Tyra Biosciences, Inc. (NASDAQ:TYRA) is a clinical-stage biotechnology company at the forefront of developing innovative precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology. With a strategic focus on oncology and genetically defined conditions, Tyra Biosciences is poised to transform the treatment landscape through its proprietary SNÅP platform.
Company History and Overview Tyra Biosciences was incorporated in the state of Delaware on August 2, 2018, with the goal of developing next-generation precision medicines targeting FGFR biology. In its early years, the company focused on organizing and staffing the organization, business planning, raising capital, and developing its proprietary SNÅP platform for accelerated small molecule drug discovery.
The company primarily funded its operations through private placements of its convertible preferred stock, raising over $157 million in net proceeds between 2018 and 2021. This initial funding was crucial in supporting the company's research and development efforts, including the advancement of its lead product candidate, TYRA-300.
A significant milestone in Tyra Biosciences' history was its initial public offering in September 2021, which raised approximately $181 million in net proceeds. This influx of capital allowed the company to further accelerate its research and development activities, particularly in progressing TYRA-300 into clinical trials.
Despite its progress, Tyra Biosciences has faced financial challenges typical of early-stage biotechnology companies. The company has incurred significant operating losses since inception, reporting net losses of $69.1 million, $55.3 million, and $26.3 million in 2023, 2022, and 2021, respectively. These losses reflect the substantial investment in research and development to support its drug discovery and clinical programs.
In 2023, the company underwent a leadership change, announcing a transition agreement with its former Chief Medical Officer. This agreement included accelerated vesting of stock options and an extended exercise period, demonstrating the company's commitment to managing its human capital effectively during transitions.
Tyra Biosciences' lead product candidate, TYRA-300, is an investigational, oral, FGFR3-selective inhibitor currently being evaluated in an international, multi-center, open-label Phase 1/2 clinical trial, SURF301, in metastatic urothelial carcinoma (mUC) and other advanced solid tumors with FGFR3 gene alterations. In October 2024, Tyra Biosciences announced positive interim clinical proof-of-concept data for TYRA-300 in patients with mUC, demonstrating encouraging preliminary anti-tumor activity and a favorable safety profile.
Furthermore, the company has expanded the development of TYRA-300 into achondroplasia (ACH), the most common form of dwarfism, based on positive preclinical results. In October 2024, the U.S. Food and Drug Administration (FDA) cleared Tyra's Investigational New Drug (IND) application for TYRA-300, allowing the company to proceed with a Phase 2 clinical trial in children with ACH, named BEACH301.
Tyra Biosciences' pipeline also includes TYRA-200, an investigational, oral, FGFR123 inhibitor, which is currently being evaluated in a Phase 1 clinical study, SURF201, in previously treated and resistant FGFR2 cholangiocarcinoma and other advanced solid tumors. Additionally, the company recently announced that the FDA allowed its IND application for TYRA-430, an investigational FGFR4/3 biased inhibitor for FGF19/FGFR4-driven cancers, to proceed with a Phase 1 clinical study, SURF431.
Financial Performance and Liquidity Tyra Biosciences has strategically managed its financial resources to support its robust research and development efforts. As of September 30, 2024, the company reported cash, cash equivalents, and marketable securities of $360.1 million, providing ample runway to advance its pipeline.
For the nine months ended September 30, 2024, Tyra Biosciences reported a net loss of $60.9 million, compared to a net loss of $46.3 million for the same period in 2023. The increase in net loss was primarily driven by the company's continued investment in research and development activities, including the advancement of its clinical trials and preclinical programs.
Despite the ongoing losses, Tyra Biosciences has demonstrated a strong cash position, with a current ratio of 29.5 and a quick ratio of 29.5 as of September 30, 2024, indicating a robust liquidity profile to fund its operations. The company's free cash flow for the nine months ended September 30, 2024, was negative $50.2 million, reflecting the significant investments being made in the development of its pipeline.
Tyra Biosciences has not generated any revenue to date, as the company's focus has been on advancing its product candidates through clinical trials and regulatory milestones. However, the company's strong cash position and prudent financial management provide a solid foundation to support its future growth and development plans.
For the most recent fiscal year 2023, Tyra Biosciences reported an annual net loss of $69.1 million and an annual operating cash flow of negative $50.1 million. The annual free cash flow for 2023 was negative $50.9 million. In the most recent quarter (Q3 2024), the company reported a net loss of $24 million.
The company's balance sheet remains strong, with $103.89 million in cash and cash equivalents as of September 30, 2024. Tyra Biosciences has a debt-to-equity ratio of 0.017, indicating a low level of debt relative to its equity. The company's current ratio and quick ratio both stand at 29.5, suggesting a very strong short-term liquidity position.
In February 2024, Tyra Biosciences completed a $200 million private placement financing, further strengthening its financial position. The company believes its current cash reserves will be sufficient to fund operations through at least 2026, providing a substantial runway for advancing its clinical programs and pipeline development.
Operational Highlights and Milestones In addition to the positive interim results for TYRA-300 in mUC and the IND clearance for the ACH program, Tyra Biosciences has achieved several key operational milestones that demonstrate its progress and growth.
In September 2024, the company announced the appointment of Doug Warner, M.D., as Chief Medical Officer. Dr. Warner brings over 20 years of proven clinical development leadership, having successfully led global development and secured approvals for medicines across oncology and skeletal disease.
Furthermore, in July 2024, Tyra Biosciences reported positive preclinical proof-of-concept data for TYRA-300 in hypochondroplasia (HCH), another skeletal dysplasia closely related to ACH. The data showed that TYRA-300 increased the length of long bones, such as the femur, tibia, humerus, and ulna, in FGFR3 mutated mice.
The company also announced the expansion of its FGFR-focused pipeline with the IND clearance for TYRA-430, an investigational FGFR4/3 biased inhibitor, to proceed with a Phase 1 clinical study in advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGFR pathway aberrations.
Tyra Biosciences has demonstrated its commitment to scientific excellence by presenting its research at renowned industry conferences. In October 2024, the company was selected to present a late-breaking oral presentation on the preliminary safety and anti-tumor activity of TYRA-300 from the SURF301 study at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.
Risks and Challenges Despite Tyra Biosciences' impressive progress, the company faces several risks and challenges inherent to the biotechnology industry. As a clinical-stage company, the success of its product candidates is heavily dependent on the outcomes of its ongoing and future clinical trials. Delays or failures in these trials could significantly impact the company's development timeline and financial performance.
Moreover, the highly competitive nature of the pharmaceutical and biotechnology sectors poses challenges for Tyra Biosciences. The company must continuously innovate and differentiate its platform and product candidates to maintain a competitive edge and secure regulatory approvals.
Tyra Biosciences also faces the risk of potential setbacks related to manufacturing, supply chain disruptions, and the ability to scale its operations to meet the demands of its growing pipeline. Additionally, the company's reliance on collaborations and partnerships to expand its capabilities introduces additional risks, such as the loss of key partnerships or the failure to successfully integrate new technologies and capabilities.
Product Pipeline and Development Programs Tyra Biosciences' product pipeline is centered around its proprietary SNÅP platform, which enables rapid and precise drug design through iterative molecular snapshots to predict genetic alterations most likely to cause acquired resistance to existing therapies.
The company's lead oncology product candidate, TYRA-300, has shown promising results in the ongoing SURF301 Phase 1/2 clinical trial. At the 90mg once daily dose, 6 out of 11 (54.5%) patients with FGFR3 mUC achieved a confirmed partial response, and a 100% disease control rate was observed. Based on these positive interim results, Tyra plans to initiate a Phase 2 study of TYRA-300 in non-muscle invasive bladder cancer (NMIBC) by the end of 2024.
TYRA-200, the company's second oncology candidate, is an investigational, oral, FGFR123 inhibitor with potency against activating FGFR2 gene alterations as well as clinically important molecular brake and gatekeeper resistance mutations. It is currently being evaluated in the SURF201 Phase 1 clinical trial in previously treated and resistant FGFR2 cholangiocarcinoma and other advanced solid tumors.
In the field of genetically-defined conditions, Tyra Biosciences is advancing TYRA-300 for the treatment of achondroplasia (ACH). The company has initiated the BEACH301 Phase 2 clinical trial to evaluate TYRA-300 in children ages 3 to 10 with ACH and open growth plates. Tyra has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for TYRA-300 in ACH.
Additionally, in July 2024, Tyra announced the expansion of TYRA-300 development into hypochondroplasia (HCH), another skeletal dysplasia caused by FGFR3 mutations, based on positive preclinical results.
Conclusion Tyra Biosciences is at the forefront of the precision medicine revolution, leveraging its proprietary SNÅP platform to develop innovative therapies that address the limitations of current targeted treatments. With a robust pipeline, positive interim clinical data, and a strong financial position, the company is well-positioned to transform the treatment paradigm for oncology and genetically defined conditions.
As Tyra Biosciences continues to execute on its strategic priorities and achieve key milestones, the company's story will undoubtedly captivate the attention of investors, clinicians, and patients alike, solidifying its position as a leader in the FGFR-focused biotechnology landscape.