The following excerpt is from the company's SEC filing.
First
regulatory submissions for lead oncology programs aumolertinib and sugemalimab are expected
to be ex-U.S. in 2H 2022; continuing to engage in discussions with the FDA
Continue
expanding the Global Buyers Club; goal is to have MOUs in place with payers and health systems
that cover approximately 350 million lives by the end of 2022
Strong
cash position with expected runway in
to 2025; $1.7 billion in cash and cash equivalents as
of December 31, 2021
EQRx
to host conference call and webcast today at 8:00 a.m. ET
CAMBRIDGE,
Mass.
March 23, 2022
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 Con
ference 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 Health
, 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 Information
EQRx 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 EQRx
EQRx 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 Statements
This 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.
CVS 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.
Consolidated Statements of Operations and Comprehensive
Loss
(unaudited)
(in thousands, except share and per share data)
Year Ended December 31,
Operating expenses:
118,109
224,391
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
Interest income, net
Other expense,
net
Total other income,
net
96,366
(100,009
(249,983
Other comprehensive loss:
Foreign currency
translation adjustments
Comprehensive loss
(100,008
Loss attributable to common stockholders
- basic and diluted
Net loss per share - basic and diluted
Weighted average common shares outstanding
- basic and diluted
324,008,969
137,824,126
Selected Consolidated Balance Sheet Data
(in thousands)
1,678,542
489,682
Working capital
1,666,556
478,080
Total assets
1,729,442
500,528
Total stockholders’ equity
1,514,839
482,082
Restricted cash
Working capital is defined as current assets less current liabilities.
EQRx Contacts:
Media:
Dan Budwick
dan@1abmedia.com
Investors:
investors@eqrx.com
The above information was disclosed in a filing to the SEC. To see the filing, click here.
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