Overview
- TickerLTRN on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersDallas, Texas1
- Incorporated inTX2
- Business address1920 Mckinney Avenue, 7Th Floor, Dallas, Tx 752012
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
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Winter 2014, and Mucke, HAM, A New Journal for the Drug Repurposing Community. Drug Repurposing, Rescue & Repositioning 1, 3-4 (2014).4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.8
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| General and administrative | $6.5M | $6.1M |
| Research and development | $11.5M | $16.1M |
| Total operating expenses | $18.0M | $22.2M |
| Loss from operations | -$18.0M | -$22.2M |
| Interest income | $437.9K | $742.4K |
| Other income, net | $421.1K | $692.9K |
| NET LOSS | -$17.1M | -$20.8M |
| Net loss per share of common shares, basic | -$1.57 | -$1.93 |
| Net loss per share of common shares, diluted | -$1.57 | -$1.93 |
| Weighted-average number of common shares outstanding, basic | 10.9M shares | 10.8M shares |
| Weighted-average number of common shares outstanding, diluted | 10.9M shares | 10.8M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.8
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $4.4M | $7.5M | |
| Marketable securities | $5.7M | $16.5M | |
| Prepaid expenses & other current assets | $683.9K | $1.2M | |
| Total current assets | $10.8M | $25.2M | |
| Property and equipment, net | $31.9K | $47.4K | |
| Operating lease right-of-use assets | $75.6K | $240.0K | $228.3K |
| Deferred offering costs | $88.4K | ||
| Other assets | $36.7K | $36.7K | |
| TOTAL ASSETS | $11.0M | $25.6M | |
| Accounts payable and accrued expenses | $4.4M | $4.1M | |
| Operating lease liabilities, current | $78.5K | $190.8K | |
| Total current liabilities | $4.5M | $4.3M | |
| Operating lease liabilities, net of current portion | $52.8K | ||
| TOTAL LIABILITIES | $4.5M | $4.4M | |
| Common Stock (25,000,000 authorized at December 31, 2025 and December 31, 2024; $.0001 par value) (11,254,697 shares issued and outstanding at December 31, 2025; 10,784,725 shares issued and outstanding at December 31, 2024) | $1.1K | $1.1K | |
| Additional paid-in capital | $99.7M | $97.1M | |
| Accumulated other comprehensive income | $25.4K | $154.0K | |
| Accumulated deficit | -$93.1M | -$76.0M | |
| Total stockholders equity | $6.5M | $21.2M | $40.9M |
| TOTAL LIABILITIES AND STOCKHOLDERS EQUITY | $11.0M | $25.6M | |
| Preferred stock, shares authorized | 1.0M shares | 1.0M shares | |
| Preferred stock, par value | $0.00 | $0.00 | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, shares authorized | 25.0M shares | 25.0M shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares issued | 11.3M shares | 10.8M shares | |
| Common stock, shares outstanding | 11.3M shares | 10.8M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $4.4M | $7.5M | |
| Marketable securities | $5.7M | $16.5M | |
| Prepaid expenses & other current assets | $683.9K | $1.2M | |
| Total current assets | $10.8M | $25.2M | |
| Property and equipment, net | $31.9K | $47.4K | |
| Operating lease right-of-use assets | $75.6K | $240.0K | $228.3K |
| Deferred offering costs | $88.4K | ||
| Other assets | $36.7K | $36.7K | |
| TOTAL ASSETS | $11.0M | $25.6M | |
| Accounts payable and accrued expenses | $4.4M | $4.1M | |
| Operating lease liabilities, current | $78.5K | $190.8K | |
| Total current liabilities | $4.5M | $4.3M | |
| Operating lease liabilities, net of current portion | $52.8K | ||
| TOTAL LIABILITIES | $4.5M | $4.4M | |
| Common Stock (25,000,000 authorized at December 31, 2025 and December 31, 2024; $.0001 par value) (11,254,697 shares issued and outstanding at December 31, 2025; 10,784,725 shares issued and outstanding at December 31, 2024) | $1.1K | $1.1K | |
| Additional paid-in capital | $99.7M | $97.1M | |
| Accumulated other comprehensive income | $25.4K | $154.0K | |
| Accumulated deficit | -$93.1M | -$76.0M | |
| Total stockholders equity | $6.5M | $21.2M | $40.9M |
| TOTAL LIABILITIES AND STOCKHOLDERS EQUITY | $11.0M | $25.6M | |
| Preferred stock, shares authorized | 1.0M shares | 1.0M shares | |
| Preferred stock, par value | $0.00 | $0.00 | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, shares authorized | 25.0M shares | 25.0M shares | |
| Common stock, par value | $0.00 | $0.00 | |
| Common stock, shares issued | 11.3M shares | 10.8M shares | |
| Common stock, shares outstanding | 11.3M shares | 10.8M 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.8
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$17.1M | -$20.8M |
| Depreciation and amortization | $17.3K | $17.3K |
| Accretion of discounts on available for sale debt securities, net | -$196.4K | -$238.6K |
| Non-cash lease adjustments | $189.9K | $173.2K |
| Issuance of restricted common stock for services | $366.9K | |
| Stock-based compensation | $650.9K | $732.9K |
| Foreign currency remeasurement (gain) loss | -$158.0K | $219.7K |
| Realized gain on redemptions of available for sale debt securities | -$22.4K | -$9.1K |
| Realized loss on equity securities | $264.9K | |
| Unrealized gain on equity securities | -$305.9K | -$155.6K |
| Operating lease liabilities | -$190.6K | -$175.7K |
| Prepaid expenses & other current assets | $554.1K | $778.3K |
| Accounts payable and accrued expenses | $271.8K | $1.6M |
| Other assets | -$10.9K | |
| Net cash flows used in operating activities | -$15.7M | -$17.8M |
| Purchase of property and equipment | -$1.7K | -$12.6K |
| Purchase of marketable securities | -$14.7M | -$17.3M |
| Redemptions of marketable securities | $25.8M | $20.7M |
| Net cash flows provided by investing activities | $11.1M | $3.4M |
| Proceeds from option exercises | $13.4K | |
| Proceeds from warrant exercises | $66.7K | |
| Proceeds from the issuance of common stock under the ATM Sales Agreement | $1.6M | |
| Payments of offering cost related to the ATM Sales Agreement | -$139.7K | |
| Net cash flows provided by financing activities | $1.5M | $66.7K |
| Effect of foreign exchange rates on cash | $33.4K | -$49.5K |
| CHANGE IN CASH AND CASH EQUIVALENTS FOR THE YEAR | -$3.1M | -$14.4M |
| Operating lease right-of-use asset acquired through operating lease liability | $78.4K | $348.6K |
| Removal of operating lease right-of-use assets and related operating lease liabilities upon early termination of leases | $52.8K | $163.7K |
| Deferred offering costs included in accounts payable and accrued expenses | $10.0K |
No quarter-by-quarter statement was filed.
Corporate structure
Lantern Pharma Inc. sits at the top of its group. 3 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Lantern Pharma Inc.
- Empery Asset Management, LP Filed SCHEDULE 13G/A on Lantern Pharma Inc., latest Oct 13, 2026 (3 filings since Jan 11, 2022)
- Thomas A. Satterfield Jr. Filed SCHEDULE 13G/A on Lantern Pharma Inc., latest Jul 23, 2026 (2 filings since Apr 3, 2026)
- Bios Equity Partners, LP Filed SCHEDULE 13D/A on Lantern Pharma Inc., latest May 15, 2026 (7 filings since Mar 22, 2022)
- Lantern Pharma Inc. Dallas, Texas
- Lantern Pharma Australia Pty Ltd Subsidiary · Australia
- Starlight Therapeutics Inc. Subsidiary · Delaware, United States
Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Lantern Pharma 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, net | $31.9K8 Dec 31, 2025 | $47.4K8 Dec 31, 2024 | −32.8% |
| Operating-lease assets (leased space) | $75.6K8 Dec 31, 2025 | $240.0K8 Dec 31, 2024 | −68.5% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $4.4M8 Dec 31, 2025 | $7.5M8 Dec 31, 2024 | −41.1% |
| Marketable securities, current | $5.7M8 Dec 31, 2025 | $16.5M8 Dec 31, 2024 | −65.5% |
Properties, in its own words
Our principal executive office is located at 1920 McKinney Avenue, 7th Floor, Dallas, Texas 75201. During 2025 and 2024, we leased access to office space and meeting facilities at this location under month-to-month lease arrangements. We also leased additional office space in the Dallas, Texas area and in the Atlanta, Georgia area under operating leases that commenced in May 2021. The Dallas operating lease ended in November 2025 and was replaced with a 12-month lease, while the Atlanta operating lease ends in December 2026. Our operating lease expense was approximately $205,000 and $191,000 for the years ended December 31, 2025 and 2024, respectively.
Item 2 of the 10-K filed Mar 30, 2026.4
Leadership
Who has led Lantern Pharma Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
- Chief executive officerPanna Sharma Jun 10, 2020 to now13
- PresidentPanna Sharma Jun 10, 2020 to now13
- Chief financial officerDavid R. Margrave Jun 10, 2020 to now14
Board members and other officers (9)
- Chief Scientific OfficerKishor G. Bhatia Jun 10, 2020 to now15
- Board memberLee Troy Schalop Jul 30, 2025 to now16
- Board memberMaria-Luisa Maccecchini Jun 17, 2022 to now17
- Board memberD. Jeffrey Keyser Jun 10, 2020 to now18
- Board memberDavid S. Silberstein Jun 10, 2020 to now19
- Board memberFranklyn G. Prendergast Jun 10, 2020 to Nov 8, 202120
- Board memberLeslie W. Kreis Jun 10, 2020 to Mar 21, 202221
- Board memberPanna Sharma Jun 10, 2020 to now13
- Board memberVijay Chandru Jun 10, 2020 to now22
Named in SEC Form D filings
People the company listed in its private-offering notices.
- Chairman of the BoardDonald Jeffrey Keyser named May 21, 202623
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Former names
- Lantern PharmaJan 14, 2019 to Jan 14, 20192
Timeline
- Oct 1, 20268-K Listing notice or transfer24
- Sep 30, 20268-K Entered a material agreement; Unregistered sale of shares25
- Sep 24, 20268-K Regulation FD disclosure26
- Sep 23, 20268-K Regulation FD disclosure27
- Aug 14, 20268-K Results of operations; Regulation FD disclosure28
- Aug 3, 20268-K Regulation FD disclosure29
- Jun 2, 20268-K Regulation FD disclosure30
- May 15, 20268-K Results of operations31
- May 14, 20268-K Entered a material agreement; Unregistered sale of shares; Other events32
- Apr 10, 20268-K Regulation FD disclosure33
- Mar 30, 20268-K Results of operations; Regulation FD disclosure34
- Jan 23, 20268-K Regulation FD disclosure35
- Jun 10, 2020New chief executive Panna Sharma becomes CEO13
Calendar
Coming up
- Nov 11, 2026Reports results for the quarter ending Sep/202636
When it reported results
- Aug 14, 2026Reported quarterly or annual results28
- May 15, 2026Reported quarterly or annual results31
- Mar 30, 2026Reported quarterly or annual results34
- Nov 13, 2025Reported quarterly or annual results37
- Aug 13, 2025Reported quarterly or annual results38
- May 15, 2025Reported quarterly or annual results39
- Mar 27, 2025Reported quarterly or annual results40
- Nov 7, 2024Reported quarterly or annual results41
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
172 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 47 major events, 54 insider forms, 14 large holders, 1 private raises, 34 other. The latest 20:
- Oct 13, 2026SCHEDULE 13G/A EDGAR
- Oct 8, 2026PRE 14A EDGAR
- Oct 1, 20268-K EDGAR
- Sep 30, 20268-K EDGAR
- Sep 30, 2026424B5 EDGAR
- Sep 24, 20268-K EDGAR
- Sep 23, 20268-K EDGAR
- Aug 14, 20268-K EDGAR
- Aug 14, 202610-Q EDGAR
- Aug 4, 2026SCHEDULE 13G EDGAR
- Aug 3, 20268-K EDGAR
- Jul 23, 2026SCHEDULE 13G/A EDGAR
- Jun 18, 2026EFFECT EDGAR
- Jun 12, 2026S-1 EDGAR
- Jun 2, 20268-K EDGAR
- May 21, 2026D EDGAR
- May 15, 2026SCHEDULE 13D/A EDGAR
- May 15, 20268-K EDGAR
- May 15, 202610-Q EDGAR
- May 14, 20268-K EDGAR
The 172 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
34 open-market trades by officers, directors and large owners since October 2021: 2 buys and 32 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| May 12, 2026 | Schalop Lee TroyDirector | Buy | 48,544 | $2.06 | $100.0K | Form 4 |
| May 12, 2026 | KEYSER D JEFFREYDirector | Buy | 48,544 | $2.06 | $100.0K | Form 4 |
| Jun 13, 2025 | BIOS Fund II QP, LP10% owner | Sale | 40,000 | $3.09 | $123.6K | Form 4 |
| Jun 13, 2025 | BP Directors, LP10% owner | Sale | 40,000 | $3.09 | $123.6K | Form 4 |
| Jun 12, 2025 | BIOS Fund I, LP10% owner | Sale | 60,647 | $3.38 | $205.0K | Form 4 |
| Jun 12, 2025 | Cavu Advisors, LLC10% owner | Sale | 60,647 | $3.38 | $205.0K | Form 4 |
| Jun 11, 2025 | BIOS Fund I, LP10% owner | Sale | 950 | $3.40 | $3.2K | Form 4 |
| Jun 11, 2025 | Cavu Advisors, LLC10% owner | Sale | 950 | $3.40 | $3.2K | Form 4 |
| Jun 10, 2025 | BIOS Fund I, LP10% owner | Sale | 16 | $3.40 | $54 | Form 4 |
| Jun 10, 2025 | Cavu Advisors, LLC10% owner | Sale | 16 | $3.40 | $54 | Form 4 |
| May 29, 2025 | BIOS Advisors GP, LLC10% owner | Sale | 20,200 | $3.03 | $61.2K | Form 4 |
| May 29, 2025 | Cavu Advisors, LLC10% owner | Sale | 20,200 | $3.03 | $61.2K | Form 4 |
| May 28, 2025 | BIOS Advisors GP, LLC10% owner | Sale | 15,000 | $2.87 | $43.0K | Form 4 |
| May 28, 2025 | Cavu Advisors, LLC10% owner | Sale | 15,000 | $2.87 | $43.0K | Form 4 |
| May 27, 2025 | BIOS Advisors GP, LLC10% owner | Sale | 21,037 | $3.05 | $64.2K | Form 4 |
| May 27, 2025 | Cavu Advisors, LLC10% owner | Sale | 21,037 | $3.05 | $64.2K | Form 4 |
| May 24, 2024 | Cavu Advisors, LLC10% owner | Sale | 20,000 | $6.33 | $126.6K | Form 4 |
| May 24, 2024 | Fletcher Aaron G.L.10% owner | Sale | 20,000 | $6.33 | $126.6K | Form 4 |
| May 23, 2024 | Cavu Advisors, LLC10% owner | Sale | 10,000 | $6.25 | $62.5K | Form 4 |
| May 23, 2024 | Fletcher Aaron G.L.10% owner | Sale | 10,000 | $6.25 | $62.5K | Form 4 |
All 34 trades can be filtered by person here when JavaScript is on.
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.
- Empery Asset Management, LPSCHEDULE 13G/A, 3 filings Jan 11, 2022 to Oct 13, 202642
- Thomas A. Satterfield Jr.SCHEDULE 13G/A, 2 filings Apr 3, 2026 to Jul 23, 202643
- Bios Equity Partners, LPSCHEDULE 13D/A, 7 filings Mar 22, 2022 to May 15, 202644
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 |
|---|---|---|---|---|
| 2024 | Panna Sharma, | 54 | $575.0K | $1.1M45 |
| 2024 | David R. Margrave, | 65 | $413.8K | $752.9K45 |
| 2024 | Kishor BhatiaPh.D., | 71 | $316.0K | $539.1K45 |
| 2023 | Chief Executive Officer and President | $525.3K | $684.4K45 | |
| 2023 | Chief Financial Officer and Secretary | $353.3K | $442.7K45 | |
| 2023 | Chief Scientific Officer | $235.0K | $283.2K45 |
Money raised
Private offerings the company reported to the SEC on Form D.
- May 14, 2026Filed a private offering of equity Form D: 6 investors so far Form D
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 39. Change is in shares since the quarter before.
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Lantern Pharma Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARLantern Pharma Inc.1
- CIK0001763950
- Employer ID (EIN)46-39734634
- 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 address1920 Mckinney Avenue, 7Th Floor, Dallas, TX 752011
- Phone972-277-11361
- Shares outstanding12,784,146 as of Aug 10, 202612
- Public float$33.9M as of Jun 30, 20254
- AuditorEisnerAmper LLP, Philadelphia, Pennsylvania PCAOB ID 274; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceJan 14, 20191
- Filings260 in all: 4 (65), 8-K (57), 10-Q (19), 3 (14), 144 (13), CORRESP (10), UPLOAD (7), 10-K (6)1
All 35 form types
DEF 14A (5), EFFECT (5), 424B5 (4), SC 13G (4), SCHEDULE 13D/A (4), ARS (3), D (3), S-1 (3), S-1/A (3), SC 13D (3), SC 13D/A (3), 10-K/A (2), 424B4 (2), DEFA14A (2), DRS (2), DRSLTR (2), FWP (2), PRE 14A (2), S-1MEF (2), S-3 (2), SC 13G/A (2), SCHEDULE 13G (2), SCHEDULE 13G/A (2), SEC STAFF LETTER (2), 8-A12B (1), CERT (1), S-8 (1)
- Latest filingsAnnual report (10-K) Mar 30, 2026
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) Aug 8, 2025
Latest 8-K (8-K) Oct 1, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.0001 par value | LTRN | The Nasdaq Stock Market |
From the cover page of the 10-K filed Mar 30, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Lantern Pharma Inc. names in Item 1A of its 10-K filed Mar 30, 2026: 73 risks under these headings, as written.4
- Risks Related to Financial Position and Need for Capital
- We will need substantial additional funding in the near future, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our drug development programs or commercialization efforts.
- We have a limited operating history and have never generated any revenues other than from research grants, which may make it difficult to evaluate the success of our business to date and to assess our future viability.
- We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.
- Risks Related to the Discovery and Development of Drug Candidates
- Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain, or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.
- Change in priorities at the FDA and other government agencies could hinder our ability to develop and commercialize any of our product candidates in a timely manner.
- We have limited experience in drug discovery and drug development and may not receive regulatory approval to market our drug candidates.
- Our business strategy to rescue previously failed drug candidates may not be successful, and important issues relating to safety and efficacy remain to be resolved for all of our drug candidates. Our strategy also involves risks and uncertainties that differ from other biotechnology companies that focus solely on new drug candidates that do not have a history of failed clinical trials.
- We may depend on enrollment of patients with specific genomic or biomarker signatures in our clinical trials in order for us to continue development of our drug candidates. If we are unable to enroll patients with specific genomic or biomarker signatures in our clinical trials, our research, development and commercialization efforts could be adversely affected.
- Delays in clinical testing could result in increased costs to us and delay our ability to generate revenue.
- Our drug candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
The other 63 risks
- Our RADR® platform may fail to help us discover and develop additional potential drug candidates.
- Any failure by us to comply with existing regulations could harm our reputation and operating results.
- We may be subject to extensive regulations outside the United States and may not obtain marketing approvals for drugs in Europe and other jurisdictions.
- If we are found in violation of federal or state “fraud and abuse” laws, we may be required to pay a penalty and/or be suspended from participation in federal or state health care programs, which may adversely affect our business, financial condition and results of operations.
- Our inability to obtain and retain sufficient clinical trial liability insurance at an acceptable cost to protect against potential liability claims could prevent or inhibit our ability to conduct clinical trials for drug candidates we develop.
- The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
- We may not experience a faster development or regulatory review or approval process with potential Fast Track designation.
- Risks Related to Commercialization of Our Drug Candidates
- Even if we are successful in completing all preclinical studies and clinical trials, we may not be successful in commercializing one or more of our drug candidates.
- If our drugs do not gain market acceptance, our business will suffer because we might not be able to fund future operations.
- We may rely on orphan drug status to commercialize some of our drug candidates, and even if orphan drug status is approved, such approval may not confer marketing exclusivity or other commercial advantages or expected commercial benefits.
- A breakthrough therapy designation by the FDA for our drug candidates may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our drug candidates will receive marketing approval.
- A Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process.
- Failure to obtain marketing approval in foreign jurisdictions would prevent our drug candidates from being marketed abroad.
- If we are required by the FDA to obtain approval of a companion diagnostic in connection with approval of a therapeutic drug candidate, and we do not obtain or face delays in obtaining FDA approval of a diagnostic device, we will not be able to commercialize the drug candidate and our ability to generate revenue will be materially impaired.
- Any drug candidate that we obtain marketing approval for could be subject to post-marketing restrictions or withdrawal from the market and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our drugs, when and if any of them are approved.
- Non-compliance with European Union requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of drugs for the pediatric population, can also result in significant financial penalties. Similarly, failure to comply with the European Union’s requirements regarding the protection of personal information can also lead to significant penalties and sanctions.
- We operate in a highly competitive and rapidly changing industry.
- If we are unable to develop satisfactory sales and marketing capabilities, we may not succeed in commercializing LP-300, LP-184, LP-284 or any other drug candidate.
- Even if we obtain regulatory approvals to commercialize LP-300, LP-184, LP-284 or our other drug candidates, our drug candidates may not be accepted by physicians or the medical community in general.
- Healthcare reform measures could hinder or prevent our drug candidates’ commercial success.
- Our relationships with healthcare providers, physicians and third-party payors will be subject to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security, and other healthcare laws and regulations, which, in the event of a violation, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
- Currently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug candidates and affect the prices we may obtain for any drugs that are approved in the United States or foreign jurisdictions.
- Governments outside of the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
- If we or any third-party manufacturers or contractors we engage now or in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could harm our business.
- We may experience challenges with the acquisition, development, enhancement or deployment of technology necessary for our RADR® platform.
- Risks Related to Our Reliance on Third Parties
- We rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully perform their contractual legal and regulatory duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our drug candidates and our business could be substantially harmed.
- We are substantially dependent on third parties for the manufacture of our clinical supplies of our drug candidates, and we intend to rely on third parties to produce commercial supplies of any approved drug candidate. Therefore, our development of our drugs could be stopped or delayed, and our commercialization of any future drug could be stopped or delayed or made less profitable if third party manufacturers fail to obtain approval of the FDA or comparable regulatory authorities or fail to provide us with drug products in sufficient quantities or at acceptable prices.
- We, or third-party manufacturers on whom we rely, may be unable to successfully scale-up manufacturing of our drug candidates in sufficient quality and quantity, which would delay or prevent us from developing our drug candidates and commercializing approved drugs, if any.
- Our failure to find third party collaborators to assist or share in the costs of drug development could materially harm our business, financial condition and results of operations.
- Cash balances held at banking institutions may be in excess of FDIC coverage.
- Risks Related to Our Business and Industry
- We will need to increase the size of our organization and the scope of our outside vendor relationships, and we may experience difficulties in managing growth.
- We depend on our senior management team, and the loss of one or more of our executive officers or key employees or an inability to attract and retain highly skilled employees could adversely affect our business.
- Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
- Business interruptions could adversely affect future operations, revenues, and financial conditions, and may increase our costs and expenses.
- Disruptions to our information technology systems, including future cyber-attacks and security breaches, and the costs of maintaining secure and effective information technology systems could negatively affect our business and results of operations.
- Unfavorable geopolitical and macroeconomic developments could adversely affect our business, financial condition or results of operations.
- Our failure to successfully acquire, develop and market additional drug candidates could impair our ability to grow.
- We have obtained statistical data, market data and other industry data and forecasts used throughout this report from market research, publicly available information and industry publications which we believe are reliable but have not been verified by any third party.
- Risks Related to Our Intellectual Property
- If we do not obtain patent term extension for any drug candidates we may develop, our business may be materially harmed.
- Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our drugs.
- We or our licensors may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
- Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
- Intellectual property litigation or other legal proceedings relating to intellectual property could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
- Obtaining and maintaining 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.
- If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.
- Our licensors may have relied on third-party consultants or collaborators or on funds from third parties such that our licensors are not the sole and exclusive owners of the patents and patent applications we in-licensed. If other third parties have ownership rights to our in-licensed patents, they may be able to license such patents to our competitors, and our competitors could market competing products and technology. This could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.
- We may not be able to protect our intellectual property and proprietary rights throughout the world.
- We may be subject to claims by third parties asserting that our employees, consultants, contractors or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
- Intellectual property rights do not necessarily address all potential threats.
- Risks Related to Owning our Common Stock
- Our stock price has been volatile and thinly traded which may impair your ability to sell your shares.
- Shares eligible for future sale may adversely affect the market for our common stock.
- The price of our common stock may fluctuate substantially.
- We have broad discretion in the use of our financial resources and may not use them effectively.
- We may acquire other companies or technologies, which could divert our management’s attention, result in dilution to our stockholders and otherwise disrupt our operations and adversely affect our operating results.
- Market and economic conditions, including inflation and changes in interest rates, may negatively impact our business, financial condition and share price.
- If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline.
- Because certain of our stockholders control a significant number of shares of our common stock, they may have effective control over actions requiring stockholder approval.
- Future sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall.
- We do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares.
- We may be at risk of securities class action litigation.
- Our certificate of incorporation and our by-laws, and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.
- Our by-laws designate the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware) as the exclusive forum for certain types of claims, which may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable.
- Financial reporting obligations of being a public company in the United States require well defined disclosure and financial controls and procedures that are expensive and time-consuming requiring our management to devote substantial time to compliance matters.
Legal proceedings
From time to time in the future, we may become involved in litigation or other legal proceedings that arise in the ordinary course of business. We are not currently a party to any legal proceedings, and we are not aware of any pending or threatened litigation against us that we believe could have a material adverse effect on our business, operating results or financial condition. In the event we are subject to a legal proceeding, it could have a material adverse impact on us because of litigation costs and diversion of management resources.
The opening of Item 3, Legal Proceedings.4
Sources
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- 16SEC EDGARLee Troy Schalop, Board member
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- 18SEC EDGARD. Jeffrey Keyser, Board member
- 19SEC EDGARDavid S. Silberstein, Board member
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- 21SEC EDGARLeslie W. Kreis, Board member
- 22SEC EDGARVijay Chandru, Board member
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- 24SEC EDGARListing notice or transfer
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- 26SEC EDGARRegulation FD disclosure
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- 31SEC EDGARResults of operations
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- 36NasdaqNasdaq calendar
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