Lipocine Announces Publication and Discussion of LPCN 1148 Manuscript at The Liver Meeting 2024 Editor's Cut Session

Announces Publication and Discussion of LPCN 1148 Manuscript at The Liver Meeting 2024 Editor's Cut Session

LAKE CITY, Nov. 18, 2024 - Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform

to augment therapeutics through effective oral delivery, today announced the publication and discussion of a manuscript "Oral

LPCN 1148 Improves Sarcopenia and Hepatic Encephalopathy in Male Patients with Cirrhosis: a randomized, placebo-controlled Phase 2 trial"

in the journal Hepatology and discussion at The Liver Meeting (AASLD) 2024 Editor's Cut: Clinical Study Session held on November

16, 2024. 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. A copy of the publication can be accessed here.

publication features the results from a Phase 2 proof-of-concept clinical trial (LPCN 1148-21-001) that evaluated LPCN 1148 in men with

cirrhosis and sarcopenia awaiting liver transplantation. The trial was conducted in two stages. Stage 1 was double blind, placebo-controlled

with participants randomized 1:1, to receive either oral LPCN 1148 or placebo. This was followed by Stage 2, a 28-week single-arm open

label extension. The publication reports the analyses from the Stage 1 readout.

results at 24 weeks showed that LPCN 1148 therapy resulted in a significant improvement in sarcopenia when compared with placebo. Furthermore,

despite most participants already on background therapies for HE, participants receiving LPCN 1148 also experienced significantly fewer

episodes of overt hepatic encephalopathy (OHE) compared to those on placebo. Additional beneficial effects of LPCN 1148, including improved

muscle quality, hemoglobin, and patient reported symptom improvement are also covered in the manuscript.

publication was discussed at The Liver Meeting during The Editors Cut: Clinical Studies' session. This session critically

discusses the most notable, influential, cutting edge, game changing clinical research papers published during the past year.

are pleased to publish the results from this important proof-of-concept study of LPCN 1148 in Hepatology, a leading peer-reviewed journal,"

said Benjamin Bruno, Ph.D., Pharm.D., Vice President of Clinical Development at Lipocine and lead author on the publication. "To

our knowledge, LPCN 1148 therapy is the first pharmacologic agent to demonstrate improvements in both sarcopenia and overt HE outcomes

in patients with cirrhosis. Our findings support further research on the efficacy of LPCN 1148 in managing cirrhosis complications, a

critical unmet medical need."

more information on the study, refer to ClinicalTrials.gov NCT04874350.

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 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 OHE.

is an episodic neurological disorder with a high recurrence rate. Up to 50% of patients with cirrhosis will experience an OHE 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 OHE is ~50%. Furthermore, cognitive impairment associated with cirrhosis results in utilization of more health care

1148 comprises testosterone dodecanoate, a unique androgen receptor agonist. It is targeted as a differentiated intervention option with

a novel multimodal MOA to elicit potential benefits in management of cirrhosis and associated comorbidities of cirrhosis.

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 development and commercialization of TLANDO

and TLANDO XR (LPCN 1111) by our licensees, the amount of the license fee, milestone payments, and royalty payments we will ultimately

receive, the ability of our licensees to grow the TLANDO franchise, our product development efforts, the application of our proprietary

platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of our product

candidates and related efforts with the FDA, including with respect to LPCN 1148 and LPCN 2401, 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 to treat CNS disorders, we may not have sufficient capital to complete the development processes for our product candidates,

we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will 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: