Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2024
Rhea-AI Summary
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.
Positive
- 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
Negative
- 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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