-- RLYB212 Phase 1 Multiple Dose Cohort
Complete and on Track for 4Q 2023 Data Release --
-- Initial Data from RLYB116 Phase 1 Multiple
Ascending Dose Study Including Safety, PK and PD on Track for 4Q
2023 Release --
-- $121.4 million cash, cash equivalents and
marketable securities as of September 30, 2023; Provides Runway
into 1Q 2025 --
Rallybio Corporation (Nasdaq: RLYB) today reported financial
results for the third quarter ended September 30, 2023 and provided
an update on recent program and corporate developments.
“We are pleased with the continued progress across our portfolio
in recent months, further demonstrating the ability of our team to
efficiently advance clinical trials across diverse therapeutic
areas. Prior to the end of 2023, we expect to finalize the
toxicology package for RLYB212, our anti-HPA-1a monoclonal antibody
for the prevention of fetal and neonatal alloimmune
thrombocytopenia (FNAIT), to support our planned Phase 2 and Phase
3 studies in pregnant women. In addition, we have completed the
multiple dose cohort of our ongoing Phase 1 study for RLYB212 and
have initiated regulatory discussions for RLYB212 to support the
initiation of a Phase 2 dose confirmation study in pregnant women
at higher risk for FNAIT. We also look forward to sharing more
about the ongoing FNAIT natural history study at the upcoming
American Society of Hematology Annual Meeting in December,” said
Stephen Uden, M.D., Chief Executive Officer of Rallybio.
Dr. Uden continued, “Our multiple ascending dose Phase 1 study
for RLYB116, an inhibitor of complement component 5 (C5), remains
on track and we expect to share initial data from this study,
including our indication strategy, prior to the end of 2023. In
parallel, we continue to advance our preclinical programs albeit
with a focus on capital conservation and believe our existing
capital will be sufficient to fund our operating expenses and
capital expenditure requirements into the first quarter of
2025.”
Maternal Fetal Blood Disorders Rallybio expects to
achieve the following milestones in the fourth quarter of 2023 for
RLYB212, an anti-HPA-1a monoclonal antibody being developed for the
prevention of FNAIT:
- Finalize toxicology package for RLYB212, including
maternal-fetal toxicology to support our planned Phase 2 and Phase
3 studies in pregnant women.
- Disclose preliminary data for the multiple dose cohort of the
Phase 1 safety and pharmacokinetic study of RLYB212.
- Poster presentation of abstract for the ongoing natural history
study at the 65th American Society of Hematology Annual Meeting in
December 2023.
- On track to screen 7,600 women for the natural history study by
the end of 2023.
The Company also continues to advance the FNAIT natural history
study. This non-interventional study is designed to inform on the
frequency of women at higher risk for FNAIT across a broad
population of pregnant women of different racial and ethnic
characteristics, and the occurrence of HPA-1a alloimmunization in
these women. The Company expects screening for the natural history
study to continue simultaneously with execution of the Phase 2 dose
confirmation study. The Phase 2 study for RLYB212 is expected to
initiate in the second half of 2024 and is designed to confirm the
dose regimen for RLYB212 in pregnant women at higher risk of
FNAIT.
Complement Dysregulation Rallybio remains on track to
report initial data in the fourth quarter of 2023 from the Phase 1
multiple ascending dose (MAD) study of RLYB116, a novel,
potentially long-acting, subcutaneously injected inhibitor of C5 in
development for the treatment of patients with complement-related
diseases. This single-blind, dose escalation, placebo-controlled
study is designed to evaluate the safety, pharmacokinetics, and
pharmacodynamics of RLYB116 in healthy participants. In parallel
with the initial data from this study, Rallybio also intends to
discuss its plans for potential indications for which RLYB116 could
be developed.
In September 2023, clinical data from the Phase 1 first-in-human
single ascending dose (SAD) clinical study of RLYB116 were
presented in a poster at the 29th International Complement
Workshop. The data demonstrated that single-dose administration of
RLYB116 at the two higher doses of 100 mg and 300 mg resulted in
maximum exposures of greater than 1 µM and 3 µM, respectively, and
greater than 99% reductions in free C5 concentrations.
Subcutaneously administered RLYB116 was observed to be generally
well-tolerated as a single 100 mg or 300 mg dose, with mild to
moderate adverse events and no drug-related serious adverse
events.
Third Quarter 2023 Financial Results:
- Research & Development (R&D) Expenses: R&D
expenses were $13.3 million for the third quarter of 2023, compared
to $12.1 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 RLYB331 and an increase in R&D related
headcount costs, including share-based compensation expense, as
compared to the prior year. These costs were offset by a decrease
in R&D costs related to RLYB116.
- General & Administrative (G&A) Expenses: G&A
expenses were $6.1 million for the third quarter of 2023, compared
to $6.8 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 and director and officer
insurance premiums; offset by increases in other general and
administrative related expenses.
- Net Loss and Net Loss Per Common Share: Net loss was
$18.4 million for the third quarter of 2023, or net loss per common
share of $0.45 compared to a net loss of $18.4 million, or net loss
per common share of $0.60 for the third quarter of 2022.
- Cash Position: As of September 30, 2023, cash, cash
equivalents and marketable securities were $121.4 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,
including for the Phase 1 RLYB212 study and the multiple ascending
dose RLYB116 study, 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 June
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.
Financial Tables
RALLYBIO CORPORATION
SELECTED CONDENSED
CONSOLIDATED FINANCIAL INFORMATION
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(Unaudited)
FOR THE THREE MONTHS ENDED
SEPTEMBER 30,
FOR THE NINE MONTHS ENDED
SEPTEMBER 30,
(in thousands, except share and per
share amounts)
2023
2022
2023
2022
Operating expenses:
Research and development
$
13,288
$
12,110
$
37,620
$
29,896
General and administrative
6,075
6,750
20,200
20,897
Total operating expenses
19,363
18,860
57,820
50,793
Loss from operations
(19,363
)
(18,860
)
(57,820
)
(50,793
)
Other income:
Interest income
1,545
525
4,699
892
Other income
92
98
227
311
Total other income, net
1,637
623
4,926
1,203
Loss before equity in losses of joint
venture
(17,726
)
(18,237
)
(52,894
)
(49,590
)
Loss on investment in joint venture
648
133
1,428
861
Net loss
$
(18,374
)
$
(18,370
)
$
(54,322
)
$
(50,451
)
Net loss per common share, basic and
diluted
$
(0.45
)
$
(0.60
)
$
(1.35
)
$
(1.65
)
Weighted-average common shares
outstanding, basic and diluted
40,531,497
30,777,797
40,382,625
30,562,723
Other comprehensive gain (loss):
Net unrealized gain (loss) on marketable
securities
64
(63
)
6
(434
)
Other comprehensive gain (loss)
64
(63
)
6
(434
)
Comprehensive loss
$
(18,310
)
$
(18,433
)
$
(54,316
)
$
(50,885
)
Condensed Consolidated Balance
Sheets
(Unaudited)
(in thousands)
SEPTEMBER 30,
2023
DECEMBER 31,
2022
Cash, cash equivalents and marketable
securities
$
121,384
$
168,994
Total assets
133,194
180,435
Total liabilities
9,613
11,118
Total stockholders' equity
123,581
169,317
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231107170974/en/
Investor 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 Jorge
Gaeta Mission North (516) 430-7659 Rallybio@missionnorth.com
Rallybio (NASDAQ:RLYB)
過去 株価チャート
から 4 2024 まで 5 2024
Rallybio (NASDAQ:RLYB)
過去 株価チャート
から 5 2023 まで 5 2024