Lipocine Receives Updated Regulatory Guidance on LPCN 1154

Receives Updated Regulatory Guidance on LPCN 1154

LAKE CITY, Feb. 6, 2025 - Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform

to augment therapeutics through effective oral delivery, today announced receipt of revised regulatory guidance for LPCN 1154 which the

Company is developing for postpartum depression (PPD) treatment. As previously disclosed, the Company was scheduled to meet with the

U.S. Food and Drug Administration (FDA or the Division) in Q1 2025 to discuss the NDA submission package of LPCN 1154. Following the

meeting, the Company was advised that the Division believes, in addition to the previously completed PK bridge data, an efficacy and

safety study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission.

remains committed to advancing a rapid relief treatment for postpartum depression. Based on the guidance received and observed comparable

exposure of LPCN 1154 and the reference drug in the completed PK bridge study, Lipocine is planning next steps toward the execution of

a phase 3 safety and efficacy study.

regulatory guidance regarding a safety and efficacy study provides an opportunity to generate safety and depression symptom relief data

with LPCN 1154, which we believe will be beneficial for potential inclusion in product labeling and eligibility for clinical investigation

exclusivity for a 48-hour, oral treatment option," said Mahesh Patel, CEO of Lipocine. "Furthermore," Dr. Patel added,

"the planned study will investigate the potential of oral brexanolone to treat anxiety disorders, representing another attractive

commercial opportunity with a high unmet need."

1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of PPD. Brexanolone is

a bioidentical to naturally occurring neuroactive steroid, allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABAA)

receptor. LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with severe PPD, acutely elevated

suicide risk, and in whom rapid improvement is a priority while presenting no significant risk of adverse reactions to breastfed infants

from exposure to brexanolone.

Postpartum Depression and Unmet Needs

is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12

months after childbirth. Hormonal changes leading to GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include

hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in appetite, insomnia,

sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts of

death or suicide. Results from a recent survey (Truist Securities Research, January 2024) show that obstetricians believe approximately

20-40% of their patients may suffer from PPD. Further, obstetricians are comfortable making a diagnosis and prescribing antidepressants

for PPD. Traditional antidepressants, not approved for PPD, have slow onset of action, side effects such as weight gain, and do not demonstrate

adequate remission post-acute treatment.

is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery

to develop differentiated products. Lipocine has drug candidates in development as well as drug candidates for which we are exploring

partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit

to risk profile which target large addressable markets with significant unmet medical needs.

clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101

for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral

proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in

obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms

associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm

birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated

cirrhosis, and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. TLANDO, a novel oral prodrug of testosterone containing

testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone,

also known as hypogonadism, in adult males. For more information, please visit www.lipocine.com.

release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities

Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product candidates and related clinical

trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our current

intention to conduct a safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study

relating to LPCN 1154, the timing of our submission of a NDA with the FDA for LPCN 1154, and the potential uses and benefits of our product

candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation,

the risks that we may not be successful in developing product candidates, we may not have sufficient capital to complete the development

processes for our product candidates or we may decide to allocate our available capital to other product candidates, we may not be able

to enter into partnerships or other strategic relationships to monetize our non-core assets, safety and efficacy studies, including those

relating to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the FDA may not approve

any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations

and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt

of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials,

patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks

detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q,

all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking

statements contained in this release, except as required by law.

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