ADVM.
Adverum Biotechnologies Reports Fourth Quarter 2017 Financial Results and Provides Corporate Update
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Adverum Biotechnologies, Inc. (NASDAQ:ADVM)
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Today : Tuesday 6 March 2018
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Adverum Biotechnologies, Inc. (Nasdaq:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases, today reported financial results for the fourth quarter ended December 31, 2017 and provided a corporate update.
“We enter 2018 with significant momentum following a year of critical execution to transform Adverum into a clinical-stage company,” said Amber Salzman, Ph.D., president and chief executive officer of Adverum Biotechnologies. “In ADVANCE, our Phase 1/2 clinical trial of ADVM-043 in alpha-1 antitrypsin deficiency, we have completed enrollment in the first dose cohort and have initiated patient enrollment in the second intermediate-dose cohort. We are on track to report preliminary data from this study in the second half of 2018. In addition, we plan to submit two Investigational New Drug Applications with the FDA in the second half of 2018, for ADVM-022 in wet AMD and ADVM-053 in hereditary angioedema. We begin this exciting year of clinical development and regulatory progress in a strong position, funded to execute our three lead programs through the end of 2019 with preliminary clinical data for at least two of these programs.”
Recent Progress
In February 2018, Adverum completed the dosing and evaluation of patients (n=2) in the first cohort of the ADVANCE Phase 1/2 trial for ADVM-043 in alpha-1 antitrypsin (A1AT) deficiency. Based on a review of the preliminary safety information, the independent data monitoring committee (DMC) recommended proceeding to the second cohort of patients, which is open for enrollment. Adverum has initiated patient enrollment in the second intermediate-dose cohort, which will receive an intermediate dose of ~5E12 vg/kg (equivalent to ~4E14 total vg based on an 80-kg patient). The primary endpoint is safety and tolerability, and secondary endpoints include changes in plasma concentrations of both total and M-specific A1AT levels. Additional information about this clinical trial can be found at ClinicalTrials.gov under trial identifier number NCT02168686.
In February 2018, Adverum raised $69.0 million in gross proceeds from an underwritten public offering of its common stock.
In January 2018, Adverum and Editas Medicine, Inc. announced the extension of the companies’ collaboration agreement to explore the delivery of genome editing medicines to treat up to five inherited retinal diseases.
2018 Outlook - Planned Pipeline Milestones
ADVM-043 for A1AT Deficiency
Report preliminary data from the ADVANCE Phase 1/2 clinical trial in the second half of 2018.
ADVM-022 for wAMD
Report 12-month efficacy data in non-human primates in the first half of 2018.
Complete Investigational New Drug (IND)-enabling preclinical studies.
Submit an IND Application to the U.S. Food and Drug Administration (FDA) in the second half of 2018.
ADVM-053 for Hereditary Angioedema (HAE)
Complete IND-enabling preclinical studies.
Submit an IND Application to the FDA in the second half of 2018.
Upcoming Events
Adverum plans to attend the following upcoming conferences:
° Cowen 38th Annual Health Care Conference in Boston on March 12, 2018 at 1:30 pm ET
° Cowen 17th Annual Life Sciences Winter Meeting in Colorado, March 20-23, 2018
° ARM Cell & Gene Therapy Investor Day in New York, April 17, 2018
° ARVO 2018 Annual Meeting in Honolulu, April 29-May 3, 2018
• Poster titled “Therapeutic potential and safety of sequential intravitreal dosing to the contralateral eye of novel AAV vectors in non-human primates” on May 3, 2018, 8:15 – 10:00 am HST
• Poster titled “Long-term functional delivery of the human L-opsin cDNA via intravitreal administration of an AAV vector in Mongolian gerbils” on May 3, 2018, 8:15 - 10:00 am HST
° 2nd Annual Gene Therapy for Rare Disorders 2018 Meeting in Boston, April 30-May 2, 2018
° ASGCT 21st Annual Meeting in Chicago, May 16-19, 2018
Financial Results for the Three Months Ended December 31, 2017
Cash, cash equivalents and marketable securities were $190.5 million as of December 31, 2017, compared to $186.6 million as of September 30, 2017 and $222.2 million as of December 31, 2016. The year-end cash position, added with approximately 64 million in net proceeds raised in February 2018, is expected to fund the three lead gene therapy programs through the end of 2019, including preliminary clinical data for at least two of these programs, and through the initial stage of scaling up manufacturing capabilities.
Revenues, consisting of revenue from collaborative research, were $0.5 million for the three months ended December 31, 2017, compared to $0.5 million for the same period in 2016.
Research and development expenses were $12.0 million for the three months ended December 31, 2017, compared to $7.9 million for the same period in 2016. This increase was due to an overall increase in research and development activities for the Company’s gene therapy programs, primarily for material production costs for the ADVANCE clinical trial for ADVM-043.
General and administrative expenses were $4.0 million for the three months ended December 31, 2017, compared to $4.8 million for the same period in 2016. This decrease was primarily due to lower legal fees.
Net loss attributable to common stockholders was $14.8 million, or $0.32 per basic and diluted share, for the three months ended December 31, 2017, compared to $22.4 million, or $0.54 per basic and diluted share, for the same period in 2016.
Shares of common stock outstanding were 62.2 million as of February 28, 2018.
