World News: 13:00 GMT Wednesday 15th May 2019. [Rubius Therapeutics via Globe Newswire via SPi World News]
CAMBRIDGE, Mass., May 15, 2019 (GLOBE NEWSWIRE) -- Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is generating red blood cells and bioengineering them into an entirely new class of cellular medicines, today reported first quarter 2019 financial results and provided an overview of operational progress. In addition, Rubius announced that company president, Torben Straight Nissen, Ph.D., will be leaving the Company at the end of July 2019, to join Flagship Pioneering where he has held a venture partner role since joining Rubius in 2016.
“Rubius has made significant progress this year, including the clearance of our first Investigational New Drug application for RTX-134 for the treatment of patients with phenylketonuria,” said Pablo J. Cagnoni, M.D., chief executive officer of Rubius Therapeutics. “We plan to begin enrolling patients in the Phase 1b trial during the second quarter with initial clinical data expected during the second half of the year. We presented important preclinical data from our emerging oncology portfolio at AACR, demonstrating promising anti-tumor activity with no observed toxicities for our lead product candidates, RTX-240 and RTX-224, for the treatment of solid tumors and RTX-aAPC for the treatment of HPV-positive tumors. The year is off to a great start as we continue to advance our Red Cell Therapeutics towards our ultimate goal of treating patients who are underserved by available therapies.”
“We are grateful to Torben for all his contributions towards building a world-class organization and for remaining with Rubius since I joined the company to continue supporting the scale-up of our manufacturing capabilities,” continued Dr. Cagnoni. “During his tenure, Torben also took part in executing key financings, made important leadership hires and helped drive the formation and advancement of our portfolio of programs that target rare diseases, cancer and autoimmune diseases. We wish him the best going forward.”
“I am very proud of the hard work, dedication and innovative spirit of the Rubius team that has led the company to where it is today,” said Dr. Straight Nissen. “I believe Rubius’ Red Cell Therapeutics approach has the potential to transform the future of cellular medicine, and I look forward to following the company as they work towards bringing these important therapies to patients. I wish all my talented colleagues at Rubius continued success as I transition to focus on earlier stage platform companies within the Flagship Pioneering ecosystem.”
Dr. Straight Nissen will continue to provide consulting services to Rubius into 2020. With his departure, Spencer Fisk, senior vice president of technical operations, and Thomas Wickham, Ph.D., senior vice president of discovery, will report directly to Dr. Cagnoni.
Net loss for the first quarter of 2019 was $32.6 million or $0.42 per common share, compared to $14.4 million or $1.72 per common share in the first quarter of 2018.
In the first quarter of 2019, Rubius invested $20.9 million in research and development (R&D) related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, compared to $9.5 million in the first quarter of 2018. The year-over-year increase was due to an additional $3.6 million of costs incurred in preparation for the Phase 1b clinical trial for RTX-134, and $9.3 million was associated with personnel costs, stock-based compensation, facility and laboratory costs driven by increases in R&D headcount and expanded research activities to support Rubius’ goal of delivering four to five IND’s across 2019 and 2020. These increases were offset by a decrease in external manufacturing and research costs that were not related to programs.
G&A expenses were $13.5 million during the first quarter of 2019, as compared to $5.1 million for the first quarter of 2018. The higher costs were primarily driven by a $7.4 million increase in personnel costs, stock-based compensation and facility costs, due to increased headcount in our general and administrative function, as well as increases in professional fees and infrastructure costs to support the Company’s growth and to operate as a public company.
As of March 31, 2019, cash, cash equivalents and investments were $378.9 million as compared to $404.1 million as of December 31, 2018, providing Rubius with a cash runway into 2021. During the quarter, the Company used $22.9 million of cash to fund operations and $4.2 million to fund capital expenditures.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the planned timing, enrollment and results for our preclinical and clinical activities, including the Phase 1b clinical trial for RTX-134 for the treatment of PKU, our ability to further develop our RCT product candidates, our expectations regarding the therapeutic potential of our RCTs, including RTX-240 andRTX-224 for the treatment of solid tumors, RTX-aAPC for the treatment of HPV-positive tumors and RTX-134 for the treatment of PKU, the timelines for us to file additional INDs, and our strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the development of our RCT product candidates and their therapeutic potential and other risks identified in our SEC filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
Globe Newswire: 13:00 GMT Wednesday 15th May 2019
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