Rubius Therapeutics Reports Third Quarter 2019 Financial Results and Operational Progress
“Over the last quarter, our team has successfully manufactured RTX-134 for our Phase 1b trial for the treatment of patients with phenylketonuria. Our clinical sites are actively recruiting patients, and we plan to announce when we have treated the first patient. In order for us to share follow up data from the first patients treated in the study, we expect to report initial clinical results during the first quarter of 2020,” said
Recent Highlights and Upcoming Milestones
• Over the third quarter,
• Rubius has clinical sites actively recruiting patients and plans to announce when the first patient has been treated.
• In order for Rubius to share follow up data from the first patients treated in the study, the Company expects to report initial clinical results during the first quarter of 2020, including:
- Preliminary safety;
- Longevity of RTX-134 in circulation; and
- Proof-of-mechanism as measured by production of trans-cinnamic acid, a metabolite of phenylalanine when degraded by
phenylalanine ammonia lyase, or PAL.
- RTX-321 is an allogeneic artificial antigen presenting cell engineered to express, on the cell surface, an HPV peptide antigen, 4-1BBL and IL-12 to mimic human T cell-APC interactions. RTX-321 is currently in IND-enabling studies.
- Proof-of-concept data generated in a B16-F10 melanoma mouse model demonstrated successful engineering of artificial antigen presenting cells against a melanoma tumor-associated antigen, gp100, that significantly expanded antigen-specific T cells and eliminated lung metastases with limited, reversible toxicity.
- Today, in total,
Rubius Therapeuticshas nine issued U.S. patents, including five composition of matter patents, 32 patent families and more than 150 pending patent applications worldwide.
- RTX-aAPCs with peptide-loaded MHC constructs functionally engaged TCRs and achieved robust expansion of primary cytomegalovirus (CMV)-specific T cells in healthy donor PBMCs with prior exposure to CMV.
- Rubius Therapeutics’ loadable aAPC system has the potential to generate aAPCs containing multiple neoantigens in a single therapeutic.
• The Company continued to strengthen its leadership team by appointing
Third Quarter Financial Results
Net loss for the third quarter of 2019 was
In the third quarter of 2019, Rubius invested
G&A expenses were
Nine Month Financial Results
Net loss for the first nine months of 2019 was
In the nine months ended
G&A expenses were
About Rubius Therapeutics
Rubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics™. The Company’s proprietary RED PLATFORM® was designed to genetically engineer and culture Red Cell Therapeutics™ that are selective, potent and off-the-shelf allogeneic cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Rubius’ initial focus is to advance RCT™ product candidates for the treatment of rare diseases, cancer and autoimmune diseases by leveraging three distinct therapeutic modalities — cellular shielding, potent cell-cell interaction and tolerance induction. For more information, visit www.rubiustx.com, or follow us on Twitter and LinkedIn.
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, recruitment, 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 manufacturing process, our expectations regarding the therapeutic potential of our RCTs, our expectations regarding new members of our leadership team 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 September 30, 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.
|Rubius Therapeutics, Inc.|
|Condensed Consolidated Statement of Operations|
|(in thousands, except share and per share data)|
|For the three months ended
|For the nine months
ended September 30,
|Research and development||33,530||14,363||81,919||35,230|
|General and administrative||14,952||13,191||42,254||27,311|
|Total operating expenses||48,482||27,554||124,173||62,541|
|Loss from operations||(48,482||)||(27,554||)||(124,173||)||(62,541||)|
|Other income (expense), net||1,467||1,192||5,187||529|
|Net loss per share, basic and diluted||$||(0.59||)||$||(0.42||)||$||(1.52||)||$||(2.33||)|
|Weighted average common shares outstanding, basic and diluted:||79,115,305||62,311,111||78,357,791||26,662,233|
|Rubius Therapeutics, Inc.|
|Condensed Consolidated Balance Sheet Data|
|September 30,||December 31,|
|Cash, cash equivalents and investments||$||324,689||$||404,051|
|Total stockholders’ equity and convertible preferred stock||307,343||393,008|
Source: Rubius Therapeutics