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):
May11, 2023
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 11, 2023, the Company issued a press release announcing financial and operational results for the quarter ended March 31, 2023. The press release is filed as Exhibit 99.1 and is incorporated herein by reference.
| Item<br> 9.01 | Financial<br> Statements and Exhibits. |
|---|---|
| (d) | Exhibits |
| --- | --- |
The following exhibits are filed with this report:
| Exhibit<br> No. | Description |
|---|---|
| 99.1 | Press Release announcing Financial and Operational Results for the Quarter Ended March 31, 2023 |
| 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> 11, 2023 | 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, 2023
SALTLAKE CITY, May 11, 2023 – Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform to develop differentiated products, today announced financial results for the first quarter ended March 31, 2023, and provided a corporate update.
FirstQuarter Highlights
Neuroactive Steroid for Depression
Dosing was initiated in a pilot clinical bridge study of LPCN 1154 (oral brexanolone) a neuroactive steroid product candidate that Lipocine is developing for postpartum depression (“PPD”). LPCN 1154 is targeted to be a differentiated oral treatment option as a mono or add-on therapy for patients with unresolved symptoms needing fast onset with high response in short treatment duration.
| ● | Results<br> are expected in the second quarter of the year. The FDA has agreed with Lipocine’s<br> proposal for establishing the efficacy of LPCN 1154 via the 505(b)(2) pathway. The proof-of-concept<br> study is a prelude to a single confirmatory Pivotal PK study in place of an efficacy study<br> for NDA submission. |
|---|
LPCN 1148 in liver cirrhosis
LPCN 1148 is being evaluated in an ongoing Phase 2 proof-of-concept (“POC”) study for the management of decompensated cirrhosis of various etiologies. Topline results are expected mid-2023.
Lipocine continues to explore partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1148, for the management of decompensated cirrhosis, LPCN 1144, our candidate for treatment of non-cirrhotic NASH, and LPCN 1111, a once-a-day therapy candidate for testosterone replacement therapy (TRT).
QuarterEnded March 31, 2023 Financial Results
Lipocine reported a net loss of $3.9 million, or ($0.04) per diluted share, for the three months ended March 31, 2023, compared with a net loss of $3.5 million or ($0.04) per diluted share, in the three months ended March 31, 2022.
Lipocine recognized license revenue for payments receivable from Spriaso under a licensing agreement in the cough and cold field of approximately $55,000 during the three months ended March 31, 2023. There was no revenue during the three months ended March 31, 2022.
Research and development expenses were $3.1 million and $1.9 million, respectively, for the three months ended March 31, 2023, and 2022. The increase in research and development expenses year-over-year was the result of an increase in contract research organization expense related to the Phase 2 POC study with LPCN 1148, an increase in costs related to LPCN 1154 clinical studies, an increase in personnel costs and expenses related to lab supplies, small equipment and other research and development costs. These increases were offset by a decrease in LPCN 1111 scale up costs, a decrease in contract research organization expense and outside consulting costs related to the completion of the LPCN 1144 LiFT Phase 2 clinical study, and a decrease in expenses as a result of completing the PK and food effect studies for LPCN 1154 and LPCN 1107 in 2022.
General and administrative expenses were $1.3 million and $1.2 million, respectively, for the three months ended March 31, 2023, and 2022. The increase in general and administrative expenses year-over-year was primarily due to increases in corporate legal fees, business development consulting fees, director fees, and various professional fees. These were offset by decreases in corporate insurance expense and general and administrative expenses.
As of March 31, 2023, Lipocine had $28.9 million of unrestricted cash, cash equivalents and marketable investment securities compared to $32.5 million at December 31, 2022.
AboutLipocine
Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop products for CNS disorders. Lipocine has candidates in development as well as candidates for which we are exploring partnering. Our candidates represent the enablement of patient friendly oral delivery options for a favorable benefit to risk profile which target large addressable markets with significant unmet medical needs.
Lipocine clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy and LPCN 1148, an oral prodrug of bioidentical testosterone 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 1148, for the management of decompensated cirrhosis, LPCN 1144, our candidate for treatment of non-cirrhotic NASH, and LPCN 1111, a once-a-day therapy candidate for testosterone replacement therapy (TRT). 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 non-core product candidates, 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 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, 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
(Unaudited)
| December 31, | |||||
|---|---|---|---|---|---|
| 2022 | |||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | 4,769,180 | $ | 3,148,496 | ||
| Marketable investment securities | 24,100,430 | 29,381,410 | |||
| Accrued interest income | 39,060 | 80,427 | |||
| Contract asset - current portion | 579,428 | 579,428 | |||
| Prepaid and other current assets | 1,126,731 | 945,319 | |||
| Total current assets | 30,614,829 | 34,135,080 | |||
| Contract asset - non-current portion | 3,252,500 | 3,252,500 | |||
| Property and equipment, net of accumulated depreciation of<br> 1,158,349 and 1,153,530 respectively | 130,770 | 131,589 | |||
| Other assets | 23,753 | 23,753 | |||
| Total assets | 34,021,852 | $ | 37,542,922 | ||
| Liabilities and Stockholders' Equity | |||||
| Current liabilities: | |||||
| Accounts payable | 796,476 | $ | 600,388 | ||
| Accrued expenses | 1,133,626 | 1,077,738 | |||
| Total current liabilities | 1,930,102 | 1,678,126 | |||
| Warrant liability | 131,722 | 229,856 | |||
| Total liabilities | 2,061,824 | 1,907,982 | |||
| Commitments and contingencies | |||||
| Mezzanine equity: | |||||
| Preferred stock, par value 0.0001 per share (0.001 per share redemption value), 10,000,000 shares authorized; 88,511 and zero<br> issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 9 | - | |||
| Stockholders' equity: | |||||
| Common stock, par value 0.0001 per share, 200,000,000 shares authorized; 88,516,501 issued and<br> 88,510,791 outstanding | 8,852 | 8,852 | |||
| Additional paid-in capital | 219,284,000 | 219,112,164 | |||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | |
| Accumulated other comprehensive loss | 3,241 | (20,321 | ) | ||
| Accumulated deficit | (187,295,362 | ) | (183,425,043 | ) | |
| Total stockholders’ equity | 31,960,028 | 35,634,940 | |||
| Total liabilities and stockholders’ equity | 34,021,852 | $ | 37,542,922 |
All values are in US Dollars.
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
| Three Months Ended March 31, | ||||||
|---|---|---|---|---|---|---|
| 2023 | 2022 | |||||
| Revenues: | $ | 54,990 | $ | - | ||
| Operating expenses: | ||||||
| Research and development | 3,106,310 | 1,887,953 | ||||
| General and administrative | 1,287,313 | 1,243,687 | ||||
| Total operating expenses | 4,393,623 | 3,131,640 | ||||
| Operating loss | (4,338,633 | ) | (3,131,640 | ) | ||
| Other income (expense): | ||||||
| Interest and investment income | 370,469 | 41,576 | ||||
| Interest expense | - | (19,529 | ) | |||
| Unrealized gain (loss) on warrant liability | 98,134 | (377,988 | ) | |||
| Total other income (expense), net | 468,603 | (355,941 | ) | |||
| Loss before income tax expense | (3,870,030 | ) | (3,487,581 | ) | ||
| Income tax expense | (200 | ) | (200 | ) | ||
| Net loss Net loss | (3,870,230 | ) | (3,487,781 | ) | ||
| Issuance of Series B preferred stock dividend | (89 | ) | - | |||
| Net loss attributable to common shareholders | $ | (3,870,319 | ) | $ | (3,487,781 | ) |
| Basic loss per share attributable to common stock | $ | (0.04 | ) | $ | (0.04 | ) |
| Weighted average common shares outstanding, basic | 88,510,791 | 88,309,628 | ||||
| Diluted loss per share attributable to common stock | $ | (0.04 | ) | $ | (0.04 | ) |
| Weighted average common shares outstanding, diluted | 88,510,791 | 88,309,628 | ||||
| Comprehensive loss: | ||||||
| Net loss | $ | (3,870,319 | ) | $ | (3,487,781 | ) |
| Net unrealized gain (loss) on available-for-sale securities | 23,562 | (49,400 | ) | |||
| Comprehensive loss | $ | (3,846,757 | ) | $ | (3,537,181 | ) |