The following excerpt is from the company's SEC filing.
New data on lead oncology programs aumolertinib and sugemalimab to be presented at the 2022 ASCO Annual Meeting, including pre-specified
interim overall survival (OS) data from the Phase 3 GEMSTONE-302 study of sugemalimab plus chemotherapy in first-line Stage IV NSCLC
Continue to expect first regulatory submissions for aumolertinib and sugemalimab ex-U.S. in 2H 2022; constructive conversations with
the FDA are ongoing to gain greater clarity on the regulatory path forward in the U.S.
Continue to advance the Global Buyers Club; first conversion of a memorandum of understanding (MOU) to a pre-commercializat ion agreement
EQRx to host conference call and webcast today at 8:00 a.m. ET
May 13, 2022
(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 first quarter ended March 31, 2022 and provided an overview of recent corporate
“We continue to focus on efficient execution as we advance our
catalog of medicines in development and assemble our Global Buyers Club,” said Melanie Nallicheri, president and chief executive
officer of EQRx. “For our lead oncology programs, aumolertinib and sugemalimab, we look forward to multiple new data presentations
at next month’s ASCO meeting, continue to engage in constructive conversations with the FDA to gain greater clarity on the regulatory
path forward in the U.S., and remain on track for our first regulatory applications outside the U.S. later this year. Importantly, we
ended the first quarter in a very strong financial position of $1.6 billion and expect cash runway into 2025.”
Recent Business Highlights
Catalog of Medicines in Development
Aumolertinib (third-generation EGFR inhibitor)
EGFR-mutated Non-small Cell Lung Cancer (NSCLC)
New data on aumolertinib’s activity in central nervous system (CNS) metastases from the pivotal Phase 3 AENEAS study in advanced
EGFR-mutated NSCLC will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.
The first regulatory submissions for aumolertinib for the first-line treatment of patients with EGFR-mutated NSCLC are expected outside
of the U.S. during the second half of 2022; EQRx continues to engage in constructive conversations with the U.S. Food and Drug Administration
(FDA) to gain greater clarity on the regulatory path forward in the U.S.
A clinical trial with aumolertinib in adjuvant EGFR-mutated NSCLC is ongoing in China with plans to expand the study into a multiregional
Remain on track to initiate a U.S.-led, randomized, three-arm, open-label, controlled clinical trial in the middle of 2022 to evaluate
aumolertinib vs. aumolertinib plus chemotherapy vs. osimertinib for the first-line treatment of EGFR-mutated NSCLC. This study is intended
to assess the applicability of the Phase 3 AENEAS trial results to current U.S. medical practice in a diverse patient population.
Sugemalimab (anti-PD-L1 antibody)
Stage IV Non-small Cell Lung Cancer
The first presentation of data from a pre-specified interim overall survival (OS) analysis of the pivotal Phase 3 GEMSTONE-302 study
of sugemalimab in combination with chemotherapy in first-line Stage IV NSCLC will be shared at the 2022 ASCO Annual Meeting.
in January 2022, sugemalimab plus chemotherapy demonstrated
a statistically and clinically significant OS benefit in patients with Stage IV NSCLC, regardless
of tumor pathologic subtype or PD-L1 expression levels.
The first regulatory submissions for sugemalimab for Stage IV NSCLC are expected outside of the U.S. during the second half of 2022;
EQRx continues to engage in constructive conversations with the FDA to gain greater clarity on the regulatory path forward in the U.S.
Intend to initiate a U.S.-led, randomized, comparative clinical trial in Stage IV NSCLC to evaluate sugemalimab vs. other approved
checkpoint inhibitor(s) to support a future filing in consultation with the FDA. The goal of this study is to assess the applicability
of GEMSTONE-302 study results to current U.S. medical practice in a diverse patient population.
Stage III Non-small Cell Lung Cancer
OS results from GEMSTONE-301, a Phase 3 trial in Stage III NSCLC, are expected in 2023. This study includes patients treated with
sequential or concurrent chemoradiotherapy, reflective of current U.S. medical practice.
Anticipating updated, final Stage III NSCLC progression-free survival (PFS) results, the primary endpoint from the GEMSTONE-301 trial,
to be presented at an upcoming medical meeting.
Extranodal NK/T-cell Lymphoma (ENKTL)
An oral presentation featuring the primary analysis from the Phase 2 GEMSTONE-201 study of sugemalimab in relapsed or refractory ENKTL
will be given at the 2022 ASCO Annual Meeting.
The Phase 2 GEMSTONE-201 trial met its primary endpoint of objective response rate (ORR) in patients with relapsed or refractory ENKTL.
A regulatory submission for relapsed or refractory ENKTL is expected in the U.S. in 2023; sugemalimab was granted Breakthrough Therapy
designation by the FDA for ENKTL in 2020.
Other Pipeline Programs
Other clinical-stage programs remain ongoing, including anti-PD-1 antibody nofazinlimab (EQ176, also known as CS1003) for advanced
hepatocellular carcinoma (HCC); CDK4/6 inhibitor lerociclib (EQ132) for metastatic breast cancer; and JAK-1 inhibitor EQ121 for immune-inflammatory
Entered into a research and development collaboration with Insilico Medicine to jointly advance artificial intelligence-driven drug
discovery, development and commercialization for multiple disease targets.
First conversion of a memorandum of understanding (MOU) to a pre-commercialization agreement for lead oncology programs with plans
to convert additional MOUs.
Goal remains to have MOUs signed with payers and health systems that cover approximately 350 million lives by the end of 2022.
First Quarter 2022 Financial Highlights
Cash and cash equivalents totaled $1.6 billion at March 31, 2022. Based on EQRx’s current operating
plan, management believes EQRx has sufficient capital resources to fund anticipated operations into 2025.
Total operating expenses for the three months ended March 31, 2022 were $85.7 million, as compared
to $27.0 million for the three months ended March 31, 2021. EQRx expects full year 2022 operating expenses to be $400 million or
Research and development expenses for the three months ended March 31, 2022 were $53.4 million, as compared
to $16.7 million for the three months ended March 31, 2021. This increase was primarily driven by a $18.3 million increase in discovery,
preclinical and clinical development costs; a $9.9 million increase in employee-related expenses; as well as increases in consulting and
professional fees, license and milestone fees, and other research and development activities.
General and administrative expenses for the three months ended March 31, 2022 were $32.3 million, as
compared to $10.3 million for the three months ended March 31, 2021. The increase was primarily driven by a $14.7 million increase
in employee-related expenses and a $5.2 million increase in consulting and professional fees.
Net income totaled $20.7 million for the three months ended March 31, 2022, primarily due to non-cash
income of $105.7 million resulting from the recognition of the contingent earn-out liability and warrant liabilities at fair value at
March 31, 2022, as compared to a net loss of $26.8 million for the three months ended March 31, 2021.
Conference Call and Webcast Information
will host a conference call and webcast today, May 13, 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 6893121. A live and archived audio webcast
can be accessed through the Investors section of the Company's website at
. The webcast will be made
available for replay on the Company's website beginning approximately two hours after the event.
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
and follow us on social media:
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 presentation of data for EQRx’s product candidates; timing of regulatory submissions and the ability
to gain clarity on a regulatory path forward in the U.S. or any other market; advancement of the Global Buyers Club, including timing
of MOUs, ability to convert MOUs into pre-commercialization agreements, and the number of lives covered; development of its catalog of
medicines; EQRx’s plans for clinical trials; EQRx’s cash runway and estimated operating expenses; and EQRx’s ability
to develop and deliver innovative medicines at radically lower prices and to create a new pharma platform that both improves patients’
health and delivers meaningful savings to payers, health systems, and patients around the world, 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; risks regarding the timing and outcome of EQRx’s interactions with regulatory authorities and its ability to gain clarity
on a regulatory path forward; risks that the regulatory pathway in one or more markets may not be compatible with EQRx’s business
model; 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 advancing and maintaining its Global Buyers Club; 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; 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 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 other 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
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
Three months ended
Loss from operations
Other income (expense):
Change in fair value of contingent earn-out liability
Change in fair value of warrant liabilities
Interest income, net
Other income (expense), net
Total other income, net
Net income (loss)
Net income (loss) per share - basic
Net income (loss) per share - diluted
Weighted average common shares outstanding - basic
Weighted average common shares outstanding - diluted
Selected Condensed Consolidated Balance Sheet
Total stockholders’ equity
Working capital is defined as current assets less current liabilities.
The above information was disclosed in a filing to the SEC. To see the filing, click here.
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