Lipocine Announces Second Quarter 2020 Financial and Operational Results
SALT LAKE CITY, Aug. 6, 2020 /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, 2020 and provided a corporate update.
Second Quarter and Recent Corporate Highlights
-- Presented clinical data on TLANDO(TM) at the American Urological
Association ("AUA") Virtual Experience
-- Impact of a New Oral Testosterone Undecanoate on Blood Pressure and
Cardiovascular Risk
-- A Novel Oral Testosterone Therapy Restores Testosterone to Eugonadal
Levels Without Dose Titration
-- Effects of a New Oral Testosterone Undecanoate ("TLANDO") on Liver
-- Announced that the treatment potential of LPCN 1144 was demonstrated in
a pre-clinical non-alcoholic steatohepatitis ("NASH") and hepatic
fibrosis model
-- Received FDA clearance on an Investigational New Drug ("IND")
application for a Phase 2 clinical study with LPCN 1148 for the
treatment of cirrhosis
-- Received a decision from the U.S. Court of Appeals for the Federal
Circuit affirming the decision of the United States Patent and Trademark
Office ("USPTO") in the patent interference case between Lipocine and
Clarus Therapeutics Inc. ("Clarus")
-- Received decision from Chancery Court of Delaware dismissing the
shareholder derivative action filed against Lipocine's board of
directors
Ongoing Activities and Upcoming Milestones
-- TLANDO New Drug Application ("NDA") for use in adult males for
conditions associated with hypogonadism under review by the U.S. Food
and Drug Administration ("FDA") with a Prescription Drug User Fee Act
("PDUFA") target action date of August 28, 2020
-- LPCN 1144 Phase 2 LiFT ("Liver Fat intervention with oral Testosterone")
Phase 2 clinical study, a paired-biopsy study in confirmed pre-cirrhotic
NASH subjects, has been initiated with enrollment continuing and
top-line primary endpoint results expected by the end of 2020
-- Intellectual property infringement lawsuit against Clarus is on-going,
including fact discovery and expert testimony, with the jury trial
scheduled for February 2021
Second Quarter Ended June 30, 2020 Financial Results
Lipocine reported a net loss of $6.4 million, or ($0.13) per diluted share, for the quarter ended June 30, 2020, compared with a net loss of $3.4 million, or ($0.14) per diluted share, in the quarter ended June 30, 2019.
Research and development expenses were $2.3 million for the quarter ended June 30, 2020, compared with $2.0 million for the quarter ended June 30, 2019. The increase in research and development expenses during the three months ended June 30, 2020 was primarily due to increased contract research organization and outside consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects of $965,000, as well as a $213,000 increase in personnel expense. These increases were offset by a $727,000 decrease in costs incurred in conjunction with TLANDO with the completion of the ABPM study in the first half of 2019, a $96,000 decrease in costs for TLANDO XR, a $25,000 decrease in contract manufacturing costs for LPCN 1107 and a $25,000 decrease in other research and development expenses.
General and administrative expenses were $2.0 million for the quarter ended June 30, 2020, compared with $1.4 million for the quarter ended June 30, 2019. The increase in general and administrative expenses during the three months ended June 30, 2020 was primarily due to a $613,000 increase in legal costs associated with the following activities: lawsuit filed against Clarus Therapeutics Inc. for patent infringement in April 2019, interference cases filed against Clarus and the on-going class action lawsuit defense. In addition, there was a $48,000 increase in personnel costs, offset by a $41,000 decrease marketing expense, a $34,000 decrease in administrative travel expenses and a $19,000 decrease in other general and administrative expenses.
As of June 30, 2020, we had $18.3 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.1 million at December 31, 2019. Additionally, as of June 30, 2020 and December 31, 2019 we had $5.0 million of restricted cash, which is required to be maintained as cash collateral under the SVB Loan and Security Agreement until TLANDO is approved by the FDA.
Six Months Ended June 30, 2020 Financial Results
Lipocine reported a net loss of $12.1 million, or ($0.27) per diluted share, for the six months ended June 30, 2020, compared with a net loss of $6.7 million, or ($0.28) per diluted share, for the six months ended June 30, 2019.
Research and development expenses were $4.8 million for the six months ended June 30, 2020, compared with $3.9 million for the six months ended June 30, 2019. The increase in research and development expenses during the six months ended June 30, 2020 was primarily due to increased contract research organization and outside consulting and manufacturing costs related to the LPCN 1144 LiFT Phase 2 clinical study in NASH subjects of $2.6 million and a $270,000 increase in personnel expense. These increases were offset by a $1.9 million decrease in costs incurred in conjunction with TLANDO with the completion of the ABPM study in the first half of 2019, a $46,000 decrease in costs for TLANDO XR, a $37,000 decrease in contract manufacturing costs for LPCN 1107 and a $20,000 decrease in other research and development expenses.
General and administrative expenses were $4.0 million for the six months ended June 30, 2020, compared with $2.6 million for the six months ended June 30, 2019. The increase in general and administrative expenses during the six months ended June 30, 2020 was primarily due to a $1.6 million increase in legal costs associated with the following activities: lawsuit filed against Clarus Therapeutics Inc. for patent infringement in April 2019, interference cases filed against Clarus and the on-going class action lawsuit defense, offset by a $11,000 decrease in personnel costs, a $60,000 decrease in administrative travel expense, a $41,000 decrease in marketing expense and a $112,000 decrease in other general and administrative expenses.
About Lipocine
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 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144, an oral product 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 1107 is potentially the first oral hydroxyprogesterone caproate product candidate, with end of phase 2 meeting completed, 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, our product development efforts, and potential future actions by the FDA related to TLANDO, including the PDUFA date. 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,
2020 2019
Assets
Current assets:
Cash and cash
equivalents $13,837,818 $9,728,523
Restricted cash 5,000,000 5,000,000
Marketable
investment
securities 4,466,541 4,340,041
Accrued interest
income 7,919 16,522
Prepaid and other
current assets 147,308 545,887
Total current assets 23,459,586 19,630,973
Property and equipment, net of accumulated
depreciation of
$1,141,741 and $1,140,143, respectively 1,956 3,554
Other assets 23,753 23,753
Total assets $23,485,295 $19,658,280
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $906,826 $1,182,241
Accrued expenses 993,258 449,303
Debt -current
portion 2,331,710 3,333,333
Total current liabilities 4,231,794 4,964,877
Debt - non-current portion 4,002,221 3,814,407
Warrant liability 2,166,312 4,591,200
Total liabilities 10,400,327 13,370,484
Commitments and contingencies
Stockholders' equity:
Preferred stock,
par value
$0.0001 per
share,
10,000,000
shares
authorized; zero
issued and
outstanding
Common stock, par
value $0.0001
per share,
100,000,000
shares
authorized;
61,383,016 and
37,655,175
issued
and 61,377,306
and 37,649,465
outstanding 6,138 3,766
Additional paid-
in capital 176,327,120 157,391,969
Treasury stock at
cost, 5,710
shares (40,712) (40,712)
Accumulated other
comprehensive
loss (104) (38)
Accumulated
deficit (163,207,474) (151,067,189)
Total stockholders' equity 13,084,968 6,287,796
Total liabilities and
stockholders' equity $23,485,295 $19,658,280
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Three Months Ended June 30, Six Months Ended June 30,
2020 2019 2020 2019
Operating expenses:
Research and development $2,268,984 $1,964,146 $4,780,739 $3,913,966
General and administrative 1,953,535 1,386,457 4,038,795 2,562,385
Total operating expenses 4,222,519 3,350,603 8,819,534 6,476,351
Operating loss (4,222,519) (3,350,603) (8,819,534) (6,476,351)
Other income (expense):
Interest and investment income 7,177 124,581 67,115 249,846
Interest expense (87,847) (204,575) (221,192) (428,364)
Loss on warrant liability (2,066,445) (3,166,474)
Total other expense, net (2,147,115) (79,994) (3,320,551) (178,518)
Loss before income tax expense (6,369,634) (3,430,597) (12,140,085) (6,654,869)
Income tax expense (200) (200)
Net loss $(6,369,634) $(3,430,597) $(12,140,285) $(6,655,069)
Basic loss per share attributable to common stock $(0.13) $(0.14) $(0.27) $(0.28)
Weighted average common shares outstanding, basic 49,769,253 24,591,419 45,558,442 23,990,552
Diluted loss per share attributable to common stock $(0.13) $(0.14) $(0.27) $(0.28)
Weighted average common shares outstanding, diluted 49,769,253 24,591,419 45,558,442 23,990,552
Comprehensive loss:
Net loss $(6,369,634) $(3,430,597) $(12,140,285) $(6,655,069)
Net unrealized gain (loss) on available-for-
sale securities (104) 1,528 (66) 3,880
Comprehensive loss $(6,369,738) $(3,429,069) $(12,140,351) $(6,651,189)
View original content to download multimedia:http://www.prnewswire.com/news-releases/lipocine-announces-second-quarter-2020-financial-and-operational-results-301107194.html
SOURCE Lipocine Inc.
