23andMe Holding Co. (Nasdaq: ME) (the “Company” or “23andMe”), a
leading human genetics and preventive health company, today
announced a business restructuring to streamline operations and
reduce costs. In addition, 23andMe is discontinuing further
development of all its therapeutics programs, while evaluating
strategic alternatives for its clinical and preclinical assets.
The Company is reducing its overall headcount by over 200
employees, representing approximately 40% of the workforce. The
business restructuring is expected to substantially reduce
operating expenses and result in annualized cost savings of more
than $35 million. The Company expects to incur up to $12 million in
costs and expenses primarily related to one-time severance,
transition and termination-related costs.
“We are taking these difficult but necessary actions as we
restructure 23andMe and focus on the long-term success of our core
consumer business and research partnerships,” said Anne Wojcicki,
23andMe’s CEO, Co-Founder, and Chair of the Board. “I want to thank
our team for their hard work and dedication to our mission. We are
fully committed to supporting the employees impacted by this
transition.”
Strategic Alternatives Process for Therapeutics
Programs
In parallel with the discontinuation of its therapeutics
division, the Company is actively exploring all strategic options
for a limited time to maximize the value of its therapeutics
programs, including licensing agreements, asset sales or other
transactions. 23andMe intends to wind-down its ongoing clinical
trials as quickly as practical, while the strategic alternatives
process is ongoing.
“We continue to believe in the promise shown by our clinical and
preclinical stage pipeline and will continue to pursue strategic
opportunities to continue their development. We remain deeply
grateful to the patients, investigators and study staff for their
participation in our clinical trials,” said Wojcicki.
The Company’s therapeutic programs include 23ME-00610 (a Phase
1/2a therapeutic antibody that is designed to restore the immune
system’s ability to kill cancer cells by blocking the immune
checkpoint CD200R1), 23ME-01473 (a Phase 1 therapeutic antibody
that targets ULBP6, which can be expressed and secreted by tumor
cells to suppress immune activity), and other preclinical
immunology and inflammation programs. 23ME-00610 has demonstrated
early monotherapy responses, potential patient selection
biomarkers, and combination potential for patients across multiple
difficult-to-treat solid tumors and 23ME-01473 has yielded
promising preclinical data with a novel NK-cell-activating
mechanism.
There can be no assurance that the strategic alternatives
process for the therapeutics assets will result in any course of
action and there is no definitive timeline for completion.
About 23ME-00610 (Phase 1/2a)23ME-00610 is a
monoclonal antibody that binds to CD200R1 to prevent the
interaction of CD200R1 with CD200. Using the world’s largest
proprietary database of health and genetic information, 23andMe
identified genetic variants of CD200R1, CD200, and DOK2, the
downstream signaling protein, associated with higher risks of
immune disease and lower risks of cancer, pinpointing CD200R1 as a
promising immuno-oncology target.
23ME-00610 has demonstrated preliminary evidence of clinical
benefit as monotherapy, including partial responses by RECIST
criteria in patients with neuroendocrine tumors and clear-cell
renal-cell carcinomas in the Phase 1/2a clinical trial. Additional
preclinical data and recent literature validate the CD200-CD200R1
pathway as a potential oncology target for reversing immune
tolerance, as a monotherapy or in combination (e.g., with
anti-PD-1, anti-VEGF, CAR-T cell therapies). Higher tumor
expression of CD200 and human genetics correlated with increased
clinical benefit, suggesting potential value as patient selection
biomarkers.
23ME-00610 has shown favorable pharmacokinetics (PK) for dosing
once every three weeks, expected on-target pharmacologic activity,
and a promising safety and tolerability profile suggesting
amenability to combination therapies.
About 23ME-01473 (Phase 1)23ME-01473 targets
ULBP6 to restore anti-tumor immunity through NK and T cells. ULBPs
are stress-induced ligands found on the surface of cancer cells
that bind to their receptor, NKG2D, on NK and T cells. Cancers
escape immune cell recognition by shedding decoy ULBP ligands from
their cell surface. ULBP6 has the highest binding affinity to
NKG2D, potentially 30 times higher than MICA.
Blocking the binding of soluble ULBP6 to NKG2D through ‘1473 may
restore immune cell recognition and killing of cancer cells. ‘1473
is also Fc-effector enhanced, which further enables NK cells to
induce cell death of ULBP6-expressing cancer cells.
ULBP6 was identified as a potential cancer drug target using the
23andMe immuno-oncology (I/O) genetic signature, an approach
developed by 23andMe to identify evidence for genetic variants that
increase immune function while decreasing cancer risk. Using
genetic data, 23andMe can identify immune-related genes that are
expected to have an impact on cancer biology. Specifically,
germline genetics can reveal which of the immune-related genes
harbor genetic variants that also alter an individual's
predisposition for developing cancer.
About 23andMe23andMe is a genetics-led consumer
healthcare company empowering a healthier future. For more
information, please visit www.23andMe.com.
Contactpress@23andme.cominvestors@23andme.combd@23andme.com
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended. All statements,
other than statements of historical fact, included or incorporated
in this press release are forward-looking statements. The words
“believes,” “anticipates,” “estimates,” “plans,” “expects,”
“intends,” “may,” “could,” “should,” “potential,” “likely,”
“projects,” “predicts,” “continue,” “will,” “schedule,” and “would”
or, in each case, their negative or other variations or comparable
terminology, are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. These forward-looking statements are predictions
based on 23andMe’s current expectations and projections about
future events and various assumptions. 23andMe cannot guarantee
that it will actually achieve the plans, intentions, or
expectations disclosed in its forward-looking statements and you
should not place undue reliance on 23andMe’s forward-looking
statements. These forward-looking statements involve a number of
risks, uncertainties (many of which are beyond the control of
23andMe), or other assumptions that may cause actual results or
performance to differ materially from those expressed or implied by
these forward-looking statements. The forward-looking statements
contained herein are also subject generally to other risks and
uncertainties that are described from time to time in the Company’s
filings with the Securities and Exchange Commission, including
under Item 1A, “Risk Factors” in the Company’s most recent Annual
Report on Form 10-K, as filed with the Securities and Exchange
Commission, and as revised and updated by the Company’s Quarterly
Reports on Form 10-Q and Current Reports on Form 8-K. The
statements made herein are made as of the date of this press
release and, except as may be required by law, the Company
undertakes no obligation to update them, whether as a result of new
information, developments, or otherwise.
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