Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2025
Rhea-AI Summary
Lipocine (NASDAQ:LPCN) reported third-quarter 2025 results and clinical program updates on November 6, 2025. The company had $15.1 million in unrestricted cash and marketable securities as of September 30, 2025 versus $21.6 million at year-end 2024.
Q3 results: net loss $3.2M (−$0.59/share); R&D expenses $2.7M; TLANDO royalty revenue $115k. Nine-month results: net loss $7.3M; revenue $831k (license revenue $500k; TLANDO royalties $331k).
Clinical: Phase 3 trial of LPCN 1154 for postpartum depression is enrolling; DSMB safety review and a safety update are planned in November 2025; top-line data expected Q2 2026 and a 505(b)(2) NDA submission is expected in 2026. The company is exploring partnerships for commercialization across programs.
Positive
- Phase 3 top-line data expected Q2 2026 for LPCN 1154
- NDA (505(b)(2)) for LPCN 1154 expected in 2026
- TLANDO royalties generated $115k in Q3 2025
Negative
- Cash decreased to $15.1M from $21.6M (Dec 31, 2024)
- Q3 net loss widened to $3.2M from $2.2M year-ago
- Nine-month revenue fell to $831k from $7.7M
- R&D expense rose to $2.7M in Q3 2025 from $1.6M
News Market Reaction 3 Alerts
On the day this news was published, LPCN gained 3.13%, reflecting a moderate positive market reaction. Argus tracked a peak move of +3.3% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $455K to the company's valuation, bringing the market cap to $15M at that time.
Data tracked by StockTitan Argus on the day of publication.
Neuroactive Steroids (NAS)
LPCN 1154 for Postpartum Depression (PPD)
- LPCN 1154 (oral brexanolone) is a non-invasive, rapid onset, oral formulation of the neuroactive steroid brexanolone that Lipocine is developing for the treatment of PPD.
- A Phase 3 safety and efficacy study evaluating LPCN 1154 as a treatment for PPD continues to enroll patients and top-line data is expected in the second quarter of 2026. A meeting of the independent Data Safety Monitoring Board (DSMB) overseeing this trial will take place to review safety data from the first one-third of participants who were randomized and completed the day seven follow up visit, and the Company plans to provide a safety update in November 2025 following the DSMB review.
- Lipocine believes data from the Phase 3 study will be beneficial for potential inclusion in product labeling and for eligibility for clinical investigation exclusivity for a 48-hour, oral treatment option.
- The Phase 3 trial is expected to support a global registration package for LPCN 1154 in PPD, including a 505(b)(2) New Drug Application (NDA) submission in the
U.S. which is expected in 2026. - On July 9, 2025, Lipocine hosted a virtual R&D investor event to discuss the current treatment landscape and unmet needs in PPD. The event featured presentations by Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health,
New York ) and by company management. A replay of the webinar can be accessed here. - Lipocine is exploring the possibility of partnering LPCN 1154 with a third party for commercialization.
LPCN 2101 for Epilepsy
- Lipocine is evaluating LPCN 2101, a neuroactive steroid GABA positive allosteric modulator for epilepsy including drug resistant epilepsy (DRE) and women with epilepsy (WWE), both of which pose significant treatment challenges under current standard of care.
- The Company may initiate a Phase 2 proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 2101, subject to resource prioritization. Pre-clinical and Phase 1 studies have demonstrated promising PK results, safety and tolerability.
- Two abstracts related to LPCN 2101 have been accepted for poster presentation at the 2025 American Epilepsy Society (AES) annual meeting to be held December 5-9 in
Atlanta, Georgia .- Oral Toxicokinetics of a Bioidentical GABAA Receptor Modulating Neuroactive Steroid (NAS) Anti-seizure Medication (ASM) Candidate for Women with Epilepsy (WWE)
- Clinical Pharmacokinetics (PK) and Tolerability of a Novel Oral GABAA Receptor Positive Allosteric Modulating (PAM) Candidate for Epilepsy
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 chronic weight management therapies and/or as a monotherapy post cessation of GLP-1 receptor agonist chronic weight management therapies with demonstrated benefits to the liver.
- Pending further regulatory guidance, Lipocine may conduct a proof-of-concept Phase 2 study for LPCN 2401 in elderly obese and overweight GLP-1 eligible patients, with possible appropriate body composition and functional end points such as stair climb performance measure.
- Lipocine may explore the possibility of partnering LPCN 2401 with a third party.
TLANDO™
- Lipocine has an exclusive License Agreement with Verity Pharma, entered into in 2024, under which Verity Pharma has the rights to market TLANDO, its oral testosterone replacement therapy, in the
United States and Canada. Rights to TLANDO have also been licensed to companies inSouth Korea , the GCC countries, andBrazil .
Third Quarter Ended September 30, 2025, Financial Results
As of September 30, 2025, Lipocine had
Lipocine reported a net loss of
Royalty revenue from TLANDO sales was
Research and development expenses were
General and administrative expenses were
Interest and investment income was
Nine Months Ended September 30, 2025, Financial Results
Lipocine reported a net loss of
Lipocine recognized revenue of
Research and development expenses were
General and administrative expenses were
Interest and investment income was
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.
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LIPOCINE INC. AND SUBSIDIARIES |
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Condensed Consolidated Balance Sheets |
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(Unaudited) |
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September 30, |
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December 31, |
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2025 |
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2024 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ 3,901,040 |
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$ 6,205,926 |
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Marketable investment securities |
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11,230,031 |
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15,427,385 |
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Accrued interest income |
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115,272 |
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120,447 |
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Prepaid and other current assets |
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683,797 |
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567,915 |
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Total current assets |
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15,930,140 |
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22,321,673 |
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Property and equipment, net of accumulated depreciation |
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of $1,269,098 and |
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119,274 |
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165,075 |
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Other assets |
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23,753 |
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23,753 |
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Total assets |
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$ 16,073,167 |
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$ 22,510,501 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ 861,452 |
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$ 271,696 |
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Accrued expenses |
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749,667 |
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921,240 |
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Deferred revenue |
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320,000 |
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320,000 |
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Total current liabilities |
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1,931,119 |
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1,512,936 |
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Total liabilities |
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1,931,119 |
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1,512,936 |
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Stockholders' equity: |
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Common stock, par value |
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shares authorized; 5,420,592 and 5,348,276 issued and |
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5,420,256 and 5,347,940 outstanding, respectively |
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8,870 |
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8,863 |
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Additional paid-in capital |
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221,195,546 |
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220,789,138 |
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Treasury stock at cost, 336 shares |
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(40,712) |
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(40,712) |
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Accumulated other comprehensive income |
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4,627 |
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9,138 |
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Accumulated deficit |
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(207,026,283) |
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(199,768,862) |
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Total stockholders' equity |
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14,142,048 |
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20,997,565 |
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Total liabilities and stockholders' equity |
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$ 16,073,167 |
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$ 22,510,501 |
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LIPOCINE INC. AND SUBSIDIARIES |
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Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) |
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(Unaudited) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenues: |
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License revenue |
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$ - |
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$ - |
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$ 500,000 |
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$ 7,500,000 |
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Royalty revenue |
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114,574 |
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- |
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331,287 |
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206,738 |
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Total revenues |
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114,574 |
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- |
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831,287 |
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7,706,738 |
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Operating expenses: |
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Research and development |
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2,707,777 |
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1,585,233 |
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5,906,118 |
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6,278,881 |
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General and administrative |
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767,837 |
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1,045,240 |
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2,780,747 |
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4,128,371 |
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Total operating expenses |
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3,475,614 |
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2,630,473 |
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8,686,865 |
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10,407,252 |
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Operating loss |
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(3,361,040) |
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(2,630,473) |
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(7,855,578) |
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(2,700,514) |
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Other income: |
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Interest and investment income |
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174,208 |
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273,574 |
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598,357 |
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913,784 |
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Unrealized gain on warrant liability |
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- |
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138,081 |
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- |
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13,580 |
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Total other income |
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174,208 |
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411,655 |
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598,357 |
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927,364 |
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Loss before income tax expense |
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(3,186,832) |
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(2,218,818) |
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(7,257,221) |
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(1,773,150) |
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Income tax expense |
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- |
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- |
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(200) |
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(681) |
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Net loss attributable to common shareholders |
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Basic loss per share attributable to common stock |
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$ (0.59) |
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$ (0.41) |
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$ (1.35) |
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$ (0.33) |
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Weighted average common shares outstanding, basic |
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5,413,149 |
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5,347,940 |
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5,371,458 |
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5,335,941 |
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Diluted loss per share attributable to common stock |
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$ (0.59) |
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$ (0.44) |
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$ (1.35) |
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$ (0.33) |
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Weighted average common shares outstanding, diluted |
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5,413,149 |
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5,347,940 |
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5,371,458 |
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5,335,941 |
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Comprehensive income (loss): |
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Net loss |
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Net unrealized income (loss) on marketable investment securities |
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5,870 |
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19,661 |
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(4,511) |
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2,683 |
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Comprehensive loss |
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View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-third-quarter-ended-september-30-2025-302606486.html
SOURCE Lipocine Inc.
FAQ
When will Lipocine (LPCN) report top-line results for LPCN 1154 Phase 3?
What cash balance did Lipocine (LPCN) report on September 30, 2025?
How much royalty revenue did Lipocine (LPCN) record from TLANDO in Q3 2025?
What recent corporate milestone should investors watch for Lipocine (LPCN) in November 2025?
Is Lipocine (LPCN) planning an NDA for LPCN 1154?
