ADPT vs ASND

ADPT Material

Annual filing released 2025-03-03 · GPT 6 Luna

The IM business focuses on the discovery and development of transformative immune-based therapies in the treatment of patients with cancer and autoimmune diseases. Our strategic priorities in the IM business include supporting our partner, Genentech, Inc. (“Genentech”), in its development of TCR-based cell therapies in oncology and developing targeted therapies using our differentiated precision immunology approach in select autoimmune indications. The IM business leverages our proprietary ability to sequence, map, pair and characterize TCRs and B cell receptors (“BCRs”) at scale. We have created a powerful data engine to drive the development of novel therapies. These datasets, which we own, include more than 100,000 signatures of cancer and autoimmune disease and more than 2,000,000 matches of TCRs to disease-related antigens.

We are focusing our drug discovery programs to develop therapies on our own or in partnership. In these respects, our proprietary data and capabilities uniquely position the IM business to discover and develop differentiated therapeutic candidates such as TCR-based modalities, antibodies and potentially vaccines to better understand immune-mediate biology and treat challenging conditions such as cancer and autoimmune disorders. 11

ASND Core

Annual filing released 2025-02-12 · GPT 6 Luna

We are a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we develop TransCon-based therapies that demonstrate best-in-class potential to address unmet medical needs. Our portfolio of approved Endocrinology Rare Disease products and product candidates addresses hypoparathyroidism as well as growth disorders such as growth hormone deficiency and achondroplasia. To create additional value, we have established partnerships to develop and bring to market TransCon-based products in large therapeutic areas including Metabolic, Cardiovascular and Ophthalmology. Our Vision

We currently have two marketed products and a diversified portfolio of four product candidates in clinical development in the areas of Endocrinology Rare Disease and Oncology, and we are working to apply our TransCon technology platform in additional therapeutic areas such as the glucagon-like peptide 1 (“GLP-1”) class, where we believe we have designed a potentially best-in-class, once-monthly program. 74

ADPT Core

Annual filing released 2025-03-03 · GPT 6 Luna

The MRD business focuses on the use of our highly sensitive, next-generation sequencing (“NGS”) assay to measure MRD in patients with hematologic malignancies. It is comprised of our clonoSEQ clinical diagnostic test, offered to clinicians, and our clonoSEQ assay, offered to biopharmaceutical partners to advance drug development efforts (“MRD Pharma”). We believe the total addressable market for the MRD business is approximately $5.5 billion, approximately $4.8 billion of which is derivable from clinical testing.

The MRD business focuses on the use of our highly sensitive, FDA-authorized NGS assay to measure MRD in patients with hematologic malignancies. It is comprised of our clonoSEQ clinical diagnostic testing service for clinicians and our MRD Pharma service, which consists of offering our clonoSEQ assay to biopharmaceutical partners to advance drug development efforts. We believe clonoSEQ is the preeminent MRD testing choice for hematological malignancies with industry leading sensitivity of 1 out of 1,000,000 cells, given sufficient sample input. By taking a baseline measurement prior to starting therapy and then tracking the number of cells at several time points following therapy initiation, hematologists can improve their ability to assess treatment response, predict long-term patient outcomes, monitor disease burden over time and detect potential relapse.

ASND Core

Annual filing released 2025-02-12 · GPT 6 Luna

We are a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we develop TransCon-based therapies that demonstrate best-in-class potential to address unmet medical needs. Our portfolio of approved Endocrinology Rare Disease products and product candidates addresses hypoparathyroidism as well as growth disorders such as growth hormone deficiency and achondroplasia. To create additional value, we have established partnerships to develop and bring to market TransCon-based products in large therapeutic areas including Metabolic, Cardiovascular and Ophthalmology. Our Vision

•SKYTROFA – Our first marketed product is SKYTROFA® (lonapegsomatropin-tcgd), developed as TransCon Growth Hormone (“TransCon hGH”), which has received regulatory approval in the United States for the treatment of pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone, also known as growth hormone deficiency (“GHD”). SKYTROFA has been commercially available for prescription in the United States since October 2021. In addition, SKYTROFA (lonapegsomatropin) was granted marketing authorization in the European Union (“EU”), Norway, Iceland, Liechtenstein, and Great Britain (covering England, Wales, Scotland) as a once-weekly subcutaneous injection for the treatment of children and adolescents aged 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone.

ADPT Material

Annual filing released 2025-03-03 · GPT 6 Luna

We are focusing our drug discovery programs to develop therapies on our own or in partnership. In these respects, our proprietary data and capabilities uniquely position the IM business to discover and develop differentiated therapeutic candidates such as TCR-based modalities, antibodies and potentially vaccines to better understand immune-mediate biology and treat challenging conditions such as cancer and autoimmune disorders. 11

Therapeutically, our goal is to develop antibodies that directly eliminate or block the activation of these problem T cells and stop them from attacking healthy tissue. Functional characterization of select antibodies is ongoing with the goal of developing a robust preclinical data package, following which we aim to designate a therapeutic candidate. IM Pharma Partnering

ASND Material

Annual filing released 2025-02-12 · GPT 6 Luna

TransCon IL-2 b/g (onvapegleukin alfa) is an investigational long-acting prodrug designed to improve cancer immunotherapy through sustained release of an IL-2 variant that selectively activates IL-2 b/g, with minimal binding to IL-2Rα. The IL-Believe Trial, a Phase 1/2 clinical trial to evaluate the safety and efficacy of TransCon IL-2 b/g in locally advanced or metastatic solid tumors, alone or in combination with pembrolizumab or standard of care chemotherapy, has completed dose escalation and is enrolling patients in multiple indication-specific dose expansion cohorts, including platinum-resistant ovarian cancer (“PROC”), cervical cancer, melanoma, non-small cell lung cancer (“NSCLC”), and small cell lung cancer (“SCLC”) at the RP2D.

In June 2024, we reported updated results from our ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 b/g. Data included the first presentation of Phase 2 dose expansion Cohort 4 (TransCon IL-2 β⁄γ in combination with TransCon TLR7/8 Agonist) in post anti-PD-1 melanoma and new analyses of patients from dose escalation cohorts with prior disease progression on checkpoint inhibitors, along with biomarker studies correlating cytotoxic immune cell expansion and observed clinical benefit. As of the April 16, 2024, data cutoff, confirmed clinical partial responses were observed in 40% (two out of five) of efficacy-evaluable patients from Cohort 4, suggesting potential synergy of our two novel immunotherapy candidates in patients who did not derive sufficient benefit from checkpoint inhibitors.

ADPT Material

Annual filing released 2025-03-03 · GPT 6 Luna

We believe that by tapping into these datasets, there is tremendous value in the development of immune-based therapeutics. In cancer, we are working with Genentech under our worldwide collaboration and license agreement (the “Genentech Agreement”) to develop TCR-based cell therapies to treat patients with solid tumors. Our role is to discover and characterize TCRs against cancer antigens. In 2023, Genentech secured the first FDA-cleared investigational new drug (“IND”) for a cell therapy product candidate under the Genentech Agreement. This milestone established an important TCR-based cell therapy product candidate proof of concept that supports our antigen-specific TCR discovery approach. In autoimmunity, we apply our immune medicine platform to discover the specific T cells that are attacking ‘self’ or healthy tissue.

Under the Genentech Agreement, the IM business supports Genentech in the development of cancer antigen-directed TCR-based cancer cell therapies for the treatment of patients with solid tumors. In 2023, a first FDA-cleared investigational new drug (“IND”) for a cell therapy product candidate was secured by Genentech. This milestone established an important TCR-based cell therapy product candidate proof of concept that supports our antigen-specific TCR discovery approach.

ASND Material

Annual filing released 2025-02-12 · GPT 6 Luna

We are currently investigating one clinical-stage product candidate designed to activate the patient’s own immune system to eradicate malignant cells. We believe our approach, if successfully developed, has the potential to improve the efficacy of systemically administered, clinically validated therapies while limiting adverse effects. Our TransCon product candidate currently being investigated in solid tumors is designed to provide sustained systemic administration, which we believe could provide potent and durable anti-tumor efficacy. Our nonclinical studies have shown sustained activation of cytotoxic immune cells that resulted in robust anti-tumor responses by TransCon product candidates using infrequent administration. TransCon IL-2 b/g for Sustained Systemic Release

TransCon IL-2 b/g (onvapegleukin alfa) is an investigational long-acting prodrug designed to improve cancer immunotherapy through sustained release of an IL-2 variant that selectively activates IL-2 b/g, with minimal binding to IL-2Rα. The IL-Believe Trial, a Phase 1/2 clinical trial to evaluate the safety and efficacy of TransCon IL-2 b/g in locally advanced or metastatic solid tumors, alone or in combination with pembrolizumab or standard of care chemotherapy, has completed dose escalation and is enrolling patients in multiple indication-specific dose expansion cohorts, including platinum-resistant ovarian cancer (“PROC”), cervical cancer, melanoma, non-small cell lung cancer (“NSCLC”), and small cell lung cancer (“SCLC”) at the RP2D.

ADPT Material

Annual filing released 2025-03-03 · GPT 6 Luna

We are focusing our drug discovery programs to develop therapies on our own or in partnership. In these respects, our proprietary data and capabilities uniquely position the IM business to discover and develop differentiated therapeutic candidates such as TCR-based modalities, antibodies and potentially vaccines to better understand immune-mediate biology and treat challenging conditions such as cancer and autoimmune disorders. 11

Therapeutically, our goal is to develop antibodies that directly eliminate or block the activation of these problem T cells and stop them from attacking healthy tissue. Functional characterization of select antibodies is ongoing with the goal of developing a robust preclinical data package, following which we aim to designate a therapeutic candidate. IM Pharma Partnering

ASND Core

Annual filing released 2025-02-12 · GPT 6 Luna

•SKYTROFA – Our first marketed product is SKYTROFA® (lonapegsomatropin-tcgd), developed as TransCon Growth Hormone (“TransCon hGH”), which has received regulatory approval in the United States for the treatment of pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone, also known as growth hormone deficiency (“GHD”). SKYTROFA has been commercially available for prescription in the United States since October 2021. In addition, SKYTROFA (lonapegsomatropin) was granted marketing authorization in the European Union (“EU”), Norway, Iceland, Liechtenstein, and Great Britain (covering England, Wales, Scotland) as a once-weekly subcutaneous injection for the treatment of children and adolescents aged 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone.

In the EU, SKYTROFA has been commercially available for prescription in Germany since September 2023. •YORVIPATH – Our second marketed product is YORVIPATH® (palopegteriparatide), developed as TransCon PTH. In the EU, Norway, Iceland, Liechtenstein, and Great Britain (covering England, Wales, and Scotland), YORVIPATH has been granted marketing authorization as a once-daily subcutaneous injection for the treatment of adults with chronic hypoparathyroidism. In the EU, YORVIPATH has been commercially available for prescription in Germany and Austria since January 2024 and has also been available to patients in other countries under named patient programs. In August 2024, YORVIPATH received regulatory approval in the U.S. for the treatment of hypoparathyroidism in adults. YORVIPATH has been commercially available for prescription in the United States since December 2024.

ADPT Material

Annual filing released 2025-03-03 · GPT 6 Luna

The goal of our IM business is to scale our target discovery and drug discovery efforts to bring transformative therapies into the clinic either on our own or with a partner. The engine driving the immune medicine platform is our immunosequencing technology that allows us to tap into the massive diversity of the immune repertoire at unparalleled scale and specificity. Our immunosequencing approach utilizes multiplex, bias-controlled PCR to accurately and quantitatively sequence, map, pair and characterize millions of TCRs and BCRs at scale. The proprietary datasets we have generated to date include more than 100,000 signatures of disease (such as cancer and autoimmune conditions) and over 2,000,000 matches of paired TCRs to disease-related antigens.

Given our focus in drug discovery (discussed below), we have strategically repurposed our infrastructure, sizable immunomics database and AI and machine learning models and continue to map at scale TCR sequences to the disease antigens they bind to enable our discovery efforts where we believe we have the greatest opportunity to succeed and create long-term value. We expect to evolve our work with Microsoft and continue to access cloud services and super computing power to help scale our data generation and machine learning modeling efforts. We aim to accelerate development of a ‘digital’ TCR-antigen binding prediction model that will allow us to pursue multiple high-value therapeutic applications and achieve our business goals. Drug Discovery

ASND Not tagged

Annual filing released 2025-02-12 · GPT 6 Luna

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

ADPT Material

Annual filing released 2025-03-03 · GPT 6 Luna

Our clonoSEQ diagnostic test detects and monitors the remaining number of cancer cells that are present in a patient’s body during and after treatment, known as MRD. We believe clonoSEQ has broad applicability across all lymphoid malignancies, including ALL, CLL, MM, and Non-Hodgkins Lymphoma (“NHL”) conditions, such as DLBCL, MCL and cutaneous T cell lymphoma (“CTCL”). In September 2018, clonoSEQ was granted marketing authorization from the FDA, under the de novo process, for patients with MM and ALL to monitor their MRD from bone marrow samples. In August 2020, the clonoSEQ label was expanded to include patients with CLL from bone marrow and blood samples.

Our first diagnostic product, clonoSEQ, was granted marketing authorization by the FDA for the detection and monitoring of MRD in bone marrow samples in patients with MM and ALL under the de novo process in September 2018, which classified clonoSEQ and future DNA-based tests to measure MRD in hematological malignancies as Class II devices, as explained further below. In August 2020, we received FDA clearance for clonoSEQ, following a 510(k) submission, for CLL in bone marrow as well as blood samples. We also received FDA clearance in 2021 for ALL from blood samples, launched in DLBCL and MCL, subtypes of NHL, under CLIA as a LDT and are actively advancing validation studies in certain other NHL sub-types such as CTCL.

ASND Not tagged

Annual filing released 2025-02-12 · GPT 6 Luna

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

ADPT Not tagged

Annual filing released 2025-03-03 · GPT 6 Luna

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ASND Material

Annual filing released 2025-02-12 · GPT 6 Luna

In November 2024, we entered into a research and development collaboration and license agreement with Novo Nordisk A/S (“Novo Nordisk”) pursuant to which we granted Novo Nordisk an exclusive worldwide license to the TransCon technology platform to develop, manufacture and commercialize Novo Nordisk proprietary products (including Semaglutide) in metabolic diseases (including obesity and type 2 diabetes) and a product-by-product exclusive license in cardiovascular diseases.

Under the agreement, we have the potential to receive total payments of up to $285 million in upfront, development and regulatory milestone payments for the lead program. In addition, we have the potential to receive sales-based milestone payments and tiered royalties on global net sales. The $285 million includes an upfront fee of $100 million for the exclusive license. For each additional metabolic or cardiovascular disease product candidate, we will be eligible to receive payments of up to $77.5 million in development and regulatory milestone payments. In addition, we have the potential to receive sales-based milestone payments and tiered royalties on global net sales.