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 first quarter 2023 financial results and corporate
highlights.
“We have made important progress so far in 2023 by continuing to
advance our clinical and pre-clinical programs,” said Sanjiv Patel,
M.D., president and chief executive officer of Relay Therapeutics.
“At the AACR Annual Meeting, we announced initial clinical data for
RLY-2608, which showed that selectively inhibiting mutant PI3Kα
avoided key common off-target toxicities. Of the eight patients
with measurable breast cancer who received a dose at target
exposure, one experienced a confirmed partial response after data
cut-off and the other seven experienced a best overall response of
stable disease; seven of these patients continue on treatment.
Given the early but promising nature of these data, we are moving
quickly to initiate dose expansion cohorts in the second half of
the year.”
Recent Corporate Highlights
RLY-4008 (FGFR2 inhibitor)
- Presented data at AACR Annual Meeting 2023, which showed that
food and esomeprazole did not have a clinically relevant effect on
the pharmacokinetics (PK) of RLY-4008
- Full dose escalation data from the ReFocus trial accepted for
presentation at 2023 American Society of Clinical Oncology (ASCO)
Annual Meeting, June 2-6, 2023
Breast Cancer Portfolio
- RLY-2608 (pan-mutant and isoform-selective PI3Kα inhibitor)
- Presented initial clinical data from
the first-in-human ReDiscover trial at the AACR Annual Meeting,
which support initial clinical proof of mechanism, demonstrating
that RLY-2608 achieved selective target engagement at multiple
predicted efficacious doses with a favorable initial safety and
tolerability profile. The cut-off date for these data was March 9,
2023. Key highlights include:
- Multiple doses achieved sustained
target exposure of approximately 80 percent or greater mutant PI3Kα
inhibition
- No Grade 3 hyperglycemia, rash or
diarrhea observed at target exposures
- Favorable initial safety profile at
target exposures with mostly low-grade adverse events that were
manageable and reversible
- Partial response in breast cancer
patient with 12 prior lines of therapy, which was confirmed
subsequent to the data cut-off date
- Initial anti-tumor activity in
breast cancer patients observed across a range of doses
- Median treatment duration among the
27 patients with breast cancer was approximately 4 months, with 70
percent (19/27) still on treatment as of the cut-off date
- Dose exploration is ongoing to determine the recommended
dose(s) for the dose expansion cohorts, which Relay Therapeutics
anticipates initiating in the second half of 2023
- RLY-5836 (pan-mutant and isoform-selective PI3Kα inhibitor)
- In April 2023, initiated a first-in-human trial in patients
with advanced solid tumors with a PIK3CA (PI3Kα) mutation
- RLY-2139 (CDK2 inhibitor)
- Selected development candidate; anticipate early 2024 clinical
start, pending regulatory authorization
Anticipated Upcoming Milestones
- RLY-4008
- Full dose escalation data to be presented at ASCO Annual
Meeting
- Complete enrollment of pivotal cohort in the second half of
2023
- Data from non-CCA expansion cohorts in the second half of
2023
- Breast Cancer
- RLY-2608: initiation of expansion cohorts in the second half of
2023
- ERα degrader: development candidate nomination in 2023
- RLY-2139 (selective CDK2 inhibitor): clinical start in early
2024, pending regulatory authorization
First Quarter 2023 Financial Results
Cash, Cash Equivalents and Investments: As of
March 31, 2023, cash, cash equivalents and investments totaled
$937.8 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 2025.
R&D Expenses: Research and development
expenses were $82.8 million for the first quarter of 2023, as
compared to $51.7 million for the first quarter of 2022. The
increase was primarily due to $16.3 million of additional clinical
trial expenses, $9.4 million of additional employee-related costs,
which include $4.5 million of additional stock-based compensation
expense, and $3.3 million of additional costs for preclinical
programs and platform technologies.
G&A Expenses: General and administrative
expenses were $19.6 million for the first quarter of 2023, as
compared to $16.1 million for the first quarter of 2022. The
increase was primarily due to additional employee-related costs,
which include $3.6 million of additional stock-based compensation
expense.
Net Loss: Net loss was $94.2 million for the
first quarter of 2023, or a net loss per share of $0.78, as
compared to a net loss of $62.0 million for the first quarter of
2022, or a net loss per share of $0.57.
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, timing
of enrollment completion, 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
RLY-4008, the initiation of expansion cohorts for RLY-2608, the
clinical initiation of RLY-2139, and the nomination of a
development candidate for Relay Therapeutics’ ERα degrader program;
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, or public health epidemics or outbreaks of an
infectious disease, such as COVID-19, 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 of any
current or planned clinical trials or the development of Relay
Therapeutics’ drug candidates; the risk that the
preliminary results of its preclinical 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 March 31, |
|
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
License and other revenue |
|
$ |
226 |
|
|
$ |
419 |
|
Total revenue |
|
|
226 |
|
|
|
419 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development expenses |
|
$ |
82,827 |
|
|
$ |
51,667 |
|
Change in fair value of contingent consideration liability |
|
|
(1,003 |
) |
|
|
(4,595 |
) |
General and administrative expenses |
|
|
19,579 |
|
|
|
16,068 |
|
Total operating expenses |
|
|
101,403 |
|
|
|
63,140 |
|
Loss from operations |
|
|
(101,177 |
) |
|
|
(62,721 |
) |
Other income: |
|
|
|
|
|
|
Interest income |
|
|
6,941 |
|
|
|
696 |
|
Other expense |
|
|
(3 |
) |
|
|
(21 |
) |
Total other income, net |
|
|
6,938 |
|
|
|
675 |
|
Net loss |
|
$ |
(94,239 |
) |
|
$ |
(62,046 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.78 |
) |
|
$ |
(0.57 |
) |
Weighted average shares of
common stock, basic and diluted |
|
|
121,320,865 |
|
|
|
108,293,251 |
|
Other comprehensive loss: |
|
|
|
|
|
|
Unrealized holding gain (loss) |
|
|
4,618 |
|
|
|
(8,130 |
) |
Total other comprehensive gain (loss) |
|
|
4,618 |
|
|
|
(8,130 |
) |
Total comprehensive loss |
|
$ |
(89,621 |
) |
|
$ |
(70,176 |
) |
Relay Therapeutics, Inc. |
Selected Condensed Consolidated Balance Sheet Data |
(In thousands) |
(Unaudited) |
|
|
|
March
31, |
|
December 31, |
|
|
2023 |
|
2022 |
Cash, cash equivalents and investments |
|
$ |
937,804 |
|
|
$ |
998,917 |
|
Working capital (1) |
|
|
887,921 |
|
|
|
955,796 |
|
Total assets |
|
|
1,037,560 |
|
|
|
1,099,771 |
|
Total liabilities |
|
|
154,148 |
|
|
|
149,553 |
|
Total stockholders’ equity |
|
|
883,412 |
|
|
|
950,218 |
|
Restricted cash |
|
|
2,578 |
|
|
|
2,578 |
|
(1) Working capital is defined as current assets less current
liabilities.
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