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Core Viewpoint - The strategic alliance between Lisata Therapeutics and GATC Health aims to enhance drug development success rates by leveraging GATC's AI-powered Multiomics Advanced Technology® platform, with a focus on advancing a therapeutic for opioid use disorder into human clinical trials by early 2026 [1][3][4]. Company Overview - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and serious diseases, with a notable product candidate, certepetide, designed to improve targeting of solid tumors [8]. - GATC Health Corp. is a technology company that utilizes AI to transform drug discovery and development, with its MAT platform capable of simulating human biochemistry to create novel therapeutics and predict drug efficacy and safety [9][11]. Collaboration Details - The collaboration builds on previous work where GATC provided AI-derived analysis for Lisata's certepetide candidate, and under the expanded relationship, Lisata will utilize GATC's MAT platform to identify new combination therapies across various therapeutic areas [2][3]. - Lisata will lead the development of a non-opioid small molecule candidate for opioid use disorder, which has shown significant efficacy in preclinical studies by reducing fentanyl intake in animal models [3][12]. Financial and Strategic Implications - The partnership is expected to create substantial value for the pharmaceutical industry, with predictions suggesting AI technologies could generate $350 to $400 billion by the end of 2025, while also significantly shortening the drug discovery timeline [4]. - GATC will cover all R&D costs for its development assets, while Lisata will receive milestone fees and royalties from any successfully commercialized products, indicating a financially symbiotic relationship [7]. Technology Validation - GATC's MAT platform has demonstrated high predictive accuracy, with sensitivity at 86% and specificity at 91%, validated by the University of California, Irvine, positioning it to meet FDA requirements for new methodologies prioritizing human-relevant data [5][11].

Core Insights - Lisata Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases [1][3] - The company will present a corporate overview at the 2025 BIO International Convention in Boston, scheduled for June 17, 2025 [1][2] Company Overview - Lisata's lead product candidate, certepetide, is designed to activate a novel uptake pathway for more effective targeting and penetration of solid tumors by anti-cancer drugs [3] - The company has established significant commercial and R&D partnerships based on its CendR Platform technology [3] - Lisata anticipates announcing multiple milestones over the next 1.5 years and expects its capital to fund operations into Q3 2026, covering anticipated data milestones from ongoing and planned clinical trials [3]

Company Overview - Lisata Therapeutics is a clinical-stage therapeutics company developing a novel solid tumor targeting and penetration technology with tumor microenvironment (TME) modifying properties[7] - The company's mission is to enhance the treatment benefits of existing and emerging therapies for solid tumors without additional side effects[9] - Lisata has a cash runway extending into 3Q2026 with no debt, funding current clinical programs[11] Certepetide Technology and Partnerships - Certepetide is designed to optimize solid tumor treatment by converting tumor stroma, reducing TME immunosuppression, inhibiting metastasis, and working with any modality of anti-cancer therapeutics[23] - Lisata has existing partnerships with Qilu Pharmaceutical, Kuva Labs, and Valo Therapeutics, with potential for additional partnerships[25] - Qilu granted exclusive rights in China, Taiwan, Hong Kong and Macau, Lisata collected $15 million in milestones to date, with potential for additional $221 million in milestones plus royalties[27] Clinical Development and Regulatory Designations - Certepetide has FDA Fast Track Designation for pancreatic cancer, potentially eligible for Accelerated Approval, Priority Review and Rolling Review[93] - Certepetide has FDA Rare Pediatric Disease Designation for Osteosarcoma, eligible for Priority Review Voucher upon approval, vouchers have sold recently for $75-$100 million[94] - Lisata is pursuing rapid global registration in mPDAC, initially combined with gemcitabine/nab-paclitaxel standard-of-care (SoC)[67] Clinical Trial Data - Two Phase 1 clinical trials (CEND1-001 in Australia and CEND1-201 in China) demonstrate that certepetide plus SoC chemotherapy improves overall survival in metastatic PDAC[90] - ASCEND Phase 2 trial Cohort A data demonstrate positive trend in overall survival, including 4 complete responses observed in certepetide treatment group compared to none in placebo group[90] - In ASCEND Phase 2 trial Cohort A, the median overall survival was 1268 months for the Certepetide arm compared to 972 months for the Placebo arm[86]

Group 1 - Lisata Therapeutics held its Q1 2025 earnings conference call on May 8, 2025, to discuss financial results and provide a business update [1][3] - The management team present included John Menditto (VP of IR and Corporate Communications), Dr. David Mazzo (President and CEO), Dr. Kristen Buck (EVP of R&D and Chief Medical Officer), and James Nisco (SVP of Finance and Treasury and Chief Accounting Officer) [3][4] - A press release detailing the Q1 2025 financial results was issued shortly before the call, available on the company's website [4]

Financial Data and Key Metrics Changes - Operating expenses for Q1 2025 totaled $5.8 million, a decrease of $800,000 or 11.4% compared to $6.6 million in Q1 2024 [8] - Research and development expenses were approximately $2.6 million for Q1 2025, down from $3.2 million in Q1 2024, representing a decrease of $600,000 or 19.7% [9] - General and administrative expenses were about $3.2 million for Q1 2025, compared to $3.4 million in Q1 2024, a decrease of approximately $100,000 or 3.4% [9] - Net losses were $4.7 million for Q1 2025, compared to $5.4 million for Q1 2024 [9] - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities of approximately $25.8 million, expected to support operations into Q3 2026 [10] Business Line Data and Key Metrics Changes - The company is focused on the development of cerdepatide for advanced solid tumors and other difficult-to-treat diseases, with ongoing clinical trials showing promising preliminary results [6][11] - The ASCEND trial is evaluating cerdepatide in combination with standard care for metastatic pancreatic ductal adenocarcinoma, with preliminary results indicating a positive trend in overall survival [15] - The BOLTAR trial for cholangiocarcinoma has completed enrollment ahead of schedule, with a second cohort added for second-line treatment [16] Market Data and Key Metrics Changes - The company continues to face persistent market headwinds for small-cap healthcare companies but maintains strong momentum into 2025 [5] - The ASCEND trial data presented at the ASCO GI symposium reinforced the potential of cerdepatide and the overall development strategy [6] Company Strategy and Development Direction - The company aims to advance cerdepatide as a cornerstone treatment for advanced solid tumors, with several key milestones anticipated in the next 12 to 18 months [7] - Collaborations with other companies, such as Qilu Pharmaceutical and AstraZeneca, are being pursued to enhance the development of cerdepatide [18][22] - The company is exploring additional opportunities to advance its development strategy, including progressing cerdepatide into a global Phase III trial for pancreatic cancer [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the transformative potential of cerdepatide for patients and significant long-term value for shareholders [26] - The company is focused on prudent capital management and expense minimization while advancing its R&D activities [9][10] Other Important Information - The company has secured multiple special designations from both the FDA and EMA for cerdepatide, enhancing its regulatory position [12] - The company is actively exploring new strategic development opportunities across oncology and other therapeutic areas [22] Q&A Session Summary Question: Impact of capped enrollment in the BOLTAR trial on regulatory path - Management clarified that the BOLTAR trial is not powered to any specific endpoint, and the reduced enrollment will still allow for meaningful data analysis [30] Question: Depth of data analysis for ASCEND presentation - Management indicated that preliminary data will be presented, with definitive data expected at the ESMO GI conference in July [35] Question: Timeline for data from Qilu Pharmaceutical's study - Management noted that they have no control over Qilu's timelines but emphasized the importance of obtaining approval in China before other markets [39] Question: Potential partnerships in endometriosis field - Management stated that discussions are in early stages, with most potential partners currently focused on clinically ready assets [51] Question: Manufacturing capabilities for clinical trials - Management explained that big pharma typically does not function as contract manufacturers for other products unless they have signed deals [43]

Lisata Therapeutics (LSTA) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 Welcome to the Losada Therapeutics First Quarter twenty twenty five Financial Results and Business Update Conference Call. Currently, participants are in listen only mode. Following management's prepared remarks, we will hold a Q and A session. As a reminder, this call is being recorded today, Thursday, 05/08/2025. I will now turn the call over to John Mendito, Vice President of Investor Relations and Corporate Communications ...

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 and qualified news journalists who produce independent content [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 across various 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 recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Cautionary Note Regarding Forward-Looking Statements [Forward-Looking Statements Overview](index=3&type=section&id=Forward-Looking%20Statements%20Overview) The report contains forward-looking statements, which are predictions subject to inherent uncertainties and risks - Forward-looking statements are subject to uncertainties and known/unknown risks that could cause actual results to differ materially[7](index=7&type=chunk) - Key risk factors include the ability to obtain sufficient capital, build human resources, establish a market for products, navigate scientific/regulatory developments, secure intellectual property, realize benefits from licensing agreements, diversify the pipeline, complete clinical trials, and manage impacts from public health crises[9](index=9&type=chunk) - The company undertakes no obligation to update any forward-looking statements, except as required by law[10](index=10&type=chunk) Part I - Financial Information [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Unaudited consolidated financial statements for Lisata Therapeutics, Inc. and its subsidiaries are presented [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) | Metric (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------- | :------------- | :---------------- | | Cash and cash equivalents | $20,217 | $16,209 | | Marketable securities | $5,616 | $15,036 | | Total current assets | $28,617 | $34,578 | | Total assets | $28,981 | $35,002 | | Total current liabilities | $3,807 | $5,613 | | Total liabilities | $3,879 | $5,685 | | Total stockholders' equity | $25,356 | $29,571 | | Total equity | $25,102 | $29,317 | - Total assets decreased from **$35.0 million** at December 31, 2024, to **$29.0 million** at March 31, 2025[16](index=16&type=chunk) - Total current liabilities decreased from **$5.6 million** to **$3.8 million**, primarily due to reductions in accounts payable and accrued liabilities[16](index=16&type=chunk) [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) | Metric (in thousands, except per share) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Research and development | $2,602 | $3,241 | | General and administrative | $3,245 | $3,360 | | Total operating expenses | $5,847 | $6,601 | | Operating loss | $(5,847) | $(6,601) | | Net loss | $(4,724) | $(5,401) | | Basic and diluted loss per share | $(0.55) | $(0.65) | - Net loss decreased from **$5.4 million** in Q1 2024 to **$4.7 million** in Q1 2025, a **12.5% improvement**[19](index=19&type=chunk) - Operating expenses decreased by **$0.8 million** (**11.4%**) year-over-year, driven by lower R&D and G&A costs[19](index=19&type=chunk) [Consolidated Statements of Comprehensive Loss](index=8&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Net loss | $(4,724) | $(5,401) | | Total other comprehensive gain (loss) | $3 | $(62) | | Comprehensive loss attributable to Lisata Therapeutics, Inc. common stockholders | $(4,721) | $(5,463) | - Total other comprehensive gain (loss) improved from a loss of **$62 thousand** in Q1 2024 to a gain of **$3 thousand** in Q1 2025, primarily due to a positive foreign currency translation adjustment[21](index=21&type=chunk) [Consolidated Statements of Equity](index=9&type=section&id=Consolidated%20Statements%20of%20Equity) | Metric (in thousands, except shares) | March 31, 2025 | December 31, 2024 | | :----------------------------------- | :------------- | :---------------- | | Common Stock (Shares) | 8,621 | 8,410 | | Common Stock (Amount) | $9 | $8 | | Additional Paid-in Capital | $578,923 | $578,418 | | Accumulated Deficit | $(552,790) | $(548,066) | | Total Stockholders' Equity | $25,356 | $29,571 | - Total stockholders' equity decreased from **$29.6 million** at December 31, 2024, to **$25.4 million** at March 31, 2025, primarily due to the net loss[23](index=23&type=chunk) - The company issued **$211 thousand** in net proceeds from common stock issuances and **$8 thousand** from option exercises during Q1 2025[23](index=23&type=chunk) [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(5,402) | $(7,027) | | Net cash provided by investing activities | $9,431 | $6,436 | | Net cash used in financing activities | $(23) | $(142) | | Net increase (decrease) in cash and cash equivalents | $4,008 | $(788) | | Cash and cash equivalents at end of period | $20,217 | $21,805 | - Net cash used in operating activities decreased from **$7.0 million** in Q1 2024 to **$5.4 million** in Q1 2025[25](index=25&type=chunk) - Net cash provided by investing activities increased significantly to **$9.4 million** in Q1 2025, primarily from net sales of marketable securities[25](index=25&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) [Note 1 – Description of Business](index=11&type=section&id=Note%201%20%E2%80%93%20Description%20of%20Business) Lisata Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on innovative therapies for solid tumors - Lisata Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on innovative therapies for solid tumors and other major diseases[28](index=28&type=chunk) - Its investigational product, certepetide, activates a novel uptake pathway to enhance co-administered anti-cancer drug penetration into solid tumors and modifies the tumor microenvironment[28](index=28&type=chunk) - Certepetide is currently in several Phase 2 clinical studies globally for various solid tumor types, including metastatic pancreatic ductal adenocarcinoma (mPDAC), cholangiocarcinoma, appendiceal cancer, colon cancer, and glioblastoma multiforme[28](index=28&type=chunk) - The company has a history of net operating losses and negative cash flows, with **$25.8 million** in cash, cash equivalents, and marketable securities as of March 31, 2025, and believes it has sufficient cash for the next year but will need additional long-term financing[30](index=30&type=chunk) [Note 2 – Summary of Significant Accounting Policies](index=12&type=section&id=Note%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) Financial statements are prepared under U.S. GAAP, with the company operating as one R&D segment - The financial statements are prepared in accordance with U.S. GAAP for interim financial information and SEC Regulation S-X[31](index=31&type=chunk) - The company operates as one operating segment focused on the research and development of its investigational drug product[34](index=34&type=chunk) - All marketable securities are classified as available-for-sale and carried at estimated fair values, with unrealized gains/losses reported in accumulated other comprehensive income (loss)[40](index=40&type=chunk)[41](index=41&type=chunk) - Research and development expenses are expensed as incurred, and grants are accounted for as a deduction to related R&D expenses[47](index=47&type=chunk)[48](index=48&type=chunk) - The company recognized no revenue for the three months ended March 31, 2025, and 2024, and has not recognized any royalty revenue to date[52](index=52&type=chunk)[54](index=54&type=chunk) [Note 3 – Available-for-Sale Securities](index=15&type=section&id=Note%203%20%E2%80%93%20Available-for-Sale%20Securities) The fair value of available-for-sale securities decreased, with a shift towards money market funds | Security Type (in thousands) | March 31, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :--------------------------- | :-------------------------- | :----------------------------- | | Corporate debt securities | $10,295 | $16,021 | | Money market funds | $12,129 | $6,614 | | Agency bonds | $0 | $613 | | Treasury bills | $0 | $1,496 | | Municipal debt securities | $560 | $905 | | Total | $22,984 | $25,649 | - The total estimated fair value of available-for-sale securities decreased from **$25.6 million** at December 31, 2024, to **$23.0 million** at March 31, 2025[55](index=55&type=chunk) - There was a significant shift from corporate debt, agency bonds, and treasury bills to money market funds during the quarter[55](index=55&type=chunk) [Note 4 – Property and Equipment](index=17&type=section&id=Note%204%20%E2%80%93%20Property%20and%20Equipment) Net property and equipment remained stable, with minor depreciation expense for the quarter | Metric (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------- | :------------- | :---------------- | | Computer equipment | $617 | $589 | | Leasehold improvements | $72 | $72 | | Property and equipment, gross | $689 | $661 | | Accumulated depreciation | $(615) | $(589) | | Property and equipment, net | $74 | $72 | - Net property and equipment remained relatively stable at **$74 thousand** as of March 31, 2025, compared to **$72 thousand** at December 31, 2024[58](index=58&type=chunk) - Depreciation expense was **$26 thousand** for Q1 2025, a slight decrease from **$29 thousand** in Q1 2024[58](index=58&type=chunk) [Note 5 – Income (Loss) Per Share](index=17&type=section&id=Note%205%20%E2%80%93%20Income%20(Loss)%20Per%20Share) Due to net losses, no common stock equivalents were included in diluted loss per share calculations - Due to net losses, no common stock equivalents were utilized in the calculation of diluted loss per share as they were anti-dilutive[59](index=59&type=chunk) | Potentially Dilutive Securities (in thousands) | March 31, 2025 | March 31, 2024 | | :--------------------------------------------- | :------------- | :------------- | | Stock options | 1,529 | 1,454 | | Warrants | 1,497 | 1,422 | | Restricted stock units | 325 | 354 | [Note 6 – Fair Value Measurements](index=17&type=section&id=Note%206%20%E2%80%93%20Fair%20Value%20Measurements) Fair value measurements are classified into Level 1 (cash equivalents) and Level 2 (marketable securities) - The company classifies fair value measurements into Level 1 (quoted prices in active markets), Level 2 (observable inputs other than Level 1), and Level 3 (unobservable inputs)[60](index=60&type=chunk)[61](index=61&type=chunk) | Financial Assets (in thousands) | March 31, 2025 (Level 1) | March 31, 2025 (Level 2) | December 31, 2024 (Level 1) | December 31, 2024 (Level 2) | | :------------------------------ | :----------------------- | :----------------------- | :-------------------------- | :-------------------------- | | Cash equivalents | $17,368 | $0 | $10,613 | $0 | | Marketable securities | $0 | $5,616 | $0 | $15,036 | | Total | $17,368 | $5,616 | $10,613 | $15,036 | - Cash equivalents are primarily Level 1, while marketable securities are Level 2[63](index=63&type=chunk) [Note 7 – Accrued Liabilities](index=18&type=section&id=Note%207%20%E2%80%93%20Accrued%20Liabilities) Total accrued liabilities decreased by $1.1 million, mainly due to reduced employee-related costs | Accrued Liability (in thousands) | March 31, 2025 | December 31, 2024 | | :------------------------------- | :------------- | :---------------- | | Salaries, employee benefits, and related taxes | $1,532 | $2,640 | | Clinical and R&D related liabilities | $1,166 | $1,333 | | Accounting & tax consulting liabilities | $133 | $55 | | Operating lease liabilities — current | $92 | $137 | | Other | $282 | $164 | | Total | $3,205 | $4,329 | - Total accrued liabilities decreased by **$1.1 million** (**26%**) from December 31, 2024, to March 31, 2025, primarily due to a reduction in salaries, employee benefits, and related taxes[64](index=64&type=chunk) [Note 8 – Operating Leases](index=18&type=section&id=Note%208%20%E2%80%93%20Operating%20Leases) The company maintains an operating lease for one office, expiring in September 2025 - The company has an operating lease for one office expiring on September 30, 2025[65](index=65&type=chunk) | Lease Metric (in thousands) | March 31, 2025 | | :-------------------------- | :------------- | | Right-of-Use Assets | $93 | | Operating Lease Liabilities | $92 | | Weighted average remaining lease term | 0.50 years | | Weighted average discount rate | 9.625% | [Note 9 – Stockholders' Equity](index=19&type=section&id=Note%209%20%E2%80%93%20Stockholders'%20Equity) Total stockholders' equity decreased due to net loss, with some common stock issued under an ATM agreement - The company has an At The Market (ATM) Offering Agreement to sell up to **$50.0 million** in common stock, subject to a 'Baby Shelf Limitation' of one-third of its public float (**$9.9 million** currently)[69](index=69&type=chunk)[135](index=135&type=chunk) - During Q1 2025, **55,578 shares** were issued under the ATM Agreement for net proceeds of **$211,369**[69](index=69&type=chunk)[135](index=135&type=chunk) | Equity Instrument (in thousands) | Outstanding at March 31, 2025 | Outstanding at December 31, 2024 | | :------------------------------- | :---------------------------- | :------------------------------- | | Stock Options (Shares) | 1,529 | 1,441 | | Warrants (Shares) | 1,497 | 1,497 | | Restricted Stock Units (Shares) | 85 | 104 | - The company granted **111,400 stock options** and **215,550 restricted stock shares** during Q1 2025[71](index=71&type=chunk)[72](index=72&type=chunk) [Note 10 – Share-Based Compensation](index=22&type=section&id=Note%2010%20%E2%80%93%20Share-Based%20Compensation) Total share-based compensation expense increased year-over-year, with unrecognized costs remaining | Expense Category (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------ | :-------------------------------- | :-------------------------------- | | Research and development | $126 | $86 | | General and administrative | $404 | $368 | | Total share-based compensation expense | $530 | $454 | - Total share-based compensation expense increased by **$76 thousand** (**16.7%**) year-over-year[76](index=76&type=chunk) | Unrecognized Compensation Cost (in thousands) | Stock Options | Restricted Stock Units | Restricted Stock | | :-------------------------------------------- | :------------ | :--------------------- | :--------------- | | Unrecognized compensation cost | $393 | $251 | $925 | | Expected weighted-average period (years) | 2.21 | 0.75 | 2.32 | [Note 11 – Income Taxes](index=23&type=section&id=Note%2011%20%E2%80%93%20Income%20Taxes) The company has a full valuation allowance against deferred tax assets and sold New Jersey NOLs - The company has a full valuation allowance against its net deferred tax assets due to uncertainty regarding future utilization[79](index=79&type=chunk) - In January 2025, the company sold **$10.7 million** of New Jersey net operating losses (NJ NOLs) for net proceeds of **$871 thousand**, resulting in a **$962 thousand** deferred income tax benefit[88](index=88&type=chunk) - As of December 31, 2024, the company had **$57.9 million** in Federal NOLs, **$0.5 million** in federal R&D credit carryforwards, and **$0.1 million** in state R&D credit carryforwards[80](index=80&type=chunk)[83](index=83&type=chunk) [Note 12 – Segment Information](index=24&type=section&id=Note%2012%20%E2%80%93%20Segment%20Information) The company operates as a single R&D segment, with the CEO reviewing consolidated financial information - The company operates as one operating segment: the research and development of its investigational drug product[89](index=89&type=chunk) - The CEO, as the Chief Operating Decision Maker (CODM), reviews financial information on a consolidated basis, using net loss as a measure of profit/loss and assessing performance through clinical development goals[89](index=89&type=chunk) | Operating Expense (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $2,602 | $3,241 | | General and administrative | $3,245 | $3,360 | | Net loss | $(4,724) | $(5,401) | | Cash and marketable securities | $25,833 | $43,349 | [Note 13 – Australia Research and Development Tax Incentive](index=25&type=section&id=Note%2013%20%E2%80%93%20Australia%20Research%20and%20Development%20Tax%20Incentive) The Australian subsidiary is eligible for a refundable R&D tax incentive, with a receivable recorded - The company's Australian subsidiary is eligible for a refundable tax incentive (**43.5% to 48.5%**) for qualified R&D activities[92](index=92&type=chunk) - As of March 31, 2025, and December 31, 2024, the company had **$0.6 million** recorded as an income tax incentive receivable[92](index=92&type=chunk) [Note 14 – Contingencies](index=26&type=section&id=Note%2014%20%E2%80%93%20Contingencies) The company settled a litigation threat from Lingmed Limited in March 2024 for $0.5 million - The company settled a litigation threat from Lingmed Limited in March 2024, agreeing to pay **$0.5 million** and **5.0%** of future milestone payments under the Qilu Agreement, plus an additional **$250 thousand** for the first future milestone[94](index=94&type=chunk) - The legal action was dismissed with prejudice on April 9, 2024[94](index=94&type=chunk) [Note 15 – Technology Transfer Agreement](index=26&type=section&id=Note%2015%20%E2%80%93%20Technology%20Transfer%20Agreement) Rights to the TPN platform were transferred to Impilo Therapeutics, with the company owning 38.6% - In July 2023, the company transferred rights to its tumor penetrating nanocomplex (TPN) platform to Impilo Therapeutics, receiving **574,500 shares** of Impilo's pre-seed preferred stock[95](index=95&type=chunk) - The company purchased Simple Agreements for Future Equity (SAFE) from Impilo for **$100 thousand** in March 2024 and an additional **$30 thousand** in July 2024[96](index=96&type=chunk) - As of March 31, 2025, and December 31, 2024, the company owned **38.6%** of Impilo[96](index=96&type=chunk) [Note 16 – License Agreements](index=26&type=section&id=Note%2016%20%E2%80%93%20License%20Agreements) The company holds an exclusive worldwide license from SBP for certepetide, involving fees and royalties - The company holds an exclusive, worldwide, royalty-bearing license from Sanford Burnham Prebys (SBP) for certepetide-related patent rights and know-how[97](index=97&type=chunk) - Consideration for the SBP license includes annual maintenance fees, potential milestone payments up to **$10.6 million**, **4%** royalties on net sales, and **25%** of sublicensing income[97](index=97&type=chunk) [Note 17 – Research Collaboration and License Agreements](index=27&type=section&id=Note%2017%20%E2%80%93%20Research%20Collaboration%20and%20License%20Agreements) Exclusive license agreements for certepetide are in place with Qilu Pharmaceutical and Kuva Labs - The company has an exclusive license and collaboration agreement with Qilu Pharmaceutical for certepetide development and commercialization in Greater China, with potential milestone payments up to **$96.0 million** (development) and **$125.0 million** (commercial), plus tiered royalties (**10-15%**) and sublicensing revenues (**12-35%**)[101](index=101&type=chunk) - An exclusive license and collaboration agreement was granted to Kuva Labs, Inc. in November 2024 for certepetide with Kuva's NanoMark™ imaging technology, with potential milestone payments up to **$1.5 million** (development) and **$17.5 million** (commercial), **5.0%** royalty on net sales, and **50%** sublicensing revenues[104](index=104&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operations, business overview, clinical progress, and liquidity outlook [Overview](index=28&type=section&id=Overview) Lisata Therapeutics is a clinical-stage pharmaceutical company developing innovative therapies for solid tumors - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for solid tumors, with certepetide as its primary investigational product[106](index=106&type=chunk) - Certepetide is designed to enhance the penetration of anti-cancer drugs into solid tumors and modify the tumor microenvironment, making tumors more susceptible to immunotherapies[106](index=106&type=chunk) - The company's goal is to develop and commercialize products addressing unmet medical needs, leveraging its leadership team's extensive biopharmaceutical development experience[107](index=107&type=chunk) [Targeted Solid Tumor Penetration via CendR Active Transport](index=28&type=section&id=Targeted%20Solid%20Tumor%20Penetration%20via%20CendR%20Active%20Transport) Certepetide activates the CendR active transport mechanism to enhance anti-cancer drug penetration into solid tumors - Solid tumors like PDAC and cholangiocarcinoma are often hindered by dense fibrotic tissue (tumor stroma) and an immunosuppressive tumor microenvironment (TME), limiting therapy efficacy[108](index=108&type=chunk) - Certepetide activates the C-end rule (CendR) active transport mechanism in a tumor-specific manner, enabling more selective and efficient uptake of systemically administered anti-cancer drugs[109](index=109&type=chunk) - Co-administration of certepetide with anti-cancer therapies is the initial approach, offering a faster path to market compared to creating new chemical entities (NCEs)[109](index=109&type=chunk) [Certepetide as a treatment for solid tumor cancers in combination with other anti-cancer agents](index=29&type=section&id=Certepetide%20as%20a%20treatment%20for%20solid%20tumor%20cancers%20in%20combination%20with%20other%20anti-cancer%20agents) Certepetide modifies the tumor microenvironment and shows promising efficacy in clinical trials for solid tumors - Certepetide modifies the TME, making it less immunosuppressive and inhibiting the metastatic cascade, by targeting integrins and neuropilin-1 upregulated in solid tumors[112](index=112&type=chunk) - In a Phase 1b/2a trial for first-line mPDAC, certepetide combined with standard-of-care chemotherapy showed an Objective Response Rate (ORR) of **59%** and a Disease Control Rate (DCR) of over **79%**, significantly higher than the MPACT trial's **23%** ORR and **48%** DCR[113](index=113&type=chunk) - Preliminary data from Cohort A of the ASCEND trial in mPDAC showed a median overall survival (mOS) of **12.68 months** for the certepetide group versus **9.72 months** for placebo, with **6.2%** complete responses in the certepetide group[115](index=115&type=chunk) [Additional Out-licensing Opportunities](index=30&type=section&id=Additional%20Out-licensing%20Opportunities) The company's intellectual property portfolio includes programs available for out-licensing and partnering - The company's intellectual property portfolio includes programs available for out-licensing and/or partnering to augment or continue clinical development[119](index=119&type=chunk) - The long-term strategy focuses on advancing therapies through development to obtain market authorizations and commercialization, either alone or with partners[119](index=119&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) Net losses improved by $0.7 million, driven by decreased operating expenses year-over-year | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change ($) | Change (%) | | :-------------------- | :-------------------------------- | :-------------------------------- | :--------- | :--------- | | Research and development | $2,602 | $3,241 | $(639) | -19.7% | | General and administrative | $3,245 | $3,360 | $(115) | -3.4% | | Total operating expenses | $5,847 | $6,601 | $(754) | -11.4% | | Net loss | $(4,724) | $(5,401) | $677 | -12.5% | - Net losses improved by **$0.7 million**, from **$5.4 million** in Q1 2024 to **$4.7 million** in Q1 2025[120](index=120&type=chunk) [Operating Expenses](index=32&type=section&id=Operating%20Expenses) Total operating expenses decreased by $0.8 million, primarily due to reduced R&D and G&A costs - Total operating expenses decreased by **$0.8 million** (**11.4%**) to **$5.8 million** in Q1 2025[121](index=121&type=chunk) - Research and development expenses decreased by **$0.6 million** (**19.7%**) due to reduced CRO and site expenses for the Bolster trial and lower spend on chemistry, manufacturing, and controls (CMC)[123](index=123&type=chunk) - General and administrative expenses decreased by **$0.1 million** (**3.4%**) due to one-off settlement costs in the prior year, partially offset by increased consulting and severance costs in the current year[123](index=123&type=chunk) [Other Income (Expense)](index=32&type=section&id=Other%20Income%20(Expense)) Other income is mainly from investment income, offset by losses on sales of New Jersey NOLs - Total other income is primarily derived from investment income from cash, cash equivalents, and marketable securities, and losses on sales of New Jersey net operating losses[122](index=122&type=chunk) [Income Tax Benefit](index=32&type=section&id=Income%20Tax%20Benefit) The company recognized an income tax benefit from the sale of New Jersey net operating losses - In January 2025, the company received final approval to sell **$10.7 million** of NJ NOLs for net proceeds of **$0.9 million**, resulting in a **$1.0 million** income tax benefit and a **$0.1 million** loss on sale[123](index=123&type=chunk)[124](index=124&type=chunk) - In March 2024, the company sold NJ NOLs for net proceeds of **$0.7 million**, resulting in a **$0.8 million** income tax benefit and a **$0.1 million** loss on sale[125](index=125&type=chunk) [Analysis of Liquidity and Capital Resources](index=34&type=section&id=Analysis%20of%20Liquidity%20and%20Capital%20Resources) Cash and marketable securities are sufficient for the next 12 months, with future capital needs dependent on financing | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(5,402) | $(7,027) | | Net cash provided by investing activities | $9,431 | $6,436 | | Net cash used in financing activities | $(23) | $(142) | - As of March 31, 2025, the company had **$25.8 million** in cash, cash equivalents, and marketable securities, with working capital of **$24.8 million**[126](index=126&type=chunk) - Net cash used in operating activities decreased by **$1.6 million** year-over-year, while net cash provided by investing activities increased by **$3.0 million**, primarily from marketable securities sales[128](index=128&type=chunk)[130](index=130&type=chunk) - The company believes its current cash and marketable securities are sufficient to fund operating expenses for at least the next 12 months[134](index=134&type=chunk) - Future capital requirements will depend on strategic transactions, collaboration partnerships, and the ability to raise additional financing through debt, equity, or asset sales[134](index=134&type=chunk) [Off-Balance Sheet Arrangements](index=35&type=section&id=Off-Balance%20Sheet%20Arrangements) The company does not have any off-balance sheet arrangements to report - The company does not have any off-balance sheet arrangements[137](index=137&type=chunk) [Critical Accounting Policies and Estimates](index=35&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) No material changes occurred in critical accounting policies and estimates during the quarter - There have been no material changes in critical accounting policies and estimates during the three months ended March 31, 2025, compared to those reported in the 2024 Form 10-K[138](index=138&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) There are no applicable quantitative and qualitative disclosures about market risk for the company - The company has no applicable quantitative and qualitative disclosures about market risk[139](index=139&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective, with no material changes in internal control over financial reporting [Disclosure Controls and Procedures](index=35&type=section&id=Disclosure%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective - As of March 31, 2025, management, including the CEO and SVP of Finance, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[141](index=141&type=chunk)[142](index=142&type=chunk) - Disclosure controls are designed to ensure information required for SEC reports is recorded, processed, summarized, and reported timely, and communicated to management for disclosure decisions[140](index=140&type=chunk) [Changes in Internal Control over Financial Reporting](index=36&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes occurred in internal control over financial reporting during the quarter - There were no changes in internal control over financial reporting during the quarter ended March 31, 2025, that materially affected or are reasonably likely to materially affect internal control over financial reporting[143](index=143&type=chunk) Part II - Other Information [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[145](index=145&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously reported in the 2024 Form 10-K - No material changes to the risk factors previously reported in the 2024 Form 10-K[146](index=146&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported during the period - None to report for unregistered sales of equity securities and use of proceeds[146](index=146&type=chunk) [Item 3. Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the period - None to report for defaults upon senior securities[147](index=147&type=chunk) [Item 4. Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[148](index=148&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20Other%20Information) No director or officer adopted, modified, or terminated trading arrangements during the quarter - No director or officer adopted, modified, or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended March 31, 2025[149](index=149&type=chunk) [Item 6. Exhibits](index=37&type=section&id=Item%206.%20Exhibits) The Exhibit Index, including certifications and XBRL documents, is incorporated by reference - The Exhibit Index, including certifications and XBRL documents, is incorporated by reference[150](index=150&type=chunk)[155](index=155&type=chunk)

[Company Overview](index=3&type=section&id=Company%20Overview) This section provides an overview of Lisata Therapeutics, including its core focus, key strengths, and leadership team [Lisata at a Glance](index=3&type=section&id=Lisata%20at%20a%20Glance) Lisata Therapeutics (Nasdaq: LSTA) is a clinical-stage company developing certepetide, a novel technology designed to improve the treatment of solid tumors by enhancing the penetration and effectiveness of anti-cancer therapies - Lisata is a clinical-stage company focused on a novel solid tumor targeting and penetration technology that modifies the tumor microenvironment (TME)[8](index=8&type=chunk) - The company's mission is to improve the efficacy of existing and new solid tumor therapies without adding side effects, using a patient-friendly and cost-effective approach[10](index=10&type=chunk) - Key attributes include experienced management, proprietary technology with global IP protection beyond 2040, and multiple milestones expected in the next 12-18 months[12](index=12&type=chunk)[13](index=13&type=chunk) - The company has a cash runway extending into Q3 2026 with no debt, sufficient to fund its current clinical programs[15](index=15&type=chunk) [Leadership](index=6&type=section&id=Leadership) The company is led by a seasoned management team with a proven track record of successful drug approvals worldwide - President and CEO, David J. Mazzo, PhD, is a global pharmaceutical executive with over 40 years of experience in developing and launching new products[18](index=18&type=chunk) - EVP of R&D and Chief Medical Officer, Kristen K. Buck, MD, is a board-certified physician with over 20 years of experience in strategic global drug development, safety, and FDA interactions[18](index=18&type=chunk) [Therapeutic Focus and Rationale](index=7&type=section&id=Therapeutic%20Focus%20and%20Rationale) This section details the significant unmet need in solid tumor treatment and introduces certepetide as a novel solution to overcome these challenges [The Unmet Need in Solid Tumors](index=8&type=section&id=The%20Unmet%20Need%20in%20Solid%20Tumors) There is a significant and growing global need for improved solid tumor treatments, as cancer incidence is projected to rise substantially by 2050 Projected Worldwide Cancer Incidence | Year | New Cases | Deaths | | :--- | :--- | :--- | | 2022 | 20 million | 10 million | | 2050 (Projected) | 35 million | 18.5 million | - Solid tumors account for more than **90%** of all diagnosed cancers[23](index=23&type=chunk) - The tumor stroma acts as a physical barrier, and the immunosuppressive TME contributes to tumor resistance, hindering the efficacy of anti-cancer therapies[27](index=27&type=chunk) [Certepetide as a Solution](index=10&type=section&id=Certepetide%20as%20a%20Solution) Certepetide is a proprietary iRGD cyclic peptide designed to overcome the challenges of solid tumor treatment - Certepetide is a proprietary internalizing RGD (iRGD) cyclic peptide with tumor-specific targeting and penetration activity[28](index=28&type=chunk) - It functions by converting tumor stroma into a conduit for drugs, reducing immunosuppressive T cells, recruiting cytotoxic T cells, and inhibiting the metastatic cascade[29](index=29&type=chunk) - The drug is approaching Phase 3 readiness in metastatic pancreatic ductal adenocarcinoma (mPDAC) and is compatible with any modality of anti-cancer therapeutic via co-administration[29](index=29&type=chunk) [Partnerships](index=11&type=section&id=Partnerships) Lisata has established several strategic partnerships that validate its technology and provide non-dilutive funding and resources Key Strategic Partnerships | Partner | Agreement Details | | :--- | :--- | | **Qilu Pharmaceutical** | Exclusive rights in Greater China. Lisata has received **$15 million** in milestones and is eligible for an additional **$221 million** plus royalties. Qilu covers all costs in its territories | | **Kuva Labs** | Exclusive worldwide rights for diagnostic tumor imaging. Lisata received a **$1 million** upfront fee and is eligible for **~$20 million** in milestones plus royalties | | **Catalent, Inc.** | Preclinical evaluation of certepetide with Catalent's SMARTag® ADC platform. Catalent assumes R&D costs | | **Valo Therapeutics** | Preclinical investigation combining certepetide with Valo's oncolytic adenovirus platform for melanoma treatment | - The company has R&D alliances with clinical trialist consortiums like the Australasian Gastro-Intestinal Trials Group (AGITG) and the WARPNINE foundation[33](index=33&type=chunk) [Certepetide Scientific Foundation](index=13&type=section&id=Certepetide%20Scientific%20Foundation) This section elucidates the detailed mechanism of action of certepetide, supported by extensive preclinical evidence, and outlines the company's strategic development approach [Mechanism of Action (MOA)](index=14&type=section&id=Mechanism%20of%20Action%20%28MOA%29) Certepetide utilizes a unique, multi-step mechanism to enhance drug delivery to tumors - **Step 1: Integrin Binding:** Certepetide, a 9-amino acid cyclic peptide, binds with high specificity to ανβ3 and/or ανβ5 integrins upregulated on tumor cells[37](index=37&type=chunk) - **Step 2 & 3: Cleavage and NRP-1 Binding:** The bound peptide is cleaved in the TME, creating a CendR fragment that binds to the adjacent Neuropilin-1 (NRP-1) receptor[37](index=37&type=chunk)[38](index=38&type=chunk) - **Step 4: Tumor Penetration:** This binding activates the CendR active transport pathway, which encapsulates and ferries circulating anti-cancer drugs into the tumor[38](index=38&type=chunk)[40](index=40&type=chunk) [Preclinical Evidence](index=15&type=section&id=Preclinical%20Evidence) Extensive preclinical data from over 370 scientific publications consistently demonstrate certepetide's ability to enhance the efficacy of various anti-cancer treatments - Whole-body imaging in mouse models demonstrates that certepetide selectively promotes the accumulation of co-administered agents within tumor tissue[43](index=43&type=chunk)[45](index=45&type=chunk) - Numerous preclinical studies have shown improved survival when certepetide is combined with various therapies, including gemcitabine in lung cancer, nab-paclitaxel in breast cancer, and irinotecan nanoparticles in pancreatic cancer[49](index=49&type=chunk)[51](index=51&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk) - In a cholangiocarcinoma mouse model, certepetide combined with standard-of-care chemo- and immunotherapy improved survival, reduced morbidity, and inhibited metastasis[67](index=67&type=chunk) - Certepetide enhances the selective tumor penetration of monoclonal antibodies, as demonstrated with trastuzumab in a human breast tumor mouse model, leading to greater tumor shrinkage[69](index=69&type=chunk)[70](index=70&type=chunk) [Development Strategy](index=20&type=section&id=Development%20Strategy) Lisata employs a two-pillar development strategy for certepetide - **Pillar 1:** Pursue rapid global registration in mPDAC, initially combined with the gemcitabine/nab-paclitaxel standard-of-care, with Phase 3 preparation underway[72](index=72&type=chunk)[73](index=73&type=chunk) - **Pillar 2:** Demonstrate certepetide's effectiveness across a variety of solid tumors and treatment regimens (chemotherapy, immunotherapy, etc.) through multiple ongoing Phase 2a studies[72](index=72&type=chunk) [Certepetide Clinical Development](index=21&type=section&id=Certepetide%20Clinical%20Development) This section presents the clinical data for certepetide in metastatic pancreatic ductal adenocarcinoma and other solid tumors, outlining the path forward and regulatory designations [Clinical Data in mPDAC](index=21&type=section&id=Clinical%20Data%20in%20mPDAC) Clinical data for certepetide in metastatic pancreatic ductal adenocarcinoma (mPDAC) is promising Phase 1 Median Overall Survival (mOS) in mPDAC | Trial | Treatment | mOS (Months) | Improvement vs. SoC | | :--- | :--- | :--- | :--- | | Von Hoff 2013 (SoC) | Gemcitabine + Nab-paclitaxel | 8.5 | - | | CEND1-001 (Australia) | SoC + Certepetide | 13.2 | 55% | | CEND1-201 (China) | SoC + Certepetide | 11.1 | 31% | ASCEND Phase 2b (Cohort A) Preliminary Overall Survival | Treatment Arm | N | Median OS (Months) | | :--- | :--- | :--- | | Certepetide | 66 | 12.68 | | Placebo | 29 | 9.72 | - In the ASCEND trial's Cohort A, the primary endpoint of Progression-Free Survival (PFS) was not met (HR: 0.94, p=0.79)[83](index=83&type=chunk)[84](index=84&type=chunk) - A key finding from ASCEND Cohort A was the observation of **4 complete responses** in the certepetide arm, compared to **0 complete responses** in the placebo arm[90](index=90&type=chunk) [Clinical Data in Other Solid Tumors](index=23&type=section&id=Clinical%20Data%20in%20Other%20Solid%20Tumors) Certepetide has shown remarkable activity in other solid tumors beyond pancreatic cancer - A patient with metastatic gastroesophageal adenocarcinoma (mGEAC) achieved a sustained complete response for over **31 months** after certepetide was added to his treatment regimen, following a partial response to standard of care[80](index=80&type=chunk) [Clinical Data Summary & Path Forward](index=27&type=section&id=Clinical%20Data%20Summary%20%26%20Path%20Forward) To date, certepetide has demonstrated a favorable safety profile with no dose-limiting toxicities and has shown improved overall survival in mPDAC across multiple trials - Certepetide has been well tolerated in clinical trials, with no dose-limiting toxicity observed[92](index=92&type=chunk) - Final, definitive data from the ASCEND Phase 2 trial's Cohort B are expected by mid-2025[92](index=92&type=chunk) - Preparations for a Phase 3 trial are currently underway[92](index=92&type=chunk) [Regulatory Designations & Development Portfolio](index=28&type=section&id=Regulatory%20Designations%20%26%20Development%20Portfolio) Certepetide has secured several valuable regulatory designations from the FDA and EMA, including Fast Track for pancreatic cancer and multiple Orphan Drug Designations - Certepetide has received FDA Fast Track Designation for pancreatic cancer, enabling more frequent communication with the FDA and eligibility for accelerated approval[94](index=94&type=chunk)[95](index=95&type=chunk) - The drug has been granted Orphan Drug Designations for pancreatic cancer (FDA & EMA), malignant glioma (FDA), osteosarcoma (FDA), and cholangiocarcinoma (FDA), providing tax credits, fee waivers, and marketing exclusivity[94](index=94&type=chunk)[95](index=95&type=chunk) Certepetide Clinical Development Pipeline Overview | Trial Name | Indication | Phase | Status | | :--- | :--- | :--- | :--- | | ASCEND | First-line mPDAC | 2b | Enrollment complete | | BOLSTER | Cholangiocarcinoma | 2a | Enrollment complete | | CENDIFOX | Pancreatic, Colon, Appendiceal | 1b/2a | Enrollment complete | | Qilu Trial | First-line mPDAC (China) | 1b/2a | Enrollment complete | | iLSTA | Locally advanced PDAC | 1b/2a | Enrolling | | Tartu Univ. Trial | Glioblastoma (GBM) | 2a | Enrolling | | Qilu Trial | First-line mPDAC (China) | 2 | Enrollment complete | | FORTIFIDE | First-line mPDAC | 1b/2a | Enrollment pending | [Clinical Development Milestones](index=32&type=section&id=Clinical%20Development%20Milestones) Lisata has a rich pipeline of anticipated clinical milestones over the next 18 months - **ASCEND (mPDAC):** Final Progression-Free Survival (PFS) and Overall Survival (OS) data for both Cohort A and B are anticipated in Q2 2025[101](index=101&type=chunk) - **BOLSTER (Cholangiocarcinoma):** Second-line OS data is expected in Q2 2025, with first-line OS data targeted for mid-2026[101](index=101&type=chunk) - **Qilu Phase 1b/2a (mPDAC in China):** Final data from this trial is expected in Q2 2025[101](index=101&type=chunk) - **iLSTA (Locally Advanced PDAC):** Last patient in (LPI) is targeted for Q2 2025, with final 6-month PFS/OS data expected in Q4 2025[101](index=101&type=chunk) [Financial Highlights](index=34&type=section&id=Financial%20Highlights) As of March 31, 2025, Lisata Therapeutics is in a strong financial position with **$25.8 million** in cash and investments and no debt Financial Snapshot (as of 3/31/2025) | Metric | Value | | :--- | :--- | | Cash & Investments | **$25.8 million** | | Debt | **$0** | | Projected Cash Runway | Into 3Q 2026 | | Common Shares Outstanding | **8.6 million** | | Options Outstanding | **1.5 million** | | Warrants Outstanding | **1.5 million** | [Investment Summary](index=36&type=section&id=Investment%20Summary) The investment thesis for Lisata Therapeutics is built on several key pillars: a seasoned management team, a validated platform technology, robust global intellectual property, significant clinical milestones, and a strong capital position - **People:** Led by a seasoned management team with extensive international drug development and approval experience[106](index=106&type=chunk) - **Partnering:** The platform technology is validated by existing partnerships, with potential for many more[106](index=106&type=chunk) - **Intellectual Property:** Possesses proprietary, field-leading technology with global IP protection extending beyond 2040[106](index=106&type=chunk) - **Milestones:** Multiple product and business milestones are projected over the next 12-18 months[106](index=106&type=chunk) - **Capital:** Strong financial position with **$25.8 million** in cash, no debt, and funding to support the advancement of current clinical programs[106](index=106&type=chunk) [Appendix: Clinical Trial Details](index=38&type=section&id=Appendix%3A%20Clinical%20Trial%20Details) This appendix provides detailed information on key clinical trials for certepetide, including their design, patient populations, and objectives [ASCEND Trial (mPDAC)](index=40&type=section&id=ASCEND%20Trial%20%28mPDAC%29) The ASCEND trial is a Phase 2b, randomized, double-blind study evaluating certepetide with standard-of-care (gemcitabine + nab-paclitaxel) in 158 patients with first-line mPDAC across Australia and New Zealand - Design: Phase 2b, randomized, double-blind, placebo-controlled trial[114](index=114&type=chunk) - Population: N=158 patients with first-line mPDAC[114](index=114&type=chunk) - Endpoints: Primary endpoint is Progression-Free Survival (PFS); secondary endpoints include Overall Survival (OS) and Objective Tumor Response Rate[114](index=114&type=chunk) [CEND1-201 Trial (mPDAC in China)](index=42&type=section&id=CEND1-201%20Trial%20%28mPDAC%20in%20China%29) This Phase 1b/2a open-label trial, sponsored and funded by Qilu Pharmaceutical, evaluated the safety, pharmacokinetics, and preliminary efficacy of certepetide added to standard-of-care chemotherapy in 55 Chinese patients with advanced mPDAC - Sponsor: Qilu Pharmaceutical (funds all development in China)[118](index=118&type=chunk) - Design: Phase 1b/2a open-label study in Chinese patients with mPDAC[118](index=118&type=chunk) - Size: N=55 patients across ~15 sites[118](index=118&type=chunk) [CENDIFOX Trial (Pancreatic, Colon, Appendiceal)](index=44&type=section&id=CENDIFOX%20Trial%20%28Pancreatic%2C%20Colon%2C%20Appendiceal%29) CENDIFOX is an investigator-initiated Phase 1b/2a open-label trial conducted at the University of Kansas Medical Center - Sponsor: University of Kansas Medical Center (Investigator-initiated trial)[122](index=122&type=chunk) - Indications: Pancreatic (N=24), colon (N=15), and appendiceal (N=11) cancers[122](index=122&type=chunk) - Objective: Evaluate safety and therapeutic effect of certepetide with FOLFIRINOX-based therapies[122](index=122&type=chunk) [BOLSTER Trial (Cholangiocarcinoma)](index=46&type=section&id=BOLSTER%20Trial%20%28Cholangiocarcinoma%29) BOLSTER is a Lisata-sponsored Phase 2 randomized, double-blind, placebo-controlled trial in the U.S - Sponsor: Lisata (U.S.)[126](index=126&type=chunk) - Population: N=69 patients with first-line (N=47) and second-line (N=22) cholangiocarcinoma[126](index=126&type=chunk) - Primary Endpoint: Overall Survival (OS)[126](index=126&type=chunk) [Qilu Phase 2 Trial (mPDAC in China)](index=48&type=section&id=Qilu%20Phase%202%20Trial%20%28mPDAC%20in%20China%29) This is a Phase 2b, double-blind, placebo-controlled, randomized study sponsored by Qilu Pharmaceutical in China - Sponsor: Qilu Pharmaceutical (funds all development in China)[131](index=131&type=chunk) - Design: Phase 2b, double-blind, placebo-controlled, randomized study[131](index=131&type=chunk) - Size: N=96 patients[131](index=131&type=chunk) [iLSTA Trial (Locally Advanced PDAC)](index=50&type=section&id=iLSTA%20Trial%20%28Locally%20Advanced%20PDAC%29) The iLSTA trial is a Phase 1b/2a study in Australia, funded by the WARPNINE charity, with Lisata providing the study drug - Sponsor: WARPNINE, Inc. (Australian charity)[135](index=135&type=chunk) - Population: N=30 patients with locally advanced non-resectable PDAC[135](index=135&type=chunk) - Objective: Determine if the treatment combination can make inoperable tumors operable[135](index=135&type=chunk) [GBM Phase 2a Trial (Glioblastoma)](index=53&type=section&id=GBM%20Phase%202a%20Trial%20%28Glioblastoma%29) This is an investigator-initiated Phase 2a, double-blind, placebo-controlled trial at Tartu University Hospital in Estonia and Latvia - Sponsor: Tartu University Hospital (Investigator-initiated)[142](index=142&type=chunk) - Indication: Newly diagnosed Glioblastoma Multiforme (GBM)[142](index=142&type=chunk) - Size: N=30 patients[142](index=142&type=chunk) [FORTIFIDE Trial (mPDAC Continuous Infusion)](index=55&type=section&id=FORTIFIDE%20Trial%20%28mPDAC%20Continuous%20Infusion%29) FORTIFIDE is a planned Phase 1b/2a, double-blind, placebo-controlled study sponsored by Lisata in the U.S - Design: Phase 1b/2a study evaluating a 4-hour continuous infusion of certepetide[147](index=147&type=chunk) - Population: First-line mPDAC patients who have progressed on FOLFIRINOX[147](index=147&type=chunk) - Status: Enrollment is pending[147](index=147&type=chunk)