☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 As of November 3, 2023, the registrant had 127,486,326 shares of common stock, $0.0001 par value per share, outstanding. FORM 10-Q | --- | --- | |------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | | | | Commission File Number: | 001-39696 | | COMPASS THERAPEUTICS, INC. (Exact Name of Registrant as | Specifi ...

The following discussion of the financial condition and results of operations of Compass Therapeutics, Inc. should be read in conjunction with the financial statements and the notes to those statements included in this Quarterly Report on Form 10-Q for the three and six month periods ended June 30, 2023. Some of the information contained in this discussion and analysis, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risk, uncer ...

FORM 10-Q OR For the transition period from _________________ to _________________ COMPASS THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) 80 Guest St., Suite 601 Boston, Massachusetts 02135 (Address of principal executive offices) (Zip Code) Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 mont ...

Medicines can be authorized in the European Union by using either the centralized authorization procedure or national authorization procedures. 42 National authorization procedures. There are also two other possible routes to authorize medicinal products in several European Union countries, which are available for investigational medicinal products that fall outside the scope of the centralized procedure: Mutual recognition procedure. In the mutual recognition procedure, a medicine is first authorized in on ...

Corporate Presentation December 2022 SRC DISCLAIMER This presentation has been prepared by Compass Therapeutics, Inc. ("we," "us," "our," or the "Company"). Statements contained herein are made as of the date of this presentation unless stated otherwise, and this presentation shall not under any circumstances create an implication that the information contained herein is correct as of any time after such date or that information will be updated or revised to reflect information that subsequently becomes ava ...

Corporate Strategy & Resources - Compass Therapeutics is a clinical-stage biotech company focused on developing antibody therapeutics for cancer[6] - The company's cash runway extends into 2026, with $120 million in cash and marketable securities as of September 2022, plus an $80 million PIPE in November 2022[6] CTX-009 (DLL4 x VEGF-A Bispecific Antibody) - Phase 1a monotherapy showed clinical activity at RP2D dosages (10 and 12.5 mg/kg), with a 19% partial response (PR) rate and a 69% clinical benefit rate (PR + SD) in all patients (n=16)[15] - In a Phase 1b combination study, cholangiocarcinoma patients showed a 50% overall response rate (ORR) and a 75% clinical benefit rate, with a median duration of response of 9.7 months[13] - Interim Phase 2 data in biliary tract cancers (BTC) showed a 42% ORR and a 92% clinical benefit rate (CBR) in patients treated in the second- and third-line settings[38, 54] - A Phase 2/3 randomized BTC study in the US is planned, randomizing 80 patients to CTX-009 + Paclitaxel vs 40 patients to Paclitaxel[55] CTX-471 (CD137 Agonist Antibody) - Phase 1 monotherapy study showed 4 partial responses (PRs) in post PD-1 population: small cell lung cancer, metastatic melanoma, mucosal melanoma, mesothelioma[64, 80] - A Phase 1b study of CTX-471 in combination with Keytruda® (anti-PD-1 therapy) is planned[67] CTX-8371 (PD-1 x PD-L1 Bispecific Antibody) - Preclinical studies showed superior activity to commercial PD-1 and PD-L1 inhibitors, with a unique mechanism of action enhancing T-cell activation[69, 80] - IND submission is targeted for H1 2023[79]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-39696 COMPASS THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) D ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________ to _________________ Commission File Number: 001-39696 COMPASS THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delawa ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for the three months ended March 31, 2022 For Q1 2022, the company reported a net loss of $7.2 million, a slight improvement from a $7.4 million loss in Q1 2021 Total assets decreased to $146.6 million from $153.8 million at year-end 2021, primarily due to a decrease in cash and cash equivalents to $136.4 million Net cash used in operating activities was $7.9 million [Condensed Consolidated Balance Sheets (Unaudited)](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) The balance sheet as of March 31, 2022, shows total assets of $146.6 million, a decrease from $153.8 million at the end of 2021 This was driven by a reduction in cash and cash equivalents from $144.5 million to $136.4 million Total liabilities decreased from $13.7 million to $12.1 million, and total stockholders' equity declined to $134.5 million | | March 31, 2022 (unaudited) | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $136,379 | $144,514 | | Total current assets | $140,283 | $147,105 | | Total assets | $146,564 | $153,757 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $9,334 | $10,631 | | Total liabilities | $12,074 | $13,679 | | Total stockholders' equity | $134,490 | $140,078 | | Total liabilities and stockholders' equity | $146,564 | $153,757 | [Condensed Consolidated Statements of Operations (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(Unaudited)) For the first quarter of 2022, the company reported a net loss of $7.2 million, or ($0.07) per share, compared to a net loss of $7.4 million, or ($0.14) per share, for the same period in 2021 Total operating expenses were slightly lower at $7.2 million versus $7.3 million in the prior-year quarter, mainly due to a small decrease in research and development costs | (In thousands, except per share data) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $4,415 | $4,704 | | General and administrative | $2,767 | $2,635 | | **Total operating expenses** | **$7,182** | **$7,339** | | Loss from operations | ($7,182) | ($7,339) | | **Net loss** | **($7,162)** | **($7,422)** | | Net loss per share - basic and diluted | ($0.07) | ($0.14) | | Basic and diluted weighted average shares outstanding | 100,858 | 51,313 | [Condensed Consolidated Statements of Stockholders' Equity (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20(Unaudited)) Stockholders' equity decreased from $140.1 million at December 31, 2021, to $134.5 million at March 31, 2022 The decrease was primarily driven by the net loss of $7.2 million for the quarter, partially offset by $1.6 million in stock-based compensation - The change in stockholders' equity during Q1 2022 was primarily influenced by the net loss of $7,162 thousand, which was partially offset by stock-based compensation of $1,574 thousand[12](index=12&type=chunk) [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) For the first quarter of 2022, net cash used in operating activities was $7.9 million, an increase from $5.6 million in the prior-year period Cash used in investing activities was minimal at $0.2 million, and there were no financing activities The company's cash and cash equivalents decreased by $8.1 million during the quarter | (In thousands) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($7,942) | ($5,605) | | Net cash used in investing activities | ($193) | ($13) | | Net cash used in financing activities | — | ($1,875) | | **Net change in cash, cash equivalents and restricted cash** | **($8,135)** | **($7,493)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business as a clinical-stage oncology biopharmaceutical firm and confirm its liquidity position As of March 31, 2022, the company had $136.4 million in cash and cash equivalents, which management expects will fund operations into the second half of 2024 Significant commitments include a $6.0 million milestone payment to ABL Bio related to the CTX-009 clinical trial and future payments under collaboration agreements - The company is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics, focusing on the relationship between angiogenesis and the immune system[17](index=17&type=chunk) - As of March 31, 2022, the company had cash and cash equivalents of $136.4 million, which is expected to fund operating expenses and capital expenditure requirements into the second half of 2024[21](index=21&type=chunk) - The company has accrued a $6.0 million milestone payment to ABL Bio for the completion of Phase 1 of the clinical trial for CTX-009[30](index=30&type=chunk)[36](index=36&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical pipeline progress, financial results, and liquidity Key updates were provided for CTX-009, which showed a promising 42% preliminary overall response rate in a Phase 2 trial for biliary tract cancer The company's net loss for Q1 2022 was $7.2 million, slightly down from $7.4 million in Q1 2021 With $136 million in cash, the company projects a cash runway into the second half of 2024 [Business Overview and Pipeline Update](index=15&type=section&id=Business%20Overview%20and%20Pipeline%20Update) The company highlights its focus on developing antibody-based therapeutics for oncology The pipeline is led by two clinical-stage candidates, CTX-009 and CTX-471, and one preclinical candidate, CTX-8371 Interim data from the Phase 2 trial of CTX-009 in biliary tract cancer (BTC) showed a preliminary overall response rate (ORR) of 42% and a clinical benefit rate (CBR) of 92% The company plans to advance CTX-009 into a Phase 2/3 study and is targeting an IND submission for CTX-8371 in Q1 2023 - **CTX-009 (DLL4/VEGF-A bispecific):** Interim data from its Phase 2 clinical trial in Biliary Tract Cancer (BTC) as of April 14, 2022, showed a preliminary overall response rate (ORR) of 42% (10 partial responses out of 24 patients) and a clinical benefit rate (CBR) of 92%[66](index=66&type=chunk)[67](index=67&type=chunk) - **CTX-471 (CD137 agonist):** The ongoing Phase 1b dose expansion study has enrolled 49 patients Among 38 evaluable patients, the preliminary ORR is 8% and the CBR is 58%[83](index=83&type=chunk) - **CTX-8371 (PD-1/PD-L1 bispecific):** Due to delays in GMP manufacturing, the company is now targeting an IND submission in the first quarter of 2023[86](index=86&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) This section compares financial results for Q1 2022 and Q1 2021 The net loss slightly decreased by $0.3 million to $7.2 million Research and development expenses decreased by $0.3 million (6%) due to lower manufacturing costs General and administrative expenses increased by $0.1 million (5%) | (In thousands) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change | | :--- | :--- | :--- | :--- | | Research and development | $4,415 | $4,704 | ($289) | | General and administrative | $2,767 | $2,635 | $132 | | **Total operating expenses** | **$7,182** | **$7,339** | **($157)** | | **Net loss** | **($7,162)** | **($7,422)** | **$260** | - R&D expenses decreased by $0.3 million, or 6%, primarily due to a reduction in manufacturing expense[106](index=106&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) The company's operations have been funded primarily through $329.0 million in gross proceeds from equity sales As of March 31, 2022, cash and cash equivalents stood at $136 million Management believes these funds are sufficient to support operating expenses and capital needs into the second half of 2024 Future funding will be necessary to complete clinical development and for any potential commercialization - As of March 31, 2022, the company had cash and cash equivalents of $136 million[112](index=112&type=chunk) - Based on current plans, the company expects its existing cash resources will fund operating expenses and capital expenditure requirements into the second half of 2024[123](index=123&type=chunk) | (In thousands) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Cash used in operating activities | ($7,942) | ($5,605) | | Cash used in investing activities | ($193) | ($13) | | Cash used in financing activities | — | ($1,875) | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company has omitted this section, stating it is not applicable as it qualifies as a smaller reporting company - This disclosure is not applicable as the company is a smaller reporting company[126](index=126&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the Chief Executive Officer and Chief Operating Officer, evaluated the company's disclosure controls and procedures and concluded that they were effective as of March 31, 2022 There were no material changes to the company's internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2022, the Chief Executive Officer and Chief Operating Officer concluded that the company's disclosure controls and procedures were effective[128](index=128&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[129](index=129&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently involved in any material legal proceedings - As of the filing date, the company is not involved in any material legal proceedings[132](index=132&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) This section directs readers to the detailed discussion of risk factors in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2021 - The report refers to the risk factors previously disclosed in Part I, Item 1A of the company's Annual Report on Form 10-K for the year ended December 31, 2021[133](index=133&type=chunk) [Other Items (2, 3, 4, 5, 6)](index=28&type=section&id=Other%20Items%20(2%2C%203%2C%204%2C%205%2C%206)) This section covers several standard disclosure items The company reports no unregistered sales of equity securities or defaults on senior securities Mine safety disclosures are not applicable Under 'Other Information,' the company notes the furnishing of a press release for its Q1 2022 financial results The final item lists the exhibits filed with the report - There were no unregistered sales of equity securities or defaults upon senior securities during the period[135](index=135&type=chunk)[137](index=137&type=chunk) - A press release announcing financial results for the quarter ended March 31, 2022, was issued on May 9, 2022, and attached as Exhibit 99.1[138](index=138&type=chunk)

Financial Condition - The company has incurred significant net losses with an accumulated deficit of $234 million as of December 31, 2021[291]. - The company does not anticipate generating revenue from product sales for the next several years, if ever[295]. - As of December 31, 2021, the company had $144.5 million in cash and cash equivalents, expected to fund operations into the second half of 2024[302]. - The company expects to continue incurring significant expenses and operating losses for the foreseeable future[292]. - The company will require substantial additional financing to pursue its business objectives, which may not be available on acceptable terms[298]. - The company has never generated revenue from product sales and may never be profitable[295]. Clinical Development Challenges - The company anticipates significant costs associated with commercializing any product candidate that is approved for commercial sale[296]. - The company expects expenses to increase substantially as it advances preclinical and clinical development of its product candidates[292]. - The company faces potential delays in clinical trials due to various factors, including regulatory compliance and safety concerns, which could impact the commercialization of product candidates[317]. - The ongoing COVID-19 pandemic may further delay clinical trials, increasing costs and jeopardizing the ability to generate product revenues[320]. - The company has not yet completed clinical trials for certain product candidates, making it difficult to assess their safety in humans[333]. - Regulatory approval processes for the company's product candidates may be more expensive and time-consuming due to the novelty of the agonist monoclonal antibody technology[334]. - There is a high risk of failure for product candidates in the discovery or preclinical stage, which could adversely affect the ability to obtain regulatory approvals[324]. - The company must demonstrate safety, purity, and potency through extensive preclinical testing and clinical trials, with failures possible at any stage[336]. - Adverse side effects from product candidates could halt clinical development or limit commercial potential, impacting business prospects[335]. - Interim and preliminary results from clinical trials may change as more data becomes available, potentially affecting the company's business outlook[330]. - The company may face challenges in recruiting patients for clinical trials if unacceptable side effects arise, which could delay the development process[340]. - Unforeseen side effects could emerge during clinical trials or after marketing approval, impacting the company's ability to generate revenue[341]. Product Development and Regulatory Approval - The acquisition of Trigr Therapeutics, Inc. ("TRIGR") was completed on June 25, 2021, which included the anti-DLL4 x VEGF-A bispecific antibody CTX-009, currently undergoing clinical development in South Korea[358]. - A Phase 1 dose escalation study and Phase 1b dose expansion monotherapy and combination studies for CTX-009 have been completed, with a Phase 2 combination study ongoing[358]. - The company has filed an IND in the United States for CTX-009 and continues its development across multiple indications[358]. - The design and implementation of clinical trials are complex, and the company has limited experience, which may lead to increased costs and delays in obtaining regulatory approval[347][348]. - Difficulties in patient enrollment for clinical trials could adversely affect the timing and outcome of these trials, impacting the development of product candidates[349][350]. - The regulatory approval process for product candidates is lengthy and unpredictable, with no current approvals obtained for any product candidate[364][366]. - The company may face challenges in demonstrating an acceptable risk-benefit profile for its product candidates to regulatory authorities[367]. - The results from small clinical trials may be less reliable, limiting the ability to generalize findings across broader populations[354]. - The company may miss valuable opportunities by prioritizing certain product candidates over potentially more profitable ones[356][357]. - Integration of TRIGR may present significant issues and unknown liabilities, potentially leading to increased costs and delays in clinical trials[358]. - The FDA may approve product candidates for fewer or more limited indications than requested, which could adversely impact commercialization prospects[371]. - The approval process for product candidates is lengthy and uncertain, with many companies experiencing setbacks in clinical trials[373]. - Only a small percentage of biopharmaceutical products in development successfully complete the FDA approval process, which could materially harm the business if delays occur[380]. - Disruptions at the FDA due to funding shortages or global health concerns could hinder timely product development and approval[381]. - The FDA's ability to review new products can be affected by various factors, including budget levels and personnel retention, leading to fluctuating review times[382]. - The company may be required to conduct additional costly clinical trials post-approval, which could limit the product's market potential[379]. - Regulatory compliance is critical, as failure to meet ongoing requirements could result in penalties or withdrawal of marketing approvals[401]. Commercialization Risks - The company faces risks related to the commercialization of product candidates, including achieving market acceptance necessary for commercial success[403]. - Manufacturing processes are subject to strict regulations, and any contamination could adversely affect production schedules and operational results[397]. - The FDA strictly regulates promotional claims, and improper promotion of off-label uses could lead to significant penalties[399]. - The company faces challenges in gaining market acceptance for its product candidates, which may impact revenue generation and profitability[407]. - The market opportunities for the company's product candidates may be limited to patients ineligible for established therapies or those for whom prior therapies have failed[408]. - The company may initially seek approval for its product candidates as second- or third-line therapies, with potential future applications as first-line therapies[411]. - The addressable patient population for the company's product candidates may be lower than expected, affecting profitability without additional marketing approvals[413]. - Establishing marketing, sales, and distribution capabilities is crucial for the successful commercialization of product candidates, which the company currently lacks[417]. - The company may face significant liabilities from product liability lawsuits, which could limit commercialization efforts[422]. - Coverage and adequate reimbursement from third-party payors are essential for the successful commercialization of the company's product candidates[425]. - The company may need to conduct expensive pharmacoeconomic studies to demonstrate the cost-effectiveness of its products to secure coverage and reimbursement[432]. - Pricing pressures from third-party payors are expected, which may affect the company's ability to sell products profitably[432]. - Regulatory requirements for drug pricing and reimbursement vary significantly across countries, potentially impacting market access for the company's products[433]. - The company faces significant challenges in commercializing product candidates due to varying coverage and reimbursement policies from payors, which may adversely affect financial conditions[434]. - Legislative changes aimed at broadening healthcare access and reducing costs could impact the pharmaceutical industry, potentially limiting government coverage for healthcare products[435][439]. - The Patient Protection and Affordable Care Act has substantially altered healthcare financing, affecting pricing and reimbursement practices in the U.S. pharmaceutical sector[436]. - Increased scrutiny on specialty drug pricing practices may lead to limitations on coverage and reimbursement for newly approved products, impacting the company's product candidates[437]. - State-level regulations are increasingly controlling pharmaceutical pricing, which could harm the company's business and financial prospects[438]. - The company anticipates future healthcare reform measures that may further restrict government coverage and payment amounts for healthcare products[439]. Manufacturing and Intellectual Property Risks - Manufacturing risks include reliance on third-party contract development manufacturing organizations (CDMOs), which may face regulatory compliance issues and supply chain challenges[455][459]. - Changes in manufacturing processes during product development could lead to increased costs, delays, and potential impacts on clinical trial results[460][463]. - The company’s success is heavily dependent on obtaining and maintaining patent protection for its product candidates, with no patents yet issued from current applications[464][465]. - The patent landscape for biotechnology and pharmaceutical companies is complex and uncertain, with potential litigation affecting the company's ability to protect its intellectual property[466]. - The issuance, scope, validity, enforceability, and commercial value of the company's patent rights are highly uncertain, with pending and future patent applications potentially not resulting in effective protection[467]. - The patent prosecution process is expensive and complex, and the company may not be able to file or maintain all necessary patent applications in a timely manner[469]. - The company may face challenges in obtaining meaningful patent protection, as competitors could develop similar technologies in a non-infringing manner[471]. - Patent terms are limited to generally 20 years from the earliest national filing date, which may not provide sufficient protection against competition[484]. - The company may not be able to obtain patent term extensions or data exclusivity for its product candidates, which could harm its business[485]. - The Biologics Price Competition and Innovation Act allows for up to 12 years of market exclusivity, but the company may not secure such exclusivity for its products[487]. - Changes in U.S. patent law could diminish the value of patents, impairing the company's ability to protect its product candidates[488]. - The company may not be able to protect its intellectual property rights globally due to high costs and varying enforcement levels in different jurisdictions[480]. - Compulsory licensing laws in many countries could compel the company to grant licenses to third parties, adversely affecting its competitive position[482]. - The company relies on outside counsel and licensors to comply with patent maintenance requirements, and non-compliance could result in loss of patent rights[476].