse events observed [2][3]. - Enobosarm 3mg combined with semaglutide resulted in fewer gastrointestinal discomfort reports compared to the placebo plus semaglutide group [2][3]. Group 2: Primary and Secondary Endpoints - The study achieved its primary endpoint, showing that enobosarm combined with semaglutide significantly reduced lean body mass loss, with the 3mg group showing a 99.1% relative reduction in lean mass loss compared to placebo (p<0.001) [4][6]. - Enobosarm promoted fat loss in a dose-dependent manner, with the 6mg group showing a 46% reduction in fat compared to placebo at 16 weeks (p=0.014) [5][6]. Group 3: Functional Improvement - The stair climbing test indicated that only 16% of participants in the enobosarm 3mg group experienced a decline of 10% or more, representing a 62.4% reduction in decline risk compared to the placebo group (p=0.0066) [7]. - In contrast, 42.6% of the placebo plus semaglutide group showed a decline of 10% or more in the stair climbing test [7]. Group 4: Future Outlook - The QUALITY study is the first to validate the risk of accelerated lean mass loss and functional decline in elderly patients using GLP-1 receptor agonists for weight management [8]. - Veru plans to further develop enobosarm as a combination treatment with GLP-1 agonists to protect muscle mass and prevent functional decline during weight loss [8].

Core Viewpoint - Obesity has become a global health challenge, with significant advancements in the development of anti-obesity drugs, with over 100 new treatments in development aimed at providing safer and more effective weight loss options for patients [1] Group 1: Upcoming Drug Approvals - Orforglipron from Eli Lilly is expected to be approved in 2026 as an oral small-molecule drug activating the GLP-1 receptor [2] - CagriSema from Novo Nordisk, also expected in 2026, is an injectable that activates both amylin and GLP-1 receptors [2] - Survodutide from Boehringer Ingelheim and Retatrutide from Eli Lilly are anticipated in 2027, both being injectables that activate multiple receptors [3] - MariTide from Amgen and Bimagrumab from Eli Lilly are projected for approval in 2028 and beyond, with unique mechanisms targeting GLP-1 and myostatin signaling respectively [3] Group 2: Mechanisms and Efficacy - New generation drugs are focusing on protecting muscle quality while promoting weight loss, addressing the limitations of traditional drugs like semaglutide, which can lead to muscle loss [4] - Dual-action drugs like tirzepatide, which mimics both GLP-1 and GIP, have shown superior weight loss results, with participants losing an average of 20% of their body weight [5] - CagriSema has demonstrated an average weight loss of nearly 23% in a 68-week Phase III trial [9] Group 3: Delivery Methods and Patient Compliance - The industry is exploring more convenient delivery methods, including monthly injections and oral medications, to improve patient compliance [13] - Orforglipron is expected to be the first oral anti-obesity drug, with a 15% weight loss observed in a 36-week Phase II study [13] Group 4: Genetic Insights and New Targets - Advances in genetic sequencing have identified new targets for obesity treatment, with companies like Alnylam Pharmaceuticals developing therapies based on gene mutations associated with lower body weight [14][17] - The potential of next-generation CB1 antagonists is being explored, aiming to avoid severe side effects while improving metabolic outcomes [18] Group 5: Muscle Preservation - Muscle preservation is becoming a key focus in obesity treatment, with existing GLP-1 drugs potentially leading to muscle loss [19] - Bimagrumab, a monoclonal antibody targeting myostatin, has shown promise in reducing muscle loss while promoting fat breakdown, with a 22% reduction in fat mass observed in a 48-week trial [20][22] - The development of muscle-targeting therapies is still in early stages but is gaining attention as a crucial component of future obesity treatment strategies [25]

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on innovative medicines for cardiometabolic and inflammatory diseases [2][10] - The company will present at the 2nd Annual GLP-1-Based Therapeutics Summit from April 29 to May 1, 2025, in Boston, Massachusetts [1] Enobosarm Development - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by GLP-1 RA drugs, focusing on fat loss while preserving lean mass [2][3] - The Phase 2b QUALITY clinical trial demonstrated a 71% relative reduction in lean mass loss for patients receiving enobosarm with semaglutide compared to placebo [4] - The enobosarm 3mg + semaglutide group showed a >99% mean relative reduction in lean mass loss, indicating significant efficacy [4] Clinical Trial Results - Secondary endpoints indicated that enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide [5] - The median total body weight loss in the placebo + semaglutide group was 32% lean mass and 68% fat loss, while the enobosarm + semaglutide group had 9.4% lean mass and 90.6% fat loss, showing a shift towards greater fat loss [5] - The study found that 42.6% of patients on placebo + semaglutide experienced a ≥10% decline in stair climb power, while the enobosarm + semaglutide group had a 54.4% reduction in this decline [6][7] Safety and Future Studies - Safety data from the Phase 2b QUALITY study remains blinded, with an unblinded complete safety set expected after the ongoing extension study [8] - The Phase 2b extension trial will evaluate enobosarm's ability to maintain muscle and prevent fat regain after discontinuing semaglutide, with topline results expected in Q2 2025 [9] Sabizabulin Development - Veru is exploring sabizabulin for treating inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [10][13] - Sabizabulin has shown broad anti-inflammatory activity in previous studies and may be combined with statin therapy for enhanced efficacy [12] - The company plans to submit a new IND for sabizabulin in the first half of 2026, with ongoing preclinical studies [14]

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [3] Enobosarm Program - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue selective for fat loss while preserving lean mass [3] - The Phase 2b QUALITY clinical trial demonstrated a 71% relative reduction in lean mass loss for patients receiving enobosarm + semaglutide compared to placebo + semaglutide at 16 weeks (p=0.002) [5] - The enobosarm 3mg + semaglutide group showed a >99% mean relative reduction in loss of lean mass (p <0.001) [5] - Enobosarm + semaglutide resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks (p=0.014) [6] - The median total body weight loss in the placebo + semaglutide group was 32% lean mass and 68% fat loss, while in the enobosarm + semaglutide group, it was 9.4% lean mass and 90.6% fat loss, indicating a 33.2% greater fat loss [6] - The study also found that 42.6% of patients on placebo + semaglutide experienced a ≥10% decline in stair climb power, while the enobosarm + semaglutide group had a 54.4% mean relative reduction in this decline (p=0.0049) [8] Sabizabulin Program - Sabizabulin is being explored for the treatment of inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [11][14] - The drug has shown broad anti-inflammatory activity in previous studies, including Phase 2 and 3 pulmonary inflammation COVID-19 clinical studies [13] - The company plans to submit a new IND for sabizabulin in atherosclerotic coronary artery disease by the first half of calendar 2026 [14]

As filed with the Securities and Exchange Commission on September 16, 2024. Registration No. 333-281987 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ELEVAI LABS INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) Delaware 5912 85-1399981 (I.R.S. Employer Identification No. ...

As filed with the Securities and Exchange Commission on September 6, 2024. Registration No. 333-[*] UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ELEVAI LABS INC. (Exact name of registrant as specified in its charter) 120 Newport Center Drive, Ste. 250 Newport Beach, CA 92660 (866) 794-4940 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) Graydon Ben ...

As filed with the Securities and Exchange Commission on June 24, 2024 Registration No. 333-277066 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Onconetix, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 83-2262816 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 201 E ...