On August 31, 2018 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a biotechnology company pioneering the development of a new class of ready-to-use cellular therapies, reported second quarter 2018 financial results (Press release, Rubius Therapeutics, AUG 31, 2018, View Source [SID1234529444]).
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As of June 30, 2018, Rubius had cash, cash equivalents and marketable securities of $181.7 million. This amount excludes $257.9 million of proceeds after deducting underwriting discounts and commissions from Rubius’ initial public offering (IPO), which closed in July 2018. Based upon its current operating plan, Rubius expects its existing capital resources will be sufficient to fund operations into 2021.
"We have made significant progress over the course of this year – the highlight of which was the closing of our IPO," said Pablo J. Cagnoni, M.D., chief executive officer of Rubius Therapeutics, Inc. "The IPO proceeds give Rubius the resources to execute against our vision of creating life-changing cellular medicines to treat patients with rare diseases, cancer and autoimmune diseases. We are on track to file our first Investigational New Drug application for RTX-134 during the first quarter of 2019, for the treatment of patients with phenylketonuria, a rare disease affecting approximately 16,500 people in the U.S."(1)
Recent Business Highlights
Initial Public Offering
· On July 23, 2018, Rubius closed its IPO, raising $257.9 million of proceeds after deducting underwriting discounts and commissions. The proceeds from this offering, together with existing cash, cash equivalents and marketable securities are expected to be used:
·to purchase, renovate, customize and operate its manufacturing facility;
· to advance RTX-134 through a Phase 1/2a clinical proof-of-concept trial;
· to advance and expand its RED PLATFORMä and its research and development pipeline, including early discovery efforts and IND-enabling studies, and to initiate additional proof-of-concept trials in rare diseases, cancer and autoimmune diseases; and for working capital and other general corporate purposes.
Manufacturing Facility
· On July 31, 2018, Rubius purchased an existing 135,000-square foot manufacturing facility in Smithfield, Rhode Island.
· The company plans to invest approximately $95.0 million through 2020, which includes the $8.0 million purchase price.
Strategic Hires and Internal Capabilities
·Continued to build a leading scientific team and attract experienced leadership to deliver against Rubius’ vision, including the hiring of Pablo J. Cagnoni, M.D., as chief executive officer.
· Strengthened internal capabilities in discovery, platform and therapeutic development and manufacturing.
Second Quarter Financial Results
Cash, cash equivalents and marketable securities totaled $181.7 million as of June 30, 2018, compared to $104.3 million as of December 31, 2017. The increase in cash reflects the net proceeds from Rubius’ Series C preferred stock financing during the first quarter of 2018, offset by its cash used in operations during the period. Research and development expenses were $12.0 million during the second quarter of 2018, compared with $4.8 million for the second quarter of 2017. The increase was attributable to costs incurred in preparation of Rubius’ planned Phase 1/2a clinical trial of RTX-134 in phenylketonuria, as well as an increase in headcount in its research and development function and an increase in external manufacturing and research costs to improve and expand its manufacturing capabilities, prepare for clinical scale production and expand its in vivo testing to support clinical candidate selection. General and administrative expenses were $16.3 million during the second quarter of 2018, compared to $4.2 million for the second quarter of 2017. The increase was primarily due to an increase in stock-based compensation and increases in personnel costs and professional fees as Rubius prepared to operate as a public company.