Lipocine Announces Second Quarter 2019 Financial and Operational Results

Second Quarter 2019 Financial and Operational Results

LAKE CITY, August 7, 2019 - Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on

metabolic and endocrine disorders, today announced financial results for the second quarter and six

months ended June 30, 2019, and provided a corporate update.

Second Quarter and Recent Corporate

"During the second quarter, we

continued to advance our pipeline, with important milestones achieved for both TLANDO and LPCN 1144," said Dr. Mahesh Patel,

Chairman, President and Chief Executive Officer of Lipocine. "The acceptance of the NDA for TLANDO for treating hypogonadism

in males puts us on track for potential approval of this product in the fourth quarter of 2019. TLANDO is designed as a fixed dose

oral TRT. For LPCN 1144, we were excited to initiate the LiFT study in biopsy confirmed NASH subjects, and based on our

observed meaningful liver fat reduction in hypogonadal males, receive FDA clearance to expand our target patient population in

adult NASH males regardless of their hypogonadal status. We believe this increases LPCN 1144's potential utility in a broader

NASH population who reportedly have low testosterone."

Second Quarter Ended June 30, 2019

Lipocine reported a net loss of $3.4

million, or ($0.14) per diluted share, for the quarter ended June 30, 2019, compared with a net loss of $3.3 million, or ($0.15)

per diluted share, in the quarter ended June 30, 2018.

Research and development expenses were

$2.0 million for the quarter ended June 30, 2019, compared with $1.5 million for the quarter ended June 30, 2018. The increase

in research and development expenses was primarily due to increases in outside service costs related to the second quarter initiation

of the LiFT LPCN 1144 Phase 2 clinical study in confirmed pre-cirrhotic NASH subjects and increased contract research organization

and outside consulting costs for TLANDO in connection with completion of the ABPM study and the filing of the NDA.

General and administrative expenses were $1.4 million for the

quarter ended June 30, 2019, compared with $1.7 million for the quarter ended June 30, 2018. The decrease in general and administrative

was primarily due to decreased personnel costs, a decrease in severance compensation, a decrease in stock compensation expense

and a decrease in bonus expense. The decreases were offset by increases in other general and administrative expenses including

an increase in professional fees, an increase in corporate insurance and an increase in marketing expenses.

As of June 30, 2019, the Company had

total cash, cash equivalents and marketable securities aggregating $19.5 million, compared to $20.3 million at December 31, 2018.

Of the total cash, cash equivalents and marketable securities balances, $5.0 million is restricted under our agreement with Silicon

Valley Bank until TLANDO receives approval.

Six Months Ended June 30, 2019 Financial

Lipocine reported a net loss of $6.7

million, or ($0.28) per diluted share, for the six months ended June 30, 2019, compared with a net loss of $6.0 million, or ($0.28)

per diluted share, in the six months ended June 30, 2018.

Research and development expenses were $3.9 million for the

six months ended June 30, 2019, compared with $2.9 million for the six months ended June 30, 2018. The increase/decrease in research

and development expenses was primarily due to increased contract research organization and outside consulting costs for TLANDO

in connection with completion of the ABPM study and the filing of the NDA, increased manufacturing costs for TLANDO, increased

outside service costs related to the second quarter initiation of the LiFT LPCN 1144 Phase 2 clinical study in confirmed

pre-cirrhotic NASH subjects, increased outside contract research organization costs and sample storage costs related to TLANDO

XR (LPCN 1111) offset by decreased contract manufacturing costs for LPCN 1107 and decreased personnel costs.

General and administrative expenses

were $2.6 million for the six months ended June 30, 2019, compared with $3.4 million for the six months ended June 30, 2018. The

decrease in general and administrative was primarily due to decreased personnel costs, which includes a decrease in salaries and

related benefits mainly from the elimination of our commercial sales and marketing team in 2018, a decrease in severance compensation,

a decrease in stock compensation expense and a decrease in bonus expense of $12,000. The decreases were offset by increases in

other general and administrative expenses including an increase in professional fees and an increase in corporate insurance.

Lipocine Inc. is a clinical-stage biopharmaceutical

company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development

pipeline includes four development programs TLANDO, LPCN 1144, TLANDO XR (LPCN 1111) and LPCN 1107. TLANDO, a novel oral prodrug

of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men.

LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the

potential utility the in treatment of NASH. TLANDO XR (LPCN 1111), a novel oral prodrug of testosterone, originated and is being

developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in

Phase 2 testing. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention

of recurrent preterm birth and has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA has

been completed. For more information, please visit www.lipocine.com.

Forward Looking Statements

This 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 Lipocine's product candidates and related clinical trials, the potential

patient population for our product candidates, the timing of completion of clinical trials and expected FDA approvals, the potential

uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking

statements involve risks and uncertainties, including, without limitation, the risks that 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, 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

For further information:

Executive Vice President & Chief

Phone: (801) 994-7383

Phone: (617) 535-7743