AVROBIO, Inc. Reports Third Quarter 2019 Financial Results and Provides Business Update – Business Wire
By daniellenierenberg
CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVROBIO, Inc. (NASDAQ: AVRO) (the Company), a Phase 2 clinical-stage gene therapy company, today reported financial results for the third quarter ended September 30, 2019 and provided a business update.
We are thrilled with the progress across our pipeline, including the dosing of the first patient in our cystinosis program and receipt of orphan drug designation for our investigational gene therapy for Gaucher disease, commented Geoff MacKay, President and Chief Executive Officer of AVROBIO. In our Fabry program, we have now dosed eight patients across two clinical trials and we are on track to use our optimized lentiviral vector and a conditioning regimen utilizing therapeutic drug monitoring for the first time to dose a patient in our Phase 2 clinical trial for Fabry disease by the end of 2019. While our rapid expansion and early data have been exciting, we are humbled by the needs of the rare disease communities with whom we engage. They impress a sense of urgency on our work to deliver a new paradigm that we believe can supersede current treatment options and potentially provide patients freedom from a lifetime of disease.
Program Updates and Milestones
Third Quarter 2019 Financial Results
AVROBIO reported a net loss of $17.1 million for the third quarter of 2019 as compared to a net loss of $11.6 million for the comparable period in 2018. This increase was due to increased research and development expenses, as well as increased general and administrative expenses.
Research and development expenses were $13.0 million for the third quarter of 2019 as compared to $9.2 million for the comparable period in 2018. This increase was driven by increased program development activities related to the advancement of the Companys pipeline, as well as increased personnel-related costs resulting from an increase in employee headcount.
General and administrative expenses were $5.0 million for the third quarter of 2019 as compared to $3.0 million for the comparable period in 2018. This increase was primarily due to an increase in employee headcount, expenses associated with being a publicly traded company, including consulting expenses, and the impact of non-cash stock-based compensation.
As of September 30, 2019, AVROBIO had $206.4 million in cash and cash equivalents, as compared to $126.3 million in cash and cash equivalents as of December 31, 2018. The cash balance as of September 30, 2019 reflects the receipt of net proceeds of $129.5 million from the Companys July 2019 follow-on equity offering. Based on the Companys current operating plan, AVROBIO expects its cash and cash equivalents as of September 30, 2019 will enable the Company to fund its operating expenses and capital expenditure requirements into the second half of 2021.
About AVROBIO, Inc.
AVROBIO, Inc. is a leading, Phase 2 gene therapy company focused on the development of its investigational 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. The Companys plato platform includes a proprietary vector system, automated cell manufacturing solution and refined conditioning regimen deploying therapeutic drug monitoring. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON. For additional information, visit http://www.avrobio.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as aims, anticipates, believes, could, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will, and variations of these words or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding our business strategy, prospective products and goals, the therapeutic potential of our product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, clinical trial results, product approvals and regulatory pathways, the intended incentives conferred by orphan-drug designation, potential regulatory approvals and the timing thereof, expected benefits from the appointment of Ms. Verdin to the position of Chief Human Resources Officer and Ms. May to the position of Chief Commercial Officer, anticipated benefits of our gene therapy platform including potential impact on our commercialization activities, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products, and the market opportunity for and anticipated commercial activities relating to our product candidates, and statements regarding the Companys financial and cash position and expected cash runway. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.
Any forward-looking statements in this press release are based on AVROBIOs current expectations, estimates and projections about our industry as well as managements current beliefs and 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 AVROBIOs product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned clinical trials of AVROBIO or our collaborators, the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato platform, the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate, 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 AVROBIOs product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIOs actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled Risk Factors in AVROBIOs Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, as well as discussions of potential risks, uncertainties and other important factors in AVROBIOs 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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
September 30,
December 31,
2019
2018
Cash and cash equivalents
$
206,362
$
126,302
Prepaid expenses and other current assets
7,345
3,718
Property and equipment, net
2,673
2,634
Other assets
825
825
Total assets
$
217,205
$
133,479
Accounts payable
$
1,408
$
2,784
Accrued expenses and other current liabilities
8,502
7,822
Deferred rent, net of current portion
535
689
Total liabilities
10,445
11,295
Total stockholders equity
206,760
122,184
Total liabilities and stockholders equity
$
217,205
$
133,479
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2019
2018
2019
2018
Operating expenses:
Research and development
$
13,042
$
9,232
$
37,755
$
22,286
General and administrative
5,022
Continued here:
AVROBIO, Inc. Reports Third Quarter 2019 Financial Results and Provides Business Update - Business Wire
- 001 Elaine Fuchs discusses research on skin and adult stem cells [Last Updated On: June 25th, 2011] [Originally Added On: June 25th, 2011]
- 002 Skin Stem Cells: Their Biology [Last Updated On: June 25th, 2011] [Originally Added On: June 25th, 2011]
- 003 Come Back Kid [Last Updated On: June 26th, 2011] [Originally Added On: June 26th, 2011]
- 004 Emerge Labs New Anti Aging Swiss Apple Stem Cell Skin Care [Last Updated On: June 26th, 2011] [Originally Added On: June 26th, 2011]
- 005 PhytoCell.mp4 [Last Updated On: June 26th, 2011] [Originally Added On: June 26th, 2011]
- 006 Elaine Fuchs Part 2: Tapping the Potential of Adult Stem Cells, and Summary [Last Updated On: June 28th, 2011] [Originally Added On: June 28th, 2011]
- 007 Elaine Fuchs Part 1: Introduction to Stem Cells [Last Updated On: July 1st, 2011] [Originally Added On: July 1st, 2011]
- 008 Stem Cell Facial At Metamorphosis Day Spa Using Emerge Labs Skin Care [Last Updated On: July 1st, 2011] [Originally Added On: July 1st, 2011]
- 009 A Major Breakthrough in Skin Care and Nutrition [Last Updated On: July 7th, 2011] [Originally Added On: July 7th, 2011]
- 010 The Skin Gun stem cell research [Last Updated On: July 7th, 2011] [Originally Added On: July 7th, 2011]
- 011 The Skin Gun [Last Updated On: July 7th, 2011] [Originally Added On: July 7th, 2011]
- 012 E'shee HBA Global Expo 2011, NYC. Skin Care Anti-Aging Symposium [Last Updated On: July 8th, 2011] [Originally Added On: July 8th, 2011]
- 013 World's 1st Nutricosmetic with Stem Cell Nutrients [Last Updated On: July 15th, 2011] [Originally Added On: July 15th, 2011]
- 014 Stem cells acquired from human skin [Last Updated On: August 22nd, 2011] [Originally Added On: August 22nd, 2011]
- 015 DermaStem Renewal Serum - Stem Cells for Your Skin from STEMTech - New Paradigm in Beauty! [Last Updated On: August 30th, 2011] [Originally Added On: August 30th, 2011]
- 016 Stem Cells Made From Human Skin [Last Updated On: September 4th, 2011] [Originally Added On: September 4th, 2011]
- 017 ReLuma-stemcells- skin rejuvenation [Last Updated On: September 5th, 2011] [Originally Added On: September 5th, 2011]
- 018 Jeunesse Global Business Opportunity with Stem Cell Skin Care Developed by Dr Nathan Newman [Last Updated On: September 5th, 2011] [Originally Added On: September 5th, 2011]
- 019 Dr Nathan Newman- Formulator of Stem Cell Skin Care Line LUMINESCE [Last Updated On: September 6th, 2011] [Originally Added On: September 6th, 2011]
- 020 Luminesce Stem Cell Skin Care - Leaders in Jeunesse [Last Updated On: September 7th, 2011] [Originally Added On: September 7th, 2011]
- 021 Stem Cell Therapy - BioLogic Anti-Aging Skin Cream [Last Updated On: September 7th, 2011] [Originally Added On: September 7th, 2011]
- 022 Isolation and Culture of Adult Epithelial Stem Cells from Human Skin [Last Updated On: September 8th, 2011] [Originally Added On: September 8th, 2011]
- 023 Stem Cell Skin Care- What is the role of stem cells in Luminesce Featuring Dr Nathan Newman [Last Updated On: September 9th, 2011] [Originally Added On: September 9th, 2011]
- 024 Genetic Skin Disease (EB): Spotlight on Stem Cell Research - Patient Advocate [Last Updated On: September 11th, 2011] [Originally Added On: September 11th, 2011]
- 025 Genetic Skin Disease (EB): Optimizing Embryonic Stem Cell Differentiation Protocols [Last Updated On: September 12th, 2011] [Originally Added On: September 12th, 2011]
- 026 Genetic Skin Disease (EB): Spotlight on Stem Cell Research - Introduction [Last Updated On: September 13th, 2011] [Originally Added On: September 13th, 2011]
- 027 The Skin Gun (Stem Cell research to replace burnt off skin. Done in 3 days!) [Last Updated On: September 15th, 2011] [Originally Added On: September 15th, 2011]
- 028 Best natural skin care serum using stem cell technology [Last Updated On: September 22nd, 2011] [Originally Added On: September 22nd, 2011]
- 029 Stem Cells: Fulfilling the Promise - 2011 CIRM Grantee Meeting [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- 030 Jeunesse Global Opportunity- Stem Cell Skin Care [Last Updated On: September 25th, 2011] [Originally Added On: September 25th, 2011]
- 031 Research on skin cancer: ERC funds studies on stem cells [Last Updated On: September 26th, 2011] [Originally Added On: September 26th, 2011]
- 032 Stem Cell Therapy Skin Repair and Anti-Wrinkle Cream [Last Updated On: September 29th, 2011] [Originally Added On: September 29th, 2011]
- 033 Skin engineering [Last Updated On: September 30th, 2011] [Originally Added On: September 30th, 2011]
- 034 Stem Cell Face Treatment - What People Are Saying | Beverly Hills | Los Angeles [Last Updated On: October 1st, 2011] [Originally Added On: October 1st, 2011]
- 035 How To Use Your Stem Cells For Facial Skin Rejuvenation [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 036 AMAZING - Stem Cell Skin Cream And Liquid Face Lift Revealed [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 037 Dr Nathan Newman MD Stem Cell Face lift on Channel 7 KABC.flv [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 038 Genetic Skin Disease (EB): Spotlight on Stem Cell Research - Welcome [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 039 Dr.Thomas Barnes' PRP Hair Growth and Skin Rejuvenation [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 040 For Damaged Skin - Rejuvenate Your Own Stem Cells [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 041 real food real life - Stemulance stem cell face products [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 042 Dr Amiya Prasad discusses ACell for Hair Regrowth and Skin Rejuvenation with EYES IN Magazine [Last Updated On: October 5th, 2011] [Originally Added On: October 5th, 2011]
- 043 Stem Cell Face Lift - English (Part 5) [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 044 Cell Reprogramming Transformed [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 045 Care for Your Skin with Lifeline Skin Care [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 046 Dr Nathan Newman Repairs Laugh Lines With Stem Cell Face Lift [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 047 Ellis Martin Report with International Stem Cell Corp [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 048 Stem Cell Banking: The Perspective of an iPS Donor Family [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- 049 Dr Nathan Newman Stem Cell Face Lift on Entertainment Tonight [Last Updated On: October 8th, 2011] [Originally Added On: October 8th, 2011]
- 050 Elaine Fuchs Part 1: Introduction to Stem Cells English Subtitle [Last Updated On: October 12th, 2011] [Originally Added On: October 12th, 2011]
- 051 Signals Stem Cell Skin Care Anti Aging Skin Care - Video [Last Updated On: October 14th, 2011] [Originally Added On: October 14th, 2011]
- 052 Stem Cell Skin Care - Born Different.mp4 - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 053 APPLE STEMCELL by SEMCELL - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- 054 Jeunesse Luminesce Stem Cell Skin care Before and After Pictures - Video [Last Updated On: October 23rd, 2011] [Originally Added On: October 23rd, 2011]
- 055 Stem Cell Therapy -- Reduce Wrinkles,Promote Younger, Healthier Looking Skin - Video [Last Updated On: October 25th, 2011] [Originally Added On: October 25th, 2011]
- 056 Scientists Create Liver from Reprogrammed Human Skin Cells No Stem Cells Needed - Video [Last Updated On: October 25th, 2011] [Originally Added On: October 25th, 2011]
- 057 Vitiligo and Stem Cells: Narrowband UVB Phototherapy in Nonsegmental Vitiligo - Video [Last Updated On: October 25th, 2011] [Originally Added On: October 25th, 2011]
- 058 Dr Nathan Newman MD Stem Cell Face lift on Entertainment Tonight - NewHopeForAging.com - Video [Last Updated On: October 25th, 2011] [Originally Added On: October 25th, 2011]
- 059 Skin Healing And Anti-Aging - Rejuvenate Aging Skin Cells - Video [Last Updated On: October 25th, 2011] [Originally Added On: October 25th, 2011]
- 060 Stem Cell Face Lift - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- 061 Stem Cell Therapy Face Cream - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- 062 Growing skin in lab with stem cells Video Reuters - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- 063 Stem Cells and Their Lineages in Skin - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- 064 Stem Cells Rock - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- 065 Stem Cell Therapy: Healing Force of the future - Video [Last Updated On: October 29th, 2011] [Originally Added On: October 29th, 2011]
- 066 Alex Cosmeceuticals - Phyto Stem Cell Technology - Video [Last Updated On: October 29th, 2011] [Originally Added On: October 29th, 2011]
- 067 Reprogramming skin cells into embryonic stem cells - Video [Last Updated On: October 29th, 2011] [Originally Added On: October 29th, 2011]
- 068 Ellis Martin Report with International Stem Cell Corp - YouTube2.flv - Video [Last Updated On: October 30th, 2011] [Originally Added On: October 30th, 2011]
- 069 Dr Lyras Plastic Surgery - Skin Needling 3 - Tv 2011 - Video [Last Updated On: November 5th, 2011] [Originally Added On: November 5th, 2011]
- 070 Donna Queen-Lifeline Skin Care at the CACS - Video [Last Updated On: November 8th, 2011] [Originally Added On: November 8th, 2011]
- 071 Turning Science Into Action with Heather Livingston - Part 1 www.miraclecell.info - Video [Last Updated On: November 12th, 2011] [Originally Added On: November 12th, 2011]
- 072 US scientists unveil new cloning method for embryonic stem cells - Video [Last Updated On: November 12th, 2011] [Originally Added On: November 12th, 2011]
- 073 A Stem Cell Story - Video [Last Updated On: November 12th, 2011] [Originally Added On: November 12th, 2011]
- 074 Perspectives of a Stem Cell Donor Family - Video [Last Updated On: November 13th, 2011] [Originally Added On: November 13th, 2011]
- 075 Adult Stem Cell Success Stories - Amy Daniels - Video [Last Updated On: November 15th, 2011] [Originally Added On: November 15th, 2011]
- 076 StemCellTV - From National Geographic - The Skin Gun - Healing Burns with Stem Cells - Video [Last Updated On: November 16th, 2011] [Originally Added On: November 16th, 2011]
- 077 Stem Cell Skin Care Jeunesse- Dr Newman FAQ - Video [Last Updated On: November 18th, 2011] [Originally Added On: November 18th, 2011]
- 078 Dr Nathan Newman and Jeunesse Stem Cell Skin Care - Video [Last Updated On: November 26th, 2011] [Originally Added On: November 26th, 2011]
- 079 Apple Stem Cell-Skin aging solution - Video [Last Updated On: November 29th, 2011] [Originally Added On: November 29th, 2011]
- 080 Luminesce rejuvenation serum cellular rejuvenation stem cell skin Products - Video [Last Updated On: November 29th, 2011] [Originally Added On: November 29th, 2011]
