Sangamo Therapeutics(SGMO)

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Sangamo Therapeutics(SGMO) - 2023 Q4 - Annual Results
2024-03-12 16:00
Exhibit 99.1 SANGAMO THERAPEUTICS REPORTS RECENT BUSINESS HIGHLIGHTS AND FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS Richmond, California, March 13, 2024 – Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, today reported recent business highlights and fourth quarter and full year 2023 financial results, including meaningful data to support advancement of its neurology pipeline. "In 2023, Sangamo announced the prioritization of its pipeline programs that support our focus as a n ...
Sangamo Therapeutics(SGMO) - 2023 Q4 - Annual Report
2024-03-12 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________________________________________________________________________________ Form 10-K _______________________________________________________________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the trans ...
Sangamo Therapeutics Announces U.S. FDA Alignment on Abbreviated Pathway to Potential Approval and EMA Prime Eligibility for ST-920 in Fabry Disease
Businesswire· 2024-02-12 13:05
RICHMOND, Calif.--(BUSINESS WIRE)--Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced important U.S. and European regulatory updates for isaralgagene civaparvovec, or ST-920, its wholly owned gene therapy product candidate for the treatment of Fabry disease. The FDA has agreed in a Type D meeting that data from a single, adequate, and well-controlled study may form the primary basis of approval of a BLA for isaralgagene civaparvovec. The proposed study would enroll up to ...
Sangamo Therapeutics Announces Updated Phase 1/2 STAAR Study Data in Fabry Disease Showing Sustained Benefit and Differentiated Safety Profile
Businesswire· 2024-02-05 23:01
RICHMOND, Calif.--(BUSINESS WIRE)--Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced updated preliminary data from the Phase 1/2 STAAR clinical study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease. In the largest known clinical gene therapy program in Fabry disease to date, data from 24 patients continued to show durable safety and preliminary efficacy data as of the data cutoff date, whic ...
Sangamo Therapeutics(SGMO) - 2023 Q3 - Earnings Call Transcript
2023-11-02 15:51
Sangamo Therapeutics, Inc. (NASDAQ:SGMO) Q3 2023 Earnings Conference Call November 2, 2023 8:30 AM ET Company Participants Louise Wilkie - Vice President-Investor Relations and Corporate Communications Sandy Macrae - Chief Executive Officer Nathalie Dubois-Stringfellow - Chief Development Officer Mark McClung - Chief Operating Officer Jason Fontenot - Chief Scientific Officer Prathyusha Duraibabu - Chief Financial Officer Amy Pooler - Head of Research Conference Call Participants Reena Patel - RBC Capital M ...
Sangamo Therapeutics(SGMO) - 2023 Q3 - Earnings Call Presentation
2023-11-02 11:52
Forward-Looking Statements Pioneering and Delivering the Future of Genomic Medicines This presentation contains forward-looking statements regarding our current expectations. These forward-looking statements include, without limitation, statements relating to our focus on epigenetic regulation and delivery engineering, the potential to develop, obtain regulatory approvals for and commercialize durable, safe and effective therapies to treat certain diseases and the timing, availability and costs of such ther ...
Sangamo Therapeutics(SGMO) - 2023 Q3 - Quarterly Report
2023-10-31 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________________________ FORM 10-Q ________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 000-30171 __ ...
Sangamo Therapeutics(SGMO) - 2023 Q2 - Earnings Call Transcript
2023-08-09 01:29
Sangamo Therapeutics, Inc. (NASDAQ:SGMO) Q2 2023 Earnings Conference Call August 8, 2023 4:30 PM ET Company Participants Louise Wilkie – Vice President-Investor Relations and Corporate Communications Sandy Macrae – Chief Executive Officer Nathalie Dubois-Stringfellow – Chief Development Officer Mark McClung – Chief Operating Officer Jason Fontenot – Chief Scientific Officer Prathyusha Duraibabu – Chief Financial Officer Lisa Rojkjaer – Chief Medical Officer Conference Call Participants Maury Raycroft – Jeff ...
Sangamo Therapeutics(SGMO) - 2023 Q2 - Quarterly Report
2023-08-07 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________________________ FORM 10-Q ________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 000-30171 _______ ...
Sangamo Therapeutics(SGMO) - 2023 Q1 - Quarterly Report
2023-05-07 16:00
[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) This section presents Sangamo Therapeutics' unaudited Condensed Consolidated Financial Statements, showing a shift to net income in Q1 2023 driven by collaboration revenue, offset by significant impairment charges Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Total Assets** | **$440,567** | **$562,509** | | Cash and cash equivalents | $78,241 | $100,444 | | Goodwill | $— | $37,552 | | **Total Liabilities** | **$104,957** | **$267,551** | | Deferred revenues (Current) | $9,575 | $51,780 | | Deferred revenues (Non-current) | $1,816 | $109,377 | | **Total Stockholders' Equity** | **$335,610** | **$294,958** | Condensed Consolidated Statement of Operations Highlights (in thousands) | Account | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Revenues | $157,957 | $28,231 | | Research and development | $63,216 | $58,584 | | Impairment of goodwill | $38,138 | $— | | Impairment of long-lived assets | $20,433 | $— | | **Net Income (Loss)** | **$21,133** | **($43,977)** | | **Diluted EPS** | **$0.12** | **($0.30)** | - Net cash used in operating activities was **$66.3 million** for the three months ended March 31, 2023, compared to **$59.0 million** in the same period of 2022[33](index=33&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail financial statement explanations, including going concern assessment, collaboration terminations leading to accelerated revenue and impairment charges, and a significant April 2023 restructuring - The company's history of recurring net losses and an accumulated deficit of **$1.13 billion** raised substantial doubt about its ability to continue as a going concern, though management's plans are believed to alleviate this doubt for at least the next 12 months[39](index=39&type=chunk)[40](index=40&type=chunk)[42](index=42&type=chunk) - In March 2023, termination notices from Biogen and Novartis were received, with the Biogen termination leading to a contract modification resulting in a **$127.1 million** increase in revenue[83](index=83&type=chunk)[90](index=90&type=chunk)[97](index=97&type=chunk) - Due to a sustained decline in stock price and collaboration terminations, the company recognized a non-cash goodwill impairment charge of **$38.1 million** (fully impairing goodwill) and a long-lived asset impairment charge of **$20.4 million** in Q1 2023[141](index=141&type=chunk)[142](index=142&type=chunk)[143](index=143&type=chunk) - In April 2023, the company announced a restructuring expected to eliminate approximately **120 roles** (**27%** of its US workforce) and incur **$5 million to $7 million** in cash-based severance expenses[149](index=149&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, operational updates, and liquidity, focusing on collaboration terminations, a strategic restructuring, and plans to address going concern doubts through cost reductions - In March 2023, Biogen and Novartis terminated their collaboration agreements for convenience, effective June 2023, leading to a one-time revenue increase of **$127.1 million** from the Biogen agreement modification[154](index=154&type=chunk) - In April 2023, a restructuring was announced to reduce costs, eliminating approximately **120 US roles** (**27%** of US workforce) and focusing on neurology, Fabry disease (isaralgagene civaparvovec), and the TX200 CAR-Treg program[154](index=154&type=chunk) - Management has concluded there is **substantial doubt about the company's ability to continue as a going concern** but believes its cost-reduction plans are sufficient to fund operations for at least the next 12 months[193](index=193&type=chunk)[196](index=196&type=chunk) Results of Operations Comparison (in thousands) | Metric | Q1 2023 | Q1 2022 | Change | | :--- | :--- | :--- | :--- | | Revenues | $157,957 | $28,231 | $129,726 | | R&D Expenses | $63,216 | $58,584 | $4,632 | | G&A Expenses | $18,136 | $14,908 | $3,228 | | Impairment Charges | $58,571 | $0 | $58,571 | [Quantitative and Qualitative Disclosures about Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risks include interest rate fluctuations on its investment portfolio and foreign currency exchange risk from European operations, with no material changes since year-end 2022 - The company's main market risk is interest rate risk on its investment portfolio, consisting of high-credit-quality securities like U.S. government-sponsored entity debt, commercial paper, and corporate debt[210](index=210&type=chunk)[211](index=211&type=chunk) - The company is exposed to foreign currency risk from its European operations, which primarily conduct business in Euros[212](index=212&type=chunk) [Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's disclosure controls and procedures were deemed effective as of March 31, 2023, with no material changes in internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2023[214](index=214&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[217](index=217&type=chunk) [PART II. OTHER INFORMATION](index=42&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material pending legal proceedings as of the reporting period - Sangamo is not party to any material pending legal proceedings[220](index=220&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) This section highlights heightened risks including the urgent need for additional funding, negative impacts from collaboration terminations, uncertainty of restructuring benefits, and potential Nasdaq delisting - The company needs substantial additional funding to execute its operating plan and continue as a going concern, and may be unable to raise capital on favorable terms, if at all[226](index=226&type=chunk) - The recent terminations of collaboration agreements by Biogen and Novartis highlight the risk of collaborators abandoning programs, which negatively impacts revenues and development efforts[232](index=232&type=chunk)[234](index=234&type=chunk) - The April 2023 restructuring may not result in anticipated savings or operational efficiencies, could incur greater-than-expected costs, and could disrupt business operations[242](index=242&type=chunk) - There is a risk that the company's common stock may be delisted from the Nasdaq Global Select Market if it fails to meet continued listing standards, such as the **$1.00** minimum bid price requirement[244](index=244&type=chunk) - The company has recorded significant impairment charges for intangible and long-lived assets and may be required to record more in the future, which would adversely affect results of operations[245](index=245&type=chunk)[247](index=247&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period - None[248](index=248&type=chunk) [Exhibits](index=48&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including amendments to incorporation documents, offering agreements, and CEO/CFO certifications