tw0122
7 días hace
Cash, cash equivalents and short-term investments totaled $25.9 million as of September 30, 2024, compared to $33.3 million as of June 30, 2024. Equillium believes that its cash, cash equivalents and short-term investments are sufficient to fund operations into the fourth quarter of 2025, assuming certain operational changes including accelerating the completion of the Phase 3 EQUATOR study based on reduced enrollment and early unblinding of the study, pausing further development activities related to EQ101 and EQ302, the elimination of certain positions and the reduction of certain discretionary expenditures, as well as assuming no further repurchases under our stock repurchase program.
tw0122
7 días hace
Enough funding through 2025 ..
November 13 2024 - 4:01PM
Business WireEquillium retains rights to itolizumab following substantial funding from Ono partnershipEvaluating accelerating Phase 3 EQUATOR study in aGVHD to completion in Q1 2025Phase 2 ulcerative colitis study recently completed; topline data expected Q1 2025Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the third quarter 2024 and provided corporate and clinical updates.“At the end of October we announced that our partnership with Ono Pharmaceutical had ended following substantial non-dilutive financing that has fully funded itolizumab research and development since July 2022. This funding enabled us to advance the program through two recent milestones – positive interim review from the Phase 3 EQUATOR study in acute graft-versus-host disease and positive topline data from the EQUALISE study in lupus nephritis. Ono informed us that their decision was strategic in nature, and that the data we have delivered from these studies met expectations with no observed or reported safety concerns,” said Bruce Steel, chief executive officer at Equillium. “We have enrolled over 150 patients in EQUATOR, and as of the end of October have temporarily paused enrollment to review clinical options for the program, including the potential to accelerate our timeline to topline data to the first quarter of 2025 while preserving registrational integrity of the study. We maintain orphan drug and fast track designations for first-line acute graft-versus-host disease, where currently no drugs are approved. In addition, in collaboration with Equillium, our partner Biocon has recently completed a robust placebo-controlled Phase 2 study of itolizumab in biologic-naïve patients with moderate to severe ulcerative colitis, and we expect topline data from this study also in the first quarter of 2025. We remain enthusiastic about the therapeutic potential and commercial opportunity for itolizumab, and we are very pleased to maintain our rights to the program as we approach the two most important data events in Equillium’s history.”Highlights Since the Beginning of the Third Quarter of 2024:Retained rights to itolizumab following Ono partnershipPositive interim analysis of Phase 3 EQUATOR study of itolizumab in acute graft-versus-host disease subjectsPhase 2 ulcerative colitis study completed by partner BioconAnticipated Upcoming Milestones:Itolizumab: Topline data from Phase 2 study in ulcerative colitis – Q1 2025Itolizumab: Topline data from Phase 3 EQUATOR study in aGVHD – potential acceleration to Q1 2025Third Quarter 2024 Financial ResultsRevenue for the third quarter of 2024 was $12.2 million, compared to $8.9 million during the same period in 2023. Revenue in the third quarters of 2024 and 2023 consisted entirely of itolizumab development funding and amortization of the upfront payment related to our former partnership with Ono.Research and development (R&D) expenses for the third quarter of 2024 were $9.6 million, compared to $9.0 million for the same period in 2023. The increase was primarily due to greater expenses associated with chemistry, manufacturing and controls (CMC) activities related to itolizumab, greater non-clinical research expenses, and an increase in employee compensation expenses, which were partially offset by lower clinical study expenses primarily driven by the EQUALISE and EQ101 clinical studies, partially offset by greater expenses for our EQUATOR clinical study.General and administrative (G&A) expenses for the third quarter of 2024 were $3.3 million, compared with $3.5 million for the same period in 2023. The decrease was primarily driven by lower legal, audit and tax professional fees.Net loss for the third quarter of 2024 was approximately $7,000, or $(0.00) per basic and diluted share, compared with a net loss of $3.7 million, or $(0.11) per basic and diluted share, for the same period in 2023. The decrease in net loss was primarily attributable to greater revenue related to the Ono partnership, lower income tax expense, and other income, which were partially offset by the increase in R&D expense.Cash, cash equivalents and short-term investments totaled $25.9 million as of September 30, 2024, compared to $33.3 million as of June 30, 2024. Equillium believes that its cash, cash equivalents and short-term investments are sufficient to fund operations into the fourth quarter of 2025, assuming certain operational changes including accelerating the completion of the Phase 3 EQUATOR study based on reduced enrollment and early unblinding of the study, pausing further development activities related to EQ101 and EQ302, the elimination of certain positions and the reduction of certain discretionary expenditures, as well as assuming no further repurchases under our stock repurchase program.
eastunder
4 años hace
Equillium to Present at Investor Conferences in November 2020
November 10, 2020 08:35 ET | Source: Equillium
LA JOLLA, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced that Bruce Steel, Equillium’s chief executive officer and Krishna Polu, M.D., Equillium’s chief medical officer, will present at two upcoming investor conferences in November 2020.
Event:
Date:
Time:
Location: Stifel 2020 Virtual Healthcare Conference
Wednesday, November 18, 2020
3:20 PM Eastern Time | 12:20 PM Pacific Time
Virtual Webcast
Event:
Date:
Time:
Location: Jefferies Virtual London Healthcare Conference
Thursday, November 19, 2020
6:10 PM GMT | 1:10 PM Eastern Time | 10:10 AM PM Pacific Time
Virtual Webcast
Live webcasts of both presentations will be available under the “Investors” section of the Company’s website at https://ir.equilliumbio.com/. Replays will be available for 30 days following each webcast.
About Itolizumab
Itolizumab is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab is currently being evaluated in multiple clinical trials in patients with severe diseases, including aGVHD, lupus nephritis, uncontrolled asthma, and will soon be evaluated in a clinical trial of patients with COVID-19. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited. Itolizumab is marketed in India under the trade name “ALZUMAb-L” for the treatment of chronic plaque psoriasis and has received emergency use approval in India to treat cytokine release syndrome in COVID-19 patients with moderate to severe acute respiratory distress syndrome.
About Equillium
Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium is developing itolizumab for multiple severe immuno-inflammatory diseases, including COVID-19, aGVHD, lupus nephritis and uncontrolled asthma.
For more information, visit www.equilliumbio.com.
Investor Contact
Christine Zedelmayer, Chief Operating Officer
+1-858-412-5302
ir@equilliumbio.com
Media Contact
Katherine Carlyle Smith
Senior Account Associate
Canale Communications
+1-805-907-2497
katherine.smith@canalecomm.com
eastunder
4 años hace
Equillium Reports Third Quarter 2020 Financial Results and Business Highlights
Equillium, Inc.
Tue, November 10, 2020, 2:05 PM MST
LA JOLLA, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced financial results for the third quarter 2020.
“We continue to make significant progress towards our goal of bringing itolizumab to patients suffering from a range of severe immuno-inflammatory disorders,” said Bruce Steel, chief executive officer of Equillium. “We are well positioned to continue advancing our core trials including the Phase 1b EQUATE trial in acute graft-versus-host disease (aGVHD) where we recently reported positive response rates across the first three dose cohorts, as well as our Phase 1b EQUIP and EQUALISE trials in uncontrolled asthma and lupus nephritis, respectively. In parallel, we are poised to initiate the global Phase 3 EQUINOX trial of itolizumab in hospitalized COVID-19 patients during this quarter. We look forward to sharing additional updates at our upcoming Analyst Day in December.”
Business Highlights:
Reported 100% overall response rate in cohort 3 and 80% overall response rate across all cohorts to date from the EQUATE Phase 1b study of itolizumab in the first-line treatment of severe aGVHD patients
Received US Food and Drug Administration clearance to initiate global EQUINOX Phase 3 randomized, placebo-controlled trial of itolizumab in hospitalized COVID-19 patients
Presented pre-clinical data demonstrating that modulation of the CD6-ALCAM pathway with itolizumab improves kidney and skin pathology in systemic lupus erythematosus (SLE) at the 2020 American College of Rheumatology (ACR) Virtual Convergence
Presented new data and insights on the CD6-ALCAM pathway in uncontrolled asthma at the European Respiratory Society International Congress 2020
Strengthened the balance sheet by raising a total of $53.0 million in net proceeds from financings in the third quarter 2020, resulting in $90.5 million in cash and investments at the end of the quarter
Upcoming Catalysts:
Initiate EQUINOX Phase 3 trial in Q4 2020, initial data expected mid-year 2021
Report topline data from the EQUATE Phase 1b open label dose escalation study in first-line treatment of patients with aGVHD in the first half of 2021
Continue to advance the EQUALISE and EQUIP Phase 1b trials
Host company-sponsored virtual Analyst Day on December 4, 2020
Third Quarter 2020 Financial Results
Research and development (R&D) expenses. Total R&D expenses for the three months ended September 30, 2020 were $4.2 million, compared with $4.2 million for the same period in 2019. Although total R&D expenses remained flat compared to the prior period, significant changes included a reduction of R&D expenses due to an R&D tax benefit realized by Equillium’s Australian subsidiary as well as lower travel expenses offset by an increase in employee compensation and benefits primarily related to increased headcount as well as an increase in clinical expense primarily related to startup costs associated with the EQUINOX COVID-19 Phase 3 trial.
General and administrative (G&A) expenses. Total G&A expenses for the three months ended September 30, 2020 were $2.3 million, compared with $2.1 million for the same period in 2019. The increase in G&A expenses was primarily due to a $0.2 million increase in corporate consulting expenses.
Net loss. Net loss for the three months ended September 30, 2020 was $6.6 million, or $(0.31) per basic and diluted share, compared with a net loss of $6.0 million, or $(0.35) per basic and diluted share for the same period in 2019.
Cash, cash equivalents and short-term investments. Equillium held cash, cash equivalents and short-term investments totaling $90.5 million at September 30, 2020, compared to $53.1 million at December 31, 2019. The increase in cash was driven by $53.8 million in total net proceeds raised from equity financings in 2020 through September 30.
Cash used in operations. Equillium used $4.9 million of cash in its operations during the three months ended September 30, 2020, compared to $5.1 million in the prior quarter ended June 30, 2020. Over the nine-month period ended September 30, 2020, Equillium has used approximately $16.4 million of cash in its operations.
About Itolizumab
Itolizumab is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab is currently being evaluated in multiple clinical trials in patients with severe diseases, including aGVHD, lupus nephritis, uncontrolled asthma, and will soon be evaluated in a clinical trial of patients with COVID-19. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited. Itolizumab is marketed in India under the trade name “ALZUMAb-L” for the treatment of chronic plaque psoriasis and has received emergency use approval in India to treat cytokine release syndrome in COVID-19 patients with moderate to severe acute respiratory distress syndrome.
About Equillium
Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium is developing itolizumab for multiple severe immuno-inflammatory diseases, including COVID-19, aGVHD, lupus nephritis and uncontrolled asthma.
For more information, visit www.equilliumbio.com.
crudeoil24
4 años hace
"Itolizumab’s novel immune-modulating mechanism has the potential to regulate the cytokine cascade that is at the root of multiple complications seen in hospitalized COVID-19 patients, including blood clots, tissue damage and organ failure, as well as ARDS,” said Ivor S. Douglas, M.D., FRCP (UK) Professor of Medicine, Chief of Pulmonary and Critical Care and Medical Director, Medical Intensive Care Denver Health Medical Center and principal investigator for the EQUINOX trial. “As we are confronting surging rates of COVID-19 infections globally, I anticipate a sharp rise in patients with severe disease requiring oxygen support or other life-saving critical care measures. As the principal investigator in the EQUINOX trial, it is my hope that this study will help propel a highly effective new treatment option closer to availability for these vulnerable and high-risk patients.”
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