CNTX

Risk Factors” in this Annual Report on Form 10-K for the year ended December 31, 2025.
Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations. • If we are unable to raise substantial additional capital on acceptable terms, or at all, we may be forced to delay, reduce or eliminate some or all of our research programs, product development activities and commercialization efforts. • We may not be able to successfully integrate recent and future acquisitions. • We have a limited operating history, which makes it difficult to evaluate our current business and future prospects and may increase the risk of your investment. • We may expend our limited resources pursuing particular research programs or product candidates that may be less successful or profitable than other programs or product candidates. • Fluctuating foreign exchange rates could increase our operating expenses and adversely affect our results of operations. • Inflation, geopolitical developments, global supply chain disruptions and public health concerns could adversely affect our business and results of operations. • Changes in U.S. trade policy, including the imposition of tariffs and the resulting consequences, may have a material adverse impact on our business, financial condition, and results of operations.
Risks Related to Our Reliance on Third Parties ii • We expect to, and do, depend on collaborations with third parties for certain research, development and commercialization activities, and to rely on third parties to conduct, supervise and monitor our clinical trials and some aspects of our research and preclinical testing, as well as for the manufacturing process of product candidates.
If any such collaborations or services by such third parties are not successful or not performed in a satisfactory manner, it may harm our business and prospects, and we may not be able to obtain regulatory approval or commercialize product candidates, or such approval or commercialization may be delayed, and our business may be substantially harmed. • If we are unable to obtain sufficient quantities of raw materials and supplies, at acceptable prices and on a timely basis, it could harm our business. • We may become involved in disagreements or disputes with our licensees, licensors and other counterparties relating to the development and/or commercialization of our current or past product candidates, which may be time consuming, costly and could harm our efforts to develop our current or future product candidates.
Risks Related to the Market for Our Common Stock • Our common stock may be volatile or may decline regardless of our operating performance. • We may not be able to maintain compliance with the continued listing requirements of The Nasdaq Stock Market. • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates. iii NOTE REGARDING FORWARD-LOOKING STATEMENTS This Form 10-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.
Food and Drug Administration (“FDA”) approval, as well as similar applications and approvals in foreign jurisdictions, of CTIM-76, CT-95, CT-202 and any other future product candidates; • our ability to develop and advance CTIM-76, CT-95, CT-202 and any other future product candidates, and successfully complete clinical studies; • our manufacturing, commercialization, and marketing capabilities, implementations thereof, and strategy; • our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus, sales strategy, and our ability to grow a sales team; • our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering CTIM-76, CT-95, CT-202, and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights; • any disagreements or disputes with our licensees, licensors and other counterparties relating to the development and/or commercialization of our current or past product candidates, which may be time consuming, costly and could harm our efforts to develop our current or future product candidates; • the impact of economic uncertainties on our business and operations, including clinical trials, manufacturing suppliers, collaborators, use of contract research organizations and employees; • the need to hire additional personnel and our ability to attract and retain such personnel; • the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; • our competitive position and the success of competing therapies that are or may become available; • the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; • our ability to obtain and maintain regulatory approval of our product candidates; iv • our plans relating to the further development of our product candidates, including additional indications we may pursue; • existing regulations and regulatory developments in the United States, Europe, Australia, and other jurisdictions; • our continued reliance on third parties to conduct and support clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; • our ability to obtain, and negotiate favorable terms of, collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; • the pricing and reimbursement of CTIM-76, CT-95, CT-202 and other product candidates we may develop, if approved; • the rate and degree of market acceptance and clinical utility of CTIM-76, CT-95, CT-202 and other product candidates we may develop; • our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; • our current plans to seek additional capital in the future through equity and/or debt financings, partnerships, collaborations, licensing agreements or other strategic arrangements, or other sources and the availability of such future sources of capital; • our financial performance; • our ability to maintain compliance with the continued listing requirements of The Nasdaq Stock Market; • the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; • the impact of laws and regulations; • our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act; • our anticipated use of our existing cash and cash equivalents; and • other risks and uncertainties, including those listed under the caption “Risk Factors”.
Scientific and clinical data presented herein are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification. v The forward-looking statements made in this Form 10-K relate only to events or information as of the date of the Form 10-K (or any earlier date indicated in such statement).
Although we are a public company and have ongoing disclosure obligations under United States federal securities laws, we do not intend to update or otherwise revise the forward-looking statements in this Form 10-K, whether as a result of new information, future events or otherwise. vi MARKET, INDUSTRY AND OTHER DATA This Annual Report on Form 10-K contains estimates, projections, market research and other information concerning our industry, our business, markets for our product candidates, the size of those markets, and the prevalence of certain medical conditions.
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.
We expect to share Phase 1a interim data for the CTIM-76 trial in June 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.
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.
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.
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.
The preclinical data below illustrate that CTIM-76 is a highly selective and potent CLDN6 x CD3 TCE.
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.
Selected Cancer indications Incidence (US Only) R/R Incidence CLDN6 Positive CLDN6 Med/High Patient Population Based on R/R Incidence Ovarian 19,900 12,800 75% 1 35% 1 9,600 Endometrial 65,900 14,000 50% 1 22% 1 7,000 Testicular 9,910 400 100% 3 >95% 3 Non-Small Cell Lung 201,229 110,653 26% 2 6% 2 28,769 Colon 152,810 53,010 43% 3 0% 3 22,794 Breast 290,600 43,800 40% 3 0% 3 17,520 1 Context internal Phase 1 data; 2 Context internal biopsy prevalence screen data; 3 Mackensen, Nature Medicine, 2023.
Clinical Development Plan 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.
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.
We believe CT-95 has the potential to be a differentiated MSLN product candidate, due in part to: (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 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.
Selected Cancer indications Incidence (US Only) R/R Incidence MSLN Positive MSLN Med/High Patient Population Based on R/R Incidence Non-Small Cell Lung 201,229 110,653 55% 36% 60,859 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 Esophageal 22,370 16,130 41% 26% 6,613 Endometrial 65,900 14,000 45% 23% 6,300 Gastric 26,380 11,090 49% 23% 5,434 Incidences based on public estimates; R/R or last-line patient population approximated by annual mortality; MSLN target prevalence is based on Simon et al, Biomedicines, 2021.
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”).
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 There is a significant global opportunity for the treatment of patients with tumors expressing Nectin-4.
Selected Cancer indications Incidence (US Only) R/R Incidence Nectin-4 Positive Nectin-4 Med/High Patient Population Based on R/R Incidence Colon 152,810 53,010 87% 1 78% 2 46,119 Bladder (urothelial) 83,190 20,000 83% 3 60% 3 16,600 Breast (TNBC) 62,054 15,500 78% 3 58% 5 12,090 Non-Small Cell Lung 201,229 110,653 64% 3 58% 6 70,818 Pancreatic 66,440 51,750 71% 3 37% 3 36,743 Head and Neck 54,000 12,000 59% 3 18% 3 7,080 Esophageal 22,370 16,130 55% 3 24% 3 8,872 Gastric 26,890 12,000 94% 7 60% 4 11,280 Incidences based on public estimates; 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; 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 Therapeutics (BT8009), including ADC approaches, we believe this target has been clinically validated.
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.

and 170 more.

Gone since FY2024

Risk Factors” in this Annual Report on Form 10-K for the year ended December 31, 2024.
Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations. • If we are unable to raise substantial additional capital on acceptable terms, or at all, we may be forced to delay, reduce or eliminate some or all of our research programs, product development activities and commercialization efforts. • We may not be able to successfully integrate recent and future acquisitions. • We have a limited operating history, which makes it difficult to evaluate our current business and future prospects and may increase the risk of your investment. • We may expend our limited resources pursuing particular research programs or product candidates that may be less successful or profitable than other programs or product candidates. • Fluctuating foreign exchange rates could increase our operating expenses and adversely affect our results of operations. • Inflation could adversely affect our business and results of operations.
Risks Related to Our Reliance on Third Parties • We expect to, and do, depend on collaborations with third parties for certain research, development and commercialization activities, and to rely on third parties to conduct, supervise and monitor our clinical trials and some aspects of our research and preclinical testing, as well as for the manufacturing process of ii product candidates.
If any such collaborations or services by such third parties are not successful or not performed in a satisfactory manner, it may harm our business and prospects, and we may not be able to obtain regulatory approval or commercialize product candidates, or such approval or commercialization may be delayed, and our business may be substantially harmed. • We may become involved in disagreements or disputes with our licensees, licensors and other counterparties relating to the development and/or commercialization of our current or past product candidates, which may be time consuming, costly and could harm our efforts to develop our current or future product candidates.
Risks Related to the Market for Our Common Stock • Our common stock may be volatile or may decline regardless of our operating performance. • We may not be able to regain and maintain compliance with the continued listing requirements of The Nasdaq Stock Market. • We may issue debt and equity securities, which are senior to our common stock as to distributions and in liquidation, which could materially adversely affect the market price of our common stock. • We may fail to maintain effective internal control over financial reporting and effective disclosure controls and procedures.
If we fail to remediate any material weaknesses, we may not be able to report our financial results accurately or to prevent fraud, which could materially adversely affect the market price of our common stock. • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates. iii NOTE REGARDING FORWARD-LOOKING STATEMENTS This Form 10-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.
Food and Drug Administration (“FDA”) approval, as well as similar applications and approvals in foreign jurisdictions, of CTIM-76, CT-95, CT-202 and any other future product candidates; • our ability to develop and advance CTIM-76, CT-95, CT-202 and any other future product candidates, and successfully complete clinical studies; • our manufacturing, commercialization, and marketing capabilities, implementations thereof, and strategy; • our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus, sales strategy, and our ability to grow a sales team; • our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering CTIM-76, CT-95, CT-202, and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights; • any disagreements or disputes with our licensees, licensors and other counterparties relating to the development and/or commercialization of our current or past product candidates, which may be time consuming, costly and could harm our efforts to develop our current or future product candidates; • the impact of economic uncertainties on our business and operations, including clinical trials, manufacturing suppliers, collaborators, use of contract research organizations and employees; • the need to hire additional personnel and our ability to attract and retain such personnel; • the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; • our competitive position and the success of competing therapies that are or may become available; • the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; • our ability to obtain and maintain regulatory approval of our product candidates; iv • our plans relating to the further development of our product candidates, including additional indications we may pursue; • existing regulations and regulatory developments in the United States, Europe and other jurisdictions; • our continued reliance on third parties to conduct and support clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; • our ability to obtain, and negotiate favorable terms of, collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; • the pricing and reimbursement of CTIM-76, CT-95, CT-202 and other product candidates we may develop, if approved; • the rate and degree of market acceptance and clinical utility of CTIM-76, CT-95, CT-202 and other product candidates we may develop; • our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; • our current plans to seek additional capital in the future through equity and/or debt financings, partnerships, collaborations, licensing agreements or other strategic arrangements, or other sources and the availability of such future sources of capital; • our financial performance; • the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; • the impact of laws and regulations; • our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act; • our anticipated use of our existing cash and cash equivalents; and • other risks and uncertainties, including those listed under the caption “Risk Factors”.
Scientific and clinical data presented herein are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.
The forward-looking statements made in this Form 10-K relate only to events or information as of the date of the Form 10-K (or any earlier date indicated in such statement).
Although we are a public company and have v ongoing disclosure obligations under United States federal securities laws, we do not intend to update or otherwise revise the forward-looking statements in this Form 10-K, whether as a result of new information, future events or otherwise. vi MARKET, INDUSTRY AND OTHER DATA This Annual Report on Form 10-K contains estimates, projections, market research and other information concerning our industry, our business, markets for our product candidates, the size of those markets, and the prevalence of certain medical conditions.
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.
We expect to share initial data for the CTIM-76 Phase 1 trial in the first half of 2026.
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 expect to file an IND application for CT-202 in the middle of 2026.
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. • Seek opportunities to expand our pipeline of selective cancer drug candidates and targets.
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.
The figure below indicates that CTIM-76 is a highly selective and potent CLDN6 x CD3 TCE.
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.
Selected Cancer indications Incidence (US Only) R/R Incidence CLDN6 Positive CLDN6 Med/High Patient Population Based on R/R Incidence Endometrial 65,900 14,000 51% 1 22% 1 7,140 Ovarian 19,900 12,800 44% 1 25% 1 5,632 Testicular 9,910 400 94% 1 90% 1 Non-Small Cell Lung 201,229 110,653 26% 1 6% 1 28,769 Colon 152,810 53,010 40% 2 0% 2 21,204 Breast 290,600 43,800 40% 2 0% 2 9,417 Sarcoma 17,100 12,390 20% 2 10% 2 2,478 Gastric 26,380 11,090 9% 1 7% 1 1 Context internal data; 2 Mackensen, Nature Medicine, 2023.
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.
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.
We believe CT-95 has the potential to be a differentiated MSLN product candidate, due in part to: (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; 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.
Selected Cancer indications Incidence (US Only) R/R Incidence MSLN Positive MSLN Med/High Patient Population Based on R/R Incidence Non-Small Cell Lung 201,229 110,653 55% 36% 60,859 Pancreatic 66,440 51,750 80% 61% 41,400 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 Endometrial 65,900 14,000 45% 23% 6,300 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; R/R or last-line patient population approximated by annual mortality; MSLN target prevalence is based on Simon et al, Biomedicines, 2021.
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”).
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.
Market Opportunity There is a significant global opportunity for the treatment of patients with tumors expressing Nectin-4.
Selected Cancer indications Incidence (US Only) R/R Incidence Nectin-4 Positive Nectin-4 Med/High Patient Population Based on R/R Incidence Non-Small Cell Lung 201,229 110,653 64% 1 30% 1 70,818 Colon 152,810 53,010 87% 1 78% 1 46,119 Pancreatic 66,440 51,750 71% 1 37% 1 36,743 Bladder (urothelial) 83,190 20,000 83% 1 60% 1 16,600 Breast (TNBC) 62,054 15,500 69% 1 53% 1 10,695 Head and Neck 54,000 12,000 59% 1 18% 1 7,080 Esophageal 22,370 16,130 55% 1 24% 2 8,872 Gastric 26,890 12,000 71% 3 60% 3 8,520 Ovarian 19,900 12,800 57% 4 2% 4 7,296 Incidences based on public estimates; 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 Challita, Can Res, 2016; 2 Zhang, Oncol Lett, 2018; 3 Derycke, Am J Clin Pathol, 2010; 4 Kobecki, Int J Mol Sci, 2023 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.
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.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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