0001493152-23-038962.txt : 20231101 0001493152-23-038962.hdr.sgml : 20231101 20231101093111 ACCESSION NUMBER: 0001493152-23-038962 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20231101 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231101 DATE AS OF CHANGE: 20231101 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Lipocine Inc. CENTRAL INDEX KEY: 0001535955 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 990370688 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36357 FILM NUMBER: 231366818 BUSINESS ADDRESS: STREET 1: 675 ARAPEEN DRIVE, SUITE 202 CITY: SALT LAKE CITY STATE: X1 ZIP: 84108 BUSINESS PHONE: 801 994 7383 MAIL ADDRESS: STREET 1: 675 ARAPEEN DRIVE, SUITE 202 CITY: SALT LAKE CITY STATE: X1 ZIP: 84108 FORMER COMPANY: FORMER CONFORMED NAME: MARATHON BAR CORP DATE OF NAME CHANGE: 20111130 8-K 1 form8-k.htm
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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):

November 1, 2023

 

 

 

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: (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 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(c) under the Exchange Act (17 CFR 240.13e-4(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 November 1, 2023, the Company issued a press release announcing that an abstract on LPCN 1148 has been selected for a late breaking oral presentation at The American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2023. 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 Lipocine to Present Clinical Data on LPCN 1148 at The Liver Meeting® 2023
     
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: November 1, 2023   By: /s/ Mahesh V. Patel
        Mahesh V. Patel
        President and Chief Executive Officer

 

 

 

 EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

 

Lipocine to Present Clinical Data on LPCN 1148 at The Liver Meeting® 2023

 

“Late Breaking” abstract scheduled for oral presentation on November 13

 

SALT LAKE CITY, November 01, 2023 -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that an abstract on LPCN 1148 has been selected for a late breaking oral presentation at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023, to take place in Boston MA, November 10 to 14, 2023.

 

Presentation Details

 

Title   Oral LPCN 1148 improves sarcopenia and hepatic encephalopathy in patients with cirrhosis
Presenter:   Dr. Arun J. Sanyal, MD, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University Advisor to Lipocine
Session Title:   Late Breaking Abstract #1
Session Date and Time:   Monday, November 13, 2023, 2:00 PM - 3:30 PM ET
Presentation Time:   2:45 PM ET
Abstract Number:    5003

 

About LPCN 1148

 

Lipocine is currently evaluating LPCN 1148 comprising testosterone laurate (“TL”) for the management of decompensated cirrhosis. The Company believes LPCN 1148 targets unmet needs for patients with advanced cirrhosis including improvement in the quality of life of patients while on the liver transplant waiting list, prevention or reduction in the occurrence of new decompensation events such as hepatic encephalopathy (“HE”), and improvement in post liver transplant outcomes including survival and costs.

 

About Lipocine

 

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 partnering. 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 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, LPCN1154, for rapid relief of postpartum depression, 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-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, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of and filing of a NDA with the FDA for LPCN 1148,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.

 

For further information:

 

Krista Fogarty

Phone: (801) 994-7383

kf@lipocine.com

 

Investors:

 

PJ Kelleher

Phone: (617) 430-7879

pkelleher@lifesciadvisors.com

 

 

 

 

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Cover
Nov. 01, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 01, 2023
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
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