Lipocine Announces Financial Results for the First Quarter Ended March 31, 2025
- Initiated Phase 3 study for LPCN 1154 with NDA submission planned for 2026
- Secured new licensing agreement with Aché for TLANDO in Brazil
- Reduced R&D expenses by 60.7% year-over-year
- Maintained strong cash position of $19.7M
- Net loss of $1.9M compared to net income of $3.5M in Q1 2024
- Declining TLANDO royalty revenue (-19.7% YoY)
- No license revenue in Q1 2025 vs. $7.5M in Q1 2024
- Cash position decreased from $21.6M to $19.7M quarter-over-quarter
Insights
Lipocine reports Q1 net loss amid pipeline progress; cash position adequate while seeking strategic partnerships for multiple drug candidates.
Lipocine's Q1 2025 financial results reveal a significant transition from the previous year's profitability, with a $1.9 million net loss compared to $3.5 million net income in Q1 2024. This shift primarily stems from the absence of the $7.5 million one-time licensing revenue from Verity recognized in 2024, rather than operational deterioration. Current revenue streams remain limited, with TLANDO royalties at just $94,000, slightly down from $117,000 year-over-year.
The company's $19.7 million cash position (down from $21.6 million at end of 2024) provides approximately two years of runway at current spending levels. The notable reduction in R&D expenses (from $2.8 million to $1.1 million) reflects completed clinical work while potentially affecting development pace.
On the pipeline front, Lipocine shows meaningful advancement with LPCN 1154 for postpartum depression entering Phase 3 trials, targeting NDA submission in 2026. Their strategic approach to the obesity market demonstrates market awareness, with LPCN 2401 positioned as a complementary therapy to GLP-1 agonists rather than competing directly. The focus on elderly patients specifically addresses the unmet need regarding muscle mass and functionality loss associated with GLP-1 treatments.
The company's consistent pursuit of partnerships across their entire pipeline reveals a strategic realignment toward leveraging their oral drug delivery technology while managing resource constraints. The new licensing agreement with Aché for TLANDO in Brazil expands their global footprint, though financial terms remain undisclosed. This partnership-centric strategy could potentially generate future licensing revenues while reducing development and commercialization costs, but also signals limitations in independently advancing their pipeline.
Neuroactive Steroids
- Lipocine has initiated an outpatient Phase 3 safety and efficacy study of LPCN 1154, a non-invasive, rapid onset, oral formulation of brexanolone for the treatment of postpartum depression (PPD). Dosing of the first patient is anticipated in the second quarter of 2025. The Phase 3 study is expected to support a 505(b)(2) New Drug Application (NDA) submission in 2026.
- Lipocine is exploring the possibility of partnering LPCN 1154 with a third party.
LPCN 2401 for Obesity Management
- LPCN 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist. It is expected to have a favorable benefit to risk profile as a non-invasive option for use as an adjunct to GLP-1 receptor agonist therapies and/or as a monotherapy post cessation of GLP-1 receptor agonist therapies with demonstrated benefits to the liver.
- Based on a pre-IND meeting and 2025 FDA draft guidance on Obesity and Overweight, the FDA recommends identifying the appropriate patient population for treatment, and also recommends that an approvable endpoint would be one that measures how a patient feels, functions, or survives. Therefore, in an upcoming proof-of-concept study of LPCN 2401 as an adjunct to GLP-1 agonist, Lipocine plans to target the elderly patient population, reportedly the population most vulnerable to lean mass and functionality loss while on GLP-1 agonist treatment, with plans to include functionality measures.
- Lipocine is exploring the possibility of partnering LPCN 2401 with a third party.
TLANDO®
- Lipocine has an exclusive License Agreement with Verity Pharma (Verity), entered into in 2024, under which Verity has the rights to market TLANDO, its oral testosterone replacement therapy, in
the United States andCanada , if approved. - In April 2025, Lipocine entered into a license and supply agreement with Aché granting exclusive rights to market TLANDO® in
Brazil . Aché is a Brazilian pharmaceutical company founded nearly 60 years ago with a mission to improve people's lives. Today, Aché's products reach more than 20 countries acrossLatin America ,Africa ,Asia , andEurope , in addition to its home base inBrazil . - Lipocine continues to explore partnering TLANDO in territories outside the
U.S. ,Canada ,South Korea , the GCC countries andBrazil .
First Quarter Ended March 31, 2025, Financial Results
As of March 31, 2025, Lipocine had
Lipocine reported a net loss of
The company recognized royalty revenue from TLANDO sales of
Research and development expenses were
General and administrative expenses were
About Lipocine
Lipocine 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.
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, 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.
LIPOCINE INC. AND SUBSIDIARIES | ||||||||
Condensed Consolidated Balance Sheets | ||||||||
(Unaudited) | ||||||||
March 31, | December 31, | |||||||
2025 | 2024 | |||||||
Current assets: | ||||||||
Cash and cash equivalents | $ 3,354,596 | $ 6,205,926 | ||||||
Marketable investment securities | 16,364,050 | 15,427,385 | ||||||
Accrued interest income | 179,027 | 120,447 | ||||||
Prepaid and other current assets | 428,795 | 567,915 | ||||||
Total current assets | 20,326,468 | 22,321,673 | ||||||
Property and equipment, net of accumulated depreciation | ||||||||
of | 149,505 | 165,075 | ||||||
Other assets | 23,753 | 23,753 | ||||||
Total assets | $ 20,499,726 | $ 22,510,501 | ||||||
Current liabilities: | ||||||||
Accounts payable | $ 360,239 | $ 271,696 | ||||||
Accrued expenses | 619,410 | 921,240 | ||||||
Deferred revenue | 320,000 | 320,000 | ||||||
Total current liabilities | 1,299,649 | 1,512,936 | ||||||
Total liabilities | 1,299,649 | 1,512,936 | ||||||
Stockholders' equity: | ||||||||
Common stock, par value | ||||||||
shares authorized; 5,350,692 and 5,348,276 issued and | ||||||||
5,350,356 and 5,347,940 outstanding, respectively | 8,863 | 8,863 | ||||||
Additional paid-in capital | 220,860,140 | 220,789,138 | ||||||
Treasury stock at cost, 336 shares | (40,712) | (40,712) | ||||||
Accumulated other comprehensive income | 5,521 | 9,138 | ||||||
Accumulated deficit | (201,633,735) | (199,768,862) | ||||||
Total stockholders' equity | 19,200,077 | 20,997,565 | ||||||
Total liabilities and stockholders' equity | $ 20,499,726 | $ 22,510,501 | ||||||
LIPOCINE INC. AND SUBSIDIARIES | ||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) | ||||||||||
(Unaudited) | ||||||||||
Three Months Ended March 31, | ||||||||||
2025 | 2024 | |||||||||
Revenues: | ||||||||||
License revenue | $ - | $ 7,500,000 | ||||||||
Royalty revenue | 93,864 | 117,174 | ||||||||
Total revenues | 93,864 | 7,617,174 | ||||||||
Operating expenses: | ||||||||||
Research and development | 1,061,571 | 2,818,926 | ||||||||
General and administrative | 1,122,477 | 1,575,719 | ||||||||
Total operating expenses | 2,184,048 | 4,394,645 | ||||||||
Operating income (loss) | (2,090,184) | 3,222,529 | ||||||||
Other income: | ||||||||||
Interest and investment income | 225,511 | 331,364 | ||||||||
Unrealized loss on warrant liability | - | (40,072) | ||||||||
Total other income | 225,511 | 291,292 | ||||||||
Income (loss) before income tax expense | (1,864,673) | 3,513,821 | ||||||||
Income tax expense | (200) | (200) | ||||||||
Net income (loss) attributable to common shareholders | $ (1,864,873) | $ 3,513,621 | ||||||||
Basic earnings (loss) per share attributable to common stock | $ (0.35) | $ 0.66 | ||||||||
Weighted average common shares outstanding, basic | 5,348,557 | 5,315,830 | ||||||||
Diluted earnings (loss) per share attributable to common stock | $ (0.35) | $ 0.66 | ||||||||
Weighted average common shares outstanding, diluted | 5,348,557 | 5,357,530 | ||||||||
Comprehensive income (loss): | ||||||||||
Net income (loss) | $ (1,864,873) | $ 3,513,621 | ||||||||
Net unrealized loss on marketable investment securities | (3,617) | (17,863) | ||||||||
Comprehensive income (loss) | $ (1,868,490) | $ 3,495,758 | ||||||||
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SOURCE Lipocine Inc.
FAQ
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