What changed in this filing

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Item 1. Business

2026-03-23 compared with 2025-03-20 · 160 added, 112 removed, 376 unchanged (42% of the section changed)

We are a clinical-stage biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies (“bsAb”) for solid tumors.

We are building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 (“CLDN6”) x CD3 TCE, CT-95, a Mesothelin (“MSLN”) x CD3 TCE, and CT-202, a Nectin cell adhesion protein 4 (“Nectin-4”) x CD3 TCE.

Our goal is to build an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 (“CLDN6”) x CD3 TCE, CT-95, a Mesothelin (“MSLN”) x CD3 TCE, and CT-202, a Nectin cell adhesion protein 4 (“Nectin-4”) x CD3 TCE.

Our pipeline is shown below:

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We dosed the first patient in our CTIM-76 Phase 1 trial in January 2025.

We expect to share initial data for the CTIM-76 Phase 1 trial in the first half of 2026.

We expect to share Phase 1a interim data for the CTIM-76 trial in June 2026.

CT-95 is an MSLN x CD3 TCE that is intended to redirect T-cell-mediated lysis toward malignant cells expressing MSLN.

MSLN is a membrane protein overexpressed in approximately 30% of cancers.

We anticipate dosing the first patient in the CT-95 Phase 1 trial in the second quarter of 2025.

We expect to share initial data for the CT-95 Phase 1 trial in the middle of 2026.

We dosed the first patient in our CT-95 Phase 1 trial in April 2025.

We expect to share Phase 1a interim data for the CT-95 trial in September 2026.

CT-202 is a Nectin-4 x CD3 TCE that targets Nectin-4, a cell surface protein that is highly and frequently overexpressed in a variety of solid tumors, including bladder, colorectal, lung and breast.

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CT-202 is a pH-dependent TCE that is designed to be preferentially active within the tumor microenvironment.

We expect to file an IND application for CT-202 in the middle of 2026.

We submitted our application to the Australian Bellberry Human Research Ethics Committee (“HREC”) in March 2026 to support the initiation of a first-in-human trial for CT-202.

We expect to dose the first patient in our CT-202 Phase 1 trial in the third quarter of 2026.

Beyond these product candidates, we continue to evaluate opportunities to expand our pipeline.

We believe our team and capabilities position us to be a leader in developing novel therapies targeting solid tumors.

We retain full worldwide development and commercialization rights to certain CTIM-76 patents in the field of bispecific antibodies, full worldwide development and commercialization rights to CT-95 patents, and full worldwide development and commercialization rights to certain CT-202 patents.

We retain full worldwide development and commercialization rights to certain CTIM-76 patents in the field of bispecific

antibodies, full worldwide development and commercialization rights to CT-95 patents, and full worldwide development and commercialization rights to certain CT-202 patents.

Our goal is to deliver safe and effective selective cancer therapies for patient populations with significant unmet medical needs.

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• Rapidly advance our CTIM-76 and CT-95 clinical programs through Phase 1 proof of concept.

We are currently evaluating CTIM-76 in a Phase 1 clinical trial and plan to provide preliminary data in the first half of 2026.

Additionally, we anticipate dosing the first patient in the CT-95 Phase 1 trial in the second quarter of 2025 and plan to provide preliminary data in the middle of 2026.

• Rapidly advance our third program, CT-202, through preclinical development.

We are currently advancing our CT-202 program through Good Manufacturing Practices (“GMP”) manufacturing and IND enablement.

We are currently evaluating CTIM-76 in a Phase 1 clinical trial and plan to provide Phase 1a interim data for the CTIM-76 trial in June 2026.

Additionally, we plan to provide Phase 1a interim data for the CT-95 trial in September 2026.

• Rapidly advance our third program, CT-202, into clinical development.

We submitted our application to the HREC in March 2026 to support the initiation of a first-in-human trial for CT-202.

We expect to dose the first patient in our CT-202 Phase 1 trial in the third quarter of 2026.

• Seek opportunities to expand our pipeline of selective cancer drug candidates and targets.

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We intend to leverage our TCE expertise to advance a novel pipeline.

We plan to commercialize our product candidates in key markets, either alone or with strategic partners, and seek to maximize the worldwide commercial potential of our programs.

We plan to commercialize our product candidates in key markets, either alone or with strategic partners, and seek to maximize the worldwide commercial potential of our programs, including the potential to out-license certain assets during development to a third party that may accelerate development and commercialization of one or all of our assets.

Our Product Pipeline and Development

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The structural complexity of CLDN6 and its similarity to other Claudin proteins expressed on healthy tissue, particularly CLDN3, CLDN4, and CLDN9, make selectivity a key development challenge that must be addressed by CLDN6-targeting assets in development.

The figure below indicates that CTIM-76 is a highly selective and potent CLDN6 x CD3 TCE.

The preclinical data below illustrate that CTIM-76 is a highly selective and potent CLDN6 x CD3 TCE.

Market Opportunity

There is a significant global opportunity for the treatment of patients with tumors expressing CLDN6.

CLDN6 is overexpressed in several cancers with significant unmet needs, including ovarian, non-small cell lung, colon, endometrial, breast, sarcoma and testicular, with expression being highest in ovarian, endometrial, and testicular adenocarcinomas.

CLDN6 is overexpressed in several cancers with significant unmet needs, including ovarian, non-small cell lung, colon, endometrial, breast and testicular, with expression being highest in ovarian, endometrial, and testicular adenocarcinomas.

Estimated incidence information for annual new cancer cases in the United States and CLDN6 expression rates for certain cancers with significant unmet needs are shown below.

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Based on R/R Incidence

Endometrial 65,900 14,000 51% 1

Ovarian 19,900 12,800 75% 1

Endometrial 65,900 14,000 50% 1

Testicular 9,910 400 100% 3

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Breast 290,600 43,800 40% 3

Sarcoma 17,100 12,390 20% 2

Gastric 26,380 11,090 9% 1

1 Context internal data;

1 Context internal Phase 1 data;

2 Context internal biopsy prevalence screen data;

3 Mackensen, Nature Medicine, 2023.

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Clinical Validation of the Target and Potential for Broader Patient Population

Based on clinical data reported for other therapeutic agents targeting CLDN6, including BioNTech (BNT211), TORL (TORL-1-23), and Daiichi Sankyo (DS9606a), in various phases of clinical development, including ADC and

CAR T-cell approaches, we believe this target has been clinically validated.

Whereas both ADC and CAR T-cell anti-CLDN6 approaches have required a substantial portion of tumor cells with high expression of CLDN6 for anti-tumor activity, we believe a T cell engager approach could potentially target tumors with varying levels of CLDN6 expression, including tumors with low levels of expression.

Whereas both ADC and CAR T-cell anti-CLDN6 approaches have required a substantial portion of tumor cells with high expression of CLDN6 for anti-

tumor activity, we believe a T cell engager approach could potentially target tumors with varying levels of CLDN6 expression, including tumors with low levels of expression.

Therefore, CTIM-76 could potentially capture a broader patient population and greater commercial opportunity.

Clinical Development Plan

We have an active IND for CTIM-76 with the FDA, and in January 2025, we announced that the first patient had been dosed in the Phase 1 clinical trial of CTIM-76, which is a dose escalation and expansion trial in patients with solid tumors likely to express CLDN6.

In the dose escalation part of our Phase 1 trial, we expect to enroll patients with advanced unresectable or metastatic ovarian, endometrial or testicular cancer in increasing dose levels.

The primary objective in dose escalation will be to evaluate the safety and tolerability of CTIM-76.

In the expansion part of our Phase 1 trial, we plan to evaluate two doses in a single cancer type based upon dose escalation data.

The primary objective in expansion will be to evaluate preliminary anti-tumor activity of CTIM-76 and to select a dose for future trials.

CLDN6 expression will be required for enrollment in our Phase 1 trial for patients with ovarian and endometrial cancer.

Due to high CLDN6 expression, prospective screening for testicular cancer will not be required.

We have an active IND for CTIM-76 with the FDA.

In January 2025, we announced that the first patient had been dosed in the CTIM-76 Phase 1 clinical trial, which is a dose escalation and expansion trial in patients with solid tumors likely to express CLDN6.

In the dose escalation part of our Phase 1 trial, we are enrolling patients with advanced unresectable or metastatic ovarian, endometrial or testicular cancer in increasing dose levels.

The primary objective in dose escalation is to evaluate the safety and tolerability of CTIM-76.

In the expansion part of our Phase 1 trial, we plan to evaluate two doses and at least two dose schedules in a single cancer type based upon dose escalation data.

The primary objective in expansion will be to evaluate preliminary anti-tumor activity of CTIM-76 and to select a dose and dose schedule for future trials.

CLDN6 expression is required for enrollment in our Phase 1 trial for patients with ovarian and endometrial cancer.

Due to high CLDN6 expression, prospective screening for testicular cancer is not required.

Mesothelin x CD3 TCE program:

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MSLN is a membrane protein overexpressed in approximately 30% of cancers.

One challenge in developing MSLN-targeted therapies has been the presence of MSLN fragments, also referred to as shed or soluble MSLN (“sMSLN”), found in both blood and the tumor microenvironment that can serve as a decoy or sink for MSLN-targeting antibodies.

One challenge in developing MSLN-targeted therapies has been the presence of MSLN fragments, also referred to as shed MSLN (“sMSLN”), found in both blood and the tumor microenvironment that can serve as a decoy or sink for MSLN-targeting antibodies.

CT-95 is a fully humanized bispecific T cell engager that has a moderate affinity but high avidity for membrane-bound MSLN, minimizing the impact of the sMSLN.

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(i) its ability to bind to the membrane-proximal side of MSLN, which has been shown to increase potency compared to a historic program from Harpoon Therapeutics (HPN536), potentially driving improved outcomes for patients;

(ii) avidity enhancement to improve CT-95 residence in the tumor microenvironment and minimize the risk of cytokine release syndrome;

(ii) avidity enhancement that aims to minimize the risk of adverse events, including cytokine release syndrome and hypoxia;

and (iii) its potential ability to target tumors with low, medium or high levels of MSLN expression, which could potentially result in a broader target population and greater commercial opportunity compared with non-TCE approaches.

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CT-95 was designed to overcome the sMSLN sink through binding to membrane-proximal MSLN epitope and avidity enhancement.

CT-95 exhibits moderate affinity for membrane-proximal MSLN but cooperative binding

through bivalent binding of CT-95 to two MSLN epitopes results in high avidity binding of CT-95 to the tumor.

This results in a potentially wide therapeutic window due to:

CT-95 exhibits moderate affinity for membrane-proximal MSLN but cooperative binding through bivalent binding of CT-95 to two MSLN epitopes results in high avidity binding of CT-95 to the tumor.

results in a potentially wide therapeutic window due to:

(i) limited crosslinking by sMSLN, mitigating off-tumor T cell activation;

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Pancreatic 66,440 51,750 80% 61% 41,400

Colon 152,810 53,010 41% 17% 21,734

Ovarian 19,900 12,800 90% 80% 11,520

Mesothelioma 3,000 2,500 70% 60% 1,750

Colon 152,810 53,010 41% 17% 21,734

Esophageal 22,370 16,130 41% 26% 6,613

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Gastric 26,380 11,090 49% 23% 5,434

Breast (TNBC) 62,054 15,500 30% 18% 4,650

Cervical 13,820 4,360 42% 21% 1,831

Incidences based on public estimates;

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Clinical Validation of the Target and Potential for Broader Patient Population

Based on clinical data reported for other therapeutic agents targeting MSLN, including RemeGen Biosciences (RC88) and TCR2 Therapeutics (gavocabtagene autoleucel), in various phases of clinical development, including ADC and CAR T-cell approaches, we believe this target has been clinically validated.

ADC and CAR T-cell approaches, we believe this target has been clinically validated.

Whereas both ADC and CAR T-cell anti-MSLN approaches have required a substantial portion of tumor cells with high expression of MSLN for anti-tumor activity, we believe a T cell engager approach could potentially target tumors with varying levels of MSLN expression, including tumors with low levels of expression.

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We have an active IND for CT-95 with the FDA.

We anticipate dosing the first patient in the CT-95 Phase 1 trial in the second quarter of 2025, which is a dose escalation trial in patients with solid tumors likely to express MSLN.

We expect to enroll patients with advanced unresectable or metastatic high grade serous ovarian cancer, pancreatic carcinoma, and mesothelioma.

The primary objective in dose escalation will be to evaluate the safety and tolerability of CT-95.

Expression of MSLN will not be required for enrollment in our Phase 1 trial;

tumor tissue samples will be collected for retrospective biomarker assessment of MSLN expression by immunohistochemistry (“IHC”).

In April 2025, we announced that the first patient had been dosed in the CT-95 Phase 1 trial, which is a dose escalation trial in patients with solid tumors likely to express MSLN.

We are enrolling patients with advanced unresectable or metastatic high grade serous ovarian cancer, pancreatic carcinoma, and mesothelioma.

The primary objective in dose escalation is to evaluate the safety and tolerability of CT-95.

Expression of MSLN is not required for enrollment in our Phase 1 trial;

tumor tissue samples are being collected for retrospective biomarker assessment of MSLN expression by immunohistochemistry (“IHC”).

Nectin-4 x CD3 TCE program:

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The figure below indicates our two-pronged approach for CT-202 to overcome Nectin-4 expression in the skin and to generate robust antitumor responses while minimizing the risk of cytokine release syndrome.

1 Chang, PNAS, 2021

Market Opportunity

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Based on R/R Incidence

Non-Small Cell Lung 201,229 110,653 64% 1

Colon 152,810 53,010 87% 1

Pancreatic 66,440 51,750 71% 1

Bladder (urothelial) 83,190

Breast (TNBC) 62,054 15,500 78% 3

Non-Small Cell Lung 201,229 110,653 64% 3

Pancreatic 66,440 51,750 71% 3

Head and Neck 54,000 12,000 59% 3

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Gastric 26,890 12,000 94% 7

Ovarian 19,900 12,800 57% 4

Incidences based on public estimates;

R/R or last-line patient population approximated by annual mortality;

Relapsed/refractory (R/R) or last-line patient population approximated by annual mortality;

Patient population derived from Nectin-4 positive population multiplied by R/R incident population.

1 Kobecki, Int J Mol Sci, 2023;

2 Nikanjan, Can Let, 2025;

3 Challita, Can Res, 2016;

4 Zhang, Oncol Lett, 2018;

3 Derycke, Am J Clin Pathol, 2010;

4 Kobecki, Int J Mol Sci, 2023

5 Zeindler, Front Med, 2019;

6 Takano, Mol Bio, 2009;

7 Muro, ESMO Open, 2025

Clinical Validation of the Target and Potential for Broader Patient Population

Based on clinical data reported for other therapeutic agents targeting Nectin-4, including Pfizer (Padcev®) and Bicycle (BT8009), including ADC approaches, we believe this target has been clinically validated.

currently approved for locally advanced or metastatic urothelial carcinoma, which is associated with high levels of Nectin-4 expression.

Whereas ADC Nectin-4 approaches require a substantial portion of tumor cells with high expression of Nectin-4 for anti-tumor activity, we believe a TCE approach could potentially target tumors with varying levels of MSLN expression, including tumors with low levels of expression.

Therefore, MSLN could potentially capture a broader patient population and greater commercial opportunity.

PR antagonist program:

Prior to the portfolio prioritization and capital allocation strategy announced on March 22, 2023, we were primarily focused on developing treatments for female cancers.

Based upon the challenging market conditions for emerging companies, the increasingly competitive landscape for breast cancer treatments, recent study findings, and other factors, we decided to cease development and explore strategic options for ONA-XR.

We wound down our ONA-XR clinical trials and development by the end of 2023.

Based on clinical data reported for other therapeutic agents targeting Nectin-4, including Pfizer (Padcev®) and Bicycle Therapeutics (BT8009), including ADC approaches, we believe this target has been clinically validated.

Padcev is currently approved for locally advanced or metastatic urothelial carcinoma, which is associated with high

levels of Nectin-4 expression.

Whereas ADC Nectin-4 approaches require a substantial portion of tumor cells with high expression of Nectin-4 for anti-tumor activity, we believe a TCE approach could potentially target tumors with varying levels of Nectin-4 expression, including tumors with low levels of expression.

Therefore, Nectin-4 could potentially capture a broader patient population and greater commercial opportunity.

Clinical Development Plan

We submitted our application to the HREC in March 2026 to support the initiation of a first-in-human trial for CT-202.

We expect to dose the first patient in our CT-202 Phase 1 trial in the third quarter of 2026.

The primary objective in dose escalation will be to evaluate the safety and tolerability of CT-202.

Our collaboration and license agreements

Collaboration Agreement with Tyligand Bioscience

In March 2020, we entered into a process development agreement (the “Tyligand Process Development Agreement”) with Tyligand Bioscience (Shanghai) Limited (“Tyligand”) for the development, manufacturing, registration and future commercialization of ONA-XR.

Upon completion of specific performance-based milestones under the Tyligand Process Development Agreement, in August 2021, we and Tyligand entered into a license agreement (the “Tyligand License Agreement”) whereby Tyligand was granted the exclusive right to ONA-XR and was solely responsible for the development and commercialization of ONA-XR in China, Hong Kong and Macau.

We retained rights in the rest of the world to commercialize ONA-XR.

In August 2024, we and Tyligand mutually agreed to terminate the Tyligand License Agreement, and any ongoing payment obligations we may have had to Tyligand under the Tyligand Process Development Agreement.

Collaboration and Licensing Agreement with Integral Molecular

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In the course of our further due diligence review of CTIM-76, we determined that certain of the licensed rights under the Integral License Agreement may incorporate intellectual property rights currently held by a third party.

Specifically, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034 that potentially cover certain of the intellectual property included in CTIM-76.

Specifically, we are aware of issued patents in the United States and certain foreign jurisdictions expiring in January 2034, and then in 2025 became aware of a patent that issued in the United States expiring in March 2042, in each instance that potentially cover certain of the intellectual property included in CTIM-76.

While we believe we will have reasonable defenses against any potential claim of infringement, we may not be successful in such efforts, and we also may not be able to obtain a license to such patent on commercially reasonable terms, or at all.

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aggregate development and regulatory milestone payments were reduced from $55 million to $15 million, aggregate sales milestone payments were reduced from $130 million to $12.5 million, and a tiered royalty of 8-12% that commenced at first commercial sale was reduced to a flat royalty rate of 6% on net sales beginning no sooner than February 1, 2034.

The Second Amendment also narrowed the

license grant from Integral to us to only cover CTIM-76, removed any further obligation of us to reimburse Integral for any independently obtained research funding Integral applied against CTIM-76 research, and included mutual releases by the parties.

The Second Amendment also narrowed the license grant from Integral to us to only cover CTIM-76, removed any further obligation of us to reimburse Integral for any independently obtained research funding Integral applied against CTIM-76 research, and included mutual releases by the parties.

The reduced development and regulatory milestones now reflect a payment due at each of:

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As partial consideration for the exclusive license under the BioAtla License Agreement, we made an upfront payment of $11.0 million, and BioAtla is eligible to receive up to $122.5 million in additional milestone payments based upon the achievement of specified pre-clinical, clinical, development and commercial milestones, as well as tiered mid-single digit to low double-digit royalties on future net sales for products containing the BioAtla Assets, subject to standard reductions.

Menarini Clinical Trial Collaboration and Supply Agreement

On August 1, 2022, we entered into a Clinical Trial Collaboration and Supply Agreement (the “Menarini Agreement”) with Berlin-Chemie AG - Menarini Group - (“Menarini”) related to ONA-XR.

On March 21, 2023, we mutually terminated the Menarini Agreement, and the parties agreed to reasonably cooperate towards an orderly wind-down of the related clinical trial.

Commercialization

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We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment and personnel while also enabling us to focus our expertise and resources on the development of our current and any future product candidates.

To date, we have obtained active pharmaceutical ingredients (“API”) and drug product for our product candidates from several third-party contract manufacturers, including Lonza Sales AG (“Lonza Sales”) and Lonza AG (collectively, “Lonza”) and Just-Evotec Biologics, Inc.

To date, we have obtained active pharmaceutical ingredients (“API”) and drug product for our product candidates from several third-party contract manufacturers, including Lonza Sales AG (“Lonza Sales”) and Lonza AG (“Lonza AG”, and collectively with Lonza Sales, “Lonza”) and Just-Evotec Biologics, Inc.

We continue to develop our supply chain for CTIM-76, CT-95 and CT-202, and intend to put in place additional framework agreements under which third-party contract manufacturers will generally provide us with necessary quantities of API and drug product on a project-by-project basis based on our development needs.

On November 7, 2022, we entered into a license agreement (the “Lonza CTIM-76 License Agreement”) with Lonza Sales.

Under the terms of the Lonza CTIM-76 License Agreement, to the extent incorporated into CTIM-76, Lonza granted us a non-exclusive license to use certain proprietary Lonza intellectual property and systems for us to develop, manufacture and commercially exploit CTIM-76.

We shall pay certain royalties and annual payments in respect of the manufacturing and sale of CTIM-76, which amounts shall be determined by the party manufacturing CTIM-76 and ranges from a potential annual payment of up to less than $500,000 and a royalty on net sales from 0% up to a low single digit percentage.

The royalty payments and annual payments would be reduced in certain circumstances, including should the valid claims for any such patent rights not exist in the country in which CTIM-76 is being sold, and the royalty payments would expire upon the later of the expiration of the licensed patents in the country in which CTIM-76 is being sold, the expiration of the licensed patents in the country in which CTIM-76 is being manufactured, and 10 years from the first commercial sales of CTIM-76 in such country of sale.

The Lonza CTIM-76 License Agreement continues until terminated, and we or Lonza may terminate the Lonza CTIM-76 License Agreement for uncured material breaches or insolvency of the other party.

We can unilaterally terminate the Lonza CTIM-76 License Agreement with prior written notice to Lonza, and Lonza can also unilaterally terminate the Lonza CTIM-76 License Agreement upon certain actions by us.

The Lonza CTIM-76 License Agreement also contains customary representations, warranties, indemnification and other obligations of us and Lonza.

Under the terms of the Lonza CTIM-76 License Agreement, to the extent Lonza’s technology is incorporated into CTIM-76, Lonza granted us a non-exclusive license to use certain proprietary Lonza intellectual property and systems for us to develop, manufacture and commercially exploit CTIM-76.

On November 3, 2025, we entered into a license agreement (the “Lonza CT-202 License Agreement”) with Lonza Sales.

Under the terms of the Lonza CT-202 License Agreement, to the extent Lonza’s technology is incorporated into CT-202, Lonza granted us a non-exclusive license to use certain proprietary Lonza intellectual property and systems for us to develop, manufacture and commercially exploit CT-202.

We shall pay certain royalties and annual payments to Lonza under the applicable license agreement with respect to the manufacturing and sale of CTIM-76 or CT-202, as applicable, which amounts shall be determined by the party manufacturing CTIM-76 or CT-202, as applicable, and ranges from a potential annual payment of up to less than $500,000 per asset and a royalty per asset on net sales from 0% up to a low single digit percentage.

Under each respective license agreement, the royalty payments and annual payments would be reduced per asset in certain circumstances, including should the valid claims for any such patent rights not exist in the country in which CTIM-76 or CT-202, as applicable, is being sold, and the royalty payments per asset would expire upon the later of the expiration of the licensed patents in the country in which CTIM-76 or CT-202, as applicable, is being sold, the expiration of the licensed patents in the country in which CTIM-76 or CT-202, as applicable, is being manufactured, and 10 years from the first commercial sales of CTIM-76 or CT-202, as applicable, in such country of sale.

The Lonza CTIM-76 License Agreement and the Lonza CT-202 License Agreement each continue until respectively terminated.

We or Lonza may terminate either the Lonza CTIM-76 License Agreement or the Lonza CT-202 License Agreement, as applicable, for uncured material breaches or insolvency of the other party.

We can unilaterally terminate the Lonza CTIM-76 License Agreement or the Lonza CT-202 License Agreement with prior written notice to Lonza, and Lonza can also unilaterally terminate the Lonza CTIM-76 License Agreement or the Lonza CT-202 License Agreement upon certain actions by us.

The Lonza CTIM-76 License Agreement and Lonza CT-202 License Agreement also each contain customary representations, warranties, indemnification and other obligations of us and Lonza.

As we advance our current and any future product candidates through development, we will consider our lack of redundant supply for the API and drug product for each product candidate to protect against any potential supply disruptions.

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Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

Additional mergers and acquisitions may result in even more resources being concentrated in our competitors.

Mergers and acquisitions may result in even more resources being concentrated in our competitors.

Our commercial potential could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than products that we may develop.

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For CTIM-76, our CLDN6 x CD3 TCE, we are aware of several companies developing T cell engagers against CLDN6.

Several TCE candidates are currently in clinical development, including those of Chugai Pharmaceutical (SAIL66), Beigene (BGB-B455), NovaRock Biotherapeutics (NBL028), Third Arc Bio (ARC101), and Xencor (XmAb541).

We may face further competition from companies pursuing the development of product candidates that target CLDN6 through other modalities, including Daiichi Sankyo (DS9606), BioNTech (BNT211, BNT142), and TORL (TORL-1-23).

For CT-95, our MSLN x CD3 TCE, we are aware of several companies developing T cell engagers against MSLN.

Several TCE candidates are currently in clinical development, including those of Johnson & Johnson (JNJ-7903421), Zymeworks (ZW171), and Amgen (AMG-305).

We may face further competition from companies pursuing the development of product candidates that target MSLN through other modalities, including Pfizer (HBM-9033), RemeGen Biosciences (RC88), Outpace Bio (OPB-101), and Navrogen (NAV001, NAV008).

Several TCE candidates are currently in clinical development, including those of Beigene (BGB-B455), Third Arc Bio (ARC101), and Xencor (XmAb541).

For CT-95, our MSLN x CD3 TCE, we are aware that Amgen (AMG-305) has a TCE candidate currently in clinical development.

We may face further competition from companies pursuing the development of product candidates that target MSLN through other modalities, including RemeGen Biosciences (RC88), Outpace Bio (OPB-101), and Navrogen (NAV001, NAV008).

For CT-202, our Nectin-4 x CD3 TCE, we are aware of several companies developing T cell engagers against Nectin-4.

Several TCE candidates are currently in clinical development, including those of Bicycle Therapeutics (BT7480).

We may face further competition from companies pursuing the development of product candidates that target Nectin-4 through other modalities, including Pifzer (Padcev®), Bicycle Therapeutics (BT8009), Eli Lilly (LY4052031, LY4101174), Corbus Pharmaceuticals (CRB-701), Bio-Thera (BAT8007), Mabwell (PMW2821), Adcentrx (ADRX-0706), Rondo Therapeutics (RNDO-564), Aktis Oncology (AKY-1189), and Shanghai Henlius Biotech (HLX-309).

We may face further competition from companies pursuing the development of product candidates that target Nectin-4 through other modalities, including Pfizer (Padcev®), Bicycle Therapeutics (BT8009), Eli Lilly (LY4052031, LY4101174), Corbus Pharmaceuticals (CRB-701), Bio-Thera (BAT8007), Mabwell (PMW2821), Adcentrx (ADRX-0706), Aktis Oncology (AKY-1189), and Shanghai Henlius Biotech (HLX-309).

Intellectual property

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As of March 1, 2026, the Integral Molecular, Inc.

patent portfolio covering CTIM-76 and methods of use that we exclusively licensed pursuant to the Integral License Agreement includes two granted U.S.

patents, three pending U.S.

non-provisional applications, one pending International Patent Cooperation Treaty (“PCT”) application, granted patents in China, Eurasia, Japan, Saudi Arabia, Vietnam, and South Africa, and pending foreign applications in United Arab Emirates, Australia, Brazil, Canada, Chile, Europe, Hong Kong, Indonesia, Israel, India, South Korea, Mexico, New Zealand, Philippines, Singapore, Thailand, Taiwan and Ukraine.

patent portfolio covering CTIM-76 and methods of use that we exclusively licensed pursuant to the Integral License Agreement includes three granted U.S.

patents, two pending U.S.

non-provisional applications, granted patents in China, Eurasia, Japan, Saudi Arabia, Vietnam, Ukraine, and South Africa, and pending foreign applications in United Arab Emirates, Australia, Brazil, Canada, Chile, China, Eurasia, Europe, Hong Kong, Indonesia, Israel, India, Japan, South Korea, Mexico, New Zealand, the Philippines, Saudi Arabia, Singapore, South Africa, Thailand, Taiwan and Vietnam, of which the Philippines and Vietnam are allowed.

patents are expected to expire in 2040 and 2043, subject to any extensions or disclaimers.

We own two pending U.S.

provisional applications covering CTIM-76 and methods of using it, which, if converted and issued, will expire in 2045, subject to any extensions or disclaimers.

We also own two pending U.S.

provisional applications, two pending International Patent Cooperation Treaty applications, and a pending application in Taiwan covering CTIM-76 and methods of using it, which, if converted and issued, will expire in 2045, subject to any extensions or disclaimers.

As of March 1, 2026, we own the patent portfolio covering CT-95 and methods of use, which includes one U.S.

patent, one pending U.S.

non-provisional application, a pending U.S.

provisional application, and pending foreign applications in Australia, Canada, Europe, Japan, and Taiwan.

patent is expected to expire in 2042, subject to any extensions or disclaimers.

As of March 1, 2025, the BioAtla patent portfolio covering CT-202 and methods of use that we exclusively licensed pursuant to the BioAtla License Agreement includes two pending U.S.

non-provisional applications, a granted patent in Japan, and pending foreign applications in Australia, Canada, China, Europe, Hong Kong, Israel, India, Japan, South Korea, Macau, Mexico, Singapore, Thailand, and Taiwan.

non-provisional application, two pending U.S.

provisional applications, and pending

foreign applications in Australia, Canada, Europe, Japan, and Taiwan.

patent and any patents that grant from the pending applications are expected to expire in 2042, subject to any extensions or disclaimers.

As of March 1, 2026, the BioAtla patent portfolio covering CT-202 and methods of use that we exclusively licensed pursuant to the BioAtla License Agreement includes one U.S.

patent, two pending U.S.

non-provisional applications, a granted patent in Japan, Mexico and Taiwan, and pending foreign applications in Australia, Canada, China, Europe, Hong Kong, Israel, India, Japan, South Korea, Macau, Mexico, Singapore, Thailand, and Taiwan, of which Israel is allowed.

The issued patent and any patents that grant from the pending applications are expected to expire from 2039 to 2041, subject to any extensions or disclaimers.

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Patent and other intellectual property rights in the pharmaceutical and biotechnology space are evolving and involve many risks and uncertainties.

Third parties may have blocking patents that could be used to prevent us from

commercializing our product candidates and practicing our proprietary product candidates, and our issued patents may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related products or could limit the term of patent protection that otherwise may exist for our product candidates.

Third parties may have blocking patents that could be used to prevent us from commercializing our product candidates and practicing our proprietary product candidates, and our issued patents may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related products or could limit the term of patent protection that otherwise may exist for our product candidates.

Moreover, such third parties may obtain damages against us, which could require us to make commercially reasonable royalty payments, payments for lost profits, or other damages, costs and expenses.

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For these reasons, we may face competition with respect to our product candidates.

Moreover, because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that, before any particular product candidate can be commercialized, any patent protection for such product may expire or remain in force for only a short period following commercialization, thereby reducing the commercial advantage the patent provides.

Moreover, because of the extensive time required for development, testing and regulatory review of a potential product, it is possible that, before any particular product candidate can be

commercialized, any patent protection for such product may expire or remain in force for only a short period following commercialization, thereby reducing the commercial advantage the patent provides.

Government Regulation

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A facility inspection verifying the manufacturing systems is also usually performed prior to FDA approval.

The FDA offers a number of expedited development and review programs for qualifying product candidates, including the fast track program.

New drug and biological product candidates are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.

Fast track designation considers the combination of the product candidate’s therapeutic potential and the specific indication for which it is being studied.

The sponsor of a new drug or biologic may request that the FDA designate product candidate as fast track at any time during clinical development.

The sponsor of a fast track designated product candidate has opportunities for more frequent interactions with the applicable FDA review team during product candidate development.

A fast track product candidate may also be eligible for rolling review, where the FDA may consider for review sections of the NDA/BLA on a rolling basis before the complete application is submitted upon agreement with the FDA.

Fast track designation does not change the standards for approval but may expedite the development or approval process.

Even if a product candidate qualifies for this program, the FDA may later decide that the product candidate no longer meets the conditions for qualification and rescind the designation or decide that the time period for FDA review or approval will not be shortened.

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs and biologics intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for this type of disease or condition will be recovered from sales in the United States for that drug.

Orphan drug designation must be requested before submitting an NDA/BLA.

If the FDA grants orphan drug designation, the FDA then discloses publicly the identity of the therapeutic agent and its potential orphan use.

Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.

If a product that has orphan drug designation subsequently receives the first FDA market approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same indication, except in very limited circumstances, for seven years.

Orphan drug exclusivity, however, could also block the approval of one of our products for seven years if a competitor obtains approval of the same drug for the same indication or disease as defined by the FDA.

We have in the past used and intend to continue to utilize the services of third-party experts to supplement internal regulatory planning and implementation.

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These include:

• the FDA’s quality system regulation (“QSR”), which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process;

• labeling and marketing regulations which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions for use and that all claims are substantiated;

• current good manufacturing practice (“cGMP”) requirements applicable to drugs and biologics, which require manufacturers, including third-party manufacturers, to follow stringent production, control, quality assurance, supplier qualification, documentation and other procedures throughout all aspects of the manufacturing process;

• labeling and marketing regulations which require that promotion is truthful, not misleading, fairly balanced and consistent with FDA-approved labeling for prescription drug and biologic products;

• advertising and promotion requirements, including FDA prohibitions against the promotion of products for uncleared, unapproved or off-label uses and FDA guidance on off-label dissemination of information and responding to unsolicited requests for information;

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The FDA has broad post-market and regulatory enforcement powers.

Manufacturers of biologic products and drug products are subject to unannounced inspections by the FDA and other state, local and foreign regulatory authorities to assess compliance with the QSR and other applicable regulations, and these inspections may include the manufacturing facilities of any suppliers.

Manufacturers of biologic products and drug products are subject to unannounced inspections by the FDA and other state, local and foreign regulatory authorities to assess compliance with cGMP and other applicable regulations, and these inspections may include the manufacturing facilities of any suppliers.

Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:

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• criminal prosecution.

Regulatory Pathway in the EU

Like the United States, the most important and time-consuming part of seeking marketing authorization in the European Union (“EU”) is the clinical trial process.

In the EU, the various stages of non-clinical and clinical testing are subject to a significant volume of regulatory requirements and controls.

The EU Clinical Trials Regulations (“EU CTR”), adopted in April 2014, became applicable on January 31, 2022 and repealed and replaced the EU Clinical Trials Directive.

The EU CTR applies to all EU member states, unlike the precedent directive, which required each member state to enact the directive into national law.

The EU CTR aims to harmonize the assessment and supervision process for clinical trials throughout the EU through the Clinical Trials Information System (“CTIS”).

The CTR creates a centralized process, permitting clinical trial sponsors to submit a single clinical trial application, applicable to all multi-center trial sites within the EEA.

The CTR transition period ended on January 31, 2025, and all clinical trials (and related applications) are now fully subject to the provisions of the CTR.

To be placed on the market in the European Economic Area (“EEA”) following the clinical trial process, new medical products, including biologics, require a marketing authorization (“MA”).

An MA application may be made through either the centralized or decentralized process, dependent, among other things, on the type of medical product seeking authorization.

A centralized MA is issued by the European Commission based on the opinion of the European Medicines Agency (“EMA”).

Centralized MAs are valid throughout the EU and required for certain types of medicinal products like those derived from biotechnological processes, orphan medical products, advanced therapy medicinal products, and medicinal products with a new active substance for the treatment of certain diseases.

Where the centralized procedure is not mandatory or chosen, applicants may seek authorization through national procedures, the decentralized procedure, or the mutual recognition procedure, which result in national marketing authorizations granted by individual EU Member States.

Regulatory Pathway in the United Kingdom

As of January 1, 2021 and the implementation of the Windsor Framework on January 1, 2025, the UK is not generally subject to EU laws related to medical products.

The EU laws that have been transposed into UK law through secondary legislation remain applicable in the UK;

however, new EU legislation such as the EU CTR is not applicable in the UK.

As of January 1, 2025, all of the UK (including England, Wales, Scotland, and Northern Ireland) are regulated under the Medicines and Healthcare products Regulatory Agency (“MHRA”), the standalone UK medicines and medical device regulator.

The UK regulatory framework for clinical trials is the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, which is derived from the EU Clinical Trials Directive.

In 2024, the UK introduced amendments to the law that seek to streamline the process and accelerate approvals, while maintaining appropriate safety standards.

The amendment is set to take full effect starting in April 2026.

In order to obtain a UK marketing authorization to place medical products on the market in the UK, an applicant must follow one of the UK national authorization procedures or one of the remaining post-Brexit international cooperation procedures.

The MHRA may rely on the International Recognition Procedure (“IRP”) when reviewing certain types of MA applications.

Pursuant to the IRP, the MHRA will consider the expertise and decisions of trusted regulatory partners ( e.g.

, the medicines regulatory authorities in Australia, Canada, Switzerland, Singapore, Japan, the U.S.

and the EMA).

The MHRA will conduct a targeted assessment of IRP applications but retains the authority to reject applications if the evidence provided is considered insufficiently robust.

Regulatory Pathway in Australia

The Australian Therapeutic Goods Administration (“TGA”) and the National Health and Medical Research Council (“NHMRC”) set the legislative, regulatory and good clinical practice (“GCPs”) requirements for clinical trials in Australia.

Australia has also adopted the ICH guidelines on GCP.

Like other jurisdictions discussed above, pre-clinical trials are required to support a first-in-human trial in Australia.

The Therapeutic Goods Act 1989 and related regulations establish and maintain the national system of controls relating to the efficacy, quality, safety and timely availability of drugs and medical devices in Australia.

The TGA administers two pathways for clinical trials, the Clinical Trials Notification (“CTN”) and Clinical Trials Approval

(“CTA”) schemes.

These pathways govern the process through which “unapproved” ( i.e.

, not yet authorized for the Australian market) therapeutic goods may be supplied solely for experimental use in humans.

The choice of which pathway to use (CTN or CTA) is made by the clinical trial sponsor, which must be an Australian legal entity or have an Australian sponsor responsible to the TGA.

That decision is reviewed and confirmed by the HREC that approves the protocol.

The CTA pathway, which requires prior regulatory approval, is designed primarily for high-risk or novel treatments where there is limited or no knowledge of the therapeutic good’s safety for use in humans.

All therapeutic goods must be approved for inclusion in the Australian Register of Therapeutic Goods (the “ARTG”) before it may be marketed (or imported, exported, manufactured or supplied) in Australia.

In order to obtain registration of the product on the ARTG, the medical product’s sponsor must provide evidence supporting quality, safety, and efficacy, which may include clinical trials, and evidence demonstrating that the manufacture of the therapeutic product complies with all applicable principles of current good manufacturing practices (“cGMPs”).

Privacy and Security Laws

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The enhancements include imposing additional compliance obligations for covered entities and removing certain exemptions previously available under the CCPA.

While the California Attorney General retains civil enforcement authority, the CPRA also created the California

Privacy Protection Agency to implement and enforce the law.

While the California Attorney General retains civil enforcement authority, the CPRA also created the California Privacy Protection Agency to implement and enforce the law.

Since the CCPA, many other states have passed or are considering passing similar state privacy laws.

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The EU-wide General Data Protection Regulation (“GDPR”) became applicable on May 25, 2018, replacing the previous data protection laws issued by each EU Member State based on the Directive 95/46/EC.

Unlike the Directive (which needed to be transposed at national level), the GDPR text is directly applicable in each EU member state, resulting in a more uniform application of data privacy laws across the EU.

Unlike the Directive (which needed to be

transposed at national level), the GDPR text is directly applicable in each EU member state, resulting in a more uniform application of data privacy laws across the EU.

The GDPR imposes onerous accountability obligations, requiring data controllers and processors to maintain a record of their data processing and policies.

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Certain of these changes could impose additional limitations on the prices we will be able to charge and/or patients’ willingness to pay for our products.

While in general it is too early to predict what effect, if any, any future healthcare reform legislation or policies will

have on our business, current and future healthcare reform legislation and policies could have a material adverse effect on our business and prospects.

While in general it is too early to predict what effect, if any, any future healthcare reform legislation or policies will have on our business, current and future healthcare reform legislation and policies could have a material adverse effect on our business and prospects.

Pricing and Reimbursement

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Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis.

One third-party payor’s decision to cover a particular product or procedure using the product does not ensure that other payors will also provide coverage for the product.

One third-party payor’s decision to cover a particular product does not ensure that other payors will also provide coverage for the product.

Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate revenue level.

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Due to the breadth of these federal and state anti-kickback laws and the potential for additional legal or regulatory change in this area, it is possible that our sales and marketing practices and/or our relationships with physicians might be challenged under anti-kickback laws, which could harm us.

Because we plan to commercialize products that could be reimbursed under a federal healthcare program and other governmental healthcare programs, we plan to develop a

comprehensive compliance program that establishes internal controls to facilitate adherence to the rules and program requirements to which we are subject.

Because we plan to commercialize products that could be reimbursed under a federal healthcare program and other governmental healthcare programs, we plan to develop a comprehensive compliance program that establishes internal controls to facilitate adherence to the rules and program requirements to which we are subject.

The federal False Claims Act prohibits anyone from, among other things, knowingly presenting, or causing to be presented, for payment to federal programs (including Medicare and Medicaid) claims for items or services, including pharmaceutical products, that are false or fraudulent.

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For example, pharmaceutical companies have been prosecuted under the federal False Claims Act in connection with their off-label promotion of drugs.

Penalties for a False Claims Act violation include three times the actual damages sustained by the government, plus mandatory civil penalties for each separate false claim, the potential for exclusion from participation in federal healthcare programs, and, although the federal False Claims Act is a civil statute, conduct that results in a False Claims Act violation may also implicate various federal criminal statutes.

Penalties for a False Claims Act violation include three times the actual damages sustained by the government, plus mandatory civil penalties for each separate

false claim, the potential for exclusion from participation in federal healthcare programs, and, although the federal False Claims Act is a civil statute, conduct that results in a False Claims Act violation may also implicate various federal criminal statutes.

If the government were to allege that we were, or convict us of, violating these false claims laws, we could be subject to a substantial fine and may suffer a decline in our stock price.

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Human Capital

As of March 1, 2025, we had twelve full-time employees and no part-time employees.

As of March 1, 2026, we had fifteen full-time employees and no part-time employees.

None of these employees are represented by labor unions or covered by collective bargaining agreements.

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We support our colleagues with a comprehensive offering of competitive pay and benefits.

Our principal office is located in Philadelphia, Pennsylvania, where we lease approximately 3,500 square feet of office space pursuant to a lease that expires on November 30, 2026, which lease renews at our option for two additional successive one-year periods should we provide the landlord with notice of extension at least 9 months before any such successive renewal.

We believe our facility is adequate to meet our current needs, although we may seek to negotiate new leases or evaluate additional or alternate space for our operations.

We believe appropriate alternative space will be readily available on commercially reasonable terms.

Legal Proceedings

From time to time we may be involved in disputes or litigation relating to claims arising out of our operations.

We are not currently a party to any legal proceedings that could reasonably be expected to have a material adverse effect on our business, financial condition and results of operations.

Corporate Information

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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