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VERU (VERU)

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Earnings summaries and quarterly performance for VERU.

Recent press releases and 8-K filings for VERU.

Veru Announces Phase 2b PLATEAU Study and Regulatory Clarity for Enobosarm
VERU
New Projects/Investments
Guidance Update
  • Veru is initiating the Phase 2b PLATEAU study in Q1 2026 to evaluate enobosarm in combination with semaglutide for obese, non-diabetic patients over 65, with an interim look in Q1 2027 and top-line data expected in Q4 2027.
  • The FDA has provided regulatory clarity for body composition drugs, indicating that incremental weight loss of 5% or greater, clinically significant preservation of physical function, or total hip bone mineral density (BMD) at 24 months can serve as primary endpoints for approval.
  • As of December 31, 2025, Veru reported $33 million in cash.
  • Enobosarm has patent protection extending to 2034 with potential method of use patents for GLP-1 combinations to 2044, and a novel 3D-printed formulation potentially to 2046.
1 day ago
Veru Outlines Strategy for Enobosarm in Combination with GLP-1s and Provides PLATEAU Study Timeline
VERU
New Projects/Investments
Guidance Update
  • Veru is developing enobosarm in combination with GLP-1s to address muscle loss, bone loss, and the weight loss plateau, with the Phase 2b PLATEAU study initiating in Q1 2026 and top-line data expected in Q4 2027.
  • The FDA has provided regulatory clarity, indicating that incremental weight loss of 5% or greater or clinically significant positive benefit in physical function can serve as primary endpoints for approval of body composition drugs, and total hip bone mineral density (BMD) is now considered a surrogate endpoint for osteoporosis drug development.
  • Enobosarm has intellectual property protection for its composition of matter until 2034 (with extensions) and method of use patents extending to 2044 for combinations with GLP-1s, with a novel 3D-printed formulation potentially protected until 2046.
  • The company reported $33 million in cash as of December 31, 2025.
1 day ago
Veru Reports Q1 2026 Financial Results and Provides Enobosarm Development Update
VERU
Earnings
New Projects/Investments
  • Veru reported a net loss of $5.3 million or $0.26 per diluted common share for the first quarter of fiscal year 2026, ended December 31, 2025, compared to a net loss of $8.9 million or $0.61 per diluted common share in the prior year's quarter.
  • As of December 31, 2025, the company's cash, cash equivalents, and restricted cash balance increased to $33 million from $15.8 million as of September 30, 2025, primarily due to net proceeds of $23.4 million from an underwritten public offering completed on October 31, 2025.
  • The company received regulatory clarity from the FDA in September 2025 for the development of enobosarm in combination with a GLP-1 receptor agonist for obesity, and its Phase 2b PLATEAU clinical study is expected to begin in Q1 2026 with an interim analysis anticipated in Q1 calendar year 2027.
  • Research and development costs decreased to $1.3 million in Q1 2026 from $5.7 million in Q1 2025, mainly due to the wind-down of the Phase 2b QUALITY clinical study for enobosarm.
Feb 11, 2026, 1:00 PM
Veru Reports Q1 FY2026 Financial Results and Provides Update on Enobosarm Clinical Development
VERU
Earnings
New Projects/Investments
Guidance Update
  • Veru reported a net loss of $5.3 million, or $0.26 per diluted common share, for the first quarter of fiscal year 2026, an improvement from a net loss of $8.9 million in the prior year's quarter.
  • The company's cash, cash equivalents, and restricted cash balance increased to $33 million as of December 31, 2025, from $15.8 million on September 30, 2025, following $23.4 million in net proceeds from an underwritten public offering. This cash is expected to fund operations through the interim analysis of the Phase 2b PLATEAU clinical study.
  • The Phase 2b PLATEAU clinical study for enobosarm, designed to evaluate its effect on weight, fat mass, lean mass, and physical function in combination with semaglutide, is expected to begin this quarter, with an interim analysis anticipated in Q1 calendar year 2027.
  • The FDA has provided regulatory clarity for enobosarm's development, outlining two possible approval pathways based on incremental weight loss or clinically significant benefit in physical function, and confirmed enobosarm 3 mg as an acceptable dosage.
Feb 11, 2026, 1:00 PM
Veru Reports Q1 2026 Financial Results and Provides Update on Enobosarm Clinical Program
VERU
Earnings
New Projects/Investments
  • Veru reported a net loss of $5.3 million or $0.26 per diluted common share for the first quarter of fiscal year 2026, which ended December 31, 2025.
  • The company's cash, cash equivalents, and restricted cash balance increased to $33 million as of December 31, 2025, from $15.8 million on September 30, 2025, primarily due to $23.4 million in net proceeds from a public offering completed on October 31, 2025.
  • Veru's planned phase II-B PLATEAU clinical study for enobosarm, which aims to treat obesity in older patients receiving semaglutide, is expected to begin this quarter (Q1 FY2026).
  • The FDA has provided regulatory clarity for enobosarm development, outlining two potential pathways for approval based on either incremental weight loss (at least 5%) or a clinically significant benefit in the preservation of physical function.
Feb 11, 2026, 1:00 PM
Veru Inc. Announces Fiscal 2026 First Quarter Financial Results and Clinical Program Progress
VERU
Earnings
New Projects/Investments
  • Veru Inc. reported its fiscal 2026 first quarter financial results for the period ended December 31, 2025, with a net loss decreasing to $5.3 million, or $0.26 per share, compared to $8.9 million, or $0.61 per share, in the prior year's quarter.
  • Cash, cash equivalents, and restricted cash significantly increased to $33.0 million as of December 31, 2025, from $15.8 million as of September 30, 2025.
  • The Phase 2b PLATEAU clinical trial evaluating enobosarm in combination with semaglutide is on track to initiate this calendar quarter (Q1 2026), with interim analysis results anticipated in Q1 calendar year 2027.
Feb 11, 2026, 12:00 PM
Veru Reports Fiscal Q1 2026 Financial Results and Clinical Program Progress
VERU
Earnings
New Projects/Investments
  • Veru reported a net loss of $5.3 million, or $0.26 per share, for its fiscal 2026 first quarter ended December 31, 2025, an improvement from the $8.9 million net loss in the prior year.
  • Cash, cash equivalents, and restricted cash significantly increased to $33.0 million as of December 31, 2025, compared to $15.8 million on September 30, 2025.
  • The Phase 2b PLATEAU clinical trial for enobosarm, evaluating its combination with semaglutide, is on track to initiate in the first calendar quarter of 2026, with interim analysis results expected in the first calendar quarter of 2027.
  • The company received FDA regulatory clarity in September 2025 for enobosarm in combination with GLP-1 RA, outlining acceptable primary endpoints for approval, and the FDA's December 2025 validation of total hip bone mineral density as a surrogate endpoint could provide an additional regulatory pathway.
Feb 11, 2026, 11:30 AM
Veradermics announces closing of IPO and full exercise of underwriters' option
VERU
  • Veradermics announced the closing of its upsized initial public offering (IPO) of 17,339,294 shares of common stock.
  • The offering included 2,261,647 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares.
  • The shares were priced at $17.00 per share, resulting in gross proceeds of approximately $294.8 million.
  • Veradermics shares began trading on the New York Stock Exchange (NYSE) on February 4, 2026, under the ticker symbol "MANE".
Feb 5, 2026, 9:05 PM
Veru Reports Fiscal Year 2025 Results, Sells FC2 Business, and Advances Enobosarm Clinical Program
VERU
Earnings
M&A
New Projects/Investments
  • Veru reported a net loss from continuing operations of $15.7 million, or $1.07 per diluted common share, for the fiscal year ended September 30, 2025, an improvement from the prior year. Research and development costs increased to $15.6 million in fiscal 2025, driven by the Phase 2b obesity clinical study for enobosarm.
  • The company completed the sale of its FC2 Female Condom business on December 30, 2024, for $18 million in cash, yielding approximately $16.5 million in net proceeds and resulting in a $4.1 million loss on sale. This strategic divestiture allows Veru to focus exclusively on drug development.
  • Subsequent to the fiscal year-end, on October 31, 2025, Veru completed an underwritten public offering, raising approximately $23.4 million in net proceeds. As of September 30, 2025, cash, cash equivalents, and restricted cash totaled $15.8 million.
  • Veru announced positive Phase 2b QUALITY clinical trial results for enobosarm, demonstrating 100% average preservation of total lean mass and 12% greater fat loss at 16 weeks when combined with semaglutide. The company plans to initiate the Phase 2b PLATEAU clinical trial to further evaluate enobosarm in older patients with obesity (BMI ≥35, age ≥65) who are initiating GLP-1 receptor treatment.
Dec 17, 2025, 1:00 PM
Veru Inc. Reports Q4 2025 Financials, Sells FC2 Business, and Advances Enobosarm Clinical Program
VERU
Earnings
New Projects/Investments
M&A
  • Veru completed the sale of its FC2 female condom business on December 30, 2024, for $18 million in cash, shifting its focus exclusively to drug development.
  • For fiscal year 2025, the company reported a net loss from continuing operations of $15.7 million (or $1.07 per diluted common share) and a net loss from discontinued operations of $7 million (or $0.48 per diluted common share).
  • As of September 30, 2025, cash, cash equivalents, and restricted cash totaled $15.8 million, supplemented by $23.4 million in net proceeds from a public offering completed on October 31, 2025.
  • The company announced positive Phase 2b QUALIFY clinical trial results for Enobosarm, showing 100% average preservation of total lean mass and 12% greater fat loss at 16 weeks when combined with semaglutide.
  • Veru plans to initiate the Phase 2b PLATEAU clinical trial for Enobosarm in Q1 2026, targeting older patients with obesity and a BMI greater than or equal to 35, with an interim analysis expected in Q1 2027. The current cash position is sufficient to fund operations through this interim analysis.
Dec 17, 2025, 1:00 PM