Page 1

-- -- Rallybio Corporation Reports Third Quarter 2021 Financial Results and Recent Business Highlights Initiated FNAIT natural history study to inform frequency of FNAIT risk in broad population and support future potential registration trial -- On - track to announce in 4Q 2021 additional clinical data from ongoing Phase 1/2 study of RLYB211 for prevention of FNAIT -- -- Executing across preclinical portfolio , with Phase 1 studies for RLYB212 and RLYB116 expected to initiate in 1Q 2022 -- New Haven , Conn . – November 10 , 2021 -- Rallybio Corporation ( Nasdaq : RLYB ) , a clinical - stage biotechnology company committed to identifying and accelerating the development of life - transforming therapies for patients with severe and rare diseases , today reported financial results for the third quarter ended September 30 , 2021 and provided an update on recent corporate developments . " We continue to work with unwavering commitment to deliver transformative impact to people living with severe and rare disorders , " said Martin Mackay , Ph.D. , Chief Executive Officer of Rallybio . " In the third quarter , our team focused on execution across our FNAIT franchise and advanced our efforts to better define the patient populations most at risk for disease through the initiation of our natural history study , while continuing to progress RLYB212 toward the clinic for the first quarter of 2022. We plan to report data from our ongoing Phase 1/2 trial of RLYB211 in the fourth quarter , which will provide further insight into the relationship between treatment duration and platelet clearance as well as inform our clinical development strategy for RLYB212 . In parallel , we continue to advance efforts across our broader portfolio . We expect to initiate a Phase 1 study of RLYB116 , our lead C5 inhibitor , in the first quarter of 2022 , and we continue to pursue the best science around the globe to expand our pipeline with new assets and partners . " Rallybio's current pipeline is focused on addressing diseases in the areas of hematology , immuno- inflammation , maternal fetal health , and metabolic disorders . Recent 2021 Business Highlights : In September 2021 , Rallybio initiated a fetal and neonatal alloimmune thrombocytopenia ( FNAIT ) natural history alloimmunization study . The prospective , non - interventional , multinational study is designed to determine the frequency of women at higher FNAIT risk among expectant mothers of different racial and ethnic characteristics , as well as the frequency of HPA - 1a alloimmunization and pregnancy outcomes among women identified to be at higher FNAIT risk . Data from this study will be used to support a future registration trial for RLYB212 , by providing historical controlled data to support a single - arm Phase 2/3 registration trial design , operationalizing de novo the laboratory test paradigm for FNAIT risk , and generating FNAIT laboratory test performance data for future regulatory discussions . Upcoming Milestones : • • • Rallybio plans to announce additional clinical data from the ongoing Phase 1/2 clinical trial of RLYB211 in the fourth quarter of 2021 . Rallybio remains on - track to initiate a Phase 1 study of RLYB212 in the first quarter of 2022 . RLYB212 is a monoclonal anti - HPA - 1a antibody in development for the prevention of FNAIT . Rallybio expects to initiate a Phase 1 study of RLYB116 in the first quarter of 2022. RLYB116 is a novel , potentially long - acting , subcutaneously administered inhibitor of complement factor 5 , or C5 , in development for the treatment of patients with paroxysmal nocturnal hemoglobinuria ( PNH ) and generalized Myasthenia Gravis ( gMG ) . Third Quarter 2021 Financial Results : • Research & Development ( R & D ) Expenses : R & D expenses were $ 5.0 million for the third quarter of 2021 , compared to $ 5.1 million for the same period in 2020. Consistent research and