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We are not currently profitable, and we may never achieve or sustain profitability; If we continue to progress the development of our product candidates, we will require significant additional capital to fund our operations.
If we continue to progress the development of our product candidates and fail to obtain necessary financing, we may not be able to complete the development or commercialization of RLYB116 or any other product candidate.
Given our limited resources and access to capital, we may decide to prioritize development of certain product candidates, the choice of which may prove to be wrong and adversely affect our business; Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our intellectual property or product candidates; Our failure to meet the listing standards of the Nasdaq Stock Market LLC, ("Nasdaq"), could result in the delisting of our common stock.
Delisting could adversely affect the liquidity of our common stock and the market price of our common stock could decrease, and our ability to obtain sufficient additional capital to fund our operations and to continue to operate as a going concern would be substantially impaired; We are heavily dependent on the success of RLYB116, which is in early-stage clinical development.
We must be able to successfully identify patients and capture a significant market share to achieve profitability and growth; We face significant competition from biotechnology and pharmaceutical companies, and if we continue to progress the development of our product candidates, our operating results will suffer if we fail to compete effectively; If we continue to progress the development of our product candidates, we may pursue business development transactions and collaborate with third parties for the development and commercialization of our product candidates.
Our lead program, RLYB116, is a differentiated complement component 5 ( C5 ) inhibitor with the potential to treat diseases of complement dysregulation.
In addition, RLYB332, a long-acting matriptase-2 ("MTP-2") antibody for the treatment of diseases of iron overload, is currently in preclinical development.
Recent Developments On March 1, 2026, we entered into an Agreement and Plan of Merger and Reorganization (the Merger Agreement ) with Candid, a clinical-stage biotechnology company advancing a leading portfolio of T-cell engager ("TCE") therapeutics for autoimmune diseases, and Farmington Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Rallybio ( Merger Sub ).
Upon the terms and subject to the satisfaction of the conditions described in the Merger Agreement, Merger Sub will be merged with and into Candid, with Candid surviving as a wholly owned subsidiary of Rallybio (the Merger ).
The Merger is intended to qualify as a tax-free reorganization for U.S.
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These risks include the following: We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the foreseeable future.
We are not currently profitable, and we may never achieve or sustain profitability; We will require significant additional capital to fund our operations.
If we fail to obtain necessary financing, we may not be able to complete the development or commercialization of RLYB212, RLYB116 or any other product candidate.
We must be able to successfully identify patients and capture a significant market share to achieve profitability and growth; The FDA, EMA or other comparable foreign regulatory authorities could require the clearance or approval of an in vitro diagnostic or companion diagnostic device as a condition of approval for any product candidate that requires or would commercially benefit from such tests, including RLYB212.
Since our launch in January 2018, we have built a broad pipeline of promising product candidates aimed at addressing diseases with unmet medical need in the areas of maternal fetal health, complement dysregulation, hematology, and metabolic disorders.
Our two most advanced programs are in clinical development: 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.
RLYB212 is currently in a Phase 2 clinical trial in pregnant women, and we plan to initiate a confirmatory pharmacokinetics ( PK ) and pharmacodynamics ("PD") study of RLYB116 in the second quarter of 2025.
Our Approach At Rallybio Corporation ( Rallybio or the "Company"), we do not accept that millions of patients suffering from devastating rare diseases should have to live without transformative treatments.
There are an estimated 25 to 30 million people affected by as many as 7,000 rare diseases in the United States alone, with a significantly greater number affected globally.
Our goal is to transform the lives of these individuals through the development of therapeutics that provide meaningful clinical benefits.