– Prioritization of Phase 2-ready
clinical-stage programs: RLYB212 for the prevention of FNAIT and
RLYB116, a C5 inhibitor for the treatment of patients with
complement-mediated diseases –
– Anticipated cost savings, including a 45%
workforce reduction, extends cash runway into mid-2026 –
Rallybio Corporation (Nasdaq: RLYB) today announced the
prioritization of its portfolio and a 45% workforce reduction to
focus resources on its Phase 2-ready clinical stage programs,
RLYB212 and RLYB116. RLYB212 is a novel human monoclonal
anti-HPA-1a antibody in development for the prevention of fetal and
neonatal alloimmune thrombocytopenia (FNAIT), and RLYB116 is a
once-weekly, low volume subcutaneously injected inhibitor of
complement component 5 (C5) in development for patients with
complement-mediated diseases. With these changes, Rallybio expects
to extend its cash runway into mid-2026.
“Following a thorough review of our business, we have made the
decision to prioritize our portfolio. We believe that these
difficult but necessary decisions to streamline our operations and
align resources are critical to extend our cash runway, support the
advancement of our two clinical-stage programs, and put us on a
path toward long-term success,” said Stephen Uden, M.D. Chief
Executive Officer of Rallybio.
“I would like to personally thank our departing employees for
their countless contributions and tireless commitment to our
mission,” Dr. Uden continued. “It is incredibly difficult to part
ways with these talented members of the Rallybio team who have
demonstrated such dedication to bringing transformative therapies
to patients in need.”
Key Elements of Portfolio Prioritization and Corporate
Update
Prioritization of Clinical-Stage Programs
RLYB212
- The Company plans to provide an update on Phase 2 discussions
for RLYB212 with the European Medicines Agency (EMA) in the first
half of 2024.
- Rallybio continues to expect to initiate a Phase 2 dose
confirmation study for RLYB212 in pregnant women at higher risk of
FNAIT in the second half of 2024.
- The Company continues to screen mothers in the FNAIT natural
history alloimmunization study, a non-interventional study designed
to provide a contemporary dataset for HPA-1a alloimmunization
frequency in a racially and ethnically diverse population. Rallybio
expects to provide an update on screening numbers in its full-year
earnings release in March 2024.
RLYB116
- Manufacturing work announced in December 2023 is progressing,
and Rallybio is encouraged by data indicating the potential to
achieve improved tolerability at higher doses of RLYB116.
- While the exposure levels of RLYB116 demonstrated in the Phase
1 study are expected to be suitable for the treatment of patients
with generalized myasthenia gravis, the Company believes the
ongoing enhancements will enable higher exposure to RLYB116,
supporting the treatment of patients with a broader range of
complement-mediated diseases, including paroxysmal nocturnal
hemoglobinuria and antiphospholipid syndrome.
- Rallybio continues to expect to complete this manufacturing
work and provide an update on the development plan for RLYB116 in
the second half of 2024.
Preclinical Program Update The Company continues to
believe that its preclinical programs have the potential to address
significant existing unmet needs for patients and caregivers and
bring meaningful value to stakeholders. The revised operating plan
will fund preclinical program activities to important 2024
milestones, as described below. Beyond achievement of these
milestones, Rallybio will seek alternative options to further
advance these programs, including additional partnerships and other
forms of non-dilutive financing.
- RLYB331, Matriptase-2 (MTP-2) Inhibitor: Completion of
the ongoing preclinical activities, with data expected in the first
half of 2024.
- ENPP1 Inhibitor, Exscientia Partnership: Lead
AI-designed compounds enter candidate selection process in the
second half of 2024.
- AbCellera Partnership: Advancement of discovery efforts
to the next research milestone in the second half of 2024.
- RLYB114, EyePoint Collaboration: The evaluation of
Rallybio’s C5 inhibitor using EyePoint’s proprietary technology for
sustained intraocular drug delivery is ongoing. An update is
expected in the first half of 2024.
Workforce Reduction The Company will implement a 45%
workforce reduction, representing 19 positions, which will be
substantially complete by the end of the first quarter of 2024.
Rallybio estimates that the workforce reduction will result in
aggregate charges of approximately $3.3 million, primarily for
one-time employee severance and benefit costs and excluding
share-based compensation expense.
Based on the above actions, Rallybio’s cash, cash equivalents
and marketable securities of approximately $109.9 million
(unaudited) as of December 31, 2023, are now expected to fund its
revised operating plan into mid-2026.
About Rallybio
Rallybio (Nasdaq: RLYB) is a clinical-stage biotechnology
company with a mission to develop and commercialize
life-transforming therapies for patients with severe and rare
diseases. Rallybio has built a broad pipeline of promising product
candidates aimed at addressing diseases with unmet medical need in
areas of maternal fetal health, complement dysregulation,
hematology, and metabolic disorders. The Company has two clinical
stage programs: RLYB212, an anti-HPA-1a antibody for the prevention
of fetal and neonatal alloimmune thrombocytopenia (FNAIT) and
RLYB116, an inhibitor of complement component 5 (C5), with the
potential to treat several diseases of complement dysregulation, as
well as additional programs in preclinical development. Rallybio is
headquartered in New Haven, Connecticut. For more information,
please visit www.rallybio.com and follow us on LinkedIn and
Twitter.
Forward-Looking Statements This press release contains
forward-looking statements that are based on our management’s
beliefs and assumptions and on currently available information. All
statements, other than statements of historical facts contained in
this press release are forward-looking statements. In some cases,
forward-looking statements can be identified by terms such as
“may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,”
“intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential” or “continue” or the negative of
these terms or other similar expressions, although not all
forward-looking statements contain these words. Forward-looking
statements in this press release include, but are not limited to,
statements concerning the timing of initiation of the Phase 2 dose
confirmation study for RLYB212, the release of screening numbers of
women in the natural history study, whether the results of the
natural history study and the planned Phase 2 dose confirmation
study will be sufficient to support design and implementation of a
Phase 3 registrational study for RLYB212, whether the manufacturing
work for RLYB116 will be timely completed or successful, our
expectations regarding the usefulness of data from our clinical
studies, the timing of achieving milestones in 2024 for our
preclinical programs, the likelihood that Rallybio will be
successful in developing RLYB212, RLYB116, or any of our other
product candidates, our ability to successfully identify and
implement alternative and acceptable options to further advance our
programs, expected costs related to the workforce reduction and
related charges, including the timing of such charges, the expected
use of operating cost savings associated with the updated operating
plan and the timing, and our cash runway. The forward-looking
statements in this press release are only predictions and are based
largely on management’s current expectations and projections about
future events and financial trends that management believes may
affect Rallybio’s business, financial condition, and results of
operations. These forward-looking statements speak only as of the
date of this press release and are subject to a number of known and
unknown risks, uncertainties and assumptions, including, but not
limited to, our ability to successfully initiate and conduct our
planned clinical studies, and complete such clinical studies and
obtain results on our expected timelines, or at all, whether our
cash resources will be sufficient to fund our operating expenses
and capital expenditure requirements and whether we will be
successful raising additional capital, our ability to enter into
strategic partnerships or other arrangements, competition from
other biotechnology and pharmaceutical companies, and those risks
and uncertainties described in Rallybio’s filings with the U.S.
Securities and Exchange Commission (SEC), including Rallybio’s
Quarterly Report on Form 10-Q for the period ended September 30,
2023, and subsequent filings with the SEC. The events and
circumstances reflected in our forward-looking statements may not
be achieved or occur and actual future results, levels of activity,
performance and events and circumstances could differ materially
from those projected in the forward-looking statements. Except as
required by applicable law, we are not obligated to publicly update
or revise any forward-looking statements contained in this press
release, whether as a result of any new information, future events,
changed circumstances or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20240205087074/en/
Investors Ami Bavishi Head of Investor Relations and
Communications 475-47-RALLY (Ext. 282)
abavishi@rallybio.com
Hannah Deresiewicz Stern Investor Relations, Inc. 212-362-1200
hannah.deresiewicz@sternir.com
Media Lauren Cohen Mission North 410-570-2497
lcohen@missionnorth.com
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