Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2021
Lipocine Inc. (NASDAQ: LPCN) announced its financial results for Q2 2021, reporting a net loss of $6.8 million or ($0.08) per diluted share, a reduction from a net loss of $6.4 million in Q2 2020. Research and development expenses decreased to $1.5 million, primarily due to reduced costs in the LPCN 1144 clinical study. Significant corporate highlights include positive topline results from the Phase 2 LiFT study, FDA clearance for LPCN 1154's IND, and an upcoming proof-of-concept study for postpartum depression.
- Positive topline results from Phase 2 LiFT clinical study for LPCN 1144 in NASH subjects.
- FDA cleared IND for LPCN 1154, paving the way for further clinical studies.
- Cash reserves significantly increased to $46.6 million from $19.7 million since December 2020.
- Net loss increased from $6.4 million in Q2 2020 to $6.8 million in Q2 2021.
- General and administrative expenses slightly increased, impacting overall net loss.
SALT LAKE CITY, Aug. 5, 2021 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the second quarter ended June 30, 2021, and provided a corporate update.
Recent Corporate Highlights
- Announced positive topline results from the Phase 2 LiFT ("Liver Fat intervention with oral Testosterone") clinical study, investigating LPCN 1144 in biopsy-confirmed NASH male subjects
- 36-week biopsy data from the LiFT clinical study are expected in August 2021
- Continued enrolling patients into an open label extension to the LiFT clinical study in which all patients will have access to LPCN 1144
- Clinical data from the LiFT clinical study were presented at The International Liver Congress™ 2021, the annual meeting of the European Association for the Study of the Liver ("EASL"), Digital Event, which took place June 23-26, 2021
- Results from the LiFT clinical study showed that LPCN 1144 treatment significantly reduced liver fat and key liver injury markers in biopsy confirmed NASH subjects
- Data from the LiFT clinical study showed high prevalence of low normal or overtly hypogonadal levels of testosterone in histologically established NASH subjects
- LPCN 1144 was shown to improve body composition in biopsy-confirmed NASH patients
- The U.S. Food and Drug Administration ("FDA") cleared the Company's Investigational New Drug Application ("IND") to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression ("PPD") in adults
- Top-line results from an ongoing pharmacokinetic ("PK") study to assess dose proportionality are expected in the third quarter of 2021
- Following the PK study, a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD is expected to begin in the fourth quarter of 2021
- Entered into a global settlement agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between Lipocine and Clarus, as well as the on-going interference proceeding between the two companies
- Continued business development activities surrounding TLANDO related to the commercialization of TLANDO upon approval by the FDA
- Expect the first subject will be dosed in the proof-of-concept Phase 2 study in male cirrhotic subjects to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhotic subjects in the fourth quarter of 2021
Second Quarter Ended June 30, 2021 Financial Results
Lipocine reported a net loss of
Research and development expenses were
General and administrative expenses were
As of June 30, 2021, the Company had
Six Months Ended June 30, 2021 Financial Results
Lipocine reported a net loss of
Research and development expenses were
General and administrative expenses were
About Lipocine Inc.
Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. 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 Lipocine's product candidates and related clinical trials, the timing of completion of clinical trials, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that 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) | ||||||||||
June 30, | December 31, | |||||||||
2021 | 2020 | |||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ 10,967,713 | $ 19,217,382 | ||||||||
Restricted cash | - | 5,000,000 | ||||||||
Marketable investment securities | 35,672,059 | 449,992 | ||||||||
Accrued interest income | 232,568 | 391 | ||||||||
Prepaid and other current assets | 283,180 | 661,258 | ||||||||
Total current assets | 47,155,520 | 25,329,023 | ||||||||
Other assets | 23,753 | 23,753 | ||||||||
Total assets | $ 47,179,273 | $ 25,352,776 | ||||||||
Liabilities and Stockholders' Equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ 906,476 | $ 1,597,220 | ||||||||
Accrued expenses | 1,444,188 | 1,653,178 | ||||||||
Debt - current portion | 3,957,627 | 3,333,333 | ||||||||
Litigation settlement liability - current portion | 2,500,000 | - | ||||||||
Total current liabilities | 8,808,291 | 6,583,731 | ||||||||
Debt - non-current portion | - | 2,257,075 | ||||||||
Warrant liability | 1,125,429 | 1,170,051 | ||||||||
Litigation settlement liability - non-current portion | 1,500,000 | - | ||||||||
Total liabilities | 11,433,720 | 10,010,857 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders' equity: | ||||||||||
Preferred stock, par value | ||||||||||
shares authorized; zero issued and outstanding | - | - | ||||||||
Common stock, par value | ||||||||||
shares authorized; 88,296,360 and 70,041,967 issued | ||||||||||
and 88,290,650 and 70,036,257 outstanding | 8,830 | 7,005 | ||||||||
Additional paid-in capital | 217,986,752 | 187,407,634 | ||||||||
Treasury stock at cost, 5,710 shares | (40,712) | (40,712) | ||||||||
Accumulated other comprehensive loss | (186) | - | ||||||||
Accumulated deficit | (182,209,131) | (172,032,008) | ||||||||
Total stockholders' equity | 35,745,553 | 15,341,919 | ||||||||
Total liabilities and stockholders' equity | $ 47,179,273 | $ 25,352,776 | ||||||||
LIPOCINE INC. AND SUBSIDIARIES | ||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||
(Unaudited) | ||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||
Operating expenses: | ||||||||||||
Research and development | $ 1,464,687 | $ 2,268,984 | $ 3,045,228 | $ 4,780,739 | ||||||||
General and administrative | 1,525,592 | 1,953,535 | 3,059,544 | 4,038,795 | ||||||||
Total operating expenses | 2,990,279 | 4,222,519 | 6,104,772 | 8,819,534 | ||||||||
Operating loss | (2,990,279) | (4,222,519) | (6,104,772) | (8,819,534) | ||||||||
Other income (expense): | ||||||||||||
Interest and investment income | 17,344 | 7,177 | 27,993 | 67,115 | ||||||||
Interest expense | (57,428) | (87,847) | (126,401) | (221,192) | ||||||||
Unrealized gain (loss) on warrant liability | 221,322 | (2,066,445) | 26,257 | (3,166,474) | ||||||||
Litigation settlement | (4,000,000) | - | (4,000,000) | - | ||||||||
Total other expense, net | (3,818,762) | (2,147,115) | (4,072,151) | (3,320,551) | ||||||||
Loss before income tax expense | (6,809,041) | (6,369,634) | (10,176,923) | (12,140,085) | ||||||||
Income tax expense | - | - | (200) | (200) | ||||||||
Net loss | $ (6,809,041) | $ (6,369,634) | $ (10,177,123) | $ (12,140,285) | ||||||||
Basic loss per share attributable to common stock | $ (0.08) | $ (0.13) | $ (0.12) | $ (0.27) | ||||||||
Weighted average common shares outstanding, basic | 88,290,650 | 49,769,253 | 85,556,110 | 45,558,442 | ||||||||
Diluted loss per share attributable to common stock | $ (0.08) | $ (0.13) | $ (0.12) | $ (0.27) | ||||||||
Weighted average common shares outstanding, diluted | 88,290,650 | 49,769,253 | 85,556,110 | 45,558,442 | ||||||||
Comprehensive loss: | ||||||||||||
Net loss | $ (6,809,041) | $ (6,369,634) | $ (10,177,123) | $ (12,140,285) | ||||||||
Net unrealized gain (loss) on available-for-sale securities | 22,273 | (104) | (186) | (66) | ||||||||
Comprehensive loss | $ (6,786,768) | $ (6,369,738) | $ (10,177,309) | $ (12,140,351) | ||||||||
View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-second-quarter-ended-june-30-2021-301348161.html
SOURCE Lipocine Inc.
