Emraclidine

In another sign of life for biotech IPOs, MapLight Therapeutics successfully made its public debut on Sunday evening, raising more than $250 million as it advances a potential rival to Bristol Myers Squibb's muscarinic agonist, Cobenfy (xanomeline/trospium chloride).The company sold 14.8 million shares at $17 each, in-line with its proposed offering earlier this month. MapLight also brought in an additional $8.1-million private placement from Goldman Sachs, for a total raise of $258.9 million. Investors seemed to welcome the newly public company — the first to IPO in the fourth quarter, and only the second new entrant on NASDAQ since mid-February — as its shares climbed about 13% during its first day of trading on Monday. MapLight's debut follows that of LB Pharma's in September, which broke a seven-month IPO dry spell. The success of the two companies — which both have mid-stage schizophrenia candidates — during a dearth of debuts suggests that investors are keen on new neuropsychiatric drugs, and that being sufficiently advanced in the clinic is a must. Muscarinic comeback?While LB Pharma's asset, LB-102, is a methylated derivative of second-generation antipsychotic drug amisulpride, MapLight's lead candidate, ML-007C-MA, is an M1/M4 muscarinic agonist co-formulated with a peripherally acting anticholinergic. The experimental therapy has a similar mechanism of action as Cobenfy, which last year became the first approved muscarinic-targeting drug for schizophrenia — but it hasn't all been smooth sailing for the therapeutic class. AbbVie's selective M4 muscarinic modulator emraclidine, gained via its $8.7 billion buyout of Cerevel Therapeutics in late 2023, went on to fail a pair of Phase II schizophrenia studies. And BMS's attempt to expand Cobenfy's label to include its use as an add-on treatment for schizophrenia was hit with a late-stage miss that left investors and physicians alike underwhelmed (see – KOL Views Q&A: Leading psychiatrist’s disappointment with BMS’s Cobenfy runs deeper than ARISE setback). MapLight is betting that ML-007C-MA's formulation could set it apart from other muscarinic agonists by improving its efficacy while still avoiding the side effects seen with dopaminergic atypical antipsychotics.The drug is being tested in two Phase II trials: one involving in-patient adults with schizophrenia, and the other studying Alzheimer's disease psychosis. Each is enrolling about 300 participants and is expected to read out in early 2027, according to ClinicalTrials.gov.

Up to $120 million of its planned IPO funds will be used to finance the ongoing phase 2 study of Maplight Therapeutics\' muscarinic agonist ML-007C-MA for schizophrenia. \n MapLight Therapeutics is hoping to raise up to $262 million from its IPO, with the proceeds earmarked for its challenger to Bristol Myers Squibb’s schizophrenia med Cobenfy.The California-based biotech previously outlined plans for an anticipated Nasdaq listing, but only yesterday did the company attach some numbers to the plan. The idea is for MapLight to offer 14.7 million shares priced at $17 apiece, according to an Oct. 6 filing with the Securities and Exchange Commission (SEC).This should bring in net proceeds of $227.3 million—rising to $262.3 million if underwriters take up their full option of buying an additional 2.21 million shares at the same price.Up to $120 million of the funds will be used to finance the ongoing phase 2 study of MapLight’s M1/M4 muscarinic agonist ML-007C-MA for schizophrenia. The 300-person trial kicked off in July.Another batch of up to $70 million of the IPO proceeds has also been earmarked for a phase 2 study of ML-007C-MA in Alzheimer’s disease psychosis, which launched last month.Beyond that, up to $25 million is expected to fund an ongoing phase 2 study of MapLight’s 5-HT agonist ML-004 for autism spectrum disorder, with up to $40 million to be spent on preclinical studies of the GPR52 positive allosteric modulator ML-009 and the M4 antagonist ML-021.Though supported by Big Pharmas like Sanofi and Novo Nordisk parent company Novo Holdings, MapLight has readily burned through heaps of cash. The biotech’s deficit was $251.6 million as of June 30, per the latest SEC filing, with $60.5 million on hand. Should the IPO go through, MapLight would become just the second biotech to go public since February, following in the footsteps of LB Pharmaceuticals’ approximately $285 million listing earlier this month.While the IPO market has been largely stagnant for most of the year, it looks like schizophrenia biotechs are among the few willing to take the risk of going public. Besides MapLight, LB Pharmaceuticals also announced in September that it is hoping to raise up to $263 million from an IPO in order to finance its oral schizophrenia candidate.After decades of no new options, the schizophrenia space was shaken up last year with the approval of Bristol Myers Squibb’s Cobenfy. Since then, rival candidates from other companies have continued to struggle in the clinic, including Boehringer Ingelheim’s iclepertin, AbbVie’s emraclidine and Atai Life Sciences’ inidascamine.