お知らせ • Apr 29

Compass Therapeutics Announces Statistically Significant Benefit of Tovecimig in Companion-002 Study

Compass Therapeutics, Inc. announced that it met the key secondary endpoint of PFS and showed additional compelling results in the randomized COMPANION-002 study, which evaluated tovecimig plus paclitaxel versus paclitaxel alone in patients with unresectable advanced, metastatic or recurrent biliary tract cancer (BTC) treated in the second-line setting. Tovecimig (a DLL4 x VEGF-A bispecific antibody) in combination with paclitaxel demonstrated a highly statistically significant improvement versus paclitaxel alone in the key secondary endpoint of median progression-free survival (PFS) of 4.7 months versus 2.6 months, providing a 56% reduction in the risk of progression (hazard ratio=0.44, p). Secondary endpoint analyses of overall survival (OS) were confounded by both high crossover (54%) and notably prolonged survival in crossover patients randomized to the control arm then treated with tovecimig and, therefore, did not meet statistical significance. In a subset analysis of the patients in the control arm, the median OS of the crossover patients was 12.8 months vs. 6.1 months in patients who did not crossover (hazard ratio=0.54, p=0.04). 85% of patients in the study received tovecimig with a pooled median OS of 8.9 months. Tovecimig in combination with paclitaxel met the primary endpoint of overall response rate (ORR) in the study with an ORR of 17.1% vs. 5.3% in the paclitaxel control arm (p=0.031). The complete dataset, including Duration of Response (DoR), will be presented at a medical conference later this year. Primary Endpoint (previously announced in April 2025): Overall Response Rate: 17.1% ORR for tovecimig in combination with paclitaxel (19 of 111 patients) including one complete response, compared to 5.3% for paclitaxel alone (3 of 57 patients), in patients with BTC in the second line setting. This 11.8% improvement in ORR for those receiving tovecimig was statistically significant (p=0.031). All responses were assessed by blinded independent central review (BICR). Key Secondary Endpoints: Progression-Free Survival (PFS): Tovecimig in combination with paclitaxel demonstrated a statistically significant improvement in median PFS of 4.7 months compared to 2.6 months for paclitaxel alone (HR=0.44, p). In the ITT OS analysis, tovecimig in combination with paclitaxel had a median OS of 8.9 months compared to 9.4 months for the control arm, which included 26 patients (46%) who received paclitaxel alone and 31 patients (54%) who crossed over to receive tovecimig in combination with paclitaxel (HR=1.05, p=0.78). In the rank-preserving structural failure time (RPSFT) OS analysis, the combination also had a median OS of 8.9 months compared to 9.4 months for paclitaxel alone (HR=1.13, p=0.65). Though the RPSFT analysis is intended to adjust for crossover, its validity depends on certain assumptions that were not met in this study and thus its results here are largely uninterpretable. Progression-Free Survival of Crossover Patients (PFS2): An additional, pre-specified secondary endpoint analyzed PFS in the patients in the paclitaxel arm who crossed over to receive tovecimig plus paclitaxel. In this analysis, the pre-crossover PFS (PFS1) on paclitaxel alone was compared to PFS with tovecimig post-crossover (PFS2) in the same crossover patients (n=31). In this subset, tovecimig demonstrated a statistically significant improvement with median PFS2 of 3.5 months after treatment with tovecimig compared to median PFS1 of 1.9 months for paclitaxel (HR=0.36, p=0.0016). Post Hoc Subset Analyses: OS of Paclitaxel Control Arm (Crossover vs. Non-Crossover): In an analysis of OS in all patients randomized to the paclitaxel control arm (n=57), crossover patients who subsequently received tovecimig demonstrated a statistically significant improvement in median OS of 12.8 months compared to 6.1 months for non-crossover patients who received only paclitaxel (HR=0.54, p=0.04). PFS of Paclitaxel Control Arm (Crossover vs. Non-Crossover): Another analysis of these same patients randomized to the paclitaxel control arm (n=57) demonstrated that the crossover patients initially progressed faster on paclitaxel monotherapy compared to the non-crossover patients, with a median PFS of 1.9 months versus 3.6 months (HR=2.31, p=0.007). Thus, notably, despite progressing more quickly on initial paclitaxel monotherapy, crossover patients still demonstrated a statistically significant median 12.8 months OS after being treated with tovecimig. Safety: Tovecimig was generally well tolerated and the safety profile was consistent with previously reported data from prior studies, with no new safety signals. The most commonly reported treatment emergent adverse events in the tovecimig combination arm were hypertension (69%) and fatigue (67%). The most common related treatment-emergent adverse events of Grade 3 or higher included hypertension (44%) and neutropenia (36%). COMPANION-002 is a Phase 2/3 randomized, controlled study of tovecimig in patients with unresectable advanced, metastatic or recurrent biliary tract cancers who have received one prior systemic chemotherapy regimen (clinical trial information: NCT05506943). The study enrolled 168 adult patients, randomized in a 2:1 ratio to receive tovecimig plus paclitaxel (n=111) or paclitaxel alone (n=57). All patients were dosed with 80 mg/m2 of paclitaxel on days 1, 8 and 15 of every 28-day cycle. Patients in the tovecimig arm were also dosed with 10 mg/kg of tovecimig on days 1 and 15 of each 28-day cycle. The primary endpoint of the trial is ORR as confirmed by blinded independent central radiology review and secondary endpoints include PFS, OS, and DoR, among others. Patients in the paclitaxel-only arm who progressed could cross over to the tovecimig plus paclitaxel arm after centrally confirmed progression if they also still met the enrollment criteria for the study.

お知らせ • May 05

Compass Therapeutics, Inc. Reports Positive Interim Phase 2 Data of CTX-009 in Combination with Paclitaxel in Biliary Tract Cancers

Compass Therapeutics, Inc. reported additional interim results from a Phase 2 study of CTX-009 in combination with paclitaxel in patients with biliary tract cancers (BTC). The data show that: CTX-009 demonstrated a 42% overall response rate (ORR) based on 10 patients with Partial Responses (PRs), including 9 PRs confirmed by RECIST 1.1 and 1 PR pending confirmation CTX-009 demonstrated anti-tumor activity in previously treated patients with a clinical benefit rate (CBR) of 92% based on 22 patients with a PR or stable disease (SD) out of 24 enrolled patients CTX-009 was well-tolerated and preliminary safety profile is consistent with prior studies. The Phase 2 study has a Simon Two-Stage adaptive design where three PRs among the first 21 patients enrolled in the first stage of the study will advance the study to the second stage. In November 2021, Compass reported that there were five PRs observed among the first 17 evaluable patients, and therefore, the criteria to advance the study to its second stage was met. The study is currently being conducted at four leading medical centers in Korea. In the United States, an IND was opened in January of 2022 and first patient dose is projected to take place in early Third Quarter 2022. Enrollment All patients enrolled in the study had BTC, classified into four subgroups: intrahepatic cholangiocarcinoma (37.5%), extrahepatic cholangiocarcinoma (12.5%), gallbladder cancer (29.2%) and ampullary cancer (20.8%). As of the data cut-off date April 14, 2022, 24 patients were enrolled and dosed with at least one cycle of CTX-009 and paclitaxel, and 22 were evaluable for response. All patients enrolled in the study have advanced BTC; 45.8% of the patients received one prior therapy and 54.2% of the patients received at least two prior therapies. Almost all patients (95.8%) received gemcitabine/cisplatin. Patients had a median age of 61.5 years, an ECOG performance status of 0 (54.2%) or 1 (45.8%). Preliminary Activity Data CTX-009 exhibited a 42% ORR based on 10 patients with PRs, including nine confirmed PRs by RECIST 1.1 and one PR pending confirmation. Two patients were not evaluable for the purpose of efficacy, and 22 of the 24 patients have had stable disease or better observed leading to a CBR of 92%. As of the cutoff date, seven patients were continuing to receive treatment, including five patients who had been on treatment for over nine months. Preliminary Safety Data CTX-009, in combination with paclitaxel, continues to be well tolerated, consistent with the Phase 1 studies, with hypertension and neutropenia being the most common events related to CTX-009 and paclitaxel, respectively. Of the 24 subjects enrolled in the study, all subjects had at least one AE related to CTX-009 and/or paclitaxel. The most common adverse events (all Grades) occurring in at least three patients were anemia (12.5%), asthenia (25.0%), fatigue (16.7%), edema (16.7%), pyrexia (16.7%), neutropenia (54.2%), thrombocytopenia (20.8%), headache (16.7%), proteinuria (20.8%), dysphonia (12.5%), dyspnea (25%), epistaxis (33.3%), pulmonary hypertension (16.7%, all Grade 1) and hypertension (50.0%). Grade 3 or greater treatment-emergent adverse events (TEAE) occurring in more than one patient include neutropenia (n=12; 50.0%), hypertension (n=4; 16.7%), anemia (n=3; 12.5%) and thrombocytopenia (n=2; 8.3%); all TEAEs were manageable with standard treatment. The Phase 2 trial was designed as a prospective, multi-center, open-label, Simon Two-Stage adaptive design trial to evaluate the use of CTX-009 in combination with paclitaxel for the treatment of patients with BTC. The study enrolled patients with advanced, unresectable, metastatic or recurrent biliary tract cancer with an ECOG performance status of 0 or 1. The initial phase of the trial was conducted in Korea and enrolled 24 subjects at four leading medical centers. All subjects received bi-weekly doses of 10 mg/kg of CTX-009, and paclitaxel, dosed at 80 mg/m2 weekly every three out of four weeks. The primary endpoint for the study is ORR, based on the proportion of subjects whose best overall response is assessed to be Complete Response (CR) or Partial Response (PR) per Independent Radiology review. Secondary outcome measures include assessments of several standard measures of disease progression.

インタレスト・カバレッジ・レシオ	n/a
現金	US$179.88m
エクイティ	US$166.05m
負債合計	US$24.12m
総資産	US$190.17m

データ	最終更新日（UTC時間）
企業分析	2026/08/12 07:22
終値	2026/08/12 00:00
収益	2026/06/30
年間収益	2025/12/31

パッケージ	データ	タイムフレーム	米国ソース例
会社財務	10年	損益計算書キャッシュ・フロー計算書貸借対照表	SECフォーム10-K SECフォーム10-Q
アナリストのコンセンサス予想	+プラス3年	予想財務アナリストの目標株価	アナリストリサーチレポート Blue Matrix
市場価格	30年	株価配当、分割、措置	ICEマーケットデータ SECフォームS-1
所有権	10年	トップ株主インサイダー取引	SECフォーム4 SECフォーム13D
マネジメント	10年	リーダーシップ・チーム取締役会	SECフォーム10-K SECフォームDEF 14A
主な進展	10年	会社からのお知らせ	SECフォーム8-K

アナリスト	機関
Aydin Huseynov	Benchmark Company
Mayank Mamtani	B. Riley Securities, Inc.
Justin Walsh	B. Riley Securities, Inc.

Compass Therapeutics バランスシートの健全性

財務の健全性 基準チェック /56

主要情報

財務の健全性に関する最新情報

We're Not Very Worried About Compass Therapeutics' (NASDAQ:CMPX) Cash Burn Rate

We Think Compass Therapeutics (NASDAQ:CMPX) Can Afford To Drive Business Growth

We Think Compass Therapeutics (NASDAQ:CMPX) Can Afford To Drive Business Growth

We're Hopeful That Compass Therapeutics (NASDAQ:CMPX) Will Use Its Cash Wisely

Companies Like Compass Therapeutics (NASDAQ:CMPX) Are In A Position To Invest In Growth

Recent updates

We're Not Very Worried About Compass Therapeutics' (NASDAQ:CMPX) Cash Burn Rate

Compass Therapeutics, Inc.(NasdaqCM:CMPX) dropped from Russell 3000E Growth Benchmark

Price target decreased by 22% to US$8.82

Insufficient new directors

Compass Therapeutics, Inc., Annual General Meeting, Jun 10, 2026

Compass Therapeutics Announces Statistically Significant Benefit of Tovecimig in Companion-002 Study

New minor risk - Profitability

Forecast to breakeven in 2028

New minor risk - Profitability

Forecast to breakeven in 2028

New major risk - Shareholder dilution

No longer forecast to breakeven

Compass Therapeutics: Exciting Clinical Updates Inbound For 2026

Compass Therapeutics, Inc. Announces Executive Appointments, Effective as of January 1, 2026

Compass Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $100 million.

Forecast to breakeven in 2028

New minor risk - Profitability

New minor risk - Share price stability

New minor risk - Shareholder dilution

Compass Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $119.999329 million.

Compass Therapeutics, Inc. has filed a Follow-on Equity Offering.

New minor risk - Profitability

Compass Therapeutics, Inc., Annual General Meeting, Jun 11, 2025

Compass Therapeutics, Inc. Presents Data on Enhanced Efficacy of Ctx-471 in Combination with Tovecimig in Checkpoint-Refractory Models At the American Association for Cancer Research Annual Meeting

Compass Therapeutics, Inc. Announces First Patient Dosed in an Investigator Sponsored Trial of Tovecimig in the First-Line Setting for Patients with Biliary Tract Cancer

Price target increased by 15% to US$13.10

Compass Therapeutics, Inc. Announces Top-Line Data on the Primary Efficacy Endpoint for COMPANION-002

Compass Therapeutics, Inc. Announces 2024 Accomplishments and 2025 Pipeline Updates

No longer forecast to breakeven

New major risk - Share price stability

Compass Therapeutics, Inc. Announces Advancement of A New Drug Candidate

Forecast to breakeven in 2027

Price target increased by 45% to US$11.00

Compass Therapeutics, Inc. Appoints Barry Shin as Chief Financial Officer

Consensus revenue estimates increase by 49%

New minor risk - Profitability

We Think Compass Therapeutics (NASDAQ:CMPX) Can Afford To Drive Business Growth

Consensus revenue estimates increase by 32%

Price target decreased by 13% to US$8.00

Compass Therapeutics, Inc.(NasdaqCM:CMPX) dropped from Russell 2500 Growth Index

We Think Compass Therapeutics (NASDAQ:CMPX) Can Afford To Drive Business Growth

Compass Therapeutics, Inc. Announces Management Changes

Compass Therapeutics to Present Phase 1 Data for CTX-471, a Novel CD137 Agonist Antibody, Demonstrating Anti-Tumor Activity in Patients Who Have Progressed on Approved PD-1 or PD-L1 Inhibitors at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024

Compass Therapeutics, Inc., Annual General Meeting, Jun 13, 2024

Compass Therapeutics, Inc. Receives FDA Fast Track Designation for the Investigation of CTX-009 in Combination with Paclitaxel for the Treatment of Patients with Metastatic or Locally Advanced Biliary Tract Tumors That Have Been Previously Treated

Compass Therapeutics, Inc. Announces First Patient Dosed in the Phase 1 Study of CTX-8371 in Patients with Solid Tumors

New minor risk - Shareholder dilution

We're Hopeful That Compass Therapeutics (NASDAQ:CMPX) Will Use Its Cash Wisely

Compass Therapeutics, Inc. Announces Chief Executive Officer Changes, Effective January 9, 2024

Compass Therapeutics, Inc. Announces Executive Changes, Effective January 9, 2024

Companies Like Compass Therapeutics (NASDAQ:CMPX) Are In A Position To Invest In Growth

Ankyra Therapeutics Names Robert V. Tighe as Chief Scientific Officer

New major risk - Revenue and earnings growth

New minor risk - Share price stability

Co-Founder recently bought US$80k worth of stock

Co-Founder recently bought US$77k worth of stock

Compass Therapeutics, Inc. Appoints David Wurzer as Class III Director, Member and Chairman of the Audit Committee

Price target increased to US$9.46

Compass Therapeutics, Inc. Announces First Patient Dosed in the Phase 2 U.S. Study of CTX-009 in Patients with Metastatic Colorectal Cancer

Compass Therapeutics, Inc. Announces That the First Patient Has Been Dosed in the Phase 1B Study of CTX-471 in Combination with Keytruda®, Merck’S Anti-PD-1 Therapy

President & COO recently sold US$97k worth of stock

Price target increased to US$9.67

High number of new and inexperienced directors

Compass Therapeutics, Inc. announced that it expects to receive $80.25 million in funding from a group of investors

Compass Therapeutics, Merck ink collaboration deal for early-stage cancer trial

High number of new and inexperienced directors

Compass Therapeutics, Inc. Announces Resignation of Stephen Squinto as Member of the Board of Directors, Effective August 31, 2022

High number of new and inexperienced directors

Co-Founder recently bought US$61k worth of stock

Co-Founder recently bought US$50k worth of stock

財務の健全性基準チェック /56