Two venture capitalists dissect why biotech burns billions while China runs trials in weeks, and why the next Genentech won't look anything like the last one. Elliot Hershberg reveals the "three horsemen" strangling drug development as costs explode to $2.5 billion per approval, while Lada Nuzhna exposes how investigator-initiated trials in Shanghai are rewriting the competitive playbook faster than American founders can file INDs. When the infrastructure that built monoclonal antibodies becomes the commodi ...

Core Viewpoint - Apimeds Pharmaceuticals US, Inc. is expanding its ai² Futures Lab™ program through a collaboration with the University of Idaho College of Business and Economics, starting in Spring 2026, aimed at connecting student teams with real-world biopharma business development projects [1] Group 1 - The collaboration reinforces Apimeds' commitment to fostering innovation, leadership, and discovery in the biopharma sector [1]

Financial Data and Key Metrics Changes - Total revenue grew by 21% year-over-year, driven by increased recurring revenue, with recurring revenue up 26% [5][22][24] - Operating profit increased by 52%, reflecting strong financial performance despite strategic investments [5][25] - The company ended the first half of 2025 with approximately $3.4 billion in cash, providing flexibility for growth and expansion [5] Business Line Data and Key Metrics Changes - Sales from Epkinly and TIVDAK increased by 54% year-over-year, contributing 25% to total revenue growth [15][22] - Epkinly sales reached $333 million through Q3, representing a 64% year-over-year increase, establishing it as a leader in the third-line setting for diffuse large B-cell lymphoma and follicular lymphoma [17][19] - TIVDAK sales totaled $120 million year-to-date, with strong performance in both new and established markets [20] Market Data and Key Metrics Changes - Epkinly has received regulatory approvals in over 65 countries, with more than 50 countries now having dual indications [19] - The company is preparing for the launch of Epkinly in earlier lines of therapy, particularly in second-line follicular lymphoma, with an estimated 9,000 patients in this segment [42] Company Strategy and Development Direction - The proposed acquisition of Merus is seen as a transformative opportunity, advancing the company's evolution into a global biotech leader and expanding its revenue base [6][30] - The company aims to maximize the potential of its commercialized medicines while accelerating the development of its late-stage pipeline [5][6] - The focus remains on high-impact programs, with ongoing phase 3 trials for rinatabart sesutecan and Petosemtamab expected to drive future growth [7][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of rinatabart sesutecan and Petosemtamab as key growth drivers, with expectations for significant market opportunities [7][36] - The company anticipates continued strong performance and is on track to achieve double-digit revenue and profit growth for 2025 [26][28] Other Important Information - The company has initiated additional phase 3 clinical trials for rinatabart sesutecan, reinforcing its commitment to advancing its innovative pipeline [11][29] - The annual R&D updates and data review will be held virtually on December 11, 2025 [31] Q&A Session Summary Question: Competitive landscape of Petosemtamab and Rinatabart sesutecan - Management remains confident in the positioning of both drugs as best-in-class assets, with ongoing phase 3 trials supporting their development [34][36] Question: Commercial dynamics of Epkinly - The dual indication of Epkinly is beneficial for operationalization, and the company expects significant growth opportunities in earlier lines of therapy [40][41] Question: Termination of clinical development for 1042 - The decision was based on data not meeting internal development standards, leading to a halt in the program [51][52] Question: Confidence in Epkinly's upcoming PDUFA - Management expressed high confidence in the approval process, with no indications suggesting otherwise [55][57] Question: OpEx and profitability outlook for 2026 - The company maintains a disciplined investment approach, with expectations for significant profitability and operational efficiency [62][66]

Core Insights - Izotropic Corporation is targeting a significant market opportunity by focusing on breast cancer technology that addresses the needs of 50% of women who are currently underserved in this area [1][3]. Company Overview - Izotropic Corporation, listed on CSE as IZO and OTCQB as IZOZF, is actively shaping the biotech landscape with innovative solutions [3]. - CEO Robert Thast emphasizes the company's vision and strategy during interviews, providing insights into the challenges and opportunities within the industry [3]. Industry Context - The breast cancer technology sector is poised for growth, particularly in addressing the needs of women who have not been adequately served by existing solutions [1]. - The conversation around this technology is gaining traction, as evidenced by the engagement on platforms like CEO.CA, which connects investors and industry leaders [2][5].

Core Drivers - The IPO market in 2025 will reflect the global economic recovery, technological innovation, and evolving regulatory environment [2] - Key sectors driving growth include AI and computing infrastructure, renewable energy and green technology, and biotechnology and life sciences [3][4][5] AI and Computing Infrastructure - The global AI industry has shifted from model development to application and computing power competition, with increased demand for AI efficiency tools and vertical applications [6] - IPO highlights include companies focused on AI chip design, AI SaaS providers with low-code solutions, and edge AI manufacturers for IoT and autonomous driving [6] Renewable Energy and Green Technology - Major economies are accelerating their carbon neutrality goals, with policies like the US Inflation Reduction Act providing incentives for the renewable energy sector [6] - IPO highlights include long-duration energy storage companies, smart grid operators, and green hydrogen production firms [6] Biotechnology and Life Sciences - The aging global population and breakthroughs in precision medicine are driving demand for innovative therapies and digital health solutions [6] - IPO highlights include companies focused on gene and cell therapies, digital health platforms, and synthetic biology [6] Structural Opportunities - The digital transformation in consumer and service sectors is deepening, with a focus on enterprise services and consumer technology [8][9] - The subscription-based SaaS model is gaining traction due to its resilience and stable cash flow [12] Capital Market Environment - The Federal Reserve is expected to enter a rate-cutting phase, which will enhance the valuation of risk assets and benefit the Nasdaq IPO market [10] - Regulatory scrutiny is increasing, particularly for Chinese companies listed in the US, leading to a divergence in IPO opportunities [11][13] Summary of Nasdaq IPO Logic for 2025 - The Nasdaq IPO landscape will be characterized by technology-driven growth, with a focus on differentiated technological barriers and user stickiness [11] - Companies should enhance ESG disclosures to align with global capital preferences [11]

Group 1 - ARK Innovation ETF (ARKK) has reached a 52-week high, increasing approximately 92.4% from its 52-week low of $36.85 per share [1] - The ETF focuses on "disruptive innovation," investing in companies involved in DNA technologies, automation, robotics, energy storage, artificial intelligence, and Fintech [1] - Cathie Wood, CEO of Ark Investment Management, has made significant moves by purchasing shares of CRISPR Therapeutics AG and Beam Therapeutics Inc., while selling shares of 908 Devices Inc. and Roku Inc., indicating a bullish stance on gene-editing technologies [2] Group 2 - ARKK shows a weighted alpha of 60.23 and a 20-day volatility of 29.55%, suggesting potential for continued strength and gains for investors [4] - Despite market turbulence, Cathie Wood maintains a positive outlook on the transformative power of emerging technologies [3]

Innovation & R&D - The US leads the world in life science innovation due to a combination of factors including investment in basic research, venture capital, strong companies, and protection of intellectual property [3][5] - Big Pharma increasingly relies on external innovation, with internal drug development accounting for less than 30% of FDA approvals between 2015 and 2021 [11] - AI and machine learning are accelerating drug discovery by enabling the screening of 1.7 million compounds in approximately 5-10 days, significantly reducing the time required for identifying lead compounds [3][14][15] Investment & Finance - In 2021, the pharmaceutical industry invested over $80 billion annually in R&D, a tenfold increase over 10 years, representing approximately 25% of pharma companies' revenues [4] - Venture capital firms investing in biotech require patience, with a time horizon of 10-15 years to see a drug from discovery to commercialization [13] - New Jersey offers an R&D tax credit to attract big pharma companies and has a program allowing early-stage life sciences companies to monetize their net operating losses [20][21] Company Strategy & Focus - Johnson & Johnson (J&J) has invested $50 billion in R&D and M&A since the beginning of last year [10] - J&J actively scouts the world for promising innovations and technologies to leverage its scale in research, development, manufacturing, and commercialization [6] - J&J is developing an oral medicine, icotrokinra, to treat plaque psoriasis, which is expected to be a significant breakthrough and contribute to growth in the second half of the decade [7][9]