Panitumumab

– Achieved $49.3 million in OGSIVEO® (nirogacestat) net product revenue in the third quarter – – Long-term follow-up data from the Phase 3 DeFi trial of nirogacestat in adults with desmoid tumors highlight further reductions in tumor size, increase in ORR, sustained improvement in desmoid tumor symptoms, and consistent safety profile – – Granted FDA Priority Review on NDA and received validation of EU Marketing Authorization Application for mirdametinib for the treatment of adults and children with NF1-PN – – $498 million in cash, cash equivalents and marketable securities as of September 30, 2024; expected to fund the Company through profitability, which is anticipated in the first half of 2026 – – Conference call and webcast scheduled for 8:30 a.m. ET today – STAMFORD, Conn., Nov. 12, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today reported financial results for the third quarter of 2024 and provided an update on recent company developments. "In the third quarter, we continued to see robust growth in the U.S. launch of OGSIVEO for adults with desmoid tumors. As we approach nearly one full year on market, we are very encouraged by the metrics we are seeing regarding the breadth of physician prescribing, the number of patients on OGSIVEO, and the number of patients identified who may stand to benefit in the future from our medicine. We were also very pleased to receive Priority Review on our NDA for mirdametinib in NF1-PN this quarter, which positions us to potentially have a second approved medicine in early 2025," said Saqib Islam, Chief Executive Officer of SpringWorks. "Our focus for the remainder of the year is to continue building on OGSIVEO’s momentum in the U.S. while working to also bring it to patients in Europe, to advance our commercial preparations for mirdametinib in anticipation of serving patients with NF1-PN in the U.S. and Europe, and to progress our emerging portfolio." Recent Business Highlights and Upcoming Milestones OGSIVEO® (Nirogacestat) Continued strong commercial execution of the OGSIVEO launch, with net product revenue of $49.3 million in the third quarter of 2024, representing a 23% increase over the second quarter of 2024.In September, more than 800 unique desmoid tumor patients filled an OGSIVEO script. As of the end of the third quarter of 2024, approximately 420 treatment centers have ordered OGSIVEO since approval and approximately 65 percent of OGSIVEO patients on OGSIVEO are receiving the product in the 150 mg or 100 mg tablets blister packages. SpringWorks expects to complete the full transition to blister packages by the end of the year. In addition, through August 2024, approximately 10,000 unique desmoid tumor patients have been identified through the new desmoid tumor ICD-10 diagnostic code since the introduction of the code in October 2023. A Marketing Authorization Application (MAA) for nirogacestat for the treatment of adult patients with desmoid tumors is under review with the European Medicines Agency (EMA).Long-term follow-up data from the Phase 3 DeFi trial of nirogacestat in adults with progressing desmoid tumors will be presented as a late-breaking oral presentation at the upcoming Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting. These results, utilizing an August 2024 data cutoff date, showed that longer-term treatment with nirogacestat (median duration of treatment: 34 months) was associated with further reductions in tumor size, increase in objective response rate with additional partial responses and complete responses, sustained improvements in desmoid tumor symptoms including pain, and a consistent safety profile compared to the April 2022 data cutoff date for the primary results of the trial.SpringWorks expects to report initial data from the Phase 2 trial evaluating nirogacestat as a monotherapy in patients with recurrent ovarian granulosa cell tumors in the first half of 2025.SpringWorks is continuing to support several industry and academic collaborator studies evaluating nirogacestat as part of B-cell maturation antigen (BCMA) combination therapy regimens across treatment lines in patients with multiple myeloma. Mirdametinib SpringWorks' New Drug Application (NDA) for mirdametinib for the treatment of children and adults with NF1-PN was granted Priority Review by the U.S. Food and Drug Administration (FDA) and assigned a Prescription Drug User Fee Act (PDUFA) action date of February 28, 2025.SpringWorks’ MAA for mirdametinib for the treatment of children and adults with NF1-PN was validated by the EMA and is currently under review.Results from the Phase 2b ReNeu trial were published in the Journal of Clinical Oncology.Additional data from the pediatric and adult cohorts of the Phase 2b ReNeu trial will be presented in oral and poster presentations at the 2024 Society for Neuro-Oncology (SNO) meeting. Data demonstrate that the deep responses in tumor volume reduction seen in ReNeu were achieved regardless of age, sex, target PN volume at baseline, tumor location, or progression status at baseline and suggest a trend between deep response and earlier achievement of a first confirmed response. Patients with deep responses also had a trend of longer treatment duration. In addition, adults and children with NF1-PN had clinically meaningful, early, and sustained improvement in health-related quality of life over the course of mirdametinib treatment.Data from the Phase 1/2 trial evaluating mirdametinib in pediatric and young adult patients with low-grade gliomas (LGG) are being presented in an oral presentation at the 2024 SNO meeting. Results from 23 patients enrolled in the Phase 1 portion of the study suggested that mirdametinib, which has shown high blood brain barrier penetration, has encouraging clinical activity in patients with recurrent/progressive LGG across a variety of MAPK pathway aberrations. Twelve (63%) of the 19 patients with measurable tumors achieved an objective response (one major, six partial, and five minor responses). The Phase 2 portion of the study is ongoing and recruiting patients. Emerging Pipeline A Phase 1b trial evaluating brimarafenib (BGB-3245) in adult patients with RAF mutant solid tumors is ongoing; additional data from the dose expansion portion of the study is expected to be presented in the second half of 2025. Brimarafenib is an investigational, selective RAF dimer inhibitor being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene, Ltd.Several combination therapy oncology programs are ongoing: a Phase 1/2a study of brimarafenib and mirdametinib in MAPK mutant solid tumors, a Phase 1b trial of brimarafenib and Amgen’s EGFR inhibitor, panitumumab, in colorectal and pancreatic cancer patients with known MAPK pathway mutations, and a Phase 1b trial of mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in adult patients with NRAS mutant solid tumors.In October, SpringWorks presented preclinical data at the EORTC-NCI-AACR symposium on Molecular Targets and Cancer therapeutics demonstrating the utility of SW-682 as a monotherapy and in combination with mirdametinib in subsets of head and neck cancer as well as in combination with KRAS G12C inhibitors in KRAS G12C mutant NSCLC. SW-682 is an investigational novel, oral, potent, and selective pan-TEAD inhibitor and patients are being enrolled in a Phase 1a trial in Hippo-mutant solid tumors. General Corporate In July, SpringWorks appointed Martin Mackay, Ph.D. to the Company’s Board of Directors. Dr. Mackay is a highly accomplished R&D executive with more than 30 years of pharmaceutical and biotech R&D experience, including leadership roles at Pfizer, AstraZeneca and Alexion. Third Quarter 2024 Financial Results Product Revenue: OGSIVEO net product revenue was $49.3 million in the third quarter of 2024.Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $61.6 million for the third quarter of 2024, compared to $46.5 million for the comparable period of 2023. The increase in SG&A expense was primarily attributable to commercial readiness activities to support the U.S. launch of mirdametinib, if approved.Research and Development (R&D) Expenses: R&D expenses were $42.3 million for the third quarter of 2024, compared to $37.5 million for the comparable period of 2023. The increase in R&D expenses was primarily attributable to an increase in costs related to drug manufacturing, clinical trials, other research, consulting and professional services.Net Loss Attributable to Common Stockholders: SpringWorks reported a net loss of $53.5 million, or $0.72 per share, for the third quarter of 2024. This compares to a net loss of $79.4 million, or $1.27 per share, for the comparable period of 2023.Cash, Cash Equivalents, and Marketable Securities: Cash, cash equivalents and marketable securities were $498.1 million as of September 30, 2024. SpringWorks expects this cash position to fund the Company through profitability, which is expected in the first half of 2026. Conference Call Information SpringWorks will host a conference call and webcast today, Tuesday, November 12, at 8:30 a.m. ET to review its third quarter 2024 financial results and discuss recent business updates. To join the live webcast and view the corresponding slides, please click here. To access the live call by phone, please pre-register for the call by clicking here. Once registration is complete, participants will be provided with a dial-in number and conference code to access the call. A replay of the webcast will be available for a limited time following the event on the Investors and Media section of the Company’s website at https://ir.springworkstx.com. About SpringWorks Therapeutics SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer. OGSIVEO® (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment, is the Company’s first FDA-approved therapy. SpringWorks also has a diversified targeted therapy pipeline spanning solid tumors and hematological cancers, with programs ranging from preclinical development through advanced clinical trials. In addition to its wholly owned programs, SpringWorks has also entered into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients in need. For more information, visit www.springworkstx.com and follow @SpringWorksTx on X (formerly Twitter), LinkedIn, and YouTube. SpringWorks uses its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on SpringWorks' website in the Investors & Media section. Accordingly, investors should monitor such portions of the SpringWorks website, in addition to following press releases, SEC filings and public conference calls and webcasts. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, relating to our business, operations, and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our development and commercialization plans, our preclinical and clinical results, the market potential of OGSIVEO for adult patients with desmoid tumors, expectations to transition to blister packaging for OGSIVEO by the end of the year, expectations regarding the adequacy of the data contained in the nirogacestat MAA to serve as the basis for marketing approval of nirogacestat for the treatment of desmoid tumors in the European Union, the potential for mirdametinib to become an important new treatment for adult and pediatric NF1-PN patients, expectations regarding the timing and results of the reviews by the FDA and the EMA, as applicable, of each of the NDA and the MAA for mirdametinib for the treatment of adult and pediatric NF1-PN patients, including the FDA's PDUFA target action date for the NDA, our plans to report additional data from the Phase 2b ReNeu clinical trial at an upcoming medical conference in the fourth quarter of 2024, our plans to present additional data from the Phase 3 DeFi trial of nirogacestat at upcoming conferences, our plans for seeking regulatory approval for and making mirdametinib available for NF1-PN patients, if approved, expectations regarding the timing and initial data from the Phase 2 trial evaluating nirogacestat in patients with recurrent ovarian granulosa cell tumors, our expectations and the timing of the Phase 1a trial of SW-682, our plans to report additional clinical data of nirogacestat in combination with BCMA-directed therapies and initiate additional planned Phase 1 collaborator studies, our expectations and the timing of the Phase 1b dose expansion phase of brimarafenib, our expectations regarding the timing of enrollment in our combination therapy oncology programs, expectations about whether our patents for our lead assets will adequately protect SpringWorks against competition, as well as relating to other future conditions. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “would,” “should” and “could,” and similar expressions or words, identify forward-looking statements. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks relating to: (i) the success of our commercialization efforts with respect to OGSIVEO, (ii) our limited experience as a commercial company, (iii) our ability to obtain or maintain adequate coverage and reimbursement for OGSIVEO, (iv) the success and timing of our product development activities, including the initiation and completion of our clinical trials, (v) our expectations regarding the potential clinical benefit of OGSIVEO for adult patients with desmoid tumors who require systemic treatment, (vi) the potential for OGSIVEO to become the new standard of care for adult patients with desmoid tumors, (vii) estimates regarding the number of adult patients who are diagnosed with desmoid tumors annually per year in the U.S. and the potential market for OGSIVEO, (viii) the fact that topline or interim data from clinical studies may not be predictive of the final or more detailed results of such study or the results of other ongoing or future studies, (ix) the success and timing of our collaboration partners’ ongoing and planned clinical trials, (x) the timing of our planned regulatory submissions and interactions, including the timing and outcome of decisions made by the FDA, EMA, and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, (xi) whether FDA, EMA, or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of our product candidates, including nirogacestat and mirdametinib, (xii) our ability to obtain regulatory approval of any of our product candidates or maintain regulatory approvals granted for our products, (xiii) our plans to research, discover and develop additional product candidates, (xiv) our ability to enter into collaborations for the development of new product candidates and our ability to realize the benefits expected from such collaborations, (xv) our ability to maintain adequate patent protection and successfully enforce patent claims against third parties, (xvi) the adequacy of our cash position to fund our operations through any time period indicated herein, (xvii) our ability to establish manufacturing capabilities, and our and our collaboration partners’ abilities to manufacture our product candidates and scale production, and (xviii) our ability to meet any specific milestones set forth herein. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. For further information regarding the risks, uncertainties and other factors that may cause differences between SpringWorks’ expectations and actual results, you should review the “Risk Factors” in Item 1A of Part II of SpringWorks’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as well as discussions of potential risks, uncertainties and other important factors in SpringWorks’ subsequent filings. SpringWorks Therapeutics, Inc.Condensed Consolidated Statements of Operations(Unaudited) ​Three Months Ended September 30, Nine Months Ended September 30,(in thousands, except share and per-share data) 2024 2023 2024 2023 Revenue: Product revenue, net$49,301 $— $110,493 $— Other revenue (1) — — 19,547 — Total revenue 49,301 — 130,040 — Operating costs and expenses: Cost of product revenue 3,341 — 6,996 — Selling, general and administrative 61,601 46,546 179,553 137,715 Research and development 42,296 37,453 140,280 106,835 Total operating costs and expenses 107,238 83,999 326,829 244,550 ​ Loss from operations (57,937) (83,999) (196,789) (244,550)Interest and other income: Interest and other income, net 6,216 5,586 20,565 16,971 Total interest and other income 6,216 5,586 20,565 16,971 Equity method investment loss (1,809) (1,024) (4,610) (3,203)Net loss$(53,530) $(79,437) $(180,834) $(230,782)​ Net loss per share, basic and diluted$(0.72) $(1.27) $(2.44) $(3.70)Weighted average common shares outstanding, basic and diluted 74,264,501 62,521,772 74,052,151 62,386,496 (1) Related to recognition of all previously deferred revenue associated with the GSK License Agreement following notice of termination of the agreement received from GSK, as announced in June 2024. SpringWorks Therapeutics, Inc.Selected Balance Sheet Data(Unaudited) September 30, 2024 December 31, 2023(in thousands) Cash, cash equivalents and marketable securities$498,123 $662,588 Working Capital (1) 364,498 422,742 Total assets 608,878 725,788 Total liabilities 76,297 99,569 Accumulated deficit (1,075,868) (895,034)Total stockholders’ equity 532,581 626,219 (1) We define Working Capital as current assets less current liabilities.Contacts: Investorsinvestors@springworkstx.com Mediamedia@springworkstx.com

- 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 $360.1 million at Q3 2024 - CARLSBAD, Calif., Nov. 7, 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 reported financial results for the quarter ended September 30, 2024, and highlighted recent corporate progress. "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), with 100% 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 Previo Usly 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 $24.0 million compared to $21.2 million for the same period in 2023. Third quarter 2024 research and development expenses were $22.7 million compared to $19.3 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. Third quarter 2024 general and administrative expenses were $5.9 million compared to $4.7 million for the same period in 2023. The increase was primarily driven by increased personnel-related costs, including stock-based compensation. As of September 30, 2024, TYRA had cash, cash equivalents, and marketable securities of $360.1 million. The Company's current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans through at least 2026. 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 Previo Usly 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 Carlsbad, CA. For more information about our science, pipeline and people, please visit 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 the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; we may use our capital resources sooner than we expect; unstable market and economic conditions and military conflict may adversely affect our business and financial condition and the broader economy and biotechnology industry; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Amy Conrad [email protected] SOURCE Tyra Biosciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED