CMPX Compass Therapeutics Inc Com
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
CTX-471
Solid Tumors
|
Phase 1
Phase 1
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
Latest News
-
View Full Article Hide Full Article
To Obtain Global Rights to TR009, A Novel bispecific antibody and Inhibitor of the Notch Pathway Targeting DLL4 and VEGF-A
Compass Therapeutics, Inc. (("Compass", OTCQB:CMPX), a clinical-stage biotechnology company developing proprietary antibody therapeutics to treat cancer, and TRIGR Therapeutics, Inc. ("TRIGR"), a private biotechnology oncology company, today announced that the companies have entered into a definitive merger agreement, under which Compass, through a subsidiary, will acquire TRIGR, a private cancer drug development company founded by George Uy, an industry veteran and a former commercial executive at Roche, in a stock-for-stock transaction. Under the terms of the agreement, Compass' subsidiary will acquire all of the outstanding shares of TRIGR. In addition, Miranda Toledano, TRIGR's Chief Financial Officer and Chief Operating Officer, will be joining the Compass Board of Directors. The transaction was unanimously approved by the Boards of Directors of both companies.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210513005892/en/
At the core of this transaction is a differentiated bispecific antibody targeting both DLL4 and VEGF-A, which inhibits both DLL4-mediated Notch signaling and VEGF signaling, which has been renamed CTX-009 (formerly designated TR009/ABL001/NOV1501). CTX-009 has completed a Phase 1 dose escalation study and is in a Phase 1b study in patients with solid tumors in S. Korea, where it has been observed to be well tolerated. In addition, there have been multiple confirmed partial responses (PRs) by RECIST criteria in several tumors in those studies, including PRs in colorectal cancer, cholangiocarcinoma, gastric cancer, and pancreatic cancer. The Phase 1b study in combination with chemotherapy is expected to be completed in the second half of this year. Compass plans to file an IND in the US in H2 2021 and initiate clinical studies in patients with cholangiocarcinoma, ovarian cancer and advanced colorectal cancer. Exclusive global rights to the program, except for S. Korea and China, are held by TRIGR through a license with ABL Bio Inc. (KOSDAQ: 298380). South Korean rights are held by Handok Inc. (KOSDAQ: 002390) and China rights were out-licensed to Elpiscience Biopharmaceuticals Co., Limited, under a license agreement executed on Jan 20th, 2021.
"The time now has come to maximize the therapeutic potential of this promising bispecific antibody, and I am confident that Compass has the management and development capabilities supporting the goal to advance CTX-009 to Phase 2 and Phase 3 studies in multiple indications" said George Uy, TRIGR Founder and Chief Executive Officer. "I am honored to join the Compass board and look forward to CTX-009's success as part of Compass' stellar immunotherapy pipeline" said Miranda Toledano, TRIGR's Chief Operating Officer and Chief Financial Officer.
"CTX-009 presents an important addition to our pipeline of novel therapeutic antibodies and bispecific antibodies. It is uncommon to see multiple confirmed partial responses in a Phase 1 study in such an advanced patient population, and we are excited to begin to develop a robust Phase 2 program to evaluate the therapeutic potential of CTX-009 across all of the indications where this bispecific has shown substantial promise to-date" said Thomas Schuetz, MD, Ph.D., Co-Founder and Chief Executive Officer of Compass Therapeutics. "When we reviewed the data for CTX-009, we immediately saw the fit with our corporate strategy of advancing the best therapeutic candidates forward, regardless of origin" said Vered Bisker-Leib, Compass President and Chief Operating Officer. "We then moved quickly to conduct due diligence and reach agreement on a merger structure designed to deliver enhanced value for the shareholders of both companies".
Under the terms of the agreement, TRIGR will be acquired by Compass' wholly owned subsidiary, Compass Acquisition Company, LLC, subject to certain customary conditions including the consent of the holders of a majority of TRIGR's common shares. Consideration payable to TRIGR shareholders at closing totals an aggregate of 10,265,154 shares of Compass' common stock, issued as unregistered shares in a private placement. In addition, TRIGR shareholders are eligible to receive up to $9 million, representing earnout payments that depend on certain events, including $5 million upon BLA approval of CTX-009 in the United States. Following the issuance of the share consideration, Compass has agreed to register such shares for resale by the recipients thereof. The transaction is expected to close in the second quarter of 2021.
About CTX-009
CTX-009 (formerly designated TR009/ABL001/NOV1501) is an anti-DLL4 X VEGF-A bispecific antibody. In November 2018, TRIGR licensed the exclusive, global rights to CTX-009, outside of South Korea, from ABL Bio, Inc. (KOSDAQ: 298380), a South Korea-based clinical-stage company focused on developing antibody therapeutics. A Phase 1 dose escalation study and a Phase 1b dose expansion monotherapy study have been completed and a Phase 1b combination study is ongoing in S. Korea. Data from CTX-009's Phase 1 dose escalation and dose expansion monotherapy study demonstrates an approximately 20% Overall Response Rate (ORR) at the targeted therapeutic doses, with confirmed partial responses per RECIST criteria in heavily pre-treated colorectal and gastric cancer patients in whom multiple therapies have failed, including VEGF-targeted therapeutics, anti-PD-1/PD-L1 regimens and chemotherapies. Interim results from the ongoing Phase 1b combination study testing the tolerability and activity of CTX-009 in combination with irinotecan or paclitaxel, have also shown deep and sustained partial responses in difficult to treat intrahepatic cholangiocarcinoma (biliary tract cancer) patients in whom multiple lines of therapy have failed. In contrast to historical anti-DLL4 antibodies and other Notch targeted therapies, the administration of CTX-009 has not been associated with severe pulmonary hypertension. Full data from the ongoing Phase 1b studies is expected to be provided later in 2021.
About Compass Therapeutics
Compass Therapeutics is a clinical-stage biopharmaceutical company developing proprietary antibody therapeutics to treat both solid tumors and hematologic malignancies. Compass is leveraging its proprietary StitchMabs™ and common light-chain based multispecific platforms to empirically identify multispecifics and combinations of antibody therapeutics that synergistically modulate key nodes in the immune system. The company's lead product candidate, CTX-471, is a fully human agonistic antibody of CD137, and is currently being evaluated in a Phase 1 study in patients who were previously treated with PD-1/PD-L1 checkpoint inhibitors and who subsequently relapsed or progressed after a period of stable disease. The company offices and labs are based in Boston, Mass. More information can be found at 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 our product candidates and the development and therapeutic potential thereof, our technologies for identifying additional product candidates, our business and development plans, including our planned acquisition of TRIGR, the terms thereof and the intended benefits from such transaction, as well as the planned development and therapeutic potential of CTX-009. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, our ability to complete the planned acquisition of TRIGR and to integrate its product candidates into our pipeline, our ability to develop new pipeline candidates, including CTX-009, and to achieve the intended benefits of the planned acquisition of TRIGR, our ability to identify additional product candidates for development, our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates, and competition in the industry in which we operate 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 we file with the SEC available at www.sec.gov, including without limitation our Form 10-K for the year ended December 31, 2020, and our subsequent filings with the SEC.
Related Links:
http://www.compasstherapeutics.comView source version on businesswire.com: https://www.businesswire.com/news/home/20210513005892/en/
-
View Full Article Hide Full Article
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, today reported fourth quarter and full year 2020 financial results and provided a business update.
"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.
About Compass Therapeutics
Compass Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing proprietary antibody therapeutics intended to engage the immune system to treat both solid tumors and hematologic malignancies. Compass is leveraging its proprietary StitchMabs™ and common light-chain based multispecific platforms to empirically identify multispecifics and combinations of antibody therapeutics that synergistically modulate key nodes in the immune system. The Company's lead product candidate, CTX-471, is a fully human agonistic antibody of CD137, and is currently being evaluated in a Phase 1b study. The Company's offices and labs are located in Boston, MA. Visit website at 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 the Company's financial position to continue advancing its product candidates, expectations about the Company's cash runway, our product candidates and the development and therapeutic potential thereof, our technologies for identifying additional product candidates, and our business and development plans. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, our ability to identify additional product candidates for development, our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates, and competition in the industry in which we operate 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 we file with the SEC available at www.sec.gov, including without limitation our Form 10-K for the year ended December 31, 2020, and our subsequent filings with the SEC.
Compass Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
Three Months Ended
Year Ended
December 31,
December 31,
2020
2019
2020
2019
Operating expenses: Research and development $
4,406
$
3,303
$
14,904
$
22,449
General and administrative 3,544
3,099
12,908
11,603
Loss from operations (7,950
)
(6,402
)
(27,812
)
(34,052
)
Total other income (expense) (441
)
(200
)
(1,656
)
(601
)
Income tax expense —
(10
)
(32
)
(91
)
Net loss $
(8,391
)
$
(6,612
)
$
(29,500
)
$
(34,744
)
Basic and diluted EPS ($0.16
)
($0.95
)
($0.96
)
($5.19
)
Weighted average shares outstanding 51,052
6,956
30,776
6,691
Compass Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
December 31,
2020
2019
Cash and cash equivalents $
47,076
$
25,303
Total assets 51,911
30,381
Total debt 9,334
14,869
Total Liabilities 11,966
19,114
Total stockholders' equity (deficit) 39,945
(118,603
)
View source version on businesswire.com: https://www.businesswire.com/news/home/20210305005342/en/
-
View Full Article Hide Full Article
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, today announced that Thomas Schuetz, MD, PhD, Co-Founder and Chief Executive Officer of Compass Therapeutics, will participate in the following virtual investor conferences:
- H.C. Wainwright Global Life Sciences Conference, March 9-10, 2021: Compass presentation will be broadcasted at 7:00 a.m. EST on March 9, 2021 and available on demand during the conference.
- 33rd Annual Roth Conference, March 15-17, 2021: as part of a live panel on bispecific antibodies that will take place at 3:00 p.m. EDT on Tuesday, March 16, 2021.
A replay of Compass presentation will be available after the completion of the H.C. Wainwright Global Life Sciences Conference in the "Investors – Events and Presentations" tab on the Compass website www.compasstherapeutics.com.
About Compass Therapeutics
Compass Therapeutics, Inc. (OTCQB:CMPX), is a clinical-stage biopharmaceutical company developing proprietary antibody therapeutics intended to engage the immune system to treat both solid tumors and hematologic malignancies. Compass is leveraging its proprietary StitchMabs™ and common light-chain based multispecific platforms to empirically identify multispecifics and combinations of antibody therapeutics that synergistically modulate key nodes in the immune system. The company's lead product candidate, CTX-471, is a fully human agonistic antibody of CD137, and is currently being evaluated in a Phase 1b study. The Company's offices and labs are located in Boston, MA. Its website is at 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 our product candidates and the development and therapeutic potential thereof, our technologies for identifying additional product candidates, and our business and development plans. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, our ability to identify additional product candidates for development, our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates, and competition in the industry in which we operate 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 we file with the SEC available at www.sec.gov, including without limitation our Form 10-Q for the quarter ended September 30, 2020, and our subsequent filings with the SEC.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210304006143/en/
-
View Full Article Hide Full Article
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, announced today that shares of the company's common stock have been cleared for trading on the OTCQB Venture Market in the United States. The Company's shares will trade under the ticker symbol "CMPX", effective at the market open on March 5, 2021.
About Compass Therapeutics
Compass Therapeutics is a clinical-stage biopharmaceutical company developing proprietary antibody therapeutics intended to engage the immune system to treat both solid tumors and hematologic malignancies. Compass is leveraging its proprietary StitchMabs™ and common light-chain based multispecific platforms to empirically identify multispecifics and combinations of antibody therapeutics that synergistically modulate key nodes in the immune system. The company's lead product candidate, CTX-471, is a fully human agonistic antibody of CD137, and is currently being evaluated in a Phase 1 study in patients who were previously treated with PD-1/PD-L1 checkpoint inhibitors and who subsequently relapsed or progressed after a period of stable disease. The company's offices and labs are located in Boston, MA. Its website is at 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, the commencement of trading on OTCQB, references to our product candidates and the development and therapeutic potential thereof, our technologies for identifying additional product candidates, and our business and development plans. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, our ability to identify additional product candidates for development, our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates, and competition in the industry in which we operate 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 we file with the SEC available at www.sec.gov, including without limitation our Form 10-Q for the quarter ended September 30, 2020, and our subsequent filings with the SEC.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210304006114/en/