Rubius Therapeutics Reports Second Quarter 2020 Financial Results and Positive Progress Across Pipeline
Strong Momentum in Dosing Patients and Manufacturing Clinical Supply for RTX-240 Phase 1/2 Solid Tumor Clinical Trial
Investigational New Drug Application on Track by Year-End for RTX-321 for HPV-Positive Cancers
“Rubius Therapeutics is making excellent progress in advancing our pipeline of Red Cell Therapeutics™, including the completion of dosing of the second cohort in the RTX-240 Phase 1/2 solid tumor clinical trial with no observed adverse events to date attributed to RTX-240. As we enter the higher-level dose cohorts, we expect to see the biological effects of RTX-240 on innate and adaptive immunity, including activation and increased numbers of NK cells and T cells. We are continuing to leverage virtual capabilities to engage our clinical trial sites with a concentration on oncology-focused centers, which have been less impacted than hospitals by the ongoing pandemic. Ensuring patient, clinician and employee safety remains our top priority,” said
Second Quarter Highlights and Upcoming Milestones
• Dosing of the first two cohorts completed in the Phase 1/2 solid tumor clinical trial with no adverse events observed to date that were attributed to RTX-240.
- As Rubius enters higher-level dose cohorts, it expects to see the biological effects of RTX-240 on innate and adaptive immunity, including activation and increased numbers of NK cells and T cells.
- The Company continues to leverage virtual capabilities to engage clinical trial sites and is concentrating on oncology-focused centers to enroll patients during the pandemic, while ensuring that patient and clinician safety is a top priority.
- Rubius’ fully owned manufacturing facility in Smithfield, RI, continues to successfully manufacture clinical supply of RTX-240.
• Rubius highlighted preclinical data for RTX-321 at the
- At AACR, the preclinical data suggested that RTX-321 may promote epitope spreading, meaning that RTX-321 may induce the expansion of an immune response to secondary epitopes, or antigens, that are not expressed on RTX-321. This finding is important because it suggests that RTX-321 may create a broad and effective immune response against multiple tumor antigens. Additionally, the preclinical surrogate of RTX-321 induced tumor-specific memory, potentially enabling the body to remember a cancer’s identity, which is critical to providing long-term protection from recurrence of the tumor.
- At ASGCT, preclinical in vitro data demonstrated that RTX-321 can expand the different cell populations - effector and long-lived memory CD8+ cells - that are critical for delivering and maintaining long-term, anti-tumor responses in patients.
Second Quarter Financial Results
Net loss for the second quarter of 2020 was
In the second quarter of 2020, Rubius invested
G&A expenses were
Six Month Financial Results
Net loss for the first six months of 2020 was
In the six months ended
G&A expenses were
About Rubius Therapeutics
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, our expectations regarding the therapeutic potential of our Red Cell Therapeutics, including RTX-240 for the treatment of patients with relapsed/refractory or locally advanced solid tumors, our expectations regarding the timing, enrollment, data from and success of the future cohorts and phases of the clinical trial of RTX-240, our expectations regarding the biological effects of RTX-240 on innate and adaptive immunity, including activation and increased numbers of NK cells and T cells in higher-level dose cohorts in the clinical trial of RTX-240, our expectations regarding the therapeutic potential of RTX-321, the timelines for us to file an IND for RTX-321, , our expectations regarding our cash runway 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 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
|For the six months
|Research and development||26,096||27,518||62,282||48,389|
|General and administrative||11,601||13,767||24,265||27,302|
|Total operating expenses||37,697||41,285||86,547||75,691|
|Loss from operations||(37,697||)||(41,285||)||(86,547||)||(75,691||)|
|Other income (expense), net||(157||)||1,895||207||3,720|
|Net loss per share, basic and diluted||$||(0.47||)||$||(0.50||)||$||(1.07||)||$||(0.92||)|
|Weighted average common shares outstanding, basic and diluted:||80,481,756||78,396,714||80,376,830||77,972,757|
Condensed Consolidated Balance Sheet Data
|Cash, cash equivalents and investments||$||236,538||$||283,287|
|Total stockholders’ equity||205,474||274,213|
Vice President, Corporate Communications and Investor Relations
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Director, Corporate Communications
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Source: Rubius Therapeutics