On August 10, 2020 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines, reported second quarter 2020 financial results and provided an overview of operational progress (Press release, Rubius Therapeutics, AUG 10, 2020, View Source [SID1234563286]).
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"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 Pablo J. Cagnoni, M.D., chief executive officer of Rubius Therapeutics. "During the second quarter, we presented preclinical data supporting our lead artificial antigen-presenting cell program, RTX-321, at the American Association of Cancer Research and American Society of Gene and Cell Therapy Virtual Annual Meetings. Taken together, these data suggest that RTX-321 may lead to durable responses in patients with HPV 16-positive cancers. We are on track to file an Investigational New Drug application for RTX-321 for the treatment of HPV-positive cancers by year-end."
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.
oAs 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.
oRubius’ 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 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II and the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 23rd Annual Meeting, supporting its lead artificial antigen-presenting cell program, RTX-321, for the treatment of HPV 16-positive tumors.
oAt AACR (Free AACR Whitepaper), 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.
oAt ASGCT (Free ASGCT Whitepaper), 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 $37.9 million or $0.47 per common share, compared to $39.4 million or $0.50 per common share in the second quarter of 2019.
In the second quarter of 2020, Rubius invested $26.1 million in research and development (R&D) related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, as compared to $27.5 million in the second quarter of 2019. The year-over-year decrease was driven by a $7.0 million reduction in costs following the deprioritization of our rare disease pipeline in March 2020. The decrease in rare disease program expenses was offset by $8.8 million in incremental spend to advance our cancer programs, including costs associated with our Phase 1/2 clinical trial for RTX-240 for the treatment of solid tumors as well as costs associated with preclinical and IND-enabling activities for RTX-321. In addition, R&D expenses not allocated to programs decreased by $3.2 million driven by a $2.2 million reduction in laboratory supplies, research materials and contract research as pilot-scale manufacturing and discovery activities shifted to support clinical programs. Other costs not allocated to programs also decreased resulting primarily from a decrease in stock-based compensation expense.
G&A expenses were $11.6 million during the second quarter of 2020, as compared to $13.8 million for the second quarter of 2019. The lower costs were principally driven by a reduction in stock-based compensation expense.
Six Month Financial Results
Net loss for the first six months of 2020 was $86.3 million or $1.07 per common share, compared to $72.0 million or $0.92 per common share in the first six months of 2019.
In the six months ended June 30, 2020, Rubius invested $62.3 million in R&D related to its novel RED PLATFORM and towards expanding and advancing its product pipeline, as compared to $48.4 million in the first six months of 2019. The year-over-year increase was driven by $18.7 million of incremental costs to advance our cancer programs, including costs incurred for our Phase 1/2 clinical trial for RTX-240 for the treatment of solid tumors as well as costs of preclinical and IND-enabling activities for RTX-321. The increase in cancer program costs was offset by a $5.3 million decrease in expenses related to our rare disease pipeline following the deprioritization of these programs in March 2020. Additionally, costs not allocated to programs increased by $0.5 million, primarily driven by R&D headcount growth.
G&A expenses were $24.3 million during the first six months of 2020, as compared to $27.3 million for the same period in 2019. The lower costs were principally driven by a reduction in stock-based compensation expense.
Cash Position
As of June 30, 2020, cash, cash equivalents and investments were $236.5 million as compared to $283.3 million as of December 31, 2019, providing Rubius with a cash runway into 2022. During 2020, the Company used $68.6 million of cash to fund operations and $3.9 million to fund capital expenditures, consisting mostly of payments for assets purchased in 2019. In addition, during the second quarter, the Company drew down the third and final tranche of $25.0 million pursuant to its $75.0 million loan agreement with Solar Capital.