Rallybio Reports Second Quarter 2023 Financial Results and Provides Business Updates
-- RLYB212 Phase 1b Proof-of-Concept Study Results Presented at the 31st
-- 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 --
--
“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
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
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.
The Company also continues to advance the FNAIT natural history alloimmunization study. In
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
Corporate Updates
On August, 1, 2023,
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
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
Financial Tables
|
|||||||||||||||
|
FOR THE THREE MONTHS ENDED |
|
FOR THE SIX MONTHS ENDED |
||||||||||||
(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 |
|||||
(in thousands) |
|
|
|
||
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
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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