Financial Data and Key Metrics Changes - For Q3 2023, operating expenses totaled $6 million, a decrease of 84.2% compared to $37.7 million in Q3 2022. Excluding a $30.4 million in-process research and development expense from a merger, operating expenses decreased by $1.4 million or 18.6% year-over-year [5][82]. - General and administrative expenses were approximately $2.6 million for Q3 2023, down 35.3% from $4.0 million in Q3 2022, primarily due to nonrecurring merger-related costs in the prior year [81]. - Net losses were $5.3 million for Q3 2023, compared to $37.4 million in Q3 2022. Excluding the merger-related expense, net losses decreased by $1.7 million or 24.7% year-over-year [82]. Business Line Data and Key Metrics Changes - Research and development expenses were approximately $3.4 million for Q3 2023, slightly up from $3.3 million in Q3 2022, primarily due to study activities associated with ongoing clinical trials [71]. - The ASCEND trial has achieved full enrollment in Cohort A and is approximately 95% complete overall, with top-line data expected in late 2024, a year earlier than initially anticipated [85][61]. Market Data and Key Metrics Changes - The company had cash, cash equivalents, and marketable securities of approximately $54.4 million as of September 30, 2023, which is projected to fund operations into early 2026 [6]. - The company is experiencing a low trading volume, averaging 20,000 to 25,000 shares per day out of over 8 million outstanding, which contributes to stock price volatility [60]. Company Strategy and Development Direction - The company aims to enhance the efficacy of various anticancer therapies through its lead product candidate, LSTA1, which targets advanced solid tumors [70][84]. - The strategy includes conducting multiple clinical trials globally, focusing on the combination of LSTA1 with standard therapies for various solid tumors, including pancreatic and glioblastoma cancers [21][54]. Management's Comments on Operating Environment and Future Outlook - Management noted that the biotech market has faced challenges due to high interest rates, impacting stock prices across the sector, despite the company's strong fundamentals and execution [46]. - The company believes that the current market cap is irrational, trading at approximately 35% to 40% of its cash on hand, and expects this to change as pivotal data from trials is released [46][48]. Other Important Information - LSTA1 has received multiple orphan drug designations, including for pancreatic cancer and malignant glioma, which may facilitate faster market access [54][64]. - The company is eligible for a refundable tax incentive in Australia for qualifying R&D activities, which significantly offsets trial expenses [92]. Q&A Session Summary Question: What are the implications of the orphan drug and fast-track designations? - These designations allow for accelerated approval consideration and more rapid review cycles with the FDA, which are beneficial for getting products to market faster [42][64]. Question: How does the company view its market cap and stock price? - Management expressed concern over the inconsistency between the company's advanced clinical programs and its low market cap, attributing it to broader market conditions and shareholder behavior [46][48]. Question: What factors are contributing to rapid trial enrollment? - The trial's design allows control arm participants to receive standard care, making participation more appealing, alongside the treatment-naive population in Australia [15][90].

PART I - FINANCIAL INFORMATION [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited consolidated financial statements of Lisata Therapeutics, Inc. and its subsidiaries for the periods ended September 30, 2023, and December 31, 2022, including balance sheets, statements of operations, comprehensive loss, equity, and cash flows, along with detailed notes explaining the company's business, accounting policies, merger impact, and other financial details [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) Consolidated Balance Sheet Highlights (in thousands) | Metric | Sep 30, 2023 (Unaudited) | Dec 31, 2022 | | :-------------------------------- | :----------------------- | :----------- | | Cash and cash equivalents | $32,428 | $32,154 | | Marketable securities | $21,966 | $37,072 | | Total current assets | $57,233 | $71,876 | | Total assets | $58,089 | $73,034 | | Total current liabilities | $5,132 | $6,383 | | Total liabilities | $5,385 | $6,710 | | Total stockholders' equity | $52,704 | $66,324 | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :------------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $3,380 | $3,335 | $9,721 | $9,853 | | In-process research and development | $— | $30,393 | $— | $30,393 | | General and administrative | $2,584 | $3,992 | $9,962 | $10,815 | | Total operating expenses | $5,964 | $37,720 | $19,683 | $51,061 | | Operating loss | $(5,964) | $(37,720) | $(19,683) | $(51,061) | | Net loss attributable to Lisata Therapeutics, Inc. | $(5,261) | $(37,383) | $(15,475) | $(48,235) | | Basic and diluted loss per share | $(0.65) | $(7.88) | $(1.92) | $(11.28) | [Consolidated Statements of Comprehensive Loss](index=8&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) Consolidated Statements of Comprehensive Loss Highlights (in thousands) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :---------------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net loss | $(5,261) | $(37,383) | $(15,475) | $(48,235) | | Total other comprehensive loss | $(50) | $(20) | $(71) | $(20) | | Comprehensive loss attributable to common stockholders | $(5,311) | $(37,403) | $(15,546) | $(48,255) | [Consolidated Statements of Equity](index=9&type=section&id=Consolidated%20Statements%20of%20Equity) - Total stockholders' equity decreased from **$66,324 thousand** at December 31, 2022, to **$52,704 thousand** at September 30, 2023, primarily due to the net loss incurred during the period[15](index=15&type=chunk)[26](index=26&type=chunk) - The company issued **3,773 thousand shares** of common stock in connection with the Merger in September 2022, increasing additional paid-in capital by **$26,094 thousand**[24](index=24&type=chunk) - Accumulated deficit increased from **$(507,241) thousand** at December 31, 2022, to **$(522,716) thousand** at September 30, 2023, reflecting the net loss[15](index=15&type=chunk)[26](index=26&type=chunk) [Consolidated Statements of Cash Flows](index=11&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Consolidated Statements of Cash Flows Highlights (in thousands) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(15,963) | $(14,702) | | Net cash provided by investing activities | $15,816 | $21,805 | | Net cash provided by (used in) financing activities | $361 | $(238) | | Net increase in cash and cash equivalents | $274 | $6,831 | | Cash and cash equivalents at end of period | $32,428 | $31,478 | [Notes to Unaudited Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) [Note 1 – The Business](index=12&type=section&id=Note%201%20%E2%80%93%20The%20Business) Lisata Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on innovative therapies for solid tumors, with its lead product candidate LSTA1 designed to enhance drug penetration. The company completed a merger with Cend Therapeutics, Inc. in September 2022, which included a name change and a 1:15 reverse stock split, and was accounted for as an asset acquisition - Lisata Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on discovering, developing, and commercializing innovative therapies for solid tumors and other major diseases[32](index=32&type=chunk) - The lead investigational product candidate, LSTA1, is designed to activate a novel uptake pathway for co-administered anti-cancer drugs to penetrate solid tumors more effectively and potentially modify the tumor microenvironment[32](index=32&type=chunk) - On September 15, 2022, the company (then Caladrius Biosciences, Inc.) completed the acquisition of Cend Therapeutics, Inc., changed its name to Lisata Therapeutics, Inc., and effected a **1:15 reverse stock split**[34](index=34&type=chunk)[35](index=35&type=chunk) - The merger was accounted for as an asset acquisition, with substantially all fair value concentrated in in-process research and development (IPR&D), which was expensed[38](index=38&type=chunk) [Note 2 – Summary of Significant Accounting Policies](index=14&type=section&id=Note%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the company's key accounting policies, including the classification and valuation of cash, marketable securities, property and equipment, and the expensing of research and development costs, including in-process R&D. It also details the revenue recognition policy, noting no revenue was recognized from license or collaboration arrangements in the reported periods - All marketable securities are classified as available-for-sale, carried at estimated fair values, with unrealized gains and losses reported in accumulated other comprehensive income (loss)[47](index=47&type=chunk) - Research and development (R&D) expenses, including salaries, clinical trial costs, and contract fees, are expensed as incurred[53](index=53&type=chunk) - Upfront payments for new drug compounds and pre-commercial milestone payments are immediately expensed as in-process research and development (IPR&D) if the drug has no alternative future use without regulatory approval[55](index=55&type=chunk) - No revenue was recognized from license and collaboration arrangements for the three and nine months ended September 30, 2023 and 2022[58](index=58&type=chunk) [Note 3 – Merger](index=17&type=section&id=Note%203%20%E2%80%93%20Merger) The merger with Cend Therapeutics was accounted for as an asset acquisition with a total purchase price of $36.1 million, primarily allocated to in-process research and development (IPR&D) which was expensed - The Merger was accounted for as an asset acquisition, with substantially all of the fair value concentrated in IPR&D[62](index=62&type=chunk) Merger Purchase Price Calculation and Allocation (in thousands) | Item | Amount | | :---------------------------------------------------- | :------- | | Total purchase price | $36,098 | | Acquired in-process research and development | $30,393 | | License | $355 | | Cash and cash equivalents | $7,062 | | Net working capital (excluding cash) | $(1,690) | | Other liabilities | $(22) | | Net assets acquired | $36,098 | [Note 4 – Available-for-Sale-Securities](index=17&type=section&id=Note%204%20%E2%80%93%20Available-for-Sale-Securities) The company's available-for-sale securities portfolio, totaling $51.1 million at September 30, 2023, primarily consists of corporate debt, commercial paper, money market funds, agency bonds, treasury bills, and municipal debt securities, all with maturities less than one year Available-for-Sale Securities (in thousands) | Security Type | Sep 30, 2023 Estimated Fair Value | Dec 31, 2022 Estimated Fair Value | | :-------------------- | :-------------------------------- | :-------------------------------- | | Corporate debt securities | $28,812 | $44,291 | | Commercial paper | $1,978 | $7,953 | | Money market funds | $13,572 | $4,871 | | Agency bonds | $1,986 | $— | | Treasury bills | $3,996 | $— | | Municipal debt securities | $725 | $7,625 | | **Total** | **$51,069** | **$64,740** | - All available-for-sale securities at September 30, 2023, have contractual maturities of less than one year[65](index=65&type=chunk) [Note 5 – Property and Equipment](index=19&type=section&id=Note%205%20%E2%80%93%20Property%20and%20Equipment) Net property and equipment decreased to $204 thousand at September 30, 2023, from $296 thousand at December 31, 2022, with depreciation expense of $89 thousand for the nine months ended September 30, 2023 Property and Equipment, Net (in thousands) | Item | Sep 30, 2023 | Dec 31, 2022 | | :---------------------- | :----------- | :----------- | | Property and equipment, gross | $661 | $713 | | Accumulated depreciation | $(457) | $(417) | | **Property and equipment, net** | **$204** | **$296** | - Depreciation expense for the nine months ended September 30, 2023, was approximately **$89 thousand**, compared to **$22 thousand** for the same period in 2022[66](index=66&type=chunk) [Note 6 – Income (Loss) Per Share](index=19&type=section&id=Note%206%20%E2%80%93%20Income%20%28Loss%29%20Per%20Share) Due to net losses incurred, potentially dilutive securities such as stock options, warrants, and restricted stock units were excluded from the diluted loss per share calculation as they were anti-dilutive - Basic and diluted loss per share for Lisata Therapeutics, Inc. common stockholders was **$(1.92)** for the nine months ended September 30, 2023, and **$(11.28)** for the nine months ended September 30, 2022[18](index=18&type=chunk) Potentially Dilutive Securities Excluded from Diluted Loss Per Share (in thousands) | Security Type | Sep 30, 2023 | Sep 30, 2022 | | :-------------------- | :----------- | :----------- | | Stock options | 1,321 | 1,399 | | Warrants | 1,422 | 1,424 | | Restricted stock units | 202 | 48 | [Note 7 – Fair Value Measurements](index=19&type=section&id=Note%207%20%E2%80%93%20Fair%20Value%20Measurements) The company classifies its financial assets and liabilities based on a fair value hierarchy, with cash equivalents primarily in Level 1 and marketable securities in Level 2, reflecting observable inputs Fair Value Measurements (in thousands) as of September 30, 2023 | Asset Type | Level 1 | Level 2 | Level 3 | Total | | :------------------------------------ | :------ | :------ | :------ | :------ | | Cash equivalents | $29,103 | $— | $— | $29,103 | | Marketable securities - available for sale | $— | $21,966 | $— | $21,966 | | **Total Assets** | **$29,103** | **$21,966** | **$—** | **$51,069** | - The carrying values of accounts payable and accrued expenses approximate fair value due to their short maturity[70](index=70&type=chunk) [Note 8 – Accrued Liabilities](index=20&type=section&id=Note%208%20%E2%80%93%20Accrued%20Liabilities) Accrued liabilities totaled $3,820 thousand at September 30, 2023, with salaries, employee benefits, and clinical/R&D related liabilities being the largest components Accrued Liabilities (in thousands) | Item | Sep 30, 2023 | Dec 31, 2022 | | :------------------------------------ | :----------- | :----------- | | Salaries, employee benefits and related taxes | $2,366 | $2,586 | | Clinical and R&D related liabilities | $915 | $785 | | Accounting & tax consulting liabilities | $230 | $— | | Operating lease liabilities — current | $164 | $180 | | Other | $145 | $177 | | **Total** | **$3,820** | **$3,728** | [Note 9 – Operating Leases](index=20&type=section&id=Note%209%20%E2%80%93%20Operating%20Leases) The company has an operating lease for office space expiring in 2025, with a right-of-use asset of $348 thousand and total operating lease liabilities of $345 thousand as of September 30, 2023 Operating Lease Balances (in thousands) | Item | Sep 30, 2023 | Dec 31, 2022 | | :-------------------------- | :----------- | :----------- | | Right-of-Use Assets (Other assets) | $348 | $487 | | Operating Lease Liabilities (Current) | $164 | $180 | | Operating Lease Liabilities (Long-term) | $181 | $305 | | **Total Operating Lease Liabilities** | **$345** | **$485** | - As of September 30, 2023, the weighted average remaining lease term was **2.0 years**, and the weighted average discount rate was **9.625%**[73](index=73&type=chunk) Future Minimum Lease Payments (in thousands) | Year | Operating Leases | | :--- | :--------------- | | 2023 | $48 | | 2024 | $190 | | 2025 | $143 | | **Total lease payments** | **$381** | | Less: Amounts representing interest | $(36) | | **Present value of lease liabilities** | **$345** | [Note 10 – Stockholders' Equity](index=21&type=section&id=Note%2010%20%E2%80%93%20Stockholders%27%20Equity) This note details changes in stockholders' equity, including the 1:15 reverse stock split in September 2022, the issuance of common stock through an At The Market (ATM) offering, and activity related to stock options, warrants, and restricted stock/units - The company implemented a **1:15 reverse stock split** on September 14, 2022, to increase its common stock's per share trading price for Nasdaq listing compliance[39](index=39&type=chunk)[75](index=75&type=chunk) - During the nine months ended September 30, 2023, the company issued **64,394 shares** of common stock under its ATM Agreement for net proceeds of **$270,774 thousand**[76](index=76&type=chunk) Stock Options and Warrants Activity (Nine Months Ended Sep 30, 2023) | Item | Stock Options (Shares) | Warrants (Shares) | | :------------------------------------ | :--------------------- | :---------------- | | Outstanding at December 31, 2022 | 1,391,352 | 1,423,774 | | Granted | 180,896 | — | | Exercised | (82,500) | — | | Forfeited | (144,594) | — | | Expired | (24,603) | (2,000) | | Outstanding at September 30, 2023 | 1,320,551 | 1,421,744 | | Weighted Average Exercise Price (Stock Options) | $10.82 | N/A | | Weighted Average Exercise Price (Warrants) | N/A | $42.51 | - The company issued **159,950 restricted stock** and **188,850 restricted stock units** for services during the nine months ended September 30, 2023[80](index=80&type=chunk)[81](index=81&type=chunk) [Note 11 – Share-Based Compensation](index=23&type=section&id=Note%2011%20%E2%80%93%20Share-Based%20Compensation) Total share-based compensation expense for the nine months ended September 30, 2023, was $1,565 thousand, with $221 thousand in unrecognized compensation cost for stock options, $161 thousand for restricted stock units, and $483 thousand for restricted stock Share-Based Compensation Expense (in thousands) | Category | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :-------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Research and development | $103 | $271 | $517 | $63 | | General and administrative | $203 | $769 | $1,048 | $1,53 | | **Total share-based compensation expense** | **$306** | **$1,040** | **$1,565** | **$2,16** | Unrecognized Compensation Cost (in thousands) as of September 30, 2023 | Award Type | Unrecognized Compensation Cost | | :-------------------- | :----------------------------- | | Stock Options | $221 | | Restricted Stock Units | $161 | | Restricted Stock | $483 | [Note 12 – Income Taxes](index=23&type=section&id=Note%2012%20%E2%80%93%20Income%20Taxes) The company maintains a full valuation allowance against its net deferred tax assets due to uncertainty regarding future utilization of net operating losses (NOLs). Ownership changes in 2021 and 2022 significantly limited the usability of Federal NOLs, and the company received $2.2 million from the sale of New Jersey NOLs in April 2023 - A full valuation allowance is provided against net deferred tax assets due to uncertainty of future utilization of existing deferred tax assets, including NOLs[84](index=84&type=chunk) - Ownership changes on January 25, 2021, and September 15, 2022, resulted in **$168.8 million** and **$88.2 million**, respectively, of Federal NOLs expiring unutilized[85](index=85&type=chunk)[87](index=87&type=chunk) - In April 2023, the company received final approval to sell a percentage of its New Jersey NOLs for net proceeds of **$2.2 million**, recorded as a benefit from income taxes[93](index=93&type=chunk) [Note 13 – Australia Research and Development Tax Incentive](index=24&type=section&id=Note%2013%20%E2%80%93%20Australia%20Research%20and%20Development%20Tax%20Incentive) The company's Australian subsidiary is eligible for a refundable R&D tax incentive, with $0.5 million recorded as a receivable for the nine months ended September 30, 2023, and a $0.6 million refund received for the 2022 tax year - The Australian subsidiary is eligible for a refundable tax incentive of **43.5% to 48.5%** for qualified research and development activities[95](index=95&type=chunk) - As of September 30, 2023, **$0.5 million** was recorded as an income tax incentive receivable[95](index=95&type=chunk) - A **$0.6 million** tax refund related to the 2022 tax year was received from the Australian Taxation Office on September 4, 2023[96](index=96&type=chunk) [Note 14 – Contingencies](index=25&type=section&id=Note%2014%20%E2%80%93%20Contingencies) The company is involved in a legal proceeding with Lingmed Limited, which filed a complaint in May 2022 claiming entitlement to a success fee related to Cend's collaboration with Qilu Pharmaceuticals. The trial date is set for August 2, 2024, and the company intends to vigorously defend itself - Lingmed Limited filed a complaint in May 2022, alleging breach of contract, fraud, and declaratory relief, claiming a success fee based on Cend's agreement with Qilu Pharmaceuticals[98](index=98&type=chunk) - A trial date for the Lingmed litigation has been set for **August 2, 2024**[98](index=98&type=chunk) - The company denies Lingmed's allegations and intends to vigorously defend itself[98](index=98&type=chunk) [Note 15 – Technology Transfer Agreement](index=25&type=section&id=Note%2015%20%E2%80%93%20Technology%20Transfer%20Agreement) In July 2023, the company transferred its rights to the tumor penetrating nanocomplex (TPN) platform to Impilo Therapeutics, receiving 574,500 shares of Impilo's pre-seed preferred stock as consideration - In July 2023, the company entered into a technology transfer agreement with Impilo Therapeutics, transferring its rights to the tumor penetrating nanocomplex (TPN) platform[99](index=99&type=chunk) - As consideration, Impilo issued **574,500 shares** of its pre-seed preferred stock to the company[99](index=99&type=chunk) [Note 16 – License Agreements](index=25&type=section&id=Note%2016%20%E2%80%93%20License%20Agreements) The company holds license agreements with Sanford Burnham Prebys (SBP) for LSTA1, with potential milestone payments up to $10.6 million and 4% royalties. Licenses with the University of California at San Diego (UCSD) and a second SBP agreement were assigned to Impilo, and a license with MIT was terminated effective December 30, 2023 - The company has an exclusive, worldwide, royalty-bearing license with Sanford Burnham Prebys (SBP) for LSTA1, with potential aggregate milestone payments of approximately **$10.6 million** and **4% royalties** on net sales[100](index=100&type=chunk) - A license agreement with UCSD for nano-particles to modulate immune response was assigned in full to Impilo on **August 2, 2023**[104](index=104&type=chunk)[106](index=106&type=chunk) - A second license agreement with SBP was assigned in full to Impilo on **September 14, 2023**[102](index=102&type=chunk) - The license agreement with MIT for tissue-specific delivery of interfering RNA was terminated, effective **December 30, 2023**[107](index=107&type=chunk)[109](index=109&type=chunk) [Note 17 – Research Collaboration and License Agreement](index=27&type=section&id=Note%2017%20%E2%80%93%20Research%20Collaboration%20and%20License%20Agreement) Cend (now Lisata) granted an exclusive license to Qilu Pharmaceutical for the development and commercialization of LSTA1 in Greater China, receiving an upfront payment of $10 million and a $5 million development milestone prior to the merger. The company is eligible for additional milestone payments up to $220 million and tiered royalties - Cend granted an exclusive license to Qilu Pharmaceutical for the development and commercialization of LSTA1 in the Greater Area of China[110](index=110&type=chunk) - Prior to the Merger, Cend received and recognized an upfront payment of **$10 million** and a **$5 million** development milestone from Qilu[110](index=110&type=chunk) - The company is eligible to receive additional developmental and commercial milestone payments up to **$95 million** and **$125 million**, respectively, and tiered royalties on net sales ranging from **10% to 15%**[110](index=110&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting its focus on LSTA1 for solid tumors, the impact of the Cend merger, and a detailed comparison of financial performance for the three and nine months ended September 30, 2023, versus 2022, along with an outlook on liquidity and capital resources [Overview](index=28&type=section&id=Overview) Lisata Therapeutics is a clinical-stage pharmaceutical company developing LSTA1 to enhance anti-cancer drug penetration in solid tumors by activating the CendR active transport system. LSTA1 has shown favorable safety and activity in clinical trials for pancreatic cancer. The company also has CD34+ cell therapy programs for ischemic repair, which it is seeking to partner, and completed a merger with Cend Therapeutics in September 2022 - Lisata Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative therapies for solid tumors, with LSTA1 as its lead investigational product candidate[114](index=114&type=chunk) - LSTA1 is designed to activate the C-end rule (CendR) active transport system, enabling more selective and efficient uptake of co-administered anti-cancer drugs into solid tumors and potentially modifying the tumor microenvironment[117](index=117&type=chunk)[119](index=119&type=chunk) - LSTA1 has demonstrated favorable safety, tolerability, and activity in clinical trials for metastatic pancreatic ductal adenocarcinoma (mPDAC), with an Objective Response Rate (ORR) of **59%** and median overall survival of over **13 months**[120](index=120&type=chunk) - The company also has development programs based on its autologous CD34+ cell therapy technology platform for ischemic repair, which it is seeking to partner[124](index=124&type=chunk)[125](index=125&type=chunk) - The merger with Cend Therapeutics, Inc. was completed on **September 15, 2022**, leading to a name change and a **1:15 reverse stock split**, and was accounted for as an asset acquisition[127](index=127&type=chunk)[128](index=128&type=chunk)[130](index=130&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) The company reported a significant reduction in net loss for both the three and nine months ended September 30, 2023, compared to the prior year, primarily driven by the absence of a large in-process research and development expense related to the Cend merger in 2022 - Net loss decreased significantly to **$5.3 million** for the three months ended September 30, 2023, from **$37.4 million** in the prior year[133](index=133&type=chunk) - Net loss decreased to **$15.5 million** for the nine months ended September 30, 2023, from **$48.2 million** in the prior year[138](index=138&type=chunk) - The primary driver for the decrease in net loss and operating expenses was the absence of the **$30.4 million** in-process research and development expense related to the Cend merger, which was recognized in the prior year[134](index=134&type=chunk)[139](index=139&type=chunk) [Three Months Ended September 30, 2023 Compared to Three Months Ended September 30, 2022](index=32&type=section&id=Three%20Months%20Ended%20September%2030%2C%202023%20Compared%20to%20Three%20Months%20Ended%20September%2030%2C%202022) For the three months ended September 30, 2023, net loss decreased by $32.1 million to $5.3 million, primarily due to the $30.4 million in-process R&D expense in the prior year. Operating expenses decreased by 84.2%, or 18.6% excluding the IPR&D expense, driven by lower general and administrative costs Operating Expenses (in thousands) - Three Months Ended September 30 | Expense Category | 2023 | 2022 | Change | | :-------------------------- | :----- | :----- | :------- | | Research and development | $3,380 | $3,335 | $45 | | In-process research and development | $— | $30,393 | $(30,393) | | General and administrative | $2,584 | $3,992 | $(1,408) | | **Total operating expenses** | **$5,964** | **$37,720** | **$(31,756)** | | **Net loss** | **$(5,261)** | **$(37,383)** | **$32,122** | - General and administrative expenses decreased by **$1.4 million** (**35.3%**) due to non-recurring merger-related costs, lower equity expense, and timing of the annual stockholder meeting in the prior year[136](index=136&type=chunk) - Research and development expenses slightly increased by **$45 thousand** (**1.3%**) due to LSTA1 clinical trial activities, offset by reduced expenses for Ischemic Repair programs[136](index=136&type=chunk) [Nine Months Ended September 30, 2023 Compared to Nine Months Ended September 30, 2022](index=33&type=section&id=Nine%20Months%20Ended%20September%2030%2C%202023%20Compared%20to%20Nine%20Months%20Ended%20September%2030%2C%202022) For the nine months ended September 30, 2023, net loss decreased by $32.8 million to $15.5 million. Total operating expenses decreased by 61.5%, or 4.8% excluding the IPR&D expense, driven by lower general and administrative costs and a slight decrease in R&D expenses Operating Expenses (in thousands) - Nine Months Ended September 30 | Expense Category | 2023 | 2022 | Change | | :-------------------------- | :----- | :----- | :------- | | Research and development | $9,721 | $9,853 | $(132) | | In-process research and development | $— | $30,393 | $(30,393) | | General and administrative | $9,962 | $10,815 | $(853) | | **Total operating expenses** | **$19,683** | **$51,061** | **$(31,378)** | | **Net loss** | **$(15,475)** | **$(48,235)** | **$32,760** | - General and administrative expenses decreased by **$0.9 million** (**7.9%**) due to non-recurring merger-related costs, lower equity expense, reduced annual stockholder meeting expenses, and decreased D&O insurance premiums, partially offset by severance costs[140](index=140&type=chunk) - Research and development expenses slightly decreased by **$0.1 million** (**1.3%**) due to LSTA1 clinical trial activities being offset by reduced expenses for Ischemic Repair programs[140](index=140&type=chunk) - The company recognized a **$2.3 million** benefit from income taxes in 2023 from the sale of New Jersey NOLs, compared to **$2.5 million** in 2022[142](index=142&type=chunk)[143](index=143&type=chunk) [Analysis of Liquidity and Capital Resources](index=35&type=section&id=Analysis%20of%20Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company had $54.4 million in cash, cash equivalents, and marketable securities, and $52.1 million in working capital. Net cash used in operating activities was $16.0 million, while investing activities provided $15.8 million, and financing activities provided $0.4 million. The company believes existing cash and marketable securities will fund operations for at least the next 12 months but acknowledges the need for additional capital for long-term needs Liquidity and Capital Resources (in thousands) | Metric | Sep 30, 2023 | | :------------------------------------ | :----------- | | Cash, cash equivalents and marketable securities | $54,400 | | Working capital | $52,100 | | Stockholders' equity | $53,000 | Net Cash Flows (in thousands) - Nine Months Ended September 30 | Activity | 2023 | 2022 | | :------------------------------------ | :--------- | :--------- | | Net cash used in operating activities | $(15,963) | $(14,702) | | Net cash provided by investing activities | $15,816 | $21,805 | | Net cash provided by (used in) financing activities | $361 | $(238) | - Cash provided by financing activities in 2023 included **$0.3 million** from the ATM Agreement and **$0.2 million** from option exercises, partially offset by tax withholding payments[151](index=151&type=chunk) - The company believes its cash on hand and marketable securities will fund operating expenses for at least the next **12 months**[153](index=153&type=chunk) - Future capital requirements are difficult to forecast and may necessitate additional debt or equity financings, partnerships, or asset sales, with no assurance of availability on acceptable terms[153](index=153&type=chunk)[156](index=156&type=chunk) [Off-Balance Sheet Arrangements](index=36&type=section&id=Off-Balance%20Sheet%20Arrangements) The company does not have any off-balance sheet arrangements - The company does not have any off-balance sheet arrangements[157](index=157&type=chunk) [Critical Accounting Policies and Estimates](index=36&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) There have been no material changes in the company's critical accounting policies and estimates during the three and nine months ended September 30, 2023, compared to those reported in its 2022 Form 10-K - No material changes occurred in critical accounting policies and estimates during the three and nine months ended September 30, 2023, compared to the 2022 Form 10-K[158](index=158&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there are no quantitative and qualitative disclosures about market risk applicable to the company for the reported period - The company states that this item is not applicable[159](index=159&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the Chief Executive Officer, evaluated the effectiveness of the company's disclosure controls and procedures as of September 30, 2023, concluding they were effective at a reasonable assurance level. There were no material changes in internal control over financial reporting during the quarter - As of September 30, 2023, the Chief Executive Officer concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[161](index=161&type=chunk) - There were no changes in internal control over financial reporting during the last quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[162](index=162&type=chunk) PART II - OTHER INFORMATION [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) There are no material changes to the legal proceedings disclosures previously reported in the company's 2022 Form 10-K, other than those detailed in Note 14 – Contingencies - No material changes to legal proceedings disclosures from the 2022 Form 10-K, except as disclosed in Note 14 – Contingencies[164](index=164&type=chunk) [Item 1A. Risk Factors](index=38&type=page&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously reported in the company's 2022 Form 10-K - No material changes to the risk factors previously reported in the 2022 Form 10-K[165](index=165&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - None to report for this item[165](index=165&type=chunk) [Item 3. Defaults Upon Senior Securities](index=38&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - None to report for this item[166](index=166&type=chunk) [Item 4. Mine Safety Disclosures](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - The company states that this item is not applicable[167](index=167&type=chunk) [Item 5. Other Information](index=38&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - None to report for this item[168](index=168&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section incorporates the Exhibit Index by reference, listing certifications and Inline XBRL documents - The Exhibit Index, appearing immediately after the signature page, is incorporated by reference[169](index=169&type=chunk) - Exhibits include certifications of principal executive and financial officers (31.1, 32) and Inline XBRL documents (101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104)[175](index=175&type=chunk)

Lisata Therapeutics, Inc. (NASDAQ:LSTA) Q2 2023 Results Conference Call August 15, 2023 8:30 AM ET Company Participants John Menditto - VP, IR and Corporate Communications Dr. David Mazzo - President and Chief Executive Officer Dr. Kristen Buck - EVP, Research and Development and Chief Medical Officer James Nisco - VP, Finance and Treasury Conference Call Participants Steve Brozak - WBB Securities Pete Enderlin - MAZ Partners Kemp Dolliver - Brookline Capital Markets Operator Welcome to the Lisata Therapeut ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from __________________ to _________________________ Commission File Number 001-33650 LISATA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware ...

Lisata Therapeutics, Inc. (NASDAQ:LSTA) Q1 2023 Earnings Conference Call May 9, 2023 4:30 PM ET Company Participants John Menditto - VP, IR and Corporate Communications David Mazzo - CEO James Nisco - VP, Finance and Treasury Kristen Buck - EVP, Research and Development and Chief Medical Officer Conference Call Participants Steve Brozak - WBB Securities Kemp Dolliver - Brookline Capital Markets Pete Enderlin - MAZ Partner Joe Pantginis - H.C. Wainwright Operator Welcome to the Lisata Therapeutics First Quar ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from __________________ to _________________________ Commission File Number 001-33650 LISATA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delawar ...

PART I [Business](index=6&type=section&id=ITEM%201.%20BUSINESS) Lisata Therapeutics is a clinical-stage pharmaceutical company developing therapies for solid tumors, with its lead candidate LSTA1 designed to enhance anti-cancer drug penetration - The company's lead product is **LSTA1**, a drug designed to improve the efficacy of co-administered anti-cancer drugs by increasing their penetration into solid tumors[17](index=17&type=chunk)[18](index=18&type=chunk) - Following the **acquisition of Cend Therapeutics in September 2022**, the company was renamed and executed a **1:15 reverse stock split**[22](index=22&type=chunk)[23](index=23&type=chunk)[25](index=25&type=chunk) - The **COVID-19 pandemic caused significant delays** in clinical trial enrollment for HONEDRA and XOWNA, leading to the suspension of enrollment for both studies[26](index=26&type=chunk) - The company's CD34+ cell therapy programs, including HONEDRA and LSTA201, **require strategic partners for further development** due to high costs[18](index=18&type=chunk)[39](index=39&type=chunk)[42](index=42&type=chunk) - Intellectual property for the CendR Platform™ (LSTA1) includes **two pending U.S. patent applications** and thirteen pending applications outside the U.S[44](index=44&type=chunk)[46](index=46&type=chunk) [Risk Factors](index=22&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces significant financial, clinical development, regulatory, and operational risks, including a history of losses and dependence on its lead product candidate LSTA1 - The company has a history of substantial losses, with an **accumulated net loss of approximately $507.2 million** since inception, and will require significant additional financing[104](index=104&type=chunk)[105](index=105&type=chunk) - The business is **substantially dependent on its lead product candidate, LSTA1**, and any failure in its development or commercialization would materially harm the company[123](index=123&type=chunk) - The **COVID-19 pandemic has adversely affected business operations**, causing significant delays and suspension of the HONEDRA and XOWNA clinical trials[131](index=131&type=chunk)[133](index=133&type=chunk) - The company **relies on single-source contract manufacturing organizations (CMOs)**, creating a risk of disruption to clinical trials and future commercial supply[165](index=165&type=chunk) - Product development is subject to **extensive and rigorous regulation by the FDA** and other global authorities, and failure to obtain approvals would have a material adverse effect[210](index=210&type=chunk) - The company's ability to use its **net operating loss (NOL) carryforwards is subject to limitations** under Section 382 of the Code due to ownership changes[115](index=115&type=chunk)[116](index=116&type=chunk) - The company faces risks related to the **recent merger with Cend**, including challenges in successfully integrating the businesses and potential litigation[321](index=321&type=chunk)[323](index=323&type=chunk) [Unresolved Staff Comments](index=64&type=section&id=ITEM%201B.%20UNRESOLVED%20STAFF%20COMMENTS) The company reports no unresolved comments from SEC staff - There are no unresolved staff comments[342](index=342&type=chunk) [Properties](index=64&type=section&id=ITEM%202.%20PROPERTIES) The company's corporate headquarters are located in a leased office space in Basking Ridge, New Jersey - The company's main office is an **8,100 sq. ft. leased space** in Basking Ridge, NJ, with the lease running until September 30, 2025[343](index=343&type=chunk) - The lease for the Rye Brook, New York office **expired in March 2023 and was not renewed**[343](index=343&type=chunk) [Legal Proceedings](index=64&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The company is defending against a lawsuit inherited from the Cend merger concerning an alleged breach of contract - Cend, now a subsidiary, is in **litigation with Lingmed Limited**, which claims it is owed a success fee related to a collaboration with Qilu Pharmaceuticals[345](index=345&type=chunk) - The company **denies Lingmed's allegations** and plans to vigorously defend against the claim[345](index=345&type=chunk) [Mine Safety Disclosures](index=64&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This section is not applicable to the company's operations - Not applicable[346](index=346&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=65&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT'S%20COMMON%20EQUITY,%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's common stock trades on The Nasdaq Capital Market, and it has never paid cash dividends - The company's common stock trades on The Nasdaq Capital Market under the **ticker symbol "LSTA"**[349](index=349&type=chunk) - The company has **never paid cash dividends** and does not plan to in the foreseeable future, retaining earnings to fund growth[350](index=350&type=chunk) Equity Compensation Plan Information as of December 31, 2022 | Plan Category | Securities to be issued upon exercise of outstanding options | Weighted Average exercise price | Securities remaining available for future issuance | |---|---|---|---| | Equity compensation plans approved by security holders | 1,391,352 | $10.83 | 587,449 | [[Reserved]](index=65&type=section&id=ITEM%206.%20%5BRESERVED%5D) This item is intentionally left blank [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=66&type=section&id=ITEM%207.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) The company's net loss increased significantly in 2022, primarily due to a one-time R&D expense from the Cend merger, but it maintains sufficient capital for near-term operations - The increase in net loss for 2022 was primarily due to a **one-time $30.4 million in-process research and development expense** associated with the Cend merger[362](index=362&type=chunk) - Research and development expenses **decreased by $4.5 million (25.7%)** in 2022, mainly due to the suspension of the XOWNA Phase 2b study[362](index=362&type=chunk) - As of December 31, 2022, the company had approximately **$69.2 million in cash, cash equivalents, and marketable securities**[368](index=368&type=chunk) - Management believes that current cash and marketable securities are **sufficient to fund operating expenses for at least the next 12 months**[376](index=376&type=chunk) Comparison of Operating Results | Metric | 2022 (in millions) | 2021 (in millions) | |---|---|---| | Research and development | $13.1 | $17.6 | | In-process research and development | $30.4 | $0 | | General and administrative | $14.1 | $11.5 | | **Total operating expenses** | **$57.6** | **$29.1** | | **Net loss** | **$54.2** | **$27.5** | [Quantitative and Qualitative Disclosures About Market Risk](index=70&type=section&id=ITEM%207A.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) This section is not applicable as the company is a smaller reporting company - Not applicable[385](index=385&type=chunk) [Financial Statements and Supplementary Data](index=70&type=section&id=ITEM%208.%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) The consolidated financial statements reflect a higher net loss in 2022 versus 2021, driven by merger-related expenses - The merger with Cend Therapeutics was accounted for as an asset acquisition with a total purchase price of $36.1 million, of which **$30.4 million was expensed as IPR&D**[449](index=449&type=chunk)[450](index=450&type=chunk) - The company's ability to use its Federal Net Operating Losses (NOLs) is **significantly limited due to ownership changes** under IRC Section 382[480](index=480&type=chunk)[481](index=481&type=chunk) Consolidated Balance Sheet | Consolidated Balance Sheet (in thousands) | Dec 31, 2022 | Dec 31, 2021 | |---|---|---| | Cash and cash equivalents | $32,154 | $24,647 | | Marketable securities | $37,072 | $70,323 | | **Total Assets** | **$73,034** | **$97,008** | | Total current liabilities | $6,383 | $4,523 | | **Total Liabilities** | **$6,710** | **$5,008** | | **Total Stockholders' Equity** | **$66,324** | **$92,000** | Consolidated Statement of Operations | Consolidated Statement of Operations (in thousands) | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | |---|---|---| | Operating Expenses | $57,601 | $29,050 | | Operating Loss | ($57,601) | ($29,050) | | **Net Loss** | **($54,225)** | **($27,466)** | | Basic and Diluted Loss Per Share | ($10.47) | ($7.45) | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=96&type=section&id=ITEM%209.%20CHANGES%20IN%20AND%20DISAGREEMENTS%20WITH%20ACCOUNTANTS%20ON%20ACCOUNTING%20AND%20FINANCIAL%20DISCLOSURE) This section is not applicable to the company - Not applicable[505](index=505&type=chunk) [Controls and Procedures](index=97&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of year-end 2022 - As of December 31, 2022, management concluded that the company's **disclosure controls and procedures were effective**[507](index=507&type=chunk) - Management assessed internal control over financial reporting based on the COSO framework and found it to be **effective as of December 31, 2022**[510](index=510&type=chunk) - **No material changes** occurred during the fourth quarter of 2022 that affected the company's internal control over financial reporting[512](index=512&type=chunk) [Other Information](index=98&type=section&id=ITEM%209B.%20OTHER%20INFORMATION) The company adopted a clawback policy for recouping incentive-based executive compensation in the event of an accounting restatement - On March 28, 2023, the company adopted a **Clawback Policy to recoup incentive-based compensation** from executives if a material accounting restatement is required[514](index=514&type=chunk) [Disclosure Regarding Foreign Jurisdictions That Prevent Inspections](index=98&type=section&id=ITEM%209C.%20DISCLOSURE%20REGARDING%20FOREIGN%20JURISDICTIONS%20THAT%20PREVENT%20INSPECTIONS) This section is not applicable to the company - Not applicable[516](index=516&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=99&type=section&id=ITEM%2010.%20DIRECTORS,%20EXECUTIVE%20OFFICERS%20AND%20CORPORATE%20GOVERNANCE) This section details the company's leadership team and board of directors, with other governance information incorporated by reference - The report lists the **executive officers and directors as of March 30, 2023**, including CEO David J. Mazzo, Ph.D., and provides their professional biographies[519](index=519&type=chunk)[520](index=520&type=chunk)[521](index=521&type=chunk) - Detailed information regarding corporate governance, compliance, and code of ethics is **incorporated by reference from the 2023 Proxy Statement**[519](index=519&type=chunk) [Executive Compensation](index=102&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) Information regarding executive compensation is incorporated by reference from the company's 2023 Proxy Statement - Information on executive compensation is **incorporated by reference from the 2023 Proxy Statement**[537](index=537&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=102&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) Information regarding security ownership is incorporated by reference from the company's 2023 Proxy Statement - Information on security ownership and equity compensation plans is **incorporated by reference from the 2023 Proxy Statement**[538](index=538&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=102&type=section&id=ITEM%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS,%20AND%20DIRECTOR%20INDEPENDENCE) Information regarding related party transactions and director independence is incorporated by reference from the company's 2023 Proxy Statement - Information on related transactions and director independence is **incorporated by reference from the 2023 Proxy Statement**[539](index=539&type=chunk) [Principal Accountant Fees and Services](index=102&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTING%20FEES%20AND%20SERVICES) Information regarding principal accountant fees and services is incorporated by reference from the company's 2023 Proxy Statement - Information on principal accountant fees and services is **incorporated by reference from the 2023 Proxy Statement**[540](index=540&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=103&type=section&id=ITEM%2015.%20EXHIBITS,%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists all financial statements, schedules, and exhibits filed as part of the annual report - This item provides a list of all **financial statements, schedules, and exhibits** filed as part of the Form 10-K[542](index=542&type=chunk)[544](index=544&type=chunk) [Form 10-K Summary](index=106&type=section&id=ITEM%2016.%20FORM%2010-K%20SUMMARY) The company has elected not to provide a Form 10-K summary - None[548](index=548&type=chunk)

2nd line Esophageal SCC (after failure on first line IO) Sponsor/Partner Qilu Pharmaceutical (funds all development in China) Phase 2b, double-blind, placebo-controlled, randomized study evaluating LSTA1 + SoC (Qilu-produced nab-paclitaxel and gemcitabine) vs. placebo + SoC Objective response rate, progression free survival, overall survival Safety 47 • Sponsor/Partner: Qilu Pharmaceutical (funds all development in China) Gemcitabine + Qilu produced nab-paclitaxel + LSTA1 3.2 mg/kg Disease Progression MORPH ...

Lisata Therapeutics, Inc. (NASDAQ:LSTA) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants John Menditto - VP, IR and Corporate Communications Dave Mazzo - CEO David Slack - President and Chief Business Officer James Nisco - VP, Finance and Treasury Kristen Buck - EVP, Research and Development and Chief Medical Officer Conference Call Participants Peter Enderlin - MAZ Partners Shubhendu Roy - Brooklyn Capital Markets Operator Welcome to the Lisata Therapeutics Third Quarter 2 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from __________________ to _________________________ Commission File Number 001-33650 LISATA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Del ...