Good Afternoon and welcome to HotCopper Highlights wrapping up Week 41 of the year, I’m Jon Davidson. In this segment the top stocks most watched and most discussed by you, HotCopper users, let’s get straight into it starting with the most viewed. Findi, a fintech that’s ultimately rolling out ATMs in parts of India where there aren’t any, has had a very uniquely HotCopper experience this week after a user claiming to be a former member of staff, apparently drunk, took to the forums of this very website to ...

U.S. stock futures were higher this morning, with the Dow futures gaining around 100 points on Monday.Shares of Quantum Computing Inc. (NASDAQ:QUBT) fell sharply in pre-market trading.Quantum Computing raised $750 million from institutional investors in market-priced private placement led by top shareholders.Quantum Computing shares dipped 11.7% to $21.70 in pre-market trading.Here are some other stocks moving lower in pre-market trading.Rich Sparkle Holdings Ltd (NASDAQ:ANPA) tumbled 15% to $22.10 in pre-m ...

U.S. stock futures were higher this morning, with the Dow futures gaining around 100 points on Monday.Shares of Quantum Computing Inc. (NASDAQ:QUBT) fell sharply in pre-market trading.Quantum Computing raised $750 million from institutional investors in market-priced private placement led by top shareholders.Quantum Computing shares dipped 11.7% to $21.70 in pre-market trading.Here are some other stocks moving lower in pre-market trading.Rich Sparkle Holdings Ltd (NASDAQ:ANPA) tumbled 15% to $22.10 in pre-m ...

Group 1 - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by over 350 points on Friday [1] - White Mountains Insurance Group announced plans to sell a controlling interest in its technology-driven homeowners' insurance distribution platform, Bamboo, to CVC Capital Partners, leading to a significant rise in its stock price [1][2] - The deal values Bamboo at $1.75 billion, and the company specializes in data-enabled underwriting and distribution for the residential property market in California and Texas [2] Group 2 - White Mountains Insurance Group shares surged by 9.2%, reaching $1,817.83 on Friday following the announcement of the Bamboo deal [2] - Other notable stock gains included Anbio Biotechnology, which rose by 69.6% to $43.07, and Lithium Americas Corp., which increased by 29.1% to $8.85 [4] - USA Rare Earth, Inc. shares climbed 21.4% to $27.56 amid reports of discussions with the White House [4]

Core Insights - Mesoblast Limited is a global leader in allogeneic cellular medicines for inflammatory diseases, emphasizing that its products are manufactured from U.S. donors and are not subject to tariffs on imported pharmaceutical products [1][2]. Company Overview - Mesoblast specializes in developing allogeneic (off-the-shelf) cellular medicines aimed at treating severe and life-threatening inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [4]. - The company has a strong intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to last until at least 2041 in major markets [7]. Product Information - Ryoncil (remestemcel-L) is the only FDA-approved allogeneic mesenchymal stromal cell therapy for any indication, specifically for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGvHD) [2][5]. - Ryoncil is also being developed for additional inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, while another product, rexlemestrocel-L, targets heart failure and chronic low back pain [6]. Manufacturing and Distribution - Mesoblast's manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [8]. - The company operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange and Nasdaq [9].

Summary of Cue Biopharma Conference Call Company Overview - Cue Biopharma is based on a protein engineering platform developed from the Albert Einstein School of Medicine, focusing on designing molecules that interact specifically with T cells and lymphocytes [3][4][5] - The company has developed several bioprotein assets, including CUE-401 and CUE-501, targeting autoimmune diseases and oncology [4][36] Key Points on CUE-401 - CUE-401 is engineered to foster TGF-β binding signaling along with IL-2, essential for maintaining regulatory T cells (Tregs) and immune balance [10][19] - The mechanism of action involves conditional binding, requiring both TGF-β and IL-2 to activate targets, which enhances safety profiles compared to traditional therapies [12][13][34] - Preclinical data shows significant proliferation of Tregs, with a notable increase in induced regulatory T cells (IT-regs) from T effector cells [18][20] - In a graft-versus-host disease model, 100% of treated animals survived longer than control groups, demonstrating the potential for long-term immune tolerance [21][22] - The company plans to file an IND for CUE-401 in June 2026, with ongoing GLP toxicology studies [24][23] Development Strategy and Market Potential - Cue Biopharma aims to target multiple autoimmune diseases, with atopic dermatitis as a primary indication for initial trials [27][35] - The company believes that CUE-401 will not require chronic dosing, establishing durable Treg populations to manage diseases [26][34] - The broader application of CUE-401 is anticipated across various autoimmune diseases, including ulcerative colitis and rheumatoid arthritis [35] CUE-501 and Partnership with Boehringer Ingelheim - CUE-501 targets B cell depletion and has been partnered with Boehringer Ingelheim, focusing on differentiating from existing bispecific therapies [39][41] - The partnership includes a $12 million upfront payment and ongoing preclinical studies to define lead candidates for IND filing [45] - The preclinical data indicates equivalent B cell killing efficacy compared to bispecifics without the associated cytokine release, highlighting a favorable safety profile [42][43] Financial Overview - Cue Biopharma ended the last quarter with $28 million in cash, with an annual burn rate of approximately $25 to $28 million [51] - The company anticipates strategic partnerships and milestone payments to enhance its financial position [51] Market Dynamics and Competitive Landscape - The company is positioned to capture the pediatric market for acute graft-versus-host disease, with a significant opportunity in the adult market as well [64][68] - The competitive landscape includes existing therapies like Jakafi, which has limitations in pediatric applications and efficacy in severe cases [79][82] - Cue Biopharma's approach is expected to establish itself as a first-line therapy in children and potentially in adults with severe disease [80][82] Regulatory Engagement - Positive feedback was received from the FDA regarding the T-reg induction mechanism, with guidance towards earlier intervention in treatment protocols [22][90] - The company is aligning its clinical strategy with regulatory expectations to maximize market entry and patient impact [91]

Core Viewpoint - Mesoblast Limited has announced a plan to issue up to US$50 million in unsecured convertible notes to support its capital structure and ongoing pipeline growth opportunities, subject to shareholder approval [1][2]. Group 1: Convertible Notes Details - The company may issue the convertible notes in tranches of US$10 million, with a maturity date of 5 years after the first issuance [2]. - The conversion price is set at US$16.25 per ADR, which is a 126% premium over the last closing price on Nasdaq and a 29% premium on the ASX [3]. - The notes will carry a coupon of 5% per annum on the face value [3]. Group 2: Investor Considerations - Investors will receive a commitment fee of US$100,000 and warrants for 2 million ordinary shares upon entering the agreement, with additional warrants for 3 million shares if the option is exercised [4]. - The warrants will have the same exercise price as the conversion price and a maturity date of 4 years from the issuance date [4]. Group 3: Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [6]. - The company has FDA-approved therapies, including Ryoncil for treating steroid-refractory acute graft versus host disease in pediatric patients [7]. - Mesoblast is also developing additional therapies for various inflammatory diseases and has established commercial partnerships in multiple regions [8]. Group 4: Intellectual Property and Manufacturing - Mesoblast holds over 1,000 granted patents or applications related to its cell therapy technologies, providing commercial protection expected to last until at least 2041 in major markets [9]. - The company has proprietary manufacturing processes that yield industrial-scale, cryopreserved cellular medicines, ensuring availability to patients worldwide [10].

Core Insights - Mesoblast Limited achieved FDA approval for Ryoncil, the first FDA-approved mesenchymal stromal cell (MSC) product in the U.S., and successfully launched it for treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients [2][10][34] - The company aims to transform into a commercial biotechnology entity with plans for additional approved indications for Ryoncil and the launch of next-generation platform technologies targeting heart failure and chronic low back pain [2][6] Financial Highlights - Total revenue from cell therapy products reached US$17.2 million, a 191% increase from the previous year, driven by Ryoncil's launch [6][31] - Net operating cash spend was US$50.0 million, a 3% increase year-over-year, reflecting costs associated with the commercial team and product launch [6] - Cash on hand as of June 30, 2025, was US$162 million (A$247 million) [6] Product and Market Opportunities - Ryoncil has a potential annual addressable market of approximately $1 billion for pediatric and adult SR-aGvHD, with additional markets for biologic-refractory inflammatory bowel disease exceeding $5 billion, heart failure with reduced ejection fraction (HFrEF) over $10 billion, and chronic low back pain (CLBP) also exceeding $10 billion [7][35] - The company is developing Ryoncil for additional indications, including adult SR-aGvHD and inflammatory bowel disease, and has a pipeline of therapies targeting unmet medical needs [7][35] Operational Developments - Ryoncil became commercially available on March 28, 2025, shortly after FDA approval [10] - The company has expanded coverage for Ryoncil, with over 250 million U.S. lives insured and federal Medicaid coverage effective July 1, 2025 [11] - Mesoblast has onboarded 32 transplant centers and aims to onboard the top 45 centers that account for 80% of pediatric bone marrow transplants in the U.S. [11] Corporate Governance - The Board of Directors was strengthened with the appointments of Dr. Gregory George and Ms. Lyn Cobley, bringing extensive experience in medical science and financial services [30]

Financial Data and Key Metrics Changes - Revenue from cell therapy products increased to $17.2 million, up 191% from the prior year, driven by the successful launch of Ryoncil [12][15] - Net operating cash spend for the year was $50 million, consistent with the prior year, despite investments in commercial team build-out and product launch activities [13][15] - Cash on hand as of June 30 was $162 million [13] Business Line Data and Key Metrics Changes - Ryoncil generated $13.2 million in gross sales and $11.3 million in net sales after a 14.6% gross to net adjustment [12] - Cost of revenues related to product sales was $1.2 million, representing 10% of net product sales, resulting in a gross margin of 90% [15] - Selling, general, and administrative expenses rose to $39.3 million, an increase of $14.3 million from FY 2024, primarily due to the commercial team build-out and product launch [15] Market Data and Key Metrics Changes - The addressable market for Ryoncil in pediatric acute graft versus host disease (GVHD) is approximately $1 billion, with potential label extensions in adults and inflammatory bowel disease exceeding $5 billion [8] - The addressable market for chronic low back pain and heart failure with reduced ejection fraction is each over $10 billion [8] Company Strategy and Development Direction - The company aims to expand Ryoncil's label to include adult patients with GVHD and other inflammatory conditions, leveraging existing pediatric treatment centers [24][25] - Plans to initiate pivotal studies for Ryoncil in inflammatory bowel disease and chronic low back pain, targeting significant unmet medical needs [40][41] - The company is transitioning from an R&D-focused organization to a commercial biotech entity, emphasizing the importance of building a robust commercial infrastructure [87] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the successful launch of Ryoncil and the potential for continued revenue growth as more treatment centers are onboarded [76] - The company is focused on addressing the opioid crisis by providing alternatives for chronic pain management through its RexLemistroCell product [32] - Management highlighted the importance of FDA alignment for accelerated approval pathways and ongoing discussions regarding trial designs for heart failure and inflammatory bowel disease [77] Other Important Information - Ryoncil became commercially available on March 28, 2025, shortly after receiving FDA approval in December 2024 [10] - The company has onboarded 32 transplant centers in the U.S. and aims to reach 45 centers that account for 80% of pediatric bone marrow transplants [10][11] - Medicaid coverage for Ryoncil was mandated on July 1, expanding access to over 250 million lives in the U.S. [11][82] Q&A Session Summary Question: Timeline for adult GVHD label extension - Management expects to commence an adult acute GVHD trial this quarter, aiming to add Ryoncil on top of existing second-line agents [45][46] Question: Update on Phase III chronic lower back pain trial - Enrollment is progressing well with almost 40 sites, and management is optimistic about outcomes similar to previous trials [48][50] Question: Monthly treatment kits administered and inventory dynamics - Treatment kits are stocked based on weight bands, and inventory is replenished as children are treated [55][56] Question: Gross to net dynamics and adult GVHD trial design - Management expects gross to net adjustments to remain flat and will target patients on Jakafi for the adult trial [59][60] Question: Details on adult study and trial design - The trial will focus on patients with severe disease on Jakafi, aiming to increase responder rates significantly [64][65] Question: Timeline for inflammatory bowel disease trials - A KOL group is designing the trial, with updates expected this quarter [68] Question: Distribution of initial sales and revenue trajectory - It is too early to project future sales, but management expects continued strengthening of sales as infrastructure is built [73][76] Question: Market access progress - The company has engaged with over 97 payers, achieving coverage for over 250 million lives, with Medicaid coverage in place across all states [81][82]

Core Insights - The first domestically approved stem cell drug, Aimi Maitosai Injection, has been prescribed for a patient with acute graft-versus-host disease (aGVHD) [1][2] - The drug is priced at 19,800 yuan per dose, significantly lower than its US counterpart, Ryoncil, which is priced at 1/70 of the latter [1] - The pharmaceutical company behind the drug, PlasBio, has partnered with Alibaba Health for comprehensive support in drug distribution and patient management [3][4] Group 1: Drug Development and Approval - Aimi Maitosai Injection is the first stem cell therapy approved in China, targeting patients over 14 years old with aGVHD [2][3] - The drug's approval follows years of clinical trials and regulatory processes, marking a significant milestone in stem cell therapy commercialization [2][3] - The drug requires cold chain logistics for distribution, which Alibaba Health's established logistics network can provide [4] Group 2: Market Potential and Competition - The stem cell therapy market is projected to grow significantly, with the global market expected to reach $2.7 billion by 2027 and China's market projected to grow from 1.4 billion yuan to 18 billion yuan in the same period [6][7] - Over 120 stem cell products have entered clinical trials in China since 2017, indicating a growing interest and investment in this field [7][8] - Despite the promising market, no dominant products have emerged yet, suggesting a competitive landscape with multiple players [7][8] Group 3: Challenges and Regulatory Environment - The stem cell therapy sector faces significant technical barriers, regulatory scrutiny, and a lack of robust clinical data supporting efficacy [10][11] - The approval of Aimi Maitosai Injection is conditional, requiring ongoing observation of clinical outcomes and potential long-term risks [11] - The Chinese government is actively promoting stem cell therapy advancements, with recent policies aimed at facilitating research and commercialization [13][15] Group 4: Financial and Insurance Aspects - PlasBio has partnered with ZhongAn Insurance to provide coverage for Aimi Maitosai Injection, which may enhance patient access [12] - The drug's commercial success may depend on its inclusion in national health insurance schemes, as reliance solely on private insurance could limit market penetration [12][15] - The collaboration with Alibaba Health is seen as a strategic move to streamline patient access and distribution channels [4][15]