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]

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]

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]

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].

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]

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-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 ...

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 ...

CARLSBAD, Calif., Oct. 23, 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, today announced that it will host a conference call and webcast on October 25, 2024 at 8:00 am ET to share interim clinical results of TYRA-300 from the SURF301 Phase 1/2 study in metastatic urothelial cancer (mUC). These data will be presente ...

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...