UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM
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CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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On August 12, 2024, Compass Therapeutics, Inc. issued a press release announcing financial results for the quarter ended June 30, 2024. A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated herein by reference.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release dated August 12, 2024 (furnished pursuant to Item 2.02) | |
| 104 | The cover page from this Current Report on Form 8-K formatted in Inline XBRL (included as Exhibit 101) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Compass Therapeutics, Inc. | ||
| Date: August 12, 2024 | By: | /s/ Neil Lerner |
| Neil Lerner | ||
| VP Finance | ||
EXHIBIT 99.1
Compass Therapeutics Reports 2024 Second Quarter Financial Results and Provides Corporate Update
BOSTON, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported second quarter 2024 financial results and provided a business update.
“We are excited to report the achievement of an important milestone in our CTX-009 BTC program with the completion of enrollment in COMPANION-002, our Phase 2/3 trial in patients with BTC,” said Thomas Schuetz, MD, PhD, CEO of Compass and Vice Chairman of the Board of Directors. “In addition, we approved an Investigator Sponsored Trial at The University of Texas MD Anderson Cancer Center, which will evaluate CTX-009 for the first time in the front-line setting in patients with BTC.”
Dr. Schuetz continued, “We are pleased to confirm the CTX-009 monotherapy Phase 1 data in patients with advanced CRC. There is a significant unmet medical need in this patient population; VEGF-targeted therapies have response rates of 1.5% or less and median overall survival is approximately 7 months. Our monotherapy data demonstrate an important efficacy signal in the third- and fourth-line patient populations. In particular, the observed median overall survival with CTX-009 monotherapy is encouraging in this very advanced patient population. Based on these results and the previously reported response data from the Phase 1 trial, we are designing the next study combining CTX-009 with chemotherapy to treat patients with advanced CRC in the second-line setting, selecting patients whose tumors are DLL4-positive. Based on our Phase 1 data, we believe these patients are more likely to respond to therapy with CTX-009. Beyond CTX-009, we continue to execute across our portfolio, with planning underway for a Phase 2 monotherapy study of CTX-471 in patients whose tumors express a potential biomarker of CTX-471 activity. Additionally, our first-in-human study of CTX-8371 is progressing well, having initiated the second dosing cohort.”
DEVELOPMENT PIPELINE UPDATES:
CTX-009 (DLL4 and VEGF-A bispecific antibody)
CTX-471 (CD137 agonist antibody)
CTX-8371 (PD-1 x PD-L1 bispecific antibody)
General Updates
FINANCIAL RESULTS:
Net loss for the quarter ended June 30, 2024, was $13.1 million or $0.10 per share of common stock, compared to $11.3 million or $0.09 per share of common stock for the same period in 2023. Net loss for the six months ended June 30, 2024, was $23.9 million or $0.17 per share of common stock, compared to $19.1 million or $0.15 per share of common stock for the same period in 2023. The company received a $1 million milestone payment based on the completion of a phase 1 trial of CTX-009 in China, reflected as $850 thousand of license revenue (net of sublicense royalty) in the statements of operations.
Research and Development (R&D) Expenses
R&D expenses were $11.2 million for the quarter ended June 30, 2024, as compared to $10.2 million for the same period in 2023, an increase of $1.0 million. This increase was primarily attributable to a $2.5 million increase in clinical costs related to the COMPANION-002 trial, partially offset by $1.8 million less in manufacturing expense for CTX-009. R&D expenses were $20.7 million for the six months ended June 30, 2024, as compared to $16.9 million for the same period in 2023, an increase of $3.8 million. This increase was primarily attributable to a $4.8 million increase in clinical costs related to the COMPANION-002 trial, partially offset by $2.1 million less in manufacturing expense for CTX-009.
General and Administrative (G&A) Expenses
G&A expenses were $4.7 million for the quarter ended June 30, 2024, as compared to $3.1 million for the same period in 2023, an increase of $1.6 million. G&A expenses were $8.0 million for the six months ended June 30, 2024, as compared to $6.2 million for the same period in 2023, an increase of $1.8 million. The quarter and year-to-date increases were due to expenses related to the departure of the CEO in the quarter.
CASH POSITION:
As of June 30, 2024, cash and marketable securities were $146 million as compared to $152 million as of December 31, 2023, which gives a cash runway into the first quarter of 2027.
During the first six months of 2024, Compass decreased its cash position by $6 million, primarily by cash used in operating activities partially offset by $18 million cash received from issuance of stock through its at-the-market offering program.
About CTX-009
CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Preclinical and early clinical data of CTX-009 suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer. Partial responses to CTX-009 as a monotherapy have been observed in heavily pre-treated patients with cancer who were resistant to approved anti-VEGF therapies.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About Compass Therapeutics
Compass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s financial position to continue advancing its product candidates, expectations about cash runway, business and development plans, and statements regarding Compass’s product candidates, including their development and clinical trial milestones such as the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC.
Investor Contact
ir@compasstherapeutics.com
Media Contact
Anna Gifford, Senior Manager of Communications
media@compasstherapeutics.com
617-500-8099
| Compass Therapeutics, Inc. and Subsidiaries | ||||||||||||||||
| Condensed Consolidated Statement of Operations (unaudited) | ||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| License revenue | $ | 850 | $ | — | $ | 850 | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 11,174 | 10,223 | 20,695 | 16,862 | ||||||||||||
| General and administrative | 4,721 | 3,114 | 7,969 | 6,183 | ||||||||||||
| Total operating expenses | 15,895 | 13,337 | 28,664 | 23,045 | ||||||||||||
| Loss from operations | (15,045 | ) | (13,337 | ) | (27,814 | ) | (23,045 | ) | ||||||||
| Other income | 1,969 | 2,059 | 3,951 | 3,930 | ||||||||||||
| Net loss | $ | (13,076 | ) | $ | (11,278 | ) | $ | (23,863 | ) | $ | (19,115 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.10 | ) | $ | (0.09 | ) | $ | (0.17 | ) | $ | (0.15 | ) | ||||
| Basic and diluted weighted average shares outstanding | 137,589 | 126,729 | 137,098 | 126,539 | ||||||||||||
| Compass Therapeutics, Inc. and Subsidiaries | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (In thousands) | ||||||||
| June 30, 2024 | December 31, 2023 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 19,404 | $ | 24,228 | ||||
| Marketable securities | 126,823 | 128,233 | ||||||
| Prepaid expenses and other current assets | 7,319 | 1,420 | ||||||
| Total current assets | 153,546 | 153,881 | ||||||
| Property and equipment, net | 592 | 898 | ||||||
| Operating lease, right-of-use ("ROU") asset | 1,153 | 1,776 | ||||||
| Other assets | 320 | 320 | ||||||
| Total assets | $ | 155,611 | $ | 156,875 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,192 | $ | 4,090 | ||||
| Accrued expenses | 7,227 | 2,514 | ||||||
| Operating lease obligations, current portion | 1,088 | 1,197 | ||||||
| Total current liabilities | 9,507 | 7,801 | ||||||
| Operating lease obligations, long-term portion | — | 536 | ||||||
| Total liabilities | 9,507 | 8,337 | ||||||
| Total stockholders' equity | 146,104 | 148,538 | ||||||
| Total liabilities and stockholders' equity | $ | 155,611 | $ | 156,875 | ||||
Cover |
Aug. 12, 2024 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Aug. 12, 2024 |
| Entity File Number | 001-39696 |
| Entity Registrant Name | Compass Therapeutics, Inc. |
| Entity Central Index Key | 0001738021 |
| Entity Tax Identification Number | 82-4876496 |
| Entity Incorporation, State or Country Code | DE |
| Entity Address, Address Line One | 80 Guest Street, Suite 601 |
| Entity Address, City or Town | Boston |
| Entity Address, State or Province | MA |
| Entity Address, Postal Zip Code | 02135 |
| City Area Code | 617 |
| Local Phone Number | 500-8099 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Common Stock, $0.0001 par value per share |
| Trading Symbol | CMPX |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | true |
| Elected Not To Use the Extended Transition Period | false |