Financial Data and Key Metrics Changes - For Q3 2025, operating expenses totaled $4.4 million, a decrease of $0.9 million or 17.3% compared to $5.3 million in Q3 2024 [6] - Research and development expenses were approximately $2 million, down from $2.5 million in Q3 2024, representing a decrease of $0.6 million or 22.9% [7] - General and administrative expenses were approximately $2.5 million, compared to $2.8 million in Q3 2024, a decrease of $0.3 million or 12.1% [8] - Net losses for Q3 2025 were $4.2 million, compared to $4.9 million in Q3 2024 [8] - As of September 30, 2025, cash and cash equivalents were approximately $19 million, projected to support operations into Q1 2027 [9] Business Line Data and Key Metrics Changes - The company achieved several development milestones for sirtepotide, including positive preliminary results from multiple studies [4] - A strategic alliance was formed with GATC Health to utilize their AI Drug Discovery Platform for identifying product candidates [5] Market Data and Key Metrics Changes - The ASCEND trial, a phase 2b study, is evaluating sirtepotide in combination with standard chemotherapy for metastatic pancreatic cancer, with preliminary data showing a positive trend in overall survival [11][13] - The Bolster trial, a phase 2a study, completed enrollment ahead of schedule, with top-line data expected in Q4 2025 [16] - The Sendafox trial, a phase 1b/2a study, showed promising early survival data, including a 60% two-year overall survival rate in pancreatic cancer patients [18] Company Strategy and Development Direction - The company is focused on expanding its development pipeline for sirtepotide across various cancer types and exploring non-oncology applications [24] - A new patent for sirtepotide was issued, extending protection until March 2040, covering its chemical structures and applications [25] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging macro environment affecting small-cap biotech companies, impacting stock performance despite positive clinical results [28] - The company is actively seeking partnerships to fund future phase 3 trials, emphasizing the need for collaboration to minimize shareholder dilution [35] Other Important Information - The company has secured multiple special designations from the U.S. FDA and EMA for sirtepotide [10] - The iLISTA trial, evaluating sirtepotide in combination with immunotherapy, has completed enrollment, with final data expected in Q1 2026 [21][22] Q&A Session Summary Question: When should we expect the next phase 2b data cut for Sendafox? - The timeline is under the control of the investigator, and a precise estimate cannot be provided [26] Question: Can you provide an update on the GBM trial enrollment status? - Enrollment is approximately two-thirds complete, targeting 30 patients [27] Question: What does the cash flow runway to Q1 2027 include? - It covers all operating expenses and costs to support ongoing clinical trials, but does not include assumptions for a phase 3 trial for Sendafox [27] Question: Why has the stock not reacted positively to recent clinical data? - The company attributes this to a combination of negative market forces affecting small-cap biotech and limited trading activity among shareholders [28] Question: Is there a plan to pursue additional licensing opportunities? - The company is actively pursuing new licensing opportunities internally, leveraging existing partnerships [30] Question: What are the next steps following the final analysis of the Sendafox data? - The company plans to seek partners to help fund the phase 3 trial, as raising capital independently would be challenging in the current environment [34]

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Clinical Trial Results - Certepetide has shown a 41.5% overall response rate (ORR) across all doses in a Phase 1b/2a study for metastatic pancreatic ductal adenocarcinoma (mPDAC) patients[121]. - The median overall survival (mOS) for the certepetide-treated group in the ASCEND trial was 12.68 months, compared to 9.72 months for the placebo group[122]. - The median progression-free survival (mPFS) was 7.5 months for the certepetide-treated group in the ASCEND trial, compared to 4.7 months for the placebo group[122]. - Certepetide is currently being evaluated in multiple Phase 2 clinical studies globally for various solid tumor types[115]. - The ASCEND trial is a double-blind, randomized, placebo-controlled study evaluating two dosing regimens of certepetide in mPDAC patients[122]. - The drug has demonstrated favorable safety and tolerability profiles in ongoing clinical trials[119]. - Certepetide is designed to enhance the delivery of anti-cancer therapies by modifying the tumor microenvironment and improving drug penetration[120]. Financial Performance - The net loss for the three months ended September 30, 2025, was $4.2 million, an improvement from a net loss of $4.9 million in the same period in 2024[127]. - For the nine months ended September 30, 2025, revenue totaled $70 thousand, an increase from $0 for the same period in 2024[133]. - Net loss for the nine months ended September 30, 2025, was $13.6 million, an improvement from a net loss of $15.4 million in 2024[132]. Operating Expenses - Operating expenses decreased by $0.9 million or 17.3% to $4.4 million for the three months ended September 30, 2025, compared to $5.3 million for the same period in 2024[129]. - Operating expenses decreased by $2.3 million or 12.9%, totaling $15.2 million for the nine months ended September 30, 2025, compared to $17.5 million in 2024[134]. - General and administrative expenses were approximately $8.4 million for the nine months ended September 30, 2025, down $0.7 million or 7.6% from $9.1 million in 2024[135]. Research and Development Expenses - Research and development expenses were approximately $2.0 million for the three months ended September 30, 2025, a decrease of 22.9% from $2.5 million in the same period in 2024[130]. - Research and development expenses were approximately $6.8 million for the nine months ended September 30, 2025, a decrease of $1.6 million or 18.7% from $8.4 million in 2024[135]. Cash and Liquidity - Cash and cash equivalents as of September 30, 2025, were approximately $19.0 million, with working capital of approximately $17.0 million[139]. - Net cash used in operating activities was $12.7 million for the nine months ended September 30, 2025, compared to $14.8 million in 2024[140]. - Cash provided by investing activities totaled $15.1 million for the nine months ended September 30, 2025, primarily from net sales of marketable securities[143]. - The company expects to use existing cash balances and other means to meet short and long-term liquidity needs, including potential issuances of debt or equity securities[147]. - The company issued 197,980 shares of common stock under the ATM Agreement for net proceeds of $600,663 during the nine months ended September 30, 2025[148].

Company Overview - Lisata Therapeutics is a clinical stage pharmaceutical company focused on developing innovative therapies for cancer treatment, with a mission to improve patient outcomes [8][10]. - The company has a cash runway extending into Q1 2027 and operates with no debt, indicating strong financial health [15]. - Lisata's leadership team has extensive experience in global drug development, which is crucial for navigating the complexities of the pharmaceutical industry [12][18]. Product Development and Efficacy - Certepetide, a proprietary cyclic peptide, is designed to optimize solid tumor treatment by converting tumor stroma from a barrier to a conduit for anti-cancer drugs and selectively reducing immunosuppressive T cells [28][29]. - Certepetide improved median overall survival in metastatic pancreatic ductal adenocarcinoma (mPDAC) to 12.68 months compared to 9.23 months for standard of care (SoC) [92]. - In the ASCEND Phase 2b study, Certepetide demonstrated a median progression-free survival (PFS) of 7.46 months versus 5.29 months for SoC, nearing statistical significance (HR 0.61, p=0.09) [96]. - Certepetide showed a 55% improvement in overall survival compared to the historical control of gemcitabine plus nab-paclitaxel [77]. - Certepetide achieved a 45% objective response rate (CR + PR) in Cohort B compared to 19% in the placebo group [101]. - Certepetide demonstrated internal consistency across two Phase 1b/2a trials, supporting its efficacy in mPDAC [79]. - Certepetide demonstrated improved overall survival in metastatic pancreatic ductal adenocarcinoma (mPDAC) compared to standard of care, with median overall survival (mOS) of 10.32 months versus 9.23 months for the control group [107]. - In Cohort B, the median progression-free survival (mPFS) was 7.46 months for Certepetide compared to 5.29 months for placebo, with a hazard ratio (HR) of 0.61 and a p-value of 0.09 [107]. - The overall response rate (ORR) for Certepetide treated patients was 50.0%, significantly higher than the 21.1% for placebo, with 1 complete response observed in the Certepetide group [107]. - Certepetide was well tolerated, with adverse events (AEs) similar to those of standard of care, and the most common AEs included fatigue (73.85% in Cohort A) and nausea (53.85% in Cohort A) [105]. Clinical Trials and Studies - The ASCEND Phase 2b trial for first-line mPDAC has completed enrollment with 158 participants, testing gemcitabine/nab-paclitaxel with certepetide or placebo [189]. - The BOLSTER Phase 2a trial for cholangiocarcinoma has completed enrollment for both first-line and second-line cohorts, with a total of 69 participants [171]. - The CENDIFOX Phase 1b/2a trial for pancreatic, colon, and appendiceal cancers has completed enrollment with 50 participants [171]. - The ILSTA Phase 1b/2a trial for locally advanced, non-resectable PDAC has completed enrollment with 30 participants [171]. - The company is targeting mid-2026 for the final data from the BOLSTER trial, which is expected to be achieved 6 months early [175]. - The primary endpoints included Progression Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS) metrics [193]. - A Phase 1b/2a trial in China (CEND1-201) is evaluating the safety and preliminary efficacy of certepetide in 55 patients with mPDAC, with results expected to contribute to overall survival and disease control rates [193]. - The CENDIFOX trial aims to complete enrollment by Q4 2024, focusing on drug safety and overall response rates [197]. - The intervention arm of the Phase 2b study included 63 patients receiving two IV pushes of certepetide, while the control arm had 29 patients receiving placebo [191]. - The study design includes treatment on days 1, 8, and 15 every 28 days, allowing for consistent monitoring of patient responses [191]. - The trials are being conducted across approximately 30 sites, including locations in Australia and New Zealand [191]. - Preliminary data from the trials was presented at the 2023 ASCO Annual Meeting, indicating ongoing research and development efforts in the field [193]. Strategic Partnerships and Financials - Lisata has established partnerships with organizations such as Catalent, GATC Health Corp., and Qilu Pharmaceutical, which support the development and commercialization of Certepetide [32][34]. - The company is eligible to receive over $10 million in tiered development milestone payments from Catalent, along with revenue sharing on future sales [34]. - Certepetide has a robust intellectual property portfolio, including 25 granted patents and 26 pending patents, with market exclusivity of 7 to 10 years post-approval in the U.S. and EU [30]. - Lisata's strategic partnerships are expected to enhance the development of Certepetide and its combinations with other therapies, potentially leading to significant revenue growth [34]. - The company is exploring additional commercial partnership opportunities to expand the reach of Certepetide in various oncology applications [129]. - As of September 30, 2025, the company has $19.0 million in cash and investments, with no debt, providing a projected cash runway into 2027 [178]. - The company has 8.8 million common shares outstanding and 1.5 million options outstanding, with a weighted average exercise price of $40.52 for warrants [179]. Market Context and Future Outlook - The global cancer burden is projected to increase significantly, with an estimated 35 million new cases and 18.5 million deaths by 2050, highlighting the urgent need for effective cancer therapies [22][23]. - The company anticipates multiple product and business milestones over the next 12 months, indicating a proactive approach to market expansion [13]. - Certepetide's commercial prospects are bolstered by its applicability across various treatment lines for mPDAC, including first-line, second-line, and third-line therapies [123]. - Certepetide's development strategy includes rapid global registration and combination studies with various SoC regimens [71]. - The global Phase 3 trial design for Certepetide has been agreed upon with the FDA, targeting 657 patients and focusing on overall survival as the primary endpoint [134]. - Certepetide has received FDA Fast Track Designation and Orphan Drug Designations, enhancing its regulatory advantages and potential market access [130].

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]