CATX

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How CATX rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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Risks Related to Our Business and Industry Our product candidates are in early stages of development and must go through clinical trials, which are very expensive, time consuming and difficult to design and implement.
The outcomes of clinical trials are uncertain, and delays in the completion or termination of any clinical trial of our product candidates could harm our business, financial condition and prospects. • We rely on single vendors to provide supplies and services used in the development and production of our alpha-particle therapies. • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected. • Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance into clinical trials may not have favorable results in later clinical trials, if any, or receive regulatory approval. • Delays in the commencement, execution or completion of our clinical trials could result in increased costs and delay our ability to pursue regulatory approval and commercialization of our product candidates. • We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive, or the trials are not well designed. • The approval processes of regulatory authorities are lengthy, time consuming, expensive and inherently unpredictable; if we experience unanticipated delays or are unable to obtain approval for our product candidates from applicable regulatory authorities, we will not be able to market and sell those product candidates in those countries or regions and our business will be substantially harmed. • Disruptions at the FDA, including due to a lapse in appropriations and/or decreased funding for the FDA, could prevent the FDA from performing functions on which our business relies, which could negatively impact our business. • We receive federal funding to conduct certain research on our product candidates and other programs, and recent federal policy changes could disrupt that funding. • Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of the approved labeling, or result in significant negative consequences following marketing approval, if any. • If we are unable to execute our sales and marketing strategy for our product candidates, if commercialized, and are unable to gain market acceptance, we may be unable to generate sufficient revenue to sustain our business. • Because we license technology underlying some of our product candidates from third parties, any dispute with our licensors or non-performance by us or by our licensors may adversely affect our ability to develop and commercialize the applicable product candidates. • We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements. • We may rely partially on third parties to manufacture our clinical pharmaceutical supplies and could continue to rely on third parties to produce commercial supplies of any approved product candidate, and our dependence on third party suppliers could adversely impact our business. • We may not be successful in managing the build-out of our manufacturing facilities and associated costs or satisfying manufacturing-related regulatory requirements. • We rely on third parties to conduct our clinical trials, and if these third parties do not meet their deadlines or otherwise conduct the trials as required, our clinical development programs could be delayed or unsuccessful, and we may not be able to obtain regulatory approval for or commercialize our product candidates when expected or at all. • We have in-sourced part of the research, development and clinical operations functions previously assigned to clinical research organizations, and we may not be able to efficiently execute those operations, or the cost savings expected from this transition may not materialize, which may adversely affect the financial performance of our business and our ability to advance our pipeline. • We may seek orphan drug designation, rare pediatric disease designation or other FDA designations but may not receive such designation.
Even if the FDA grants the designation, we may not receive orphan drug exclusivity or a priority review voucher if the product candidate does not meet the FDA requirements at the time of approval or licensure. • We have received Fast Track designation for VMT-α-NET and VMT01, but such designation may not actually lead to a faster development or regulatory review or approval process.
Additionally, the FDA may rescind the designation if it determines the applicable product candidate no longer meets the qualifying criteria for Fast Track. • We will face intense competition and may not be able to compete successfully. • We may rely on market exclusivity periods that may not be or remain available to us. • If any product candidate that we successfully develop does not achieve broad market acceptance among physicians, patients, healthcare payors and the medical community, the revenues that it generates from their sales will be limited. • Coverage and adequate reimbursement may not be available for our products, if commercialized, which could make it difficult for us to sell any future products profitably. • Due to the significant resources required for the development of our drug candidates, we must prioritize development of certain drug candidates and/or certain disease indications and may expend our limited resources on candidates or indications that do not yield a successful program and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success. • If we fail to attract and retain key management, scientific and clinical development personnel, we may be unable to successfully develop or commercialize our product candidates.
Legal and Regulatory Risks Related to Our Operations • Significant disruptions of information technology systems or cybersecurity incidents could materially adversely affect our business, results of operations and financial condition. • Our employees and independent contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory pricing standards and requirements, which could have an adverse effect on our results of operations. • If we fail to comply with applicable healthcare regulations, we could face substantial penalties, and our business, operations and financial condition could be adversely affected. • Healthcare reform measures could hinder our programs’ commercial success. • Failure to comply with government regulations could harm our business. • Our business exposes us to product liability claims. • Our business involves environmental risks.
Risks Related to Intellectual Property Matters • Our success will depend upon intellectual property, proprietary technologies and regulatory market exclusivity periods, and we may be unable to protect our intellectual property. • Our ability to compete may be adversely affected if we do not adequately protect our proprietary rights. • Potential patent litigation could be costly and disruptive and may have an adverse effect on our business, financial condition and results of operations. • The value of our granted patents and our patents pending is uncertain.
Risks Related to Ownership of Shares of Common Stock and Public Company Status • The concentration of our common share ownership will likely limit the ability of other shareholders to influence corporate matters. • Our stock price has been and may continue to be volatile. • The price of our common stock may be adversely affected by the future issuance and sale of shares of our common stock or other equity securities.
PART I ITEM 1 – BUSI NESS Overview We are a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body.
Our neuroendocrine tumor (VMT-α-NET), melanoma (VMT01) and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials in the U.S.
We are growing our regional network of drug product candidate finishing facilities, enabled by our proprietary 212 Pb generator technologies, to deliver patient-ready product candidates for clinical trials and commercial operations.
The key elements of our strategy are to: Discover and Develop a Broad Oncology Pipeline • Advance our initial drug candidate, VMT-α-NET, through clinical development for the treatment of neuroendocrine tumors expressing somatostatin receptor type 2 (SSTR2). • Expand the potential of our product candidates in additional indications and as combination therapies in current and additional indications. • Advance our second drug candidate, VMT01, through clinical development for the treatment of melanoma tumors expressing melanocortin 1 receptor (MC1R). • Advance our third drug candidate, PSV359, through clinical development for the treatment of solid tumors expressing fibroblast activation protein.
Deploy Our Innovative Platform Technology • Continue to leverage our TAT platform to expand our pipeline of product candidates. • Utilize a precision medicine approach by leveraging imaging diagnostics.
Radiopharmaceuticals Radiopharmaceuticals have been developed to precisely apply the tumor-killing power of radiation to a wider array of cancers, including for patients who have metastatic disease.
Targeted radiopharmaceuticals are drugs that contain a radionuclide payload, which are unstable elements that emit radiation and can be used to diagnose and treat cancers, and a targeting moiety.
We believe that our TAT platform and current and future product candidates, if approved, could provide several potential advantages over currently available radiopharmaceuticals, including: • enhanced tumor-killing power by using 212 Pb alpha-particle radiation in an outpatient setting; • ability to pursue multiple targets and use multiple classes of targeting molecules; • broad applicability across multiple tumor types, including neuroendocrine, metastatic melanomas and others cancers; • increased tolerability and therapeutic window associated with our lead-based TATs; • exploitation of multiple mechanisms of action, including direct deoxyribonucleic acid (DNA) damage through double-stranded DNA breaks, and an alpha particle-mediated enhanced anti-tumor immune response; • a scalable manufacturing process and supply chain using our proprietary generator technologies; and • ability to use our 203 Pb imaging diagnostics to enrich targeted patient populations and determine treatment therapeutic suitability.
A secondary mechanism, which would likely expand the effective direct cell kill range of the alpha particles, is referred to as the Bystander Effect, which involves the propagation of alpha particle-induced cell death from irradiated dying cells to kill adjacent non-irradiated cells in a three-dimensional solid tumor model.
Beta Radiopharmaceuticals There are two main classes of therapeutic radiopharmaceuticals, which differ based on the types of particles that are emitted - beta-emitting isotopes and alpha-emitting isotopes.
Compared to beta particles, alpha particles can cause greater physical damage to cancer cells, including multiple double-stranded DNA breaks, which are very difficult for cancer cells to overcome, unlike in the case of single-stranded DNA breaks.
Alpha particles are over 7,000 times more massive than beta particles, resulting in a significantly higher energy transfer rate, providing alpha particles the advantage of depositing a high amount of tumor-killing energy over a short distance of one to two cells, compared to the relatively long distance of up to 12 mm for beta particles.
Novartis reported that fiscal year 2025 sales revenue from Lutathera was $816 million, up 12% from fiscal year 2024, despite only being approved for a subset of neuroendocrine cancers that affect the pancreas or gastrointestinal tract, known as GEP-NETs.
Novartis reported that fiscal year 2025 sales revenue for Pluvicto was $2.0 billion, up 42% from fiscal year 2024.
Our TAT Platform Through the use of proprietary, specialized targeting peptides, we are able to obtain patient images using Lead-203 ( 203 Pb) and then deliver a powerful alpha-particle radiotherapy directly to the tumor using 212 Pb labeled radiotherapies, potentially limiting damage to healthy tissue.
Utilizing a radioactive imaging agent that emits gamma rays, 203 Pb, connected to a specific targeting peptide, we have the ability to image tumors.
Because 203 Pb and 212 Pb are elementally identical, we can use the imaging information to understand the biodistribution and pharmacokinetics of the 212 Pb alpha-particle therapy using the same targeting peptide to treat and potentially kill cancerous cells.
We believe that our TATs have the potential to be broadly applicable across multiple targets and tumor types and transform the treatment landscape of radiopharmaceuticals for the treatment of cancer. 212 Pb (Lead-212) Although there are many beta- and alpha-emitting isotopes, we believe that the ideal therapeutic isotope should emit alpha particles at a high rate over a relatively short period of time in order to maximize damage to cancer cells and increase efficacy.
Our findings were reported by our Vice President of Discovery, Dr.
Mengshi Li, et.al. in the peer-reviewed journal Cancers 2021, 13: 3676, 2021 and showed that the cooperative effect between [ 212 Pb]VMT01 and immune checkpoint inhibitors were also observed in a heterogeneous preclinical melanoma model.
The graphic below provides our illustration of the comparison of the key differences between beta particles and alpha emitters. *Daughter isotopes USPI for 177Lu vipivotide tetraxetan.
Michael Schultz, colleagues at the University of Iowa and our team members resulted in the development of our proprietary TAT, Pb-specific chelator (PSC) and peptide linker technology to enable the delivery of isotopes to tumor cells while simultaneously promoting enhanced clearance of the non-tumor localized isotopes.
Due to the short half-life of 212 Pb and the small size of the compounds, when our TATs are not bound to targeted cancer cells, they rapidly clear from the body, primarily through the urinary system, along with any isotopes bound to the linker.
For example, the high energy emitted from 212 Pb could cause product candidates to prematurely degrade.
We believe we have the experience and know-how to develop molecules and formulations of 212 Pb to maximize the shelf-life of our product candidates and allow for regional production and distribution.
Imaging Diagnostics – 203 Pb For each of our product candidates, we create an imaging analogue that utilizes the same linker and targeting molecule but replaces 212 Pb with the radioactive imaging isotope 203 Pb.
The imaging analogue versions of our product candidates are leveraged in both preclinical and clinical development and are used to enrich the patient population in our clinical trials by identifying the patients and tumor types more likely to respond to therapy. 203 Pb is a gamma-emitting nuclide that acts as the diagnostic in our innovative theranostic approach. 203 Pb has a long enough half-life to facilitate radiopharmaceutical preparation and gamma-ray imaging (e.g., SPECT or planar gamma camera) at time points up to 24 hours and, potentially, 48 hours post administration.
The table below details our current pipeline of TATs, indicating the status of each of our three lead programs in clinic within our broad proprietary pipeline at March 12, 2026.
To date, we have retained global development and commercialization rights to all our product candidates.
In January 2024, we announced we had entered into a strategic agreement with an affiliate of Lantheus Holdings, Inc.
(Lantheus) whereby in exchange for an upfront payment of $28 million (less certain withholding amounts), Lantheus obtained an exclusive option to negotiate for an exclusive license to our [ 212 Pb]VMT-α-NET and a right to co-fund the Investigational New Drug (IND)-enabling studies for early-stage therapeutic candidates targeting PSMA and gastrin-releasing peptide receptor (GRPR) and, prior to IND filing, a right to negotiate for an exclusive license to such candidates.
Programs VMT-α-NET: A Targeted Alpha Therapy Targeting SSTR2 Overview We designed VMT-α-NET to target and deliver 212 Pb to cancer-specific receptors on tumor cells expressing SSTR2, a protein that is overexpressed in neuroendocrine tumors (NETs) and other cancers. [ 212 Pb]VMT-α-NET is a TAT in development for patients with unresectable or metastatic SSTR2-expressing tumors who have not previously received peptide-targeted radiopharmaceutical therapy, such as Lutathera.
It is estimated that 80% of NETs over-express SSTR2.

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Gone since FY2024

Risks Related to Our Business and Industry Our program candidates are in early stages of development and must go through clinical trials, which are very expensive, time consuming and difficult to design and implement.
The outcomes of clinical trials are uncertain, and delays in the completion of or the termination of any clinical trial of our program candidates could harm our business, financial condition and prospects. • We rely on single vendors to provide supplies and services used in the development and production of our alpha-particle therapies. • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected. • Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, any program candidate we advance into clinical trials may not have favorable results in later clinical trials, if any, or receive regulatory approval. • Delays in the commencement, execution or completion of our clinical trials could result in increased costs and delay our ability to pursue regulatory approval and commercialization of our program candidates. • We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive, or the trials are not well designed. • The approval processes of regulatory authorities are lengthy, time consuming, expensive and inherently unpredictable; if we experience unanticipated delays or are unable to obtain approval for our program candidates from applicable regulatory authorities, we will not be able to market and sell those program candidates in those countries or regions and our business will be substantially harmed. • Disruptions at the FDA, including due a reduction in the FDA’s workforce and/or decreased funding for the FDA, could prevent the FDA from performing functions on which our business relies, which could negatively impact our business. • We rely on federal funding for conducting certain research on our products or product candidates, and recent federal policy changes could disrupt that funding. • Our program candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of the approved labeling, or result in significant negative consequences following marketing approval, if any. • If we are unable to execute our sales and marketing strategy for our programs and are unable to gain market acceptance, we may be unable to generate sufficient revenue to sustain our business. • Because we license technology underlying some of our program candidates from third parties, any dispute with our licensors or non-performance by us or by our licensors may adversely affect our ability to develop and commercialize the applicable program candidates. • We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements. • We may rely partially on third parties to manufacture our clinical pharmaceutical supplies and could continue to rely on third parties to produce commercial supplies of any approved program candidate, and our dependence on third party suppliers could adversely impact our business. • We may not be successful in managing the build-out of our manufacturing facilities and associated costs or satisfying manufacturing-related regulatory requirements. • We rely on third parties to conduct our clinical trials, and if these third parties do not meet their deadlines or otherwise conduct the trials as required, our clinical development programs could be delayed or unsuccessful, and we may not be able to obtain regulatory approval for or commercialize our program candidates when expected or at all. • We have in-sourced part of the research, development and clinical operations functions previously assigned to clinical research organizations (CROs), and we may not be able to efficiently execute those operations, or the cost savings expected from this transition may not materialize, which may adversely affect the financial performance of our business and our ability to advance our pipeline. • We may seek orphan drug designation, rare pediatric disease designation or other FDA designations but may not receive such designation.
Even if the FDA grants the designation, we may not receive orphan drug exclusivity or a priority review voucher, if the program candidate does not meet the FDA requirements at the time of approval or licensure. • We have received Fast Track designation for VMT-α-NET and VMT01, but such designation may not actually lead to a faster development or regulatory review or approval process.
Additionally, the FDA may rescind the designation if it determines the applicable program candidate no longer meets the qualifying criteria for Fast Track. • We will face intense competition and may not be able to compete successfully. • We may rely on market exclusivity periods that may not be or remain available to us. • If any program candidate that we successfully develop does not achieve broad market acceptance among physicians, patients, healthcare payors and the medical community, the revenues that it generates from their sales will be limited. • Coverage and adequate reimbursement may not be available for our products, if commercialized, which could make it difficult for us to sell our products profitably. • Due to the significant resources required for the development of our drug candidates, we must prioritize development of certain drug candidates and/or certain disease indications and may expend our limited resources on candidates or indications that do not yield a successful program and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success. • If we fail to attract and retain key management, scientific and clinical development personnel, we may be unable to successfully develop or commercialize our program candidates.
Legal and Regulatory Risks Related to Our Operations • Significant disruptions of information technology systems or breaches of data security could materially adversely affect our business, results of operations and financial condition. • Our employees and independent contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory pricing standards and requirements, which could have an adverse effect on our results of operations. • If we fail to comply with applicable healthcare regulations, we could face substantial penalties, and our business, operations and financial condition could be adversely affected. • Healthcare reform measures could hinder our programs’ commercial success. • Failure to comply with government regulations could harm our business. • Our business exposes us to product liability claims. • Our business involves environmental risks.
Risks Related to Intellectual Property Matters • Our success will depend upon intellectual property, proprietary technologies and regulatory market exclusivity periods, and we may be unable to protect our intellectual property. • Our ability to compete may decline if we do not adequately protect our proprietary rights. • Potential patent litigation could be costly and disruptive and may have an adverse effect on our financial condition and results of operations. • The value of our granted patents, and our patents pending, is uncertain.
Risks Related to Ownership of Shares of Common Stock and Public Company Status • The concentration of our common share ownership will likely limit the ability of other shareholders to influence corporate matters. • Our stock price has been and may continue to be volatile. • Our common stock price is likely to be volatile and may be adversely affected by the future issuance and sale of shares of our stock or other equity interests. • The price of our common stock may be adversely affected by the future issuance and sale of shares of our common stock or other equity securities.
PART I ITEM 1 – BUSI NESS Overview We are a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body.
Our melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs are in Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors in the U.S.
We are growing our regional network of drug product finishing facilities, enabled by our proprietary 212 Pb generator, to deliver patient-ready products for clinical trial and commercial operations.
The key elements of our strategy are to: Discover and Develop a Broad Oncology Pipeline Advance our initial drug candidate, VMT-α-NET, through clinical development for the treatment of neuroendocrine tumors expressing SSTR2.
In 2024, we continued dosing in Cohort 1 and initiated dosing in Cohort 2 of our Phase 1/2a study of [ 212 Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2)-expressing neuroendocrine tumors (NETs) who have not received prior radiotherapy (clinicaltrials.gov identifier NCT05636618).
Subsequently, the safety monitoring committee (SMC) determined that the safety data observations during the dose-limiting toxicity period supported proceeding with dose escalation to Cohort 3 and increasing the number of patients dosed at 5 mCi.
Food and Drug Administration (FDA) prior to the initiation of patient dosing in this study, which occurred in late 2023, the decision to open Cohort 3 will follow consultation and alignment with the agency.
FDA interactions are ongoing with regards to the initiation of the next dosing cohort.
Expand the potential of our program candidates in additional indications and as combination therapies in current and additional indications.
SSTR2, the molecular target of [ 212 Pb]VMT-α-NET, is overexpressed in a number of cancers that are not classified as NETs, including meningioma and neuroblastoma.
Both of these cancers can be difficult to treat when advanced and inoperable, but this is especially true for advanced neuroblastoma, a rare and orphan pediatric disease that is one of the most morbid of pediatric cancers.
We intend to prioritize seeking regulatory approval to test [ 212 Pb]VMT-α-NET in other cancers.
Advance our second drug candidate , VMT01, through clinical development for the treatment of melanoma tumors expressing melanocortin 1 receptor (MC1R).
VMT01 can be radiolabeled with either Lead-203 ( 203 Pb) for patient selection and dosimetry assessments, or 212 Pb for alpha-particle therapy.
In September 2024, we announced that on the basis of these results, the FDA granted Fast Track Designation for the clinical development of [ 212 Pb]VMT01.
In 2024, we continued dosing in Cohort 1 and initiated dosing in Cohort 2 of our Phase 1/2a study.
We released the results of the patients dosed in the first two cohorts in October 2024 and announced that we would deescalate the dose in Cohort 3 to 1.5mCi.
In addition, in July 2024 we submitted an amendment to the Phase 1/2a trial to explore the combination of the checkpoint inhibitor nivolumab with [ 212 Pb]VMT01 which was subsequently approved.
We are currently enrolling patients in both the monotherapy and combination therapy cohorts.
Obtain Fast Track designation from the FDA under our Investigational New Drug (IND) application for our novel asset, PSV359.
In June 2024, at the Society of Nuclear Medicine and Molecular Imaging 2024 Annual Meeting (SNMMI), researchers presented on a novel cyclic peptide targeting fibroblast activation protein alpha (FAP-α), which is a protein abundantly expressed in certain cancer cells as well as cancer-associated fibroblasts in tumor lesions and involved in promoting disease progression.
To target FAP-α, we created the novel radiotherapeutic, PSV359, comprising a peptide directed against FAP-α conjugated to the chelator-bound radioisotope 212 Pb or 203 Pb. [ 203/212 Pb]PSV359 was evaluated in vitro and in preclinical xenograft models.
Overall, strong anti-tumor clinical activity of [ 212 Pb]PSV359 was found in both FAP-α on cancer cells and in stromal tissues xenograft models.
In September 2024, research was presented on the preclinical evaluation of [ 203/212 Pb]PSV359 for imaging and alpha-particle therapy of cancers expressing FAP-α, in which our team of researchers found that in vitro, [ 203/212 Pb]PSV359 demonstrated superior FAP-α-binding affinity and specificity as compared to other FAP-targeted drugs, and that [ 203 Pb]PSV359 showed strong tumor uptake and clearance from the blood via the renal system.
In the study, [ 212 Pb]PSV359 also showed strong anti-tumor effects in xenograft models in which FAP-α was either on cancer cells or in stromal tissues.
In January 2025, we received approval from the FDA to proceed and anticipate dosing our first patients with this compound in mid 2025.
We plan to seek to obtain Fast Track designation from the FDA for this compound.
Deploy Our Innovative Platform Technology Continue to leverage our TAT platform to expand our pipeline of program candidates .
Our technology allows us to create novel TATs by combining 212 Pb encased within its PSC with a wide variety of targeting peptides and other delivery vehicles.
Targeting molecules can come from discontinued programs, novel molecules currently in development, approved molecules or other proprietary targeting agents.
As such, we continuously evaluate opportunities to acquire or in-license additional new targeting molecules such as those licensed from the Mayo Foundation for Medical Education and Research (Mayo Clinic) and Stony Brook University that we believe can be utilized with our platform to create a potent alpha therapeutic agent.
We are leveraging our platform to progress our existing program candidates into clinical development for additional indications, including breast and pancreatic cancers, as well as the development of new program candidates.
Utilize a precision medicine approach by leveraging imaging diagnostics .

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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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