| • | | Continued preparation for the initial use of optimized platform in patients in 2019.Key to AVROBIO’s strategy is to continuously advance its technology and production process to improve the performance of its gene therapies. The company continues its ongoing work to transition to LV2, AVROBIO’s four-plasmid lentiviral vector, to automate a closed manufacturing system, and to optimize the conditioning regimen.In vitro comparability testing of LV2 is in progress, and regulatory filing and potential approval for use in ongoing and future clinical trials is expected in 2019. |
| • | | AVR-RD-03 (Pompe disease) andAVR-RD-04 (cystinosis) continue to advance as planned.AVROBIO continues to make progress withAVR-RD-03, a gene therapy candidate being investigated for Pompe disease currently in early preclinical development.AVR-RD-04, a gene therapy candidate being investigated for the treatment of patients with cystinosis, remains on track to enroll the first patient in 2019 in an investigator-sponsored Phase 1/2 study by the University of California, San Diego. |
Third Quarter Financial Results
AVROBIO reported a net loss of $11.6 million for the third quarter 2018 as compared to $6.4 million for the prior year period. The increase in net loss for the year was due to increased research and development expenses, as well as an increase in general and administrative expenses primarily related to investments in the Company’s infrastructure as a publicly traded company.
Research and development expenses for the third quarter 2018 were $9.2 million as compared to $5.4 million for the prior year period. The increase in research and development expenses was primarily driven by increased spending on expenses and other costs used to advance AVROBIO’s preclinical and clinical development activities for the Company’s pipeline, as well as increased personnel-related costs due to the increase in employee headcount.
General and administrative expenses were $3.0 million for the third quarter 2018 as compared to $1.0 million for the prior year period. The increase in general and administrative expenses was primarily due to an increase in employee headcount, consulting and professional fees related to the support for ongoing business operations as a publicly traded company and the impact of stock-based compensation in 2018.
AVROBIO ended the quarter with $138.6 million in cash and cash equivalents compared to $6.0 million as of December 31, 2017. The increase was primarily the result of the completion of the Company’s initial public offering, from which the Company received aggregate net proceeds of $104.0 million, and the Series B financing completed in January 2018 that generated net proceeds of $58.3 million.
Based on its current operating plan, AVROBIO expects its cash and cash equivalents as of September 30, 2018, will enable it to fund its operating expenses and capital expenditure requirements into 2020.
About AVROBIO, Inc.
AVROBIO, Inc., is a Phase 2 clinical-stage gene therapy company developing gene therapies to potentially cure rare diseases with a single dose. AVROBIO’s lentiviral-based gene therapies employ hematopoietic stem cells that are collected from the patient and then modified with a lentiviral vector to insert a functional copy of the gene that is defective in the target disease. AVROBIO is focused on the development of its gene therapy,AVR-RD-01, in Fabry disease, as well as additional gene therapy
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