Rubius Therapeutics Reports First Quarter 2020 Financial Results and Provides Operational Update
May 11 2020 - 8:00AM
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, today
reported first quarter 2020 financial results and provided an
overview of operational progress.
“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 Pablo J. Cagnoni, chief
executive officer of Rubius Therapeutics. “With the advances in our
oncology pipeline, a fully owned and operational manufacturing
facility and cash runway that takes us into 2022, we believe we are
well positioned to execute our objectives and bring potentially
life-saving therapies to patients.”
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
Smithfield, RI facility.
- 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 Gene and 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, RI manufacturing 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 $48.5 million or
$0.60 per common share, compared to $32.6 million or $0.42 per
common share in the first quarter of 2019.
In the first quarter of 2020, Rubius invested $36.2 million in
research and development (R&D) related to its novel RED
PLATFORM® and towards expanding and advancing its product pipeline,
compared to $20.9 million in the first quarter of 2019. The
year-over-year increase was driven by $9.9 million of incremental
costs incurred in advancing our cancer programs, including
preparation for the Phase 1/2 clinical trial for RTX-240 and
preclinical and IND-enabling activities for RTX-321. There was also
a $1.6 million increase in costs incurred for our rare disease
pipeline prior to the deprioritization of these programs in March
2020. In addition, costs not allocated to programs increased by
$3.8 million, resulting from increases in personnel-related costs,
stock-based compensation, contract research and development and
facility related and other costs. These higher costs were driven by
R&D headcount growth and expanded platform development and drug
discovery activities.
G&A expenses were $12.7 million during the first quarter of
2020, compared to $13.5 million for the first quarter of 2019. The
lower costs were primarily driven by a reduction in stock-based
compensation expense.
Cash Position
As of March 31, 2020, cash, cash equivalents and investments
were $241.4 million, compared to $283.3 million as of December 31,
2019, providing Rubius with a cash runway into 2022. During the
quarter, the Company used $40.0 million of cash to fund operations
and $2.9 million to fund capital expenditures, consisting mostly of
payments for assets purchased in 2019.
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 SEC
filings, including our Annual Report on Form 10-K for the year
ended December 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.
Rubius Therapeutics,
Inc.Condensed Consolidated Statement of
Operations(in thousands, except share and per
share data)(unaudited)
|
For the three monthsended March
31, |
|
|
2020 |
|
|
2019 |
|
Revenue |
|
$ |
|
|
|
$ |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
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 |
|
$ |
(48,486 |
) |
|
$ |
(32,581 |
) |
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 |
|
|
|
|
|
|
|
|
|
|
Rubius Therapeutics,
Inc.Condensed Consolidated Balance Sheet
Data(in
thousands)(unaudited)
|
March 31, |
|
December 31, |
|
2020 |
|
2019 |
Cash, cash equivalents and investments |
$ |
241,391 |
|
$ |
283,287 |
Total assets |
|
348,327 |
|
|
394,841 |
Total liabilities |
|
113,170 |
|
|
120,628 |
Total stockholders’
equity |
|
235,157 |
|
|
274,213 |
|
|
|
|
|
|
Contacts:Lori Melançon Vice President,
Corporate Communications and Investor Relations +1 (617) 949-5296
lori.melancon@rubiustx.com Media
Contact: Dan Budwick 1AB +1 (973) 271-6085
dan@1abmedia.com
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