Tyra Biosciences, Inc. (NASDAQ:TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (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.

Business Overview

Tyra Biosciences' initial focus is on applying its accelerated small molecule drug discovery engine to develop therapies in targeted oncology and genetically defined conditions. The company's lead product candidate, TYRA-300, is an investigational, oral, FGFR3-selective inhibitor currently being evaluated in an international, multi-center, open label Phase 1 clinical trial, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors). SURF301 is 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.

Beyond oncology, FGFR3 is implicated in many genetically-defined conditions, such as achondroplasia (ACH) and other skeletal dysplasias, due to its role in regulating bone and cartilage formation. In March 2023, Tyra announced it was expanding development of TYRA-300 into ACH based on positive preclinical results. The company is conducting additional Investigational New Drug Application (IND)-enabling studies and plans to submit an IND application to the FDA in the second half of 2024 for the initiation of a Phase 2 clinical trial testing multiple doses of TYRA-300 to support children with ACH.

Tyra's second oncology product candidate, TYRA-200, is an investigational, oral, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations, as well as clinically important molecular brake and gatekeeper resistance mutations. TYRA-200 is currently being evaluated in a multi-center, open label Phase 1 clinical study, SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors).

The company has also nominated its third candidate for clinical development, TYRA-430, an FGFR4/3 selective inhibitor for FGF19+/FGFR4-driven cancers, and is focused on completing IND-enabling studies for this program.

Financials

Tyra Biosciences has not generated any revenue to date and has funded its operations primarily from its initial public offering (IPO), private placements of its convertible preferred stock, and the issuance of Simple Agreements for Future Equity. The company reported a net loss of $18.2 million for the three months ended March 31, 2023, compared to a net loss of $11.9 million for the same period in 2022. For the full year 2022, the company reported a net loss of $69.1 million and had no revenue.

The company's research and development expenses were $17.2 million for the three months ended March 31, 2023, up from $10.4 million in the same period of 2022. The increase was primarily due to higher costs related to the company's ongoing and planned clinical trials, as well as an increase in personnel and stock-based compensation expenses. General and administrative expenses were $5.1 million for the three months ended March 31, 2023, up from $3.9 million in the same period of 2022, driven by higher stock-based compensation and professional services costs.

As of March 31, 2023, Tyra Biosciences had cash, cash equivalents, and marketable securities of $382.5 million. The company believes its current cash position will be sufficient to fund its operating expenses and capital expenditures through at least 2026.

Liquidity

Tyra Biosciences has funded its operations primarily through equity financings, including its IPO in September 2021, which raised net proceeds of approximately $181.2 million, and a private placement in February 2023, which raised gross proceeds of approximately $200 million. The company has not generated any revenue to date and has incurred significant operating losses since its inception, with a net loss of $69.1 million for the full year 2022.

As of March 31, 2023, the company had $382.5 million in cash, cash equivalents, and marketable securities, which it believes will be sufficient to fund its operating expenses and capital expenditures through at least 2026. The company's primary uses of cash to date have been to fund its research and development activities, including with respect to TYRA-300, TYRA-300 ACH and TYRA-200 and other research programs, as well as for business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support.

Tyra Biosciences has also entered into an at-the-market (ATM) equity offering program, under which it may sell shares of its common stock having an aggregate offering price of up to $150.0 million. As of March 31, 2023, the company has not sold any shares under the ATM program.

Risks and Challenges

Tyra Biosciences faces several risks and challenges as a clinical-stage biotechnology company, including:

• The company is early in its development efforts and has only recently begun testing TYRA-300 in clinical trials. The approach it is taking to discover and develop drugs based on its 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.

• There is a risk of potential delays in the commencement, enrollment, data readouts, and completion of preclinical studies and clinical trials for the company's product candidates.

• Results from preclinical studies or early clinical trials may not be predictive of future results, and the potential for proof-of-concept results to fail to result in successful subsequent development of TYRA-300.

• The company is dependent on third parties in connection with manufacturing, research, and preclinical testing, which introduces additional risks and uncertainties.

• There is no guarantee that the FDA or comparable foreign regulatory authorities will accept INDs or similar regulatory submissions for the conduct of clinical trials of TYRA-300 in pediatric achondroplasia or that an accelerated development or approval pathway will be available.

• Unfavorable results from preclinical studies or clinical trials, or developments with the company's competitors, could negatively impact Tyra's programs and prospects.

• The company may not realize the benefits associated with Orphan Drug Designation or Rare Pediatric Disease Designation for TYRA-300, including potential exclusivity or a Priority Review Voucher.

Outlook

Tyra Biosciences has not provided specific financial guidance for the full year 2023. However, the company has outlined the following key milestones and expected timelines:

• Submission of an IND application to the FDA in the second half of 2024 for the initiation of a Phase 2 clinical trial testing multiple doses of TYRA-300 to support children with achondroplasia.

• Presentation of initial results from the SURF301 Phase 1 portion for TYRA-300 in the second half of 2024.
• Completion of IND-enabling studies for the company's TYRA-430 program.

The company believes its current cash position will be sufficient to fund its operating expenses and capital expenditures through at least 2026 as it continues to advance its pipeline of precision medicine candidates.

Conclusion

Tyra Biosciences is a clinical-stage biotechnology company with a promising pipeline of precision medicine candidates targeting FGFR biology. The company's lead program, TYRA-300, is being evaluated in both oncology and rare genetic conditions, with plans to initiate a Phase 2 trial in pediatric achondroplasia in the second half of 2024.

While Tyra Biosciences faces the typical risks and challenges associated with a clinical-stage biotech company, its strong cash position and anticipated milestones over the next 12-24 months suggest the company is well-positioned to continue advancing its pipeline and addressing unmet medical needs in targeted oncology and genetically defined conditions. Investors will want to closely monitor the company's progress, particularly with the upcoming IND submission and initial clinical data readouts for TYRA-300.