Core Insights - Hemostemix Inc. has successfully completed its pre-Investigational New Drug (pre-IND) meeting with the U.S. FDA, which is a significant step for the company in advancing its autologous stem cell therapy for various ischemic conditions [1][5]. Company Overview - Hemostemix is an autologous stem cell therapy platform company founded in 2003, recognized as a World Economic Forum Technology Pioneer. The company has developed and patented VesCell™ (ACP-01), a blood-based stem cell therapy [7]. - The company has conducted seven clinical studies involving 318 subjects, with results published in eleven peer-reviewed publications. ACP-01 has shown safety and clinical relevance as a treatment for several conditions, including peripheral arterial disease and chronic limb threatening ischemia [7]. FDA Guidance and Protocols - The FDA has provided guidance on Hemostemix's basket protocol approach, which is deemed acceptable provided it includes clearly defined eligibility criteria and rigorous clinical design. This protocol aims to evaluate ACP-01 across multiple ischemic and vascular-related conditions [3]. - The FDA also supported the company's plan to capture real-world evidence (RWE) for ACP-01 in jurisdictions such as Florida, Canada, and The Bahamas, emphasizing the importance of patient privacy and data integrity [4]. Next Steps and Regulatory Milestones - Hemostemix is moving forward with the filing of its IND, which will include product comparison validation studies. The company plans to release updates throughout this process [6]. - The CEO of Hemostemix, Thomas Smeenk, stated that the FDA's guidance will enable the company to advance its strategy across multiple ischemic diseases, incorporating FDA feedback into their IND submission and data models [5].

Summary of IQVIA (IQV) 2025 Conference Call Company Overview - **Company**: IQVIA (IQV) - **Industry**: Life Sciences Tools and Diagnostics Key Financial Highlights - **Q1 Performance**: Revenue exceeded the high end of guidance, EBITDA was above the midpoint, and EPS was at the high end of guidance [3][4] - **TAS Growth**: TAS experienced over 7.6% growth at constant currency [3] - **Cash Flow**: Cash flow increased by 13% year-over-year, representing 89% of adjusted net income, which is at the high end of forecasts [4] - **Revenue Guidance**: Revenue guidance was raised by $275 million, primarily due to foreign exchange (FX) impacts [4] - **Bookings**: Book-to-bill ratio was 1.02, with a noted slowdown in decision-making and an increase in the time between RFPs and awards by about 10% [5][6] Industry Dynamics - **Emerging Biopharma vs. Large Pharma**: Emerging biopharma is experiencing a slowdown in funding, while large pharma is facing delays in decision-making due to uncertainty from recent government actions [8][9] - **Funding Environment**: The funding environment for biotech has been weak year-to-date, impacting order placements and decision-making [10][11] - **Regulatory Environment**: Concerns regarding agency changes, tariffs, and pricing actions are affecting large pharma's decision-making processes [13][14][17] Market Trends - **Real World Evidence (RWE)**: Growth in RWE is driven by the introduction of new drugs and increased scrutiny from payers for evidence of effectiveness [29][32] - **TAS Business**: The TAS segment is expected to continue its recovery, supported by new drug approvals and the need for commercialization support [22][23][26] Competitive Landscape - **Pricing Pressure**: Increased competition has led to pricing pressures, particularly in the FSP business, but management is focused on offsetting this with cost reductions [40][41] - **Market Dynamics**: Smaller CROs are feeling more pressure for business, which may lead to increased pricing competition [42] Margin and Growth Outlook - **Margin Projections**: Adjusted EBITDA margin is projected to contract by 20 basis points due to FX impacts, but long-term margin growth is expected to remain stable [45][49] - **Revenue Growth Expectations**: Anticipated constant currency revenue growth of 6-9% annually, driven by pharma spending, market share expansion, outsourcing, and M&A [49][50] Capital Deployment Strategy - **M&A and Share Repurchase**: The company is focused on M&A and share repurchase, with a preference for M&A opportunities that enhance growth capabilities [51][54] - **Debt Management**: Comfortable with current debt levels, with a net leverage ratio between 3.3 and 3.5 [52] Underappreciated Aspects - **Business Model**: IQVIA is not a pure CRO; its TAS business represents 40% of operations, which is often overlooked in comparisons with CRO peers [57][58] This summary encapsulates the key points discussed during the IQVIA conference call, highlighting the company's financial performance, industry dynamics, market trends, competitive landscape, margin outlook, capital deployment strategy, and aspects of the business that may be underappreciated.

As filed with the Securities and Exchange Commission on April 16, 2024 Registration No. 333-276130 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 ONEMEDNET CORPORATION (Exact name of registrant as specified in its charter) Delaware 3721 86-2049355 (Primary Standard Industrial Classification Code Number) OneMedNet Corporation 6385 Old Shady Oak Road, Suite 250 Eden Prairie, MN 55344 Telephone: 800-918 ...