Tyra Biosciences Reports Third Quarter 2024 Financial Results and Highlights
Tyra Biosciences (Nasdaq: TYRA), a clinical-stage biotechnology company, reported its Q3 2024 financial results and corporate highlights. Key points include positive interim clinical proof-of-concept results for TYRA-300 in metastatic urothelial cancer (mUC) from the SURF301 Phase 1/2 study. The company received IND clearance for a Phase 2 study of TYRA-300 in pediatric achondroplasia (BEACH301) and plans to submit an IND for a Phase 2 study in non-muscle invasive bladder cancer (NMIBC) by year-end 2024.
Tyra also advanced its TYRA-200 and TYRA-430 programs and appointed Dr. Doug Warner as Chief Medical Officer. Financially, Tyra reported a net loss of $24.0 million for Q3 2024, with increased R&D and administrative expenses. The company holds $360.1 million in cash and equivalents, expected to fund operations through 2026.
Tyra Biosciences (Nasdaq: TYRA), una società di biotecnologie in fase clinica, ha riportato i risultati finanziari del terzo trimestre del 2024 e i principali eventi aziendali. I punti chiave includono risultati positivi di prova di concetto clinico intermedio per TYRA-300 nel cancro uroteliale metastatico (mUC) dallo studio di Fase 1/2 SURF301. L'azienda ha ricevuto l'approvazione IND per uno studio di Fase 2 di TYRA-300 nell'achondroplasia pediatrica (BEACH301) e prevede di presentare un'IND per uno studio di Fase 2 nel cancro della vescica non muscolo invasivo (NMIBC) entro la fine del 2024.
Tyra ha anche avanzato i programmi TYRA-200 e TYRA-430 e ha nominato il Dr. Doug Warner come Chief Medical Officer. Dal punto di vista finanziario, Tyra ha riportato una perdita netta di 24,0 milioni di dollari per il terzo trimestre del 2024, con un aumento delle spese per R&D e amministrative. L'azienda detiene 360,1 milioni di dollari in contante e equivalenti, previste per finanziare le operazioni fino al 2026.
Tyra Biosciences (Nasdaq: TYRA), una compañía de biotecnología en etapa clínica, informó sus resultados financieros del tercer trimestre de 2024 y los aspectos destacados corporativos. Los puntos clave incluyen resultados positivos de prueba de concepto clínica interinos para TYRA-300 en cáncer urotelial metastásico (mUC) del estudio de Fase 1/2 SURF301. La compañía recibió la autorización IND para un estudio de Fase 2 de TYRA-300 en achondroplasia pediátrica (BEACH301) y planea presentar una IND para un estudio de Fase 2 en cáncer de vejiga no músculo invasivo (NMIBC) para finales de 2024.
Tyra también avanzó en sus programas TYRA-200 y TYRA-430, y nombró al Dr. Doug Warner como Director Médico. Desde el punto de vista financiero, Tyra reportó una pérdida neta de 24,0 millones de dólares para el tercer trimestre de 2024, con un aumento en los gastos de I+D y administrativos. La compañía tiene 360,1 millones de dólares en efectivo y equivalentes, que se espera financien sus operaciones hasta 2026.
Tyra Biosciences (Nasdaq: TYRA), 임상 단계의 생명공학 회사가 2024년 3분기 재무 결과 및 기업 하이라이트를 발표했습니다. 주요 내용으로는 SURF301 1/2상 연구에서 전이성 요로 상피암(mUC) 치료를 위한 TYRA-300의 긍정적인 중간 임상 개념 증명이 포함됩니다. 이 회사는 소아 왜소증에 대한 TYRA-300의 2상 연구에 대한 IND 승인을 받았으며, 2024년 연말까지 비근육 침습성 방광암(NMIBC)에 대한 2상 연구를 위한 IND를 제출할 계획입니다.
Tyra는 또한 TYRA-200 및 TYRA-430 프로그램을 발전시켰고, Doug Warner 박사를 최고 의료 책임자로 임명했습니다. 재무적으로 Tyra는 2024년 3분기 동안 2,400만 달러의 순손실을 기록했으며, 연구 개발 및 관리 비용이 증가했습니다. 이 회사는 3억 6천 10만 달러의 현금 및 현금성 자산을 보유하고 있으며, 2026년까지 운영 자금을 지원할 것으로 예상됩니다.
Tyra Biosciences (Nasdaq: TYRA), une entreprise de biotechnologie en phase clinique, a publié ses résultats financiers du troisième trimestre 2024 ainsi que ses points forts en entreprise. Les points clé incluent des résultats positifs intermédiaires de preuve de concept clinique pour TYRA-300 dans le cancer urotélial métastatique (mUC) issus de l'étude de Phase 1/2 SURF301. L'entreprise a obtenu l'autorisation IND pour une étude de Phase 2 de TYRA-300 dans l'achondroplasie pédiatrique (BEACH301) et prévoit de soumettre une IND pour une étude de Phase 2 dans le cancer de la vessie non-muscle invasif (NMIBC) d'ici la fin 2024.
Tyra a également développé ses programmes TYRA-200 et TYRA-430 et a nommé Dr. Doug Warner en tant que Directeur Médical. Sur le plan financier, Tyra a rapporté une perte nette de 24,0 millions de dollars pour le troisième trimestre 2024, avec une augmentation des dépenses de R&D et administratives. L'entreprise dispose de 360,1 millions de dollars en liquidités et équivalents, prévus pour financer ses opérations jusqu'en 2026.
Tyra Biosciences (Nasdaq: TYRA), ein biopharmazeutisches Unternehmen in der klinischen Phase, hat seine finanziellen Ergebnisse für das dritte Quartal 2024 sowie die Unternehmenshighlights veröffentlicht. Wichtige Punkte sind positive vorläufige klinische Nachweis-Ergebnisse für TYRA-300 bei metastasierendem Urothelkarzinom (mUC) aus der SURF301 Phase 1/2 Studie. Das Unternehmen erhielt die IND-Freigabe für eine Phase 2-Studie von TYRA-300 bei pädiatrischer Achondroplasie (BEACH301) und plant, bis Ende 2024 eine IND für eine Phase 2-Studie bei nicht-muskelinvasivem Blasenkrebs (NMIBC) einzureichen.
Tyra hat auch die Programme TYRA-200 und TYRA-430 vorangetrieben und Dr. Doug Warner zum Chief Medical Officer ernannt. Finanziell berichtete Tyra im dritten Quartal 2024 einen Nettoverlust von 24,0 Millionen USD, mit gestiegenen Forschung- und Entwicklungskosten sowie Verwaltungsausgaben. Das Unternehmen verfügt über 360,1 Millionen USD in Bargeld und Äquivalenten, was voraussichtlich die Betriebsabläufe bis 2026 finanzieren wird.
- Positive interim clinical proof-of-concept results for TYRA-300 in mUC.
- IND clearance for Phase 2 study of TYRA-300 in pediatric achondroplasia.
- Planned IND submission for Phase 2 study of TYRA-300 in NMIBC by year-end 2024.
- Appointment of Dr. Doug Warner as Chief Medical Officer.
- $360.1 million in cash and equivalents, funding operations through 2026.
- Net loss of $24.0 million for Q3 2024.
- Increased R&D expenses to $22.7 million.
- Increased administrative expenses to $5.9 million.
Insights
The Q3 results reveal a strong financial position with
The positive interim clinical data for TYRA-300 in mUC with
The appointment of an experienced CMO strengthens the executive team at a important growth phase. With multiple clinical milestones expected through 2025, including Phase 2 initiations, the company is well-capitalized to execute its development plans.
The interim TYRA-300 data demonstrates compelling efficacy with
The expansion into multiple indications including NMIBC and pediatric achondroplasia highlights the broad therapeutic potential. The BEACH301 trial design with multiple dose cohorts and inclusion of both treatment-naïve and previously treated patients will provide comprehensive efficacy data in achondroplasia. The advancing TYRA-200 and TYRA-430 programs further demonstrate the platform's versatility in targeting FGFR biology.
- Reported positive interim clinical proof-of-concept results for TYRA-300 in mUC from SURF301 Ph1/2 study -
- IND cleared for Phase 2 study of TYRA-300 in pediatric achondroplasia (BEACH301) -
- Strengthened leadership with appointment of Doug Warner, MD as Chief Medical Officer -
- Cash, cash equivalents, and marketable securities of
"These are exciting times at TYRA. We are very pleased with the interim data reported with TYRA-300 at ENA 2024. TYRA-300 demonstrated impressive anti-tumor activity at dose levels ≥ 90 mg once daily and was generally well-tolerated with infrequent FGFR1 and FGFR2 toxicities that limit the tolerability of pan-FGFR inhibitors. These data provide clinical support that an FGFR3 inhibitor designed to be highly selective can deliver meaningful clinical benefit to heavily pretreated patients with cancer," said Todd Harris, CEO of TYRA. "These results allow us to expand into larger studies for multiple bladder cancer indications, including metastatic urothelial cancer (mUC) and non-muscle invasive bladder cancer (NMIBC), while aiming to achieve best-in-class annualized growth velocity in achondroplasia (ACH). We look forward to initiating the Phase 2 study for ACH in the first quarter of 2025 and submitting an IND for NMIBC by the end of this year."
Third Quarter 2024 and Recent Corporate Highlights
TYRA-300
- Reported Interim Clinical Proof-of-Concept Results from SURF301 Phase 1/2 Study (NCT05544552) in Patients with mUC. In October 2024, TYRA reported interim data with TYRA-300 during a late-breaking oral presentation at the 36th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain. The results included encouraging preliminary anti-tumor activity observed in a heavily pre-treated population: at ≥ 90 mg once daily (QD), 6 out of 11 (
54.5% ) patients with FGFR3+ mUC achieved a confirmed partial response (PR), with100% disease control rate and sustained duration of activity; positive safety results were reported across all once-daily (QD) doses, with infrequent FGFR2/FGFR1-associated toxicities. The interim results warrant continued development of TYRA-300 for mUC and the Company is prioritizing QD dosing in SURF301 and future oncology studies. TYRA-300 is currently being evaluated in Part B of SURF301 at potentially therapeutic QD doses in preparation for potential future Phase 2 studies in NMIBC and mUC. - Phase 2 IND Submission for NMIBC on Track for Year-End 2024. TYRA plans to expand the clinical development of TYRA-300 into NMIBC to address the unmet needs in this cancer population with an efficacious, orally available therapy. TYRA remains on track to submit an Investigational New Drug (IND) application for a Phase 2 study of TYRA-300 in NMIBC before year-end 2024.
- IND Clearance Received for Phase 2 Achondroplasia (ACH) Study (BEACH301). In October 2024, TYRA announced that the
U.S. Food and Drug Administration (FDA) cleared its IND application for TYRA-300 allowing the company to proceed with a Phase 2 clinical trial of TYRA-300 for children with achondroplasia (BEACH301). The study will be a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating TYRA-300 in children ages 3 to 10 with achondroplasia with open growth plates. The study will enroll children who are treatment-naïve (Cohort 1) and those who have received prior growth-accelerating therapy (Cohort 2) at multiple sites across the globe. Each of these cohorts is expected to enroll up to 10 participants per dose level (0.125, 0.25, 0.375, 0.50 mg/kg) for up to 12 months. Prior to initiation of Cohorts 1 and 2, the study will enroll a safety sentinel cohort of up to 3 treatment-naïve participants per dose level in children ages 5 to 10. TYRA expects to dose the first child with achondroplasia in BEACH301 in Q1 2025. - Peer-Reviewed Manuscript Published in Journal of Medicinal Chemistry. In September 2024, a manuscript titled "Discovery of TYRA-300: First oral selective FGFR3 inhibitor for the treatment of urothelial cancers and achondroplasia" was published in the Journal of Medicinal Chemistry (J. Chem) by the American Chemical Society. The published data provides preclinical evidence that TYRA-300 is a potentially best-in-class, novel precision small molecule designed to be selective for FGFR3 while sparing FGFR1 and 2 isoform toxicities and on-target gatekeeper resistant mutations. These results support the advancement of TYRA-300 in the ongoing SURF301 Phase 1/2 clinical study and the expansion into achondroplasia and hypochondroplasia.
TYRA-200
- Phase 1 SURF201 Study Continued to Advance. The SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752) continued to advance. The study is a multi-center, open label study designed to evaluate the safety, tolerability, and PK of TYRA-200 and determine the optimal and maximum tolerated dose (MTD) and RP2D, as well as evaluate the preliminary antitumor activity of TYRA-200.
TYRA-200 is an investigational, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The SURF201 study is currently enrolling and dosing adults with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating FGFR2 gene alterations.
TYRA-430
- Continued Phase 1 Planning Following IND Clearance. TYRA announced that the FDA cleared its IND to proceed with a Phase 1 clinical study of TYRA-430, an investigational, FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The Phase 1 study will be a multicenter, open-label, first-in-human study of TYRA-430 in advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations (SURF431). We believe TYRA-430 has the potential to address a significant unmet need in HCC, where there are no approved biomarker-driven, targeted therapies.
Corporate
- Appointed Doug Warner, MD, as Chief Medical Officer (CMO). In September 2024, TYRA announced the appointment of Dr. Warner as CMO, who brings over twenty years of proven clinical development leadership to TYRA having successfully led global development and secured approvals for medicines across oncology and skeletal disease. Prior to TYRA, Dr. Warner held roles of increasing responsibility over 18 years at Amgen where he oversaw clinical development for programs across oncology and bone diseases. This included being an Executive Director and Group Product Area Lead, where Dr. Warner led a team responsible for the development of a portfolio of medicines ranging from those in Phase 1 to those with approved indications, including Vectibix®, XGEVA®, and Prolia®. Most recently, Dr. Warner was Chief Medical Officer for eFFECTOR Therapeutics where he was responsible for overseeing eFFECTOR's clinical pipeline, including its KICKSTART Phase 2b trial of tomivosertib in non-small cell lung cancer, and its Phase 1/2 study of zotatifin in solid tumors. Dr. Warner is co-author of numerous peer-reviewed articles including those in The Lancet, The Lancet Oncology, and The Journal of Clinical Oncology. He received his B.A. from the University of
Pennsylvania , his M.D. from the Duke University School of Medicine, and his M.B.A. from the UCLA Anderson School of Management.
SNÅP Platform and Pipeline
- TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, to develop therapies in targeted oncology and genetically defined conditions.
Third Quarter 2024 Financial Results
- Third quarter 2024 net loss was
compared to$24.0 million for the same period in 2023.$21.2 million - Third quarter 2024 research and development expenses were
compared to$22.7 million for the same period in 2023. The increase was driven by increased expenses incurred in connection with our ongoing and planned clinical trials and personnel-related costs, partially offset by decreased drug manufacturing and preclinical costs.$19.3 million - Third quarter 2024 general and administrative expenses were
compared to$5.9 million for the same period in 2023. The increase was primarily driven by increased personnel-related costs, including stock-based compensation.$4.7 million - As of September 30, 2024, TYRA had cash, cash equivalents, and marketable securities of
. The Company's current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans through at least 2026.$360.1 million
About TYRA-300
TYRA-300 is the Company's lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasias, including achondroplasia and hypochondroplasia. In oncology, TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552). The study is designed to determine the optimal and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. Part A of the study included patients with all solid tumors who are FGFR3 +/-, and explored doses of TYRA-300 ranging from 10mg -120mg once-daily (QD). Part A of SURF301 is complete. The Company continues to advance TYRA-300 through dose expansion in Part B, which includes patients with solid tumors who are FGFR3+, to evaluate potentially therapeutic doses in preparation for potential future Phase 2 studies in metastatic urothelial carcinoma (mUC) and non-muscle invasive bladder cancer (NMIBC). In skeletal dysplasia, TYRA-300 has demonstrated positive preclinical results in achondroplasia and hypochondroplasia and TYRA has received IND clearance from the FDA to proceed with its BEACH301 clinical trial in children with achondroplasia.
About TYRA-200
TYRA-200 is an investigational, oral, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations currently in development for the treatment of cancer. TYRA-200 is 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). SURF201 (NCT06160752) was designed to determine the optimal and MTD and the RP2D of TYRA-200, as well as to evaluate the preliminary antitumor activity of TYRA-200. SURF201 is currently enrolling adults with advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2.
About Tyra Biosciences
Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in 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. TYRA's expertise in FGFR biology has created a differentiated pipeline with three clinical-stage programs in targeted oncology and genetically defined conditions. The Company's lead precision medicine stemming from SNÅP, TYRA-300, is a potential first-in-class selective FGFR3 inhibitor that is designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for the FGFR3 gatekeeper mutations. TYRA-300 is in development for the treatment of cancer in the SURF301 Phase 1/2 study and for achondroplasia in the BEACH301 Phase 2 study. TYRA is also developing TYRA-200, an investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma, and TYRA-430, an investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. TYRA is based in
For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn.
Forward-Looking Statements
TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the potential to develop next-generation and potentially best-in-class precision medicines and the potential safety and therapeutic benefits of TYRA-300, TYRA-200, TYRA-430 and other product candidates; the continued evaluation of TYRA-300 through Part B dose escalation in SURF301; the sufficiency of our cash position to support our clinical and operational plans; expected cash runway; the expected timing and phase of clinical development of TYRA-300, TYRA-200, and TYRA-430, including timing of a submission of an IND for TYRA-300 in NMIBC and initiating dosing in BEACH301; the design and goals of BEACH301; and the potential for SNÅP to develop therapies in targeted oncology and genetically defined conditions. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of TYRA-300; we are early in our development efforts of testing TYRA-300 and TYRA-200 for oncology in clinical trials and the approach we are taking to discover and develop drugs based on our 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; potential delays in the commencement, enrollment, data readouts and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; later developments with the FDA may be inconsistent with prior feedback from the FDA, including with respect to the proposed initiation and design of our BEACH301 study; our dependence on third parties in connection with manufacturing, research and preclinical testing; we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of TYRA-300 in pediatric achondroplasia and hypochondroplasia; an accelerated development or approval pathway may not be available for TYRA-300 or other product candidates and any such pathway may not lead to a faster development process; later developments with the FDA may be inconsistent with the minutes from our prior meetings, including with respect to the proposed design of our planned Phase 2 study of TYRA-300 in ACH; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; unfavorable results from preclinical studies; we may not realize the benefits associated with Orphan Drug Designation, including that orphan drug exclusivity may not effectively protect a product from competition and that such exclusivity may not be maintained, or from the Rare Pediatric Disease Designation, including receipt of a Priority Review Voucher or any value therefrom; regulatory developments in
Contact:
Amy Conrad
aconrad@tyra.bio
Tyra Biosciences, Inc. Condensed Balance Sheet Data (in thousands) | |||||||
September 30, | December 31, | ||||||
2024 | 2023 | ||||||
(unaudited) | |||||||
Balance Sheet Data: | |||||||
Cash, cash equivalents and marketable securities | $ | 360,130 | $ | 203,469 | |||
Working capital | 353,238 | 196,338 | |||||
Total assets | 380,592 | 225,857 | |||||
Accumulated deficit | (225,740) | (164,830) | |||||
Total stockholders' equity | 362,288 | 204,262 |
Tyra Biosciences, Inc. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (unaudited) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 22,697 | $ | 19,271 | $ | 57,897 | $ | 41,841 | ||||||||
General and administrative | 5,907 | 4,692 | 16,536 | 12,470 | ||||||||||||
Total operating expenses | 28,604 | 23,963 | 74,433 | 54,311 | ||||||||||||
Loss from operations | (28,604) | (23,963) | (74,433) | (54,311) | ||||||||||||
Other income: | ||||||||||||||||
Interest and other income, net | 4,588 | 2,811 | 13,523 | 8,007 | ||||||||||||
Total other income | 4,588 | 2,811 | 13,523 | 8,007 | ||||||||||||
Net loss | (24,016) | (21,152) | (60,910) | (46,304) | ||||||||||||
Unrealized gain on marketable securities | 1,936 | — | 1,371 | — | ||||||||||||
Comprehensive loss | $ | (22,080) | $ | (21,152) | $ | (59,539) | $ | (46,304) | ||||||||
Net loss per share, basic and diluted | $ | (0.41) | $ | (0.49) | $ | (1.08) | $ | (1.09) | ||||||||
Weighted-average shares used to compute net loss | 58,874,497 | 42,868,340 | 56,599,050 | 42,619,075 |
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SOURCE Tyra Biosciences
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