Summary of Key Points from Biotechnology Equity Research Conference Call Industry Overview - The report focuses on the biotechnology sector, specifically highlighting companies with significant potential for growth and upcoming catalysts in 2026. Key Companies and Their Outlook 1. **Dianthus Therapeutics, Inc. (DNTH)** - Market Cap: $1.82 billion - Price Target: $66 - Key catalysts include: - CIDP Phase III interim analysis in Q2 2026 - Initiation of gMG Phase III study in mid-2026 - Phase II MMN topline data in 2H26 - Potential for significant upside based on peak revenue estimates of ~$2 billion across neuromuscular diseases [19][20][24] 2. **Taysha Gene Therapies, Inc. (TSHA)** - Market Cap: $1.50 billion - Price Target: $11 - Focus on pivotal study for TSHA-102 in Rett syndrome with potential for a 6-month interim readout by YE26/1Q27 [26][27] 3. **Tyra Biosciences (TYRA)** - Market Cap: $1.36 billion - Price Target: $32 - Major catalysts include: - Phase III data for achondroplasia in early 2026 - Initial data for IR-NMIBC in 1H26 - Potential to disrupt the market with oral FGFR3 inhibitors [31][35] 4. **Tango Therapeutics, Inc. (TNGX)** - Market Cap: $1.15 billion - Price Target: $14 - Expected to show de-risking data for vopimetostat in combination with RVMD's RAS inhibitors in 2026 [37][40] 5. **ORIC Pharmaceuticals (ORIC)** - Market Cap: $783 million - Price Target: $23 - Key catalysts include dose-optimization data for prostate cancer and validating data from PFE's MEVPRO-1 trial [42][48] 6. **Solid Biosciences (SLDB)** - Market Cap: $463 million - Price Target: $15 - Focus on DMD program with key regulatory feedback expected in 1H26 [49][53] Major Catalysts and Events - **Upcoming Catalysts:** - RARE and MREO Phase III ORBIT final analysis expected in Dec'25/Jan'26 with potential stock movements of +100%/-30% [2] - ALNY, CRSP, and others expected to provide revenue guidance and business plans early in 2026 [1] - Regulatory events including FDA's Rare Disease Day on 2/23/26 [12] - **Drug Launches:** - Expected launches in 2026 include drugs from ALNY, ARWR, KALV, and others targeting various conditions [3] Financial Updates - **Price Target Changes:** - ARWR raised from $67 to $90 - KOD raised from $24 to $39 [6][10] Market Dynamics - **Pricing Stability:** - 2026 net pricing expected to remain stable with current Medicare contracts influencing high gross-to-net (GTN) guidance [12] - **Strategic Interest:** - Potential for M&A activity as companies like ORIC attract interest due to their prostate cancer programs [43] Conclusion - The biotechnology sector is poised for significant developments in 2026, with multiple companies presenting strong investment opportunities based on upcoming catalysts, drug launches, and strategic positioning in the market.

Core Insights - Jefferies has released a report on the outlook for the U.S. biotech industry in 2026, highlighting key clinical trial data disclosures, new drug approvals, and policy dynamics that could lead to value re-evaluation for companies in the sector [1] Six Preferred Stocks - Jefferies identified six companies as core recommendations for 2026 based on market catalysts and valuation potential: - Dianthus Therapeutics (DNTH.US), target price $66: Focused on claseprubart for various neuromuscular diseases, with peak revenue estimated at $2 billion [2] - Taysha Gene Therapies (TSHA.US), target price $11: TSHA-102 for Rett syndrome, with peak revenue potential of $2 billion and a key trial data disclosure expected by the end of 2026 [2] - Tyra Biosciences (TYRA.US), target price $32: Dabogratinib for bladder cancer and achondroplasia, with critical data expected next year [3] - Tango Therapeutics (TNGX.US), target price $14: Collaboration with Revolution Medicines for a pancreatic cancer treatment, with data expected in mid-2026 [3] - ORIC Pharmaceuticals (ORIC.US), target price $23: Two potential assets targeting prostate cancer and lung cancer, with key data expected next year [4] - Solid Biosciences (SLDB.US), target price $15: Focused on gene therapy for Duchenne muscular dystrophy, with critical meetings with the FDA planned for 2026 [4] Seven Undervalued Companies - The report also highlighted seven undervalued companies with significant catalysts: - Ultragenyx Pharmaceutical (RARE.US), target price $114: Expected key catalysts in 2026, including data for treatments for osteogenesis imperfecta and Angelman syndrome [5] - Beam Therapeutics (BEAM.US), target price $41: Updates on AATD therapy and SCD therapy expected in 2026, showcasing strong potential [5] - Aurinia Pharmaceuticals (AUPH.US), target price $21: Steady growth in lupus nephritis treatment, with new drug development paths expected to expand growth [6] - Kodiak Sciences (KOD.US), target price $39: Anticipated data from three pivotal trials in 2026, with significant potential for stock volatility [7] - Intellia Therapeutics (NTLA.US), target price $45: Key data for hereditary angioedema therapy expected in mid-2026, with sufficient cash reserves to support operations [7] - Compass Therapeutics (CMPX.US), target price $8: Data for cholangiocarcinoma therapy expected in early 2026, with a significant market opportunity [8] - KalVista Pharmaceuticals (KALV.US), target price $38: First oral treatment for hereditary angioedema expected to see rapid growth in 2026 [8] Five Potential Acquisition Targets - Jefferies identified five companies that may become acquisition targets in 2026 due to their unique assets or market positions: - Arrowhead Pharmaceuticals (ARWR.US): Strong RNAi product line for cardiovascular and metabolic diseases [9] - Celcuity (CELC.US): Unique efficacy of gedatolisib in breast cancer [9] - ORIC Pharmaceuticals: High-value prostate and lung cancer projects [9] - Travere Therapeutics (TVTX.US): Potential for significant market expansion in rare kidney diseases [9] - KalVista Pharmaceuticals: First-mover advantage in oral HAE treatment [9]

Key Points Robert More reported the sale of 246,871 shares on Nov. 21 as part of a Rule 10b5-1 trading plan. The director still owns nearly 4 million shares, worth approximately $77.6 million. The stock is up more than 80% year to date, but the company has yet to generate any revenue. These 10 stocks could mint the next wave of millionaires › On Nov. 21, 2025, Robert J. More, Director of Tyra Biosciences (NASDAQ:TYRA), executed an open-market sale of 246,871 shares; see the SEC Form 4 filing for ...

Tyra Biosciences Conference Call Summary Company Overview - **Company**: Tyra Biosciences (NasdaqGS:TYRA) - **Focus**: Precision small molecule medicine, specifically targeting FGFR3 with their lead drug, dabogratinib [2][4] Key Points and Arguments Drug Development and Clinical Trials - **Dabogratinib**: An FGFR3 selective inhibitor recently cleared for a phase two study in upper tract urothelial carcinoma, with ongoing trials for intermediate risk NMIBC and achondroplasia [2][3] - **Market Opportunity**: The FGFR3 positive bladder cancer market is estimated to be over $5 billion, with a significant unmet need in patients, particularly in the intermediate risk NMIBC setting [3][4] - **Efficacy Data**: Erdafitinib, a competitor, has shown a 35.3% overall response rate (ORR) at 8-9 mg dose, while a lower dose in the NMIBC setting yielded an 89% complete response (CR) rate [5][6] Competitive Landscape - **Unique Position**: Tyra is the only company advancing an FGFR3 selective oral drug, which is expected to have a better safety profile compared to existing treatments that affect FGFR1, 2, and 4 [4][6] - **Safety Profile**: Dabogratinib demonstrated significantly reduced toxicity compared to erdafitinib, with lower rates of common side effects such as nail disorders and hyperphosphatemia [6][8] Market Dynamics - **Urologist Engagement**: There is strong enthusiasm among urologists for oral therapies, as they can enhance practice revenue through in-office dispensing, similar to oral prostate cancer drugs [10][11] - **Switch Market Potential**: The treatment landscape is expected to shift towards oral options, with urologists likely to prefer oral therapies for recurrent patients rather than invasive procedures [29][30] Achondroplasia Program - **Growth Impact**: FGFR3 inhibition has shown potential to improve annualized height velocity (AHV) in children with achondroplasia, with Tyra aiming to exceed the 6 cm/year benefit seen in competitors [15][18] - **Preclinical Validation**: Studies indicate that targeting FGFR3 can lead to significant growth without severe toxicity, suggesting a favorable therapeutic window [17][19] Future Milestones - **Data Readouts**: Tyra expects to provide data on NMIBC and achondroplasia in 2026, with a well-financed position into 2028, holding $275 million [24] - **Regulatory Path**: Positive data could lead to a rapid transition to registrational studies, similar to competitors' paths [32][33] Additional Important Insights - **Unmet Needs in Upper Tract Urothelial Carcinoma**: This area presents a high burden of unmet need, with a significant percentage of patients being FGFR3 positive [12][13] - **Community Engagement**: There is a strong interest from the medical community in Tyra's studies, indicating a robust pipeline and potential for successful patient recruitment [21][23] This summary encapsulates the critical aspects of Tyra Biosciences' conference call, highlighting the company's strategic focus, competitive advantages, and future opportunities in the biotech landscape.

Financial Performance - For the nine months ended September 30, 2025, the company reported net losses of $86.1 million, compared to $60.9 million for the same period in 2024, indicating a year-over-year increase of approximately 41% in losses[86]. - Net loss for the three months ended September 30, 2025, was $29.9 million, compared to a net loss of $24.0 million in 2024, representing an increase of $5.9 million[98]. - Total operating expenses for the nine months ended September 30, 2025, were $96.2 million, an increase of $21.8 million from $74.4 million in 2024[104]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $71.5 million, compared to $50.2 million in 2024, reflecting an increase of $21.3 million[112]. - Research and development expenses increased to $25.5 million for the three months ended September 30, 2025, compared to $22.7 million in 2024, reflecting a $2.8 million increase[99]. - Research and development expenses for the nine months ended September 30, 2025, totaled $74.7 million, an increase of $16.8 million from $57.9 million in 2024[105]. - General and administrative expenses rose to $7.5 million for the three months ended September 30, 2025, up from $5.9 million in 2024, primarily due to higher personnel costs[100]. - Other income decreased to $3.1 million for the three months ended September 30, 2025, down from $4.6 million in 2024, a decline of $1.5 million[101]. - The company reported a decrease in total other income for the nine months ended September 30, 2025, to $10.1 million from $13.5 million in 2024, a decline of $3.4 million[108]. Cash and Funding - As of September 30, 2025, the company had an accumulated deficit of $337.4 million and cash, cash equivalents, and marketable securities totaling $274.9 million[86]. - The company expects to continue incurring significant operating losses, particularly as it conducts preclinical studies and clinical trials, and anticipates that its cash reserves will be sufficient to fund operations through at least 2027[88]. - The company plans to finance its operations through equity offerings and other capital sources until it can generate significant revenue from product sales[88]. - 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 2027[119]. - Future capital requirements will depend on various factors, including the ability to generate substantial product revenues to support the cost structure[120]. - The company may finance cash needs through equity offerings, debt financings, or other capital sources, but may be unable to raise additional funds on favorable terms[120]. - The company has material cash requirements for expected operating expenses related to clinical trials and research and development activities[117]. Clinical Development - The lead program, dabogratinib, is currently in multiple Phase 2 clinical studies targeting pediatric achondroplasia and low-grade bladder cancer, with initial results expected in the second half of 2026[78][79]. - In the SURF301 study, 54.5% of patients with FGFR3+ metastatic urothelial carcinoma achieved a confirmed partial response when receiving doses of dabogratinib ≥ 90 mg once daily[81]. - TYRA-430 is currently being evaluated in a global Phase 1 study for advanced hepatocellular carcinoma, with patient dosing commenced in April 2025[83]. - The research and development expenses are expected to increase substantially as the company advances its product candidates through clinical trials and expands its pipeline[90]. - The process of conducting preclinical studies and clinical trials is costly, and the timing of progress and expenses is uncertain[119]. Risks and Uncertainties - The costs and timing of manufacturing for current or future product candidates, including commercial scale manufacturing, are uncertain[121]. - The company faces risks related to the costs and timing of regulatory review of current or future product candidates[121]. - The company may need to relinquish valuable rights to technologies or future revenue streams if additional funds are raised through collaborations[122]. - As of September 30, 2025, there have been no material changes to critical accounting policies and estimates compared to the previous annual report[125]. - There have been no material changes surrounding market risk, including interest rate risk and inflation risk, from the previous annual report[127]. Other Information - The company completed a private placement on February 6, 2024, raising approximately $199.6 million in net proceeds[109]. - As of September 30, 2025, the total future aggregate operating lease commitments were $8.0 million, with approximately $0.2 million due during 2025, and the remaining due from 2026 through 2033[124].

Financial Position - Tyra Biosciences reported cash, cash equivalents, and marketable securities of $274.9 million as of September 30, 2025, providing a runway through at least 2027[5]. - Total current assets decreased from $347,463,000 on December 31, 2024, to $281,216,000 on September 30, 2025, representing a decline of approximately 19%[26]. - Cash and cash equivalents decreased from $91,966,000 on December 31, 2024, to $61,951,000 on September 30, 2025, a decline of approximately 33%[26]. - The total liabilities increased from $20,407,000 on December 31, 2024, to $21,342,000 on September 30, 2025, an increase of about 5%[26]. - The accumulated deficit grew from $(251,311,000) on December 31, 2024, to $(337,424,000) on September 30, 2025, reflecting a deterioration of approximately 34%[26]. Expenses - Research and Development (R&D) expenses for Q3 2025 were $25.5 million, up from $22.7 million in Q3 2024, primarily due to start-up and enrollment activities for clinical studies[13]. - General and Administrative (G&A) expenses increased to $7.5 million in Q3 2025 from $5.9 million in Q3 2024, driven by higher personnel-related costs[13]. - Research and development expenses increased by 12% from $22,697,000 in Q3 2024 to $25,469,000 in Q3 2025[28]. - General and administrative expenses rose by 26% from $5,907,000 in Q3 2024 to $7,475,000 in Q3 2025[28]. - Total operating expenses for the nine months ended September 30, 2025, were $96,246,000, up 29% from $74,433,000 for the same period in 2024[28]. Net Loss - The net loss for Q3 2025 was $29.9 million, compared to a net loss of $24.0 million for the same period in 2024[13]. - The net loss for Q3 2025 was $29,868,000, compared to a net loss of $24,016,000 in Q3 2024, reflecting a 24% increase in losses[28]. - The comprehensive loss for the nine months ended September 30, 2025, was $86,441,000, compared to $59,539,000 for the same period in 2024, indicating a 45% increase[28]. - Net loss per share, basic and diluted, was $0.50 for Q3 2025, compared to $0.41 for Q3 2024, indicating a worsening in per-share losses[28]. Development Pipeline - Tyra is advancing the development of dabogratinib into low-grade upper tract urothelial carcinoma (LG-UTUC), with an IND cleared by the FDA for a Phase 2 study expected to initiate in 2026[5]. - Interim results from the BEACH301 Phase 2 study for pediatric achondroplasia are expected in 2H 2026, while initial three-month complete response data from the SURF302 study is anticipated in 1H 2026[13]. - Approximately 85% of low-grade upper tract urothelial carcinoma cases have FGFR3 alterations, reinforcing the focus on dabogratinib for this indication[3]. - Tyra's lead candidate, dabogratinib, is an oral FGFR3-selective inhibitor currently in development for multiple indications, including pediatric achondroplasia and bladder cancer[11]. - The SURF431 study for TYRA-430, an FGFR4/3-biased inhibitor, is currently enrolling patients with hepatocellular carcinoma and other solid tumors[7]. - The company continues to advance its SNÅP platform for precision medicine, aimed at developing targeted therapies for oncology and genetically defined conditions[9].

Core Insights - Tyra Biosciences is advancing its clinical programs, particularly focusing on dabogratinib for treating conditions like pediatric achondroplasia and bladder cancer, with interim results expected in 2026 [1][2][8] Clinical Development - The company has dosed the first patients in its Phase 2 studies, BEACH301 and SURF302, with expectations for interim results in 2026 [1][2] - Dabogratinib is being expanded into low-grade upper tract urothelial carcinoma (LG-UTUC), where FGFR3 alterations are present in approximately 85% of cases, with an IND cleared by the FDA [1][4][8] - The BEACH301 study is evaluating dabogratinib in children aged 3 to 10 with achondroplasia, while SURF302 focuses on FGFR3-altered low-grade intermediate risk non-muscle invasive bladder cancer [4][10] Financial Overview - As of September 30, 2025, Tyra Biosciences reported cash, cash equivalents, and marketable securities totaling $274.9 million, providing a runway through at least 2027 [1][10] - Research and development expenses for Q3 2025 were $25.5 million, an increase from $22.7 million in Q3 2024, primarily due to start-up and enrollment activities [10][19] - The net loss for Q3 2025 was $29.9 million, compared to $24.0 million for the same period in 2024 [10][19] Pipeline and Future Plans - The company is also developing TYRA-430, an FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, and TYRA-200, an FGFR1/2/3 inhibitor for advanced intrahepatic cholangiocarcinoma [4][12][14] - Upcoming milestones include initial results from the safety sentinel cohort of BEACH301 in 2H 2026 and initial three-month complete response data from SURF302 in 1H 2026 [10][11]

Summary of Tyra Biosciences FY Conference Call Company Overview - **Company**: Tyra Biosciences - **Focus**: Precision medicine, specifically targeting FGFR (Fibroblast Growth Factor Receptor) biology through drug discovery and development using the SNAP chemistry platform [4][5] Key Programs and Initiatives - **Lead Drug**: FGFR3 selective inhibitor, the first of its kind in clinical trials, aimed at treating bladder cancer and growth disorders like achondroplasia [4][6] - **Bladder Cancer**: Approximately 50% of bladder cancer cases are driven by FGFR3 mutations, with over 70% positivity in intermediate-risk non-muscle invasive bladder cancer (NMIBC) [5][6] - **Growth Disorders**: FGFR3 alterations lead to conditions like dwarfism, with the potential for a once-a-day oral agent to restore typical bone growth [7][8] Clinical Development - **Phase Two Studies**: Ongoing for both bladder cancer and achondroplasia, with a focus on identifying the right dosing for each indication [9][10] - **Efficacy Data**: Phase one data showed over 50% overall response rate (ORR) in FGFR3 positive metastatic cases, with a favorable safety profile [8][11] Market Opportunity - **Unmet Need**: High demand for effective treatments in both bladder cancer and achondroplasia, with Tyra's oral FGFR3 selective inhibitor positioned as a potential best-in-class option [39][40] - **Market Size**: The NMIBC market is projected to exceed $5 billion, while the total addressable market for growth conditions could reach $5 to $10 billion [39][40] Competitive Landscape - **Differentiation**: Tyra's oral FGFR3 selective inhibitor offers a less invasive alternative to existing therapies, which often require surgical interventions or intravesical therapies [16][18] - **Comparison with Competitors**: Other companies like Johnson & Johnson and BioMarin are also developing FGFR inhibitors, but Tyra's selective approach aims to avoid the toxicities associated with pan-FGFR inhibitors [25][39] Safety and Tolerability - **Safety Profile**: Tyra's FGFR3 selective inhibitor is designed to minimize adverse effects associated with FGFR1 and FGFR2, which are common with pan-FGFR therapies [32][34] - **Key Pediatric Safety Events**: Hyperphosphatemia and other toxicities related to FGFR2 are significant concerns that Tyra aims to mitigate with its selective approach [32][34] Future Outlook - **Underappreciated Aspects**: The size of the unmet need and the potential market opportunities for Tyra's single drug are significant, with a strong clinical data foundation supporting its efficacy [38][39] - **Strategic Positioning**: Tyra aims to optimize dosing and move quickly into phase three trials, leveraging its first-mover advantage in FGFR3 selective therapies [35][39] This summary encapsulates the key points discussed during the Tyra Biosciences FY Conference Call, highlighting the company's strategic focus, clinical development, market opportunities, and competitive positioning in the biotech landscape.

Tyra Biosciences (TYRA) Conference Summary Company Overview - **Company**: Tyra Biosciences (TYRA) - **Focus**: Discovery and development of selective FGFR3 inhibitors for cancer and achondroplasia treatment - **Key Products**: Lead compound is an FGFR3 selective inhibitor, dabogratinib (formerly TYR3-100) Pipeline Initiatives - **Active Phase II Trials**: - **Bladder Cancer**: Targeting intermediate risk FGFR3 positive non-muscle invasive bladder cancer (NMIBC) with a patient population of approximately 700,000 in the US, where FGFR3 positivity is 70-80% [5][11] - **Achondroplasia**: Addressing skeletal dysplasia caused by FGFR3 alterations, which leads to significant health complications [6][11] Study Design and Efficacy - **NMIBC Study**: - Phase II study randomizing patients to receive either 50 mg or 60 mg of dabogratinib daily [12] - Primary endpoint: 3-month complete response (CR) rate; secondary endpoints include duration of response and time to recurrence [12] - Anticipated CR rate benchmark is around 70% based on expert feedback [26] - **Achondroplasia Study**: - Initiated with a focus on pediatric dosing, starting at 0.125 to 0.5 mg/kg [73] - Emphasis on FGFR3 selectivity to optimize growth and reduce complications associated with the condition [78][86] Safety and Tolerability - **Dabogratinib Safety Profile**: - Demonstrated a pristine safety profile with low-grade adverse events (AEs) such as diarrhea and asymptomatic ALT/AST elevations [19][40] - No hyperphosphatemia observed at doses of 50-60 mg, contrasting with other pan FGFR inhibitors [40][64] Competitive Landscape - **Comparison with Other Treatments**: - Dabogratinib shows a significantly improved safety profile compared to erdafitinib, with lower rates of nail toxicity and stomatitis [63] - The oral administration of dabogratinib is expected to enhance patient adherence compared to intravesical therapies [50][51] Market Dynamics - **Community Channel Dynamics**: - The evolution of oral therapies in urology, supported by EuroGPO, has facilitated the adoption of oral drugs in community practices [55][58] - Oral drug spend in urology has reportedly increased from 5% to 15% since 2008, with indications that it may be as high as 40% today [57] Future Outlook - **Prioritization of Trials**: - The company is focusing on the intermediate risk NMIBC and achondroplasia settings due to larger patient populations and unmet needs [70][72] - Future discussions with the FDA regarding the metastatic urothelial carcinoma setting are planned, but current focus remains on ongoing Phase II trials [69][72] Key Takeaways - Tyra Biosciences is advancing innovative treatments for bladder cancer and achondroplasia with a strong emphasis on safety and patient convenience - The company is well-positioned in the market with a promising pipeline and a clear strategy for commercialization and patient engagement - Ongoing studies are expected to provide critical data that will shape the future of treatment options in these therapeutic areas [21][72]

Core Insights - Tyra Biosciences has initiated the BEACH301 Phase 2 clinical study for dabogratinib, the only oral FGFR3-selective inhibitor in development for achondroplasia, marking a significant milestone in the treatment of this condition [1][2][3] Company Overview - Tyra Biosciences, Inc. is a clinical-stage biotechnology company focused on developing precision medicines targeting FGFR biology, utilizing its in-house SNÅP platform for drug design [9] - Dabogratinib is the lead candidate from Tyra's pipeline, designed to be a first-in-class oral FGFR3-selective inhibitor, with ongoing clinical trials for both pediatric achondroplasia and cancer [7][9] Clinical Study Details - The BEACH301 study will evaluate dabogratinib in children aged 3 to 10 with achondroplasia, enrolling treatment-naïve participants and those who have received prior therapies [4][5] - The study aims to assess safety, tolerability, and growth velocity changes, with a focus on improving the quality of life for children with achondroplasia [5][6] Market Context - Achondroplasia affects approximately 1 in 15,000 to 40,000 children, with around 250,000 individuals impacted globally, highlighting a significant unmet medical need [2][6] - The FGFR3 G380R mutation is responsible for about 99% of achondroplasia cases, indicating a targeted therapeutic approach could be beneficial [2][6]