Overview
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.3
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | $16.7M | $51.2M |
| General and administrative | $13.7M | $13.7M |
| Total operating loss | -$30.4M | -$64.8M |
| Interest income | $3.9M | $1.7M |
| Realized gain on sale of marketable securities, net | $119.0K | $955.0K |
| Gain (loss) on change in fair value of derivative instruments | $1.2M | -$947.0K |
| Total non-operating income | $5.2M | $1.7M |
| Loss before income tax | -$25.2M | -$63.1M |
| Income tax provision | $1.0K | $1.0K |
| Net loss | -$25.2M | -$63.1M |
| Net loss per share, basic | -$3.13 | -$176.15 |
| Net loss per share, diluted | -$3.13 | -$176.15 |
| Weighted average shares outstanding used in calculating net loss per share, basic | 8.0M shares | 358.2K shares |
| Weighted average shares outstanding used in calculating net loss per share, diluted | 8.0M shares | 358.2K shares |
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.3
| Period ending | 2025-12-31 | 2025-09-30 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $250.2M | $23.0M | ||
| Marketable securities | $45.0M | $5.0M | ||
| Prepaid expenses and other current assets | $13.2M | $880.0K | ||
| Total current assets | $308.4M | $28.9M | ||
| Operating lease right-of-use assets, net | $2.2M | $2.3M | ||
| Property and equipment, net | $1.6M | $1.9M | ||
| Restricted cash | $770.0K | $498.0K | ||
| Total assets | $312.9M | $33.5M | ||
| Accounts payable | $2.1M | $2.3M | ||
| Accrued expenses | $4.6M | $5.3M | ||
| Operating lease liability, current | $730.0K | $487.0K | ||
| Total current liabilities | $7.4M | $8.1M | ||
| Derivative liability - warrants | $1.3M | $2.5M | ||
| Operating lease liability, noncurrent | $2.8M | $3.2M | ||
| Total liabilities | $11.6M | $13.8M | ||
| Common stock, $0.0001 par value, 500,000,000 and 105,000,000 shares authorized, 25,299,372 and 251,655 shares issued and outstanding as of December 31, 2025 and 2024, respectively. | $3.0K | $114.3M | $1.0K | |
| Additional paid-in capital | $430.7M | $9.7M | ||
| Accumulated deficit | -$129.5M | -$104.3M | ||
| Accumulated other comprehensive income | $168.0K | $111.0K | ||
| Total stockholders' equity (deficit) | $301.3M | -$94.6M | -$34.5M | |
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $312.9M | $33.5M | ||
| Preferred stock, par value | $0.00 | |||
| Preferred stock, shares authorized | 10.0M shares | |||
| Common stock, par value | $0.00 | $0.00 | ||
| Common stock, shares authorized | 500.0M shares | 105.0M shares | ||
| Common Stock, Shares, Issued | 25.3M shares | 3.2M shares | 251.7K shares | |
| Common stock, shares outstanding | 25.3M shares | 251.7K shares |
| Period ending | 2025-12-31 | 2025-09-30 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|
| Cash and cash equivalents | $250.2M | $23.0M | ||
| Marketable securities | $45.0M | $5.0M | ||
| Prepaid expenses and other current assets | $13.2M | $880.0K | ||
| Total current assets | $308.4M | $28.9M | ||
| Operating lease right-of-use assets, net | $2.2M | $2.3M | ||
| Property and equipment, net | $1.6M | $1.9M | ||
| Restricted cash | $770.0K | $498.0K | ||
| Total assets | $312.9M | $33.5M | ||
| Accounts payable | $2.1M | $2.3M | ||
| Accrued expenses | $4.6M | $5.3M | ||
| Operating lease liability, current | $730.0K | $487.0K | ||
| Total current liabilities | $7.4M | $8.1M | ||
| Derivative liability - warrants | $1.3M | $2.5M | ||
| Operating lease liability, noncurrent | $2.8M | $3.2M | ||
| Total liabilities | $11.6M | $13.8M | ||
| Common stock, $0.0001 par value, 500,000,000 and 105,000,000 shares authorized, 25,299,372 and 251,655 shares issued and outstanding as of December 31, 2025 and 2024, respectively. | $3.0K | $114.3M | $1.0K | |
| Additional paid-in capital | $430.7M | $9.7M | ||
| Accumulated deficit | -$129.5M | -$104.3M | ||
| Accumulated other comprehensive income | $168.0K | $111.0K | ||
| Total stockholders' equity (deficit) | $301.3M | -$94.6M | -$34.5M | |
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $312.9M | $33.5M | ||
| Preferred stock, par value | $0.00 | |||
| Preferred stock, shares authorized | 10.0M shares | |||
| Common stock, par value | $0.00 | $0.00 | ||
| Common stock, shares authorized | 500.0M shares | 105.0M shares | ||
| Common Stock, Shares, Issued | 25.3M shares | 3.2M shares | 251.7K shares | |
| Common stock, shares outstanding | 25.3M shares | 251.7K 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.3
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net Income (Loss) | -$25.2M | -$63.1M |
| Stock-based compensation expense | $4.2M | $3.1M |
| Shares issued for services rendered | $0 | $71.0K |
| Loss on write off of property and equipment | $8.0K | $0 |
| Write off of deferred offering costs | $0 | $3.2M |
| Depreciation and amortization | $321.0K | $91.0K |
| Noncash lease expense | $147.0K | $308.0K |
| Realized gain on sale of marketable securities, net | -$119.0K | -$955.0K |
| Amortization (accretion) of premiums (discounts) on investments, net | $261.0K | -$34.0K |
| (Gain) loss on change in fair value of derivative instruments | -$1.2M | $947.0K |
| Prepaid expenses and other current assets | -$12.3M | -$1.8M |
| Operating lease liability | -$134.0K | -$60.0K |
| Accrued interest on marketable securities | -$268.0K | $114.0K |
| Accounts payable and accrued expenses | -$910.0K | $5.0M |
| Net cash used in operating activities | -$35.2M | -$53.1M |
| Purchases of property and equipment | -$52.0K | -$769.0K |
| Purchase of marketable securities | -$44.8M | -$29.7M |
| Proceeds from the sale of marketable securities | $2.5M | $23.6M |
| Maturities of marketable securities | $2.5M | $30.1M |
| Net cash (used in) provided by investing activities | -$39.9M | $23.2M |
| Proceeds from initial public offering | $327.8M | $0 |
| Payment of issuance costs for initial public offering | -$25.4M | $0 |
| Proceeds from exercise of warrants and options | $247.0K | $23.0K |
| Proceeds from issuance of redeemable convertible Series C preferred stock | $0 | $40.0M |
| Payment of issuance costs for redeemable convertible Series C preferred stock | $0 | -$1.7M |
| Net cash provided by financing activities | $302.6M | $38.3M |
| Net increase in cash, cash equivalents and restricted cash | $227.5M | $8.5M |
| Income tax paid | $1.0K | $1.0K |
| Conversion of 78,072,306 shares (1) of redeemable convertible preferred stock to common stock upon the closing of initial public offering | $114.3M | $0 |
| Right of use assets in exchange for operating lease liabilities | $0 | $2.4M |
| Acquisition of leasehold improvements | $0 | $1.2M |
No quarter-by-quarter statement was filed.
Corporate structure
LB PHARMACEUTICALS 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 LB PHARMACEUTICALS INC
- JPMorgan Chase Filed SCHEDULE 13G/A on LB PHARMACEUTICALS INC, latest Oct 13, 2026 (4 filings since Jan 21, 2026)
- TCG Crossover GP II, LLC Filed SCHEDULE 13G/A on LB PHARMACEUTICALS INC, latest Aug 14, 2026 (3 filings since Sep 18, 2025)
- BlackRock Filed SCHEDULE 13G/A on LB PHARMACEUTICALS INC, latest Jul 29, 2026 (2 filings since Jan 21, 2026)
- Caligan Partners LP Filed SCHEDULE 13G on LB PHARMACEUTICALS INC, latest May 15, 2026
- Commodore Capital LP Filed SCHEDULE 13G/A on LB PHARMACEUTICALS INC, latest May 15, 2026 (2 filings since Sep 18, 2025)
- RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on LB PHARMACEUTICALS INC, latest Feb 17, 2026 (2 filings since Sep 19, 2025)
- Deep Track Capital, LP Filed SCHEDULE 13D/A on LB PHARMACEUTICALS INC, latest Feb 10, 2026 (2 filings since Sep 19, 2025)
- BlackRock Portfolio Management LLC Filed SCHEDULE 13G/A on LB PHARMACEUTICALS INC, latest Jan 21, 2026 (2 filings since Oct 17, 2025)
- Trails Edge Capital Partners, LP Filed SCHEDULE 13G on LB PHARMACEUTICALS INC, latest Dec 31, 2025
- Pontifax Management 4 G.P. (2015) Ltd. Filed SCHEDULE 13D on LB PHARMACEUTICALS INC, latest Sep 25, 2025
- LB PHARMACEUTICALS INC New York, New York
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What LB PHARMACEUTICALS 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 | $2.0M3 Dec 31, 2025 | $2.0M3 Dec 31, 2024 | +2.1% |
| Accumulated depreciation | $420.0K3 Dec 31, 2025 | $101.0K3 Dec 31, 2024 | +315.8% |
| Property and equipment, net | $1.6M3 Dec 31, 2025 | $1.9M3 Dec 31, 2024 | −15.0% |
| Operating-lease assets (leased space) | $2.2M3 Dec 31, 2025 | $2.3M3 Dec 31, 2024 | −6.4% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $250.2M3 Dec 31, 2025 | $23.0M3 Dec 31, 2024 | +988.8% |
| Marketable securities, current | $45.0M3 Dec 31, 2025 | $5.0M3 Dec 31, 2024 | +797.0% |
Properties, in its own words
Our principal office is located at One Pennsylvania Plaza, Suite 1025, New York, NY 10119, where we lease approximately 8,900 square feet of office space under a lease that will expire in 2032. In November 2025, we entered into an amendment to our lease providing for approximately 4,600 square feet of additional office space through March 2032. We believe that our existing facility is adequate to meet our current needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms.
Item 2 of the 10-K filed Mar 26, 2026.6
Leadership
Who has led LB PHARMACEUTICALS INC, and when. Pick a name to see everywhere that person has worked.
- Chief executive officerHeather D. Turner Sep 10, 2025 to now7
- Chief financial officerJoseph M. Miller Sep 14, 2026 to now8
Board members and other officers (14)
- Chief Medical OfficerSusan Gani Kozauer Sep 24, 2026 to now9
- Chief Medical OfficerAnna Eramo Sep 10, 2025 to now10
- Chief Business OfficerGad Soffer Sep 10, 2025 to now11
- SVP, Technical OperationsRichard Anthony Silva Sep 11, 2025 to now12
- Senior Vice President, FinanceMarc L. Panoff Sep 29, 2025 to now13
- Chief Commercial OfficerPanandiker Kaya Kamlesh Pai Nov 18, 2025 to now14
- Board memberRobert A. Lenz Mar 10, 2026 to now15
- Board memberHeather D. Turner Sep 10, 2025 to now7
- Board memberJ. Scott Garland Sep 10, 2025 to now16
- Board memberRebecca Luse Sep 10, 2025 to now17
- Board memberRekha Hemrajani Sep 10, 2025 to now18
- Board memberRobert R. Ruffolo Sep 10, 2025 to now19
- Board memberZachary Prensky Sep 10, 2025 to now20
- Board memberRan Nussbaum Sep 11, 2025 to now21
Named in SEC Form D filings
People the company listed in its private-offering notices.
Former names
- LB PHARMACEUTICALS INC.Dec 15, 2016 to Dec 12, 20182
Timeline
- Sep 15, 20268-K Executive or director change; Regulation FD disclosure24
- Sep 3, 20268-K Executive or director change; Regulation FD disclosure25
- Aug 11, 20268-K Results of operations26
- Jul 29, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure27
- Jul 22, 20268-K Other events28
- Jun 10, 20268-K Executive or director change29
- Jun 9, 20268-K Shareholder vote30
- May 12, 20268-K Results of operations31
- Mar 26, 20268-K Results of operations32
- Mar 16, 20268-K Executive or director change33
- Mar 10, 20268-K Executive or director change; Regulation FD disclosure34
- Feb 5, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure35
- Sep 10, 2025New chief executive Heather D. Turner becomes CEO7
Calendar
Coming up
- Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.61) a share, on Nov 6, 2025.36
When it reported results
- Aug 11, 2026Reported quarterly or annual results26
- May 12, 2026Reported quarterly or annual results31
- Mar 26, 2026Reported quarterly or annual results32
- Nov 6, 2025Reported quarterly or annual results37
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
135 filings to the SEC since October 2021: 1 annual reports, 3 quarterly reports, 16 major events, 49 insider forms, 20 large holders, 5 private raises, 41 other. The latest 20:
- Oct 13, 20264 EDGAR
- Oct 13, 20264 EDGAR
- Oct 13, 2026SCHEDULE 13G/A EDGAR
- Oct 5, 2026EFFECT EDGAR
- Oct 1, 2026POS AM EDGAR
- Oct 1, 2026S-3ASR EDGAR
- Sep 24, 20263 EDGAR
- Sep 15, 2026424B3 EDGAR
- Sep 15, 20268-K EDGAR
- Sep 14, 20263 EDGAR
- Sep 3, 2026424B3 EDGAR
- Sep 3, 20268-K EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 11, 2026424B3 EDGAR
- Aug 11, 202610-Q EDGAR
- Aug 11, 20268-K EDGAR
- Aug 3, 20264 EDGAR
- Jul 29, 2026SCHEDULE 13G/A EDGAR
- Jul 29, 2026424B3 EDGAR
- Jul 29, 20268-K EDGAR
The 135 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
4 open-market trades by officers, directors and large owners since October 2021: 4 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Sep 12, 2025 | Deep Track Capital, LP10% owner | Buy | 2,666,666 | $15.00 | $40.0M | Form 4 |
| Sep 12, 2025 | Pontifax Management 4 G.P. (2015) Ltd.10% owner | Buy | 1,000,000 | $15.00 | $15.0M | Form 4 |
| Sep 12, 2025 | Nussbaum RanDirector | Buy | 1,000,000 | $15.00 | $15.0M | Form 4 |
| Sep 12, 2025 | Vida Ventures GP III, L.L.C.10% owner | Buy | 333,333 | $15.00 | $5.0M | 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.
- JPMorgan ChaseSCHEDULE 13G/A, 4 filings Jan 21, 2026 to Oct 13, 202638
- TCG Crossover GP II, LLCSCHEDULE 13G/A, 3 filings Sep 18, 2025 to Aug 14, 202639
- BlackRockSCHEDULE 13G/A, 2 filings Jan 21, 2026 to Jul 29, 202640
- Caligan Partners LPSCHEDULE 13G, 1 filing May 15, 202641
- Commodore Capital LPSCHEDULE 13G/A, 2 filings Sep 18, 2025 to May 15, 202642
- RA CAPITAL MANAGEMENT, L.P.SCHEDULE 13G/A, 2 filings Sep 19, 2025 to Feb 17, 202643
- Deep Track Capital, LPSCHEDULE 13D/A, 2 filings Sep 19, 2025 to Feb 10, 202644
- BlackRock Portfolio Management LLCSCHEDULE 13G/A, 2 filings Oct 17, 2025 to Jan 21, 202645
- Trails Edge Capital Partners, LPSCHEDULE 13G, 1 filing Dec 31, 202546
- Pontifax Management 4 G.P. (2015) Ltd.SCHEDULE 13D, 1 filing Sep 25, 202547
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 | Heather Turner | 53 | $568.8K | $11.9M48 |
| 2025 | Anna Eramo | 51 | $414.1K | $2.4M48 |
| 2024 | Chief Executive Officer | $68.8K | $4.8M48 | |
| 2024 | Chief Medical Officer | $375.0K | $891.0K48 |
Money raised
Private offerings the company reported to the SEC on 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 100. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Deep Track Capital, LP | 3,352,804 | $108.8M | 1.6% | No change |
| BlackRock, Inc. | 2,734,305 | $88.7M | 0.0% | +263,460 |
| Ra Capital Management, L.P. | 2,208,604 | $71.7M | 0.6% | No change |
| Nantahala Capital Management, LLC | 2,105,788 | $68.3M | 2.1% | +1,052,894 |
| Trails Edge Capital Partners, LP | 1,523,022 | $49.4M | 7.8% | +203,660 |
| Jpmorgan Chase & Co | 1,497,293 | $48.9M | 0.0% | +69,725 |
| Commodore Capital LP | 1,500,000 | $48.7M | 2.9% | No change |
| TCG Crossover Management, LLC | 1,447,310 | $47.0M | 1.1% | −392,179 |
| Caligan Partners LP | 1,438,070 | $46.7M | 2.3% | No change |
| Spruce Street Capital LP | 1,376,159 | $44.7M | 8.8% | No change |
| Vanguard Capital Management LLC | 971,165 | $31.5M | 0.0% | +76,512 |
| Balyasny Asset Management L.P. | 921,471 | $29.9M | 0.1% | −2,223 |
| Alyeska Investment Group, L.P. | 863,947 | $28.0M | 0.1% | No change |
| Vivo Capital, LLC | 800,000 | $26.0M | 2.4% | No change |
| Nan Fung Group Holdings Ltd | 630,657 | $20.5M | 15.6% | No change |
| Geode Capital Management, LLC | 612,793 | $19.9M | 0.0% | +94,565 |
| State Street Corp | 602,028 | $19.5M | 0.0% | +97,655 |
| Logos Global Management LP | 585,000 | $19.0M | 0.8% | −330,000 |
| Goldman Sachs Group Inc | 576,456 | $18.7M | 0.0% | +212,657 |
| Jennison Associates LLC | 540,902 | $17.6M | 0.0% | +2,686 |
| Great Point Partners LLC | 317,221 | $10.3M | 2.4% | +17,221 |
| Boothbay Fund Management, LLC | 275,675 | $8.9M | 0.2% | New |
| Millennium Management LLC | 259,219 | $8.4M | 0.0% | +122,253 |
| Ameriprise Financial Inc | 227,485 | $7.4M | 0.0% | +119,178 |
| Citadel Advisors LLC | 215,969 | $7.0M | 0.0% | −200,937 |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How LB PHARMACEUTICALS INC is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARLB PHARMACEUTICALS INC1
- CIK0001691082
- Employer ID (EIN)81-18543476
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company6
- Incorporated inDelaware6
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address575 Madison Avenue, New York, NY 100221
- Phone917-450-65811
- Shares outstanding32,259,175 as of Aug 5, 20265
- AuditorBDO USA, P.C, New York PCAOB ID 243; no auditor attestation of internal control over financial reporting6
- On EDGAR sinceDec 15, 20161
- Filings141 in all: 4 (29), 3 (20), 8-K (16), 424B3 (9), D (9), SCHEDULE 13G (9), SCHEDULE 13G/A (8), CORRESP (5)1
All 31 form types
UPLOAD (4), 10-Q (3), EFFECT (3), D/A (2), DRS/A (2), DRSLTR (2), S-1 (2), S-8 (2), SCHEDULE 13D (2), 10-K (1), 144 (1), 424B4 (1), 8-A12B (1), ARS (1), CERT (1), DEF 14A (1), DEFA14A (1), DRS (1), POS AM (1), S-1/A (1), S-1MEF (1), S-3ASR (1), SCHEDULE 13D/A (1)
- Latest filingsAnnual report (10-K) Mar 26, 2026
Quarterly report (10-Q) Aug 11, 2026
Proxy statement (DEF 14A) Apr 23, 2026
Latest 8-K (8-K) Sep 15, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.0001 par value | LBRX | The Nasdaq Stock Market LLC |
From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).6
Risk factors and legal proceedings
The risks LB PHARMACEUTICALS INC names in Item 1A of its 10-K filed Mar 26, 2026: 73 risks under these headings, as written.6
- Risks Related to Our Limited Operating History, Financial Position, and Need for Capital
- We are a clinical-stage biopharmaceutical company with a limited operating history and no history of commercializing products, which may make it difficult to evaluate our approach to the discovery and development of our product candidate and the prospects for our future viability.
- We have incurred substantial losses since our inception. We anticipate incurring substantial and increasing losses for the foreseeable future and may never achieve or maintain profitability.
- We will require substantial additional financing to achieve our goals, and failure to obtain additional capital when needed, or on acceptable terms to us, could cause us to delay, limit, reduce, or terminate our product development or future commercialization efforts.
- We have concentrated our research and development efforts on the treatment of psychiatric and neurological conditions, a field that faces certain challenges in drug development.
- The obligations from our royalty agreements may be a drain on our cash resources or may cause us to incur debt obligations to satisfy the payment obligations.
- Risks Related to Product Candidate Development and Commercialization
- Preclinical and clinical development involves a lengthy and expensive process, with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial or real-world results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our current product candidate or any future product candidates.
- Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming, and uncertain and may prevent us or any future collaboration partners from obtaining approvals for the commercialization of our product candidate.
- Even if our product candidate receives regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.
- We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- Use of our product candidate could be associated with adverse side effects, adverse events, or other safety risks, which could delay or preclude the candidate’s approval, cause us to suspend or discontinue clinical trials, cause us to abandon the product candidate, limit the commercial profile of any future approved product, or result in other significant negative consequences that could severely harm our business, prospects, operating results, and financial condition.
The other 63 risks
- We have never commercialized a product candidate and may experience delays or unexpected difficulties in obtaining, or fail to obtain, regulatory approval for our product candidate.
- Interim, “top-line,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- If we fail to develop and commercialize our current product candidate for additional indications or fail to discover, develop, and commercialize other product candidates, we may be unable to grow our business and our ability to achieve our strategic objectives would be impaired.
- We may expend our resources to pursue a particular product candidate or indication and forgo the opportunity to capitalize on product candidates or indications that may ultimately be more profitable or for which there is a greater likelihood of success.
- Obtaining and maintaining regulatory approval of LB-102 or any future product candidates we may develop in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of such product candidate in other jurisdictions.
- The successful commercialization of our product candidate, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels, and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidate could limit our ability to market those products and decrease our ability to generate revenue.
- Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
- We may conduct certain of our clinical trials for our product candidate outside of the United States in the future. However, the FDA may not accept data from such trials, in which case our development plans may be delayed, which could materially harm our business.
- Risks Related to Our Business and Operations
- Neuroscience drug development is a field that has seen limited success. The ability to successfully develop drugs in this field is difficult and is subject to a number of unique challenges.
- Our business depends on the success of our product candidate. If we are ultimately unable to successfully commercialize our product candidate, or experience significant delays in doing so, our business will be materially harmed.
- We rely on, and intend to continue to rely on, our internal clinical development expertise to conduct our current and future clinical trials. This model includes internal teams and systems as well as external vendors and CROs to comprise a full clinical trial team. If our clinical trial team does not comply with applicable regulatory requirements, meet expected deadlines, or run trials effectively, our development programs and our ability to seek or obtain regulatory approval for or commercialize our product candidate may be delayed.
- Competitive products may reduce or eliminate the commercial opportunity for our product candidate for our current or future indications. If our competitors develop technologies or product candidates more rapidly than we do, or their technologies are more effective or safer than ours, our ability to develop and successfully commercialize our current products may be adversely affected.
- We will need to grow our organization, and we may experience difficulties in managing our growth and expanding our operations, which could adversely affect our business.
- We are dependent on the services of our management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer.
- Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- Our business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could adversely affect our business, financial condition, results of operations, and prospects.
- If our information technology systems or those of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
- We have identified material weaknesses in our internal control over financial reporting. If we fail to remediate these material weaknesses, or if we experience additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting in the future, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stock.
- Our projections regarding the market opportunities for our product candidate may not be accurate, and the actual market for our products may be smaller than we estimate.
- Our business could be adversely affected by the effects of health pandemics or epidemics, which could cause significant disruptions in our operations and those of our current or future CDMOs, CROs, and other third parties upon whom we rely.
- Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
- Risks Related to Intellectual Property, Collaborations, and Related Agreements
- If we are unable to obtain and maintain sufficient intellectual property protection for our technologies, and product candidate and any future product candidates we may develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully develop and commercialize our product candidate may be adversely affected.
- Issued patents covering our product candidate, or the method of use of our product candidate could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
- We may not be successful in obtaining or maintaining necessary rights to third party patents for our product candidate through acquisitions and in-licenses.
- We may form or seek collaborations or strategic alliances, enter into licensing arrangements or other business transactions in the future, and we may not realize the benefits of such transactions.
- We may not be able to protect our intellectual property rights throughout the world.
- Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
- We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope, or expiration of a third-party patent, which might adversely affect our ability to develop and market our product candidate.
- We may be involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
- Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidate.
- We may become subject to claims challenging the inventorship or ownership of our or our future licensors’ patents and other intellectual property.
- Patent terms may be inadequate to protect our competitive position on our product candidate for a sufficient amount of time.
- If we do not obtain patent term extension for our product candidate, our business may be materially harmed.
- Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated as a result of noncompliance with these requirements.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
- We may be subject to claims asserting that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
- We may develop or license intellectual property for which development was funded or otherwise assisted by, the U.S. government and/or government agencies, such as the National Institutes of Health, for development of our technology and product candidates. Failure to meet our own obligations to future licensors or upstream licensors, including such government agencies, may result in the loss of our rights to such intellectual property, which could harm our business.
- Risks Related to Our Reliance on Third Parties
- We have relied and expect to continue to rely on third parties to conduct certain aspects of our clinical trials. If those third parties do not perform as contractually required, fail to satisfy legal or regulatory requirements, miss expected deadlines, or terminate the relationship, our development programs could be delayed, more costly, or unsuccessful, and we may never be able to seek or obtain regulatory approval for or commercialize our product candidate.
- We rely on third-party manufacturers and suppliers to supply our product candidate. The loss of our third-party manufacturers or suppliers, or their failure to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, within acceptable timeframes, or at all, would materially and adversely affect our business.
- If any third-party manufacturer of our product candidate is unable to increase the scale of its production of our product candidate, and/or increase the product yield of its manufacturing, then our costs to manufacture product candidate may increase and commercialization may be delayed.
- We depend on limited source suppliers for certain drug substances, drug products, raw materials, components, and other materials used in our product candidate. If we are unable to source these supplies on a timely basis, we will not be able to complete our clinical trials on time and the development of our product candidate may be delayed.
- The operations of our suppliers that are located outside of the United States are subject to additional risks that are beyond our control and that could harm our business, financial condition, results of operations, and prospects.
- We may have conflicts with our current or future licensors or collaborators that could delay or prevent the development or commercialization of our product candidate.
- Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
- We may engage third party collaborators to market and commercialize our product candidate, who may fail to effectively commercialize our product candidate.
- Risks Related to Government Regulation
- Our relationships with healthcare providers, including physicians, and third-party payors may be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to significant penalties, including criminal sanctions, civil penalties, contractual damages, reputational harm, and diminished profits and future earnings.
- EU drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the EU member states.
- Even if we receive regulatory approval of our product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidate.
- The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
- Ongoing healthcare legislative and regulatory reform measures may adversely affect our business, results of operations, and financial condition.
- Disruptions at the FDA and other national and foreign government authorities caused by funding shortages or global health concerns could hinder their ability to hire, retain, or deploy key leadership and other personnel, or prevent new or modified products from being developed, reviewed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.
- Additional laws and regulations governing international operations could adversely affect our business, results of operations and financial condition.
- We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
- Risks Related to Ownership of Our Common Stock
- An active and liquid trading market for our common stock may not be sustained, or we may in the future fail to satisfy the continued listing requirements of Nasdaq and our stock may be delisted, and you may not be able to resell your shares of common stock at or above the public offering price, if at all.
- Our quarterly and annual operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts or any guidance we may publicly provide, each of which may cause our stock price to fluctuate or decline.
- Our stock price may be volatile, which could result in substantial losses for investors.
- We do not intend to pay dividends on our common stock for the foreseeable future, so any returns will be limited to the value of our stock.
- Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
- We are an emerging growth company and a smaller reporting company, and the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.
- Conflicts of interest may arise because some members of our board of directors are representatives of our principal stockholders.
- Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
Legal proceedings
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We do not have any pending litigation that, separately or in the aggregate, would, in the opinion of management, have a material adverse effect on our results of operations, financial condition, or cash flows.
The opening of Item 3, Legal Proceedings.6
Sources
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- 10SEC EDGARAnna Eramo, Chief Medical Officer
- 11SEC EDGARGad Soffer, Chief Business Officer
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- 15SEC EDGARRobert A. Lenz, Board member
- 16SEC EDGARJ. Scott Garland, Board member
- 17SEC EDGARRebecca Luse, Board member
- 18SEC EDGARRekha Hemrajani, Board member
- 19SEC EDGARRobert R. Ruffolo, Board member
- 20SEC EDGARZachary Prensky, Board member
- 21SEC EDGARRan Nussbaum, Board member
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- 26SEC EDGARResults of operations
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- 28SEC EDGAROther events
- 29SEC EDGARExecutive or director change
- 30SEC EDGARShareholder vote
- 31SEC EDGARResults of operations
- 32SEC EDGARResults of operations
- 33SEC EDGARExecutive or director change
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