# EDGAR Filing Document

**Accession Number:** 0001535955
**File Stem:** 0001493152-23-007177
**Filing Date:** 2023-3
**Character Count:** 17216
**Document Hash:** c2727867fe96118b13cd5599a8761c6d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-23-007177.hdr.sgml**: 20230310

**ACCESSION NUMBER**: 0001493152-23-007177

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230310

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230310

**DATE AS OF CHANGE**: 20230310

**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:** 23721709

**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

?xml version="1.0" encoding="utf-8"?

**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):

**March 10, 2023**

![](form8-k_001.jpg)

**LIPOCINE INC.**

(Exact name of registrant as specified in its charter)

Commission File No. 001-36357

Delaware 99-0370688 <br> (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 <u>Section 12(b)</u> 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 March 10, 2023, the Company issued a press release announcing financial and operational results for the year ended December 31, 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:

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| | |
|:---|:---|
| Exhibit No. | Description |
| 99.1 | [Press Release announcing Financial and Operational Results for the Year Ended December 31, 2023](ex99-1.htm) |
| 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. | LIPOCINE INC. |
| Date: | March 10, 2023 | By: | */s/ Mahesh V. Patel* |
|  |  |  | Mahesh V. Patel |
|  |  |  | President and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](form8-k_001.jpg)

**Lipocine Announces Financial Results for the Year Ended December 31, 2022**

**SALT LAKE CITY, March 10, 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 year ended December 31, 2022 and provided a corporate update.

In 2022, Lipocine announced a new strategic direction, focusing on the development of endogenous neuroactive steroids which have broad applicability in treating various CNS conditions. The Company is currently exploring partnering non-core assets including LPCN 1107, for prevention of pre-term birth, LPCN 1148, for the management of decompensated cirrhosis, LPCN 1144, for treatment of non-cirrhotic NASH, LPCN 1111, a once-a-day therapy candidate for TRT and LPCN 1021 (TLANDO in the U.S.) outside of the U.S.

**Clinical Program Highlights**

<u>Neuroactive Steroids</u>

● The Company completed an oral PK study and a food effect study with LPCN 1154 demonstrating the first enablement of effective oral delivery of brexanalone, a bioidentical neuroactive steroid.

● A pilot PK bridge study of LPCN 1154, an oral neuroactive steroid ("NAS") product candidate, in postpartum depression ("PPD") has been initiated. Results are expected in the first half of the year. The FDA has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 via the 505(b)(2) pathway. The proof-of-concept study is a prelude to a pivotal study required for NDA filing.

<u>LPCN 1148 in liver cirrhosis</u>

● Enrollment has been completed in a Phase 2 proof-of-concept ("POC") study evaluating the therapeutic potential of LPCN 1148 for the management of decompensated cirrhosis of various etiologies. Topline results on the primary endpoint (change in skeletal muscle index at Week 24) are expected mid-2023.

<u>TLANDO® for hypogonadism</u>

● TLANDO™ was approved and granted Market Exclusivity by the U.S. Food and Drug Administration ("FDA") for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism). TLANDO™ has been licensed to Antares and was launched commercially in the U.S. in June 2022.

**Year Ended December 31, 2022 Financial Results**

Lipocine reported a net loss of $10.8 million, or ($0.13) per diluted share, for the year ended December 31, 2022, compared with a net loss of $634,399, or ($0.01) per diluted share, for the year ended December 31, 2021.

Lipocine recognized license revenue of $500,000 during the year ended December 31, 2022, compared to $16.1 million during the year ended December 31, 2021. License revenue in 2022 was related to a non-refundable cash fee of $500,000 received from Antares for consideration of a 90-day extension to exercise its option to license LPCN 1111. License revenue in 2021 primarily related to the Antares Licensing Agreement for TLANDO which was signed in October 2021 and was comprised of licensing fees, minimum royalties and the sale of finished goods inventory.

Research and development expenses were $8.6 million and $7.7 million, respectively, for the years ended December 31, 2022, and 2021. The increase in research and development expenses during the year ended December 31, 2022 was primarily 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 manufacturing scale up costs, an increase in personnel expense primarily resulting from additional headcount, and an increase in other R&D expenses. These increases were offset by decreases in costs related to LPCN 1144, LPCN 1107, and LPCN 1154.

General and administrative expenses were $4.1 million and $5.3 million, respectively, for the years ended December 31, 2022, and 2021. The decrease in general and administrative expenses during the year ended December 31, 2022 was primarily due to a decrease in legal fees, a decrease in personnel related costs and a decrease in other general and administrative expenses. These decreases were offset by an increase in costs related to the recruitment and compensation for two additional directors, an increase in other various professional fees, an increase in strategic advisory services, an increase related to proxy solicitation services, and an increase in travel related costs.

As of December 31, 2022, Lipocine had $32.5 million of unrestricted cash, cash equivalents and marketable investment securities compared to $46.6 million at December 31, 2021.

**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 candidates in development as well as candidates for which we are exploring partnering. Our candidates represent enablement of patient friendly oral delivery options for 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 pre-term 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 <u>www.lipocine.com</u>.

**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 <u>www.sec.gov</u>. 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**

Consolidated Balance Sheets

December 31, 2022 and 2021

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| | | |
|:---|:---|:---|
|  | **2022** | **2021** |
| **Assets** |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;Cash and cash equivalents | $3148496 | $2950552 |
| &nbsp;&nbsp;&nbsp;Marketable investment securities | 29381410 | 41667405 |
| &nbsp;&nbsp;&nbsp;Accrued interest income | 80427 | 247253 |
| &nbsp;&nbsp;&nbsp;Contract asset - current | 579428 |  |
| &nbsp;&nbsp;&nbsp;Prepaid and other current assets | 945319 | 1514465 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 34135080 | 46379675 |
| Marketable investment securities |  | 2021800 |
| Contract asset - non-current | 3252500 | 4050000 |
| Property and equipment, net of accumulated depreciation of $1,153,530 and $1,144,077, respectively | 131589 | 7211 |
| Other assets | 23753 | 23753 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total assets | $37542922 | $52482439 |
| **Liabilities and Stockholders' Equity** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;Accounts payable | $600388 | $1289342 |
| &nbsp;&nbsp;&nbsp;Accrued expenses | 1077738 | 1016458 |
| &nbsp;&nbsp;&nbsp;Debt - current portion |  | 2310825 |
| &nbsp;&nbsp;&nbsp;Litigation settlement liability - current portion | - | 1000000 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 1678126 | 5616625 |
| &nbsp;&nbsp;&nbsp;Warrant liability | 229856 | 795796 |
| &nbsp;&nbsp;&nbsp;Litigation settlement liability - non-current portion | - | 500000 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities | 1907982 | 6912421 |
| Stockholders' equity: |  |  |
| &nbsp;&nbsp;&nbsp;Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized; zero issued and outstanding |  |  |
| &nbsp;&nbsp;&nbsp;Common stock, par value $0.0001 per share, 200,000,000 and 100,000,000 shares authorized; 88,516,501 and 88,296,360 issued and 88,510,791 and 88,290,650 outstanding | 8852 | 8830 |
| &nbsp;&nbsp;&nbsp;Additional paid-in capital | 219112164 | 218286323 |
| &nbsp;&nbsp;&nbsp;Treasury stock at cost, 5,710 shares | (40712) | (40712) |
| &nbsp;&nbsp;&nbsp;Accumulated other comprehensive loss | (20321) | (18016) |
| &nbsp;&nbsp;&nbsp;Accumulated deficit | (183425043) | (172666407) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total stockholders' equity | 35634940 | 45570018 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities and stockholders' equity | $37542922 | $52482439 |

---

**LIPOCINE INC. AND SUBSIDIARIES**

Consolidated Statements of Operations and Comprehensive Loss

Years Ended December 31, 2022 and 2021

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| | | |
|:---|:---|:---|
|  | **2022** | **2021** |
| Revenues | $500000 | $16140838 |
| Operating expenses: |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | 8556888 | 7665559 |
| &nbsp;&nbsp;&nbsp;General and administrative | 4062487 | 5329776 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 12619375 | 12995335 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Operating income (loss) | (12119375) | 3145503 |
| Other income (expense) |  |  |
| &nbsp;&nbsp;&nbsp;Interest and investment income | 572578 | 67700 |
| &nbsp;&nbsp;&nbsp;Interest expense | (27098) | (203292) |
| &nbsp;&nbsp;&nbsp;Unrealized gain on warrant liability | 565940 | 355890 |
| &nbsp;&nbsp;&nbsp;Gain (loss) on litigation settlement liability | 250000 | (4000000) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total other income (expense), net | 1361420 | (3779702) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Loss before income tax expense | (10757955) | (634199) |
| Income tax expense | (681) | (200) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net loss | $(10758636) | $(634399) |
| Basic loss per share attributable to common stock | $(0.12) | $(0.01) |
| Weighted average common shares outstanding, basic | 88457243 | 86934618 |
| Diluted loss per share attributable to common stock | $(0.13) | $(0.01) |
| Weighted average common shares outstanding, diluted | 88875946 | 87623452 |
| Comprehensive loss: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Net loss | $(10758636) | $(634399) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Unrealized net loss on available-for-sale securities | (2305) | (18016) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Comprehensive loss | $(10760941) | $(652415) |

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For further information:

Krista Fogarty

Phone: (801) 994-7383

<u>kf@lipocine.com</u>

Investors:

PJ Kelleher

Phone: (617) 430-7579

<u>pkelleher@lifesciadvisors.com</u>