On March 5, 2021 Compass Therapeutics, Inc. (OTCQB: CMPX), a clinical-stage biotechnology company developing proprietary antibody therapeutics intended to engage the immune system to treat both solid tumors and hematological malignancies, reported fourth quarter and full year 2020 financial results and provided a business update (Press release, Compass Therapeutics, MAR 5, 2021, View Source [SID1234576157]).
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"2020 was a transformational year for Compass," said Thomas J. Schuetz, M.D., Ph.D., co-founder and chief executive officer. "We initiated the dose expansion stage (Phase 1b) of our Phase 1 study for our lead product candidate CTX-471 (CD137 agonist) in September after successfully completing the dose escalation stage of the study in July. Importantly, among the six evaluable patients in the dose expansion stage of the study, who have reached their week 9 evaluation, five patients had stable disease. Subsequently, one of those patients who has advanced small cell lung cancer had a partial response (PR) at week 17. In addition, in the dose escalation stage of the study (Phase 1a) we reported a patient with melanoma of mucosal origin who had a 24% decline in his linear tumor burden. These early signs of anti-tumor activity are encouraging, and we look forward to receiving more CTX-471 data as the study progresses. Top-line data from the Phase 1b stage of the study is expected in the second half of the year, and we could initiate a Phase 2/3 study in the second half of 2022.
"On the financing side, we completed a $60M private placement and became a public reporting company in June 2020. We also recently announced that our common stock has been cleared for trading on the OTCQB tier of the OTC market. These events represent significant achievements for the company as we continue to build the infrastructure to support the future growth of Compass."
Development Pipeline Update and Highlights:
CTX-471, a CD137 Agonist monoclonal antibody:
Completed CTX-471 Phase 1a dose escalation study and found CTX-471 to be generally well-tolerated
Initiated CTX-471 Phase 1b dose expansion study and treated 11 patients in the study as of February 28, 2021
Of the six evaluable patients in the dose expansion part of the study, five patients with advanced solid tumors who have reached their week 9 evaluation had stable disease. Additionally, a patient with advanced small cell lung cancer had a PR at week 17 of the study
Data published in the peer-reviewed Journal of Clinical Investigation Insight (JCI Insight) demonstrated the preclinical monotherapy activity and safety of CTX-471 across various syngeneic tumor models
CTX-8371, a PD-1 X PD-L1 Bispecific:
Initiated IND-enabling studies and the GMP manufacturing campaign
Generated preclinical data that demonstrated the differentiation between CTX-8371 and commercially available single PD-1 blockers, single PD-L1 blockers or combinations of PD-1 and PD-L1 blockers
Initiated preparation of IND submission materials with the goal of submission of the IND in early 2022 and potential for early safety and top-line data later in 2022
Financial Highlights:
Completed $60.5M in gross proceeds ($54.2M net of expenses) private placement financing in combination with reverse merger with a public shell that transitioned the company to a public company and enabled listing of the company stock on the OTC market under the symbol "CMPX"
Established public company reporting process including internal controls over financial reporting
Other Business Updates:
Promoted Vered Bisker-Leib, Ph.D., to Chief Operating Officer in January and President and COO in July
Strengthened our board with the addition of Brett Kaplan as an independent board member and chair of the audit committee of the board and audit committee financial expert
Published preclinical data in the journal Science supporting the potential of CTX-2026, a novel antibody to the butyrophilin BTN3A1 in ovarian cancer tumor models
Based on a review of our pipeline, made a strategic decision to deprioritize the development of our NKp30 innate cell engager platform and discontinued efforts to advance CTX-8573 to IND-enabling studies
Entered into a new lease agreement for our lab and office space and relocated our operations to 80 Guest Street, Boston, MA
Financial Results for Fourth Quarter and Full Year Ended December 31, 2020
Net loss for the full year 2020 was $29.5 million or $0.96 per common share, compared to $34.7 million or $5.19 per common share for the full year 2019. Net loss for the fourth quarter of 2020 was $8.4 million or $0.16 per common share, compared to $6.6 million or $0.95 per common share in the fourth quarter of 2019.
Research and development (R&D) Expenses
R&D expenses were $14.9 million for the full year of 2020, as compared to $22.4 million for the same period in 2019, a reduction of $7.5 million or 34%. The lower costs were principally driven by a strategic reduction in head count and the completion of preclinical efforts for CTX-471. R&D expenses were $4.4 million during the fourth quarter of 2020, as compared to $3.3 million for the same period in 2019, an increase of $1.1 million or 33%. The higher costs were primarily related to manufacturing expenses and toxicological studies for CTX-8371.
General and Administrative (G&A) Expenses
G&A expenses were $12.9 million for the full year 2020, as compared to $11.6 million for the same period in 2019, an increase of $1.3 million or 11%. The higher costs were principally driven by an increase in stock-based compensation expenses and costs associated with the transition of the company from private to public. G&A expenses were $3.5 million during the fourth quarter of 2020, as compared to $3.1 million for the same period in 2019, an increase of $0.4 million or 14%. The higher costs were driven by higher stock-based compensation expenses.
Cash Position
As of December 31, 2020, cash and cash equivalents were $47.1 million as compared to $25.3 million as of December 31, 2019, providing the Company with an anticipated cash runway into the second quarter of 2022. During 2020, the Company increased its cash position through proceeds from financing activities of $48.5 million, primarily from $54.2 million of net proceeds from issuance of common stock, partially offset with loan payments of $5.6 million. The Company used $26.8 million of cash to fund operations.