8-K
Lipocine Inc. (LPCN)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
The
Securities Exchange Act of 1934
Date
of Report (Date of Earliest Event Reported):
May9, 2024
LIPOCINE
INC.
(Exact name of registrant as specified in its charter)
Commission
File No. 001-36357
| Delaware | 99-0370688 |
|---|---|
| (State<br> or other jurisdiction<br><br> <br>of<br> incorporation) | (IRS<br> Employer<br><br> <br>Identification<br> Number) |
675Arapeen Drive, Suite 202
SaltLake City, Utah 84108
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (801) 994-7383
Former
name or former address, if changed since last report: Not Applicable
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4© under the Exchange Act (17 CFR 240.13©(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title<br> of each class | Trading<br> Symbol(s) | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock, par value $0.0001 per share | LPCN | The<br> NASDAQ Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR § 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR § 240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 8.01 | Other Events |
|---|
On May 9, 2024, the Company issued a press release announcing financial and operational results for the quarter ended March 31, 2024. The press release is filed as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
|---|---|
| (d) | Exhibits |
| --- | --- |
The following exhibits are filed with this report:
| Exhibit<br> No. | Description |
|---|---|
| 99.1 | Press Release announcing Financial Results for the Quarter Ended March 31, 2024 |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| LIPOCINE<br> INC. | |||
|---|---|---|---|
| Date: | May<br> 9, 2024 | By: | /s/ Mahesh V. Patel |
| Mahesh<br> V. Patel | |||
| President<br> and Chief Executive Officer |
Exhibit99.1
LipocineAnnounces Financial Results for the First Quarter Ended March 31, 2024
SALT LAKE CITY, May 9, 2024 — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced financial results for the first quarter ended March 31, 2024 and provided a corporate update.
LPCN 1154 for Postpartum Depression
| ● | In<br> May 2024, dosing of subjects was completed in the pivotal pharmacokinetic (PK) study designed<br> to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being<br> developed as a treatment for postpartum depression |
|---|---|
| ● | The<br> FDA has agreed with Lipocine’s proposal for establishing the efficacy of LPCN 1154<br> through the pivotal PK bridge to an approved IV infusion of brexanolone via a 505(b)(2) NDA<br> filing |
| ● | Topline<br> results from the pivotal PK study are expected late in 2Q 2024. Positive results would support<br> an NDA filing at the end of Q4 2024 |
LPCN 1148 for Management of Cirrhosis
| ● | In<br> March 2024, Lipocine announced positive Week 52 results from the LPCN 1148 Phase 2 study<br> in patients with cirrhosis. The study met primary and hepatic encephalopathy endpoints |
|---|---|
| ○ | Increase<br> in Skeletal Muscle Index (SMI) observed at Week 24 was maintained through 52 weeks |
| --- | --- |
| ○ | Participants<br> on placebo increased SMI when switched to LPCN 1148 |
| ● | Patients<br> on LPCN 1148 therapy had fewer overt hepatic encephalopathy (OHE) events and longer time<br> to first recurrent OHE event, with no OHE background therapy restrictions |
| --- | --- |
| ● | LPCN<br> 1148 was well-tolerated, with adverse events (AE) rates and severities similar to placebo.<br> Participants on LPCN 1148 were hospitalized for fewer days |
LPCN 2401 for Obesity Management
| ● | In<br> April 2024, Lipocine announced positive clinical results from a multi-center prospective,<br> blinded Phase 2 study evaluating LPCN 2401 in participants with obesity (BMI ≥30) and<br> participants with BMI ≥27 with at least one weight-related comorbidity |
|---|---|
| ● | Results<br> showed treatment with LPCN 2401 resulted in statistically significant body composition improvements |
| ○ | Increased<br> lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7% |
| --- | --- |
| ○ | Reduced<br> android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8% |
| ● | LPCN<br>2401 was well-tolerated; AEs were similar to placebo. A replay of the webcast discussing the LPCN 2401 Phase 2 results can be accessed<br>on Lipocine’s website at www.lipocine.com |
| --- | --- |
| ● | Potential<br> for LPCN 2401 to be used in combination with incretin mimetics (GLP-1 agonists and GLP/GIP<br> dual agonists) for improved body composition (ameliorate muscle loss with android fat loss)<br> or as a monotherapy post discontinuation |
LPCN 2203 for Essential Tremor
| ● | Oral<br> GABA Positive Allosteric Modulator, targeting improved efficacy with fewer side effects e.g.<br> somnolence, dizziness |
|---|---|
| ● | Daytime<br> efficacy and improved tolerability remains an unmet need |
| ● | Achieved<br> relevant target blood levels with good tolerability in multiple Phase 1 studies with no incidence<br> of somnolence, sedation or dizziness |
TRT Franchise - TLANDO™ and LPCN 1111 (TLANDO XR)
| ● | In<br> January 2024, Lipocine and Verity Pharma entered into an exclusive License Agreement under<br> which Verity Pharma will market TLANDO in the United States and, if approved, in Canada.<br> The terms of the license agreement call for a license fee of $11 million and development<br> and sales milestones of up to $259 million in aggregate, dependent on achievement of certain<br> milestones. In addition, the Company is eligible to receive tiered royalty payments ranging<br> from 12% up to 18% on net sales in the U.S. and Canada. |
|---|
FirstQuarter Ended March 31, 2024 Financial Results
Lipocine reported net income of $3.5 million, or $0.66 per diluted share, for the first quarter ended March 31, 2024, compared with a net loss of $3.9 million, or ($0.76) per diluted share, for the quarter ended March 31, 2023.
Revenue in the first quarter of 2024 was $7.6 million, primarily consisting of licensing revenue received from the Verity License Agreement. This compares with revenue of $0.06 million in the comparable period in 2023.
Research and development expenses were $2.8 million and $3.1 million, respectively, for the quarters ended March 31, 2024 and 2023. The decrease in research and development expenses was a result of a decrease in contract research organization expense and outside consulting costs related to the completion of our LPCN 1148 study late in 2023, a decrease in personnel related costs, and a decrease in LPCN 1111 costs, offset by an increase in costs related to our LPCN 1154 clinical studies, and an increase in other R&D related costs.
General and administrative expenses were $1.6 million and $1.3 million, respectively for the quarters ended March 31, 2024 and 2023. The increase in general and administrative expenses was a result of an increase in business development expenses and in other various general and administrative expenses. These increases were offset by a decrease in various administrative consulting fees, a decrease in corporate insurance expense, a decrease in personnel salaries and benefits, and a decrease in legal fees.
As of March 31, 2024, Lipocine had $24.6 million of unrestricted cash, cash equivalents and marketable investment securities compared to $22.0 million at December 31, 2023.
AboutLipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products for CNS disorders. 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.
Lipocine’s 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 combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant, as an adjunct therapy to incretin mimetics as an aid for improved body composition in chronic weight management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis including prevention of the recurrence of overt hepatic encephalopathy. Lipocine is exploring partnership opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 1148, for the management of decompensated cirrhosis, LPCN 2401 for obesity management 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.
Forward-LookingStatements
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 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.
SOURCE Lipocine Inc.
For further information:
Krista Fogarty
Phone: (801) 994-7383
kf@lipocine.com
Investors:
PJ Kelleher
Phone: (617) 430-7579
pkelleher@lifesciadvisors.com
LIPOCINEINC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
| December 31, | |||||
|---|---|---|---|---|---|
| 2023 | |||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | 3,081,337 | $ | 4,771,758 | ||
| Marketable investment securities | 21,550,661 | 17,263,788 | |||
| Accrued interest income | 100,134 | 52,254 | |||
| Prepaid and other current assets | 583,087 | 773,424 | |||
| Total current assets | 25,315,219 | 22,861,224 | |||
| Property and equipment, net of accumulated depreciation of 1,190,703 and 1,182,191 respectively | 107,583 | 116,095 | |||
| Other assets | 23,753 | 23,753 | |||
| Total assets | 25,446,555 | $ | 23,001,072 | ||
| Liabilities and Stockholders’ Equity | |||||
| Current liabilities: | |||||
| Accounts payable | 671,445 | $ | 1,395,977 | ||
| Accrued expenses | 761,465 | 1,218,486 | |||
| Warrant liability - current portion | 57,238 | 17,166 | |||
| Total current liabilities | 1,490,148 | 2,631,629 | |||
| Total liabilities | 1,490,148 | 2,631,629 | |||
| Stockholders’ equity: | |||||
| Common stock, par value 0.0001 per share, 200,000,000 shares authorized; 5,316,166 issued and 5,315,830 outstanding | 8,860 | 8,860 | |||
| Additional paid-in capital | 220,262,456 | 220,171,250 | |||
| Treasury stock at cost, 336 shares | (40,712 | ) | (40,712 | ) | |
| Accumulated other comprehensive gain (loss) | (10,604 | ) | 7,259 | ||
| Accumulated deficit | (196,263,593 | ) | (199,777,214 | ) | |
| Total stockholders’ equity | 23,956,407 | 20,369,443 | |||
| Total liabilities and stockholders’ equity | 25,446,555 | $ | 23,001,072 |
All values are in US Dollars.
LIPOCINEINC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
| Three Months Ended March 31, | ||||||
|---|---|---|---|---|---|---|
| 2024 | 2023 | |||||
| Revenues: | ||||||
| License revenue | $ | 7,500,000 | $ | 54,990 | ||
| Royalty revenue | 117,174 | - | ||||
| Total revenues | 7,617,174 | 54,990 | ||||
| Operating expenses: | ||||||
| Research and development | 2,818,926 | 3,106,310 | ||||
| General and administrative | 1,575,719 | 1,287,313 | ||||
| Total operating expenses | 4,394,645 | 4,393,623 | ||||
| Operating income (loss) | 3,222,529 | (4,338,633 | ) | |||
| Other income (expense): | ||||||
| Interest and investment income | 331,364 | 370,469 | ||||
| Unrealized gain (loss) on warrant liability | (40,072 | ) | 98,134 | |||
| Total other income, net | 291,292 | 468,603 | ||||
| Income (loss) before income tax expense | 3,513,821 | (3,870,030 | ) | |||
| Income tax expense | (200 | ) | (200 | ) | ||
| Net income (loss) | 3,513,621 | (3,870,230 | ) | |||
| Issuance of Series B preferred stock dividend | - | (89 | ) | |||
| Net income (loss) attributable to common shareholders | $ | 3,513,621 | $ | (3,870,319 | ) | |
| Basic income (loss) per share attributable to common stock | $ | 0.66 | $ | (0.74 | ) | |
| Weighted average common shares outstanding, basic | 5,315,830 | 5,234,830 | ||||
| Diluted income (loss) per share attributable to common stock | $ | 0.66 | $ | (0.76 | ) | |
| Weighted average common shares outstanding, diluted | 5,357,530 | 5,234,830 | ||||
| Comprehensive loss: | ||||||
| Net income (loss) | $ | 3,513,621 | $ | (3,870,319 | ) | |
| Net unrealized gain (loss) on available-for-sale securities | (17,863 | ) | 23,562 | |||
| Comprehensive income (loss) | $ | 3,495,758 | $ | (3,846,757 | ) |