Private company
Clearside Biomedical, Inc.
In its 2025 annual report the company says: “We are a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space, or SCS. We are leveraging our SCS injection platform by building an internal research and development pipeline targeting retinal diseases and by creating external collaborations with other companies.”4 It is headquartered in Alpharetta, United States.2
Last updated Oct 21, 2026.
Overview
- IndustryPharmaceutical Preparations2
- HeadquartersAlpharetta, United States2
- Incorporated inDE3
- Business address900 North Point Parkway, Suite 200, Alpharetta, Ga 300053
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI529900GQSUZO5HQ9DS292
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressc/o CORPORATION SERVICE COMPANY, 251 LITTLE FALLS DRIVE, 19808 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 49861062
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We are a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space, or SCS. Our novel SCS injection platform, utilizing our proprietary SCS Microinjector, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Our SCS injection platform can be used in conjunction with existing drugs designed for delivery to the SCS, novel therapies and future therapeutic innovations. We believe our proprietary suprachoroidal administration platform has the potential to become a standard for delivery of therapies intended to treat chorioretinal diseases.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 2024
Where the money goes
Where each dollar of revenue went, fiscal 2024
- Cost of revenue1¢$149.0K
- Research and development99¢$18.6M
Out of $1.7M in revenue.5 The company lost money this year.
Financial statements
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Revenue | $30.0K6 | $2.2M7 | $7.9M8 | $29.6M9 | $1.3M5 | $8.2M5 | $1.7M5 |
| Cost of revenue | $09 | $204.0K5 | $355.0K5 | $149.0K5 | |||
| Research and development | $68.3M6 | $15.7M7 | $15.1M8 | $18.5M9 | $19.6M5 | $20.8M5 | $18.6M5 |
| Operating expenses | $30.2M9 | $31.6M9 | $33.1M9 | ||||
| Operating income | -$82.9M6 | -$30.3M7 | -$17.9M8 | -$627.0K9 | -$30.3M5 | -$24.8M5 | -$28.9M5 |
| Net income | -$82.8M6 | -$30.8M7 | -$18.2M8 | $376.0K9 | -$32.9M5 | -$32.5M5 | -$34.4M5 |
| Earnings per share | -$0.817 | -$0.398 | $0.019 | -$0.555 | -$0.535 | -$0.475 | |
| Earnings per share (diluted) | -$0.817 | -$0.398 | $0.019 | -$0.555 | -$0.535 | -$0.475 | |
| Shares (weighted, basic) | 58.5M shares9 | 60.2M shares5 | 61.8M shares5 | 73.8M shares5 | |||
| Shares (weighted, diluted) | 59.9M shares9 | 60.2M shares5 | 61.8M shares5 | 73.8M shares5 |
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash | $8.0M6 | $22.6M7 | $17.3M8 | $30.4M9 | $48.3M5 | $28.9M5 | $20.0M5 |
| Receivables | $10.0M8 | $09 | $467.0K5 | $507.0K5 | |||
| Current assets | $42.9M12 | $25.2M6 | $18.1M7 | $42.1M8 | $49.4M9 | $30.1M5 | $21.3M5 |
| Property, plant and equipment | $238.0K8 | $755.0K9 | $3.0M5 | $3.2M5 | |||
| Total assets | $44.1M12 | $26.8M6 | $19.3M7 | $42.9M8 | $51.3M9 | $34.0M5 | $25.1M5 |
| Accounts payable | $941.0K8 | $1.1M9 | $2.2M5 | $1.5M5 | |||
| Current liabilities | $10.5M12 | $10.9M6 | $9.9M7 | $4.6M8 | $5.8M9 | $6.8M5 | $4.8M5 |
| Long-term debt | $9.4M12 | $3.8M6 | |||||
| Total liabilities | $20.5M12 | $15.6M6 | $10.6M7 | $4.9M8 | $40.7M9 | $49.9M5 | $64.0M5 |
| Retained earnings | -$255.5M8 | -$288.4M9 | -$320.9M5 | -$355.3M5 | |||
| Shareholders’ equity | $23.6M7 | $11.2M8 | $8.8M9 | $38.0M5 | $10.6M5 | -$15.9M5 | -$38.9M5 |
| Shares outstanding | 32.1M shares12 | 44.4M shares6 | 51.9M shares7 | 59.7M shares8 | 60.6M shares9 | 62.9M shares5 | 76.6M shares5 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|
| Cash from operations | -$79.2M6 | -$27.1M7 | -$13.1M8 | -$10.7M9 | -$13.4M5 | -$18.1M5 | -$24.7M5 |
| Depreciation and amortization | $05 | $05 | -$339.0K5 | ||||
| Stock-based compensation | $5.1M9 | $4.9M5 | $4.2M5 | $4.5M5 | |||
| Capital spending | $88.0K6 | $25.0K7 | $55.0K8 | $09 | $246.0K5 | $1.8M5 | $977.0K5 |
| Free cash flow | -$79.3M | -$27.1M | -$13.2M | -$10.7M | -$13.6M | -$19.9M | -$25.7M |
| Cash from investing | $09 | -$246.0K5 | -$1.8M5 | -$638.0K5 | |||
| Cash from financing | $23.8M9 | $31.3M5 | $414.0K5 | $16.4M5 |
Corporate structure
Clearside Biomedical, 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 Clearside Biomedical, Inc.
- Stephen Boyd Wiles Filed SCHEDULE 13G on Clearside Biomedical, Inc., latest Apr 1, 2025
- Bradford T. Whitmore Filed SCHEDULE 13G/A on Clearside Biomedical, Inc., latest Mar 4, 2025 (4 filings since Jan 24, 2022)
- Hatteras Venture Advisors IV SBIC, LLC Filed SCHEDULE 13D/A on Clearside Biomedical, Inc., latest Feb 21, 2025
- RTW INVESTMENTS, LP Filed SC 13G/A on Clearside Biomedical, Inc., latest Feb 14, 2023 (2 filings since Feb 14, 2022)
- Gestion Carmignac Filed SC 13G/A on Clearside Biomedical, Inc., latest Feb 13, 2023 (2 filings since Feb 9, 2022)
- Hatteras Venture Advisors III, LLC Filed SC 13D/A on Clearside Biomedical, Inc., latest Jan 4, 2023
- Clearside Biomedical, Inc. Alpharetta, Georgia, 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 Clearside Biomedical, 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 | $4.4M5 Dec 31, 2024 | $3.9M5 Dec 31, 2023 | +11.6% |
| Accumulated depreciation | $1.1M5 Dec 31, 2024 | $920.0K5 Dec 31, 2023 | +24.6% |
| Property and equipment, net | $3.2M5 Dec 31, 2024 | $3.0M5 Dec 31, 2023 | +7.6% |
| Operating-lease assets (leased space) | $597.0K5 Dec 31, 2024 | $869.0K5 Dec 31, 2023 | −31.3% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $20.0M5 Dec 31, 2024 | $28.9M5 Dec 31, 2023 | −30.8% |
Properties, in its own words
Our principal offices occupy approximately 14,000 square feet of office space in Alpharetta, Georgia under a lease with an initial term until November 2026, with a renewal option for one additional three-year term.
We believe that our current leased facilities are suitable and adequate to meet our current and anticipated needs. We believe that suitable additional or substitute space will be available as needed to accommodate any expansion of our operations.
Item 2 of the 10-K filed Mar 27, 2025.4
Leadership
Who has led Clearside Biomedical, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
- Chief executive officerGeorge M. Lasezkay Apr 10, 2019 to Jan 10, 202513
- Chief executive officerDaniel H. White Jun 1, 2016 to Feb 7, 201914
- PresidentDaniel H. White Jun 1, 2016 to Feb 7, 201914
- Chief financial officerCharles A. Deignan Jun 1, 2016 to Jan 10, 202515
Board members and other officers (18)
- CHIEF MEDICAL OFFICERNgai Hang Victor Chong Mar 18, 2024 to Jan 10, 202516
- Chief Medical OfficerThomas Ciulla Jun 26, 2020 to Jan 20, 202317
- Chief Commercial OfficerBrion S. Raymond Feb 27, 2018 to Jun 4, 201918
- Executive Vice President, R&DGlenn Noronha Jun 1, 2016 to Dec 12, 201719
- Board memberAnthony S. Gibney Apr 16, 2024 to Jun 21, 202420
- Board memberBenjamin R. Yerxa Mar 4, 2022 to Jun 21, 202421
- Board memberNancy J. Hutson Apr 23, 2020 to Jun 21, 202422
- Board memberJeffrey L. Edwards Sep 28, 2018 to Jun 21, 202423
- Board memberGeorge M. Lasezkay Aug 10, 2017 to Jan 10, 202524
- Board memberChristy L. Shaffer Jun 1, 2016 to Jun 21, 202425
- Board memberClay Thorp Jun 1, 2016 to Feb 24, 202526
- Board memberDaniel H. White Jun 1, 2016 to Feb 7, 201914
- Board memberDerek Yoon Jun 1, 2016 to Jul 5, 201727
- Board memberEvgeny Zaytsev Jun 1, 2016 to Jun 21, 201828
- Board memberGerald D. Cagle Jun 1, 2016 to Jun 26, 201829
- Board memberRichard Croarkin Jun 1, 2016 to Jun 21, 202430
- Board memberWilliam D. Humphries Jun 1, 2016 to Jun 21, 202431
- Board memberBihua Chen Jun 13, 2016 to Jun 13, 201632
Timeline
- Dec 29, 20258-K Bankruptcy or receivership; Other events33
- Dec 8, 20258-K Listing notice or transfer34
- Nov 25, 20258-K Bankruptcy or receivership; Listing notice or transfer; Regulation FD disclosure35
- Oct 7, 20258-K Other events36
- Sep 11, 20258-K Bylaws or fiscal year changed37
- Sep 11, 20258-K Bylaws or fiscal year changed38
- Sep 8, 20258-K Entered a material agreement39
- Sep 3, 20258-K Listing notice or transfer; Shareholder vote40
- Aug 14, 20258-K Listing notice or transfer; Executive or director change41
- Jul 17, 20258-K Exit or restructuring costs; Executive or director change; Other events42
- May 30, 20258-K Bylaws or fiscal year changed; Shareholder vote43
- May 14, 20258-K Results of operations44
- Apr 10, 2019New chief executive George M. Lasezkay becomes CEO13
- Jun 1, 2016New chief executive Daniel H. White becomes CEO14
Calendar
When it reported results
- May 14, 2025Reported quarterly or annual results44
- Mar 27, 2025Reported quarterly or annual results45
- Nov 12, 2024Reported quarterly or annual results46
- Aug 12, 2024Reported quarterly or annual results47
- May 9, 2024Reported quarterly or annual results48
- Mar 12, 2024Reported quarterly or annual results49
- Nov 13, 2023Reported quarterly or annual results50
- Aug 14, 2023Reported quarterly or annual results51
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
187 filings to the SEC since October 2021: 4 annual reports, 13 quarterly reports, 48 major events, 69 insider forms, 11 large holders, 42 other. The latest 20:
- Jan 7, 202615-12G EDGAR
- Dec 29, 20258-K EDGAR
- Dec 16, 2025EFFECT EDGAR
- Dec 16, 2025EFFECT EDGAR
- Dec 15, 2025S-8 POS EDGAR
- Dec 15, 2025S-8 POS EDGAR
- Dec 15, 2025S-8 POS EDGAR
- Dec 15, 2025S-8 POS EDGAR
- Dec 15, 2025S-8 POS EDGAR
- Dec 15, 2025S-8 POS EDGAR
- Dec 15, 2025S-8 POS EDGAR
- Dec 15, 2025S-8 POS EDGAR
- Dec 15, 2025POS AM EDGAR
- Dec 15, 2025S-8 POS EDGAR
- Dec 15, 2025POS AM EDGAR
- Dec 15, 2025S-8 POS EDGAR
- Dec 8, 20258-K EDGAR
- Dec 8, 202525 EDGAR
- Nov 25, 20258-K EDGAR
- Nov 14, 202510-Q EDGAR
The 187 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
25 open-market trades by officers, directors and large owners since October 2021: 15 buys and 10 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Feb 24, 2025 | Thorp ClayDirector | Buy | 15,000 | $0.92 | $13.8K | Form 4 |
| Nov 1, 2024 | Chong Ngai Hang VictorChief Medical Officer | Buy | 36,500 | $1.00 | $36.5K | Form 4 |
| Jun 24, 2024 | Chong Ngai Hang VictorChief Medical Officer | Buy | 23,500 | $1.06 | $24.9K | Form 4 |
| May 15, 2024 | YERXA BENJAMIN RDirector | Buy | 7,813 | $1.31 | $10.2K | Form 4 |
| Apr 18, 2024 | Gibney Anthony SDirector | Buy | 93,290 | $1.30 | $121.3K | Form 4 |
| Apr 17, 2024 | Gibney Anthony SDirector | Buy | 6,710 | $1.25 | $8.4K | Form 4 |
| Mar 20, 2024 | Chong Ngai Hang VictorChief Medical Officer | Buy | 30,000 | $1.60 | $48.0K | Form 4 |
| Feb 7, 2024 | WHITMORE BRADFORD T10% owner | Buy | 444,444 | $1.35 | $600.0K | Form 4 |
| Jan 19, 2024 | LASEZKAY GEORGE MCEO | Sale | 18,000 | $1.27 | $22.9K | Form 4 |
| Jan 19, 2024 | Deignan Charles A.Chief Financial Officer | Sale | 12,900 | $1.28 | $16.5K | Form 4 |
| Nov 1, 2023 | WHITMORE BRADFORD T10% owner | Buy | 64,366 | $0.74 | $47.6K | Form 4 |
| Oct 31, 2023 | WHITMORE BRADFORD T10% owner | Buy | 70,812 | $0.73 | $51.7K | Form 4 |
| Oct 30, 2023 | WHITMORE BRADFORD T10% owner | Buy | 600 | $0.69 | $414 | Form 4 |
| Oct 3, 2023 | Hutson Nancy JDirector | Buy | 10,000 | $0.86 | $8.6K | Form 4 |
| Sep 25, 2023 | Thorp ClayDirector | Buy | 10,000 | $0.86 | $8.6K | Form 4 |
| Jan 20, 2023 | Ciulla ThomasChief Medical Officer | Sale | 13,700 | $1.47 | $20.1K | Form 4 |
| Jan 19, 2023 | LASEZKAY GEORGE MCEO | Sale | 20,030 | $1.46 | $29.2K | Form 4 |
| Jan 19, 2023 | Deignan Charles A.Chief Financial Officer | Sale | 14,030 | $1.50 | $21.0K | Form 4 |
| Jan 10, 2023 | Ciulla ThomasChief Medical Officer | Sale | 2,170 | $1.62 | $3.5K | Form 4 |
| Dec 21, 2022 | Thorp ClayDirector | Buy | 14,000 | $1.02 | $14.3K | Form 4 |
All 25 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.
- Stephen Boyd WilesSCHEDULE 13G, 1 filing Apr 1, 202552
- Bradford T. WhitmoreSCHEDULE 13G/A, 4 filings Jan 24, 2022 to Mar 4, 202553
- Hatteras Venture Advisors IV SBIC, LLCSCHEDULE 13D/A, 1 filing Feb 21, 202554
- RTW INVESTMENTS, LPSC 13G/A, 2 filings Feb 14, 2022 to Feb 14, 202355
- Gestion CarmignacSC 13G/A, 2 filings Feb 9, 2022 to Feb 13, 202356
- Hatteras Venture Advisors III, LLCSC 13D/A, 1 filing Jan 4, 202357
Funding
Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.
- PPP loans $991.1K
Figures by year
| Year | PPP loans | Total |
|---|---|---|
| 2020 | $991.1K | $991.1K |
PPP loans
Paycheck Protection Program loans of $150,000 and up, approved April 2020 to July 2021, from the SBA58. Matched to this company by name and state.
- Apr 13, 2020$991.1K PPP loan (first draw) from Silicon Valley Bridge Bank NA58To CLEARSIDE BIOMEDICAL, INC., Alpharetta GA; $998.4K forgiven Jan 12, 2021
SEC filer profile
How Clearside Biomedical, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARClearside Biomedical, Inc.1
- CIK0001539029
- Employer ID (EIN)45-24373754
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not 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 address900 North Point Parkway, Suite 200, Alpharetta, GA 300051
- Phone678-270-36311
- Shares outstanding5,233,981 as of Nov 12, 202511
- Public float$92.0M as of Jun 28, 20244
- AuditorErnst & Young LLP, Atlanta, Georgia PCAOB ID 424
- On EDGAR sinceJan 9, 20121
- Filings552 in all: 4 (199), 8-K (118), 10-Q (29), 3 (24), SC 13G/A (22), CORRESP (14), DEF 14A (10), S-8 (10)1
All 42 form types
S-8 POS (10), 10-K (9), 424B5 (9), UPLOAD (9), DEFA14A (8), EFFECT (8), SC 13G (8), D (7), S-1/A (6), SC 13D/A (6), DRS/A (5), 4/A (4), S-3 (4), ARS (3), DRSLTR (3), PRE 14A (3), 144 (2), 424B4 (2), CT ORDER (2), FWP (2), POS AM (2), S-1 (2), 15-12G (1), 25 (1), 3/A (1), 8-A12B (1), CERTNAS (1), D/A (1), DRS (1), S-3/A (1), SC 13D (1), SCHEDULE 13D/A (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Mar 27, 2025
Quarterly report (10-Q) Nov 14, 2025
Proxy statement (DEF 14A) Aug 4, 2025
Latest 8-K (8-K) Dec 29, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.001 per share | CLSD | The Nasdaq Stock Market LLC |
From the cover page of the 10-K filed Mar 27, 2025 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Clearside Biomedical, Inc. names in Item 1A of its 10-K filed Mar 27, 2025: 69 risks under these headings, as written.4
- Risks Related to Our Financial Position and Capital Needs
- We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.
- We will need substantial additional funding to meet our financial obligations and to pursue our business objectives. If we are unable to raise capital when needed, we could be forced to delay, reduce or altogether cease our drug development programs or commercialization efforts.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
- We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern.
- Our agreements with HCR contain various covenants and other provisions, which, if violated, could materially adversely affect our financial condition.
- Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, political crises, geopolitical events, such as the conflicts in Ukraine and the Middle East, or other macroeconomic conditions.
- Risks Related to the Development of Our Product Candidates
- Our efforts are focused on the development of product candidates for treatment of eye disease through suprachoroidal injection and partnering with companies who can leverage our SCS Microinjector to deliver their ophthalmic product candidates to the SCS. Suprachoroidal injection is a novel approach and may fail to achieve and sustain market acceptance.
- Our licensing partners may require that we modify our SCS Microinjector to deliver their product candidates, and we may be unable to do so.
- If we are unable to obtain regulatory approval for, and commercialize either on our own or with a third party, CLS-AX or our other product candidates, or if we experience significant delays in doing so, our business may be harmed.
- Data from our clinical trials that we announce or publish from time to time may change as more patient data become available, and such data are subject to audit and verification procedures that could result in material changes in the final data.
The other 59 risks
- We may not be successful in our efforts to build a pipeline of product candidates.
- Clinical drug development involves a lengthy and expensive process with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of our product candidates.
- If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
- If serious adverse or unacceptable side effects are identified during the development of our product candidates, we may need to abandon or limit our development of some of our product candidates.
- We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- Risks Related to Our Dependence on Third Parties
- We have granted an exclusive license to Bausch for the commercialization and development of XIPERE in the United States and Canada. After we have satisfied our obligations under the Purchase and Sale Agreement, if we are unable to maintain our partnership with Bausch, or if Bausch fails to successfully commercialize XIPERE, our business and prospects will be materially harmed.
- We have entered into, and intend to continue to enter into, collaborations with third parties for the development and commercialization of XIPERE. In addition, we may seek commercialization partners for our product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of XIPERE and our product candidates.
- We rely on third parties to conduct our clinical trials for our product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials or failing to comply with applicable regulatory requirements.
- We do not have our own manufacturing capabilities and rely on third parties to produce clinical and commercial supplies of our current product candidates and our SCS Microinjector. This reliance on third parties increases the risk that we will not have sufficient quantities of our drug products and our SCS Microinjector, or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
- If we are not able to establish additional collaborations, we may have to alter some of our future development and commercialization plans.
- Risks Related to the Commercialization of Our Product Candidates
- If we are unable to establish sales and distribution capabilities for our product candidates for which we do not out-license commercialization rights, we may not be successful in commercializing those product candidates, if and when they are approved.
- XIPERE and any of our product candidates that receive marketing approval, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
- We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
- XIPERE and our product candidates may be subject to unfavorable pricing regulations, third-party coverage and reimbursement policies or healthcare reform initiatives.
- Product liability lawsuits against us could cause us to incur substantial liabilities.
- Risks Related to Employee Matters and Managing Our Growth
- Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
- Risks Related to Our Intellectual Property
- If we are unable to obtain and maintain patent protection for our technology and product candidates, or if our licensors are unable to obtain and maintain patent protection for the technology or product candidates that we license from them, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and product candidates may be impaired.
- Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
- We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
- Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could significantly harm business.
- Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
- If we fail to comply with our obligations under our existing intellectual property licenses with third parties, we could lose license rights that are important to our business.
- We may need to license additional intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
- We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
- Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
- Some intellectual property that we have in-licensed may have been discovered through a government funded program and may be subject to certain federal regulations.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
- If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we and our collaborators will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired.
- If the FDA does not conclude that a product candidate satisfies the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements under Section 505(b)(2) are not as we expect, the approval pathway for our product candidates in this pathway will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
- Additional time may be required to obtain regulatory approval for our product candidates because of the complexity involved with co-packaging a drug-device combination product.
- Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad.
- A variety of risks associated with marketing our product candidates internationally could affect our business.
- We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
- Any product candidate for which we obtain marketing approval could be subject to post-marketing restrictions or recall or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.
- Even though we have received orphan drug designation in the European Union for the treatment of non-infectious uveitis, we may not be able to obtain orphan drug marketing exclusivity for this product candidate.
- Our employees, independent contractors, principal investigators, CROs, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
- Our current and future relationships with healthcare professionals, principal investigators, consultants, customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to penalties.
- Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.
- Governments outside the United States tend to impose strict price controls, which may affect our revenue, if any.
- Risks Related to Ownership of Our Common Stock
- The trading price of the shares of our common stock may be volatile, and purchasers of our common stock could incur substantial losses.
- If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
- The issuance of additional stock and other equity-linked securities in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.
- If we fail to meet all applicable requirements of Nasdaq and Nasdaq determines to delist our common stock, the delisting could adversely affect the market liquidity of our common stock and the market price of our common stock could decrease.
- If a significant number of our shares are sold into the market, it could cause the market price of our common stock to drop significantly, even if our business is doing well.
- Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for certain litigation that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- We are a “smaller reporting company” and as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors.
- We have broad discretion in the use of our cash and cash equivalents and may invest or spend our cash in ways with which investors do not agree.
- Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be the sole source of gains and investors may never receive a return on their investment.
- General Risk Factors
- If our information technology systems or those third parties upon which we rely 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.
- 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.
- The 2017 comprehensive tax reform bill, as modified by the CARES Act, the Inflation Reduction Act, and possible future changes in tax laws or regulations could adversely affect our business and financial condition.
- Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
- We plan to use potential future operating losses and our federal and state NOL carryforwards to offset future taxable income, if any. However, our ability to use existing NOL carryforwards could be limited as a result of issuances of equity securities.
- If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
- We incur significant costs and demands upon management as a result of being a public company.
- Climate change, extreme weather events, earthquakes and other natural disasters could adversely affect our business.
- Adverse global economic conditions and geopolitical tensions could have a negative effect on our business, results of operations and financial condition and liquidity.
Legal proceedings
We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results or financial condition.
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.
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- 17SEC EDGARThomas Ciulla, Chief Medical Officer
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- 20SEC EDGARAnthony S. Gibney, Board member
- 21SEC EDGARBenjamin R. Yerxa, Board member
- 22SEC EDGARNancy J. Hutson, Board member
- 23SEC EDGARJeffrey L. Edwards, Board member
- 24SEC EDGARGeorge M. Lasezkay, Board member
- 25SEC EDGARChristy L. Shaffer, Board member
- 26SEC EDGARClay Thorp, Board member
- 27SEC EDGARDerek Yoon, Board member
- 28SEC EDGAREvgeny Zaytsev, Board member
- 29SEC EDGARGerald D. Cagle, Board member
- 30SEC EDGARRichard Croarkin, Board member
- 31SEC EDGARWilliam D. Humphries, Board member
- 32SEC EDGARBihua Chen, Board member
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- 34SEC EDGARListing notice or transfer
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- 36SEC EDGAROther events
- 37SEC EDGARBylaws or fiscal year changed
- 38SEC EDGARBylaws or fiscal year changed
- 39SEC EDGAREntered a material agreement
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- 44SEC EDGARResults of operations
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