Lipocine Announces Financial Results for the Third Quarter of 2026

Quarterly revenue included $2.1 million in license revenue, while nine-month research and development spending increased.

Rhea-AI Summary

Lipocine (NASDAQ: LPCN) reported a third-quarter 2026 net loss of $666,192, narrowing from the comparable quarter in 2025. Diluted loss per share improved to $0.08 from $0.59, while revenue rose to $2,290,072 from $114,574. Unrestricted cash, cash equivalents and marketable investment securities totaled $21.5 million at September 30, versus $14.9 million at year-end 2025; the unaudited November 4 balance was approximately $28.5 million.

Lipocine initiated BLOOM, a Phase 3 postpartum depression study expected to enroll approximately 120 participants. The company said FDA feedback identified a positive, well-controlled Phase 3 trial as the remaining requirement for its proposed application package. TLANDO received Canadian approval, and TESTYRA received UAE authorization; partners plan launches in early 2027. Nine-month net loss narrowed to $6,960,681 from $7,257,421, despite higher research and administrative expenses.

15 points · 0 major

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1 major · 7 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointThird-quarter revenue rose to $2,290,072 from $114,574, including $2,100,000 license revenue and $190,072 royalties.
• Moderate pointThird-quarter net loss narrowed to $666,192 from $3,186,832; diluted loss per share improved to $0.08 from $0.59.
• Moderate pointUnrestricted cash and investments increased to $21.5 million at September 30 from $14.9 million at year-end 2025.
• Moderate pointNovember 4 unrestricted cash and investments totaled approximately $28.5 million, unaudited.
• Moderate pointThird-quarter research and development expenses fell to $2,070,033 from $2,707,777 a year earlier.
• Moderate point. Forward-looking: it has not happened yet and may not happen.BLOOM Phase 3 study initiated for postpartum depression, with approximately 120 participants expected.
• Moderate pointTLANDO received Health Canada approval for testosterone replacement in adult males with deficient or absent endogenous testosterone.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Canadian and UAE launches are planned by Verity Pharma and Pharmalink, respectively, in early 2027.

7 minor points

• Minor pointNine-month revenue increased to $2,599,568 from $831,287, including $2,100,000 license revenue and $499,568 royalties.
• Minor pointNine-month net loss narrowed to $6,960,681 from $7,257,421; diluted loss per share improved to $0.90 from $1.35.
• Minor pointThird-quarter interest and investment income increased to $202,333 from $174,208; nine-month income reached $599,754 versus $598,357.
• Minor pointTESTYRA received UAE marketing authorization through distribution partner Pharmalink.
• Minor point. Forward-looking: it has not happened yet and may not happen.LPCN 2203 oral pharmacokinetic studies completed; Lipocine plans a Phase 2 essential tremor protocol submission.
• Minor point. Forward-looking: it has not happened yet and may not happen.LPCN 2201 Phase 2 protocol submission planned after clinical assessment of oral brexanolone formulations.
• Minor pointPartnership exploration continues for BRLIZIO development and commercialization and TLANDO in additional territories.

Negative

• Major pointOutstanding common shares increased to 8,245,462 at September 30 from 6,158,443 at year-end 2025, diluting holders.
• Moderate pointOne positive, well-controlled Phase 3 trial remains necessary for the proposed BRLIZIO application package.
• Minor pointThird-quarter general and administrative expenses increased to $1,088,564 from $767,837 a year earlier.
• Minor pointNine-month research and development expenses increased to $6,875,816 from $5,906,118 a year earlier.
• Minor pointNine-month general and administrative expenses increased to $3,283,987 from $2,780,747 a year earlier.

2 minor points

• Minor pointLPCN 2201 and LPCN 2203 future studies remain subject to resource prioritization.
• Minor pointLPCN 2401 study was placed on hold in 2025.

News Explained

The third-quarter report records 8,245,462 common shares outstanding at September 30, 2026, versus 6,158,443 at December 31, 2025; compared with the year-end share base, unchanged holdings represent a smaller portion of outstanding common stock.

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SALT LAKE CITY, Nov. 5, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company focused on the development of novel oral therapeutics, today announced financial results for the third quarter ended September 30, 2026 and provided a corporate update.

Recent Developments and Corporate Update

LPCN 1154 (BRLIZIO™) for Postpartum Depression (PPD)

In September 2026, Lipocine announced the initiation of the BLOOM (Brexanolone Lifting Outcomes of Moms) study.  The Phase 3 placebo-controlled outpatient study is expected to enroll approximately 120 participants with PPD and is designed to generate prospective efficacy and safety evidence to support a potential New Drug Application (NDA) under the 505(b)(2) pathway. Feedback from a recent meeting with the FDA, including the necessity of a positive and well-controlled Phase 3 trial, together with learnings from the prior Phase 3 trial, are incorporated into the BLOOM study design. Further, feedback from the FDA acknowledged that the NDA submission package presented to FDA appears complete to support 505(b)(2) NDA submission with the exception of the need for a single positive and well controlled Phase 3 trial.

• Lipocine continues to explore business partnerships for the development, approval and commercialization of BRLIZIO™ (LPCN 1154).

Other Neuroactive Steroid Programs

• LPCN 2201 for Major Depressive Disorder (MDD): Following planned clinical assessment of unique oral brexanolone formulations, Lipocine plans to submit a Phase 2 protocol to the FDA and may initiate a study of LPCN 2201 in MDD, subject to resource prioritization.
• LPCN 2203 for Essential Tremor (ET): Lipocine has completed oral pharmacokinetic studies of LPCN 2203 and plans to submit a protocol for a proof-of-concept Phase 2 study in essential tremor to the FDA. Any future studies of LPCN 2203 will be subject to resource prioritization. 

TLANDO®

• In September 2026, Health Canada approved TLANDO® (testosterone undecanoate) capsules for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (male hypogonadism). Verity Pharma, Lipocine's partner in North America, is planning for launch in Canada in early 2027.
• In July 2026, Lipocine's distribution partner Pharmalink received product marketing authorization approval in the United Arab Emirates for TESTYRA® (TLANDO). Pharmalink is planning for launch in the UAE in early 2027.
• Lipocine continues to explore partnering TLANDO in territories outside the U.S., Canada, South Korea, the GCC countries and Brazil.

Third Quarter Ended September 30, 2026 Financial Results

As of September 30, 2026, Lipocine had $21.5 million of unrestricted cash, cash equivalents and marketable investment securities, compared to $14.9 million at December 31, 2025. As of November 4, 2026, the Company had approximately $28.5 million of unrestricted cash, cash equivalents and marketable investment securities (unaudited).

Lipocine reported a net loss of $0.7 million, or ($0.08) per diluted share, for the quarter ended September 30, 2026, compared to a net loss of $3.2 million, or ($0.59) per diluted share, for the quarter ended September 30, 2025.

Lipocine recognized total revenue of $2.3 million during the quarter ended September 30, 2026, compared to $115,000 during the quarter ended September 30, 2025. Revenue for the third quarter of 2026 consisted of license and collaboration revenue of $2.1 million and royalty revenue from TLANDO sales of $190,000. Revenue for the third quarter of 2025 consisted entirely of royalty revenue from TLANDO sales.

Research and development expenses were $2.1 million and $2.7 million, respectively, for the quarters ended September 30, 2026 and 2025. The decrease primarily reflects lower costs related to the LPCN 2401 study, which was placed on hold in 2025, and lower LPCN 1154 clinical costs in 2026 compared with costs incurred for the prior Phase 3 study during the third quarter of 2025, partially offset by an increase in personnel costs.

General and administrative expenses were $1.1 million and $0.8 million, respectively, for the quarters ended September 30, 2026 and 2025. The increase primarily reflects higher personnel costs and higher legal fees related to protecting the Company's intellectual property and promoting its corporate strategy.

Interest and investment income was $0.2 million for each of the quarters ended September 30, 2026 and 2025.

Nine Months Ended September 30, 2026 Financial Results

Lipocine reported a net loss of $7.0 million, or ($0.90) per diluted share, for the nine months ended September 30, 2026, compared to a net loss of $7.3 million, or ($1.35) per diluted share, for the nine months ended September 30, 2025.

Lipocine recognized revenue of $2.6 million and $831,000 during the nine months ended September 30, 2026 and 2025, respectively. Revenue for the 2026 period consisted of license and collaboration revenue of $2.1 million and royalty revenue from TLANDO sales of $500,000. Revenue for the 2025 period consisted of license revenue of $500,000 and royalty revenue from TLANDO sales of $331,000.

Research and development expenses were $6.9 million and $5.9 million, respectively, for the nine-month periods ended September 30, 2026 and 2025. The increase primarily reflects higher costs related to LPCN 1154 studies and other clinical trial costs, as well as an increase in personnel expense.

General and administrative expenses were $3.3 million and $2.8 million, respectively, for the nine-month periods ended September 30, 2026 and 2025. The increase primarily reflects higher legal fees related to protecting the Company's intellectual property and promoting its corporate strategy, as well as an increase in personnel expense.

Interest and investment income was $0.6 million for each of the nine-month periods ended September 30, 2026 and 2025.

For further detail on Lipocine's financial results for the three and nine months ended September 30, 2026, refer to the Company's Form 10-Q filed with the SEC.

About Lipocine

Lipocine is a biopharmaceutical company developing oral therapeutics using its proprietary drug-delivery technology platform. The Company advances product candidates addressing significant unmet medical needs and explores partnerships to support their development and commercialization.

Lipocine's development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2201 for treatment of major depressive disorder, LPCN 2101 for the treatment of epilepsy, LPCN 2203 targeted for the management of essential tremor, LPCN 2401 as an aid for improved body composition in obesity management, LPCN 1148 targeted for the management of symptoms associated with liver cirrhosis, and LPCN 1107 our candidate for prevention of preterm birth. 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 development of our products and product candidates and related efforts with the FDA, including the design, planned enrollment, timing and potential outcomes of the BLOOM study; the sufficiency of existing financial and operational resources to execute the study; expected average monthly cash use, study expenditures and cash needs; the timing of clinical trials and regulatory submissions; the timing of anticipated commercial launches of licensed products; the potential uses and benefits of our products and product candidates; the commercial potential for our product candidates; and potential strategic partnerships and other opportunities. 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, 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 an 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, variability in enrollment and site performance, study costs exceeding current estimates, 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,
						2026		2025
Current assets:
	Cash and cash equivalents					$              25,94,151		$         52,05,842
	Marketable investment securities					1,88,61,297		97,24,545
	Accrued interest income					2,08,462		14,189
	License fee and royalties receivable					6,90,071		11,45,390
	Prepaid and other current assets					7,58,676		7,87,600
	Total current assets					2,31,12,657		1,68,77,566
Property and equipment, net of accumulated depreciation
of $1,328,188 and $1,284,079 respectively						60,184		1,04,293
Other assets						23,753		23,753
	Total assets					$           2,31,96,594		$      1,70,05,612
	Liabilities and Stockholders' Equity
Current liabilities:
	Accounts payable					$                5,44,347		$          9,71,822
	Accrued expenses					11,70,099		12,36,374
	Deferred revenue					3,20,000		3,20,000
		Total current liabilities				20,34,446		25,28,196
		Total liabilities				20,34,446		25,28,196
Commitments and contingencies
Stockholders' equity:
	Common stock, par value $0.0001 per share, 75,000,000
	shares authorized; 8,245,798 and 6,158,779 issued and
	8,245,462 and 6,158,443 outstanding, respectively					9,153		8,944
	Additional paid-in capital					23,75,77,314		22,39,01,106
	Treasury stock at cost, 336 shares					(40,712)		(40,712)
	Accumulated other comprehensive income					(26,559)		4,445
	Accumulated deficit					(21,63,57,048)		(20,93,96,367)
		Total stockholders' equity				2,11,62,148		1,44,77,416
		Total liabilities and stockholders' equity				$           2,31,96,594		$      1,70,05,612

 

	LIPOCINE INC. AND SUBSIDIARIES
	Condensed Consolidated Statements of Operations and Comprehensive Loss
	(Unaudited)
							Three Months Ended September 30,				Nine Months Ended September 30,
							2026		2025		2026		2025
	Revenues:
		License revenue					$            21,00,000		$                       -		$            21,00,000		$             5,00,000
		Royalty revenue					1,90,072		1,14,574		4,99,568		3,31,287
		Total revenues					22,90,072		1,14,574		25,99,568		8,31,287
	Operating expenses:
		Research and development					20,70,033		27,07,777		68,75,816		59,06,118
		General and administrative					10,88,564		7,67,837		32,83,987		27,80,747
		Total operating expenses					31,58,597		34,75,614		1,01,59,803		86,86,865
		Operating loss					(8,68,525)		(33,61,040)		(75,60,235)		(78,55,578)
	Other income:
		Interest and investment income					2,02,333		1,74,208		5,99,754		5,98,357
		Total other income					2,02,333		1,74,208		5,99,754		5,98,357
		Loss before income tax expense					(6,66,192)		(31,86,832)		(69,60,481)		(72,57,221)
	Income tax expense						-		-		(200)		(200)
		Net loss attributable to common shareholders					$            (6,66,192)		$         (31,86,832)		$          (69,60,681)		$         (72,57,421)
	Basic loss per share attributable to common stock						$                  (0.08)		$                 (0.59)		$                  (0.90)		$                 (1.35)
	Weighted average common shares outstanding, basic						82,44,542		54,13,149		77,57,487		53,71,458
	Diluted loss per share attributable to common stock						$                  (0.08)		$                 (0.59)		$                  (0.90)		$                 (1.35)
	Weighted average common shares outstanding, diluted						82,44,542		54,13,149		77,57,487		53,71,458
	Comprehensive loss:
		Net loss					$            (6,66,192)		$         (31,86,832)		$          (69,60,681)		$         (72,57,421)
		Net unrealized gain (loss) on marketable investment securities					(13,158)		5,870		(31,004)		(4,511)
		Comprehensive loss					$            (6,79,350)		$         (31,80,962)		$          (69,91,685)		$         (72,61,932)

 

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SOURCE Lipocine Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is Lipocine's BLOOM study for postpartum depression?

BLOOM is a Phase 3 placebo-controlled outpatient study of LPCN 1154, or BRLIZIO, expected to enroll approximately 120 participants with postpartum depression. It is designed to generate prospective efficacy and safety evidence supporting a potential New Drug Application under the 505(b)(2) pathway.

Why did Lipocine's third-quarter 2026 research and development expenses decrease?

The decrease primarily reflected lower LPCN 2401 and LPCN 1154 study costs, partly offset by higher personnel costs. The LPCN 2401 study was placed on hold in 2025, while LPCN 1154 clinical costs were lower than costs for the prior Phase 3 study during the third quarter of 2025.