The following excerpt is from the company's SEC filing.
Aumolertinib: Clarity on path for potential U.S. approval; continue to pursue
ex-U.S. approvals based on existing data, with MAA under review by U.K.’s MHRA
Sugemalimab: Based on recent FDA feedback, EQRx has concluded that there is
no commercially viable path for sugemalimab plus chemotherapy in Stage IV NSCLC in the U.S.; continue to pursue ex-U.S. approvals based
on existing data
Late-stage pipeline: Prioritize development of aumolertinib and lerociclib,
which could form the basis of future combination therapies for multiple cancer types
U.S. commercial strategy: Adopt market-based pricing f
or aumolertinib and
lerociclib in the U.S. only
Strong financial position: $1.5 billion cash and short-term investments at
quarter-end; anticipate extended runway into 2028
EQRx to host conference call and webcast today at 8:00 a.m. ET
CAMBRIDGE, Mass.
November 10, 2022
EQRx, Inc.
(Nasdaq: EQRX), a new type of pharmaceutical company
committed to developing and delivering innovative medicines to patients, today provided a business update and reported financial results
for the third quarter ended September 30, 2022.
Based on recent feedback from the U.S. Food and Drug Administration
(FDA), EQRx now has the clarity to make decisions on sugemalimab and aumolertinib and is providing the following updates:
Potential U.S. regulatory filing for aumolertinib now anticipated in 2027:
Based on recent interactions with the FDA, EQRx believes that results of the ongoing Phase 3b study comparing the combination of aumolertinib
and chemotherapy versus either osimertinib or aumolertinib alone could potentially support the use of aumolertinib in combination with
chemotherapy as a future standard of care and/or as a monotherapy for EGFR-mutated non-small cell lung cancer (NSCLC). Based on these
interactions, EQRx believes that an interim comparison of the monotherapy arms will not address the FDA’s applicability concerns,
and thus EQRx does not anticipate a filing for a monotherapy indication prior to the final results of the study.
No commercially viable path for sugemalimab plus chemotherapy for Stage
IV NSCLC in the U.S.:
The Company believes based on recent interactions with the FDA that only the final overall survival results
of a second Phase 3 trial comparing sugemalimab with approved PD(L)1 therapy would support a U.S. filing for a Stage IV NSCLC indication,
and that interim study readouts of such a trial would not be supportive of a filing based on the GEMSTONE-302 study. As such, EQRx plans
to discontinue future U.S. development efforts for sugemalimab plus chemotherapy in this indication. EQRx remains in discussions with
the FDA on an approval pathway for extranodal NK/T-cell lymphoma (ENKTL).
EQRx to prioritize development of aumolertinib and lerociclib,
which
offer the potential to form the basis of future combination therapies for multiple cancer types including lung, breast and other cancers.
Lerociclib, a CDK4/6 inhibitor being evaluated in an ongoing Phase 2 study, was in-licensed from U.S.-based G1 Therapeutics. EQRx believes
lerociclib has the potential to be differentiated from other CDK4/6 inhibitors.
EQRx plans to adopt market-based pricing for lead oncology programs aumolertinib
and lerociclib
in the U.S., in order to enable EQRx to deliver on outcomes for patients and maximize value for shareholders.
“With clear regulatory guidance on a pathway for aumolertinib
in the US, we are adapting and believe that utilizing a market-based pricing approach for our lead cancer programs, aumolertinib and lerociclib,
will ensure that we can still get these important medicines to patients, said Melanie Nallicheri, president and chief executive officer
of EQRx. “We believe aumolertinib and lerociclib are two potential best-in-class medicines that could serve as the basis of future
combination treatments. Importantly, we continue executing on our regulatory filing and payer partnership strategies for sugemalimab and
aumolertinib outside of the U.S. We believe the combination of our lead cancer assets and cash runway into 2028 puts us in an exceptionally
strong position to deliver on outcomes for patients and maximize value for shareholders.”
Pipeline Highlights
Aumolertinib (third-generation epidermal growth factor
receptor (EGFR) inhibitor)
A U.S.-led, randomized, three-arm Phase 3b clinical trial evaluating the safety
and efficacy of aumolertinib in combination with chemotherapy versus aumolertinib and osimertinib reference arms for the first-line treatment
of EGFR-mutated NSCLC is ongoing.
Results from this trial could be used to support combination and monotherapy
use, with the potential ability to file for U.S. approval in 2027.
A marketing authorization application (MAA) for aumolertinib for EGFR-mutated
NSCLC is currently under review by the United Kingdom’s (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA).
EQRx plans to submit an MAA to the European Medicines Agency (EMA) for aumolertinib
in 2023.
Lerociclib (CDK4/6 inhibitor)
A Phase 2 multiregional trial of lerociclib as first - and second-line
treatment for metastatic breast cancer is ongoing.
Plan to initiate a U.S.-led Phase 3 clinical trial for lerociclib in advanced
endometrial cancer in the first half of 2023.
Sugemalimab (anti-PD-L1 antibody)
Expect a filing for marketing authorization by MHRA for sugemalimab by end
of 2022.
An interim analysis of OS from the pivotal Phase 3 GEMSTONE-301 trial of sugemalimab
in Stage III NSCLC is expected in 2023.
In discussions with the FDA on approval pathway for sugemalimab for relapsed
or refractory ENKTL; sugemalimab was granted Breakthrough Therapy designation by the FDA for ENKTL in 2020.
Plan to submit an MAA to the EMA for sugemalimab for Stage IV NSCLC in 2023.
Early Pipeline Programs
Continue to advance early-stage research and development (R&D) programs
through collaborations with leading drug engineering companies, including an ER PROTAC with Relay Therapeutics and a selective PARP1 inhibitor
with Exscientia, which are potential combination therapy partners for lerociclib.
Third Quarter 2022 Financial Highlights
Cash Position:
Cash, cash equivalents and short-term investments totaled
$1.5 billion at September 30, 2022. EQRx expects to maintain sufficient capital resources to fund anticipated operations into 2028, beyond
its previous guidance of 2025.
Operating Expenses:
Total operating expenses for the three months ended
September 30, 2022 were $90.4 million, as compared to $40.0 million for the three months ended September 30, 2021. EQRx continues to expect
full year 2022 operating expenses to be less than $400.0 million.
R&D Expenses:
R&D expenses for the three months ended September 30, 2022 were $56.3 million, as compared to $23.8 million
for the three months ended September 30, 2021. This increase was primarily driven by a $17.7 million increase in discovery, preclinical
and clinical development costs; an $8.3 million increase in employee-related expenses; as well as a net increase in consulting and professional
fees and other R&D activities.
G&A Expenses:
General and administrative expenses for the three months ended September 30, 2022 were $34.1 million, as
compared to $16.2 million for the three months ended September 30, 2021. This increase was primarily driven by a $11.5 million increase
in employee-related expenses and a $5.6 million increase in consulting and professional fees.
Net Loss:
Net loss totaled $85.1 million for the three months ended
September 30, 2022, as compared to a net loss of $39.9 million for the three months ended September 30, 2021.
Conference Call and Webcast Information
EQRx will host a conference call and
webcast today, November 10, 2022, at 8:00 a.m. Eastern Time. A live webcast of the call will be available on the “Investor Relations”
page of EQRx’s website at
https://investors.eqrx.com/news-events/events-presentations
. To access the call by phone,
participants should visit this link (
registration link
) to receive dial-in details. Participants are requested to register at
least 15 minutes before the start of the call. The webcast will be made available for replay on EQRx’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 for some of the most prevalent disease areas, including cancer and
immune-inflammatory conditions. Launched in January 2020, EQRx is leveraging cutting-edge science, technology and strategic partnerships
with stakeholders from across the healthcare system toward the goal of increasing access for patients around the world. To learn more,
visit www.eqrx.com and follow us on social media: Twitter:
@EQRx_US
LinkedIn
, Instagram:
@eqrxinc
EQRx™ is a trademark 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 the path to
U.S. regulatory approval for aumolertinib, including timing of filing for approvals; timing of regulatory submissions; the
therapeutic potential of EQRx’s pipeline candidates; pricing plans for aumolertinib and lerociclib; EQRx’s cash runway;
plans for sugemalimab development; EQRx’s ability to deliver outcomes for patients and maximize shareholder value; timing of
data from clinical trials; and EQRx’s estimated operating expenses; among others. 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 the inherent risks in pharmaceutical development, including with
respect to the conduct of clinical trials and risk of delays; risks that the results of prior clinical trials may not be predictive
of future results or that additional clinical trials become necessary due to changes in standard of care; risks associated with
successfully demonstrating the safety and efficacy of its drug candidates and obtaining regulatory approvals; risks associated with
EQRx’s ability to otherwise implement its business plans, including risks associated with its growth strategy and expanding
and maintaining the Global Buyers Club, particularly in light of its recent determination to adopt a market based pricing strategy
in the U.S. for aumolertinib and lerociclib; variations in operating performance across competitors; changes in the competitive and
highly regulated industries in which EQRx operates, including laws and regulations affecting EQRx’s business such as the
recently enacted Inflation Reduction Act; and other risks associated with its plans to create a new kind of pharmaceutical company,
among others. 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
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 EQRx communicates with its investors
and the public using its website www.eqrx.com, including, but not limited to, EQRx disclosures, investor presentations and FAQs, SEC filings,
press releases, public conference call transcripts and webcast transcripts. The information that EQRx posts on its website could be deemed
to be material information. As a result, EQRx encourages investors, the media and other interested parties to review the information that
EQRx posts there on a regular basis. The contents of EQRx’s website shall not be deemed incorporated by reference in any filing
with the SEC.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
Three months ended
Nine months ended
September 30,
Operating expenses:
Research and development
56,271
23,800
156,997
61,893
34,095
16,176
98,150
39,681
90,366
39,976
255,147
101,574
Loss from operations
(90,366
(39,976
(255,147
(101,574
Other (expense) income:
Change in fair value of contingent earn-out liability
(2,706
90,863
Change in fair value of warrant liabilities
Interest income, net
12,482
Other (expense) income, net
Total other income, net
108,235
(85,092
(39,890
(146,912
(101,233
Net loss per share - basic
Net loss per share - diluted
Weighted average common shares outstanding - basic
475,565,990
320,644,286
473,101,935
316,837,967
Weighted average common shares outstanding - diluted
Selected Condensed Consolidated Balance Sheet
Data
(in thousands)
December 31,
1,499,348
1,678,542
Working capital
1,461,331
1,666,556
Total assets
1,543,413
1,729,442
Total stockholders’ equity
1,399,962
1,514,839
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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