ADPT vs APUS

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

APUS Core

Annual filing released 2025-04-15 · GPT 6 Luna

We are a clinical stage biopharmaceutical company in the process of developing Apitox, an intradermally administered bee venom-based toxin. Our focus is primarily on developing innovative therapies that address inflammation and pain management symptoms associated with knee OA and, to a lesser extent, MS. Apitox is currently marketed and sold by Apimeds Inc. (“Apimeds Korea”) in South Korea as “Apitoxin” for the treatment of OA. Apimeds US is not associated with the market, sale and revenues generated from Apitoxin in South Korea, and Apitoxin has not yet been approved by the FDA for any indication.

Apimeds Pharmaceuticals US, Inc. is a clinical stage biopharmaceutical company that is in the process of developing Apitox, a proprietary intradermally administered bee venom-based toxin. Our primary focus is to advance Apitox in the treatment of inflammatory conditions in the United States, specifically osteoarthritis (“OA”) and, eventually, multiple sclerosis (“MS”). Apitox, is currently marketed and sold by Apimeds, Inc. in South Korea (“Apimeds Korea”) as “Apitoxin” for the treatment of inflammation and pain management symptoms associated with OA. There is an extensive history of use of bee venom, both in the United States and around the world, to assist with pain management. We believe that, in addition to knee OA and MS, Apitox has the potential to help manage difficult to control pain and inflammation issues, which we will explore in the future. 27 Our Product Candidate

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.

APUS Core

Annual filing released 2025-04-15 · GPT 6 Luna

We are a clinical stage biopharmaceutical company in the process of developing Apitox, an intradermally administered bee venom-based toxin. Our focus is primarily on developing innovative therapies that address inflammation and pain management symptoms associated with knee OA and, to a lesser extent, MS. Apitox is currently marketed and sold by Apimeds Inc. (“Apimeds Korea”) in South Korea as “Apitoxin” for the treatment of OA. Apimeds US is not associated with the market, sale and revenues generated from Apitoxin in South Korea, and Apitoxin has not yet been approved by the FDA for any indication.

We are currently engaged exclusively in the clinical development of Apitox for continued use in knee OA through a Phase III trial in knee OA and potential use for MS through the early prosecution of appropriate patient populations through non-registered corporate sponsorship studies. Sales and Marketing The healthcare providers associated with the treatment of inflammation and pain management symptoms associated with OA and MS are not limited to one specialist but involve a comprehensive team of providers focused on slowing the progression of the disease along with the physical, emotional and day-to-day management of the condition. Each of these providers represents a potential customer for Apitox.

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

APUS Material

Annual filing released 2025-04-15 · GPT 6 Luna

The anti-inflammatory and analgesic effects are attributed to the presence of Peptide 401, adolapin and other components that inhibit prostaglandin synthesis. The hormone-stimulating effects are attributed to the presence of melittin, cardiopep and other components that stimulate the pituitary-adrenal axis to produce cortisol. Results from an animal study entitled “Effect of bee venom and melittin on plasma cortisol in the unanesthetized monkey” published by Vick et al., indicate that melittin appears to stimulate the production of cortisol from the adrenal gland. The immune-modulating effects, especially as it pertains to MS, are suggested to be mediated by CD4+CD2S+Foxp3+ regulatory T cells (Tregs) that are influenced by phospholipase A2.

From June 2014 to June 2018, Apimeds Korea corresponded with the FDA and there were no clinical holds at that time. Sponsorship of IND 122804 was transferred from Apimeds Korea to us in October 2020. On September 21, 2021, we responded to customary non-clinical hold comments from the FDA. In November 2021, we received a customary clinical hold from the FDA due to the retirement of the former principal investigator. We have subsequently updated the FDA with a new principal investigator via our Chief Medical Officer, Dr. Christopher Kim. In February 2023, the FDA removed the clinical hold and concluded it may be initiated. We have subsequently made the strategic decision to focus our efforts and capital on our Phase III trial in knee OA, and instead focus our MS efforts on the early prosecution of appropriate MS patient populations through non-registered corporate sponsorship studies.

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

APUS Core

Annual filing released 2025-04-15 · GPT 6 Luna

We are a clinical stage biopharmaceutical company in the process of developing Apitox, an intradermally administered bee venom-based toxin. Our focus is primarily on developing innovative therapies that address inflammation and pain management symptoms associated with knee OA and, to a lesser extent, MS. Apitox is currently marketed and sold by Apimeds Inc. (“Apimeds Korea”) in South Korea as “Apitoxin” for the treatment of OA. Apimeds US is not associated with the market, sale and revenues generated from Apitoxin in South Korea, and Apitoxin has not yet been approved by the FDA for any indication.

We are currently engaged exclusively in the clinical development of Apitox for continued use in knee OA through a Phase III trial in knee OA and potential use for MS through the early prosecution of appropriate patient populations through non-registered corporate sponsorship studies. Sales and Marketing The healthcare providers associated with the treatment of inflammation and pain management symptoms associated with OA and MS are not limited to one specialist but involve a comprehensive team of providers focused on slowing the progression of the disease along with the physical, emotional and day-to-day management of the condition. Each of these providers represents a potential customer for Apitox.

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

APUS Not tagged

Annual filing released 2025-04-15 · GPT 6 Luna

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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.

APUS Not tagged

Annual filing released 2025-04-15 · GPT 6 Luna

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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.

APUS Not tagged

Annual filing released 2025-04-15 · GPT 6 Luna

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