Quince Therapeutics(QNCX) - 2021 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION This section presents Cortexyme, Inc.'s unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations Item 1. Financial Statements (Unaudited) This section presents Cortexyme, Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes. The financial data reflects the company's ongoing net losses, increased operating expenses, and a decrease in total stockholders' equity, while also detailing its liquidity position and significant accounting policies Condensed Consolidated Balance Sheets This section provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity at specific points in time Condensed Consolidated Balance Sheets (In thousands) | Metric | June 30, 2021 (In thousands) | December 31, 2020 (In thousands) | | :-------------------------------- | :------------ | :---------------- | | Total Assets | $161,390 | $189,466 | | Total Liabilities | $19,310 | $17,204 | | Total Stockholders' Equity | $142,080 | $172,262 | | Accumulated Deficit | $(191,494) | $(146,654) | - Total assets decreased by $28,076k (14.8%) from December 31, 2020, to June 30, 2021[10] - Total liabilities increased by $2,106k (12.2%) from December 31, 2020, to June 30, 2021[10] - Total stockholders' equity decreased by $30,182k (17.5%) from December 31, 2020, to June 30, 2021, primarily due to the accumulated deficit[10] Condensed Consolidated Statements of Operations and Comprehensive Loss This section outlines the company's financial performance over specific periods, highlighting revenue, operating expenses, and net loss Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except per share amounts) | Metric | Three Months Ended June 30, 2021 (In thousands) | Three Months Ended June 30, 2020 (In thousands) | Six Months Ended June 30, 2021 (In thousands) | Six Months Ended June 30, 2020 (In thousands) | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $14,719 | $14,086 | $31,543 | $28,467 | | General and administrative | $7,064 | $4,185 | $13,553 | $7,662 | | Total operating expenses | $21,783 | $18,271 | $45,096 | $36,129 | | Net loss | $(21,754) | $(17,612) | $(44,840) | $(34,788) | | Net loss per share - basic and diluted | $(0.74) | $(0.60) | $(1.52) | $(1.21) | - Net loss increased by 23.5% for the three months ended June 30, 2021, and by 28.9% for the six months ended June 30, 2021, compared to the respective prior year periods[13] - Total operating expenses increased by 19.2% for the three months and 24.8% for the six months ended June 30, 2021, primarily driven by higher general and administrative costs[13] Condensed Consolidated Statements of Stockholders' Equity This section details changes in the company's equity accounts, including common stock, additional paid-in capital, and accumulated deficit Condensed Consolidated Statements of Stockholders' Equity (In thousands, except share amounts) | Metric | Balance Dec 31, 2020 (In thousands) | Balance June 30, 2021 (In thousands) | Change (6 months) (In thousands) | | :-------------------------------- | :------------------- | :-------------------- | :------------------ | | Common Stock (Shares) | 29,543,222 | 29,655,786 | +112,564 | | Common Stock (Amount) | $29 | $30 | +$1 | | Additional Paid in Capital | $318,574 | $333,427 | +$14,853 | | Accumulated Other Comprehensive Income | $313 | $117 | -$(196) | | Accumulated Deficit | $(146,654) | $(191,494) | -$(44,840) | | Total Stockholders' Equity | $172,262 | $142,080 | -$(30,182) | - Stock-based compensation contributed $13,741k to additional paid-in capital for the six months ended June 30, 2021[19] - The accumulated deficit increased by $44,840k for the six months ended June 30, 2021, reflecting the net loss for the period[19] Condensed Consolidated Statements of Cash Flows This section presents the company's cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Consolidated Statements of Cash Flows (In thousands) | Cash Flow Activity | Six Months Ended June 30, 2021 (In thousands) | Six Months Ended June 30, 2020 (In thousands) | | :-------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(31,172) | $(25,171) | | Net cash provided by / (used in) investing activities | $37,267 | $(78,628) | | Net cash provided by financing activities | $1,113 | $118,741 | | Net increase in cash and cash equivalents | $7,208 | $14,942 | | Cash and cash equivalents at end of period | $74,049 | $66,156 | - Net cash used in operating activities increased by $6,001k (23.8%) for the six months ended June 30, 2021, compared to the prior year[21] - Investing activities shifted from using $78,628k in 2020 to providing $37,267k in 2021, primarily due to proceeds from maturities of investments[21] - Financing activities provided significantly less cash in 2021 ($1,113k) compared to 2020 ($118,741k), as the prior year included proceeds from a private placement offering[21] Notes to Unaudited Condensed Consolidated Financial Statements This section provides detailed explanations and additional information supporting the unaudited condensed consolidated financial statements Note 1. Organization This note describes Cortexyme, Inc.'s business, its focus on Alzheimer's therapeutics, and its financial position and funding needs - Cortexyme, Inc. is a clinical stage biopharmaceutical company focused on developing therapeutics for Alzheimer's disease and other degenerative disorders, targeting an infectious pathogen (P. gingivalis) and its proteases (gingipains)[24] - The company completed a Private Investment in Public Equity (PIPE) financing in February 2020, selling 2,500,000 common shares for aggregate gross proceeds of $125.0 million (net $117.6 million)[25][101] - As of June 30, 2021, the company had an accumulated deficit of $191.5 million and cash, cash equivalents, and short-term investments of $130.0 million, which it believes will fund operations for at least 12 months[26][99][102] Note 2. Summary of Significant Accounting Policies This note outlines the key accounting principles and methods used in preparing the unaudited condensed consolidated financial statements - The unaudited condensed consolidated financial statements are prepared in accordance with GAAP for interim financial information and SEC instructions on Form 10-Q, including normal recurring adjustments[29] - The company's future operating results are subject to risks and uncertainties, including clinical trial outcomes, regulatory approval, market acceptance, competition, proprietary technology, and the impact of the COVID-19 pandemic[32] - No significant changes to accounting policies occurred during the six months ended June 30, 2021, compared to the Annual Report on Form 10-K[35] - The company is evaluating ASU 2016-13, 'Financial Instruments—Credit Losses', which is effective for fiscal years beginning after December 15, 2022, for smaller reporting companies[39] Note 3. Fair Value Measurements This note details the fair value hierarchy and measurements applied to the company's financial assets and liabilities - The company measures and reports cash equivalents and investments at fair value, classifying money market funds as Level 1 and other investments (Certificates of Deposit, Repurchase Agreements, Corporate notes, Government and agency notes, Municipal notes) as Level 2[41][42] Fair Value Measurements of Financial Assets (In thousands) | Asset Type | June 30, 2021 (Total, In thousands) | December 31, 2020 (Total, In thousands) | | :------------------------ | :-------------------- | :------------------------ | | Money market funds | $47,049 | $15,661 | | Certificates of Deposit | $12,613 | $30,765 | | Repurchase Agreements | $21,000 | $15,000 | | Corporate notes | $57,749 | $75,426 | | Government and agency notes | $4,734 | $8,296 | | Municipal notes | $4,577 | $3,446 | | Total | $147,722 | $148,594 | - As of June 30, 2021, the company had total unrealized gains of $141k and unrealized losses of $(24)k on available-for-sale securities[44] Note 4. Cash, Cash Equivalents and Investments This note provides a breakdown of the company's cash, cash equivalents, and investment portfolio Cash, Cash Equivalents and Investments (In thousands) | Category | June 30, 2021 (In thousands) | December 31, 2020 (In thousands) | | :-------------------------- | :------------ | :---------------- | | Total cash and cash equivalents | $74,049 | $66,841 | | Total short-term investments | $55,901 | $66,979 | | Total long-term investments | $23,516 | $50,464 | | Grand Total | $153,466 | $184,284 | - Cash and cash equivalents increased by $7,208k (10.8%) from December 31, 2020, to June 30, 2021[48] - Long-term investments decreased significantly by $26,948k (53.4%) from December 31, 2020, to June 30, 2021[48] Note 5. Balance Sheet Components This note offers detailed breakdowns of specific balance sheet accounts, including prepaid expenses and accrued liabilities Prepaid Expenses and Other Current Assets (In thousands) | Category | June 30, 2021 (In thousands) | December 31, 2020 (In thousands) | | :-------------------------------- | :------------ | :---------------- | | Prepaid expenses | $459 | $274 | | Prepaid insurance | $2,775 | $964 | | Prepaid research and development expenses | $2,221 | $2,110 | | Other current assets | $438 | $694 | | Total | $5,893 | $4,042 | Accrued Expenses and Other Current Liabilities (In thousands) | Category | June 30, 2021 (In thousands) | December 31, 2020 (In thousands) | | :-------------------------------- | :------------ | :---------------- | | Personnel expenses | $2,082 | $2,415 | | Professional fees | $172 | $141 | | Research and development expenses | $8,368 | $10,603 | | Other | $722 | $282 | | Total | $11,344 | $13,441 | - Prepaid expenses and other current assets increased by $1,851k (45.8%) from December 31, 2020, to June 30, 2021, primarily due to prepaid insurance[49] - Accrued expenses and other current liabilities decreased by $2,097k (15.6%) from December 31, 2020, to June 30, 2021, mainly due to a reduction in accrued research and development expenses[51] Note 6. Leases This note describes the company's lease arrangements, including right-of-use assets and lease liabilities - In May 2021, the company extended its existing facility lease to July 15, 2022, and recognized an additional right-of-use asset and corresponding lease liability of $1.2 million[56] Lease Information (In thousands, except lease terms and discount rates) | Metric | June 30, 2021 (In thousands) | December 31, 2020 (In thousands) | | :-------------------------------- | :------------ | :---------------- | | Operating lease right of use asset, net | $1,496 | $674 | | Short-term operating lease liability | $699 | $238 | | Long-term operating lease liability | $773 | $208 | | Weighted average remaining lease term (Operating) | 2.1 years | 1.6 years | | Weighted average discount rate (Operating) | 1.88% | 2.10% | - Total future rent expense from all real estate operating leases is $1,435k, to be recognized over the remaining terms of 25 months as of June 30, 2021[58] Note 7. Stock-Based Compensation This note details the company's stock-based compensation plans and the associated expenses recognized - The 2019 Equity Incentive Plan has 1,149,925 shares available for future issuance as of June 30, 2021[67] Stock-Based Compensation Expense (In thousands) | Expense Category | Three Months Ended June 30, 2021 (In thousands) | Three Months Ended June 30, 2020 (In thousands) | Six Months Ended June 30, 2021 (In thousands) | Six Months Ended June 30, 2020 (In thousands) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative expense | $3,629 | $1,616 | $7,108 | $2,654 | | Research and development expense | $3,121 | $1,782 | $6,633 | $2,699 | | Total stock-based compensation | $6,750 | $3,398 | $13,741 | $5,353 | - Total stock-based compensation expense increased by 98.6% for the three months and 156.7% for the six months ended June 30, 2021, compared to the prior year periods[70] - As of June 30, 2021, total unamortized employee stock-based compensation was $71.5 million, expected to be recognized over 3.02 years[68] Note 8. Related Party Transactions This note discloses transactions between the company and its related parties, including directors and affiliated entities - In February 2020, the company sold 30,000 shares of common stock for $1.5 million to an entity affiliated with a member of its Board of Directors as part of a private placement[73] - For the six months ended June 30, 2021, the company incurred $306,000 in expenses related to consulting agreements with LifeSci Advisors, LLC, where its COO and CFO has an investment in a sister entity[74] Note 9. Income Taxes This note explains the company's income tax position, including its history of losses and deferred tax assets - The company has a history of losses and expects to record a loss in 2021, resulting in no provision for income taxes due to available net operating loss carryforwards[76][78] - A valuation allowance is provided for significant deferred tax assets as their realization is determined not likely to occur[78] - The CARES Act and CAA Act are concluded to have no material impact on the company's 2021 provision for income taxes[79] Note 10. Net Loss Per Share This note presents the calculation of basic and diluted net loss per share, including potentially dilutive securities Net Loss Per Share - Basic and Diluted | Period | 2021 | 2020 | | :-------------------------------- | :----- | :----- | | Three Months Ended June 30 | $(0.74) | $(0.60) | | Six Months Ended June 30 | $(1.52) | $(1.21) | - Potentially dilutive shares, including 4,978,919 stock options and 675,000 performance stock options as of June 30, 2021, were excluded from diluted net loss per share calculation due to their anti-dilutive effect[80] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on Cortexyme's financial condition and operational results. It highlights the company's focus as a clinical-stage biopharmaceutical entity, its lead drug candidate atuzaginstat for Alzheimer's disease with topline data expected in Q4 2021, and its pipeline for other degenerative and infectious diseases. The discussion covers the company's history of net losses, its current liquidity, and the need for future funding, alongside a detailed analysis of operating expenses and cash flows for the reported periods. It also addresses critical accounting policies and the impact of the COVID-19 pandemic Overview This section provides an executive summary of Cortexyme's business, drug development pipeline, and key operational updates - Cortexyme is a clinical stage biopharmaceutical company advancing atuzaginstat (COR388) in a pivotal Phase 2/3 GAIN trial for mild to moderate Alzheimer's patients, with topline data expected in Q4 2021[84][85] - The company's therapeutic approach targets Porphyromonas gingivalis and its gingipain proteases, which are tied to neurodegeneration and chronic inflammation in Alzheimer's disease[84][88] - Pipeline includes COR588 (second-generation gingipain inhibitor, Phase 1 in Q3 2021 for periodontal disease), COR803 (3CLpro inhibitor for coronavirus), and arginine gingipain inhibitors COR788 and COR822 (preclinical)[90][92][93] - The FDA placed a partial clinical hold on the open-label extension (OLE) phase of the GAIN trial due to hepatic adverse events, but the fully enrolled double-blind phase continues[95] - The COVID-19 pandemic has not resulted in significant hinderances to operations or material negative financial impacts, nor changes to GAIN trial analysis timelines to date[33][97] Financial Overview This section summarizes the company's financial performance, including net losses, liquidity, and future funding requirements - The company has incurred net losses since inception, with an accumulated deficit of $191.5 million as of June 30, 2021, and does not expect to be profitable in the foreseeable future[99] - Net loss for the three months ended June 30, 2021, was $21.8 million, and for the six months ended June 30, 2021, was $44.8 million[99] - As of June 30, 2021, cash, cash equivalents, and short-term investments totaled $130.0 million, which is believed to be sufficient to fund planned operations through 2023[102][103] - Substantial additional funding will be required to support continuing operations, expand the pipeline, and advance drug candidates through clinical development and commercialization[104][105] Critical Accounting Policies and Significant Judgments and Estimates This section discusses the key accounting policies and estimates that significantly impact the company's financial statements - The most significant estimates in the financial statements relate to stock-based awards, accruals for research and development costs, useful lives of long-lived assets, incremental borrowing rate for leases, and income tax uncertainties[34][107] - Accrued research and development expenditures and stock-based compensation are considered critical accounting policies[107][108] - There have been no material changes in critical accounting policies during the six months ended June 30, 2021[108] Components of Results of Operations This section defines the primary components of the company's operating expenses, including research and development and general and administrative costs - Research and development (R&D) expenses include payroll, lab supplies, licenses, consulting, contract research, regulatory, preclinical/clinical expenses, and allocated facilities costs, expensed as incurred[109] - R&D expenses are expected to increase substantially in the coming years due to existing and additional clinical trials, regulatory approval efforts for atuzaginstat, and advancement of other drug candidates[111] - General and administrative (G&A) expenses consist primarily of personnel-related costs (including stock-based compensation), professional fees, and allocated facilities costs, and are anticipated to increase with business growth[117][118] Results of Operations This section provides a comparative analysis of the company's financial results for the reported periods Comparison of the three months ended June 30, 2021 to the three months ended June 30, 2020 This section analyzes the financial performance changes between the two three-month periods, focusing on key expense categories Results of Operations (Three Months Ended June 30, In thousands) | Metric | 2021 (In thousands) | 2020 (In thousands) | Change ($ In thousands) | Change (%) | | :-------------------------- | :----- | :----- | :--------- | :--------- | | Research and development | $14,719 | $14,086 | $633 | 4.5% | | General and administrative | $7,064 | $4,185 | $2,879 | 68.8% | | Loss from operations | $(21,783) | $(18,271) | $(3,512) | 19.2% | | Interest income | $160 | $659 | $(499) | (75.7)% | | Net loss | $(21,754) | $(17,612) | $(4,011) | 22.8% | - Research and development expenses increased by $0.6 million (4.5%), driven by a $2.1 million increase in personnel-related expenses (including stock-based compensation) and $0.3 million in other R&D expenses, partially offset by a $3.1 million decrease in atuzaginstat costs[121][122][123][124] - General and administrative expenses increased by $2.9 million (68.8%), primarily due to a $2.3 million increase in employee headcount-related costs (including stock-based compensation), $0.3 million in consulting, and $0.2 million in insurance[126] Comparison of the six months ended June 30, 2021 to the six months ended June 30, 2020 This section analyzes the financial performance changes between the two six-month periods, focusing on key expense categories Results of Operations (Six Months Ended June 30, In thousands) | Metric | 2021 (In thousands) | 2020 (In thousands) | Change ($ In thousands) | Change (%) | | :-------------------------- | :----- | :----- | :--------- | :--------- | | Research and development | $31,543 | $28,467 | $3,076 | 10.8% | | General and administrative | $13,553 | $7,662 | $5,891 | 76.9% | | Loss from operations | $(45,096) | $(36,129) | $(8,967) | 24.8% | | Interest income | $387 | $1,341 | $(954) | (71.1)% | | Net loss | $(44,840) | $(34,788) | $(9,921) | 28.5% | - Research and development expenses increased by $3.1 million (10.8%), driven by a $5.7 million increase in personnel-related expenses (including stock-based compensation) and $2.3 million in COR588 and other direct research costs, partially offset by a $5.8 million decrease in atuzaginstat development costs[130][131][132][133] - General and administrative expenses increased by $5.9 million (76.9%), primarily due to a $5.3 million increase in personnel costs (including stock-based compensation), $0.4 million in consulting, and $0.2 million in insurance[134] Liquidity, Capital Resources and Plan of Operations This section assesses the company's ability to meet its short-term and long-term financial obligations and its future funding strategy - As of June 30, 2021, the company had an accumulated deficit of $191.5 million and $153.5 million in cash, cash equivalents, and investments[137] - Existing capital resources are believed to be sufficient to fund anticipated operations through at least 2023[138][143] - The company will require substantial additional capital to develop drug candidates and fund operations, potentially through equity, debt financings, or collaborative arrangements[140] Summary Statement of Cash Flows (Six Months Ended June 30, In thousands) | Activity | 2021 (In thousands) | 2020 (In thousands) | | :-------------------------- | :----- | :----- | | Operating activities | $(31,172) | $(25,171) | | Investing activities | $37,267 | $(78,628) | | Financing activities | $1,113 | $118,741 | | Net increase in cash and cash equivalents | $7,208 | $14,942 | Contractual Obligations and Commitments This section outlines the company's significant contractual obligations and future financial commitments - No material changes to contractual obligations and other commitments as of June 30, 2021, compared to the Annual Report on Form 10-K[150] - Primary contractual obligations consist of non-cancellable operating leases and other purchase obligations[150] - Accrued expenses for vendor services were approximately $8.4 million, with $10.5 million in cancellable future commitments as of June 30, 2021[151] Off-Balance Sheet Arrangements This section confirms the absence of any material off-balance sheet arrangements for the reporting periods - The company did not have any off-balance sheet arrangements during the periods presented[152] Recent Accounting Pronouncements This section refers to the notes for updates on new accounting standards relevant to the company - Refer to Note 2 of the unaudited condensed consolidated financial statements for a discussion of new accounting standards updates[153] Available information This section details where the company's public information and SEC filings can be accessed - The company's corporate website (www.cortexyme.com) serves as a routine channel for investor relations information, including news releases, presentations, and financial information[154] - SEC filings are posted on the company's website and are also available free of charge on the SEC's website (www.sec.gov)[154](index=154&type=chunk) Item 3. Quantitative and Qualitative Disclosures About Market Risk This section discusses Cortexyme's exposure to market risks, primarily interest rate sensitivities and foreign currency exchange rate risk. The company's investment strategy focuses on capital preservation and income maximization through high-credit quality, short-term duration securities. While an immediate 100 basis point change in interest rates is not expected to materially impact its investment portfolio, the company acknowledges foreign currency risk from international clinical trials but has not utilized hedging instruments. Historically, inflation, interest rate changes, or exchange rate fluctuations have not significantly affected its operations - The company is exposed to interest rate risk from its $153.5 million portfolio of cash, cash equivalents, and marketable securities as of June 30, 2021[157] - An immediate 100 basis point change in interest rates is not expected to have a material effect on the fair market value of the company's cash equivalents and marketable securities due to their short-term maturities and low-risk profile[157] - Foreign currency exchange rate risk exists due to international clinical trials (e.g., Australia), but the company has not used hedging instruments in the past or for the reported periods[158] - Inflation, interest rate changes, or exchange rate fluctuations did not have a significant impact on the company's results of operations for the three and six months ended June 30, 2021[159] Item 4. Controls and Procedures Cortexyme's management, including the Chief Executive Officer and Chief Operating Officer/Chief Financial Officer, evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2021, and concluded they were effective. No material changes in internal control over financial reporting occurred during the quarter - Disclosure controls and procedures were evaluated by management (CEO and COO/CFO) and concluded to be effective as of June 30, 2021[161] - There have been no changes in internal control over financial reporting during the quarter ended June 30, 2021, that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting[162] PART II. OTHER INFORMATION This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and exhibits Item 1. Legal Proceedings Cortexyme, Inc. is not currently involved in any material legal proceedings - The company is not currently a party to any material legal proceedings[165] Item 1A. Risk Factors This section details various risks and uncertainties that could materially and adversely affect Cortexyme's business, financial condition, and results of operations. Key risks include the company's early stage of development and lack of profitability, heavy reliance on the success of its lead drug candidate atuzaginstat, the novel and unproven nature of its therapeutic approach, the inherent challenges and uncertainties of clinical drug development (including potential adverse side effects and regulatory holds), the need for substantial additional funding, intense competition, manufacturing complexities, and regulatory compliance. Furthermore, risks related to intellectual property protection, product liability, international operations, and the ongoing impact of the COVID-19 pandemic are highlighted - Cortexyme is a clinical-stage biopharmaceutical company with a limited operating history, no approved drug candidates, no revenue from sales, and an accumulated deficit of $191.5 million as of June 30, 2021, with no expectation of profitability in the foreseeable future[169][170] - The company is substantially dependent on the success of atuzaginstat, its only clinical-stage drug candidate, which requires significant additional clinical testing and regulatory approval, with no guarantee of success[178] - The company's novel therapeutic approach targeting P. gingivalis and gingipains for Alzheimer's disease is based on limited data and exposes it to unforeseen risks, as there is no current consensus on Alzheimer's causation or effective treatments[182] - Clinical drug development is lengthy, expensive, and uncertain; results from preclinical and early clinical trials are not always predictive of future outcomes, and adverse side effects (e.g., hepatic events leading to a partial clinical hold on the GAIN trial's OLE phase) could delay or preclude approval[183][186][187][192] - Substantial additional funding will be required beyond existing capital (sufficient through 2023) to finance operations, complete development, and commercialize drug candidates, with potential for dilution or operational delays if funding is not secured[173][175][177] - The company faces significant competition from major pharmaceutical and biotechnology companies with greater resources and expertise in the highly competitive degenerative disease field[216][219] - Commercial success depends on obtaining and maintaining sufficient intellectual property protection (patents and trade secrets), which is uncertain due to complex legal and factual questions, potential challenges, and the high cost of prosecution and enforcement[285][286][297] - The COVID-19 pandemic presents ongoing risks, including potential delays in clinical trials, supply chain disruptions, and adverse impacts on financial markets and operations, despite current mitigation efforts[96][97][196][236] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds Cortexyme, Inc. reported no unregistered sales of equity securities or issuer repurchases of equity securities during the period. The planned use of proceeds from its initial public offering (IPO) remains materially unchanged from what was previously disclosed - No unregistered sales of equity securities occurred[361] - No issuer repurchases of equity securities occurred[362] - There has been no material change in the planned use of proceeds from the IPO from that described in the final prospectus filed on May 9, 2019[363] Item 3. Defaults Upon Senior Securities This item is not applicable to Cortexyme, Inc. for the reporting period - Not Applicable[364] Item 4. Mine Safety Disclosures This item is not applicable to Cortexyme, Inc. for the reporting period - Not Applicable[365] Item 5. Other Information No other information is reported under this item for the reporting period - None[366] Item 6. Exhibits This section lists all exhibits filed or furnished as part of the Quarterly Report on Form 10-Q. These include various change in control and severance agreements for key executives, a third amendment to a sub-sublease agreement, and certifications from the Chief Executive Officer and Chief Financial Officer - Exhibits include Change in Control and Severance Agreements for Casey C. Lynch, Caryn McDowell, Christopher Lowe, Leslie Holsinger, Michael Detke, and Stephen S. Dominy, M.D[369] - A Third Amendment to Sub-Sublease by and between Cortexyme, Inc. and Verily Life Sciences LLC, dated July 15, 2021, is filed[369] - Certifications of the Chief Executive Officer and Chief Financial Officer pursuant to Rules 13a-14(a), 15d-14(a), and 13a-14(b) of the Exchange Act and 18 U.S.C. Section 1350 are included[369] Signatures This section provides the official signatures of the company's authorized officers, certifying the report's contents - The report was signed on August 6, 2021, by Casey C. Lynch, President, Chief Executive Officer and Chairman, and Christopher Lowe, Chief Operating Officer and Chief Financial Officer[372]