Latest news with #REV102
Business Wire
6 days ago
- Business
- Business Wire
Rallybio Reports Second Quarter 2025 Financial Results and Provides Business Updates
NEW HAVEN, Conn.--(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 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. Condensed Consolidated Balance Sheets (Unaudited) (in thousands) JUNE 30, 2025 DECEMBER 31, 2024 Cash, cash equivalents and marketable securities $ 45,749 $ 65,511 Total assets 51,003 68,108 Total liabilities 5,039 6,454 Total stockholders' equity 45,964 61,654 Expand
Yahoo
21-07-2025
- Business
- Yahoo
Recursion Pharmaceuticals Acquires Full Rights to REV102, Potential Oral Therapy for Rare Bone Disorder Hypophosphatasia
Recursion Pharmaceuticals Inc. (NASDAQ:RXRX) is one of the best small cap AI stocks to buy according to analysts. On July 8, Rallybio Corporation (NASDAQ:RLYB) announced a definitive agreement to sell its interest in REV102 to its joint venture partner, Recursion Pharmaceuticals. The deal is valued at up to $25 million, with an upfront equity payment of $7.5 million and near-term milestone payments. REV102 is an ENPP1 inhibitor currently in preclinical development for the treatment of hypophosphatasia/HPP, which is a rare inherited disorder affecting bone and tooth mineralization. The program originated from a joint venture between Rallybio and Recursion focused on discovering and developing novel, orally available small-molecule inhibitors of ENPP1 for HPP patients. A close-up of white lab coats and protective masks in a biotechnology research laboratory. REV102, the lead candidate from this collaboration, entered IND-enabling studies in early 2025. Rallybio will also receive low single-digit royalties on all future net sales of REV102 by Recursion. Rallybio may also receive additional payments if Recursion sells the REV102 program to a third party. Recursion Pharmaceuticals Inc. (NASDAQ:RXRX) is a clinical-stage biotechnology company that decodes biology and chemistry by integrating technological innovations across biology, chemistry, automation, data science, and engineering to industrialize drug discovery in the US. Rallybio Corporation (NASDAQ:RLYB) is a clinical-stage biotechnology company that develops and commercializes life-transforming therapies for patients suffering from severe and rare diseases. While we acknowledge the potential of RXRX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-07-2025
- Business
- Yahoo
Recursion Pharmaceuticals (RXRX) Rallies 8.7% on Hypophosphatasia
Recursion Pharmaceuticals, Inc. (NASDAQ:RXRX) is one of . Recursion Pharmaceuticals bounced back by 8.72 percent on Tuesday to close at $5.36 apiece following news that it acquired a $25-million interest in REV102—an ENPP1 inhibitor in preclinical development for the treatment of hypophosphatasia. In a statement on Tuesday, Rallybio said it entered into a definitive agreement with Recursion Pharmaceuticals, Inc. (NASDAQ:RXRX) for the sale of its interest, under which it will be eligible to receive $7.5 million in upfront equity, a contingent equity payment of $12.5 million upon the initiation of additional preclinical studies, and a $5 million milestone payment in connection with the initiation of dosing in a Phase 1 clinical study. A pharmacist in a hospital pharmacy stands next to a row of various drug containers. It will also be eligible to receive low single-digit royalties on all future net sales by Recursion Pharmaceuticals, Inc. (NASDAQ:RXRX) and likewise earn payments in the event of the latter's sale of the REV102 program. 'By combining Rallybio's expertise in HPP preclinical and translational research with Recursion's integrated AI/experimental platform, we transformed this concept into the first potential oral disease-modifying treatment for HPP,' said Rallybio CEO Stephen Uden. While we acknowledge the potential of RXRX as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the . READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
09-07-2025
- Business
- Yahoo
Rallybio to sell interest in REV102 to Recursion Pharmaceuticals for up to $25M
Rallybio (RLYB) announced that it has entered into a definitive agreement to sell its interest in REV102, an ENPP1 inhibitor in preclinical development for the treatment of patients with hypophosphatasia, to joint venture partner Recursion Pharmaceuticals (RXRX) for up to $25M, including an upfront equity payment of $7.5M and near term milestones. With the upfront payment, Rallybio expects its cash runway to extend into mid-2027. The REV102 program originated from a joint venture between Rallybio and Recursion focused on the discovery and development of novel, orally available small molecule inhibitors of ENPP1 for the treatment of patients with HPP. The lead candidate from the joint venture, REV102, entered into IND-enabling studies in early 2025. Under the terms of the agreement, Rallybio is eligible to receive certain payments, including $7.5M in upfront equity, a contingent equity payment of $12.5M upon the initiation of additional preclinical studies, and a $5M 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. In addition, Rallybio may be eligible to receive certain payments in the event of Recursion's sale of the REV102 program. Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on RLYB: Disclaimer & DisclosureReport an Issue Recursion Pharmaceuticals acquires full rights to hypophosphatasia drug REV102 Rallybio Finalizes Employment Agreement with CMO Rallybio's FNAIT Study: A Closer Look at HPA-1a Alloimmunization Rallybio's Phase 2 Study on RLYB212: A Potential Game-Changer for Pregnant Women at Risk Rallybio initiates dosing in RLYB116 study Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Insider
09-07-2025
- Business
- Business Insider
Rallybio Stock (RLYB) Rockets 25% on a Recursion Pharmaceuticals Agreement
Rallybio (RLYB) stock rallied on Tuesday after the clinical-stage biotechnology company reached an agreement with Recursion Pharmaceuticals (RXRX). This saw Recursion Pharmaceuticals agree to acquire full interest in the two companies' joint ENPP1 inhibitor program, REV102, as well as a connected backup molecule. Don't Miss TipRanks' Half-Year Sale Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. REV102 is a program designed to treat hypophosphatasia (HPP). This is a rare and debilitating genetic disorder that causes metabolic bone disease due to mutations in the ALPL gene. The issue results in a lack of alkaline phosphatase enzyme, which is needed for proper bone and tooth mineralization. Recursion Pharmaceuticals has agreed to an upfront payment of $7.5 million in equity to Rallybio, a contingent equity payment of $12.5 million when preclinical studies start, and a $5 million milestone payment when a Phase 1 trial begins. Rallybio will also receive low single-digit royalties on all future net sales by Recursion and potential payments if Recursion Pharmaceuticals sells REV102. Rallybio Stock Movement Today Rallybio stock was up 26.65% during pre-market trading on Tuesday, following a 2.31% rally yesterday. Even so, the shares have fallen 65.54% year-to-date and 73.61% over the past 12 months. Today's rally came with heavy trading, as some 34 million shares changed hands, compared to a three-month daily average of roughly 241,000 units. Is Rallybio Stock a Buy, Sell, or Hold? Turning to Wall Street, the analysts' consensus rating for Rallybio is Hold, based on three Hold ratings over the past three months. With that comes an aver age RLYB stock price target of $7, representing a potential 1,956.4% upside for the shares.
