H.C. Wainwright & Co., LLC’s Post

Ensuring diversity in clinical trials is going to be a significant addition to FDA review processes. Remember when breakthrough applications were first introduced? That was a big shift because the decision-making is different from any other type of submission. This effort isn't quite like that; it's more an extension of what's already done. Unlike breakthrough, however, you're not really going to have a choice when it comes to diversity action plans. Can't wait for this discussion!

Optimistic Highlights from the 2nd Annual UBS Life Sciences Conference 🌟 On June 6, 2024, the UBS offices in London hosted the 2nd Annual UBS Life Sciences Conference, bringing together key stakeholders from academia, industry, medical fields, and finance. The conference provided a platform to discuss and navigate the current challenges and future opportunities within the life sciences sector. Reflecting on the Past Year: The past year has seen a significant downward trend in capital flow and valuation adjustments. 2023 was marked by a reactive market environment where many companies focused on survival. However, the precise market trend predictions made at the first UBS Life Sciences Conference in 2023 offered valuable insights that have proven accurate. Key topics discussed: The impact of inflation on interest, VC investment focus, pharma partnering (the importance of symbiotic collaborations. Notably, 70% of the pharma pipeline now originates from in-licensing, which reduces biological risks and shortens the time to market), infrastructure for growth, AI and drug discovery (integration of AI in drug discovery and healthcare has the potential to improve the current low success rates from Phase-II to market, which currently stand at 9%-10%), collaboration across the EU (enhanced collaboration across the EU is vital, especially in light of the shared health challenges exemplified by the COVID-19 pandemic). Optimistic Outlook: Speakers at the conference expressed optimism about the future, predicting potential market stabilization and a return to more realistic valuations and growth similar to pre-COVID levels over the next 12 months. The IPO route remains a viable option for financing, though it may require more prudent listing strategies. The UK's life sciences ecosystem boasts academic centres of excellence, creative talent, and an innovative industry. However, there is a significant need for political support and funding to consolidate development. The COVID-19 pandemic demonstrated the necessity of cross-border collaboration, and the UK and EU together possess substantial resources ("dry powder") to contribute to and compete with other major global health players. With the right support, collaboration, and strategic investments, the industry is poised for a period of stabilization and growth, overcoming recent challenges and moving towards a brighter future. #LifeSciences #UBSConference #FutureOutlook #venture UBS #Funding #AI Gijsbert van Riemsdijk, MRICS, Olaf Margeirsson, Tim Haines , Dina Chaya , Jasper Bos , Alexander Mayweg , Nicola Goll-Kimmel, Parthiv Patel , David Roblin , Robert Jones , Dipankar Ghosh , Rob Allen , Matthias Schieker, Prof. Dr. med., Michiel Bröker, Elizabeth Macintyre Ellie Junod, Nicholas Clare, CFA

Congratulations to Miami University and Miami University College of Engineering and Computing alum Maria Bennett (MU '95 in Engineering Management), Founder, President, and CEO at Cleveland-based SPR Therapeutics, Inc., a private medical device company focused on treating pain and improving the quality of life for patients managing acute or chronic pain. Last week, Maria was named to the Crain's Cleveland Business 2024 Women of Note, honoring women across Northeast Ohio for their "outstanding work, leadership, and impact on their communities." In February, SPR Therapeutics announced the close of an $85 million in financing at a $270 million post-money valuation. The financing includes a $25 million in Series D-1 insider equity and a $60 million debt facility. The equity financing was led by Revelation Partners, SPR’s lead investor of the Series D equity financing, and incumbent investors, RC Capital and Mutual Capital Partners. According to PitchBook, the company has raised $164.46 million in funding to date. SPR® Therapeutics SPRINT® PNS System marks an innovative shift in the treatment of pain with a breakthrough, 60-day First-Line PNS™ treatment option that "uniquely reconditions the central nervous system to provide significant and sustained relief from chronic pain — without a permanent implant, nerve destruction or the risk of addiction." The system has been studied extensively for low back pain, shoulder pain, post-amputation pain, and chronic and acute post-operative pain, is cleared for use up to 60 days, and is recognized by leading pain management centers. For more information about Crain's Business Cleveland's 2024 Women of Note, visit https://lnkd.in/giAC9_8i. #LoveandHonor #BeyondReady #TherapeuticDevice #Healthcare #Innovation #FemaleFounders #WomeninBusiness Miami University Alumni Association

🌟 Key Takeaways from Johnson & Johnson’s Q4 2024 Earnings Call 🌟 Johnson & Johnson continues to demonstrate resilience and innovation in a dynamic healthcare landscape. Here’s a snapshot of what stood out: ✅ Strong Financial Performance: 2024 revenue grew 5.9% YoY to $88.8B, driven by oncology (Darzalex, Carvykti) and medtech (Abiomed, Shockwave). Adjusted EPS of $9.98, with 2025 guidance targeting 3% operational sales growth and 8.7% EPS growth. 🚀 Strategic Growth Drivers: Innovation Leadership: 27 approvals in 2024, including Tremfya for ulcerative colitis and Rybrevant for lung cancer. Disease-Centric Approach: Focus on end-to-end solutions for high-need areas like multiple myeloma, heart recovery, and mental health. M&A Momentum: Acquisitions like Intra-Cellular Therapies and Shockwave strengthen J&J’s position in neuroscience and cardiovascular care. 🔍 Addressing Market Gaps: Developing next-gen CAR-T therapies for solid tumors, AI-driven precision medicine platforms, and minimally invasive robotic surgery systems. Expanding into digital health and wearable devices for chronic disease management. ⚠️ Navigating Risks: Managing biosimilar competition for Stelara, macroeconomic pressures in China, and regulatory challenges. Ensuring smooth integration of acquisitions and maintaining a patient-centric approach. 💡 What’s Next? Advance pipeline assets like Tremfya, Rybrevant, and Varipulse. Focus on operational efficiency and cost management to improve margins. Explore M&A opportunities in digital health, biotech, and emerging markets. J&J’s commitment to innovation, strategic acquisitions, and patient-centric solutions reinforces its leadership in healthcare. Excited to see how these initiatives shape the future of medicine! 💊💡 What are your thoughts on Johnson&Johnson's strategy? Let’s discuss! 👇 Or, feel free to contact us to learn more about our work and to access a more detailed analysis. 😀 #HealthcareInnovation #JohnsonAndJohnson #StrategicGrowth #PatientCentricity #MergersAndAcquisitions #LeadershipInHealthcare

🚀 Last week, Florida Secretary Jason Weida and I had the pleasure of visiting three highly innovative companies at the NLC Health Ventures Booth during HLTH Europe. We were excited to meet with MLA Diagnostics, Angiogenesis Analytics, and HEMEO, all pioneers in their fields. 🔬 MLA Diagnostics, led by CEO Egbert Smit, specializes in groundbreaking molecular diagnostic technologies that enhance early disease detection and patient outcomes. Their innovative product is an in vitro diagnostic (IVD) method capable of determining melanoma patients with low or high metastatic risk. 💉 Angiogenesis Analytics Analytics, under the leadership of CEO Mark Bloemendaal, focuses on developing advanced analytics solutions for angiogenesis research. They strive to make prostate cancer diagnosis quicker, more affordable, and less invasive by pairing artificial intelligence technology with ultrasound imaging, providing critical insights into vascular health and disease. 🩸 HEMEO, with CTO Rene van den Ham, uses AI-based clinical decision support applications to personalize prevention and treatment of coagulation complications. Their technology consolidates data from multiple sources, enabling doctors to act early and confidently, reducing morbidity and mortality, improving patient recovery, and significantly saving costs. We look forward to connecting these three remarkable companies with the Florida 🌴 Health ecosystem and fostering new opportunities for collaboration and growth. Are you also looking to expand to the US? The Sunshine ☀ State offers world-class research institutions, robust industry clusters, and abundant investment opportunities, making it the ideal location for innovative healthcare companies looking to make a significant impact. Thank you Jikke de Jong, Johanneke Maenhout, Nina Rijnders, and Hidde ten Brink for introducing us to these outstanding companies! 🌟 TJ Villamil SelectFlorida Lisette den Breems Stefan Theunissen Justin Quiles, MS Madison Lawson Bert-Arjan Millenaar #Innovation #Healthcare #LifeSciences #FloridaHealth #HLTHEurope #Expansion #USMarket #Florida #InternationalExpansion #BioFlorida

Johnson & Johnson (JNJ) is expanding its neuroscience portfolio with the $14.6 billion acquisition of Intra-Cellular Therapies (ITCI). The deal, expected to close later this year, adds CAPLYTA and a promising pipeline to J&J's existing neurology franchise. The company will provide further details on the transaction's impact on its financials during its Q4 earnings call on January 22nd. #nilooferfinancialnews #niloofermarketviews #followers #M&A #Acquisition #Healthcare #Biotech #BusinessNews #JNJ #IntraCellularTherapies #CAPLYTA #Neuroscience

Memorial Sloan Kettering Cancer Center (MSK) is committed to developing and promoting solutions that improve the ways that clinical research happens around the globe. One way is through data accuracy and operational efficiencies. In a recent presentation to the FDA's Center for Drug Evaluation & Research Health IT Board, Michael Buckley, Associate Director for MSK's Clinical Research Information & Technology (CRIT), reported results from a real-world mirror study of the impact of electronic health record (EHR) to electronic data capture (EDC) technology. Significant findings included a 99% reduction in data entry errors through the use of electronic rather manual data entry methods. Meanwhile, MSK’s switch to electronic data entry in this study raised productivity levels among data managers by nearly 60%. “We work closely with our peers in academia, biopharma, consortiums, and the FDA to accelerate the adoption of healthcare data standards for clinical research,” Michael explains. Learn more about this research: https://bit.ly/3CtqLsY

# Only put off until tomorrow what you are willing to die having left undone ## Seize the Opportunity: Act Now to Avert FOMO! 💪💼🚀 The Austin-based biotech firm, Shattuck Labs, has encountered a significant setback as its lead cancer therapy failed during clinical trials. As a result, the company's stock has plummeted, sending shockwaves through the investment community. Furthermore, Shattuck Labs announced plans to implement a broader restructuring strategy, which includes slashing 40% of its workforce. This news serves as a stark reminder of the ever-changing landscape of the healthcare industry and the risks associated with biotech investments. However, it also presents an opportunity for savvy investors to capitalize on potential market fluctuations. By being proactive and staying informed, you can position yourself for success in the long run. With an HSA account, you have the chance to invest in the future of healthcare while simultaneously growing your savings. By taking advantage of the tax advantages and potential investment gains offered by HSAs, you can secure a brighter financial future for yourself and your loved ones. Don't let the Fear of Missing Out \(FOMO\) hold you back. Act now to explore the possibilities of investing in the healthcare sector through your HSA account. Together, we can navigate the ever-evolving market trends, empowering you to make confident investment decisions that align with your goals. #hsa #investing #healthcare #health #family #wellness 🏥💰❤️👨👩👧👦🌟✨

Live from #LausanneXI: Panelists Steven Verdooner, Joel Braunstein, MD, John Dwyer, Bruno Graversen, Christian Howell, and Frances-Catherine Q. who dove deep into the challenges and opportunities surrounding #Alzheimers diagnostics and care pathways in both the US and EU - highlighting how the US and EU can learn from each other to improve access to cutting edge diagnostics and care solutions. Top takeaways? Improve payer coverage, invest in health system infrastructure, build healthcare provider confidence in emerging diagnostics, and create a robust data ecosystem. C2N Diagnostics, Global Alzheimer's Platform Foundation, Roche, Cognito Therapeutics, Inc., Eli Lilly and Company, NeuroVision Imaging, Inc.