Compass Therapeutics Reports F – GuruFocus.com

  • The FDA cleared the Investigational New Drug Application for CTX-009 (DLL4 X VEGF-A bispecific) in January, allowing the company to expand the ongoing Phase 2 study in patients with prostate cancer. bile ducts (BTC) in a global study and initiate dosing to patients in the United States in early Q3 2022
  • The company reported interim data from the ongoing Phase 2 study of CTX-009 and paclitaxel in patients with advanced BTC demonstrating an overall response rate (ORR) of 42% and clinical benefit rate ( CBR) of 92% among the first 24 patients recruited and treated with median intermediate study patient duration of approximately 6 months
  • The company has completed enrollment in the Phase 1b monotherapy study of CTX-471 (CD137 agonist) and reported 3 partial responses in patients with advanced solid tumors who received one dose of CTX-471 following progression of a prior PD-1/PD-L1 checkpoint inhibitor
  • CTX-8371 GMP manufacturing campaign has commenced and program is on track for IND in Q1 2023
  • $136.4 million in cash and cash equivalents at the end of the first quarter

BOSTON, May 09, 2022 (GLOBE NEWSWIRE) — Compass Therapeutics, Inc. (CMPX), a clinical-stage biopharmaceutical company focused on oncology and developing proprietary antibody-based treatments to treat multiple human diseases, announced today its financial results for the first quarter of 2022 today.

Development pipeline

CTX-009 (DLL4 and VEGF-A bispecific antibody)

In January, the company announced that the FDA had cleared its IND application for CTX-009, and in May the company released interim results from a Phase 2 study of CTX-009 in combination with the paclitaxel in patients with BTC. The data shows that:

  • CTX-009 demonstrated an overall response rate (ORR) of 42% based on 10 patients with partial responses (PRs), including 9 PRs confirmed by RECIST 1.1 and 1 PR awaiting confirmation
  • CTX-009 demonstrated anti-tumor activity in previously treated patients with a clinical benefit rate (CBR) of 92% based on 22 patients with PR or stable disease (SD) out of 24 patients enrolled
  • CTX-009 was well tolerated and preliminary safety profile is consistent with phase 1 studies

CTX-471 (CD137 agonist)

  • As of February 25, 2022, 49 patients with 15 different cancers have been enrolled in the study and 38 of these patients are evaluable. Of the 38 evaluable patients, 3 patients had PR; the first two have been confirmed by RECIST 1.1 and the third PR is unconfirmed. Additionally, 19 patients achieved stable disease, leading to a preliminary ORR of 8% and CBR of 58%
  • The 3 partial responses observed in the study were one patient with advanced small cell lung cancer, one patient with metastatic melanoma, and one patient with metastatic melanoma of mucosal origin.

CTX-8371 (bispecific antibody PD-1 and PD-L1)

  • CTX-8371 GMP manufacturing campaign has commenced and program is on track for IND in Q1 2023
  • The Company presented preclinical data on CTX-8371 involving a unique mechanism of action (MOA) that involves PD-1 cell surface cleavage, at the 2022 American Association for Cancer Research (AACR) Annual Meeting )

First quarter 2022 financial results

  • Treasury: As of March 31, 2022, cash and cash equivalents were $136.4 million, compared to $39.7 million as of March 31, 2021, providing the company with an expected cash trail through the second half 2024. The company used $7.9 million of cash for fund operations in the first quarter of 2022.
  • Research and development (R&D) expenditure: R&D expenses were $4.4 million for the first quarter ended March 31, 2022, compared to $4.7 million for the same period in 2021, a decrease of $0.3 million or 6%.
  • General and administrative expenses (G&A): General and administrative expenses were $2.7 million for the first quarter ended March 31, 2022, compared to $2.6 million for the same period in 2021, an increase of $0.1 million or 5%.
  • Net loss: Net loss for the first quarter ended March 31, 2022 was $7.2 million or $0.07 per common share, compared to $7.3 million or $0.14 per common share for the same period in 2021.

About Compass Therapeutics

Compass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapies to treat several human diseases. The scientific focus of Compass is the relationship between angiogenesis, the immune system and tumor growth. The Company’s pipeline of novel product candidates is designed to target several critical biological pathways necessary for an effective anti-tumor response. These include modulation of microvasculature via agents targeted to angiogenesis, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and attenuation of immunosuppressive mechanisms used by tumors to escape immune surveillance. Compass plans to advance its product candidates through clinical development as stand-alone therapies and in combination with proprietary pipeline antibodies based on supporting clinical and non-clinical data. The company was founded in 2014 and is based 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. These forward-looking statements include, among other things, references to the Company’s financial condition to continue to advance its product candidates, expectations regarding the Company’s cash flow, business and development plans, and statements regarding the Company’s product candidates, their development, regulatory plans with respect thereto and their therapeutic potential, anticipated interactions with regulatory authorities and anticipated clinical development. Actual results could differ from those projected in the forward-looking statements due to many factors. These factors include, among others, the Company’s ability to raise the additional funds it will need to pursue its business and product development plans, the uncertainties inherent in developing product candidates and operating as a development-stage company, the Company’s ability to identify additional product candidates to develop, the Company’s ability to develop, complete clinical trials, obtain approvals and commercialize any of our product candidates, competition in the industry in which the Company operates and market conditions. These forward-looking statements are made as of the date of this press release, and the Company undertakes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the statements. forward-looking, except as required by law. Investors should review all of the information set forth herein and should also refer to the disclosure of risk factors set forth in the reports and other documents we file with the SEC available at www.sec.gov, including, without s limited to, our Form 10-Q for the quarter ended March 31, 2022, and our subsequent filings with the SEC.

Contact Investor
Vered Bisker-Leib, President and Chief Operating Officer
[email protected]

Media Contact
Anna Gifford, Communications Manager
[email protected]
617-500-8099

Compass Therapeutics, Inc. and its subsidiaries
Consolidated Statement of Income (unaudited)
(In thousands, except per share data)
Quarter ended March 31
2022 2021
Operating costs :
Research and development $ 4,415 $ 4,704
general and administrative 2,767 2,635
Total operating expenses 7,182 7,339
Operating loss (7,182 ) (7,339 )
Other income (expenses) 20 (83 )
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
Compass Therapeutics, Inc. and its subsidiaries
Consolidated balance sheets
(In thousands, except nominal value)
March, 31st,
2022
(unaudited)
The 31st of December,
2021
(checked)
Assets
Current assets:
Cash and cash equivalents $ 136,379 $ 144,514
Prepaid expenses and other current assets 3,904 2,591
Total current assets 140,283 147 105
Property and equipment, net 2,142 2,243
Operating Lease, Right-of-Use Asset (“ROU”) 3,819 4,089
other assets 320 320
Total assets $ 146,564 $ 153,757
Liabilities and equity
Current liabilities:
Accounts payable $ 257 $ 867
Increased expenses 8,050 8,775
Obligations under operating leases, current portion 1,027 989
Total current liabilities 9,334 10,631
Obligations under operating leases, long-term portion 2,740 3,048
Total responsibilities 12,074 13,679
Equity:
Common Stock, $0.0001 par value: 300,000 shares authorized; 101,286 and 101,303 shares issued as of March 31, 2022 and December 31, 2021 respectively; 100,905 and 100,832 shares outstanding as of March 31, 2022 and December 31, 2021, respectively ten ten
Premium 375 231 373,657
Accumulated deficit (240,751 ) (233,589 )
Full shareholder equity 134,490 140,078
Total Liabilities and Equity $ 146,564 $ 153,757

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