Many drugs are available for schizophrenia, but insufficient efficacy and intolerable side effects leave an unmet need that biotech companies are still trying to fill. LB Pharmaceuticals is not pursuing a novel target. It did not even discover a new molecule. The company’s lead asset offers a new twist on an old antipsychotic that could improve on limitations of the current slate of schizophrenia drugs. LB has been building its case with clinical data. As its drug candidate approaches a pivotal test, LB is now preparing to present that case to investors.
In defiance of an IPO market that, with a few exceptions, has been mostly closed to biotech companies this year, LB has formally submitted the paperwork to take itself public. The prospectus filed late Friday does not yet list a per share price range or estimate for how much LB expects to raise, but IPO research firm Renaissance Capital penciled in a $100 million placeholder figure for the planned stock offering. New York-based LB has applied to list on the Nasdaq under the proposed stock symbol “LBRX.”
There are no stock market debuts scheduled for this week as the IPO market takes its August break, Renaissance CEO Bill Smith said in his weekly newsletter. Smith added that with the growing number of companies in the IPO backlog, his firm expects a wave of new public companies this fall. If LB becomes one of them, its IPO will be a financial lifeline for a company whose dwindling cash necessitated a recent corporate restructuring that shrank its C-suite.
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The main pharmaceutical ingredient in LB’s drug, LB-102, is a derivative of amisulpride, a compound that emerged from Sanofi’s labs in the 1980s as the schizophrenia medication branded as Solian, LB said in the filing. Solian is approved and available in more than 50 countries, but the U.S. is not one of them. In 2000, Sanofi said it would not seek FDA approval because clinical trial and regulatory timelines for the U.S. were incompatible with the timeline for the drug’s patents. Since amisulpride’s patents expired in 2008, generic versions of the drug have launched in markets where the drug is approved.
Amisulpride is a small molecule antagonist of the dopamine receptor, the target of many schizophrenia drugs. Of the five dopamine receptors, amisulpride specifically blocks the D2 and D3 receptors. In the IPO filing, LB said third-party studies comparing antipsychotic drugs show amisulpride consistently scored near the top. LB has made changes to the molecule to improve it. The biotech said in the filing that its modifications to amisulpride enhance the molecule’s ability to cross the blood-brain barrier while preserving potency and selectivity to its targets. These changes enable the once-daily pill to be formulated at a lower dose intended to reduce side effects. Beyond the modifications that LB has made to oral amisulpride, the biotech is also developing a long-acting injectable version of the drug.
In LB-102’s dose-finding Phase 2 study, LB reported all three doses of its once-daily pill achieved statistically significant reduction in scores compared to placebo according to a scale used to measure schizophrenia symptoms. The company said the study drug was safe and well tolerated. Adverse events were consistent with other D2 antagonists; the placebo-adjusted weight gain was 2 kg (about 4.4 pounds) and across all 251 dosed subjects and only one case of sedation was reported. LB presented these results in March during the annual meeting of the Schizophrenia International Research Society.
“We developed LB-102 in order to address the limitations of amisulpride with a differentiated therapeutic profile and strong intellectual property protection,” LB said in the IPO filing. “We believe LB-102’s mechanism of action, data from our recently completed Phase 2 trial of LB-102 in acute schizophrenia, and the legacy of clinical experience with amisulpride support the continued development of LB-102 in schizophrenia and bipolar depression.”
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LB said it has raised $120 million since its inception in 2015. Deep Track Capital is the largest shareholder owning 19.6% of the company followed by Vida Ventures’ 15.7% stake, the filing shows. Both firms participated in LB’s most recent financing, a $75 million Series C round that closed in early 2024. That money is dwindling. As of the end of June, LB reported its cash position was just $14.2 million. The shortage of funds sparked a corporate restructuring in May to streamline operations and extend the cash runway, LB said in the filing. The job cuts included the chief financial officer and chief scientific officer. As of Aug. 15, LB said its headcount was 16.
Without specifying any dollar amounts, the IPO filing states LB’s existing cash combined with the IPO proceeds will fund a Phase 3 test of LB-102 in acute schizophrenia as well as an open-label safety trial to gather the data to support regulatory approval. LB plans to begin the Phase 3 test in the first quarter of next year with preliminary data expected in the second half of 2027.
LB-102 has also reached Phase 1 development in bipolar depression. LB plans to use the new capital to advance the drug through Phase 2 testing in this indication. This mid-stage test is planned to start in the first quarter of 2026; preliminary data are expected in early 2028. LB believes LB-102 has the potential address other psychosis-related diseases, such as bipolar mania and Alzheimer’s disease-related psychosis. The company is assessing other mood disorders and neuropsychiatric diseases for potential future development, the filing states.
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