Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2024
Lipocine Inc (NASDAQ: LPCN) reported Q3 2024 financial results with a net loss of $2.2 million ($0.44 per share), compared to a $6.7 million loss in Q3 2023. The company had $19.8 million in cash and equivalents as of September 30, 2024. Key developments include positive results from LPCN 1154's qEEG study for postpartum depression treatment, with NDA submission targeted for end of 2024. Lipocine signed exclusive distribution agreements for TLANDO in GCC countries and South Korea. For the nine months ended September 30, 2024, revenue was $7.7 million, primarily from licensing, with a net loss of $1.8 million.
Lipocine Inc (NASDAQ: LPCN) ha riportato i risultati finanziari del terzo trimestre del 2024 con una perdita netta di 2,2 milioni di dollari (0,44 dollari per azione), rispetto a una perdita di 6,7 milioni di dollari nel terzo trimestre del 2023. L'azienda aveva 19,8 milioni di dollari in contante e equivalenti al 30 settembre 2024. Sviluppi chiave includono risultati positivi dallo studio qEEG di LPCN 1154 per il trattamento della depressione postpartum, con una richiesta di NDA prevista per la fine del 2024. Lipocine ha firmato accordi di distribuzione esclusiva per TLANDO nei paesi del GCC e in Corea del Sud. Per i nove mesi terminati il 30 settembre 2024, il fatturato è stato di 7,7 milioni di dollari, principalmente derivante da licenze, con una perdita netta di 1,8 milioni di dollari.
Lipocine Inc (NASDAQ: LPCN) reportó resultados financieros del tercer trimestre de 2024 con una pérdida neta de 2.2 millones de dólares (0.44 dólares por acción), en comparación con una pérdida de 6.7 millones de dólares en el tercer trimestre de 2023. La compañía contaba con 19.8 millones de dólares en efectivo y equivalentes al 30 de septiembre de 2024. Los desarrollos clave incluyen resultados positivos del estudio qEEG de LPCN 1154 para el tratamiento de la depresión posparto, con una presentación de NDA prevista para finales de 2024. Lipocine firmó acuerdos de distribución exclusivos para TLANDO en los países del CCG y en Corea del Sur. Para los nueve meses que terminaron el 30 de septiembre de 2024, los ingresos fueron de 7.7 millones de dólares, principalmente por licencias, con una pérdida neta de 1.8 millones de dólares.
리포신 Inc (NASDAQ: LPCN)는 2024년 3분기 재무 결과를 보고했으며, 순손실은 220만 달러 (주당 0.44달러)로, 2023년 3분기의 670만 달러 손실과 비교됩니다. 2024년 9월 30일 기준으로 회사는 1980만 달러의 현금 및 현금성 자산을 보유하고 있었습니다. 주요 발전 사항으로는 산후 우울증 치료를 위한 LPCN 1154의 qEEG 연구에서 긍정적인 결과가 도출되었으며, NDA 제출이 2024년 말로 예정되어 있습니다. 리포신은 GCC 국가 및 한국에서 TLANDO의 독점 유통 계약을 체결했습니다. 2024년 9월 30일로 종료된 9개월 동안의 매출은 770만 달러로, 주로 라이센스에서 발생했으며, 순손실은 180만 달러였습니다.
Lipocine Inc (NASDAQ: LPCN) a annoncé les résultats financiers du troisième trimestre 2024, enregistrant une perte nette de 2,2 millions de dollars (0,44 dollar par action), contre une perte de 6,7 millions de dollars au troisième trimestre 2023. La société avait 19,8 millions de dollars en liquidités et équivalents au 30 septembre 2024. Les développements clés incluent des résultats positifs de l'étude qEEG de LPCN 1154 pour le traitement de la dépression postpartum, avec une soumission de NDA prévue pour la fin de 2024. Lipocine a signé des accords de distribution exclusifs pour TLANDO dans les pays du CCG et en Corée du Sud. Pour les neuf mois se terminant le 30 septembre 2024, les revenus s'élevaient à 7,7 millions de dollars, principalement issus de licences, avec une perte nette de 1,8 million de dollars.
Lipocine Inc (NASDAQ: LPCN) hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht, wobei ein Nettoverlust von 2,2 Millionen Dollar (0,44 Dollar pro Aktie) verzeichnet wurde, im Vergleich zu einem Verlust von 6,7 Millionen Dollar im dritten Quartal 2023. Das Unternehmen verfügte zum 30. September 2024 über 19,8 Millionen Dollar in bar und Äquivalenten. Wichtige Entwicklungen umfassen positive Ergebnisse der qEEG-Studie von LPCN 1154 zur Behandlung von postpartaler Depression, mit einer NDA-Einreichung, die für Ende 2024 angestrebt wird. Lipocine hat exklusive Vertriebsvereinbarungen für TLANDO in den GCC-Staaten und Südkorea unterzeichnet. Für die neun Monate bis zum 30. September 2024 belief sich der Umsatz auf 7,7 Millionen Dollar, hauptsächlich aus Lizenzgebühren, mit einem Nettoverlust von 1,8 Millionen Dollar.
- Significant reduction in net loss from $6.7M in Q3 2023 to $2.2M in Q3 2024
- Revenue increase to $7.7M for nine months of 2024, primarily from licensing
- New distribution agreements for TLANDO in GCC countries and South Korea
- Strong cash position of $19.8M as of September 30, 2024
- Positive qEEG study results for LPCN 1154
- No revenue recorded in Q3 2024
- Cash position decreased from $22.0M in December 2023 to $19.8M
- Increased general administrative expenses for nine-month period
Insights
The Q3 2024 financial results show mixed signals for Lipocine. The company reduced its net loss significantly to
Key positives include reduced R&D expenses and stable G&A costs. However, the absence of revenue in Q3 2024 is concerning. The company's strategy appears focused on partnership opportunities and licensing deals, as evidenced by the
The pipeline developments show promising progress, particularly in two key areas. First, LPCN 1154 (oral brexanolone) for postpartum depression demonstrated positive qEEG results, indicating robust CNS activity. The planned NDA submission by end-2024 could position the company in the valuable PPD market. Second, LPCN 2401 for obesity management shows potential as both a standalone treatment and in combination with popular GLP-1/GIP agonists, addressing the critical need for muscle mass preservation during weight loss.
The company's strategic focus on oral delivery of established therapeutics reduces development risk while addressing important market needs. The expansion of TLANDO into new international markets through partnership agreements demonstrates commercial validation of their technology platform.
Neuroactive Steroids
- LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression (PPD). It is targeted to be a highly effective, oral, fast-acting and short duration treatment option.
- The Company has completed labeling studies such as a food effect study and PK profiling in women with PPD, and is targeting NDA submission for LPCN 1154 by the end of 2024.
- In October, Lipocine announced positive results from a quantitative electroencephalogram (qEEG) study conducted in healthy subjects administered single doses of LPCN 1154. The results indicated robust central nervous system (CNS) activity of LPCN 1154, with concentration- and time-dependent post-dose changes in qEEG. The study confirmed GABAA positive allosteric modulation and supports future development of LPCN 1154 in neuropsychiatric indications.
LPCN 2401 for obesity management
- LPCN 2401 is an oral formulation comprised of a proprietary anabolic androgen receptor agonist targeted for once daily regimen.
- In October, Lipocine hosted a virtual key opinion leader (KOL) event on LPCN 2401.
- The event highlighted positive data from the Phase 2 study of LPCN 2401 and the data support the potential for the product to be used as an adjunct with incretin mimetics (GLP-1/GIP agonists) or as a monotherapy, including post incretin mimetic discontinuation.
- Frank Greenway, MD (Professor and Chief Medical Officer at Pennington Biomedical Research Center) discussed the unmet needs and current treatment landscape in obesity management with a focus on fat loss and lean muscle mass preservation for patients on incretin therapies.
- A poster "Oral LPCN 2401 Reduces Fat Mass and Increases Lean Mass in Men With Obesity" featuring the Phase 2 data was presented by Dr. Greenway at the Obesity Society's Annual ObesityWeek® conference on November 5, 2024 in
San Antonio, TX. - Lipocine plans to meet with the FDA to discuss the study design for a proof-of-concept Phase 2 study for LPCN 2401 and expansion to the female population.
LPCN 1148 Management of Cirrhosis
- Lipocine is evaluating LPCN 1148 for the management of decompensated cirrhosis and has conducted a successful Phase 2 study that met its primary endpoint. The Company plans to request a Type C meeting with the FDA to discuss the clinical development plan for LPCN 1148.
TLANDO®
- In October, Lipocine signed an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO, its oral testosterone replacement therapy, in the Gulf Cooperation Council (GCC) countries consisting of Saudi Arabia, Kuwait, the United Arab Emirates (
UAE ), Qatar, Bahrain, and Oman. - In September, Lipocine signed an exclusive distribution and license agreement with SPC Korea to commercialize TLANDO in
South Korea .
The company continues to pursue opportunities for partnering and/or development arrangements for the continued development and/or marketing of our remaining pipeline candidates.
Third Quarter Ended September 30, 2024 Financial Results
Lipocine reported a net loss of
There were no revenues recorded during the third quarter ended September 30, 2024. In the third quarter of 2023, the company recorded a non-cash revenue reversal of variable consideration for minimum guaranteed royalties of
Research and development expenses were
General and administrative expenses were
As of September 30, 2024, Lipocine had
Nine Months Ended, September 30 2024, Financial Results
Lipocine reported a net loss of
Revenues for the nine-month period ended September 30, 2024 were
Research and development expenses were
General administrative expenses were
For more information on Lipocine's financial results, refer to Form 10-Q filed by the Company with the SEC.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. 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 non-cirrhotic NASH. 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 development and commercialization of TLANDO and TLANDO XR by our licensees, the amount of the license fee, milestone payments, and royalty payments we will ultimately receive, the ability of our licensees to grow the TLANDO franchise, our product development efforts, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1148 and LPCN 2401, the timing of our submission of a NDA with the FDA for LPCN 1154, 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 to treat CNS disorders, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will 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 | |||||||||
September 30, | December 31, | ||||||||
2024 | 2023 | ||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ 3,742,941 | $ 4,771,758 | |||||||
Marketable investment securities | 16,080,691 | 17,263,788 | |||||||
Accrued interest income | 91,482 | 52,254 | |||||||
Prepaid and other current assets | 588,824 | 773,424 | |||||||
Total current assets | 20,503,938 | 22,861,224 | |||||||
Property and equipment, net of accumulated depreciation | |||||||||
of | 170,627 | 116,095 | |||||||
Other assets | 23,753 | 23,753 | |||||||
Total assets | $ 20,698,318 | $ 23,001,072 | |||||||
Liabilities and Stockholders' Equity | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ 285,347 | $ 1,395,977 | |||||||
Accrued expenses | 1,292,285 | 1,218,486 | |||||||
Warrant liability | 3,586 | 17,166 | |||||||
Total current liabilities | 1,581,218 | 2,631,629 | |||||||
Total liabilities | 1,581,218 | 2,631,629 | |||||||
Stockholders' equity: | |||||||||
Common stock, par value | |||||||||
shares authorized; 5,348,276 and 5,316,166 issued, and | |||||||||
5,347,940 and 5,315,830 outstanding, respectively | |||||||||
outstanding | 8,863 | 8,860 | |||||||
Additional paid-in capital | 220,690,052 | 220,171,250 | |||||||
Treasury stock at cost, 336 shares | (40,712) | (40,712) | |||||||
Accumulated other comprehensive gain (loss) | 9,942 | 7,259 | |||||||
Accumulated deficit | (201,551,045) | (199,777,214) | |||||||
Total stockholders' equity | 19,117,100 | 20,369,443 | |||||||
Total liabilities and stockholders' equity | $ 20,698,318 | $ 23,001,072 | |||||||
LIPOCINE INC. AND SUBSIDIARIES | |||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||
Revenues: | |||||||||||||
License revenue | $ - | $ - | $ 7,500,000 | $ 54,990 | |||||||||
Royalty revenue | - | - | 206,738 | - | |||||||||
Minimum guaranteed royalties revenue (reversal of | |||||||||||||
variable consideration) | - | (3,121,996) | - | (3,121,996) | |||||||||
Total revenues | - | (3,121,996) | 7,706,738 | (3,067,006) | |||||||||
Operating expenses: | |||||||||||||
Research and development | 1,585,233 | 2,878,798 | 6,278,881 | 8,500,319 | |||||||||
General and administrative | 1,045,240 | 1,042,572 | 4,128,371 | 3,770,281 | |||||||||
Total operating expenses | 2,630,473 | 3,921,370 | 10,407,252 | 12,270,600 | |||||||||
Operating loss | (2,630,473) | (7,043,366) | (2,700,514) | (15,337,606) | |||||||||
Other income: | |||||||||||||
Interest and investment income | 273,574 | 317,569 | 913,784 | 1,067,561 | |||||||||
Unrealized gain on warrant liability | 138,081 | 74,827 | 13,580 | 200,416 | |||||||||
Total other income | 411,655 | 392,396 | 927,364 | 1,267,977 | |||||||||
Loss before income tax expense | (2,218,818) | (6,650,970) | (1,773,150) | (14,069,629) | |||||||||
Income tax expense | - | - | (681) | (200) | |||||||||
Net loss | (2,218,818) | (6,650,970) | (1,773,831) | (14,069,829) | |||||||||
Issuance of Series B preferred stock dividend | - | - | - | (89) | |||||||||
Net loss attributable to common shareholders | $ (2,218,818) | $ (6,650,970) | $ (1,773,831) | $ (14,069,918) | |||||||||
Basic loss per share attributable to common stock | $ (0.41) | $ (1.26) | $ (0.33) | $ (2.68) | |||||||||
Weighted average common shares outstanding, basic | 5,347,940 | 5,292,058 | 5,335,941 | 5,254,116 | |||||||||
Diluted loss per share attributable to common stock | $ (0.44) | $ (1.27) | $ (0.33) | $ (2.72) | |||||||||
Weighted average common shares outstanding, diluted | 5,347,940 | 5,292,058 | 5,335,941 | 5,254,116 | |||||||||
Comprehensive loss: | |||||||||||||
Net loss | $ (2,218,818) | $ (6,650,970) | $ (1,773,831) | $ (14,069,829) | |||||||||
Net unrealized gain on marketable investment securities | 19,661 | 1,309 | 2,683 | 5,818 | |||||||||
Comprehensive loss | $ (2,199,157) | $ (6,649,661) | $ (1,771,148) | $ (14,064,011) | |||||||||
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SOURCE Lipocine Inc.
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