08.09.18

REGENXBIO Reports Second Quarter 2018 Financial and Operating Results and Interim Data From Ongoing Clinical Trials

Source: REGENXBIO Inc.

REGENXBIO Inc. announced financial results for the quarter ended June 30, 2018, and recent operational highlights including updates to interim data from its ongoing clinical trials.

Financial Results

Cash, cash equivalents, and marketable securities were $306.3 million as of June 30, 2018, compared to $176.4 million as of December 31, 2017. Cash, cash equivalents, and marketable securities as of June 30, 2018 include $180.0 million received in 2018 in connection with the amendment to the company’s license agreement with AveXis for the development and commercialization of treatments for spinal muscular atrophy.

Revenues were $40.0 million for the three months ended June 30, 2018, compared to $6.6 million for the three months ended June 30, 2017. The increase is primarily attributable to $40.0 million of license revenue recognized during the three months ended June 30, 2018 under the amended license agreement with AveXis. The May 2018 acquisition of AveXis by Novartis triggered the acceleration of $100.0 million in license payments to REGENXBIO, of which $40.0 million, related to an accelerated sale-based milestone payment, was recognized as revenue during the three months ended June 30, 2018. Due to the nonrecurring license revenue recognized under the amended license agreement with AveXis during the three and six months ended June 30, 2018, REGENXBIO expects license revenue for the remainder of 2018 to be substantially lower than the first half of 2018.

Research and development expenses were $21.5 million for the three months ended June 30, 2018, compared to $13.9 million for the three months ended June 30, 2017. The increase was primarily attributable to personnel costs as a result of increased headcount, laboratory and facilities costs and expenses associated with conducting clinical trials and externally sourced manufacturing-related services.

General and administrative expenses were $8.3 million for the three months ended June 30, 2018, compared to $6.4 million for the three months ended June 30, 2017. The increase was primarily attributable to personnel costs as a result of increased headcount and professional fees for advisory services.

Net income was $10.6 million, or $0.33 basic and $0.30 diluted net income per share, for the three months ended June 30, 2018, compared to a net loss of $14.5 million, or $0.47 basic and diluted net loss per share, for the three months ended June 30, 2017. Net income for the three months ended June 30, 2018 was primarily driven by the nonrecurring license revenue recognized under the amended license agreement with AveXis.

Based on its current operating plan, REGENXBIO expects that its balance in cash, cash equivalent, and marketable securities will be between $250 million and $260 million as of December 31, 2018, which will be used to support the continued development of its lead product candidate programs.

Interim Phase I Trial Update for RGX-314 for the Treatment of Wet Age-Related Macular Degeneration:

“We are very encouraged by the positive interim data for RGX-314 and the potential of NAV gene therapy as a one-time treatment for wet age-related macular degeneration (AMD), particularly as this is a non-rare patient population with a significant treatment burden,” said Kenneth T. Mills, president and chief executive officer of REGENXBIO. “REGENXBIO looks forward to applying what we are learning from this trial to expand the RGX-314 clinical program into a Phase II trial and bring this novel therapy to patients as quickly as possible.”

  • Well-tolerated at all doses
  • Dose-dependent protein expression levels
  • Dose-dependent reduction in anti-VEGF injections, along with maintenance of retinal thickness and vision
  • 50% of subjects treated in Cohort 3 are free of anti-VEGF injections at 6 months
  • Company plans to proceed to Phase II clinical trial as soon as possible
  • Current clinical trial expanded to include new Cohort 4 dose and the first subject has been dosed
  • Additional data expected to be presented at the American Academy of Ophthalmology meeting in October 2018

To see more data from ongoing clinical trials, read the full news release.

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