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Rubius Therapeutics, Inc. (RUBY)

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Previous Close23.55
Open23.54
Bid25.41 x 900
Ask25.86 x 800
Day's Range23.54 - 25.71
52 Week Range4.20 - 38.71
Volume459,719
Avg. Volume1,854,955
Market Cap2.282B
Beta (5Y Monthly)2.57
PE Ratio (TTM)N/A
EPS (TTM)-1.99
Earnings DateAug 09, 2021 - Aug 13, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est30.20
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  • Rubius Therapeutics Announces Publication of RTX-321 Preclinical Data in Nature Communications
    GlobeNewswire

    Rubius Therapeutics Announces Publication of RTX-321 Preclinical Data in Nature Communications

    Preclinical Data Demonstrate RTX-321 Potently Activates and Expands HPV 16-Reactive Anti-Tumor T Cells and Provides Broad Immune StimulationCAMBRIDGE, Mass., May 12, 2021 (GLOBE NEWSWIRE) -- Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics™, today announced the publication of preclinical data in the peer-reviewed journal Nature Communications, for its lead artificial antigen-presenting (aAPC) cell program, RTX-321, for the potential treatment of human papillomavirus (HPV) 16-positive cancers. RTX-321 is an allogeneic, off-the-shelf Red Cell Therapeutic product candidate that is engineered as an aAPC with a dual mechanism of action: to boost HPV 16-specific CD8+ T cell responses and promote broad stimulation of both innate and adaptive immune responses. Rubius Therapeutics is currently enrolling patients with persistent, recurrent, or metastatic, unresectable, HPV 16-positive cancers, including cervical cancer, head and neck squamous cell carcinoma (HNSCC) and anal cancer, in a Phase 1 clinical trial. The paper entitled “Engineered red blood cells as an off-the-shelf allogeneic anti-tumor therapeutic” highlights preclinical findings demonstrating that the surrogate model of RTX-321 induced a target antigen-specific immune response, epitope spreading, memory formation as well as broad immune stimulation. This suggests that in patients, an effective immune response could be generated against multiple HPV antigens, and potentially enable the patient’s own immune system to remember a cancer’s identity, which could lead to long-term protection from tumor recurrence. The paper is available here: https://rdcu.be/ckodl. “These preclinical findings support the potential of RTX-321 as an effective antigen-specific therapy for advanced HPV 16-positive cancers, where few treatment options exist in the metastatic setting for this group of patients. Our publication describes an elegant mechanism of action for RTX-321, combining antigen-specific responses with the addition of broad immune stimulation,” said Laurence Turka, M.D., chief scientific officer of Rubius Therapeutics. “We are very excited about the potential of this investigational therapy and plan to share initial clinical results from our Phase 1 clinical trial in the first quarter of 2022.” For additional background on the paper, see accompanying article on Rubius Therapeutics’ RED PLATFORM® from the authors in Nature’s Behind the Paper Channel, here. About HPV 16-Positive CancersHuman papillomavirus (HPV) 16 is associated with approximately 70 percent of cervical cancers, approximately 40 percent of head and neck squamous cell carcinoma (HNSCC) arising in the oropharynx, approximately 25-40 percent of HNSCC arising in other locations and approximately 80-85 percent of anal cancers. A critical need remains for better treatment options for advanced HPV 16-associated cancers. The prognosis remains poor for patients with metastatic disease with few treatment options beyond the first-line setting. About the RTX-321 Clinical TrialRubius Therapeutics is enrolling patients in a Phase 1 open-label, multicenter, monotherapy dose escalation, first-in-human study of RTX-321 for the treatment of patients that are HLA-A*02:01-positive with persistent, recurrent, or metastatic, unresectable, HPV 16-positive cancers, including unresectable cervical cancer (squamous, adeno, or adenosquamous histology), head and neck squamous cell carcinoma (including of the nasal and oral cavities, larynx, hypopharynx, nasopharynx, and oropharynx) and squamous cell cancer of the anal canal that is not amenable to curative therapy. The purpose of the trial is to determine the safety and tolerability, recommended Phase 2 dose and pharmacology, and antitumor activity of RTX-321. For more information about the Phase 1 clinical trial of RTX-321, please visit clinicaltrials.gov (NCT04672980). About RTX-321RTX-321 is an allogeneic, off-the-shelf aAPC therapy product candidate that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses hundreds of thousands of copies of an HPV peptide antigen bound to major histocompatibility complex (MHC) class I proteins, the costimulatory molecule 4-1BBL and the cytokine IL-12 on the cell surface to mimic human T cell-APC interactions. About Rubius TherapeuticsRubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics™. The Company’s proprietary RED PLATFORM® was designed to genetically engineer and culture Red Cell Therapeutics™ that are selective, potent and off-the-shelf allogeneic cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Rubius’ initial focus is to advance RCT™ product candidates for the treatment of cancer and autoimmune diseases by leveraging two distinct therapeutic modalities — potent cell-cell interaction and tolerance induction. Rubius Therapeutics was named among the 2020 Top Places to Work in Massachusetts by the Boston Globe, and its manufacturing site was recently named 2021 Best Places to Work in Rhode Island by Providence Business News. For more information, visit www.rubiustx.com, follow us on Twitter or LinkedIn or like us on Facebook. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding our expectations regarding the therapeutic potential of our pipeline of Red Cell Therapeutics, including the dual mechanism of RTX-321 for the treatment of HPV 16-positive cancers, the potential therapeutic benefits of RTX-321, timelines related to the Phase 1 clinical trial of RTX-321, and our expectations regarding our strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the development of our Red Cell Therapeutic product candidates and their therapeutic potential and other risks identified in our SEC filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and subsequent filings with the SEC and risks and uncertainties related to the severity and duration of the impact of COVID-19 on our business and operations. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. Contacts: InvestorsElhan Webb, CFA, Vice President of Investor Relationselhan.webb@rubiustx.com Media Marissa Hanify, Director, Corporate CommunicationsMarissa.hanify@rubiustx.com Dan Budwick, 1AB+1 (973) 271-6085dan@1abmedia.com

  • Rubius Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update
    GlobeNewswire

    Rubius Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update

    Positive Initial Data from Phase 1/2 Trial of RTX-240 in Advanced Solid Tumors Demonstrated Single-Agent Activity Providing Initial Validation of the RED PLATFORM®;Dose Optimization and Enrollment Continues Continued Progress in Advancing Clinical Programs with Further Enrollment in Phase 1 RTX-240 Acute Myeloid Leukemia and RTX-321 Advanced HPV 16-Positive Cancer TrialsOn Track for Several Anticipated Data Milestones and Catalysts in 2021, and Supported by a Strong Balance Sheet CAMBRIDGE Mass., May 10, 2021 (GLOBE NEWSWIRE) -- Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics™, today reported first quarter 2021 financial results and provided a business update. “We had a great start to the year by reporting initial positive data from our ongoing Phase 1/2 clinical trial of RTX-240 in patients with advanced solid tumors, which provided evidence of the broad potential of the RED PLATFORM® across our entire pipeline of cancer and autoimmune programs,” said Pablo J. Cagnoni, M.D., president and chief executive officer of Rubius Therapeutics. “With several expected clinical milestones from our pipeline, the coming year is poised to be an exciting one for patients, our employees and shareholders.” Enabled by the RED PLATFORM, Red Cell Therapeutics’ (RCTs) are expected to provide advantages over other therapies by potentially generating a broad anti-tumor response with limited side effects and a wide therapeutic window given the biodistribution of RCTs to the vasculature and spleen. Additionally, RCTs do not have the complex supply chain and administration logistics of other cell therapies, as RCTs are designed to be prepared in the pharmacy, administered in an outpatient setting and do not require lymphodepletion prior to administration. First Quarter 2021 Highlights RTX-240 Phase 1/2 Clinical Program for Advanced Solid Tumors On March 15, 2021, the Company reported preliminary safety (n=16) and efficacy (n=15) findings based on RECIST v1.1., with a data cutoff of February 28, 2021. The key takeaways from the initial data were: RTX-240 demonstrated favorable emerging safety results across dose levels: There were no treatment-related Grade 3/4 adverse events and no dose-limiting toxicities. The most common treatment-related Grade 1/2 adverse events were fatigue, chills, nausea, decreased appetite and arthralgias. There was a single Grade 1 event of liver toxicity. Single-agent activity was observed with two partial responses: A confirmed partial response (PR) in a patient with metastatic anal cancer and an unconfirmed PR in a patient with metastatic uveal melanoma. Both patients’ disease had progressed on prior anti-PD-1 therapy.Stable disease (SD) was observed in six patients, including four individual patients with stable disease for at least 12 weeks, (one each with non-small cell lung cancer, soft tissue sarcoma, pancreatic cancer and prostate cancer). Pharmacodynamic effects observed included the activation and/or expansion of the key natural killer (NK) and/or T cells types in all patients (n=16).Observed evidence of immune cell trafficking of activated NK and T cells into the tumor microenvironment in two solid tumor biopsies and one AML biopsy. Dose optimization and enrollment continues in the RTX-240 Phase 1/2 advanced solid tumor study. The Company plans to present additional data from the study this year. Phase 1 Arm in Ongoing Phase 1/2 RTX-240 Clinical Trial in Relapsed/Refractory Acute Myeloid Leukemia (AML) RTX-240 is currently being evaluated as a single-agent in a Phase 1 arm of the ongoing Phase 1/2 clinical trial of RTX-240 in patients with relapsed/refractory AML.As of May 10, 2021, Rubius is enrolling patients in the third and fourth dose cohorts, in accordance with the statistical design of the study, which allows enrollment of two dose cohorts simultaneously.On March 15, 2021, the Company presented preliminary trafficking data from the first patient in the trial, indicating strong accumulation of activated, granzyme B-positive NK and T cells in the bone marrow, which is the site of disease in AML. RTX-321 Artificial Antigen-Presenting Cell (aAPC) Development Program for Human Papillomavirus (HPV) 16-Positive Cancers Dosing additional patients in the Phase 1 clinical trial of RTX-321 in patients with advanced HPV 16-positive cancers, including cervical, head and neck and anal cancer.RTX-321 has a unique frozen drug substance formulation, enabling a potential truly off-the-shelf product with a shelf life of up to several years. Following liquid reformulation, RTX-321 has an in-vial shelf life of approximately 52 days. Presentations at Medical Conferences Preliminary safety and efficacy data from RTX-240 Phase 1/2 Clinical Trial for advanced solid tumors was presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting on April 10, 2021. Anticipated 2021 Catalysts and Operational Objectives Present additional clinical data from the RTX-240 solid tumor Phase 1 clinical trial;Select specific solid tumor types that will be pursued in the Phase 2 expansion cohort of RTX-240;Report initial clinical data from the Phase 1 arm of the RTX-240 clinical trial in relapsed/refractory AML;Initiate the Phase 1 clinical trial of RTX-240 in combination with anti-PD-1 therapy in advanced solid tumors in the second half of 2021;Report initial Phase 1 clinical data from RTX-321 for the treatment of HPV 16-positive cancers by the first quarter of 2022; andSubmit an Investigational New Drug Application for RTX-224 by year-end. About RTX-240RTX-240, Rubius Therapeutics' lead oncology program, is an allogeneic, off-the-shelf cellular therapy product candidate that is engineered to simultaneously present hundreds of thousands of copies of the costimulatory molecule 4-1BB ligand (4-1BBL) and IL-15TP (trans-presentation of IL-15 on IL-15Rα) in their native forms. RTX-240 is designed to broadly stimulate the immune system by activating and expanding both NK and memory T cells to generate a potent anti-tumor response. About RTX-321RTX-321, Rubius Therapeutics’ second oncology program, is an allogeneic, off-the-shelf aAPC therapy product candidate that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses hundreds of thousands of copies of an HPV peptide antigen bound to major histocompatibility complex class I proteins, the costimulatory molecule 4-1BBL and the cytokine IL-12 on the cell surface to mimic human T cell-APC interactions. First Quarter 2021 Financial ResultsNet loss for the first quarter of 2021 was $42.3 million or $0.51 per common share, compared to $48.5 million or $0.60 per common share in the first quarter of 2020. In the first quarter of 2021, Rubius invested $27.7 million in research and development (R&D) related to its novel RED PLATFORM® and towards expanding and advancing its product pipeline, compared to $36.2 million in the first quarter of 2020. This year-over-year decrease was driven primarily by a $4.9 million reduction in program expenses consisting of a $6.7 million reduction in rare disease program costs, following the deprioritization of the Company’s rare disease pipeline in March 2020, partially offset by an increase in costs incurred for the Company’s cancer programs, including, RTX-240 and RTX-321. Additionally, platform development, early stage research and other unallocated expenses decreased by $3.6 million due principally to $2.5 million in reductions in contract R&D, laboratory supplies and research materials driven primarily by a shift in activities to support the oncology clinical programs. Personnel-related costs also decreased as a result of non-recurring costs incurred in the first quarter of 2020. G&A expenses were $13.2 million during the first quarter of 2021, compared to $12.7 million for the first quarter of 2020. The higher costs were primarily driven by an increase in professional and consultant fees related to increased patent costs and an increase in facility-related and other expenses due to higher building operating costs. During the first quarter of 2021, other income and expenses decreased by $1.8 million, from net income of $0.4 million in the first quarter of 2020, to net expense of $1.4 million. The change was due to a lower average cash balance, lower prevailing interest rates and an increase in outstanding debt following the final borrowing under the Company’s debt facility in June 2020. Cash PositionAs of March 31, 2021, cash, cash equivalents and investments were $330.7 million, compared to $176.3 million as of December 31, 2020. During the quarter, the Company received net proceeds, after deducting underwriting discounts and commission, of $188.0 million in connection with its underwritten public offering completed in March 2021. About Rubius TherapeuticsRubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics™. The Company’s proprietary RED PLATFORM® was designed to genetically engineer and culture Red Cell Therapeutics™ that are selective, potent and off-the-shelf allogeneic cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Rubius’ initial focus is to advance RCT™ product candidates for the treatment of cancer and autoimmune diseases by leveraging two distinct therapeutic modalities — potent cell-cell interaction and tolerance induction. Rubius Therapeutics was named among the 2020 Top Places to Work in Massachusetts by the Boston Globe, and its manufacturing site was recently named 2021 Best Places to Work in Rhode Island by Providence Business News. For more information, visit www.rubiustx.com, follow us on Twitter or LinkedIn or like us on Facebook. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding our expectations regarding the therapeutic potential of our pipeline of Red Cell Therapeutics, including RTX-240 for the treatment of patients with relapsed/refractory or locally advanced solid tumors and its advantages over other therapies and RTX-321 for the treatment of HPV 16-positive cancers, our expectations regarding the timing, enrollment, additional data from and success of the current and future cohorts and phases of the clinical trial of RTX-240, our expectations regarding the biological effects of RTX-240 on innate and adaptive immunity, including activation and increased numbers of NK cells and T cells in the clinical trial of RTX-240, and our expectations regarding the full data set from the Phase 1 clinical trial and its ability to unlock the potential of the RED PLATFORM across our entire pipeline of Red Cell Therapeutics for the treatment of cancer, including our expectations regarding the therapeutic potential of RTX-321, timelines related to the Phase 1 clinical trial of RTX-321 and our release of initial data from such trial, our expectations regarding the timing of an IND for RTX-224, our expectations regarding our ability to expand manufacturing capabilities, our expectations regarding the potential shelf life of our frozen drug substance for RTX-321, our expectations regarding our cash runway and our strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the development of our Red Cell Therapeutic product candidates and their therapeutic potential and other risks identified in our SEC filings, including our Quarterly Report on Form 10-K for the year ended December 31, 2020, and subsequent filings with the SEC and risks and uncertainties related to the severity and duration of the impact of COVID-19 on our business and operations. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. Contacts: InvestorsElhan Webb, CFA, Vice President of Investor Relationselhan.webb@rubiustx.com Media Marissa Hanify, Director, Corporate Communicationsmarissa.hanify@rubiustx.com Dan Budwick, 1AB+1 (973) 271-6085dan@1abmedia.com Rubius Therapeutics, Inc.Condensed Consolidated Statement of Operations(in thousands, except share and per share data)(unaudited) For the three monthsended March 31, 2021 2020 Revenue $ $ Operating expenses: Research and development 27,677 36,186 General and administrative 13,240 12,664 Total operating expenses 40,917 48,850 Loss from operations (40,917) (48,850)Other income (expense), net (1,413) 364 Net loss $(42,330) $(48,486)Net loss per share, basic and diluted $(0.51) $(0.60)Weighted average common shares outstanding, basic and diluted: 82,314,577 80,271,848 Rubius Therapeutics, Inc.Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) March 31, December 31, 2021 2020Cash, cash equivalents and investments$330,650 $176,287Total assets 430,230 277,794Total liabilities 129,247 136,234Total stockholders’ equity 300,983 141,560

  • Rubius Therapeutics to Announce First Quarter 2021 Financial Results
    GlobeNewswire

    Rubius Therapeutics to Announce First Quarter 2021 Financial Results

    CAMBRIDGE, Mass., April 26, 2021 (GLOBE NEWSWIRE) -- Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics™ for the treatment of cancer and autoimmune diseases, today announced plans to report first quarter financial results on Monday, May 10, 2021, before market open. The company will not be hosting a teleconference in conjunction with its financial results press release. About Rubius TherapeuticsRubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics™. The Company’s proprietary RED PLATFORM® was designed to genetically engineer and culture Red Cell Therapeutics™ that are selective, potent and off-the-shelf allogeneic cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Rubius’ initial focus is to advance RCT™ product candidates, for the treatment of cancer and autoimmune diseases, by leveraging two distinct therapeutic modalities — potent cell-cell interaction and tolerance induction. Rubius Therapeutics was recently named among the Top Places to Work in Massachusetts by the Boston Globe, and its manufacturing site was recently named 2020 Top 5 Best Places to Work in Rhode Island among medium-sized companies by Providence Business News. For more information, visit www.rubiustx.com, follow us on Twitter or LinkedIn or like us on Facebook. Contacts:Elhan Webb, CFAVice President, Investor Relationselhan.webb@rubiustx.comMedia: Marissa HanifyDirector, Corporate Communicationsmarissa.hanify@rubiustx.com Dan Budwick1AB +1 (973) 271-6085dan@1abmedia.com