RELAY THERAPEUTICS, INC. Item 7.01 Regulation FD Disclosure.
On
The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
RLY-4008 Regulatory and Clinical Data Update
On
The Company conducted an end-of-phase 1 meeting with the FDA to discuss next steps for the clinical development of RLY-4008. Based on discussions with the FDA, the Company has decided to move forward with a single arm trial design for FGFRi-naïve FGFR2-fusion CCA at 70 mg once daily to potentially support accelerated approval. The Company also intends to add additional supportive CCA cohorts to a New Drug Application submission, including frontline, FGFRi-experienced and FGFR2 mutation and amplification patients that could potentially facilitate a line and alteration agnostic label if the submission is approved.
The interim clinical data the Company shared with the FDA included a data
cut-off of
The safety analysis as of the Data Cut-off Date was consistent with the analysis
from the Company's initial data disclosure for its RLY-4008 clinical trial in
The efficacy analysis from this interim clinical data on the once daily dosing schedule presented by the Company to the FDA demonstrated confirmed partial responses in 8 out of 13, or 62%, FGFRi-naïve FGFR2-fusion CCA patients across the 20 mg to 70 mg QD cohorts. There were four patients treated at the registrational trial dose of 70 mg QD as of the Data Cut-off Date, all of which had confirmed partial responses.
Breast Cancer Portfolio and New Targets
The Company also announced the following three new programs in its breast cancer franchise: a selective cyclin dependent kinase 2 ("CDK2") inhibitor, a rationally designed estrogen receptor alpha ("ER?") degrader and a selective and chemically distinct pan-mutant phosphoinostide 3-kinase alpha inhibitor, RLY-5836.
Cautionary Note Regarding Forward Looking Statements
This Current Report on Form 8-K and certain materials furnished or filed herewith contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the Company's strategy, business plans and focus; the progress and timing of updates on the clinical development of the programs across the Company's portfolio, including the timing of a clinical data update for RLY-4008 and the clinical initiation of the Company's CDK2 program, ER? program and RLY-5836; the expected therapeutic benefits of its programs; whether preclinical or early clinical results of the Company's product candidates will be predictive of future clinical trials; the Company's expectations
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relating to its current and future interactions with the FDA, including its
belief regarding a potential accelerated path to registration and label for
RLY-4008; expectations regarding the Company's operating plan, use of capital,
expenses, and other financial results during 2022 and in the future; and
Any forward-looking statements are based on management's current expectations
and beliefs, and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in this in this
Current Report on Form 8-K or the materials furnished or filed herewith,
including, without limitation, risks associated with: the impact of the ongoing
COVID-19 pandemic, changing macroeconomic conditions or uncertain geopolitical
factors where the Company has operations or does business, as well as on the
timing and anticipated results of its clinical trials, strategy and future
operations; the delay of any current or planned clinical trials or the
development of the Company's drug candidates; the risk that the results of its
clinical trials may not be predictive of future results in connection with
future clinical trials; the Company's ability to successfully demonstrate the
safety and efficacy of its drug candidates; the timing and outcome of its
planned interactions with regulatory authorities; and obtaining, maintaining and
protecting its intellectual property. These and other risks and uncertainties
are described in greater detail in the section entitled "Risk Factors" in the
Company's most recent Annual Report on Form 10-K and Quarterly Report on Form
10-Q, as well as any subsequent filings with the
Item 9.01 Financial Statements and Exhibits.
99.1 Press release issued by
furnished herewith.
99.2 Virtual analyst and investor event presentation, dated June 27, 2022 ,
furnished herewith.
104 Cover Page Interactive Data File (embedded within Inline XBRL document).
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