Full Press Release Details
Announces Financial Results for the Third Quarter Ended September 30, 2024
LAKE CITY, Nov. 7, 2024 - Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform
to augment therapeutics through effective oral delivery, today announced financial results for the third quarter and nine months ended
September 30, 2024 and provided a corporate update.
| 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 GABA A positive allosteric modulation and supports future development of LPCN 1154 in neuropsychiatric indications. |
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. |
1148 Management of Cirrhosis
| 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. |
company continues to pursue opportunities for partnering and/or development arrangements for the continued development and/or marketing
of our remaining pipeline candidates.
Quarter Ended September 30, 2024 Financial Results
reported a net loss of $2.2 million, or ($0.44) per diluted share, for the third quarter ended September 30, 2024, compared with a net
loss of $6.7 million, or ($1.27) per diluted share, for the quarter ended September 30, 2023.
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 $3.1 million related to the termination of the Antares
and development expenses were $1.6 million and $2.9 million, respectively, for the quarters ended September 30, 2024 and 2023. The decrease
was a result of a decrease in TLANDO related costs, a decrease in contract research organization expense and outside consulting costs
related to the wind down of the LPCN 1148 study in 2024, and a decrease in costs related to LPCN 1154 clinical studies, offset by increases
in personnel related costs and other research and development related costs and supplies.
and administrative expenses were $1.0 million in each of the quarters ended September 30, 2024 and 2023.
of September 30, 2024, Lipocine had $19.8 million of unrestricted cash, cash equivalents and marketable investment securities compared
to $22.0 million at December 31, 2023.
Months Ended, September 30 2024, Financial Results
reported a net loss of $1.8 million, or ($0.33) per diluted share, for the nine months ended September 30, 2024, compared with a net
loss of $14.1 million, or ($2.72) per diluted share, for the nine months ended September 30, 2023.
for the nine-month period ended September 30, 2024 were $7.7 million, primarily consisting of licensing revenue received from our Verity
License Agreement, in addition to TLANDO royalty revenue of $206,000. During the nine months ended September 30, 2023, the company recognized
a non-cash revenue reversal of variable consideration for minimum guaranteed royalties of $3.1 million relating to the termination of
the Antares License Agreement offset by licensing revenue of approximately $55,000 for payments received related to the Spriaso license
and development expenses were $6.3 million and $8.5 million, respectively, for the nine months ended September 30, 2024 and 2023. The
decrease was a result of a decrease in contract research organization expense and outside consulting costs related to the wind down of
the LPCN 1148 study in 2024, a decrease in TLANDO related costs, a decrease in personnel related costs, and a decrease in other research
and development related costs. These decreases were offset an increase in costs related to the LPCN 1154 clinical studies.
administrative expenses were $4.1 million and $3.8 million respectively, for the nine months ended September 30, 2024 and 2023. The increase
in general and administrative expenses was a result of increases in business development expenses, corporate legal fees and director
fees, offset by decreases in corporate insurance expense, professional fees, other administrative consulting fees, personnel related
costs, and travel related costs.
more information on Lipocine's financial results, refer to Form 10-Q filed by the Company with the SEC.
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.
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.
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.
further information:
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
| 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 $1,207,726 and $1,182,191 respectively | 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 $0.0001 per share, 200,000,000 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
Condensed Consolidated Statements of Operations and Comprehensive Loss
| 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 | ) |