Core Viewpoint - Federal health officials are targeting telehealth companies for promoting unofficial versions of prescription drugs, particularly weight loss medications, as part of a crackdown on pharmaceutical advertising initiated by the Trump administration [1][6]. Regulatory Actions - The FDA issued over 100 warning letters to drugmakers and online prescribing companies, including Hims & Hers, which has developed a multibillion-dollar business around lower-cost obesity medications [2][9]. - Hims & Hers received a warning to remove misleading promotional statements from its website, specifically claims that their products contain the same active ingredients as FDA-approved drugs like Wegovy and Ozempic [3][4]. Company Responses - Hims stated it looks forward to engaging with the FDA and emphasized that its materials indicate compounded treatments are not FDA-approved [4]. - The company has faced scrutiny for its advertising practices, including a Super Bowl ad that failed to disclose side effects of its weight-loss medications [7][9]. Industry Context - The FDA's recent actions mark a shift towards more direct regulation of online platforms, which have previously argued they are not bound by traditional drug advertising rules [4][6]. - The FDA has determined that GLP-1 drugs no longer meet the criteria for shortage, which impacts the compounding practices of companies like Hims [8]. Market Impact - Following the FDA's warning letters, shares of Hims & Hers Health Inc. fell by more than 6.47% [9].

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had approximately $4 million in cash, cash equivalents, and marketable securities [20] - Research and development expenses for the year ended December 31, 2024, were $6.2 million, a decrease from $10.9 million for the year ended December 31, 2023 [21] - General and administrative expenses for the year ended December 31, 2024, were $13.7 million, down from $21.1 million for the year ended December 31, 2023 [21] Business Line Data and Key Metrics Changes - The company is advancing multiple clinical programs, including a Phase 2 trial for pancreatic cancer and a Phase 2 study for advanced ovarian cancer, both of which are nearing completion [14][15] - The AMP518 study for post-COVID conditions has been completed, and a follow-up study is being planned [18] Market Data and Key Metrics Changes - The company is actively evaluating options to maintain compliance with the New York Stock Exchange American listing requirements, including a potential reverse stock split [22][24] Company Strategy and Development Direction - The company is focused on advancing Ampligen across multiple areas of significant medical need, including collaborations with AstraZeneca and the University of Alabama Birmingham Medical Center [8][10] - The addition of experienced board members is expected to strengthen the company's leadership and strategic execution [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential of Ampligen to address high medical needs [19] - The company is committed to maintaining its NYSE listing, which is seen as essential for long-term success and access to capital [22] Other Important Information - The company has been granted new patents for the treatment of endometriosis and for addressing post-COVID fatigue, expanding its intellectual property estate [12] Q&A Session Summary Question: Does the company have adequate supply of Ampligen for clinical trials this year? - Management confirmed that there is a budget tied to ongoing clinical activities to ensure sufficient supply for current trials, and they do not anticipate issues unless unforeseen circumstances arise [28][30] Question: How easy would it be to obtain new supply of Ampligen? - Management indicated that while future clinical trials will require additional manufacturing of Ampligen, they are actively analyzing the process and working with manufacturers to ensure supply [30][31]