Tyra Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights
PR Newswire
CARLSBAD, Calif., March 27, 2025
- Three INDs cleared by US FDA for TYRA's proprietary precision small molecules -
- TYRA-300 to be evaluated in three Phase 2 studies: SURF302 for Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC), BEACH301 for pediatric achondroplasia $(ACH)$ and SURF301 for metastatic urothelial cancer (mUC) -
- Cash, cash equivalents, and marketable securities of $341.4 million at YE 2024; runway through at least 2027 -
CARLSBAD, Calif., March 27, 2025 /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 fourth quarter and full year ended December 31, 2024, and highlighted recent corporate progress.
"2024 was a momentous year for TYRA and the patient communities we serve, highlighted by the positive interim results from our SURF301 study, which demonstrated a combination of high anti-tumor activity with favorable tolerability results in very sick, heavily pre-treated cancer patients. Importantly, the oncology doses tested in SURF301 are significantly higher than those to be tested in BEACH301, giving us confidence as we advance TYRA-300 in ACH," said Todd Harris, CEO of TYRA. "Our conviction in TYRA-300 has never been stronger and we are working diligently to advance this potential best-in-class agent for multiple high-value indications in oncology and skeletal dysplasia into three Phase 2 studies in NMIBC, ACH and mUC."
Fourth Quarter and Full Year 2024 and Recent Corporate Highlights
TYRA-300
-- Advanced Clinical Evaluation of TYRA-300 into Three Phase 2 Studies.
During 2024, TYRA progressed TYRA-300, an oral, investigational
FGFR3-selective inhibitor, for the treatment of IR NMIBC, mUC and ACH,
and achieved the following milestones:
-- Cleared Phase 2 NMIBC IND with US FDA -- SURF302. TYRA expanded
the clinical development of TYRA-300 into NMIBC to address the
unmet needs in this cancer population for an efficacious, orally
available therapy. SURF302 is an open-label Phase 2 clinical study
evaluating the efficacy and safety of TYRA-300 in participants
with FGFR3-altered low-grade, IR NMIBC. The study will enroll up
to 90 participants at multiple sites primarily in the United
States. Participants will be randomized initially to treatment
with TYRA-300 at 50 mg once-daily $(QD)$ (Cohort 1) or treatment
with TYRA-300 at 60 mg QD (Cohort 2). Following a review of
efficacy and safety, an additional dosing cohort may be evaluated.
The primary endpoint is complete response $(CR)$ rate at three
months. Secondary endpoints include time to recurrence, the median
duration of response, recurrence free survival (RFS), progression
free survival $(PFS)$, safety and tolerability.
-- Cleared Phase 2 ACH IND with US FDA - BEACH301. The study is a
Phase 2, multicenter, open-label, dose-escalation/dose-expansion
study evaluating TYRA-300 in children ages 3 to 10 with
achondroplasia with open growth plates. The study will enroll
children who are treatment-naïve (Cohort 1) and those who
have received prior growth-accelerating therapy (Cohort 2) at
multiple sites across the globe. Each of these cohorts is expected
to enroll up to 10 participants per dose level (0.125, 0.25,
0.375, 0.50 mg/kg) for up to 12 months. The study will initially
enroll a safety sentinel cohort of up to 3 treatment-naïve
participants per dose level in children ages 5 to 10.
-- Reported Interim Clinical Proof-of-Concept Results in mUC Patients
-- SURF301. TYRA-300 demonstrated encouraging preliminary
anti-tumor activity in a heavily pre-treated population: at >= 90
mg QD, 6 out of 11 (54.5%) patients with FGFR3+ mUC achieved a
confirmed partial response $(PR)$, with 100% disease control rate
and sustained duration of activity; positive safety results were
reported across all QD doses, with infrequent
FGFR2/FGFR1-associated toxicities (data cutoff of August 15,
2024). TYRA-300 is being evaluated in Part B of SURF301
(NCT05544552) at potentially therapeutic QD doses in preparation
for potential future Phase 2 studies.
TYRA-200
-- Advanced Phase 1 SURF201 Study. TYRA-200 is an FGFR1/2/3 inhibitor with
potency against activating FGFR2 gene alterations and resistance
mutations. SURF201 (Study in PrevioUsly treated and Resistant FGFR2+
Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752) is a
multi-center, open label study designed to evaluate the safety,
tolerability, and pharmacokinetics of TYRA-200 and determine the optimal
and maximum tolerated dose and recommended Phase 2 dose, as well as
evaluate the preliminary antitumor activity of TYRA-200. The SURF201
study is currently enrolling and dosing adults with unresectable locally
advanced/metastatic intrahepatic cholangiocarcinoma and other advanced
solid tumors with activating FGFR2 gene alterations.
TYRA-430
-- Cleared Phase 1 IND with US FDA -- SURF431. TYRA-430 is an oral,
investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers.
The Phase 1 study will be a multicenter, open-label, first-in-human study
of TYRA-430 in advanced hepatocellular carcinoma $(HCC)$ and other solid
tumors with activating FGF/FGFR pathway aberrations (SURF431). We believe
TYRA-430 has the potential to address a significant unmet need in HCC,
where there are no approved biomarker-driven, targeted therapies.
Corporate
-- Strengthened Leadership Team and Board of Directors. In 2024, TYRA
appointed Doug Warner, MD, as Chief Medical Officer, and Erik Goluboff,
MD, as SVP, Clinical Development to lead the Company's oncology strategy
and clinical development plans. In 2025, TYRA appointed accomplished drug
developer Adele Gulfo to its Board of Directors, Sinette Heys as SVP,
Clinical Operations to lead the Company's clinical operations team, and
Will Charlton, MD, as SVP, Clinical Development to lead the Company's
skeletal dysplasia clinical development group.
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.
Fourth Quarter and Full-Year 2024 Financial Results
-- Cash, Cash Equivalents and Short-Term Investments. As of December 31,
2024, TYRA had cash, cash equivalents, and marketable securities of
$341.4 million, compared to $203.5 million at the end of 2023. The
increase was primarily due to the completion of a private placement
financing for net proceeds of $199.6 million in the first quarter of
2024. The Company's current cash, cash equivalents and marketable
securities are expected to allow TYRA to execute on its plans through at
least 2027.
-- Research and Development (R&D) Expenses. Research and development
expenses for the three months ended December 31, 2024 were $22.2 million
compared to $20.7 million for the same period in 2023, and $80.1 million
for the full year 2024 compared to $62.5 million for the same period in
2023. The increases were primarily driven by increased expenses incurred
in connection with our ongoing and planned clinical trials and
personnel-related costs, including stock-based compensation, partially
offset by decreased drug manufacturing and preclinical costs.
-- General and Administrative (G&A) Expenses. General and administrative
expenses for the three months ended December 31, 2024 were $7.6 million
compared to $5.0 million for the same period in 2023, and $24.1 million
for the full year 2024 compared to $17.4 million for the same period in
2023. The increases were primarily driven by increased personnel-related
costs, including stock-based compensation.
-- Net Loss. Fourth quarter 2024 net loss was $25.6 million compared to
$22.8 million for the same period in 2023, and $86.5 million for the full
year 2024 compared to $69.1 million for the same period in 2023.
Upcoming Anticipated Milestones and Events
-- BEACH301: dose first child with achondroplasia with TYRA-300 -- Q2 2025 -- SURF302: dose first NMIBC patient with TYRA-300 -- Q2 2025 -- SURF431: dose first HCC patient with TYRA-430 -- Q2 2025
About TYRA-300
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