PRAX vs RADX

PRAX Core

Annual filing released 2025-02-28 · GPT 6 Luna

Item 1. Business BUSINESS COMPANY OVERVIEW We are a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for central nervous system, or CNS, disorders characterized by neuronal excitation-inhibition imbalance. Normal brain function requires a delicate balance of excitation and inhibition in neuronal circuits, which, when dysregulated, can lead to abnormal function and both rare and more prevalent neurological disorders. We are applying genetic insights to the discovery and development of therapies for neurological disorders through two proprietary platforms, using our understanding of shared biological targets and circuits in the brain.

1. Nature of the Business Praxis Precision Medicines, Inc. (“Praxis” or the “Company”) is a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for central nervous system ("CNS"), disorders characterized by neuronal excitation-inhibition imbalance. Normal brain function requires a delicate balance of excitation and inhibition in neuronal circuits, which, when dysregulated, can lead to abnormal function and both rare and more prevalent neurological disorders. The Company is applying genetic insights to the discovery and development of therapies for neurological disorders through two proprietary platforms, using its understanding of shared biological targets and circuits in the brain.

RADX Core

Annual filing released 2025-09-18 · GPT 6 Luna

We develop targeted and scientifically validated radiopharmaceutical technologies that are in both pre-clinical and clinical stages of development. These technologies span all size molecules comprising peptides, small molecules and antibodies attached to medical quality radioisotopes. We are pursuing registration and marketing approval for each product and therapy under development in the United States, the European Union, the United Kingdom, China, Japan, Australia and Canada. To achieve our goals, we intend to: ● Focus on tumor types that can be considered radiosensitive. There are several tumor types that are considered radiosensitive and that are difficult to detect and treat. We intend to develop theranostic clinical products that enable detection and treatment of solid tumor with high mortality rates that is more effective than what current treatments provide.

In addition, “Radiopharm Ventures LLC”, a joint venture with MD Anderson, has been created to develop novel radiopharmaceutical products based on MD Anderson intellectual property. We are developing theranostic radiopharmaceuticals based on six licensed platform technologies to target several indications of solid tumors. The clinical trials we intend to undertake are based upon novel licensed technology that aims to target cancer cells with innovative mechanisms of action (MoAs) and pathways. 30 Our Licensed Platform Technologies Nano-mAbs Nano-mAbs is a novel radiopharmaceutical platform invented by Dr Hong Hoi Ting. Nano-mAbs are made using genetically engineered camelid derived single domain antibodies (sdAb) that can be labelled with radioisotopes in order to diagnose and treat specific cancers expressing HER-2, PD-L1 and PTK7 receptors.

PRAX Core

Annual filing released 2025-02-28 · GPT 6 Luna

Item 1. Business BUSINESS COMPANY OVERVIEW We are a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for central nervous system, or CNS, disorders characterized by neuronal excitation-inhibition imbalance. Normal brain function requires a delicate balance of excitation and inhibition in neuronal circuits, which, when dysregulated, can lead to abnormal function and both rare and more prevalent neurological disorders. We are applying genetic insights to the discovery and development of therapies for neurological disorders through two proprietary platforms, using our understanding of shared biological targets and circuits in the brain.

Our development strategies are tailored to demonstrate these benefits. CLINICAL STAGE PROGRAMS We have advanced four product candidates to clinical stage, including three small molecules through the Cerebrum™ platform and one ASO through the Solidus™ platform: Ulixacaltamide for Essential Tremor Our most advanced program, ulixacaltamide, is a differentiated and highly selective small molecule inhibitor of T-type calcium channels currently in Phase 3 clinical development for the treatment of Essential Tremor, or ET. Additionally, we have an exclusive collaboration and license agreement with Tenacia Biotechnology (Shanghai) Company, Ltd., a China-based portfolio company of Bain Capital, to develop and commercialize ulixacaltamide for the treatment of ET in China, Hong Kong, Macau and Taiwan.

RADX Core

Annual filing released 2025-09-18 · GPT 6 Luna

Item 4a. Unresolved Staff Comments None. Item 5. Operating and Financial Review and Prospects Overview Radiopharm Theranostics Limited was incorporated under the laws of Australia in February 2021. We are a clinical-stage radiotherapeutics company that focuses on the development of radiopharmaceutical products for diagnostic and therapeutic uses in areas of high unmet medical need.

We develop targeted and scientifically validated radiopharmaceutical technologies that are in both pre-clinical and clinical stages of development. These technologies span all size molecules comprising peptides, small molecules and antibodies attached to medical quality radioisotopes. We are pursuing registration and marketing approval for each product and therapy under development in the United States, the European Union, the United Kingdom, China, Japan, Australia and Canada. To achieve our goals, we intend to: ● Focus on tumor types that can be considered radiosensitive. There are several tumor types that are considered radiosensitive and that are difficult to detect and treat. We intend to develop theranostic clinical products that enable detection and treatment of solid tumor with high mortality rates that is more effective than what current treatments provide.

PRAX Core

Annual filing released 2025-02-28 · GPT 6 Luna

Through this approach, we have established a diversified, multimodal CNS portfolio with four clinical-stage product candidates across movement disorders and epilepsy. Cerebrum™ (small molecule platform) We have built Cerebrum™, enabled by innovative computational and experimental tools, to discover and develop first- and best-in-class CNS small molecule therapies. Our world-class ion channel discovery science team, along with external collaborators, accelerate our ability to create and execute novel screening cascades for our selected genetic targets. Fundamental to advancement of candidates are our multiscale disease models that link genetic cause to network function to elucidate novel drivers of disease phenotype.

Our development strategies are tailored to demonstrate these benefits. CLINICAL STAGE PROGRAMS We have advanced four product candidates to clinical stage, including three small molecules through the Cerebrum™ platform and one ASO through the Solidus™ platform: Ulixacaltamide for Essential Tremor Our most advanced program, ulixacaltamide, is a differentiated and highly selective small molecule inhibitor of T-type calcium channels currently in Phase 3 clinical development for the treatment of Essential Tremor, or ET. Additionally, we have an exclusive collaboration and license agreement with Tenacia Biotechnology (Shanghai) Company, Ltd., a China-based portfolio company of Bain Capital, to develop and commercialize ulixacaltamide for the treatment of ET in China, Hong Kong, Macau and Taiwan.

RADX Core

Annual filing released 2025-09-18 · GPT 6 Luna

Item 4a. Unresolved Staff Comments None. Item 5. Operating and Financial Review and Prospects Overview Radiopharm Theranostics Limited was incorporated under the laws of Australia in February 2021. We are a clinical-stage radiotherapeutics company that focuses on the development of radiopharmaceutical products for diagnostic and therapeutic uses in areas of high unmet medical need.

We develop targeted and scientifically validated radiopharmaceutical technologies that are in both pre-clinical and clinical stages of development. These technologies span all size molecules comprising peptides, small molecules and antibodies attached to medical quality radioisotopes. We are pursuing registration and marketing approval for each product and therapy under development in the United States, the European Union, the United Kingdom, China, Japan, Australia and Canada. To achieve our goals, we intend to: ● Focus on tumor types that can be considered radiosensitive. There are several tumor types that are considered radiosensitive and that are difficult to detect and treat. We intend to develop theranostic clinical products that enable detection and treatment of solid tumor with high mortality rates that is more effective than what current treatments provide.

PRAX Material

Annual filing released 2025-02-28 · GPT 6 Luna

Each platform currently has multiple programs, with significant potential for additional program and indication expansion: •Cerebrum™, our small molecule platform, utilizes deep understanding of neuronal excitability and neuronal networks and applies a series of computational and experimental tools to develop orally available precision therapies •Solidus™, our antisense oligonucleotide, or ASO, platform, is an efficient, targeted precision medicine discovery and development engine anchored on a proprietary, computational methodology Our platforms utilize a deliberate, pragmatic and patient-guided approach, leveraging a suite of translational tools, including novel transgenic and predictive translational animal models and electrophysiology markers, to enable an efficient path to proof-of-concept in patients.

Cerebrum™ has the potential to continue delivering first- and best-in-class orally available therapies for genetic CNS targets. Solidus™ (ASO platform) We have built Solidus™ to discover and develop first- and best-in-class ASOs with high probability of advancement into the clinic. Solidus™ is enabled by our proprietary, computational workflow to discover ASOs with desired drug-like properties to optimize for up/down-regulation, avoidance of toxic motifs and optimization of binding affinity and specificity. Led by our clinical-stage product candidate, elsunersen (formerly known as PRAX-222), Solidus™ has also generated three novel ASOs with preclinical proof of mechanism that we expect to nominate development candidates for in 2025 — PRAX-080 targeting PCDH19-related developmental epilepsy; PRAX-090 targeting SYNGAP1 loss-of-function, or LoF, mutation driven developmental epilepsy;

RADX Not tagged

Annual filing released 2025-09-18 · GPT 6 Luna

This activity has no positive tag in the selected filing snapshot.

PRAX Not tagged

Annual filing released 2025-02-28 · GPT 6 Luna

This activity has no positive tag in the selected filing snapshot.

RADX Core

Annual filing released 2025-09-18 · GPT 6 Luna

We develop targeted and scientifically validated radiopharmaceutical technologies that are in both pre-clinical and clinical stages of development. These technologies span all size molecules comprising peptides, small molecules and antibodies attached to medical quality radioisotopes. We are pursuing registration and marketing approval for each product and therapy under development in the United States, the European Union, the United Kingdom, China, Japan, Australia and Canada. To achieve our goals, we intend to: ● Focus on tumor types that can be considered radiosensitive. There are several tumor types that are considered radiosensitive and that are difficult to detect and treat. We intend to develop theranostic clinical products that enable detection and treatment of solid tumor with high mortality rates that is more effective than what current treatments provide.

In addition, “Radiopharm Ventures LLC”, a joint venture with MD Anderson, has been created to develop novel radiopharmaceutical products based on MD Anderson intellectual property. We are developing theranostic radiopharmaceuticals based on six licensed platform technologies to target several indications of solid tumors. The clinical trials we intend to undertake are based upon novel licensed technology that aims to target cancer cells with innovative mechanisms of action (MoAs) and pathways. 30 Our Licensed Platform Technologies Nano-mAbs Nano-mAbs is a novel radiopharmaceutical platform invented by Dr Hong Hoi Ting. Nano-mAbs are made using genetically engineered camelid derived single domain antibodies (sdAb) that can be labelled with radioisotopes in order to diagnose and treat specific cancers expressing HER-2, PD-L1 and PTK7 receptors.