Rallybio Reports First Quarter 2024 Financial Results and Provides Business Updates
Rallybio (Nasdaq: RLYB) reported first quarter 2024 financial results, highlighting $94.2 million in cash as of March 31, 2024. The company is on track to start a Phase 2 trial for RLYB212 in pregnant women at higher risk of FNAIT in the second half of 2024. Rallybio also announced a collaboration with Johnson & Johnson, received an equity investment of $6.6 million, and is prioritizing its portfolio with a focus on RLYB212 and RLYB116. The company continues to progress in its clinical programs and expects to share additional data in the second half of 2024.
Rallybio is well-funded with $94.2 million in cash, cash equivalents, and marketable securities as of March 31, 2024, providing financial stability and runway into mid-2026.
The collaboration with Johnson & Johnson and the equity investment of $6.6 million signify a significant step forward for Rallybio in advancing complementary therapeutic solutions for pregnant women at risk of FNAIT.
The prioritization of the company's portfolio and focus on Phase 2 ready assets, RLYB212 and RLYB116, demonstrate a strategic approach to resource allocation and efficiency in advancing transformative therapies.
R&D expenses increased to $12.9 million in the first quarter of 2024, primarily due to payroll and personnel-related costs, including severance costs from a 45% workforce reduction, impacting the company's financial performance.
The net loss of $19.0 million for the first quarter of 2024, compared to $17.3 million in the same period in 2023, reflects ongoing challenges in controlling expenses and achieving profitability.
Rallybio's focus on clinical-stage assets may hinder the progress of its preclinical programs, potentially limiting the exploration of alternative therapeutic avenues and value creation for stakeholders.
Insights
The increase in Research & Development (R&D) expenses for Rallybio can be attributed to strategic changes in the company's workforce, evidenced by severance costs arising from a 45% workforce reduction. This action suggests a reorientation of resources towards high-potential projects such as RLYB212 and RLYB116. Investors should note that such reductions can lead to short-term cost savings but may also raise concerns about the company's ability to execute long-term plans.
The decrease in General & Administrative (G&A) expenses indicates a more streamlined operational cost structure, potentially improving the company's overall financial efficiency. However, investors should watch for any impact these cost reductions may have on the company's operational capacity and governance. The anticipated cash runway extending into mid-2026 provides a measure of financial stability, allowing investors to anticipate no immediate need for dilutive financing.
While the net loss has increased compared to the previous year, it is common for clinical-stage biotech companies to incur losses due to heavy R&D investment. The current cash position of
The progression towards the Phase 2 trial of RLYB212 indicates that Rallybio is moving forward in the clinical development pipeline, which is important for investors tracking the company's milestones. The drug's focus on preventing Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) represents a niche but significant market opportunity. The collaboration with Johnson & Johnson could be leveraged not only to amplify resource allocation to this project but also to enhance credibility and broaden the scope of awareness programs.
Insights from the ongoing FNAIT natural history study and the partnership with HealthLumen for epidemiological analysis are poised to provide valuable data that can refine market understanding and potential. These developments may underpin the stock's value by positioning Rallybio as a leader in addressing FNAIT.
The stock market typically reacts favorably to positive clinical trial news and partnerships with industry giants. The precise impact on Rallybio's stock will depend on the outcomes of the announced initiatives and the investors' perception of the company's capacity to capitalize on its clinical assets.
Rallybio's strategic collaboration with Johnson & Johnson's Momenta Pharmaceuticals harnesses synergies that may enhance its market position. Such alliances often generate positive market sentiment as they may lead to enhanced R&D capabilities, shared risks and an expanded network of expertise. Rallybio's approach to prioritizing two Phase 2 ready assets demonstrates a focused strategy that can be appealing to investors who prefer companies with a clear direction.
Furthermore, the company seeking alternative options for its preclinical programs indicates a pragmatic allocation of resources towards the most commercially viable projects. This could reassure investors about the company's commitment to efficiency and value creation, potentially having a favorable effect on the stock's attractiveness.
- On Track to Initiate RLYB212 Phase 2 Dose Confirmation Trial in Pregnant Women at Higher Risk of FNAIT in 2H 2024 -
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“This year is off to a strong start as we continue to progress towards the initiation of our Phase 2 dose confirmation trial for RLYB212 in pregnant women at higher risk of FNAIT, which is on track for the second half of 2024," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "Last month, we were particularly pleased to announce our collaboration with Johnson & Johnson, marking a significant step forward in our mission to eliminate FNAIT and its devastating consequences. Together with Johnson & Johnson, we look forward to further driving awareness of FNAIT, emphasizing the importance of screening for FNAIT risk, and advancing our complementary therapeutic approaches, which aim to ensure all pregnant women at risk of FNAIT have a potential treatment option regardless of their alloimmunization status."
Dr. Uden continued, "In the near-term, we look forward to sharing initial data from an epidemiologic analysis investigating the genetic markers of FNAIT risk in a racially and ethnically diverse population beyond the Caucasian population, where FNAIT risk has been better established in published literature. This analysis will more accurately inform the number of pregnant women at higher risk for FNAIT annually. We expect that these data combined with data from our ongoing FNAIT natural history study will further emphasize the need for a preventative therapeutic and identify a market opportunity for RLYB212 that is larger than our current estimates."
Recent Business Highlights and Upcoming Milestones:
Corporate Updates
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In April 2024, Rallybio announced a collaboration with Momenta Pharmaceuticals, Inc., a Johnson & Johnson Company, to advance complementary therapeutic solutions for pregnant women at risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT). Rallybio received an equity investment of
$6.6 million
-
In February 2024, Rallybio announced a prioritization of its portfolio and a
45% workforce reduction to focus the Company’s resources on its two Phase 2 ready assets, RLYB212, a novel human monoclonal anti-HPA-1a antibody in development for the prevention of FNAIT, and RLYB116, a once-weekly, low volume subcutaneously injected inhibitor of complement component 5 (C5) in development for patients with complement-mediated diseases.
RLYB212 Program
- Rallybio is on track to initiate a Phase 2 trial in pregnant women at higher risk for HPA-1a alloimmunization and FNAIT in the second half of 2024. The primary objectives of this trial are to assess the pharmacokinetics and safety of subcutaneously administered RLYB212 in pregnant women. Secondary objectives include assessments of pregnancy and neonatal outcomes, and the occurrence of emergent HPA-1a alloimmunization. Administration of RLYB212 will be initiated by Gestational Week 16 and continue every 4 weeks through parturition.
- Screening in the Company's FNAIT natural history study is ongoing. This study is designed to provide a contemporary dataset for HPA-1a alloimmunization frequency in a racially and ethnically diverse population. As of May 1, 2024, Rallybio has screened approximately 10,000 pregnant women. The FNAIT natural history study is designed to run in parallel with the Phase 2 study and to continue through to initiation of the planned Phase 3 trial to enable seamless transition of participating sites into the registration trial.
- To better understand the frequency of HPA-1a-negative, HLA-DRB3*01:01-positive status in a broad and diverse population, Rallybio partnered with HealthLumen, a leader in epidemiological modeling of rare genetic diseases, to conduct an epidemiologic analysis utilizing information from large genomic datasets. Rallybio expects data from this analysis to be disclosed in mid-2024.
- Several presentations and publications are expected in the second half of 2024, including additional data from the Phase 1b proof-of-concept study and an integrated summary of clinical and nonclinical data supporting the RLYB212 Phase 2 dose.
RLYB116 Program
- RLYB116 manufacturing work continues and is on track to complete in the second half of 2024. Furthermore, additional biomarker development work is underway to further evaluate results of the Phase 1 multiple ascending dose (MAD) study, which was completed in the fourth quarter of 2023. Rallybio expects to provide an update on this analysis and future development plans for RLYB116 in the second half of 2024.
Preclinical Programs
Rallybio continues to believe that its preclinical programs have the potential to address significant existing unmet needs for patients and caregivers and bring meaningful value to stakeholders. Given Rallybio's focus of current capital and resources on its clinical-stage assets, primarily RLYB212, the Company is seeking alternative options to further advance its preclinical programs, including partnerships and other forms of non-dilutive financing.
- RLYB332: In the first quarter of 2024, Rallybio completed nonclinical studies that demonstrated favorable tolerability, dose-dependent pharmacokinetics, and sustained pharmacodynamic effects with RLYB332, a long-acting version of the RLYB331 anti-Matriptase-2 antibody. These findings support the continued development of RLYB332 as a potentially best-in-class therapeutic for treating diseases of iron overload. Presentation of this data is expected in the second half of 2024.
- RLYB114, EyePoint Collaboration: EyePoint has demonstrated feasibility for sustained delivery of Rallybio’s inhibitor of C5 using EyePoint’s proprietary intraocular drug delivery technology, and optimization work is ongoing.
First Quarter 2024 Financial Results
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Research & Development (R&D) Expenses: R&D expenses were
$12.9 million $11.2 million
-
General & Administrative (G&A) Expenses: G&A expenses were
$6.9 million $7.2 million
-
Net Loss and Net Loss Per Common Share: Rallybio reported a net loss of
$19.0 million $0.47 $17.3 million $0.43
-
Cash Position: As of March 31, 2024, cash, cash equivalents, and marketable securities were
$94.2 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
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 timing of initiation of the Phase 2 dose confirmation study for RLYB212, the release of screening numbers of women in the natural history study, whether the results of the natural history study and the planned Phase 2 dose confirmation study will be sufficient to support design and implementation of a Phase 3 registrational study for RLYB212, whether the manufacturing work for RLYB116 will be timely completed or successful, the timing of the availability of data from our clinical studies, 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 based on the results of the genomic analysis, our estimates of the market opportunity for RLYB212, the timing of publications relating to FNAIT and RLYB212, the timing of completion of the RLYB116 biomarker work, the timing of achieving milestones in 2024 for our preclinical programs, the likelihood that Rallybio will be successful in developing RLYB212, RLYB116, or any of our other product candidates, our ability to successfully identify and implement alternative and acceptable options to further advance our programs, our estimates of our capital requirements and the sufficiency thereof, and our cash runway. 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 2 clinical trial for RLYB212, 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 enter into strategic partnerships or other arrangements, competition from other biotechnology and pharmaceutical companies, and those risks and uncertainties described in Rallybio’s filings with the
Financial Tables
RALLYBIO CORPORATION SELECTED CONDENSED CONSOLIDATED FINANCIAL INFORMATION
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) |
|||||||
|
FOR THE THREE MONTHS ENDED MARCH 31, |
||||||
(in thousands, except share and per share amounts) |
|
2024 |
|
|
|
2023 |
|
Operating expenses: |
|
|
|
||||
Research and development |
$ |
12,936 |
|
|
$ |
11,202 |
|
General and administrative |
|
6,851 |
|
|
|
7,172 |
|
Total operating expenses |
|
19,787 |
|
|
|
18,374 |
|
Loss from operations |
|
(19,787 |
) |
|
|
(18,374 |
) |
Other income: |
|
|
|
||||
Interest income |
|
1,276 |
|
|
|
1,546 |
|
Other income |
|
167 |
|
|
|
73 |
|
Total other income, net |
|
1,443 |
|
|
|
1,619 |
|
Loss before equity in losses of joint venture |
|
(18,344 |
) |
|
|
(16,755 |
) |
Loss on investment in joint venture |
|
685 |
|
|
|
563 |
|
Net loss |
$ |
(19,029 |
) |
|
$ |
(17,318 |
) |
|
|
|
|
||||
Net loss per common share, basic and diluted |
$ |
(0.47 |
) |
|
$ |
(0.43 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
40,773,615 |
|
|
|
40,248,893 |
|
|
|
|
|
||||
Other comprehensive (loss) gain: |
|
|
|
||||
Net unrealized (loss) gain on marketable securities |
|
(86 |
) |
|
|
153 |
|
Other comprehensive (loss) gain |
|
(86 |
) |
|
|
153 |
|
Comprehensive loss |
$ |
(19,115 |
) |
|
$ |
(17,165 |
) |
Condensed Consolidated Balance Sheets (Unaudited) |
|||||
(in thousands) |
MARCH 31,
|
|
DECEMBER 31,
|
||
Cash, cash equivalents and marketable securities |
$ |
94,175 |
|
$ |
109,929 |
Total assets |
|
99,359 |
|
|
115,620 |
Total liabilities |
|
10,202 |
|
|
9,436 |
Total stockholders' equity |
|
89,157 |
|
|
106,184 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240508082564/en/
Investors
Samantha Tracy
Rallybio Corporation
(475) 47-RALLY (Ext. 282)
investors@rallybio.com
Kevin Lui
Stern Investor Relations, Inc.
(760) 579-2134
Kevin.Lui@sternir.com
Media
Victoria Reynolds
Mission North
(760) 579-2134
rallybio@missionnorth.com
Source: Rallybio Corporation
FAQ
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