On August 10, 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 ended June 30, 2023 and highlighted recent corporate progress (Press release, Tyra Biosciences, AUG 10, 2023, View Source [SID1234634221]).

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"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

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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.
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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

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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

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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

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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

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Second quarter 2023 net loss was $13.3 million compared to $15.1 million for the same period in 2022.
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Second quarter 2023 research and development expenses were $12.2 million compared to $12.0 million for the same period in 2022.
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Second quarter 2023 general and administrative expenses were $3.9 million compared to $3.4 million for the same period in 2022.
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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.