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 fourth quarter and full year 2023 financial results
and corporate highlights.
“We made important progress across our portfolio during 2023,
advancing multiple clinical programs and continuing to invest
significantly in our research engine – the Dynamo platform,” said
Sanjiv Patel, M.D., President and Chief Executive Officer of Relay
Therapeutics. “We are very pleased with the RLY-2608 data disclosed
to-date and how its clinical profile continued to mature throughout
last year. Our clinical team is focused on advancing this program
in the near term in both a doublet and a triplet combination, and
we look forward to sharing additional data in the second half of
2024. Our Dynamo platform continues to demonstrate precision and
productivity with each target we’ve chosen to-date, and we are
excited to disclose at least one new program that has come out of
it later this year, which is being designed to have first-in-class
potential.”
Recent Corporate Highlights
PI3Kα
- RLY-2608 doublet
- Completed enrollment in initial dose
expansion cohort of RLY-2608 600mg BID + fulvestrant in patients
with PI3Kα-mutant, HR+, HER2- locally advanced or metastatic breast
cancer
- Initiated two additional dose
expansion cohorts of RLY-2608 in combination with fulvestrant – a
second 600mg BID cohort as well as one at 400mg BID
- Published RLY-2608 preclinical
profile and clinical proof-of-concept in Cancer Discovery
(Discovery and Clinical Proof-of-Concept of RLY-2608, a
First-in-Class Mutant-Selective Allosteric PI3Kα Inhibitor That
Decouples Antitumor Activity from Hyperinsulinemia) with vignettes
from two patients with advanced HR+ breast cancer with kinase or
helical mutations, with no observed wildtype PI3Kα-related
toxicities
- RLY-2608 triplet
- Initiated RLY-2608 + fulvestrant +
ribociclib triplet combination in patients with PI3Kα-mutant, HR+,
HER2- locally advanced or metastatic breast cancer
- RLY-5836
- Deprioritized further clinical
development
Lirafugratinib (RLY-4008)
- 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
- As previously disclosed, the company
will minimize resource allocation in 2024 to allow data to mature
and inform future clinical development decisions
Anticipated 2024 Milestones
- RLY-2608
- RLY-2608 + fulvestrant data update in the second half of
2024
- RLY-2608 + fulvestrant + ribociclib initial safety data in the
second half of 2024
- Lirafugratinib: tumor agnostic data and regulatory update in
the second half of 2024
- Pre-clinical: disclose new program(s) in 2024
Fourth Quarter and Full Year 2023 Financial
Results
Cash, Cash Equivalents and Investments: As of
December 31, 2023, cash, cash equivalents and investments totaled
$750.1 million compared to approximately $1 billion as of December
31, 2022. 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.
Revenue: There was no material revenue for the
fourth quarter of 2023 or 2022. Revenue was $25.5 million for the
full year 2023, as compared to $1.4 million for the full year 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 $77.5 million for the fourth quarter of 2023, as
compared to $67.3 million for the fourth quarter of 2022. The
increase was primarily due to additional clinical trial expenses
and employee-related costs, which were offset by a decrease in
other external research costs. Research and development expenses
were $330.0 million for the full year 2023, as compared to $246.4
million for the full year 2022. The increase was primarily due to
$50.0 million of additional external costs in connection with our
clinical trials and $32.4 million of additional employee costs from
increased headcount in our research and development functions,
which includes $17.7 million of additional stock compensation
expense.
G&A Expenses: General and administrative
expenses were $16.8 million for the fourth quarter of 2023, as
compared to $16.4 million for the fourth quarter of 2022. The
increase was primarily due to additional stock compensation
expense. General and administrative expenses were $75.0 million for
the full year 2023, as compared to $66.0 million for the full year
2022. The increase was primarily due additional stock compensation
expense.
Net Loss: Net loss was $83.5 million for the
fourth quarter of 2023, or a net loss per share of $0.67, as
compared to a net loss of $67.5 million for the fourth quarter of
2022, or a net loss per share of $0.56. Net loss was $342.0 million
for the full year 2023, or a net loss per share of $2.79, as
compared to a net loss of $290.5 million for the full year 2022, or
a net loss per share of $2.59.
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 progress of doublet and triplet
combinations for RLY-2608, the timing of clinical updates 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 EndedDecember
31, |
|
Twelve Months Ended December 31, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
| Revenue: |
|
|
|
|
|
|
|
|
|
|
License and other revenue |
$ |
— |
|
|
$ |
253 |
|
|
$ |
25,546 |
|
|
$ |
1,381 |
|
| Total revenue |
|
— |
|
|
|
253 |
|
|
|
25,546 |
|
|
|
1,381 |
|
| Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
$ |
77,496 |
|
|
$ |
67,277 |
|
|
$ |
330,018 |
|
|
$ |
246,355 |
|
|
Change in fair value of contingent consideration liability |
|
(2,066 |
) |
|
|
(10,544 |
) |
|
|
(6,422 |
) |
|
|
(11,677 |
) |
|
General and administrative expenses |
|
16,766 |
|
|
|
16,371 |
|
|
|
74,950 |
|
|
|
65,978 |
|
| Total operating expenses |
|
92,196 |
|
|
|
73,104 |
|
|
|
398,546 |
|
|
|
300,656 |
|
| Loss from operations |
|
(92,196 |
) |
|
|
(72,851 |
) |
|
|
(373,000 |
) |
|
|
(299,275 |
) |
| Other income: |
|
|
|
|
|
|
|
|
|
|
Interest income |
|
8,700 |
|
|
|
5,372 |
|
|
|
31,045 |
|
|
|
8,786 |
|
|
Other income (expense) |
|
1 |
|
|
|
(24 |
) |
|
|
(18 |
) |
|
|
(20 |
) |
| Total other income, net |
|
8,701 |
|
|
|
5,348 |
|
|
|
31,027 |
|
|
|
8,766 |
|
| Net loss |
$ |
(83,495 |
) |
|
$ |
(67,503 |
) |
|
$ |
(341,973 |
) |
|
$ |
(290,509 |
) |
| Net loss per share, basic and
diluted |
$ |
(0.67 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.79 |
) |
|
$ |
(2.59 |
) |
| Weighted average shares of common
stock, basic and diluted |
|
124,752,843 |
|
|
|
120,966,401 |
|
|
|
122,576,527 |
|
|
|
112,233,649 |
|
| Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
Unrealized holding gain (loss) |
|
3,210 |
|
|
|
(2,969 |
) |
|
|
10,224 |
|
|
|
(9,332 |
) |
|
Total other comprehensive gain (loss) |
|
3,210 |
|
|
|
(2,969 |
) |
|
|
10,224 |
|
|
|
(9,332 |
) |
| Total comprehensive loss |
$ |
(80,285 |
) |
|
$ |
(64,534 |
) |
|
$ |
(331,749 |
) |
|
$ |
(299,841 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Relay Therapeutics, Inc.Selected Condensed Consolidated Balance
Sheet Data(In thousands)(Unaudited) |
|
|
|
|
December 31,2023 |
|
December 31,2022 |
|
Cash, cash equivalents and investments |
$ |
750,086 |
|
|
$ |
998,917 |
|
| Working capital (1) |
|
739,834 |
|
|
|
955,796 |
|
| Total assets |
|
843,980 |
|
|
|
1,099,771 |
|
| Total liabilities |
|
91,977 |
|
|
|
149,553 |
|
| Total stockholders’ equity |
|
752,003 |
|
|
|
950,218 |
|
| Restricted cash |
|
2,707 |
|
|
|
2,578 |
|
(1) Working capital is defined as current assets less current
liabilities.
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