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 2024 financial results and corporate
highlights.
“In the second quarter, we made important progress continuing to
advance our clinical programs, which we believe has positioned us
well for multiple data readouts later this year. Additionally, we
look forward to expanding the RLY-2608 development program, with
the initiation of a new triplet combination with Pfizer's novel
investigative selective-CDK4 inhibitor atirmociclib by the end of
the year,” said Sanjiv Patel, M.D., President and Chief Executive
Officer of Relay Therapeutics. “Looking further ahead, we are very
excited by the pre-clinical programs we unveiled in June, including
our first two genetic disease programs, which will be important in
driving our continued growth and diversification.”
Recent Corporate Highlights
RLY-2608 (ReDiscover study)
- RLY-2608 doublet: continued to
enroll patients with PI3Kα-mutant, HR+, HER2- locally advanced or
metastatic breast cancer in dose expansion cohorts of RLY-2608
400mg BID and 600mg BID in combination with fulvestrant
- The next data update is expected in
the fourth quarter of 2024 and will include approximately 100
patients across doses in the safety database and approximately 60
patients at the 600mg BID dose, including about 40 who have had the
opportunity to be on RLY-2608 for at least 6 months
- RLY-2608 triplet:
- CDK4/6: continued enrollment of
RLY-2608 + fulvestrant + ribociclib triplet combination in patients
with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast
cancer
- CDK4: announced a clinical trial
collaboration to evaluate atirmociclib, Pfizer’s investigative
selective-CDK4 inhibitor, in combination with RLY-2608 and
fulvestrant in patients with PI3Kα-mutant, HR+, HER2- metastatic
breast cancer. The RLY-2608 + atirmociclib + fulvestrant triplet
combination is planned to begin by the end of 2024
- RLY-2608 monotherapy: continued to
enroll patients with unresectable or metastatic solid tumors with a
PI3Kα mutation in dose escalation portion of RLY-2608 monotherapy
arm and reported partial responses in multiple tumor types
Migoprotafib (GDC-1971)
- As previously disclosed, Genentech
has terminated the collaboration agreement for the development and
commercialization of migoprotafib
- The company will not continue
development of migoprotafib
Pre-Clinical Programs
- Disclosed three new pre-clinical
programs: vascular malformations, Fabry disease and NRAS
- Vascular Malformations
- PI3Kα is the most common driver
mutation among specific types of vascular malformations, which are
a series of rare syndromes that occur due to atypical development
of lymphatic and/or blood vessels and can become life-threatening,
depending on what vessel(s) are involved
- In the U.S., an estimated 170,000
people have one of the sub-types driven by a PI3Kα mutation, which
include PIK3CA-related overgrowth spectrum, lymphatic
malformations, venous malformations and cerebral cavernous
malformations
- A mutant selective PI3Kα inhibitor
provides the opportunity for greater target coverage, leading to
the potential for improved efficacy and better chronic
tolerability
- Relay Therapeutics plans to initiate
clinical development of RLY-2608 in vascular malformations in the
first quarter of 2025
- Fabry Disease
- In Fabry disease, harmful levels of
Gb3 accumulate in blood cells and tissues throughout the body, due
to insufficient αGal enzyme activity, which can lead to a range of
symptoms, including potentially life-threatening ones such as
kidney failure, heart failure and stroke. In the U.S.,
approximately 8,000 people have Fabry disease
- Relay Therapeutics has created the
first investigational non-inhibitory chaperone for Fabry disease,
which is designed to stabilize the αGal protein without inhibiting
its activity, thus enabling greater Gb3 clearance across
organs
- The company expects its
non-inhibitory chaperone to enter the clinic in the second half of
2025
- NRAS
- In the U.S., an estimated 28,000
people are diagnosed annually with mutated NRAS solid tumors, which
are a known oncogene driver in the RAS family and can lead to a
number of cancers, including melanoma, colorectal and
non-small-cell lung
- Relay Therapeutics has created the
first NRAS-selective inhibitor, which has been designed to address
the liabilities of current pan-RAS inhibitors by only binding to
NRAS, while sparing KRAS and HRAS
- The company expects to initiate
clinical development of its NRAS-selective inhibitor in the second
half of 2025
Anticipated Upcoming Milestones
- Breast Cancer
- RLY-2608 + fulvestrant data update
in the fourth quarter of 2024
- RLY-2608 + fulvestrant + ribociclib
initial safety data in the fourth quarter of 2024
- RLY-2608 + fulvestrant +
atirmociclib clinical trial initiation by the end of 2024
- RLY-2608 + fulvestrant potential
Phase 3 trial initiation in 2025
- Lirafugratinib: tumor agnostic data
and regulatory update in the second half of 2024
- Pre-clinical
- Vascular malformations: RLY-2608
clinical trial initiation in the first quarter of 2025
- Fabry disease: clinical start in the
second half of 2025
- NRAS: clinical start in the second
half of 2025
Second Quarter 2024 Financial Results
Cash, Cash Equivalents and Investments: As of
June 30, 2024, cash, cash equivalents and investments totaled
$688.4 million compared to $750.1 million as of December 31, 2023.
The company expects its current cash, cash equivalents and
investments will be sufficient to fund its current operating plan
into the second half of 2026.
R&D Expenses: Research and development
expenses were $92.0 million for the second quarter of 2024, as
compared to $88.2 million for the second quarter of 2023. The
increase was primarily due to additional external costs in
connection with the ReDiscover trial for RLY-2608.
G&A Expenses: General and administrative
expenses were $20.1 million for the second quarter of 2024, as well
as for the second quarter of 2023.
Net Loss: Net loss was $92.2 million for the
second quarter of 2024, or a net loss per share of $0.69, as
compared to a net loss of $98.5 million for the second quarter of
2023, or a net loss per share of $0.81.
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 and progress of doublet and
triplet combinations for RLY-2608, the timing and scope of clinical
updates for RLY-2608, the timing of a clinical data and regulatory
update for lirafugratinib; the timing of clinical initiation of
Relay Therapeutics’ various programs, including a potential pivotal
trial for RLY-2608, clinical development in vascular malformations,
clinical development of Relay Therapeutics’ non-inhibitory
chaperone, and clinical development of its NRAS-selective
inhibitor; the potential of Relay Therapeutics’ product candidates
to address a major unmet medical need; the cash runway projection;
the competitive landscape and potential market opportunities for
Relay Therapeutics’ product candidates; the expected strategic
benefits under Relay Therapeutics’ collaborations; and expectations
regarding Relay Therapeutics’ pipeline, operating plan, use of
capital, expenses and other financial results. 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
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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, |
|
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
License and other revenue |
|
$ |
— |
|
|
$ |
119 |
|
|
$ |
10,007 |
|
|
$ |
345 |
|
| Total
revenue |
|
|
— |
|
|
|
119 |
|
|
|
10,007 |
|
|
|
345 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
91,992 |
|
|
$ |
88,201 |
|
|
$ |
174,395 |
|
|
$ |
171,028 |
|
|
Change in fair value of contingent consideration liability |
|
|
(11,374 |
) |
|
|
(2,152 |
) |
|
|
(13,206 |
) |
|
|
(3,155 |
) |
|
General and administrative expenses |
|
|
20,139 |
|
|
|
20,120 |
|
|
|
39,938 |
|
|
|
39,699 |
|
| Total
operating expenses |
|
|
100,757 |
|
|
|
106,169 |
|
|
|
201,127 |
|
|
|
207,572 |
|
| Loss
from operations |
|
|
(100,757 |
) |
|
|
(106,050 |
) |
|
|
(191,120 |
) |
|
|
(207,227 |
) |
| Other
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
8,547 |
|
|
|
7,559 |
|
|
|
17,498 |
|
|
|
14,500 |
|
|
Other (expense) income |
|
|
(2 |
) |
|
|
(14 |
) |
|
|
23 |
|
|
|
(17 |
) |
| Total
other income, net |
|
|
8,545 |
|
|
|
7,545 |
|
|
|
17,521 |
|
|
|
14,483 |
|
| Net
loss |
|
$ |
(92,212 |
) |
|
$ |
(98,505 |
) |
|
$ |
(173,599 |
) |
|
$ |
(192,744 |
) |
| Net loss
per share, basic and diluted |
|
$ |
(0.69 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.32 |
) |
|
$ |
(1.59 |
) |
| Weighted
average shares of common stock, basic and diluted |
|
|
132,821,826 |
|
|
|
121,680,844 |
|
|
|
131,832,420 |
|
|
|
121,501,849 |
|
| Other
comprehensive (loss) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized holding (loss) gain |
|
|
(182 |
) |
|
|
(279 |
) |
|
|
(1,144 |
) |
|
|
4,339 |
|
|
Total other comprehensive (loss) income |
|
|
(182 |
) |
|
|
(279 |
) |
|
|
(1,144 |
) |
|
|
4,339 |
|
| Total
comprehensive loss |
|
$ |
(92,394 |
) |
|
$ |
(98,784 |
) |
|
$ |
(174,743 |
) |
|
$ |
(188,405 |
) |
|
|
|
Relay Therapeutics, Inc.Selected Condensed Consolidated Balance
Sheet Data(In thousands)(Unaudited) |
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
Cash, cash equivalents and investments |
|
$ |
688,415 |
|
|
$ |
750,086 |
|
| Working
capital (1) |
|
|
659,227 |
|
|
|
739,834 |
|
| Total
assets |
|
|
772,750 |
|
|
|
843,980 |
|
| Total
liabilities |
|
|
90,806 |
|
|
|
91,977 |
|
| Total
stockholders’ equity |
|
|
681,744 |
|
|
|
752,003 |
|
|
Restricted cash |
|
|
2,707 |
|
|
|
2,707 |
|
(1) Working capital is defined as current assets less current
liabilities.
Relay Therapeutics (NASDAQ:RLAY)
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