NEW YORK, June 12, 2024 (GLOBE NEWSWIRE) -- SO WHAT: If you purchased Gritstone securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Be wise in selecting counsel. The Rosen Law ...

NEW YORK, June 11, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Gritstone bio, Inc. ("Gritstone" or the "Company") (NASDAQ: GRTS) in the United States District Court for the Northern District of California on behalf of all persons and entities who purchased or otherwise acquired Gritstone securities between March 9, 2023 and February 29, 2024, both dates inclusive (the "Class Period"). ...

Core Viewpoint - A class action lawsuit has been filed against Gritstone bio, Inc. for allegedly making false and misleading statements regarding its COVID-19 vaccine candidate and its ability to launch the Phase 2b CORAL Study, which has negatively impacted investors [6][9]. Group 1: Lawsuit Details - The lawsuit claims that Gritstone misrepresented its timeline for launching the Phase 2b CORAL Study, which compares its COVID-19 vaccine candidate with an approved vaccine [6]. - It is alleged that Gritstone's inability to launch the study would impair its ability to secure external funding, affecting its financial stability [6]. - The lawsuit asserts that Gritstone overstated its capability to develop and commercialize its products, leading to materially false and misleading public statements [6]. Group 2: Class Action Participation - Investors who purchased Gritstone securities during the Class Period from March 9, 2023, to February 29, 2024, may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [5][9]. - Interested parties can join the class action by submitting a form or contacting the law firm for more information [2][3].

Core Viewpoint - A securities class action lawsuit has been filed against Gritstone bio, Inc. for allegedly making false and misleading statements regarding its Phase 2b CORAL Study and its financial position, impacting investors who purchased securities between March 9, 2023, and February 29, 2024 [1][3]. Group 1 - The lawsuit was filed in the United States District Court for the Northern District of California on behalf of all persons and entities who purchased Gritstone securities during the specified class period [1]. - Investors are encouraged to contact the law firm Gainey McKenna & Egleston before the lead plaintiff motion deadline of August 6, 2024 [2]. - The complaint alleges that Gritstone misrepresented its ability to launch the Phase 2b CORAL Study on time, which would affect its funding and overall financial health [3]. Group 2 - The lawsuit claims that Gritstone overstated its capability to develop and commercialize its products, leading to materially false and misleading public statements [3]. - Investors reportedly suffered damages when the true details about Gritstone's situation became known [3].

NEW YORK, June 11, 2024 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP: Did you purchase your shares between March 9, 2023 and February 29, 2024, inclusive? Did you lose money in your investment in Gritstone bio, Inc.? Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of Gritstone bio, Inc. ("Gritstone" or the "Company") (NASDAQ: GRTS) between March 9, 2023 and February 29, 2024, inclusive (the "Class Period"). ...

Group 1 - Gritstone entered into a contract with BARDA for a 10,000 participant Phase 2b study of its COVID-19 vaccine candidate, expected to launch in Q1 2024 [1] - The company allegedly failed to disclose its inability to launch the study on time, which could impair its ability to secure external funding and maintain its financial position [2] - On February 12, 2024, Gritstone announced a delay of the study launch to Fall 2024, followed by a 40% workforce reduction due to the lack of anticipated external funding [3] Group 2 - A class action was filed on behalf of investors who purchased Gritstone securities between March 9, 2023, and February 29, 2024, alleging misleading information regarding the Phase 2b study [9][10] - Shareholders interested in serving as lead plaintiffs must file motions by August 6, 2024, and can remain absent class members if they choose not to participate [4]

[Click here for information about joining the class action] On February 12, 2024, Gritstone issued a press release announcing that the Company was delaying the launch of the Study until Fall 2024 to purportedly "allow use of fully GMP-grade raw materials in the vaccine, which is expected to increase the regulatory utility of the trial." Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities ...

EMERYVILLE, Calif., June 04, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinicalstage biotechnology company working to develop the world's most potent vaccines, today announced that management will be participating in the following investor and scientific conferences: Goldman Sachs 45th Annual Global Healthcare Conference (Fireside Chat*) Date and Time: Tuesday, June 11, 2024 at 1:20pm ET Location: Miami, FL JonesHealthcare Seaside Summit 2024 (1x1s) Dates: Monday, July 15 - Tuesday, Jul ...

PART I. FINANCIAL INFORMATION This section presents the company's unaudited financial statements and management's analysis of its financial condition and operational results [ITEM 1. FINANCIAL STATEMENTS (unaudited)](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's financial position, performance, liquidity, and significant accounting policies [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20March%2031%2C%202024%20and%20December%2031%2C%202023) This table presents the company's financial position, detailing assets, liabilities, and equity at specific reporting dates Condensed Consolidated Balance Sheets (in thousands) | Item | March 31, 2024 | December 31, 2023 | Change (2024 vs 2023) | | :---------------------------------- | :--------------- | :---------------- | :-------------------- | | Cash and cash equivalents | $42,395 | $62,986 | $(20,591) | | Marketable securities | $3,908 | $16,288 | $(12,380) | | Total current assets | $51,853 | $87,435 | $(35,582) | | Total assets | $137,212 | $177,769 | $(40,557) | | Total current liabilities | $25,870 | $27,339 | $(1,469) | | Total liabilities | $123,248 | $125,919 | $(2,671) | | Total stockholders' equity | $13,964 | $51,850 | $(37,886) | | Accumulated deficit | $(699,946) | $(659,561) | $(40,385) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202024%20and%202023) This table outlines the company's revenues, expenses, and net loss over the reported periods Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Collaboration and license revenues | $49 | $542 | $(493) | | Grant revenues | $1,693 | $1,901 | $(208) | | Total revenues | $1,742 | $2,443 | $(701) | | Research and development expenses | $33,041 | $30,514 | $2,527 | | General and administrative expenses | $8,502 | $6,745 | $1,757 | | Total operating expenses | $41,543 | $37,259 | $4,284 | | Loss from operations | $(39,801) | $(34,816) | $(4,985) | | Interest income | $712 | $1,678 | $(966) | | Interest expense | $(1,296) | $(844) | $(452) | | Net loss | $(40,385) | $(33,982) | $(6,403) | | Net loss per share, basic and diluted | $(0.34) | $(0.30) | $(0.04) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202024%20and%202023) This table details changes in the company's equity components, including common stock, additional paid-in capital, and accumulated deficit Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Item | Balance at Dec 31, 2023 | Net Loss (Q1 2024) | Stock-based Compensation (Q1 2024) | Balance at Mar 31, 2024 | | :---------------------------------- | :---------------------- | :------------------ | :-------------------------------- | :---------------------- | | Common Stock Amount | $22 | — | — | $22 | | Additional Paid-In Capital | $711,386 | — | $3,246 | $713,889 | | Accumulated Deficit | $(659,561) | $(40,385) | — | $(699,946) | | Total Stockholders' Equity | $51,850 | $(40,385) | $3,246 | $13,964 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202024%20and%202023) This table summarizes the company's cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Net cash used in operating activities | $(33,567) | $(40,090) | $6,523 | | Net cash provided by investing activities | $12,303 | $21,173 | $(8,870) | | Net cash (used in) provided by financing activities | $(379) | $8,647 | $(9,026) | | Net decrease in cash, cash equivalents and restricted cash | $(21,643) | $(10,270) | $(11,373) | | Cash, cash equivalents and restricted cash at end of period | $48,932 | $54,495 | $(5,563) | [Notes to Condensed Consolidated Financial Statements (unaudited)](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section provides detailed explanations and disclosures supporting the unaudited condensed consolidated financial statements [Note 1. Organization](index=9&type=section&id=Note%201.%20Organization) This note describes the company's business, operational segment, and significant liquidity challenges, including its going concern status - Gritstone bio, Inc. is a clinical-stage biotechnology company developing vaccines, operating in one segment[20](index=20&type=chunk) Financial Performance and Liquidity (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | As of March 31, 2024 | As of December 31, 2023 | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :------------------- | :---------------------- | | Net Loss | $(40,385) | $(33,982) | N/A | N/A | | Cash used by operating activities | $(33,567) | $(40,090) | N/A | N/A | | Accumulated Deficit | N/A | N/A | $(699,946) | $(659,561) | | Cash, cash equivalents and marketable securities | N/A | N/A | $46,300 | N/A | - The company's cash, cash equivalents, and marketable securities of $**46.3** million as of March 31, 2024, are insufficient to fund planned operations for **12 months** from the financial statement issuance date, even after a $**32.5** million public offering in April 2024[22](index=22&type=chunk) - Management expects to be in default of the minimum liquidity requirement of its Loan Agreement in Q3 2024 if unable to raise additional funds or renegotiate terms, which would limit funding to Q3 2024[23](index=23&type=chunk)[24](index=24&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=10&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and policies applied in preparing the interim condensed consolidated financial statements - Interim condensed consolidated financial statements are unaudited, prepared in accordance with U.S. GAAP and SEC rules, and include normal recurring adjustments[26](index=26&type=chunk)[27](index=27&type=chunk)[28](index=28&type=chunk) - Revenue recognition policies differentiate between customer contracts (ASC 606) for collaboration/license agreements and nonreciprocal contributions (ASC 958-605) for grant funding agreements[45](index=45&type=chunk)[56](index=56&type=chunk) - The company did not record income tax expense for Q1 2024 and 2023 due to expected cumulative taxable losses and a full valuation allowance against net deferred tax assets[59](index=59&type=chunk) - Adoption of ASU 2020-06 (Debt with Conversion and Other Options) on January 1, 2024, did not materially impact financial statements. ASU 2023-07 (Segment Reporting) and ASU 2023-09 (Income Tax Disclosures) are being evaluated for future impact[64](index=64&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk) [Note 3. Cash Equivalents and Marketable Securities](index=15&type=section&id=Note%203.%20Cash%20Equivalents%20and%20Marketable%20Securities) This note details the composition and fair value of the company's cash equivalents and marketable securities Cash Equivalents and Marketable Securities (in thousands) | Description | March 31, 2024 Fair Value | December 31, 2023 Fair Value | Change (YoY) | | :---------------------------------- | :-------------------------- | :--------------------------- | :----------- | | Total cash equivalents | $38,086 | $45,977 | $(7,891) | | Total short-term marketable securities | $3,908 | $16,288 | $(12,380) | | Total | $41,994 | $62,265 | $(20,271) | - All marketable securities as of March 31, 2024, have contractual maturities of less than one year[68](index=68&type=chunk) [Note 4. Fair Value Measurements](index=16&type=section&id=Note%204.%20Fair%20Value%20Measurements) This note provides information on the fair value hierarchy used for financial assets and liabilities Fair Value Measurements (in thousands) as of March 31, 2024 | Description | Total | Level 1 | Level 2 | Level 3 | | :---------------------------------- | :------ | :------ | :------ | :------ | | Money market funds | $38,086 | $38,086 | $— | $— | | U.S. government treasuries | $3,662 | $3,662 | $— | $— | | Commercial paper | $246 | $— | $246 | $— | | Total | $41,994 | $41,748 | $246 | $— | - There were no transfers between Level 1 and Level 2 during the periods presented[72](index=72&type=chunk) [Note 5. Property and Equipment, Net](index=17&type=section&id=Note%205.%20Property%20and%20Equipment%20%2C%20Net) This note presents the carrying value of the company's property and equipment, net of accumulated depreciation Property and Equipment, Net (in thousands) | Item | March 31, 2024 | December 31, 2023 | Change | | :---------------------------------- | :--------------- | :---------------- | :------- | | Total property and equipment, gross | $47,538 | $49,681 | $(2,143) | | Less accumulated depreciation and amortization | $(33,465) | $(32,415) | $(1,050) | | Total property and equipment, net | $14,088 | $17,281 | $(3,193) | - Depreciation and amortization expense was $**1.7** million for the three months ended March 31, 2024, compared to $**1.8** million for the same period in 2023[73](index=73&type=chunk) [Note 6. Commitments and Contingencies](index=17&type=section&id=Note%206.%20Commitments%20and%20Contingencies) This note discloses the company's lease obligations, guarantees, and indemnifications [Leases](index=17&type=section&id=Leases) This section details the company's operating lease commitments for office and laboratory spaces - The company leases office and laboratory space in Emeryville, Pleasanton, Cambridge, and Boston, with the Boston Lease being a significant **120-month** operating lease[74](index=74&type=chunk)[77](index=77&type=chunk)[80](index=80&type=chunk)[83](index=83&type=chunk) - The Boston Lease, commenced in April 2023, involved recognizing an ROU Asset of $**59.3** million and a lease liability of $**50.9** million[85](index=85&type=chunk) Lease Financing Obligation (in thousands) as of March 31, 2024 | Year Ending December 31, | Lease Financing Obligation | | :----------------------- | :------------------------- | | 2024 (remaining nine months) | $9,627 | | 2025 | $10,749 | | 2026 | $10,376 | | 2027 | $10,466 | | 2028 | $10,732 | | Thereafter | $41,615 | | Total minimum payments | $93,565 | | Present value of future minimum lease payments | $62,952 | [Guarantees and Indemnifications](index=21&type=section&id=Guarantees%20and%20Indemnifications) This section outlines the company's indemnification obligations for officers and directors - The company indemnifies its officers and directors for certain events, with the maximum potential future indemnification being unlimited[89](index=89&type=chunk) - Director and officer liability insurance is held to limit the company's exposure, and no liabilities have been recognized for these obligations due to their minimal estimated fair value[89](index=89&type=chunk) [Note 7. Balance Sheet Components](index=21&type=section&id=Note%207.%20Balance%20Sheet%20Components) This note provides a breakdown of specific balance sheet accounts, including prepaid expenses and long-term assets [Prepaid Expenses and Other Current Assets](index=21&type=section&id=Prepaid%20Expenses%20and%20Other%20Current%20Assets) This section details the components of prepaid expenses and other current assets Prepaid Expenses and Other Current Assets (in thousands) | Item | March 31, 2024 | December 31, 2023 | Change | | :---------------------------------- | :--------------- | :---------------- | :------- | | Prepaid research and development-related expenses | $2,462 | $3,904 | $(1,442) | | Total prepaid expenses and other current assets | $4,303 | $5,862 | $(1,559) | [Deposits and Other Long-Term Assets](index=22&type=section&id=Deposits%20and%20Other%20Long-Term%20Assets) This section outlines the company's long-term deposits and other non-current assets Deposits and Other Long-Term Assets (in thousands) | Item | March 31, 2024 | December 31, 2023 | | :---------------------------------- | :--------------- | :---------------- | | Lease security deposits | $924 | $924 | [Note 8. Debt](index=22&type=section&id=Note%208.%20Debt) This note describes the company's term loan facility, interest rates, and associated covenants - The company has an $**80.0** million term loan facility, with $**40.0** million drawn as of March 31, 2024[92](index=92&type=chunk)[98](index=98&type=chunk) - The loan bears interest at a cash rate (greater of prime + **3.15%** or **7.15%**) and a **2.00%** payment-in-kind rate, with an effective interest rate of **13%**[93](index=93&type=chunk)[98](index=98&type=chunk) - The company is subject to minimum liquidity requirements (**0.55x** outstanding balance if market cap <= $**400** million) and expects to be in default in Q3 2024 if additional funds are not raised or terms renegotiated[95](index=95&type=chunk)[218](index=218&type=chunk) Long-Term Debt Balance (in thousands) as of March 31, 2024 | Item | Amount | | :---------------------------------- | :----- | | Principal loan balance | $40,000 | | Final fee | $2,300 | | Unamortized debt discount, issuance costs, and unaccreted value of final fee | $(1,970) | | Long term debt, net | $40,330 | [Note 9. Collaboration and License Agreements and Grant Revenue](index=23&type=section&id=Note%209.%20Collaboration%20and%20License%20Agreements%20and%20Grant%20Revenue) This note details the company's revenue-generating collaboration, license, and grant agreements [2seventy bio, Inc.](index=23&type=section&id=2seventy%20bio%2C%20Inc.) This section outlines the collaboration agreement with 2seventy bio, including upfront payments and potential milestones - The company received a $**20.0** million upfront payment and is eligible for up to $**1.2** billion in milestones and single-digit royalties under the 2seventy Agreement[99](index=99&type=chunk) - Collaboration revenue of $**0.4** million was recognized in Q1 2023, but no deferred revenue or receivables remained as of March 31, 2024, as revenue was fully recognized in 2023[103](index=103&type=chunk)[212](index=212&type=chunk) [Gilead Sciences, Inc.](index=25&type=section&id=Gilead%20Sciences%2C%20Inc.) This section details the collaboration agreement with Gilead Sciences for HIV vaccine development - The company received a $**30.0** million upfront payment and $**30.0** million from common stock sale under the Gilead Collaboration Agreement for HIV vaccine development[106](index=106&type=chunk)[108](index=108&type=chunk) - The company is eligible for a $**40.0** million option fee and up to $**685.0** million in clinical, regulatory, and commercial milestones, plus tiered royalties[106](index=106&type=chunk) - De minimis collaboration revenue was recorded in Q1 2024, compared to $**0.1** million in Q1 2023, with variable consideration for milestones fully constrained[109](index=109&type=chunk)[112](index=112&type=chunk)[212](index=212&type=chunk) [Arbutus Biopharma Corporation](index=26&type=section&id=Arbutus%20Biopharma%20Corporation) This section describes the exclusive license agreement with Arbutus Biopharma for immunotherapy intellectual property - The company has an exclusive license from Arbutus for immunotherapy IP, with potential milestone payments up to $**123.5** million and royalties[114](index=114&type=chunk) - Milestone payments of $**2.5** million (GRANITE) and $**3.0** million (SLATE) were made in 2018 and 2019, respectively[114](index=114&type=chunk)[115](index=115&type=chunk) - No research and development expense was recorded under this agreement for the three months ended March 31, 2024, and 2023[114](index=114&type=chunk)[201](index=201&type=chunk) [Non-Profit Hospital Cancer Center](index=27&type=section&id=Non-Profit%20Hospital%20Cancer%20Center) This section outlines the exclusive license agreement with a non-profit hospital cancer center for immunotherapy - The company has an exclusive license with a non-profit hospital cancer center for immunotherapy, with milestone payments and low single-digit royalties[116](index=116&type=chunk) - An insignificant milestone payment was made in 2019 for the GRANITE GO-004 clinical trial[116](index=116&type=chunk) [Genevant Sciences GmbH](index=27&type=section&id=Genevant%20Sciences%20GmbH) This section details the company's license agreements with Genevant for LNP technology in oncology and infectious diseases - The company has three license agreements with Genevant for LNP technology, covering oncology and infectious disease applications[117](index=117&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk) - Upfront payments and initial milestones under these agreements (totaling $**7.0** million in upfront payments and $**2.0** million in milestones) were recorded as R&D expense in prior years[117](index=117&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk) - No new milestone events under any Genevant license agreements had occurred as of March 31, 2024[117](index=117&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk) [Coalition for Epidemic Preparedness Innovations (CEPI)](index=28&type=section&id=Coalition%20for%20Epidemic%20Preparedness%20Innovations%20(CEPI)) This section describes the funding agreement with CEPI for the CORAL program, a COVID-19 vaccine - CEPI Funding Agreement provides up to $**25.6** million for the CORAL program, a second-generation COVID-19 vaccine[121](index=121&type=chunk)[124](index=124&type=chunk) - Grant revenue recognized was $**1.0** million in Q1 2024, compared to $**1.5** million in Q1 2023[126](index=126&type=chunk)[212](index=212&type=chunk) CEPI Deferred Revenue (in thousands) | Item | Balance at Dec 31, 2023 | Additions (Q1 2024) | Deductions (Q1 2024) | Balance at Mar 31, 2024 | | :---------------------------------- | :---------------------- | :------------------ | :------------------- | :---------------------- | | Deferred Revenue | $2,291 | $— | $(1,057) | $1,234 | [Gates Foundation](index=29&type=section&id=Gates%20Foundation) This section outlines the grant agreement with the Gates Foundation for HPV vaccine development - The Gates Grant Agreement provides funding for HPV vaccine development, with an upfront payment of $**2.2** million and an additional $**0.7** million received in April 2023[128](index=128&type=chunk) - Grant revenue recognized was $**0.3** million in Q1 2024, compared to $**0.4** million in Q1 2023[129](index=129&type=chunk)[212](index=212&type=chunk) Gates Foundation Deferred Revenue (in thousands) | Item | Balance at Dec 31, 2023 | Additions (Q1 2024) | Deductions (Q1 2024) | Balance at Mar 31, 2024 | | :---------------------------------- | :---------------------- | :------------------ | :------------------- | :---------------------- | | Deferred Revenue | $8 | $281 | $(275) | $14 | [Biomedical Advanced Research and Development Authority (BARDA)](index=29&type=section&id=Biomedical%20Advanced%20Research%20and%20Development%20Authority%20(BARDA)) This section details the BARDA contract for a Phase 2b COVID-19 vaccine clinical trial - The BARDA Contract could provide up to $**433.0** million for a Phase 2b COVID-19 vaccine clinical trial, with a base period funding of up to $**10.0** million[131](index=131&type=chunk)[132](index=132&type=chunk)[193](index=193&type=chunk)[194](index=194&type=chunk) - Grant revenue of $**0.4** million was recognized and received under the BARDA Contract for the three months ended March 31, 2024[133](index=133&type=chunk)[212](index=212&type=chunk) - Future funding beyond the base period is contingent on a new award from the Rapid Response Partnership Vehicle (RRPV Consortium), which is not yet secured[132](index=132&type=chunk)[194](index=194&type=chunk) [Note 10. Stockholders' Equity](index=31&type=section&id=Note%2010.%20Stockholders'%20Equity) This note provides information on the company's common stock, warrants, and equity financing activities [Sale of Common Stock and Pre-Funded Warrants](index=31&type=section&id=Sale%20of%20Common%20Stock%20and%20Pre-Funded%20Warrants) This section details the company's PIPE financings involving the issuance of common stock and pre-funded warrants - The company completed three PIPE financings (Dec 2020, Sep 2021, Oct 2022) issuing common stock and pre-funded warrants[136](index=136&type=chunk)[139](index=139&type=chunk)[142](index=142&type=chunk) - Aggregate net proceeds from these financings were approximately $**119.8** million (First PIPE), $**52.7** million (Second PIPE), and $**42.4** million (Third PIPE)[136](index=136&type=chunk)[139](index=139&type=chunk)[142](index=142&type=chunk) - Warrants are equity-classified, immediately exercisable, and do not embody an obligation for the company to repurchase shares[138](index=138&type=chunk)[144](index=144&type=chunk) [Common Stock Warrants](index=32&type=section&id=Common%20Stock%20Warrants) This section provides a summary of outstanding common stock warrants, including exercise prices and expiration dates Common Stock Warrants Outstanding as of March 31, 2024 | Issue Date | Expiration Date | Exercise Price | Number of Warrants Outstanding | | :---------------- | :-------------- | :------------- | :----------------------------- | | December 28, 2020 | None | $0.01 | 7,214,333 | | October 24, 2022 | None | $0.0001 | 13,274,923 | | Total | | | 20,489,256 | - No warrants were exercised during the three months ended March 31, 2024, and 2023[146](index=146&type=chunk) [Note 11. Stock-Based Compensation](index=33&type=section&id=Note%2011.%20Stock-Based%20Compensation) This note details the company's stock-based compensation plans, activity, and expense recognition [Award Incentive Plans](index=33&type=section&id=Award%20Incentive%20Plans) This section describes the company's equity incentive plans for employees and directors - The 2018 Plan automatically increases reserved shares annually by **4%** of outstanding stock[148](index=148&type=chunk) - The 2021 Plan is for new employee inducement awards and is exempt from Nasdaq shareholder approval rules[151](index=151&type=chunk) - The 2021 Plan's share reserve was increased by **700,000 shares** in April 2022 and **1,300,000 shares** in February 2023[153](index=153&type=chunk) [Stock Option Activity](index=34&type=section&id=Stock%20Option%20Activity) This section summarizes the activity and status of stock options granted by the company Stock Option Activity as of March 31, 2024 | Item | Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (years) | Aggregate Intrinsic Value (in thousands) | | :---------------------------------- | :--------------- | :------------------------------ | :------------------------------------------ | :--------------------------------------- | | Balance at December 31, 2023 | 7,273,461 | $7.50 | 7.26 | $264 | | Granted (Q1 2024) | 3,971,589 | $2.45 | N/A | N/A | | Balance at March 31, 2024 | 10,306,517 | $5.95 | 7.91 | $998 | | Vested and exercisable at March 31, 2024 | 5,146,980 | $8.29 | 6.61 | $352 | - $**11.0** million of total unrecognized compensation cost related to non-vested options is expected to be recognized over a weighted-average period of **1.63 years**[155](index=155&type=chunk) [Restricted Stock Units](index=34&type=section&id=Restricted%20Stock%20Units) This section details the activity of restricted stock units, including grants, vesting, and cancellations Restricted Stock Unit Activity for Three Months Ended March 31, 2024 | Item | Number of Shares | Weighted Average Grant Date Fair Value | | :---------------------------------- | :--------------- | :------------------------------------- | | Outstanding, unvested at December 31, 2023 | 3,088,970 | $3.29 | | Issued | 644,826 | $2.46 | | Vested | (826,642) | $3.28 | | Canceled/Forfeited | (324,626) | $3.09 | | Outstanding, unvested at March 31, 2024 | 2,582,528 | $3.11 | [Performance-Based Restricted Stock Units](index=36&type=section&id=Performance-Based%20Restricted%20Stock%20Units) This section outlines the performance-based restricted stock unit awards granted to executives - **1,117,020** performance-based restricted stock unit awards (PSUs) were granted to executives in March 2024, with vesting dependent on performance metrics through December 31, 2025[157](index=157&type=chunk) - No stock-based compensation expense was recorded for PSUs in Q1 2024, as achievement of performance metrics was not deemed probable[158](index=158&type=chunk) [Stock-Based Compensation Expense](index=36&type=section&id=Stock-Based%20Compensation%20Expense) This section presents the breakdown of stock-based compensation expense across different operating categories Stock-Based Compensation Expense (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Research and development expenses | $1,660 | $1,613 | $47 | | General and administrative expenses | $1,586 | $1,278 | $308 | | Total | $3,246 | $2,891 | $355 | [Note 12. Net Loss Per Common Share](index=36&type=section&id=Note%2012.%20Net%20Loss%20Per%20Common%20Share) This note provides the calculation of basic and diluted net loss per common share Net Loss Per Common Share (in thousands, except per share amounts) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :---------------------------------- | :-------------------------------- | :-------------------------------- | | Net loss | $(40,385) | $(33,982) | | Weighted-average common shares outstanding, basic and diluted | 118,391,224 | 114,423,000 | | Net loss per share, basic and diluted | $(0.34) | $(0.30) | - Potentially dilutive securities, including options, ESPP shares, and restricted stock, totaling **14.2 million** in Q1 2024 (vs. **10.6 million** in Q1 2023), were excluded from diluted EPS calculations as they were anti-dilutive due to the net loss[161](index=161&type=chunk) [Note 13. Severance and Other Costs](index=37&type=section&id=Note%2013.%20Severance%20and%20Other%20Costs) This note details the costs associated with the company's workforce reduction in February 2024 - The company announced a **40%** workforce reduction in February 2024 to reduce costs and preserve capital[162](index=162&type=chunk) Severance and Other Costs (in thousands) for Three Months Ended March 31, 2024 | Item | Amount | | :---------------------------------- | :----- | | Severance and Incentive Compensation | $2,198 | | Stock Based Compensation | $185 | | Asset Impairments | $1,483 | | Total Severance and Other Costs | $3,866 | - These charges were recorded to research and development ($**3.7** million) and general and administrative ($**0.2** million) operating expense categories[163](index=163&type=chunk) [Note 14. Subsequent Event](index=37&type=section&id=Note%2014.%20Subsequent%20Event) This note discloses significant events occurring after the balance sheet date, specifically a public offering - On April 4, 2024, the company completed a public offering of common stock and warrants[164](index=164&type=chunk) - The offering generated gross proceeds of $**32.5** million before deducting underwriting discounts and estimated expenses[164](index=164&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=38&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20FO%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's perspective on the company's financial condition and results of operations, highlighting its clinical-stage biotechnology focus, ongoing operating losses, and significant liquidity challenges. It details program updates for oncology (GRANITE, SLATE) and infectious diseases (CORAL, HIV), and analyzes revenue and expense trends, emphasizing the need for additional funding to continue as a going concern [Overview](index=38&type=section&id=Overview) This section provides an overview of the company's clinical-stage biotechnology focus, key programs, and critical liquidity challenges - Gritstone bio is a clinical-stage biotechnology company focused on developing potent vaccine-based immunotherapies for cancer and infectious diseases, utilizing self-amplifying mRNA (samRNA) technology[166](index=166&type=chunk)[168](index=168&type=chunk) - The company's clinical programs include GRANITE (individualized neoantigen vaccine), SLATE (off-the-shelf neoantigen vaccine), CORAL (next-generation SARS-CoV-2 vaccine), and an HIV vaccine collaboration with Gilead[169](index=169&type=chunk)[171](index=171&type=chunk) - As of March 31, 2024, cash, cash equivalents, and marketable securities were $**46.3** million. Even with $**32.5** million from an April 2024 offering, funds are expected to last only into Q4 2024, and potentially only into Q3 2024 if minimum liquidity requirements of the Loan Agreement are not met or renegotiated[173](index=173&type=chunk)[218](index=218&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern, necessitating additional financing to avoid delaying or eliminating R&D activities[174](index=174&type=chunk)[218](index=218&type=chunk) [Oncology Program Updates](index=40&type=section&id=Oncology%20Program%20Updates) This section provides updates on the company's oncology vaccine programs, GRANITE and SLATE, including clinical trial progress and key findings [GRANITE – Individualized Vaccine Program for Solid Tumors](index=40&type=section&id=GRANITE%20%E2%80%93%20Individualized%20Vaccine%20Program%20for%20Solid%20Tumors) This section details the progress of the individualized neoantigen vaccine program for solid tumors, including FDA designation and clinical data - GRANITE, an individualized neoantigen-based immunotherapy, received FDA Fast Track designation for microsatellite stable colorectal cancer (MSS-CRC)[179](index=179&type=chunk) - Preliminary Phase 2 data showed a favorable trend in overall progression-free survival (PFS) (HR=**0.82**) and extended PFS in high-risk patients (HR=**0.52**), with median PFS of **12 months** vs. **7 months** in the control arm for high-risk patients[181](index=181&type=chunk)[182](index=182&type=chunk) - GRANITE was generally well tolerated, with common mild systemic and local adverse events, and achieved a **100%** vaccine manufacturing success rate[183](index=183&type=chunk) - Mature PFS data and additional long-term ctDNA data are expected in Q3 2024, with overall survival data in mid-2025[184](index=184&type=chunk) [SLATE – "Off-the-shelf" Vaccine Program for Solid Tumors](index=41&type=section&id=SLATE%20%E2%80%93%20%22Of%20the%20shelf%22%20Vaccine%20Program%20for%20Solid%20Tumors) This section outlines the development of the off-the-shelf neoantigen vaccine program for solid tumors, highlighting its design and interim results - SLATE is an "off-the-shelf" neoantigen-directed immunotherapy designed to target common driver mutations, offering speed advantages over individualized vaccines[185](index=185&type=chunk) - Interim Phase 1 results published in Nature Medicine identified a novel immunodominance hierarchy of tumor neoantigens[186](index=186&type=chunk) - SLATE-KRAS demonstrated superior immunogenicity in a subsequent Phase 2 study and is being evaluated in a cell therapy-vaccine combination study with the NCI[186](index=186&type=chunk) [Infectious Disease Programs](index=41&type=section&id=Infectious%20Disease%20Programs) This section provides updates on the company's infectious disease vaccine programs, CORAL and HIV, including clinical trial status and funding [CORAL – Next-Generation COVID-19 Vaccine Program](index=41&type=section&id=CORAL%20%E2%80%93%20Next-Generation%20COVID-19%20Vaccine%20Program) This section details the progress of the next-generation COVID-19 vaccine program, including clinical trial phases and BARDA contract funding - The CORAL program has completed three Phase 1 clinical trials, demonstrating induction and persistence of high neutralizing antibody levels and broad T cell responses against SARS-CoV-2[190](index=190&type=chunk) - The BARDA Contract, valued at up to $**433.0** million, supports a **10,000-participant** randomized Phase 2b comparative study for the company's next-generation COVID-19 vaccine[192](index=192&type=chunk)[193](index=193&type=chunk) - Funding beyond the base period of the BARDA Contract (up to $**10.0** million) is contingent on a new award from the RRPV Consortium, which is not yet certain[194](index=194&type=chunk) [HIV Vaccine Collaboration with Gilead Sciences](index=42&type=section&id=HIV%20Vaccine%20Collaboration%20with%20Gilead%20Sciences) This section outlines the ongoing collaboration with Gilead Sciences for HIV vaccine development, including trial status and potential milestones - The HIV vaccine collaboration with Gilead Sciences is progressing, with a Phase 1 trial currently ongoing[195](index=195&type=chunk) - Preclinical data showed strong and broad CD8+ T cell immune responses induced by SIV, ChAd, and samRNA vaccines, enhanced by immune modulators[196](index=196&type=chunk) - Gilead has an exclusive option to advance development beyond Phase 1, which would result in a $**40.0** million non-refundable option exercise fee[195](index=195&type=chunk) [Components of Our Operating Results](index=42&type=section&id=Components%20of%20Our%20Operating%20Results) This section analyzes the key components contributing to the company's operating results, including revenue and expense categories [Collaboration, License and Grant Revenue](index=42&type=section&id=Collaboration%2C%20License%20and%20Grant%20Revenue) This section details the sources and trends of the company's collaboration, license, and grant revenues Total Revenues (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Total revenues | $1,742 | $2,443 | $(701) | - Revenue sources include collaboration with Gilead, and grants from CEPI, BARDA, and Gates Foundation[212](index=212&type=chunk) - The company has not generated product sales revenue and does not expect to in the foreseeable future, with future revenue dependent on collaboration agreements and milestone payments[197](index=197&type=chunk)[198](index=198&type=chunk) [Operating Expenses](index=43&type=section&id=Operating%20Expenses) This section provides an analysis of the company's research and development and general and administrative expenses [Research and Development Expenses](index=43&type=section&id=Research%20and%20Development%20Expenses) This section details the breakdown and changes in the company's research and development expenditures Research and Development Expenses (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | GRANITE program external expenses | $2,947 | $5,409 | $(2,462) | | SLATE program external expenses | $172 | $616 | $(444) | | CORAL program external expenses | $4,025 | $2,133 | $1,892 | | Other program external R&D expenses | $4,615 | $5,752 | $(1,137) | | Personnel-related expenses | $11,502 | $11,851 | $(349) | | Severance and other costs | $3,678 | $— | $3,678 | | Other unallocated R&D expenses | $6,102 | $4,753 | $1,349 | | Total research and development expenses | $33,041 | $30,514 | $2,527 | - The increase in R&D expenses was primarily due to a $**3.7** million one-time severance and other charge and increased facilities-related costs, partially offset by decreases in laboratory supplies and outside services[214](index=214&type=chunk) - R&D expenses are expected to increase substantially as product candidates advance through clinical studies and regulatory approval[206](index=206&type=chunk) [General and Administrative Expenses](index=44&type=section&id=General%20and%20Administrative%20Expenses) This section outlines the components and changes in the company's general and administrative expenses General and Administrative Expenses (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | General and administrative expenses | $8,502 | $6,745 | $1,757 | - The increase was primarily due to a $**0.2** million one-time severance charge, and increases in personnel-related expenses ($**0.7** million), facilities-related costs ($**0.5** million), and outside services ($**0.4** million)[215](index=215&type=chunk) - G&A expenses are expected to increase as the company expands operating activities and prepares for potential commercialization[208](index=208&type=chunk) [Interest Income](index=44&type=section&id=Interest%20Income) This section explains the trends and factors influencing the company's interest income Interest Income (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Interest income | $712 | $1,678 | $(966) | - The decrease is primarily due to lower cash, cash equivalent, and investment balances in 2024 compared to 2023[216](index=216&type=chunk) [Interest Expense](index=44&type=section&id=Interest%20Expense) This section details the company's interest expense, primarily related to its term loan facility Interest Expense (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Interest expense | $1,296 | $844 | $452 | - The increase is due to a higher principal balance of $**40.0** million outstanding under the Loan Agreement as of March 31, 2024, compared to $**30.0** million outstanding as of March 31, 2023[217](index=217&type=chunk) [Results of Operations](index=45&type=section&id=Results%20of%20Operations) This section summarizes the company's financial performance, including total revenues, operating expenses, and net loss Summary of Results of Operations (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Total revenues | $1,742 | $2,443 | $(701) | | Total operating expenses | $41,543 | $37,259 | $4,284 | | Loss from operations | $(39,801) | $(34,816) | $(4,985) | | Net loss | $(40,385) | $(33,982) | $(6,403) | - Collaboration and license revenues decreased by $**0.5** million, and grant revenues decreased by $**0.2** million, contributing to the overall revenue decline[212](index=212&type=chunk) - Research and development expenses increased by $**2.5** million, largely due to a one-time severance charge, while general and administrative expenses increased by $**1.8** million[214](index=214&type=chunk)[215](index=215&type=chunk) [Liquidity and Capital Resources](index=46&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's financial liquidity, capital sources, and future funding requirements [Sources of Liquidity](index=46&type=section&id=Sources%20of%20Liquidity) This section identifies the company's current cash position, marketable securities, and available financing options - As of March 31, 2024, cash, cash equivalents, and marketable securities were $**46.3** million, and accumulated deficit was $**699.9** million[218](index=218&type=chunk) - A $**32.5** million public offering completed on April 4, 2024, is expected to fund operations into Q4 2024[218](index=218&type=chunk)[225](index=225&type=chunk) - The company expects to default on its Loan Agreement's minimum liquidity requirement in Q3 2024 if additional funds are not raised or terms renegotiated, limiting funding to Q3 2024[218](index=218&type=chunk) - The company has $**71.6** million available under its 2022 ATM Offering Program as of March 31, 2024[220](index=220&type=chunk) [Future Funding Requirements](index=47&type=section&id=Future%20Funding%20Requirements) This section outlines the company's anticipated capital needs for ongoing operations and development programs - The company does not expect positive cash flows from operations or meaningful product sales revenue in the foreseeable future[226](index=226&type=chunk) - Substantial additional funding is required for ongoing R&D, clinical trials, regulatory approvals, commercialization, and manufacturing investments[226](index=226&type=chunk) - Future funding will be sought through private and public equity offerings, debt financings, and potential collaboration agreements, but availability on acceptable terms is not assured[227](index=227&type=chunk) - Failure to raise additional capital could force the company to significantly reduce operating expenses, delay, or discontinue development programs[228](index=228&type=chunk) [Cash Flows](index=49&type=section&id=Cash%20Flows) This section analyzes the company's cash flows from operating, investing, and financing activities [Cash Used in Operating Activities](index=49&type=section&id=Cash%20Used%20in%20Operating%20Activities) This section details the cash outflows from the company's primary business operations Cash Used in Operating Activities (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Net cash used in operating activities | $(33,567) | $(40,090) | $6,523 | - Non-cash charges in Q1 2024 totaled $**10.1** million, including $**1.7** million depreciation, $**3.2** million stock-based compensation, and $**1.5** million impairment of property and equipment[234](index=234&type=chunk) - Changes in operating assets and liabilities included decreases in accrued compensation ($**5.0** million), lease liability ($**3.1** million), and deferred revenue ($**1.1** million), offset by increases in accounts payable ($**3.5** million) and prepaid expenses ($**1.6** million)[234](index=234&type=chunk) [Cash Provided by Investing Activities](index=50&type=section&id=Cash%20Provided%20by%20Investing%20Activities) This section outlines the cash flows generated or used by the company's investment activities Cash Provided by Investing Activities (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Net cash provided by investing activities | $12,303 | $21,173 | $(8,870) | - Proceeds from marketable securities maturities were $**12.7** million in Q1 2024, down from $**38.6** million in Q1 2023[236](index=236&type=chunk)[237](index=237&type=chunk) - Purchases of marketable securities were $**0.4** million in Q1 2024, significantly lower than $**15.9** million in Q1 2023[236](index=236&type=chunk)[237](index=237&type=chunk) [Cash (Used in) Provided by Financing Activities](index=50&type=section&id=Cash%20(Used%20in)%20Provided%20by%20Financing%20Activities) This section details the cash flows related to the company's debt and equity financing activities Cash (Used in) Provided by Financing Activities (in thousands) | Item | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Net cash (used in) provided by financing activities | $(379) | $8,647 | $(9,026) | - Q1 2024 cash used was primarily due to financing/offering costs ($**0.4** million) and tax payments for RSUs ($**0.8** million)[238](index=238&type=chunk) - Q1 2023 cash provided was mainly from long-term debt proceeds ($**9.9** million) and ATM equity offering proceeds ($**1.9** million)[239](index=239&type=chunk) [Contractual Obligations and Commitments](index=50&type=section&id=Contractual%20Obligations%20and%20Commitments) This section discloses the company's significant contractual obligations, including lease payments and license agreements - Total future minimum lease payments are $**93.6** million, with $**9.6** million due in the remaining **nine months** of 2024[240](index=240&type=chunk) - License agreements obligate the company to make milestone payments and low-single-digit royalties on sales of licensed products, but no royalties were due in Q1 2024 or Q1 2023[241](index=241&type=chunk) - Contracts with CROs, CMOs, and other vendors are generally cancelable within **30 days** and are not included in long-term obligations[242](index=242&type=chunk) [Critical Accounting Policies and Use of Estimates](index=50&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) This section highlights the accounting policies requiring significant management judgment and estimates - Financial statements require management estimates and judgments for items such as preclinical study accruals, fair value of assets/liabilities, and stock-based compensation[243](index=243&type=chunk) - No changes to critical accounting policies have occurred since the Annual Report on Form 10-K for the year ended December 31, 2023[244](index=244&type=chunk) [Recent Accounting Pronouncements](index=51&type=section&id=Recent%20Accounting%20Pronouncements) This section refers to disclosures regarding recently adopted or issued accounting standards - Refer to Note 2 for a discussion of recent accounting pronouncements[245](index=245&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risks](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) There have been no material changes in market risk from the information provided in the Annual Report on Form 10-K for the year ended December 31, 2023 - No material changes in market risk from the Annual Report on Form 10-K for the year ended December 31, 2023[246](index=246&type=chunk) [Item 4. Controls and Procedures](index=51&type=section&id=Item%204.%20Controls%20and%20Procedures) As of March 31, 2024, management, with the participation of principal executive, financial, and accounting officers, evaluated the effectiveness of disclosure controls and procedures and concluded they were effective at a reasonable assurance level. No changes in internal control over financial reporting materially affected or are reasonably likely to materially affect internal control during Q1 2024 - Disclosure controls and procedures were evaluated and deemed effective at a reasonable assurance level as of March 31, 2024[247](index=247&type=chunk)[248](index=248&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended March 31, 2024[249](index=249&type=chunk) PART II. OTHER INFORMATION This section contains additional information not covered in the financial statements, including legal proceedings, risk factors, and exhibits [ITEM 1. Legal Proceedings](index=52&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not currently a party to any litigation or legal proceedings that management believes would have a material adverse effect on its business. However, litigation, regardless of outcome, can negatively impact the company due to costs and diversion of resources - The company is not currently involved in any legal proceedings deemed to have a material adverse effect on its business[251](index=251&type=chunk) - Litigation can adversely impact the company due to defense/settlement costs and diversion of management resources[251](index=251&type=chunk) [ITEM 1A. Risk Factors](index=52&type=section&id=ITEM%201A.%20Risk%20Factors) Investing in the company's common stock involves a high degree of risk. There have been no material changes to the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2023. These risks are exacerbated by current macroeconomic and geopolitical environments - Investing in the company's common stock involves a high degree of risk[252](index=252&type=chunk) - No material changes to the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023[253](index=253&type=chunk) - Risks are exacerbated by current macroeconomic and geopolitical environments, including inflation, high interest rates, and market volatility[252](index=252&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=52&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is marked "Not applicable" for unregistered sales of equity securities and use of proceeds, as well as issuer purchases of equity securities - No unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities to report[254](index=254&type=chunk)[255](index=255&type=chunk)[256](index=256&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=52&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - No defaults upon senior securities[257](index=257&type=chunk) [ITEM 4. Mine Safety Disclosures](index=52&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is marked "Not applicable" for mine safety disclosures - Mine safety disclosures are not applicable[258](index=258&type=chunk) [ITEM 5. Other Information](index=52&type=section&id=ITEM%205.%20Other%20Information) The company reported no other information - No other information to report[259](index=259&type=chunk) [ITEM 6. EXHIBITS](index=53&type=section&id=ITEM%206.%20EXHIBITS) This section lists the exhibits filed with the Form 10-Q, including corporate documents, common stock certificates, certifications of officers, and Inline XBRL documents - The report includes various exhibits such as corporate governance documents, common stock certificates, officer certifications (31.1, 31.2, 32.1), and Inline XBRL documents[261](index=261&type=chunk) - Exhibit 32.1 certification is not deemed filed with the SEC and is not incorporated by reference into other filings[261](index=261&type=chunk) SIGNATURES This section confirms the official signing and certification of the report by the company's executive officers [Signatures](index=55&type=section&id=SIGNATURES_DETAIL) This section confirms the official signing and certification of the report by the company's executive officers - The report was signed on May 9, 2024, by the President and CEO, Andrew Allen, and the CFO, Vassiliki Economides[265](index=265&type=chunk)

[Q1 2024 Financial Results and Corporate Updates](index=1&type=section&id=Q1%202024%20Financial%20Results%20and%20Corporate%20Updates) [Executive Summary and Key Highlights](index=1&type=section&id=Executive%20Summary%20and%20Key%20Highlights) Gritstone bio reported Q1 2024 results, highlighting a favorable PFS trend for its GRANITE vaccine and advancements in its neoantigen platforms - A **favorable progression-free survival (PFS) trend** was observed in preliminary data from the randomized Phase 2 study of GRANITE in metastatic MSS-CRC, with mature PFS data expected in Q3 2024[1](index=1&type=chunk) - A Nature Medicine publication on the SLATE platform and improvements to the EDGE™ platform highlight Gritstone's **leadership in the neoantigen-directed cancer vaccine field**[1](index=1&type=chunk) - The CEO noted the **promising preliminary Phase 2 GRANITE data** suggests a potential benefit in metastatic CRC patients and aims to unlock immunologically 'cold' tumors for potential Phase 3 discussions[2](index=2&type=chunk) [Corporate Developments](index=1&type=section&id=Corporate%20Updates) Gritstone completed a public offering raising $32.5 million in gross proceeds and appointed a seasoned biotechnology finance executive to its Board of Directors - Completed an underwritten public offering in April 2024, resulting in **gross proceeds of $32.5 million**[4](index=4&type=chunk)[5](index=5&type=chunk) - **Appointed Stephen Webster**, a veteran finance executive with over 30 years in the biotechnology industry, **to its Board of Directors** in April 2024[5](index=5&type=chunk)[6](index=6&type=chunk) [Clinical Program Updates](index=2&type=section&id=Clinical%20Program%20Updates) [Tumor-Specific Neoantigen Oncology Programs](index=2&type=section&id=Tumor-Specific%20Neoantigen%20Oncology%20Programs) The company updated its oncology programs, noting promising GRANITE data, EDGE™ platform advancements, and an ongoing NCI collaboration [GRANITE – Personalized Neoantigen Vaccine Program](index=2&type=section&id=GRANITE%20%E2%80%93%20Personalized%20neoantigen%20vaccine%20program) Preliminary Phase 2 results for GRANITE in metastatic MSS-CRC showed a favorable PFS trend and aligning ctDNA data, with mature data expected in Q3 2024 - Preliminary results from the Phase 2 study in metastatic MSS-CRC demonstrated a **favorable trend in progression-free survival (PFS)**[8](index=8&type=chunk) | Metric | Overall Population (less mature data) | High-Risk Group (more mature data) | | :----- | :------------------------------------ | :--------------------------------- | | Hazard Ratio (PFS) | 0.82 (18% relative risk reduction) | 0.52 (48% relative risk reduction) | | 95% CI | [95% CI, 0.34-1.67]; 62% censored | [95% CI, 0.15-1.38]; 44% censored | - In the high-risk group, **ctDNA shifted from high to low in 56% of GRANITE patients vs 22% of control patients**, with progressive disease observed in 44% vs 78%, respectively[8](index=8&type=chunk) - Gritstone expects to share **mature PFS data** and additional long-term ctDNA data in the third quarter of 2024[8](index=8&type=chunk) [SLATE – "Off-the-Shelf" Neoantigen Vaccine Program](index=2&type=section&id=SLATE%20%E2%80%93%20%22Off-the-shelf%22%20neoantigen%20vaccine%20program) The SLATE platform's development was detailed in Nature Medicine, and a clinical trial collaboration with the NCI is ongoing - A March 2024 Nature Medicine paper detailed the SLATE platform's development and the **discovery of a novel immunodominance hierarchy of tumor neoantigens**[8](index=8&type=chunk)[9](index=9&type=chunk) - A **clinical trial collaboration with the National Cancer Institute (NCI) is ongoing** to evaluate SLATE-KRAS in combination with TCR-T cell therapy[9](index=9&type=chunk) [EDGE™ – Tumor Antigen Identification Platform](index=2&type=section&id=EDGE%E2%84%A2%20%E2%80%93%20Tumor%20Antigen%20Identification%20Platform) The EDGE™ platform now predicts HLA Class I presentation with over 80% accuracy, and a new model, EDGE-II, shows superior predictive performance - The EDGE™ neoantigen prediction platform now **predicts HLA Class I presentation with >80% accuracy**, a performance level believed to be field-leading[8](index=8&type=chunk) - A new model, **EDGE-II, has achieved superior predictive performance** of HLA Class II presentation and CD4+ immunogenicity over publicly available models[8](index=8&type=chunk) [Infectious Disease Programs](index=4&type=section&id=Infectious%20Disease%20Programs) Gritstone updated its CORAL vaccine program, noting a study delay to incorporate GMP-grade materials, and the ongoing HIV collaboration with Gilead [CORAL – Next-Generation SARS-CoV-2 Vaccine Program](index=4&type=section&id=CORAL%20%E2%80%93%20Next-generation%20SARS-CoV-2%20vaccine%20program) The CORAL Phase 2b study is delayed to incorporate GMP-grade materials, while Phase 1 results highlighted durable and broad immune responses - Gritstone announced a **delay of the CORAL Phase 2b study** to incorporate GMP-grade materials and increase its regulatory utility[13](index=13&type=chunk) - Phase 1 CORAL-CEPI study results highlighted the durability and potential broad utility of its samRNA vaccine, reinforcing findings of **broad and durable immune responses through 12 months**[13](index=13&type=chunk) [HIV – Collaboration with Gilead](index=4&type=section&id=HIV%20%E2%80%93%20Collaboration%20with%20Gilead) The collaboration with Gilead to develop a vaccine-based HIV immunotherapy treatment continues under Gilead's direction - The **collaboration to research and develop a vaccine-based HIV immunotherapy treatment continues under Gilead's direction**[11](index=11&type=chunk) [Detailed Financial Statements](index=4&type=section&id=Detailed%20Financial%20Statements) [First Quarter 2024 Financial Summary](index=4&type=section&id=First%20Quarter%202024%20Financial%20Results) The company's Q1 2024 net loss increased to $40.4 million, driven by higher operating expenses, while cash and equivalents decreased to $52.8 million | Metric | Q1 2024 (in millions) | Q1 2023 (in millions) | Change (YoY) | | :----- | :-------------------- | :-------------------- | :----------- | | Cash, cash equivalents, marketable securities and restricted cash (as of period end) | $52.8 | $86.9 (as of Dec 31, 2023) | -$34.1 | | Research and development expenses | $33.0 | $30.5 | +$2.5 | | General and administrative expenses | $8.5 | $6.7 | +$1.8 | | Collaboration, license, and grant revenues | $1.7 | $2.4 (Total revenues) | -$0.7 | | Net loss | -$40.4 | -$34.0 | -$6.4 | | Net loss per share, basic and diluted | -$0.34 | -$0.30 | -$0.04 | - **Research and development expenses increased by $2.5 million**, primarily due to a one-time severance charge and higher facilities-related costs[13](index=13&type=chunk) - **General and administrative expenses increased by $1.8 million**, mainly attributable to higher personnel-related expenses, facilities costs, and a one-time severance charge[13](index=13&type=chunk) - Q1 2024 revenues included **$0.4 million in grant revenue from BARDA**, **$1.0 million from CEPI**, and **$0.3 million from the Gates Foundation**[14](index=14&type=chunk) [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(unaudited)) Total assets decreased to $137.2 million as of March 31, 2024, driven by a reduction in cash, cash equivalents, and marketable securities | Metric (in thousands) | March 31, 2024 | December 31, 2023 | Change | | :-------------------- | :------------- | :---------------- | :----- | | Cash and cash equivalents | $42,395 | $62,986 | -$20,591 | | Marketable securities | $3,908 | $16,288 | -$12,380 | | Total current assets | $51,853 | $87,435 | -$35,582 | | Total assets | $137,212 | $177,769 | -$40,557 | | Total current liabilities | $25,870 | $27,339 | -$1,469 | | Total liabilities | $123,248 | $125,919 | -$2,671 | | Total stockholders' equity | $13,964 | $51,850 | -$37,886 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(unaudited)) For Q1 2024, total revenues decreased to $1.7 million while the net loss widened to $40.4 million due to increased operating expenses | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Change (YoY) | | :-------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Collaboration and license revenues | $49 | $542 | -$493 | | Grant revenues | $1,693 | $1,901 | -$208 | | Total revenues | $1,742 | $2,443 | -$701 | | Research and development expenses | $33,041 | $30,514 | +$2,527 | | General and administrative expenses | $8,502 | $6,745 | +$1,757 | | Total operating expenses | $41,543 | $37,259 | +$4,284 | | Loss from operations | $(39,801) | $(34,816) | -$4,985 | | Interest income | $712 | $1,678 | -$966 | | Interest expense | $(1,296) | $(844) | -$452 | | Net loss | $(40,385) | $(33,982) | -$6,403 | | Net loss per share, basic and diluted | $(0.34) | $(0.30) | -$0.04 | [Company Information and Disclosures](index=5&type=section&id=Company%20Information%20and%20Disclosures) [About Gritstone bio](index=5&type=section&id=About%20Gritstone%20bio) Gritstone bio is a clinical-stage biotechnology company developing potent vaccines to treat and prevent viral diseases and solid tumors - Gritstone bio, Inc (Nasdaq: GRTS) is a **clinical-stage biotechnology company** that aims to develop the world's most potent vaccines[16](index=16&type=chunk) - The company leverages innovative vectors and payloads to **treat and prevent viral diseases and solid tumors**[16](index=16&type=chunk) [Forward-Looking Statements and Disclaimer](index=5&type=section&id=Gritstone%20Forward-Looking%20Statements) This section outlines the forward-looking nature of statements in the press release, highlighting inherent risks in drug development - The press release contains **forward-looking statements** related to clinical development plans and data expectations, which involve **substantial risks and uncertainties**[17](index=17&type=chunk) - The drugs discussed are **under clinical investigation**, have **not yet been approved for marketing** by the FDA, and are limited to investigational use[18](index=18&type=chunk) [Contacts](index=6&type=section&id=Gritstone%20Contacts) Contact information for investor relations and media inquiries is provided for Gritstone bio - Investors can contact George E MacDougall at ir@gritstone.com[19](index=19&type=chunk) - Media can contact Dan Budwick at 1AB, dan@1abmedia.com[19](index=19&type=chunk)