UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure |
On December 19, 2018, Adaptive Biotechnologies Corporation (the “Company”) entered into a Strategic Collaboration and License Agreement (the “Agreement”) with Genentech, Inc. (“Genentech”) to research, develop and commercialize neoantigen-directed T-cell therapies for cancer (each, a “Therapy”). On May 9, 2023, Genentech advised the Company that the U.S. Food and Drug Administration has accepted an investigational new drug (IND) application submitted for use of the Therapy.
| Item 8.01. | Other Events |
The information in the first paragraph of Item 7.01 of this Current Report on Form 8-K (this “Report”) is incorporated by reference into this Item 8.01.
This Report contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this Report other than statements of historical fact are forward-looking statements, including express or implied statements regarding the Company’s continued efforts to develop other shared and personalized products for cellular therapy in oncology, continued scaling of research and development efforts, anticipated costs, revenue guidance and related matters, as well as the ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts and other matters regarding our business strategies, use of capital, results of operations and financial position and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words “anticipate,” “believe,” “continue,” “expect,” “may,” “plan,” “project,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections concerning the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this Report represent our views as of the date hereof. The Company undertakes no obligation to update any forward-looking statements for any reason, except as required by law.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Press Release dated May 9, 2023 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
In accordance with General Instruction B.2 of Form 8-K, the exhibits 99.1 and 104 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
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 thereunto duly authorized.
| Adaptive Biotechnologies Corporation | ||||
| Date: May 9, 2023 | By: | /s/ Tycho Peterson | ||
| Tycho Peterson | ||||
| Chief Financial Officer | ||||
Exhibit 99.1
Press Release
Adaptive Biotechnologies Announces FDA Acceptance of Genentech’s Investigational New Drug Application for the First Neoantigen-Directed T-Cell Therapy Product in Oncology
- The T-Cell Therapy product candidate contains a neoantigen-specific T-cell receptor (TCR) identified and characterized through Adaptive’s TCR discovery platform
SEATTLE, Wash., May 9, 2023 – Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to detect and treat disease, today announced that the U.S. Food and Drug Administration has accepted an investigational new drug (IND) application submitted by its collaborator, Genentech, a member of the Roche Group, for a T-cell receptor (TCR) based T-Cell Therapy. This is the first TCR-based therapeutic product candidate to advance into clinical development based on Adaptive’s collaboration with Genentech in oncology.
“This IND acceptance reaffirms the value of our immune medicine platform and Adaptive’s ability to identify and characterize clinical grade, therapeutic T-cell receptors, which is the cornerstone of our drug discovery capabilities,” said Chad Robins, chief executive officer and co-founder, Adaptive Biotechnologies. “We look forward to supporting Genentech’s world-class team of scientists and drug developers to advance this potentially life-saving therapy into the clinic for patients with solid tumors.”
Under the terms of Adaptive and Genentech’s collaboration agreement, Genentech has responsibility for clinical, regulatory and commercialization efforts for any T-Cell Therapy product candidate. Adaptive reiterates its full year revenue guidance in the range of $205 to $215 million.
About Adaptive Biotechnologies and Genentech’s Cell Therapy Collaboration
In 2019, Adaptive Biotechnologies and Genentech, a member of the Roche Group, entered into a worldwide collaboration and license agreement to develop, manufacture and commercialize novel neoantigen directed T-cell therapies for the treatment of a broad range of cancers. The collaboration combines Genentech’s global cancer immunotherapy research and development leadership with Adaptive’s proprietary T-cell receptor (TCR) discovery platform to accelerate a transformational new treatment paradigm of tailoring cellular therapy for each patient’s individual cancer.
About Adaptive Biotechnologies
Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. For more information, please visit adaptivebiotech.com and follow us on www.twitter.com/adaptivebiotech.
Forward Looking Statements
This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize
and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.
In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections concerning the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.
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MEDIA CONTACT:
Erica Jones
206-279-2423
media@adaptivebiotech.com
ADAPTIVE INVESTORS:
Karina Calzadilla, Vice President, Investor Relations
201-396-1687
Carrie Mendivil, Gilmartin Group
investors@adaptivebiotech.com