BERKELEY HEIGHTS, N.J., March 12, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on its business. Recent Corporate Highlights: On November 15, 2023, CorMedix received FDA approval for its new drug application (NDA) for ...

PART I [Business](index=9&type=section&id=Item%201.%20Business) CorMedix focuses on commercializing DefenCath, its FDA-approved antimicrobial catheter lock solution, for hemodialysis patients, with market exclusivity until 2033 and established reimbursement pathways - The company's primary focus is the U.S. commercialization of its lead product, DefenCath, an antimicrobial catheter lock solution (CLS)[26](index=26&type=chunk) - On November 15, 2023, the FDA approved the New Drug Application (NDA) for DefenCath to reduce catheter-related bloodstream infections (CRBSI) in adult kidney failure patients on hemodialysis via a central venous catheter (CVC)[28](index=28&type=chunk) - DefenCath has been granted New Chemical Entity (NCE) exclusivity until November 2028 and an additional 5-year GAIN exclusivity, extending its market protection to **November 2033**[29](index=29&type=chunk) - The company has secured a New Technology Add-On Payment (NTAP) for inpatient hospital use of DefenCath and has applied for a Transitional Drug Add-on Payment Adjustment (TDAPA) for outpatient dialysis settings, with a target implementation date of July 1, 2024[32](index=32&type=chunk)[33](index=33&type=chunk) - CorMedix relies on third-party contract manufacturing organizations (CMOs) for production and is in the process of qualifying alternative manufacturing sites and suppliers for its key active pharmaceutical ingredients (APIs)[54](index=54&type=chunk)[55](index=55&type=chunk)[57](index=57&type=chunk) [Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including operating losses, high dependence on DefenCath's commercialization, reimbursement uncertainties, market concentration, and reliance on third-party manufacturers - The company has a history of operating losses, incurring a net loss of **$46.3 million in 2023** and an accumulated deficit of **$321.7 million** as of December 31, 2023; future profitability is uncertain[118](index=118&type=chunk) - CorMedix is highly dependent on the successful commercialization of its only approved product, DefenCath; failure to successfully launch and market the product would severely limit revenue generation[123](index=123&type=chunk) - Successful commercialization hinges on obtaining adequate coverage and reimbursement from third-party payors like Medicare and private insurers; a pending TDAPA application for outpatient use is critical, and any delay or denial would adversely impact the launch[126](index=126&type=chunk)[128](index=128&type=chunk) - The outpatient dialysis market is highly concentrated, with two large providers accounting for over **70% of treatments**; failure to secure utilization from these key customers could significantly harm the commercial launch[129](index=129&type=chunk) - The company relies on single FDA-approved suppliers for its key APIs (taurolidine and heparin) and a single approved manufacturing site for the finished product, creating risks of supply chain disruption[187](index=187&type=chunk)[188](index=188&type=chunk) [Cybersecurity](index=50&type=section&id=Item%201C.%20Cybersecurity) The company manages cybersecurity threats through its Audit Committee, implementing annual employee training, threat simulations, and cyber liability insurance, with no material incidents reported - The Board's Audit Committee has primary oversight responsibility for cybersecurity risk management[227](index=227&type=chunk) - The company's cybersecurity strategy includes annual mandatory employee training, regular simulation modules, and carrying cyber liability insurance[225](index=225&type=chunk) - No cybersecurity threats or incidents have materially affected the company during the period covered by this report[226](index=226&type=chunk) [Properties](index=51&type=section&id=Item%202.%20Properties) CorMedix's principal executive office is in Berkeley Heights, New Jersey, under a seven-year lease, supplemented by a small leased office in Germany, both deemed adequate for current needs - The company's main office is in Berkeley Heights, NJ, under a seven-year lease that began in September 2020 with an average monthly cost of approximately **$17,000**[230](index=230&type=chunk) [Legal Proceedings](index=51&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its business operations - Management does not believe any current legal proceedings will have a material adverse effect on the business[232](index=232&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=52&type=section&id=Item%205.%20Market%20for%20the%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) CorMedix's common stock trades on Nasdaq under "CRMD," and the company has never paid dividends, intending to retain earnings for business growth - The company's common stock is listed on the Nasdaq Global Market under the symbol **"CRMD"**[236](index=236&type=chunk) - The company has never paid dividends and does not intend to in the foreseeable future, retaining earnings for business growth[237](index=237&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=52&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For 2023, CorMedix reported a net loss of $46.3 million, driven by increased SG&A and R&D expenses, ending the year with $76.0 million in cash, sufficient to fund operations for at least twelve months and support DefenCath's launch Selected Financial Data | | 2023 ($) | 2022 ($) | % Change | | :--- | :--- | :--- | :--- | | **Revenue** | 0 | 65,000 | (100)% | | **Research and development** | (13,155,000) | (10,680,000) | 23% | | **Selling, general and administrative** | (35,803,000) | (20,006,000) | 79% | | **Loss from operations** | (48,958,000) | (30,625,000) | 60% | | **Net loss** | (46,339,000) | (29,702,000) | 56% | - The increase in R&D expense was primarily due to higher personnel costs from increased headcount, increased medical affairs activities, and costs related to manufacturing operations for DefenCath prior to its approval[264](index=264&type=chunk) - The significant increase in SG&A expense was mainly driven by **$12.2 million** in costs for market research and pre-launch activities for DefenCath, along with a **$3.7 million** increase in personnel expenses from new hires in preparation for the launch[265](index=265&type=chunk) - Net cash used in operating activities increased to **$38.4 million in 2023** from **$24.4 million in 2022**, driven by the higher net loss and increased operating expenses for DefenCath's pre-launch activities[272](index=272&type=chunk) - The company raised net proceeds of **$42.9 million** from a public offering and **$12.9 million** from its ATM program in 2023; as of December 31, 2023, cash, cash equivalents, and short-term investments totaled **$76.0 million**[271](index=271&type=chunk)[275](index=275&type=chunk) - Management estimates that current cash is sufficient to fund operations for at least twelve months and support the commercial launch of DefenCath through to anticipated profitability, assuming a launch in Q2 2024[279](index=279&type=chunk) [Controls and Procedures](index=59&type=section&id=Item%209A.%20Controls%20and%20Procedures) The CEO and CFO concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with no material changes reported - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period[286](index=286&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023, based on the COSO framework[293](index=293&type=chunk) PART III [Directors, Executive Officers, and Corporate Governance](index=61&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) The report details the company's directors and executive officers, noting that most directors are independent and the Board maintains key committees with independent members - The Board of Directors consists of seven members, with Myron Kaplan serving as Chairman of the Board[299](index=299&type=chunk)[303](index=303&type=chunk) - The Board has determined that all directors are independent under Nasdaq rules, with the exception of CEO Joseph Todisco[309](index=309&type=chunk) - The Board has established Audit, Compensation, and Nominating and Governance committees, all composed of independent directors[310](index=310&type=chunk) [Executive Compensation](index=67&type=section&id=Item%2011.%20Executive%20Compensation) Non-employee directors receive cash and stock options, while CEO Joseph Todisco's 2023 total compensation was approximately $2.46 million, with executive agreements including severance provisions Executive Compensation Summary | Name and Principal Position | Year | Salary ($) | Option Awards ($) | Non-equity Incentive Plan Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | **Joseph Todisco**, CEO | 2023 | 616,962 | 1,388,400 | 401,700 | 2,459,342 | | **Matthew David**, CFO | 2023 | 389,135 | 433,875 | 156,000 | 1,031,150 | | **Erin Mistry**, CCO | 2023 | 389,577 | 694,200 | 156,800 | 1,240,577 | | **Phoebe Mounts**, Former General Counsel | 2023 | 375,000 | 433,875 | 112,500 | 1,254,582 | - Non-employee directors receive an annual cash fee of **$55,000**, additional fees for chair and committee roles, and an annual grant of **20,000 stock options** (increased to **30,000** in March 2024)[330](index=330&type=chunk)[331](index=331&type=chunk) - CEO Joseph Todisco's employment agreement provides for an annual salary of **$618,000** and a target bonus of **65% of base salary**[336](index=336&type=chunk) - Executive employment agreements contain severance provisions, including salary continuation (**12 months for the CEO**) and accelerated equity vesting upon termination without cause or for good reason, with enhanced benefits following a corporate transaction[342](index=342&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=74&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 7, 2024, directors and executive officers collectively owned 4.8% of common stock, with Blackrock and Nomura as major institutional shareholders, and the company maintains an equity compensation plan - As of March 7, 2024, **Blackrock, Inc.** was the largest beneficial owner with **6.4%** of common stock, followed by **Nomura Global Financial Products, Inc.** with **5.4%**[359](index=359&type=chunk) - All current executive officers and directors as a group beneficially owned approximately **2.73 million shares**, representing **4.8%** of the outstanding common stock[359](index=359&type=chunk) Equity Compensation Plan Information | Plan Category | Securities to be issued upon exercise (a) | Weighted average exercise price (b) | Securities remaining available for future issuance (c) | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 6,365,243 | $5.44 | 3,108,929 | [Principal Accounting Fees and Services](index=77&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) For 2023, CorMedix paid Marcum LLP $225,225 in audit fees, an increase from 2022, with all services pre-approved by the Audit Committee Audit Fees | Fee Type | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Audit Fees (Marcum LLP) | 225,225 | 127,000 | | Audit Fees (Friedman LLP) | 0 | 42,400 | | **Total** | **225,225** | **169,400** | - All audit and permissible non-audit services provided by the independent registered public accounting firm were pre-approved by the Audit Committee[367](index=367&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=78&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section provides an index of consolidated financial statements and all exhibits filed with the Form 10-K, including various corporate and contractual documents - This section contains the index of financial statements and a list of all exhibits filed with the Form 10-K[370](index=370&type=chunk)[371](index=371&type=chunk) Financial Statements [Consolidated Financial Statements](index=84&type=section&id=Consolidated%20Financial%20Statements) The 2023 consolidated financial statements show a net loss of $46.3 million, increased assets and liabilities, and higher stockholders' equity, reflecting financing activities Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term investments | $76,031 | $58,792 | | Total Assets | $82,060 | $62,038 | | Total Liabilities | $11,918 | $6,979 | | Total Stockholders' Equity | $70,142 | $55,060 | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenue | $0 | $65 | | Loss From Operations | $(48,958) | $(30,624) | | Net Loss | $(46,339) | $(29,702) | | Net Loss Per Share | $(0.91) | $(0.74) | [Notes to Consolidated Financial Statements](index=88&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, liquidity, ongoing securities litigation, 2023 financing proceeds, and the full valuation allowance against deferred tax assets - The company's existing cash, cash equivalents, and short-term investments are expected to fund operations for at least twelve months from the report's issuance date[415](index=415&type=chunk) - The company is a defendant in a consolidated securities class action lawsuit and shareholder derivative lawsuits alleging false and misleading statements related to the DefenCath NDA submission process; the company intends to vigorously contest these claims[466](index=466&type=chunk)[467](index=467&type=chunk) - In 2023, the company raised approximately **$42.9 million (net)** from a public offering of common stock and pre-funded warrants, and **$12.9 million (net)** from its ATM program[478](index=478&type=chunk)[481](index=481&type=chunk) - The company maintains a full valuation allowance of **$70.8 million** against its net deferred tax assets as of December 31, 2023, as it is more likely than not that these assets will not be realized[456](index=456&type=chunk)[462](index=462&type=chunk) - Upon FDA approval of DefenCath, costs related to manufacturing inventory are capitalized; inventory previously expensed as R&D prior to approval amounted to **$6.4 million**[432](index=432&type=chunk)

CORMEDIX INC. REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Berkeley Heights, NJ – March 12, 2024 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on its business. ● On November 15, 2023, CorMedix re ...

BERKELEY HEIGHTS, N.J., March 06, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2023, before the market opens on Tuesday, March 12, 2024, and will host a corporate update conference call at 8:30am Eastern Time.  Tuesday, ...

BERKELEY HEIGHTS, N.J., March 06, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2023, before the market opens on Tuesday, March 12, 2024, and will host a corporate update conference call at 8:30am Eastern Time.  Tuesday, ...

BERKELEY HEIGHTS, N.J., Jan. 30, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced updates related to its business and anticipated launch of DefenCath®. Recent Updates: On January 25, 2024 the Center for Medicare & Medicaid Services (CMS) notified CorMedix that the agency has determined DefenCath will be eligible for reim ...

CorMedix Inc. (NASDAQ:CRMD) Q3 2023 Earnings Conference Call November 14, 2023 4:30 PM ET Company Participants Daniel Ferry - LifeSci Advisors Joseph Todisco - CEO Matt David - EVP and CFO Phoebe Mounts - EVP and General Counsel Conference Call Participants Jason Butler - JMP Securities Leszek Sulewski - Truist Securities Gregory Renza - RBC Capital Markets Operator Good afternoon, and welcome to CorMedix Third Quarter 2023 Earnings Conference Call. Today's call is being recorded. [Operator Instructions] At ...

As previously agreed with the FDA, an interim efficacy analysis was performed when the first 28 potential CRBSI cases were identified in our LOCK-IT-100 study that occurred through early December 2017. Based on these first 28 cases, there was a highly statistically significant 72% reduction in CRBSI by DefenCath relative to the active control of heparin (p=0.0034). Because the prespecified level of statistical significance was reached for the primary endpoint and efficacy had been demonstrated with no safet ...

CorMedix Inc. (NASDAQ:CRMD) Q2 2023 Earnings Conference Call August 8, 2023 8:30 AM ET Company Participants Daniel Ferry - LifeSci Advisors Joseph Todisco - Chief Executive Officer Matt David - Executive Vice President and Chief Financial Officer Phoebe Mounts - Executive Vice President and General Counsel Elizabeth Hulbert - EVP, Clinical and Medical Affairs Erin Mistry - Executive Vice President and Chief Commercial Officer Conference Call Participants Jason Butler - JMP Securities Joon Lee - Truist Secur ...

PART I [Item 1. Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) CorMedix Inc.'s H1 2023 unaudited financials show decreased assets, zero revenue, and a widened net loss, reflecting pre-revenue DefenCath focus [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$57.0 million** by June 30, 2023, from **$62.0 million** at year-end 2022, primarily due to reduced cash Condensed Consolidated Balance Sheet Data (in thousands) | Metric | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $19,700 | $43,148 | | Short-term investments | $32,701 | $15,644 | | Total current assets | $54,625 | $59,551 | | Total Assets | $57,033 | $62,038 | | **Liabilities & Equity** | | | | Total current liabilities | $7,387 | $6,311 | | Total Liabilities | $7,982 | $6,979 | | Total Stockholders' Equity | $49,051 | $55,060 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Zero revenue for Q2 and H1 2023, with operating expenses rising significantly, led to a **48-49% increase** in net losses year-over-year Statement of Operations Highlights (in thousands) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $0 | $21 | $0 | $29 | | Total Operating Expenses | ($11,805) | ($8,261) | ($22,822) | ($15,300) | | Loss From Operations | ($11,805) | ($8,240) | ($22,822) | ($15,273) | | Net Loss | ($11,274) | ($7,605) | ($21,841) | ($14,639) | | Net Loss Per Share | ($0.25) | ($0.19) | ($0.49) | ($0.38) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to **$19.0 million** for H1 2023, with a **$23.5 million** net decrease in cash despite **$12.6 million** from financing activities Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($18,966) | ($12,206) | | Net cash used in investing activities | ($17,073) | ($3,593) | | Net cash provided by financing activities | $12,551 | $11,415 | | **Net Decrease in Cash** | **($23,486)** | **($4,398)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail DefenCath focus, sufficient liquidity for twelve months including July 2023 offering proceeds, and ongoing legal proceedings related to NDA submissions - The company believes existing cash, short-term investments, and July 2023 public offering proceeds are sufficient to fund operations for at least **twelve months** from the filing date[81](index=81&type=chunk) - A consolidated class action lawsuit alleges securities law violations related to allegedly false statements about DefenCath NDA submissions[147](index=147&type=chunk) - In July 2023, a public offering and underwriters' option exercise raised approximately **$43.2 million** in net proceeds[171](index=171&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses DefenCath's regulatory progress, including NDA resubmission, and financial performance, noting zero revenue, increased losses, and sufficient liquidity for future operations [Overview](index=25&type=section&id=Overview) The company focuses on DefenCath development, resubmitting its NDA in May 2023 with an FDA target review date of November 15, 2023, and securing a conditional NTAP from CMS - CorMedix resubmitted the NDA for DefenCath on **May 15, 2023**, addressing prior manufacturing deficiencies[212](index=212&type=chunk) - The FDA accepted the NDA resubmission as a Class 2 response, setting a target action date of **November 15, 2023**[212](index=212&type=chunk) - CMS included a New Technology Add-On Payment (NTAP) of up to **$17,111** per hospital stay for DefenCath in its 2024 proposed rule, conditional on FDA approval before **July 1, 2024**[243](index=243&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Zero revenue for Q2 and H1 2023 due to discontinued Neutrolin sales, while R&D and SG&A expenses significantly increased by **49%** and **49%** respectively, widening the net loss Comparison of Operating Results (in thousands) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $0 | $21 | $0 | $29 | | R&D Expense | ($4,795) | ($3,209) | ($8,202) | ($5,497) | | SG&A Expense | ($7,010) | ($5,052) | ($14,620) | ($9,803) | | Net Loss | ($11,274) | ($7,605) | ($21,841) | ($14,639) | - The **49%** increase in R&D expense for the six months ended June 30, 2023 was driven by higher costs for DefenCath manufacturing (**$915k**), personnel expenses (**$1.06M**), and medical affairs activities (**$542k**)[11](index=11&type=chunk) - The **49%** increase in SG&A expense for the six months ended June 30, 2023 was primarily due to market research and pre-launch activities for DefenCath (**$3.65M**) and increased personnel costs (**$937k**)[12](index=12&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company held **$52.4 million** in cash and investments, with **$19.0 million** net cash used in operations, but believes current resources and July 2023 offering proceeds are sufficient for twelve months - Total cash on hand and short-term investments was **$52.4 million** as of **June 30, 2023**, compared to **$58.8 million** at **December 31, 2022**[18](index=18&type=chunk) - Net cash used in operating activities increased by **$6.8 million** to **$19.0 million** for the six months ended **June 30, 2023**, compared to the same period in 2022, primarily due to a higher net loss[17](index=17&type=chunk) - Management estimates that current cash resources, plus net proceeds from the July 2023 public offering, will fund operations for at least **twelve months** from the filing date and support the DefenCath launch to anticipated profitability[231](index=231&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company's market risk is primarily limited to interest rate fluctuations on its **$52.4 million** cash and investment portfolio, with no material impact expected from interest rate changes - The company's primary market risk exposure is from interest rate fluctuations on its portfolio of cash, cash equivalents, and short-term investments[234](index=234&type=chunk) - As of **June 30, 2023**, the company held **$52.4 million** in cash, cash equivalents, and short-term investments[21](index=21&type=chunk) - Management does not believe the company is materially exposed to changes in interest rates and estimates a **1%** unfavorable change would not have a material effect on interest expense[21](index=21&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2023, the CEO and CFO concluded that disclosure controls and procedures are effective, with no material changes to internal control over financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that as of **June 30, 2023**, the company's disclosure controls and procedures were effective[29](index=29&type=chunk) - No changes were made to the company's internal control over financial reporting during the quarter ended **June 30, 2023**, that materially affected or are likely to materially affect internal controls[271](index=271&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) Details on the company's legal proceedings are incorporated by reference from Note 4, 'Commitments and Contingencies,' within the financial statements - Details on legal proceedings are incorporated by reference from Note 4 of the financial statements in Part I, Item 1 of this report[237](index=237&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This report updates risk factors from the Annual Report on Form 10-K for the year ended December 31, 2022, covering financial position, product development, industry, intellectual property, and third-party dependence - The report updates risk factors from the Annual Report on Form 10-K for the year ended **December 31, 2022**, and should be read in conjunction with it[24](index=24&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2023 - No director or officer adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" during the three months ended **June 30, 2023**[26](index=26&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) The report includes an exhibit index listing all filed documents, including Pre-Funded Warrant forms, Sarbanes-Oxley certifications, and Inline XBRL documents - The exhibit index is incorporated by reference, listing certifications and XBRL data files as exhibits[33](index=33&type=chunk)