We are a clinical-stage biologics company focused on discovering and developing a novel class of engineered precision biologics (EPBs) using our proprietary expanded genetic code technology platform that allows us to incorporate, in a site-specific manner, synthetic amino acids (SAAs) into proteins within living cells. Our product candidates are designed to overcome the inherent limitations of conventional conjugation approaches that use natural amino acids for non-site-specific conjugation, offering potential safety and efficacy benefits to treat patients across multiple therapeutic areas. We believe that our technology allows us to engineer a single optimized structure by designing the conjugation chemistries, selecting the precise number of amino acids and conjugation positions in the protein, and expanding the types of payloads that can be conjugated. Our precision engineering capabilities and the broad applicability of our expanded genetic code technology platform have the potential to enhance and enable the therapeutic functions of conventional biologics and bio-conjugates. Our SAA incorporation technology allows us to develop a wide array of product candidate modalities, such as antibody-drug conjugates (ADCs), bispecific antibodies, PEGylated peptides, modified cytokines and immuno-stimulating antibody conjugates (ISACs). Our most advanced internal product candidate is ARX788, an anti-HER2 ADC, currently being investigated in multiple clinical trials for the treatment of breast cancer, gastric/gastroesophageal junction (GEJ) cancer and other solid tumors, including an ongoing Phase 2/3 clinical trial for the treatment of HER2-positive metastatic breast cancer. Initially we are focusing our internal efforts on developing a portfolio of ADC and immuno-oncology conjugate (IOC) candidates. Our lead ADC candidate is ARX788, an anti-HER2 ADC currently being studied broadly in breast, gastric and other solid tumor trials. The most advanced trial, ACE-Breast-02, is an ongoing Phase 2/3 clinical trial for HER2-positive metastatic breast cancer being conducted in China by our partner, NovoCodex Biopharmaceuticals Ltd. (NovoCodex), a subsidiary of Zhejiang Medicine Co. Ltd. (ZMC). As of April 7, 2021, 99 of the target 440 patients had been randomized in this trial (including 47 patients randomized to the ARX788 treatment arm and 52 patients randomized to the control arm) and we expect to report topline data by the end of 2022. We believe that this trial is potentially registrational in China, meaning that if it is successfully completed, it could support a submission seeking regulatory approval. NovoCodex also recently initiated ACE-Gastric-02, a global Phase 2/3 clinical trial for HER2-positive gastric/GEJ cancer, which will initially enroll patients in China, and for which we, as the sponsor outside of China, intend to subsequently enroll patients in additional countries, including the United States, after submission of clinical trial applications for those jurisdictions. ACE-Breast-01 is an ongoing Phase 1 clinical trial of ARX788 in HER2-positive metastatic breast cancer patients whose diseases have failed other available therapies, including anti-HER2 ADCs, which is being conducted in China by our partner, NovoCodex. In this trial, we have observed promising anti-tumor activity in both the cohorts of patients receiving 1.3 mg/kg of ARX 788 at every three weeks (Q3W) or every four weeks (Q4W), with a 50% (8 of 16 patients) confirmed objective response rate (ORR) as of April 7, 2021, and a 66% (19 of 29 patients) confirmed ORR in the cohort of patients receiving 1.5 mg/kg of ARX 788 at Q3W as of April 7, 2021. The U.S. Food and Drug Administration (FDA) has granted ARX788 Fast Track designation as a monotherapy for the treatment of advanced or metastatic HER2-positive metastatic breast cancer patients who have received one or more prior anti-HER2-based regimens in the metastatic setting. In addition, the China National Medical Products Administration (NMPA) granted ARX788 Breakthrough Therapy designation for the second-line treatment of HER2-positive metastatic breast cancer in May 2021. Although we have not been required to repeat Phase 1 trials to initiate Phase 2 or Phase 3 HER2-positive metastatic breast cancer trials in the United States, the FDA or comparable foreign regulatory authorities may not interpret the results of the trials being conducted in China by our partner, NovoCodex, as we do. Our clinical strategy includes additional clinical trials which we expect to serve as the basis of our U.S. marketing applications, including ACE-Breast-03, our first global, potentially pivotal trial for HER2-positive metastatic breast cancer for which we began screening patients for enrollment in April 2021. ACE-Pan tumor-01 is our ongoing Phase 1 clinical trial of ARX788 in the United States and Australia in multiple HER2-expressing tumors. In the dose escalation portion of this trial, we have observed a confirmed ORR of 67% (2 of 3 patients) in the cohort of patients receiving the 1.5 mg/kg Q4W dose, and no confirmed responses among 8 patients in the 1.3 mg/kg Q4W cohort, each as of April 8, 2021. ACE-Gastric-01 is an ongoing Phase 1 clinical trial of ARX788 in HER2-positive metastatic gastric/GEJ cancer where patients have failed other available therapies, including trastuzumab, which is being conducted in China by our partner, NovoCodex. In this trial, we have observed promising anti-tumor activity in the cohorts of patients receiving 1.5 mg/kg of ARX788 Q3W, with a 46% (6 of 13 patients) confirmed ORR, and a 43% (3 of 7 patients) confirmed ORR in the cohort of patients receiving 1.3 mg/kg of ARX788 at Q3W as of April 7, 2021. We have received Orphan Drug designation from the FDA for the treatment of gastric cancer, including cancer at the GEJ. Treatment with ARX788 in the ACE-Breast-01, ACE-Pan tumor-01 and ACE-Gastric-01 trials has also been generally well-tolerated and while most patients in these trials have experienced at least one drug-related adverse event, there have only been an aggregate of four drug-related serious adverse events (SAEs) reported from the 138 patients dosed with ARX788 in these trials as of April 7, 2021. Our mission is to discover and develop a pipeline of EPBs to treat a broad range of diseases and disorders, with an initial focus on cancers with a high unmet medical need. As the pioneer of EPBs, we intend to leverage our proprietary platform technology to not only deliver on this mission but also maintain our leadership position in the field. We believe that combining our pioneering efforts in expanding the genetic code and developing site-specific bio-conjugates with a team of dedicated professionals bound by a culture and vision that embraces innovation, practicality, and accountability allows us to pursue this mission. We are an exempted company incorporated in the Cayman Islands with limited liability. We commenced our operations in the United States in January 2003 through Ambrx, Inc., a Delaware corporation (Ambrx US). In May 2015, we incorporated under the laws of the Cayman Islands and have become the ultimate holding company through a series of transactions. As of December 31, 2020, we owned approximately 89% of Shanghai Ambrx Biomedical Co., Ltd., a limited liability company organized and existing under the laws of the People’s Republic of China (Ambrx Shanghai). As of the same date, Ambrx Shanghai owned 100% of Biolaxy Pharmaceutical Hong Kong Limited, a company incorporated in Hong Kong (Ambrx HK); Ambrx HK owned 100% of Ambrx US, and Ambrx US owned 100% of Ambrx Australia Pty Limited, a company incorporated in Australia (Ambrx AU). Our principal executive offices are located at 10975 North Torrey Pines Road, La Jolla, California 92037. Our telephone number at this address is (858) 875-2400. Our registered office in the Cayman Islands is located at the offices of Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Grand Cayman KY1-1104, Cayman Islands.

Ambrx Biopharma Inc

We are a clinical-stage biologics company focused on discovering and developing a novel class of engineered precision biologics (EPBs) using our proprietary expanded genetic code technology platform that allows us to incorporate, in a site-specific manner, synthetic amino acids (SAAs) into proteins within living cells. Our registered office in the Cayman Islands is located at the offices of Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Grand Cayman KY1-1104, Cayman Islands.

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