Organization and Summary of Significant Accounting Policies | Organization and Summary of Significant Accounting Policies Organization RayzeBio, Inc. (the “Company”) was incorporated in the state of Delaware on January 2, 2020 and is based in San Diego, California. The Company is building a vertically integrated radiopharmaceutical therapeutics (“RPT”) company. Reverse Stock Split On September 7, 2023, the Company effected a 1-for-5.141 reverse stock split of its common stock and the convertible preferred stock. The par value and the authorized shares of the common stock and the convertible preferred stock were not adjusted as a result of the reverse stock split. The accompanying condensed financial statements and notes to the condensed financial statements give retroactive effect to the reverse stock split for all periods presented. Initial Public Offering On September 19, 2023, the Company completed its initial public offering (“IPO”) in which the Company issued and sold 18,706,240 shares of common stock (including 2,591,640 shares of common stock in connection with the full exercise of the underwriters’ option to purchase additional shares) at an offering price to the public of $18.00 per share. Proceeds from the IPO, net of offering costs, were $310.4 million. In connection with the completion of the IPO, all outstanding shares of convertible preferred stock were converted into 35,616,773 shares of common stock. Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 ("JOBS Act"). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has irrevocably elected to avail itself of this exemption from new or revised accounting standards, and therefore, will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. Use of Estimates The Company’s financial statements are prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of the Company’s financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s condensed financial statements and accompanying notes. The most significant estimates in the Company’s condensed financial statements relate to accruals for research and development expenses, stock-based compensation and other fair value measurements. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. Unaudited Interim Financial Information The accompanying condensed balance sheet as of September 30, 2023, the condensed statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, condensed statements of convertible preferred stock and stockholders’ equity (deficit) for the three and nine months ended September 30, 2023 and 2022 and condensed statements of cash flows for the nine months ended September 30, 2023 and 2022 and the related footnote disclosures are unaudited. In management’s opinion, the unaudited interim financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of September 30, 2023 and its results of operations for the three and nine months ended September 30, 2023 and 2022 required by GAAP for complete financial statements. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results expected for the full fiscal year or any other interim period. These unaudited condensed financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2022 included in the Company’s final prospectus dated September 14, 2023 filed with the Securities and Exchange Commission (the "SEC") on September 18, 2023 pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act"). There have been no changes to the significant accounting policies disclosed in Note 1 to the consolidated financial statements for the years ended December 31, 2022 included in the Company’s final prospectus for the IPO filed pursuant to Rule 424(b)(4) under the Securities Actt with the SEC on September 18, 2023. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies that the Company adopt as of the specified effective date. The Company has evaluated recently issued accounting pronouncements and, based on its assessment, does not believe any will have a material impact on its unaudited condensed financial statements or related footnote disclosures. Liquidity and Capital Resources From its inception through September 30, 2023, the Company has devoted substantially all its resources and efforts to building its organization, developing its RPT discovery engine, identifying and developing potential drug candidates, preparing for and executing preclinical studies and clinical trials, acquiring technology, organizing and staffing the Company, business planning, establishing and securing its intellectual property portfolio, raising capital, building out its GMP manufacturing facility and providing general and administrative support for these operations. The Company has incurred net losses and negative cash flows from operations since inception and had an accumulated deficit of $180.1 million as of September 30, 2023. Since inception through September 30, 2023, the Company has funded its operations primarily with the net proceeds from the issuance of its convertible preferred stock and the issuance of common stock from the Company’s IPO. The Company expects to incur substantial operating losses for the next several years and will need to obtain additional financing in order to complete clinical trials and launch and commercialize any drug candidates for which it receives regulatory approval. The Company plans to continue to fund its losses from operations and capital funding needs through public or private equity or debt financings or other sources. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, financial condition, results of operations and prospects. There can be no assurance that such financing will be available or will be at terms acceptable to the Company. As of September 30, 2023, the Company had cash, cash equivalents and short-term investment securities of $540.2 million, which will be sufficient to fund its planned operations for a period of at least 12 months from the issuance date of these condensed financial statements. Fair Value Measurements The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets. Level 2: Inputs, other than the quoted prices in active markets that are observable either directly or indirectly. Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. The carrying value of the Company’s cash, cash equivalents, restricted cash, prepaid and other current assets, accounts payable and accrued liabilities are considered to be representative of their respective fair values due to the short-term nature of those instruments. Financial assets measured at fair value on a recurring basis consist of marketable securities. The fair value of marketable securities is based upon market prices quoted on the last day of the fiscal period or other observable market inputs. The Company obtains pricing information from its investment manager and generally determines the fair value of investment securities using standard observable inputs, including reported trades, broker/dealer quotes, bids and/or offers. The Company has no financial liabilities recorded at fair value on a recurring basis. None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis. No transfers between levels have occurred during the periods presented. The following tables summarize the Company’s financial instruments measured at fair value on a recurring basis (in thousands): Fair Value Measurements at Total Quoted Prices in Significant Significant As of September 30, 2023: Assets: Cash equivalents: Money market funds $ 220,045 $ 220,045 $ — $ — Commercial paper 7,478 — 7,478 — U.S. treasury securities 14,856 14,856 — — Total cash equivalents 242,379 234,901 7,478 — Short-term investments: Commercial paper 47,653 — 47,653 — Corporate debt securities 8,042 — 8,042 — U.S. agency securities 25,233 — 25,233 — U.S. treasury securities 207,277 207,277 — — Total short-term investments 288,205 207,277 80,928 — Total assets measured at fair value on a recurring basis $ 530,584 $ 442,178 $ 88,406 $ — As of December 31, 2022: Assets: Cash equivalents: Money market fund $ 9,691 $ 9,691 $ — $ — Commercial paper 106,042 — 106,042 — Corporate debt securities 7,677 — 7,677 — Total cash equivalents 123,410 9,691 113,719 — Short-term investments: Asset backed securities 105 — 105 — Commercial paper 85,732 — 85,732 — Corporate debt securities 16,661 — 16,661 — U.S. agency securities 15,351 — 15,351 — U.S. treasury securities 49,238 49,238 — — Total short-term investments 167,087 49,238 117,849 — Total assets measured at fair value on a recurring basis $ 290,497 $ 58,929 $ 231,568 $ — Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with original maturities of three months or less when purchased to be cash equivalents. Cash and cash equivalents include cash in readily available checking accounts, money market funds, commercial paper, corporate debt securities and U.S. treasury securities. Restricted cash primarily represents money market accounts held as collateral in connection with the Company’s facility leases and is reported as a long-term asset in the accompanying condensed balance sheets. Cash, cash equivalents and restricted cash presented in the accompanying condensed statements of cash flows consist of the following (in thousands): September 30, 2023 2022 Cash and cash equivalents $ 251,964 $ 215,585 Restricted cash 339 339 Total $ 252,303 $ 215,924 Marketable Securities The Company’s marketable securities primarily consist of money market funds, asset backed securities, commercial paper, corporate debt securities, U.S. agency securities and U.S. treasury securities classified within cash and cash equivalents and short-term investments depending on their maturity at the time of purchase. The Company classifies marketable securities as available-for-sale, as the sale of such investments may be required prior to maturity to implement management strategies, and therefore has classified all marketable securities with maturity dates beyond three months at the date of purchase as current assets in the accompanying condensed balance sheets. As of September 30, 2023, the Company had no intent to sell any marketable securities prior to maturity. Marketable securities classified as available-for-sale are carried at fair value with the unrealized gains and losses included in other comprehensive loss as a component of stockholders’ equity (deficit) until realized. Any premium or discount arising at purchase is amortized and/or accreted to interest income as an adjustment to yield using the straight-line method over the life of the instrument. Realized gains and losses are calculated using the specific identification method and recorded as interest income or expense. The Company segments its portfolio based on the underlying risk profiles of their current securities being held. The Company regularly reviews the securities in an unrealized loss position and evaluates the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, current and expected future economic conditions. The Company has determined there were no material declines in fair values of its marketable securities due to credit-related factors through September 30, 2023. The following tables summarize available-for-sale securities (in thousands): As of September 30, 2023 Maturity Amortized Unrealized Estimated Gains Losses Cash equivalents: Money market funds $ 220,045 $ — $ — $ 220,045 Commercial paper 1 year or less 7,477 1 — 7,478 U.S. treasury securities 1 year or less 14,854 2 — 14,856 Total cash equivalents 242,376 3 — 242,379 Short-term investments: Commercial paper 2 years or less 47,701 — (48) 47,653 Corporate debt securities 2 years or less 8,078 1 (37) 8,042 U.S. agency securities 2 years or less 25,323 — (90) 25,233 U.S. treasury securities 2 years or less 207,492 4 (219) 207,277 Total short-term investments 288,594 5 (394) 288,205 Total $ 530,970 $ 8 $ (394) $ 530,584 As of December 31, 2022 Maturity Amortized Unrealized Estimated Gains Losses Cash equivalents: Money market funds $ 9,691 $ — $ — $ 9,691 Commercial paper 1 year or less 106,014 28 — 106,042 Corporate debt securities 1 year or less 7,677 — — 7,677 Total cash equivalents 123,382 28 — 123,410 Short-term investments: Asset backed securities 2 years or less 105 — — 105 Commercial paper 1 year or less 85,746 33 (47) 85,732 Corporate debt securities 2 years or less 16,699 2 (40) 16,661 U.S. agency securities 2 years or less 15,353 10 (12) 15,351 U.S. treasury securities 2 years or less 49,765 — (527) 49,238 Total short-term investments 167,668 45 (626) 167,087 Total $ 291,050 $ 73 $ (626) $ 290,497 The amortized cost and estimated fair value in the table above excludes $0.7 million and $0.5 million of accrued interest receivable included in prepaid expenses and other current assets in the accompanying condensed balance sheets as of September 30, 2023 and December 31, 2022, respectively. As of September 30, 2023, 47 of the Company’s available-for-sale debt securities with a fair market value of $232.8 million were in a gross unrealized loss position of $0.4 million. Of those, none of the Company’s available-for-sale debt securities were in a continuous loss position for greater than 12 months. As of December 31, 2022, 29 of the Company’s available-for-sale debt securities with a fair market value of $101.6 million were in a gross unrealized loss position of $0.6 million. Of those, 8 of the Company’s available-for-sale debt securities with a fair market value of $34.3 million and a gross unrealized loss position of $0.5 million have been in a continuous loss position for greater than 12 months. The Company considers the decline in market value for the securities to be primarily attributable to current economic conditions and interest rate adjustments, rather than credit-related factors and does not intend to sell any securities prior to maturity. Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, short-term investments and restricted cash. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company is exposed to credit risk in the event of default by the institutions holding its cash, cash equivalents, restricted cash and any marketable securities to the extent of the amounts recorded in the condensed balance sheets. Deferred Offering Costs The Company capitalizes certain legal, accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After the consummation of the equity financing, these costs are recorded in members’ deficit as a reduction of additional paid-in capital or the associated preferred unit account, as applicable. In the event the offering is terminated, all capitalized deferred offering costs, currently recorded within other current assets, will be expensed immediately as a charge to operating expenses in the condensed statement of operations and comprehensive loss. As of September 30, 2023 and December 31, 2022, the Company had no deferred offering costs. Research and Development Costs All costs for research and development are expensed in the period incurred. Research and development costs primarily consist of salaries and related expenses for personnel, stock-based compensation expense, outside service providers, facilities costs, fees paid to consultants and other professional services, external research and development costs incurred under agreements with contract research organizations, license and collaboration fees, supplies used in research and development and facilities, depreciation and other allocated expenses. Payments made prior to the receipt of goods or services to be used in research and development are capitalized until the related goods are delivered or services performed. The Company has entered into various research and development contracts with research organizations and other companies. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and payments made in advance of performance are reflected in the accompanying condensed balance sheets as prepaid expenses and other current assets. The Company records accruals for estimated costs incurred for ongoing research and development activities. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates may be made in determining the prepaid or accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. Historically, there have been no material differences between the Company’s estimates and the amounts actually incurred. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company and its chief operating decision-maker view the Company’s operations and manage its business in one operating segment. Net Loss Per Share Basic net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. The Company has excluded weighted-average unvested shares of 1,275,436 shares and 1,230,860 shares, from the weighted-average number of common shares outstanding for the three months ended September 30, 2023 and 2022, respectively, and 1,143,588 shares and 1,440,400 shares, from the weighted-average number of common shares outstanding for the nine months ended September 30, 2023 and 2022, respectively. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. Dilutive common stock equivalents are comprised of convertible preferred stock, unvested common stock subject to repurchase and options outstanding under the Company’s stock option plans. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities would be anti-dilutive. Potentially dilutive securities not included in the calculation of diluted net loss per share, because to do so would be anti-dilutive, are as follows (in common stock equivalent shares): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Convertible preferred stock outstanding – 35,543,204 – 35,543,204 Common stock options 4,257,580 2,983,404 4,257,580 2,983,404 Unvested common stock 1,221,005 1,129,250 1,221,005 1,129,250 Total 5,478,585 39,655,858 5,478,585 39,655,858 |