Core Insights - Lisata Therapeutics reported positive data from multiple clinical studies involving certepetide, highlighting its potential effectiveness in treating advanced solid tumors [3][4][6] - The company has formed a strategic alliance with GATC Health to utilize their AI-driven drug discovery platform, enhancing the development of certepetide and its applications [3][15] - Lisata has extended its cash runway into the first quarter of 2027, with no debt, indicating a stable financial position for ongoing operations [3][12] Business Developments - A global license agreement was established with Catalent for the use of certepetide in their SMARTag® Antibody-Drug Conjugate Technology Platform, which may enhance the targeting and effectiveness of ADCs [3][15] - The company achieved complete enrollment in the BOLSTER trial for cholangiocarcinoma ahead of schedule, with topline data expected in the fourth quarter of 2025 [8] - Certepetide has received multiple designations, including Fast Track and Orphan Drug Designation for various cancers, indicating its potential significance in oncology [5] Clinical Trial Highlights - The ASCEND trial showed promising preliminary results, with a positive trend in overall survival for patients treated with certepetide in combination with standard chemotherapy [4][6] - The CENDIFOX trial demonstrated a 50% R0 resection rate and a 70% pathologic partial response in patients with pancreatic cancer, suggesting that certepetide may enhance the effectiveness of existing therapies [8][10] - The iLSTA trial provided compelling data supporting certepetide's ability to improve immunotherapy outcomes in patients with locally advanced non-resectable pancreatic cancer [8][10] Financial Performance - For Q3 2025, operating expenses decreased to $4.4 million from $5.3 million in Q3 2024, reflecting a 17.3% reduction [9][11] - Research and development expenses were approximately $2.0 million, down 22.9% from the previous year, primarily due to lower spending in certain areas [10] - The company reported a net loss of $4.2 million for Q3 2025, compared to $4.9 million in Q3 2024, indicating improved financial management [11][19]

Core Insights - Lisata Therapeutics has been awarded "Overall BioPharma Solution of the Year" for its innovative therapies targeting advanced solid tumors, marking the second consecutive year of recognition [1][4][5] - The company utilizes its proprietary CendR Platform technology to enhance the delivery and efficacy of anti-cancer drugs, addressing unmet medical needs in oncology [2][6] Company Achievements - Over the past year, Lisata has reported significant clinical trial results, including a 60.8% six-month progression-free survival rate in the ASCEND Phase 2b trial for metastatic pancreatic ductal adenocarcinoma, compared to 25% for placebo [3] - The iLSTA trial for locally advanced, non-resectable pancreatic cancer achieved a 60% overall response rate and a 100% disease control rate, showcasing the effectiveness of its therapies [3][8] Technology and Innovation - The CendR Platform allows for more effective tumor-targeted delivery of anti-cancer drugs by activating the CendR transport mechanism, which enhances the penetration of drugs into solid tumors [2][6] - Certepetide, an investigational drug developed by Lisata, is designed to improve the uptake of anti-cancer therapies and has received multiple designations, including Fast Track and Orphan Drug Designation for various cancers [7][8][9] Industry Context - The biotechnology sector is rapidly evolving, with innovations in gene therapies, precision medicine, and sustainable bio-manufacturing driving significant advancements in healthcare [4][5] - The BioTech Breakthrough Awards program highlights the importance of recognizing companies that contribute to transformative solutions in life sciences and biotechnology [5][10]

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Core Insights - Lisata Therapeutics highlighted positive preclinical data for certepetide, a proprietary cyclic peptide, presented by its licensing partner Catalent at the 16th Annual World ADC San Diego Conference, indicating improved tumor selective penetration and efficacy of antibody-drug conjugates (ADCs) [1][2] Company Overview - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [4] - The company has established significant commercial and R&D partnerships based on its CendR Platform technology [4] Product Details - Certepetide is designed to activate a novel uptake pathway, enhancing the targeting and penetration of anti-cancer drugs in solid tumors [3][4] - The investigational drug has shown favorable safety, tolerability, and clinical activity in trials aimed at enhancing standard chemotherapy for pancreatic cancer [3] - Certepetide has received multiple designations, including Fast Track and Orphan Drug Designation for pancreatic cancer, glioma, and osteosarcoma [3] Partnership and Strategy - The licensing partnership with Catalent aims to leverage certepetide's unique mechanism to enhance the therapeutic potential of ADCs [2] - Enhanced Conjugates, developed by Catalent, combine non-cytotoxic payloads like certepetide with cytotoxic agents to amplify efficacy while maintaining safety [2]

Core Insights - Lisata Therapeutics, Inc. is set to report its financial results for Q3 2025 on November 6, 2025, after market close, followed by a conference call at 4:30 p.m. Eastern time [1] Company Overview - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [3] - The company's lead product candidate, certepetide, is designed to enhance the delivery of anti-cancer drugs to solid tumors through a novel uptake pathway [3] - Lisata has established significant commercial and R&D partnerships based on its CendR Platform® technology [3] - The company anticipates announcing multiple milestones over the next 1.5 years and projects that its capital will support operations into Q1 2027, including data milestones from ongoing clinical trials [3]

Company Overview - Lisata Therapeutics is a clinical stage pharmaceutical company focused on developing innovative therapies for cancer and other serious diseases[8] - The company's mission is to rapidly develop and commercialize innovative treatments that improve outcomes for patients with cancer or other serious diseases[10] - Lisata has a proprietary field-leading technology with global IP protection extending beyond 2040[12] - The company projects multiple product and business milestones over the next 12 months[12] - Lisata has existing partnerships that validate its platform technology, with potential for many others[12] - The company's cash runway extends into 1Q 2027 with no debt[12] Certepetide Development and Clinical Trials - Certepetide is designed to optimize solid tumor treatment by converting tumor stroma, reducing immunosuppression, and inhibiting metastasis[23, 24] - In mPDAC, two Phase 1b/2a trials showed that Certepetide plus SoC chemotherapy improved overall survival[73] - In the ASCEND Phase 2b study, Cohort A showed a median overall survival of 12.68 months with Certepetide + SoC compared to 9.23 months with Standard of Care[87] - In the ASCEND Phase 2b study, Cohort B showed a median PFS of 7.46 months with Certepetide + SoC compared to 5.29 months with Standard of Care, nearing statistical significance (HR 0.61, p=0.09)[91, 92] - The iLSTA Phase 1b/2a trial in locally advanced PDAC with chemo & IO showed an Overall Response Rate of 69% in Cohort 3[110] Financial Position - As of June 30, 2025, Lisata had $22 million in cash and investments[140]

Summary of Lisada Therapeutics Conference Call Company Overview - **Company Name**: Lisada Therapeutics (NasdaqCM:LSTA) - **Industry**: Clinical stage pharmaceutical company focused on solid tumor cancer treatment - **Management Team**: Over 200 years of combined experience in drug development across big pharma and emerging companies [2][3] Core Points and Arguments - **Market Need**: Over 90% of newly diagnosed cancers are solid tumors, with a growing prevalence, particularly pancreatic cancer, which is projected to become the second leading cause of cancer death in the U.S. by the end of the decade [4] - **Product Development**: The company is developing **Sotepatide**, a proprietary cyclic peptide designed to penetrate tumor stroma and reduce immunosuppressive environments, enhancing the efficacy of various anticancer therapies [5][6] - **Intellectual Property**: Strong IP portfolio protecting products until 2040, with several strategic alliances and licenses established [3][9][8] - **Clinical Trials**: - Completed Phase 2B and is Phase 3 ready for metastatic pancreatic ductal adenocarcinoma (MPDAC) [12] - Significant improvement in overall survival by 5-6 months compared to standard care, representing a 150% improvement [14] - Cohort A and B data from trials show promising results in overall survival and progression-free survival (PFS) [18][20] - Positive preliminary data from the I LISTA study combining Sotepatide with chemotherapy and immunotherapy [23] Financial Position - **Cash Reserves**: Approximately $20 million available, with a cash runway extending into early 2027 [30] - **Debt-Free**: The company maintains a clean capital structure [30] Regulatory Status - **Designations**: Fast track designation in the U.S. for pancreatic cancer, orphan designations in both the U.S. and Europe, and rare pediatric disease designation for osteosarcoma [27] - **Phase 3 Protocol**: Approved by the FDA, with ongoing discussions with the EMA for global registration [28] Additional Insights - **Combination Therapy**: Sotepatide can be used with various anticancer modalities, showing improved efficacy without increasing safety risks [21][22] - **Future Studies**: Ongoing studies in other cancers, including cholangiocarcinoma and gastroesophageal adenocarcinoma, with data expected in the near future [29] - **Market Strategy**: Plans to raise capital for further development and potential licensing agreements to enhance product offerings [27] Conclusion Lisada Therapeutics is positioned strongly within the oncology market, with innovative therapies addressing significant unmet medical needs, a solid financial foundation, and a robust pipeline of clinical data supporting its product efficacy and safety. The company is actively pursuing strategic partnerships to enhance its market presence and therapeutic offerings [31]

Group 1 - Lisata Therapeutics will present a corporate overview at the LD Micro Main Event XIX Conference in San Diego from October 19-21, 2025 [1][3] - The presentation is scheduled for October 20th at 10:30 a.m. Pacific time, with opportunities for one-on-one meetings throughout the conference [2] - The LD Micro Main Event XIX will feature around 120 companies presenting and conducting private meetings with investors [3] Group 2 - Lisata Therapeutics is focused on developing innovative therapies for advanced solid tumors and other serious diseases, with its lead product candidate, certepetide, designed to enhance the targeting of anti-cancer drugs [4] - The company has established significant commercial and R&D partnerships based on its CendR Platform® technology and anticipates announcing multiple milestones over the next 1.5 years [4] - Lisata expects its projected capital to fund operations through the fourth quarter of 2026, including anticipated data milestones from ongoing and planned clinical trials [4]

Core Insights - Lisata Therapeutics Inc has entered a collaboration with Catalent to leverage its lead molecule, certepetide, across various cancer types and treatment modalities [1] Revenue Potential - The Catalent deal is described as having "unlimited revenue potential," particularly in the rapidly growing antibody-drug conjugate (ADC) class in oncology [2] - Major players in the industry are actively developing ADCs and seeking ways to enhance their efficacy [2] Partnership Details - The arrangement with Catalent is non-exclusive, allowing Lisata to partner with other companies in the ADC space [3] - This partnership introduces a new therapeutic modality, as certepetide has not been tested specifically with ADCs prior to this collaboration [4] Validation of Technology - The collaboration marks the first instance of a third party using a certepetide-related molecule conjugated to another molecule, validating the hypothesis of co-administration or conjugation benefits [5] Strategic Vision - The strategic vision for certepetide is to exploit its broad applicability across various cancers and treatment modalities, primarily through partnerships [6] - Collaborating with a well-established company like Catalent is seen as a significant advancement for Lisata, which recognizes its limitations as a small company [7] Future Partnerships - Lisata is actively seeking additional partnerships to further exploit the applicability of certepetide and is open to evaluating different transaction types [8]

Group 1 - Lisata Therapeutics has initiated a global product license agreement with Catalent, allowing Catalent to incorporate Lisata's certepetide into antibody-drug conjugates (ADCs) using its SMARTag technology platform [1][2] - The partnership is seen as a validation of certepetide's versatility and positions Lisata's technology within a leading ADC platform [1] - Catalent has acquired non-exclusive rights to develop and commercialize products utilizing certepetide and its analogs, highlighting the broad potential of certepetide [2]