Lipocine Announces Financial Results for the Third Quarter Ended September 30, 2023

 

SALT LAKE CITY, Nov. 8, 2023 /PRNewswire/ --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 third quarter and nine months ended September 30, 2023, and provided a corporate update.

Clinical Program Highlights

Neuroactive Steroids

  • On October 18, Lipocine completed a successful meeting with the FDA on LPCN 1154, which is in development for postpartum depression (PPD). The FDA agreed on Lipocone's proposal for a 505(b)(2) NDA filing based on a single pivotal study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone
    • Lipocine anticipates initiating the pivotal study program in Q1 2024 with the LPCN 1154 "to be marketed" formulation
    • Top line results from the study are expected by Q2 2024, with a goal of filing a New Drug Application (NDA) in 2024
    • If approved, LPCN 1154, has the potential to be a differentiated preferred treatment option for PPD with rapid and high remission/response rates with short treatment duration

LPCN 1148 in liver cirrhosis

  • In July, Lipocine announced positive topline results from its Phase 2 proof-of-concept ("POC") study evaluating LPCN 1148 in cirrhosis
    • Study met primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relative to placebo (P <0.01)
    • Fewer hepatic encephalopathy (HE) events of grade >1 in the LPCN 1148 treatment arm relative to placebo (P < 0.05)
    • More patients on LPCN 1148 reported symptom improvement compared to placebo (P < 0.05)
    • LPCN 1148 was well-tolerated, with AE rates and severities similar to placebo
    • Lipocine plans to meet with the FDA to discuss the development path to NDA filing

Quarter Ended September 30, 2023 Financial Results

Lipocine reported a net loss of $6.7 million, or ($1.27) per diluted share, for the three months ended September 30, 2023, compared with a net loss of $2.4 million or ($0.52) per diluted share, in the three months ended September 30, 2022.

During the three months ended September 30, 2023, the Company recognized a non-cash minimum guaranteed royalties revenue reversal of variable consideration revenue of $3.1 million related to the termination of the Antares License Agreement.  The reversal of revenue is due to the fact that Lipoocine will not receive anticipated royalties that were previously recorded for the Antares License Agreement due to the termination of the agreement.

Research and development expenses were $2.9 million during the three months ended September 30, 2023, as compared with $2.1 million in the three months ended September 30, 2022.  The increase in research and development expenses was a result of an increase in costs related to the LPCN 1154 clinical studies, an increase in TLANDO manufacturing related costs, and an increase in personnel related costs, offset by a decrease in LPCN 1111 scale up costs in 2022, a decrease in contract research organization expense related to the LPCN 1148 Phase 2 POC study in male subjects with cirrhosis, a decrease in contract research organization expense and outside consulting costs related to the completion of the LPCN 1144 LiFT study in 2022, and a decrease in LPCN 1107 PK and food effect studies and other research and development costs in 2022.

General and administrative expenses were $1.0 million during the three months ended September 30, 2023, as compared to $0.8 million in the three months ended September 30, 2022. The increase in expenses is mainly due to increases in business development expenses,  and an increase in professional services and legal fees.  These increases were offset by a decrease in corporate insurance expense. 

As of September 30, 2023, Lipocine had $23.8 million of unrestricted cash, cash equivalents and marketable investment securities compared to $32.5 million at December 31, 2022. 

Nine Months Ended September 30, 2023 Financial Results

Lipocine reported a net loss of $14.1 million, or ($2.72) per diluted share, for the nine months ended September 30, 2023, compared with a net loss of $8.5 million or ($1.72) per diluted share, in the nine months ended September 30, 2022.

The Company recognized a non-cash minimum guaranteed royalties revenue reversal of variable consideration revenue of $3.1 million related to the termination of the Antares License Agreement during the nine months ended September 30, 2023.  The reversal of variable consideration revenue is offset by license revenue of approximately $55,000 for payments received from Spriaso, a related party, under a licensing agreement for the cough and cold field during the nine months ended September 30, 2023. The Company recognized revenue related to a non-refundable cash fee of $500,000 received from Antares for consideration of a 90-day extension for Antares to exercise its option to license LPCN 1111 during the nine months ended September 30, 2022.

Research and development expenses were $8.5 million and $6.9 million, respectively, for the nine months ended September 30, 2023, and 2022. The increase was due to an increase in costs related to the LPCN 1154 clinical studies, an increase in TLANDO manufacturing related costs, an increase in contract research organization expense related to the LPCN 1148 Phase 2 POC study in male subjects with cirrhosis, and an increase in personnel salaries and benefits. These increases were offset by a decrease related to LPCN 1111 scale up costs in 2022, a decrease in contract research organization expense and outside consulting costs related to the completion of our LPCN 1144 LiFT study, a decrease related to the completion of our LPCN 1107 PK and food effect studies and a decrease in other research and development activities.   

General and administrative expenses were $3.8 million and $3.2 million, respectively, for the nine months ended September 30, 2023, and 2022. The increase consisted of an increase in business development expenses, an increase in professional and legal fees and an increase in other general and administrative expenses.  These increases were offset by decrease resulting from a decrease in corporate insurance expense and a decrease in various other consulting fees.

For more information on Lipocine's financial results for the three and nine months ended September 30, 2023, refer to Form 10Q filed with the SEC.

About Lipocine

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 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, our strategic plans for developing products to treat CNS disorders, our ability to monetize non-core 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 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.

LIPOCINE INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(Unaudited)

                 
           

September 30,

 

December 31,

           

2023

 

2022

Assets

       

Current assets:

       
 

Cash and cash equivalents

 

$              4,072,706

 

$        3,148,496

 

Marketable investment securities

 

19,775,290

 

29,381,410

 

Accrued interest income

 

41,061

 

80,427

 

Contract asset - current portion

 

130,505

 

579,428

 

Prepaid and other current assets

 

594,097

 

945,319

                 
       

Total current assets

 

24,613,659

 

34,135,080

                 

Contract asset - non-current portion

 

-

 

3,252,500

Property and equipment, net of accumulated depreciation

       

 of $1,174,189 and $1,153,530 respectively

 

114,931

 

131,589

Other assets

 

23,753

 

23,753

                 
       

Total assets

 

$            24,752,343

 

$       37,542,922

                 
                 

Liabilities and Stockholders' Equity

       

Current liabilities:

       
   

Accounts payable

 

$              1,101,068

 

$           600,388

   

Accrued expenses

 

1,140,313

 

1,077,738

                 
       

Total current liabilities

 

2,241,381

 

1,678,126

                 

Warrant liability

 

29,440

 

229,856

                 
       

Total liabilities

 

2,270,821

 

1,907,982

                 
                 
                 
                 

Stockholders' equity:

           
 

Common stock, par value $0.0001 per share, 200,000,000 

       
   

shares authorized; 5,316,166 and 5,235,166 issued and

       
   

5,315,830 and 5,234,830 outstanding

 

8,860

 

8,852

 

Additional paid-in capital

 

220,022,838

 

219,112,164

 

Treasury stock at cost, 336 shares

 

(40,712)

 

(40,712)

 

Accumulated other comprehensive loss

 

(14,503)

 

(20,321)

 

Accumulated deficit

 

(197,494,961)

 

(183,425,043)

                 
       

Total stockholders' equity

 

22,481,522

 

35,634,940

                 
                 
       

Total liabilities and stockholders' equity

 

$            24,752,343

 

$       37,542,922

 

LIPOCINE INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

                         
           

Three Months Ended September 30,

 

Nine Months Ended September 30,

           

2023

 

2022

 

2023

 

2022

                         

Revenues:

                 
 

License revenue

 

$                         -

 

$                        -

 

$          54,990

 

$              500,000

 

Minimum guaranteed royalties revenue (reversal of

             

-

 

 variable consideration)

 

(3,121,996)

 

-

 

(3,121,996)

 

-

   

Total revenues (reversal of variable consideration), net

 

(3,121,996)

 

-

 

(3,067,006)

 

500,000

                         

Operating expenses:

               
 

Research and development

 

2,878,798

 

2,100,432

 

8,500,319

 

6,886,398

 

General and administrative

 

1,042,572

 

798,939

 

3,770,281

 

3,172,144

   

Total operating expenses

 

3,921,370

 

2,899,371

 

12,270,600

 

10,058,542

                         
   

Operating loss

 

(7,043,366)

 

(2,899,371)

 

(15,337,606)

 

(9,558,542)

                         

Other income (expense):

               
 

Interest and investment income

 

317,569

 

163,966

 

1,067,561

 

275,420

 

Interest expense

 

-

 

-

 

-

 

(27,098)

 

Unrealized gain on warrant liability

 

74,827

 

326,240

 

200,416

 

531,697

 

Gain on litigation settlement liability

 

-

 

-

 

-

 

250,000

   

Total other income, net

 

392,396

 

490,206

 

1,267,977

 

1,030,019

                         
   

Loss before income tax expense

 

(6,650,970)

 

(2,409,165)

 

(14,069,629)

 

(8,528,523)

                         

Income tax expense

 

-

 

-

 

(200)

 

(200)

                         
   

Net loss

     

(6,650,970)

 

(2,409,165)

 

(14,069,829)

 

(8,528,723)

                         
   

Issuance of Series B preferred stock dividend

 

-

 

-

 

(89)

 

-

   

Net loss attributable to common shareholders

 

$          (6,650,970)

 

$         (2,409,165)

 

$  (14,069,918)

 

$          (8,528,723)

                         

Basic loss per share attributable to common stock

 

$                  (1.26)

 

$                 (0.46)

 

$            (2.68)

 

$                  (1.63)

                         

Weighted average common shares outstanding, basic

 

5,292,058

 

5,234,576

 

5,254,116

 

5,230,619

                         

Diluted loss per share attributable to common stock 

 

$                  (1.27)

 

$                 (0.52)

 

$            (2.72)

 

$                  (1.72)

                         

Weighted average common shares outstanding, diluted

 

5,292,058

 

5,250,179

 

5,254,116

 

5,260,530

                         

Comprehensive loss:

               
   

Net loss

 

$          (6,650,970)

 

$         (2,409,165)

 

$  (14,069,829)

 

$          (8,528,723)

   

Net unrealized gain (loss) on available-for-sale securities

 

1,309

 

7,972

 

5,818

 

(58,919)

                         
   

Comprehensive loss

 

$          (6,649,661)

 

$         (2,401,193)

 

$  (14,064,011)

 

$          (8,587,642)

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/lipocine-announces-financial-results-for-the-third-quarter-ended-september-30-2023-301979148.html

SOURCE Lipocine Inc.

 
 
Company Codes: NASDAQ-SMALL:LPCN
 

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