Attralus, Inc.

124I-evuzamitide (AT-01) is one of the first investigational diagnostic imaging agents to receive Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA), and the only diagnostic imaging agent that has received BTD for cardiac amyloidosis.124I-evuzamitide received orphan drug designations as a diagnostic for the management of ATTR and AL amyloidosis by both the US FDA and the European Commission.A Phase 3 study for 124I-evuzamitide in patients with suspected cardiac amyloidosis is anticipated to begin in the first half of 2025. BURLINGAME, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Attralus, Inc., a clinical stage biopharmaceutical company developing transformative products to improve the lives of patients with systemic amyloidosis, today announced that its investigational diagnostic imaging agent drug, 124I-evuzamitide (AT-01), has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for positron emission tomography (PET) imaging in patients with suspected or known cardiac amyloidosis. FDA granted BTD for 124I-evuzamitide (AT-01) based on clinical data from Attralus-sponsored and investigator-initiated studies evaluating the use of 124I-evuzamitide in patients with cardiac amyloidosis, representing experience in more than 200 trial participants. BTD is a program used by the FDA to expedite the development and review of a product when: (1) intended to treat or diagnose a serious or a life-threatening condition; and (2) when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints. BTD products are eligible for more intensive guidance from FDA to expedite development, including an organizational commitment by FDA and eligibility for Biologics License Application (BLA) rolling and priority review. “We are highly encouraged by FDA’s decision to grant Breakthrough Therapy Designation to 124I-evuzamitide (AT-01), recognizing its potential as an innovative diagnostic agent for patients with systemic amyloidosis” said Gregory Bell, M.D., Chief Medical Officer, Attralus. “There are no FDA approved diagnostic imaging agents for cardiac amyloidosis. The diagnosis of cardiac amyloidosis is a challenging and time-consuming process for patients, with many going years without an accurate diagnosis, and losing critical time in the process. We remain committed to bringing 124I-evuzamitide to the market as quickly as possible and look forward to working more closely with FDA to bring 124I-evuzamitide to patients.” About Systemic Amyloidosis Systemic amyloidosis encompasses a diverse group of rare diseases that occur due to accumulation of toxic amyloid deposits in tissues and organs, a consequence of aberrant protein misfolding events. These diseases are progressive, debilitating and often fatal. The majority of systemic amyloidosis patients have cardiac involvement, including the two most common forms, with ~95% of ATTR and 75% of AL patients having cardiac involvement. Other rare types of systemic amyloidosis such as AA, AApoAI, AApoAIV also have cardiac involvement. Cardiac amyloidosis is significantly underdiagnosed due to low awareness, non- specific symptoms, and lack of disease-specific diagnostics. There remains a significant unmet need for better diagnostics that may be able to more accurately diagnose patients earlier in the disease process. About 124I-evuzamitide (AT-01) Pan-Amyloid Diagnostic124I-evuzamitide (AT-01) is the first non-invasive pan-amyloid PET imaging agent specifically designed for systemic amyloidosis. 124I-evuzamitide utilizes the company’s pan-amyloid binding peptide labeled with iodine-124 as an amyloid-specific imaging agent to image all types of systemic amyloidosis by PET/CT imaging. In clinical trials, 124I-evuzamitide has been shown to detect multiple types of amyloid deposits, including ATTR and AL, in major organs such as the heart, kidney, liver, and spleen. Orphan drug designations have been granted to 124I-evuzamitide as a diagnostic for the management of ATTR and AL amyloidosis by both the Food and Drug Administration (FDA) and the European Commission. About Attralus Attralus is a clinical stage biopharmaceutical company focused on creating transformative products to improve the lives of patients with systemic amyloidosis. The company’s proprietary pan-amyloid removal (PAR) therapeutics are designed to directly bind to and remove toxic amyloid in organs and tissues. By targeting the disease-causing pathology in systemic amyloidosis diseases, PAR therapeutics have the potential to treat and reverse disease in patients with all types and stages of systemic amyloidosis. Attralus was founded by scientific experts in the field of amyloidosis and the company is headquartered in Burlingame, CA. Forward-Looking Statements This press release contains forward-looking statements, including statements related to the efficacy, continued development, and potential of AT-01. Words such as “developing,” “potential,” “shown” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Attralus’ current expectations. Forward-looking statements involve risks and uncertainties. Attralus’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Attralus expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Attralus’ expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. Contact:Krishna Gorti, M.D. FRCSCorporate Developmentkgorti@attralus.com

AT-02 has been granted COMP positive opinions for orphan medicinal product designations in the EU for both ATTR and AL amyloidosisAT-02 is the Company’s lead pan-amyloid removal therapeutic candidate in developmentAT-02 is currently being evaluated in a Phase 1 and Phase 2 trial in ATTR and AL amyloidosis patients to support its use as an immunotherapy for treatment of systemic amyloidosis BURLINGAME, Calif., July 29, 2024 (GLOBE NEWSWIRE) -- Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, announced today that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has adopted positive opinions for orphan medicinal product designations for AT-02 for the treatment of the two most common forms of systemic amyloidosis, transthyretin-associated amyloidosis (ATTR) and immunoglobulin light-chain-associated (AL) amyloidosis. AT-02, the company’s lead pan-amyloid removal therapeutic candidate, is currently being evaluated in a three-part Phase 1 clinical trial and a Phase 2 open label extension trial in ATTR and AL amyloidosis patients to support its use as an immunotherapy in patients with systemic amyloidosis. These designations granted for each of the two indications support the unique properties of AT-02 to potentially treat ATTR and AL amyloidosis, as well as other types of systemic amyloidosis. AT-02 is the first and only therapeutic to receive positive opinions for orphan medicinal product designation for both ATTR and AL amyloidosis from the COMP. “We are pleased to receive positive opinions on our requests for orphan medicinal product designations from the COMP for AT-02 in ATTR and AL, further supporting our efforts to develop a potentially transformative therapy for systemic amyloidosis,” said Gregory Bell, M.D., Chief Medical Officer at Attralus. “Current approved therapies for systemic amyloidosis target precursor protein production, reducing the formation of new amyloid, but there is a significant unmet need for new therapies that can remove the existing toxic amyloid fibrils that cause organ damage and mortality.” In the European Union (EU), orphan medicinal product designation is granted to drugs and biologics intended for treating, diagnosing, or preventing rare, life-threatening or chronically debilitating conditions. To qualify, the condition’s prevalence in the EU must be no more than five in 10,000 people. If satisfactory diagnosis, prevention, or treatment methods already exist for the disease, orphan designation may only be granted when the drug or biologic has the potential to provide significant benefit over existing therapies. Following the adoption of a positive opinion by the COMP, the legally binding final decision on the granting of orphan designation is issued by the European Commission. Following Commission Decision, orphan designation allows companies certain benefits, including a special category of scientific advice, reduced regulatory fees, research grants and up to ten years of market exclusivity in the EU if a product is approved. When combined with the EU Small or Medium-Sized Enterprise (SME) status granted to Attralus earlier this year, orphan-designated programs receive additional administrative and procedural assistance from the Agency's SME office and even greater fee reductions. About AT-02, Pan-Amyloid Removal TherapeuticAT-02 is the company’s lead pan-amyloid removal (PAR) therapeutic candidate for systemic amyloidosis. AT-02 is a humanized IgG1 monoclonal antibody genetically fused with the company’s proprietary pan-amyloid binding peptide, enabling binding to multiple types of amyloid deposits. The Fc region of the antibody stimulates the immune system to remove amyloid deposits that are bound by AT-02. AT-02 uses a similar pan-amyloid peptide to 124I-evuzamitide, the company’s diagnostic agent, which has been shown in multiple clinical trials to selectively bind to amyloid deposits in the heart, liver, kidney, and other organs in multiple types of amyloidosis. As a result, the company expects AT-02 to bind specifically to amyloid in systemic amyloidosis patients. Preclinical data have shown the ability of AT-02 to bind to multiple amyloid types in major organs induce macrophage mediated amyloid phagocytosis and amyloid removal. AT-02 is currently being evaluated in a 3-part Phase 1 trial and a Phase 2 open label extension trial in ATTR and AL amyloidosis patients. About Systemic Amyloidosis Systemic amyloidosis encompasses a diverse group of rare diseases that occur due to accumulation of toxic amyloid deposits in tissues and organs, a consequence of aberrant protein misfolding events. These diseases are progressive, debilitating and often fatal. Systemic amyloidosis is significantly underdiagnosed due to low awareness, lack of specific symptoms, and no current disease-specific diagnostics. There are approximately 17 different types of systemic amyloidosis, in the United States, the European Union and Japan. The two most common forms of systemic amyloidosis are transthyretin-associated amyloidosis (ATTR) and immunoglobulin light-chain-associated (AL) amyloidosis. While currently approved treatments slow disease progression by targeting precursor proteins, there is a significant unmet need for new therapies that can remove toxic amyloid deposits across all amyloid types and improve organ function and patient quality of life. About Attralus Attralus is a clinical stage biopharmaceutical company focused on creating transformative medicines to improve the lives of patients with systemic amyloidosis. The company’s proprietary pan-amyloid removal (PAR) therapeutics are designed to directly bind to and remove toxic amyloid in organs and tissues. By targeting the disease-causing pathology in systemic amyloidosis diseases, PAR therapeutics have the potential to treat and reverse disease in patients with all types and stages of systemic amyloidosis. Attralus was founded by scientific experts in the field of amyloidosis and the company is headquartered in Burlingame, CA. Forward-Looking Statements This press release contains forward-looking statements, including statements related to the efficacy, continued development, and potential of AT-01. Words such as “developing,” “potential,” “shown” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Attralus’ current expectations. Forward-looking statements involve risks and uncertainties. Attralus’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Attralus expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Attralus’ expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. Contact:Krishna Gorti, M.D. FRCSCorporate Developmentkgorti@attralus.com

After the positive opinion, the final decision now rests with European Commission. Image credit: Shutterstock / Lubo Ivanko. The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has given positive opinions for the awarding of an orphan drug designation to Attralus’s monoclonal antibody AT-02 in two of the most common forms of systemic amyloidosis. Though the European Commission is not mandated to agree with the COMP’s opinion for orphan medicinal product designations, it historically follows suit. The US biopharma is now eligible for extra scientific advice on its drug, fee reductions, and the potential for ten years of market exclusivity, as per European orphan drug incentives. Attralus’s AT-02, a pan-amyloid removal (PAR) therapeutic candidate, has been issued positive opinions in transthyretin-associated amyloidosis (ATTR) and immunoglobulin light-chain-associated (AL) amyloidosis—the two most common forms of systemic amyloidosis. AT-02 is currently being evaluated in a Phase I trial (NCT05521022) and a Phase II open-label extension trial in ATTR and AL amyloidosis patients. The company, which raised $56m in February this year, stated its asset is the first therapeutic to receive positive orphan designation opinions for both ATTR and AL amyloidosis, according to a 29 July press release. See Also: AbCellera and Lilly broadens antibody discovery partnership NICE recommends BeiGene’s MZL tablet for NHS use The current standard of care treatment for newly diagnosed patients with AL amyloidosis is a combination of anti-plasma cell agents, namely cyclophosphamide, bortezomib, and dexamethasone (CyBorD). Systemic amyloidosis is an umbrella group of rare diseases that occur due to a build-up of amyloid deposits in tissues and organs. The condition causes a range of symptoms including swelling, numbness and skin changes. Serious symptoms include bleeding and irregular heartbeats. The groups of diseases, comprising around 17 types, can be fatal. AT-02 works by stimulating the body’s immune response to remove amyloid deposits. The candidate comprises a humanised immunoglobulin 1 (IgG1) monoclonal antibody genetically fused with a pan-amyloid binding peptide.  The company presented positive preclinical data with the drug earlier this year, demonstrating its binding persists in amyloid deposits ten days after injection. Attralus chief medical officer Gregory Bell said: “Currently approved therapies for systemic amyloidosis target precursor protein production, reducing the formation of new amyloid, but there is a significant unmet need for new therapies that can remove the existing toxic amyloid fibrils that cause organ damage and mortality.” In January 2021, Johnson and Johnson Innovation Medicine won the first US Food and Drug Administration (FDA) approval for AL amyloidosis for Darzalex (daratumumab and hyaluronidase-fihj) in combination with CyBorD. The anti-CD38 drug works by stopping more amyloid from being produced. In February this year, England’s National Institute for Health and Care Excellence ( Nice ) recommended the use of the treatment on the NHS for AL amyloidosis patients.