Equillium(EQ) - 2020 Q1 - Quarterly Report

PART I FINANCIAL INFORMATION This section provides the company's financial statements and management's analysis for the reporting period ITEM 1. FINANCIAL STATEMENTS Equillium, Inc.'s condensed consolidated financial statements for Q1 2020, including balance sheets, operations, equity, and cash flows, with detailed notes Condensed Consolidated Balance Sheets A snapshot of Equillium, Inc.'s financial position, detailing assets, liabilities, and stockholders' equity as of March 31, 2020 Condensed Consolidated Balance Sheets (in thousands) | Asset/Liability Category | March 31, 2020 (Unaudited) (in thousands) | December 31, 2019 (in thousands) | | :----------------------- | :---------------------------------------- | :------------------------------- | | Total Current Assets | $49,822 | $55,431 | | Cash and cash equivalents | $20,614 | $13,219 | | Short-term investments | $27,061 | $39,924 | | Total Assets | $49,911 | $55,539 | | Total Current Liabilities | $3,711 | $3,883 | | Accounts payable | $1,801 | $1,873 | | Accrued expenses | $1,910 | $2,010 | | Long-term notes payable | $9,746 | $9,681 | | Total Liabilities | $13,565 | $13,691 | | Total Stockholders' Equity | $36,346 | $41,848 | | Accumulated deficit | $(48,949) | $(41,112) | - Total current assets decreased by $5.6 million from December 31, 2019, to March 31, 2020, primarily due to a decrease in short-term investments, partially offset by an increase in cash and cash equivalents[9] - The accumulated deficit increased by $7.8 million, from $(41,112) thousand at December 31, 2019, to $(48,949) thousand at March 31, 2020, reflecting ongoing operating losses[9] Condensed Consolidated Statements of Operations and Comprehensive Loss Presents Equillium, Inc.'s financial performance, including revenues, expenses, and net loss for the three months ended March 31, 2020 Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended March 31, 2020 (in thousands) | Three Months Ended March 31, 2019 (in thousands) | | :--------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Research and development | $4,706 | $3,759 | | General and administrative | $2,746 | $2,589 | | Total operating expenses | $7,452 | $6,348 | | Loss from operations | $(7,452) | $(6,348) | | Interest expense | $(273) | $- | | Interest income | $220 | $398 | | Other expense, net | $(332) | $- | | Net loss | $(7,837) | $(5,950) | | Comprehensive loss | $(7,384) | $(5,906) | | Net loss per share (basic & diluted) | $(0.45) | $(0.34) | - Net loss increased to $7.837 million for the three months ended March 31, 2020, from $5.950 million in the same period of 2019, driven by higher operating expenses and new interest and other expenses[12] - Research and development expenses increased by $0.947 million (25.2%) year-over-year, while general and administrative expenses increased by $0.157 million (6.1%)[12] Condensed Consolidated Statements of Stockholders' Equity Details changes in Equillium, Inc.'s stockholders' equity, including common stock, additional paid-in capital, and accumulated deficit Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Equity Item | Balance at December 31, 2019 (in thousands) | Balance at March 31, 2020 (in thousands) | | :------------------------------- | :---------------------------------------- | :--------------------------------------- | | Common Shares Outstanding | 17,425,654 | 17,683,965 | | Additional Paid-in Capital | $82,938 | $84,820 | | Accumulated Other Comprehensive Income | $21 | $474 | | Accumulated Deficit | $(41,112) | $(48,949) | | Total Stockholders' Equity | $41,848 | $36,346 | - Total stockholders' equity decreased by $5.502 million from December 31, 2019, to March 31, 2020, primarily due to the net loss of $7.837 million, partially offset by increases in additional paid-in capital from stock issuances and stock-based compensation[14] - Common shares outstanding increased by 258,311 shares during the quarter, mainly due to issuances under the ATM facility and other common stock issuances[14] Condensed Consolidated Statements of Cash Flows Summarizes Equillium, Inc.'s cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2020 Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2020 (in thousands) | Three Months Ended March 31, 2019 (in thousands) | | :------------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Net cash used in operating activities | $(6,370) | $(4,464) | | Net cash provided by (used in) investing activities | $13,005 | $(2,651) | | Net cash provided by financing activities | $775 | $- | | Net increase (decrease) in cash and cash equivalents | $7,395 | $(7,115) | | Cash and cash equivalents at end of period | $20,614 | $21,394 | - Net cash used in operating activities increased by $1.906 million year-over-year, reflecting higher operating expenses[18] - Investing activities shifted from a net cash outflow of $2.651 million in 2019 to a net cash inflow of $13.005 million in 2020, primarily due to a significant increase in maturities of short-term investments[18] - Financing activities provided $0.775 million in cash in 2020, mainly from common stock issuance under the ATM facility, compared to no financing activities in 2019[18] Notes to Condensed Consolidated Financial Statements Provides detailed explanations and disclosures regarding the accounting policies, estimates, and specific financial statement items of Equillium, Inc 1. Organization and Accounting Pronouncements Outlines Equillium, Inc.'s corporate structure, business focus, and the application of relevant accounting standards - Equillium, Inc. was incorporated in Delaware on March 16, 2017, focusing on research and development for severe autoimmune and inflammatory disorders, with itolizumab (EQ001) as its initial product candidate[21] - As of March 31, 2020, the Company had $47.7 million in cash, cash equivalents, and short-term investments, which management believes will fund operations for at least the next 12 months[23] - The Company paused enrollment in Phase 1b clinical trials for uncontrolled asthma and lupus nephritis in March 2020 due to COVID-19, but continues enrollment for the Phase 1b/2 aGVHD trial[24] 2. Summary of Significant Accounting Policies Details the key accounting principles and estimation methods used in preparing Equillium, Inc.'s financial statements - The financial statements require estimates and assumptions, particularly for clinical trial accruals and equity award valuations, which are subject to change and could materially differ from actual results[33] - Research and development expenses are accrued based on the progress of preclinical or clinical studies, determined by contract review, financial models, and discussions with personnel[34] Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share (in common stock equivalent shares) | Type of Security | 2020 | 2019 | | :------------------ | :---------- | :---------- | | Common stock options | 2,014,093 | 1,150,483 | | Common stock warrants | 80,428 | - | | Total | 2,094,521 | 1,150,483 | 3. Fair Value of Financial Instruments Describes the valuation methodologies and fair value measurements for Equillium, Inc.'s financial assets and liabilities Short-Term Investments Fair Value (March 31, 2020, in thousands) | Category | Total Fair Value | Level 1 (Quoted Prices) | Level 2 (Observable Inputs) | | :----------------------- | :--------------- | :---------------------- | :-------------------------- | | U.S. treasury securities | $18,686 | $18,686 | $- | | Agency securities | $2,005 | $- | $2,005 | | Certificates of deposit | $6,370 | $6,370 | $- | | Total | $27,061 | $25,056 | $2,005 | Short-Term Investments Fair Value (December 31, 2019, in thousands) | Category | Total Fair Value | Level 1 (Quoted Prices) | Level 2 (Observable Inputs) | | :----------------------- | :--------------- | :---------------------- | :-------------------------- | | U.S. treasury securities | $28,549 | $28,549 | $- | | Agency securities | $5,994 | $- | $5,994 | | Certificates of deposit | $5,381 | $5,381 | $- | | Total | $39,924 | $33,930 | $5,994 | - The carrying amounts of cash, prepaid assets, accounts payable, and accrued liabilities approximate fair value due to their short maturities. Long-term notes payable of $9.7 million also approximated fair value[40] 4. Certain Financial Statement Caption Information Provides disaggregated details for specific line items within Equillium, Inc.'s condensed consolidated financial statements Short-Term Investments (March 31, 2020, in thousands) | Category | Maturity (in years) | Amortized Cost | Unrealized Gains | Estimated Fair Value | | :----------------------- | :------------------ | :------------- | :--------------- | :------------------- | | U.S. treasury securities | 1 or less | $18,543 | $143 | $18,686 | | Agency securities | 1 or less | $2,000 | $5 | $2,005 | | Certificates of deposit | 1 or less | $5,840 | $36 | $5,876 | | Certificates of deposit | >1 and <5 | $490 | $4 | $494 | | Total | | $26,873 | $188 | $27,061 | Accrued Expenses (in thousands) | Category | March 31, 2020 | December 31, 2019 | | :--------------------------------- | :------------- | :---------------- | | Accrued payroll and other employee benefits | $703 | $1,215 | | Clinical studies | $934 | $442 | | Other accruals | $153 | $267 | | Preclinical studies | $49 | $15 | | Accrued interest | $71 | $71 | | Total Accrued Expenses | $1,910 | $2,010 | - Accrued expenses decreased by $100 thousand from December 31, 2019, to March 31, 2020, primarily due to a decrease in accrued payroll and other employee benefits, partially offset by an increase in clinical studies accruals[45] 5. Notes Payable Details Equillium, Inc.'s debt obligations, including terms of the loan agreement and carrying amounts - On September 30, 2019, the Company entered into a Loan and Security Agreement for up to $20.0 million in term loans, initially borrowing $10.0 million (Term A Loan)[46] - Additional Term B and Term C Loans of $5.0 million each are available upon achieving positive topline data in specific Phase 1b clinical trials for itolizumab (EQ001) in aGVHD and asthma, supporting advancement to Phase 2[48] Aggregate Carrying Amounts of Term Loans (in thousands) | Component | March 31, 2020 | December 31, 2019 | | :---------------------------------------- | :------------- | :---------------- | | Principal | $10,000 | $10,000 | | Add: accreted liability for Final Payment fee | $71 | $35 | | Less: unamortized discount | $(325) | $(354) | | Total | $9,746 | $9,681 | 6. Collaboration and License Agreement Outlines the key terms of Equillium, Inc.'s exclusive license agreement with Biocon SA for itolizumab (EQ001) - The Company has an exclusive license agreement with Biocon SA (now Biocon Limited) for itolizumab (EQ001) in the United States, Canada, Australia, and New Zealand for specific indications[59] - The agreement includes potential regulatory milestone payments up to $30 million and sales milestone payments up to $565 million, plus tiered royalties on net sales[62] - Biocon is the exclusive supplier of itolizumab clinical drug product, providing it at no cost for up to three concurrent orphan indications until the first U.S. regulatory approval[59] 7. Stockholders' Equity Provides details on Equillium, Inc.'s common stock activity, including shares outstanding and reserved for future issuance - As of March 31, 2020, the Company had 17,683,965 shares of common stock outstanding, an increase from 17,425,654 shares at December 31, 2019[63] - The Company sold 174,649 shares of common stock under its ATM facility for net proceeds of $0.8 million during the three months ended March 31, 2020[64] Common Stock Reserved for Future Issuance (Shares) | Category | March 31, 2020 | December 31, 2019 | | :---------------------------------------- | :------------- | :---------------- | | Stock options issued and outstanding | 2,014,093 | 1,821,093 | | Warrants for common stock | 80,428 | 80,428 | | Awards available under the 2018 Equity Incentive Plan | 1,491,755 | 813,473 | | Employee stock purchase plan | 677,972 | 503,716 | | Total | 4,264,248 | 3,218,710 | 8. Subsequent Events Discloses significant events that occurred after the balance sheet date but before the financial statements were issued - Effective April 22, 2020, the Board approved a repricing of outstanding options for 1,475,093 shares of common stock, lowering the exercise price to $2.45 per share to realign value and motivate employees[69][70] ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Management's analysis of Equillium, Inc.'s financial condition and results for Q1 2020, including COVID-19 impact, R&D, and liquidity Overview Provides a high-level summary of Equillium, Inc.'s business, product development, and financial performance for the period - Equillium is a clinical-stage biotechnology company developing itolizumab (EQ001), a monoclonal antibody targeting CD6, for severe autoimmune and inflammatory disorders[75] - The Company paused enrollment in Phase 1b trials for uncontrolled asthma and lupus nephritis in March 2020 due to COVID-19, but continues the Phase 1b/2 trial for acute graft-versus-host disease (aGVHD)[76] - Equillium has incurred significant operating losses since inception, with a net loss of $7.8 million for Q1 2020 and an accumulated deficit of $48.9 million as of March 31, 2020[80] Financial Overview Discusses Equillium, Inc.'s financial strategy, revenue expectations, and anticipated trends in operating expenses - The Company has not generated any revenue from product sales to date and does not expect to for several years, relying on equity offerings, debt financings, and collaboration agreements[84][82] - Research and development expenses are expected to increase substantially due to ongoing and future clinical development of itolizumab (EQ001) and potential expansion into new indications[87] - General and administrative expenses are also anticipated to rise due to expanding infrastructure and costs associated with being a public company[92] Results of Operations Analyzes Equillium, Inc.'s operating expenses, interest income, and net loss for the three months ended March 31, 2020 Operating Expenses (in thousands) | Expense Category | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | Change (YoY) | | :--------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Research and development | $4,706 | $3,759 | +$947 | | General and administrative | $2,746 | $2,589 | +$157 | | Interest expense | $273 | $- | +$273 | | Interest income | $220 | $398 | -$178 | | Other expense, net | $332 | $- | +$332 | - Research and development expenses increased by $0.9 million, primarily due to a $0.6 million increase in clinical development activities (CROs) and a $0.6 million increase in employee compensation and benefits[98] - Interest income decreased by $0.2 million due to lower average cash, cash equivalents, and short-term investment balances, as well as lower interest rates[100] Liquidity and Capital Resources Assesses Equillium, Inc.'s cash position, funding sources, and ability to meet future capital requirements - As of March 31, 2020, the Company had $20.6 million in cash and cash equivalents and $27.1 million in short-term investments, totaling $47.7 million[102] - The Company has access to up to $20.0 million in term loans, with $10.0 million already borrowed, and additional tranches contingent on achieving specific clinical milestones for itolizumab (EQ001)[104] - Management estimates that existing cash, cash equivalents, and short-term investments are sufficient to fund operations for at least the next 12 months, but future capital requirements are substantial and uncertain[108] Off-Balance Sheet Arrangements Confirms the absence of any off-balance sheet arrangements for Equillium, Inc. during the reporting period - The Company did not have any off-balance sheet arrangements or holdings in variable interest entities during the periods presented[119] ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK As a smaller reporting company, Equillium, Inc. is not required to provide market risk disclosures - The Company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[120] ITEM 4. CONTROLS AND PROCEDURES Management concluded Equillium, Inc.'s disclosure controls and procedures were effective as of March 31, 2020, with no material changes to internal control - The CEO and CFO concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2020[122] - There have been no material changes in the Company's internal control over financial reporting during the most recent fiscal quarter[123] PART II OTHER INFORMATION This section includes non-financial disclosures such as legal proceedings, risk factors, and equity security sales ITEM 1. LEGAL PROCEEDINGS Equillium, Inc. is not currently involved in any legal proceedings - The Company is not currently involved in any legal proceedings[126] ITEM 1A. RISK FACTORS Significant risks impacting Equillium, Inc.'s business, including COVID-19, product development, manufacturing, third-party reliance, and intellectual property Risks Related to Our Business and to the Development and Regulatory Approval of Itolizumab (EQ001) Discusses risks inherent in Equillium, Inc.'s business model and the clinical development and regulatory pathway for itolizumab (EQ001) - The COVID-19 pandemic has adversely impacted clinical trials, leading to paused enrollment in Phase 1b trials for asthma and lupus nephritis, and could further disrupt supply chain, personnel, and business development[128][130] - The Company has a very limited operating history, has never generated revenue, and expects significant losses for the foreseeable future, making future profitability uncertain[134][135] - Future success is highly dependent on the successful development, regulatory approval, and commercialization of its sole product candidate, itolizumab (EQ001), which is in early-stage clinical development[138][139] - Compliance with U.S. export control and economic sanctions, particularly regarding itolizumab's Cuban origin, is critical; any revocation or modification of the general license could prohibit commercialization[141][144] - Substantial additional funding is required to complete development and commercialization of itolizumab (EQ001); inability to raise capital could force delays or termination of R&D programs[149][157] - Delays in clinical trials, including those due to COVID-19 or patient enrollment challenges, could increase costs, delay revenue generation, and adversely affect commercial prospects[177][179][185] - Adverse side effects or unexpected characteristics of itolizumab (EQ001) could delay or preclude approval, limit commercial profile, or lead to significant negative consequences post-approval[188][190][194] - Data from clinical trials conducted outside the U.S. (e.g., Australia) may not be accepted by the FDA, potentially delaying development plans and increasing costs[199][200] - The Company faces substantial competition from larger pharmaceutical and biotechnology companies with greater resources and more advanced product candidates in its target indications[220][221][222] - Orphan drug designation for aGVHD does not guarantee faster development or approval, and exclusivity can be lost under certain conditions, potentially leading to earlier biosimilar competition[233] Risks Related to Manufacturing and Our Reliance on Third Parties Addresses risks associated with manufacturing itolizumab (EQ001) and dependence on third-party contract research organizations and suppliers - The Company is entirely dependent on Biocon for clinical and commercial supply of itolizumab (EQ001); manufacturing complexities, contamination risks, and regulatory compliance issues could cause delays or stoppages[235] - Reliance on third-party CROs and consultants for clinical trials and preclinical studies means the Company has limited control over their performance, potentially leading to delays, increased costs, or failure to obtain regulatory approval[239][242] - Unfavorable pricing regulations or inadequate third-party coverage and reimbursement policies could make it difficult to profitably sell itolizumab (EQ001) if approved[243][247] - Sharing trade secrets with third-party collaborators and manufacturers increases the risk of misappropriation or disclosure, potentially harming the Company's competitive position[251][253] Risks Related to Intellectual Property Covers risks concerning Equillium, Inc.'s ability to obtain, protect, and enforce its intellectual property rights for product candidates - Inability to obtain or protect broad intellectual property rights for product candidates, including itolizumab, could allow competitors to commercialize similar products, impairing the Company's market competitiveness[258][260] - The Company relies on intellectual property licensed from Biocon; termination of this license due to non-compliance with diligence obligations or other factors would result in the loss of significant rights and harm the business[270][272] - Litigation for infringing third-party intellectual property rights could be costly, time-consuming, divert resources, and potentially prevent or delay the development and commercialization of product candidates[287][288][291] - Reliance on trade secrets and proprietary know-how carries risks of disclosure or misappropriation, which could erode the Company's competitive position if not adequately protected[311][313] - Changes in patent law, such as the Leahy-Smith America Invents Act, or judicial interpretations, could diminish the value of patents and increase costs for prosecution and enforcement[304][305] Risks Related to Employee Matters and Managing Growth and Other Risks Related to Our Business Examines risks related to human resources, organizational growth, compliance, and other operational aspects of Equillium, Inc.'s business - The Company is highly dependent on key personnel, and the loss of their services could adversely affect operations[324] - Expected significant growth in employees and operations, particularly in clinical development and regulatory affairs, may be difficult to manage and could disrupt operations[325][327] - Misconduct by employees, clinical trial investigators, or other third parties, including non-compliance with regulatory standards or insider trading, could lead to significant penalties and reputational harm[332][333] - Failures or security breaches in internal IT systems or those of third parties could disrupt development programs, compromise sensitive information, and expose the Company to liability[335][336][337] - Non-compliance with health and data protection laws (e.g., HIPAA, GDPR, CCPA) could result in government enforcement actions, private litigation, and adverse publicity, negatively impacting operating results[338][341][344][345] - Adverse events like natural disasters or public health crises (e.g., COVID-19 export restrictions from India) could disrupt supply chains and clinical trials, materially affecting the business[347] - Changes in tax laws or regulations, such as the Tax Cuts and Jobs Act or the CARES Act, or limitations on net operating loss carryforwards, could adversely affect financial condition[348][349][350] - The Loan Agreement imposes restrictive covenants and events of default that could limit operating and financial flexibility, potentially requiring immediate loan repayment or cessation of operations[353][354] - Product liability lawsuits, particularly during clinical trials or commercial sales, could lead to substantial liabilities, delays, decreased demand, and reputational damage[355] - Changes in healthcare laws and policies, including the Affordable Care Act and efforts to control drug pricing, could impact the Company's ability to obtain marketing approval and profitably sell products[358][360][364] - Non-compliance with federal and state fraud and abuse, transparency, and other healthcare laws could result in significant civil, criminal, and administrative penalties[367][374] Risks Related to our Common Stock Discusses factors that could affect the market price and liquidity of Equillium, Inc.'s common stock, including dilution and market volatility - The market price of the Company's common stock may be volatile and decline due to various factors, including operating performance, clinical trial results, regulatory developments, and broader market conditions, including the impact of COVID-19[388][391] - Raising additional capital through equity or convertible debt will dilute existing stockholders' ownership and may impose restrictive covenants or require relinquishing rights to technologies[392][393][394] - Substantial sales of common stock by directors, executive officers, and significant stockholders, or the perception of such sales, could cause the stock price to decline[395][396] - The Company's status as an 'emerging growth company' allows for reduced reporting requirements, which may make its common stock less attractive to some investors and increase stock price volatility[405][407][408] - Delaware law and provisions in the Company's corporate documents could make mergers, tender offers, or proxy contests difficult, potentially depressing the stock price[412][413][417][418] ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS. Details Equillium, Inc.'s unregistered equity sales and the allocation of proceeds from its initial public offering Recent Sales of Unregistered Securities Reports on Equillium, Inc.'s issuance of common stock as compensation, exempt from SEC registration requirements - During Q1 2020, the Company issued 10,973 shares to Del Mar Consulting Group, Inc. and 7,315 shares to Alex Partners, LLC as partial compensation for consulting services[423] - These issuances were exempt from registration under Section 4(a)(2) of the Securities Act, as they were made to accredited investors and did not involve a public offering[424] Use of Proceeds Explains how Equillium, Inc. has utilized the net proceeds obtained from its initial public offering - The Company received approximately $64.5 million in net proceeds from its IPO in October 2018[425] - As of March 31, 2020, $27.3 million of the IPO net proceeds have been used, with the remaining unused proceeds invested in fixed, non-speculative income instruments and money market funds[426] - There has been no material change in the expected use of IPO net proceeds from what was described in the final prospectus[426] ITEM 6. EXHIBITS Lists all exhibits accompanying Equillium, Inc.'s Quarterly Report on Form 10-Q, including corporate documents and certifications - The exhibits include corporate documents such as the Amended and Restated Certificate of Incorporation and Bylaws, warrant agreements, and a Registration Rights Agreement[429] - It also includes certifications from the Principal Executive Officer and Principal Financial Officer, as well as XBRL instance and taxonomy documents[429] SIGNATURES Official endorsements of the report by Equillium, Inc.'s President, CEO, and Chief Financial Officer - The report was signed on May 13, 2020, by Bruce D. Steel, President and Chief Executive Officer, and Jason A. Keyes, Chief Financial Officer[432]