Executive Summary / Key Takeaways

• TYRA Biosciences is a clinical-stage biotech leveraging its proprietary SNÅP platform to develop highly selective Fibroblast Growth Factor Receptor (FGFR) inhibitors aimed at overcoming limitations of existing therapies in oncology and skeletal conditions.
• The lead program, TYRA-300, is advancing into three Phase 2 studies in Q2 2025 (pediatric achondroplasia, non-muscle invasive bladder cancer, metastatic urothelial carcinoma), building on promising interim Phase 1/2 data in mUC showing a 54.5% confirmed partial response rate at higher doses.
• The company maintains a solid liquidity position with $318.9 million in cash, cash equivalents, and marketable securities as of March 31, 2025, providing expected funding through at least 2027, supplemented by a new $150 million ATM facility.
• Increased R&D expenses ($25.0 million in Q1 2025, up from $17.2 million in Q1 2024) reflect significant investment in advancing the clinical pipeline and CMC activities, driving a wider net loss ($28.1 million in Q1 2025 vs $18.2 million in Q1 2024).
• TYRA's competitive positioning relies on the SNÅP platform's speed and its drug candidates' selectivity (e.g., TYRA-300's FGFR3 bias), aiming for improved efficacy and tolerability profiles compared to less selective or first-generation inhibitors from larger competitors like Johnson & Johnson (JNJ), AstraZeneca (AZN), and Bayer (BAYRY).

TYRA Biosciences is carving out a distinct path in the precision medicine landscape, focusing intently on the complex biology of Fibroblast Growth Factor Receptors (FGFR). Founded in 2018, the company's strategic genesis was rooted in the recognition that existing FGFR inhibitors, while demonstrating clinical benefit, were often hampered by off-target toxicities and the rapid emergence of acquired resistance mutations. TYRA's response was to build an in-house precision medicine platform, SNÅP, designed to accelerate the discovery and design of next-generation small molecules capable of addressing these critical limitations. This foundational technology and strategic focus position TYRA within a competitive oncology and rare disease market, challenging established players and vying for leadership in specific FGFR-driven indications.

The competitive landscape for FGFR inhibitors includes large pharmaceutical companies with approved drugs and other biotechs with pipeline candidates. Giants like Johnson & Johnson, with its approved FGFR inhibitor Balversa (erdafitinib), and AstraZeneca and Bayer with drugs in development or on the market, represent significant scale and market presence. Smaller, agile biotechs like Blueprint Medicines (BPMC) also compete in the precision oncology space. TYRA's strategy is not to compete head-to-head across the entire FGFR spectrum but to target specific, large opportunities where its precision approach and selective inhibitors can offer a differentiated profile.

TYRA's core competitive advantage stems directly from its SNÅP platform. This technology enables iterative molecular design, allowing researchers to rapidly predict and design compounds that are potent against specific FGFR alterations while minimizing activity against other FGFR isoforms (FGFR1, FGFR2, FGFR4) that are often associated with dose-limiting toxicities. This targeted approach is designed to yield drug candidates with potentially improved tolerability and efficacy profiles compared to less selective pan-FGFR inhibitors or even highly selective inhibitors that are vulnerable to common resistance mutations. For instance, TYRA-300 was designed with high selectivity for FGFR3 over FGFR1, 2, and 4. This selectivity is intended to reduce off-target side effects, a key differentiator against drugs like JNJ's Balversa, which inhibits multiple FGFR subtypes. While direct, comprehensive quantitative comparisons across all competitor programs are complex due to varying trial designs and patient populations, the company's preclinical data and early clinical results aim to demonstrate a superior therapeutic index. The SNÅP platform's iterative design process is also intended to accelerate the drug discovery timeline, potentially offering a speed advantage in bringing optimized molecules to the clinic compared to more traditional discovery methods.

The company's pipeline reflects this precision strategy, led by TYRA-300, an investigational oral FGFR3-selective inhibitor. TYRA-300 is being developed for multiple indications where FGFR3 plays a key role. In oncology, this includes metastatic urothelial carcinoma (mUC) and non-muscle invasive bladder cancer (NMIBC). In genetically defined conditions, it targets pediatric achondroplasia (ACH), a skeletal dysplasia caused by activating FGFR3 mutations. The advancement of TYRA-300 into three distinct Phase 2 studies – SURF301 (mUC), SURF302 (NMIBC), and BEACH301 (ACH) – in the second quarter of 2025 marks a critical operational phase for the company.

Recent operational highlights underscore this progress. In late October 2024, TYRA reported interim data from the Phase 1/2 SURF301 study in mUC. In patients treated at doses of 90 mg once daily (QD) or higher, 6 out of 11 patients (54.5%) achieved a confirmed partial response. Preliminary data suggested the drug was generally well-tolerated with infrequent toxicities typically associated with FGFR1 and FGFR2 inhibition, supporting the potential benefit of its selective design. The company received IND clearance for the SURF302 study in IR NMIBC in January 2025 and initiated patient dosing in the Phase 1 SURF431 study for TYRA-430 (an FGFR4/3-biased inhibitor) in April 2025. These milestones demonstrate the platform's ability to generate clinical candidates and the company's execution in moving them through early development.

Financially, TYRA's performance reflects its stage as a clinical-stage biotechnology company heavily invested in R&D. For the three months ended March 31, 2025, the company reported a net loss of $28.1 million, an increase from the $18.2 million net loss for the same period in 2024. This wider loss was primarily driven by a significant increase in operating expenses, which totaled $31.9 million in Q1 2025 compared to $22.3 million in Q1 2024. Research and development expenses were the main contributor to this increase, rising by $7.8 million to $25.0 million. This surge in R&D spending is directly attributable to the costs associated with launching and initiating clinical trial activities for BEACH301, SURF302, and SURF431, as well as increased manufacturing (CMC) activities and higher personnel costs driven by headcount growth necessary to support the expanding pipeline. General and administrative expenses also increased by $1.8 million to $6.9 million, similarly influenced by higher personnel costs.

Despite the increasing expenses, TYRA maintains a strong liquidity position. As of March 31, 2025, the company held $318.9 million in cash, cash equivalents, and marketable securities. This substantial cash balance is largely a result of previous financing activities, including approximately $199.6 million in net proceeds from a private placement completed in Q1 2024. The company's cash burn from operations was $25.5 million in Q1 2025, an increase from $22.0 million in Q1 2024, reflecting the ramp-up in clinical activities. Based on its current operating plan, TYRA anticipates that its existing cash resources will be sufficient to fund operations and capital expenditures through at least 2027. Furthermore, in May 2025, the company established a new at-the-market (ATM) sales agreement allowing it to sell up to $150 million of common stock, providing an additional potential source of capital flexibility, replacing a previous ATM facility under which no shares were sold.

The outlook for TYRA is closely tied to the progress and results of its clinical programs. Management expects to dose the first patients in the BEACH301 (ACH) and SURF302 (IR NMIBC) Phase 2 studies in the second quarter of 2025. Initial three-month complete response data from the SURF302 study is anticipated to follow the initiation of dosing. These data readouts will be critical catalysts, providing the first look at TYRA-300's efficacy and safety profile in these specific patient populations. The successful initiation of the SURF431 study for TYRA-430 also signals continued pipeline advancement beyond the lead program. The company's guidance on cash runway through at least 2027 suggests that current resources are sufficient to reach multiple key clinical milestones across its pipeline, assuming expenses align with the current operating plan.

However, investing in a clinical-stage biotechnology company like TYRA carries significant risks. The SNÅP platform, while promising, is a novel approach, and its ability to consistently generate successful clinical candidates is not yet fully proven. Clinical trials are inherently uncertain; results from early-stage studies or interim data may not be predictive of final outcomes. Delays in trial enrollment, execution, or data analysis could impact timelines and increase costs. The company is dependent on third parties for manufacturing and conducting clinical trials, introducing potential points of failure. Unexpected adverse side effects or insufficient efficacy could halt or delay development and regulatory approval. The competitive landscape is dynamic, and advancements or regulatory decisions by competitors could negatively impact TYRA's programs. Future capital requirements are substantial, and the ability to raise additional funds on favorable terms, or at all, is not guaranteed, potentially forcing delays or termination of programs. Geopolitical instability and macroeconomic factors could also impact operations and financial markets.

Conclusion

TYRA Biosciences presents an investment thesis centered on its differentiated precision medicine platform and a pipeline of selective FGFR inhibitors designed to address significant unmet needs in oncology and skeletal conditions. The company's strategic focus on overcoming the limitations of existing therapies through its SNÅP technology positions it as an innovator in the competitive FGFR space, aiming to offer improved efficacy and tolerability compared to less targeted approaches. Recent operational progress, including the initiation of multiple Phase 2 studies for the lead candidate TYRA-300 and the advancement of TYRA-430, demonstrates execution against its development plan. While the company continues to incur significant losses characteristic of its clinical stage, its substantial cash reserves provide a runway expected to support operations through key clinical milestones over the next few years. The success of TYRA's approach hinges on positive data readouts from its ongoing and planned clinical trials, which will be critical determinants of its ability to challenge established competitors and realize the potential of its precision medicine strategy. Investors should closely monitor the upcoming clinical data, particularly from the TYRA-300 Phase 2 studies, as these will provide crucial validation of the SNÅP platform and the company's pipeline potential.