In after-hours trading on Monday, Lipocine Inc. (NASDAQ: LPCN) rose 10.60% to $0.48 on no relevant news. LPCN stock lost -4.62% to finish the trading session at $0.43 fluctuating between $0.4339 and $0.4774.
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How has LPCN been recent?
It was recently announced that Lipocine (LPCN) is planning to treat disorders of the central nervous system. LPCN announced a new strategic direction, which involves developing new CNS treatments using its Lip’ral technology.
- Endogenous neuroactive steroids are LPCN’s initial focus, where it can leverage its platform to develop highly differentiated oral therapeutics that are applicable to a wide range of CNS conditions.
- They have broad applicability in treating a wide variety of CNS conditions.
- By implementing these changes, LPCN will be able to focus on a small number of candidates in active development and manage its resources more efficiently.
- The company continues to hold its non-core candidates in high regard and believes that a partnership will be the best way to advance these assets.
- It will allow LPCN to diversify its risk and create opportunities for nondilutive financing.
CNS-focused strategic direction:
Endogenous neuroactive steroids (NAS), which are shown to significantly impact central nervous system function through allosteric modulation of the GABAA receptor, are Lipocine’s top priority.
- Due to their potential to treat multiple neuropsychiatric conditions including depression, movement disorders, epilepsy, anxiety, and neurodegenerative diseases, NAS has received considerable attention as a novel class of drugs.
- A key advantage of Lipocine’s technology is that it can be used to deliver endogenous GABAA receptor modulators orally, which are traditionally difficult to deliver due to poor water solubility.
- Recently, Lippocine announced that the US Food and Drug Administration (“FDA”) agreed with its proposal to establish LPCN 1154’s efficacy by filing an NDA with a pivotal pharmacokinetic (“PK”) bridge to an approved IV infusion of brexanolone.
- In the first quarter of 2023, results are expected from the pilot PK bridge study (a prerequisite to the pivotal NDA study).
Non-core assets to be monetized
A portfolio of clinical-stage candidates has been developed by Lipcine, including LPCN 1144 for treating non-cirrhotic NASH, LPCN 1148 for treating decompensated liver cirrhosis, LPCN 1107 for preventing preterm births, and LPCN 1111 for treating TRT once a day.
This strategy aims to diversify risks and potentially create non-dilutive financing opportunities by advancing these programs through partnerships. There will be no further significant investment in these programs. Instead, LPCN 1148’s Phase 2 proof-of-concept study is being completed, and the company is pursuing ex-U.S. commercialization through partnerships of LPCN 1148 and TLANDO.
What will be the next step for LPCN?
Lipocine (LPCN) currently has $37.4 million in cash, cash equivalents, and marketable investments as of June 30, 2022. LPCN believes this cash will last until at least September 30, 2023, as well as support operations.
