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Editas Medicine to Present Clinical Data from the RUBY and EdiTHAL Trials of Reni-cel at the European Hematology Association 2024 Congress in June
Newsfilter· 2024-05-14 14:00
CAMBRIDGE, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (NASDAQ:EDIT), a clinical-stage gene editing company, today announced that two abstracts, including one oral presentation and one poster presentation, detailing clinical data from the RUBY and EdiTHAL trials of renizgamglogene autogedtemcel (reni-cel) have been accepted for presentation at the European Hematology Association (EHA) Hybrid Congress being held June 13-16, 2024, in Madrid, Spain, and via livestream. Clinical data from pati ...
Editas Medicine Preclinical Data Highlights Advancement of in vivo Gene Editing Medicine Technologies at the American Society of Gene and Cell Therapy Annual Meeting
Newsfilter· 2024-05-10 10:00
Research includes the first-ever application of AsCas12a in vivo, optimized LNP delivery, and gene editing RNA guide modifications Data to support development of the Company's in vivo gene editing medicines pipeline   CAMBRIDGE, Mass., May 10, 2024 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (NASDAQ:EDIT), a clinical-stage gene editing company, today announced the presentation of preclinical data demonstrating several in vivo capabilities towards developing transformative in vivo gene editing medicines. The C ...
Editas (EDIT) Q1 Earnings & Revenues Lag Estimates, Stock Down
Zacks Investment Research· 2024-05-09 17:41
Editas Medicine, Inc. (EDIT) incurred a loss of 76 cents per share in the first quarter of 2024, wider than the Zacks Consensus Estimate of a loss of 63 cents. The company had reported a loss of 71 cents per share in the year-ago quarter.Collaboration and other research and development (R&D) revenues, which comprise the company’s top line, were $1.1 million in the first quarter, down from $9.8 million reported in the year-ago quarter. The reported figure missed the Zacks Consensus Estimate of $12 million. T ...
Editas Medicine(EDIT) - 2024 Q1 - Quarterly Report
2024-05-08 20:21
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Editas Medicine's unaudited condensed consolidated financial statements for Q1 2024 are presented, highlighting financial position and performance [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$440.3 million** as of March 31, 2024, primarily due to reduced cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $69,227 | $123,652 | | Marketable securities | $307,549 | $303,483 | | Total current assets | $305,555 | $340,829 | | **Total assets** | **$440,347** | **$499,153** | | **Liabilities & Equity** | | | | Total current liabilities | $66,487 | $63,217 | | **Total liabilities** | **$145,947** | **$150,056** | | **Total stockholders' equity** | **$294,400** | **$349,097** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss increased to **$62.0 million** in Q1 2024, driven by higher R&D expenses and decreased collaboration revenues Q1 2024 vs. Q1 2023 Statement of Operations (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Collaboration and other R&D revenues | $1,135 | $9,851 | | Research and development expenses | $48,787 | $37,804 | | General and administrative expenses | $19,339 | $23,008 | | Total operating expenses | $68,126 | $60,812 | | Operating loss | ($66,991) | ($50,961) | | **Net loss** | **($61,950)** | **($49,036)** | | **Net loss per share, basic and diluted** | **($0.76)** | **($0.71)** | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$49.9 million** in Q1 2024, leading to a **$54.4 million** decrease in total cash Q1 2024 vs. Q1 2023 Cash Flow Summary (in thousands) | Activity | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($49,872) | ($35,768) | | Net cash (used in) provided by investing activities | ($4,745) | $23,267 | | Net cash provided by financing activities | $192 | $0 | | **Net decrease in cash, cash equivalents, and restricted cash** | **($54,425)** | **($12,501)** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail liquidity, accumulated deficit, collaboration agreements, and stock-based compensation expenses - Existing cash and marketable securities are projected to fund operations for at least the next **twelve months** from May 8, 2024[28](index=28&type=chunk) - As of March 31, 2024, the company reported an accumulated deficit of **$1.3 billion**, indicating a need for substantial additional capital[28](index=28&type=chunk) - The March 2024 amendment to the BMS collaboration agreement extends it to November 2026, with **$56.7 million** in deferred revenue to be recognized prospectively[44](index=44&type=chunk)[45](index=45&type=chunk)[47](index=47&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Research and development | $2,908 | $2,086 | | General and administrative | $4,677 | $2,421 | | **Total** | **$7,585** | **$4,507** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's genomic medicine development, Q1 2024 financial results, and liquidity projections into 2026 - The company focuses on advancing its lead ex vivo program, reni-cel, for SCD and TDT, and developing next-generation in vivo gene editing medicines[60](index=60&type=chunk)[61](index=61&type=chunk) - Existing cash, marketable securities, and Vertex payments are expected to fund operations and capital expenditures into **2026**[106](index=106&type=chunk) - Net loss for Q1 2024 was **$62.0 million**, up from **$49.0 million** in Q1 2023, due to higher R&D expenses and lower collaboration revenue[70](index=70&type=chunk) [Overview](index=16&type=section&id=Overview) Editas Medicine, a clinical-stage gene editing company, focuses on its reni-cel program and strategic partnerships with Vertex and BMS - The lead program, reni-cel, is undergoing evaluation in the RUBY trial for severe SCD and the EdiTHAL trial for TDT[61](index=61&type=chunk)[63](index=63&type=chunk) - Additional clinical data from RUBY and EdiTHAL trials are expected in **mid-2024** and by **year-end 2024**[64](index=64&type=chunk) - A Vertex license agreement provided a **$50.0 million** upfront payment in Q4 2023 and a **$10.0 million** annual license fee in Q1 2024[67](index=67&type=chunk) - The BMS collaboration was extended in **March 2024** to **November 2026**, with options for further extension[68](index=68&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) Q1 2024 saw decreased collaboration revenue, increased R&D expenses, and reduced G&A expenses from lower professional fees Q1 2024 vs. Q1 2023 Operating Results Summary (in thousands) | Item | Q1 2024 | Q1 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Collaboration & other R&D revenues | $1,135 | $9,851 | ($8,716) | (88)% | | Research and development | $48,787 | $37,804 | $10,983 | 29% | | General and administrative | $19,339 | $23,008 | ($3,669) | (16)% | | **Total operating expenses** | **$68,126** | **$60,812** | **$7,314** | **12%** | - The **$11.0 million** increase in R&D expenses was primarily due to **$5.2 million** in reni-cel program costs and **$4.6 million** in sublicense and license fees[87](index=87&type=chunk)[89](index=89&type=chunk) - The **$3.7 million** decrease in G&A expenses resulted mainly from a **$6.1 million** reduction in professional service expenses from 2023 strategic initiatives[89](index=89&type=chunk)[90](index=90&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$376.8 million** in cash and marketable securities as of March 31, 2024, projecting liquidity into **2026** - As of March 31, 2024, the company held **$376.8 million** in cash, cash equivalents, and marketable securities[92](index=92&type=chunk) - A **$300.0 million** at-the-market (ATM) facility is available but remained unused as of March 31, 2024[93](index=93&type=chunk) - Cash runway is projected to extend into **2026**, supported by current reserves and Vertex license payments[106](index=106&type=chunk) Q1 2024 vs. Q1 2023 Cash Flow Summary (in thousands) | Activity | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($49,872) | ($35,768) | | Net cash (used in) provided by investing activities | ($4,745) | $23,267 | | Net cash provided by financing activities | $192 | $0 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risk is interest rate sensitivity on its **$376.8 million** investment portfolio, with no material foreign currency exposure - The company's primary market risk is interest rate sensitivity on its **$376.8 million** portfolio of cash, cash equivalents, and marketable securities[115](index=115&type=chunk) - A **1%** (100 basis point) change in interest rates is not expected to materially affect the portfolio's fair value due to its short-term, low-risk nature[115](index=115&type=chunk) - The company has no material exposure to foreign currency exchange rate risk, as liabilities are primarily U.S. dollar-denominated[116](index=116&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes in internal control - The CEO and CFO concluded that disclosure controls and procedures were effective at a reasonable assurance level as of **March 31, 2024**[117](index=117&type=chunk) - No material changes occurred in internal control over financial reporting during the quarter[118](index=118&type=chunk) [PART II. OTHER INFORMATION](index=28&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company may face legal proceedings in the ordinary course of business, including intellectual property disputes, with uncertain outcomes - The company may be involved in ordinary course litigation, and certain licensed intellectual property rights are subject to validity disputes[121](index=121&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the comprehensive risk factors detailed in the Annual Report on Form 10-K, with no new material changes - Readers are directed to the 'Risk Factors' section of the Annual Report on Form 10-K for a full discussion of risks[122](index=122&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) This section discloses that no directors or officers adopted or terminated trading arrangements during Q1 2024 - No directors or officers adopted or terminated Rule 10b5-1 or other trading arrangements during the **first quarter of 2024**[125](index=125&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the BMS collaboration amendment and officer certifications - Key exhibits include the First Amendment to the collaboration agreement with Juno Therapeutics, Inc., dated **March 21, 2024**, and officer certifications[127](index=127&type=chunk)
Editas Medicine(EDIT) - 2024 Q1 - Earnings Call Transcript
2024-05-08 14:57
Editas Medicine, Inc. (NASDAQ:EDIT) Q1 2024 Earnings Conference Call May 8, 2024 8:00 AM ET Company Participants Cristi Barnett - Corporate Communications and IR Gilmore O'Neill - CEO Baisong Mei - CMO Erick Lucera - CFO Linda Burkly - CSO Caren Deardorf - Chief Commercial and Strategy Officer Conference Call Participants Samantha Semenkow - Citi Joon Lee - Truist Securities Mary Kate Davis - Bank of America Jack Allen - Baird Gena Wang - Barclays Brian Cheng - JPMorgan Eric Schmidt - Cantor Fitzgerald Jay ...
Editas Medicine (EDIT) Reports Q1 Loss, Misses Revenue Estimates
Zacks Investment Research· 2024-05-08 13:25
Editas Medicine (EDIT) came out with a quarterly loss of $0.76 per share versus the Zacks Consensus Estimate of a loss of $0.63. This compares to loss of $0.71 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -20.63%. A quarter ago, it was expected that this genome editing company would post a loss of $0.52 per share when it actually produced a loss of $0.23, delivering a surprise of 55.77%.Over the last four quarters, the comp ...
Editas Medicine(EDIT) - 2024 Q1 - Quarterly Results
2024-05-08 11:08
Financial Performance - Editas Medicine reported a net loss of $62.0 million, or $0.76 per share, for Q1 2024, compared to a net loss of $49.0 million, or $0.71 per share, in Q1 2023[15]. - Collaboration and other research and development revenues decreased to $1.1 million in Q1 2024 from $9.9 million in Q1 2023, primarily due to a one-time sale of oncology assets[15]. - Research and development expenses increased by $11.0 million to $48.8 million in Q1 2024, driven by sublicense and license payments as well as clinical and manufacturing costs for the reni-cel program[15]. - Cash, cash equivalents, and marketable securities as of March 31, 2024, were $376.8 million, down from $427.1 million as of December 31, 2023[11]. Clinical Trials and Developments - Editas has completed enrollment of the adult cohort in the Phase 1/2/3 RUBY trial for severe sickle cell disease and is on track to present clinical data in mid-2024[6]. - The company continues to enroll patients in the EdiTHAL trial for transfusion-dependent beta-thalassemia, with additional data expected by year-end 2024[6]. - Editas signed a two-year extension with Bristol Myers Squibb for collaboration on T cell medicines for cancer and autoimmune diseases[7]. - The company is set to present pre-clinical data at the ASGCT Annual Meeting, showcasing advancements in in vivo gene editing technologies[10]. - The company aims to establish in vivo preclinical proof-of-concept for an undisclosed indication by year-end 2024[18]. Financial Outlook - Editas expects its cash runway to support operations into 2026, aided by near-term license fees and contingent payments from Vertex Pharmaceuticals[11].
Editas Medicine Announces First Quarter 2024 Results Conference Call and Upcoming Investor Events
Newsfilter· 2024-05-02 11:00
CAMBRIDGE, Mass., May 02, 2024 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (NASDAQ:EDIT), a clinical-stage gene editing company, today announced that it will host a conference call and webcast on Wednesday, May 8, 2024, at 8:00 a.m. ET to discuss results for the first quarter 2024 and to provide a corporate update. To access the conference call: U.S. callers should dial +1-877-407-0989 and international callers should dial +1-201-389-0921 approximately five minutes before the call begins.Participants should a ...
Editas Medicine Announces First Quarter 2024 Results Conference Call and Upcoming Investor Events
Globenewswire· 2024-05-02 11:00
CAMBRIDGE, Mass., May 02, 2024 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage gene editing company, today announced that it will host a conference call and webcast on Wednesday, May 8, 2024, at 8:00 a.m. ET to discuss results for the first quarter 2024 and to provide a corporate update. To access the conference call: U.S. callers should dial +1-877-407-0989 and international callers should dial +1-201-389-0921 approximately five minutes before the call begins.Participants should ...
Will Editas Medicine (EDIT) Report Negative Q1 Earnings? What You Should Know
Zacks Investment Research· 2024-04-26 15:05
The market expects Editas Medicine (EDIT) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if th ...