- On Track to Initiate RLYB212 Phase 2 Dose
Confirmation Trial in Pregnant Women at Higher Risk of FNAIT in 2H
2024 -
- $94.2 Million in Cash, Cash Equivalents, and
Marketable Securities as of March 31, 2024; Provides Runway into
Mid-2026 -
Rallybio Corporation (Nasdaq: RLYB), a clinical-stage
biotechnology company translating scientific advances into
transformative therapies for patients with devastating rare
diseases, today reported first quarter financial results for the
period ended March 31, 2024 and provided an update on recent
company developments.
“This year is off to a strong start as we continue to progress
towards the initiation of our Phase 2 dose confirmation trial for
RLYB212 in pregnant women at higher risk of FNAIT, which is on
track for the second half of 2024," said Stephen Uden, M.D., Chief
Executive Officer of Rallybio. "Last month, we were particularly
pleased to announce our collaboration with Johnson & Johnson,
marking a significant step forward in our mission to eliminate
FNAIT and its devastating consequences. Together with Johnson &
Johnson, we look forward to further driving awareness of FNAIT,
emphasizing the importance of screening for FNAIT risk, and
advancing our complementary therapeutic approaches, which aim to
ensure all pregnant women at risk of FNAIT have a potential
treatment option regardless of their alloimmunization status."
Dr. Uden continued, "In the near-term, we look forward to
sharing initial data from an epidemiologic analysis investigating
the genetic markers of FNAIT risk in a racially and ethnically
diverse population beyond the Caucasian population, where FNAIT
risk has been better established in published literature. This
analysis will more accurately inform the number of pregnant women
at higher risk for FNAIT annually. We expect that these data
combined with data from our ongoing FNAIT natural history study
will further emphasize the need for a preventative therapeutic and
identify a market opportunity for RLYB212 that is larger than our
current estimates."
Recent Business Highlights and Upcoming
Milestones:
Corporate Updates
- In April 2024, Rallybio announced a collaboration with Momenta
Pharmaceuticals, Inc., a Johnson & Johnson Company, to advance
complementary therapeutic solutions for pregnant women at risk of
fetal and neonatal alloimmune thrombocytopenia (FNAIT). Rallybio
received an equity investment of $6.6 million from Johnson &
Johnson Innovation – JJDC, Inc.
- In February 2024, Rallybio announced a prioritization of its
portfolio and a 45% workforce reduction to focus the Company’s
resources on its two Phase 2 ready assets, RLYB212, a novel human
monoclonal anti-HPA-1a antibody in development for the prevention
of FNAIT, and RLYB116, a once-weekly, low volume subcutaneously
injected inhibitor of complement component 5 (C5) in development
for patients with complement-mediated diseases.
RLYB212 Program
- Rallybio is on track to initiate a Phase 2 trial in pregnant
women at higher risk for HPA-1a alloimmunization and FNAIT in the
second half of 2024. The primary objectives of this trial are to
assess the pharmacokinetics and safety of subcutaneously
administered RLYB212 in pregnant women. Secondary objectives
include assessments of pregnancy and neonatal outcomes, and the
occurrence of emergent HPA-1a alloimmunization. Administration of
RLYB212 will be initiated by Gestational Week 16 and continue every
4 weeks through parturition.
- Screening in the Company's FNAIT natural history study is
ongoing. This study is designed to provide a contemporary dataset
for HPA-1a alloimmunization frequency in a racially and ethnically
diverse population. As of May 1, 2024, Rallybio has screened
approximately 10,000 pregnant women. The FNAIT natural history
study is designed to run in parallel with the Phase 2 study and to
continue through to initiation of the planned Phase 3 trial to
enable seamless transition of participating sites into the
registration trial.
- To better understand the frequency of HPA-1a-negative,
HLA-DRB3*01:01-positive status in a broad and diverse population,
Rallybio partnered with HealthLumen, a leader in epidemiological
modeling of rare genetic diseases, to conduct an epidemiologic
analysis utilizing information from large genomic datasets.
Rallybio expects data from this analysis to be disclosed in
mid-2024.
- Several presentations and publications are expected in the
second half of 2024, including additional data from the Phase 1b
proof-of-concept study and an integrated summary of clinical and
nonclinical data supporting the RLYB212 Phase 2 dose.
RLYB116 Program
- RLYB116 manufacturing work continues and is on track to
complete in the second half of 2024. Furthermore, additional
biomarker development work is underway to further evaluate results
of the Phase 1 multiple ascending dose (MAD) study, which was
completed in the fourth quarter of 2023. Rallybio expects to
provide an update on this analysis and future development plans for
RLYB116 in the second half of 2024.
Preclinical Programs
Rallybio 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.
Given Rallybio's focus of current capital and resources on its
clinical-stage assets, primarily RLYB212, the Company is seeking
alternative options to further advance its preclinical programs,
including partnerships and other forms of non-dilutive
financing.
- RLYB332: In the first quarter of 2024, Rallybio
completed nonclinical studies that demonstrated favorable
tolerability, dose-dependent pharmacokinetics, and sustained
pharmacodynamic effects with RLYB332, a long-acting version of the
RLYB331 anti-Matriptase-2 antibody. These findings support the
continued development of RLYB332 as a potentially best-in-class
therapeutic for treating diseases of iron overload. Presentation of
this data is expected in the second half of 2024.
- RLYB114, EyePoint Collaboration: EyePoint has
demonstrated feasibility for sustained delivery of Rallybio’s
inhibitor of C5 using EyePoint’s proprietary intraocular drug
delivery technology, and optimization work is ongoing.
First Quarter 2024 Financial Results
- Research & Development (R&D) Expenses: R&D
expenses were $12.9 million for the first quarter of 2024, compared
to $11.2 million for the same period in 2023. The increase in
R&D expense was primarily due to an increase in payroll and
personnel-related costs, largely related to severance costs
incurred in connection with the workforce reduction, effective
March 6, 2024. The increase was partially offset by a decrease in
costs related to the development of RLYB212.
- General & Administrative (G&A) Expenses: G&A
expenses were $6.9 million for the first quarter of 2024, compared
to $7.2 million for the same period in 2023. The decrease in
G&A expense was primarily related to decreases in other general
and administrative related expenses and director and officer
insurance premiums. This decrease was partially offset by an
increase in payroll and personnel-related costs, primarily related
to severance costs incurred in connection with the workforce
reduction, effective March 6, 2024.
- Net Loss and Net Loss Per Common Share: Rallybio
reported a net loss of $19.0 million, or $0.47 per common share,
for the first quarter of 2024. This compares to a net loss of $17.3
million, or $0.43 per common share, for the first quarter of
2023.
- Cash Position: As of March 31, 2024, cash, cash
equivalents, and marketable securities were $94.2 million.
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, the timing
of the availability of data from our clinical studies, our
expectations regarding the usefulness of data from our clinical
studies, our expectations regarding driving awareness of FNAIT
through the Johnson & Johnson collaboration, our ability to
more accurately identify the number of pregnant women at higher
risk of FNAIT based on the results of the genomic analysis, our
estimates of the market opportunity for RLYB212, the timing of
publications relating to FNAIT and RLYB212, the timing of
completion of the RLYB116 biomarker work, 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, our estimates of our capital
requirements and the sufficiency thereof, 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
trials, including the FNAIT natural history study, and the Phase 2
clinical trial for RLYB212, and complete such clinical trials 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
Annual Report on Form 10-K for the period ended December 31, 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.
Financial Tables
RALLYBIO CORPORATION
SELECTED CONDENSED
CONSOLIDATED FINANCIAL INFORMATION
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(Unaudited)
FOR THE THREE MONTHS ENDED
MARCH 31,
(in thousands, except share and per
share amounts)
2024
2023
Operating expenses:
Research and development
$
12,936
$
11,202
General and administrative
6,851
7,172
Total operating expenses
19,787
18,374
Loss from operations
(19,787
)
(18,374
)
Other income:
Interest income
1,276
1,546
Other income
167
73
Total other income, net
1,443
1,619
Loss before equity in losses of joint
venture
(18,344
)
(16,755
)
Loss on investment in joint venture
685
563
Net loss
$
(19,029
)
$
(17,318
)
Net loss per common share, basic and
diluted
$
(0.47
)
$
(0.43
)
Weighted-average common shares
outstanding, basic and diluted
40,773,615
40,248,893
Other comprehensive (loss) gain:
Net unrealized (loss) gain on marketable
securities
(86
)
153
Other comprehensive (loss) gain
(86
)
153
Comprehensive loss
$
(19,115
)
$
(17,165
)
Condensed Consolidated Balance
Sheets
(Unaudited)
(in thousands)
MARCH 31, 2024
DECEMBER 31,
2023
Cash, cash equivalents and marketable
securities
$
94,175
$
109,929
Total assets
99,359
115,620
Total liabilities
10,202
9,436
Total stockholders' equity
89,157
106,184
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version on businesswire.com: https://www.businesswire.com/news/home/20240508082564/en/
Investors Samantha Tracy Rallybio Corporation (475)
47-RALLY (Ext. 282) investors@rallybio.com Kevin Lui Stern Investor
Relations, Inc. (760) 579-2134 Kevin.Lui@sternir.com Media
Victoria Reynolds Mission North (760) 579-2134
rallybio@missionnorth.com
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