Clearside Biomedical, Inc. (NASDAQ:CLSD) Q4 2021 Results Conference Call March 10, 2022 4:30 PM ET Company Participants Jenny Kobin - Investor Relations George Lasezkay - Chief Executive Officer Dr. Thomas Ciulla - Chief Medical Officer and Chief Development Officer Charlie Deignan - Chief Financial Officer Conference Call Participants Annabel Samimy - Stifel Andreas Argyrides - Wedbush Zegbeh Jallah - ROTH Capital Partners Rohit Basin - Needham Jon Wolleben - JMP Securities Operator Good day. Thank you for ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to __________ | --- | --- | --- | |-------------------------------------------------------------------------------------------------------------------------- ...

Clearside Biomedical, Inc. (NASDAQ:CLSD) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Jenny Kobin - Investor Relations George Lasezkay - Chief Executive Officer Thomas Ciulla - Chief Medical Officer and Chief Development Officer Charlie Deignan - Chief Financial Officer Conference Call Participants Annabel Samimy - Stifel Yi Chen - H.C. Wainwright Andreas Argyrides - Wedbush Jon Wolleben - JMP Securities Zegbeh Jallah - ROTH Capital Partners Operator Good day. Thank you ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Large accelerated filer ☐ Accelerated filer ☐ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37783 Clearside Biomedical, Inc. (Exact Name of Registrant as Specified in its Charter) Securities registered pur ...

Clearside Biomedical, Inc. (NASDAQ:CLSD) Q2 2021 Earnings Conference Call August 10, 2021 4:30 PM ET Company Participants Jenny Kobin - Investor Relations George Lasezkay - Chief Executive Officer Thomas Ciulla - Chief Medical Officer and Chief Development Officer Charlie Deignan - Chief Financial Officer Conference Call Participants Zegbeh Jallah - ROTH Capital Partners Annabel Samimy - Stifel Andreas Argyrides - Wedbush Securities Yi Chen - H.C. Wainwright Jon Wolleben - JMP Securities Serge Belanger - Ne ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37783 | --- | --- | |---------------------------------------------------------------------------------|----------------------------------------| | Clearside Biomedi ...

Clearside Biomedical, Inc. (NASDAQ:CLSD) Q1 2021 Earnings Conference Call May 17, 2021 4:30 PM ET Company Participants Jenny Kobin - Head of Investor Relations George Lasezkay - President, Chief Executive Officer Thomas Ciulla - Chief Medical Officer and Chief Development Officer Charles Deignan - Chief Financial Officer Conference Call Participants Zegbeh Jallah - ROTH Capital Partners, LLC Annabel Samimy - Stifel, Nicolaus & Company, Inc. Andreas Argyrides - Wedbush Securities Inc. Serge Belanger - Needha ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Emerging growth company ☒ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37783 Clearside Biomedical, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 45-2437375 (State or other jurisdiction ...

Part I [Business](index=5&type=section&id=Item%201.%20Business) Clearside Biomedical develops treatments for back-of-the-eye diseases using its SCS Microinjector, advancing internal pipeline candidates and leveraging collaborations [Overview and Technology Platform](index=5&type=section&id=Item%201.%20Business-Overview%20and%20Technology%20Platform) Clearside utilizes its proprietary SCS Microinjector platform for non-surgical, targeted drug delivery to the suprachoroidal space, aiming to improve treatment for back-of-the-eye diseases - Clearside is a biopharmaceutical company developing treatments for serious back-of-the-eye diseases using its **proprietary SCS Microinjector** to target the suprachoroidal space (SCS)[25](index=25&type=chunk) - The suprachoroidal injection platform is a novel, patented method for **targeted, non-surgical, in-office drug delivery**, potentially offering lower administration frequency and improved safety[27](index=27&type=chunk)[28](index=28&type=chunk) - The company's intellectual property includes **22 issued U.S. patents** and **over 50 international patents** covering the SCS Microinjector device, administration methods, and product candidates[28](index=28&type=chunk) [Pipeline and Collaborations](index=7&type=section&id=Item%201.%20Business-Pipeline%20and%20Collaborations) Clearside pursues internal development, led by CLS-AX for wet AMD, and external collaborations, including licensing XIPERE™ to Bausch and Arctic Vision, leveraging its SCS Microinjector platform - The internal pipeline focuses on small molecules and gene therapy, with **CLS-AX for wet AMD** as the most advanced program in a Phase 1/2a clinical trial[33](index=33&type=chunk)[34](index=34&type=chunk) - Multiple external collaborations, including partnerships with **Bausch, REGENXBIO, Aura Biosciences, and Arctic Vision**, validate the SCS Microinjector platform[37](index=37&type=chunk) - Through license agreements, Clearside received **$11.1 million in upfront payments** and is eligible for **over $200 million in potential future milestones** plus royalties[37](index=37&type=chunk) [XIPERE (triamcinolone acetonide suprachoroidal injectable suspension)](index=8&type=section&id=Item%201.%20Business-XIPERE%20(triamcinolone%20acetonide%20suprachoroidal%20injectable%20suspension)) XIPERE, for uveitic macular edema, is awaiting NDA resubmission to the FDA in Q2 2021 after addressing manufacturing issues, with commercial rights licensed to Bausch and Arctic Vision - XIPERE is being developed for macular edema associated with uveitis, affecting approximately **350,000 patients in the U.S.**[39](index=39&type=chunk) - Following a **Complete Response Letter (CRL)** in October 2019, Clearside expects to resubmit the XIPERE NDA in **Q2 2021**, with an anticipated six-month FDA review[40](index=40&type=chunk)[42](index=42&type=chunk) - The Phase 3 PEACHTREE trial met its primary endpoint, with **47% of XIPERE-treated patients gaining at least 15 letters in visual acuity** at 24 weeks (p<0.001)[47](index=47&type=chunk) - Commercial rights are licensed to **Bausch for the U.S. and Canada** (up to **$71 million in milestones**) and to **Arctic Vision for Greater China and South Korea** (up to **$35.5 million in upfront and milestone payments**), plus royalties[44](index=44&type=chunk)[45](index=45&type=chunk) [CLS-AX (axitinib injectable suspension)](index=11&type=section&id=Item%201.%20Business-CLS-AX%20(axitinib%20injectable%20suspension)) CLS-AX, a proprietary axitinib suspension for wet AMD, is Clearside's lead internal candidate, with its Phase 1/2a OASIS trial enrolling patients and initial safety data expected mid-2021 - CLS-AX is a proprietary suspension of **axitinib, a pan-VEGF inhibitor**, being developed as a long-acting therapy for wet AMD[49](index=49&type=chunk) - The FDA accepted the IND for CLS-AX in **August 2020**, and the Phase 1/2a OASIS clinical trial enrolled its first patient in **January 2021**[50](index=50&type=chunk) - Patient dosing for the first cohort of the OASIS trial was completed in **March 2021**, with initial safety data expected in **mid-2021**[51](index=51&type=chunk) [Competition](index=13&type=section&id=Item%201.%20Business-Competition) Clearside faces intense competition from larger pharmaceutical companies, with XIPERE competing against existing corticosteroids and CLS-AX against established anti-VEGF therapies and other TKIs - XIPERE faces competition from other corticosteroids, including off-label Kenalog and approved products like **Triesence, OZURDEX, Retisert, and Yutiq**[59](index=59&type=chunk)[60](index=60&type=chunk) - CLS-AX will compete against established anti-VEGF therapies for wet AMD, such as **Lucentis, Eylea, and Beovu**, and other TKIs in development[62](index=62&type=chunk)[63](index=63&type=chunk) - Many competitors possess significantly **greater financial, R&D, manufacturing, and marketing resources** than Clearside[64](index=64&type=chunk) [Intellectual Property](index=14&type=section&id=Item%201.%20Business-Intellectual%20Property) Clearside's success relies on a robust IP portfolio, including 22 U.S. and over 60 foreign patents covering SCS delivery technology, with expirations between 2027 and 2041, and key licenses from Emory and Georgia Tech - The company's worldwide patent estate includes **22 granted U.S. patents** and **61 issued foreign patents**, covering devices, SCS administration methods, and therapeutic candidates[67](index=67&type=chunk) - Patents for SCS delivery technology, drug candidates, and therapeutic uses are expected to expire between **2027 and 2041**, excluding potential extensions[69](index=69&type=chunk) - Clearside holds an exclusive worldwide license from **Emory University and Georgia Tech Research Corporation** for key microinjector drug delivery patents, requiring annual fees and future royalties[74](index=74&type=chunk)[75](index=75&type=chunk) [Government Regulation](index=16&type=section&id=Item%201.%20Business-Government%20Regulation) Clearside's combination products are extensively regulated by the FDA, primarily as drugs, pursuing the 505(b)(2) NDA pathway for XIPERE, and are subject to ongoing post-approval, healthcare, and reimbursement regulations - The company's product candidates are regulated as **combination products**, with the FDA's **CDER** having primary jurisdiction[81](index=81&type=chunk) - Clearside is pursuing the **Section 505(b)(2) NDA pathway for XIPERE**, allowing reliance on prior FDA findings and potentially reducing required studies[99](index=99&type=chunk)[101](index=101&type=chunk) - The business is subject to numerous federal and state laws, including the **Anti-Kickback Statute, False Claims Act, HIPAA**, and transparency laws like the **Physician Payments Sunshine Act**[112](index=112&type=chunk)[113](index=113&type=chunk)[125](index=125&type=chunk) - Commercial success depends on adequate coverage and reimbursement from third-party payors, with a **Category III CPT code for suprachoroidal injection** effective since 2017[129](index=129&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) Clearside faces significant risks including substantial financial losses, going concern uncertainty, high development risks for novel technology, heavy reliance on third-party manufacturing and commercialization partners, regulatory delays, intense competition, and intellectual property challenges - The company has a history of significant losses (**$18.2 million in 2020**) and expects future losses, raising substantial doubt about its ability to continue as a going concern without additional capital[149](index=149&type=chunk)[154](index=154&type=chunk) - The novel suprachoroidal injection approach may fail to gain market acceptance from physicians, patients, or payors[165](index=165&type=chunk) - Clearside is dependent on **Bausch's commercialization efforts** for XIPERE in the U.S. and Canada, with potential material harm if Bausch terminates the agreement due to lack of FDA approval by **August 31, 2021**[188](index=188&type=chunk)[192](index=192&type=chunk) - The company relies on **third-party CMOs** for product manufacturing, and their failure to comply with cGMP or pass FDA inspections could significantly delay or prevent product approval[202](index=202&type=chunk)[207](index=207&type=chunk) - The **COVID-19 pandemic** could adversely impact business operations, potentially delaying clinical trials due to hospital resource prioritization and disruptions to patient enrollment[183](index=183&type=chunk) [Properties](index=58&type=section&id=Item%202.%20Properties) Clearside leases approximately **20,000 square feet** of office space in Alpharetta, Georgia, with a lease term until September 2023 and a five-year renewal option - The company leases approximately **20,000 square feet of office space** in Alpharetta, Georgia for its principal offices[355](index=355&type=chunk) - The current lease term extends until **September 2023**, with an option to renew for an additional **five-year term**[355](index=355&type=chunk) [Legal Proceedings](index=58&type=section&id=Item%203.%20Legal%20Proceedings) As of the report date, Clearside Biomedical is not a party to any material legal proceedings and is unaware of any pending or threatened actions that would materially affect its business - The company is not currently a party to any **material legal proceedings**[357](index=357&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=58&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Clearside Biomedical's common stock trades on Nasdaq under "CLSD", with **57,422,475 shares outstanding** as of March 10, 2021, and no plans for future cash dividends - The company's common stock is listed on **The Nasdaq Global Market** under the ticker symbol **"CLSD"**[360](index=360&type=chunk) - The company has never declared or paid dividends and does not plan to in the foreseeable future[361](index=361&type=chunk) - As of **March 10, 2021**, there were **57,422,475 shares of common stock outstanding**[362](index=362&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=59&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Clearside reported a **net loss of $18.2 million** in 2020, driven by increased license revenue and reduced G&A expenses, but faces substantial doubt about its going concern ability with cash expected to fund operations into Q1 2022 [Results of Operations](index=64&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Results%20of%20Operations) In 2020, revenue increased to **$7.9 million** from license agreements, while R&D expenses slightly decreased to **$15.1 million**, and G&A expenses significantly fell to **$10.8 million**, resulting in a **net loss of $18.2 million** Results of Operations (in thousands) | | Year Ended December 31, 2020 | Year Ended December 31, 2019 | Period-to-Period Change | |:---|---:|---:|---:| | License and other revenue | $7,894 | $2,173 | $5,721 | | **Operating expenses:** | | | | | Research and development | 15,073 | 15,658 | (585) | | General and administrative | 10,756 | 16,819 | (6,063) | | Total operating expenses | 25,829 | 32,477 | (6,648) | | Loss from operations | (17,935) | (30,304) | 12,369 | | Other expense | (275) | (466) | 191 | | **Net loss** | **$(18,210)** | **$(30,770)** | **$12,560** | Research and Development Expenses by Program (in thousands) | | 2020 | 2019 | 2018 | |:---|---:|---:|---:| | XIPERE (uveitis program) | $3,841 | $2,947 | $8,803 | | XIPERE (RVO program) | 84 | 2,323 | 44,432 | | CLS-AX (wet AMD program) | 2,169 | 67 | 3 | | Total program expense | 6,094 | 5,204 | 56,300 | | Unallocated | 8,979 | 10,454 | 11,991 | | **Total R&D expense** | **$15,073** | **$15,658** | **$68,291** | - General and administrative expenses decreased by **$6.1 million in 2020**, primarily due to a **$4.1 million reduction in marketing expenses** following a shift to a partnership strategy for XIPERE[407](index=407&type=chunk) [Liquidity and Capital Resources](index=65&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Liquidity%20and%20Capital%20Resources) As of December 31, 2020, Clearside had **$17.3 million in cash**, with subsequent capital raises of **$11.1 million** and **$3.3 million**, but recurring losses raise substantial doubt about its going concern ability beyond Q1 2022 - As of **December 31, 2020**, the company had cash and cash equivalents of **$17.3 million**[414](index=414&type=chunk) - Subsequent to year-end, the company raised **$11.1 million** from a registered direct offering and **$3.3 million** from its at-the-market (ATM) facility[414](index=414&type=chunk)[416](index=416&type=chunk) - Management expects existing cash and cash equivalents as of **March 15, 2021**, to fund planned operations into the **first quarter of 2022**[425](index=425&type=chunk) - Due to recurring losses and negative cash flows, management has concluded there is **substantial doubt about the company's ability to continue as a going concern**[425](index=425&type=chunk) Summary of Cash Flows (in thousands) | | 2020 | 2019 | 2018 | |:---|---:|---:|---:| | Net cash used in operating activities | $(13,120) | $(27,068) | $(79,200) | | Net cash (used in) provided by investing activities | (55) | 32,925 | (3,760) | | Net cash provided by financing activities | 7,867 | 8,695 | 81,779 | | **Net change in cash and cash equivalents** | **$(5,308)** | **$14,552** | **$(1,181)** | [Financial Statements and Supplementary Data](index=70&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The audited financial statements for 2020 report a **net loss of $18.2 million**, with total assets of **$19.3 million** and liabilities of **$10.6 million**, and the auditor's report highlights substantial doubt about the company's going concern ability [Report of Independent Registered Public Accounting Firm](index=71&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data-Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Ernst & Young LLP issued an unqualified opinion on the financial statements, including a "Going Concern" paragraph highlighting substantial doubt due to recurring losses and negative cash flows - The auditor's report contains a **"Going Concern" paragraph**, highlighting recurring losses and negative cash flows that raise substantial doubt about the company's ability to continue as a going concern[445](index=445&type=chunk) [Financial Statements](index=72&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data-Financial%20Statements) As of December 31, 2020, the company reported **$17.3 million in cash**, **$19.3 million in total assets**, **$10.6 million in total liabilities**, **$7.9 million in revenue**, and a **net loss of $18.2 million** Balance Sheet Data (in thousands) | | Dec 31, 2020 | Dec 31, 2019 | |:---|---:|---:| | Cash and cash equivalents | $17,287 | $22,595 | | Total current assets | $18,118 | $25,219 | | Total assets | $19,322 | $26,776 | | Total current liabilities | $9,943 | $10,903 | | Total liabilities | $10,559 | $15,619 | | Total stockholders' equity | $8,763 | $11,157 | Statement of Operations Data (in thousands) | | 2020 | 2019 | 2018 | |:---|---:|---:|---:| | License and other revenue | $7,894 | $2,173 | $30 | | Total operating expenses | $25,829 | $32,477 | $82,975 | | Net loss | $(18,210) | $(30,770) | $(82,818) | | Net loss per share | $(0.39) | $(0.81) | $(2.69) | [Notes to Financial Statements](index=76&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data-Notes%20to%20Financial%20Statements) Notes detail liquidity and going concern issues, ASC 606 adoption, **$5.0 million debt prepayment**, **$1.0 million PPP loan forgiveness**, and specifics of license agreements with Bausch, REGENXBIO, and Arctic Vision - The **$5.0 million upfront payment** from the Bausch license agreement remains deferred revenue as of **Dec 31, 2020**, due to FDA approval refund provisions[541](index=541&type=chunk) - The company received a **$4.0 million upfront payment from Arctic Vision** in **March 2020** and **$3.0 million in milestone payments from REGENXBIO** in **September 2020**[543](index=543&type=chunk)[545](index=545&type=chunk) - In **May 2020**, the company fully prepaid its outstanding **$5.0 million principal loan balance** plus fees[497](index=497&type=chunk) - The company received a **$1.0 million PPP loan** in **April 2020**, which was fully forgiven in **January 2021**[499](index=499&type=chunk) [Controls and Procedures](index=91&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of **December 31, 2020**, with no material changes to internal control over financial reporting during Q4 2020 - Management concluded that the company's **disclosure controls and procedures were effective** as of **December 31, 2020**[559](index=559&type=chunk) - No material changes were made to the **internal control over financial reporting** during the **fourth quarter of 2020**[560](index=560&type=chunk) Part III [Directors, Executive Compensation, Security Ownership, and Accountant Fees](index=93&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%2014) Information for Items 10-14, covering directors, executive compensation, security ownership, and accountant fees, is incorporated by reference from the company's **2021 Proxy Statement** - Information for **Part III (Items 10-14)** is incorporated by reference from the company's **2021 Proxy Statement**[567](index=567&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=94&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the Form 10-K, including key license agreements, with financial statement schedules omitted as inapplicable - This section lists all exhibits filed with the annual report, including key license agreements with **Bausch, REGENXBIO, and Arctic Vision**[573](index=573&type=chunk)[574](index=574&type=chunk) - Financial statement schedules have been omitted as inapplicable or because the information is already present in the financial statements and notes[572](index=572&type=chunk)

Clearside Biomedical, Inc. (NASDAQ:CLSD) Q4 2020 Earnings Conference Call March 10, 2021 4:30 PM ET Company Participants Jenny Kobin - Head, IR George Lasezkay - President and CEO Thomas Ciulla - CMO and Chief Development Officer Charles Deignan - CFO Conference Call Participants Andreas Argyrides - Wedbush Securities Annabel Samimy - Stifel Jonathan Wolleben - JMP Securities Operator Greetings, and welcome to the Clearside Biomedical Fourth Quarter and Year-End Financial Results and Corporate Update Confer ...