Blog: RELAY THERAPEUTICS, INC. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K) – Marketscreener.com

Item 7.01 Regulation FD Disclosure.

On September 11, 2022, Relay Therapeutics, Inc. (the “Company”) issued a press
release announcing late breaking interim clinical data from the Company’s
ReFocus trial for RLY-4008, an investigational, potent, selective and oral small
molecule inhibitor of fibroblast growth factor receptor 2 (“FGFR2”), a copy of
which is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The Company intends to host a conference call and live webcast to discuss the
interim clinical data on September 12, 2022 at 8:00 a.m. E.T. The Company has
made available a slide presentation to accompany the call, a copy of which is
being furnished as Exhibit 99.2 to this Current Report on Form 8-K. The Company
undertakes no obligation to update, supplement or amend the materials attached
hereto as Exhibit 99.2.

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, as amended (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.

On September 11, 2022, the Company announced interim clinical data for RLY-4008
that was presented at the European Society for Medical Oncology (“ESMO”)
Congress 2022.

The interim clinical data were based on an August 1, 2022 data cut-off date from
both the dose escalation and dose expansion phases of the RLY-4008 clinical
trial. The interim clinical data included a safety database of 195 patients,
with 89 patients treated at the pivotal dose of 70 mg once daily (“QD”) dose, of
which 17 were pan-FGFR (“FGFRi”) treatment-naïve FGFR2-fusion cholangiocarcinoma
(“CCA”) patients eligible for efficacy evaluation (patients with measurable
disease who had opportunity for two or more tumor assessments to confirm
response or discontinued treatment with less than two tumor assessments).

Key interim clinical data include:

15 out of 17 of the efficacy evaluable patients at the pivotal dose experienced
a partial response resulting in an 88% interim overall response rate (“ORR”),
with 14 confirmed partial responses and one unconfirmed partial response in an
ongoing patient.

13 out of 15 responders remain on treatment; one responder came off study to be
resected with curative intent.

The two patients with the best response of stable disease remain on treatment.

More broadly across all dose levels and schedules, 38 FGFRi-naïve FGFR2-fusion
CCA patients were eligible for efficacy evaluation, of which 24 experienced a
partial response resulting in a 63% interim ORR, with 22 confirmed partial
responses and 2 unconfirmed partial responses.

The interim safety analysis as of the August 1, 2022 data cut-off date was
generally consistent with the Company’s analysis of the interim clinical data
for RLY-4008 as of April 19, 2022 that was shared with the U.S. Food and Drug
Administration (“FDA”) as well as the Company’s initial clinical data for
RLY-4008 as of September 9, 2021 that was announced in October 2021. In
particular:

Most treatment emergent adverse events were expected FGFR2 on-target, low-grade,
monitorable, manageable and largely reversible.

There were no observed Grade 4 or 5 adverse events.

Off-target toxicities of hyperphosphatemia and diarrhea continued to be
clinically insignificant.

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 disclosures regarding additional clinical data updates and enrollment for
RLY-4008 and initial clinical data for RLY-2608; the expected therapeutic
benefits of its programs, including potential efficacy and tolerability; whether
preliminary results from its preclinical or clinical trials will be predictive
of the final results of the trials or any future clinical trials of its product
candidates; the possibility that unconfirmed results from these trials will not
be confirmed by additional data as the clinical trials progress; and the
Company’s expectations relating to its current and future interactions with the
FDA, including its belief regarding a potential pivotal cohort. The words “may,”
“might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,”
“believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,”
“potential,” “continue,” “target” and similar words or expressions are intended
to identify forward-looking statements, although not all forward-looking
statements contain these identifying words.

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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 Current
Report on Form 8-K or the materials furnished or filed herewith, including,
without limitation, risks associated with: the impact of 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 Securities and
Exchange Commission. In addition, any forward-looking statements represent the
Company’s views only as of today and should not be relied upon as representing
its views as of any subsequent date. The Company explicitly disclaims any
obligation to update any forward-looking statements. No representations or
warranties (expressed or implied) are made about the accuracy of any such
forward-looking statements.

Item 9.01 Financial Statements and Exhibits.

99.1     Press release issued by Relay Therapeutics, Inc. on September 11, 2022,
       furnished herewith  .
99.2     Corporate presentation, dated September 12, 2022, furnished herewith.
104    Cover Page Interactive Data File (embedded within Inline XBRL document)



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