Thermo Fisher Scientific (NYSE:TMO) Q3 2025 Earnings Call October 22, 2025 08:30 AM ET Company ParticipantsStephen Williamson - SVP and CFORafael Tejada - VP, Investor RelationsMarc Casper - Chairman, President and CEOConference Call ParticipantsTycho Peterson - Senior Equity AnalystDan Arias - Senior AnalystDan Brennan - Senior Equity Research AnalystJack Meehan - Equity Research AnalystPatrick Donnelly - Senior Equity Research AnalystAndrew Cooper - Equity Research AnalystMike Ryskin - Equity Research Ana ...

Significant progress in bulk RNA sequencing, methylation mapping, multiomics integration, and spatial analyses unlocks research previously out of reach for traditional short read platforms.Leveraging Roche’s SBX technology, Broad Clinical Labs achieved the new GUINNESS WORLD RECORD™ for fastest DNA sequencing technique in under four hours, in collaboration with Roche Sequencing Solutions and Boston Children’s Hospital.Wellcome Sanger Institute joins a growing network of early collaborators using SBX technol ...

Core Insights - Capricor Therapeutics is focused on developing therapies for Duchenne cardiomyopathy and has faced regulatory challenges but is working on a clear path forward for approval [2][4] - The company has made significant progress with its exosome platform, StealthX™, which has received FDA clearance for clinical trials [4][6] - Financial results indicate a net loss for the second quarter of 2025, with revenues dropping to zero compared to the previous year [8][10] Corporate Update - Capricor aims to resubmit its Biologics License Application (BLA) for Deramiocel based on existing data, with additional data from the HOPE-3 trial expected in Q4 2025 [4][5] - The FDA has accepted all observations from the Pre-License Inspection, marking a milestone in regulatory progress [4][5] - The company is preparing for a Type A meeting with the FDA to discuss the approval pathway [4][5] Financial Performance - Cash position as of June 30, 2025, was approximately $122.8 million, down from $151.5 million at the end of 2024 [7][26] - Revenues for Q2 2025 were $0, a decrease from approximately $4.0 million in Q2 2024, and for the first half of 2025, revenues were also $0 compared to approximately $8.9 million in the first half of 2024 [8][10] - Total operating expenses for Q2 2025 were approximately $27.7 million, up from $15.6 million in Q2 2024 [9][10] Clinical Development - The HOPE-3 Phase 3 clinical trial is ongoing, with topline data expected in Q4 2025 [5][6] - The FDA has cleared the IND for the StealthX™ exosome-based vaccine, marking its first clinical entry [4][6] - Orphan Drug Designation has been granted for Deramiocel in Becker muscular dystrophy, expanding its therapeutic strategy [5][6]

Core Insights - Calidi Biotherapeutics reported a net loss of $5.7 million for Q2 2025, slightly worse than analyst expectations of $(1.92) per share, indicating ongoing funding needs and cash reduction despite operational improvements [1][2][5] Financial Performance - The company recorded an EPS (GAAP) of $(1.99), compared to $(16.75) in Q2 2024, showing a significant year-over-year improvement [2] - Net loss attributable to common stockholders decreased by 23% from $7.4 million in Q2 2024 to $5.7 million in Q2 2025 [2][5] - Research and Development expenses increased to $2.6 million, while General and Administrative expenses decreased to $3.1 million, reflecting cost discipline [2][5] - Cash at the end of the period was $5.3 million, down 44.8% from $9.6 million as of December 31, 2024, indicating a need for additional funding [2][6] Business Overview - Calidi Biotherapeutics focuses on developing cancer treatments using stem cell-based delivery systems and enveloped virus platforms, aiming to enhance the effectiveness of oncolytic viruses [3] - The company is advancing preclinical and early-phase clinical assets, including the RedTail enveloped virus system and proprietary stem cell delivery technologies [4] Product Development - Key advancements were made with the RedTail platform, which effectively delivers an IL-15 superagonist payload to tumor sites, with an IND filing for CLD-401 targeted by the end of 2026 [7] - The company received Fast Track Designation from the U.S. FDA for CLD-201, its allogeneic stem cell-based immunotherapy for soft tissue sarcomas, with an IND for a Phase 1 trial opened in Q1 2025 [8] Leadership Changes - Notable changes in senior leadership occurred, with the appointment of a new Chief Executive Officer and Chief Medical Officer, both with substantial biopharmaceutical experience [9] Future Outlook - Management did not provide quantitative financial guidance but emphasized the focus on progressing core therapeutic platforms and upcoming milestones [10]

Core Viewpoint - Assembly Biosciences, Inc. has announced a registered offering of common stock and warrants, aiming to raise capital for its innovative therapeutics targeting serious viral diseases [1][4]. Group 1: Offering Details - The offering consists of 5,591,840 shares of common stock and pre-funded warrants for 1,040,820 shares, with a combined price of $19.60 per share and accompanying warrants [1]. - Each pre-funded warrant has a nominal exercise price of $0.001 and is immediately exercisable, while Class A and Class B warrants have an exercise price of $21.60 and specific expiration conditions [1]. - The offering and a private placement with Gilead Sciences, Inc. are expected to close on August 11, 2025, contingent upon customary closing conditions [4]. Group 2: Investor Participation - The offering includes participation from both new and existing investors, such as Commodore Capital, Blackstone Multi-Asset Investing, and Farallon Capital Management [2]. - Gilead will purchase 2,295,920 shares in a private placement at the same price as the offering, which will not be registered under the Securities Act [3]. Group 3: Use of Proceeds - The net proceeds from the offering and private placement will be utilized for general corporate purposes [4]. Group 4: Company Overview - Assembly Biosciences is focused on developing small-molecule therapeutics aimed at serious viral diseases, including herpesvirus and hepatitis infections [7][8].

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Core Insights - Adia Nutrition Inc. is advancing its regenerative care offerings by filing to become an in-network provider with TRICARE, which serves approximately 9.5 million beneficiaries, including active-duty service members and their families [2][5] - The company anticipates approval as a United Healthcare provider by August 1, 2025, which will further enhance its healthcare access initiatives [2][5] - Adia Med aims to secure TRICARE in-network provider status by August 31, 2025, tapping into a program that disbursed $50.6 billion for medical treatments in FY2019 [2][3] Company Developments - Adia Med plans to offer innovative regenerative treatments such as Umbilical Cord Blood Stem Cell therapies, Autologous Hematopoietic Stem Cell Transplantation, and Therapeutic Plasma Exchange, targeting conditions like Multiple Sclerosis and joint pain [3][5] - The filing with TRICARE complements Adia Med's progress with United Healthcare, where the company has begun submitting patient insurance claims, indicating near-final integration into the healthcare system [5] - By securing in-network status with both TRICARE and United Healthcare, Adia Med will join a select group of providers recognized for clinical excellence and compliance, enhancing patient care and insurance reimbursement opportunities [5][6] Market Positioning - The strategic move to join TRICARE's network is expected to make advanced regenerative therapies more accessible and affordable for military personnel and their families, aligning with the company's mission to revolutionize healthcare accessibility [3][5] - Adia Nutrition Inc. operates with a dual focus on premium organic supplements and leading-edge stem cell therapies, positioning itself as a key player in the healthcare and wellness industry [6]

Core Insights - Senti Biosciences, Inc. presented positive preliminary data for SENTI-202, a potential first-in-class CAR-NK cell therapy for relapsed/refractory AML, at the AACR Annual Meeting 2025 [1][2][3] Clinical Data Summary - The Phase 1 study of SENTI-202 involved 9 patients with relapsed or refractory AML, with 7 evaluable for overall response [3] - The study identified a preliminary recommended Phase 2 dose (RP2D) of 1.5 x 10 CAR NK cells administered on Days 0, 7, and 14 in 28-day cycles [3] - 5 of 7 evaluable patients achieved an overall response rate (ORR), with 4 achieving composite complete remission (cCR) [3][7] - All cCR patients were measurable residual disease (MRD) negative, indicating a strong efficacy profile [3][7] Safety and Tolerability - SENTI-202 was well-tolerated with no dose-limiting toxicities reported, and a maximum tolerated dose was not reached [3][7] - Adverse events were consistent with other investigational NK cell therapies, with no grade 5 adverse events observed [7] Financial Highlights - As of March 31, 2025, Senti Bio held approximately $33.8 million in cash and cash equivalents [13] - Research and development expenses for Q1 2025 were $9.3 million, an increase from $8.8 million in Q1 2024 [13] - The net loss for the quarter was $14.1 million, or $1.41 per share [13] Pipeline Update - The Phase 1 study of SENTI-202 is ongoing, with plans for disease-specific expansion cohorts [4] - Senti Bio is also evaluating SENTI-301A for HCC, but enrollment has been stopped due to observed dose-limiting toxicities [10] Company Overview - Senti Bio is focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][15] - The company aims to engineer therapies that selectively target and eliminate cancer cells while sparing healthy cells [15]

Financial Data and Key Metrics Changes - For the year ended December 31, 2024, the company reported revenues of $152.3 million, a decrease of $14.5 million from $166.8 million in 2023 [27] - For Q4 2024, revenues were $22.8 million, down $8.1 million from $30.9 million in Q4 2023 [27] - The net loss for the year was approximately $80.9 million, or $3 per diluted share, compared to a net loss of $29.7 million, or $1.12 per diluted share in 2023 [31] - Cash and cash equivalents were $293.9 million as of December 31, 2024, down from $348.9 million a year earlier [32] Business Line Data and Key Metrics Changes - The KOSTAIVE vaccine program achieved European Commission approval, with a reported gross profit share of approximately $28 million for Q4 2024 [24] - Research and development expenses for the year were $195.2 million, up from $192.1 million in 2023, driven by higher clinical trial costs [28] - General and administrative expenses remained relatively stable at $52.8 million for the year, compared to $52.9 million in 2023 [30] Market Data and Key Metrics Changes - The company anticipates increased burn rates in the next two years due to ongoing clinical trials for cystic fibrosis (CF) and ornithine transcarbamylase (OTC) programs [33] - The cash runway is expected to extend until the end of Q1 2027, despite the anticipated decline in development milestones from the COVID program [33] Company Strategy and Development Direction - The company is focused on advancing its self-amplifying mRNA platform pipeline, with ongoing studies for ARCT-2304 (influenza) and ARCT-032 (cystic fibrosis) [12][15] - The strategic partnership with CSL Seqirus is crucial for the KOSTAIVE vaccine's development and commercialization [25] - The company aims to differentiate its mRNA therapeutics through proprietary delivery technologies and unique mRNA sequences [42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming year, highlighting the potential for multiple clinical data readouts and continued development of vaccine programs [34] - The approval of KOSTAIVE is seen as a transformative milestone, positioning the company for future growth [35] - Management acknowledged the competitive landscape in cystic fibrosis treatments and emphasized the unique advantages of their mRNA technology [106] Other Important Information - The company appointed Dr. Moncef Slaoui as Chair designate, bringing significant industry experience to the board [20] - The company is preparing for the U.S. BLA filing for KOSTAIVE anticipated later in 2025 [10] Q&A Session Summary Question: What is the cadence of development milestones within the CSL collaboration? - Management indicated that milestones will continue to be received throughout the year, with specific updates expected in the first quarter call [40] Question: How does the CF program differentiate from competitors? - Management highlighted differences in mRNA technology, delivery systems, and manufacturing processes as key competitive advantages [42] Question: What is the expected size of the CF trial cohort? - The Phase II trial is expected to involve approximately 12 participants, with flexibility to increase that number [48] Question: What are the next steps for KOSTAIVE commercialization in Europe? - Management stated that CSL is leading the commercialization process, and specific details will be provided as they become available [78] Question: What safety monitoring parameters are in place for the CF study? - A data and safety monitoring committee is overseeing safety and tolerability, with thresholds for adverse events established [84] Question: What is the expected visibility into orders for KOSTAIVE in 2025? - Management noted that visibility into orders will depend on Meiji's guidance, with expectations for updates as the year progresses [63]