Core Insights - The KOMET-007 trial demonstrated encouraging clinical activity for ziftomenib in combination with 7+3 for newly diagnosed NPM1-m and KMT2A-r AML patients, showing high rates of complete remission and minimal residual disease negativity [1][2][4] Group 1: Clinical Data - In the KOMET-007 trial, 93% (41/44) of NPM1-m patients and 89% (24/27) of KMT2A-r patients achieved complete remission composite (CRc) [1] - Among responding patients, 71% (24/34) of NPM1-m and 88% (14/16) of KMT2A-r patients achieved measurable residual disease (MRD) negativity [1] - The median follow-up times were 24.9 weeks for NPM1-m patients and 15.7 weeks for KMT2A-r patients, with 96% (47/49) of NPM1-m and 88% (29/33) of KMT2A-r patients remaining alive [3] Group 2: Safety and Tolerability - The safety profile of ziftomenib was consistent with previous data, with Grade 3 adverse events occurring in over 10% of patients, including febrile neutropenia (15%) and decreased platelet count (15%) [4] - No dose-limiting toxicities or additive myelosuppression were observed, indicating a favorable safety profile for ziftomenib [4] Group 3: Future Developments - Kura Oncology plans to initiate the KOMET-017-IC and NIC Phase 3 studies in the second half of 2025 to further evaluate ziftomenib's efficacy in AML treatment [1][5] - A virtual investor event is scheduled for June 18, 2025, to discuss the results and broader development plans for ziftomenib [6] Group 4: Company Background - Kura Oncology is focused on developing precision medicines for cancer, with ziftomenib being the first investigational therapy to receive Breakthrough Therapy Designation from the FDA for R/R NPM1-m AML [7] - Kyowa Kirin, a partner in the development of ziftomenib, has a long history in drug discovery and biotechnology innovation, aiming to address high unmet medical needs [9]

欢迎扫描下方二维码关注： = | 增值税处理 适用税目为现代服务-租赁服务-有 形动产租赁服务,税率为 13%。 有形动产融资 不动产融资 租赁服务 租赁服务 | 增值税处理 适用税目为现代服务-租赁服务，不动 产租赁服务税率为 9% ，有形动产租赁服 务税率为 13%。 (2) 融资性售后回租 是指承租方以融资为目的，将资产出 售给从事融资性售后回租业务的企业后, 从事融资性售后回租业务的企业将该资产 出租给承租方的业务活动。 从事融资性售 以融资为目的) 层回租亚务的 » 》 资产出售 > 企业 (家)承租方 1 资产出租 2 = | 增值税处理 适用税目为金融服务-贷款服务, 税率为 6%。 -. 各种交通工具的 租赁业务 1. 程租业务: 是指运输企业为租船人完成某一特定航次的 运输任务并收取租赁费的业务。 = | 增值税处理 适用税目为交通运输服务-水路运 输服务,税率为 9%。 2. 期租业务: 是指运输企业将配备有操作人员的船舶承 租给他人使用一定期限，承租期内听候承租方 调遣，不论是否经营,均按天向承租方收取租 赁费,发生的固定费用均由船东负担的业务。 = | 增值税处理 适用税目为交通运输服 ...

Aytu Biopharma (AYTU) Update / Briefing June 11, 2025 04:30 PM ET Speaker0 Greetings. Welcome to the Aytu BioPharma Analyst and Investor Conference Call, ExuA Opportunity and Commercialization Plan. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. I will now turn the conference over to your host, Robert Blum with Lytham Partners. You may begin. Speaker1 Thank you very much, John. Good a ...

Summary of Iterum Therapeutics Conference Call Company Overview - **Company**: Iterum Therapeutics - **Product**: Orlynda (oral solopenem) - **Partnership**: Eversana for commercialization Key Points Industry Context - The uncomplicated urinary tract infection (UTI) market in the U.S. generates approximately **40 million prescriptions annually** [10] - **Two-thirds** of these prescriptions (about **26 million**) are for at-risk patients, including elderly women and those with comorbidities [10] - There have been **no new oral treatments** for uncomplicated UTIs in over **25 years**, with the market leader, nitrofurantoin, approved in **1953** [11] - Rising rates of **antibiotic resistance** are diminishing the effectiveness of existing treatments [12] Product Development and Commercialization - Orlynda received **FDA approval** in **October 2024** and is the only FDA-approved oral penum in the U.S. for uncomplicated UTIs [9] - Iterum has signed a **commercialization agreement** with Eversana to expedite the launch of Orlynda [8] - The expected launch date for Orlynda is by the **fourth quarter of 2025** [3][9] Financial Updates - Pfizer extended the due date for a **$20 million regulatory milestone** payment related to Orlynda from **October 2026** to **October 2029**, alleviating financial pressure [7] - Pricing strategy for Orlynda is not finalized, but expected to be between **$1,400 and $4,700** per treatment course [18] Market Dynamics and Research Insights - Physicians report a **high unmet need** for new antibiotics in the uncomplicated UTI space, with low confidence in existing treatments for at-risk patients [13] - Orlynda is viewed favorably by payers for its efficacy and safety, particularly against multidrug-resistant pathogens [13] Commercialization Strategy - A team of **national account managers** has been trained to ensure optimal market access for Orlynda [14] - The launch will occur in **phases**, with initial focus on territories with high prescription rates [15][16] - Each high-value physician in target territories writes an average of **over 500 prescriptions** for uncomplicated UTIs annually [17] Intellectual Property and Manufacturing - Orlynda has **10 years of marketing exclusivity** in the U.S. from the FDA, expiring in **October 2034** [21] - The company holds multiple patents related to Orlynda, with expiration dates ranging from **2039 to 2041** [24] - Current inventory is projected to last through **mid to late 2026**, with a shelf life of **six years** from manufacture [25] Conclusion - Iterum Therapeutics is making significant progress towards the commercialization of Orlynda, addressing a critical need in the UTI market, and anticipates a successful launch by the end of 2025 [26]

Châtillon, France, June 11, 2025 DBV Technologies Announces the Voting Results of its 2025 Combined General Meeting Shareholders approved all proposed resolutions DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company (the “Company”), held its Combined General Meeting (the “General Meeting”). The General Meeting was chaired by Michel de Rosen, Chairman of the Company. The Company’s shareholders approved all resolutions submitted by the ...

Vera Therapeutics (VERA) FY 2025 Conference June 11, 2025 03:15 PM ET Speaker0 Okay. Good afternoon. We'll continue with the next session. I'm Paul Choi, and I cover the SpidCap biotech sector here at Goldman Sachs. It's my pleasure to have Vera Therapeutics here on stage with us. To my immediate left is CEO, Marshall Fortis, and to my far left, Chief Medical Officer Rob Brenner. Maybe what we'll do is let Marshall kick it off with maybe some high level comments or an introduction of Avera, just kind of wha ...

Core Viewpoint - Allarity Therapeutics has appointed Jesper Høiland to its Board of Directors, replacing Joseph Vazzano, as the company prepares for the next phases of clinical development and potential commercialization of its cancer treatment, stenoparib [1][4]. Group 1: Leadership Changes - Jesper Høiland has been a strategic consultant for Allarity since October 2024 and brings over 30 years of experience in global pharmaceutical commercialization [2][3]. - Joseph Vazzano will resign from the Board effective June 30, 2025, after contributing to Allarity's development for two years [1][4]. Group 2: Company Overview - Allarity Therapeutics is a Phase 2 clinical-stage pharmaceutical company focused on developing stenoparib, a dual PARP and WNT pathway inhibitor, as a personalized cancer treatment [1][7]. - The company utilizes its proprietary Drug Response Predictor (DRP) technology to select patients who may benefit most from stenoparib [6][8]. Group 3: Product Information - Stenoparib is an orally available small-molecule inhibitor targeting PARP1/2 and tankyrase 1/2, with potential applications in various cancers, including ovarian cancer [5]. - Allarity holds exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [5]. Group 4: Strategic Importance - The appointment of Jesper Høiland is seen as a strategic move to enhance Allarity's governance and operational focus during a critical time in the company's development [4]. - Høiland's experience in preparing for the commercialization phase of investigational drugs is expected to be valuable as Allarity advances its clinical development [4].

Financial Data and Key Metrics Changes - The launch of ResDiffera has been described as outstanding, with over 17,000 patients on the product by March 2025, compared to almost zero a year prior [6][7] - The company reported that over 80% of commercial lives were covered by payers at the six-month mark post-launch [6] - The company anticipates robust growth for 2025, with expectations for gross to net discounts typical for specialty medicines [44][45] Business Line Data and Key Metrics Changes - The company is focusing on expanding its prescriber base, with over 70% of targeted prescribers having written prescriptions for ResDiffera [9] - The company is currently at 5% penetration of the identified 315,000 diagnosed patients, indicating significant room for growth [8][9] - The management noted that the product is becoming standard of care, which is expected to facilitate further adoption [11] Market Data and Key Metrics Changes - The company sees favorable market dynamics in the NASH space, with a potential patient population that is many multiples of the diagnosed patients [8] - The anticipated approval of semaglutide is viewed as a market growth opportunity rather than a direct threat [31][32] Company Strategy and Development Direction - The company is optimistic about extending its intellectual property (IP) into the 2040s and is actively pursuing new IP to enhance its position [23][24] - The focus on lifecycle management includes ongoing trials and exploring distinct populations for potential new indications [24][26] - The company is strategically positioned to leverage its existing product while selectively pursuing business development opportunities [65][66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product's performance and its acceptance in the market, noting positive feedback from prescribers and patients [36][37] - The company is well-prepared for the European launch, with a strong team in place and high anticipation from the treating community [78][79] - Management believes that the competitive landscape will not hinder their growth, as they maintain a strong product profile [30][31] Other Important Information - The company has a strong balance sheet with $848 million in cash and only $115 million in debt, providing ample capacity for future initiatives [69] - The management emphasized the importance of time in building familiarity with the product among prescribers and patients [11] Q&A Session Summary Question: What are the expectations for reauthorization? - Management believes reauthorization will not be a challenge, as criteria are fair and based on physician assessments of patient stabilization or improvement [21][22] Question: How does the company plan to manage competition? - The company is focused on gross to net strategies and has begun contracting for access, anticipating competition while maintaining a long-term view [42][44] Question: What is the company's approach to business development? - The company is selectively looking for opportunities to enhance its pipeline without risking its current strong position [66][70] Question: How does the company view the upcoming European launch? - Management is optimistic about the European launch, noting that the market is better prepared than the U.S. was at launch [75][78] Question: What is the anticipated impact of MFN on pricing in Europe? - The company is optimistic that Europe will recognize innovation and is prepared to approach pricing based on unfolding information [84]

Structure Therapeutics (GPCR) FY Conference June 11, 2025 10:40 AM ET Speaker0 Following session is not open to the press. Speaker1 Perfect. Thanks, everyone, who's joining us here at the Goldman Sachs Annual Healthcare Conference. Thrilled to have Ray Stevens from Structured Therapeutics here to join us. Maybe you could just start with a quick overview of the business. I would love to kind of get started there, then we'll dig in. Speaker2 Absolutely, Corinne. So Structured Therapeutics is really built arou ...

Core Insights - Shares of Novo Nordisk (NVO) increased by 5% on June 10 due to news that activist hedge fund Parvus Asset Management is building a stake in the company to influence the appointment of a new CEO [1][9] - The company's previous CEO, Lars Fruergaard Jørgensen, stepped down following a mutual agreement with the board amid market challenges and a decline in share price [2][3] - Year-to-date, Novo Nordisk's shares have decreased by 6.7%, contrasting with the industry's growth of 3.1% [4] Company Developments - Novo Nordisk's semaglutide products, including Ozempic and Wegovy, have gained significant market traction, with Wegovy recently receiving FDA approval to reduce heart disease risk [6] - Upcoming presentations at the American Diabetes Association (ADA) 85th Scientific Sessions will include data from the STEP UP trial for a higher dose of Wegovy and full results from phase III REDEFINE studies on CagriSema [7][8] - The company is also set to present data on the pipeline candidate amycretin, showcasing its commitment to obesity innovation [10] Competitive Landscape - Novo Nordisk faces intense competition in the obesity market from Eli Lilly (LLY), which has seen success with its obesity drugs [11] - To address competitive pressures, Novo Nordisk is developing new obesity treatments and has submitted a regulatory application for oral semaglutide 25 mg for obesity, with a decision expected around year-end [12]