Veru(US:VERU)2024-05-08 17:09Financial Performance - The company restated its net loss for the three months ended March 31, 2023, to $33,788,974, improving from the previously reported loss of $38,792,906[28]. - For the three months ended March 31, 2024, total net revenues were $4,135,301, a decrease of 37.1% compared to $6,585,967 for the same period in 2023[48]. - Net loss for the three months ended March 31, 2024 was $10.0 million, or $(0.07) per share, compared to a net loss of $33.8 million, or $(0.42) per share, for the same period in 2023[169]. - For the six months ended March 31, 2024, net revenues were $6.3 million, a decrease of 31% compared to $9.1 million for the same period in 2023[184]. - The Company recorded a gain on the sale of ENTADFI assets of $0.9 million in the six months ended March 31, 2024[195]. Assets and Liabilities - Veru Inc. reported total current assets of $43,372,058 as of March 31, 2023, after adjustments[28]. - Total liabilities were restated to $48,525,614 as of March 31, 2023, reflecting a decrease of $5,012,054[28]. - The accumulated deficit was adjusted to $(236,113,448) as of March 31, 2023, an improvement of $5,095,835[28]. - Cash and cash equivalents increased to $34.7 million as of March 31, 2024, compared to $9.6 million at September 30, 2023, primarily due to a public offering[200]. - Working capital increased to $35.6 million as of March 31, 2024, compared to $5.1 million as of September 30, 2023[200]. Revenue Sources - The company has a commercial product, FC2, which generated most of its net revenues during the reporting periods[25]. - Revenue from the U.S. prescription channel for the three months ended March 31, 2024, was $597,307, down from $4,146,160 in the same period of 2023[48]. - U.S. prescription channel revenues decreased by 86% to $0.6 million, while global public health sector revenues increased by 45% to $3.5 million for the three months ended March 31, 2024[171]. Research and Development - Research and development expenses for the three months ended March 31, 2023, were restated to $17,860,701, down from $22,864,633[28]. - Research and development expenses were $3.0 million and $17.9 million for the three months ended March 31, 2024 and 2023, respectively, reflecting a strategic refocus on drug candidates with the best long-term prospects[167]. - The Company has initiated a Phase 2b clinical study for enobosarm, with the primary endpoint being total lean body mass and results expected by the end of Q4 2024[134]. Clinical Trials and Product Development - Enobosarm has been evaluated in 27 clinical studies involving approximately 1,580 subjects, demonstrating a favorable safety profile with no increase in gastrointestinal side effects[131]. - The Company completed the Stage 1a portion of its Phase 3 clinical trial for enobosarm in metastatic breast cancer in October 2023, but further advancement is contingent on funding availability[138]. - The Phase 2b extension trial aims to assess enobosarm's ability to maintain muscle and prevent fat rebound after discontinuation of GLP-1 RA treatment, with results expected in Q2 2025[136]. - The company is developing enobosarm as a second-line treatment for ER+ HER2- metastatic breast cancer, showing greater tumor growth suppression in preclinical studies when combined with a CDK 4/6 inhibitor compared to the inhibitor alone[140]. Financing and Capital Structure - The Company completed a public offering of 52,708,332 shares at a price of $0.72 per share, generating net proceeds of approximately $35.2 million[72]. - The Company has a shelf registration statement with a capacity of $200 million, of which $35.1 million remains available as of March 31, 2024[71]. - Under the Lincoln Park Purchase Agreement, the Company may sell up to $100 million of shares over a 36-month term, with an amendment reducing the registration amount to $50 million until at least $50 million is sold[73]. - The Company entered into a common stock purchase agreement with Lincoln Park Capital, allowing for the sale of up to $100 million in shares over 36 months[218]. Legal and Regulatory Matters - The company is currently involved in multiple shareholder lawsuits, which may impact its corporate governance and financial standing, but it is unable to estimate potential losses related to these litigations[106]. - The company entered into an agreement to resolve a commercial dispute, agreeing to pay $8.3 million, which includes $2.3 million payable upon execution and $3.5 million in monthly installments over 48 months[111]. Operational Expenses - Selling, general and administrative expenses were $7.6 million for the three months ended March 31, 2024, a decrease from $12.8 million in the same period of 2023[177]. - The total lease cost for the three months ended March 31, 2024, was $299,940, compared to $298,156 for the same period in 2023, reflecting a slight increase of 0.6%[97].