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 second quarter 2023 financial results and corporate
highlights.
“In the second quarter of 2023, we continued to advance our
pipeline and progress our breast cancer portfolio,” said Sanjiv
Patel, M.D., president and chief executive officer of Relay
Therapeutics. “In July, we initiated the first RLY-2608 +
fulvestrant dose expansion cohort. The additional RLY-2608 data
supporting this decision, and the breadth of our breast cancer
franchise, continue to drive our confidence that we are building a
comprehensive solution for the more than 100,000 patients diagnosed
with PI3Kα-mutated breast cancer in the U.S. each year.”
RLY-2608 Update
In July 2023, initiated dose expansion cohort with RLY-2608
600mg BID + fulvestrant in patients with PI3Kα-mutant, HR+, HER2–
locally advanced or metastatic breast cancer
- Selection of 600mg BID dose supported by updated data from 17
breast cancer patients treated with RLY-2608 600mg BID +
fulvestrant (cut-off date of July 24, 2023)
- Interim clinical benefit rate (CBR)
of 86 percent (6 of 7 CBR-evaluable patients) (CBR defined as the
proportion of patients with stable disease, complete response, or
partial response for at least 24 weeks)
- Fifteen of 17 patients remain on
treatment as of the cut-off date
- One of five efficacy-evaluable
patients with measurable disease achieved a confirmed partial
response (PR) and remains on treatment as of the cut-off date
(helical mutation)
- Interim safety data compelling for use in metastatic breast
cancer combinations
- Overall, updated data strengthen the RLY-2608 profile and
continue to support selective target engagement across doses and
mutation types with favorable interim safety and tolerability data.
As of the July 24th data cut-off, 43 total breast cancer patients
had received RLY-2608 monotherapy (n=4) or RLY-2608 + fulvestrant
(n=39)
- Four of 24 efficacy-evaluable
patients with measurable disease achieved PRs, including three
confirmed (400mg BID mono with double mutation; 100mg BID combo
with kinase mutation; 600mg BID combo with helical mutation) and
one unconfirmed (800mg BID combo with helical mutation)
- The interim safety profile of
RLY-2608 remains consistent with safety data previously reported at
AACR
- No adverse event-related
discontinuations
- No Grade 3+ hyperglycemia or diarrhea
- Data from ongoing dose escalation arms could support decision
to bring an additional dose into dose expansion in the future
- Next data update expected in 2024
Additional Recent Corporate Highlights
RLY-4008
- Presented full dose escalation data from the ReFocus study at
2023 American Society of Clinical Oncology Annual Meeting
Anticipated Upcoming Milestones
- RLY-4008
- Complete enrollment of pivotal cohort in the second half of
2023
- Data from non-CCA expansion cohorts in the second half of
2023
- RLY-2608
- Next data update expected in 2024
- ERα degrader: development candidate nomination in 2023
- RLY-2139 (selective CDK2 inhibitor): clinical start in early
2024, pending regulatory authorization
Second Quarter 2023 Financial Results
Cash, Cash Equivalents and Investments: As of
June 30, 2023, cash, cash equivalents and investments totaled
$871.6 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 2025.
R&D Expenses: Research and development
expenses were $88.2 million for the second quarter of 2023, as
compared to $60.5 million for the second quarter of 2022. The
increase was primarily due to $13.6 million of additional clinical
trial expenses and $9.3 million of additional employee-related
costs, which include $5.0 million of additional stock-based
compensation expense.
G&A Expenses: General and administrative
expenses were $20.1 million for the second quarter of 2023, as
compared to $17.5 million for the second quarter of 2022. The
increase was primarily due to additional employee-related costs,
which include $3.3 million of additional stock-based compensation
expense.
Net Loss: Net loss was $98.5 million for the
second quarter of 2023, or a net loss per share of $0.81, as
compared to a net loss of $76.8 million for the second quarter of
2022, or a net loss per share of $0.71.
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-2608, the initiation of an
additional expansion cohort for RLY-2608, the timing of a clinical
data update for RLY-4008, the completion of the pivotal cohort
enrollment for RLY-4008, 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 June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
License and other revenue |
|
$ |
119 |
|
|
$ |
365 |
|
|
$ |
345 |
|
|
$ |
784 |
|
Total
revenue |
|
|
119 |
|
|
|
365 |
|
|
|
345 |
|
|
|
784 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
88,201 |
|
|
$ |
60,511 |
|
|
$ |
171,028 |
|
|
$ |
112,178 |
|
Change in fair value of contingent consideration liability |
|
|
(2,152 |
) |
|
|
200 |
|
|
|
(3,155 |
) |
|
|
(4,395 |
) |
General and administrative expenses |
|
|
20,120 |
|
|
|
17,465 |
|
|
|
39,699 |
|
|
|
33,533 |
|
Total
operating expenses |
|
|
106,169 |
|
|
|
78,176 |
|
|
|
207,572 |
|
|
|
141,316 |
|
Loss
from operations |
|
|
(106,050 |
) |
|
|
(77,811 |
) |
|
|
(207,227 |
) |
|
|
(140,532 |
) |
Other
income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
7,559 |
|
|
|
1,005 |
|
|
|
14,500 |
|
|
|
1,701 |
|
Other (expense) income |
|
|
(14 |
) |
|
|
18 |
|
|
|
(17 |
) |
|
|
(3 |
) |
Total
other income, net |
|
|
7,545 |
|
|
|
1,023 |
|
|
|
14,483 |
|
|
|
1,698 |
|
Net
loss |
|
$ |
(98,505 |
) |
|
$ |
(76,788 |
) |
|
$ |
(192,744 |
) |
|
$ |
(138,834 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.81 |
) |
|
$ |
(0.71 |
) |
|
$ |
(1.59 |
) |
|
$ |
(1.28 |
) |
Weighted
average shares of common stock, basic and diluted |
|
|
121,680,844 |
|
|
|
108,644,329 |
|
|
|
121,501,849 |
|
|
|
108,469,760 |
|
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized holding (loss) gain |
|
|
(279 |
) |
|
|
(2,688 |
) |
|
|
4,339 |
|
|
|
(10,818 |
) |
Total other comprehensive (loss) gain |
|
|
(279 |
) |
|
|
(2,688 |
) |
|
|
4,339 |
|
|
|
(10,818 |
) |
Total
comprehensive loss |
|
$ |
(98,784 |
) |
|
$ |
(79,476 |
) |
|
$ |
(188,405 |
) |
|
$ |
(149,652 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Relay Therapeutics, Inc.Selected Condensed
Consolidated Balance Sheet Data(In thousands)(Unaudited)
|
|
June 30,2023 |
|
|
December 31,2022 |
|
Cash, cash equivalents and investments |
|
$ |
871,573 |
|
|
$ |
998,917 |
|
Working
capital (1) |
|
|
812,765 |
|
|
|
955,796 |
|
Total
assets |
|
|
962,016 |
|
|
|
1,099,771 |
|
Total
liabilities |
|
|
151,897 |
|
|
|
149,553 |
|
Total
stockholders’ equity |
|
|
810,119 |
|
|
|
950,218 |
|
Restricted cash |
|
|
2,707 |
|
|
|
2,578 |
|
|
|
|
|
|
|
|
|
|
(1) Working capital is defined as current assets less current
liabilities.
Relay Therapeutics (NASDAQ:RLAY)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Relay Therapeutics (NASDAQ:RLAY)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024