Rubius Therapeutics Reports First Quarter 2020 Financial Results and Provides Operational Update
Completed Strategic Reprioritization of Pipeline to Focus on Oncology and Autoimmunity
Dosed First Patient in Phase 1/2 Clinical Trial of RTX-240 for Advanced Solid Tumors
Successfully Produced cGMP Clinical Supply of RTX-240 from Fully Owned Manufacturing Facility
Strong Cash Position
“During the first quarter, we made significant progress in advancing our business by reprioritizing our therapeutic areas of focus and progressing our oncology pipeline of Red Cell Therapeutics™, including the dosing of our first patient in the RTX-240 clinical trial. RTX-240 is an allogeneic cellular therapy product candidate that is designed to mimic and amplify the functions of the innate and adaptive immune systems by activating and expanding NK cells and T cells to generate a potent anti-tumor response, potentially providing patients with a dual-mechanistic approach to fight their cancer,” said
First Quarter and Recent Highlights
- Completed strategic reprioritization of the pipeline to focus on the development of oncology and autoimmune Red Cell Therapeutic programs.
º Development in these therapeutic areas is enabled by the investment in internal manufacturing at the Rubius
- Dosed the first patient in the Phase 1/2 clinical trial of RTX-240 for the treatment of patients with relapsed/refractory or locally advanced solid tumors.
º The cGMP cells used to dose the first patient were produced at the fully owned Rubius manufacturing facility. All subsequent clinical supply for the Company’s oncology programs is expected to be produced from this facility.
- On track to file an Investigational New Drug application for lead artificial antigen-presenting cell program, RTX-321, for the treatment of HPV 16-positive cancers by year-end 2020.
- Unveiled abstracts for the
American Society of Geneand Cell Therapy(ASGCT) 23rd Annual Meeting, highlighting preclinical data from its oncology pipeline of Red Cell Therapeutics™, including data supporting RTX-321.
º The posters will be made available at the beginning of the virtual meeting tomorrow,
Tuesday, May 12, 2020, at 6:00 a.m. ET.
- Implemented multiple measures in response to the COVID-19 pandemic to safeguard the health and well-being of employees, their families, business partners and healthcare providers, while continuing to operate its
Smithfield, RImanufacturing facility and conduct research and development activities. The extent to which the COVID-19 pandemic may impact Rubius will depend on future developments.
First Quarter 2020 Financial Results
Net loss for the first quarter of 2020 was
In the first quarter of 2020, Rubius invested
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 cancer and autoimmune diseases by leveraging two distinct therapeutic modalities —potent cell-cell interaction and tolerance induction. For more information, visit www.rubiustx.com, follow us on Twitter or LinkedIn or like us on Facebook.
Forward Looking Statements
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 1/2 clinical trial for RTX-240, our expectations regarding the impact of COVID-19 pandemic on our operations and business, including the Phase 1/2 clinical trial for RTX-240, our expectations regarding the therapeutic potential of our Red Cell Therapeutics, including RTX-240 for the treatment of cancer, our expectations and planned timing for filing an Investigational New Drug application for RTX-321 and our strategy, objectives, business plans and focus, including the benefits we expect from our recent strategic shift to focus on the development of our oncology and autoimmunity pipeline. 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 Red Cell Therapeutic product candidates and their therapeutic potential and other risks identified in our
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
|For the three months
|Research and development||36,186||20,871|
|General and administrative||12,664||13,535|
|Total operating expenses||48,850||34,406|
|Loss from operations||(48,850||)||(34,406||)|
|Other income, net||364||1,825|
|Net loss per share, basic and diluted||$||(0.60||)||$||(0.42||)|
|Weighted average common shares outstanding, basic and diluted:||80,271,848||77,544,089|
Condensed Consolidated Balance Sheet Data
|Cash, cash equivalents and investments||$||241,391||$||283,287|
|Total stockholders’ equity||235,157||274,213|
Source: Rubius Therapeutics