for those who've suffered a traumatic spinal cord injury and are paralyzed. There's rarely encouraging news, which is why what's happening in early clinical trials in a research lab in Loausanne, Switzerland, is so remarkable. A renowned French neuroscientist Gregoire Cortine and Swiss neurosurgeon Dr.. Joseen Block have implanted a small stimulation device on the spine of paralyzed patients helping them once again stand up and walk. What's even more surprising is their newest innovation which uses an impla ...

Financial Performance - Revenue increased by 100% to $156,000 for the six months ended June 30, 2025, compared to the same period in 2024 [3] - Other operating income decreased by 8.5% year on year, from $422,000 in H1 2024 to $386,000 in H1 2025 [5] - Net loss reported was $2,050,000 in 2025, which could be reduced to $1,440,000 when excluding certain costs [3][7] - Loss per share was $0.19 for the six months ended June 30, 2025 [4] - Cash and bank balances decreased from $4,970,000 as of December 31, 2024, to $2,860,000 as of June 30, 2025 [7] Business Line Performance - Revenue of $156,000 was generated from private banking services after acquiring a license and certain assets under IPSE depository in Malaysia [4] - Research expenses increased by 19.3% from $974,000 in H1 2024 to $1,160,000 in H1 2025, driven by higher employee benefits and clinical trial expenses [6] Market Data - The company reported a net loss in currency exchange of $402,000 and a net loss of $227,000 in fair value changes on warrant liability [5] - As of June 30, 2025, there were 72,371 warrants outstanding, with fair value changes of $76,000 recorded in the profit and loss account [8] Company Strategy and Industry Competition - The company is focusing on clinical trials and collaborations, with ongoing projects including CTM and iPSC GDNKT [9][10] - A new ATM agreement was signed with Levity to raise up to $4.3 million, indicating a strategy to enhance funding [11] - The corporate banking business is being rebranded as Longevity Bank, reflecting a strategic shift [11] Management Commentary on Operating Environment and Future Outlook - Management highlighted the completion of dose level one in a clinical trial and plans to complete Phase one trials in 2026 [9] - The company aims to apply for GDT trials in Malaysia and other locations, indicating a focus on expanding its market presence [10] Other Important Information - The company’s manufacturing facility has been audited by the Ministry of Health of Malaysia, ensuring compliance and operational readiness [11] Q&A Session Summary - The earnings call concluded without any questions from participants, indicating a lack of immediate inquiries regarding the financial performance or strategic direction [12]

home system. I've got two of the three words. All right.Former FDA Commissioner Scott Gottlieb recently wrote an op ed in the Washington Post titled the FDA Should Copy China's Strategy to Speed Drug Discovery. He talks about how China is gaining ground in the United States in biotech, noting that its advantage is cost, not science. By cost, we mean cheaping out.Joining us right now is Doctor Scott Gottlieb. He's also a CNBC contributor, and he serves on the boards of both Illumina and Pfizer. And Scott, th ...

Drug Approval & Efficacy - Half (50%) of approved cancer drugs lack proof of extending survival for approved uses [1] - The pharmaceutical industry's primary motive is generating profits for shareholders [1] - Financial pressures can lead to rushed clinical trials and approvals based on uncertain evidence [2] Treatment & Dosage - Lower dosages can result in less revenue for pharmaceutical companies [2] - A second line of treatment may not always be beneficial for patients [2] Patient Needs & Conflicts - Clinicians and researchers should focus on patient needs, which can sometimes conflict with other factors [3]

Core Insights - China's biotech sector is experiencing significant growth, driven by regulatory reforms and increased global collaboration, positioning the country as a leader in clinical trials [4][7][12] Group 1: Regulatory Environment and Challenges - Recent tariff increases have created financial burdens for companies importing drugs for clinical trials in China, complicating supply chain operations [1] - Despite positive developments, companies face logistical and operational challenges, particularly in navigating cross-border supply chains and trade regulations [2] - The National Medical Products Administration (NMPA) has proposed a 30-day review mechanism to accelerate drug approvals, which is a key reform for trial sponsors [3] Group 2: Trust and Data Quality - Trust in China's clinical research capabilities hinges on the delivery of high-quality, reliable data and clear regulatory expectations [5][24] - International sponsors remain cautious about conducting first-in-human studies in China due to concerns over data reliability and patient medical history traceability [9][10] Group 3: Global Engagement and Strategy - Chinese life sciences companies are expanding their global footprint through licensing deals and international collaborations, necessitating a shift in operational mindset [7][23] - Companies are encouraged to start trials in markets like Australia or the US, where regulatory processes are more streamlined, to gain early safety or efficacy data [18] - Building global-ready teams and engaging proactively with local regulators are essential for navigating international clinical trials [20][19] Group 4: Investment Opportunities - The Chinese biotech sector is increasingly attractive to international investors, with a notable interest in acquiring drug candidates developed in China [10][11] - The government is prioritizing biotech as part of its strategy to support high-tech industries, providing R&D subsidies and tax incentives [12][13] - Chinese-developed assets are often priced significantly lower than typical market valuations, presenting compelling investment opportunities [11][14]

Industry Overview - Biotech and healthcare stocks are responding positively to clinical trial progress, regulatory developments, and economic indicators, particularly with the Federal Reserve's first rate cut of 2025, which is expected to improve funding conditions for capital-intensive sectors like biotechnology [1] Company Highlights - **Sonnet BioTherapeutics Holdings Inc. (SONN)**: Shares increased by 11.19% in after-hours trading, reaching $7.85 after a regular session close of $7.06. The stock has a 52-week range of $1.08 - $19.30. The company expanded clinical evaluation of its lead candidate, SON-1010, for ovarian cancer, reporting a strong safety profile and a partial response at the highest dose level [2][3] - **Akari Therapeutics Plc (AKTX)**: Shares surged 11.58% in after-hours trading to $0.8855 after closing at $0.7936. The stock has a 52-week range of $0.5710 - $3.8500. The increase follows a provisional patent filing for its antibody-drug conjugate platform aimed at cancer treatment, which is expected to enhance its intellectual property and support the development of first-in-class ADCs [4][5] - **Safety Shot Inc. (SHOT)**: Shares rose 9.75% in after-hours trading to $0.3333 after closing at $0.3037. The company announced a strategic refresh of its Board of Directors with three new members to strengthen its capabilities in digital assets and operations [6][7] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares climbed 10.09% in after-hours trading to $0.4451 after closing at $0.4043. The stock has a 52-week range of $0.3000 - $4.2800. The price movement follows a revised analyst rating maintaining a "Speculative Buy" while lowering the price target from $14.00 to $7.00. Reviva's lead candidate, brilaroxazine, is being developed for multiple neuropsychiatric and respiratory indications [8][9][10] - **Cognition Therapeutics Inc. (CGTX)**: Shares rose 7.48% in after-hours trading to $1.58 after closing down at $1.47. The company is focused on its lead candidate, Zervimesine, for Alzheimer's disease, and recently closed a $30 million offering to support its Phase 3 development [12][13]

VALOR Study Topline Results - The VALOR study of Brepocitinib in Dermatomyositis (DM) succeeded with highly significant, robust, and consistent data across primary and all key secondary endpoints[18] - A consistent dose response was observed between 15 mg and 30 mg, establishing 30 mg as the optimal dose[18] - Brepocitinib 30 mg showed a mean TIS of 46.5, a delta of >15 points (p=0.0006) relative to placebo at week 52 (TIS of 31.2)[18] - Over two-thirds (68%) of brepocitinib 30 mg patients experienced at least a moderate response (TIS40), compared to 44.3% on placebo[37,61] - Nearly half (46.1%) of brepocitinib 30 mg patients experienced a major response (TIS60), compared to 26.4% on placebo[37,61] - Median time to a TIS40 response was approximately 2 months[18] - At week 52, 54.3% of patients achieving TIS40 Response + ≤2.5 mg OCS on Brepocitinib 30mg vs 26.6% on Placebo[61] - At week 52, CDASI-A change from baseline at -11.7 for Brepocitinib 30mg vs -7.0 for Placebo[61] Safety and Regulatory - The safety profile of Brepocitinib 30 mg in VALOR was consistent with prior clinical studies[18] - FDA filing is planned for the first half of 2026[18]

Lexicon Pharmaceuticals (LXRX) Conference Summary Company Overview - **Company**: Lexicon Pharmaceuticals (LXRX) - **Date of Conference**: September 03, 2025 - **Key Speakers**: Mike Exton (CEO), Craig Granowitz (CMO) Key Points and Arguments Company Evolution and Pipeline Focus - Lexicon Pharmaceuticals has shifted back to a pure R&D focus, emphasizing its pipeline development [4][5] - The company has made significant progress with three main assets in its pipeline [4] Licensing and Collaborations - In Q1 2025, Lexicon licensed LX9851, a preclinical asset for obesity, to Novo Nordisk, a leader in obesity treatment [4] Clinical Trials and Data - The PROGRESS Phase 2b study for pilovapitan, a non-opioid treatment for diabetic peripheral neuropathic pain, has shown promising results, with plans to move into Phase 3 trials in early 2026 [5][6] - The company is preparing for a busy September with multiple data rollouts at medical meetings [6] Heart Failure and HCM Programs - Lexicon continues to market sotagliflozin for heart failure under PEPFAR, maintaining sales levels from the previous year [6] - The SONARDA trial for hypertrophic cardiomyopathy (HCM) is progressing well, with full patient enrollment expected by 2026 [7] Data Analysis and Findings - A pooled analysis of over 12,000 patients in heart failure studies showed consistent responses across age groups, particularly in elderly patients [10] - The analysis indicated a 50% reduction in hospital readmissions and cardiovascular death at various time points, highlighting the efficacy of sotagliflozin compared to other SGLT inhibitors [12][14] Differentiation in Treatment - Lexicon's approach to treating HFpEF and non-obstructive HCM is unique, as sotagliflozin addresses underlying metabolic disorders in the myocardium [29] - The company aims to position sotagliflozin as the first-line treatment for both HFpEF and HCM, leveraging its efficacy and safety profile [35] Trial Design and Regulatory Engagement - The SONARDA trial is designed to include both obstructive and non-obstructive HCM patients, with a primary endpoint focused on symptom relief [40] - Lexicon is in discussions with the FDA to finalize the design for Phase 3 trials, aiming for a straightforward approval process based on previous Phase 2 data [62][66] Financial and Partnership Strategy - Lexicon plans to partner for the Phase 3 program, seeking a partner that is committed to long-term investment in the drug's development [78] - The company is exploring various partnership structures, aiming for a worldwide deal [79] Upcoming Events - The Arrowhead meeting in October will feature data presentations across Lexicon's Phase 2 programs, which are expected to inform the end of Phase 2 meeting with the FDA [81] Additional Important Insights - The analysis of the MAPLE trial indicated that beta blockers may cause harm, suggesting a potential shift in treatment paradigms for HCM [34] - The company is focused on simplifying trial designs to reduce variability and enhance the clarity of results [68] This summary encapsulates the key discussions and insights from the Lexicon Pharmaceuticals conference, highlighting the company's strategic focus on R&D, clinical advancements, and market positioning in the biopharmaceutical landscape.

Summary of Karolinska Development Conference Call - September 01, 2025 Company Overview - **Company Name**: Karolinska Development - **Industry**: Investment in biotechnology and medical technology - **Founded**: 2003, publicly listed since 2011 - **Portfolio**: 11 companies focused on clinical phase innovations and medical technology [4][5][6] Core Insights and Arguments - **Investment Strategy**: Focus on finding and developing new companies, particularly those in clinical phases, often when other investors are not involved [4][5] - **Market Focus**: Emphasis on achieving cash flow positivity in the U.S. market for medical technology companies, with a revenue threshold of over 200 million SEK to attract buyers [5] - **Innovation Type**: Targeting "first in class" innovations, which are unique and carry higher risks but potentially offer greater rewards [5] - **Active Management**: The company takes an active role in its portfolio companies, assisting with capital raising and strategic direction [6] Portfolio Highlights - **Dilafor**: Currently in phase 3, previously had disagreements with the FDA regarding study endpoints, now resolved [7] - **Modus Therapeutics**: Focused on chronic kidney disease and malaria, with a significant need for treatments; phase 2 readout expected in 2026 [8] - **SVF-vaccin**: Aiming to develop a vaccine for hepatitis B and D, with a phase 1 study completed for COVID-19, but not pursuing further in that area [10] - **Anacardio**: A heart failure company with significant interest from big pharma; awaiting phase 2 results in November [12] - **Human Kind Cognition**: Focused on CNS diseases related to liver failure, with a shift to a different liver disease for exclusivity in the market [14][15] - **Boost Pharma**: Targeting osteogenesis imperfecta (brittle bone disease) with unique clinical data showing an 80% reduction in fractures [17][18] Financial and Market Dynamics - **Exit Strategy**: The company has made 12 exits, generating approximately 488 million SEK, with a long-term strategy focused on achieving cash flows from successful exits [20][21] - **Current Market Conditions**: The investment climate remains challenging, but there are signs of improvement; fundraising is competitive [22][23] - **Investment Opportunities**: Current pricing allows for entry into early-stage startups at lower costs, with a focus on helping these companies reach clinical milestones [34] Upcoming Developments - **Anacardio Phase 2 Data**: Expected in November, which could significantly impact the company's valuation [38] - **Yumikran Cognition**: Anticipated data on Parkinson's disease and a major study expected early next year [38] - **Boost Pharma**: Potential financing for a phase 3 study is anticipated [39] - **Modus Therapeutics**: Phase 2 data expected in 2026 [39] Additional Insights - **Investor Dynamics**: There is a mix of cooperation and competition among VC investors, with varying strategies on exits and funding [25][30] - **Clinical Challenges**: The company has faced setbacks, such as issues with capsule leakage in studies, but has resolved these [14][15] This summary encapsulates the key points discussed during the conference call, highlighting the strategic direction, portfolio developments, and market conditions affecting Karolinska Development.

Core Viewpoint - Terns Pharmaceuticals is hosting an investor educational webinar on TERN-701, an investigational treatment for chronic myeloid leukemia (CML), ahead of data release expected in Q4 2025 [1][2]. Group 1: TERN-701 Overview - TERN-701 is a next-generation oral, allosteric BCR-ABL inhibitor targeting the ABL myristoyl pocket, currently evaluated for CML treatment [2][3]. - The CARDINAL Phase 1 clinical trial is assessing TERN-701's safety, tolerability, and efficacy in previously treated chronic phase CML patients [3]. Group 2: Clinical Trial Details - The dose escalation portion of the CARDINAL trial was completed in January 2025, with no dose limiting toxicities observed up to a maximum dose of 500 mg QD [3][4]. - The dose expansion phase began in April 2025, randomizing patients into two cohorts (320 mg or 500 mg QD) with up to 40 patients per arm [3]. - Efficacy and safety data from the Phase 1 trial are expected to be reported in Q4 2025, including the 6-month major molecular response achievement rate [3]. Group 3: Interim Data - Positive interim data from the dose escalation phase showed compelling molecular responses at the lowest dose in heavily pre-treated CML patients with high baseline BCR-ABL transcript levels [4]. - The trial demonstrated an encouraging safety profile with no dose limiting toxicities or treatment discontinuations across all cohorts [4]. Group 4: Company Background - Terns Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing small-molecule product candidates for serious diseases, including oncology and obesity [5]. - The company's pipeline includes three clinical stage programs: an allosteric BCR-ABL inhibitor, a small-molecule GLP-1 receptor agonist, and a THR-β agonist, along with a preclinical GIPR modulator discovery effort [5].