LB Pharma prepares for IPO funding 3-phase test with new schizophrenia drug
Many drugs can be used for schizophrenia, but the efficacy and intolerable side effects are insufficient, so biotech companies are still trying to fill in biotech. LB Pharmaceuticals is not pursuing new goals. It didn't even find new molecules. The company's lead assets provide a new twist to old antipsychotic drugs that could improve the limitations of current schizophrenia drugs. LB has been using clinical data to establish cases. As drug candidates undergo critical testing, LB is now ready to introduce the case to investors.
It does not violate the IPO market, with few exceptions, most of the biotech companies have been closed this year, and LB has formally submitted paperwork to make it public. The prospectus has not yet listed an estimate of the price range per share or estimates of how much LB is looking to raise on Friday afternoon, but the IPO research firm's Renaissance capital has a share of the placeholder in the $100 million placeholder. New York-based LB has applied for the Nasdaq list under the proposed stock symbol “LBRX”.
Renaissance CEO Bill Smith said in a weekly newsletter that there were no stock market debuts this week. Smith added that as more and more companies are stolen in the backlog of IPOs, his company expects a new wave of public companies this fall. If LB is one of them, then an IPO will become a financial lifeline, and for a company's financial life, its increasing amount of cash requires a recent company restructuring, which will reduce its C Suite.
LB said in the document that the main drug ingredient in the LB drug LB-102 is a derivative of Amisulpride, a compound that emerged from Sanofi's lab in the 1980s because Solian called Solian's schizophrenia drug. Solian was approved and obtained in more than 50 countries, but the United States is not one of them. Sanofi said in 2000 that it would not seek FDA approval because the U.S. clinical trials and regulatory schedule is incompatible with the drug patent timeline. Since Amisulpride's patent expired in 2008, a general version of the drug has been launched in the market where the drug is approved.
Amino sulfates are small-molecule antagonists of dopamine receptors, a target for many schizophrenia drugs. Among the five dopamine receptors, amino sulfate specifically blocks the D2 and D3 receptors. In an IPO application, LB said that third-party studies comparing antipsychotics showed continued scoring near the top. LB makes changes to the molecule to improve it. The biotechnology said in the document that its modifications to amino sulfate enhance the molecule's ability to cross the blood-brain barrier while retaining its potency and selectivity to its target. These changes allow once-daily medication to be formulated in lower doses to reduce side effects. In addition to LB's modifications to oral Amisulpride, biotech is developing a long-acting injection version of the drug.
In the Phase 2 study of LB-102, LB reported its three doses once a day, with a statistically significant decrease in scores compared to placebo based on the scale used to measure schizophrenia symptoms. The company said the study drug is safe and well tolerated. Adverse events were consistent with other D2 antagonists. The placebo-adjusted weight gain was 2 kg (approximately 4.4 lbs), and in all 251 subjects, there was only one sedative. LB presented these results in March at the annual meeting of the International Society for Research on Schizophrenia.
“We developed LB-102 to address the limitations of Amisulpride with differentiated therapeutic concepts and strong intellectual property protection,” LB said in the IPO filing. “We believe that the mechanism of action of LB-102, data from our recently completed Phase 2 trial of LB-102 acute schizophrenia, and the legacy of Amisulpride's clinical experience supports the continued development of LB-102 in schizophrenia and bipolar depression.”
LB said it has raised $120 million since its inception in 2015. Deep Track and Field Capital is the largest shareholder that owns 19.6% of the company, followed by a 15.7% stake in Vida Ventures. Both companies participated in LB’s recent financing, which is the $75 million Series C Series C in 2024. This money is decreasing. As of the end of June, LB reported its cash position of only $14.2 million. The shortage of funds triggered a company restructuring in May to simplify operations and expand the cash runway, LB said in the filing. The layoffs include Chief Financial Officer and Chief Scientific Officer. As of August 15, LB said its number of employees was 16.
The IPO application states that no dollar amount was specified, and that the existing cash of LB combined with IPO proceeds will fund Phase 3 testing of LB-102 for acute schizophrenia, as well as an open-label safety trial to collect data to support regulatory approval. LB plans to start the third phase of testing in the first quarter of next year and expect preliminary data for the second half of 2027.
LB-102 has also reached its first stage of development in bipolar depression. The LB plans to use new capital to advance the drug through a Phase 2 test in this direction. The interim test is scheduled to begin in the first quarter of 2026; preliminary data are expected in early 2028. LB believes that LB-102 has potential other psychiatric-related diseases, such as bipolar mania and Alzheimer's disease-related psychiatric disorders. The company is evaluating other mood disorders and neuropsychiatric disorders to achieve potential future developments.
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