Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2024
LPCN 1154 for Postpartum Depression (PPD)
- In
June 2024 ,Lipocine announced positive topline study results from the NDA enabling study of LPCN 1154. LPCN 1154 treatment was well tolerated with no sedation nor somnolence events observed - The Company is targeting NDA submission for LPCN 1154 by the end of the fourth quarter of 2024
- LPCN 1154, oral brexanolone, is being developed as a 48-hour oral dosing duration treatment for treatment of postpartum depression. It is targeted to be a highly effective, fast-acting and outpatient treatment option
LPCN 2401 for Chronic Weight Management
- In
April 2024 , the Company announced positive results from the multi-center perspective, blinded Phase 2 study evaluating LPCN 2401 in participants with obesity (BMI ≥30) and participants with BMI ≥27 with at least one weight-related comorbidity - LPCN 2401 treatment resulted in significant improvements in body composition through increased lean mass (LM) or fat free mass (FFM) and bone mineral content in addition to decreased fat mass (FM) and android fat. LPCN 2401 was well-tolerated; adverse events (AEs) including GI events were similar to placebo with no muscle spasm reported
- LPCN 2401 has potential for use in combination with incretin mimetics (GLP-1/GIP agonists) including amplification of GLP-1R insulinotropic actions supported by studies demonstrating the role of the androgen receptor agonist in regulation of GLP-1R. Target benefits of LPCN 2401 in combination with GLP-1 agonists include improved body composition with quality weight loss while attenuating lean mass loss, a serious unmet need, and quality fat loss through appreciable abdominal fat loss. LPCN 2401 could also be potentially used as monotherapy post discontinuation of GLP-1 agonist to manage weight/fat regain and durability of diabetes remission
-
Lipocine plans to meet with FDA to discuss the further development of LPCN 2401 as an aid to weight management interventions
LPCN 1148 for Management of Cirrhosis
- In June, results from a Phase 2 study evaluating LPCN 1148 in cirrhosis were featured in a late breaking oral presentation at the
European Association for the Study of Liver (EASL) Congress . The presentation was delivered byArun J. Sanyal , MD, Director,Stravitz-Sanyal Institute for Liver Disease and Metabolic Health ,Virginia Commonwealth University . The presentation was featured in the symposium "Revolutionary Advances in Liver Disease Research Unveiled atEASL Congress 2024" highlighting significant advances in liver disease- As previously announced, the study met primary and hepatic encephalopathy (HE) endpoints and LPCN 1148 was well-tolerated, with AE rates and severities similar to placebo
We continue to pursue opportunities for partnering and/or development arrangements for the continued development and/or marketing of our pipeline candidates.
Second quarter Ended June 30, 2024 Financial Results
Revenues were approximately
Research and development expenses were
General and administrative expenses were
As of
Six Months Ended,
Revenues for the six-month period ended
Research and development expenses were
General administrative expenses were
For more information on
About
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, our ability to monetize product candidates, including through entering into partnering arrangements, 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, 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
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Condensed Consolidated Balance Sheets |
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2024 |
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2023 |
Assets |
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Current assets: |
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Cash and cash equivalents |
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$ 5,553,371 |
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$ 4,771,758 |
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Marketable investment securities |
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16,995,424 |
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17,263,788 |
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Accrued interest income |
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63,636 |
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52,254 |
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Prepaid and other current assets |
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297,051 |
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773,424 |
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Total current assets |
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22,909,482 |
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22,861,224 |
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Property and equipment, net of accumulated depreciation |
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of |
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99,071 |
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116,095 |
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Other assets |
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23,753 |
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23,753 |
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Total assets |
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$ 23,032,306 |
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$ 23,001,072 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ 448,798 |
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$ 1,395,977 |
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Accrued expenses |
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1,233,477 |
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1,218,486 |
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Warrant liability |
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141,668 |
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17,166 |
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Total current liabilities |
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1,823,943 |
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2,631,629 |
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Total liabilities |
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1,823,943 |
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2,631,629 |
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Stockholders' equity: |
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Common stock, par value |
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shares authorized; 5,348,276 and 5,316,166 issued, and |
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5,347,940 and 5,315,830 outstanding, respectively |
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outstanding |
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8,863 |
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8,860 |
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Additional paid-in capital |
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220,582,158 |
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220,171,250 |
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(40,712) |
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(40,712) |
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Accumulated other comprehensive gain (loss) |
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(9,719) |
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7,259 |
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Accumulated deficit |
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(199,332,227) |
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(199,777,214) |
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Total stockholders' equity |
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21,208,363 |
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20,369,443 |
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Total liabilities and stockholders' equity |
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$ 23,032,306 |
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$ 23,001,072 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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Three Months Ended |
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Six Months Ended |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenues: |
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License revenue |
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$ - |
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$ - |
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$ 7,500,000 |
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$ 54,990 |
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Royalty revenue |
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89,565 |
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- |
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206,738 |
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- |
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Total revenues |
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89,565 |
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- |
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7,706,738 |
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54,990 |
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Operating expenses: |
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Research and development |
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1,874,721 |
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2,515,211 |
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4,693,646 |
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5,621,521 |
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General and administrative |
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1,507,412 |
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1,440,394 |
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3,083,131 |
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2,727,708 |
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Total operating expenses |
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3,382,133 |
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3,955,605 |
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7,776,777 |
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8,349,229 |
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Operating loss |
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(3,292,568) |
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(3,955,605) |
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(70,039) |
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(8,294,239) |
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Other income (expense): |
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Interest and investment income |
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308,845 |
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379,521 |
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640,209 |
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749,991 |
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Unrealized gain (loss) on warrant liability |
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(84,430) |
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27,455 |
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(124,502) |
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125,589 |
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Total other income, net |
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224,415 |
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406,976 |
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515,707 |
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875,580 |
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Income (loss) before income tax expense |
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(3,068,153) |
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(3,548,629) |
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445,668 |
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(7,418,659) |
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Income tax expense |
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(481) |
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- |
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(681) |
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(200) |
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Net income (loss) |
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(3,068,634) |
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(3,548,629) |
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444,987 |
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(7,418,859) |
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Issuance of Series B preferred stock dividend |
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- |
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- |
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- |
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(89) |
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Net income (loss) attributable to common shareholders |
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$ (3,068,634) |
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$ (3,548,629) |
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$ 444,987 |
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$ (7,418,948) |
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Basic earnings (loss) per share attributable to common stock |
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$ (0.57) |
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$ (0.68) |
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$ 0.08 |
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$ (1.42) |
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Weighted average common shares outstanding, basic |
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5,343,922 |
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5,234,830 |
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5,329,876 |
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5,234,830 |
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Diluted earnings (loss) per share attributable to common stock |
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$ (0.56) |
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$ (0.68) |
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$ 0.10 |
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$ (1.44) |
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Weighted average common shares outstanding, diluted |
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5,343,922 |
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5,234,830 |
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5,459,204 |
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5,234,830 |
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Comprehensive income (loss): |
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Net income (loss) |
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$ (3,068,634) |
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$ (3,548,629) |
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$ 444,987 |
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$ (7,418,859) |
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Net unrealized gain (loss) on marketable investment securities |
885 |
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(19,053) |
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(16,978) |
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4,509 |
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Comprehensive income (loss) |
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$ (3,067,749) |
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$ (3,567,682) |
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$ 428,009 |
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$ (7,414,350) |
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