EQRx, Inc. (Nasdaq: EQRX), a new type of pharmaceutical company
committed to developing and delivering innovative medicines to
patients at radically lower prices, today reported financial
results for the quarter and full year ended December 31, 2021 and
provided an overview of recent corporate progress.
“2021 was a year of relentless execution highlighted by
promising Phase 3 clinical data for our lead oncology programs,
important progress advancing relationships with payers and health
systems, and transitioning to a public company,” said Melanie
Nallicheri, chief executive officer of EQRx. “Our team’s focus this
year is on submitting our first regulatory applications outside the
U.S., continuing to engage in discussions with the FDA on our lead
cancer programs, and expanding our Global Buyers Club. With
expected cash runway into 2025, we are in a strong financial
position to further shape our portfolio to create a new pharma
platform that both improves patients’ lives and delivers meaningful
savings to payers and health systems around the world.”
Recent and 2021 Business Highlights
Catalog of Medicines in Development
Aumolertinib
(third-generation EGFR inhibitor)
- The first regulatory submissions for
aumolertinib for the first-line treatment of patients with
EGFR-mutated non-small cell lung cancer (NSCLC) are expected
outside of the U.S. during the second half of 2022; continuing to
engage in discussions with the U.S. Food and Drug Administration
(FDA).
- Aumolertinib received Innovation
Passport designation pursuant to the Innovative Licensing and
Access Pathway (ILAP) in the U.K.
- Positive Phase 3 results with
aumolertinib were presented at medical meetings in 2021.
- The Phase 3 AENEAS trial in
first-line NSCLC met its primary endpoint of improved
progression-free survival (PFS), and topline results were presented
at the 2021 ASCO Annual Meeting.
- Results of the Phase 2 APOLLO study
of aumolertinib in second-line NSCLC were presented at ESMO 2021
and published in the Journal of Thoracic Oncology.
- Finished a pharmacokinetic (PK)
study conducted in the U.S. and New Zealand in an ethnically
diverse population; a clinical trial in adjuvant EGFR+ NSCLC is
ongoing.
- Plan to initiate a randomized, 3-arm, open-label, controlled
clinical trial by the middle of 2022 to evaluate aumolertinib vs.
aumolertinib plus chemotherapy vs. osimertinib for the first-line
treatment of EGFR-mutated NSCLC. This U.S.-led study will assess
the applicability of the pivotal Phase 3 AENEAS trial results to
current medical practice in a diverse patient population.
- Entered into a clinical collaboration with Turning Point
Therapeutics to evaluate aumolertinib in combination with Turning
Point’s elzovantinib in EGFR mutant MET-amplified advanced
NSCLC.
Sugemalimab (anti-PD-L1 antibody)
- The first regulatory submissions for
sugemalimab for Stage IV NSCLC are expected outside of the U.S.
during the second half of 2022; continuing to engage in discussions
with the FDA.
- Sugemalimab received Innovation
Passport designation pursuant to the ILAP in the U.K.
- Sugemalimab in combination with chemotherapy demonstrated a
statistically and clinically significant overall survival (OS)
benefit from a pre-specified analysis in patients with Stage IV
NSCLC in the pivotal Phase 3 GEMSTONE-302 clinical trial,
regardless of tumor pathologic subtype or PD-L1 expression
levels.
- Phase 3 results of sugemalimab in Stage III and Stage IV NSCLC
were presented at the European Society for Medical Oncology
Congress and the International Association for the Study of Lung
Cancer 2021 World Conference on Lung Cancer, respectively, in 2021.
These data, which underscore the potential of sugemalimab to treat
a broad NSCLC patient population, were recently published in The
Lancet Oncology.
- Expecting Stage III NSCLC OS results in 2023 from a
pre-specified analysis. This includes both patients treated with
sequential or concurrent chemoradiotherapy. There is currently no
FDA-approved maintenance therapy for patients with Stage III NSCLC
treated with sequential chemoradiotherapy.
- The Phase 2 GEMSTONE-201 trial of sugemalimab met its primary
endpoint of objective response rate (ORR) in patients with
relapsed/refractory extranodal natural killer (NK)/T cell lymphoma
(ENKTL).
- Sugemalimab was granted Breakthrough Therapy designation by the
FDA for ENKTL; a regulatory submission for this indication is
expected in the U.S. in 2023.
- Plan to initiate a randomized,
comparative clinical trial during the second half of 2022 to
evaluate sugemalimab vs. other approved checkpoint inhibitor(s).
This U.S.-led study will assess the applicability of GEMSTONE-302
study results to current medical practice in a diverse patient
population.
Other Pipeline Programs
- Continued to advance other clinical-stage programs including
anti-PD-1 antibody nofazinlimab (EQ176, formerly known as CS1003)
for advanced hepatocellular carcinoma (HCC), CDK4/6 inhibitor
lerociclib (EQ132) for hormone-receptor positive breast cancer and
JAK-1 inhibitor EQ121 for immune-inflammatory diseases.
- The Phase 3 multiregional, registrational trial of nofazinlimab
in combination with lenvatinib as first-line treatment for patients
with advanced HCC reached its pre-specified enrollment target.
- Entered into multiple R&D collaborations with leading drug
engineering companies including AbCellera, Absci, Evotec,
Exscientia and Relay Therapeutics.
Global Buyers Club and Commercialization
Partnerships
- Entered into memoranda of
understanding (MOUs) with leading payers and health systems around
the world, that cover more than 180 million lives, including CVS
Health1, the National Health Service in England, Geisinger, Blue
Shield of California and additional U.S.-based health plans.
- Aim to have MOUs in place with payers and health systems that
cover approximately 350 million lives by the end of 2022.
- Entered into a strategic collaboration agreement with Abdul
Latif Jameel Health to commercialize aumolertinib and sugemalimab,
if approved, in the Middle East, Africa and Turkey.
Corporate
- Completed business combination with CM Life Sciences III (CMLS
III), a life science-focused special purpose acquisition company
(SPAC), resulting in EQRx’s debut as a public company in December
2021.
- Announced formation of mission advisory board, which includes
world leaders in pharmaceutical R&D, clinical medicine and
patient advocacy: Otis Webb Brawley, M.D.; Sandra J. Horning, M.D.;
Mace Rothenberg, M.D.; Richard L. Schilsky, M.D.; Ellen V. Sigal,
Ph.D.; Gail Wilensky, Ph.D. and Elias A. Zerhouni, M.D.
- Added Amy Abernethy, M.D., Ph.D., and Kathy Giusti to board of
directors and continued to expand management team.
Fourth Quarter and Full Year 2021 Financial
Highlights
- Cash
Position: Cash and cash equivalents totaled $1.7 billion
at December 31, 2021. EQRx expects full year 2022 cash outflows to
be $400 million or less. Based on EQRx’s current operating plan,
management believes EQRx has sufficient capital resources to fund
anticipated operations into 2025. Cash and cash equivalents used in
operating activities during the year totaled $183.2 million in
2021, as compared to $241.5 million in 2020. The decrease in the
cash used was primarily due to a reduction in license and milestone
fees associated with new compounds added to the pipeline.
- R&D
Expenses: Research and development expenses for the three
months ended December 31, 2021 were $56.2 million, as compared to
$169.1 million for the three months ended December 31, 2020. This
decrease was primarily driven by a reduction of $151.5 million in
license and milestone fees associated with new compounds added to
the pipeline, partially offset by an increase of $23.8 million in
discovery, preclinical and clinical development costs, as well as
increases in employee related expenses, and information technology,
facilities and other allocated expenses that support overall
research and development activities.Research and development
expenses for the year ended December 31, 2021 were
$118.1 million, as compared to $224.4 million for
the year ended December 31, 2020. This decrease was
primarily driven by a reduction of $194.0 million in license and
milestone fees associated with new compounds added to the pipeline
during 2021 and 2020, partially offset by a $46.4 million
increase in discovery, preclinical and clinical development costs,
as well as increases in employee related expenses, information
technology, facilities and other allocated expenses that support
overall research and development activities, and consulting and
professional fees.
- G&A Expenses:
General and administrative expenses for the three months ended
December 31, 2021 were $38.6 million, as compared to $8.6 million
for the three months ended December 31, 2020. The increase was
primarily driven by a $23.9 million increase in employee
related expenses and a $4.8 million increase in consulting and
professional fees.General and administrative expenses for the year
ended December 31, 2021 were $78.3 million, as compared to $25.7
million for the year ended December 31, 2020. The increase was
primarily driven by a $39.4 million increase in employee related
expenses and a $9.5 million increase in consulting and professional
fees.
- Net Income/Loss:
Net income totaled $1.2 million for the three months ended December
31, 2021, which included $95.9 million of non-cash gains resulting
from the remeasurement of the contingent earn-out liability and
warrant liabilities recognized upon completion of the business
combination, as compared to a net loss of $177.6 million for the
three months ended December 31, 2020.Net loss totaled $100.0
million for the year ended December 31, 2021, which included $95.9
million of non-cash gains resulting from the remeasurement of the
contingent earn-out liability and warrant liabilities recognized
upon completion of the business combination, compared to a net loss
of $250.0 million for the year ended December 31, 2020.
Conference Call and Webcast InformationEQRx
will host a conference call and webcast today, March 23, 2022 at
8:00 a.m. Eastern Time. To participate by telephone, please dial
855-718-8094 (Domestic) or 484-747-6788 (International). The
conference ID number is 4596972. A live and archived audio webcast
can be accessed through the Investors section of the Company's
website at investors.eqrx.com. The webcast will be made available
for replay on the Company's website beginning approximately two
hours after the event.
About EQRxEQRx is a new type of pharmaceutical
company committed to developing and delivering innovative medicines
to patients at radically lower prices. Launched in January 2020,
EQRx is purpose-built, at scale, with a growing catalog of
medicines in development in high-cost drug categories and emerging
partnerships with leading payers and providers. Leveraging
cutting-edge science and technology and strategic partnerships with
stakeholders from across the healthcare system, EQRx aims to
provide innovative, patent-protected medicines more efficiently and
cost-effectively than ever before. To learn more, visit
www.eqrx.com and follow us on social media:
Twitter: @EQRxInc, LinkedIn, Instagram: @eqrxinc.
EQRx™ and Remaking Medicine™ are trademarks of EQRx.
Cautionary Statement Regarding Forward-Looking
StatementsThis press release contains certain
forward-looking statements within the meaning of the federal
securities laws. These forward-looking statements may be identified
by the use of words such as “believe,” “project,” “expect,”
“anticipate,” “estimate,” “intend,” “design,” “strategy,” “future,”
“opportunity,” “continue, “aim,” “goal”, “plan,” “may,” “look
forward,” “should,” “will,” “would,” “will be,” “will likely
result,” and similar expressions. These forward-looking statements
include, but are not limited to, express or implied statements
regarding EQRx’s ability to develop and deliver innovative
medicines at radically lower prices, EQRx’s ability to create a new
pharma platform that both improves patients’ lives and delivers
meaningful savings to payers and health systems around the world,
EQRx’s plans and timelines for the clinical development and
regulatory review of EQRx’s product candidates both in and outside
the U.S., including with respect to regulators’ acceptance of
clinical data generated by third parties, the therapeutic potential
and clinical benefits and tolerability of EQRx’s product
candidates, expectations regarding EQRx’s Global Buyers Club and
number of covered lives reached and ability to convert MOUs into
binding, definitive agreements, EQRx’s cash runway and estimated
cash outflows, as well as other statements regarding plans and
market opportunities of EQRx. Forward-looking statements are
predictions, projections and other statements about future events
that are based on current expectations and assumptions and, as a
result, are subject to risks and uncertainties. Many factors could
cause actual future events to differ materially from the
forward-looking statements in this press release, including but not
limited to changes in the competitive and highly regulated
industries in which EQRx operates, the timing and outcome of EQRx’s
planned interactions with regulatory authorities, variations in
operating performance across competitors, changes in laws and
regulations affecting EQRx’s business, delay of any current and
future clinical trials or the development of aumolertinib,
sugemalimab or EQRx’s other drug candidates, the risk that the
results of prior clinical trials may not be predictive of future
results in connection with future clinical trials, EQRx’s ability
to successfully demonstrate the safety and efficacy of its drug
candidates, the timing and outcome of EQRx’s planned interactions
with regulatory authorities; obtaining, maintaining and protecting
its intellectual property, EQRx’s relationships with its existing
and future collaboration partners, risks associated with EQRx’s
ability to otherwise implement its business plans, including risks
associated with its growth strategy, obtaining regulatory
approvals, and creating and maintaining its Global Buyers Club, and
other risks associated with its plans to create a new kind of
pharmaceutical company, the risk of downturns and a changing
regulatory landscape in the highly competitive healthcare and
biopharmaceutical industries, the size and growth of the markets in
which EQRx operates and its ability to offer innovative medicines
at reduced prices, and EQRx’s ability to operate as a public
company. The foregoing list of factors is not exhaustive. You
should carefully consider the foregoing factors and the other risks
and uncertainties described in the “Risk Factors” section in EQRx’s
most recent Annual Report on Form 10-K or Quarterly Report on Form
10-Q, as well as any other filings with the SEC. These filings
identify and address other important risks and uncertainties that
could cause actual events and results to differ materially from
those contained in the forward-looking statements. Forward-looking
statements speak only as of the date they are made. Readers are
cautioned not to put undue reliance on forward-looking statements,
and EQRx assumes no obligation and does not intend to update or
revise these forward-looking statements, whether as a result of new
information, future events, or otherwise.
Investors and others should note that we communicate with our
investors and the public using our website www.eqrx.com, including,
but not limited to, company disclosures, investor presentations and
FAQs, SEC filings, press releases, public conference call
transcripts and webcast transcripts. The information that we post
on our website could be deemed to be material information. As a
result, we encourage investors, the media and others interested
parties to review the information that we post there on a regular
basis. The contents of our website shall not be deemed incorporated
by reference in any filing with the SEC.
1CVS Health legal entities named in the MOU include CVS
Pharmacy, Inc., Caremark Rx, L.L.C. and CVS Health Clinical Trial
Services. The foregoing names are trademarks of CVS Health.
EQRx, Inc.Consolidated
Statements of Operations and Comprehensive
Loss(unaudited)(in thousands,
except share and per share data)
|
|
Year Ended December 31, |
|
|
2021 |
|
|
2020 |
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
118,109 |
|
|
$ |
224,391 |
|
General and administrative |
|
|
78,266 |
|
|
|
25,689 |
|
Total operating expenses |
|
|
196,375 |
|
|
|
250,080 |
|
Loss from operations |
|
|
(196,375 |
) |
|
|
(250,080 |
) |
Other income
(expense): |
|
|
|
|
|
|
Change in fair value of contingent earn-out liability |
|
|
87,065 |
|
|
|
— |
|
Change in fair value of warrant liabilities |
|
|
8,880 |
|
|
|
— |
|
Interest income, net |
|
|
436 |
|
|
|
97 |
|
Other expense, net |
|
|
(15 |
) |
|
|
— |
|
Total other income, net |
|
|
96,366 |
|
|
|
97 |
|
Net loss |
|
$ |
(100,009 |
) |
|
$ |
(249,983 |
) |
Other comprehensive
loss: |
|
|
|
|
|
|
Foreign currency translation adjustments |
|
|
1 |
|
|
|
— |
|
Comprehensive
loss |
|
$ |
(100,008 |
) |
|
$ |
(249,983 |
) |
Loss attributable to common
stockholders - basic and diluted |
|
$ |
(100,009 |
) |
|
$ |
(249,983 |
) |
Net loss per share - basic and
diluted |
|
$ |
(0.31 |
) |
|
$ |
(1.81 |
) |
Weighted average common shares
outstanding - basic and diluted |
|
|
324,008,969 |
|
|
|
137,824,126 |
|
EQRx, Inc.Selected
Consolidated Balance Sheet
Data(unaudited)(in
thousands)
|
|
December 31, |
|
|
2021 |
|
2020 |
Cash and cash equivalents |
|
$ |
1,678,542 |
|
$ |
489,682 |
Working capital(1) |
|
|
1,666,556 |
|
|
478,080 |
Total assets |
|
|
1,729,442 |
|
|
500,528 |
Total stockholders’
equity |
|
|
1,514,839 |
|
|
482,082 |
Restricted cash |
|
|
633 |
|
|
633 |
_________________
(1) Working
capital is defined as current assets less current liabilities.
EQRx Contacts:
Media:Dan Budwick1ABdan@1abmedia.com
Investors:investors@eqrx.com
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