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Item 1. Business

2025-02-27 compared with 2024-03-21 · 179 added, 334 removed, 648 unchanged (44% of the section changed)

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We plan to advance our product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data.

Our pipeline is comprised of three product candidates.

Our lead product candidate, CTX-009, is a bispecific antibody targeting Delta-like ligand 4 (“DLL4”), a ligand of Notch-1, and vascular endothelial growth factor A (“VEGF-A”).

Our pipeline comprises three clinical product candidates and one candidate in investigational new drug application (“IND”) enabling studies.

Our lead product candidate, tovecimig (formerly known as CTX-009), is a bispecific antibody targeting Delta-like ligand 4 (“DLL4”), a ligand of Notch-1, and vascular endothelial growth factor A (“VEGF-A”).

Simultaneous blockade of the VEGF-A and the Notch pathways is known to turn productive angiogenesis into non-productive angiogenesis, which leads to tumor shrinkage and apoptosis.

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Our third program, CTX-8371, is a bispecific antibody targeting the programmed cell death protein-1 (“PD-1”), an inhibitory immune checkpoint receptor and its ligand PD-L1, two validated immune-oncology targets.

CTX-009, our bispecific antibody targeting DLL4 and VEGF-A, is currently undergoing clinical studies as a monotherapy and in combination with chemotherapy in the United States.

We currently have two open U.S.

clinical trials with CTX-009:

a Phase 2 trial of CTX-009 as monotherapy in patients with metastatic colorectal cancer (“CRC”) who received two or three prior treatment regimens and a randomized Phase 2/3 trial of CTX-009 in combination with paclitaxel in patients with biliary tract cancer (“BTC”) who received one prior treatment regimen.

The two initial indications of BTC and CRC for CTX-009 were selected based on the results of the Phase 1,1b and 2 clinical trials and the significant unmet need for effective therapeutic regimens in these patient populations.

There are an estimated 18,600 patients diagnosed with BTC in the U.S.

each year and over 200,000 patients worldwide.

Patients with BTC have a poor prognosis despite first line treatment with chemotherapy and immunotherapy, and no accepted standard of care in later treatment lines.

In addition, we are in the process of IND enabling studies with CTX-10726, a bispecific antibody targeting PD-1 and VEFG-A.

Tovecimig (CTX-009), our bispecific antibody targeting DLL4 and VEGF-A, is currently being evaluated in a randomized Phase 2/3 trial in the United States in combination with paclitaxel in patients with biliary tract cancer (“BTC”) who received one prior treatment regimen.

We expect top-line data from this study at the end of the first quarter of 2025.

In August 2024, we also announced that tovecimig demonstrated a 5% overall response rate (“ORR”) as a monotherapy in our Phase 2 study of patients with advanced, metastatic colorectal cancer (“CRC”).

The two initial indications of BTC and CRC for tovecimig were selected based on the results of the Phase 1,1b and 2 clinical trials and the significant unmet need for effective therapeutic regimens in these patient populations.

We estimate that there are approximately 23,000 patients diagnosed with BTC in the United States each year and over 200,000 patients worldwide.

Patients with BTC have a poor prognosis despite first-line treatment with chemotherapy and immunotherapy, and there is no generally accepted standard of care in later lines of treatment, except for therapies for targeted mutations, which is estimated to be approximately 15% of the market.

For CRC, there are approximately 153,000 new patients diagnosed each year in the United States and more than 1.9 million patients worldwide.

Despite advances in treatment of CRC in recent years with angiogenesis inhibitors and targeted therapies, there are few safe and effective treatment options for patients with CRC, and the majority of the patients are refractory to existing therapeutic regimens or relapse quickly and advance to later lines of therapy where treatment options are even more limited.

We intend to expand the development of CTX-009 to additional tumor types with significant unmet need such as ovarian cancer and gastric cancer, among others.

Following the generation of positive clinical data in later lines of therapy, we plan on studying CTX-009 in earlier settings in all indications where the data support it.

CTX-471, our CD137 agonistic antibody, is undergoing a two-part clinical trial.

A Phase 1a trial of CTX-471 as monotherapy in patients with solid tumors who were previously treated with at least one checkpoint blocker and showed benefit for 3 months or more but ultimately progressed is fully enrolled and nearing completion.

As of January 31, 2024, there is one patient remaining on treatment.

In addition, a Phase 1b trial of CTX-471 in combination with the PD-1 inhibitor KEYTRUDA® in patients with selected solid tumors began in November 2022.

The dose-escalation part of the study has been fully enrolled and enrollment in the dose expansion cohorts has begun.

In the expansion cohort part of the study, we plan to enroll 60 patients with melanoma, non-small cell lung cancer (“NSCLC”) and small cell lung cancer (“SCLC”), who will randomly receive one of two doses.

CTX-471 targets a key node of the immune system with the goal of identifying a next generation immune-oncology treatment for the majority of patients who do not have a sustained response to current therapies across a variety of cancers.

We also intend to expand the development of tovecimig to additional indications with significant unmet need such as ovarian cancer and gastric cancer.

Following the generation of positive clinical data in later lines of therapy, we plan to study tovecimig in earlier settings in all indications where the data support it.

CTX-471, our CD137 agonistic antibody, targets a key node of the immune system with the goal of becoming a next generation immune-oncology treatment for patients across a variety of cancers who do not have a sustained response to current therapies.

During its early clinical development, CTX-471 demonstrated monotherapy activity in the post-PD-1/PD-L1 patient population across three solid tumor indications:

melanoma, small cell lung cancer and mesothelioma.

In the ongoing Phase 1b combination trial of CTX-471 with KEYTRUDA® we are looking to restore responses in patients who were previously treated with a checkpoint inhibitor, initially responded, but then progressed.

The hypothesis we are testing is whether the addition of CTX-471 to KEYTRUDA® will restore responses in those patients.

This trial is being conducted in patients with one of the following solid tumors:

melanoma, non-small cell lung cancer and small cell lung cancer.

Restoration of meaningful responses in one or more of those indications can help shape the regulatory path for CTX-471.

Our third program, CTX-8371, a bispecific antibody targeting PD-1 and PD-L1, is currently in a first-in-human Phase 1 clinical trial.

We filed an investigational new drug application (“IND”) for CTX-8371 in the third quarter of 2023 and the IND was cleared by the FDA in the fourth quarter of 2023.

The study is now open in the U.S.

with the first patient expected to be dosed in the clinical trial by early second quarter 2024.

CTX-8371 emerged from an unbiased screen conducted with our StitchMabs TM platform.

We have subsequently tested CTX-8371 in several in vitro and in vivo models where it demonstrated enhanced activation of immune responses when compared with commercially available checkpoint blockers.

We believe that CTX-8371 has a potential to become a next generation checkpoint inhibitor with improved activity across various solid tumors relative to approved checkpoint blockers.

Additionally, we are in the process of preclinically evaluating proprietary combination regimens of CTX-8371 with our other product candidates, CTX-009 and CTX-471.

In the fourth quarter of 2023 we announced a CEO succession plan;

Vered Bisker-Leib, who was previously Compass President and COO, transitioned to Compass Chief Executive Officer and joined Compass board of directors and Thomas Schuetz, MD, PhD, Compass’ Scientific Founder and previously Chief Executive Officer, transitioned to President of Research and Development and appointed Vice Chair of the Compass board of directors.

The transition took place on January 9, 2024.

Our management team has a successful track record of building and growing biotechnology companies.

Our Chief Executive Officer, Vered Bisker-Leib, Ph.D., M.B.A., has over 20 years of experience in strategy, finance, business development, and operations of biotechnology and pharmaceutical companies.

Under her financial leadership, Compass completed public and private financing transactions that generated more than $290 million in total proceeds since 2020.

Bisker-Leib identified and led the acquisition of TRIGR Therapeutics in a stock-for-stock transaction, which resulted in the addition of CTX-009 to the Compass’ pipeline.

Bisker-Leib is also a board member of Ayala Pharmaceuticals.

Prior to joining Compass Therapeutics, she served as an entrepreneur-in-residence with Atlas Venture.

Previously, Dr.

Bisker-Leib was chief business officer of Cydan (a biotech accelerator) and served as an executive director and global head of business development for the cardiovascular and metabolic franchises of Bristol-Myers Squibb.

Our President of Research and Development and Co-Founder, Thomas J.

Schuetz, M.D., Ph.D.

has over 30 years of experience in oncology, biopharmaceutical drug development and life science venture investing.

Prior to co-founding Compass Therapeutics, Dr.

Schuetz was a venture partner with OrbiMed Advisors LLC where he participated in OrbiMed’s investments in Enobia Pharma (sold to Alexion), Relypsa (sold to Galenica), Arteaus Therapeutics (sold to Eli Lilly), and Audentes (sold to Astellas) and served on the board of each of these companies.

Schuetz was also the chief medical officer of Therion Biologics Corporation and was vice president of clinical affairs at Transkaryotic Therapies, a company acquired by Shire.

melanoma, small cell lung cancer (“SCLC”) and mesothelioma.

The Phase 1 program, which included one complete response, also identified a potential biomarker of activity for CTX-471, neural cell adhesion molecule (NCAM or CD56).

We expect to initiate a Phase 2 basket study of CTX-471 in patients with NCAM+ tumors in mid-2025.

CTX-8371, our bispecific antibody targeting PD-1 and PD-L1, is currently in a first-in-human Phase 1 clinical trial.

CTX-8371 emerged from an unbiased screen for synergy conducted with our StitchMabs TM platform.

We subsequently tested CTX-8371 in several in vitro and in vivo models where it demonstrated enhanced activation of immune responses when compared with commercially available checkpoint blockers.

We believe that CTX-8371 has the potential to become a next generation checkpoint inhibitor with improved activity across various solid tumors relative to approved checkpoint blockers.

We expect to complete our Phase 1 study of CTX-8371 in the second half of 2025.

Finally, CTX-10726, our bispecific antibody targeting PD-1 and VEGF-A, is currently in IND enabling studies, with an IND filing expected by year end 2025.

CTX-10726 is a fully human IgG1 with silenced Fc-γ receptor binding that was discovered and developed in-house.

We expect to accelerate the development of CTX-10726 by leveraging our experience developing and manufacturing bispecific structures containing VEGF-A (tovecimig) and PD-1 (CTX-8371) components.

The figure below details our pipeline of product candidates.

CTX-009, CTX-471 and CTX-8371.

Our scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth.

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Our strategy to achieve this goal includes:

Advance our product candidate, CTX-009 (DLL4 x VEGF-A bispecific antibody), through clinical development to drug approval in multiple indications, either as a monotherapy or in combination with other therapies .

CTX-009 is an investigational bispecific antibody that simultaneously blocks the DLL4 and VEGF-A signaling pathways, which are critical to angiogenesis and tumor vascularization.

We chose BTC and CRC as our first indications based on a number of factors, including CTX-009 activity observed in the Phase 1, 1b and 2 clinical trials and lack of effective therapies for these patient populations.

We have initiated a Phase 2 trial of CTX-009 in patients with advanced colorectal cancer and a randomized Phase 2/3 trial of CTX-009 in combination with paclitaxel in patients with BTC.

Additionally, we intend to explore the potential of CTX-009 in other indications where the data support its potential therapeutic benefit such as ovarian cancer, gastric cancer, pancreatic cancer, renal cell cancer, liver cancer, neuroendocrine cancer and more.

We are also developing a plan to study the combination of CTX-009 with our other product candidates, CTX-8371 and CTX-471.

Advance our product candidate, CTX-471 (CD137 agonist antibody), through clinical development to evaluate its therapeutic potential alone and in combination with other therapies, and define a regulatory pathway for approval.

We seek to translate the antitumor activity of CTX-471 observed in preclinical testing and in our Phase 1 trial into meaningful clinical results in patients with solid tumors, such as SCLC, NSCLC and melanoma.

Our first Phase 1a clinical trial was conducted in patients who relapsed or progressed after at least three months of stable disease on prior checkpoint therapies.

As of January 31, 2024, one patient remains on trial.

Additionally, in November 2022, we dosed the first patient in a Phase 1b trial of CTX-471 in combination with KEYTRUDA®.

Patients enrolled in the trial will be treated with CTX-471 in combination with KEYTRUDA® with the goal of restoring response.

The dose-escalation portion of the study has been fully enrolled and enrollment in the dose expansion cohorts has begun.

In the dose expansion cohorts, we plan on enrolling 60 patients with melanoma, NSCLC and SCLC, who will randomly receive one of two doses.

This trial is enrolling patients with metastatic or locally advanced NSCLC, melanoma, and SCLC who have progressed after treatment with a checkpoint inhibitor.

Advance our product candidate, tovecimig (DLL4 x VEGF-A bispecific antibody), through clinical development and potential commercialization for multiple indications .

Tovecimig is an investigational bispecific antibody that simultaneously blocks the DLL4 and VEGF-A signaling pathways, which are critical to angiogenesis and tumor vascularization.

We chose BTC and CRC as our first indications based on a number of factors, including tovecimig’s activity observed in the Phase 1, 1b and 2 clinical trials and the lack of effective therapies for these patient populations.

We completed enrollment of a randomized Phase 2/3 trial of tovecimig in combination with paclitaxel in patients with BTC and a Phase 2 trial of tovecimig in patients with advanced CRC.

In addition, an investigator sponsored trial of tovecimig in the first-line setting in combination with gemcitabine/cisplatin and durvalumab in patients with BTC was initiated in the first quarter of 2025.

We intend to explore the potential of tovecimig in other indications where the data support its potential therapeutic benefit such as ovarian cancer, gastric cancer, renal cell cancer, and liver cancer.

Advance our product candidate, CTX-471 (CD137 agonist antibody), through clinical development to evaluate its therapeutic potential and define a regulatory pathway for approval.

Our Phase 1a clinical trial was conducted in patients who relapsed or progressed after at least three months of a prior checkpoint therapy.

As of January 31, 2025, two patients remain on trial.

During the Phase 1a trial, we identified a potential biomarker of activity, neural cell adhesion molecule (NCAM or CD56), which we intend to use in a Phase 2 basket study of CTX-471, expected to start in mid-2025.

Advance CTX-8371 (PD-1 x PD-L1 bispecific antibody) through clinical development as a next generation checkpoint inhibitor.

CTX-8371 , our bispecific inhibitor that targets PD-1 and PD-L1, has demonstrated better antitumor activity in preclinical experiments than a single PD-1, a single PD-L1, or combinations of PD-1 and PD-L1 inhibitors.

We submitted an IND to the FDA in the third quarter of 2023 and the FDA cleared the IND for CTX-8371 in the fourth quarter of 2023 allowing us to initiate a first-in-human Phase 1 clinical trial.

The study is now open in the U.S.

and we expect to dose the first patient in this study by early second quarter 2024.

CTX-8371 has demonstrated better antitumor activity in preclinical experiments than a single PD-1, a single PD-L1, or combinations of PD-1 and PD-L1 inhibitors.

We initiated a first-in-human Phase 1 clinical trial with the first patient dosed in April 2024.

As of January 2025, the third cohort of this trial completed with no dose limiting toxicities observed.

Advance CTX-10726 (PD-1 x VEFG-A bispecific antibody) through IND-enabling studies and clinical development.

CTX-10726 was developed at Compass leveraging our experience with the VEGF-A component of tovecimig and the PD-1 component of CTX-8371.

We are currently performing IND enabling studies and anticipate filing an IND by year end 2025.

Seek strategic partnerships for select product candidates.

Our technology platform is designed to generate a broad pipeline of product candidates with high potential for clinical application.

We intend to assess on a case-by-case basis the opportunities for accelerating the preclinical and clinical development of these candidates in a capital-efficient manner, including selectively pursuing strategic partnerships with leading biopharmaceutical companies with domain-specific clinical development expertise to maximize the value of our pipeline.

We intend to assess on a case-by-case basis the opportunities for accelerating the preclinical development, clinical development and commercialization of these candidates in a capital-efficient manner, including selectively pursuing strategic partnerships with leading biopharmaceutical companies with domain-specific clinical development and commercial expertise to maximize the value of our pipeline.

Product Candidates

We currently have three product candidates in the clinical stage of development:

CTX-009, CTX-471 and CTX-8371.

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

CTX-009 (a.k.a.

ABL001) is an investigational bispecific antibody that is designed to simultaneously block the DLL4 and VEGF-A signaling pathways, which are critical to angiogenesis and tumor vascularization.

Preclinical and early clinical data of CTX-009 as a monotherapy and in combination with chemotherapy suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumor indications, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer.

CTX-009 is undergoing clinical development in patients with advanced solid tumors in the United States.

A Phase 1 dose escalation and dose expansion monotherapy trial in patients with solid tumors, a Phase 1b trial of CTX-009 in combination with chemotherapy and a Phase 2 trial of CTX-009 in combination with chemotherapy in patients with advanced biliary tract cancer were completed in South Korea.

Data from the Phase 2 trial were presented at ASCO GI in January 2023.

We currently have two open clinical trials in the United States:

a Phase 2 trial of CTX-009 in patients with advanced colorectal cancer and a randomized Phase 2/3 trial of CTX-009 in combination with paclitaxel in patients with advanced biliary tract cancer.

We have licensed exclusive global rights to CTX-009, outside of South Korea, from ABL Bio, Inc.

tovecimig, CTX-471 and CTX-8371.

Additionally, we have one product candidate in IND enabling studies, CTX-10726.

Tovecimig (DLL4 X VEGF-A bispecific antibody)

Tovecimig (formerly known as CTX-009) is an investigational bispecific antibody that is designed to simultaneously block the DLL4 and VEGF-A signaling pathways, which are critical to angiogenesis and tumor vascularization.

Preclinical and early clinical data of tovecimig as a monotherapy and in combination with chemotherapy suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumor indications, including colorectal, gastric, cholangiocarcinoma, pancreatic and NSCLC.

Tovecimig is undergoing clinical development in patients with advanced solid tumors in the United States.

A Phase 1 dose escalation and dose expansion monotherapy trial in patients with solid tumors, a Phase 1b trial of tovecimig in combination with chemotherapy and a Phase 2 trial of tovecimig in combination with chemotherapy in patients with advanced biliary tract cancer were completed in South Korea.

Data from the Phase 2 trial were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (“ASCO GI”) in January 2023.

We are currently conducting a randomized Phase 2/3 trial of tovecimig in combination with paclitaxel in patients with advanced BTC.

We have licensed exclusive global rights to tovecimig, outside of South Korea, from ABL Bio, Inc.

(“ABL Bio”), a South Korea-based clinical-stage company focused on developing antibody therapeutics.

South Korean rights are held by Handok Pharmaceuticals, Inc.

(“Handok”) and China rights were out-licensed from the Company to Elpiscience Biopharmaceuticals Co., Limited (“Elpiscience”).

Monotherapy Clinical Trial of CTX-009

An open-label, Phase 1 dose escalation and expansion trial designed to identify the optimal dose and to evaluate the safety, tolerability, pharmacokinetics (“PK”), pharmacodynamics and the anti-tumor activity of CTX-009 in patients with advanced solid tumors after failure of standard of care treatment was conducted by ABL Bio in South Korea.

This trial consisted of a Phase 1a monotherapy dose escalation arm and a Phase 1b dose expansion arm.

The trial was initiated in September 2017 and enrollment was completed in February 2021.

The dose escalation portion of the trial followed a traditional 3+3 dosing scheme where CTX-009 was administered by intravenous infusion across nine dose cohorts ranging from 0.3 to 17.5 mg/kg biweekly.

Patients were enrolled in two arms:

a Phase 1a dose escalation arm and a Phase 1b dose expansion arm.

The expansion cohorts were 7.5, 10, 12.5 and 15 mg/kg.

Patient tumor volumes were measured using CT scans at baseline and then every eight weeks.

Patient Demographics .

A total of 45 patients were enrolled in the trial with advanced solid tumors that had been heavily pretreated, with a median of four prior lines of therapy.

The median age of the patients was 53 years old and 54% of the patients were male and 46% female.

Importantly, 75% of the patients had been previously dosed with anti-VEGF therapy.

Most patients enrolled in the trial had either advanced colorectal cancer or advanced gastric cancer.

Safety Data Summary .

A total of 45 patients were enrolled in the trial and received at least one dose of CTX-009.

The dose escalation portion of the trial took place without interruption, and the highest dose arm was 17.5 mg/kg.

Importantly, the maximal tolerated dose was not determined in this trial.

CTX-009 was observed to be generally well-tolerated.

There were 44 Treatment Related Adverse Events (“TRAEs”) observed in more than 5% of the 45 patients enrolled.

The most prominent TRAE was hypertension, which was observed in 37.8% of the patients.

Grade 3 or higher TRAEs observed in over 5% of the patients include a total of 11 Grade 3 events, the most frequent being hypertension observed in 15.6% of the patients, followed by gastrointestinal disorders, observed in 4.4% of the patients, followed by general disorders and nervous system disorders, observed in 2.2% of the patients each.

A summary of the TRAEs observed in over 5% of the patients is depicted in the table below.

Treatment-related adverse events observed in > 5% of patients

Hypertension*

General disorders (fatigue, fever, asthenia, edema, etc.)

Nervous system disorders (headache, dizziness)

Gastrointestinal disorders (nausea, vomiting, etc.)

Pulmonary hypertension

* Hypertension is a well-known side effect of anti-VEGF blockers.

In clinical trials of bevacizumab, incidence of Grade 3-4 hypertension ranged between 5%-18% (as indicated in the label).

Hypertension is typically managed by anti-hypertensive drugs.

Activity Data Summary.

A total of 40 out of the 45 patients enrolled in the trial were evaluable for the purpose of determination of anti-tumor activity of CTX-009 since five patients did not reach their first scan at week eight due to progressive disease ("PD") or for other reasons.

Responses started to emerge at the 10 mg/kg dose level.

Sixteen of the 40 evaluable patients were dosed at the 10 or 12.5 mg/kg dose levels, which represent what we project to be the efficacious dose levels.

Among those 16 patients, there were three partial responses ("PRs") confirmed by RECIST 1.1 with an overall response rate ("ORR") of 18.8% and eight patients with stable disease (“SD”), with a clinical benefit rate ("CBR") of 68.8%.

Two of the three PRs were in patients with advanced colorectal cancer and one of the three PRs was in a patient with advanced gastric cancer.

In addition, one of the patients with gastric cancer had a 35% decline in tumor mass relative to baseline.

However, that regression was not confirmed upon a second CT scan, and hence not included in the ORR, and the best response of this patient included in the data set is stable disease.

The average time to progression (“TTP”) of the advanced colorectal cancer patients treated at the 10 or 12.5 mg/kg was 6.7 months, and the average TTP of the advanced gastric cancer patients treated at the 10 or 12.5 mg/kg was 3.9 months

Phase 1 monotherapy trial:

expansion cohorts (10 and 12.5 mg/kg)

Monotherapy expansion cohorts (10 and 12.5 mg/kg)

Prior VEGF target therapy

Median time to progression (“TTP”)

Colorectal cancer

Gastric cancer

A waterfall plot depicting the best responses for each of the 40 evaluable patients is presented below.

Combination Clinical Trial of CTX-009

An open-label, combination Phase 1b clinical trial to evaluate the safety, PK, anti-tumor activity and the recommended Phase 2 dose (“RP2D”) of CTX-009 in combination with paclitaxel or irinotecan chemotherapy was conducted by ABL Bio and Handok in South Korea.

This trial was initiated in June 2020, enrollment was completed in December 2020, and the trial was completed in November 2021 (clinicaltrials.gov identifier NCT04492033).

The trial includes two cohorts, each of which is divided into two groups.

The first cohort was administered 10 or 12.5 mg/kg of CTX-009 on a biweekly basis, in combination with 80 mg/m 2 paclitaxel administered weekly.

The second cohort was administered 10 or 12.5 mg/kg of CTX-009 in combination with 150 mg/m 2 irinotecan on a biweekly basis.

Patient Demographics .

A total of 17 patients were enrolled in the trial.

Patients enrolled in the trial were heavily pretreated, and the trial included patients with advanced cholangiocarcinoma, colorectal, pancreatic, gastric and other cancers with a median of three prior lines of therapy.

Safety Data Summary .

In general, CTX-009 was observed to be well-tolerated.

Adverse Events (“AEs”) that were determined to be probably or possibly related to CTX-009 treatment included Grade 3 hypertension observed in four patients (24%).

Other AEs observed were Grade 3 neutropenia (12%), Grade 3 anemia (18%) and Grade 3 thrombocytopenia (12%), which were all attributed to the concomitant chemotherapy agent (paclitaxel or irinotecan).

Pulmonary hypertension was monitored carefully in the trial via measurement of BNP levels and echocardiograms, and there were five Grade 1 pulmonary hypertension events, all of which resolved.

A summary of the TRAEs is depicted in the table below:

Drug-related adverse events

observed in > 1 patient

Thrombocytopenia*

Pulmonary hypertension (all grade 1)

Gingival edema (mucositis)

Anal hemorrhage

*Labeled Grade 3/4 cytopenia events for concomitant chemotherapy agent:

31.4% neutropenia, 4.5% anemia, 1.7% thrombocytopenia

52% neutropenia, 16% anemia, 7% thrombocytopenia

Activity data summary .

Of the 17 patients enrolled, there were four PRs, including three PRs that were confirmed by RECIST 1.1 and one PR which was unconfirmed, representing a 23.5% ORR and nine patients with SD, representing a CBR of 76.5%.

The unconfirmed PR was in a patient with NSCLC who was on the trial for over a year with a measurable tumor decline.

Of the four patients with advanced cholangiocarcinoma enrolled in the trial, there were two PRs confirmed by RECIST 1.1 with 41% and 62% declines in tumor burden, respectively, representing an ORR in cholangiocarcinoma of 50%.

A third patient with cholangiocarcinoma had stable disease with 28% decline in the patient’s tumor burden, and therefore the CBR observed in cholangiocarcinoma is three out of four, or 75%.

The responses in cholangiocarcinoma were particularly durable with a median duration of response, or DOR, of 9.7 months.

A waterfall plot depicting the best responses for each of the 17 evaluable patients in the Phase 1b trial is presented below.

Summary of Clinical Activity of CTX-009 at the RP2D

The observed ORR of CTX-009 at the 10 and 12.5 mg/kg doses were 18.8% (3/16) as a monotherapy and 23.5% (4/17) in combination with chemotherapy.

The CBR of CTX-009 at the 10 and 12.5 mg/kg were 68.8% (11/16) as a monotherapy and 76.5% (13/17) in combination with chemotherapy

On October 8, 2021, we, along with ABL Bio, presented clinical trial data from the CTX-009 Phase 1a/1b dose escalation and dose expansion trial at a plenary oral session during the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Abstract Number:

(“Handok”) and China rights were out-licensed from us to Elpiscience Biopharmaceuticals Co., Limited (“Elpiscience”).

Phase 1 Summary of Clinical Activity of Tovecimig at the Recommended Phase 2 Dose ( RP2D ) – South Korea

The observed ORR of tovecimig at the 10 and 12.5 mg/kg doses were 18.8% (3/16) as a monotherapy and 23.5% (4/17) in combination with chemotherapy.

The clinical benefit rate (“CBR”) of tovecimig at the 10 and 12.5 mg/kg were 68.8% (11/16) as a monotherapy and 76.5% (13/17) in combination with chemotherapy.

In October 2021, we, along with ABL Bio, presented clinical trial data from the tovecimig Phase 1a/1b dose escalation and dose expansion trial at a plenary oral session during the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Abstract Number:

Session title:

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The significant findings presented were as follows:

CTX-009 was generally well-tolerated and demonstrated single agent activity in heavily pre-treated patients with solid tumors who were resistant to anti-VEGF therapies, mostly of colorectal and gastric origins

The maximum tolerated dose (“MTD”) was not reached, and the RP2D of CTX-009 were determined to be 10.0 and 12.5 mg/kg biweekly

ORR of CTX-009 as a monotherapy across all doses tested (0.3 – 17.5 mg/kg) was 8% and the CBR was 62% in patients treated at the 3rd and 4th line settings

Treatment with CTX-009 as a monotherapy at the RP2D (10.0 mg/kg and 12.5 mg/kg) led to 18.8% (n=3/16) ORR, not including an additional unconfirmed PR, and a 68.5% CBR (n=11/16)

Data from Combination Clinical Trial of CTX-009 in BTC in South Korea

A Phase 2 trial of CTX-009 in combination with paclitaxel was initiated by Handok in the first quarter of 2021 in patients with BTCs.

The study has been completed and final data analysis has begun.

The trial enrolled patients with unresectable advanced, metastatic, or relapsed BTCs who had received one or two prior systemic therapies.

This Phase 2 trial utilizes a Simon Two-Stage adaptive design where the criteria to advance to the second stage of the trial was three PRs observed in 21 evaluable patients.

As of November 9, 2022, in the preliminary analysis of all 24 patients participating in the study, CTX-009 with paclitaxel demonstrated a 37.5% ORR based on 9 patients with PRs that were confirmed by RECIST 1.1.

The trial has met the criteria to advance to Part 2 and Part 1 of the study is now complete.

The results of Part 1 of the Phase 2 trial were presented at the 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (“ASCO GI”) in January 2023.

Tovecimig was generally well-tolerated and demonstrated single agent activity in heavily pre-treated patients with solid tumors who were resistant to anti-VEGF therapies, mostly of colorectal and gastric origins

The maximum tolerated dose (“MTD”) was not reached, and the RP2D of tovecimig were determined to be 10.0 and 12.5 mg/kg biweekly

ORR of tovecimig as a monotherapy across all doses tested (0.3 – 17.5 mg/kg) was 8% and the CBR was 62% in patients treated at the 3rd and 4th line settings

Treatment with tovecimig as a monotherapy at the RP2D (10.0 mg/kg and 12.5 mg/kg) led to 18.8% (n=3/16) ORR, not including an additional unconfirmed PR, and a 68.5% CBR (n=11/16)

Phase 2 Trial of Tovecimig with Paclitaxel in BTC - South Korea

In the Phase 1b Study, there were four patients enrolled with cholangiocarcinoma.

Two of these four patients had deep, durable, and confirmed responses.

Both of these patients received tovecimig in combination with paclitaxel.

Based on this observation, a Phase 2 trial of tovecimig in combination with paclitaxel was completed by ABL Bio in patients with BTC, with data reported in the first quarter of 2023.

The trial enrolled patients with unresectable advanced, metastatic, or relapsed BTC who had received one or two prior systemic therapies.

This Phase 2 trial utilized a Simon Two-Stage adaptive design where the criteria to advance to the second stage of the trial was three PRs observed in 21 evaluable patients.

In the preliminary analysis of all 24 patients participating in the study, tovecimig with paclitaxel demonstrated a 37.5% ORR based on 9 patients with PRs that were confirmed by RECIST 1.1.

The results of Part 1 of the Phase 2 trial were presented at the 2024 ASCO GI meeting in January 2024.

Based on the efficacy data and following discussions with the U.S.

Food and Drug Administration (“FDA”), while the trial had met the criteria to advance to Part 2, we elected to terminate the study and advance tovecimig directly to a randomized Phase 2/3 study in patients with BTC treated in the second-line setting.

Safety Data Summary

CTX-009 safety data has been analyzed and was observed to be generally well-tolerated.

The Phase 2 safety data are generally consistent with the safety data of the Phase 1 trials.

Tovecimig safety data has been analyzed and was observed to be generally well-tolerated.

Of the 24 patients enrolled in the first stage of the trial, all patients had at least one treatment emergent adverse event (“TEAE”).

Grade 3 or greater TEAEs were reported in 95.8% of patients regardless of the relationship to CTX-009 or paclitaxel, including decreased neutrophil count (83.3%), hypertension (16.7%), anemia (20.8%), and decreased platelet count (12.5%).

Grade 3 or greater TEAEs were reported in 95.8% of patients regardless of the relationship to tovecimig or paclitaxel, including decreased neutrophil count (83.3%), hypertension (16.7%), anemia (20.8%), and decreased platelet count (12.5%).

Grade 3 or greater adverse events that were designated to be of special interest (“AESIs”) by the trial investigators were hemoptysis or hemorrhage (12.5%) and GI or tumor perforation (8.3%), with 0% for pulmonary hypertension, wound healing complication and cardiac failure.

The table below depicts a summary of the TEAEs in 24 patients as of November 9, 2022.

The table below depicts a summary of the TEAEs in 24 patients for the study.

Treatment Emergent Adverse Events observed in > 1 patient

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Activity Data Summary

The first stage of the trial enrolled 24 patients and 22 of those patients are considered evaluable.

The first stage of the trial enrolled 24 patients and 22 of those patients were considered evaluable.

Nine PRs confirmed by RECIST 1.1 were observed leading to an ORR of 37.5%, and 22 of the 24 patients evaluated have had stable disease or better with a decline in tumor burden leading to a CBR of 92%.

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After a median follow up of approximately 12 months, the median progression free survival (“PFS”) was 9.4 months, median duration of response (“DOR”) was 6.9 months and median overall survival (“OS”) was 12.5 months.

For reference, one regimen that has been studied in patients with advanced BTC is FOLFOX, the regimen recommended in the guidelines of the National Comprehensive Cancer Network (NCCN) for patients with BTC treated in the second-line setting.

For reference, one regimen that has been studied in patients with advanced BTC is the three-drug combination FOLFOX.

FOLFOX demonstrated an ORR of 5%, a median PFS of 4.0 months, and a median OS of 6.2 months in a randomized study against best supportive care.

The waterfall plot below depicts the best response for the 22 patients evaluated in the trial as of November 9, 2022.

CTX-009 + paclitaxel in BTC

The waterfall plot below depicts the best response for the 22 patients evaluated in the trial.

tovecimig + paclitaxel in BTC

Best Response by Patient

The swimmer plot below depicts the duration that each patient has been on treatment as of November 9, 2022 (N=24):

CTX-009 + paclitaxel in BTC

Duration of Treatment by Patient

The median PFS of all patients in the study is 9.4 months.

Patients treated in the second line setting had a median PFS of 10.0 months and patients treated in the third line setting had a median PFS of 5.5 months.

CTX-009 + paclitaxel in BTC

Progression Free Survival

The median OS of all 24 patients enrolled and dosed in the study is 12.5 months.

Patients treated in the second line setting had a median OS of 11.7 months and patients treated in the third line setting has a median OS of 12.9 months.

CTX-009 + paclitaxel in BTC

Overall Survival

Status of CTX-009 Development

Our strategy is to develop CTX-009 in all of the indications in which patients have a need for effective and novel therapeutic agents and data support the potential therapeutic benefit of CTX-009.

We chose BTC and CRC as our lead indications based on a number of factors, including CTX-009 activity observed in the Phase 1, 1b and 2 clinical trials, lack of effective therapies for these patient populations and the potential for a straight-forward regulatory route to approval.

We submitted an IND to the FDA in December 2021 for CTX-009 and the FDA cleared our IND application in January 2022.

The following trials are being conducted in the United States under this IND.

Biliary Tract Cancers – BTC

Following conversations with the FDA, we submitted a protocol for a randomized Phase 2/3 trial for CTX-009 in combination with paclitaxel in adult patients with unresectable, advanced, metastatic or recurrent biliary tract cancers who have received one prior systemic chemotherapy regimen.

The trial is designed to assess the safety and efficacy of the combination of CTX-009 and paclitaxel versus paclitaxel alone.

Phase 2/3 Trial of Tovecimig with Paclitaxel in BTC – United States

Following conversations with the FDA, we submitted a protocol for a randomized Phase 2/3 trial for tovecimig in combination with paclitaxel in adult patients with unresectable, advanced, metastatic or recurrent biliary tract cancers who have received one prior systemic chemotherapy regimen.

The trial is designed to assess the safety and efficacy of the combination of tovecimig and paclitaxel versus paclitaxel alone.

A schema of the trial design is provided below:

The trial will enroll 150 patients, who will be randomized in a 2:1 ratio to receive CTX-009 plus paclitaxel (n=100) or paclitaxel alone (n=50).

The primary endpoint of the trial is ORR and the secondary endpoints include PFS, DCR, DOR and OS among other.

Patients who were randomized to receive paclitaxel and have progressed on their regimen may cross over to the CTX-009 plus paclitaxel arm after progression on paclitaxel if they still meet the enrollment criteria for the study.

The trial was designed to enroll 150 patients, randomized in a 2:1 ratio to receive tovecimig plus paclitaxel (n=100) or paclitaxel alone (n=50).

The primary endpoint of the trial is ORR and the secondary endpoints include PFS, OS, DOR and DCR among others.

Patients who were randomized to receive paclitaxel and have progressed on their regimen can cross over to the tovecimig plus paclitaxel arm after progression on paclitaxel if they still meet the enrollment criteria for the study.

A detailed description of the trial can be found on www.clinicaltrials.gov (Identifier NCT 05506943).

We are currently enrolling patients for this trial.

Depending on the trial results, this trial could serve as a registrational trial to support a biologics license application ("BLA") submission for CTX-009 in combination with paclitaxel as a treatment of BTC patients in the second line setting.

Enrollment is expected to be completed by mid-year 2024, with top line data expected in the second half of 2024.

Based on the trial results, a BLA could be filed as early as the second half of 2025.

Colorectal Cancer – CRC

We are also conducting a Phase 2 monotherapy clinical trial of CTX-009 in patients with metastatic colorectal cancer who have received two or three prior systemic therapies.

This trial is designed to assess the safety and efficacy of CTX-009 as a monotherapy in patients with advanced colorectal cancer.

A schema of the trial design is provided below:

The trial utilizes a Simon Two-Stage adaptive design where the criteria to advance to the second stage of the trial is three PRs observed in 37 patients enrolled in Stage 1 of the trial.

Based on the Simon Two-Stage design, when the criteria for the first stage is met, the trial may progress to the second stage, at which time 47 additional patients could be enrolled.

The trial can be found on www.clinicaltrials.gov (identifier NCT 05513742).

In January 2023, the first patient was dosed in this trial and enrollment in Stage 1 of the trial was complete in the first quarter of 2024.

Initial results from Stage 1 of this trial are expected by mid-year 2024.

Additional Plans for CTX-009

We intend to explore the potential of CTX-009 in additional indications, based on data from pre-clinical models, potential biomarkers such as DLL4, and clinical data from CTX-009 trials providing signs of potential activity of CTX-009 in additional indications such as ovarian cancer, gastric cancer, pancreatic cancer, renal cell cancer, liver cancer, neuroendocrine cancer and others.

In addition, we are developing a plan to study the combination of CTX-009 with our novel bispecific checkpoint blocker, CTX-8371, and with other checkpoint blockers, such as pembrolizumab and atezolizumab.

Additionally, we are considering the combination of CTX-009 with our novel CD137 agonistic antibody, CTX-471, which is currently in a Phase 1b clinical trial in patients with advanced solid tumors.

This trial was fully enrolled in August 2024.

Top line data is expected at the end of the first quarter of 2025.

Phase 2 Trial of Tovecimig in CRC – United States

We conducted a Phase 2 monotherapy clinical trial of tovecimig in patients with metastatic colorectal cancer who have received two or three prior systemic therapies.

This trial was designed to assess the safety and efficacy of tovecimig as a monotherapy in patients with advanced CRC.

The trial utilized a Simon Two-Stage adaptive design where the criteria to advance to the second stage of the trial was three PRs observed in 37 patients enrolled in Stage 1 of the trial.

The first stage of the trial enrolled 41 patients in the United States, of which 26 (63%) were treated in the fourth line.

Tovecimig demonstrated an ORR of 5% (2 out of 41), a DCR of 71% (29 out of 41), median PFS of 3.9 months and median overall survival (“OS”) of 10.2 months.

The safety profile was consistent with the prior clinical trials with hypertension as the most common adverse event.

The ORR did not meet the criteria to advance to the second stage of the trial, but based on this efficacy signal we are planning to initiate a new second-line trial of tovecimig.

We are evaluating the details of this study to investigate tovecimig in combination with chemotherapy in patients with metastatic CRC based on DLL4 positivity and expect to initiate it in mid-2025.

Additional Plans for Tovecimig

We intend to explore the potential of tovecimig in additional indications, based on data from pre-clinical models, potential biomarkers such as DLL4, and clinical data from tovecimig trials providing signs of potential activity of tovecimig in additional indications such as ovarian cancer, gastric cancer,, renal cell cancer, and liver cancer.

In addition, we are developing a plan to study the combination of tovecimig with our novel bispecific checkpoint blocker, CTX-8371, and with other checkpoint blockers, such as pembrolizumab and atezolizumab.

Additionally, we are considering the combination of tovecimig with our novel CD137 agonistic antibody, CTX-471.

CTX-471 (CD137 agonist antibody)

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We believe that the ability of CTX-471 to transform the tumor microenvironment through the combined action of immune cell recruitment, alleviation of T-cell exhaustion, suppression of Tregs, and reduction of tumor suppressing macrophages leads to CTX-471’s antitumor activity in mouse models.

Dosing Strategy

In contrast to dosing strategies for other immuno-oncology antibodies, such as checkpoint inhibitors where the goal is often to deliver a dose that is capable of fully inhibiting the receptor at all times, our dose selection for CTX-471 studies was aimed at binding to only a fraction of the available CD137 receptors.

Dosing of an agonist antibody, such as CTX-471, at levels capable of binding to the majority of receptors can lead to inappropriate cell activation and downregulation of the receptor and overall weaker activity.

Agonist antibodies typically trigger their activity through independent binding of each of their two antigen-binding domains to individual receptors on a cell surface.

This binding to both receptors at once forces the receptors into close physical proximity.

This grouping of receptors that drives receptor activation, especially when the ratio of antibody molecules to receptor molecules is relatively low.

As the ratio of antibody to receptor increases, the level of receptor activation increases up to a point above which activation may decrease due to down-regulation of the receptors.

This results in a bell-shaped activation curve in which maximal activation occurs at intermediate antibody concentrations.

We observed evidence of the importance of lower receptor occupancy while screening candidate antibodies against CD137.

The antibodies with the greatest tumor-killing activity were the ones with intermediate potency.

Very high-potency antibodies had weaker antitumor activity.

Consistent with the finding of lower activity at high antibody to receptor levels, we observed that the antitumor activity of CTX-471 appeared to peak at doses between 50 ug and 100 ug in the mouse CT26 tumor model.

At the higher dose of 200 ug, the number of complete responses, four out of eight mice, was less than that observed at 100 ug, seven out of eight mice, suggesting that the optimal receptor occupancy had been exceeded.

This is also consistent with our observation that intermediate affinity antibodies exhibited greater antitumor activity compared to high affinity antibodies.

Antitumor activity of CTX-471 is optimized at intermediate dose and decreased at the highest dose level

Our findings are consistent with those reported for an agonist antibody against OX40, another immune target in oncology.

Thus, for many agonist antibodies, it is likely that both intermediate affinities and intermediate doses will deliver optimal activity.

Phase 1 Clinical Trial of CTX-471

We are conducting a Phase 1, open-label, first-in-human trial of CTX-471 administered as a monotherapy or in combination with pembrolizumab (KEYTRUDA®) in patients with metastatic or locally advanced malignancies that have progressed while receiving an approved PD-1 or PD-L1 inhibitor.

We selected this population of patients for this trial because multiple clinical trials and meta-analyses have shown that not all patients respond to checkpoint inhibitor therapy due to many possible factors.

By focusing on those that did previously respond to checkpoint inhibitor therapy, we believe that this trial design enriches for patients who have tumors that are capable of being recognized and killed by their immune systems.

The trial is being conducted with two treatment arms, the Monotherapy Arm and the Combination Arm.

Each arm will have two parts:

a dose escalation cohort and a dose expansion cohort.

The Monotherapy Arm is nearing completion and enrollment began in the Combination Arm in the fourth quarter of 2022.

In a Phase 1b monotherapy study, CTX-471 was evaluated in patients with solid tumors that had progressed after at least three months on an approved PD-1 or PD-L1 inhibitor.

Initial results reported from the study included five clinical responses, including a durable PR in a patient with SCLC that converted to a complete response (as confirmed by PET scan) and four additional PRs (one unconfirmed) in patients with melanoma and mesothelioma.

The ORR in the subset of patients with advanced melanoma was 27% (3 of 11).

Data were presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting in June 2024.

Phase 1 Clinical Trial Data

In July 2019, we initiated a Phase 1 trial evaluating the safety and tolerability of CTX-471 as a monotherapy in patients with solid tumors who were previously treated with PD-1 or PD-L1 immune checkpoint inhibitors and subsequently relapsed or progressed after a period of stable disease.

The design of this trial includes a dose escalation stage followed by a dose expansion stage.

The dose-escalation stage of the Phase 1 monotherapy (Phase 1a monotherapy) has been completed and CTX-471 was observed to be generally well-tolerated.

The dose expansion stage of the monotherapy trial (Phase 1b monotherapy) is currently ongoing and nearing completion.

Dose Escalation – Monotherapy Arm

In the Phase 1a dose escalation stage, 19 patients received CTX-471 in the four dosing cohorts set forth in Figure 8 below.

The number of patients dosed with CTX-471 in the Phase 1a dose escalation stage

CTX-471 was observed to be generally well-tolerated in the Phase 1a stage of the trial.

There were two serious adverse events (“SAEs”) determined to be treatment-related, which included one hypoxia event that resolved with approximately one day of supplemental oxygen therapy and one immune thrombocytic purpura event that also resolved.

The dose-limiting toxicities were two events of thrombocytopenia in Cohort 4, which was expanded from three to six patients to collect additional safety data.

The design of this trial included a Phase 1a dose escalation stage followed by a Phase 1b dose expansion stage.

In the Phase 1a dose escalation, CTX-471 was observed to be generally well-tolerated in the Phase 1a stage of the trial.

The dose-limiting toxicity was two thrombocytopenia based on two observed events in Cohort 4, which was expanded from three to six patients to collect additional safety data.

Based on these results, 0.6 mg/kg was determined to be the maximum tolerated dose.

While the goal of the Phase 1a stage of the trial was to evaluate the safety and tolerability of CTX-471, we also collected data from these patients to evaluate the PK of CTX-471, the potential development of anti-drug antibodies of CTX-471, and to obtain certain efficacy data, based on the ORR, as per Response Evaluation Criteria in Solid Tumors, RECIST.

Patients who were enrolled in the Phase 1a stage of the trial have been evaluated every eight weeks by imaging techniques, such as MRI or CT, until disease progression or withdrawal from the trial, in order to collect such data.

The Phase 1a stage of the trial is now complete.

None of the patients enrolled in the Phase 1a stage of the trial had a complete response (“CR”) or a PR by RECIST.

The best overall response has been stable disease.

Two patients with NSCLC had stable disease until progression at Weeks 25 and 41, respectively.

In addition, one patient with metastatic melanoma of mucosal origin had an approximately 24% decline in the total size of his measured metastatic tumors (target lesions) at week 33.

This patient remained on the trial and received CTX-471 for 49 weeks.

We have analyzed preliminary PK data from the trial and these data have confirmed our receptor occupancy modeling.

Based on this modeling and the correlation of the observed PK with our predictions, we selected 0.3 mg/kg and 0.6 mg/kg as the doses of the cohorts of our Phase 1b stage of the trial.

We estimate that a dose of 0.3 mg/kg would lead to a peak receptor occupancy of approximately 50% and a dose of 0.6 mg/kg would lead to a peak receptor occupancy of approximately 70%.

Dose Expansion – Monotherapy Arm

The dose expansion stage of the trial is fully enrolled, and as of January 31, 2024, there is one ongoing patient in the trial and the study is nearing completion.

60 patients with 17 different cancers have been enrolled in the trial.

Phase 1b Dose Expansion

The dose expansion stage of the trial is completed.

60 patients with 17 different cancers were enrolled in the trial.

One patient (noted below) had a CR and four additional patients had a PR.

Of the four partial responses observed in this dose expansion cohort, three PRs have been confirmed by RECIST 1.1 and the fourth PR is unconfirmed and will remain unconfirmed.

Of the four PRs observed in this dose expansion cohort, three PRs have been confirmed by RECIST 1.1 and the fourth PR was unconfirmed.

There have been nine SAEs related to CTX-471 in the dose expansion stage of the trial.

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This patient has been on the study for more than 2 years and is still ongoing.

The CR was observed in a patient with advanced small cell lung cancer who was previously treated with the carboplatin/etoposide and atezolizumab (a PD-L1 blocker) regimen in the first line followed by a treatment with nivolumab (a PD-1 blocker) in the second line.

The CR was observed in a patient with advanced SCLC who was previously treated with the carboplatin/etoposide and atezolizumab (a PD-L1 blocker) regimen in the first line followed by a treatment with nivolumab (a PD-1 blocker) in the second line.

After progression on prior regimens this patient joined the trial and had a PR at week 17 which was confirmed at week 25.

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The other responses were in mesothelioma (1 out of 4) and SCLC (1 out of 3).

Dosing - Combination Arm

In October 2022, we announced a clinical collaboration with Merck (known as MSD outside the United States and Canada) to evaluate CTX-471 in combination with KEYTRUDA® (pembrolizumab).

Compass is the study sponsor and Merck provides the clinical supply of KEYTRUDA®.

Additionally, we formed a joint development committee (JDC) with Merck to review the results of this clinical trial.

In November 2022, we announced the first patient was dosed in the combination arm of the Phase 1 trial.

Patients enrolled in the combination arm will be treated with CTX-471 by intravenous infusion every two weeks in combination with a fixed dose of pembrolizumab (400 mg) by intravenous infusion every six weeks with the goal of restoring response.

The dose-escalation portion of the study enrolled patients with metastatic or locally advanced non-small cell lung cancer, melanoma, small cell lung cancer, mesothelioma and head and neck cancer that have progressed after treatment with a PD-1 or PD-L1 checkpoint inhibitor.

At the end of 2023, the dose-escalation portion of the study was fully enrolled and this portion of the study is near completion.

No dose-limiting toxicities were observed.

As of January 30, 2024, there have been no responses observed in the dose escalation portion of the Phase 1 combination study.

In the expansion cohort, we plan on enrolling 60 patients with melanoma, NSCLC and SCLC, who will be randomly receive one of two doses of CTX-471:

0.3 (mg/Kg) every two weeks or 0.6 (mg/Kg) every two weeks in combination with a fixed dose of pembrolizumab (400 mg) every six weeks.

Enrollment in the dose expansion cohorts began in Q4 2023.

Biomarker discovery

In November 2024, we presented novel biomarker data associated with CTX-471 at the 39th Society for Immunotherapy of Cancer (“SITC”) Annual Meeting.

Our research showed a correlation between the levels of neural cell adhesion molecule (“NCAM” or CD56) in baseline tumor cell biopsies and disease control in patients treated with CTX-471.

To measure pharmacodynamic effects, comparisons were made between pre- and post-CTX-471 treatment.

To survey response biomarkers, values from baseline samples obtained from patients with tumors showing complete or partial responses as well as stable disease were compared with tumors showing progressive disease.

We hypothesize that NCAM facilitates responses to CTX-471 by enriching for activated NK cells expressing the CTX-471 target, CD137.

The dataset shows these effects to be specific for NCAM expressing lymphocytes such as NK cells and is not observed in other lymphocyte subsets such as CD8 T cells.

These findings are novel in a clinical setting and support potential use of NCAM as a selection marker.

Development Plans for CTX-471

The results of the monotherapy and combination arms of the Phase 1 trial will inform us on the next development steps.

Based on the results of the monotherapy and combination arms of the Phase 1 trial, we are currently evaluating the design of a Phase 2 study of CTX-471 using NCAM as a biomarker, which we expect to initiate in mid-2025.

CTX-8371 (PD-1 x PDL-1 Bispecific Antibody)

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IND-enabling studies on CTX-8371, including GLP toxicology studies in non-human primates (“NHPs”) were completed in the first quarter of 2023.

The FDA cleared the IND for CTX-8371 in the fourth quarter of 2023 and the first patient in the Phase 1 clinical trial is expected to be dosed by early second quarter 2024.

The FDA cleared the IND for CTX-8371 in the fourth quarter of 2023 and the first patient in the Phase 1 clinical trial was dosed in April 2024.

CTX-8371 is a PD-1 x PD-L1 bispecific antibody

Overview of PD-1 and PD-L1 Checkpoint Inhibitors

PD-L1 is a surface protein that is overexpressed by over 35% of certain types of cancer, such as melanoma, hepatocellular carcinoma, colorectal cancer, and NSCLC.

PD-L1 is a surface protein that is overexpressed by over 35% of certain types of cancer, such as melanoma, hepatocellular carcinoma, CRC, and NSCLC.

Binding of PD-L1 to its receptor, PD-1, on immune T-cells leads to suppression of cytotoxic CD8+ T-cells preventing immune attack of the tumor.

Multiple inhibitors of PD-1 and PD-L1 have been approved as therapies for a broad range of tumors including melanoma, NSCLC, small cell lung cancer, head and neck squamous cell cancer, renal cell carcinoma, bladder cancer, gastric cancer, cervical cancer and other cancers with microsatellite instability or mismatch repair deficiency.

Multiple inhibitors of PD-1 and PD-L1 have been approved as therapies for a broad range of tumors including melanoma, NSCLC, SCLC, head and neck squamous cell cancer, renal cell carcinoma, bladder cancer, gastric cancer, cervical cancer and other cancers with microsatellite instability or mismatch repair deficiency.

While PD-1/PD-L1 checkpoint therapies have resulted in remarkable clinical efficacy across multiple cancer types, their efficacy, even in tumors with high immunogenicity, is limited to approximately 20% of patients.

Nevertheless, sales of checkpoint therapies in 2022 were estimated to be $34 billion, and grew to $39.8 billion in 2023 at a compounded annual growth rate (CAGR) of 16.4%.

The PD-1 and PD-L1 inhibitors market is expected to reach $70 billion in 2027 at a CAGR of 15.1%.

Nevertheless, sales of checkpoint therapies in 2023 were estimated to be $48 billion.

There is no approved therapy that combines inhibition of both PD-1 and PD-L1 in the same molecule.

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Taken together, the murine and cynomolgus monkey PK data, receptor occupancy data, and in vivo efficacy data in murine models was used to calculate the predicted human efficacious dose range for CTX-8371

Development Plans for CTX-8371

An IND was submitted to the FDA in the third quarter of 2023.

Phase 1 and Development Plans for CTX-8371

We submitted an IND to the FDA in the third quarter of 2023.

This IND was cleared by the FDA in October 2023.

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Other eligibility criteria include patients with metastatic of locally advanced melanoma, non-small cell lung cancer, head and neck cancer, Hodgkin’s Lymphoma and triple negative breast cancer.

The first patient in this Phase 1 clinical trial is expected to be dosed by early second quarter 2024.

As of January 2025, the third cohort of this trial was fully enrolled with no dose limiting toxicities observed.

Initial data from the trial is expected in the second half of 2025.

CTX-10726 (PD-1 x VEGF-A Bispecific Antibody)

CTX-10726 is a novel, tetravalent PD-1 x VEGF-A bispecific antibody that we discovered, engineered and developed since 2023.

CTX-10726 is designed to synergistically deliver VEGF-A blockade and checkpoint inhibition, which is potentially applicable to multiple solid tumor indications.

CTX-10726 utilizes a fully human, glycosylated IgG1 with silenced Fc-γ receptor binding and demonstrates a highly stable structure with high affinity target binding.

Based on preclinical studies, CTX-10726 exhibits several-fold more potent PD-1 blockade compared with publicly available data reported for other drugs in the class, and we believe this may be a key differentiator from comparable bispecifics.

The development of CTX-10726 was informed and accelerated by our experience with two of our clinical-stage assets:

tovecimig, which contains a VEGF-A targeted component, and CTX-8371, which contains a PD-1 targeted component.

We are continuing IND-enabling studies and expect to file an IND by the end of 2025.

CTX-10726 is a PD-1 x VEGF-A bispecific antibody

Early-Stage Discovery

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License Agreements

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

Tovecimig (DLL4 X VEGF-A bispecific antibody)

Our wholly owned subsidiary Trigr Therapeutics, Inc.

(“TRIGR”) and ABL Bio, a South Korean biotechnology company, entered into an exclusive global (excluding South Korea) license agreement (the “TRIGR License Agreement”) which granted TRIGR a license to ABL001, ABL Bio’s bispecific antibody targeting DLL4 and VEGF-A (renamed CTX-009).

Under the terms of the agreement, ABL Bio and TRIGR would jointly develop CTX-009, with ABL Bio responsible for development of CTX-009 throughout the end of Phase 1 clinical trials and TRIGR responsible for the development of CTX-009 from Phase 2 and onward.

Under the terms of the agreement, ABL Bio and TRIGR would jointly develop tovecimig, with ABL Bio responsible for development of tovecimig throughout the end of Phase 1 clinical trials and TRIGR responsible for the development of tovecimig from Phase 2 and onward.

ABL Bio received a $5 million upfront payment and a $6 million milestone payment.

In addition, ABL Bio is eligible to receive up to $96 million of development and regulatory milestone payments, up to $303 million of commercial milestone payments and tiered single-digit royalties on net sales of CTX-009 in Oncology.

ABL Bio is also eligible to receive up to $75 million in development and regulatory milestone payments and up to $110 million in commercial milestone payments and tiered, single-digit royalties on net sales of CTX-009 in Ophthalmology.

The financial terms of the agreement were amended in May 2021 but remain substantially similar to the terms in the TRIGR License Agreement.

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This agreement relates to our license from Adimab for certain antibodies for development and commercialization as biopharmaceutical products, including our product candidate, CTX-471.

We were granted an exclusive option to license antibodies under the agreement, which we exercised with respect to CTX-471.

We were granted an exclusive option to license and potentially acquire antibodies under the agreement, which we exercised with respect to CTX-471.

We are required to make payments upon achievement of development milestones that, as of December 31, 2024, amounted to $3.5 million, of which we have already made $1.5 million in milestone payments, and we have additional potential payments due in the amount of $2.0 million.

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Our patent estate includes patent applications with claims relating to our product candidates, methods of use and manufacturing processes, and claims for potential future products and developments.

As of January 31, 2024, we have greater than 80 issued patents and patent applications pending in the United States and foreign jurisdictions relating to CTX-009, CTX-471, CTX-8371 and other discovery and research programs.

We have 7 patents issued in the United States and 1 patent issued in Taiwan related to our CTX-471 program, and 1 patent issued in the United States related to our CTX-8371 program.

We also have access to patents issued in Australia, Europe and the United States related to our antibody and display programs, as well as 27 patents issued in Australia, Canada, China, Europe, Japan, Korea, Russia and 2 in United States related to our CTX-009 program.

As of January 31, 2025, we have greater than 90 issued patents and patent applications pending in the United States and foreign jurisdictions relating to tovecimig, CTX-471, CTX-8371, CTX-10726 and other discovery and research programs.

We have 7 patents issued in the United States and issued patents in Taiwan, China, Eurasia, Japan, Korea, Malaysia, Singapore and New Zealand related to our CTX-471 program, and 2 patents issued in the United States, and issued patents in China, Japan and Taiwan, related to our CTX-8371 program.

More specifically, we have licensed 2 patent families with 2 issued patents in U.S.

and 27 issued patents in foreign jurisdictions, related to our DLL4/VEGF antibody program including, but not limited to, our CTX-009 therapeutic candidate.

and 27 issued patents in foreign jurisdictions, related to our DLL4/VEGF antibody program including, but not limited to, our tovecimig therapeutic candidate.

Patents in these patent families are generally expected to start to expire in 2033, subject to possible extension.

We own 4 pending patent families with 11 issued U.S.

patents and 1 issued patent in Taiwan, 3 U.S.

patents and issued patents in Taiwan, China, Eurasia, Japan, Korea, Malaysia, Singapore, and New Zealand, 3 U.S.

patent applications, and 39 patent applications in foreign jurisdictions, related to our CD137 agonist antibody therapeutic platform including, but not limited to, our CTX-471 therapeutic candidate.

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We own 1 pending patent family with 2 issued U.S.

patent, 1 U.S.

patents, issued patents in China, Japan, and Taiwan, 1 U.S.

patent application, and 20 patent applications in foreign jurisdictions, related to our PD-1/PD-L1 bispecific antibody therapeutic platform including, but not limited to, our CTX-8371 therapeutic candidate.

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We own 1 pending patent family with 1 U.S.

pending patent application and 1 patent application in foreign jurisdictions related to our antibody and display programs including, but not limited to, common light chains and mammalian display platforms.

pending patent application and 1 patent application in foreign jurisdictions related to our antibody and display programs including, but not limited to, common light chains.

Patents that grant from this patent family are generally expected to start to expire in 2039, subject to possible patent term extension.

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The biotechnology and pharmaceutical industries, and the immuno-oncology subsector, are characterized by rapid evolution of technologies, fierce competition and strong defense of intellectual property.

We believe that our programs, including CTX-009, CTX-471, CTX-8371 and our platform technologies, including our StitchMabs TM platform and our programs, technology, knowledge, experience and scientific resources provide us with competitive advantages, but we also face competition from pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private research institutions, among others.

We believe that our programs, including tovecimig, CTX-471, CTX-8371, CTX-10726 and our platform technologies, including our StitchMabs TM platform and our programs, technology, knowledge, experience and scientific resources provide us with competitive advantages, but we also face competition from pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private research institutions, among others.

Our competitors include larger and better funded biopharmaceutical, biotechnology and therapeutics companies, including companies focused on cancer immunotherapies, such as AbbVie, Amgen, Inc., AstraZeneca plc, Bristol-Myers Squibb Company, Eli Lilly, Genentech, Inc., GlaxoSmithKline PLC, Johnson & Johnson, Merck & Co., Inc., Merck KGaA, Novartis AG, Pfizer Inc., Roche Holding Ltd and Sanofi S.A.

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In September of 2022, AstraZeneca received FDA approval of durvalumab in combination with gemcitabine/cisplatin for the first line treatment of BTC.

In addition, Merck received FDA approval of pembrolizumab in combination with gemcitabine/cisplatin for the first line treatment of BTC in October of 2023.

The only FDA approved therapies for second line treatment of BTC are targeted therapies that address specific tumor mutations or solid tumors that are microsatellite instability high.

There is also recently emerging clinical data that blockade of the human epidermal growth factor receptor 2 (“Her-2”) may be beneficial to the small subset of patients in whom HER-2 is amplified.

We believe that these targeted therapies are appropriate for 10-15% of BTC patients.

For example, in November 2024, Jazz Pharmaceuticals received FDA approval of ziihera for previously treated, unresectable, or metastatic human epidermal growth factor receptor (“Her-2”) positive biliary tract cancer, which may be beneficial to the small subset of patients in whom Her-2 is amplified.

We believe that the combination of all targeted therapies are appropriately 10-15% of BTC patients.

Colorectal cancer is the second most common cause of cancer deaths in the United States and constitutes approximately 10% of all annually diagnosed cancer and cancer related deaths globally.

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Sales and Marketing

We hold worldwide rights to all of our product candidates (with the exception of limited countries for CTX-009), which provide us the optionality to grow our internal pipeline independently or partner selected rights to our product candidates in different geographies throughout the world.

We hold worldwide rights to all of our product candidates (with the exception of limited countries for tovecimig), which provide us the optionality to grow our internal pipeline independently or partner selected rights to our product candidates in different geographies throughout the world.

Subject to receiving marketing approval, we intend to maximize the value of our product candidates by either independently planning to pursue the commercialization of our products in one or more major geographies by building an internal sales and marketing organization, or by seeking collaborations with third parties with commercialization infrastructure.

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Such post-approval trials are typically referred to as Phase 4 clinical trials.

In March 2022, the FDA released a final guidance entitled “Expansion Cohorts:

In March 2022, the FDA released a final guidance titled “Expansion Cohorts:

Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics,” which outlines how drug developers can utilize an adaptive trial design commonly referred to as a seamless trial design in early stages of oncology drug development (i.e., the first-in-human clinical trial) to compress the traditional three phases of trials into one continuous trial called an expansion cohort trial.

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Under federal law, the submission of most BLAs is subject to an application user fee.

For fiscal year 2024, the application user fee is $4,048,695, and the sponsor of an approved BLA is also subject to an annual program fee of $416,734 for each approved biological product on the market.

For fiscal year 2025, the user fee for an application requiring clinical data is $4,310,002, and the sponsor of an approved BLA is also subject to an annual program fee of $403,889 for each approved biological product on the market.

These fees are typically increased annually.

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The Clinical Trials Regulation aims to simplify and streamline the approval of clinical trials in the European Union.

Under the new coordinated procedure for the approval of clinical trials, the sponsor of a clinical trial is required to submit a single application for approval of a clinical trial to a reporting European Union Member State through a European Union Portal.

The submission procedure is the same irrespective of whether the clinical trial is to be conducted in a single European Union Member State or in more than one European Union Member State.

Marketing Authorization Procedures in the European Union

Medicines can be authorized in the European Union by using either the centralized authorization procedure or national authorization procedures.

Medicines can be authorized in the European Union by using either the centralized authorization procedure or a national authorization procedure.

Centralized procedure .

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This procedure results in a single marketing authorization issued by the EMA that is valid across the EEA.

The centralized procedure is compulsory for human medicines that are:

derived from biotechnology processes, such as genetic engineering, contain a new active substance indicated for the treatment of certain diseases, such as HIV, AIDS, cancer, diabetes, neurodegenerative disorders or autoimmune diseases and other immune dysfunctions, advanced therapy medicines (gene-therapy, somatic cell-therapy or tissue-engineered medicines) and officially designated orphan medicines.

For medicines that do not fall within these categories, an applicant has the option of submitting an application for a centralized marketing authorization to the European Commission following a favorable opinion by the EMA, as long as the medicine concerned is a significant therapeutic, scientific or technical innovation, or if its authorization would be in the interest of public health in the European Union.

The centralized procedure is compulsory for human medicines that:

are derived from biotechnology processes, such as genetic engineering;

contain a new active substance indicated for the treatment of certain diseases, such as HIV, AIDS, cancer, diabetes, neurodegenerative disorders or autoimmune diseases and other immune dysfunctions;

are advanced therapy medicines (gene-therapy, somatic cell-therapy or tissue-engineered medicines);

and are officially designated orphan medicines.

For medicines that do not fall within these categories, an applicant has the option of submitting an application for a centralized marketing, as long as the medicine concerned is a significant therapeutic, scientific or technical innovation, or if its authorization would be in the interest of public health in the European Union.

Under the centralized procedure, the EMA’s Committee for Medicinal Products for Human Use ("CHMP") is responsible for conducting the initial assessment of a product and for several post-authorization and maintenance activities, such as the assessment of modifications or extensions to an existing marketing authorization.

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Following this, further marketing authorizations can be sought from other European Union Member States in a procedure whereby the Member State concerned agree to recognize the validity of the original, national marketing authorization.

In some cases, a Pediatric Investigation Plan ("PIP"), or a request for waiver or deferral, is required for submission prior to submitting a marketing authorization application.

A PIP describes, among other things, proposed pediatric trials and their timing relative to clinical trials in adults.

Companies applying for a marketing authorization in the Europea Union must also agree upon a pediatric investigation plan (“PIP”) with the EMA’s Pediatric Committee and must conduct pediatric clinical trials in accordance with that PIP unless the EMA has granted a product-specific waiver, a class waiver, or a deferral for one or more of the measures included in the PIP.

Data and Market Exclusivity in the European Union

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This data exclusivity, if granted, prevents regulatory authorities in the European Union from referencing the innovator’s pre-clinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilar marketing authorization in the European Union, during a period of eight years from the date on which the reference product was first authorized in the European Union.

During an additional two-year period of market exclusivity, a generic or biosimilar MAA can be submitted and authorized, and the innovator’s data may be referenced, but no generic or biosimilar medicinal product can be placed on the European Union market until the expiration of the market exclusivity.

During an additional two-year period of market exclusivity, a generic or biosimilar marketing authorization application can be submitted and authorized, and the innovator’s data may be referenced, but no generic or biosimilar medicinal product can be placed on the European Union market until the expiration of the market exclusivity.

The overall ten-year period will be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.

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Even if a product is considered to be an innovative medicinal product so that the innovator gains the prescribed period of data exclusivity, another company nevertheless could also market another version of the product if such company obtained a marketing authorization based on a marketing authorization application with a complete and independent data package of pharmaceutical tests, preclinical tests and clinical trials.

The aforementioned European Union rules are generally applicable in the EEA.

All of the aforementioned European Union rules are generally applicable in the EEA.

Reform of the Regulatory Framework in the European Union

The European Commission introduced legislative proposals in April 2023 that, if implemented, will replace the current regulatory framework in the European Union for all medicines (including those for rare diseases and for children).

The European Commission has provided the legislative proposals to the European Parliament and the European Council for their review and approval.

The European Commission has provided the legislative proposals to the European Parliament and the European Council for their review and approval and, in April 2024, the European Parliament proposed amendments to the legislative proposals.

Once the European Commission’s legislative proposals are approved (with or without amendment), they will be adopted into EU law.

In October 2023, the European Parliament published draft reports proposing amendments to the legislative proposals, which will be debated by the European Parliament.

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To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular product candidate to currently available therapies.

A Member State may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market.

Approaches between Member States are diverging.

A European Union Member State may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market.

Approaches between European Union Member States are diverging.

For example, in France, effective market access will be supported by agreements with hospitals and products may be reimbursed by the Social Security Fund.

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On May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020.

On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024.

Due to the Statutory Pay-As-You-Go Act of 2010, estimated budget deficit increases resulting from the American Rescue Plan Act of 2021, and subsequent legislation, Medicare payments to providers will be further reduced starting in 2025 absent further legislation.

On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminated the statutory Medicaid drug rebate cap, set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024.

These laws and regulations may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.

Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives.

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Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare and reform government program reimbursement methodologies for drug products.

For example, at the federal level, President Biden has issued multiple executive orders that have sought to reduce prescription drug costs.

In February 2023, HHS also issued a proposal in response to an October 2022 executive order from President Biden that includes a proposed prescription drug pricing model that will test whether targeted Medicare payment adjustments will sufficiently incentivize manufacturers to complete confirmatory trials for drugs approved through FDA’s accelerated approval pathway.

Although a number of these and other proposed measures may require authorization through additional legislation to become effective, and the Biden administration may reverse or otherwise change these measures, both the Biden administration and Congress have indicated that they will continue to seek new legislative measures to control drug costs.

For example, at the federal level, President Trump reversed some of President Biden’s executive orders including rescinding Executive Order 14087 titled “Lowering Prescription Drug Costs for Americans." President Trump may issue new executive orders designed to impact drug pricing.

A number of these and other proposed measures may require authorization through additional legislation to become effective.

Congress and the Trump administration have indicated that they will continue to seek new legislative measures to control drug costs.

In August 2022, the IRA was signed into law.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business