Financial Data and Key Metrics Changes - Curis reported a net loss of $8.6 million or $0.68 per share for Q2 2025, compared to a net loss of $11.8 million or $2.03 per share for the same period in 2024, indicating an improvement in financial performance [11] - Research and development expenses decreased to $7.5 million in Q2 2025 from $10.3 million in Q2 2024, primarily due to lower employee-related costs and clinical expenses [11] - General and administrative expenses also decreased to $3.5 million in Q2 2025 from $4.8 million in Q2 2024, reflecting reduced employee-related and legal costs [12] Business Line Data and Key Metrics Changes - The company is focused on the "take aim lymphoma" study evaluating emigosertib in combination with ibrutinib for patients with primary CNS lymphoma (PCNSL), with plans to enroll 30 to 40 additional patients over the next 12 to 18 months [5][6] - In the AML segment, emivocertib showed a 38% composite complete response (CR) rate in relapsed/refractory AML patients with FLT3 mutations, compared to 21% for gilteritinib, indicating a competitive edge [8][9] Market Data and Key Metrics Changes - The company is exploring emivacertib's potential in high-risk myelodysplastic syndromes (MDS) following the failure of the Varonis study, which has generated interest in combining azacitidine with emivacertib [10] - The competitive landscape in CLL is evolving with the introduction of BTK degraders and next-generation BCL2 inhibitors, but the company believes there is still room for its combination therapy [18][20] Company Strategy and Development Direction - Curis aims to improve the standard of care for CLL and NHL patients by adding emivacertib to BTK inhibitors, potentially allowing patients to achieve deeper responses and reduce the risk of resistance [7] - The company is also planning a registrational study comparing emivacertib to gilteritinib in the relapsed/refractory AML setting, indicating a strategic focus on expanding its treatment options [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing discussions with the FDA and EMA regarding accelerated submissions for the lymphoma study, despite the current uncertain regulatory environment [39] - The company believes its lead indication in NHL, particularly in PCNSL where there are no approved drugs, positions it favorably for future growth [39] Other Important Information - Curis completed a registered direct offering and private placement in July 2025, raising approximately $6 million, which, along with existing cash, is expected to fund operations into 2026 [12] - The company has over 30 clinical sites open for patient enrollment in the lymphoma study, with expectations of enrolling one patient per site per year due to the ultra-rare nature of the indication [24] Q&A Session Summary Question: What do you think the bar would be for the BTK combination study in CLL? - Management believes that adding emivacertib to a commercially available BTK inhibitor can lead to minimal residual disease (MRD) negativity or complete remissions, addressing an unmet medical need in CLL [16][17] Question: Can you provide any color on enrollment progression for the lymphoma study? - Enrollment is steady but challenging due to the ultra-rare population, with expectations of one patient per site per year [24][30] Question: How do you plan to prioritize development between PCNSL and CLL? - The company is actively discussing how to allocate resources efficiently, given the compelling data and multiple potential studies [48] Question: What is the status of discussions with the FDA regarding accelerated approval? - Management confirmed that discussions with the FDA remain positive and aligned with key activities [39] Question: Are there any updates on the investigator-sponsored solid tumor studies? - There are no current updates, but the company is hopeful for data from at least one study this year [51]

Core Viewpoint - Nicox SA's exclusive Japanese partner, Kowa, has initiated a Phase 3 safety clinical trial for NCX 470 in Japan, which will trigger a €2 million milestone payment to Nicox. This trial is part of the process to seek marketing approval for NCX 470 in Japan, requiring only one additional confirmatory Phase 3 trial [1][6]. Group 1: Clinical Trials and Development - Kowa is responsible for financing and managing the Phase 3 trials under a license agreement with Nicox, and the first patient has been enrolled in the safety trial [2][6]. - The confirmatory trial, involving 500 patients, is expected to start shortly and is necessary for the marketing approval submission [3]. - NCX 470 is currently in Phase 3 clinical development programs in the U.S., China, and Japan, aimed at lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension [4]. Group 2: Product Information - NCX 470 is a novel NO-donating bimatoprost eye drop, and its Phase 3 trials are designed to meet regulatory requirements for safety and efficacy to support NDA submissions in the U.S. and China [4]. - The results of the first Phase 3 clinical trial, Mont Blanc, have been published, and topline results from the second trial, Denali, are expected between mid-August and mid-September 2025 [4]. Group 3: Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for ocular health, with NCX 470 being its lead clinical product candidate [5]. - The company has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, in collaboration with Glaukos [5]. - Nicox's first product, VYZULTA®, is commercially available in the U.S. and over 15 other territories, and the company generates revenue from ZERVIATE® in allergic conjunctivitis [5].

Core Insights - hVIVO PLC reported first-half revenue of £24 million, driven by growth in diversified services, particularly in laboratory operations and the newly acquired Clinical Research Services (CRS) [2][5] - The company maintains a debt-free status with cash deposits of approximately £23 million [2][6] - The integration of CRS and Cryostore is progressing well, with CRS contributing £5.2 million in revenue and Cryostore adding £300,000 [3][7] Financial Performance - EBITDA margins for the first half stood at around 12%, supported by operational efficiencies and upfront non-refundable fees from cancelled contracts [2][6] - The company aims for £47 million in revenue for 2025, with low single-digit EBITDA expected due to cost control measures [5][11] Market Conditions - Macroeconomic headwinds, including U.S. regulatory shifts and biotech funding pressures, have delayed clinical trial decisions [4][8] - Despite these challenges, the order book was £40 million at the end of June, with proposals submitted in 2025 already exceeding those of 2024 [4][10] Strategic Outlook - hVIVO is diversifying beyond infectious diseases, focusing on areas like cardio-metabolic trials, which positions the company for broader growth [5][12] - The company is optimistic about the sales pipeline, having submitted more proposals in the first half of 2025 than in all of 2024 [9][10] Integration and Acquisitions - The integration of CRS and Cryostore is largely complete, with operational teams aligned and backend integration ongoing [3][8] - The acquisitions were made for around £11 million, net of cash acquired, laying a foundation for long-term growth [7][8] Future Plans - The company is actively recruiting a new chair, with due diligence ongoing and an announcement expected soon [11] - hVIVO is confident in delivering strong results, supported by a strong foundation and a diverse service offering [12]

Core Insights - Modus Therapeutics has successfully completed patient enrollment for part 1 of its clinical phase 2a study evaluating sevuparin as a treatment for chronic kidney disease with anemia [1][2] - The study aims to assess the safety and dosing levels of sevuparin in patients with chronic kidney disease (stage 3-5) and healthy volunteers, conducted in Italy [2] - Karolinska Development holds a 66% ownership stake in Modus Therapeutics, indicating significant investment in the company's potential [3] Company Overview - Karolinska Development AB is a Nordic life sciences investment company focused on identifying and developing breakthrough medical innovations in the Nordic region [4][5] - The company aims to build companies around leading scientists and experienced management teams, co-funded by international investors to enhance the likelihood of success [5][6] - Karolinska Development has a portfolio of eleven companies targeting innovative treatments for serious diseases, supported by a strong global network [6]

Core Insights - Moleculin Biotech, Inc. announced positive topline efficacy results from its U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of Soft Tissue Sarcoma Lung Metastases [3][5] - The trial was a multi-center, open-label, single-arm study that determined the Maximum Tolerable Dose and Recommended Phase 2 Dose, and explored the efficacy of Annamycin as a single agent [3][5] - Annamycin is designed to avoid multidrug resistance mechanisms and lacks the cardiotoxicity common with currently prescribed anthracyclines, making it a promising candidate for treating relapsed or refractory acute myeloid leukemia and STS lung metastases [5][6] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses [2][5] - The company is advancing a pipeline that includes Annamycin and WP1066, an Immune/Transcription Modulator targeting various cancers [7] - The company has initiated the MIRACLE Trial, a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia [6]

Core Insights - Portage Biotech Inc. has entered a mutual Subscription Agreement with Compedica Holdings Limited, involving the issuance of 625,000 ordinary shares at $8.00 each in exchange for 1,165,501 shares of Compedica valued at $4.29 per share, totaling $5 million [2] - Following the transaction, Compedica will own 27.4% of Portage's issued and outstanding ordinary shares [2] - Portage is committed to using at least 50% of net funds from future equity funding to subscribe for new Compedica equity, aimed at supporting the development and commercialization of Compedica's medical device [2] Company Overview - Portage Biotech is a clinical-stage immuno-oncology company focused on developing novel biologics to enhance the immune system's ability to combat cancer [5] - Compedica is a medical device technology company dedicated to creating innovative solutions for preventing and treating Diabetic Foot Ulcers (DFUs) through its OptiPulse active therapy system [6] Market Potential - The diabetic foot ulcer market is valued at over $4 billion in the US, with Compedica's OptiPulse device expected to become a gold standard treatment, improving patient outcomes and reducing costs for insurers [3] - Approximately 18.6 million people globally suffer from diabetic foot ulcers, which have a five-year mortality rate of around 30%, comparable to cancer diagnoses [3] Strategic Partnership - The alliance between Portage and Compedica is seen as a strategic move to support Compedica's scaling operations in North America, with the first commercial sales anticipated in the first half of 2026 [3] - Compedica is expected to publish results from its randomized clinical trial in Q4 2025, marking a critical milestone in its growth [3][4]

Group 1 - Vera Therapeutics, Inc. experienced a share price increase of over 65% during pre-market trading following the release of ORIGIN Phase 3 trial data [1] - Participants treated with atacicept for immunoglobulin A nephropathy (IgAN) showed a 46% reduction in proteinuria from baseline, with a statistically significant 42% reduction compared to placebo at week 36 (p<0.0001) [1][2] - The safety profile of atacicept was favorable and comparable to that of the placebo [2] Group 2 - Vera plans to present the trial results to the FDA soon and will submit full results to the American Society of Nephrology Kidney Week [3] - The company is targeting a potential commercial launch of atacicept in 2026 [3] - The ongoing trial will continue to evaluate kidney function changes over two years, with completion expected in 2027 [4]

Core Viewpoint - ANI Pharmaceuticals, Inc. has initiated a Phase 4 clinical trial to evaluate the safety and efficacy of two dose levels of Purified Cortrophin Gel for treating acute gout flares, marking a significant step in the company's commitment to building scientific evidence for this therapy [1][3]. Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics, particularly in rare diseases, ophthalmology, rheumatology, nephrology, neurology, and pulmonology [11]. Clinical Trial Details - The Phase 4 trial will compare two dose levels (40 USP units and 80 USP units) of Cortrophin Gel in a randomized, double-blind study involving up to 160 patients, aiming to enroll 70 evaluable patients per dose group [4][5]. - The primary endpoint is the change in gout pain intensity from baseline at day 3 post-administration, measured by Visual Analog Scale (VAS) [5]. Expert Involvement - Dr. Hyon Choi, a leading physician investigator with extensive experience in gout research, will conduct the trial, emphasizing the need for effective treatments for patients who do not respond adequately to conventional therapies [2][3]. Product Background - Cortrophin Gel is the only ACTH therapy approved by the FDA for acute gout flares and is indicated for short-term administration as an adjunctive therapy during acute episodes [1][7]. - The product has seen steady growth since the launch of a 1-mL vial in October 2023, aimed at increasing access for in-office treatment [3].

Summary of Conference Call Company and Industry Overview - The conference call discusses the performance and commercialization of **Ogemda**, a drug recently launched by the company, which has generated approximately **$90 million** in revenue within the first **11 months** of its launch [1][2] - The company is optimistic about achieving **double-digit growth** moving forward [2] Key Performance Metrics - The company reported **$54 million** in revenue for Ogemda in **2024**, significantly exceeding the initial consensus estimate of **$12 million** [3] - In **Q1**, net product sales reached over **$30 million**, indicating a potential annual run rate of **$120 million** if growth remains stable [4] Market Dynamics and Growth Potential - The company is focusing on expanding the use of Ogemda among prescribers, particularly in earlier lines of therapy, as many have initially used it in later line patients [5][6] - There is a significant opportunity to increase the number of patients treated with Ogemda, especially among healthier patients who are likely to stay on the drug longer [6] - The company has identified **200 centers** in the U.S. where **90%** of PLGG patients are treated, allowing for an efficient commercial model [11] Prescriber Engagement - The company has categorized prescriber accounts into three priority levels based on volume, with **100%** of priority one accounts having tried Ogemda, **75%** of priority two, and **35%** of priority three [11][12] - The focus is on deepening the engagement with prescribers to increase the number of patients treated and to educate them on the appropriate use of Ogemda [14] Compliance and Treatment Duration - Compliance with Ogemda has been reported as excellent, with high rates of on-time refills and minimal drug holidays observed [24][25] - The anticipated treatment duration in the commercial setting is expected to differ from clinical trials, with ongoing monitoring of patient experiences [22][23] Regulatory and Market Expansion - The company has filed for regulatory approval in the EU, with an anticipated decision by mid-2026, and expects a similar patient population in Europe as in the U.S. [40][41] - Pricing in Europe is expected to be lower than in the U.S., but the company sees this as a significant opportunity for market expansion [42] Business Development Strategy - The company is actively pursuing business development opportunities, particularly in oncology, and is interested in acquiring early clinical assets that align with its strategic focus [66][67] - The recent acquisition of **Day Three Zero One**, a PTK7 targeted ADC, exemplifies the company's strategy to invest in promising assets with clinical validation [56][63] Conclusion - The company is in a strong financial position and is focused on expanding the market for Ogemda while also exploring new business development opportunities in oncology [1][66] - The ongoing clinical trials and regulatory filings are expected to enhance the company's growth prospects and market presence in the coming years [48][49]

Financial Data and Key Metrics Changes - The company recorded total Danielza net product revenues of $20.9 million in Q1 2025, representing an 8% increase from $19.4 million in Q1 2024 [20][24] - The net loss for Q1 2025 was $5.2 million, or a negative $0.12 per share, compared to a net loss of $6.6 million, or a negative $0.15 per share in Q1 2024 [23][24] - Cash and cash equivalents at the end of Q1 2025 were $60.3 million, down from $67.2 million at the end of 2024, indicating an investment of $6.9 million in Q1 2025 [24][26] Business Line Data and Key Metrics Changes - Danielza's net product revenues in the U.S. for Q1 2025 were $13.4 million, down 28% from the prior year, while ex-U.S. revenues were $7.5 million, an increase of $6.7 million, driven by the named patient program in Western Asia [15][20] - The Danielza business unit achieved a segment profit from operations of $8.8 million, reflecting a 42% segment profit margin based on total revenues [24] - The radiopharmaceuticals business unit reported a segment loss from operations of $6.1 million for Q1 2025, compared to a loss of $6.0 million in Q1 2024 [24] Market Data and Key Metrics Changes - The company noted a slowdown in new patient enrollment in the U.S. due to competitive pressures and market dynamics, impacting revenue [16][18] - The addition of Danielza to the NCCN guidelines for treating relapsed or refractory neuroblastoma is expected to enhance its market position and drive future growth [18][100] Company Strategy and Development Direction - The company has established two distinct internal business units, Danielza and Radiopharmaceuticals, to maximize potential and accelerate development [6][24] - The focus is on enhancing advocacy, increasing new patient starts, and expanding into high-volume commercial accounts to improve Danielza's market share [12][71] - Upcoming updates on the radiopharmaceutical R&D event are scheduled for May 28, which will include data from clinical trials and pipeline updates [9][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position and ability to fund operations into 2027, despite current challenges [7][25] - The anticipated revenue guidance for Q2 2025 is between $17 million and $19 million, reflecting seasonal trends and historical performance [25][40] - Management remains optimistic about the potential for growth in the U.S. market, particularly with the recent inclusion of Danielza in treatment guidelines [100][102] Other Important Information - The company is monitoring potential tariff impacts on its supply chain, with expectations of minimal effects [26] - Research and development expenses decreased to $11.4 million in Q1 2025 from $13.3 million in Q1 2024, reflecting prudent spending [22][23] Q&A Session Summary Question: Understanding U.S. and ex-U.S. revenue dynamics for Danielza - Management noted steady growth outside the U.S. and a slower start in the U.S. due to competitive pressures, but an uptick in enrollments is expected [30][32] Question: Q2 revenue guidance and historical trends - Management explained that seasonality and previous stock ins influenced the guidance, projecting slight growth in U.S. sales [38][40] Question: Plans for naxitamab in osteosarcoma - The company continues to support research in osteosarcoma and aims to improve diagnostics for GD2 expression [46][47] Question: Details on CD38 SADA trial - The first patient has been dosed, with plans to enroll 12 to 15 patients in a safety study [50][52] Question: Medicaid reserve perspective - Management indicated stabilization in Medicaid gross to net elements, with no major adjustments anticipated for 2025 [55][58] Question: Impact of new construct for GD2 SADA on study timelines - A bridging study will be conducted to assess safety before moving forward with Part B of the study [61][62] Question: Long-term growth for Danielza - The focus is on advocacy development, financial messaging, and global expansion to drive long-term growth [71][72] Question: NCCN guidelines impact on Danielza growth - Inclusion in the guidelines is expected to remove a headwind and provide potential tailwinds for market discussions [99][100]