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Tyra Biosciences(TYRA) - 2023 Q4 - Annual Results
2024-03-19 20:05
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 ...
Tyra Biosciences(TYRA) - 2023 Q3 - Quarterly Report
2023-11-07 21:16
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 ...
Tyra Biosciences(TYRA) - 2023 Q2 - Quarterly Report
2023-08-10 20:27
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 | ...
Tyra Biosciences(TYRA) - 2023 Q1 - Quarterly Report
2023-05-04 20:16
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 ...
Tyra Biosciences(TYRA) - 2022 Q4 - Annual Report
2023-03-22 20:16
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)
Tyra Biosciences(TYRA) - 2022 Q3 - Quarterly Report
2022-11-03 20:34
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, 2022 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 ...
Tyra Biosciences(TYRA) - 2022 Q2 - Quarterly Report
2022-08-04 20:35
PART I. FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited financial statements for H1 2022 reflect decreased assets, increased liabilities, and significant operating losses from higher R&D and G&A expenses [Balance Sheets](index=3&type=section&id=Balance%20Sheets) As of June 30, 2022, total assets decreased to **$287.1 million**, while liabilities increased and equity decreased, reflecting the period's net loss Balance Sheet Summary (in thousands) | Balance Sheet Items | June 30, 2022 (unaudited) | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $275,107 | $302,182 | | Total current assets | $277,299 | $304,057 | | Total assets | $287,118 | $306,701 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $5,455 | $3,616 | | Total liabilities | $8,265 | $4,964 | | Accumulated deficit | $(70,292) | $(40,371) | | Total stockholders' equity | $278,853 | $301,737 | [Statements of Operations and Comprehensive Loss](index=4&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss significantly increased to **$29.9 million** for H1 2022, driven by substantial rises in research and development and general and administrative expenses Operating Results Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $12,047 | $4,381 | $21,692 | $7,902 | | General and administrative | $3,381 | $1,127 | $8,570 | $1,816 | | Total operating expenses | $15,428 | $5,508 | $30,262 | $9,718 | | Loss from operations | $(15,428) | $(5,508) | $(30,262) | $(9,718) | | Net loss | $(15,095) | $(5,512) | $(29,921) | $(9,721) | | Net loss per share | $(0.36) | $(2.43) | $(0.72) | $(4.54) | [Statements of Cash Flows](index=6&type=section&id=Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to **$26.1 million** for H1 2022, while financing cash flow decreased, resulting in a **$26.3 million** net cash decrease Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(26,093) | $(9,139) | | Net cash used in investing activities | $(490) | $(300) | | Net cash provided by financing activities | $265 | $129,419 | | Net cash (decrease) increase | $(26,318) | $119,980 | [Notes to Financial Statements](index=7&type=section&id=Notes%20to%20Financial%20Statements) Notes detail the company's precision oncology focus, IPO proceeds of **$181.2 million**, management's liquidity assessment, stock-based compensation, and new lease agreements - The company is a precision oncology firm focused on developing therapies to overcome therapy resistance in cancer patients[18](index=18&type=chunk) - Management believes it has sufficient working capital to fund operations through at least the next twelve months from the report's issuance date[24](index=24&type=chunk) - In September 2021, upon completing its IPO, all convertible preferred stock was converted into **26,228,089** shares of common stock[39](index=39&type=chunk) - In March 2022, the company entered into an expansion lease for additional office and laboratory space, with projected lease payments of **$5.5 million** over a **120-month** term starting in Q2 2023[57](index=57&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=14&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's oncology pipeline, including FDA clearance for TYRA-300, significant increases in operating expenses, and liquidity sufficient to fund operations through at least 2024 - The company is a precision oncology company focused on developing therapies to overcome tumor resistance, with lead candidates TYRA-300 (FGFR3 inhibitor) and TYRA-200 (FGFR2 inhibitor)[64](index=64&type=chunk) - An Investigational New Drug (IND) application for TYRA-300 was submitted in June 2022, and the company received FDA clearance in July 2022 to proceed with its Phase 1/2 clinical study (SURF301)[64](index=64&type=chunk) - The company expects to continue incurring significant expenses and operating losses as it advances its product candidates through clinical trials and expands its pipeline[67](index=67&type=chunk)[72](index=72&type=chunk) - Based on the current operating plan, existing cash and cash equivalents of **$275.1 million** are expected to be sufficient to fund operations and capital expenditures through at least 2024[68](index=68&type=chunk)[95](index=95&type=chunk) [Results of Operations](index=17&type=section&id=Results%20of%20Operations) Operating expenses sharply increased for H1 2022, with R&D rising to **$21.7 million** due to program advancement and G&A increasing to **$8.6 million** from higher personnel and public company costs R&D Expenses by Program (Six Months Ended June 30, in thousands) | Program | 2022 | 2021 | | :--- | :--- | :--- | | TYRA-300 | $5,352 | $2,818 | | TYRA-200 | $2,864 | $1,391 | | FGFR3 ACH | $1,392 | $— | | RET | $2,589 | $817 | | FGFR4 | $1,084 | $356 | | Unallocated & Personnel | $7,941 | $2,513 | | **Total R&D Expense** | **$21,692** | **$7,902** | - The increase in R&D expenses for the six months ended June 30, 2022 was primarily due to advancing TYRA-300 and TYRA-200, including **$4.7 million** in higher personnel-related costs (of which **$2.8 million** was non-cash stock-based compensation)[84](index=84&type=chunk) - The increase in G&A expenses for the six months ended June 30, 2022 was mainly due to a **$4.5 million** increase in personnel-related expenses (including **$3.3 million** in non-cash stock-based compensation) and higher professional fees and operating costs[86](index=86&type=chunk) [Liquidity and Capital Resources](index=19&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is primarily from **$181.2 million** IPO proceeds, with **$275.1 million** cash as of June 30, 2022, expected to fund operations through at least 2024, though future capital may be required - The company completed its IPO on September 17, 2021, raising net proceeds of approximately **$181.2 million**[87](index=87&type=chunk) Summary of Cash Flows (Six Months Ended June 30, in thousands) | Category | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(26,093) | $(9,139) | | Net cash used in investing activities | $(490) | $(300) | | Net cash provided by financing activities | $265 | $129,419 | - Future funding requirements will depend on many factors, including the costs and timing of clinical trials, manufacturing, and regulatory reviews[96](index=96&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes to market risk exposures, including interest rate, foreign currency, and inflation risks, have occurred since the 2021 Annual Report disclosures - As of June 30, 2022, there were no material changes to the company's market risk exposures from those discussed in the 2021 Annual Report[102](index=102&type=chunk) [Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2022, with internal control over financial reporting evaluation deferred until year-end 2022 - Management concluded that as of the end of the quarter, the company's disclosure controls and procedures were effective[105](index=105&type=chunk) - As a newly public company, management is not yet required to evaluate the effectiveness of internal control over financial reporting until the Annual Report for the year ending December 31, 2022[106](index=106&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not currently a party to any material legal proceedings[109](index=109&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the company's 2021 Annual Report on Form 10-K - No material changes have occurred to the risk factors disclosed in the 2021 Annual Report[110](index=110&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=23&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred, and the **$181.2 million** net IPO proceeds' planned use remains materially unchanged - The company's IPO in September 2021 generated net proceeds of approximately **$181.2 million** after deducting underwriting discounts and offering costs[112](index=112&type=chunk) - There has been no material change in the planned use of proceeds from the IPO as described in the final prospectus[113](index=113&type=chunk) [Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents and CEO/CFO certifications - The report includes a list of exhibits filed, such as the CEO and CFO certifications required under the Sarbanes-Oxley Act of 2002[118](index=118&type=chunk)
Tyra Biosciences (TYRA) Investor Presentation - Slideshow
2022-05-13 20:44
TYRA 1 Targeting acquired resistance in oncology with purpose-built drugs May 2022 Disclaimers THIS PRESENTATION IS MADE PURSUANT TO SECTION 5(D) OF THE SECURITIES ACT OF 1933, as amended (the "Act"), and is intended solely for investors that are qualified institutional buyers or institutional accredited investors solely for the purposes of familiarizing such investors with Tyra Biosciences, Inc. (the "Company," "Tyra," "we" or "us") and determining whether such investors might have an interest in a securit ...
Tyra Biosciences(TYRA) - 2022 Q1 - Quarterly Report
2022-05-05 20:32
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, 2022 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. (Address of principal executive offices) (Zip Code) Delaware 83-1476348 (I.R.S. ...
Tyra Biosciences (TYRA) Investor Presentation - Slideshow
2022-03-07 18:27
1 Targeting acquired resistance in oncology with purpose-built drugs March 2022 Disclaimers THIS PRESENTATION IS MADE PURSUANT TO SECTION 5(D) OF THE SECURITIES ACT OF 1933, as amended (the "Act"), and is intended solely for investors that are qualified institutional buyers or institutional accredited investors solely for the purposes of familiarizing such investors with Tyra Biosciences, Inc. (the "Company," "Tyra," "we" or "us") and determining whether such investors might have an interest in a securities ...