UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 5, 2021
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer ID Number) | ||||||||||||
(Address of principal executive offices) (Zip Code)
(510 ) 970-6000
(Registrant’s telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 5, 2021, Sangamo Therapeutics, Inc. (“Sangamo”) issued a press release announcing its financial results for the quarter ended June 30, 2021 (the “Press Release”).
A copy of the Press Release is furnished hereto as Exhibit 99.1 and is incorporated by reference herein. The information contained in this Item 2.02 and in the Press Release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the Press Release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the SEC made by Sangamo whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |||||||||||||
| 99.1 | ||||||||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| SANGAMO THERAPEUTICS, INC. | ||||||||||||||||||||
| Dated: August 5, 2021 | By: | /s/ ALEXANDER D. MACRAE | ||||||||||||||||||
| Name: | Alexander D. Macrae | |||||||||||||||||||
| Title: | President and Chief Executive Officer | |||||||||||||||||||
Exhibit 99.1
SANGAMO THERAPEUTICS REPORTS RECENT BUSINESS HIGHLIGHTS AND
SECOND QUARTER 2021 FINANCIAL RESULTS
Conference Call and Webcast Scheduled for 4:30 p.m. Eastern Time
Brisbane, California, August 5, 2021 – Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today reported recent business highlights and second quarter 2021 financial results.
“This is an exciting time at Sangamo, as we look forward to multiple clinical catalysts over the next several quarters representing potential near-term value drivers, while we continue to advance our promising preclinical pipeline focused on the emerging areas of CAR-Tregs and transcriptional regulation, representing potential mid-term value drivers,” said Sandy Macrae, Chief Executive Officer of Sangamo.
Recent Business Highlights
•We dosed a fourth patient in our wholly-owned Phase 1/2 STAAR study evaluating ST-920 gene therapy for Fabry disease, completing dosing of the second cohort. Based on initial safety data from patients dosed to date, the Safety Monitoring Committee recommended dose escalating to the third dose as planned under the study protocol. We are currently screening patients for the third dose cohort.
•Biogen selected a fourth neurological disease gene target under our collaboration agreement, and we have begun early research activities on therapies addressing this target.
•We appointed Prathyusha Duraibabu as Chief Financial Officer and Scott Willoughby as General Counsel and Corporate Secretary.
Second Quarter 2021 Financial Results
Consolidated net loss attributable to Sangamo for the second quarter ended June 30, 2021 was $47.2 million or $0.33 per share, compared to a net loss attributable to Sangamo of $35.9 million or $0.26 per share for the same period in 2020.
Revenues
Revenues for the second quarter ended June 30, 2021 were $27.9 million, compared to $21.6 million for the same period in 2020.
The increase of $6.3 million in revenues was primarily due to the recognition of upfront license fees and research revenue of $9.6 million under our collaboration agreement with Novartis and $2.6 million higher revenue related to our collaboration agreement with Biogen. These increases were partially offset by a decrease of $3.8 million in research revenue related to our giroctocogene fitelparvovec and C9ORF72 collaboration agreements with Pfizer, due to completion of our activities under these collaborations, a decrease of $1.1 million in research revenue related to our collaboration agreement with Kite, and a decrease of $0.9 million in research revenue related to our collaboration agreement with Sanofi.
GAAP and Non-GAAP operating expenses
| (In millions) | |||||||||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| Research and development | $ | 60.1 | $ | 41.5 | $ | 116.6 | $ | 83.0 | |||||||||||||||
| General and administrative | 16.5 | 17.9 | 32.6 | 34.0 | |||||||||||||||||||
| Total operating expenses | 76.6 | 59.4 | 149.2 | 117.0 | |||||||||||||||||||
| Stock-based compensation expense | (9.5) | (6.7) | (17.1) | (12.3) | |||||||||||||||||||
| Non-GAAP operating expenses | $ | 67.1 | $ | 52.7 | $ | 132.1 | $ | 104.7 | |||||||||||||||
Total operating expenses on a GAAP basis for the second quarter ended June 30, 2021 were $76.6 million compared to $59.4 million for the same period in 2020. Non-GAAP operating expenses, which exclude stock-based compensation expense, for the second quarter ended June 30, 2021 were $67.1 million compared to $52.7 million for the same period in 2020.
The increase in total operating expenses on a GAAP basis was primarily driven by our higher clinical and manufacturing supply expenses along with our increased headcount to support the advancement of our clinical trials and our new collaborations.
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of June 30, 2021 were $578.9 million compared to $692.0 million as of December 31, 2020.
Guidance for 2021 Reiterated (initial guidance provided on February 24, 2021)
On a GAAP basis, we expect total operating expenses, including non-cash stock-based compensation expenses, to be in the range of approximately $285 million to $305 million for the year ended December 31, 2021.
On a non-GAAP basis, we expect total operating expenses, excluding estimated non-cash stock-based compensation expense of approximately $30 million, to be in the range of approximately $255 million to $275 million for the year ended December 31, 2021.
Conference Call
Sangamo will host a conference call today, August 5, 2021, at 4:30 p.m. Eastern Time, which will be open to the public. The call will also be webcast with live Q&A and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.
The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 1971045. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 1971045.
About Sangamo Therapeutics
Sangamo Therapeutics is a clinical-stage biopharmaceutical company with a robust genomic medicines pipeline. Using ground-breaking science, including our proprietary zinc finger genome engineering technology and manufacturing expertise, Sangamo aims to create new genomic medicines for patients suffering from diseases for which existing treatment options are inadequate or currently don’t exist. For more information about Sangamo, visit www.sangamo.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding our current expectations. These forward-looking statements include, without limitation, statements relating to our potential value drivers, clinical catalysts and advancement of our pre-clinical pipeline, our 2021 financial guidance related to GAAP and non-GAAP total operating expenses and stock-based compensation and other statements that are not historical fact. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the effects of the evolving COVID-19 pandemic and the impacts of the pandemic on the global business environment, healthcare systems and business and operations of Sangamo and
our collaborators, including the initiation and operation of clinical trials; the research and development process, including the enrollment, operation and results of clinical trials and the presentation of clinical data; and our ability to achieve expected future financial performance.
There can be no assurance that we and our collaborators will be able to develop commercially viable products. Actual results may differ materially from those projected in these forward-looking statements due to the risks and uncertainties described above and other risks and uncertainties that exist in the operations and business environments of Sangamo and our collaborators. These risks and uncertainties are described more fully in our Securities and Exchange Commission filings and reports, including in our Annual Report on Form 10-K for the year ended December 31, 2020 as supplemented by our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. Forward-looking statements contained in this announcement are made as of this date, and we undertake no duty to update such information except as required under applicable law.
Non-GAAP Financial Measure
To supplement our financial results and guidance presented in accordance with GAAP, we present non-GAAP total operating expenses, which exclude stock-based compensation expense from GAAP total operating expenses. We believe that this non-GAAP financial measure, when considered together with our financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare our results from period to period and to our forward-looking guidance, and to identify operating trends in our business. We have excluded stock-based compensation expense because it is a non-cash expense that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. This non-GAAP financial measure is in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. We encourage investors to carefully consider our results under GAAP, as well as our supplemental non-GAAP financial information, to more fully understand our business.
Contact
Investor Relations & Media Inquiries
Aron Feingold
628.252.7494
afeingold@sangamo.com
-more-
SELECTED CONSOLIDATED FINANCIAL DATA
(unaudited; in thousands, except per share data)
| Statement of Operations Data: | |||||||||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
| Revenues | $ | 27,872 | $ | 21,553 | $ | 54,152 | $ | 34,629 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | 60,086 | 41,523 | 116,520 | 83,002 | |||||||||||||||||||
| General and administrative | 16,486 | 17,927 | 32,634 | 34,046 | |||||||||||||||||||
| Total operating expenses | 76,572 | 59,450 | 149,154 | 117,048 | |||||||||||||||||||
| Loss from operations | (48,700) | (37,897) | (95,002) | (82,419) | |||||||||||||||||||
| Interest and other income, net | 1,550 | 1,932 | 2,176 | 3,480 | |||||||||||||||||||
| Loss before taxes | (47,150) | (35,965) | (92,826) | (78,939) | |||||||||||||||||||
| Income tax expense | 24 | — | 287 | — | |||||||||||||||||||
| Net loss | (47,174) | (35,965) | (93,113) | (78,939) | |||||||||||||||||||
| Net loss attributable to non-controlling interest | (5) | (36) | (11) | (97) | |||||||||||||||||||
| Net loss to Sangamo Therapeutics, Inc. stockholders | $ | (47,169) | $ | (35,929) | $ | (93,102) | $ | (78,842) | |||||||||||||||
| Basic and diluted net loss per share attributable to Sangamo Therapeutics, Inc. stockholders | $ | (0.33) | $ | (0.26) | $ | (0.65) | $ | (0.62) | |||||||||||||||
| Shares used in computing basic and diluted net loss per share attributable to Sangamo Therapeutics, Inc. stockholders | 143,984 | 138,977 | 143,550 | 127,519 | |||||||||||||||||||
| Balance Sheet Data: | |||||||||||
| June 30, 2021 | December 31, 2020 | ||||||||||
| Cash, cash equivalents and marketable securities | $ | 578,858 | $ | 691,953 | |||||||
| Total assets | $ | 835,363 | $ | 938,550 | |||||||
| Total stockholders’ equity | $ | 445,457 | $ | 497,366 | |||||||
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