Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2025
Lipocine (NASDAQ: LPCN) reported Q2 2025 financial results, highlighting a net loss of $2.2 million ($0.41 per share) and cash position of $17.9 million. The company's key developments include progress in their LPCN 1154 Phase 3 trial for postpartum depression treatment and plans to initiate a Phase 2 study for LPCN 2401 in obesity management.
Revenue for Q2 2025 included $123,000 in TLANDO royalties and $500,000 in license revenue. The company expanded TLANDO's global reach through partnerships with Aché Laboratórios for Brazil and Verity Pharma's NDS filing in Canada. Operating expenses showed improved efficiency with reduced G&A costs of $0.9 million, down from $1.5 million in Q2 2024.
Lipocine (NASDAQ: LPCN) ha comunicato i risultati finanziari del secondo trimestre 2025, evidenziando una perdita netta di 2,2 milioni di dollari (0,41 dollari per azione) e una posizione di cassa di 17,9 milioni di dollari. Tra i principali sviluppi dell'azienda si segnalano i progressi nella sperimentazione di fase 3 di LPCN 1154 per il trattamento della depressione post-partum e i piani per avviare uno studio di fase 2 su LPCN 2401 nella gestione dell'obesità.
I ricavi del secondo trimestre 2025 hanno incluso 123.000 dollari da royalties di TLANDO e 500.000 dollari da licenze. L'azienda ha ampliato la diffusione globale di TLANDO grazie a partnership con Aché Laboratórios per il Brasile e la presentazione di NDS da parte di Verity Pharma in Canada. Le spese operative hanno mostrato una maggiore efficienza con una riduzione dei costi generali e amministrativi a 0,9 milioni di dollari, in calo rispetto a 1,5 milioni nel secondo trimestre 2024.
Lipocine (NASDAQ: LPCN) reportó los resultados financieros del segundo trimestre de 2025, destacando una pérdida neta de 2,2 millones de dólares (0,41 dólares por acción) y una posición de efectivo de 17,9 millones de dólares. Los desarrollos clave de la compañía incluyen avances en el ensayo de fase 3 de LPCN 1154 para el tratamiento de la depresión posparto y planes para iniciar un estudio de fase 2 de LPCN 2401 en el manejo de la obesidad.
Los ingresos del segundo trimestre de 2025 incluyeron 123,000 dólares en regalías de TLANDO y 500,000 dólares en ingresos por licencias. La empresa amplió el alcance global de TLANDO mediante asociaciones con Aché Laboratórios para Brasil y la presentación de NDS de Verity Pharma en Canadá. Los gastos operativos mostraron una mayor eficiencia con una reducción en los costos generales y administrativos a 0,9 millones de dólares, frente a 1,5 millones en el segundo trimestre de 2024.
Lipocine (NASDAQ: LPCN)은 2025년 2분기 재무 결과를 발표하며, 220만 달러(주당 0.41달러)의 순손실과 1790만 달러의 현금 보유고를 보고했습니다. 회사의 주요 진전 사항으로는 산후 우울증 치료를 위한 LPCN 1154 3상 시험 진행과 비만 관리용 LPCN 2401 2상 시험 개시 계획이 포함됩니다.
2025년 2분기 매출에는 TLANDO 로열티로 12만 3천 달러, 라이선스 수익으로 50만 달러가 포함되었습니다. 회사는 브라질 시장 진출을 위해 Aché Laboratórios와, 캐나다 시장을 위한 Verity Pharma의 NDS 제출을 통해 TLANDO의 글로벌 확장을 확대했습니다. 운영비용은 2024년 2분기 150만 달러에서 90만 달러로 G&A 비용이 감소하며 효율성이 향상되었습니다.
Lipocine (NASDAQ : LPCN) a publié ses résultats financiers du deuxième trimestre 2025, mettant en avant une perte nette de 2,2 millions de dollars (0,41 dollar par action) et une trésorerie de 17,9 millions de dollars. Les développements clés de la société incluent des progrès dans l’essai de phase 3 de LPCN 1154 pour le traitement de la dépression post-partum ainsi que des projets de lancement d’une étude de phase 2 pour LPCN 2401 dans la gestion de l’obésité.
Les revenus du deuxième trimestre 2025 comprenaient 123 000 dollars de redevances TLANDO et 500 000 dollars de revenus de licences. L’entreprise a étendu la portée mondiale de TLANDO grâce à des partenariats avec Aché Laboratórios au Brésil et le dépôt de NDS par Verity Pharma au Canada. Les dépenses d’exploitation ont montré une meilleure efficacité avec une réduction des coûts administratifs et généraux à 0,9 million de dollars, contre 1,5 million au deuxième trimestre 2024.
Lipocine (NASDAQ: LPCN) meldete die Finanzergebnisse für das zweite Quartal 2025 mit einem Nettoverlust von 2,2 Millionen US-Dollar (0,41 US-Dollar pro Aktie) und einer Barreserve von 17,9 Millionen US-Dollar. Zu den wichtigsten Entwicklungen des Unternehmens zählen Fortschritte in der Phase-3-Studie von LPCN 1154 zur Behandlung von postpartaler Depression sowie Pläne zur Einleitung einer Phase-2-Studie für LPCN 2401 im Bereich der Adipositasbehandlung.
Die Einnahmen im zweiten Quartal 2025 umfassten 123.000 US-Dollar an TLANDO-Royaltys und 500.000 US-Dollar an Lizenzgebühren. Das Unternehmen erweiterte die globale Reichweite von TLANDO durch Partnerschaften mit Aché Laboratórios für Brasilien und die NDS-Einreichung von Verity Pharma in Kanada. Die Betriebskosten zeigten eine verbesserte Effizienz mit reduzierten G&A-Kosten von 0,9 Millionen US-Dollar, gegenüber 1,5 Millionen im zweiten Quartal 2024.
- None.
- Net loss of $2.2M in Q2 2025, though improved from $3.1M loss in Q2 2024
- Decreased interest and investment income due to lower rates and cash balances
- Limited TLANDO royalty revenue of only $123,000 in Q2 2025
- Cash position declined from $21.6M at end of 2024 to $17.9M
Insights
Lipocine reports Q2 losses with promising pipeline advancements in PPD treatment and obesity management despite cash burn concerns.
Lipocine's Q2 2025 results paint a mixed financial picture with a net loss of
Revenue streams remain relatively thin with only
On the pipeline front, Lipocine has made significant progress with LPCN 1154, an oral brexanolone candidate for postpartum depression (PPD). The company has initiated patient dosing in a pivotal Phase 3 trial, with results expected in Q2 2026 and potential NDA submission by mid-2026. This represents a substantial opportunity in the underserved PPD market, with potential advantages over existing treatments in terms of daily activity limitations, treatment duration, and speed of effect.
Additionally, LPCN 2401 for obesity management as an adjunct to GLP-1 receptor agonists represents another strategic opportunity, with a Phase 2 proof-of-concept study planned for Q3 2025. This positions Lipocine to potentially capitalize on the booming GLP-1 market by addressing the muscle loss concerns associated with these therapies.
The company continues to expand TLANDO's global footprint through licensing agreements with Verity Pharma (US/Canada), SPC Korea, Pharmalink (GCC countries), and most recently Aché Laboratórios (Brazil). The Canadian NDS filing in June 2025 represents another potential market expansion.
The
Lipocine shows improved Q2 loss with strategic pipeline advancement but faces sustainability challenges with limited revenue streams.
Lipocine's Q2 2025 financial performance shows some positive momentum despite ongoing losses. The company reduced its quarterly net loss to
Revenue streams remain minimal but show incremental growth, with
The company's cash position of
R&D expenses increased
The company's geographic expansion strategy for TLANDO through multiple international licensing agreements (Canada, South Korea, GCC countries, Brazil) provides diversification of future revenue streams, though significant royalty contributions appear years away. The Brazilian agreement specifically includes milestone payments, royalties, and supply agreements that could provide incremental revenue.
The financial model remains heavily dependent on successful clinical development and potential partnering deals, with management explicitly stating they "may explore partnering" for both lead candidates (LPCN 1154 and LPCN 2401). This signals recognition that commercialization will likely require additional resources beyond Lipocine's current capacity.
Neuroactive Steroids
- LPCN 1154 (oral brexanolone product candidate) is a non-invasive, 48-hour treatment option targeted for rapid symptom relief of postpartum depression (PPD), a serious unmet medical need. LPCN 1154 could have advantages with respect to limitations on daily activities, treatment duration, and time to effect.
- During the second quarter, Lipocine began treating patients with PPD in the pivotal Phase 3 safety and efficacy study of LPCN 1154. This outpatient trial is expected to support a global registration package for LPCN 1154 in PPD, with topline results expected in the second quarter of 2026 and a 505(b)(2) New Drug Application (NDA) submission in the
U.S. expected in mid-2026. - On July 9, 2025, Lipocine hosted a virtual R&D investor event featuring a presentation by Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health,
New York ) discussing the current treatment landscape and unmet needs in PPD, followed by a company management presentation which reviewed the target attributes of LPCN 1154, provided a clinical development progress update including relevant data and rationale for success, and discussed next steps in the product development. A replay of the webinar can be accessed here. - Lipocine may explore the possibility of partnering LPCN 1154 with a third party for commercialization.
LPCN 2401 for Management of GLP-1 Agonist Use in Obesity
- LPCN 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist, a regulator of myostatin. It is expected to have a favorable benefit to risk profile as a non-invasive option as an adjunct to GLP-1 receptor agonist use for quality weight loss though improved body composition and/or as a monotherapy for weight maintenance and/or newly achieved glycemic status post cessation of GLP-1 receptor agonist use with demonstrated liver benefits.
- Lipocine plans to initiate a proof-of-concept Phase 2 study for LPCN 2401 in obese and overweight GLP-1 eligible patients, with appropriate body composition and functional endpoints such as measured by stair climb performance with first patient dosing targeted for the third quarter of 2025.
- 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 andCanada , if approved. In addition to the Verity License Agreement, Lipocine has entered into license/distribution agreements with SPC Korea forSouth Korea and Pharmalink for the GCC countries. - In June 2025, Verity Pharma filed a New Drug Submission (NDS) for TLANDO® in
Canada . - In April 2025, Lipocine entered a license and supply agreement with Aché Laboratórios Farmacêuitcos S.A., granting an exclusive license to commercialize TLANDO in
Brazil . Under the agreement, Lipocine is entitled to receive fees upon the achievement of certain regulatory milestones, royalties on net sales and will supply TLANDO to Aché at an agreed transfer price. TLANDO is expected to be the first oral testosterone product to be registered inBrazil .
Second Quarter Ended June 30, 2025, Financial Results
As of June 30, 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
Six Months Ended June 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 six months ended June 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 PPD, LPCN 2101 for the potential treatment of refractory 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 PPD, 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 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, 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) | ||||||||
June 30, | December 31, | |||||||
2025 | 2024 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ 6,043,980 | $ 6,205,926 | ||||||
Marketable investment securities | 11,891,702 | 15,427,385 | ||||||
Accrued interest income | 121,732 | 120,447 | ||||||
Prepaid and other current assets | 362,629 | 567,915 | ||||||
Total current assets | 18,420,043 | 22,321,673 | ||||||
Property and equipment, net of accumulated depreciation | ||||||||
of | 133,397 | 165,075 | ||||||
Other assets | 23,753 | 23,753 | ||||||
Total assets | $ 18,577,193 | $ 22,510,501 | ||||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ 442,994 | $ 271,696 | ||||||
Accrued expenses | 685,779 | 921,240 | ||||||
Deferred revenue | 320,000 | 320,000 | ||||||
Total current liabilities | 1,448,773 | 1,512,936 | ||||||
Total liabilities | 1,448,773 | 1,512,936 | ||||||
Stockholders' equity: | ||||||||
Common stock, par value | ||||||||
shares authorized; 5,374,431 and 5,348,276 issued and | ||||||||
5,374,095 and 5,347,940 outstanding, respectively | 8,865 | 8,863 | ||||||
Additional paid-in capital | 221,000,961 | 220,789,138 | ||||||
Treasury stock at cost, 336 shares | (40,712) | (40,712) | ||||||
Accumulated other comprehensive income | (1,243) | 9,138 | ||||||
Accumulated deficit | (203,839,451) | (199,768,862) | ||||||
Total stockholders' equity | 17,128,420 | 20,997,565 | ||||||
Total liabilities and stockholders' equity | $ 18,577,193 | $ 22,510,501 | ||||||
LIPOCINE INC. AND SUBSIDIARIES | ||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) | ||||||||||||
(Unaudited)
| ||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||
Revenues: | ||||||||||||
License revenue | $ 500,000 | $ - | $ 500,000 | $ 7,500,000 | ||||||||
Royalty revenue | 122,849 | 89,565 | 216,713 | 206,738 | ||||||||
Total revenues | 622,849 | 89,565 | 716,713 | 7,706,738 | ||||||||
Operating expenses: | ||||||||||||
Research and development | 2,136,769 | 1,874,721 | 3,198,341 | 4,693,646 | ||||||||
General and administrative | 890,433 | 1,507,412 | 2,012,910 | 3,083,131 | ||||||||
Total operating expenses | 3,027,202 | 3,382,133 | 5,211,251 | 7,776,777 | ||||||||
Operating loss | (2,404,353) | (3,292,568) | (4,494,538) | (70,039) | ||||||||
Other income (loss): | ||||||||||||
Interest and investment income | 198,637 | 308,845 | 424,149 | 640,209 | ||||||||
Unrealized loss on warrant liability | - | (84,430) | - | (124,502) | ||||||||
Total other income | 198,637 | 224,415 | 424,149 | 515,707 | ||||||||
Income (loss) before income tax expense | (2,205,716) | (3,068,153) | (4,070,389) | 445,668 | ||||||||
Income tax expense | - | (481) | (200) | (681) | ||||||||
Net income (loss) attributable to common shareholders | $ (2,205,716) | $ (3,068,634) | $ (4,070,589) | $ 444,987 | ||||||||
Basic earnings (loss) per share attributable to common stock | $ (0.41) | $ (0.57) | $ (0.76) | $ 0.08 | ||||||||
Weighted average common shares outstanding, basic | 5,351,957 | 5,343,922 | 5,350,267 | 5,329,876 | ||||||||
Diluted earnings (loss) per share attributable to common stock | $ (0.41) | $ (0.56) | $ (0.76) | $ 0.10 | ||||||||
Weighted average common shares outstanding, diluted | 5,351,957 | 5,343,922 | 5,350,267 | 5,459,204 | ||||||||
Comprehensive income (loss): | ||||||||||||
Net income (loss) | $ (2,205,716) | $ (3,068,634) | $ (4,070,589) | $ 444,987 | ||||||||
Net unrealized income (loss) on marketable investment securities | (6,764) | 885 | (10,381) | (16,978) | ||||||||
Comprehensive income (loss) | $ (2,212,480) | $ (3,067,749) | $ (4,080,970) | $ 428,009 | ||||||||
View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-second-quarter-ended-june-30-2025-302521416.html
SOURCE Lipocine Inc.
FAQ
What were Lipocine's (LPCN) Q2 2025 financial results?
What is the status of Lipocine's LPCN 1154 development for postpartum depression?
How has Lipocine expanded TLANDO's market presence in 2025?
What are Lipocine's plans for LPCN 2401 in obesity management?
How did Lipocine's operating expenses change in Q2 2025 compared to Q2 2024?
