Lisata Therapeutics Q1 2024 Financials and Business Update

Lisata Therapeutics, Inc. (Nasdaq: LSTA), a clinical-stage pharmaceutical enterprise, is advancing therapies for advanced solid tumors and other severe diseases. In a recent business update, the company highlighted key developments and financial outcomes for the first quarter of 2024. According to David J. Mazzo, Ph.D., President and CEO of Lisata, 2024 is a crucial period for the company, marked by notable progress and financial stability.

A pivotal highlight for the company is the top-line data anticipated from the Phase 2b ASCEND trial in the fourth quarter of 2024. The ASCEND trial is significant for Lisata, as its results could shape the company's future strategies. These findings will be essential for exploring conditional approvals with regulatory bodies or designing an optimized Phase 3 program in pancreatic ductal adenocarcinoma. Furthermore, in 2024, Lisata secured U.S. FDA Orphan Drug and Rare Pediatric Disease designations for certepetide in osteosarcoma, enhancing the therapeutic potential of this innovative compound.

On the financial front, Lisata maintains that its available cash will support operations through early 2026, ensuring the completion of all ongoing and planned trials. This financial projection is bolstered by prudent financial management, which enables the company to reach critical milestones efficiently.

Development Portfolio Highlights

Certepetide is Lisata's lead drug candidate, designed to enhance the delivery of anti-cancer drugs to solid tumors. The drug activates the CendR uptake pathway, allowing co-administered drugs to penetrate tumors more effectively while sparing normal tissues. Preclinical models suggest that certepetide can modify the tumor microenvironment, potentially increasing the effectiveness of immunotherapies and inhibiting metastasis.

Certepetide has demonstrated favorable safety, tolerability, and activity in clinical trials, particularly in enhancing the delivery of standard-of-care chemotherapy for metastatic pancreatic cancer (mPDAC). The drug has received multiple designations, including orphan drug status for pancreatic cancer, glioblastoma multiforme (GBM), and osteosarcoma in the U.S. and Europe, as well as Fast Track and Rare Pediatric Disease designations from the FDA.

Several clinical studies are underway or planned to evaluate certepetide's effectiveness in various solid tumors:

1. ASCEND Trial: A Phase 2b double-blind, randomized, placebo-controlled trial evaluating two dosing regimens of certepetide in combination with gemcitabine/nab-paclitaxel SOC chemotherapy in mPDAC patients. Conducted at 25 sites in Australia and New Zealand, the trial's interim analysis in 2023 indicated it should proceed to completion, with top-line data expected in late 2024 and full data by mid-2025.

2. BOLSTER Trial: A Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the U.S. assessing certepetide with SOC in first-line cholangiocarcinoma. Enrollment is expected to conclude by the end of the third quarter of 2024.

3. CENDIFOX Trial: A Phase 1b/2a open-label trial in the U.S. testing certepetide with neoadjuvant FOLFIRINOX-based therapies in pancreatic, colon, and appendiceal cancers. Enrollment completion is anticipated by the end of 2024.

4. Qilu Pharmaceutical Collaboration: In Greater China, Qilu Pharmaceutical is evaluating certepetide with gemcitabine and nab-paclitaxel for mPDAC. Preliminary data presented at the 2023 ASCO Annual Meeting supported earlier findings, and a Phase 2 placebo-controlled trial is now underway.

5. iLSTA Trial: A Phase 1b/2a single-center trial in Australia testing certepetide with the checkpoint inhibitor durvalumab plus SOC chemotherapy in locally advanced non-resectable PDAC. Enrollment completion is expected in the second half of 2024.

Additionally, a Lisata-funded Phase 2a study is evaluating certepetide with temozolomide in newly diagnosed GBM patients in Estonia and Latvia.

First Quarter 2024 Financial Highlights

For the quarter ending March 31, 2024, Lisata reported operating expenses of $6.6 million, slightly down from $6.8 million in the same period of 2023. Research and development expenses remained stable at approximately $3.2 million, while general and administrative expenses decreased by 8.3% to $3.4 million, primarily due to reduced staffing costs and other operational efficiencies. Consequently, net losses decreased to $5.4 million from $6.2 million in the previous year.

Balance Sheet Highlights

As of March 31, 2024, Lisata reported cash, cash equivalents, and marketable securities totaling approximately $43.3 million. The company is confident that its current capital will support operations through early 2026, covering all anticipated data milestones from ongoing and planned clinical trials.

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