LSTA.NASDAQLisata Therapeutics, INC
10-K: Lisata Therapeutics Reports 2024 Financial Results, Provides Business Update
Sentiment:
Annual Results
Lisata Therapeutics, a clinical-stage pharmaceutical company, details its financial performance for 2024 and provides an overview of its ongoing development programs.
Capital raiseThe company anticipates needing substantial additional financing to continue operations and develop product candidates.To both fund our clinical trials and support our future operations, it is highly probable that we would raise capital through a variety of different public and/or private financings vehicles.This could include, but not be limited to, utilization of our at-the-market offering agreement with H.C. Wainwright & Co., LLC, potential issuances of other debt or equity securities in public or private financings and/or sale or licensing of assets.
Worse than expectedThe company continues to operate at a loss, with a net loss of $20.0 million in 2024.The company has no products approved for commercial sale, and does not anticipate generating any revenue from product sales until sometime after it has received regulatory approval for a product candidate, which may never occur.
Summary
- Lisata Therapeutics, a clinical-stage pharmaceutical company, reported a net loss of $20.0 million for the year ended December 31, 2024, compared to a net loss of $20.8 million for the previous year.
- The company's research and development expenses decreased to $11.3 million in 2024 from $12.7 million in 2023, primarily due to reduced expenses in the Phase 2b ASCEND trial and lower spending on manufacturing and controls.
- General and administrative expenses also decreased to $12.1 million in 2024 from $13.0 million in 2023, attributed to severance costs, reduced equity expenses, and lower legal fees.
- Revenue for 2024 was $1.0 million, stemming from an upfront license fee related to an agreement with Kuva Labs, Inc., while there was no revenue in 2023.
- As of December 31, 2024, Lisata's cash, cash equivalents, and marketable securities totaled $31.2 million, which the company believes will fund operations into early 2026.
- The company anticipates needing substantial additional financing to continue operations and develop product candidates.
- Lisata is exploring certepetide as a means to enable a variety of treatment modalities to treat a range of solid tumors more effectively.
- Certepetide is currently the subject of several Phase 2 clinical studies being conducted globally in a variety of solid tumor types, including metastatic pancreatic ductal adenocarcinoma (mPDAC), cholangiocarcinoma, appendiceal cancer, colon cancer and glioblastoma multiforme in combination with a variety of anti-cancer regimens.
Sentiment
Score: 5
Explanation: The document presents a mixed picture. While the company has made some progress in reducing losses and securing revenue, it still faces significant challenges, including the need for additional funding and the uncertainty of clinical trials. The sentiment is neutral, reflecting the balance of positive and negative factors.
Positives
- The company's net loss decreased slightly from 2023 to 2024.
- Lisata secured a license agreement with Kuva Labs, generating $1.0 million in revenue.
- The company reduced both research and development and general and administrative expenses.
- Lisata believes its current cash position will fund operations into early 2026.
Negatives
- The company continues to operate at a loss, with a net loss of $20.0 million in 2024.
- Lisata anticipates needing substantial additional financing to continue its operations.
- The company has no products approved for commercial sale, and does not anticipate generating any revenue from product sales until sometime after it has received regulatory approval for a product candidate, which may never occur.
Risks
- The company's ability to continue as a going concern is dependent on securing additional funding.
- Clinical trials may not demonstrate the safety and efficacy of product candidates.
- The company relies on contract manufacturing organizations, and any disruption could impact its ability to perform clinical trials.
- The company may be subject to product liability claims and litigation.
- The company's stock price is highly volatile.
- The company may fail to comply with the continued listing requirements of the Nasdaq Capital Market.
Future Outlook
The company believes that its cash on hand and marketable securities will enable it to fund operating expenses for at least the next 12 months following the issuance of its financial statements. The company anticipates needing substantial additional financing to continue operations and develop product candidates.
Industry Context
The health care industry is one of the most highly regulated industries in the United States and abroad. The company faces intense competition from pharmaceutical, biopharmaceutical and biotechnology companies, as well as numerous academic and research institutions and governmental agencies engaged in drug discovery and development activities or funding, both in the United States and abroad.
Comparison to Industry Standards
- The Objective Response Rate (ORR) of 59% was observed, compared to the 23% ORR observed in the MPACT clinical trial that served as the basis for approval of the chemotherapy combination nab-paclitaxel and gemcitabine for the treatment of first line mPDAC (Von Hoff, et al. 2013).
- A Disease Control Rate (DCR) (partial and complete responses plus stable disease) of over 79% was also observed in comparison to a DCR of 48% observed in the MPACT trial.
- Reduction in the level of circulating tumor biomarker CA19-9 was observed in 96% of patients versus 61% in the MPACT trial.
- Importantly, median progression-free survival and median overall survival of nearly ten months and over thirteen months were observed versus less than six months and less than nine months, respectively, in the MPACT trial.
- The preliminary data from Cohort A were reported at the ASCO GI meeting on January 24, 2025, demonstrating a median overall survival (mOS) of 12.68 months for the certepetide treated group, compared to 9.72 months for the placebo treated group.
Management Changes
| Role | Previous Person | New Person | Effective Date | Reason |
|---|---|---|---|---|
| Senior Vice President, Finance and Treasury and Chief Accounting Officer | David J. Mazzo, PhD | James Nisco | April 15, 2024 | Appointment |
| Senior Vice President, Business Development and Operations and General Counsel | NA | Tariq Imam | February 3, 2025 | Appointment |
Legal Proceedings
- In May 2021, Cend received a written threat of litigation on behalf of a Chinese entity called Lingmed Limited (Lingmed) claiming Lingmed was entitled to a success fee based on Cends Collaboration and License Agreement with Qilu Pharmaceuticals.
- In May 2022, Cend was served with a complaint filed by Lingmed in the San Diego County Superior Court, alleging claims for breach of contract, fraud and declaratory relief.
- On March 25, 2024 the Company entered into a settlement agreement whereby the Company was required to pay Lingmed $0.5 million within 30 days of the effective date and the Company effected payment on April 4, 2024.
- Lingmed is also entitled to 5.0% of any future milestone payments received by the Company under the license agreement with Qilu in addition to a sum of $250 thousand with respect to the first future milestone received by the Company.
- On April 9, 2024, pursuant to the parties joint request, the Court entered a dismissal with prejudice of the entire action as to all parties and all claims and the matter was settled.
Stakeholder Impact
- Shareholders may experience dilution from future fundraising activities.
- Employees may be affected by changes in compensation or benefits.
- Patients may benefit from the development of new therapies.
- Suppliers and creditors may be affected by the company's financial performance.
Next Steps
- Continue clinical trials for certepetide in various solid tumor types.
- Explore partnerships to exploit the CendR Platform for applications to enhance or enable effective diagnosis and treatment of solid tumor cancers across a range of treatment modalities.
- Seek additional funding through various public and/or private financing vehicles.
Key Dates
| Date | Description |
|---|---|
| 1980 | Lisata Therapeutics, Inc. incorporated in 1980 as a Delaware corporation. |
| September 16, 2011 | Leahy-Smith America Invents Act signed into law. |
| January 1, 2013 | Employee stock purchase plan adopted. |
| 2014 | New Clinical Trials Regulation (EU) No 536/2014 was adopted. |
| July 15, 2015 | 2015 Equity Incentive Compensation Plan effective. |
| October 30, 2015 | Insider Trading Policy effective. |
| December 1, 2015 | Cend entered into an Exclusive License Agreement with the Sanford Burnham Prebys Medical Discovery Institute. |
| March 8, 2016 | First Amendment to Exclusive License Agreement between Cend and Sanford Burnham Prebys Medical Discovery Institute. |
| May 2016 | European Union formally adopted the General Data Protection Regulation (GDPR). |
| July 27, 2016 | Amended and Restated Certificate of Incorporation and Bylaws of Lisata Therapeutics, Inc. effective. |
| October 2016 | Gregory B. Brown, M.D. appointed to the board of directors. |
| March 28, 2017 | David J. Mazzo, Ph.D. appointed as President and Chief Executive Officer. |
| March 28, 2017 | 2017 Employee Stock Purchase Plan effective. |
| September 21, 2017 | Amendments to Amended and Restated Bylaws of Lisata Therapeutics, Inc. effective. |
| June 20, 2018 | 2018 Equity Incentive Compensation Plan effective. |
| November 2018 | Cynthia L. Flowers appointed to the board of directors. |
| May 10, 2019 | Second Amendment to Exclusive License Agreement between Cend and Sanford Burnham Prebys Medical Discovery Institute. |
| January 1, 2020 | California Consumer Privacy Act of 2018 (CCPA) went into effect. |
| March 2020 | Kristen K. Buck, M.D. worked at ICON plc. |
| July 1, 2020 | California Attorney General commenced enforcement actions for violations of the CCPA. |
| September 24, 2020 | Third Amendment to Exclusive License Agreement between Cend and Sanford Burnham Prebys Medical Discovery Institute. |
| March 19, 2021 | Amended and Restated Employment Agreement with David J. Mazzo dated. |
| April 14, 2021 | IND for certepetide submitted. |
| May 14, 2021 | IND for certepetide cleared by the FDA. |
| June 4, 2021 | ATM Agreement entered into with H.C. Wainwright & Co., LLC. |
| January 1, 2021 | European Union law no longer directly applies in the United Kingdom. |
| January 1, 2024 | The MHRA launched the International Recognition Procedure, or IRP. |
| January 1, 2025 | The Windsor Framework is effective. |
| January 24, 2025 | Preliminary data from Cohort A of the ASCEND trial reported at the ASCO GI meeting. |
| September 15, 2022 | Certificate of Amendment (Name Change) to the Amended and Restated Certificate of Incorporation, dated September 15, 2022. |
| September 15, 2022 | The Company performed an analysis and determined that they had an ownership change of greater than 50% on September 15, 2022. |
| September 2022 | Heidi Henson was appointed to the Lisata Board. |
| September 2022 | Mohammad Azab, MD, MBA was appointed to the board of directors. |
| February 1, 2023 | Use of the CTIS became mandatory for new clinical trial application submissions. |
| March 2023 | The United Kingdom government and the European Commission reached agreement on a regulatory framework to replace the Northern Ireland Protocol, referred to as the Windsor Framework. |
| March 4, 2024 | The Company received final approval from the New Jersey Economic Development Authority (NJEDA) under the Technology Business Tax Certificate Transfer Program (Program) to sell $8.9 million of its New Jersey net operating losses (NJ NOLs). |
| March 25, 2024 | The Company entered into a settlement agreement with Lingmed. |
| April 5, 2023 | The Company received final approval from the NJEDA under the Program to sell $25.9 million of its NJ NOLs. |
| April 15, 2024 | Mr. Nisco was appointed as our Senior Vice President, Finance and Treasury and Chief Accounting Officer. |
| April 2023 | The European Commission issued a proposal for a new Directive and a new Regulation, which will revise and replace the existing general pharmaceutical legislation. |
| July 26, 2024 | The Company's Australian subsidiary received a $0.9 million tax refund from the Australian Taxation Office related to the 2023 tax year. |
| February 3, 2025 | Mr. Imam was appointed as our Senior Vice President, Business Development and Operations and General Counsel. |
| February 27, 2025 | Class Outstanding as of February 27, 2025 Common stock, $0.001 par value per share 8,620,162 shares |
Keywords
Lisata Therapeutics, certepetide, clinical-stage pharmaceutical, financial results, research and development, oncology, solid tumors, biotechnology, clinical trials, pharmaceutical
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