-- RLYB212 Phase 1b Proof-of-Concept Study
Results Presented at the 31st Congress of the International Society
of Thrombosis and Haemostasis (ISTH) in June 2023 --
-- RLYB212 Phase 1 Multiple Dose Cohort Study
Results Expected in 4Q 2023 --
-- Initial Data from RLYB116 Phase 1 Multiple
Ascending Dose Study Including Safety, PK and PD Expected in 4Q
2023 --
-- $137.8 million cash, cash equivalents and
marketable securities as of June 30, 2023; Provides Runway into 1Q
2025 --
Rallybio Corporation (Nasdaq: RLYB) today reported financial
results for the second quarter ended June 30, 2023 and provided an
update on recent program and corporate developments.
“We continue to make significant progress across our portfolio.
We were pleased to have results from the Phase 1b proof-of-concept
study for RLYB212, our anti-HPA-1a monoclonal antibody for the
prevention of fetal and neonatal alloimmune thrombocytopenia
(FNAIT), presented at the International Society on Thrombosis and
Haemostasis Congress in June. With both dose groups in the study
meeting the proof-of-concept criteria of at least 90% reduction in
mean platelet elimination half-life, these results continue to
support the potential use of subcutaneous RLYB212 for the
prevention of HPA-1a alloimmunization and FNAIT. In the fourth
quarter of 2023, we plan to complete the toxicology program for
RLYB212, and share the results from the multiple dose cohort of our
ongoing Phase 1 study for RLYB212. In parallel, we expect to
initiate regulatory discussions which will support the initiation
of a Phase 2 dose confirmation study in pregnant women at higher
risk of FNAIT for RLYB212 in the second half of 2024,” said Stephen
Uden, M.D., Chief Executive Officer of Rallybio.
Dr. Uden continued, “We continue to advance our multiple
ascending dose Phase 1 study of RLYB116, an inhibitor of complement
component 5 (C5) and expect to share initial data from this study,
as well as details on our initial indication strategy for RLYB116,
in the fourth quarter of 2023. As we continue to fortify our
position as a leader in the development of transformative medicines
for underserved rare diseases, we believe our existing capital will
allow us to advance our portfolio through upcoming milestones.”
Maternal Fetal Blood Disorders
Results from the Phase 1b proof-of-concept study of RLYB212, an
anti-HPA-1a monoclonal antibody in development for the prevention
of FNAIT, were presented at the 31st Congress of the International
Society for Thrombosis and Haemostasis in June 2023. In this study,
subcutaneous RLYB212 administration produced a dose-dependent,
rapid and complete elimination of transfused HPA-1a positive
platelets in HPA-1a negative subjects, with both dose groups
meeting the pre-specified proof-of-concept criteria of ≥ 90%
reduction in mean platelet elimination half-life. Mean platelet
elimination half-life was 5.8 hours (0.09mg dose) and 1.5 hours
(0.29mg dose) for RLYB212 compared to 71.7 hours for placebo.
Consistent with previously reported data, RLYB212 was
well-tolerated with no reports of serious or severe adverse
events.
The Company expects to achieve the following milestones in the
fourth quarter of 2023 for RLYB212:
- Complete the comprehensive toxicology program for RLYB212,
including maternal-fetal toxicology.
- Report results from the multiple dose cohort of the Phase 1
safety and pharmacokinetic study of RLYB212. This multiple dose
cohort, which was initiated in the first quarter of 2023, is
designed to evaluate safety and pharmacokinetics of subcutaneous
RLYB212 based on repeat dosing over 12 weeks.
Rallybio expects to initiate a Phase 2 dose confirmation study
for RLYB212 in the second half of 2024 in order to confirm the
RLYB212 dose regimen in pregnant women at higher risk of FNAIT.
Following completion of the Phase 2 dose confirmation study and
consultation with regulatory authorities, Rallybio expects to
initiate a Phase 3 registrational study.
The Company also continues to advance the FNAIT natural history
alloimmunization study. In June 2023, the Company announced
approximately 4,500 women have been screened to date and an
estimated 7,600 women are planned to be screened by the end of
2023. The Company expects screening for the natural history study
to continue simultaneously with execution of the Phase 2 study.
Complement Dysregulation
The Phase 1 multiple ascending dose study of RLYB116, a novel,
potentially long-acting, subcutaneously injected inhibitor of C5 in
development for the treatment of patients with complement-related
diseases continues to advance. This single-blind, dose escalation,
placebo-controlled study is designed to evaluate the safety,
pharmacokinetics, and pharmacodynamics of RLYB116 in healthy
participants.
The Company expects to report initial data from this study in
the fourth quarter of 2023 along with its initial plans for
potential indications for which RLYB116 could be developed.
In July 2023, Rallybio announced the acceptance of an abstract
for a poster that will report data from the Phase 1 first-in-human
single ascending dose clinical study of RLYB116. The poster will be
presented at the 29th International Complement Workshop, which will
take place in Newcastle, UK from August 31 to September 5,
2023.
Corporate Updates
On August, 1, 2023, Stephen Uden, M.D. became Chief Executive
Officer of Rallybio, and a member of the Board of Directors. Dr.
Uden remains President of Rallybio. He succeeded Martin Mackay,
Ph.D. as Chief Executive Officer. Dr. Mackay was appointed
Executive Chairman effective on August 1, 2023. As Executive
Chairman, Dr. Mackay remains a full-time employee and is actively
involved with the Company, with a particular focus on company
strategy, investor relations and related activities.
Second Quarter 2023 Financial Results:
- Research & Development (R&D) Expenses: R&D
expenses were $13.1 million for the second quarter of 2023,
compared to $10.1 million for the same period in 2022. The increase
in R&D expenses was primarily due to an increase in costs to
advance RLYB212 and RLYB116 and an increase in R&D related
headcount costs, including share-based compensation expense, as
compared to the prior year.
- General & Administrative (G&A) Expenses: G&A
expenses were $7.0 million for the second quarter of 2023, compared
to $7.5 million for the same period in 2022. The decrease in
G&A expenses was primarily due to a decrease in G&A related
payroll and personnel-related costs, including share-based
compensation expense.
- Net Loss and Net Loss Per Common Share: Net loss was
$18.6 million for the second quarter of 2023, or net loss per
common share of $0.46 compared to a net loss of $17.6 million, or
net loss per common share of $0.57 for the second quarter of
2022.
- Cash Position: As of June 30, 2023, cash, cash
equivalents and marketable securities were $137.8 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 with an
additional facility at the University of Connecticut’s Technology
Incubation Program in Farmington, 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 initiation, progress, substance, design and timing
of our planned or ongoing studies for RLYB212 and RLYB116,
including the planned RLYB212 Phase 2 and Phase 3 studies, the
timing of the availability of data from such studies, our
expectations regarding reporting of data from such studies, and our
expectations regarding the usefulness of data from such studies,
the timing of the availability of data from the RLYB212 toxicology
program and our expectations regarding the usefulness of such data,
the potential markets for RLYB212 and RLYB116, the potential
indications for which RLYB116 could be developed and our plans for
presenting such potential indications, our estimates of our capital
requirements and the sufficiency thereof, our ability to advance
our portfolio, our plans for development of our inhibitor of C5 for
the treatment of ophthalmic disorders, and our plans for
development activities with our strategic collaboration partners.
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 1
and 1b clinical trials for RLYB212 and the Phase 1 study for
RLYB116, 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 identify new product candidates
and successfully acquire such product candidates from third
parties, our ability to enter into strategic partnerships or other
arrangements, including such an arrangement for the development of
our inhibitor of C5 for the treatment of ophthalmic disorders,
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 March
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
JUNE 30,
FOR THE SIX MONTHS ENDED JUNE
30,
(in thousands, except share and per
share amounts)
2023
2022
2023
2022
Operating expenses:
Research and development
$
13,130
$
10,138
$
24,332
$
17,786
General and administrative
6,953
7,477
14,125
14,147
Total operating expenses
20,083
17,615
38,457
31,933
Loss from operations
(20,083
)
(17,615
)
(38,457
)
(31,933
)
Other income:
Interest income
1,608
270
3,154
367
Other income
62
100
135
213
Total other income, net
1,670
370
3,289
580
Loss from continuing operations
(18,413
)
(17,245
)
(35,168
)
(31,353
)
Loss on investment in joint venture
217
338
780
728
Net loss
$
(18,630
)
$
(17,583
)
$
(35,948
)
$
(32,081
)
Net loss per common share, basic and
diluted
$
(0.46
)
$
(0.57
)
$
(0.89
)
$
(1.05
)
Weighted-average common shares
outstanding, basic and diluted
40,363,902
30,588,931
40,306,715
30,453,913
Other comprehensive loss:
Net unrealized loss on marketable
securities
(211
)
(249
)
(58
)
(371
)
Other comprehensive loss
(211
)
(249
)
(58
)
(371
)
Comprehensive loss
$
(18,841
)
$
(17,832
)
$
(36,006
)
$
(32,452
)
Condensed Consolidated Balance
Sheets (Unaudited)
(in thousands)
JUNE 30, 2023
DECEMBER 31,
2022
Cash, cash equivalents and marketable
securities
$
137,838
$
168,994
Total assets
147,576
180,435
Total liabilities
8,319
11,118
Total stockholders' equity
139,257
169,317
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230804335209/en/
Investors Ami Bavishi Head of Investor Relations and
Corporate Communications (475) 47-RALLY (Ext. 282)
abavishi@rallybio.com Hannah Deresiewicz Stern Investor Relations,
Inc. 212-362-1200 hannah.deresiewicz@sternir.com Media Tara
DiMilia 908-369-7168 Tara.dimilia@tmstrat.com
Rallybio (NASDAQ:RLYB)
Historical Stock Chart
From Apr 2024 to May 2024
Rallybio (NASDAQ:RLYB)
Historical Stock Chart
From May 2023 to May 2024