Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2023
- Lipocine reported positive topline results from the Phase 2 study of LPCN 1148 in liver cirrhosis, including increased L3 skeletal muscle index, fewer hepatic encephalopathy events, and more symptom improvement compared to placebo.
- The FDA agreed on Lipocine's proposal for a 505(b)(2) NDA filing based on a single pivotal study for LPCN 1154, which has the potential to be a differentiated preferred treatment option for postpartum depression.
- The company had $23.8 million of unrestricted cash, cash equivalents, and marketable investment securities as of September 30, 2023, compared to $32.5 million at December 31, 2022.
- Lipocine reported a net loss of $6.7 million for Q3 2023, compared to a net loss of $2.4 million in Q3 2022.
- Research and development expenses were $8.5 million for the nine months ended September 30, 2023, compared to $6.9 million in the same period in 2022.
Clinical Program Highlights
Neuroactive Steroids
- On October 18, Lipocine completed a successful meeting with the FDA on LPCN 1154, which is in development for postpartum depression (PPD). The FDA agreed on Lipocone's proposal for a 505(b)(2) NDA filing based on a single pivotal study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone
- Lipocine anticipates initiating the pivotal study program in Q1 2024 with the LPCN 1154 "to be marketed" formulation
- Top line results from the study are expected by Q2 2024, with a goal of filing a New Drug Application (NDA) in 2024
- If approved, LPCN 1154, has the potential to be a differentiated preferred treatment option for PPD with rapid and high remission/response rates with short treatment duration
LPCN 1148 in liver cirrhosis
- In July, Lipocine announced positive topline results from its Phase 2 proof-of-concept ("POC") study evaluating LPCN 1148 in cirrhosis
- Study met primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relative to placebo (P <0.01)
- Fewer hepatic encephalopathy (HE) events of grade >1 in the LPCN 1148 treatment arm relative to placebo (P < 0.05)
- More patients on LPCN 1148 reported symptom improvement compared to placebo (P < 0.05)
- LPCN 1148 was well-tolerated, with AE rates and severities similar to placebo
- Lipocine plans to meet with the FDA to discuss the development path to NDA filing
Quarter Ended September 30, 2023 Financial Results
Lipocine reported a net loss of
During the three months ended September 30, 2023, the Company recognized a non-cash minimum guaranteed royalties revenue reversal of variable consideration revenue of
Research and development expenses were
General and administrative expenses were
As of September 30, 2023, Lipocine had
Nine Months Ended September 30, 2023 Financial Results
Lipocine reported a net loss of
The Company recognized a non-cash minimum guaranteed royalties revenue reversal of variable consideration revenue of
Research and development expenses were
General and administrative expenses were
For more information on Lipocine's financial results for the three and nine months ended September 30, 2023, refer to Form 10Q filed with the SEC.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop products for CNS disorders. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnering. 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 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, LPCN1154, for rapid relief of postpartum depression, LPCN 1148, for the management of decompensated cirrhosis, LPCN 1144, our candidate for treatment of non-cirrhotic NASH, and LPCN 1111, a once-a-day therapy candidate for testosterone replacement therapy (TRT). 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 development efforts, our strategic plans for developing products to treat CNS disorders, our ability to monetize non-core product candidates, including through entering into partnering arrangements, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, the achievement of milestones within and completion of clinical trials, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates, 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 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, 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) | ||||||||
September 30, | December 31, | |||||||
2023 | 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ 4,072,706 | $ 3,148,496 | ||||||
Marketable investment securities | 19,775,290 | 29,381,410 | ||||||
Accrued interest income | 41,061 | 80,427 | ||||||
Contract asset - current portion | 130,505 | 579,428 | ||||||
Prepaid and other current assets | 594,097 | 945,319 | ||||||
Total current assets | 24,613,659 | 34,135,080 | ||||||
Contract asset - non-current portion | - | 3,252,500 | ||||||
Property and equipment, net of accumulated depreciation | ||||||||
of | 114,931 | 131,589 | ||||||
Other assets | 23,753 | 23,753 | ||||||
Total assets | $ 24,752,343 | $ 37,542,922 | ||||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ 1,101,068 | $ 600,388 | ||||||
Accrued expenses | 1,140,313 | 1,077,738 | ||||||
Total current liabilities | 2,241,381 | 1,678,126 | ||||||
Warrant liability | 29,440 | 229,856 | ||||||
Total liabilities | 2,270,821 | 1,907,982 | ||||||
Stockholders' equity: | ||||||||
Common stock, par value | ||||||||
shares authorized; 5,316,166 and 5,235,166 issued and | ||||||||
5,315,830 and 5,234,830 outstanding | 8,860 | 8,852 | ||||||
Additional paid-in capital | 220,022,838 | 219,112,164 | ||||||
Treasury stock at cost, 336 shares | (40,712) | (40,712) | ||||||
Accumulated other comprehensive loss | (14,503) | (20,321) | ||||||
Accumulated deficit | (197,494,961) | (183,425,043) | ||||||
Total stockholders' equity | 22,481,522 | 35,634,940 | ||||||
Total liabilities and stockholders' equity | $ 24,752,343 | $ 37,542,922 | ||||||
LIPOCINE INC. AND SUBSIDIARIES | ||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||
(Unaudited) | ||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||
Revenues: | ||||||||||||
License revenue | $ - | $ - | $ 54,990 | $ 500,000 | ||||||||
Minimum guaranteed royalties revenue (reversal of | - | |||||||||||
variable consideration) | (3,121,996) | - | (3,121,996) | - | ||||||||
Total revenues (reversal of variable consideration), net | (3,121,996) | - | (3,067,006) | 500,000 | ||||||||
Operating expenses: | ||||||||||||
Research and development | 2,878,798 | 2,100,432 | 8,500,319 | 6,886,398 | ||||||||
General and administrative | 1,042,572 | 798,939 | 3,770,281 | 3,172,144 | ||||||||
Total operating expenses | 3,921,370 | 2,899,371 | 12,270,600 | 10,058,542 | ||||||||
Operating loss | (7,043,366) | (2,899,371) | (15,337,606) | (9,558,542) | ||||||||
Other income (expense): | ||||||||||||
Interest and investment income | 317,569 | 163,966 | 1,067,561 | 275,420 | ||||||||
Interest expense | - | - | - | (27,098) | ||||||||
Unrealized gain on warrant liability | 74,827 | 326,240 | 200,416 | 531,697 | ||||||||
Gain on litigation settlement liability | - | - | - | 250,000 | ||||||||
Total other income, net | 392,396 | 490,206 | 1,267,977 | 1,030,019 | ||||||||
Loss before income tax expense | (6,650,970) | (2,409,165) | (14,069,629) | (8,528,523) | ||||||||
Income tax expense | - | - | (200) | (200) | ||||||||
Net loss | (6,650,970) | (2,409,165) | (14,069,829) | (8,528,723) | ||||||||
Issuance of Series B preferred stock dividend | - | - | (89) | - | ||||||||
Net loss attributable to common shareholders | $ (6,650,970) | $ (2,409,165) | $ (14,069,918) | $ (8,528,723) | ||||||||
Basic loss per share attributable to common stock | $ (1.26) | $ (0.46) | $ (2.68) | $ (1.63) | ||||||||
Weighted average common shares outstanding, basic | 5,292,058 | 5,234,576 | 5,254,116 | 5,230,619 | ||||||||
Diluted loss per share attributable to common stock | $ (1.27) | $ (0.52) | $ (2.72) | $ (1.72) | ||||||||
Weighted average common shares outstanding, diluted | 5,292,058 | 5,250,179 | 5,254,116 | 5,260,530 | ||||||||
Comprehensive loss: | ||||||||||||
Net loss | $ (6,650,970) | $ (2,409,165) | $ (14,069,829) | $ (8,528,723) | ||||||||
Net unrealized gain (loss) on available-for-sale securities | 1,309 | 7,972 | 5,818 | (58,919) | ||||||||
Comprehensive loss | $ (6,649,661) | $ (2,401,193) | $ (14,064,011) | $ (8,587,642) | ||||||||
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SOURCE Lipocine Inc.
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