On August 29, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics (EPBs), reported financial results for the first half of 2022 (Press release, Ambrx, AUG 29, 2022, View Source [SID1234618741]).
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"I am very grateful for all that Tian accomplished during his tenure leading Ambrx, from spearheading the development of the company’s research and development programs to the transition to a public company last year," said Kate Hermans, Interim Chief Executive Officer of Ambrx. "While the Board conducts a search for a permanent CEO, we will review the company’s pipeline to focus on Ambrx’s strongest commercial opportunities and further extend our cash runway. Additionally, I would like to congratulate NovoCodex for their recent successful Series B financing and am thankful for the relationship we have built. Our strong partnerships will remain a priority for us. We remain confident in our platform to deliver on the promise of precision medicine and I look forward to having the opportunity to lead Ambrx during this transition."
1H 2022 and Subsequent Highlights
Appointed Kate Hermans as Interim Chief Executive Officer. In August, Ambrx announced the appointment of Kate Hermans as Interim Chief Executive Officer (CEO), replacing Feng Tian, Ph.D. Ms. Hermans has more than two decades of commercial and operational experience in the healthcare industry, previously serving in executive leadership roles at companies including Radius Health, Bristol Myers Squibb and Pfizer. Ambrx’s Board has commenced a search for a permanent CEO. Dr. Tian has agreed to continue with Ambrx in an advisory capacity.
Received a "Study May Proceed" letter from the FDA related to an IND application for ARX305. In February, Ambrx announced that the FDA accepted the company’s IND and provided a "Study May Proceed" letter for ARX305 for the treatment of solid and hematological tumors. ARX305 is the third antibody drug conjugate (ADC) developed by Ambrx on its proprietary EPB platform to receive IND clearance. In July, Ambrx’s partner in China, NovoCodex, announced that it had received drug clinical trial approval notice for ARX305 and intends to initiate a Phase 1 trial in China in the second half of 2022.
Announced Inclusion of ARX788 in a Quantum Leap’s I-SPY 2.2 Phase 2 Clinical Trial. In April, the company announced the inclusion of ARX788 in Quantum Leap Healthcare Collaborative’s investigational treatment arm in the I-SPY 2.2 TRIAL for the treatment of HER2-positive breast cancer in the neoadjuvant setting. Sponsored by Quantum Leap, I-SPY 2.2 is an adaptive Phase 2 clinical trial that evaluates emerging targeted agents, allowing those agents to either be combined with less toxic chemotherapeutic regimens or to replace cytotoxic chemotherapy entirely. The first patient was dosed with ARX788 in August 2022.
Appointed Janice Lu, M.D., Ph.D., as Chief Medical Officer. In May, Janice Lu, M.D., Ph.D., joined Ambrx as its Chief Medical Officer. Dr. Lu is a distinguished clinical professor of medicine who has more than 18 years of experience in leading clinical trials and breast cancer drug development. Dr. Lu, a board-certified medical oncologist, was on the faculty in Hematology and Oncology at UCLA, and most recently served as Clinical Professor of Medicine and Medical Director of the Breast Oncology Program at the USC Keck School of Medicine.
Strengthened Board of Directors. In August, Ambrx announced the appointment of Katrin Rupalla, Ph.D. to Chair of the Board of Directors. Since the start of 2022, Ambrx has appointed Paul V. Maier, Janet Loesberg, Pharm. D., Edward Hu and Kate Hermans to its Board.
Financial Highlights
Cash and Cash Equivalents and Marketable Securities: Cash and cash equivalents and marketable securities were $129.7 million as of June 30, 2022, of which $64.1 million are marketable securities, compared to $170.1 million in cash and cash equivalents as of December 31, 2021.
Revenue: Revenue was $2.9 million for the six months ended June 30, 2022, as compared to $5.1 million for the six months ended June 30, 2021. The decrease was primarily driven by less revenue recognized in connection with our R&D and license agreements, partially offset by increased third party reimbursable charges.
Research and development (R&D) expenses: R&D expenses were $32.8 million for the six months ended June 30, 2022, as compared to $22.1 million for the six months ended June 30, 2021. The increase was mainly due to increased costs related to our clinical trial programs, primarily driven by our lead product candidate ARX788, and related manufacturing costs, partially offset by lower stock-based compensation expense.
Impairment loss on intangible assets: The loss of $9.7 million for the six months ended June 30, 2022 was driven by the impairment of intangible assets related to assets that were in development with a collaboration partner.
General and administrative (G&A) expenses: G&A expenses were $9.4 million for the six months ended June 30, 2022, as compared to $8.4 million for the six months ended June 30, 2021. The increase was mainly attributable to professional services and fees in connection with operating as a public company including directors & officer insurance.
Other expenses, net: Other expense, net, for the six months ended June 30, 2022 were $0.9 million, as compared to $3.9 million for the six month ended June 20, 2021. The current period expense is mainly related to fees and interest incurred related to a promissory note settlement and capital reduction related to Ambrx Shanghai.
Net loss: Net loss for the six months ended June 30, 2022 was $51.5 million, as compared to $29.0 million for the six months ended June 30, 2021.