Miami Biotech Longeveron Hires Lucid Capital Markets to Explore a Sale or Merger After Mixed Trial Results

MIAMI — Longeveron, the Miami cell therapy company that bet much of its future on a single pediatric heart trial, has formally opened the door to a sale or merger.

The company announced on Oct. 28 that it has retained Lucid Capital Markets as its financial advisor “to explore potential strategic opportunities, including a potential business combination.” Longeveron trades on Nasdaq under the ticker LGVN. It did not disclose terms of the engagement or a timeline, and it cautioned that the review may not produce any transaction, StreetInsider reported.

The South Florida Business Journal framed the move as the company exploring a sale or merger days after reporting new findings from the trial.

The Trial Behind the Decision

The engagement caps a turbulent two months. Longeveron’s lead product is laromestrocel, an investigational therapy made from mesenchymal stem cells taken from the bone marrow of young, healthy adult donors. Its most advanced test was ELPIS II, a Phase 2b study in 40 infants with hypoplastic left heart syndrome, or HLHS, a rare congenital defect in which the left side of the heart is underdeveloped. The company says HLHS affects roughly 1,000 infants a year in the U.S.

In September, Longeveron reported that ELPIS II missed its primary endpoint, an improvement in right ventricular ejection fraction at 12 months. Fierce Biotech reported at the time that the stock fell 60% to $2.70 in after-hours trading following the readout, and that the company said it would implement cash conservation measures and engage an investment bank to review “all options with the goal of maximizing shareholder value.”

Then, on Oct. 26, the company released updated results from additional analysis conducted with the trial’s NIH-funded investigators. A prespecified secondary endpoint, major adverse cardiac events, reached statistical significance: eight events in the standard-of-care group versus one in the laromestrocel group (P=0.043). The company also reported no treatment-related serious adverse events through 12 months.

Longeveron said it believes the secondary findings suggest laromestrocel “has the potential to meaningfully improve clinical outcomes” for children with HLHS, and that it intends to request a meeting with the FDA to discuss next steps. The ELPIS II data were also selected for a late-breaking podium presentation at the American Heart Association’s Scientific Sessions in Chicago, scheduled for Nov. 8.

It is worth reading those results carefully. As 22Miami noted, the findings point in different directions: the trial did not show the improvement it was designed to detect, and the secondary result does not establish that the therapy works or that regulators will approve it. Longeveron itself has disclosed that the FDA advised it that ejection fraction alone would not be sufficient to demonstrate efficacy for approval.

Why the Money Matters

The financial backdrop explains the urgency. According to Fierce Biotech, Longeveron ended June with $10.1 million in cash and cash equivalents, which it projected would fund operations into the fourth quarter. Earlier in the year, the company extended its runway through a private placement that provided $15 million upfront, with the potential for another $15 million tied to the Phase 2b data, Fierce reported.

The company’s own risk disclosures in the Lucid announcement list its cash position, its need to raise additional capital, its ability to continue as a going concern and the continued listing of its stock on Nasdaq among the factors investors should weigh. They also reference a planned shift toward “a more capital-efficient, asset-light operating model” and efforts to secure licensing partners for laromestrocel.

Fierce also noted turnover in the finance chair this year: CFO Lisa Locklear stepped down in July, and the company briefly named Marie Washburn to the role before appointing Nirav Jhaveri.

What a Deal Could Look Like

Longeveron has not said what kind of transaction it prefers, and “business combination” covers a wide range: an outright acquisition, a merger with another clinical-stage company, or a reverse merger in which a private biotech uses a listed company to reach the public markets. For a company of Longeveron’s size, partnerships or licensing deals for individual programs are also on the table, based on its own stated goals.

What the company has to offer is a Nasdaq listing, a cell therapy platform with five FDA designations across its HLHS and Alzheimer’s disease programs, according to the company, and fresh secondary data that it hopes regulators will find meaningful. The Nov. 8 AHA presentation and any FDA meeting are likely to shape how potential partners value that package.

The Local Angle

Longeveron is a Nasdaq-listed biotech headquartered in Miami, at 1951 NW Seventh Avenue, according to 22Miami’s review of its SEC filings. The outcome of its review will be watched closely by a regional life sciences community that has been trying to build scale alongside Miami’s better-known tech and finance boom.

For now, there is no deal, no price and no deadline. What there is: an advisor hired, a podium slot in Chicago, and a company trying to convert a mixed scientific result into a financial future.

Sources: GlobeNewswire / Longeveron, Longeveron investor relations, Fierce Biotech, 22Miami, StreetInsider, South Florida Business Journal.