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): February 20, 2018
SANGAMO THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 000-30171 | 68-0359556 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
501 Canal Blvd., Richmond, California 94804
(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 (see General Instruction A.2. below):
| ☐ | 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)) |
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 1.01 Entry into a Material Definitive Agreement.
On February 20, 2018, Sangamo Therapeutics, Inc. (“Sangamo”) entered into a Collaboration and License Agreement (the “Kite Agreement”) with Kite Pharma, Inc. (“Kite”), a wholly-owned subsidiary of Gilead Sciences, Inc. (“Gilead”), for the research, development and commercialization of potential engineered cell therapies for cancer. Gilead is also a party to the Kite Agreement for the sole purpose of guaranteeing the performance of Kite. Pursuant to the Kite Agreement, Sangamo will work together with Kite on a research program under which Sangamo will design zinc finger nucleases (“ZFNs”) and adeno-associated viruses (“AAVs”) to disrupt and insert certain genes in T cells and NK cells, including the insertion of genes that encode chimeric antigen receptors (“CARs”), T-cell receptors (“TCRs”) and NK cell receptors (“NKRs”) directed to mutually agreed targets (“Candidate Targets”). Kite will be responsible for all clinical development and commercialization of any resulting products. Except for confidentiality obligations and certain representations, warranties and covenants, which are effective upon execution, the effectiveness of the Kite Agreement is subject to the expiration or termination of all applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), and other customary closing conditions.
Subject to the terms of the Kite Agreement, Sangamo will, upon effectiveness of the Kite Agreement, grant to Kite an exclusive, royalty-bearing, worldwide, sublicensable license, under Sangamo’s relevant patents and know-how, to develop, manufacture and commercialize, for the purpose of treating cancer, specific cell therapy products that may result from the research program and that are engineered ex vivo, using selected ZFNs and AAVs developed under the research program, to express CARs, TCRs or NKRs directed to Candidate Targets (the “Licensed Products”).
During the research program term and subject to certain exceptions, except pursuant to the Kite Agreement, Sangamo will be prohibited from researching, developing, manufacturing and commercializing, for the purpose of treating cancer, any cell therapy product that, as a result of ex vivo genome editing, expresses a CAR, TCR or NKR that is directed to a target expressed on or in a human cancer cell. After the research program term concludes and subject to certain exceptions, except pursuant to the Kite Agreement, Sangamo will be prohibited from developing, manufacturing and commercializing, for the purpose of treating cancer, any cell therapy product that, as a result of ex vivo genome editing, expresses a CAR, TCR or NKR that is directed to a Candidate Target.
Under the terms of the Kite Agreement, Sangamo will, upon the effectiveness of the Kite Agreement, receive a $150 million upfront payment from Kite. Kite will reimburse Sangamo’s direct costs to conduct the joint research program under the Kite Agreement, and Kite will be operationally and financially responsible for all subsequent development, manufacturing and commercialization of Licensed Products. Sangamo is also eligible to receive contingent research-, development- and sales-based milestone payments that could total up to $3.01 billion if all of the specified milestones set forth in the Kite Agreement are achieved. Of this amount, approximately $1.26 billion relates to the achievement of specified research, clinical development and first commercial sale milestones, and approximately $1.75 billion relates to the achievement of specified commercial sales-based milestones if annual worldwide net sales of Licensed Products reach specified levels. Each development- and sales-based milestone payment is payable (i) only once for each Licensed Product, regardless of the number of times that the associated milestone event is achieved by such Licensed Product, and (ii) only for the first ten times that the associated milestone event is achieved, regardless of the number of Licensed Products that may achieve such milestone event. In addition, Sangamo will be entitled to receive escalating, tiered royalty payments with a percentage in the single digits based on potential future annual worldwide net sales of Licensed Products. These royalty payments will be subject to reduction due to patent expiration, entry of biosimilar products to the market and payments made under certain licenses for third-party intellectual property.
Kite has the right to terminate the Kite Agreement, in its entirety or on a Licensed Product-by-Licensed Product or Candidate Target-by-Candidate Target basis, for any reason after a specified notice period. Each party has the right to terminate the Kite Agreement on account of the other party’s bankruptcy or material, uncured breach of the Kite Agreement.
The foregoing description of the Kite Agreement and the transactions contemplated thereby does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the Kite Agreement, which will be filed as an exhibit to Sangamo’s Quarterly Report on Form 10-Q for the quarterly period ending March 31, 2018. Sangamo intends to seek confidential treatment for certain portions of the Kite Agreement pursuant to a confidential treatment request that it intends to submit to the Securities and Exchange Commission (the “SEC”) pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
Item 2.02 Results of Operations and Financial Condition.
On February 22, 2018, Sangamo issued a press release announcing its financial results for the quarter and year ended December 31, 2017 (the “Earnings Release”). A copy of the Earnings 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 Earnings 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 Earnings 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 8.01 Other Events.
On February 22, 2018, Sangamo and Kite issued a joint press release in connection with the Kite Agreement (the “Joint Release”). A copy of the Joint Release is filed hereto as Exhibit 99.2 and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number |
Description | |
| 99.1 | Earnings Release dated February 22, 2018. | |
| 99.2 | Joint Release dated February 22, 2018. | |
Forward-Looking Statements
This Current Report on Form 8-K and the accompanying Earnings Release and Joint Release (together, the “Press Releases”) contain forward-looking statements. These forward-looking statements include, without limitation references relating to the advancement of Sangamo’s preclinical projects toward IND; expected timing of presentation of preliminary clinical trial data by mid year for Sangamo’s most advanced clinical trials, SB-525 for hemophilia A and SB913 for MPS II; initiation of a Phase 1/2 clinical trial for ST-400 beta thalassemia program in early 2018; filing an IND application for sickle cell disease; filing an IND application for ST-920 for the Fabry disease program; advancements and improvements to Sangamo’s technology platforms; potential for additional collaborations; the establishment of Sangamo’s new headquarters and the construction of a state-of-the-art cGMP manufacturing facility; anticipated cash and investment balance, operating expenses, revenue and potential milestone and royalty payments under Sangamo’s collaboration agreements; the potential benefit of therapeutic applications of Sangamo’s ZFN technology platform to modify genes to develop next-generation cell therapies for autologous and allogeneic use in treating different cancers; the potential of Sangamo’s ZFN technology to provide a treatment option that can be accessed directly within the hospital, thus reducing the time to infusion for patients; the anticipated effectiveness of the Kite Agreement and the timing and benefits thereof; and Sangamo’s receipt of an upfront payment and potential receipt of research-, development- and sales-based milestones, as well as royalties on potential future sales of Licensed Products. Because such statements deal with future events and are based on current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements could differ materially from those described in or implied by the statements in this Current Report on Form 8-K and in the Press Releases due to a number of factors, including the dependence on the success of the clinical trials of lead programs, the lengthy and uncertain regulatory approval process, uncertainties related to the initiation and completion of clinical trials, whether clinical trial results will validate and support the safety and efficacy of Sangamo’s product candidates, the reliance on partners and other third-parties to meet their obligations, the ability to establish additional strategic partnerships, the ability to cause the Kite Agreement to become effective on the proposed terms and schedule; the ability to obtain clearance under the HSR Act and to satisfy the closing conditions under the Kite Agreement; the new, uncertain and time consuming gene editing product candidate development and regulatory process, including the risks that Sangamo and Kite may not be successful in their research efforts under the Kite Agreement and that, even if successful, Kite may be unable to successfully develop and commercialize licensed products; Sangamo’s dependence on collaborative partners, including the risks that if Kite were to breach or terminate the Kite agreement or otherwise fail to successfully develop and commercialize the licensed products and in a timely manner, Sangamo would not obtain the anticipated financial and other benefits of the Kite agreement and the development and/or commercialization of Sangamo’s genome editing technology could be delayed, perhaps
substantially. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that Sangamo and its partners will be able to develop commercially viable gene-based therapeutics. A more detailed discussion of these and other risks and uncertainties may be found under the caption “Risk Factors” and elsewhere in Sangamo’s SEC filings and reports, including Sangamo’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 and future filings and reports by Sangamo, including Sangamo’s Annual Report on Form 10-K. Sangamo assumes no obligation to update the forward-looking information contained in this Current Report on Form 8-K and in the Press Releases.
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.
| DATE: February 22, 2018 |
SANGAMO THERAPEUTICS, INC. | |||||
| By: |
/s/ ALEXANDER D. MACRAE | |||||
| Alexander D. Macrae, M.B., Ch.B., Ph.D. | ||||||
| President, Chief Executive Officer | ||||||
Exhibit 99.1
|
Sangamo Therapeutics, Inc. Point Richmond Tech Center 501 Canal Boulevard Richmond, CA 94804 510-970-6000 | sangamo.com |
SANGAMO THERAPEUTICS REPORTS FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS
Company Also Separately Announced Collaboration with Kite, a Gilead Company, to Develop Next-Generation Engineered Cell Therapies for the Treatment of Cancer
Conference Call and Webcast at 8:00 a.m. Eastern Time Today
Richmond, California, February 22, 2018 – Sangamo Therapeutics, Inc. (NASDAQ: SGMO) today reported its fourth quarter and full year 2017 financial results and recent accomplishments.
“With two collaboration announcements since the beginning of the year, 2018 is off to a brisk start,” said Sandy Macrae, CEO of Sangamo. “This year we continue the important work of laying the foundation for Sangamo as a sustainable, fully integrated company that develops, manufacturers and commercializes novel genomic therapies on our own and, where appropriate, in collaboration with industry partners. We now have five active clinical programs, with additional preclinical assets advancing toward IND. Perhaps most importantly, we expect to begin reporting data by mid-year from our most advanced clinical trials, SB-525 for hemophilia A and SB-913 for MPS II.”
Recent Highlights
Corporate
| • | Established global collaboration and license agreement with Kite, a Gilead company, to develop next-generation cell therapies for the treatment of cancer |
| • | Formed a second collaboration and license agreement with Pfizer to apply Sangamo’s zinc finger protein transcription factor (ZFP-TF) gene regulation platform to the development of potential gene therapies for C9ORF72-linked amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration (FTLD) |
| • | Strengthened and expanded the breadth of talent and experience of the Company’s leadership team with recent key appointments |
| • | Appointment of Heather D. Turner, J.D., as senior vice president and general counsel |
| • | Appointment of Andy Ramelmeier, Ph.D., as senior vice president, head of technical operations and manufacturing |
| • | Appointment of Dr. Duncan McKay as general manager and vice president of Europe |
Clinical
| • | Presented initial safety data from the first patient treated in the SB-913 Phase 1/2 CHAMPIONS Study for MPS II at the 2018 WORLDSymposium congress |
| • | Six week follow-up safety data demonstrated that an infusion of SB-913 at a dose of 5.00E+12 vg/kg was well tolerated |
| • | To-date, two patients have been treated in the CHAMPIONS Study |
| • | Treated a third patient in the SB-525 Phase 1/2 Alta Study for hemophilia A |
| • | In collaboration with Case Western Reserve University, announced the award of an $11 million grant from the National Institutes of Health for planned clinical study of gene-edited T cells designed to eradicate persistent HIV infection in patients receiving anti-retroviral therapy (ART) |
Priorities and Expectations for 2018
| • | Clinical – Demonstrate clinical progress on core assets with initial clinical data readouts by mid-year 2018 |
| • | Pipeline – Initiate Phase 1/2 clinical trial for ST-400 beta-thalassemia program in early 2018; support Bioverativ in filing IND application for sickle cell disease; file IND application for ST-920 Fabry disease program |
| • | Technology – Continue to set gene editing standards for precision, efficiency and specificity and operationalize platform improvements |
| • | Partnerships – Collaborate with the right partners to develop best-in-class medicines for patients |
| • | Corporate – Establish new headquarters and construct state-of-the-art cGMP manufacturing facility in Brisbane, CA |
Fourth Quarter 2017 Financial Results
For the fourth quarter ended December 31, 2017, Sangamo reported a consolidated net loss of $13.1 million, or $0.15 per share, compared to a net loss of $9.6 million, or $0.14 per share, for the same period in 2016. As of December 31, 2017, the Company had cash, cash equivalents, marketable securities and interest receivable of $244.6 million.
Revenues for the fourth quarter of 2017 were $13.1 million, compared to $8.9 million for the same period in 2016. The increase in revenues was primarily related to our hemophilia A collaboration and license agreement with Pfizer. Fourth quarter 2017 revenues were primarily generated from Sangamo’s collaboration agreements with Pfizer, Bioverativ and Dow AgroSciences.
Total operating expenses for the fourth quarter of 2017 were $26.8 million, compared to $18.8 million for the same period in 2016. Research and development expenses were $19.4 million for the fourth quarter of 2017, compared to $13.9 million for the same period in 2016. The increase was primarily due to clinical and manufacturing expenses in support of current clinical studies and investment in dedicated manufacturing capacity. General and administrative expenses were $7.5 million for the fourth quarter of 2017, compared to $4.9 million for the fourth quarter of 2016. The increase was primarily due to salaries and related costs and other professional fees in support of overall company growth.
Full Year 2017 Results
For the year ended December 31, 2017, the consolidated net loss was $54.6 million, or $0.70 per share, compared to a consolidated net loss of $71.7 million, or $1.02 per share, for the year ended December 31, 2016. Revenues were $36.6 million for the year ended December 31, 2017, compared to $19.4 million for the same period in 2016. The increase in revenues was primarily related to our hemophilia A collaboration and license agreement with Pfizer. Total operating expenses were $92.9 million for the year ended December 31, 2017, compared to $91.9 million for the same period in 2016.
Conference Call
Sangamo will host a conference call today, February 22, 2018, at 8:00 a.m. ET, which will be open to the public. The call will also be webcast live 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 4392918. For those unable to listen in at the designated time, a conference call replay will be available for one week following the conference call, from approximately 11:00 a.m. ET on February 22, 2018 to 11:00 a.m. ET on March 1, 2018. 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 4392918.
About Sangamo
Sangamo Therapeutics, Inc. is focused on translating ground-breaking science into genomic therapies that transform patients’ lives using the company’s industry leading platform technologies in genome editing, gene therapy, gene regulation and cell therapy. For more information about Sangamo, visit www.sangamo.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding Sangamo’s current expectations. These forward looking statements include, without limitation, references to the advancement of our preclinical projects toward IND, expected timing of presentation of preliminary clinical trial data by mid-year for our most advanced clinical trials, SB-525 for hemophilia A and SB913 for MPS II, Initiation of a Phase 1/2 clinical trial for ST-400 beta thalassemia program in early 2018; filing an IND application for sickle cell disease; filing an IND application for ST-920 for the Fabry disease program; advancements and improvements to our technology platforms; additional collaborations; the establishment of our new headquarters and the construction of a state-of-the-art cGMP manufacturing facility; and anticipated cash and investment balance, operating expenses, revenue and potential milestone and royalty payments under Sangamo’s collaboration agreements. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the dependence on the success of clinical trials of lead programs, the lengthy and uncertain regulatory approval process, uncertainties related to the initiation and completion of clinical trials, whether clinical trial results will validate and support the safety and efficacy of Sangamo’s therapeutics, the reliance on partners and other third-parties to meet their obligations, and the ability to establish strategic partnerships. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that Sangamo and its partners will be able to develop commercially viable gene-based therapeutics. Actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in Sangamo’s operations and business environments. These risks and uncertainties are described more fully in Sangamo’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q as filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Sangamo undertakes no duty to update such information except as required under applicable law.
Contact
Sangamo Therapeutics, Inc.
McDavid Stilwell
(510) 970-6000, x219
mstilwell@sangamo.com
Varant Shirvanian
(510) 970-6000, x205
vshirvanian@sangamo.com
-more-
SELECTED CONSOLIDATED FINANCIAL DATA
(unaudited; in thousands, except per share data)
| Three Months Ended December 31, |
Twelve Months Ended December 31, |
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| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Statement of Operations Data: |
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| Revenues: |
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| Collaboration agreements |
$ | 12,918 | $ | 8,850 | $ | 35,960 | $ | 18,881 | ||||||||
| Research grants |
159 | 72 | 607 | 508 | ||||||||||||
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| Total revenues |
13,077 | 8,922 | 36,567 | 19,389 | ||||||||||||
| Operating expenses: |
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| Research and development |
19,377 | 13,890 | 65,728 | 65,618 | ||||||||||||
| General and administrative |
7,466 | 4,862 | 27,200 | 26,330 | ||||||||||||
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| Total operating expenses |
26,843 | 18,752 | 92,928 | 91,948 | ||||||||||||
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| Loss from operations |
(13,766 | ) | (9,830 | ) | (56,361 | ) | (72,559 | ) | ||||||||
| Interest and other income, net |
675 | 219 | 1,793 | 887 | ||||||||||||
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| Loss before taxes |
(13,091 | ) | (9,611 | ) | (54,568 | ) | (71,672 | ) | ||||||||
| Benefit (provision) from income taxes |
— | (13 | ) | — | 14 | |||||||||||
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| Net loss |
$ | (13,091 | ) | $ | (9,624 | ) | $ | (54,568 | ) | $ | (71,658 | ) | ||||
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| Basic and diluted net loss per common share |
$ | (0.15 | ) | $ | (0.14 | ) | $ | (0.70 | ) | $ | (1.02 | ) | ||||
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| Shares used in computing basic and diluted net loss per common share |
84,820 | 70,730 | 78,084 | 70,553 | ||||||||||||
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SELECTED BALANCE SHEET DATA
| December 31, 2017 | December 31, 2016 | |||||||
| Cash, cash equivalents, marketable securities and interest receivable |
$ | 244,560 | $ | 142,759 | ||||
| Total assets |
286,741 | 157,891 | ||||||
| Total stockholders’ equity |
187,900 | 136,195 | ||||||
Exhibit 99.2
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CONTACTS
| Gilead/Kite | Sangamo | |
| Sung Lee, Investors (650) 524-7792 |
McDavid Stilwell or Varant Shirvanian, Investors (510) 970-6005 | |
| Nathan Kaiser, Media (650) 522-1853 |
Ryan Ferrell and John Kang, Media 312-506-5202 sangamo@hdmz.com | |
For Immediate Release
KITE, A GILEAD COMPANY, AND SANGAMO THERAPEUTICS ANNOUNCE COLLABORATION TO DEVELOP NEXT-GENERATION ENGINEERED CELL THERAPIES FOR THE TREATMENT OF CANCER
— Kite to Receive Exclusive License to Leverage Sangamo’s Gene Editing Technology in Allogeneic and Autologous Cell Therapy Programs in Oncology —
Santa Monica, Calif. and Richmond, Calif., February 22, 2018 – Kite, a Gilead Company (Nasdaq: GILD) and Sangamo Therapeutics, Inc. (Nasdaq: SGMO) today announced the companies have entered into a worldwide collaboration using Sangamo’s zinc finger nuclease (ZFN) technology platform for the development of next-generation ex vivo cell therapies in oncology.
Kite will use Sangamo’s ZFN technology to modify genes to develop next-generation cell therapies for autologous and allogeneic use in treating different cancers. Allogeneic cell therapies from healthy donor cells or from renewable stem cells would provide a potential treatment option that can be accessed directly within the oncology infusion center, thus reducing the time to infusion for patients.
Under the terms of the agreement, Sangamo will receive an upfront payment of $150 million and is eligible to receive up to $3.01 billion in potential payments, aggregated across 10 or more products utilizing Sangamo’s technology, based on the achievement of certain research, development, regulatory and successful commercialization milestones. Sangamo would also receive tiered royalties on sales of potential future products resulting from the collaboration. Kite will be responsible for all development, manufacturing and commercialization of products under the collaboration, and will be responsible for agreed upon expenses incurred by Sangamo.
“This collaboration between Kite and Sangamo brings together two leading platforms to develop best-in-class cell therapies in oncology,” said Sandy Macrae, President and Chief Executive Officer of Sangamo. “We are excited by Kite’s commitment to driving innovation in this field and look forward to working together to realize the full promise of cell therapy in treating cancer.”
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| February 22, 2018 | Page 2 |
“The emergence of gene editing as a tool to edit immune cells holds promise in the development of therapies with potentially improved safety, efficacy and efficiency,” said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “We believe Sangamo’s zinc finger nucleases provide the optimal gene editing platform, and we look forward to working with Sangamo to accelerate our efforts to develop next-generation autologous cell therapies, as well as allogeneic treatments that can be accessed more conveniently in the hospital setting for people living with cancer.”
This transaction is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act and other customary closing conditions. A Current Report on Form 8-K describing the proposed transaction in more detail will be filed by Sangamo, and this press release is subject to further detail provided in Sangamo’s 8-K.
Sangamo Conference Call
Sangamo will host a conference call today, February 22, 2018 at 8:00 a.m. ET, which will be open to the public, to discuss the details of the collaboration and the Company’s fourth quarter and full year 2017 business and financial results. The call will also be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A replay of the webcast will also be available for one week after the call.
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 4392918. 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 4392918.
About Kite
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. For more information on Kite, please visit www.kitepharma.com.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
About Sangamo Therapeutics
Sangamo Therapeutics, Inc. is focused on translating ground-breaking science into genomic therapies that transform patients’ lives using the company’s industry leading platform technologies in genome editing, gene therapy, gene regulation and cell therapy. Sangamo is conducting Phase 1/2 clinical trials in Hemophilia A and Hemophilia B, and lysosomal storage disorders MPS I and MPS II. Sangamo has an exclusive, global collaboration and license agreement with Pfizer Inc. for gene therapy programs for Hemophilia A and gene regulation programs for C9ORF72-linked amyotrophic lateral sclerosis and frontotemporal lobar degeneration; with Bioverativ Inc. for hemoglobinopathies, including beta thalassemia and sickle cell disease; and with Shire International GmbH to develop therapeutics for Huntington’s disease. In addition, it has established strategic partnerships with companies in non-therapeutic applications of its technology, including Sigma-Aldrich Corporation and Dow AgroSciences. For more information about Sangamo, visit Sangamo’s website at www.sangamo.com.
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| February 22, 2018 | Page 3 |
Gilead Forward-Looking Statements
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that clearance under the Hart-Scott Rodino Antitrust Improvements Act may not be obtained, the closing conditions may not be met and the agreement may not become effective. In addition, Kite may be unsuccessful in developing and commercializing cell therapies utilizing the ZFN technology, the development of such products may take longer than expected and the benefits of the partnership may not be realized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include risks and uncertainties detailed from time to time in Gilead Sciences, Inc.’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 as filed with the Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.
Sangamo Forward-Looking Statements
This press release contains or may imply “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, without limitation references relating to the potential benefit of therapeutic applications of Sangamo’s ZFN technology platform to modify genes to develop next-generation cell therapies for autologous and allogeneic use in treating different cancers, the potential of Sangamo’s ZFN technology to provide a treatment option that can be accessed directly within the hospital, thus reducing the time to infusion for patients, statements related the anticipated effectiveness of the collaboration and the timing and benefits thereof, Sangamo’s receipt of an upfront payment and potential receipt of development- and sales-based milestones, as well as royalties on potential future sales, and other statements that are not historical fact Because such statements deal with future events and are based on current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements could differ materially from those described in or implied by the statements in this press release due to a number of factors, including the ability to cause the agreement to become effective on the proposed terms and schedule, the ability to obtain clearance under the Hart-Scott-Rodino Antitrust Improvements Act and to satisfy the closing conditions, the new, uncertain and time consuming gene editing product candidate development and regulatory process, including the risks that Sangamo and Kite may not be successful in their research efforts under the collaboration and that, even if successful, Kite may be unable to successfully develop and commercialize licensed products resulting from the collaboration; Sangamo’s dependence on collaborative partners, including the risks that if Kite were to breach or terminate the agreement or otherwise fail to successfully develop and commercialize licensed products resulting from the collaboration and in a timely manner, Sangamo would not obtain the anticipated financial and other benefits of the collaboration and the development and/or commercialization of Sangamo’s gene editing technology could be delayed, perhaps substantially. These forward-looking statements are subject to risks and uncertainties, including those discussed under the heading “Risk Factors” in Sangamo’s most recently filed Quarterly Report on Form 10-Q, including the documents incorporated by reference therein, and subsequent filings with the SEC, including Sangamo’s Annual Report on Form 10-K for the year ended December 31, 2017. Except as otherwise required by law, Sangamo disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof.
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