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Investor releaseQuarter not tagged2025-11-06Rallybio Reports Third Quarter 2025 Financial Results and Provides Business Updates
Business Wire
Rallybio Reports Third Quarter 2025 Financial Results and Provides Business Updates
– RLYB116 Confirmatory PK/PD Study Data Expected in 4Q 2025 – – Generated $20 Million from Sale of Interest in REV102 – – Cash Runway Extended through 2027 – NEW HAVEN, Conn., November 06, 2025--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported financial results for the third quarter ended September 30, 2025, and provided an update on recent company developments. "In the third quarter, we continued to execute with discipline and focus, advancing our lead program, RLYB116, and achieving a key clinical milestone with the completion of dosing in Cohort 1 in our confirmatory PK/PD Phase 1 study," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "In parallel, we strengthened our balance sheet with non-dilutive capital received from the sale of our interest in REV102. With the second cohort of the RLYB116 study progressing, we remain on track to report data in the fourth quarter of 2025 and are increasingly confident in RLYB116's potential to be an effective therapeutic. Our internal and external market assessments further validate the importance of advancing this program, as we plan for the next stage in development and in RLYB116’s potential to address serious unmet needs in complement-mediated diseases." Recent Business Highlights and Upcoming Milestones: Corporate Updates In the third quarter of 2025, Rallybio generated a total of $20 million pursuant to its agreement with Recursion Pharmaceuticals for the sale of its interest in REV102, an investigational ENPP1 inhibitor in development for the treatment of hypophosphatasia (HPP). The total included $7.5 million from an upfront payment and $12.5 million related to the initiation of additional preclinical studies. RLYB116 Program In September 2025, Rallybio completed dosing of Cohort 1 in the RLYB116 Phase 1 confirmatory pharmacokinetic/pharmacodynamic (PK/PD) clinical trial, which is planned for development in two hematologic conditions with significant unmet need: immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS).The Phase 1 study is designed to demonstrate complete and sustained complement inhibition as well as favorable tolerability. Data from Cohort 1 support the advancement of RLYB116…Read full documentShow less
– RLYB116 Confirmatory PK/PD Study Data Expected in 4Q 2025 – – Generated $20 Million from Sale of Interest in REV102 – – Cash Runway Extended through 2027 – NEW HAVEN, Conn., November 06, 2025--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported financial results for the third quarter ended September 30, 2025, and provided an update on recent company developments. "In the third quarter, we continued to execute with discipline and focus, advancing our lead program, RLYB116, and achieving a key clinical milestone with the completion of dosing in Cohort 1 in our confirmatory PK/PD Phase 1 study," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "In parallel, we strengthened our balance sheet with non-dilutive capital received from the sale of our interest in REV102. With the second cohort of the RLYB116 study progressing, we remain on track to report data in the fourth quarter of 2025 and are increasingly confident in RLYB116's potential to be an effective therapeutic. Our internal and external market assessments further validate the importance of advancing this program, as we plan for the next stage in development and in RLYB116’s potential to address serious unmet needs in complement-mediated diseases." Recent Business Highlights and Upcoming Milestones: Corporate Updates In the third quarter of 2025, Rallybio generated a total of $20 million pursuant to its agreement with Recursion Pharmaceuticals for the sale of its interest in REV102, an investigational ENPP1 inhibitor in development for the treatment of hypophosphatasia (HPP). The total included $7.5 million from an upfront payment and $12.5 million related to the initiation of additional preclinical studies. RLYB116 Program In September 2025, Rallybio completed dosing of Cohort 1 in the RLYB116 Phase 1 confirmatory pharmacokinetic/pharmacodynamic (PK/PD) clinical trial, which is planned for development in two hematologic conditions with significant unmet need: immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS).The Phase 1 study is designed to demonstrate complete and sustained complement inhibition as well as favorable tolerability. Data from Cohort 1 support the advancement of RLYB116 as a differentiated therapeutic and enables progression to Cohort 2. Rallybio is on track to report data from the study in the fourth quarter of 2025. RLYB332 Program Rallybio continues to evaluate plans for future development of RLYB332, a long-acting, monoclonal anti-matriptase-2 antibody with the potential to be a best-in-class treatment for diseases of iron overload. Preclinical data have demonstrated superior impact on PD parameters, including serum iron, unsaturated iron binding capacity, and transferrin saturation, relative to comparator molecules. Third Quarter 2025 Financial Results Revenue: Revenue was $0.2 million for the third quarter of 2025, compared to $0.3 million for the same period in 2024. The decrease in revenue for the third quarter of 2025 was related to the collaboration agreement with Johnson & Johnson in the third quarter of 2024 and the recognition of revenue related to the collaboration's performance obligations. Research & Development (R&D) Expenses: R&D expenses were $4.1 million for the third quarter of 2025, compared to $8.2 million for the same period in 2024. The decrease in R&D expenses were primarily due to a decrease in development costs related to RLYB212 and other program candidates, in addition to a decrease in payroll and personnel-related expenses, largely related to the Company's workforce reduction announced in May 2025; offset by an increase in development costs related to RLYB116. General & Administrative (G&A) Expenses: G&A expenses were $3.0 million for the third quarter of 2025, compared to $4.1 million for the same period in 2024. The decrease in G&A expenses were primarily due to a decrease in payroll and personnel-related expenses, largely related to lower headcount as compared to the same period in 2024. Net Loss and Net Loss Per Common Share: Rallybio reported a net income of $16.0 million, or $0.36 per common share, for the third quarter of 2025 compared to a net loss of $11.5 million, or $0.26 per common share, for the same period in 2024. Cash Position: As of September 30, 2025, cash, cash equivalents, and marketable securities were $59.3 million. Rallybio expects that its cash, cash equivalents and marketable securities will be sufficient to support operations through 2027. 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 pipeline of promising product candidates aimed at addressing diseases with unmet medical need in areas of complement dysregulation and hematology. The Company’s lead program, RLYB116, is a differentiated C5 inhibitor with the potential to treat diseases of complement dysregulation, with an initial focus on immune platelet transfusion refractoriness and refractory antiphospholipid syndrome. Rallybio’s pipeline also includes RLYB332, a preclinical long-acting matriptase-2 antibody for the treatment of diseases of iron overload. Rallybio is headquartered in New Haven, Connecticut. For more information, please visit www.rallybio.com and follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements that are based on our management’s beliefs and assumptions and 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 dosing of Cohort 2 in the RLYB116 confirmatory PK/PD study and the periods in which data from the trial are expected to be available, whether the PK/PD confirmatory study will demonstrate improved tolerability and complete and sustained inhibition of terminal complement, whether RLYB116 will be effective in treating a broad range of complement-mediated diseases, the potential commercial opportunity for RLYB116, the potential for future development of RLYB332, the potential for RLYB332 to be a best-in-class treatment for diseases of iron overload, and the Company's 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 RLYB116 PK/PD confirmatory study, 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 U.S. Securities and Exchange Commission (SEC), including Rallybio’s Quarterly Report on Form 10-Q for the period ended June 30, 2025, and subsequent filings with the SEC. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we are not obligated to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise. Financial Tables View source version on businesswire.com: https://www.businesswire.com/news/home/20251105235045/en/ Contacts Investor Contacts Samantha Tracy Rallybio Corporation (475) 47-RALLY (Ext. 282) [email protected] Kevin Lui Precision AQ (212) 698-8691 [email protected] Media Contact [email protected]
Investor releaseQuarter not tagged2025-08-09Rallybio First Half 2025 Earnings: US$0.43 loss per share (vs US$0.83 loss in 1H 2024)
Simply Wall St.
Rallybio First Half 2025 Earnings: US$0.43 loss per share (vs US$0.83 loss in 1H 2024)
Explore Rallybio's Fair Values from the Community and select yours Net loss: US$19.1m (loss narrowed by 46% from 1H 2024). US$0.43 loss per share (improved from US$0.83 loss in 1H 2024). Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. All figures shown in the chart above are for the trailing 12 month (TTM) period Looking ahead, revenue is forecast to grow 78% p.a. on average during the next 2 years, compared to a 19% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's share price is broadly unchanged from a week ago. We should say that we've discovered 4 warning signs for Rallybio (2 don't sit too well with us!) that you should be aware of before investing here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-08-07Rallybio Reports Second Quarter 2025 Financial Results and Provides Business Updates
Business Wire
Rallybio Reports Second Quarter 2025 Financial Results and Provides Business Updates
– Data Readouts from Cohort 1 and Cohort 2 of RLYB116 Confirmatory PK/PD Study on Track for 3Q and 4Q 2025, Respectively – – Sold Interest in REV102 to Recursion Pharmaceuticals for Up to $25 Million, including an Upfront Equity Payment of $7.5 Million – – Cash Runway into Mid-2027 – NEW HAVEN, Conn., August 07, 2025--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported financial results for the second quarter ended June 30, 2025, and provided an update on recent company developments. "The second quarter marked a pivotal step forward as we advanced our lead program, RLYB116, into a confirmatory PK/PD study, which is an important milestone that reflects the strength of our science and the dedication of our team. Meanwhile, the strategic divestiture of a preclinical asset underscores our commitment to disciplined portfolio management, enabling us to sharpen our focus and strengthen the balance sheet as we continue to develop transformative therapies for patients and build long-term value for shareholders," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "With the RLYB116 confirmatory PK/PD study underway, we continue to look forward to the release of topline data from Cohort 1 and Cohort 2, expected in the third and fourth quarter of 2025, respectively." Recent Business Highlights and Upcoming Milestones: Corporate Updates In July 2025, Rallybio announced that it entered into a definitive agreement to sell its interest in REV102, an ENPP1 inhibitor in preclinical development for the treatment of patients with hypophosphatasia (HPP), to its joint venture partner Recursion Pharmaceuticals (Recursion) for up to $25.0 million, including an upfront equity payment of $7.5 million and near-term milestones. The upfront payment extends Rallybio’s cash runway into the middle of 2027. In addition to the upfront payment, Rallybio is eligible to receive a contingent equity payment of $12.5 million upon the initiation of additional preclinical studies, and a $5.0 million cash milestone payment in connection with the initiation of dosing in a Phase 1 clinical study, as defined in the agreement. Rallybio is also eligible to receive low single-digit royalties on all future net sales by Recursion of produ…Read full documentShow less
– Data Readouts from Cohort 1 and Cohort 2 of RLYB116 Confirmatory PK/PD Study on Track for 3Q and 4Q 2025, Respectively – – Sold Interest in REV102 to Recursion Pharmaceuticals for Up to $25 Million, including an Upfront Equity Payment of $7.5 Million – – Cash Runway into Mid-2027 – NEW HAVEN, Conn., August 07, 2025--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported financial results for the second quarter ended June 30, 2025, and provided an update on recent company developments. "The second quarter marked a pivotal step forward as we advanced our lead program, RLYB116, into a confirmatory PK/PD study, which is an important milestone that reflects the strength of our science and the dedication of our team. Meanwhile, the strategic divestiture of a preclinical asset underscores our commitment to disciplined portfolio management, enabling us to sharpen our focus and strengthen the balance sheet as we continue to develop transformative therapies for patients and build long-term value for shareholders," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "With the RLYB116 confirmatory PK/PD study underway, we continue to look forward to the release of topline data from Cohort 1 and Cohort 2, expected in the third and fourth quarter of 2025, respectively." Recent Business Highlights and Upcoming Milestones: Corporate Updates In July 2025, Rallybio announced that it entered into a definitive agreement to sell its interest in REV102, an ENPP1 inhibitor in preclinical development for the treatment of patients with hypophosphatasia (HPP), to its joint venture partner Recursion Pharmaceuticals (Recursion) for up to $25.0 million, including an upfront equity payment of $7.5 million and near-term milestones. The upfront payment extends Rallybio’s cash runway into the middle of 2027. In addition to the upfront payment, Rallybio is eligible to receive a contingent equity payment of $12.5 million upon the initiation of additional preclinical studies, and a $5.0 million cash milestone payment in connection with the initiation of dosing in a Phase 1 clinical study, as defined in the agreement. Rallybio is also eligible to receive low single-digit royalties on all future net sales by Recursion of products comprising or incorporating certain compounds developed as part of the joint venture. In addition, Rallybio may be eligible to receive certain payments in the event of Recursion’s sale of the REV102 program. RLYB116 Program Rallybio announced the initiation of dosing in the RLYB116 confirmatory clinical pharmacokinetic/pharmacodynamic (PK/PD) study in June 2025. Results from Cohort 1 and Cohort 2 are anticipated in the third and fourth quarter of 2025, respectively. Data from this study are expected to demonstrate complete and sustained complement inhibition as well as improved tolerability of RLYB116. In June 2025, Rallybio also announced that the initial indication focus for RLYB116 will be on two hematologic conditions with significant unmet need: immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS). RLYB332 Program Rallybio continues to evaluate plans for future development of RLYB332, a long-acting, monoclonal anti-matriptase-2 antibody that has the potential to be a best-in-class treatment for diseases of iron overload. Preclinical data has demonstrated superior impact on PD parameters relative to comparator molecules, including serum iron, unsaturated iron binding capacity (UIBC), and transferrin saturation (TSAT). RLYB212 Program In April 2025, Rallybio announced the discontinuation of the RLYB212 program for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT). The Company’s decision to discontinue RLYB212 development was based on PK data from the Phase 2 clinical trial demonstrating the inability of the RLYB212 dose regimen to achieve predicted target concentrations, as well as the minimum target concentration required for efficacy. Safety follow-up of the sentinel participant in the Phase 2 trial will continue as specified in the clinical trial protocol. Second Quarter 2025 Financial Results Revenue: Revenue was $0.2 million for the second quarter of 2025, compared to $0.3 million for the same period in 2024. The decrease in revenue for the second quarter of 2025 was related to the collaboration agreement with Johnson & Johnson in the second quarter of 2024 and the recognition of revenue related to the collaboration's performance obligations. Research & Development (R&D) Expenses: R&D expenses were $6.1 million for the second quarter of 2025, compared to $12.9 million for the same period in 2024. The decrease in R&D expenses was primarily due to a decrease in development costs related to RLYB212, RLYB116 and other program candidates; offset by an increase related to payroll and personnel-related costs, largely related to the Company’s workforce reduction announced in May 2025. General & Administrative (G&A) Expenses: G&A expenses were $4.2 million for the second quarter of 2025, compared to $4.4 million for the same period in 2024. The decrease in G&A expenses was primarily due to a decrease in professional fees and other general and administrative expenses; offset by an increase related to payroll and personnel-related costs, largely related to the 2025 workforce reduction. Net Loss and Net Loss Per Common Share: Rallybio reported a net loss of $9.7 million, or $0.22 per common share, for the second quarter of 2025 compared to a net loss of $16.2 million, or $0.37 per common share, for the same period in 2024. Cash Position: As of June 30, 2025, cash, cash equivalents, and marketable securities were $45.7 million. Rallybio expects these funds, together with the upfront payment received from the sale of REV102 to Recursion in July 2025, will be sufficient to support operations into the middle of 2027. 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 pipeline of promising product candidates aimed at addressing diseases with unmet medical need in areas of complement dysregulation and hematology. The Company’s lead program, RLYB116, is a differentiated C5 inhibitor with the potential to treat diseases of complement dysregulation, with an initial focus on immune platelet transfusion refractoriness (PTR) and refractory antiphospholipid syndrome (APS). Rallybio’s pipeline also includes RLYB332, a preclinical long-acting matriptase-2 antibody for the treatment of diseases of iron overload. Rallybio is headquartered in New Haven, Connecticut. For more information, please visit www.rallybio.com and follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements that are based on our management’s beliefs and assumptions and 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 data for the RLYB116 confirmatory PK/PD study, including data for Cohorts 1 and 2, whether the PK/PD confirmatory study will demonstrate improved tolerability and complete and sustained complement inhibition, the potential commercial opportunity for RLYB116, the Company’s eligibility for certain future payments in connection with the Company’s sale to Recursion of the REV102 program, and the Company's 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 conduct our clinical trials, including the RLYB116 PK/PD confirmatory study, 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 U.S. Securities and Exchange Commission (SEC), including Rallybio’s Quarterly Report on Form 10-Q for the period ended March 31, 2025, and subsequent filings with the SEC. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we are not obligated to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise. Financial Tables View source version on businesswire.com: https://www.businesswire.com/news/home/20250805214081/en/ Contacts Investor Contacts Samantha Tracy Rallybio Corporation (475) 47-RALLY (Ext. 282) [email protected] Kevin Lui Precision AQ (212) 698-8691 [email protected] Media Contact [email protected]
Investor releaseQuarter not tagged2025-08-05Recursion Reports Second Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire
Recursion Reports Second Quarter 2025 Financial Results and Provides Business Update
Company shares partnership and clinical updates including $7 million Sanofi milestone and more information on patient populations for REC-1245 (RBM39) and REC-617 (CDK7) SALT LAKE CITY, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX) a leading clinical stage TechBio company decoding biology to radically improve lives, today reported business updates and financial results for its second quarter ended June 30, 2025. Recursion will host a (L)earnings Call on August 5, 2025 at 8:00 am ET / 6:00 am MT / 1:00 pm BST from Recursion’s X (formerly Twitter), LinkedIn, and YouTube accounts giving analysts, investors, and the public the opportunity to ask questions of the company by submitting questions here: https://forms.gle/tZx2fkcmm7BDk9cJ8. "The power of our platform not only allows us to discover and develop potential new medicines, but also gives us insights on patient populations to target that would be challenging using traditional methods,” said Chris Gibson, Co-Founder and CEO of Recursion. “In discovery, we’re deploying advanced models like Boltz-2 to rapidly design ligands for high-value targets. State of the art platform capabilities helped us drive our fourth partnered discovery milestone with Sanofi this quarter, reflecting tangible momentum across our joint pipeline. We are leveraging these and other improvements to the Recursion OS to not only accelerate and improve our funnel of new programs, but also execution of later stage programs in our pipeline like RBM39 and CDK7.” Summary of Business Highlights Portfolio - Internal and Partnered Programs “REC-1245, our potential first-in-class RBM39 degrader, was identified using phenomap-derived insight, and mimics CDK12 loss to induce replication stress and suppress DDR pathways without CDK12 related toxicities. Early data show strong activity in tumors characterized by replication stress and DNA repair vulnerabilities. Our DAHLIA trial is now enrolling select tumor types to identify responsive populations. For REC-617, our CDK7 inhibitor, we leveraged multi-omic and real world patient data and causal AI modeling to select platinum-resistant ovarian cancer as the first combination cohort,” said Najat Khan, PhD, Chief R&D Officer and Chief Commercial Officer of Recursion. Internal Pipeline Updates: REC-1245 (RBM39): Recursion provided updates on the biomarker strategy and patient population curren…Read full documentShow less
Company shares partnership and clinical updates including $7 million Sanofi milestone and more information on patient populations for REC-1245 (RBM39) and REC-617 (CDK7) SALT LAKE CITY, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX) a leading clinical stage TechBio company decoding biology to radically improve lives, today reported business updates and financial results for its second quarter ended June 30, 2025. Recursion will host a (L)earnings Call on August 5, 2025 at 8:00 am ET / 6:00 am MT / 1:00 pm BST from Recursion’s X (formerly Twitter), LinkedIn, and YouTube accounts giving analysts, investors, and the public the opportunity to ask questions of the company by submitting questions here: https://forms.gle/tZx2fkcmm7BDk9cJ8. "The power of our platform not only allows us to discover and develop potential new medicines, but also gives us insights on patient populations to target that would be challenging using traditional methods,” said Chris Gibson, Co-Founder and CEO of Recursion. “In discovery, we’re deploying advanced models like Boltz-2 to rapidly design ligands for high-value targets. State of the art platform capabilities helped us drive our fourth partnered discovery milestone with Sanofi this quarter, reflecting tangible momentum across our joint pipeline. We are leveraging these and other improvements to the Recursion OS to not only accelerate and improve our funnel of new programs, but also execution of later stage programs in our pipeline like RBM39 and CDK7.” Summary of Business Highlights Portfolio - Internal and Partnered Programs “REC-1245, our potential first-in-class RBM39 degrader, was identified using phenomap-derived insight, and mimics CDK12 loss to induce replication stress and suppress DDR pathways without CDK12 related toxicities. Early data show strong activity in tumors characterized by replication stress and DNA repair vulnerabilities. Our DAHLIA trial is now enrolling select tumor types to identify responsive populations. For REC-617, our CDK7 inhibitor, we leveraged multi-omic and real world patient data and causal AI modeling to select platinum-resistant ovarian cancer as the first combination cohort,” said Najat Khan, PhD, Chief R&D Officer and Chief Commercial Officer of Recursion. Internal Pipeline Updates: REC-1245 (RBM39): Recursion provided updates on the biomarker strategy and patient population currently enrolling in the ongoing Phase 1/2 DAHLIA study. About REC-1245 Potential first-in-class oral RBM39 degrader that selectively impairs alternative splicing to silence multiple DDR pathways, leading to high replication stress. Characterized to selectively mimic the phenotype associated with CDK12 loss of function using Recursion’s AI-powered maps of human biology. Update on target patient population Early preclinical data shows REC-1245 reduces viability in tumors characterized by replication stress and DNA repair vulnerabilities (DDR defects) across multiple solid tumor types, including MSI-H/dMMR, HRR altered cancers, and other tumors. Multi‑omic profiling underway to refine the molecular signature of sensitivity. Additional DAHLIA trial details Monotherapy dose-escalation of Phase 1/2 DAHLIA trial in patients with advanced solid tumors ongoing. Early safety and PK data from the Phase 1 dose-escalation portion on track for 1H26. REC-617 (CDK7): Recursion initiated a combination dose escalation portion of the ELUCIDATE Phase 1/2 trial in 1H25. About REC-617 Orally bioavailable, highly potent, and selective CDK7 inhibitor with best-in-class potential. Precision-designed using Recursion’s generative AI and active learning platform to optimize for non-covalent binding and ADME/PK, potentially delivering a broader therapeutic window, reduced off-target effects, and enhanced absorption. Early Phase 1/2 results demonstrated promising safety and efficacy signals, including a durable partial response in a late-stage metastatic ovarian cancer patient and stable disease across four other patients with solid tumors (e.g. CRC, NSCLC). Update on target patient population Based on early clinical, preclinical, and causal AI modeling data, Recursion selected ovarian cancer as the initial combination dose expansion cohort. Additional ELUCIDATE combination trial details REC-617 in combination with standards of care in 2L+ platinum-resistant ovarian cancer population. Enrollment activities have been initiated. Additional tumor types and therapies for single-arm expansion cohorts under evaluation. Additional data from monotherapy dose-escalation on-track for 2H25. REC-102 (ENPP1): Acquired full rights to REC-102, Recursion’s ENPP1 inhibitor for the treatment of hypophosphatasia (HPP), from its joint venture with Rallybio. REC-102 is the first potential oral disease-modifying treatment for HPP, a rare and debilitating genetic disorder with limited treatment options. Additional preclinical data from the REC-102 program will be presented at the 2025 American Society for Bone and Mineral Research (ASMBR), being held in Seattle, WA. A poster titled Amelioration of osteomalacia in late-onset HPP mice via pharmacological inhibition of ENPP1 is scheduled for presentation on September 6, 2025 between 2:00 PM - 3:30 PM PT, during the Basic and Translational session. Phase 1 initiation remains on-track for 2H26. Upcoming milestones: REC-4881 (MEK1/2): Additional data in FAP from TUPELO expected in 2H25. REC-617 (CDK7): Additional monotherapy data expected in 2H25. REC-7735 (PI3Kα H1047R): Preclinical studies ongoing with development candidate expected in 2H25. REC-1245 (RBM39): Early Phase 1 safety and PK monotherapy data expected in 1H26. REC-3565 (MALT1): Early Phase 1 safety and PK monotherapy data expected in 2H26. REC-102 (ENPP1): Phase 1 initiation expected in 2H26. Potential for over $100 million in partnership milestones by the end of 2026. Several programs are advancing towards potential development candidate designation over the next 12-15 months. Multiple neuroscience target validation programs advancing by leveraging the Recursion OS. Partnered Discovery Updates: Sanofi: Recursion and Sanofi continue to advance multi-target collaboration for up to 15 best-in-class or first-in-class programs across oncology and immunology, with $130 million in upfront and milestone payments achieved to date. Each program has the potential for over $300 million in milestone payments. In 2Q, achieved a $7 million milestone payment for an immunology program. Under the collaboration, this is the fourth partnered program reaching a significant discovery milestone in 18 months. Sanofi is now leveraging combined Recursion OS 2.0, including phenomics, to identify new program opportunities. Several programs are advancing towards potential development candidate designation over the next 12-15 months. Roche and Genentech: Recursion continues to make meaningful progress on both building additional neuromaps and driving target validation and small molecule programs in a single GI oncology indication. Neuro: To date, the collaboration has built a whole-genome knockout phenomap derived from over one trillion iPSC-derived neural cells, alongside around 5,000 transcriptomes representing approximately 171 TB of data. Potential neuroscience targets have been identified for validation from the map, and today multiple novel target validation programs are advancing leveraging the Recursion OS and Genentech’s biological expertise. Building additional neuromaps, including multi-modal maps, combining Roche and Genentech's expertise in single cell screens with Recursion’s and Genentech’s multi-omic machine learning capabilities. GI-Oncology: To date, Recursion has generated all whole genome scale and small molecule GI-oncology specific phenomaps contemplated in the partnership, from which both novel target and small molecule programs can be surfaced. One optioned program continues to advance toward lead series. Focused on advancing multiple novel target and/or compound programs. Bayer: Recursion and Bayer have nominated multiple early discovery precision oncology programs against previously “undruggable” targets. Work is underway to advance multiple programs to lead series milestone decisions. Merck KgAa, Darmstadt, Germany: Collaboration ongoing to identify first-in-class and best-in-class targets. Platform Recursion OS 2.0: The platform is continuing to drive program development with applications across biology, chemistry and clinical development. Actively expanding the Virtual Cell to understand and predict cellular behavior across a wider range of biology. Boltz-2 open source model released with MIT and Nvidia to commoditize state of the art performance for binding affinity prediction approaching the accuracy of physics-based free energy perturbation (FEP) calculations while being over 1,000 times faster and less computationally expensive. The open source tool has been downloaded by over 40,000 unique users to date. Incorporating diverse cell types beyond HUVEC and disease areas beyond oncology, to discover more novel biology and new medicines. Recursion continues to expand its ClinTech platform, integrating high-quality, linked patient datasets like Tempus, HealthVerity, and Helix to strengthen programs, bolster preclinical and early clinical data to select patients (e.g., for REC-617), and optimize recruitment. Second Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and restricted cash were $533.8 million as of June 30, 2025 compared to $603.0 million as of December 31, 2024. Based on current operating plans, the Company believes that its expected cash runway will extend into the fourth quarter of 2027. Revenue: Total revenue, consisting primarily of revenue from collaboration agreements, was $19.2 million for the second quarter of 2025, compared to $14.4 million for the second quarter of 2024. Research and Development Expenses: Research and development expenses were $128.6 million for the second quarter of 2025, compared to $73.9 million for the second quarter of 2024. The increase was primarily driven by the Company’s agreement with Tempus as well as its business combination with Exscientia in November 2024. This includes recognition of $22.7 million in non-cash expenses for use of Tempus’ patient-centric multimodal oncology data under the companies’ ongoing collaboration. General and Administrative Expenses: General and administrative expenses were $46.7 million for the second quarter of 2025 compared to $31.8 million for the second quarter of 2024. The increase compared to the prior period was primarily due to the inclusion of G&A expenses from the business combination with Exscientia. Net Loss: Net loss was $171.9 million for the second quarter of 2025, compared to a net loss of $97.5 million for the second quarter of 2024. Operational cash flows: Net cash used in operating activities was $208.4 million for the six months ended June 30, 2025, compared to net cash used in operating activities of $184.5 million for the six months ended June 30, 2024. The increase in cash used in operating activities was primarily driven by the inclusion of Exscientia’s operations, for which the business combination with Recursion closed in November 2024. This was partially offset by cash inflows from partnerships and operational tax rebates totaling $7.0 million and $28.6 million respectively for the three and six months of 2025. No cash inflows from partnerships or operational tax rebates were recorded during the six months ended June 30, 2024. In association with the restructuring activities announced in June 2025, the Company expects to incur costs totalling $9.3 million, of which $3.9 million has been paid in the second quarter of 2025. Recursion expects to incur all of these expenses in the year ending December 31, 2025. About Recursion Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine. Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Montréal, New York, London, and the Oxford area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn. Media Contact [email protected] Investor Contact [email protected] Forward-Looking Statements This document contains information that includes or is based upon “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding Recursion’s ability to discover and develop medicines and the occurrence or realization of near-term milestones; the timing of data readouts and other milestones; the impact of preclinical data on trial outcomes; Recursion's future as a leader in TechBio and ability to deliver better treatments to patients faster; the completion of core integration plans and the results of the business combination with Exscientia; expectations relating to early and late stage discovery, preclinical, and clinical programs, including timelines for commencement of and enrollment in studies, data readouts, and progression toward IND-enabling studies; expectations and developments with respect to licenses and collaborations, including option exercises by partners and the amount and timing of potential milestone payments, and the acceleration of progress across multiple partnered programs; prospective products and their potential future indications and market opportunities; developments with Recursion OS, including the ability to discover and develop new medicines and provide insights into patient populations; financial position and cash runway; and other technologies; business and financial plans and performance; and all other statements that are not historical facts. Forward-looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All forward-looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law. Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5f177435-1e39-422b-a35b-582abb38a535 https://www.globenewswire.com/NewsRoom/AttachmentNg/36c0f8b5-9b3c-4d4f-9101-384a9a91fde1
Investor releaseQuarter not tagged2025-05-08Rallybio Reports First Quarter 2025 Financial Results and Provides Business Updates
Business Wire
Rallybio Reports First Quarter 2025 Financial Results and Provides Business Updates
– On Track to Initiate Dosing in RLYB116 Confirmatory PK/PD Study in 2Q 2025, with Multiple Data Readouts Anticipated in 2H 2025 – – $54.5 Million in Cash, Cash Equivalents, and Marketable Securities as of March 31, 2025 Provides Runway into 1H 2027 – NEW HAVEN, Conn., May 08, 2025--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported first quarter financial results for the period ended March 31, 2025, and provided an update on recent company developments. "We are focused on advancing RLYB116 into a confirmatory pharmacokinetic/pharmacodynamic study this quarter, and believe that data from this study will demonstrate RLYB116’s potential to be a best-in-class therapeutic for patients with complement-driven diseases," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "Leveraging our team’s deep expertise in the complement field, we are well-positioned to maximize RLYB116’s transformative potential across multiple billion-dollar market opportunities. Additionally, we believe significant value resides within our preclinical pipeline, which includes REV102 and RLYB332. By advancing our innovative pipeline, we are committed to creating exceptional value for our shareholders while delivering life-changing therapies to patients who need them most." Recent Business Highlights and Upcoming Milestones: RLYB116 Program Rallybio is on track to initiate dosing in the RLYB116 confirmatory clinical pharmacokinetic/pharmacodynamic (PK/PD) study in the second quarter of 2025. Results from Cohort 1 (150 mg once weekly) and Cohort 2 (225 mg once weekly) are anticipated in the third and fourth quarter of 2025, respectively. Data from this study are expected to demonstrate complete and sustained complement inhibition with improved tolerability of RLYB116. REV102 Program Investigational new drug application (IND)-enabling studies are underway for REV102, an ENPP1 inhibitor for the treatment of patients with hypophosphatasia (HPP), which is being developed through a joint venture with Recursion Pharmaceuticals. These studies are expected to support the initiation of a Phase 1 study in the second half of 2026. Presentation of data evaluating REV102 in a preclinical model of later-onset HPP is expected in the sec…Read full documentShow less
– On Track to Initiate Dosing in RLYB116 Confirmatory PK/PD Study in 2Q 2025, with Multiple Data Readouts Anticipated in 2H 2025 – – $54.5 Million in Cash, Cash Equivalents, and Marketable Securities as of March 31, 2025 Provides Runway into 1H 2027 – NEW HAVEN, Conn., May 08, 2025--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported first quarter financial results for the period ended March 31, 2025, and provided an update on recent company developments. "We are focused on advancing RLYB116 into a confirmatory pharmacokinetic/pharmacodynamic study this quarter, and believe that data from this study will demonstrate RLYB116’s potential to be a best-in-class therapeutic for patients with complement-driven diseases," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "Leveraging our team’s deep expertise in the complement field, we are well-positioned to maximize RLYB116’s transformative potential across multiple billion-dollar market opportunities. Additionally, we believe significant value resides within our preclinical pipeline, which includes REV102 and RLYB332. By advancing our innovative pipeline, we are committed to creating exceptional value for our shareholders while delivering life-changing therapies to patients who need them most." Recent Business Highlights and Upcoming Milestones: RLYB116 Program Rallybio is on track to initiate dosing in the RLYB116 confirmatory clinical pharmacokinetic/pharmacodynamic (PK/PD) study in the second quarter of 2025. Results from Cohort 1 (150 mg once weekly) and Cohort 2 (225 mg once weekly) are anticipated in the third and fourth quarter of 2025, respectively. Data from this study are expected to demonstrate complete and sustained complement inhibition with improved tolerability of RLYB116. REV102 Program Investigational new drug application (IND)-enabling studies are underway for REV102, an ENPP1 inhibitor for the treatment of patients with hypophosphatasia (HPP), which is being developed through a joint venture with Recursion Pharmaceuticals. These studies are expected to support the initiation of a Phase 1 study in the second half of 2026. Presentation of data evaluating REV102 in a preclinical model of later-onset HPP is expected in the second half of 2025. RLYB332 Program Rallybio continues to evaluate plans for future development of RLYB332, a long-acting, monoclonal anti-matriptase-2 antibody that has the potential to be a best-in-class treatment for diseases of iron overload. Preclinical data has demonstrated superior impact on PD parameters relative to comparator molecules, including serum iron, unsaturated iron binding capacity (UIBC), and transferrin saturation (TSAT). RLYB212 Program In April 2025, Rallybio announced the discontinuation of the RLYB212 program for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT). The Company’s decision to discontinue RLYB212 development was based on PK data from the Phase 2 clinical trial demonstrating the inability of the RLYB212 dose regimen to achieve predicted target concentrations, as well as the minimum target concentration required for efficacy. Safety follow-up of the sentinel participant in the Phase 2 trial will continue as specified in the clinical trial protocol. Corporate Update Rallybio is implementing a 40% workforce reduction, representing nine positions, which will be substantially complete by the end of the second quarter of 2025. Rallybio estimates that the workforce reduction will result in aggregate charges of approximately $1.7 million, primarily for one-time employee severance and benefit costs, and excluding share-based compensation expense. First Quarter 2025 Financial Results Revenue: Revenue was $0.2 million for the first quarter of 2025. There was no revenue for the first quarter of 2024. The increase in revenue for the first quarter of 2025 was related to Rallybio's entrance into the collaboration agreement with Johnson & Johnson in the second quarter of 2024 and the recognition of revenue related to the collaboration's performance obligations. Research & Development (R&D) Expenses: R&D expenses were $5.7 million for the first quarter of 2025, compared to $12.9 million for the same period in 2024. The decrease in R&D expenses was primarily due to a decrease in development costs related to RLYB212, RLYB116, and other program candidates, in addition to a decrease in payroll and personnel-related costs, largely related to the workforce reduction in the first quarter of 2024. General & Administrative (G&A) Expenses: G&A expenses were $4.2 million for the first quarter of 2025, compared to $6.9 million for the same period in 2024. The decrease in G&A expenses was primarily due to a decrease in other general and administrative expenses in addition to lower payroll and personnel-related costs, largely related to the workforce reduction in the first quarter of 2024 and lower ongoing headcount in 2025 as compared to 2024. Net Loss and Net Loss Per Common Share: Rallybio reported a net loss of $9.4 million, or $0.21 per common share, for the first quarter of 2025 compared to a net loss of $19.0 million, or $0.47 per common share, for the same period in 2024. Cash Position: As of March 31, 2025, cash, cash equivalents, and marketable securities were $54.5 million. Rallybio expects these funds will be sufficient to support operations into the first half of 2027. 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 pipeline of promising product candidates aimed at addressing diseases with unmet medical need in areas of complement dysregulation, hematology, and metabolic disorders. The Company’s lead program, RLYB116, is a differentiated C5 inhibitor with the potential to treat diseases of complement dysregulation. Rallybio also has two programs in preclinical development, including REV102, an ENPP1 inhibitor for the treatment of patients with hypophosphatasia (HPP), and RLYB332, a long-acting matriptase-2 antibody for the treatment of diseases of iron overload. Rallybio is headquartered in New Haven, Connecticut. For more information, please visit www.rallybio.com and follow us on LinkedIn and Twitter. Forward-Looking Statements This press release contains forward-looking statements that are based on our management’s beliefs and assumptions and 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 initiating the RLYB116 confirmatory PK/PD study and the periods in which data is available, including data for Cohorts 1 and 2, whether the PK/PD confirmatory study will demonstrate improved tolerability and complete and sustained inhibition of terminal complement, whether RLYB116 will be effective in treating a broad range of complement-mediated diseases, the potential commercial opportunity for RLYB116, the potential value of Rallybio's pipeline, whether IND enabling studies for REV102 will support initiation of a Phase 1 study, the timing of initiation of a REV102 Phase 1 study, the timing of presenting data evaluating REV102 in a preclinical model of later-onset HPP, expected costs related to the workforce reduction and related charges, including the timing of such charges, and the Company's 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 RLYB116 PK/PD confirmatory study, 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 U.S. Securities and Exchange Commission (SEC), including Rallybio’s Annual Report on Form 10-K for the period ended December 31, 2024, and subsequent filings with the SEC. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we are not obligated to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise. Financial Tables View source version on businesswire.com: https://www.businesswire.com/news/home/20250506897052/en/ Contacts Investor Contacts Samantha Tracy Rallybio Corporation (475) 47-RALLY (Ext. 282) [email protected] Kevin Lui Precision AQ (212) 698-8691 [email protected] Media Contact [email protected]
Investor releaseQuarter not tagged2025-03-13Rallybio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates
Business Wire
Rallybio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates
— Key Data Readouts from Sentinel Participant in RLYB212 Phase 2 Clinical Trial Expected in 2Q 2025 and 3Q 2025 — — Initiation of RLYB116 Confirmatory PK/PD Study Expected in 2Q 2025, with Data Anticipated in 2H 2025 — — $65.5 Million in Cash, Cash Equivalents, and Marketable Securities as of December 31, 2024 Provides Runway into 2H 2026 — NEW HAVEN, Conn., March 13, 2025--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided an update on recent company developments. "We are pleased with our strong execution in 2024, and look forward to reporting on our planned milestones in 2025," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "Dosing in our RLYB212 Phase 2 trial is underway, our differentiated C5 inhibitor, RLYB116, is on track to enter a confirmatory pharmacokinetic/pharmacodynamic study in the second quarter, and our potentially best-in-class ENPP1 inhibitor for patients with hypophosphatasia, REV102, is advancing toward Phase 1 in 2026. Through exceptional execution of these programs and continued financial discipline, we are laser focused on driving value for Rallybio in 2025 and positioning the Company for sustained growth and success in the future." Recent Business Highlights and Upcoming Milestones: RLYB212 Program In February 2025, Rallybio announced that the sentinel participant was dosed in the Phase 2 trial investigating RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT). Pharmacokinetic (PK) and safety data from the second trimester are expected in the second quarter of 2025, with PK and safety data at the time of delivery expected in the third quarter of 2025. The Company received regulatory approval to begin the Phase 2 trial in October 2024 and initiated screening in November 2024. More than 14,300 pregnant women were screened in Rallybio’s FNAIT natural history study as of January 31, 2025, at which time screening was concluded at sites in the United States and Canada. Natural history data will continue to be collected in a sub-study of the Phase 2 trial, where participants at higher risk for HPA-1a…Read full documentShow less
— Key Data Readouts from Sentinel Participant in RLYB212 Phase 2 Clinical Trial Expected in 2Q 2025 and 3Q 2025 — — Initiation of RLYB116 Confirmatory PK/PD Study Expected in 2Q 2025, with Data Anticipated in 2H 2025 — — $65.5 Million in Cash, Cash Equivalents, and Marketable Securities as of December 31, 2024 Provides Runway into 2H 2026 — NEW HAVEN, Conn., March 13, 2025--(BUSINESS WIRE)--Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided an update on recent company developments. "We are pleased with our strong execution in 2024, and look forward to reporting on our planned milestones in 2025," said Stephen Uden, M.D., Chief Executive Officer of Rallybio. "Dosing in our RLYB212 Phase 2 trial is underway, our differentiated C5 inhibitor, RLYB116, is on track to enter a confirmatory pharmacokinetic/pharmacodynamic study in the second quarter, and our potentially best-in-class ENPP1 inhibitor for patients with hypophosphatasia, REV102, is advancing toward Phase 1 in 2026. Through exceptional execution of these programs and continued financial discipline, we are laser focused on driving value for Rallybio in 2025 and positioning the Company for sustained growth and success in the future." Recent Business Highlights and Upcoming Milestones: RLYB212 Program In February 2025, Rallybio announced that the sentinel participant was dosed in the Phase 2 trial investigating RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT). Pharmacokinetic (PK) and safety data from the second trimester are expected in the second quarter of 2025, with PK and safety data at the time of delivery expected in the third quarter of 2025. The Company received regulatory approval to begin the Phase 2 trial in October 2024 and initiated screening in November 2024. More than 14,300 pregnant women were screened in Rallybio’s FNAIT natural history study as of January 31, 2025, at which time screening was concluded at sites in the United States and Canada. Natural history data will continue to be collected in a sub-study of the Phase 2 trial, where participants at higher risk for HPA-1a alloimmunization and FNAIT who do not receive RLYB212 are eligible to enroll. Rallybio expects to present interim data from the FNAIT natural history study in mid-2025, including data evaluating the frequency of FNAIT risk across racial and ethnic populations. RLYB116 Program In December 2024, Rallybio presented biomarker characterization analyses indicating that RLYB116 led to a meaningfully greater degree of complement inhibition in the Phase 1 multiple ascending dose (MAD) study than initially reported and as a result, may be effective in treating a broad range of complement-mediated diseases, including paroxysmal nocturnal hemoglobinuria (PNH), generalized myasthenia gravis (gMG), and antiphospholipid syndrome (APS). Rallybio plans to initiate a confirmatory clinical pharmacokinetic/pharmacodynamic (PK/PD) study in the second quarter of 2025, with data readouts from Cohorts 1 and 2 expected in the third and fourth quarter of 2025, respectively. REV102 Program Rallybio advanced REV102, an ENPP1 inhibitor for the treatment of patients with hypophosphatasia (HPP), which is being developed through a joint venture with Recursion Pharmaceuticals. Investigational new drug application (IND)-enabling studies are underway to support the initiation of a Phase 1 study in 2026. Presentation of data evaluating REV102 in a preclinical model of later-onset HPP is expected in the second half of 2025. RLYB332 Program In December 2024, Rallybio presented preclinical data for RLYB332 at the American Society for Hematology (ASH) annual meeting, which demonstrated that single intravenous injections of RLYB332 to humanized FcRn mice had rapid and sustained effects on PD parameters, including serum iron, unsaturated iron binding capacity (UIBC), and transferrin saturation (TSAT), with greater impact than those produced by comparator molecules. The favorable PD data relative to comparator molecules support RLYB332 as a long-acting, potentially best-in-class therapy for the treatment of diseases of iron overload. Fourth Quarter and Full Year 2024 Financial Results Revenue: Revenue was $38 thousand for the fourth quarter of 2024 and $0.6 million for the year ended December 31, 2024, compared to no revenue in the same periods in 2023. The increase in revenue for both the fourth quarter of 2024 and the year ended December 31, 2024 was related to Rallybio's entrance into the collaboration agreement with Johnson & Johnson in the second quarter of 2024 and the recognition of revenue related to the collaboration's performance obligations. Research & Development (R&D) Expenses: R&D expenses were $7.4 million for the fourth quarter of 2024, compared to $15.9 million for the same period in 2023. R&D expenses were $41.5 million for the year ended December 31, 2024 compared to $53.5 million for the year ended December 31, 2023. The decrease in R&D expenses for both the fourth quarter of 2024 and the year ended December 31, 2024 was primarily due to a decrease in development costs related to RLYB212, RLYB116 and other program candidates, in addition to a decrease in payroll and personnel-related costs, largely related to the workforce reduction. General & Administrative (G&A) Expenses: G&A expenses were $4.3 million for the fourth quarter of 2024, compared to $5.2 million for the same period in 2023. G&A expenses were $19.6 million for the year ended December 31, 2024, compared to $25.4 million for the year ended December 31, 2023. The decrease in G&A expenses for both the fourth quarter of 2024 and the year ended December 31, 2024 was primarily due to a decrease in other general and administrative expenses including consulting fees, director and officer insurance premiums and professional fees, in addition to lower payroll and personnel-related costs, largely related to the workforce reduction and lower ongoing headcount in 2024 as compared to 2023. Net Loss and Net Loss Per Common Share: Rallybio reported a net loss of $11.0 million, or $0.25 per common share, for the fourth quarter of 2024 compared to a net loss of $20.2 million, or $0.50 per common share, for the same period in 2023. A net loss of $57.8 million, or $1.33 per common share, was reported for the year ended December 31, 2024 compared to a net loss of $74.6 million, or $1.84 per common share, for the year ended December 31, 2023. Cash Position: As of December 31, 2024, cash, cash equivalents, and marketable securities were $65.5 million. Rallybio expects these funds will be sufficient to support operations into the second half of 2026. 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, a C5 inhibitor with the potential to treat several diseases of complement dysregulation, as well as additional programs in preclinical development. Rallybio is headquartered in New Haven, Connecticut. For more information, please visit www.rallybio.com and follow us on LinkedIn and Twitter. Forward-Looking Statements This press release contains forward-looking statements that are based on our management’s beliefs and assumptions and 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 disclosure of preliminary PK and safety data for the sentinel participant in the RLYB212 Phase 2 trial, presenting or disclosing interim data from the FNAIT natural history study and the timing of such disclosure, whether RLYB212 will be an effective therapeutic approach for FNAIT, the timing of initiating the RLYB116 confirmatory PK/PD study and the date when data is available, including data for Cohorts 1 and 2, whether RLYB116 will be effective in treating a broad range of complement-mediated diseases, the timing of initiation of IND-enabling activities for REV102, and the timing of data in a preclinical model of later-onset HPP. 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 RLYB116 confirmatory PK/PD study, and the Phase 2 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 U.S. Securities and Exchange Commission (SEC), including Rallybio’s Quarterly Report on Form 10-Q for the period ended September 30, 2024, and subsequent filings with the SEC. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we are not obligated to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20250312158841/en/ Contacts Investor Contacts Samantha Tracy Rallybio Corporation (475) 47-RALLY (Ext. 282) [email protected] Kevin Lui Precision AQ (212) 698-8691 [email protected] Media Contact [email protected]

