Core Viewpoint - Tyra Biosciences, Inc. (TYRA) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates and potential stock price increase [1][2][3]. Earnings Estimates and Rating Upgrade - The recent upgrade reflects an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][2]. - Over the past three months, the Zacks Consensus Estimate for Tyra Biosciences has increased by 12.6% [5]. - The upgrade positions Tyra Biosciences in the top 20% of Zacks-covered stocks based on estimate revisions, suggesting potential for stock price appreciation in the near term [15]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [4]. - The Zacks rating system maintains a balanced distribution of 'buy' and 'sell' ratings, ensuring that only the top 20% of stocks are rated favorably, which indicates superior earnings estimate revisions [10]. Earnings Outlook - For the fiscal year ending December 2024, Tyra Biosciences is expected to report earnings of -$1.71 per share, reflecting a change of -5.6% from the previous year [9].

TD Cowen's 5th Annual Oncology Innovation Summit: Insights for ASCO & EHA, May 28-29, 2024: Todd Harris, CEO of TYRA, will participate in a fireside chat on Tuesday, May 28, 2024, at 1:00 pm ET. Jefferies Global Healthcare Conference, June 5-6, 2024: TYRA management will participate in one- on-one meetings with investors during the conference. 45th Annual Goldman Sachs Global Healthcare Conference, June 10-13, 2024: Todd Harris, CEO of TYRA, will present on Wednesday, June 12, 2024, at 8:40 am ET. TYRA mana ...

Financial Performance - The company reported net losses of $18.2 million for Q1 2024, compared to $11.9 million for Q1 2023, with an accumulated deficit of $183.0 million as of March 31, 2024[76]. - Net loss for Q1 2024 was $18.2 million compared to a net loss of $11.9 million in Q1 2023, reflecting an increase in loss of 53.5%[88]. - Other income increased to $4.1 million in Q1 2024 from $2.5 million in Q1 2023, a growth of 64.0%[94]. - Total operating expenses for Q1 2024 were $22.3 million, compared to $14.3 million in Q1 2023, marking an increase of 55.8%[88]. Cash and Financing - Cash, cash equivalents, and marketable securities totaled $382.5 million as of March 31, 2024, expected to fund operations through at least 2026[80]. - Net cash used in operating activities was $22.0 million in Q1 2024, up from $9.8 million in Q1 2023, representing an increase of 124.5%[102]. - Net cash provided by financing activities was $200.3 million in Q1 2024, significantly higher than $0.4 million in Q1 2023[106]. - The company completed a private placement in February 2024, raising approximately $200 million from the sale of 9,286,023 shares of common stock and warrants[77]. - The company completed a private placement in February 2024, raising approximately $200 million before expenses[96]. - Future capital requirements will depend on various factors, including the ability to generate product revenues and the costs associated with clinical trials[110]. Research and Development - Research and development expenses are expected to increase significantly as the company advances its product candidates through clinical trials[83]. - Research and development expenses increased to $17.2 million in Q1 2024 from $10.4 million in Q1 2023, a rise of 65.2%[89]. - The lead product candidate, TYRA-300, is in a Phase 1 clinical trial (SURF301) for FGFR3+ advanced solid tumors, with initial results expected in the second half of 2024[71]. - TYRA-300 showed significant preclinical results in achondroplasia, increasing body length in mice by 17.9% and femur length by 22.6%[72]. - The company plans to submit an IND application for TYRA-300 for achondroplasia in the second half of 2024, focusing on safety and tolerability in children[73]. - The second product candidate, TYRA-200, is in a Phase 1 clinical study (SURF201) targeting FGFR2+ cholangiocarcinoma and other advanced solid tumors[74]. General and Administrative Expenses - General and administrative expenses are anticipated to rise due to increased research and development activities and costs associated with being a public company[87]. - General and administrative expenses rose to $5.1 million in Q1 2024 from $3.9 million in Q1 2023, an increase of 30.8%[93].

CARLSBAD, Calif., May 9, 2024 – 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 March 31, 2024, and highlighted recent corporate progress. Exhibit 99.1 Tyra Biosciences Reports First Quarter 2024 Financial Results and Highlights - TYRA-300 on track in ACH and oncology; SURF301 Ph1 in ...

PART I [Business](index=4&type=section&id=Item%201.%20Business) Tyra Biosciences develops precision medicines for FGFR-driven cancers and genetic conditions using its proprietary SNÅP platform [Overview](index=4&type=section&id=Overview) - Tyra Biosciences is a clinical-stage biotechnology company using its proprietary SNÅP platform to develop precision medicines targeting Fibroblast Growth Factor Receptor (FGFR) biology for oncology and genetically defined conditions[14](index=14&type=chunk) - Lead product candidate, TYRA-300, is an oral, FGFR3-selective inhibitor being evaluated in the SURF301 Phase 1 study for advanced solid tumors with FGFR3 gene alterations. The study has completed dose escalation without reaching a **maximum tolerated dose (MTD)**[16](index=16&type=chunk) - TYRA-300 is also being developed for achondroplasia (ACH), the most common form of dwarfism. The FDA has granted it **Orphan Drug Designation (ODD)** and **Rare Pediatric Disease (RPD) Designation** for this indication, with an IND submission planned for the **second half of 2024**[17](index=17&type=chunk)[18](index=18&type=chunk) - Second product candidate, TYRA-200, is an oral, FGFR1/2/3 inhibitor being evaluated in the SURF201 Phase 1 study for cholangiocarcinoma and other advanced solid tumors with FGFR2 alterations and resistance mutations[20](index=20&type=chunk) [Our SNÅP Platform](index=5&type=section&id=Our%20SN%C3%85P%20Platform) - The proprietary SNÅP platform is designed to rapidly and precisely design drugs by generating molecular "SNÅPshots" that predict genetic alterations causing acquired resistance[14](index=14&type=chunk)[21](index=21&type=chunk) - The platform is built on three key pillars that provide iterative data concurrently: - **Protein crystallography:** Generates co-crystal structures in as little as three days - **Cell-based assays:** Assesses inhibitor potency and cell penetration in as little as two days - **In vivo models:** Provides bioavailability, PK, and anti-tumor activity data in as little as five days[22](index=22&type=chunk)[23](index=23&type=chunk) [Our Programs](index=6&type=section&id=Our%20Programs) Development Pipeline Overview | Indication Category | Program | Annual US Addressable Patients | Development Stage | Anticipated Milestone | | :--- | :--- | :--- | :--- | :--- | | **Genetic Conditions** | | | | | | FGFR3 ACH | TYRA-300 | ~3K | IND-Enabling | Submit IND 2H '24 | | **Oncology** | | | | | | FGFR3 ONC | TYRA-300 | ~40K | Phase 1 (SURF301) | Ph1 data in 2H '24 | | FGFR2 ONC | TYRA-200 | ~5.5K | Phase 1 (SURF201) | Complete Ph1 | | FGFR4/3 ONC | TYRA-430 | ~9K | IND-Enabling | Complete IND-enabling | - TYRA-300 is designed as a selective FGFR3 inhibitor to treat metastatic urothelial carcinoma (mUC) by addressing gatekeeper resistance mutations (e.g., V555M) and minimizing off-target toxicities associated with pan-FGFR inhibitors[27](index=27&type=chunk)[28](index=28&type=chunk) - TYRA-200 is an FGFR1/2/3 inhibitor with potency against activating FGFR2 alterations and key resistance mutations, initially targeting intrahepatic cholangiocarcinoma (ICC)[35](index=35&type=chunk) - TYRA-430 is being developed to address cancers driven by the FGF19/FGFR4 axis, initially focusing on hepatocellular carcinoma (HCC), with a design intended to also inhibit FGFR3 to address bypass mechanisms[37](index=37&type=chunk) [Our Strategy](index=8&type=section&id=Our%20Strategy) - Advance next-generation precision medicines through clinical development, focusing on overcoming acquired resistance and off-target toxicities of existing FGFR inhibitors[38](index=38&type=chunk) - Utilize the SNÅP platform to rapidly expand the pipeline with additional therapies for oncology and genetically-defined conditions[41](index=41&type=chunk) - Leverage recent advances in precision medicine, such as the potential for expedited regulatory pathways, to accelerate product development[41](index=41&type=chunk) - Maximize product candidate value across multiple therapeutic areas by retaining worldwide rights and considering strategic partnerships opportunistically[40](index=40&type=chunk) [Intellectual Property](index=39&type=section&id=Intellectual%20Property) - As of March 15, 2024, the company's IP portfolio, which is solely owned, includes **6 pending U.S. provisional applications**, **5 pending U.S. nonprovisional applications**, **46 pending foreign applications**, and **6 PCT applications**. The company does not own any issued patents[181](index=181&type=chunk) - For the FGFR3 program (including TYRA-300), the company owns **3 pending U.S. provisional**, **2 pending U.S. nonprovisional**, **3 pending PCT**, and **30 pending foreign applications**. Any resulting patents are expected to expire between **2040 and 2045**[184](index=184&type=chunk) - For the FGFR2 program (including TYRA-200), the company owns **2 pending U.S. provisional**, **2 pending U.S. nonprovisional**, and **14 pending foreign applications**. Any resulting patents are expected to expire between **2040 and 2042**[185](index=185&type=chunk) [Government Regulation](index=43&type=section&id=Government%20Regulation) - The company's products are subject to extensive regulation by the FDA in the U.S. and comparable authorities in other countries, covering research, development, testing, manufacturing, approval, and marketing[200](index=200&type=chunk) - The U.S. drug development process involves preclinical studies, submitting an Investigational New Drug (IND) application, conducting Phase 1, 2, and 3 clinical trials under Good Clinical Practices (GCPs), and submitting a New Drug Application (NDA) for FDA review and approval[201](index=201&type=chunk)[203](index=203&type=chunk) - The FDA offers expedited programs like Fast Track, Breakthrough Therapy, priority review, and accelerated approval for qualifying product candidates intended for serious conditions, which can potentially speed up the development and review process[220](index=220&type=chunk)[223](index=223&type=chunk)[225](index=225&type=chunk) - The company is also subject to foreign regulations, including the EU's Clinical Trials Regulation (CTR) for clinical studies and the centralized or national procedures for obtaining Marketing Authorization (MA) from the European Medicines Agency (EMA) or member state authorities[265](index=265&type=chunk)[270](index=270&type=chunk)[274](index=274&type=chunk) [Human Capital](index=57&type=section&id=Human%20Capital) - As of March 18, 2024, the company had **49 full-time employees**, with **37 engaged in research and development**. This includes **16 employees with M.D. or Ph.D. degrees**[289](index=289&type=chunk) - None of the employees are represented by labor unions or covered by collective bargaining agreements. The company considers its employee relations to be good[289](index=289&type=chunk) [Risk Factors](index=59&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks from its early development stage, funding needs, third-party reliance, competition, and IP protection challenges - **Financial Risks:** The company has a limited operating history, has incurred significant net losses since inception (**$69.1 million in 2023**), and expects to continue incurring losses. It will require substantial additional financing to fund operations, and failure to obtain it could force delays or termination of programs[299](index=299&type=chunk)[302](index=302&type=chunk)[305](index=305&type=chunk) - **Development and Regulatory Risks:** The company is early in its development efforts with only two candidates in Phase 1 trials. Preclinical and clinical development is a lengthy, expensive, and uncertain process. Difficulties in patient enrollment or unexpected adverse events could delay or halt trials[298](index=298&type=chunk)[315](index=315&type=chunk)[319](index=319&type=chunk) - **Reliance on Third Parties:** The company relies on third parties for manufacturing its product candidates and conducting clinical trials. This dependency increases risks related to supply sufficiency, cost, quality control (cGMP compliance), and adherence to timelines and protocols[300](index=300&type=chunk)[396](index=396&type=chunk)[409](index=409&type=chunk) - **Commercial and Market Risks:** The company faces significant competition from larger, better-funded companies. The commercial success of its products, if approved, will depend on market acceptance, pricing, and reimbursement from payors. Market opportunities may also be smaller than estimated[300](index=300&type=chunk)[421](index=421&type=chunk)[434](index=434&type=chunk) - **Intellectual Property Risks:** The company's success depends on obtaining and maintaining patent protection. The patent process is uncertain, and the company may not be able to protect its technology from competitors. The company currently does not own any issued patents[300](index=300&type=chunk)[501](index=501&type=chunk)[509](index=509&type=chunk) [Unresolved Staff Comments](index=122&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[597](index=597&type=chunk) [Cybersecurity](index=124&type=section&id=Item%201C.%20Cybersecurity) The company's cybersecurity risk management program, based on the NIST framework, is overseen by the audit committee, with management handling day-to-day threats - The company has a cybersecurity risk management program guided by the **National Institute of Standards and Technology Cybersecurity Framework (NIST CSF)**[600](index=600&type=chunk) - Oversight is provided by the board of directors, which has delegated the function to the audit committee. The committee receives periodic reports from management[603](index=603&type=chunk)[605](index=605&type=chunk) - A management team including the CFO, General Counsel, and IT Senior Director is responsible for assessing and managing cybersecurity risks[606](index=606&type=chunk) - The company has not identified any risks from cybersecurity threats that have materially affected or are reasonably likely to materially affect its business, operations, or financial condition[602](index=602&type=chunk) [Properties](index=125&type=section&id=Item%202.%20Properties) The company leases approximately 13,065 square feet of laboratory and office space in Carlsbad, California for its corporate headquarters - The company leases approximately **13,065 square feet** of laboratory and office space in Carlsbad, California for its corporate headquarters[608](index=608&type=chunk) - The lease for the combined space commenced in **November 2023** and has a term of **120 months (10 years)**[608](index=608&type=chunk) [Legal Proceedings](index=125&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently subject to any material legal proceedings[610](index=610&type=chunk) [Mine Safety Disclosures](index=125&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable[611](index=611&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=126&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq, has never paid dividends, and used **$112.4 million** of IPO proceeds for operations by year-end 2023 - The company's common stock is traded on the **Nasdaq Global Select Market** under the ticker symbol **"TYRA"**[614](index=614&type=chunk) - The company has never declared or paid cash dividends and intends to retain future earnings to finance business operations[616](index=616&type=chunk) - The September 2021 IPO generated net proceeds of approximately **$181.2 million**. As of December 31, 2023, approximately **$112.4 million** of these proceeds have been used for general corporate purposes and to fund development programs[620](index=620&type=chunk)[621](index=621&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=128&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Net loss increased to **$69.1 million** in 2023 due to higher R&D expenses; **$203.5 million** cash at year-end, plus a **$200 million** PIPE, is expected to fund operations through 2026 [Results of Operations](index=132&type=section&id=Results%20of%20Operations) Results of Operations (in thousands) | | Year Ended December 31, 2023 | Year Ended December 31, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $62,518 | $43,008 | $19,510 | | General and administrative | $17,427 | $15,919 | $1,508 | | **Total operating expenses** | **$79,945** | **$58,927** | **$21,018** | | Loss from operations | $(79,945) | $(58,927) | $(21,018) | | Interest income | $10,850 | $3,652 | $7,198 | | **Net loss** | **$(69,134)** | **$(55,325)** | **$(13,809)** | - Research and development expenses increased by **$19.5 million** in 2023 compared to 2022, primarily due to a **$13.7 million** increase in CRO and drug manufacturing costs for ongoing and planned clinical trials, and a **$4.0 million** increase in personnel costs[648](index=648&type=chunk) - General and administrative expenses increased by **$1.5 million** in 2023, mainly due to a **$1.0 million** increase in professional services costs and a **$0.9 million** increase in personnel costs[651](index=651&type=chunk) [Liquidity and Capital Resources](index=133&type=section&id=Liquidity%20and%20Capital%20Resources) - As of December 31, 2023, the company had cash, cash equivalents, and marketable securities of **$203.5 million**[633](index=633&type=chunk) - In February 2024, the company completed a private placement (PIPE) for gross proceeds of approximately **$200 million**[634](index=634&type=chunk) - Management believes that existing cash combined with the 2024 PIPE proceeds will be sufficient to fund operations and capital expenditures through at least **2026**[636](index=636&type=chunk) Summary of Cash Flows (in thousands) | | Year Ended December 31, 2023 | Year Ended December 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(50,139) | $(50,285) | | Net cash used in investing activities | $(144,605) | $(559) | | Net cash provided by financing activities | $1,537 | $632 | [Quantitative and Qualitative Disclosures About Market Risk](index=137&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces immaterial market risks from interest rate fluctuations on short-term investments and foreign currency exchange, with inflation having no material effect - **Interest Rate Risk:** The company's portfolio of cash, cash equivalents, and marketable securities is exposed to interest rate changes. However, due to the short-term nature of these investments, a hypothetical **10% change** in interest rates would not have a material impact[680](index=680&type=chunk) - **Foreign Currency Exchange Risk:** The company has limited exposure as most expenses are denominated in U.S. dollars. A hypothetical **10% change** in exchange rates would not have had a material impact[681](index=681&type=chunk) - **Inflation:** The company does not believe inflation has had a material effect on its financial results[682](index=682&type=chunk) [Financial Statements and Supplementary Data](index=138&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited financial statements show a net loss of **$69.1 million** in 2023, with total assets decreasing to **$225.9 million**, and an unqualified opinion from Ernst & Young LLP Key Balance Sheet Data (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $203,469 | $251,213 | | Total current assets | $211,671 | $257,288 | | Total assets | $225,857 | $266,181 | | Total current liabilities | $15,333 | $5,701 | | Total liabilities | $21,595 | $8,352 | | Total stockholders' equity | $204,262 | $257,829 | Key Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development expense | $62,518 | $43,008 | | General and administrative expense | $17,427 | $15,919 | | Loss from operations | $(79,945) | $(58,927) | | Net loss | $(69,134) | $(55,325) | | Net loss per share, basic and diluted | $(1.62) | $(1.32) | - The independent registered public accounting firm, Ernst & Young LLP, issued an **unqualified opinion** on the financial statements[686](index=686&type=chunk) - Subsequent to year-end, in February 2024, the company closed a private placement (PIPE) for gross proceeds of approximately **$200 million**[799](index=799&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=161&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[800](index=800&type=chunk) [Controls and Procedures](index=161&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023 - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2023[802](index=802&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2023[803](index=803&type=chunk) - No changes in internal control over financial reporting occurred during the fourth quarter of 2023 that materially affected, or are reasonably likely to materially affect, internal controls[805](index=805&type=chunk) [Other Information](index=162&type=section&id=Item%209B.%20Other%20Information) No officers or directors adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q4 2023 - During the three months ended December 31, 2023, no officers or directors adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements[807](index=807&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=162&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item is incorporated by reference from the company's definitive proxy statement for the 2024 Annual Meeting of Stockholders - The required information is incorporated by reference from the company's definitive proxy statement for the 2024 annual meeting of stockholders[810](index=810&type=chunk) [Executive Compensation](index=162&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's definitive proxy statement for the 2024 Annual Meeting of Stockholders - The required information is incorporated by reference from the company's definitive proxy statement for the 2024 annual meeting of stockholders[812](index=812&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=162&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership is incorporated by reference from the company's definitive proxy statement for the 2024 Annual Meeting of Stockholders - The required information is incorporated by reference from the company's definitive proxy statement for the 2024 annual meeting of stockholders[813](index=813&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=163&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding related party transactions and director independence is incorporated by reference from the company's definitive proxy statement for the 2024 Annual Meeting of Stockholders - The required information is incorporated by reference from the company's definitive proxy statement for the 2024 annual meeting of stockholders[815](index=815&type=chunk) [Principal Accounting Fees and Services](index=163&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the company's definitive proxy statement for the 2024 Annual Meeting of Stockholders - The required information is incorporated by reference from the company's definitive proxy statement for the 2024 annual meeting of stockholders[816](index=816&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=163&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) Financial statements are in Part II, Item 8, with schedules omitted as not applicable, and a list of exhibits is referenced - The financial statements are included in Part II, Item 8 of the Annual Report[818](index=818&type=chunk) - All financial statement schedules have been omitted because they are not applicable or the required information is otherwise provided[819](index=819&type=chunk) [Form 10-K Summary](index=163&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has not provided a summary for Form 10-K - None[821](index=821&type=chunk)

Exhibit 99.1 Tyra Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights - Advanced SURF301 Phase 1 oncology study; Initial Phase 1 results to be reported in 2H 2024 - - TYRA-300 Phase 2 ACH IND submission on track for 2H 2024 - - Initiated SURF201 Phase 1 study and dosed first patient with TYRA-200 - - Strengthened balance sheet with approximately $200 million PIPE in Q1 2024; pro-forma cash, cash equivalents, and marketable securities of approximately $403.5 million - CARLS ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR For the transition period from _________ to _________. Commission File Number: 001-40800 TYRA BIOSCIENCES, INC. (Exact Name of Registrant as Specified in its Charter) | Delaware | 83-1476348 | | --- | --- | | (State or other jurisdiction of incorporation or organization) | (I.R ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________. Commission File Number: 001-40800 TYRA BIOSCIENCES, INC. (Exact Name of Registrant as Specified in its Charter) | Delaware | 83-1476348 | ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________. Commission File Number: 001-40800 TYRA BIOSCIENCES, INC. (Exact Name of Registrant as Specified in its Charter) | Delaware | 83-1476348 ...

PART I [Business](index=4&type=section&id=Item%201.%20Business) Tyra Biosciences develops precision medicines for oncology and genetic conditions, advancing TYRA-300 and TYRA-200 via its SNÅP platform - Tyra Biosciences is a clinical-stage biotechnology company focused on developing **precision medicines** targeting **Fibroblast Growth Factor Receptor (FGFR) biology** for oncology and genetically defined conditions[14](index=14&type=chunk) - The company's proprietary **SNÅP platform** enables rapid and precise drug design to address **acquired resistance** to existing therapies[15](index=15&type=chunk)[19](index=19&type=chunk) - Lead product candidate **TYRA-300**, an **FGFR3 selective inhibitor**, is in a **Phase 1/2 clinical trial** (SURF301) for metastatic urothelial carcinoma (mUC), with the first patient dosed in November 2022[16](index=16&type=chunk) - TYRA-300 development is expanding into **achondroplasia**, with plans to submit an IND for a **Phase 2 study in pediatric patients in 2024**[17](index=17&type=chunk) - Second product candidate **TYRA-200**, an **FGFR1/2/3 inhibitor**, received **IND clearance** in January 2023 for a **Phase 1 trial** in intrahepatic cholangiocarcinoma, with the first patient expected to be dosed in the second half of 2023[18](index=18&type=chunk) [Our SNÅP Platform](index=4&type=section&id=Our%20SN%C3%85P%20Platform) - The **SNÅP platform** is designed to efficiently identify and target vulnerabilities in mutant proteins that cause **acquired drug resistance**[19](index=19&type=chunk)[56](index=56&type=chunk) - The platform is built on **three key pillars** that provide iterative data rapidly and concurrently: protein crystallography, cell-based assays, and in vivo models[22](index=22&type=chunk)[23](index=23&type=chunk) - Proprietary **protein crystallography** techniques can generate co-crystal structures of compounds in target proteins in as little as **three days**, enabling rapid structural insights[26](index=26&type=chunk)[57](index=57&type=chunk) - The company utilizes custom **cell-based assays** to assess inhibitor potency, cell penetration, and target-specific cell killing, generating data in as little as **two days**[26](index=26&type=chunk)[60](index=60&type=chunk) - In-house **animal models** provide bioavailability, pharmacokinetic data, and anti-tumor activity in as little as **five days**, completing the rapid, iterative drug design cycle[26](index=26&type=chunk)[61](index=61&type=chunk) [Our Programs](index=6&type=section&id=Our%20Programs) Pipeline Overview | Program | Target | Lead Indication(s) | Development Stage | | :--- | :--- | :--- | :--- | | **TYRA-300** | FGFR3 | Metastatic Urothelial Carcinoma (mUC) | Phase 1/2 Clinical Trial (SURF301) | | **TYRA-300** | FGFR3 | Achondroplasia (ACH) | Preclinical / IND-enabling | | **TYRA-200** | FGFR1/2/3 | Intrahepatic Cholangiocarcinoma (ICC) | Phase 1 Clinical Trial (IND cleared) | | **FGFR4/FGF19 Program** | FGFR4/FGF19 | Hepatocellular Carcinoma (HCC) | Discovery | | **RET Program** | RET | RET-related cancers | Discovery | - **TYRA-300** is designed to be a **selective FGFR3 inhibitor** that overcomes **gatekeeper resistance mutations** (e.g., V555M) and minimizes off-target toxicities associated with pan-FGFR inhibitors[28](index=28&type=chunk)[29](index=29&type=chunk) - **TYRA-200** is an **FGFR1/2/3 inhibitor** designed to be potent against activating **FGFR2 alterations** and key **resistance mutations** (molecular brake and gatekeeper) that emerge during treatment with other FGFR inhibitors[34](index=34&type=chunk) - The **FGFR4/FGF19 program** is focused on **hepatocellular carcinoma (HCC)** and aims to address bypass mechanisms and **acquired resistance mutations** that limited previous FGFR4 inhibitors[35](index=35&type=chunk) - The **RET program** is focused on overcoming **acquired drug resistance mutations** (e.g., G810 solvent front) observed in response to existing RET inhibitors like selpercatinib and pralsetinib[36](index=36&type=chunk)[171](index=171&type=chunk) [Competition](index=38&type=section&id=Competition) - The company faces **intense competition** from major pharmaceutical and biotechnology companies with **greater financial resources** and experience[175](index=175&type=chunk)[176](index=176&type=chunk) - Key competitors in the **FGFR inhibitor space** for oncology include **Janssen** (Balversa), **Incyte** (Pemazyre), **Taiho Oncology** (Lytgobi), **Relay Therapeutics** (RLY-4008), and **Kinnate Biopharma** (KIN-3248)[178](index=178&type=chunk)[182](index=182&type=chunk) - In **achondroplasia**, competitors include **BioMarin Pharmaceutical** (Voxzogo), **BridgeBio Pharma** (infigratinib), and **Ascendis Pharma** (TransCon CNP)[183](index=183&type=chunk) - In the **RET inhibitor space**, competitors include **Lilly's Loxo Oncology** (Retevmo) and **Blueprint Medicines** (Gavreto)[185](index=185&type=chunk) [Intellectual Property](index=39&type=section&id=Intellectual%20Property) - As of March 15, 2023, the company's IP portfolio consists of **eight pending U.S. provisional applications**, **two pending U.S. nonprovisional applications**, and **three PCT applications**, all solely owned, and the company **does not own any issued patents**[187](index=187&type=chunk) - For the **FGFR3 program** (including TYRA-300), the company owns **one pending PCT application** and other filings, with any patents issued expected to **expire between 2040 and 2043**[191](index=191&type=chunk) - For the **FGFR2 program** (including TYRA-200), the company owns **one pending PCT application** and other filings, with any patents issued expected to **expire between 2040 and 2042**[192](index=192&type=chunk) - The company also relies on **trade secret protection** for its confidential and proprietary information, including its **SNÅP platform**, and uses confidentiality agreements with employees, consultants, and collaborators[199](index=199&type=chunk) [Government Regulation](index=42&type=section&id=Government%20Regulation) - The company's operations are **extensively regulated by the FDA** in the United States and comparable authorities in other countries, covering research, development, testing, manufacturing, and marketing[205](index=205&type=chunk) - The U.S. drug development process involves **preclinical studies**, submitting an **Investigational New Drug (IND) application**, and conducting **Phase 1, 2, and 3 clinical trials** under Good Clinical Practices (GCPs)[207](index=207&type=chunk)[213](index=213&type=chunk) - The FDA offers **expedited programs** like **Fast Track**, **Breakthrough Therapy**, **priority review**, and **accelerated approval** for qualifying product candidates intended for serious conditions[227](index=227&type=chunk)[228](index=228&type=chunk)[231](index=231&type=chunk) - In the **European Union**, clinical trials are now governed by the **Clinical Trials Regulation (CTR)**, which harmonizes the assessment and supervision processes via a centralized portal[275](index=275&type=chunk) - The company is also subject to **healthcare laws** concerning **fraud and abuse** (e.g., Anti-Kickback Statute), **pricing transparency** (e.g., Sunshine Act), and **data privacy** (e.g., GDPR, CCPA)[254](index=254&type=chunk)[294](index=294&type=chunk) [Human Capital](index=57&type=section&id=Human%20Capital) - As of March 20, 2023, the company had **38 full-time employees**, with **28 engaged in research and development**[295](index=295&type=chunk) - The company's human capital objectives include identifying, recruiting, retaining, and incentivizing employees through **stock-based compensation** and **competitive benefits**[296](index=296&type=chunk) [Risk Factors](index=58&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from early development, clinical trial uncertainties, capital needs, third-party reliance, and regulatory complexities - The company is in the **early stages of development** with a **limited operating history**, **no approved products**, and a history of **significant net losses**, making future success difficult to evaluate[303](index=303&type=chunk)[306](index=306&type=chunk) - **Substantial additional financing is required** to achieve goals, and failure to obtain capital could force delays or termination of development programs[309](index=309&type=chunk) - Preclinical and clinical development is a **lengthy, expensive process with an uncertain outcome**, and the company's **SNÅP platform is novel and unproven** and may not lead to approved products[323](index=323&type=chunk)[339](index=339&type=chunk) - The company **relies on third parties for manufacturing and conducting clinical trials**, which increases risks related to supply, cost, quality, and timelines[394](index=394&type=chunk)[407](index=407&type=chunk) - The company faces **significant competition** from better-funded companies and must **obtain and maintain patent protection** for its product candidates, which is uncertain[431](index=431&type=chunk)[497](index=497&type=chunk) [Properties](index=122&type=section&id=Item%202.%20Properties) The company's Carlsbad headquarters occupies 4,734 sq ft, with an additional 7,377 sq ft expansion expected in late 2023 - The company leases approximately **4,734 square feet** of laboratory and office space for its headquarters in Carlsbad, California[588](index=588&type=chunk) - An expansion is underway to lease an **additional 7,377 square feet** in an adjacent building, with the new lease expected to commence in the **second half of 2023**[588](index=588&type=chunk) [Legal Proceedings](index=123&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings, though minor matters may arise in the ordinary course of business - The company is **not currently a party to any material legal proceedings**[591](index=591&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=123&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under 'TYRA', has never paid dividends, and used $61.5 million of its $181.2 million IPO proceeds - The company's common stock is traded on the **Nasdaq Global Select Market** under the ticker symbol "**TYRA**"[594](index=594&type=chunk) - The company has **never declared or paid cash dividends** and intends to retain future earnings to finance business operations[596](index=596&type=chunk) - The company received net proceeds of approximately **$181.2 million** from its IPO in September 2021[600](index=600&type=chunk)[601](index=601&type=chunk) - As of December 31, 2022, approximately **$61.5 million** of the IPO proceeds have been used to fund the development of TYRA-300, TYRA-200, and other programs[602](index=602&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=125&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Net loss increased to **$55.3 million** in 2022 due to higher R&D and G&A expenses, with **$251.2 million** cash expected to fund operations through 2024 Results of Operations (in thousands) | | Year Ended December 31, | | Change | | :--- | :--- | :--- | :--- | | | **2022** | **2021** | **($)** | | **Operating expenses:** | | | | | Research and development | $43,008 | $20,636 | $22,372 | | General and administrative | $15,919 | $5,652 | $10,267 | | **Total operating expenses** | **$58,927** | **$26,288** | **$32,639** | | **Loss from operations** | **($58,927)** | **($26,288)** | **($32,639)** | | Interest income | $3,652 | $13 | $3,639 | | **Net loss** | **($55,325)** | **($26,294)** | **($29,031)** | - The **$22.4 million increase in R&D expenses** in 2022 was primarily due to a **$15.1 million increase in clinical trial and preclinical study costs** for TYRA-300 and TYRA-200, and a **$7.3 million increase in personnel-related costs**[626](index=626&type=chunk) - The **$10.2 million increase in G&A expenses** in 2022 was driven by a **$6.5 million increase in personnel costs** (including **$4.1 million in stock-based compensation**), a $1.8 million increase in professional services, and a $1.9 million increase in other operating expenses[628](index=628&type=chunk) - As of December 31, 2022, the company had cash and cash equivalents of **$251.2 million** and an accumulated deficit of **$95.7 million**[612](index=612&type=chunk) - Existing cash and cash equivalents are expected to be **sufficient to fund operations and capital expenditures through at least 2024**[614](index=614&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=134&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risks are low for interest rates and foreign currency, with inflation noted as a potential future cost factor - The company's cash and cash equivalents are held in checking accounts and money market funds, making the portfolio's fair value **relatively insensitive to interest rate changes**[655](index=655&type=chunk) - Foreign currency exchange risk is **not considered material** as most expenses are denominated in U.S. dollars, and the company does not have a formal hedging program[656](index=656&type=chunk) - Inflation has **not had a material effect** on financial results but is acknowledged as a factor that generally **increases labor and clinical trial costs**[657](index=657&type=chunk) [Financial Statements and Supplementary Data](index=135&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited financial statements for 2022 and 2021 show total assets of **$266.2 million**, a **$55.3 million** net loss, and **$50.3 million** net cash used in operations Balance Sheet Highlights (in thousands) | | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $251,213 | $302,182 | | Total current assets | $257,288 | $304,057 | | **Total assets** | **$266,181** | **$306,701** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $5,701 | $3,616 | | **Total liabilities** | **$8,352** | **$4,964** | | **Total stockholders' equity** | **$257,829** | **$301,737** | Statement of Operations Highlights (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Research and development | $43,008 | $20,636 | | General and administrative | $15,919 | $5,652 | | **Loss from operations** | **($58,927)** | **($26,288)** | | **Net loss** | **($55,325)** | **($26,294)** | | Net loss per share, basic and diluted | ($1.32) | ($1.91) | Cash Flow Highlights (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($50,285) | ($23,745) | | Net cash used in investing activities | ($559) | ($645) | | Net cash provided by financing activities | $632 | $311,348 | [Controls and Procedures](index=157&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2022 - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2022[771](index=771&type=chunk) - Based on an assessment using the COSO framework, management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2022[772](index=772&type=chunk) - **No changes** in internal control over financial reporting occurred during the fourth quarter of 2022 that materially affected, or are reasonably likely to materially affect, internal controls[773](index=773&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=158&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the 2023 proxy statement - Information regarding directors, executive officers, and corporate governance is **incorporated by reference** from the company's definitive proxy statement for the 2023 annual meeting[778](index=778&type=chunk) - The company has adopted a **Code of Business Conduct and Ethics** applicable to all officers, directors, and employees, which is available on its website[779](index=779&type=chunk) [Executive Compensation](index=158&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation details are incorporated by reference from the company's definitive proxy statement for the 2023 Annual Meeting - Details on executive compensation are **incorporated by reference** from the upcoming Definitive Proxy Statement[780](index=780&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=158&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership and equity compensation plan information is incorporated by reference from the 2023 definitive proxy statement - Information on security ownership and equity compensation plans is **incorporated by reference** from the upcoming Definitive Proxy Statement[781](index=781&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=159&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on related party transactions and director independence is incorporated by reference from the 2023 definitive proxy statement - Details on related transactions and director independence are **incorporated by reference** from the upcoming Definitive Proxy Statement[783](index=783&type=chunk) [Principal Accounting Fees and Services](index=159&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information on principal accounting fees and services is incorporated by reference from the 2023 definitive proxy statement - Information on principal accounting fees and services is **incorporated by reference** from the upcoming Definitive Proxy Statement[784](index=784&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=159&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists financial statements and exhibits filed with the 10-K, noting that all financial statement schedules are omitted - This section contains the **financial statements**, notes that **all financial statement schedules are omitted**, and references the **Exhibit Index** for a list of all filed exhibits[786](index=786&type=chunk)[787](index=787&type=chunk)[788](index=788&type=chunk)