Overview
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- TickerLPCN on Nasdaq2
- IndustryPharmaceutical Preparations2
- HeadquartersSalt Lake City, United States2
- Incorporated inDE3
- Business address675 Arapeen Drive, Suite 202, Salt Lake City, X1 841083
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI549300RXPEQXOJXVBI102
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O INCORP SERVICES, INC., 19801 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 50515882
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Inc. (“Lipocine” or the “Company”) is incorporated under the laws of the State of Delaware.4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2025
What sells
Revenue by product, business segment and region, as the company reports it to the SEC.
Products and services
License brought in 76% of the revenue Lipocine Inc. broke down this way in fiscal 2025.
Products and services by year
| Products and services | 2024 | 2025 |
|---|---|---|
| License | $10.9M | $1.5M |
| Royalty | $298.1K | $476.7K |
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Research and development100¢$8.6M
- Income tax0¢$200
Out of $2.0M in revenue.5 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| License revenue | $1.5M | $10.9M |
| Royalty revenue | $476.7K | $298.1K |
| Total revenues | $2.0M | $11.2M |
| Research and development | $8.6M | $7.4M |
| General and administrative | $3.8M | $5.0M |
| Total operating expenses | $12.3M | $12.4M |
| Operating loss | -$10.4M | -$1.2M |
| Interest and investment income | $744.1K | $1.1M |
| Unrealized gain on warrant liability | $17.2K | |
| Total other income | $744.1K | $1.2M |
| Income (loss) before income tax expense | -$9.6M | $9.0K |
| Income tax expense | -$200 | -$681 |
| Net income (loss) | -$9.6M | $8.4K |
| Basic income (loss) per share attributable to common stock | -$1.77 | |
| Weighted average common shares outstanding, basic | 5.4M shares | 5.3M shares |
| Diluted income (loss) per share attributable to common stock | -$1.69 | |
| Weighted average common shares outstanding, diluted | 5.7M shares | 5.4M shares |
| Net unrealized gain (loss) on available-for-sale securities | -$4.7K | $1.9K |
| Comprehensive gain (loss) | -$9.6M | $10.2K |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.5
| Period ending | 2025-12-31 | 2025-05-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $5.2M | $6.2M | ||
| Marketable investment securities | $9.7M | $15.4M | ||
| Accrued interest income | $14.2K | $120.4K | ||
| License fee and royalties receivable | $1.1M | $91.4K | ||
| Prepaid and other current assets | $787.6K | $476.5K | ||
| Total current assets | $16.9M | $22.3M | ||
| Property and equipment, net of accumulated depreciation of $1,284,079 and $1,223,297, respectively | $104.3K | $165.1K | ||
| Other assets | $23.8K | $23.8K | ||
| Total assets | $17.0M | $22.5M | ||
| Accounts payable | $971.8K | $271.7K | ||
| Accrued expenses | $1.2M | $921.2K | ||
| Deferred revenue | $320.0K | $320.0K | ||
| Total current liabilities | $2.5M | $1.5M | ||
| Total liabilities | $2.5M | $1.5M | ||
| Common stock, par value $0.0001 per share, 75,000,000 shares authorized; 6,158,779 and 5,348,276 issued and 6,158,443 and 5,347,940 outstanding, respectively | $8.9K | $8.9K | ||
| Additional paid-in capital | $223.9M | $220.8M | ||
| Treasury stock at cost, 336 shares | -$40.7K | -$40.7K | ||
| Accumulated other comprehensive gain | $4.4K | $9.1K | ||
| Accumulated deficit | -$209.4M | -$199.8M | ||
| Total stockholders equity | $14.5M | $21.0M | $20.4M | |
| Total liabilities and stockholders equity | $17.0M | $22.5M | ||
| Accumulated depreciation | $1.3M | $1.2M | ||
| Common stock, par value | $0.00 | $0.00 | ||
| Common stock, shares authorized | 75.0M shares | 200.0M shares | 75.0M shares | |
| Common stock, shares issued | 6.2M shares | 5.3M shares | ||
| Common stock, shares outstanding | 6.2M shares | 5.3M shares | ||
| Treasury stock, shares | 336 shares | 336 shares |
| Period ending | 2025-12-31 | 2025-05-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $5.2M | $6.2M | ||
| Marketable investment securities | $9.7M | $15.4M | ||
| Accrued interest income | $14.2K | $120.4K | ||
| License fee and royalties receivable | $1.1M | $91.4K | ||
| Prepaid and other current assets | $787.6K | $476.5K | ||
| Total current assets | $16.9M | $22.3M | ||
| Property and equipment, net of accumulated depreciation of $1,284,079 and $1,223,297, respectively | $104.3K | $165.1K | ||
| Other assets | $23.8K | $23.8K | ||
| Total assets | $17.0M | $22.5M | ||
| Accounts payable | $971.8K | $271.7K | ||
| Accrued expenses | $1.2M | $921.2K | ||
| Deferred revenue | $320.0K | $320.0K | ||
| Total current liabilities | $2.5M | $1.5M | ||
| Total liabilities | $2.5M | $1.5M | ||
| Common stock, par value $0.0001 per share, 75,000,000 shares authorized; 6,158,779 and 5,348,276 issued and 6,158,443 and 5,347,940 outstanding, respectively | $8.9K | $8.9K | ||
| Additional paid-in capital | $223.9M | $220.8M | ||
| Treasury stock at cost, 336 shares | -$40.7K | -$40.7K | ||
| Accumulated other comprehensive gain | $4.4K | $9.1K | ||
| Accumulated deficit | -$209.4M | -$199.8M | ||
| Total stockholders equity | $14.5M | $21.0M | $20.4M | |
| Total liabilities and stockholders equity | $17.0M | $22.5M | ||
| Accumulated depreciation | $1.3M | $1.2M | ||
| Common stock, par value | $0.00 | $0.00 | ||
| Common stock, shares authorized | 75.0M shares | 200.0M shares | 75.0M shares | |
| Common stock, shares issued | 6.2M shares | 5.3M shares | ||
| Common stock, shares outstanding | 6.2M shares | 5.3M shares | ||
| Treasury stock, shares | 336 shares | 336 shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net income (loss) | -$9.6M | $8.4K |
| Depreciation expense | $60.8K | $41.1K |
| Stock-based compensation expense | $242.5K | $408.6K |
| Non-cash gain on change in fair value of warrant liability | -$17.2K | |
| Amortization of discounts on marketable investment securities | -$192.9K | -$697.9K |
| Accrued interest income | $106.3K | -$68.2K |
| License and royalties receivable | -$1.1M | $91.4K |
| Prepaid and other current assets | -$311.1K | $114.1K |
| Accounts payable | $700.1K | -$1.1M |
| Accrued expenses | $315.1K | -$297.2K |
| Deferred revenue | $320.0K | |
| Cash used in operating activities | -$9.8M | -$1.2M |
| Purchase of property and equipment | -$90.1K | |
| Purchases of marketable investment securities | -$14.7M | -$32.9M |
| Maturities of marketable investment securities | $20.6M | $35.4M |
| Cash provided by investing activities | $5.9M | $2.4M |
| Net proceeds from sale of common stock through ATM | $2.9M | $209.3K |
| Cash provided by financing activities | $2.9M | $209.3K |
| Net increase (decrease) in cash and cash equivalents | -$1.0M | $1.4M |
| Income taxes paid | $200 | $681 |
| Net unrealized gain (loss) on available-for-sale securities | -$4.7K | $1.9K |
No quarter-by-quarter statement was filed.
Corporate structure
Lipocine Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Lipocine Inc.
- Squadron Capital Management LLC Filed SCHEDULE 13G/A on Lipocine Inc., latest Aug 14, 2026 (4 filings since Dec 23, 2025)
- Ikarian Capital, LLC Filed SCHEDULE 13G on Lipocine Inc., latest May 15, 2026
- VANGUARD GROUP INC Filed SC 13G/A on Lipocine Inc., latest Feb 10, 2022
- Lipocine Inc. Salt Lake City, Utah, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Lipocine Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $1.4M5 Dec 31, 2025 | $1.4M5 Dec 31, 2024 | 0% |
| Accumulated depreciation | $1.3M5 Dec 31, 2025 | $1.2M5 Dec 31, 2024 | +5.0% |
| Property and equipment, net | $104.3K5 Dec 31, 2025 | $165.1K5 Dec 31, 2024 | −36.8% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $5.2M5 Dec 31, 2025 | $6.2M5 Dec 31, 2024 | −16.1% |
| Marketable securities, current | $9.7M5 Dec 31, 2025 | $15.4M5 Dec 31, 2024 | −37.0% |
| Debt securities available for sale | $9.7M5 Dec 31, 2025 | $15.4M5 Dec 31, 2024 | −37.0% |
Properties, in its own words
Our corporate headquarters are located in a leased facility in Salt Lake City, Utah. Our lease expires on February 28, 2027. We believe that our existing facility is suitable and adequate and that we have sufficient capacity to meet our current anticipated needs.
Item 2 of the 10-K filed Mar 10, 2026.4
Leadership
Who has led Lipocine Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
- Chief executive officerMahesh Patel V. Dec 11, 2013 to now13
- ChairMahesh Patel V. Dec 8, 2016 to Dec 6, 201714
- PresidentMahesh Patel V. Dec 11, 2013 to Mar 12, 202413
- PresidentIsrael Menahem Vizel Feb 14, 2012 to Feb 14, 201215
- Chief financial officerMorgan R. Brown Sep 18, 2013 to Dec 8, 202116
Board members and other officers (20)
- Principal Accounting OfficerKrista Fogarty Jan 27, 2022 to now17
- Chief Medical OfficerGeorge Nomikos Nov 8, 2022 to Nov 8, 202218
- EVP and Chief Commercial OfficGregory Brooks Bass Feb 1, 2017 to Jan 2, 201819
- Chief Business OfficerJyrki Mattila May 18, 2015 to Jan 30, 201720
- Executive Vice PresidentMorgan R. Brown Aug 15, 2014 to Aug 15, 201421
- OfficerGerald T. Simmons Aug 2, 2013 to Aug 15, 201422
- SecretaryGordhan Patel Aug 2, 2013 to Aug 2, 201323
- OfficerMahesh Patel V. Aug 2, 2013 to Aug 2, 201324
- Vice President, FinanceRobert K. Merrell Aug 2, 2013 to Dec 11, 201325
- OfficerSrinivasan Venkateshwaran Aug 2, 2013 to Aug 15, 201426
- Board memberMichael Grissinger Aug 7, 2026 to now27
- Board memberJill M. Jene Apr 12, 2022 to now28
- Board memberSpyridon Papapetropoulos Apr 12, 2022 to now29
- Board memberRichard Dana Ono Jan 8, 2014 to now30
- Board memberStephen A. Hill Jan 8, 2014 to Dec 17, 202031
- Board memberGordhan Patel Aug 2, 2013 to Aug 2, 201323
- Board memberJohn W. Higuchi Aug 2, 2013 to now32
- Board memberMahesh Patel V. Aug 2, 2013 to now24
- Board memberWilliam I. Higuchi Aug 2, 2013 to Aug 2, 201333
- Board memberIsrael Menahem Vizel Feb 14, 2012 to Feb 14, 201215
Former names
- MARATHON BAR CORPNov 30, 2011 to Jul 9, 20133
Timeline
- Oct 7, 20268-K Other events34
- Sep 16, 20268-K Other events35
- Sep 14, 20268-K Other events36
- Sep 11, 20268-K Other events37
- Sep 10, 20268-K Other events38
- Aug 21, 20268-K Executive or director change39
- Aug 4, 20268-K Results of operations40
- Aug 3, 20268-K Executive or director change; Regulation FD disclosure41
- Jun 12, 20268-K Other events42
- Jun 4, 20268-K Other events43
- Jun 4, 20268-K Executive or director change; Shareholder vote44
- May 26, 20268-K Other events45
- Dec 11, 2013New chief executive Mahesh Patel V. becomes CEO13
Calendar
Coming up
- Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.59) a share, on Nov 6, 2025.46
When it reported results
- Aug 4, 2026Reported quarterly or annual results40
- May 7, 2026Reported quarterly or annual results47
- Mar 10, 2026Reported quarterly or annual results48
- Feb 18, 2026Reported quarterly or annual results49
- Nov 6, 2025Reported quarterly or annual results50
- Aug 5, 2025Reported quarterly or annual results51
- Mar 7, 2024Reported quarterly or annual results52
Drug trials and FDA: coming up
- Aug 2027Phase 3 trial readout expected Phase 3 trial of LPCN 1154A in Depression, Postpartum: primary completion expected Aug 2027 (ClinicalTrials.gov NCT07822321).53
Drug trials and FDA: recently
- Jan 16, 2026Phase 3 trial completed Phase 3 trial of LPCN 1154A in Depression, Postpartum: primary completion Jan 16, 2026, no results posted yet (ClinicalTrials.gov NCT06979544).54
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar
Filings
272 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 161 major events, 64 insider forms, 6 large holders, 21 other. The latest 20:
- Oct 7, 20268-K EDGAR
- Oct 1, 20264 EDGAR
- Sep 30, 20264 EDGAR
- Sep 16, 20268-K EDGAR
- Sep 14, 20268-K EDGAR
- Sep 11, 20268-K EDGAR
- Sep 10, 20268-K EDGAR
- Aug 21, 20268-K/A EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 7, 20264 EDGAR
- Aug 7, 20263 EDGAR
- Aug 4, 20268-K EDGAR
- Aug 4, 202610-Q EDGAR
- Aug 3, 20268-K EDGAR
- Jun 30, 20264 EDGAR
- Jun 12, 20268-K EDGAR
- Jun 9, 2026S-8 EDGAR
- Jun 4, 20268-K EDGAR
- Jun 4, 20264 EDGAR
- Jun 4, 20264 EDGAR
The 272 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
15 open-market trades by officers, directors and large owners since October 2021: 15 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Sep 28, 2026 | Higuchi John W.Director | Buy | 12,561 | $2.16 | $27.1K | Form 4 |
| Apr 7, 2026 | Higuchi John W.Director | Buy | 40,000 | $2.03 | $81.2K | Form 4 |
| Apr 6, 2026 | Higuchi John W.Director | Buy | 123,000 | $2.05 | $252.2K | Form 4 |
| Apr 6, 2026 | Patel Mahesh V.Chief Executive Officer | Buy | 25,000 | $2.03 | $50.8K | Form 4 |
| Apr 2, 2026 | Patel Mahesh V.Chief Executive Officer | Buy | 25,000 | $2.02 | $50.5K | Form 4 |
| May 25, 2023 | Patel Mahesh V.Chief Executive Officer | Buy | 8,706 | $5.03 | $43.8K | Form 4 |
| Mar 24, 2023 | Patel Mahesh V.Chief Executive Officer | Buy | 150,000 | $0.32 | $48.0K | Form 4 |
| Mar 20, 2023 | Ono Richard DanaDirector | Buy | 4,000 | $0.34 | $1.4K | Form 4 |
| Mar 17, 2023 | Patel Mahesh V.Chief Executive Officer | Buy | 50,000 | $0.33 | $16.5K | Form 4 |
| Nov 22, 2022 | Papapetropoulos SpyrosDirector | Buy | 21,739 | $0.47 | $10.2K | Form 4 |
| Nov 14, 2022 | Patel Mahesh V.Chief Executive Officer | Buy | 75,000 | $0.39 | $29.2K | Form 4 |
| Sep 27, 2022 | Patel Mahesh V.Chief Executive Officer | Buy | 100,000 | $0.41 | $41.0K | Form 4 |
| May 17, 2022 | Fogarty KristaPrincipal Accounting Officer | Buy | 12,500 | $0.86 | $10.8K | Form 4 |
| May 16, 2022 | Patel Mahesh V.Chief Executive Officer | Buy | 50,000 | $0.77 | $38.5K | Form 4 |
| Nov 18, 2021 | Patel Mahesh V.Chief Executive Officer | Buy | 25,000 | $1.09 | $27.2K | Form 4 |
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Squadron Capital Management LLCSCHEDULE 13G/A, 4 filings Dec 23, 2025 to Aug 14, 202655
- Ikarian Capital, LLCSCHEDULE 13G, 1 filing May 15, 202656
- VANGUARD GROUP INCSC 13G/A, 1 filing Feb 10, 202257
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | President and Chief Executive Officer | $584.8K | $986.3K58 | |
| 2025 | Senior Vice PresidentResearch and Development | $331.2K | $530.9K58 | |
| 2025 | Principal Accounting Officer and Corporate Controller | $275.3K | $446.0K58 | |
| 2024 | President and Chief Executive Officer | $565.0K | $761.8K58 | |
| 2024 | Senior Vice PresidentResearch and Development | $320.0K | $413.8K58 | |
| 2024 | Principal Accounting Officer and Corporate Controller | $266.0K | $340.6K58 |
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 36. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Squadron Capital Management LLC | 810,000 | $2.1M | 0.7% | +360,000 |
| Ikarian Capital, LLC | 508,556 | $1.3M | 0.2% | No change |
| Eversept Partners, LP | 294,989 | $755.2K | 0.0% | No change |
| Vanguard Capital Management LLC | 230,823 | $590.9K | 0.0% | +30,155 |
| Boothbay Fund Management, LLC | 140,487 | $359.6K | 0.0% | No change |
| Jane Street Group, LLC | 95,227 | $243.8K | 0.0% | +75,200 |
| BlackRock, Inc. | 89,272 | $228.5K | 0.0% | No change |
| Two Sigma Investments, LP | 84,887 | $217.3K | 0.0% | +51,137 |
| Citadel Advisors LLC | 81,221 | $207.9K | 0.0% | +52,133 |
| Seven Fleet Capital Management LP | 78,842 | $201.8K | 0.0% | −46,100 |
| Geode Capital Management, LLC | 74,477 | $190.8K | 0.0% | +11,342 |
| Renaissance Technologies LLC | 69,209 | $177.2K | 0.0% | +30,712 |
| Vanguard Fiduciary Trust Co | 54,539 | $139.6K | 0.0% | +22,126 |
| Dimensional Fund Advisors LP | 36,775 | $94.1K | 0.0% | +17,653 |
| Susquehanna International Group, Llp | 25,376 | $65.0K | 0.0% | +468 |
| State Street Corp | 22,407 | $57.4K | 0.0% | No change |
| Birchview Capital, LP | 16,712 | $42.8K | 0.0% | −95,074 |
| Northern Trust Corp | 15,942 | $40.8K | 0.0% | +2,900 |
| Barclays PLC | 9,827 | $25.2K | 0.0% | +415 |
| UBS Group AG | 3,596 | $9.2K | 0.0% | +102 |
| Wells Fargo & Company/mn | 2,706 | $6.9K | 0.0% | No change |
| Vanguard Global Advisers, LLC | 1,691 | $4.3K | 0.0% | No change |
| Tower Research Capital LLC (TRC) | 678 | $1.7K | 0.0% | −255 |
| Morgan Stanley | 574 | $1.5K | 0.0% | No change |
| Caldwell Sutter Capital, Inc. | 471 | $1.2K | 0.0% | No change |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Lipocine Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARLipocine Inc.1
- CIK0001535955
- Employer ID (EIN)99-03706884
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address675 Arapeen Drive, Suite 202, Salt Lake City, X1 841081
- Phone801 994 73831
- Shares outstanding8,244,253 as of Aug 3, 202612
- Public float$16.4M as of Jun 30, 20254
- AuditorTanner LLP, Salt Lake City, Utah PCAOB ID 270; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceNov 30, 20111
- Filings820 in all: 8-K (421), 4 (151), 10-Q (44), 3 (22), SC 13G/A (18), 424B3 (17), 424B5 (17), 10-K (15)1
All 36 form types
SC 13G (14), DEF 14A (13), EFFECT (9), UPLOAD (9), S-1/A (8), CORRESP (6), PRE 14A (6), S-8 (6), 8-K/A (5), DEFA14A (5), S-3 (4), 10-K/A (3), S-1 (3), SCHEDULE 13G/A (3), 8-A12G (2), CT ORDER (2), D (2), POS AM (2), PX14A6G (2), S-3/A (2), SCHEDULE 13G (2), 10-Q/A (1), 4/A (1), 424B4 (1), 8-A12B (1), ARS (1), CERTNAS (1), S-1MEF (1)
- Latest filingsAnnual report (10-K) Mar 10, 2026
Quarterly report (10-Q) Aug 4, 2026
Proxy statement (DEF 14A) Apr 21, 2026
Latest 8-K (8-K) Oct 7, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | LPCN | NASDAQ |
From the cover page of the 10-K filed Mar 10, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Lipocine Inc. names in Item 1A of its 10-K filed Mar 10, 2026: 56 risks under these headings, as written.4
- Risks Relating to Our Business and Industry
- Risks Related to Our Dependence on Third Parties
- Risks Related to Ownership of Our Common Stock
- Risks Relating to Our Financial Position and Capital Requirements
- Risks Relating to Our Intellectual Property
- The timelines and costs of our clinical trials may be impacted by numerous factors and any delays may adversely affect our ability to execute our current business strategy.
- LPCN 1154 is in development and an NDA submission may not be filed, or if filed, may not be accepted by the FDA.
- LPCN 1154 may not achieve planned commercialization or commercialization objectives for a variety of reasons.
- LPCN 2201 is in a very early stage of development and may not be further developed for a variety of reasons.
- LPCN 2101 is in a very early stage of development and may not be further developed for a variety of reasons.
- LPCN 2203 is in an early stage of development and may not be further developed for a variety of reasons.
- LPCN 2401 is in a very early stage of development and may not be further developed for a variety of reasons.
The other 49 risks
- LPCN 1148 is in a very early stage of development for management of liver cirrhosis in male patients and while there are no therapies specifically approved by the FDA for secondary sarcopenia or cirrhosis beyond treatment of underlying conditions, there are candidates known to be under development for cirrhosis related indication(s).
- LPCN 1107 is in a very early stage of development and may not be further developed for a variety of reasons.
- Our research and development programs and processes are at an early stage of development, which makes it difficult to evaluate our business and prospects or predict if or when we will successfully commercialize or partner our product candidates.
- All of our clinical candidates will be subject to extensive regulation which can be costly and time consuming, cause delays or prevent approval of the products for commercialization.
- Our business depends, in part, on the commercial success of our licensed product, TLANDO, for royalty revenue and potential milestone payments.
- If T-replacement therapies are found, or are perceived, to create health risks, our ability to realize any revenue from TLANDO could be materially adversely affected, and our business could be harmed. Physicians and patients may be deterred from prescribing and using T-replacement therapies, which could depress demand for TLANDO and compromise the successful commercialization of TLANDO.
- If we fail to obtain adequate healthcare reimbursement for our products, our revenue-generating ability will be diminished and there is no assurance that the anticipated market for our products will be sustained.
- Our Licensees’ ability to commercialize TLANDO may be limited.
- We will not be able to successfully commercialize our product candidates without establishing sales, marketing and market access capabilities internally or through collaborators.
- Even if we receive marketing approval in the United States, we may never receive regulatory approval to market our products outside the United States, which could reduce the size of our potential markets and have a material adverse impact on our business.
- We are subject to stringent government regulations concerning the clinical testing of our products and will continue to be subject to government regulation of any product that receives regulatory approval.
- The successful commercialization of our product candidates and ability to generate significant revenue will depend on achieving market acceptance.
- Even if we obtain marketing approval for our products, physicians and patients using existing products may choose not to switch to our products.
- The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found to have improperly promoted off-label uses, we may become subject to significant liability.
- If we fail to comply with federal and state healthcare laws, including fraud and abuse and health information privacy and security laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected.
- Our future success depends on our ability to retain our chief executive officer and other key executives and to attract, retain and motivate qualified personnel.
- Federal legislation and actions by state and local governments may permit re-importation of drugs from foreign countries into the United States, including foreign countries where the drugs are sold at lower prices than in the United States, which could materially adversely affect our operating results.
- We may become subject to the risk of product liability claims.
- Testosterone is a Schedule III substance under the Controlled Substances Act and any failure to comply with this Act or its state equivalents would have a negative impact on our business.
- We may have to dedicate resources to the defense and resolution of litigation.
- Cyber security risks and the failure to maintain the integrity of company, employee or clinical data could expose us to data loss, litigation and liability, and our reputation could be significantly harmed.
- We may enter into license agreements and/or collaborations with third parties for the development and commercialization of our drug candidates. If those collaborations, including, without limitation, our license arrangement with Verity for the development and commercialization of TLANDO, are not successful, we may not be able to capitalize on the market potential of these drug candidates and may have to alter our development and commercialization plans for our products.
- We rely upon third-party contractors and service providers for the execution of some aspects of our development programs. Failure of these collaborators to provide services of a suitable quality and within acceptable timeframes may cause the delay or failure of our development programs.
- Due to our reliance on CROs or other third parties to assist us or who have historically assisted us in conducting clinical trials, we will be unable to directly control all aspects of our clinical trials.
- We and our Licensees rely/will rely on a single supplier for our supply of testosterone esters, the active pharmaceutical ingredient of TLANDO, LPCN 1111, LPCN 2401, and LPCN 1148, and the loss of this supplier could harm our business.
- We rely on limited suppliers for our supply of NAS, the active pharmaceutical ingredients of LPCN 1154, LPCN 2201, LPCN 2101, and LPCN 2203 and the loss of these limited suppliers could harm our business.
- If we do not establish successful collaborations, we may have to alter our development and commercialization plans for our products.
- Our stock price could decline significantly based on the results and timing of clinical trials, and/or regulatory and other decisions affecting our product candidates.
- If we do not maintain effective internal controls over financial reporting in the future, the accuracy and timeliness of our financial reporting may be adversely affected.
- We incur significant expenses in order to comply with the requirements of being a public company in the United States.
- Our share price is expected to be volatile and may be influenced by numerous factors that are beyond our control.
- We may not be able to maintain our listing on the Nasdaq Capital Market, which would adversely affect the price and liquidity of our common stock.
- Anti-takeover provisions in our amended and restated certificate of incorporation and our amended and restated bylaws, as well as provisions of Delaware law and our stockholder rights plan, might discourage, delay or prevent a change in control of our Company or changes in our Board of Directors or management and, therefore, depress the trading price of our common stock.
- We have no current plans to pay dividends on our common stock and investors must look solely to stock appreciation for a return on their investment in us.
- Our management and directors will be able to exert influence over our affairs.
- The market price of our common stock has been volatile over the past year and may continue to be volatile.
- If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price could decline.
- We will need substantial additional capital in the future. If additional capital is not available, we will have to delay, reduce or cease operations.
- Raising additional capital may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish rights.
- We cannot predict when we will generate product revenues and may never achieve or maintain profitability.
- We have incurred significant operating losses in most years since our inception and anticipate that we will incur continued losses for the foreseeable future.
- Our operating results may fluctuate significantly, and any failure to meet financial expectations may disappoint securities analysts or investors and result in a decline in the price of our securities.
- Our success depends in part on our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
- If we do not obtain additional protection under the Drug Price Competition and Patent Term Restoration Act and similar foreign legislation by extending the patent terms and obtaining data exclusivity for our product candidates, our business may be materially harmed.
- We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, and we may be unable to protect our rights to our products and technology.
- If we are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
- Although we own worldwide rights to our product candidates, we do not have patent protection for the product candidates in a significant number of countries, and we will be unable to prevent infringement in those countries.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
Legal proceedings
On November 14, 2019, we and certain of our officers were named as defendants in a purported shareholder class action lawsuit, Solomon Abady v. Lipocine Inc. et al., 2:19-cv-00906-PMW, filed in the United States District Court for the District of Utah. The complaint alleged that the defendants made false and/or misleading statements and/or failed to disclose that our filing of the NDA for TLANDO to the FDA contained deficiencies and as a result the defendants’ statements about our business and operations were false and misleading and/or lacked a reasonable basis in violation of federal securities laws. The lawsuit sought certification as a class action (for a purported class of purchasers of the Company’s securities from March 27, 2019, through November 8, 2019), compensatory damages in an unspecified amount, and unspecified equitable or injunctive relief. We have insurance that covers claims of this nature. The retention amount payable by us under our policy is $1.5 million. On April 14, 2023, a judgment was issued ordering the case dismissed with prejudice and closure of the action.
We are not currently a party to any material litigation or other material legal proceedings. We may, from time to time, be involved in various legal proceedings arising from the normal course of business activities, and, while the Company has insurance that covers claims of this nature, unfavorable resolution of any of these matters could materially affect our future results of operations, cash flows, or financial position.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1SEC EDGARLipocine Inc. filings on SEC EDGAR
- 2
- 3SEC EDGARLipocine Inc. filings on SEC EDGAR
- 4
- 5SEC EDGARLipocine Inc. 10-K for fiscal 2025
- 6SEC EDGARLipocine Inc. 10-K for fiscal 2019
- 7SEC EDGARLipocine Inc. 10-K for fiscal 2021
- 8SEC EDGARLipocine Inc. 10-K for fiscal 2023
- 9SEC EDGARLipocine Inc. 10-K for fiscal 2020
- 10SEC EDGARLipocine Inc. 10-K for fiscal 2022
- 11SEC EDGARLipocine Inc. 10-Q for fiscal 2026
- 12SEC EDGARLipocine Inc. 10-Q for fiscal 2026
- 13
- 14SEC EDGARMahesh Patel V., Chair
- 15SEC EDGARIsrael Menahem Vizel, President
- 16
- 17
- 18
- 19
- 20
- 21
- 22SEC EDGARGerald T. Simmons, Officer
- 23SEC EDGARGordhan Patel, Secretary
- 24SEC EDGARMahesh Patel V., Officer
- 25
- 26SEC EDGARSrinivasan Venkateshwaran, Officer
- 27SEC EDGARMichael Grissinger, Board member
- 28SEC EDGARJill M. Jene, Board member
- 29
- 30SEC EDGARRichard Dana Ono, Board member
- 31SEC EDGARStephen A. Hill, Board member
- 32SEC EDGARJohn W. Higuchi, Board member
- 33SEC EDGARWilliam I. Higuchi, Board member
- 34SEC EDGAROther events
- 35SEC EDGAROther events
- 36SEC EDGAROther events
- 37SEC EDGAROther events
- 38SEC EDGAROther events
- 39SEC EDGARExecutive or director change
- 40SEC EDGARResults of operations
- 41
- 42SEC EDGAROther events
- 43SEC EDGAROther events
- 44
- 45SEC EDGAROther events
- 46NasdaqNasdaq calendar
- 47
- 48
- 49
- 50
- 51
- 52
- 53ClinicalTrials.govClinicalTrials.gov NCT07822321: Brexanolone Lifting Outcomes Of Moms
- 54
- 55
- 56
- 57
- 58