On March 22, 2023 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, reported financial results for the quarter and year ended December 31, 2022, and highlighted recent corporate progress (Press release, Tyra Biosciences, MAR 22, 2023, View Source [SID1234629175]).

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"2022 was a momentous year for TYRA – we achieved significant milestones, evolved into a clinical-stage company, and leveraged our expertise in FGFR biology to expand our therapeutic focus beyond oncology to include genetically defined conditions," said Todd Harris, CEO of TYRA. "We believe TYRA-300 has the potential to become a best-in-class agent and we look forward to advancing it in both oncology and achondroplasia. Further, we have made steady progress utilizing our SNÅP discovery engine and expect to nominate additional clinical candidates."

Alan Fuhrman, CFO of TYRA, added, "TYRA is in a very strong financial position to begin 2023, with $251.2 million in cash and cash equivalents at year-end 2022, representing more than two years of expected cash runway to support our current development plans across our precision medicine platform."

Fourth Quarter 2022 and Recent Corporate Highlights

TYRA-300

Initiated SURF301 Phase 1/2 Study for Oncology. In November 2022, TYRA announced that patient dosing had commenced in its Phase 1/2 SURF301 clinical study of TYRA-300. 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.
Expanded Development into Achondroplasia. In March 2023, TYRA announced the expansion of development of TYRA-300 into achondroplasia (ACH) based on positive preclinical results in a study performed in collaboration with the Imagine Institute in Paris, France. TYRA-300, an investigational agent, is a once-daily oral FGFR3 selective inhibitor whose design may have a meaningful impact on achondroplasia and other skeletal dysplasias.
In the study, TYRA-300 was evaluated in FGFR3 wild-type and mutant preclinical models to measure increases in growth and bone length, compared to vehicle-treated mice. In an FGFR3 Y367C/+ model, TYRA-300 was administered daily at a 1.2 mg/kg dose for 15 days. TYRA-300 increased body length in mice by 17.6% compared to the vehicle (p<0.0001) and increased the length of the femur (+24.4%), tibia (+38.3%) and L4-L6 (+23.9%) in mice (p<0.0001).
TYRA expects 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.
TYRA-200

Announced IND Clearance. In March 2023, TYRA announced that the FDA cleared its IND to proceed with a Phase 1 clinical study of TYRA-200, an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The trial will be focused on intrahepatic cholangiocarcinoma resistant to prior FGFR inhibitors. TYRA expects the first patient will be dosed in this trial in the second half of 2023.
SNÅP Platform and Pipeline

TYRA continued to use its in-house precision medicine discovery engine, SNÅP, to develop therapies in targeted oncology and genetically defined conditions including FGF19+/FGR4-driven cancers, and RET (REarranged during Transfection kinase) driven cancers.
Corporate

Strengthened Executive Team with Key Hire. During the fourth quarter of 2022, TYRA appointed experienced biotechnology veteran Alan Fuhrman as Chief Financial Officer.
Fourth Quarter and Full-Year 2022 Financial Results

Fourth quarter 2022 net loss was $12.9 million compared to $9.9 million for the same period in 2021.
Fourth quarter 2022 research and development expenses were $10.4 million compared to $7.2 million for the same period in 2021.
Fourth quarter 2022 general and administrative expenses were $4.6 million compared to $2.7 million for the same period in 2021.
Full year 2022 net loss was $55.3 million compared to $26.3 million for the same period in 2021.
Full year 2022 research and development expenses were $43.0 million compared to $20.6 million for the same period in 2021.
Full year 2022 general and administrative expenses were $15.9 million compared to $5.7 million for the same period in 2021.
As of December 31, 2022, TYRA had cash and cash equivalents of $251.2 million.
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.