Lipocine's LPCN 1148 Highlighted in the June 2025 Edition of Hepatology

LPCN 1148 Highlighted in the June 2025 Edition of Hepatology

LAKE CITY, May 22, 2025 -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to

augment therapeutics through effective oral delivery, today announced that its development candidate LPCN 1148 for men with cirrhosis

is featured in the "Hepatology Highlights" section of the June 2025 edition of Hepatology. The article "LPCN

1148: Rebuilding muscle memory in cirrhosis patients" was contributed by Dr. Kevin Harris of the Division of Gastroenterology

and Hepatology, Mayo Clinic, Minnesota. LPCN 1148 is targeted to be a "First in Class" product candidate with a novel mechanism

of action for overt hepatic encephalopathy and sarcopenia indications.

results from the Phase 2 trial are published in the same issue of Hepatology (Vol. 81, Issue 6). The publication reports the analyses

from Stage 1 of the study, during which participants were randomized 1:1 to receive either oral LPCN 1148 or placebo for 24 weeks. The

full corresponding article (Benjamin Bruno et al) can be found here.

coverage of LPCN 1148 in Hepatology reflects the growing recognition of LPCN 1148 for management of cirrhosis," said Mahesh

Patel, CEO of Lipocine. "Treatment of sarcopenia in cirrhosis is currently limited to diet and exercise. The highlight of LPCN

1148 in the premier journal of the American Association for the Study of Liver Diseases underscores the potential value of Lipocine's

novel treatment approach to improve outcomes for patients with cirrhosis."

study results, including for the Stage 2 open label extension period, were discussed during the Late Breaking Session at EASL Congress

2024 which can be found here.

US FDA has granted fast track designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. Lipocine

is exploring partnering LPCN 1148.

is an end stage liver disease of varying etiologies such as alcoholic liver disease, chronic viral hepatitis, nonalcoholic fatty liver

disease and primary cholangitis. Complications of cirrhosis include decompensation events such as hepatic encephalopathy (HE) due

to systemic ammonia buildup, variceal bleeding, and ascites, which require frequent hospitalizations. In addition, many patients exhibit sarcopenia

382,000 patients have been diagnosed with decompensated liver cirrhosis in the US, with few options for managing their disease other

than liver transplant. Poor quality of life is common while waiting for a liver transplant. Although there is a limited supply of donor

livers, transplant is the only cure for end-stage cirrhosis.

is a frequent complication and one of the most debilitating manifestations of liver disease, severely affecting the lives of patients

and their caregivers. For patients with decompensated liver cirrhosis and sarcopenia, clinical outcomes tend to be worse - both

sarcopenia and myosteatosis are associated with an increased risk of HE.

is an episodic neurological disorder with a high recurrence rate. Up to 50% of patients with cirrhosis will experience an HE episode

in their lifetime. Patients can exhibit global neurological, psychiatric, and musculoskeletal deficits. HE has a complex pathophysiology

that includes impairment of ammonia clearance and increased inflammatory cytokine and HE recurrence is common, despite use of standard-of-care

therapies. Options for prevention/treatment are limited, resulting in significant enduring unmet medical need as the 1-year survival

for patients with HE is ~50%. Furthermore, cognitive impairment associated with cirrhosis results in utilization of more health

multi-center study enrolled and dosed a total of 29 patients across 8 centers in the United States. The primary objective was

to evaluate the efficacy of 24 weeks of LPCN 1148 treatment in men with cirrhosis and sarcopenia. The secondary objective was to

evaluate the safety and tolerability of LPCN 1148. Following Week 24, the open-label stage of the study began (Stage 2), wherein

all participants received LPCN 1148 (no placebo in Stage 2).

characteristics, including age, disease etiology baseline L3-SMI, and other comorbidities were generally well-balanced between groups.

Overall, the average baseline Model for End-Stage Liver Disease (MELD) score was 16.8, and 97% of patients had previously experienced

at least one clinical decompensation event. Sarcopenia, or low muscle mass, was assessed by computed tomography (CT) scan; total

skeletal muscle area at the third lumbar vertebra was measured by CT scan and normalized by participant height (L3-SMI, L3-skeletal muscle

index). Patients had study visits every four weeks, with CTs performed at Weeks 12, 24, 36, and 52. Patients with a variety of cirrhosis

etiologies were eligible. During the study there were no restrictions on standard of care medications, procedures, or other interventions.

Further details on the study design, including inclusion and exclusion criteria, can be found on Clinicaltrials.gov (NCT04874350).

is currently evaluating LPCN 1148 comprising testosterone laurate ("TL") for the management of decompensated cirrhosis. The

Company believes LPCN 1148 targets unmet needs for patients with cirrhosis including improvement in the quality of life of patients while

on the liver transplant waiting list, prevention or reduction in the occurrence of new decompensation events such as HE, and improvement

in post liver transplant survival, including outcomes and costs.

is a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics. 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 metabolic dysfunction-associated steatohepatitis (MASH). 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 P3 safety

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

partnering of our product candidates with third parties, 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.

further information: