Conference call to be held on Monday, March 30
at 8:00 a.m. ET
Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology
company pioneering messenger RNA (mRNA) therapeutics and vaccines
to create a new generation of transformative medicines for
patients, today provided an update on the impact of the rapidly
evolving COVID-19 pandemic on its business operations and clinical
program development.
Moderna’s paramount obligation is to ensure the safety of all
participants in its clinical programs and the integrity of the
studies in which they participate. Moderna is actively monitoring
the situation and making adjustments where necessary, and is
responding to regulatory, institutional, and government guidance
and policies related to COVID-19. The Company is using a risk-based
framework to evaluate new participant enrollment and new site
initiation on a case-by-case basis. Moderna remains committed to
its clinical development plans and is working closely with all
stakeholders to try to mitigate the impact of the pandemic on the
Company’s ongoing clinical trials.
The safety and well-being of Moderna employees is also a top
priority for the Company. On March 2, the Company created an
internal, cross-functional COVID-19 Response Team to closely
monitor the evolving situation and advise on the Company’s
response. In alignment with public health strategies designed to
slow the spread of COVID-19, as of March 12 the Company
transitioned to a remote work plan for many employees. Essential
in-person laboratory, manufacturing and related functions continue
on site, and the Company has restricted visitors and implemented
heightened policies to ensure the safety of employees and business
continuation. Other employees continue to perform business
activities from remote locations.
“The COVID-19 pandemic has created unprecedented challenges and
we are committed to ensuring the health and safety of all
participants in our and our partners’ clinical trials, our clinical
trial site teams, vendors and our employees. Moderna’s primary
focus is on the safety of all involved and the continued conduct of
our clinical programs as we navigate the pandemic together,” said
Stéphane Bancel, Moderna’s Chief Executive Officer. “We are also
focused on responding to the pandemic through our work on our
vaccine candidate against COVID-19, mRNA-1273. We are grateful to
everyone both inside and outside Moderna who is working to address
this public health crisis. We will get through this together.”
Summary of Clinical Trial Impact of COVID-19
Based on the special concerns for the safety and health of
pediatric patients and their caregivers, and the risks of
disruption to the integrity of trials from COVID-19, the Company
has decided to pause new enrollment of its Phase 1 rare disease
clinical trials (mRNA-3704 for MMA, mRNA-3927 for PA) and its age
de-escalation trial for its pediatric respiratory vaccine
(mRNA-1653 for hMPV/PIV3). These decisions will be re-evaluated on
an ongoing basis as the COVID-19 situation evolves.
The Company plans to provide a detailed update on its clinical
development programs during its first quarter 2020 conference call.
Additional program-specific updates as of today follow.
Infectious Diseases
The Company is closely monitoring its ongoing Phase 2 CMV
(mRNA-1647) and Phase 1 Zika (mRNA-1893) clinical trials. Both
trials are fully enrolled, but some participants have not yet
received all scheduled doses of the vaccines. The Company is aware
that some participants will not be able to receive their next
vaccine dose on time or at all due to the disruptions from COVID-19
and is evaluating the impact on the integrity of these trials.
Due to the pandemic, the Company has decided to suspend new
enrollment of participants in the on-going hMPV/PIV3 study
(mRNA-1653), which had been actively enrolling seropositive
pediatric participants (12-36 months of age). The Company intends
to work with appropriate medical and site personnel to determine
when to resume new enrollment.
The Company’s work on mRNA-1273, its vaccine candidate against
the novel coronavirus continues to progress and updates can be
found on the Company’s website.
Rare Diseases
Moderna has decided to pause new enrollment and new site
initiation for its rare disease clinical trials with open
Investigational New Drug (IND) applications, methylmalonic acidemia
(MMA; mRNA-3704) and propionic acidemia (PA; mRNA-3927), to ensure
the safety of these patients and their caregivers. No patients have
been dosed to date.
Moderna has also been notified that the enrollment of further
subjects in the Company’s chikungunya virus antibody trial
(mRNA-1944) has been paused by the site due to the impact of
COVID-19.
Oncology
Moderna is continuing to treat current patients and enroll new
patients in Company-sponsored oncology studies, including its
Personalized Cancer Vaccine (mRNA-4157), Triplet (mRNA-2752) and
OX40L (mRNA-2416) programs. Despite this, COVID-19 related
challenges are leading to delays in enrollment. The Company is
continuing to evaluate the initiation of new sites in oncology
using a risk-based framework.
Financial and Operations Update
In February 2020, the Company raised $550 million in net
proceeds from a common stock offering. The Company has established
a wide range of strategic alliances with leading biopharmaceutical
companies and has received grants from government-sponsored and
private organizations focused on global health initiatives. As of
February 29, 2020, Moderna had up to $183 million (unaudited) in
additional funding available from grants (including amounts not yet
committed)1. With cash and investments of approximately $1.77
billion as of February 29, 2020 (unaudited), and access to
additional grant funding, Moderna has access to up to $1.95 billion
in capital, which the Company expects will provide several years of
cash to fund the business. Certain business disruptions related to
COVID-19 are likely to lead to lower spending in 2020, while the
Company is accelerating work on its vaccine candidate (mRNA-1273)
against COVID-19 and is engaged in discussions for outside funding
of such activities. The Company will provide an update to its 2020
financial guidance, if any, on its first quarter 2020 conference
call.
Conference Call and Webcast Information
Moderna will host a live conference call and webcast at 8:00
a.m. ET on Monday, March 30, 2020. To access the live conference
call, please dial 866-922-5184 (domestic) or 409-937-8950
(international) and refer to conference ID 3457566. A webcast of
the call will also be available under “Events and Presentations” in
the Investors section of the Moderna website at
investors.modernatx.com. The archived webcast will be available on
Moderna’s website approximately two hours after the conference call
and will be available for 30 days following the call.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a
new class of transformative medicines for patients. mRNA medicines
are designed to direct the body’s cells to produce intracellular,
membrane or secreted proteins that can have a therapeutic or
preventive benefit and have the potential to address a broad
spectrum of diseases. The Company’s platform builds on continuous
advances in basic and applied mRNA science, delivery technology and
manufacturing, providing Moderna the capability to pursue in
parallel a robust pipeline of new development candidates. Moderna
is developing therapeutics and vaccines for infectious diseases,
immuno-oncology, rare diseases and cardiovascular diseases,
independently and with strategic collaborators. Moderna has 24 mRNA
development candidates in its portfolio across all modalities, with
12 in clinical studies. Four of these programs are in or preparing
for Phase 2 studies and the Company is preparing for its first
Phase 3 study.
Headquartered in Cambridge, Mass., Moderna currently has
strategic alliances for development programs with AstraZeneca, Plc.
and Merck, Inc., as well as the Defense Advanced Research Projects
Agency (DARPA), an agency of the U.S. Department of Defense, the
Biomedical Advanced Research and Development Authority (BARDA), a
division of the Office of the Assistant Secretary for Preparedness
and Response (ASPR) within the U.S. Department of Health and Human
Services (HHS) and the Coalition for Epidemic Preparedness
Innovations (CEPI). Moderna has been ranked in the top ten of
Science’s list of top biopharma industry employers for the past
four years. To learn more, visit www.modernatx.com.
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 regarding the progression of the
Company’s clinical trials, enrollment, dosing and site-initiation
decisions, potential clinical trial delays, the timing of updates
on clinical trial progress and financial matters, the Company’s
cash to fund the business, and the anticipated impact of COVID-19
on 2020 spending. In some cases, forward-looking statements can be
identified by terminology such as “will,” “may,” “should,” “could,”
“expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential,” “continue,” “likely,” or the
negative of these terms or other comparable terminology, although
not all forward-looking statements contain these words. The
forward-looking statements in this press release are neither
promises nor guarantees, and you should not place undue reliance on
these forward-looking statements because they involve known and
unknown risks, uncertainties, and other factors, many of which are
beyond Moderna’s control and which could cause actual results to
differ materially from those expressed or implied by these
forward-looking statements. These risks, uncertainties, and other
factors include, among others: the fact that there has never been a
commercial product utilizing mRNA technology approved for use; the
fact that the rapid response technology in use by Moderna is still
being developed and implemented; further potential delays in
clinical trials due to the global COVID-19 pandemic, including with
respect to site initiation, participant recruitment and enrollment,
participant dosing, distribution of clinical trial materials, study
monitoring and data analysis; other potential adverse impacts due
to the global COVID-19 pandemic such as delays in regulatory
review, manufacturing and supply chain interruptions, adverse
effects on healthcare systems and disruption of the global economy;
and those other risks and uncertainties described under the heading
“Risk Factors” in Moderna’s most recent Annual Report on Form 10-K
filed with the U.S. Securities and Exchange Commission (SEC) and in
subsequent filings made by Moderna with the SEC, which are
available on the SEC’s website at www.sec.gov. Except as required
by law, Moderna disclaims any intention or responsibility for
updating or revising any forward-looking statements contained in
this press release in the event of new information, future
developments or otherwise. These forward-looking statements are
based on Moderna’s current expectations and speak only as of the
date hereof.
1 Biomedical Advanced Research and
Development Authority (BARDA), Defense Advanced Research Projects
Agency (DARPA), The Bill and Melinda Gates Foundation (BMGF) and
the Coalition for Epidemic Preparedness Innovations. Additional
funding is subject to agreement on scope of additional
projects.
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version on businesswire.com: https://www.businesswire.com/news/home/20200329005036/en/
Moderna Media: Colleen Hussey Senior Manager, Corporate
Communications 203-470-5620 Colleen.Hussey@modernatx.com
Dan Budwick 1AB 973-271-6085 Dan@1abmedia.com
Investors: Lavina Talukdar Head of Investor Relations
617-209-5834 Lavina.Talukdar@modernatx.com
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