Rallybio Announces Portfolio Prioritization and Provides Corporate Update
- Prioritization of Phase 2-ready clinical-stage programs
- Anticipated cost savings with a 45% workforce reduction
- Cash runway extended into mid-2026
- Progress in the manufacturing work for RLYB116
- Potential to address significant unmet needs for patients and caregivers with preclinical programs
- 45% workforce reduction resulting in aggregate charges of approximately $3.3 million
- 19 positions to be reduced by the end of the first quarter of 2024
Insights
The decision by Rallybio Corporation to reduce its workforce by 45% and prioritize its clinical-stage programs RLYB212 and RLYB116 is a strategic move aimed at extending the company's cash runway until mid-2026. The reduction in workforce is expected to incur approximately $3.3 million in charges, primarily for severance and benefits. This action reflects a broader trend within the biotech industry, where companies often face the challenge of balancing the high costs of drug development with the need to manage cash burn rates effectively. Investors may view this cost-cutting measure as a necessary step to ensure the longevity of the company, particularly in a capital-intensive industry where the timeline to profitability can be extended.
From a financial perspective, the focus on RLYB212 and RLYB116 could indicate that these programs have shown promising results and may have a higher probability of success or potential market value. The prioritization of these programs suggests that Rallybio is aiming to allocate resources towards areas with the most significant potential return on investment. However, the reduction in workforce does raise questions about the company's ability to meet future operational needs and the potential impact on morale and productivity.
Investors will likely monitor the progress of the Phase 2 discussions and the updates on manufacturing work for RLYB116, as these milestones could have significant implications for the company's valuation and future funding requirements. The cash position of approximately $109.9 million, as of the end of 2023, appears sufficient to support the company's revised operating plan, but the success of the prioritized programs will be critical in determining Rallybio's financial health in the long term.
Rallybio's prioritization of RLYB212, aimed at preventing fetal and neonatal alloimmune thrombocytopenia (FNAIT) and RLYB116, a C5 inhibitor for complement-mediated diseases, highlights a strategic focus on areas with unmet medical needs. FNAIT is a rare condition that can lead to severe bleeding in fetuses and newborns and current treatment options are limited. A successful monoclonal antibody like RLYB212 could potentially transform the standard of care and offer a prophylactic solution. The ongoing non-interventional study to understand HPA-1a alloimmunization frequency is crucial as it informs the prevalence and potential market size for the therapy.
RLYB116's development for complement-mediated diseases, including generalized myasthenia gravis, paroxysmal nocturnal hemoglobinuria and antiphospholipid syndrome, targets a range of conditions with significant morbidity. The mention of improved tolerability at higher doses is promising, as it could enhance the drug's efficacy profile and competitive positioning in the market. The manufacturing enhancements are also noteworthy as they could lead to a broader therapeutic window and improved patient outcomes.
The updates on preclinical programs and partnerships, such as with Exscientia and AbCellera, are indicative of Rallybio's commitment to leveraging advanced technologies and collaborations to fuel its pipeline. While these programs are still in early stages, their progress towards key milestones in 2024 will be closely watched by stakeholders interested in the company's long-term research and development capabilities.
In the biopharmaceutical market, the prioritization of certain clinical programs often leads to a realignment of company resources and a reassessment of strategic partnerships. Rallybio's focus on RLYB212 and RLYB116 reflects an analysis of market trends and the identification of niche areas where the company can potentially establish a strong presence. The decision to engage in cost-saving measures like workforce reduction is not uncommon in the biotech sector, especially for companies that are in the clinical trial phase without revenue-generating products.
The anticipated updates on manufacturing work and development plans for RLYB116 in the second half of 2024 will be critical for investors and industry analysts who track advancements in treatment options for complement-mediated diseases. The potential for RLYB116 to treat a broader range of diseases could open up new market opportunities and drive Rallybio's growth. The collaboration with EyePoint to evaluate sustained intraocular drug delivery using Rallybio's C5 inhibitor could also tap into the ophthalmology market, which has a high demand for innovative treatment modalities.
Overall, the strategic decisions taken by Rallybio are reflective of a company seeking to navigate the complexities of drug development while positioning itself for future success. The biotech market will continue to monitor the company's progress, as the successful advancement of its clinical and preclinical programs could significantly impact its market position and investor confidence.
– Prioritization of Phase 2-ready clinical-stage programs: RLYB212 for the prevention of FNAIT and RLYB116, a C5 inhibitor for the treatment of patients with complement-mediated diseases –
– Anticipated cost savings, including a
“Following a thorough review of our business, we have made the decision to prioritize our portfolio. We believe that these difficult but necessary decisions to streamline our operations and align resources are critical to extend our cash runway, support the advancement of our two clinical-stage programs, and put us on a path toward long-term success,” said Stephen Uden, M.D. Chief Executive Officer of Rallybio.
“I would like to personally thank our departing employees for their countless contributions and tireless commitment to our mission,” Dr. Uden continued. “It is incredibly difficult to part ways with these talented members of the Rallybio team who have demonstrated such dedication to bringing transformative therapies to patients in need.”
Key Elements of Portfolio Prioritization and Corporate Update
Prioritization of Clinical-Stage Programs
RLYB212
- The Company plans to provide an update on Phase 2 discussions for RLYB212 with the European Medicines Agency (EMA) in the first half of 2024.
- Rallybio continues to expect to initiate a Phase 2 dose confirmation study for RLYB212 in pregnant women at higher risk of FNAIT in the second half of 2024.
- The Company continues to screen mothers in the FNAIT natural history alloimmunization study, a non-interventional study designed to provide a contemporary dataset for HPA-1a alloimmunization frequency in a racially and ethnically diverse population. Rallybio expects to provide an update on screening numbers in its full-year earnings release in March 2024.
RLYB116
- Manufacturing work announced in December 2023 is progressing, and Rallybio is encouraged by data indicating the potential to achieve improved tolerability at higher doses of RLYB116.
- While the exposure levels of RLYB116 demonstrated in the Phase 1 study are expected to be suitable for the treatment of patients with generalized myasthenia gravis, the Company believes the ongoing enhancements will enable higher exposure to RLYB116, supporting the treatment of patients with a broader range of complement-mediated diseases, including paroxysmal nocturnal hemoglobinuria and antiphospholipid syndrome.
- Rallybio continues to expect to complete this manufacturing work and provide an update on the development plan for RLYB116 in the second half of 2024.
Preclinical Program Update
The Company 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. The revised operating plan will fund preclinical program activities to important 2024 milestones, as described below. Beyond achievement of these milestones, Rallybio will seek alternative options to further advance these programs, including additional partnerships and other forms of non-dilutive financing.
- RLYB331, Matriptase-2 (MTP-2) Inhibitor: Completion of the ongoing preclinical activities, with data expected in the first half of 2024.
- ENPP1 Inhibitor, Exscientia Partnership: Lead AI-designed compounds enter candidate selection process in the second half of 2024.
- AbCellera Partnership: Advancement of discovery efforts to the next research milestone in the second half of 2024.
- RLYB114, EyePoint Collaboration: The evaluation of Rallybio’s C5 inhibitor using EyePoint’s proprietary technology for sustained intraocular drug delivery is ongoing. An update is expected in the first half of 2024.
Workforce Reduction
The Company will implement a
Based on the above actions, Rallybio’s cash, cash equivalents and marketable securities of approximately
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, our expectations regarding the usefulness of data from our clinical studies, 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, expected costs related to the workforce reduction and related charges, including the timing of such charges, the expected use of operating cost savings associated with the updated operating plan and the timing, 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 studies, and complete such clinical studies 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
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Investors
Ami Bavishi
Head of Investor Relations and Communications
475-47-RALLY (Ext. 282)
abavishi@rallybio.com
Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
hannah.deresiewicz@sternir.com
Media
Lauren Cohen
Mission North
410-570-2497
lcohen@missionnorth.com
Source: Rallybio Corporation
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