Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision
medicine company transforming the drug discovery process by
combining leading-edge computational and experimental technologies,
today reported third quarter 2023 financial results and corporate
highlights.
“We have made important progress expanding the
number of patients we have the potential to help with our clinical
programs,” said Sanjiv Patel, M.D., President and Chief Executive
Officer of Relay Therapeutics. “We presented data at the Triple
Meeting demonstrating the potential of lirafugratinib in patients
with many types of FGFR2-altered tumors, and we are working to
initiate RLY-2608 triplet combinations this year with the goal of
being able to treat patients with earlier stage breast cancer. We
have focused our clinical development and execution to extend our
cash runway into the second half of 2026 with the goal of having
the resources to execute these programs, and we are continuing to
advance them as quickly as possible.”
Recent Corporate Highlights
RLY-4008 (lirafugratinib)
- Presented initial clinical data in
patients with FGFR2-altered solid tumors at the 2023 AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics, which demonstrated activity across several
sub-groups, including in patients with FGFR2-fusion tumors and in
patients with FGFR2-altered HR+/HER2- breast cancer. The cut-off
date for these data was August 23, 2023. Key highlights include:
- FGFR2 fusions: Nine of 26 patients
experienced a confirmed partial response (PR) (35% overall response
rate (ORR)), with 63 percent of responders experiencing a duration
of response of at least 6 months
- HR+/HER2- breast cancer, all FGFR2
alterations: Four of 10 patients achieved PRs (40% ORR), with all
responders having a duration of response of at least 6 months, and
the longest duration of response 72 weeks and ongoing as of the
data cut-off
- Patients were very heavily
pre-treated (median of 6 prior lines of therapy) with prior
targeted therapies (100%), prior chemotherapy/ADC (93%), prior
endocrine therapy (79%) and prior CDK4/6 (71%)
- FGFR2 amplifications: Eight of 34
patients experienced a PR (24% ORR), with 43 percent of responders
experiencing a duration of response of at least 6 months
- Completed enrollment in the pivotal
expansion cohort in patients with FGFR2-fusion cholangiocarcinoma
(CCA) who have not previously received an FGFR inhibitor
- Paused near-term commercial
readiness activities for CCA to align with the broader tumor
agnostic opportunity being pursued
RLY-2608
- Announced plans to initiate RLY-2608
+ fulvestrant + CDK4/6 triplet combinations in patients with
PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast
cancer by the end of 2023
Pre-Clinical
- Paused further development efforts
on RLY-2139 (CDK2 inhibitor)
Anticipated Upcoming
Milestones
- Lirafugratinib: report additional tumor agnostic clinical data
and regulatory update in 2024
- PI3Kα: next data update expected in 2024
- Pre-clinical: disclose new program(s) in 2024
Third Quarter 2023 Financial
Results
Cash, Cash Equivalents and
Investments: As of September 30, 2023, cash, cash
equivalents and investments totaled $810.6 million compared to
approximately $1 billion as of December 31, 2022. Relay
Therapeutics expects its current cash, cash equivalents and
investments will be sufficient to fund its current operating plan
into the second half of 2026.
Revenue: Revenue was $25.2
million for the third quarter of 2023, as compared to $0.3 million
for the third quarter of 2022. The increase was primarily due to
the recognition of previously received milestone payments under the
company’s Collaboration and License Agreement with Genentech,
Inc.
R&D Expenses: Research and
development expenses were $81.5 million for the third quarter of
2023, as compared to $66.9 million for the third quarter of 2022.
The increase was primarily due to $8.2 million of additional
clinical trial expenses and $7.4 million of additional
employee-related costs, which include $4.5 million of additional
stock compensation expense.
G&A Expenses: General and
administrative expenses were $18.5 million for the third quarter of
2023, as compared to $16.1 million for the third quarter of 2022.
The increase was primarily due to additional stock compensation
expense.
Net Loss: Net loss was $65.7
million for the third quarter of 2023, or a net loss per share of
$0.54, as compared to a net loss of $84.2 million for the third
quarter of 2022, or a net loss per share of $0.76.
About Relay
Therapeutics
Relay Therapeutics
(Nasdaq: RLAY) is a clinical-stage precision medicine company
transforming the drug discovery process by combining leading-edge
computational and experimental technologies with the goal of
bringing life-changing therapies to patients. As the first of a new
breed of biotech created at the intersection of complementary
techniques and technologies, Relay Therapeutics aims to push the
boundaries of what’s possible in drug discovery. Its Dynamo™
platform integrates an array of leading-edge computational and
experimental approaches designed to drug protein targets that have
previously been intractable or inadequately addressed. Relay
Therapeutics’ initial focus is on enhancing small molecule
therapeutic discovery in targeted oncology and genetic disease
indications. For more information, please visit www.relaytx.com or
follow us on Twitter.
Cautionary Note Regarding
Forward-Looking Statements
This press release
contains 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 Relay Therapeutics’ strategy, business plans and focus;
the progress and timing of the clinical development of the programs
across Relay Therapeutics’ portfolio, including the expected
therapeutic benefits of its programs, potential efficacy and
tolerability, and the timing and success of interactions with and
approval of regulatory authorities; the timing of a clinical data
update for the PI3Kα franchise, the initiation of triplet
combinations for RLY-2608, the timing of a clinical data and
regulatory update for lirafugratinib, and the timing of disclosure
of additional pre-clinical programs; expectations regarding Relay
Therapeutics’ pipeline, operating plan, use of capital, expenses
and other financial results; and Relay Therapeutics’ cash runway
projection. 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, or the
negative thereof, are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words.
Any forward-looking
statements in this press release 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 press release,
including, without limitation, risks associated with: the impact of
global economic uncertainty, geopolitical instability and
conflicts, or public health epidemics or outbreaks of an infectious
disease on countries or regions in which Relay Therapeutics has
operations or does business, as well as on the timing and
anticipated results of its clinical trials, strategy, future
operations and profitability; the delay or pause of any current or
planned clinical trials or the development of Relay
Therapeutics’ drug candidates; the risk that the preliminary
results of its pre-clinical or clinical trials may not be
predictive of future or final results in connection with future
clinical trials of its product candidates; Relay Therapeutics’
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 Relay Therapeutics’ 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 Relay
Therapeutics' views only as of today and should not be relied upon
as representing its views as of any subsequent date. Relay
Therapeutics 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.
Contact:Megan
Goulart617-545-5526 mgoulart@relaytx.com
Media:Dan
Budwick1AB973-271-6085dan@1abmedia.com
Relay
Therapeutics, Inc.Condensed Consolidated
Statements of Operations and Comprehensive Loss(In
thousands, except share and per share
data)(Unaudited)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
License and other revenue |
|
$ |
25,202 |
|
|
$ |
344 |
|
|
$ |
25,547 |
|
|
$ |
1,128 |
|
Total revenue |
|
|
25,202 |
|
|
|
344 |
|
|
|
25,547 |
|
|
|
1,128 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
81,494 |
|
|
$ |
66,900 |
|
|
$ |
252,522 |
|
|
$ |
179,078 |
|
Change in fair value of contingent consideration liability |
|
|
(1,200 |
) |
|
|
3,262 |
|
|
|
(4,355 |
) |
|
|
(1,133 |
) |
General and administrative expenses |
|
|
18,485 |
|
|
|
16,074 |
|
|
|
58,184 |
|
|
|
49,607 |
|
Total operating expenses |
|
|
98,779 |
|
|
|
86,236 |
|
|
|
306,351 |
|
|
|
227,552 |
|
Loss from operations |
|
|
(73,577 |
) |
|
|
(85,892 |
) |
|
|
(280,804 |
) |
|
|
(226,424 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
7,845 |
|
|
|
1,713 |
|
|
|
22,345 |
|
|
|
3,414 |
|
Other (expense) income |
|
|
(2 |
) |
|
|
7 |
|
|
|
(19 |
) |
|
|
4 |
|
Total other income, net |
|
|
7,843 |
|
|
|
1,720 |
|
|
|
22,326 |
|
|
|
3,418 |
|
Net loss |
|
$ |
(65,734 |
) |
|
$ |
(84,172 |
) |
|
$ |
(258,478 |
) |
|
$ |
(223,006 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.54 |
) |
|
$ |
(0.76 |
) |
|
$ |
(2.12 |
) |
|
$ |
(2.04 |
) |
Weighted average shares of common
stock, basic and diluted |
|
|
122,231,255 |
|
|
|
110,905,940 |
|
|
|
121,843,116 |
|
|
|
109,290,743 |
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized holding gain (loss) |
|
|
2,695 |
|
|
|
(1,483 |
) |
|
|
7,034 |
|
|
|
(12,301 |
) |
Total other comprehensive gain (loss) |
|
|
2,695 |
|
|
|
(1,483 |
) |
|
|
7,034 |
|
|
|
(12,301 |
) |
Total comprehensive loss |
|
$ |
(63,039 |
) |
|
$ |
(85,655 |
) |
|
$ |
(251,444 |
) |
|
$ |
(235,307 |
) |
|
Relay Therapeutics,
Inc.Selected Condensed Consolidated Balance Sheet
Data(In
thousands)(Unaudited)
|
|
September 30,2023 |
|
|
December 31,2022 |
|
Cash, cash equivalents and investments |
|
$ |
810,615 |
|
|
$ |
998,917 |
|
Working capital (1) |
|
|
781,050 |
|
|
|
955,796 |
|
Total assets |
|
|
906,959 |
|
|
|
1,099,771 |
|
Total liabilities |
|
|
128,586 |
|
|
|
149,553 |
|
Total stockholders’ equity |
|
|
778,373 |
|
|
|
950,218 |
|
Restricted cash |
|
|
2,707 |
|
|
|
2,578 |
|
(1) Working capital is defined as current assets less current
liabilities.
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