Lipocine(US:LPCN)2022-11-09 11:20PART I—FINANCIAL INFORMATION Financial Statements 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 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) disorders95 - 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%95139 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 $34.3 million (as of Sep 30, 2022) are sufficient to fund projected operating requirements through at least September 30, 2023192200 Comparison of Results of Operations (Nine Months Ended Sep 30) | Metric | 2022 ($) | 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 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 2022217 Controls and Procedures 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, 2022219 - 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 controls220 PART II—OTHER INFORMATION Legal Proceedings 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 itself84 - 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 20218385 Risk Factors 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 compliance232 - 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 - The company's common stock has been volatile, trading between $0.39 and $1.85 per share over the past year230 - 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 losses235 Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities during the period - None236 Defaults Upon Senior Securities There were no defaults upon senior securities during the period - None237 Mine Safety Disclosures This item is not applicable to the company - None238 Other Information There was no other information to report during the period - None240 Exhibits 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 2002241