Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2025

SALT LAKE CITY, Nov. 6, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the third quarter ended September 30, 2025 and provided a corporate update.

Neuroactive Steroids (NAS)

LPCN 1154 for Postpartum Depression (PPD)

LPCN 2101 for Epilepsy

LPCN 2401 for Obesity Management

TLANDO™

Third Quarter Ended September 30, 2025, Financial Results

As of September 30, 2025, Lipocine had $15.1 million of unrestricted cash, cash equivalents and marketable investment securities compared to $21.6 million at December 31, 2024.

Lipocine reported a net loss of $3.2 million, or ($0.59) per diluted share, for the quarter ended September 30, 2025, compared with net loss of $2.2 million, or ($0.44) per diluted share, for the quarter ended September 30, 2024.

Royalty revenue from TLANDO sales was $115,000 during the quarter ended September 30, 2025. No royalty revenue was recorded during the comparable period in 2024.

Research and development expenses were $2.7 million and $1.6 million, respectively, for the quarters ended September 30, 2025 and 2024. The increase in research and development expenses was due to an increase in costs primarily related to the ongoing LPCN 1154 Phase 3 clinical trial in addition to other clinical trials, offset by a decrease in other research and development costs.

General and administrative expenses were $0.8 million and $1.1 million, respectively, for the quarters ended September 30, 2025 and 2024. The decrease in general and administrative expenses was primarily a result of a decrease in business development fees incurred in 2024, a decrease in Delaware franchise tax, and a decrease in other general and administrative costs, offset by an increase in legal fees.

Interest and investment income was $0.2 million and $0.3 million, respectively for the quarters ended September 30, 2025 and 2024. The decrease was due to lower interest rates and lower cash and marketable investment securities balances in 2025 as compared to 2024.

Nine Months Ended September 30, 2025, Financial Results

Lipocine reported a net loss of $7.3 million, or ($1.35) per diluted share, for the nine months ended September 30, 2025, compared with net loss of $1.8 million, or ($0.33) per diluted share, for the nine months ended September 30, 2024.

Lipocine recognized revenue of $831,000 and $7.7 million during the nine months ended September 30, 2025 and 2024, respectively. Revenue during the nine months ended September 30, 2025, consists of license revenue of $500,000 compared to license revenue of $7.5 million resulting from the Verity Licensing Agreement during the same period in 2024. During the nine months ended September 30, 2025, and 2024, the company recognized royalty revenue from TLANDO sales of $331,000 and $207,000, respectively.

Research and development expenses were $5.9 million and $6.3 million, respectively, for the nine month periods ended September 30 2025 and 2024. The decrease was a result of lower costs related to the LPCN 1154 Phase 3 clinical study in 2025 as compared to LPCN 1154 studies which occurred in 2024, and a decrease in other research and development related costs and supplies in 2025, offset by an increase in costs related to the initiation of the LPCN 2401 clinical study.

General and administrative expenses were $2.8 million and $4.1 million, respectively, for the nine-month period ended September 30 2025 and 2024. The decrease was a result of a decrease in business development fees, a decrease related to fees incurred in 2024 in conjunction with the Verity Pharmaceutical license agreement, a decrease in other general and administrative costs, a decrease in legal fees and a decrease in estimated Delaware franchises taxes.

Interest and investment income was $0.6 million and $0.9 million, respectively, for the nine months ended September 30 2025, and 2024. The decrease was due to lower interest rates and lower cash and marketable investment securities balances in 2025 as compared to 2024.

For further details on Lipocine's financial results from the three and nine months ended September 30, 2025, refer to Form 10Q filed with the SEC.

About Lipocine

Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery. 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.

Lipocine's 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.

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 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, LPCN 2101, and LPCN 2401, our Phase 3 safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, the potential Phase 2 proof-of-concept studies for LPCN 2101 and LPCN 2401, 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 assets, clinical and other 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 and our other product candidates, 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.

LIPOCINE INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(Unaudited)

September 30,

December 31,

2025

2024

Assets

Current assets:

Cash and cash equivalents

$ 3,901,040

$ 6,205,926

Marketable investment securities

11,230,031

15,427,385

Accrued interest income

115,272

120,447

Prepaid and other current assets

683,797

567,915

Total current assets

15,930,140

22,321,673

Property and equipment, net of accumulated depreciation

of $1,269,098 and $1,223,297 respectively

119,274

165,075

Other assets

23,753

Total assets

$ 16,073,167

$ 22,510,501

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$ 861,452

$ 271,696

Accrued expenses

749,667

921,240

Deferred revenue

320,000

Total current liabilities

1,931,119

1,512,936

Total liabilities

1,931,119

1,512,936

Stockholders' equity:

Common stock, par value $0.0001 per share, 75,000,000

shares authorized; 5,420,592 and 5,348,276 issued and

5,420,256 and 5,347,940 outstanding, respectively

8,870

8,863

Additional paid-in capital

221,195,546

220,789,138

Treasury stock at cost, 336 shares

(40,712)

Accumulated other comprehensive income

4,627

9,138

Accumulated deficit

(207,026,283)

(199,768,862)

Total stockholders' equity

14,142,048

20,997,565

Total liabilities and stockholders' equity

$ 16,073,167

$ 22,510,501

LIPOCINE INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(Unaudited)

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Revenues:

License revenue

$ -

$ 500,000

$ 7,500,000

Royalty revenue

114,574

331,287

206,738

Total revenues

114,574

831,287

7,706,738

Operating expenses:

Research and development

2,707,777

1,585,233

5,906,118

6,278,881

General and administrative

767,837

1,045,240

2,780,747

4,128,371

Total operating expenses

3,475,614

2,630,473

8,686,865

10,407,252

Operating loss

(3,361,040)

(2,630,473)

(7,855,578)

(2,700,514)

Other income:

Interest and investment income

174,208

273,574

598,357

913,784

Unrealized gain on warrant liability

138,081

13,580

Total other income

174,208

411,655

598,357

927,364

Loss before income tax expense

(3,186,832)

(2,218,818)

(7,257,221)

(1,773,150)

Income tax expense

(200)

(681)

Net loss attributable to common shareholders

$ (3,186,832)

$ (2,218,818)

$ (7,257,421)

$ (1,773,831)

Basic loss per share attributable to common stock

$ (0.59)

$ (0.41)

$ (1.35)

$ (0.33)

Weighted average common shares outstanding, basic

5,413,149

5,347,940

5,371,458

5,335,941

Diluted loss per share attributable to common stock

$ (0.59)

$ (0.44)

$ (1.35)

$ (0.33)

Weighted average common shares outstanding, diluted

5,413,149

5,347,940

5,371,458

5,335,941

Comprehensive income (loss):

Net loss

$ (3,186,832)

$ (2,218,818)

$ (7,257,421)

$ (1,773,831)

Net unrealized income (loss) on marketable investment securities

5,870

19,661

(4,511)

2,683

Comprehensive loss

$ (3,180,962)

$ (2,199,157)

$ (7,261,932)

$ (1,771,148)

SOURCE Lipocine Inc.