{"id":54518,"date":"2023-03-06T14:07:44","date_gmt":"2023-03-06T13:07:44","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/rallybio-reports-fourth-quarter-and-full-year-2022-financial-results\/"},"modified":"2023-03-06T14:07:44","modified_gmt":"2023-03-06T13:07:44","slug":"rallybio-reports-fourth-quarter-and-full-year-2022-financial-results","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/rallybio-reports-fourth-quarter-and-full-year-2022-financial-results\/","title":{"rendered":"Rallybio Reports Fourth Quarter and Full Year 2022 Financial Results"},"content":{"rendered":"
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\n— Proof-of-Concept Achieved for RLYB212; Showed Rapid and Complete Elimination of Transfused HPA-1a Positive Platelets in HPA-1a Negative Subjects <\/i>—<\/i>\n<\/p>\n

\n— Phase 1 Multiple Dose Cohort RLYB212 Study Initiated —<\/i>\n<\/p>\n

\n— Phase 1 Multiple Ascending Dose Study of RLYB116 Continues to Progress; Safety, PK and PD Data Expected in 4Q 2023 —<\/i>\n<\/p>\n

\n— $169.0 million cash, cash equivalents and marketable securities as of December 31, 2022; Provides Runway into 1Q 2025 —<\/i>\n<\/p>\n

NEW HAVEN, Conn.–(BUSINESS WIRE)–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 fourth quarter and full year ended December 31, 2022 and provided an update on recent program and corporate developments.\n<\/p>\n

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\n\u201cIn 2023, we will fortify our position as a leader in the development of transformative medicines for underserved rare diseases,\u201d said Martin Mackay, Ph.D., Chief Executive Officer of Rallybio. \u201cEarlier today, we announced proof-of-concept for RLYB212, our product candidate for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT). These data show that RLYB212 was able to markedly accelerate the elimination of transfused HPA-1a positive platelets in HPA-1a negative subjects, supporting our development of RLYB212 as a potential first-in-class medicine to prevent HPA-1a alloimmunization and, ultimately, eliminate FNAIT. We are now enrolling the multiple dose cohort of our Phase 1 trial and look forward to sharing additional data in the fourth quarter of 2023.\u201d\n<\/p>\n

\nDr. Mackay continued, \u201cIn parallel, we are advancing our efforts across complement dysregulation, hematology and metabolic disorders. In the fourth quarter of 2022, we initiated a multiple ascending dose Phase 1 study of RLYB116, our inhibitor of complement component 5 (C5), and we look forward to sharing initial data from this study in the fourth quarter of 2023. In addition, we entered into a collaboration with AbCellera, under which we will co-develop programs for up to five rare disease targets. Following our offering of common stock and pre-funded warrants in November 2022, we believe our capital will enable us to advance our growing portfolio through upcoming milestones, and opportunistically invest in strategic business development transactions that may allow us to broaden our impact and deliver life-transforming therapies to patients globally.\u201d\n<\/p>\n

\nRecent Business Highlights and Upcoming Milestones:<\/b>\n<\/p>\n

\nMaternal Fetal Blood Disorders
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<\/i><\/b>Rallybio announced today that proof-of-concept has been achieved in a Phase 1b study for RLYB212, an anti-HPA-1a monoclonal antibody for the prevention of fetal and neonatal alloimmune thrombocytopenia. Results showed that one week after a single subcutaneous dose, RLYB212 was able to rapidly and completely eliminate transfused, HPA-1a positive platelets in HPA-1a negative subjects. RLYB212 was observed to be well-tolerated with no serious adverse events reported.\n<\/p>\n

\nThe Company believes that the broad range of pharmacokinetic and pharmacodynamic data in the Phase 1b study will allow for substantive modeling to inform dose selection for a future registrational study.\n<\/p>\n

\nThe Company expects to report data from the Phase 1b clinical study of RLYB212 at a scientific conference in 2023.\n<\/p>\n

\nRallybio also announced today that testing in the multiple dose cohort of its Phase 1 trial in Europe initiated in the first quarter of 2023. This portion of the Phase 1 study will evaluate safety and pharmacokinetics of RLYB212 based on repeat dosing over 12 weeks in healthy male and female participants. The Company expects results from this cohort of subjects in the fourth quarter of 2023.\n<\/p>\n

\nThe Company continues to advance the FNAIT natural history alloimmunization study. This non-interventional study is designed to inform on the frequency of women at higher risk for FNAIT across a broad population of pregnant women of different racial and ethnic characteristics, and the occurrence of HPA-1a alloimmunization in these women. The Company expects that the data from this study will contribute to a control dataset for a future single armed registration trial for RLYB212.\n<\/p>\n

\nGiven the favorable development profile of RLYB212 as compared to RLYB211 to date, the data generated to date for RLYB212, and the expected manufacturing and supply efficiencies for RLYB212, the Company will not continue development of RLYB211, a plasma-derived polyclonal anti-HPA-1a antibody.\n<\/p>\n

\nComplement Dysregulation
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<\/i><\/b>Rallybio initiated dosing in the first multiple ascending dose cohort of a Phase 1 study of RLYB116 in the fourth quarter of 2022. RLYB116 is a novel, potentially long-acting, subcutaneously administered inhibitor of C5 in development for the treatment of patients with complement-related diseases. The single-blind, dose escalation, placebo-controlled study is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of RLYB116 in healthy participants.\n<\/p>\n

\nThe Company expects initial data from the multiple ascending dose cohort in the fourth quarter of 2023.\n<\/p>\n

\nRallybio continues to advance development of RLYB114, formulated for intravitreal injection, for the treatment of ophthalmic disorders.\n<\/p>\n

\nRallybio and EyePoint Pharmaceuticals, Inc. announced in February 2023 a research collaboration to explore and assess the viability of utilizing Rallybio\u2019s inhibitor of complement component 5 (C5) in EyePoint\u2019s Durasert\u00ae<\/sup>technology for sustained intraocular delivery. The initial focus will be on geographic atrophy, an advanced form of age-related macular degeneration that leads to irreversible vision loss.\n<\/p>\n

\nMetabolic Disorders
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<\/i><\/b>Rallybio, together with its partner Exscientia, continues to work toward the selection of a small molecule development candidate to advance into the clinic targeting ENPP1 for the treatment of patients with hypophosphatasia (HPP). In vivo efficacy data is expected in the second half of 2023. Following those results, we expect to commence investigational new drug (IND)-enabling studies.\n<\/p>\n

\nIn December 2022, Rallybio announced a strategic alliance with AbCellera to discover, develop, and commercialize novel antibody-based therapeutics for rare diseases. Under the terms of the agreement, AbCellera and Rallybio will co-develop up to five rare disease therapeutic targets, which will be chosen together by both companies. The partnership\u2019s first program will focus on addressing the significant unmet therapeutic needs of patients with rare metabolic diseases.\n<\/p>\n

\nHematological Disorders
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<\/i><\/b>Rallybio continues to conduct IND-enabling activities for RLYB331, a preclinical, potentially first-in-class therapeutic monoclonal antibody that inhibits Matriptase-2 (MTP-2), to support the transition of this asset into clinical development.\n<\/p>\n

\nCorporate Updates
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<\/i><\/b>In January 2023, Rallybio announced the appointment of Jonathan I. Lieber as Chief Financial Officer (CFO), effective February 1, 2023. Mr. Lieber succeeds Jeffrey Fryer, CPA, Rallybio\u2019s Co-Founder and former CFO. The Company announced Mr. Fryer\u2019s retirement in June 2022, and following a transition period with Mr. Lieber, Mr. Fryer departed the company on February 15, 2023.\n<\/p>\n

\nIn November 2022, Rallybio consummated a follow-on offering of common stock and pre-funded warrants that raised approximately $55.0 million in gross proceeds.\n<\/p>\n

\nFourth Quarter and Full Year 2021 Financial Results:<\/b>\n<\/p>\n