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Form 8-K Lipocine Inc. For: Aug 08

August 8, 2022 9:11 AM EDT

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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):

August 8, 2022

 

 

 

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© 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, 2022, the Company issued a press release announcing financial and operational results for the quarter ended June 30, 2022. The press release is filed as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibits are filed with this report:

 

Exhibit No.   Description
99.1   Press Release announcing Financial Operational Results for the Quarter Ended June 30,2022
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, 2022   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, 2022

 

SALT LAKE CITY, August 8, 2022 – Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on developing innovative products to treat metabolic and central nervous system (“CNS”) disorders, today announced financial results for the second quarter ended June 30, 2022 and provided a corporate update.

 

Second Quarter Highlights

 

In June, Lipocine’s commercial partner Halozyme launched TLANDO™ (testosterone undecanoate), an oral treatment indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism).
In July 2022, Lipocine held an End of Phase 2 meeting with the FDA for LPCN 1144 in NASH. The FDA recommends Lipocine conduct a phase 2 dose ranging study to identify the optimal dose prior to conducting a pivotal study. The FDA agreed to the proposed unique testosterone ester, testosterone dodecanoate, for future clinical studies.
LPCN 1111: Technology transfer for our once-a-day testosterone product candidate was completed. Scale up and manufacturing of registration batches is ongoing.
Lipocine continues to enroll subjects in a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148 for the management of cirrhosis, with enrollment in the study expected to be complete in the second half of 2022.
A type C meeting was held with the FDA to discuss the clinical development path of LPCN 1154, our candidate for postpartum depression (“PPD”). Based on feedback from the meeting, the company plans to initiate a multi-dose proof-of-concept study of LPCN 1154 in the second half of 2022.
The FDA accepted the company’s Investigational New Drug Application (“IND”) for its neuroactive steroid (“NAS”) candidate, LPCN 2101, as a potential treatment for adults with epilepsy. Lipocine plans to initiate a Phase 2 photosensitive epilepsy (“PSE”) study to evaluate the safety, tolerability, and efficacy of oral LPCN 2101 in women with epilepsy of childbearing age.

 

We continue to explore partnering LPCN 1111, LPCN 1144, LPCN 1107 and TLANDO™ ex-US to third parties.

 

 
 

 

Second Quarter Ended June 30, 2022 Financial Results

 

Lipocine reported a net loss of $2.6 million, or ($0.04) per diluted share for the quarter ended June 30, 2022, compared with a net loss of $6.8 million, or ($0.08) per diluted share, in the quarter ended June 30, 2021.

 

Revenues in the quarter ended June 30, 2022 were $0.5 million related to a non-refundable cash fee received from Antares for consideration of a 90-day extension to exercise its option to license LPCN 1111. Antares’ option to license TLANDO XR expired on June 30, 2022 and was not exercised. There was no revenue in the comparable quarter of 2021.

 

Research and development expenses were $2.9 million for the quarter ended June 30, 2022, compared with $1.5 million for the quarter ended June 30, 2021. The increase in research and development expenses for the quarter ended June 30, 2022, was a result of an increase in contract research organization expense related to the Phase 2 POC study in male cirrhotic subjects with LPCN 1148, an increase in costs related to LPCN 1154 clinical studies, increases in personnel expenses, and an increase in costs related to LPCN 1111 scale up and LPCN 1107 expenses. These increases were offset by a decrease in contract research organization expenses and outside consulting costs related to the completion of the LiFT Phase 2 clinical study in NASH subjects in 2021, a decrease in costs associated with TLANDO, as well as a decrease in other R&D expenses.

 

General and administrative expenses were $1.1 million for the quarter ended June 30, 2022, compared with $1.5 million for the quarter ended June 30, 2021. The decrease in general and administrative expenses was primarily due to decreases in legal expenses and personnel costs. These decreases were offset by an increase in professional fees, an increase related to proxy solicitation and proxy distribution services, an increase in corporate insurance expenses, and an increase in other general and administrative expenses.

 

As of June 30, 2022, the company had $37.4 million of unrestricted cash, cash equivalents and marketable investment securities, compared to $46.6 million at December 31, 2021.

 

Six Months Ended June 30, 2022 Financial Results

 

Lipocine reported a net loss of $6.1 million, or ($0.07) per diluted share, for the six months ended June 30, 2022, compared with a net loss of $10.2 million, or ($0.12) per diluted share, in the six months ended June 30, 2021.

 

Revenues in the six months ended June 30, 2022 were $0.5 million related to a non-refundable cash fee received from Antares for consideration of a 90-day extension to exercise its option to license LPCN 1111, as described above. There was no revenue in the comparable period of 2021.

 

Research and development expenses for the six months ended June 30, 2022, were $4.8 million compared to $3.0 million for the comparable period in 2021. The increase in research and development expenses was due to an increase in contract research organization expense related to the Phase 2 POC study in male cirrhotic subjects with LPCN 1148, an increase in costs related to LPCN 1154 clinical studies, an increase related to LPCN 1111 scale up activities, a food effect study in LPCN 1107, and an increase in personnel expenses and other research and development costs. These increases were offset by a decrease in contract research organization expense and outside consulting costs related to the completion of our LPCN 1144 LiFT Phase 2 clinical study in NASH subjects in 2021, and a decrease in costs associated with TLANDO.

 

 
 

 

General and administrative expenses for the six months ended June 30, 2022 were $2.4 million compared to $3.1 million for the comparable period in 2021. The decrease in general and administrative expenses was primarily due to decreases in legal expenses, personnel costs, and other general and administrative expenses. These decreases were offset by an increase in professional fees, an increase related to proxy solicitation and proxy distribution services, an increase in various other consulting fees, and an increase in corporate insurance expenses.

 

About Lipocine

 

Lipocine is biopharmaceutical company leveraging its commercially validated proprietary technology to develop innovative products to treat metabolic and CNS disorders with high unmet medical need. Our candidates target diseases with potential for orphan drug designation, comprise endogenous actives for favorable benefit to risk profile, and represent enablement of patient friendly oral delivery options. Lipocine’s clinical development pipeline includes: LPCN 1148, LPCN 1144, LPCN 1111, LPCN 1107 and oral neuroactive steroids including LPCN 1154 and LPCN 2101. TLANDO™, a novel oral prodrug of testosterone containing testosterone undecanoate, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the management of symptoms associated with liver cirrhosis. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a Phase 2 clinical study demonstrating potential utility in the treatment of non-cirrhotic NASH. LPCN 1111, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once or twice daily, LPCN 1111 met primary and secondary endpoints. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. Neuroactive steroids are currently being evaluated including LPCN 1154 for the potential treatment of postpartum depression and LPCN 2101 for the potential treatment of epilepsy. 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 Lipocine’s 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, the potential uses and benefits of our product candidates, the timing and scope of clinical trials and studies, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that 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.

 

*TLANDO® is a registered trademark assigned to Antares Pharma.

 

For further information:

 

Krista Fogarty, Phone: (801) 994-7383, [email protected];

 

Investors, Hans Vitzthum, Phone: (617) 430-7875, [email protected]

 

 
 

 

LIPOCINE INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(Unaudited)

 

   June 30,   December 31, 
   2022   2021 
Assets          
Current assets:          
Cash and cash equivalents  $4,981,193   $2,950,552 
Marketable investment securities   32,414,473    41,667,405 
Accrued interest income   80,411    247,253 
Prepaid and other current assets   603,546    1,514,465 
Total current assets   38,079,623    46,379,675 
           
Marketable investment securities   -    2,021,800 
Contract asset   4,050,000    4,050,000 
Property and equipment, net of accumulated depreciation of $1,148,374 and $1,144,077   40,013    7,211 
Other assets   23,753    23,753 
Total assets  $42,193,389   $52,482,439 
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable  $814,004   $1,289,342 
Accrued expenses   899,301    1,016,458 
Debt - current portion   -    2,310,825 
Litigation settlement liability - current portion   -    1,000,000 
Total current liabilities   1,713,305    5,616,625 
           
Warrant liability   590,339    795,796 
Litigation settlement liability - non-current portion   -    500,000 
Total liabilities   2,303,644    6,912,421 
           
Commitments and contingencies          
           
Stockholders’ equity:          
Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized; zero issued and outstanding   -    - 
Common stock, par value $0.0001 per share, 200,000,000 shares authorized; 88,504,834 and 88,296,360 issued and 88,499,124 and 88,290,650 outstanding   8,850    8,829 
Additional paid-in capital   218,792,479    218,286,324 
Treasury stock at cost, 5,710 shares   (40,712)   (40,712)
Accumulated other comprehensive loss   (84,907)   (18,016)
Accumulated deficit   (178,785,965)   (172,666,407)
           
Total stockholders’ equity   

39,889,745

    

45,570,018

 
           
Total liabilities and stockholders’ equity  $42,193,389   $52,482,439 

 

 
 

 

LIPOCINE INC. AND SUBSIDIARIES 

Condensed Consolidated Statements of Operations and Comprehensive Loss 

(Unaudited)

 

  

Three Months Ended

June 30,

  

Six Months Ended

June 30,

 
   2022   2021   2022   2021 
                 
Revenues:  $500,000   $-   $500,000   $- 
                     
Operating expenses:                    
Research and development  2,898,012   1,464,687   4,785,965   3,045,228 
General and administrative   1,129,519    1,525,592    2,373,205    3,059,544 
Total operating expenses   4,027,531    2,990,279    7,159,170    6,104,772 
Operating loss   (3,527,531)   (2,990,279)   (6,659,170)   (6,104,772)
Other income (expense):                    
Interest and investment income   69,877    17,344    111,453    27,993 
Interest expense   (7,568)   (57,428)   (27,098)   (126,401)
Unrealized gain on warrant liability   583,445    221,322    205,457    26,257 
Gain (loss) litigation settlement liability   250,000    (4,000,000)   250,000    (4,000,000)
Total other income (expense), net   895,754    (3,818,762)   539,812    (4,072,151)
Loss before income tax expense   (2,631,777)   (6,809,041)   (6,119,358)   (10,176,923)
Income tax expense   -    -    (200)   (200)
Net loss  $(2,631,777)  $(6,809,041)  $(6,119,558)  $(10,177,123)
                     
Basic loss per share attributable to common stock  $(0.03)  $(0.08)  $(0.07)  $(0.12)
Weighted average common shares outstanding, basic   88,499,067    88,290,650    88,404,999    85,556,110 
                     
Diluted loss per share attributable to common stock  $(0.04)  $(0.08)  $(0.07)  $(0.12)
Weighted average common shares outstanding, diluted   88,998,515    88,988,292    88,987,800    86,294,935 
                     
Comprehensive loss:                    
Net loss  $(2,631,777)  $(6,809,041)  $(6,119,558)  $(10,177,123)
Net unrealized gain (loss) on available-for-sale securities   (17,491)   22,273    (66,891)   (186)
                     
Comprehensive loss  $(2,649,268)  $(6,786,768)  $(6,186,449)  $(10,177,309)

 

 



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