On October 28, 2021 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop Engineered Precision Biologics (EPBs), today provided a corporate update and reported financial results for the first half of 2021 (Press release, Ambrx, OCT 28, 2021, View Source [SID1234592145]).
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"I want to thank the entire Ambrx team for their efforts in making our June IPO such a success. I believe we have created a strong foundation on which to grow our company. Subsequently, we provided several clinical updates regarding our ARX788 program in gastric cancer and our ARX517 program in PSMA expressing tumors. For ARX788, the first patient was dosed in our co-sponsored ACE-Gastric-02 Phase 2/3 clinical study and updated positive data from our co-sponsored ACE-Gastric-01 study was presented at The Chinese Society of Clinical Oncology (CSCO) annual meeting. We were also able to dose the first patient in our Phase 1 trial of ARX517 in the United States," said Feng Tian, Ph.D., Chairman of the Board, President and CEO of Ambrx. "Additionally, during the period, Ambrx strengthened its leadership team with the formation of a Scientific Advisory Board, the appointment of Sonja Nelson as CFO, and the addition to our Board of Directors of Olivia Ware and Katrin Rupalla. I am proud of how far Ambrx has come and look forward to carrying forward the momentum we have built into the end of the year and beyond."
1H 2021 and Subsequent Highlights
Positive Data on ARX788 for the Treatment of HER2+ Gastric Cancer Presented at CSCO. In October, NovoCodex Pharmaceuticals Ltd., Ambrx’s partner in China, presented positive interim data from the ACE-Gastric-01 Phase 1 clinical study of ARX788 for the treatment of HER2+ metastatic gastric / gastroesophageal junction (GEJ) cancer at CSCO. The data presented added to and updated initial trial data presented by both companies at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2021.
Advanced the Development of ARX788 in Three Trials. Subsequent to the end of first half of the year, Ambrx dosed the first patient in a global Phase 2/3 clinical study of ARX788 (ACE-Gastric-02) in patients with HER2+ gastric/GEJ cancer, initiated a global Phase 2 basket clinical study of ARX788 (ACE-Pan tumor-02) for HER2-mutated or HER2-amplified/over-expressed solid tumors, and initiated a Phase 2 clinical study of ARX788 (ACE-Breast-03) in patients with HER2+ metastatic breast cancer.
First Patient Dosed in a Phase 1 Trial for ARX517. In August, Ambrx announced that the first patient had been dosed in a Phase 1, multicenter, dose-escalation, and dose expansion study to evaluate the safety, pharmacokinetics, and anti-tumor activity of ARX517, an ADC being developed to treat subjects with prostate specific membrane antigen (PSMA) expressing tumors.
BMS Provided Update on FA Relaxin Program. In August, BMS provided notice that it closed the FA Relaxin Studies CV019-008 and CV019-010 based on internal considerations and not upon any observed safety concerns.
Completed Successful Initial Public Offering. In June, Ambrx successfully completed its initial public offering raising $126.0 million in gross proceeds prior to deducting underwriting discounts, commissions and offering expenses. Ambrx’s American Depository Shares (ADSs) began trading on the New York Stock Exchange under the symbol "AMAM" on June 18, 2021. In addition, in early July, the underwriters partially exercised their greenshoe option resulting in additional gross proceeds to Ambrx of approximately $16.1 million prior to deducting underwriting discounts, commissions and offering expenses.
Reorganization. During the second quarter of 2021, Ambrx completed a reorganization of its corporate structure. As a result, Ambrx Shanghai and Ambrx Hong Kong became wholly owned subsidiaries of Ambrx Biopharma Inc.
Formed a Scientific Advisory Board (SAB). In June, Ambrx announced the formation of a Scientific Advisory Board comprised of industry leaders in oncology and protein sciences. The board is chaired by Peter Schultz, Ph.D., President and CEO of Scripps Research and a professor of chemistry. The other founding members of the Ambrx SAB include: Stuart Lutzker, M.D., Ph.D., an industry veteran with decades of oncology drug development experience; Jakob Dupont, M.D., a renowned expert in oncology, immunology and cell therapy; Melissa Starovasnik, Ph.D., an accomplished scientific leader and 28-year Genentech veteran; Luisa Salter-Cid, Ph.D., M.Sc., the Chief Scientific Officer at Pioneering Medicines; and Feng Tian, Ph.D., the Chairman of the Board of Directors, President and CEO of Ambrx.
Appointed Sonja Nelson as CFO. In June, Sonja Nelson joined Ambrx as its Chief Financial Officer. Ms. Nelson is an experienced financial executive, who joined Ambrx with 10 years of executive experience within the biotechnology industry. Most recently, she served as Chief Financial Officer at NantKwest, now ImmunityBio.
Strengthened Board of Directors with Two New Appointments. In April, Ambrx appointed Olivia C. Ware, an accomplished biotech and pharmaceutical executive, and Katrin Rupalla, Ph.D., Senior Vice President of Regulatory Affairs, R&D Quality and Medical Information at Lundbeck, to its Board of Directors.
Anticipated Near-Term Milestones
Additional data from the Phase 1 clinical study of ARX788 (ACE-Breast-01) in patients with HER2+ metastatic breast cancer in 2H 2021.
Submit an Investigational New Drug (IND) application for ARX305 in patients with cancer (renal cell carcinoma (RCC) and other cancers) in 1H 2022.
Financial Highlights
Cash and Cash Equivalents: Cash and cash equivalents were $167.2 million as of June 30, 2021. In July, the underwriters partially exercised the greenshoe option resulting in net proceeds of $14.9 million to Ambrx.
Revenue: Revenue was $5.1 million for the six months ended June 30, 2021, as compared to $6.5 million for the six months ended June 30, 2020. The decrease was primarily driven by revenue recognized associated with upfront payments related to our R&D agreements, partially offset by increased 3rd party reimbursable charges.
Research and development (R&D) expenses: R&D expenses were $22.1 million for the six months ended June 30, 2021, as compared to $9.9 million for the six months ended June 30, 2020. The increase of $12.2 million was mainly due to increased costs related to new clinical trial programs and related manufacturing costs as well as personnel related costs including stock-based compensation expense.
General and administrative (G&A) expenses: G&A expenses were $8.4 million for the six months ended June 30, 2021, as compared to $2.6 million for the six months ended June 30, 2020. The increase of $5.8 million was mainly attributable to professional services and fees in connection with preparing for Ambrx’s IPO, expenses associated with the corporate structure reorganization, and personnel related costs including stock-based compensation expense.
Other expenses: Other expense, net, for the six months ended June 30, 2021 was $3.9 million, which is primarily due to a change in fair value of Ambrx’s redeemable noncontrolling interest liability in connection with the purchase of shares held by minority shareholders in Ambrx Shanghai which was part of Ambrx’s reorganization of its corporate structure, completed during the second quarter of 2021.
Net loss: Net loss for the six months ended June 30, 2021 was $29.0 million, as compared to $5.4 million for the six months ended June 30, 2020.