Boston Scientific (NYSE:BSX) FY Conference March 28, 2026 06:30 PM ET Company ParticipantsBrad Sutton - Chief Medical Officer in AF SolutionsDavid Roman - Managing Director in Global Investment Research DivisionJosh Jennings - Managing DirectorKen Stein - Chief Medical OfficerLauren Tengler - VP of Investor RelationsMarty Leon - Study Co-Chair, Mallah Family Professor of Cardiology, and Chief Innovation OfficerMichael Jaff - Chief Medical Officer in Vascular TherapiesConference Call ParticipantsChris Pasqua ...

As filed with the Securities and Exchange Commission on March 17, 2026. Registration No. 333-293418 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 BIOVENTRIX, INC. (I.R.S. Employer Identification No.) 120 Forbes Blvd., Suite 125 Mansfield, MA 02048 USA (925) 290-1000 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices) David Richmond Ch ...

RT James L. Nuzzo, PhD (@JamesLNuzzo)They continue to lie about women's representation in clinical trials.Since 1995, women have been more than 50% of participants in NIH-funded trials every year except in 2017. These data come directly from reports published by the NIH's Office of Research on Women's Health. https://t.co/3JE5drahXq ...

Summary of Dexcom's Conference Call Company Overview - **Company**: Dexcom - **Industry**: Continuous Glucose Monitoring (CGM) - **Key Personnel**: CFO Jereme Gloekler, new CEO Jake Leach, former Executive Chairman Kevin Sayer [1][2][6] Core Points and Arguments - **Market Size and Growth**: - Approximately 600 million people globally diagnosed with diabetes, expected to rise to 853 million by 2050 [5] - 40% of the U.S. population has prediabetes, indicating a growing crisis [5] - Only 2% of the diabetes population currently uses CGM, highlighting a significant unmet need [6] - **Company Strategy**: - Focus on being the premier glucose sensing solution and improving customer experience [7][9] - Plans to expand internationally, as Dexcom is under-indexed outside the U.S. [10] - Aiming for scalable production, with a goal to produce as many sensors as Apple makes iPhones [10] - **Financial Performance**: - Revenue growth of approximately 15% organically in 2025, with an active customer base growth of over 20% [12] - Guidance for 2026 includes revenue growth of 11%-13%, gross margins of 63%-64%, and over $1 billion in free cash flow [15][40] - **Product Developments**: - Launch of Dexcom G7 15-Day system, which includes SmartBasal for remote insulin titration [13][14] - Introduction of Dexcom ONE, an over-the-counter product, generating $130 million in revenue in 2025 [31] - Upcoming Dexcom G8 expected to be the most accurate sensor with advanced sensing capabilities [35][36] - **Clinical Evidence and Coverage**: - Ongoing efforts to secure coverage for Type 2 diabetes patients, with potential to unlock 12 million additional lives [21] - Real-world data shows significant health improvements for users of CGM, including reductions in A1C, weight, and BMI [19][20] Additional Important Content - **Customer Experience Enhancements**: - Development of a digital experience for better customer support and account management [27] - Integration with electronic health records (EHR) to facilitate data sharing with healthcare providers [30] - **International Expansion**: - Significant opportunities in countries like Japan, France, and Canada, where coverage is expanding [22][23] - Plans to launch a manufacturing facility in Ireland by 2026 to enhance global supply chain resilience [34][35] - **Challenges and Learnings**: - Acknowledgment of past challenges, including supply chain issues and an FDA warning letter, with a focus on learning and improving operations [44][45] - **Future Outlook**: - Anticipation of double-digit growth and gross margin expansion, with a strong emphasis on expanding coverage and improving product offerings [40][46] This summary encapsulates the key points discussed during the conference call, highlighting Dexcom's strategic direction, market opportunities, and financial outlook.

Financial Data and Key Metrics Changes - Total revenues for Q4 2025 were $17.8 million, up from $16.9 million in Q4 2024, while total revenues for the full year 2025 reached $88 million, compared to $18.5 million in 2024, primarily due to technology transfer and milestone recognition [27][28] - R&D expenses for Q4 2025 were $104.4 million, an increase from $93.6 million in Q4 2024, and for the full year, R&D expenses rose to $416 million from $339.4 million in 2024 [29] - G&A expenses for Q4 2025 were $91.7 million, compared to $62.3 million in Q4 2024, with full-year G&A expenses at $284.3 million, up from $215.3 million in 2024 [29] - The net loss for Q4 2025 was $183 million or $1.50 per share, compared to a net loss of $150 million or $1.26 per share in Q4 2024, with a full-year net loss of $785 million or $6.54 per share, compared to $589.5 million or $5.26 per share in 2024 [30] Business Line Data and Key Metrics Changes - The approval of MYQORZO represents a significant milestone, marking the company's transition to a global commercial-stage biopharmaceutical company [5][6] - The U.S. commercial launch of MYQORZO began immediately after FDA approval, with a focus on building customer support systems and marketing campaigns [10][12] - Initial customer feedback has been positive, with over 700 healthcare providers (HCPs) certified in the REMS program within three weeks of launch, indicating strong engagement and demand [13][14] Market Data and Key Metrics Changes - The company anticipates launching MYQORZO in Germany in Q2 2026, following its recent approval in the EU [7][18] - The company has engaged with key payers to ensure access for MYQORZO, aiming for Medicare access comparable to Camzyos by Q1 2026 and commercial access by Q4 2026 [17] Company Strategy and Development Direction - The company is focused on executing the launch of MYQORZO while advancing its muscle biology pipeline, with a disciplined approach to capital allocation [8][32] - The strategic priorities include launching MYQORZO in the U.S. and Europe, advancing clinical trials for aficamten, and investing in the muscle biology platform [32][33] - The company aims to achieve greater than 50% of CMI new patient preference share by the end of 2026 [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial prospects for MYQORZO, citing strong initial engagement from the cardiology community and a high level of interest in the new treatment option [6][13] - The company is closely monitoring the operating environment and is optimistic about the potential for MYQORZO to address significant unmet medical needs in obstructive HCM [7][36] Other Important Information - The company is committed to addressing disparities in access to care for patients with HCM through a three-year initiative with the American Heart Association [36] - The company plans to report top-line results from ACACIA-HCM in Q2 2026 and expects to receive potential FDA approval for the supplemental NDA for MAPLE-HCM by Q4 2026 [37] Q&A Session Summary Question: Is it true that the ACACIA-HCM study will be successful if at least one of the endpoints reaches statistical significance? - Management confirmed that the trial will be deemed positive if it hits on either or both of the pre-specified clinical trial endpoints [41][42][43] Question: Could you share any color on how long it's taking sites to get through the REMS certification for MYQORZO? - Management noted that REMS certification is a quick process, generally taking 10-20 minutes, and many HCPs were prepared to certify quickly due to prior experience with similar products [47][48][49] Question: What are the expectations for the placebo arm response in ACACIA-HCM? - Management indicated that they are blinded to the data but noted that previous studies showed minimal placebo response, and the trial is designed to focus on the difference between active and placebo responses [55][58] Question: How is the early market uptake for MYQORZO in the U.S.? - Management reported that demand is in line with expectations, with many patients ready to start treatment following approval [66][68] Question: What is the significance of a potential win in ACACIA-HCM for the broader HFpEF opportunity? - Management highlighted that success in ACACIA-HCM could inform expectations for HFpEF and the potential benefits of cardiac myosin inhibitors in that population [95][96]

Core Viewpoint - Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs, and it will present at the BIO Investment & Growth Summit on March 2, 2026 [1] Company Overview - Soligenix is developing HyBryte™ (SGX301), a novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL), and is seeking regulatory approvals following the successful completion of its second Phase 3 study [1] - The company is also expanding its product pipeline, which includes SGX302 for psoriasis, dusquetide (SGX942) for inflammatory diseases, and SGX945 for Behçet's Disease [1] - The Public Health Solutions segment includes the development of RiVax®, a ricin toxin vaccine, and vaccines targeting filoviruses and COVID-19, utilizing the ThermoVax® heat stabilization technology [1] Upcoming Events - Christopher J. Schaber, Ph.D., President & CEO of Soligenix, will deliver a corporate presentation at the BIO Investment & Growth Summit on March 2, 2026, in Miami Beach, Florida [1] Funding and Support - The development of Soligenix's vaccine programs has been supported by government grants and contracts from agencies such as NIAID, DTRA, and BARDA [1]

Summit Therapeutics Q4 & FY 2025 Earnings Call February 23, 2026 4:30pm ET Forward Looking Statement Any statements in this presentation about the Company's future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company's product candidates, entry into and actions related to the Company's partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company's product candidat ...

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Financial Data and Key Metrics Changes - In 2025, Prothena reported a net cash used in operating and investing activities of $163.7 million, which was favorable compared to the guidance range of $170 million to $178 million [37] - The net loss for 2025 was $244.1 million, aligning with the guidance range of $240 million to $248 million [37] - As of December 31, 2025, Prothena had $308.4 million in cash, cash equivalents, and restricted cash, exceeding the guidance of $298 million [38] Business Line Data and Key Metrics Changes - Prothena's clinical pipeline saw significant progress, with two partnered programs, prasinezumab and coramitug, advancing into phase 3 clinical trials [6][7] - The phase 2 clinical trial for BMS-986446 in early Alzheimer's disease was fully enrolled in 2025, with completion expected in the first half of 2027 [8] - The company introduced its CYTOPE technology, demonstrating potential for precise targeting of intracellular disease pathways [9][30] Market Data and Key Metrics Changes - The phase 3 PARAISO trial for prasinezumab is expected to enroll approximately 900 participants, with primary completion anticipated in 2029 [16] - The phase 3 CLEOPATTRA trial for coramitug is intended to enroll about 1,280 ATTR-CM patients, with primary completion also expected in 2029 [23] - Prothena's partnered clinical programs have the potential to deliver up to approximately $3 billion in future milestone payments [12] Company Strategy and Development Direction - Prothena aims to capture value from clinical partnerships, with potential clinical milestone payments of up to $105 million in 2026 [10][40] - The company plans to implement a share redemption program and invest in its preclinical portfolio to support ongoing partnering efforts [40] - Prothena is focused on advancing its knowledge of the preclinical portfolio to explore research collaborations and licensing agreements [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the robust pipeline addressing significant unmet needs for millions of patients [40] - The company highlighted the importance of upcoming milestones and the potential for significant medical advances in areas with high unmet needs [45] - Prothena remains well-capitalized with a strong cash position, focusing on delivering long-term shareholder value [41] Other Important Information - Prothena's collaborations with Bristol Myers Squibb progressed, with BMS-986446 receiving Fast Track designation from the U.S. FDA for Alzheimer's treatment [8] - The company is engaged in research collaborations exploring multiple approaches for applying its CYTOPE technology [11] Q&A Session Summary Question: Key milestones for partnered program trials for PARAISO and CLEOPATTRA - Management outlined expectations for sharing more information on CYTOPE activities and data from the tau program with Bristol Myers Squibb in 2027, along with the phase 3 readouts expected in 2029 for coramitug and prasinezumab [42][44] Question: Keeping the amyloid beta story alive against competitors - Management discussed the advantages of the PRX012 transferrin-based approach, emphasizing its potential for improved amyloid removal and reduced ARIA rates compared to competitors [51][55] Question: Data sharing from the phase one study of PRX019 - Management confirmed that data from the PRX019 study will be shared with Bristol Myers Squibb, who holds global rights to the program [62][68] Question: Data necessary to secure a partnership for the CYTOPE platform - Management highlighted the importance of demonstrating robust CNS activity and specificity in targeting TDP-43 aggregates, which could facilitate partnerships [71][75]

Financial Data and Key Metrics Changes - In 2025, Prothena reported a net cash used in operating and investing activities of $163.7 million, which was favorable compared to the guidance range of $170 million to $178 million [35] - The net loss for 2025 was $244.1 million, aligning with the guidance range of $240 million to $248 million [35] - As of December 31, 2025, Prothena had $308.4 million in cash, cash equivalents, and restricted cash, exceeding the guidance of $298 million [36] Business Line Data and Key Metrics Changes - Prothena's clinical pipeline saw significant advancements, with two partnered programs, prasinezumab and coramitug, moving into phase 3 clinical trials [5] - The phase 3 PARAISO trial for prasinezumab will evaluate 900 participants with early Parkinson's disease, while the CLEOPATTRA trial for coramitug will enroll approximately 1,280 patients with ATTR-CM [5][17] - The company anticipates potential milestone payments of up to $105 million in 2026 from these partnered programs [9][38] Market Data and Key Metrics Changes - The global market for Parkinson's disease treatment is significant, with over 10 million patients and no approved disease-modifying therapies currently available [13] - The ATTR-CM market represents a multi-billion dollar opportunity, with coramitug expected to capture substantial future milestone payments [18] Company Strategy and Development Direction - Prothena aims to capture value from its clinical partnerships and has a strategic priority to implement a share redemption program in 2026 [9][39] - The company is focused on advancing its preclinical portfolio and exploring research collaborations, particularly around its CYTOPE technology [9][39] - Prothena's strategic priorities are supported by a robust cash position, allowing for prudent capital utilization [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's execution and resilience in 2025, setting the stage for future growth [39] - The company is optimistic about the potential for significant medical advances in areas with high unmet needs, particularly in neurodegenerative diseases [42] - Management highlighted the importance of upcoming milestones and the potential for substantial clinical milestone payments in 2026 [46] Other Important Information - Prothena's collaborations with Bristol Myers Squibb progressed, with the phase 2 TargetTau-1 trial for BMS-986446 fully enrolled and expected to complete in the first half of 2027 [6] - The company introduced its CYTOPE technology, which aims to enable precise targeting of intracellular disease pathways [27] Q&A Session Summary Question: Key milestones for partnered program trials for PARAISO and CLEOPATTRA - Management outlined that significant activities are expected in 2026 and 2027, including updates on CYTOPE technology and data from the tau program with Bristol Myers Squibb [41][42] Question: Keeping the amyloid beta story alive versus competitors - Management discussed the advantages of the PRX012 transferrin-based approach, emphasizing its potential for robust amyloid removal and improved safety profile [50][52] Question: Data sharing from the phase one study of PRX019 - Management confirmed that data from the PRX019 study will be shared with Bristol Myers Squibb, who holds global rights to the program [61][66] Question: Data necessary for CYTOPE platform partnerships - Management highlighted the importance of demonstrating robust CNS activity and specificity in targeting TDP-43 aggregates to attract partnerships [69][73]