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Lipocine(LPCN) - 2023 Q4 - Annual Results
2024-03-07 11:08
Exhibit 99.1 Lipocine Announces Financial Results for the Full Year Ended December 31, 2023 SALT LAKE CITY, March 7, 2024 — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders, today announced financial results for the year ended December 31, 2023 and provided a corporate update. Neuroactive Steroids LPCN 1148 ● Lipocine announced positive topline results from a pharmacokinetics ("PK") pilot bridge study of LPCN 1154 (oral brexanolone). Lipo ...
Lipocine(LPCN) - 2023 Q4 - Annual Report
2024-03-07 11:07
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorp ...
Lipocine(LPCN) - 2023 Q3 - Quarterly Report
2023-11-08 18:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For Quarterly Period ended September 30, 2023 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporatio ...
Lipocine(LPCN) - 2023 Q2 - Quarterly Report
2023-08-10 12:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For Quarterly Period ended June 30, 2023 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Delaware 99-0370688 (State or Other Jurisdiction of Incorporation or Organization) For the transition period from to . 675 Arapeen Drive, Suite 202, Salt Lake City, Utah 84108 (Address of Principal Executive ...
Lipocine(LPCN) - 2023 Q1 - Quarterly Report
2023-05-11 12:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For Quarterly Period ended March 31, 2023 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from _________ to _______ . Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction o ...
Lipocine(LPCN) - 2022 Q4 - Annual Report
2023-03-10 13:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-K WASHINGTON, D.C. 20549 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorp ...
Lipocine(LPCN) - 2022 Q3 - Quarterly Report
2022-11-09 11:20
PART I—FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's total assets decreased to $39.4 million as of September 30, 2022, from $52.5 million at year-end 2021, primarily due to a reduction in cash and marketable securities used to fund operations. For the nine months ended September 30, 2022, the company reported a net loss of $8.5 million, an improvement from a $13.3 million net loss in the prior-year period, mainly due to a gain on litigation settlement and lower general and administrative expenses. Cash used in operating activities was $10.1 million Condensed Consolidated Balance Sheets Highlights | Account | September 30, 2022 ($) | December 31, 2021 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,396,960 | $2,950,552 | | Marketable investment securities | $31,858,842 | $43,689,205 | | Total current assets | $36,110,540 | $46,379,675 | | **Total assets** | **$39,424,228** | **$52,482,439** | | **Liabilities & Equity** | | | | Total current liabilities | $1,511,306 | $5,616,625 | | Total liabilities | $1,775,405 | $6,912,421 | | **Total stockholders' equity** | **$37,648,823** | **$45,570,018** | Condensed Consolidated Statements of Operations Highlights | Metric | Three Months Ended Sep 30, 2022 ($) | Three Months Ended Sep 30, 2021 ($) | Nine Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0 | $54,994 | $500,000 | $54,994 | | Research and development | $2,100,432 | $2,366,521 | $6,886,398 | $5,411,748 | | General and administrative | $798,939 | $1,222,146 | $3,172,144 | $4,281,690 | | Operating loss | $(2,899,371) | $(3,533,673) | $(9,558,542) | $(9,638,444) | | **Net loss** | **$(2,409,165)** | **$(3,081,297)** | **$(8,528,723)** | **$(13,258,420)** | | Basic loss per share | $(0.03) | $(0.03) | $(0.10) | $(0.15) | Condensed Consolidated Statements of Cash Flows Highlights | Cash Flow Activity | Nine Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | | Cash used in operating activities | $(10,129,905) | $(13,405,843) | | Cash provided by (used in) investing activities | $11,697,357 | $(34,057,767) | | Cash provided by (used in) financing activities | $(2,121,044) | $27,763,333 | | **Net decrease in cash and cash equivalents** | **$(553,592)** | **$(19,700,277)** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Lipocine is a biopharmaceutical company focused on developing oral therapies for Central Nervous System (CNS) disorders using its proprietary Lip'ral platform. Its lead product, TLANDO®, an oral testosterone replacement therapy, was approved by the FDA and is commercialized by its licensee, Halozyme (via Antares). The development pipeline is led by CNS candidates LPCN 1154 for postpartum depression and LPCN 2101 for epilepsy, along with LPCN 1148 for decompensated cirrhosis. For the nine months ended September 30, 2022, the company's net loss narrowed to $8.5 million from $13.3 million year-over-year, primarily due to a gain on litigation settlement and lower G&A expenses. The company believes its existing cash of $34.3 million is sufficient to fund operations through at least September 30, 2023, but will require additional capital for long-term operations - The company's primary focus is on leveraging its proprietary Lip'ral platform to develop oral treatments for **Central Nervous System (CNS) disorders**[95](index=95&type=chunk) - TLANDO®, an oral testosterone replacement therapy, received **FDA approval on March 28, 2022**, and was **commercially launched** by licensee Halozyme/Antares on **June 7, 2022**. Lipocine is eligible for up to **$160.0 million** in sales milestones and tiered royalties from **mid-teens to 20%**[95](index=95&type=chunk)[139](index=139&type=chunk) Key Development Pipeline Status | Product Candidate | Indication | Development Stage | | :--- | :--- | :--- | | **LPCN 1154** | Postpartum Depression (PPD) | Pilot PK bridge study initiated; results expected H1 2023 | | **LPCN 2101** | Epilepsy | IND accepted; Phase 2 proof-of-concept study planned for 2023 | | **LPCN 1148** | Decompensated Cirrhosis | Phase 2 proof-of-concept study ongoing; enrollment completion expected Q4 2022, top-line results H1 2023 | | **LPCN 1144** | Non-cirrhotic NASH | Phase 2 completed; seeking partnership | | **LPCN 1111** | Once-daily TRT | Phase 2 completed; seeking partnership | | **LPCN 1107** | Prevention of Preterm Birth | Dose finding study completed; seeking partnership | - The company believes its existing capital resources of **$34.3 million** (as of Sep 30, 2022) are sufficient to fund projected operating requirements through at least **September 30, 2023**[192](index=192&type=chunk)[200](index=200&type=chunk) Comparison of Results of Operations (Nine Months Ended Sep 30) | Metric | 2022 ($) | 2021 ($) | Variance ($) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $500,000 | $54,994 | $445,006 | $500k fee from Antares for LPCN 1111 option extension | | R&D Expenses | $6,886,398 | $5,411,748 | $1,474,650 | Increased costs for LPCN 1148, 1154, and 1111 studies, offset by completion of LPCN 1144 study | | G&A Expenses | $3,172,144 | $4,281,690 | $(1,109,546) | Decrease in legal fees related to 2021 Clarus settlement and Antares agreement | | Gain (Loss) on Litigation | $250,000 | $(4,000,000) | $4,250,000 | Gain from amended Clarus settlement in 2022 vs. initial settlement expense in 2021 | | **Net Loss** | **$(8,528,723)** | **$(13,258,420)** | **$4,729,697** | Primarily due to litigation settlement gain and lower G&A expenses | [Quantitative and Qualitative Disclosures About Market Risks](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) The company states that there have been no material changes to its market risk during the first nine months of 2022. It refers to the more detailed disclosures in its 2021 Form 10-K - There have been **no material changes** to the Company's market risk during the first nine months of 2022[217](index=217&type=chunk) [Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and Principal Financial Officer, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2022. There were no material changes in internal control over financial reporting during the quarter - The company's Chief Executive Officer and Principal Financial Officer concluded that disclosure controls and procedures were **effective as of September 30, 2022**[219](index=219&type=chunk) - **No changes** in internal control over financial reporting occurred during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, internal controls[220](index=220&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=52&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal matters. The report references Note 11 of the financial statements for details, which discusses the settlement with Clarus Therapeutics and an ongoing purported shareholder class action lawsuit filed in 2019 - The company is involved in a purported shareholder class action lawsuit, ***Solomon Abady v. Lipocine Inc. et al.***, filed in **November 2019**, alleging false and misleading statements regarding the NDA for TLANDO. The company intends to vigorously defend itself[84](index=84&type=chunk) - All outstanding litigation with Clarus Therapeutics, including a patent infringement lawsuit and a USPTO interference proceeding, was **resolved via a global settlement agreement in July 2021**[83](index=83&type=chunk)[85](index=85&type=chunk) [Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors) This section highlights material changes to risk factors, focusing on the potential for Nasdaq to delist the company's common stock due to its failure to maintain a minimum bid price of $1.00. Other risks discussed include difficulties in managing growth, the volatility of the stock price, and the financial impact of warrant liability fluctuations - On **June 7, 2022**, the company received a notice from Nasdaq for non-compliance with the minimum bid price requirement (**$1.00** per share). The company has until **December 5, 2022**, to regain compliance[232](index=232&type=chunk) - Failure to regain compliance with Nasdaq listing rules could result in **delisting**, which would lead to **reduced liquidity**, **limited market quotations**, and a potential classification as a "**penny stock**"[234](index=234&type=chunk) - The company's common stock has been volatile, trading between **$0.39** and **$1.85** per share over the past year[230](index=230&type=chunk) - The company has incurred significant operating losses since inception, with an accumulated deficit of **$181.2 million** as of **September 30, 2022**, and expects to incur continued losses[235](index=235&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=54&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[236](index=236&type=chunk) [Defaults Upon Senior Securities](index=54&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[237](index=237&type=chunk) [Mine Safety Disclosures](index=54&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - None[238](index=238&type=chunk) [Other Information](index=55&type=section&id=Item%205.%20Other%20Information) There was no other information to report during the period - None[240](index=240&type=chunk) [Exhibits](index=56&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act - The exhibits filed include **CEO and CFO certifications** pursuant to **Sections 302 and 906 of the Sarbanes-Oxley Act of 2002**[241](index=241&type=chunk)
Lipocine(LPCN) - 2022 Q2 - Quarterly Report
2022-08-08 13:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporation or Organization) 675 Arapeen Drive, Suite 202, Salt Lake City, Utah 84108 (Address of Principal Executive Offices) (Zip Code) (IRS Employer Identification No.) FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For Quarter ...
Lipocine(LPCN) - 2022 Q1 - Quarterly Report
2022-05-09 12:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For Quarterly Period ended March 31, 2022 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorporation or Organization) (IRS Employer Identification No.) 675 Arapeen Drive, Suite 202, Salt ...
Lipocine(LPCN) - 2021 Q4 - Annual Report
2022-03-09 13:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number: 001-36357 LIPOCINE INC. (Exact name of registrant as specified in its charter) Delaware 99-0370688 (State or Other Jurisdiction of Incorp ...