-Orphan Drug Designation granted to TYRA-300
for achondroplasia-
- SURF301 Phase 1/2 oncology study
remains on target; enrollment ongoing in Part B
-
-TYRA-200 Phase 1 study on track; first patient to be
dosed in 2H 2023-
- Strong cash position of $232.4 million as of Q2 2023-
CARLSBAD, Calif., Aug. 10,
2023 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq:
TYRA), a clinical-stage biotechnology company focused on developing
next-generation precision medicines that target large opportunities
in Fibroblast Growth Factor Receptor (FGFR) biology, today reported
financial results for the quarter ended June
30, 2023 and highlighted recent corporate progress.
"TYRA is a precision medicine biotech company focused on large
opportunities in FGFR biology, and we continued to advance our
pipeline and approach during the last several months," said
Todd Harris, CEO of TYRA. "We
believe that TYRA-300, our oral FGFR3-selective inhibitor, is
potentially a best-in-class agent designed to address unmet needs
in oncology and skeletal dysplasias. Our SURF301 oncology
study remains on target, and we are pleased to receive Orphan Drug
Designation for TYRA-300 in achondroplasia from the U.S. FDA. This
is another important milestone in the development of TYRA-300, and
we are excited about the opportunity to deliver a new therapeutic
option for patients."
Second Quarter 2023 and Recent Corporate Highlights
TYRA-300
- Granted Orphan Drug Designation from U.S. FDA for
Achondroplasia. In July 2023,
TYRA-300, an investigational oral FGFR3-selective inhibitor, was
granted Orphan Drug Designation (ODD) for the treatment of
achondroplasia. TYRA remains on track to submit an Investigational
New Drug application (IND) to the U.S. Food and Drug Administration
(FDA) to enable a Phase 2 study of TYRA-300 in pediatric
achondroplasia in 2024.
- SURF301 Phase 1/2 Study for Oncology is On Target.
SURF301 (Study in Untreated and Resistant
FGFR3+ Advanced Solid Tumors) (NCT05544552) is a
multi-center, open label study designed to determine the optimal
and maximum tolerated doses and the recommended Phase 2 dose of
TYRA-300, as well as to evaluate the preliminary antitumor activity
of TYRA-300. The study remains on target and enrollment is ongoing
in Part A and Part B in Phase 1 of the study at multiple clinical
sites in the U.S., Europe, and
Australia.
TYRA-200
- Advanced Preparation Activities for Phase 1 Study. TYRA
continued to advance activities for its planned Phase 1 clinical
study of TYRA-200, an FGFR1/2/3 inhibitor with potency against
activating FGFR2 gene alterations and resistance mutations, during
the second quarter of 2023. The trial will be focused on
intrahepatic cholangiocarcinoma resistant to prior FGFR inhibitors.
TYRA remains on track to dose the first patient in this trial in
the second half of 2023.
SNÅP Platform and Pipeline
- TYRA continued to advance its in-house precision medicine
discovery engine, SNÅP, to develop therapies in targeted oncology
and genetically defined conditions including
FGF19+/FGFR4-driven cancers and RET (REarranged during
Transfection kinase) driven cancers.
Corporate
- Strengthened Leadership. TYRA made key senior
appointments including Dr. Michael
Bober, Vice President, Clinical Development and Medical
Affairs, who, prior to joining TYRA, served as the Medical Director
of the Skeletal Dysplasia Program, Nemours Children's Hospital,
Delaware, and is a key opinion
leader in the skeletal dysplasia community. Additionally, TYRA
appointed George Melko, Vice
President, Regulatory Affairs and Gary
Price, Vice President, Quality.
Second Quarter 2023 Financial Results
- Second quarter 2023 net loss was $13.3
million compared to $15.1
million for the same period in 2022.
- Second quarter 2023 research and development expenses were
$12.2 million compared to
$12.0 million for the same period in
2022.
- Second quarter 2023 general and administrative expenses were
$3.9 million compared to $3.4 million for the same period in 2022.
- As of June 30, 2023, TYRA had
cash and cash equivalents of $232.4
million that will support TYRA's important clinical and
operational milestones over at least the next two years.
About TYRA-300
TYRA-300 is the Company's lead precision medicine program
stemming from its in-house SNÅP platform. TYRA-300 is an
investigational, oral, FGFR3-selective inhibitor currently in
development for the treatment of cancer and skeletal dysplasias
including achondroplasia. TYRA-300 is being evaluated in a
multi-center, open label Phase 1/2 clinical study, SURF301
(Study in Untreated and Resistant
FGFR3+ Advanced Solid Tumors). SURF301 (NCT05544552) was
designed to determine the optimal and maximum tolerated doses (MTD)
and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to
evaluate the preliminary antitumor activity of TYRA-300.
SURF301 is currently enrolling adults with advanced urothelial
carcinoma and other solid tumors with FGFR3 gene alterations.
In skeletal dysplasias, TYRA-300 has demonstrated positive
preclinical results and the Company expects to submit an IND for
the initiation of a Phase 2 clinical study in pediatric
achondroplasia in 2024.
About Tyra Biosciences
Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage
biotechnology company focused on developing next-generation
precision medicines that target large opportunities in FGFR
biology. The Company's in-house precision medicine platform, SNÅP,
enables rapid and precise drug design through iterative molecular
SNÅPshots that help predict genetic alterations most likely to
cause acquired resistance to existing therapies. TYRA's initial
focus is on applying its accelerated small molecule drug discovery
engine to develop therapies in targeted oncology and genetically
defined conditions. TYRA is based in Carlsbad, CA. For more information about our
science, pipeline and people, please visit
www.tyra.bio and engage with us on LinkedIn.
Forward-Looking Statements
TYRA cautions you that statements contained in this press
release regarding matters that are not historical facts are
forward-looking statements. The forward-looking statements are
based on our current beliefs and expectations and include, but are
not limited to: the potential to develop next-generation precision
medicines, the potential safety and therapeutic benefits of
TYRA-300 and other product candidates and the potential for
TYRA-300 to become a best-in-class agent; the sufficiency of our
cash position to support clinical and operational milestones;
expected cash runway; the expected timing and phase of clinical
development of TYRA-300 and TYRA-200, including timing of a
submission of an IND for TYRA-300 in pediatric achondroplasia and
patient dosing for TYRA-200; and the potential for SNÅP to develop
therapies in targeted oncology and genetically defined conditions.
Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in our
business, including, without limitation: we are early in our
development efforts, have only recently begun testing our lead
product candidate in clinical trials and the approach we are taking
to discover and develop drugs based on our SNÅP platform is novel
and unproven and it may never lead to product candidates that are
successful in clinical development or approved products of
commercial value; potential delays in the commencement, enrollment,
and completion of preclinical studies and clinical trials; results
from preclinical studies or early clinical trials not necessarily
being predictive of future results; our dependence on third parties
in connection with manufacturing, research and preclinical testing;
acceptance by the FDA of INDs or of similar regulatory submissions
by comparable foreign regulatory authorities for the conduct of
clinical trials of TYRA-300 in pediatric achondroplasia; an
accelerated development or approval pathway may not be available
for TYRA-300 or other product candidates and any such pathway may
not lead to a faster development process; unexpected adverse side
effects or inadequate efficacy of our product candidates that may
limit their development, regulatory approval, and/or
commercialization; the potential for our programs and prospects to
be negatively impacted by developments relating to our competitors,
including the results of studies or regulatory determinations
relating to our competitors; we may not realize the benefits
associated with ODD, including that orphan drug exclusivity may not
effectively protect a product from competition and that such
exclusivity may not be maintained; regulatory developments in
the United States and foreign
countries; we may use our capital resources sooner than we expect;
unstable market and economic conditions and adverse developments
with respect to financial institutions and associated liquidity
risk may adversely affect our business and financial condition and
the broader economy and biotechnology industry; and other risks
described in our prior filings with the Securities and Exchange
Commission (SEC), including under the heading "Risk Factors" in our
annual report on Form 10-K and any subsequent filings with the SEC.
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof,
and we undertake no obligation to update such statements to reflect
events that occur or circumstances that exist after the date
hereof. All forward-looking statements are qualified in their
entirety by this cautionary statement, which is made under the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995.
Contact:
Amy Conrad
aconrad@tyra.bio
Tyra Biosciences,
Inc.
Condensed Balance
Sheet Data
(in
thousands)
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2023
|
|
|
2022
|
|
|
|
(unaudited)
|
|
|
|
|
Balance Sheet
Data:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
232,413
|
|
|
$
|
251,213
|
|
Working
capital
|
|
|
235,341
|
|
|
|
251,587
|
|
Total assets
|
|
|
250,012
|
|
|
|
266,181
|
|
Accumulated
deficit
|
|
|
(120,848)
|
|
|
|
(95,696)
|
|
Total stockholders'
equity
|
|
|
238,572
|
|
|
|
257,829
|
|
Tyra Biosciences,
Inc.
Condensed 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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
12,162
|
|
|
$
|
12,047
|
|
|
$
|
22,570
|
|
|
$
|
21,692
|
|
General and
administrative
|
|
|
3,852
|
|
|
|
3,381
|
|
|
|
7,778
|
|
|
|
8,570
|
|
Total operating
expenses
|
|
|
16,014
|
|
|
|
15,428
|
|
|
|
30,348
|
|
|
|
30,262
|
|
Loss from
operations
|
|
|
(16,014)
|
|
|
|
(15,428)
|
|
|
|
(30,348)
|
|
|
|
(30,262)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
2,763
|
|
|
|
346
|
|
|
|
5,218
|
|
|
|
364
|
|
Other
expense
|
|
|
(21)
|
|
|
|
(13)
|
|
|
|
(22)
|
|
|
|
(23)
|
|
Total other
income
|
|
|
2,742
|
|
|
|
333
|
|
|
|
5,196
|
|
|
|
341
|
|
Net loss and
comprehensive loss
|
|
$
|
(13,272)
|
|
|
$
|
(15,095)
|
|
|
$
|
(25,152)
|
|
|
$
|
(29,921)
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.31)
|
|
|
$
|
(0.36)
|
|
|
$
|
(0.59)
|
|
|
$
|
(0.72)
|
|
Weighted-average shares
used to compute
net loss per share, basic and diluted
|
|
|
42,589,213
|
|
|
|
41,777,206
|
|
|
|
42,492,377
|
|
|
|
41,665,155
|
|
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SOURCE Tyra Biosciences, Inc.