Tyra Biosciences(TYRA)
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Tyra Biosciences(TYRA) - 2024 Q4 - Annual Report
2025-03-27 20:29
Financial Performance - The company incurred significant net losses of $86.5 million and $69.1 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $251.3 million as of December 31, 2024[216]. - The company expects to continue incurring significant net losses for the foreseeable future as it develops and seeks marketing approval for its product candidates[216]. - The company believes its existing cash, cash equivalents, and marketable securities will fund operations through at least 2027, but may need to seek additional funds sooner than planned[221]. - The company may not achieve or sustain profitability, adversely affecting its business and financial condition[324]. - The company has U.S. federal and state net operating loss (NOL) carryforwards of approximately $80.5 million and $52.2 million, respectively, as of December 31, 2024[396]. - U.S. federal NOLs generated after December 31, 2017, can be carried forward indefinitely but can only offset 80% of taxable income starting from years after December 31, 2020[397]. - The company may face limitations on its ability to utilize NOL carryforwards due to ownership changes, which could increase future income tax liabilities[398]. Product Development and Clinical Trials - The company has three product candidates in clinical development, with other programs in preclinical or discovery stages, and has not completed any clinical trials or obtained regulatory approvals[213]. - The company has not yet demonstrated an ability to successfully commercialize biopharmaceutical products, making future predictions about success uncertain[214]. - Successful completion of preclinical studies and favorable results are critical for the acceptance of INDs by the FDA, which is necessary to initiate clinical trials[229]. - The company has never completed any clinical trials or submitted a marketing application, which may hinder the development of its product candidates[231]. - Preclinical and clinical development is lengthy and expensive, with a high historical failure rate for product candidates in the biopharmaceutical industry[232]. - The company may face delays in clinical trials due to various factors, including regulatory approvals and patient enrollment challenges[240]. - Any delays in clinical trials could harm the commercial prospects of the product candidates and delay revenue generation[244]. - The company must establish commercial manufacturing capabilities and sales, marketing, and distribution capabilities to launch products if approved[229]. - The company is focused on developing targeted therapeutics for genomically defined cancers, an emerging and unproven field[237]. - The proprietary SNÅP platform is still in early development stages, with no completed clinical trials or proven product candidates yet[245]. - Patient enrollment for clinical trials is critical and may be affected by factors such as disease severity and proximity to clinical sites[247]. - The patient populations for product candidates are limited and may not be large enough to support successful commercialization[248]. - Delays in patient recruitment could significantly impact the timeline for clinical trials and marketing approval[249]. - The company faces risks related to side effects and adverse events that could hinder clinical trials and market acceptance[251]. - Regulatory authorities may impose additional requirements or delays in the approval process, impacting commercialization efforts[259]. - The company may need to conduct additional studies to support broader claims for its product candidates, potentially impacting revenue generation[274]. - The company has conducted clinical trials for certain product candidates outside the United States, but the FDA may not accept data from these trials, delaying development plans[287]. Regulatory and Compliance Risks - The regulatory landscape for clinical trials in the EU has changed, which may impact the company's development plans[236]. - Companion diagnostics are essential for patient selection, and the company plans to rely on third parties for their development[265]. - The FDA generally requires that companion diagnostics be approved simultaneously with the therapeutic product[268]. - The FDA announced plans to reclassify most in vitro diagnostic tests (IVDs) from Class III to Class II, which may simplify the approval process for companion diagnostics[273]. - The new In Vitro Medical Devices Regulation (IVDR) became applicable on May 26, 2022, establishing a uniform regulatory framework across the EU for medical devices[270]. - Companion diagnostics now require a conformity assessment by a notified body, which must seek a scientific opinion from the European Medicine Agency (EMA) for certain medicinal products[271]. - The company may face challenges in obtaining regulatory approvals for companion diagnostics, which could delay the marketing of related product candidates[272]. - The company may seek FDA approval through the accelerated approval pathway, which could expedite the commercialization of product candidates designed to treat serious conditions[292]. - If the FDA does not accept data from clinical trials conducted outside the U.S., it may result in costly and time-consuming additional trials, delaying product development[288]. - The FDA's new authority to mitigate risks from ineffective drugs could complicate the accelerated approval process for the company's product candidates[294]. - The company faces potential delays in clinical development and marketing approvals due to reliance on third-party manufacturers and the limited number of compliant facilities[303]. - Regulatory compliance is critical, and failure to adhere to GLP and GCP requirements may result in unreliable clinical data and additional studies[315]. - Legislative changes, such as the Affordable Care Act, may increase the difficulty and cost of obtaining marketing approval for product candidates[365]. - The Budget Control Act of 2011 resulted in reductions to Medicare payments, which will remain in effect until 2032 unless further action is taken[368]. - The Inflation Reduction Act of 2022 (IRA) mandates price negotiations for certain drugs with Medicare starting in 2026, which may impact future revenue[369]. - The IRA imposes penalties for price increases that exceed inflation, with rebates due in 2023[369]. - Increased state-level regulations on pharmaceutical pricing may lead to reduced demand and pressure on product pricing[370]. - Future healthcare reforms could result in additional reductions in Medicare funding and downward pressure on product prices[372]. Competition and Market Risks - The company faces significant competition in the biopharmaceutical industry, which could adversely affect its ability to develop and commercialize products[215]. - The company faces significant competition from larger, better-funded pharmaceutical companies and ongoing development of competitive products in the precision oncology field[336]. - There are currently three marketed pan-FGFR inhibitors, indicating a competitive landscape for the company's product candidates[338]. - The company’s revenue may be adversely affected if the market opportunities for its product candidates are smaller than anticipated[340]. Operational and Strategic Risks - The company will require substantial additional capital to achieve its goals, and failure to obtain this capital could delay or terminate development programs[219]. - The company relies on third parties for clinical trials and manufacturing, increasing the risk of delays or insufficient product quantities[215]. - The company may seek collaborations and licenses for product development but faces challenges in establishing favorable terms and may relinquish valuable rights[312]. - The success of collaborations is uncertain, and unfavorable terms may hinder the company's ability to maintain these partnerships[313]. - The company currently lacks a marketing and sales organization, necessitating significant investment to develop these capabilities or collaborate with third parties[327]. - The company faces risks in building a sales organization, including hiring and retaining qualified personnel, which could impact product commercialization[329]. - The company is subject to litigation and government investigations, which could result in significant fines and operational impacts[388]. - Noncompliance with regulatory standards by employees or contractors could expose the company to legal risks and penalties[390]. - The company may incur substantial costs related to compliance with health and safety regulations, which could adversely affect financial condition[375]. - Cybersecurity threats pose a risk to the company's information technology systems, potentially disrupting product development and harming reputation[383]. - The company faces risks related to patent protection, as competitors may develop similar technologies if adequate protection is not obtained[400]. - The patent prosecution process is complex and costly, and the company may not be able to secure necessary patent protections in a timely manner[403]. - The company may struggle to protect its intellectual property rights globally due to varying enforcement standards in different jurisdictions[408]. - Competitors may exploit the company's technologies in regions where patent protection is not secured, potentially impacting market competitiveness[409]. Workforce and Growth - As of March 25, 2025, the company had 60 full-time employees, with plans to expand its workforce to support development and commercialization efforts[350]. - The company's future growth may depend on its ability to navigate foreign markets, which involve additional regulatory burdens and uncertainties[342]. - The company's future financial performance will depend on its ability to manage growth effectively and may require significant management attention[351]. - Failure to expand the organization by hiring new employees or engaging third-party service providers could hinder the development and commercialization of product candidates[352].
Tyra Biosciences(TYRA) - 2024 Q4 - Annual Results
2025-03-27 20:08
Financial Performance - Cash, cash equivalents, and marketable securities totaled $341.4 million at the end of 2024, up from $203.5 million at the end of 2023, primarily due to a private placement financing that generated net proceeds of $199.6 million[10]. - The net loss for Q4 2024 was $25.6 million, compared to $22.8 million in Q4 2023, with a full-year net loss of $86.5 million versus $69.1 million in 2023[11]. - Total operating expenses for the year ended December 31, 2024, were $104,177,000, compared to $79,945,000 in 2023, reflecting a 30% increase[24]. - Net loss for the year ended December 31, 2024, was $86,481,000, compared to $69,134,000 in 2023, indicating a 25% increase in losses[24]. - Comprehensive loss for the year ended December 31, 2024, was $86,092,000, up from $68,753,000 in 2023, a 25% increase[24]. - Net loss per share, basic and diluted, improved to $(1.51) in 2024 from $(1.62) in 2023[24]. Research and Development - Research and development expenses for Q4 2024 were $22.2 million, compared to $20.7 million in Q4 2023, and full-year R&D expenses were $80.1 million, up from $62.5 million in 2023[10]. - Research and development expenses increased to $80,077,000 in 2024 from $62,518,000 in 2023, a rise of 28%[24]. - TYRA-300 is being evaluated in three Phase 2 studies: SURF302 for Intermediate Risk Non-Muscle Invasive Bladder Cancer, BEACH301 for pediatric achondroplasia, and SURF301 for metastatic urothelial cancer[4]. - In the SURF301 study, 54.5% of patients with FGFR3+ metastatic urothelial cancer achieved a confirmed partial response at doses of ≥ 90 mg QD, with a 100% disease control rate[5]. - The SURF302 study will enroll up to 90 participants with FGFR3-altered low-grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer, with a primary endpoint of complete response rate at three months[4]. - TYRA-200 is currently in a Phase 1 study (SURF201) for advanced cholangiocarcinoma and other solid tumors, while TYRA-430 has received IND clearance for a Phase 1 study in advanced hepatocellular carcinoma[6][7]. Leadership and Strategy - The company appointed new leadership, including Doug Warner as Chief Medical Officer and Erik Goluboff as SVP of Clinical Development, to enhance its oncology strategy[8]. Assets and Equity - Total assets increased to $363,558,000 in 2024 from $225,857,000 in 2023, representing a growth of 61%[22]. - Total stockholders' equity increased to $343,151,000 in 2024 from $204,262,000 in 2023, a growth of 68%[22]. Cash Position - Cash and cash equivalents rose to $91,966,000 in 2024, up from $58,006,000 in 2023, a 58% increase[22]. - The company expects its current cash position to support operations through at least 2027, allowing for continued advancement of its clinical programs[10]. - Total current liabilities decreased to $14,594,000 in 2024 from $15,333,000 in 2023, a reduction of 5%[22]. Income and Expenses - General and administrative expenses for Q4 2024 were $7.6 million, compared to $5.0 million in Q4 2023, with full-year G&A expenses increasing to $24.1 million from $17.4 million[11]. - Interest and other income, net, increased to $17,696,000 in 2024 from $10,811,000 in 2023, a growth of 64%[24].
Tyra Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights
Prnewswire· 2025-03-27 20:05
Core Insights - Tyra Biosciences has received FDA clearance for three Investigational New Drug (IND) applications for its precision small molecule, TYRA-300, which will be evaluated in three Phase 2 studies targeting various cancers and skeletal dysplasia [1][2][3] Clinical Development - TYRA-300 is being advanced into three Phase 2 studies: SURF302 for Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC), BEACH301 for pediatric achondroplasia (ACH), and SURF301 for metastatic urothelial cancer (mUC) [1][3] - The SURF302 study will enroll up to 90 participants and aims to evaluate the efficacy and safety of TYRA-300 in patients with FGFR3-altered low-grade, IR NMIBC [3] - The BEACH301 study will focus on children aged 3 to 10 with achondroplasia, enrolling treatment-naïve and previously treated participants [3] - Interim results from the SURF301 study showed that 54.5% of heavily pre-treated mUC patients achieved a confirmed partial response at a dose of ≥ 90 mg QD, with a 100% disease control rate [2][3] Financial Performance - As of December 31, 2024, Tyra Biosciences reported cash, cash equivalents, and marketable securities totaling $341.4 million, an increase from $203.5 million at the end of 2023, primarily due to a private placement financing [10] - Research and development expenses for Q4 2024 were $22.2 million, up from $20.7 million in Q4 2023, while full-year R&D expenses rose to $80.1 million from $62.5 million [10][22] - General and administrative expenses for Q4 2024 were $7.6 million, compared to $5.0 million in Q4 2023, with full-year G&A expenses increasing to $24.1 million from $17.4 million [10][22] - The net loss for Q4 2024 was $25.6 million, compared to $22.8 million in Q4 2023, and the full-year net loss was $86.5 million, up from $69.1 million [10][22] Corporate Developments - In 2024, Tyra strengthened its leadership team by appointing new executives to lead its oncology strategy and clinical development plans [6] - The company continues to advance its precision medicine discovery engine, SNÅP, aimed at developing therapies for targeted oncology and genetically defined conditions [7] Upcoming Milestones - The company plans to dose the first child with achondroplasia in the BEACH301 study and the first patient with IR NMIBC in the SURF302 study in Q2 2025 [10][11]
Tyra Biosciences Announces Poster Presentations at 2025 ASCO Gastrointestinal Cancers Symposium
Prnewswire· 2025-01-22 13:00
Core Insights - Tyra Biosciences, Inc. announced the acceptance of two abstracts for presentation at the 2025 ASCO Gastrointestinal Cancers Symposium, highlighting its focus on FGFR biology and precision medicine development [1][4] Group 1: Company Overview - Tyra Biosciences is a clinical-stage biotechnology company specializing in next-generation precision medicines targeting FGFR biology [4] - The company utilizes an in-house precision medicine platform called SNÅP for rapid drug design and predicting genetic alterations that may cause resistance to existing therapies [4] - Tyra has a differentiated pipeline with three clinical-stage programs in targeted oncology and genetically defined conditions [4] Group 2: Clinical Programs - TYRA-200 is an oral FGFR1/2/3 inhibitor currently in a Phase 1 clinical study (SURF201) for advanced intrahepatic cholangiocarcinoma and other solid tumors with FGFR2 gene alterations [2][4] - TYRA-430 is an oral FGFR4/3-biased inhibitor, with FDA clearance for a Phase 1 study in advanced hepatocellular carcinoma and other solid tumors driven by the FGF19/FGFR pathway [3][4] - The SURF201 study for TYRA-200 is designed to evaluate the maximum tolerated dose and preliminary antitumor activity, currently enrolling patients [2]
Tyra Biosciences Receives IND Clearance from FDA to Proceed with Phase 2 Study of TYRA-300 in Non-Muscle Invasive Bladder Cancer (SURF302)
Prnewswire· 2025-01-10 13:00
Core Insights - Tyra Biosciences has received FDA clearance for its IND application for TYRA-300, allowing the initiation of a Phase 2 clinical trial for low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC) [1][4] - The company has appointed Dr. Erik Goluboff as SVP of Clinical Development to lead the NMIBC program, bringing over thirty years of experience in urologic oncology [1][4][5] - TYRA-300 is a first-in-class, oral FGFR3-selective inhibitor, targeting a significant patient population with FGFR3 alterations in NMIBC [2][8] Company Overview - Tyra Biosciences is a clinical-stage biotechnology company focused on developing precision medicines targeting FGFR biology, with its lead program being TYRA-300 [9] - The company utilizes its proprietary SNÅP platform for rapid drug design and has a differentiated pipeline with three clinical-stage programs [9] - TYRA-300 is also being evaluated for other indications, including pediatric achondroplasia and metastatic urothelial carcinoma [8][9] Clinical Development - The SURF302 study will enroll up to 90 participants with FGFR3-altered low-grade IR NMIBC, evaluating the efficacy and safety of TYRA-300 [3] - The primary endpoint of the study is the complete response rate at three months, with secondary endpoints including time to recurrence and progression-free survival [3] - Initial patient dosing is expected to begin in Q2 2025, with preliminary data anticipated shortly thereafter [1][4] Market Context - There are over 730,000 individuals living with bladder cancer in the U.S., with many suffering from IR NMIBC, highlighting a significant unmet medical need for better treatment options [6][7] - Current treatments involve invasive procedures and chemotherapy, which can adversely affect patients' quality of life, underscoring the importance of developing more tolerable therapies like TYRA-300 [7]
Tyra Biosciences(TYRA) - 2024 Q3 - Quarterly Report
2024-11-07 21:13
Financial Performance - As of September 30, 2024, the company reported net losses of $60.9 million, compared to $46.3 million for the same period in 2023, with an accumulated deficit of $225.7 million[72]. - The company has not generated any revenue to date and relies on funding from its IPO and private placements, with significant operating losses expected to continue[72][74]. - Net loss for the three months ended September 30, 2024, was $24.0 million, compared to a net loss of $21.2 million in 2023, an increase of $2.9 million[85]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $50.2 million, compared to $36.6 million for the same period in 2023, reflecting an increase in net loss from $46.3 million to $60.9 million[99][100]. - Other income for the three months ended September 30, 2024, was $4.6 million, up from $2.8 million in 2023, an increase of $1.8 million[89]. - Other income for the nine months ended September 30, 2024, was $13.5 million, compared to $8.0 million in 2023, an increase of $5.5 million[94]. Cash and Funding - The company has cash, cash equivalents, and marketable securities totaling $360.1 million as of September 30, 2024, which is expected to fund operations through at least 2026[75]. - The company completed a private placement in February 2024, raising approximately $200 million before expenses[73]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $201.4 million, a substantial increase from $1.2 million in 2023, mainly from proceeds of $200 million from the 2024 Private Placement[103][104]. - The company believes that existing cash, cash equivalents, and marketable securities will be sufficient to meet anticipated operating expenses and capital expenditures through at least 2026[105]. - The company may need to finance cash needs through equity offerings, debt financings, or other capital sources, which could dilute existing stockholders' ownership[107][108]. Research and Development - The lead product candidate, TYRA-300, is currently in a Phase 1 clinical trial (SURF301) for FGFR3+ advanced solid tumors, with preliminary data showing a 54.5% confirmed partial response rate at doses ≥ 90 mg QD[64][65]. - The company plans to submit an Investigational New Drug (IND) application for a Phase 2 study of TYRA-300 in non-muscle invasive bladder cancer (NMIBC) by the end of 2024[63]. - In October 2024, the FDA allowed the IND application for TYRA-300 to proceed with a Phase 2 trial for children with achondroplasia, expected to start in Q1 2025[67]. - The company expanded the development of TYRA-300 into hypochondroplasia based on positive preclinical results, demonstrating increases in long bone length[68]. - The second oncology product candidate, TYRA-200, is currently in a Phase 1 clinical study (SURF201) targeting FGFR2+ cholangiocarcinoma and other advanced solid tumors[69][70]. - The company is developing a third candidate, TYRA-430, for advanced hepatocellular carcinoma, with the FDA allowing its IND to proceed with a Phase 1 study[71]. - The company expects research and development expenses to increase substantially over the next several years as it advances product candidates through clinical trials and expands its pipeline[79]. - Research and development expenses increased to $22.7 million for the three months ended September 30, 2024, up from $19.3 million in 2023, representing a $3.4 million increase[86]. - Research and development expenses for the nine months ended September 30, 2024, were $57.9 million, up from $41.8 million in 2023, a $16.1 million increase[91]. Operating Expenses - General and administrative expenses rose to $5.9 million for the three months ended September 30, 2024, compared to $4.7 million in 2023, an increase of $1.2 million[88]. - General and administrative expenses for the nine months ended September 30, 2024, were $16.5 million, compared to $12.5 million in 2023, an increase of $4.0 million[93]. - Total operating expenses for the three months ended September 30, 2024, were $28.6 million, up from $24.0 million in 2023, reflecting a $4.6 million increase[85]. Future Commitments and Risks - As of September 30, 2024, total future aggregate operating lease commitments were $8.9 million, with approximately $0.2 million due during 2024[110]. - Future capital requirements will depend on various factors, including the costs and timing of ongoing and planned preclinical studies and clinical trials[106]. - There have been no material changes to critical accounting policies and estimates during the three and nine months ended September 30, 2024[111]. - As of September 30, 2024, there have been no material changes surrounding market risk, including interest rate risk and inflation risk[113].
Tyra Biosciences(TYRA) - 2024 Q3 - Quarterly Results
2024-11-07 21:05
Financial Performance - Reported a net loss of $24.0 million for Q3 2024, compared to $21.2 million for the same period in 2023[10] - The net loss for the three months ended September 30, 2024, was $24,016,000, compared to a net loss of $21,152,000 for the same period in 2023, indicating a 13.5% increase in losses[17] - Comprehensive loss for the three months ended September 30, 2024, was $22,080,000, compared to $21,152,000 for the same period in 2023[17] - The accumulated deficit increased to $(225,740,000) as of September 30, 2024, from $(164,830,000) at the end of 2023[16] Expenses - Research and development expenses for Q3 2024 were $22.7 million, up from $19.3 million in Q3 2023, driven by ongoing clinical trials and personnel costs[10] - General and administrative expenses increased to $5.9 million in Q3 2024 from $4.7 million in Q3 2023, primarily due to higher personnel-related costs[10] - Research and development expenses for the three months ended September 30, 2024, were $22,697,000, compared to $19,271,000 for the same period in 2023, representing a 12.6% increase[17] - General and administrative expenses increased to $5,907,000 for the three months ended September 30, 2024, from $4,692,000 in the prior year, a rise of 25.9%[17] - Total operating expenses for the nine months ended September 30, 2024, were $74,433,000, up from $54,311,000 in the same period of 2023, reflecting a 37.1% increase[17] Cash and Assets - Cash, cash equivalents, and marketable securities totaled $360.1 million as of September 30, 2024, expected to support operations through at least 2026[10] - Cash, cash equivalents, and marketable securities increased to $360,130,000 as of September 30, 2024, compared to $203,469,000 on December 31, 2023[16] - Total assets rose to $380,592,000 as of September 30, 2024, up from $225,857,000 at the end of 2023[16] - Total stockholders' equity rose to $362,288,000 as of September 30, 2024, compared to $204,262,000 on December 31, 2023[16] Clinical Development - TYRA-300 demonstrated a 54.5% confirmed partial response rate in 6 out of 11 patients with FGFR3+ metastatic urothelial cancer at doses of ≥ 90 mg once daily[3] - The company plans to submit an IND application for a Phase 2 study of TYRA-300 in non-muscle invasive bladder cancer (NMIBC) by year-end 2024[3] - IND clearance received for the Phase 2 study of TYRA-300 in pediatric achondroplasia (BEACH301), expected to dose the first child in Q1 2025[4] - TYRA-200 is advancing in the Phase 1 SURF201 study for FGFR2+ cholangiocarcinoma and other advanced solid tumors[5] - The FDA cleared the IND for TYRA-430, an FGFR4/3-biased inhibitor, to proceed with a Phase 1 study in advanced hepatocellular carcinoma[7] Leadership - Doug Warner, MD, appointed as Chief Medical Officer, bringing over 20 years of clinical development experience[8] Share Information - The weighted-average shares used to compute net loss per share increased to 58,874,497 for the three months ended September 30, 2024, compared to 42,868,340 in the prior year[17]
Tyra Biosciences Reports Third Quarter 2024 Financial Results and Highlights
Prnewswire· 2024-11-07 21:05
Core Insights - Tyra Biosciences reported positive interim clinical proof-of-concept results for TYRA-300 in metastatic urothelial cancer (mUC) and received IND clearance for a Phase 2 study in pediatric achondroplasia [1][5] - The company appointed Doug Warner, MD, as Chief Medical Officer, enhancing its leadership team [10] - As of Q3 2024, Tyra had cash, cash equivalents, and marketable securities totaling $360.1 million, providing a strong financial position for ongoing and future clinical trials [12][19] Clinical Development Highlights - Interim data from the SURF301 Phase 1/2 study showed that at a dose of ≥ 90 mg once daily, 54.5% of patients with FGFR3+ mUC achieved a confirmed partial response, with a 100% disease control rate [3] - The company plans to expand the clinical development of TYRA-300 into non-muscle invasive bladder cancer (NMIBC) and aims to submit an IND application for this indication by the end of 2024 [4] - The FDA cleared the IND application for a Phase 2 clinical trial of TYRA-300 in children with achondroplasia, expected to begin in Q1 2025 [5] Financial Performance - For Q3 2024, Tyra reported a net loss of $24.0 million, compared to a net loss of $21.2 million in Q3 2023 [11][20] - Research and development expenses increased to $22.7 million in Q3 2024 from $19.3 million in the same period of 2023, driven by ongoing clinical trials [11] - General and administrative expenses rose to $5.9 million in Q3 2024 from $4.7 million in Q3 2023, primarily due to increased personnel-related costs [11] Pipeline and Research Initiatives - TYRA-300 is being evaluated in the SURF301 study for both oncology and skeletal dysplasias, with a focus on achieving best-in-class status [13][15] - The company is also advancing TYRA-200, an FGFR1/2/3 inhibitor, in a Phase 1 study for advanced solid tumors [14] - TYRA-430, an FGFR4/3-biased inhibitor, has received IND clearance for a Phase 1 study targeting advanced hepatocellular carcinoma and other solid tumors [9]
Tyra Biosciences Receives IND Clearance from FDA to Proceed with Phase 2 Study of TYRA-300 in Pediatric Achondroplasia (BEACH301)
Prnewswire· 2024-10-28 11:00
– TYRA-300 is the first oral FGFR-3 selective inhibitor to be well-tolerated in clinical studies –– First child with achondroplasia expected to be dosed in Q1 2025 –CARLSBAD, Calif., Oct. 28, 2024 /PRNewswire/ -- 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, announced today that the U.S. Food and Drug Administration (FDA) cleared its I ...
Why Is Cancer-Focused Tyra Biosciences Stock Falling On Friday?
Benzinga· 2024-10-25 15:34
On Thursday, Tyra Biosciences, Inc. TYRA released clinical proof-of-concept data for TYRA-300 in patients with metastatic urothelial (mUC) cancer from its ongoing SURF301 Phase 1/2 study. These data will be presented at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. TYRA-300 is a potential first-in-class, investigational, oral, FGFR3-selective inhibitor designed to avoid the toxicities associated with the inhibition of FGFR1, FGFR2, and FGFR4 while being agnostic for the FGFR3 ga ...