Compass Therapeutics(CMPX) - 2021 Q3 - Quarterly Report

PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) This section presents the company's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with detailed notes explaining the basis of presentation, significant accounting policies, and specific financial line items Condensed Consolidated Balance Sheets (Unaudited) | Metric | Sep 30, 2021 (Unaudited) (in thousands) | Dec 31, 2020 (in thousands) | | :---------------------------------- | :-------------------------------------- | :-------------------------- | | Cash and cash equivalents | $25,509 | $47,076 | | Total current assets | $28,572 | $50,202 | | Total assets | $34,899 | $51,911 | | Total current liabilities | $7,683 | $10,099 | | Total liabilities | $11,011 | $11,966 | | Total stockholders' equity | $23,888 | $39,945 | Condensed Consolidated Statements of Operations (Unaudited) | Metric | 3 Months Ended Sep 30, 2021 (in thousands) | 3 Months Ended Sep 30, 2020 (in thousands) | 9 Months Ended Sep 30, 2021 (in thousands) | 9 Months Ended Sep 30, 2020 (in thousands) | | :-------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | | Research and development | $3,154 | $3,670 | $10,763 | $10,498 | | General and administrative | $2,700 | $5,291 | $7,500 | $9,364 | | In-process R&D | — | — | $50,618 | — | | Total operating expenses | $5,854 | $8,961 | $68,881 | $19,862 | | Net loss | $(5,975) | $(9,150) | $(69,200) | $(21,109) | | Net loss per share (basic & diluted) | $(0.10) | $(0.18) | $(1.26) | $(0.88) | Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders' Equity (Deficit) (Unaudited) | Metric | Dec 31, 2020 (in thousands) | Sep 30, 2021 (in thousands) | | :-------------------------------- | :-------------------------- | :-------------------------- | | Common Stock Shares | 51,221 | 61,760 | | Common Stock Amount | $5 | $6 | | Additional Paid-in Capital | $191,348 | $244,490 | | Accumulated Deficit | $(151,408) | $(220,608) | | Total Stockholders' Equity | $39,945 | $23,888 | - Common shares issued for Trigr acquisition in Q2 2021 totaled 10,265,133 shares with a fair value of $50.3 million[32] Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Activity | 9 Months Ended Sep 30, 2021 (in thousands) | 9 Months Ended Sep 30, 2020 (in thousands) | | :-------------------------------------------------- | :----------------------------------------- | :----------------------------------------- | | Net cash used in operating activities | $(15,001) | $(20,230) | | Net cash (used in) provided by investing activities | $(994) | $32 | | Net cash (used in) provided by financing activities | $(5,625) | $50,413 | | Net change in cash, cash equivalents and restricted cash | $(21,620) | $30,215 | | Cash, cash equivalents and restricted cash at end of period | $25,719 | $55,781 | - Acquisition of Trigr Therapeutics, Inc. involved $50.3 million in non-cash consideration[36] Notes to Unaudited Condensed Consolidated Financial Statements 1. Nature of Business and Basis of Presentation - Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics[38] - The company has funded operations primarily through equity sales ($132.0 million gross proceeds) and debt borrowings ($15.0 million term loan) through September 30, 2021[42] - As of September 30, 2021, cash and cash equivalents were $25.5 million. A subsequent public offering in November 2021 raised $117.3 million net, expected to fund operations through Q4 2024[42][44] - COVID-19 has caused increased delays in patient enrollment for the Phase 1 CTX-471 clinical trial and delays in sourcing supplies for future clinical trials[46] 2. Summary of Significant Accounting Policies - The company adopted ASU No. 2016-02, Leases, on January 1, 2021, requiring the recording of right-of-use assets and corresponding lease liabilities for leases longer than 12 months[48] - The adoption of ASU No. 2019-12, Income Taxes, effective January 1, 2022, is not expected to have a material impact on the company's financial position or results of operations[49] 3. Fair Value Measurements | Asset | Sep 30, 2021 (in thousands) | Dec 31, 2020 (in thousands) | | :-------------------------- | :-------------------------- | :-------------------------- | | Cash equivalents - money market | $24,474 | $43,631 | | Total assets | $24,474 | $43,631 | - All fair value measurements for cash equivalents are classified as Level 1, indicating they are based on quoted prices in active markets for identical assets[51] 4. Property and Equipment | Category | Sep 30, 2021 (in thousands) | Dec 31, 2020 (in thousands) | | :-------------------------- | :-------------------------- | :-------------------------- | | Equipment | $5,351 | $5,356 | | Software | $364 | $180 | | Leasehold improvements | $600 | $896 | | Furniture and fixtures | $22 | $629 | | Total property and equipment–at cost | $6,337 | $7,061 | | Less: Accumulated depreciation | $(4,902) | $(5,935) | | Property and equipment, net | $1,435 | $1,126 | - Total depreciation expense for the nine months ended September 30, 2021, was $0.4 million, down from $1.3 million in the same period of 2020[52] 5. Accrued Expenses | Category | Sep 30, 2021 (in thousands) | Dec 31, 2020 (in thousands) | | :-------------------------- | :-------------------------- | :-------------------------- | | Compensation and benefits | $799 | $976 | | Research and development expenses | $734 | $212 | | Leasehold improvements | $320 | — | | Legal and professional fees | $75 | $326 | | Other | $70 | $57 | | Total accrued expenses | $1,998 | $1,571 | 6. Debt | Debt Component | Sep 30, 2021 (in thousands) | Dec 31, 2020 (in thousands) | | :---------------------------------- | :-------------------------- | :-------------------------- | | Current portion of debt, net | $3,744 | $7,467 | | Long-term debt, net | — | $1,867 | | Aggregate principal amount outstanding | $3,750 | $9,375 | - The company's term loan facility with Pacific Western Bank had an interest rate of 6.25% as of September 30, 2021, and required monthly principal payments of $625,000[56] - The company was in compliance with all debt covenants as of September 30, 2021, and subsequently paid off the balance and terminated the Credit Facility in November 2021[59][90] 7. Leases - The company adopted ASU 2016-02, Leases, effective January 1, 2021, and has one operating lease for its corporate office and laboratory facility[63][64] | Lease Payments | Amount (in thousands) | | :----------------------------------- | :-------------------- | | Total minimum lease payments | $4,900 | | Present value of future minimum lease payments | $4,401 | | Operating lease obligations, current portion | $(1,073) | | Operating lease obligations, long-term portion | $3,328 | 8. Stock-Based Compensation - The 2020 Stock Option and Incentive Plan reserved 2.93 million shares, with 1.5 million shares remaining available for future grant as of September 30, 2021[69] | Category | 9 Months Ended Sep 30, 2021 (in thousands) | 9 Months Ended Sep 30, 2020 (in thousands) | | :-------------------------- | :----------------------------------------- | :----------------------------------------- | | Research and development | $476 | $486 | | General and administrative | $2,367 | $2,480 | | Total | $2,843 | $2,966 | - As of September 30, 2021, total unrecognized compensation cost for options and restricted stock awards was $8.6 million, expected to be recognized over a weighted average period of 2.1 years[71][75] 9. Merger Transaction - On June 25, 2021, the company acquired Trigr Therapeutics, Inc. for 10,265,133 shares of common stock with a fair value of $50.3 million[78] - The acquisition was accounted for as an asset acquisition, with the $50.3 million transaction amount and $0.3 million transaction costs allocated to the acquired license (CTX-009) and expensed as in-process R&D[79] - TRIGR shareholders are eligible for up to $9.0 million in earnout payments, contingent on milestones such as IND approval of CTX-009 in China ($2.0 million) and BLA approval of CTX-009 ($5.0 million)[78] 10. Related Parties and Related-Party Transactions - The company has a collaboration agreement with Adimab, LLC, where a co-founder holds a direct ownership interest, with no R&D expenses recorded in 2021 or 2020[80] - Miranda Toledano, former CFO/COO of TRIGR, was appointed to Compass's Board of Directors and entered a six-month consulting agreement following the TRIGR acquisition[81] 11. Other Expense | Category | 3 Months Ended Sep 30, 2021 (in thousands) | 3 Months Ended Sep 30, 2020 (in thousands) | 9 Months Ended Sep 30, 2021 (in thousands) | 9 Months Ended Sep 30, 2020 (in thousands) | | :----------------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | | Interest income | $1 | $22 | $25 | $70 | | Interest expense | $(78) | $(212) | $(331) | $(730) | | Change in fair value of derivative liability | — | — | — | $(556) | | Other income (expenses) | $(44) | $1 | — | $1 | | Total other income (expenses) | $(121) | $(189) | $(306) | $(1,215) | 12. License, Research and Collaboration Agreements - The company holds an exclusive global license (excluding South Korea) for CTX-009 from ABL Bio, with potential development, regulatory, and commercial milestone payments up to $405 million and tiered single-digit royalties[84] - A collaboration agreement with Adimab, LLC, includes potential future milestone payments of $2.0 million as of September 30, 2021[86] - The company has a master services agreement with Fujifilm Diosynth Biotechnologies for manufacturing, incurring $1.0 million in R&D expense for the nine months ended September 30, 2021[87] 13. Subsequent events - In November 2021, the company completed an underwritten public offering, raising approximately $117.3 million in net proceeds from the sale of 35,715,000 shares of common stock at $3.50 per share[89] - On November 8, 2021, the company paid off the balance of its notes and terminated the Credit Facility, eliminating all outstanding debt[90] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition, results of operations, and future outlook. It details the company's business overview, clinical development progress for its product candidates, the impact of the COVID-19 pandemic, a breakdown of operating expenses, and an analysis of liquidity and capital resources Overview - Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics[93] - The company acquired Trigr Therapeutics, Inc. on June 25, 2021, for 10,265,133 shares of common stock (fair value $50.3 million), gaining CTX-009[94] - CTX-009 (anti-DLL4 x VEGF-A bispecific antibody) is in Phase 1a/1b monotherapy and combination studies in South Korea, with a Phase 2a study in biliary tract cancers (BTC) showing a preliminary ORR of 29% in 17 evaluable patients[95][96][108][110] - CTX-471 (CD137 agonist) is in an ongoing Phase 1 dose expansion stage, with a preliminary ORR of 8.0% and CBR of 52% in 25 evaluable patients[115][116] - CTX-8371 (PD-1 and PD-L1 bispecific antibody) IND submission is targeted for H2 2022 due to manufacturing delays[119] - The company reported net losses of $6.0 million for Q3 2021 and $69.2 million for the nine months ended September 30, 2021, with an accumulated deficit of $220.6 million[121] - Cash and cash equivalents were $25.5 million as of September 30, 2021. A November 2021 public offering raised $117.3 million net, extending the funding runway through Q4 2024[122] COVID-19 Update - The company has experienced increased delays in patient enrollment for its Phase 1 clinical trial of CTX-471 and delays in sourcing selected supplies for manufacturing future clinical trial materials due to the COVID-19 pandemic[126] Components of Results of Operations - Research and development expenses include employee costs, platform development, CMOs, clinical trials, manufacturing, regulatory compliance, and facilities, and are expected to increase substantially[127][129] - In-process R&D expenses consist of costs from the TRIGR acquisition (CTX-009), which were expensed as incurred[132] - General and administrative expenses cover executive, finance, corporate, business development, and administrative functions, including legal and professional fees, and are anticipated to increase with headcount[133][134] Results of Operations Comparison of the Three Months Ended September 30, 2021 and 2020 | Metric | 3 Months Ended Sep 30, 2021 (in thousands) | 3 Months Ended Sep 30, 2020 (in thousands) | Change (in thousands) | | :-------------------------- | :----------------------------------------- | :----------------------------------------- | :-------------------- | | Research and development | $3,154 | $3,670 | $(516) | | General and administrative | $2,700 | $5,291 | $(2,591) | | Total operating expenses | $5,854 | $8,961 | $(3,107) | | Net loss | $(5,975) | $(9,150) | $3,175 | - Research and development expenses decreased by $0.5 million, primarily due to $0.3 million less in depreciation and $0.2 million less in program-related expenses[137] - General and administrative expenses decreased by $2.6 million, mainly from a $1.4 million decrease in stock compensation and $0.5 million reduction in reverse merger-related legal and professional fees[140] Comparison of the Nine Months Ended September 30, 2021 and 2020 | Metric | 9 Months Ended Sep 30, 2021 (in thousands) | 9 Months Ended Sep 30, 2020 (in thousands) | Change (in thousands) | | :-------------------------- | :----------------------------------------- | :----------------------------------------- | :-------------------- | | Research and development | $10,763 | $10,498 | $265 | | General and administrative | $7,500 | $9,364 | $(1,864) | | In-process R&D | $50,618 | — | $50,618 | | Total operating expenses | $68,881 | $19,862 | $49,019 | | Net loss | $(69,200) | $(21,109) | $(48,091) | - In-process R&D was $50.6 million for the nine months ended September 30, 2021, due to the TRIGR acquisition[147] - Research and development expenses increased by $0.3 million, driven by higher lab supply costs ($0.5 million), CTX-8371 manufacturing costs ($0.4 million), and facilities expenses ($0.3 million), partially offset by $0.8 million decrease in depreciation[144] - General and administrative expenses decreased by $1.8 million, primarily due to lower legal expenses ($0.9 million) and facilities expenses ($0.6 million)[148] Liquidity and Capital Resources - The company's operations have been funded primarily by equity sales ($132.0 million gross proceeds) and debt arrangements ($15.0 million term loan) through September 30, 2021[151] - As of September 30, 2021, cash and cash equivalents totaled $25.5 million. A subsequent public offering in November 2021 raised $117.3 million net proceeds[151][152] - Existing cash resources, including the proceeds from the November 2021 offering, are expected to fund operating expenses and capital expenditure requirements through the fourth quarter of 2024[168] - Future funding requirements are substantial and depend on the progress of clinical development, manufacturing costs, regulatory approvals, and potential commercialization efforts[155][168] Cash Flows | Cash Flow Activity | 9 Months Ended Sep 30, 2021 (in thousands) | 9 Months Ended Sep 30, 2020 (in thousands) | | :-------------------------------------------------- | :----------------------------------------- | :----------------------------------------- | | Cash used in operating activities | $(15,001) | $(20,230) | | Cash provided by (used in) investing activities | $(994) | $32 | | Cash provided by (used in) financing activities | $(5,625) | $50,413 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $(21,620) | $30,215 | - Cash used in operating activities was $15.0 million in 9M 2021, primarily due to a $69.2 million net loss, partially offset by $54.7 million in non-cash charges, including $50.6 million for in-process R&D from the TRIGR acquisition[160] - Cash used in investing activities was $1.0 million in 9M 2021, mainly for leasehold improvements, equipment purchases, and TRIGR acquisition costs[162] - Cash used in financing activities was $5.6 million in 9M 2021, due to principal payments under the Credit Facility, contrasting with $50.4 million provided in 9M 2020 from a private placement[163] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section states that there have been no material changes to the company's quantitative and qualitative disclosures about market risk since its Annual Report on Form 10-K for the fiscal year ended December 31, 2020 - There have been no material changes from the market risk disclosures previously provided in the Annual Report on Form 10-K for the fiscal year ended December 31, 2020[171] Item 4. Controls and Procedures Management, including the Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the company's disclosure controls and procedures as of September 30, 2021, concluding they were effective. No material changes in internal control over financial reporting occurred during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2021[175] - No change in internal control over financial reporting occurred during the quarter ended September 30, 2021, that materially affected, or is reasonably likely to materially affect, internal control over financial reporting[176] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company is not currently involved in any material legal proceedings, though it acknowledges that such proceedings can arise in the ordinary course of business and may have an adverse impact - As of the date of this report, the company is not involved in any material legal proceedings[179] Item 1A. Risk Factors This section outlines various risks that could materially affect the company's business, financial condition, or results of operations, including those related to the TRIGR acquisition, the company's limited operating history and financial needs, the discovery and development of product candidates, regulatory approvals, commercialization, healthcare legislation, manufacturing, intellectual property, and reliance on third parties Risks related to the TRIGR acquisition - The company may experience increased costs, disruptions, or other difficulties with the integration of TRIGR and the ongoing development of the acquired product candidate, CTX-009[181][182] - The company relies on TRIGR's prior research and its licensor ABL Bio for the development and intellectual property of CTX-009, lacking historical internal development experience for this candidate[183][184] - Conducting clinical trials for CTX-009 in overseas jurisdictions (e.g., South Korea) subjects the company to risks such as regulatory delays, differing requirements, and logistical challenges[185][186] Risks related to our business and financial condition - The company has a limited operating history, a history of significant net losses ($220.6 million accumulated deficit as of Sep 30, 2021), and expects to continue incurring losses for the foreseeable future without product sales revenue[188][189][193] - Substantial additional financing will be required to pursue business objectives, including preclinical and clinical development and commercialization; a failure to obtain this capital could force delays, reductions, or termination of product development efforts[195][196][201] - Based on current plans, existing cash resources (including the November 2021 public offering) are expected to fund operating expenses and capital expenditure requirements through Q4 2024, but this estimate is subject to change[199] Risks related to the discovery and development of our product candidates - The company's business is dependent on its ability to successfully advance CTX-009, CTX-471, CTX-8371, and future product candidates through lengthy and expensive clinical trials, obtain marketing approval, and ultimately commercialize them[203][204][209] - Clinical development involves uncertain outcomes, potential delays (e.g., patient enrollment, regulatory requirements), and the risk of undesirable side effects that could halt development or prevent regulatory approval[210][212][224][228] - Preclinical development is uncertain, with a high risk of failure for early-stage candidates, and there is no guarantee that preclinical programs will advance to clinical trials on expected timelines or at all[220][221] - The company has limited experience designing and implementing pivotal clinical trials, and inadequate trial design or incorrect assumptions could adversely affect trial initiation, patient enrollment, completion, or regulatory approval[235][237] - Prioritizing the development of CTX-009, CTX-471, and CTX-8371 may lead to expending limited resources on candidates that do not yield successful products, potentially foregoing other more profitable opportunities[239][240] Risks related to regulatory approval of our product candidates - Regulatory agencies may not agree with the design of clinical development programs intended for expedited approval pathways (e.g., for CTX-009), potentially delaying the development process[242][243] - Developing product candidates in combination with other therapies (e.g., CTX-009 with chemotherapy, CTX-471 with PD-1/PD-L1 blockers) exposes the company to additional regulatory risks, including failure to demonstrate synergistic activity or safety/efficacy issues[244][245][246] Risks related to the commercialization of our product candidates - Market opportunities for approved product candidates may be limited to specific patient populations (e.g., second- or third-line therapies), potentially hindering significant revenue generation if target markets are smaller than estimated[251][252][255] - The company lacks a sales and marketing infrastructure; establishing one is expensive, time-consuming, and risky, and failure to do so (or to secure favorable third-party arrangements) could impede commercial success and profitability[256][257][260] Risks related to healthcare, insurance and legal matters - Enacted healthcare legislation (e.g., ACA) and potential future changes in healthcare law, regulations, and policy may increase the difficulty and cost of commercializing product candidates, affecting pricing and potentially having a material adverse effect on the business[261][262][267] - There is uncertainty regarding the likelihood, nature, or extent of future government regulation, which could limit coverage, reduce demand, or impose additional pricing pressures on the company's products[272] Risks related to manufacturing of our product candidates - The company relies on third-party contract manufacturing organizations (CMOs) for product candidates; lack of control over their processes and compliance with regulatory requirements poses risks of manufacturing difficulties, supply disruptions, and quality issues[273][274][275][276] - Changes in manufacturing methods or formulations as product candidates advance (e.g., scaling up for commercial production) carry risks of additional costs, delays, or requiring further testing and regulatory approval[277][280] - The manufacturing process for antibody therapeutics is complex, time-consuming, and highly regulated, subject to risks such as product loss, contamination, equipment failure, and raw material shortages[279] Risks related to intellectual property - Intellectual property agreements with third parties (e.g., ABL Bio, Adimab) are complex and susceptible to interpretation disagreements, which could narrow the scope of rights, increase financial obligations, or impair the ability to develop and commercialize product candidates[281][282] Risks related to our work with third parties - The company relies heavily on third parties (medical institutions, clinical investigators, CROs) to conduct preclinical studies and clinical trials, and their failure to perform contractual duties, comply with regulations, or meet deadlines could significantly harm the business[284][285][286] Risks related to our business - The company anticipates needing to grow its organization, which will impose significant responsibilities on management, including identifying, recruiting, and integrating additional personnel, and managing internal development efforts[287][288] - Substantial reliance on independent organizations, advisors, and consultants means that their services must remain available and effective; failure to manage outsourced activities or maintain service quality could delay clinical trials and business advancement[289] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section states that there were no unregistered sales of equity securities or use of proceeds to report during the period - No unregistered sales of equity securities or use of proceeds were reported[291] Item 3. Defaults Upon Senior Securities This section confirms that there were no defaults upon senior securities during the reporting period - No defaults upon senior securities were reported[291] Item 4. Mine Safety Disclosures This item is not applicable to the company's operations - Mine Safety Disclosures are not applicable to the company[291] Item 5. Other Information This section reports on the payoff and termination of the Credit Facility in November 2021, which eliminated all company debt, and the issuance of a press release announcing the third quarter 2021 financial results - On November 8, 2021, the company paid off the balance of its notes and terminated the Credit Facility, resulting in no additional debt facilities[291] - A press release announcing the company's financial results for the quarter ended September 30, 2021, was issued on November 12, 2021[292] Item 6. Exhibits This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including various certifications, a press release, and Inline XBRL documents - Exhibits include certifications (31.1, 31.2, 32.1, 32.2), a press release (99.1) for Q3 2021 financial results, and Inline XBRL documents (101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104)[293][294] Signatures - The report was signed on November 12, 2021, by Thomas Schuetz (Co-Founder and Chief Executive Officer), Vered Bisker-Leib (President and Chief Operating Officer), and Neil Lerner (Vice President - Finance)[298]