Core Insights - Catalent has secured global rights to evaluate certepetide and its analogs for use as SMARTag payloads in antibody-drug conjugates (ADCs) targeting difficult-to-treat diseases [1][2] - The collaboration is based on positive preclinical results indicating the potential of certepetide to enhance tumor targeting and treatment outcomes [3][4] Company Overview - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on innovative therapies for advanced solid tumors and serious diseases, with its lead product candidate being certepetide [5][6] - Catalent, a leading global contract development and manufacturing organization, aims to develop and supply products that improve patient health [8] Licensing Agreement Details - Under the licensing agreement, Catalent gains worldwide, non-exclusive rights to develop and commercialize bioconjugate products containing certepetide, including partnerships with third parties [2] - Lisata is eligible for over $10 million in tiered milestone payments and revenue sharing from future sales and partnerships [2] Preclinical Study Insights - Preclinical studies have shown that incorporating iRGD peptides into ADCs may improve efficacy and pharmacokinetics, suggesting a novel payload class [4] - The collaboration will be highlighted at the upcoming World ADC conference in San Diego [3] Certepetide Mechanism and Designation - Certepetide is designed to activate a novel uptake pathway for anti-cancer drugs, enhancing their ability to target and penetrate solid tumors [6][7] - Certepetide has received multiple designations, including Fast Track and Orphan Drug Designation for various cancers [7]

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Core Insights - Lisata Therapeutics announced promising preliminary data from the Phase 1/2a CENDIFOX trial for its investigational drug certepetide, aimed at treating pancreatic ductal adenocarcinoma (PDAC) [1][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] - The company is exploring the potential of certepetide to enhance the effectiveness of various treatment modalities for solid tumors [6] Trial Details - The CENDIFOX trial is evaluating certepetide in combination with FOLFIRINOX-based therapies for pancreatic, colon, and appendiceal cancers [1][2] - The trial is led by Dr. Anup Kasi at The University of Kansas Cancer Center [1][8] Preliminary Data Highlights - Among 35 patients in the PDAC cohort, 10 completed pre-surgical therapy and were eligible for resection, achieving a 50% R0 resection rate and a 70% pathologic partial response rate [3][4] - The trial reported a 60% two-year overall survival rate and a 12-month median disease-free survival [3][4] - Enhanced immune cell infiltration and increased expression of immune markers were observed, indicating a potential shift from "immune-cold" to "immune-hot" tumors [3][4] Significance of Findings - The results suggest that certepetide may improve drug delivery and modulate the tumor microenvironment, offering a new treatment approach for pancreatic cancer [3][4] - The findings are particularly significant given the poor prognosis associated with pancreatic cancer, which has a five-year survival rate of only 13% [4]

Company Overview - Lisata Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [3] - The company's investigational drug, certepetide, is designed to enhance the targeting and penetration of anti-cancer drugs into solid tumors through a novel uptake pathway [3] Upcoming Presentation - David J. Mazzo, Ph.D., President and CEO of Lisata, will present a corporate overview at the H.C. Wainwright 27th Annual Global Investment Conference in New York City from September 8-10, 2025 [1] - The on-demand recording of Dr. Mazzo's presentation will be available starting September 5, 2025, at 7:00 a.m. Eastern Time [2] Future Expectations - Lisata anticipates announcing numerous milestones over the next 1.5 years and believes its projected capital will fund operations into the fourth quarter of 2026 [3] - The company has established significant commercial and R&D partnerships based on its CendR Platform technology [3]

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]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights into sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is committed to adopting technology to enhance its content creation and workflow processes [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all published content is edited and authored by humans [5]

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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