Rallybio Reports Third Quarter 2024 Financial Results and Provides Business Updates
RLYB 11.07.2024
Drug:RLYB-212 RLYB212
Drug:RLYB-116 RLYB116
Diseases:Fetal and Neonatal Alloimmune Thrombocytopenia
Diseases:generalized myasthenia gravis
Date of Upcoming Event:2024-12-07
Name of Upcoming Event:American Society of Hematology (ASH) Annual Meeting
About Gravity Analytica
Recent News
- 01.10.2025 - Rallybio Highlights 2024 Accomplishments and Anticipated Milestones for 2025
- 12.10.2024 - Rallybio Announces Promising RLYB212 and RLYB332 Preclinical Data at the 66th American Society of Hematology Annual Meeting
- 12.04.2024 - be 2024 Evercore ISI HealthCONx Conference
Recent Filings
—CTA Approvals Received for RLYB212 Phase 2 Clinical Trial; On Track to Initiate Screening in 4Q 2024—
—
“Advancing RLYB212 into a Phase 2 trial marks a significant achievement for
Recent Business Highlights and Upcoming Milestones:
RLYB212 Program
Rallybio announced the approval of its CTAs for the RLYB212 Phase 2 dose confirmation trial in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT. With these approvals from theEuropean Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), activation of clinical sites is underway and screening is on track to begin in the fourth quarter of 2024.
- Screening continues in the Company's FNAIT natural history study, with more than 13,000 pregnant women screened as of
November 1, 2024 .Rallybio has now transitioned European sites from the natural history study to the Phase 2 trial, where the sites will continue to collect natural history data in those women at higher risk for HPA-1a alloimmunization who do not receive RLYB212.
- Results from the Phase 1b proof-of-concept study were published inThrombosis and Haemostasisin
August 2024 . Additional publications, including the rationale and modeling that support the RLYB212 Phase 2 dose regimen, are expected later this year.
- Data from a preclinical model demonstrating that prophylactic administration of RLYB212 safely and effectively prevents FNAIT in pregnant mice will be presented at the
American Society of Hematology (ASH) Annual Meeting being heldDecember 7 – 10 inSan Diego, CA.
Title:
This poster was also selected for the ASH Poster Walk onHemostasis and Thrombosis: from Basic Concepts to Clinical Applications Hosted by Blood Vessels, Thrombosis & Hemostasis,which will take place on
Rallybio presented full data from an epidemiological analysis that provided the first robust evidence quantifying the proportion of women of non-Caucasian ancestries that carry the genetic markers for higher FNAIT risk (HPA-1a negative, HLA-DRB3*01:01 positive) at the NORD Rare Diseases and Orphan Products Breakthrough Summit, which was heldOctober 20 – 22 inWashington D.C. , and at theAmerican Society of Human Genetics (ASHG) Annual Meeting, which is being heldNovember 5 – 9 inDenver, CO. Based on the data, it is estimated that more than 30,000 pregnancies each year are at higher risk for FNAIT inNorth America and major European countries alone.
RLYB116 Program
- RLYB116 manufacturing work was successfully completed in the third quarter of 2024.
Rallybio expects that the process enhancements from this manufacturing work will improve the tolerability of RLYB116.
- Additional complement biomarker characterization has been completed. These results, when taken together with Phase 1 MAD data, indicate that RLYB116 led to greater sustained reductions in free C5 than initially understood. Based on these analyses,
Rallybio believes that there is an opportunity to pursue indications beyond generalized myasthenia gravis, including paroxysmal nocturnal hemoglobinuria and antiphospholipid syndrome at doses tested in the Phase 1 MAD study.
- In
December 2024 ,Rallybio expects to provide updates on the manufacturing process enhancements and biomarker characterization as well as future plans for RLYB116.
Preclinical Programs
In accordance with its 2024 operating plan,
- RLYB332:Nonclinical data evaluating RLYB332, a long-acting version of the RLYB331 anti-matriptase-2 antibody, will be presented at the upcoming ASH Annual Meeting.
Title:Long-Acting Anti-Matriptase-2 Antibody as a Potentially Best-in-Class Therapy for Iron Overload DiseasesPublication Number:3854Session
- ENPP1 Inhibitor,
Exscientia Partnership :Rallybio andExscientia remain on track to nominate an ENPP1 inhibitor development candidate for the treatment of patients with hypophosphatasia (HPP) inDecember 2024 . Data from an early lead ENPP1 inhibitor in a model of HPP was presented at theAmerican Society for Bone and Mineral Research (ASBMR) meeting in September. The data demonstrated that oral dosing of REV101 to adult HPP mice lowered inorganic pyrophosphate (PPi) by 30%, leading to improvements in mineralization of long and vertebrate bones. Furthermore, data showed that ENPP1 inhibition was safe and well-tolerated. Data also showed, for the first time, that ENPP1 is a druggable target for later-onset HPP.
Corporate Updates
Rallybio was named to the 2024 Fierce 50 List as an Innovation Honoree.
Third Quarter 2024 Financial Results
- Revenue:Revenue was
$0.3 million for the third quarter of 2024, compared to no revenue in the same period in 2023. The increase was related toRallybio's entrance into the collaboration agreement with Johnson & Johnson in the second quarter of 2024 and the recognition of revenue related to the collaboration's performance obligations.
- Research & Development (R&D) Expenses:R&D expenses were
$8.2 million for the third quarter of 2024, compared to$13.3 million for the same period in 2023. The decrease in R&D expense was primarily due to a decrease in development costs related to RLYB116 and RLYB212, in addition to a decrease in payroll and personnel-related costs, largely related to the workforce reduction and lower ongoing headcount in 2024 as compared to 2023.
- General & Administrative (G&A) Expenses:G&A expenses were
$4.1 million for the third quarter of 2024, compared to$6.1 million for the same period in 2023. The decrease in G&A expense was primarily related to lower payroll and personnel-related costs, largely related to the workforce reduction and lower ongoing headcount in 2024 as compared to 2023, and reductions in other related general and administrative expenses, including a reduction in consulting fees.
- Net Loss and Net Loss Per Common Share:
Rallybio reported a net loss of$11.5 million , or$0.26 per common share, for the third quarter of 2024. This compares to a net loss of$18.4 million , or$0.45 per common share, for the third quarter of 2023.
- Cash Position:As of
September 30, 2024 , cash, cash equivalents, and marketable securities were$75.1 million .
About
Forward-Looking StatementsThis 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 clinical trial for RLYB212, whether the results of the FNAIT natural history study and the planned RLYB212 Phase 2 trial will be sufficient to support design and implementation of a Phase 3 registrational study for RLYB212, whether the manufacturing work for RLYB116 will result in improved tolerability, if and when tested in a clinical trial, 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 and our estimates of the number of women at higher risk for FNAIT in
Financial Tables
Condensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited)
FOR THE THREE MONTHS ENDED | FOR THE NINE MONTHS ENDED | ||||||||||||||
(in thousands, except share and per share amounts) | 2024 | 2023 | 2024 | 2023 | |||||||||||
Revenue: | |||||||||||||||
Collaboration and license revenue | $ | 299 | $ | — | $ | 598 | $ | — | |||||||
Total revenue | 299 | — | 598 | — | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 8,240 | 13,288 | 34,122 | 37,620 | |||||||||||
General and administrative | 4,125 | 6,075 | 15,364 | 20,200 | |||||||||||
Total operating expenses | 12,365 | 19,363 | 49,486 | 57,820 | |||||||||||
Loss from operations | (12,066 | ) | (19,363 | ) | (48,888 | ) | (57,820 | ) | |||||||
Other income: | |||||||||||||||
Interest income | 986 | 1,545 | 3,405 | 4,699 | |||||||||||
Other income | 251 | 92 | 561 | 227 | |||||||||||
Total other income, net | 1,237 | 1,637 | 3,966 | 4,926 | |||||||||||
Loss before equity in losses of joint venture | (10,829 | ) | (17,726 | ) | (44,922 | ) | (52,894 | ) | |||||||
Loss on investment in joint venture | 637 | 648 | 1,809 | 1,428 | |||||||||||
Net loss | $ | (11,466 | ) | $ | (18,374 | ) | $ | (46,731 | ) | $ | (54,322 | ) | |||
Net loss per common share, basic and diluted | $ | (0.26 | ) | $ | (0.45 | ) | $ | (1.08 | ) | $ | (1.35 | ) | |||
Weighted-average common shares outstanding, basic and diluted | 44,593,221 | 40,531,497 | 43,170,177 | 40,382,625 | |||||||||||
Other comprehensive loss: | |||||||||||||||
Net unrealized gain (loss) on marketable securities | 240 | 64 | 154 | 6 | |||||||||||
Other comprehensive gain (loss) | 240 | 64 | 154 | 6 | |||||||||||
Comprehensive loss | $ | (11,226 | ) | $ | (18,310 | ) | $ | (46,577 | ) | $ | (54,316 | ) | |||
Condensed Consolidated Balance Sheets(Unaudited)
(in thousands) | |||||
Cash, cash equivalents and marketable securities | $ | 75,139 | $ | 109,929 | |
Total assets | 79,007 | 115,620 | |||
Total liabilities | 8,189 | 9,436 | |||
Total stockholders' equity | 70,818 | 106,184 | |||
View source version onbusinesswire.com:https://www.businesswire.com/news/home/20241106127609/en/
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