Rallybio Reports First Quarter 2023 Financial Results
-- RLYB212 Phase 1b Proof-of-Concept Study Results to be Presented at 31st
-- Phase 1 Multiple Dose Cohort RLYB212 Study Initiated in 1Q 2023; Data Expected in 4Q 2023 --
-- Phase 1 Multiple Ascending Dose Study of RLYB116 Continues to Progress; Safety, PK and PD Data Expected in 4Q 2023 --
--
“We continue to progress our pipeline toward planned upcoming milestones. We recently announced that the Phase 1b proof-of-concept study results for RLYB212, our anti-HPA-1a monoclonal antibody product candidate for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT), will be presented at the
Recent Business Highlights and Upcoming Milestones:
Maternal Fetal Blood Disorders
In the first quarter of 2023,
The Company continues to advance the FNAIT natural history alloimmunization 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 that the data from this study will contribute to a control dataset for a future single armed registration trial for RLYB212.
Complement Dysregulation
The Company currently expects initial data from this Phase 1 study in the fourth quarter of 2023. In parallel with ongoing clinical activities, the Company has been evaluating potential indications for which RLYB116 could be developed and intends to provide its initial plans in conjunction with the release of the Phase 1 data, currently expected in the fourth quarter of 2023.
In
First Quarter 2023 Financial Results:
-
Research & Development (R&D) Expenses: R&D expenses were
$11.2 million for the first quarter of 2023, compared to$7.6 million for the same period in 2022. R&D expenses for the first quarter of 2023 increased 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
$7.2 million for the first quarter of 2023, compared to$6.7 million for the same period in 2022. The increase in G&A expenses was primarily due to additional G&A related payroll and personnel-related costs, including share-based compensation expense. -
Net Loss and Net Loss Per Common Share: Net loss was
$17.3 million for the first quarter of 2023, or net loss per common share of$0.43 compared to a net loss of$14.5 million , or net loss per common share of$0.48 for the first quarter of 2022. -
Cash Position: As of
March 31, 2023 , cash, cash equivalents and marketable securities were$150.4 million .
About
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, 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 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, including EyePoint. 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 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
Financial Tables
SELECTED CONDENSED CONSOLIDATED FINANCIAL INFORMATION
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FOR THE THREE MONTHS ENDED
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(in thousands, except share and per share amounts) |
|
2023 |
|
|
2022 |
|
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Operating expenses: |
|
|
|
|
|
|
||
Research and development |
|
$ |
11,202 |
|
|
$ |
7,648 |
|
General and administrative |
|
|
7,172 |
|
|
|
6,670 |
|
Total operating expenses |
|
|
18,374 |
|
|
|
14,318 |
|
Loss from operations |
|
|
(18,374 |
) |
|
|
(14,318 |
) |
Other income (expenses): |
|
|
|
|
|
|
||
Interest income |
|
|
1,546 |
|
|
|
97 |
|
Other income |
|
|
73 |
|
|
|
113 |
|
Total other income, net |
|
|
1,619 |
|
|
|
210 |
|
Loss from continuing operations |
|
|
(16,755 |
) |
|
|
(14,108 |
) |
Loss on investment in joint venture |
|
|
563 |
|
|
|
390 |
|
Net loss |
|
$ |
(17,318 |
) |
|
$ |
(14,498 |
) |
|
|
|
|
|
|
|
||
Net loss per common share, basic and diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.48 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
40,248,893 |
|
|
|
30,318,405 |
|
|
|
|
|
|
|
|
||
Other comprehensive income (loss): |
|
|
|
|
|
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||
Net unrealized income (loss) on marketable securities |
|
|
153 |
|
|
|
(122) |
|
Other comprehensive income (loss) |
|
|
153 |
|
|
|
(122 |
) |
Comprehensive loss |
|
$ |
(17,165 |
) |
|
$ |
(14,620 |
) |
Condensed Consolidated Balance Sheets
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(in thousands) |
|
|
|
|
|
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||
Cash, cash equivalents and marketable securities |
|
$ |
150,389 |
|
|
$ |
168,994 |
|
Total assets |
|
|
162,318 |
|
|
|
180,435 |
|
Total liabilities |
|
|
7,121 |
|
|
|
11,118 |
|
Total stockholders' equity |
|
|
155,197 |
|
|
|
169,317 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20230508005400/en/
Investor
Head of Investor Relations and Corporate Communications
(475) 47-RALLY (Ext. 282)
abavishi@rallybio.com
Stern Investor Relations, Inc.
212-362-1200
hannah.deresiewicz@sternir.com
Media
908-369-7168
Tara.dimilia@tmstrat.com
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