Lipocine Announces Financial Results for the First Quarter Ended March 31, 2024
LPCN 1154 for Postpartum Depression
- In
May 2024 , dosing of subjects was completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression - The FDA has agreed with
Lipocine's proposal for establishing the efficacy of LPCN 1154 through the pivotal PK bridge to an approved IV infusion of brexanolone via a 505(b)(2) NDA filing - Topline results from the pivotal PK study are expected late in 2Q 2024. Positive results would support an NDA filing at the end of Q4 2024
LPCN 1148 for Management of Cirrhosis
- In
March 2024 ,Lipocine announced positive Week 52 results from the LPCN 1148 Phase 2 study in patients with cirrhosis. The study met primary and hepatic encephalopathy endpoints- Increase in Skeletal Muscle Index (SMI) observed at Week 24 was maintained through 52 weeks
- Participants on placebo increased SMI when switched to LPCN 1148
- Patients on LPCN 1148 therapy had fewer overt hepatic encephalopathy (OHE) events and longer time to first recurrent OHE event, with no OHE background therapy restrictions
- LPCN 1148 was well-tolerated, with adverse events (AE) rates and severities similar to placebo. Participants on LPCN 1148 were hospitalized for fewer days
LPCN 2401 for Obesity Management
- In
April 2024 ,Lipocine announced positive clinical results from a multi-center prospective, 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 - Results showed treatment with LPCN 2401 resulted in statistically significant body composition improvements
- Increased lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7%
- Reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8%
- LPCN 2401 was well-tolerated; AEs were similar to placebo. A replay of the webcast discussing the LPCN 2401 Phase 2 results can be accessed on
Lipocine's website here - Potential for LPCN 2401 to be used in combination with incretin mimetics (GLP-1 agonists and GLP/GIP dual agonists) for improved body composition (ameliorate muscle loss with android fat loss) or as a monotherapy post discontinuation
LPCN 2203 for Essential Tremor
- Oral GABA Positive Allosteric Modulator, targeting improved efficacy with fewer side effects e.g. somnolence, dizziness
- Daytime efficacy and improved tolerability remains an unmet need
- Achieved relevant target blood levels with good tolerability in multiple Phase 1 studies with no incidence of somnolence, sedation or dizziness
TRT Franchise - TLANDO™ and LPCN 1111 (TLANDO XR)
- In
January 2024 ,Lipocine and Verity Pharma entered into an exclusive License Agreement under which Verity Pharma will market TLANDO inthe United States and, if approved, inCanada . The terms of the license agreement call for a license fee of$11 million and development and sales milestones of up to$259 million in aggregate, dependent on achievement of certain milestones. In addition, the Company is eligible to receive tiered royalty payments ranging from 12% up to 18% on net sales in theU.S. andCanada .
First Quarter Ended
Revenue in the first quarter of 2024 was
Research and development expenses were
General and administrative expenses were
As of
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 to treat CNS disorders, our ability to monetize 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 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 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ 3,081,337 |
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$ 4,771,758 |
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Marketable investment securities |
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21,550,661 |
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17,263,788 |
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Accrued interest income |
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100,134 |
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52,254 |
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Prepaid and other current assets |
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583,087 |
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773,424 |
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Total current assets |
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25,315,219 |
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22,861,224 |
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Property and equipment, net of accumulated depreciation of |
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107,583 |
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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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$ 25,446,555 |
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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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$ 671,445 |
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$ 1,395,977 |
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Accrued expenses |
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761,465 |
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1,218,486 |
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Warrant liability - current portion |
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57,238 |
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17,166 |
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Total current liabilities |
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1,490,148 |
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2,631,629 |
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Total liabilities |
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1,490,148 |
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2,631,629 |
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Stockholders' equity: |
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Common stock, par value 5,315,830 outstanding |
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8,860 |
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8,860 |
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Additional paid-in capital |
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220,262,456 |
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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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(10,604) |
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7,259 |
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Accumulated deficit |
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(196,263,593) |
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(199,777,214) |
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Total stockholders' equity |
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23,956,407 |
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20,369,443 |
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Total liabilities and stockholders' equity |
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$ 25,446,555 |
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$ 23,001,072 |
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Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) |
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Three Months Ended |
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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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$ 54,990 |
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Royalty revenue |
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117,174 |
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- |
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Total revenues |
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7,617,174 |
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54,990 |
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Operating expenses: |
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Research and development |
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2,818,926 |
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3,106,310 |
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General and administrative |
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1,575,719 |
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1,287,313 |
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Total operating expenses |
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4,394,645 |
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4,393,623 |
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Operating income (loss) |
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3,222,529 |
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(4,338,633) |
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Other income (expense): |
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Interest and investment income |
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331,364 |
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370,469 |
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Unrealized gain (loss) on warrant liability |
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(40,072) |
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98,134 |
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Total other income, net |
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291,292 |
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468,603 |
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Income (loss) before income tax expense |
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3,513,821 |
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(3,870,030) |
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Income tax expense |
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(200) |
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(200) |
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Net income (loss) |
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3,513,621 |
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(3,870,230) |
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Issuance of Series B preferred stock dividend |
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- |
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(89) |
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Net income (loss) attributable to common shareholders |
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Basic income (loss) per share attributable to common stock |
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$ 0.66 |
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$ (0.74) |
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Weighted average common shares outstanding, basic |
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5,315,830 |
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5,234,830 |
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Diluted income (loss) per share attributable to common stock |
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$ 0.66 |
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$ (0.76) |
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Weighted average common shares outstanding, diluted |
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5,357,530 |
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5,234,830 |
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Comprehensive loss: |
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Net income (loss) |
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Net unrealized gain (loss) on available-for-sale securities |
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(17,863) |
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23,562 |
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Comprehensive income (loss) |
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