Full Press Release Details
AVROBIO, Inc. Reports Third Quarter 2018 Financial Results and Provides Business Update
During the quarter, announced updated Fabry clinical data, acceptance of Clinical Trial
Application for Gaucher, and continued platform optimization
CAMBRIDGE, Mass., November 13, 2018 (GLOBE NEWSWIRE) AVROBIO, Inc. (NASDAQ:AVRO) (the Company ), a Phase 2 clinical-stage gene
therapy company developing gene therapies to potentially cure rare diseases with a single dose, today reported financial results for the third quarter 2018 and provided a business update.
The third quarter has been productive for AVROBIO, commented Geoff MacKay, President and Chief Executive Officer of AVROBIO. In a recent
clinical data update on AVR-RD-01, we were pleased with the -galactosidase A (AGA) enzyme activity demonstrated in patients with Fabry disease. In addition,
we have achieved our first regulatory milestone for our gene therapy for Gaucher disease as it advances towards the clinic. We are also continuing to optimize our platform, which includes refining conditioning and the 2019 transition to our
four-plasmid lentiviral vector (LV2). We look forward to providing additional updates throughout the upcoming year on our AVR-RD-01 clinical trials, platform
optimization progress, and the introduction of our next gene therapy, AVR-RD-02, for Gaucher disease, into the clinic.
Third Quarter and Recent Business Highlights
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.
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
programs in other lysosomal storage disorders including Gaucher disease, cystinosis and Pompe disease. AVROBIO is headquartered
in Cambridge, MA and has offices in Toronto, ON. For additional information, visit www.avrobio.com.
Various express or implied statements in this release concerning AVROBIO s future expectations, plans and prospects, including without
limitation, its expectations regarding the development and the continued progress of AVROBIO s programs, including the commencement of clinical trials, expansion of trial sites and timing of data release, the therapeutic potential of its
product candidates, AVROBIO s planned platform optimization efforts and the intended benefits thereof, and statements regarding the Company s cash position and expected runway, constitute forward-looking statements for the purposes of the
safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any forward-looking statements in
this press release are based on management s current expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth
in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIO s product candidates will not be successfully developed or commercialized, the risk of
cessation or delay of any of AVROBIO s ongoing or planned clinical trials, the risk that AVROBIO may not realize the intended benefits of efforts to optimize its platform, and the risk that prior results, such as signals of safety, activity or
durability of effect, observed from preclinical or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIO s product candidates. For a discussion of these and other risks and
uncertainties, and other important factors, any of which could cause AVROBIO s actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in AVROBIO s Quarterly Report
on Form 10-Q for the quarter ended June 30, 2018, as well as discussions of potential risks, uncertainties and other important factors in AVROBIO s subsequent filings with the Securities and Exchange
Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Christopher F. Brinzey
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
| September 30, 2018 | December 31, 2017 | |||||||
| Cash and cash equivalents | $ | 138,577 | $ | 5,963 | ||||
| Prepaid expenses and other current assets | 1,501 | 345 | ||||||
| Property and equipment, net | 2,306 | 349 | ||||||
| Other assets | 888 | 365 | ||||||
| Total assets | $ | 143,272 | $ | 7,022 | ||||
| Accounts payable | $ | 1,582 | $ | 527 | ||||
| Accrued expenses and other current liabilities | 3,845 | 2,098 | ||||||
| Warrant to purchase redeemable convertible preferred stock | 35 | |||||||
| Derivative liability | 371 | |||||||
| Deferred rent, net of current portion | 736 | 126 | ||||||
| Other long-term liability | 500 | |||||||
| Total liabilities | 6,163 | 3,657 | ||||||
| Redeemable convertible preferred stock | 26,500 | |||||||
| Total stockholders equity (deficit) | 137,109 | (23,135 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders equity (deficit) | $ | 143,272 | $ | 7,022 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 9,232 | $ | 5,411 | $ | 22,286 | $ | 8,726 | ||||||||
| General and administrative | 3,000 | 959 | 7,281 | 2,230 | ||||||||||||
| Total operating expenses | 12,232 | 6,370 | 29,567 | 10,956 | ||||||||||||
| Loss from operations | (12,232 | ) | (6,370 | ) | (29,567 | ) | (10,956 | ) | ||||||||
| Total other income (expense), net | 641 | (71 | ) | (773 | ) | (96 | ) | |||||||||
| Net loss | $ | (11,591 | ) | $ | (6,441 | ) | $ | (30,340 | ) | $ | (11,052 | ) | ||||
| Net loss per share attributable to common stockholders basic and diluted | $ | (0.49 | ) | $ | (2.85 | ) | $ | (3.28 | ) | $ | (5.01 | ) | ||||
| Weighted-average number of common shares used in computing net loss per share attributable to common stockholders basic and diluted | 23,747,141 | 2,263,195 | 9,945,538 | 2,216,180 |