BASKING RIDGE, N.J., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata, will provide a corporate overview in a pre-recorded, on-demand presentation at the H.C. Wainwright 27th Annual Global Investment Conference. The confe ...

Financial Data and Key Metrics Changes - For Q2 2025, revenue totaled $70,000 from a research license agreement with Catalent, compared to no revenue in Q2 2024 [9] - Operating expenses decreased to $4,900,000 in Q2 2025 from $5,500,000 in Q2 2024, a reduction of 10.6% [10] - Net losses were $4,700,000 for Q2 2025, down from $5,000,000 in Q2 2024, indicating progress in capital management [11] Business Line Data and Key Metrics Changes - Research and development expenses were approximately $2,300,000 in Q2 2025, down from $2,600,000 in Q2 2024, a decrease of 13.4% [10] - General and administrative expenses were approximately $2,700,000 in Q2 2025, compared to $2,900,000 in Q2 2024, a decrease of 8.1% [10] Market Data and Key Metrics Changes - The company anticipates a data-rich period in the next twelve months with several key milestones on the horizon [6] Company Strategy and Development Direction - The company is focused on developing its proprietary cyclic internalizing RGD peptide product candidate, certepatide, for advanced solid tumors and other difficult-to-treat diseases [12] - Recent collaborations include a research agreement with Catalent and a strategic alliance with GATC Health to enhance drug discovery [24][25] - The company has secured multiple special designations from both the FDA and EMA for certepatide [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of certepatide based on positive preliminary results from ongoing clinical trials [6][28] - The company is preparing for a Phase III trial based on FDA agreement on the protocol, with an expected enrollment of 650 to 900 patients [30] Other Important Information - The company has extended its patent protection for certepatide until March 2040, enhancing its intellectual property portfolio [25] - The company believes available funds will support current operations into 2026 [11] Q&A Session Summary Question: Insights on the ASCEND trial Phase III protocol - Management confirmed a tacit agreement with the FDA on the structure of an open-label Phase III trial, potentially including 650 to 900 patients [30] Question: Expectations on spending and runway extension - Management indicated that spending may see a modest decrease over time, depending on the initiation of the Phase III trial and results from ongoing trials [33] Question: Inclusion of future license revenues in projections - Management clarified that current projections only include a small contribution from the New Jersey sale of NOLs, with no anticipated capital raises included [36] Question: Changes in patent coverage - Management explained that the latest patent recognized specific intellectual property around the composition of matter of certepatide, securing the intellectual property portfolio [38] Question: Comparison of regulatory environments in the US and China - Management stated that it is difficult to compare the two regulatory environments due to the unique relationships Chinese companies have with their authorities [40]

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PART I - FINANCIAL INFORMATION [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Unaudited consolidated financial statements for H1 2025 show decreased assets, equity, and a reduced net loss [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to **$25.2 million**, with total equity declining to **$20.8 million** by June 30, 2025 Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $24,885 | $34,578 | | Cash and cash equivalents | $16,835 | $16,209 | | Marketable securities | $5,135 | $15,036 | | **Total Assets** | **$25,160** | **$35,002** | | **Total Current Liabilities** | $4,313 | $5,613 | | **Total Liabilities** | **$4,385** | **$5,685** | | **Total Equity** | **$20,775** | **$29,317** | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) Net loss decreased to **$4.7 million** in Q2 2025 and **$9.4 million** for H1 2025, driven by lower operating expenses Consolidated Statements of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $70 | $0 | $70 | $0 | | Research and development | $2,253 | $2,601 | $4,856 | $5,842 | | General and administrative | $2,685 | $2,922 | $5,930 | $6,282 | | Operating loss | $(4,868) | $(5,523) | $(10,716) | $(12,124) | | Net loss | $(4,659) | $(5,044) | $(9,383) | $(10,445) | | Basic and diluted loss per share | $(0.54) | $(0.61) | $(1.09) | $(1.26) | [Consolidated Statements of Cash Flows](index=11&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations decreased to **$9.4 million**, with cash and equivalents increasing by **$0.6 million** to **$16.8 million** Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,358) | $(12,310) | | Net cash provided by investing activities | $9,936 | $18,149 | | Net cash provided by (used in) financing activities | $41 | $(110) | | **Net increase in cash and cash equivalents** | **$626** | **$5,700** | | **Cash and cash equivalents at end of period** | **$16,835** | **$28,293** | [Notes to Unaudited Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) Notes detail certepetide development, liquidity, NJ tax loss sale, executive agreements, and a new patent - The company is a clinical-stage pharmaceutical firm focused on its investigational product, certepetide, designed to enhance the delivery of anti-cancer drugs to solid tumors[28](index=28&type=chunk) - As of June 30, 2025, the company had approximately **$22.0 million** in cash, cash equivalents, and marketable securities. Management believes this is sufficient to meet funding requirements for the next year but anticipates needing additional financing by the **fourth quarter of 2026**[30](index=30&type=chunk) - In January 2025, the company sold **$10.7 million** of its New Jersey net operating losses (NJ NOLs) for net proceeds of **$871 thousand**, resulting in a **$962 thousand** deferred income tax benefit[84](index=84&type=chunk) - On June 10, 2025, the company amended employment and separation agreements with key executives, including the CEO, CMO, and CAO, updating base salaries and severance terms[90](index=90&type=chunk)[92](index=92&type=chunk)[94](index=94&type=chunk) - Subsequent to the quarter end, on July 15, 2025, the company was issued a U.S. patent covering the composition of matter of certepetide, which will expire in **March 2040**[112](index=112&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses certepetide's clinical progress, reduced net loss from lower expenses, and future liquidity requirements [Overview](index=32&type=section&id=Overview) Overview details Lisata's lead drug, certepetide, its mechanism, and promising preliminary ASCEND trial data for pancreatic cancer - Certepetide is the company's lead investigational drug, designed to activate the CendR active transport mechanism, allowing co-administered anti-cancer drugs to better penetrate solid tumors[114](index=114&type=chunk)[117](index=117&type=chunk) - Preliminary data from Cohort B of the ASCEND trial showed a median Progression-Free Survival (mPFS) of **7.5 months** for the certepetide group versus **4.7 months** for the placebo group, and an Objective Response Rate (ORR) of **45.2%** versus **19%** for placebo[122](index=122&type=chunk) - Certepetide is currently being evaluated in multiple global Phase 2 clinical trials for various solid tumors, including metastatic pancreatic ductal adenocarcinoma (mPDAC), cholangiocarcinoma, and glioblastoma multiforme[114](index=114&type=chunk)[123](index=123&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) Comparative analysis shows decreased net loss for Q2 and H1 2025, driven by reduced R&D and G&A expenses Comparison of Results for the Three Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $70 | $0 | $70 | | Research and development | $2,253 | $2,601 | $(348) | | General and administrative | $2,685 | $2,922 | $(237) | | **Net loss** | **$(4,659)** | **$(5,044)** | **$385** | Comparison of Results for the Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $70 | $0 | $70 | | Research and development | $4,856 | $5,842 | $(986) | | General and administrative | $5,930 | $6,282 | $(352) | | **Net loss** | **$(9,383)** | **$(10,445)** | **$1,062** | - The decrease in R&D expenses for H1 2025 was primarily due to reduced CRO expenses, patient treatment costs for the Bolster trial, and lower spend on chemistry, manufacturing and controls (CMC)[134](index=134&type=chunk) [Analysis of Liquidity and Capital Resources](index=39&type=section&id=Analysis%20of%20Liquidity%20and%20Capital%20Resources) Lisata holds **$22.0 million** in liquid assets, sufficient for 12 months, but requires additional capital by late 2026, with ATM offering constrained - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities of approximately **$22.0 million** and working capital of **$20.6 million**[138](index=138&type=chunk) - Management believes current cash on hand is sufficient to fund operating expenses for at least the next **12 months**[146](index=146&type=chunk) - The company's ATM offering is subject to "Baby Shelf" limitations, restricting sales to **one-third** of its public float in any **12-month period**, which currently amounts to **$9.86 million**[147](index=147&type=chunk)[66](index=66&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company deems this item not applicable, indicating no significant exposure to market risks requiring disclosure - The company has determined that this disclosure is not applicable[151](index=151&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - Based on an evaluation as of June 30, 2025, the company's principal executive and financial officers concluded that disclosure controls and procedures were effective[153](index=153&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[154](index=154&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently a party to any material legal proceedings[156](index=156&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously reported in the company's 2024 Form 10-K - There have been no material changes to the risk factors previously reported in the company's 2024 Form 10-K[157](index=157&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=42&type=section&id=Other%20Items%20(Items%202,%203,%204,%205,%206)) This section covers no unregistered equity sales, defaults, mine safety disclosures, or Rule 10b5-1 trading plan changes by directors or officers - The company reported no unregistered sales of equity securities, defaults upon senior securities, or mine safety disclosures[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk) - During the three months ended June 30, 2025, no director or officer adopted, modified, or terminated a Rule 10b5-1 trading arrangement[160](index=160&type=chunk)

[Q2 2025 Business Update and Financial Results](index=1&type=section&id=Lisata%20Therapeutics%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Provides%20Business%20Update) Lisata Therapeutics reported Q2 2025 financial results, highlighting clinical development progress and a strong cash position [Management Commentary and Financial Outlook](index=1&type=section&id=Management%20Commentary%20and%20Financial%20Outlook) Management highlighted Q2 2025 clinical advancements and positive trial results, projecting cash into Q4 2026 - The company's core mission is to utilize its drug candidate, certepetide, across a range of advanced solid tumors and other difficult-to-treat diseases[3](index=3&type=chunk) - Positive preliminary results were recently announced from the ASCEND and iLSTA trials, with more data expected through the remainder of 2025 and into 2026[3](index=3&type=chunk) - The company's cash runway is projected to extend into Q4 2026, funding all current clinical programs to their next data milestone[1](index=1&type=chunk)[3](index=3&type=chunk) [Development Portfolio Highlights](index=1&type=section&id=Development%20Portfolio%20Highlights) The development portfolio focuses on certepetide, an investigational drug with regulatory designations, in global clinical trials, and patent-protected until 2040 - Certepetide is an investigational drug designed to activate a transport mechanism that helps co-administered anti-cancer agents better penetrate and accumulate in tumors[4](index=4&type=chunk) - Certepetide has received Fast Track and Orphan Drug designations for pancreatic cancer, and Orphan Drug designations for glioma, osteosarcoma, and cholangiocarcinoma in the U.S[5](index=5&type=chunk) - A new U.S. patent (No. 12,351,653) was issued for certepetide, extending its composition of matter patent protection until March 2040[7](index=7&type=chunk) [Clinical Trials Update](index=1&type=section&id=Clinical%20Trials%20Update) Certepetide clinical trials show positive preliminary data from ASCEND and iLSTA, with BOLSTER enrollment completed and CENDIFOX progressing - **ASCEND (mPDAC):** Preliminary data from Cohort B showed a positive signal in progression-free survival and objective response rate. Final data from both cohorts is expected later in 2025[5](index=5&type=chunk)[6](index=6&type=chunk) - **BOLSTER (Cholangiocarcinoma):** Completed enrollment for first-line CCA ahead of schedule, accelerating the anticipated topline data readout to Q4 2025. Enrollment in the second-line cohort was stopped at ~20 patients to accelerate data readout[8](index=8&type=chunk) - **iLSTA (PDAC):** Updated interim analyses presented at ESMO-GI Congress showed compelling preliminary data, reinforcing certepetide's potential to enhance immunotherapy effectiveness. Final data is anticipated in Q1 2026[8](index=8&type=chunk) - **CENDIFOX (Pancreatic, Colon, Appendiceal Cancers):** Enrollment is complete across all three cohorts, with data expected in the coming months[8](index=8&type=chunk) [Partnerships](index=2&type=section&id=Partnerships) Lisata advances development through partnerships with Catalent, GATC Health for AI, and Qilu Pharmaceutical, with a potential **$10 million** milestone - A research license with Catalent, Inc. is in place to preclinically evaluate certepetide in combination with Catalent's SMARTag ADC technology[7](index=7&type=chunk) - An expanded collaboration with GATC Health Corp aims to use an AI platform to optimize drug discovery, analyze certepetide for new indications, and identify combination therapies[7](index=7&type=chunk) - Partner Qilu Pharmaceutical completed enrollment in its Phase 2 trial in China for mPDAC. Progression to Phase 3 will trigger a **$10 million** milestone payment to Lisata[8](index=8&type=chunk) [Second Quarter 2025 Financial Highlights](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) Q2 2025 saw **$70 thousand** revenue, **$4.9 million** operating expenses, a **$4.7 million** net loss, and **$22.0 million** cash projected into Q4 2026 Q2 2025 Key Financial Metrics | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $70 thousand | $0 | +$70K | | Operating Expenses | $4.9 million | $5.5 million | -10.6% | | Net Loss | $4.7 million | $5.0 million | -6.0% | | Cash & Marketable Securities | $22.0 million | N/A | N/A | [Statement of Operations](index=3&type=section&id=Statement%20of%20Operations) Q2 2025 revenue was **$70 thousand**, operating expenses decreased **10.6%** to **$4.9 million**, resulting in a **$4.7 million** net loss Q2 2025 vs Q2 2024 Statement of Operations (in thousands, except per share data) | Line Item | Q2 2025 (unaudited) | Q2 2024 (unaudited) | | :--- | :--- | :--- | | Revenue | $70 | $— | | Research and development | $2,253 | $2,601 | | General and administrative | $2,685 | $2,922 | | **Total operating expenses** | **$4,938** | **$5,523** | | **Net loss** | **($4,659)** | **($5,044)** | | **Basic and diluted loss per share** | **($0.54)** | **($0.61)** | - The decrease in R&D expenses was primarily due to reduced patient treatment costs and CRO expenses for the Phase 2a BOLSTER trial and lower manufacturing spend[11](index=11&type=chunk) - The decrease in G&A expenses was mainly due to savings from an eliminated employee position and lower consulting and travel expenses[12](index=12&type=chunk) [Balance Sheet](index=3&type=section&id=Balance%20Sheet) As of June 30, 2025, Lisata reported **$22.0 million** cash, **$25.2 million** total assets, **$4.4 million** liabilities, and **$20.8 million** total equity Balance Sheet Highlights (in thousands) | Account | June 30, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $21,970 | $31,245 | | Total assets | $25,160 | $35,002 | | Total liabilities | $4,385 | $5,685 | | Total equity | $20,775 | $29,317 |

Core Viewpoint - Lisata Therapeutics, Inc. is set to report its financial results for Q2 2025 on August 7, 2025, and will host a conference call to discuss these results [1]. Group 1: Financial Reporting - The financial results for the second quarter ended June 30, 2025, will be announced after the close of trading on August 7, 2025 [1]. - A conference call will be held at 4:30 p.m. Eastern time on the same day to discuss the financial results [1]. Group 2: Conference Call Participation - Interested participants must register for the conference call via a provided link and will receive an email with dial-in options [2]. - Participants are encouraged to join the call 15 minutes early to avoid delays [2]. Group 3: Webcast Availability - A live webcast of the conference call will be available on Lisata's website and can be replayed for 12 months starting two hours after the call concludes [3]. Group 4: Company Overview - Lisata Therapeutics is focused on developing innovative therapies for advanced solid tumors and other serious diseases [4]. - The company's investigational drug, certepetide, aims to enhance the targeting and penetration of anti-cancer drugs in solid tumors [4]. - Lisata has established significant commercial and R&D partnerships based on its CendR Platform technology and anticipates announcing multiple milestones in the next 1.5 years [4]. - The company expects its capital to fund operations into Q4 2026, covering anticipated data milestones from ongoing and planned clinical trials [4].

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Core Insights - Lisata Therapeutics and WARPNINE have completed patient enrollment in the Phase 1b/2a iLSTA trial, evaluating certepetide in combination with standard-of-care chemotherapy and immunotherapy for locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC) [1][2] - The trial is significant as it targets an earlier stage of PDAC, where immunotherapy has been largely ineffective [2] - Preliminary data from the trial presented at ESMO-GI indicated a 60% overall response rate and a 100% overall disease control rate after four treatment cycles [3][4] Company Overview - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [7] - Certepetide, the company's proprietary product candidate, is designed to enhance the delivery of anti-cancer drugs to solid tumors and has shown favorable safety and clinical activity in trials [6][7] - The company has received multiple designations for certepetide, including Fast Track and Orphan Drug Designations for pancreatic cancer in the U.S. and E.U. [6] Trial Details - The iLSTA trial is randomized, single-blind, and conducted at St John of God Subiaco Hospital, a leading center for clinical research in Australia [2][3] - Participants were divided into three cohorts, with varying combinations of standard-of-care chemotherapy and immunotherapy [2] - The trial aims to assess the efficacy of certepetide in improving treatment outcomes for patients with locally advanced PDAC [2][4] Preliminary Data Highlights - After four treatment cycles, 13 out of 20 participants showed a partial response, and one participant exhibited a complete response [3] - 16 out of 20 participants experienced a decrease in CA19-9 levels, a tumor marker, with several showing significant reductions [3] - No participants showed an increase in tumor size, indicating a positive response to the treatment [3] Collaboration and Support - The collaboration between Lisata and WARPNINE combines global expertise with local clinical execution to address urgent needs in pancreatic cancer treatment [2] - AstraZeneca is involved in providing drug supply, enhancing the trial's operational capabilities [2] - The successful completion of patient enrollment reflects the commitment of both organizations to advance treatment options for patients with PDAC [4]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Points - Lisata Therapeutics has received a new composition of matter patent for certepetide, extending IP protection until March 2040, with potential for further extension [1][2] - The patent secures exclusive rights to certepetide, preventing others from manufacturing or selling the drug, thus significantly enhancing the company's IP portfolio [2][3] - The CEO of Lisata highlighted that this patent milestone boosts the value of certepetide and the company, delaying generic competition for nearly two decades and supporting commercialization efforts [3] Company Overview - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [5] - Certepetide is designed to enhance the delivery of anti-cancer drugs to solid tumors by activating a novel uptake pathway, showing promise in improving treatment efficacy [4][5] - The company has established significant partnerships and expects to announce multiple milestones in the next 1.5 years, with sufficient capital projected to fund operations into Q4 2026 [5]