Form 8-K - Current report

 

 

 

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):

August 8, 2024

 

 

LIPOCINE INC.

(Exact name of registrant as specified in its charter)

 

Commission File No. 001-36357

 

Delaware		99-0370688
(State or other jurisdiction of incorporation)		(IRS Employer Identification Number)

 

675 Arapeen Drive, Suite 202

Salt Lake City, Utah 84108

(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: [phone]

 

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 communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement 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 of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		LPCN		The 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 August 8, 2024, the Company issued a press release announcing financial and operational results for the quarter ended June 30, 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 No.		Description
99.1		Press Release announcing Financial Results for the Quarter Ended June 30, 2024
104		Cover 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 INC.
Date:	August 8, 2024		By:	/s/ Mahesh V. Patel
				Mahesh V. Patel
				President and Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

Lipocine Announces Financial Results for the Second Quarter Ended June 30, 2024

 

SALT LAKE CITY, August 08, 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 second quarter ended June 30, 2024 and provided a corporate update.

 

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 by Arun 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 at EASL 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

 

Lipocine reported a net loss of $3.1 million, or ($0.56) per diluted share, for the second quarter ended June 30, 2024, compared with a net loss of $3.6 million, or ($0.68) per diluted share, for the quarter ended June 30, 2023.

 

Revenues were approximately $90,000, consisting of royalty revenue from the Verity license agreement in the second quarter of 2024. No revenue was recorded during the second quarter of 2023.

 

Research and development expenses were $1.9 million and $2.5 million, respectively, for the quarters ended June 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 our LPCN 1148 study in 2024, a decrease in TLANDO related costs, and a decrease in personnel related costs, offset by an increase in costs related to the LPCN 1154 clinical studies, and an increase in other R&D related costs.

 

General and administrative expenses were $1.5 million and $1.4 million, respectively for the quarters ended June 30, 2024 and 2023.

 

As of June 30, 2024, Lipocine had $22.5 million of unrestricted cash, cash equivalents and marketable investment securities compared to $22.0 million at December 31, 2023.

 

Six Months Ended, June 30 2024 Financial Results

 

Lipocine reported a net profit of $0.5 million, or $0.10 per diluted share, for the six months ended June 30, 2024, compared with a net loss of $7.4 million, or ($1.42) per diluted share, for the six months ended June 30, 2023.

 

Revenues for the six-month period ended June 30, 2024 were $7.7 million, primarily consisting of licensing revenue from the Verity License Agreement. This compares with licensing revenue of $55,000 during the six months ended June 30, 2023.

 

Research and development expenses were $4.7 million and $5.6 million, respectively, for the six months ended June 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 our LPCN 1148 study in 2024, decrease in personnel related costs, and a decrease in LPCN 1111 and LPCN 1144 clinical study costs. These decreases were offset by an increase in costs related to our LPCN 1154 clinical studies, an increase in TLANDO related costs, and an increase in other research and development related costs.

 

General administrative expenses were $3.1 million and $2.7 million, respectively, for the six months ended June 30, 2024 and 2023.

 

For more information on Lipocine’s financial results, refer to Form 10Q filed by the Company with the SEC.

 

 

 

About Lipocine

 

Lipocine 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.

 

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. 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 chronic weight 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.

 

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 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: [phone]

[e-mail]

 

Investors:

 

PJ Kelleher

Phone: [phone]

[e-mail]

 

 

LIPOCINE INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

 

		June 30,				December 31,
		2024				2023
Assets
Current assets:
Cash and cash equivalents		$	5,553,371			$	4,771,758
Marketable investment securities			16,995,424				17,263,788
Accrued interest income			63,636				52,254
Prepaid and other current assets			297,051				773,424
Total current assets			22,909,482				22,861,224
Property and equipment, net of accumulated depreciation of $1,199,215 and $1,182,191 respectively			99,071				116,095
Other assets			23,753				23,753
Total assets		$	23,032,306			$	23,001,072
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	448,798			$	1,395,977
Accrued expenses			1,233,477				1,218,486
Warrant liability			141,668				17,166
Total current liabilities			1,823,943				2,631,629
Total liabilities			1,823,943				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			220,582,158				220,171,250
Treasury stock at cost, 336 shares			(40,712	)			(40,712	)
Accumulated other comprehensive gain (loss)			(9,719	)			7,259
Accumulated deficit			(199,332,227	)			(199,777,214	)
Total stockholders’ equity			21,208,363				20,369,443
Total liabilities and stockholders’ equity		$	23,032,306			$	23,001,072

 

 

LIPOCINE INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Loss

 

		Three Months Ended June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
Revenues:
License revenue		$	-			$	-			$	7,500,000			$	54,990
Royalty revenue			89,565				-				206,738				-
Total revenues			89,565				-				7,706,738				54,990
Operating expenses:
Research and development			1,874,721				2,515,211				4,693,646				5,621,521
General and administrative			1,507,412				1,440,394				3,083,131				2,727,708
Total operating expenses			3,382,133				3,955,605				7,776,777				8,349,229
Operating loss			(3,292,568	)			(3,955,605	)			(70,039	)			(8,294,239	)
Other income (expense):
Interest and investment income			308,845				379,521				640,209				749,991
Unrealized gain (loss) on warrant liability			(84,430	)			27,455				(124,502	)			125,589
Total other income, net			224,415				406,976				515,707				875,580
Income (loss) before income tax expense			(3,068,153	)			(3,548,629	)			445,668				(7,418,659	)
Income tax expense			(481	)			-				(681	)			(200	)
Net income (loss)			(3,068,634	)			(3,548,629	)			444,987				(7,418,859	)
Issuance of Series B preferred stock dividend			-				-				-				(89	)
Net loss attributable to common shareholders Net income (loss) attributable to common shareholders		$	(3,068,634	)		$	(3,548,629	)		$	444,987			$	(7,418,948	)
Basic earnings (loss) per share attributable to common stock		$	(0.57	)		$	(0.68	)		$	0.08			$	(1.42	)
Weighted average common shares outstanding, basic			5,343,922				5,234,830				5,329,876				5,234,830
Diluted earnings (loss) per share attributable to common stock		$	(0.56	)		$	(0.68	)		$	0.10			$	(1.44	)
Weighted average common shares outstanding, diluted			5,343,922				5,234,830				5,459,204				5,234,830
Comprehensive income (loss):
Net income (loss)		$	(3,068,634	)		$	(3,548,629	)		$	444,987			$	(7,418,859	)
Net unrealized gain (loss) on marketable investment securities			885				(19,053	)			(16,978	)			4,509
Comprehensive income (loss)		$	(3,067,749	)		$	(3,567,682	)		$	428,009			$	(7,414,350	)

 

 

Cover	Aug. 08, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 08, 2024
Entity File Number	001-36357
Entity Registrant Name	LIPOCINE INC.
Entity Central Index Key	0001535955
Entity Tax Identification Number	99-0370688
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	675 Arapeen Drive
Entity Address, Address Line Two	Suite 202
Entity Address, City or Town	Salt Lake City
Entity Address, State or Province	UT
Entity Address, Postal Zip Code	84108
City Area Code	(801)
Local Phone Number	994-7383
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	LPCN
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

---