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Vaxcyte Inc

For the period ended Mar 31, 2025. Filed May 7, 2025.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2025 · Filed May 7, 2025

PCVX$67.53+5.7%Stored close · as of Nov 9, 2026

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Notes to Unaudited Condensed

Notes to Unaudited Condensed Consolidated Financial Statements

  1. Company Organization and Nature of Business

Vaxcyte, Inc. (“we,” “our,” “us,” “Vaxcyte” and the “Company”) refers to Vaxcyte, Inc., a Delaware corporation, as well as its wholly-owned consolidated subsidiary. We are headquartered in San Carlos, California, and were incorporated in the state of Delaware on November 27, 2013 as SutroVax, Inc., and changed our name to Vaxcyte, Inc. on May 15, 2020. We are a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. We are developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. We are re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCFTM cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. (“Sutro Biopharma”). Unlike conventional cell-based approaches, our system for producing difficult-to-make proteins and antigens is intended to accelerate our ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits.

Our primary activities since incorporation have been to perform research and development, undertake preclinical and clinical studies and conduct manufacturing activities in support of our product development efforts; organize and staff our Company; establish our intellectual property portfolio; and raise capital to support and expand such activities.

  1. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

These condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Certain information and footnote disclosures normally included in the condensed consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted in accordance with such rules and regulations.

The condensed consolidated financial statements include the Company and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated upon consolidation.

Unaudited Interim Condensed Consolidated Financial Statements

The condensed consolidated balance sheets as of March 31, 2025, the condensed consolidated statements of operations, comprehensive loss and stockholders’ equity for the three months ended March 31, 2025 and 2024 and the condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair statement of our financial information. The financial data disclosed in the footnotes to the condensed consolidated financial statements related to the three months ended March 31, 2025 and 2024 are also unaudited. The results of operations for the three months ended March 31, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other future annual or interim period. These interim condensed consolidated financial statements should be read in conjunction with our audited consolidated financial statements and related notes thereto for the year ended December 31, 2024 included in our Annual Report on Form 10-K filed with the SEC on February 25, 2025.

Certain prior period amounts in the condensed consolidated financial statements have been reclassified to conform to current period presentation.

Use of Estimates

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements. On an ongoing basis, we evaluate our estimates and assumptions, including those related to stock-based compensation expense, accruals for certain research and development costs, the valuation of deferred tax assets and income taxes. Management bases our estimates on historical experience and on various other assumptions that are 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 that are not readily apparent from other sources. Actual results may differ materially from those estimates.

Summary of Significant Accounting Policies

There have been no material changes to our significant policies as of and for the three months ended March 31, 2025 from our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies and adopted by us as of the specified effective date. We believe that the impact of recently issued standards that are not yet effective will not have a material impact on our consolidated financial statements and disclosures.

In December 2023, the FASB issued Accounting Standards Update ("ASU") No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The final guidance adds clarifications related to the presentation of rate reconciliation for public business entities and definitions of specific categories in rate reconciliation. These amendments are effective for public business entities for annual periods beginning after December 15, 2024. We are currently evaluating the impact of this guidance on our consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40), (“ASU 2024-04”). The amendments in ASU 2024-04 intend to improve the disclosures about a public business entity’s expenses and address requests from investors for more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation, amortization, and depletion). This new guidance is effective for us for the annual period beginning after December 15, 2026. We are currently evaluating the impact of this guidance on our consolidated financial statements and related disclosures.

  1. Fair Value Measurements and Fair Value of Financial Instruments

The following tables set forth our financial instruments measured at fair value on a recurring basis by level within the fair value hierarchy at March 31, 2025 and December 31, 2024:

Fair Value Hierarchy LevelAmortized CostGross Unrealized GainsGross Unrealized LossesFair Value
Assets · (in thousands)
Cash and cash equivalents:
CashLevel 1$65,380$—$—$65,380
Money market fundsLevel 1117,218——117,218
Commercial paperLevel 2164,287—(35)164,252
Total cash and cash equivalents346,885—(35)346,850
Investments:
U.S. Treasury securitiesLevel 11,269,0881,863(2,186)1,268,765
Commercial paperLevel 2112,126—(29)112,097
Corporate debtLevel 2824,0061,308(617)824,697
Asset-backed securitiesLevel 2191,604138(88)191,654
U.S. government agency securitiesLevel 2206,641276(218)206,699
Total investments2,603,4653,585(3,138)2,603,912
Total assets measured at fair value$2,950,350$3,585$(3,173)$2,950,762
Fair Value Hierarchy Level · Amortized Cost · Gross Unrealized Gains · Gross Unrealized Losses · Fair Value
Assets · (in thousands)
Cash and cash equivalents:
CashLevel 1$60,531$—$—$60,531
Money market fundsLevel 173,566——73,566
U.S. Treasury securitiesLevel 18,9832——8,985
Commercial paperLevel 2244,8331(38)244,796
Total cash and cash equivalents387,9133(38)387,878
Investments:
U.S. Treasury securitiesLevel 11,463,3291,533(5,305)1,459,557
Commercial paperLevel 2182,30848(18)182,338
Corporate debtLevel 2691,972888(1,331)691,529
Asset-backed securitiesLevel 2195,801309(72)196,038
U.S. government agency securitiesLevel 2217,617243(482)217,378
Total investments2,751,0273,021(7,208)2,746,840
Total assets measured at fair value$3,138,940$3,024$(7,246)$3,134,718

There wereno transfers within the hierarchies during the three months ended March 31, 2025.

As of March 31, 2025 and December 31, 2024, we had investments with a total fair market value of $1.2 billion and $1.5 billion, respectively, in an unrealized loss position, of which $5.8 million and $10.5 million, respectively, were in a continuous unrealized loss position for more than 12 months. As of March 31, 2025 and December 31, 2024, the gross unrealized losses of securities that have been in a continuous unrealized loss position for both less than and greater than 12 months were $3.2 million and $7.2 million, respectively.

Unrealized losses related to our investments are primarily due to interest rate fluctuations as opposed to credit quality. We do not intend to sell any of the securities in an unrealized loss position and it is not likely that we would be required to sell these securities before recovery of their amortized cost basis, which may be at maturity. We did not recognize any credit losses related to our investments during the three months ended March 31, 2025 or 2024.

The following table presents the contractual maturities of our investments as of March 31, 2025 (in thousands):

Fair Value
Due in less than one year$1,324,881
Due in one to five years1,279,031
Total$2,603,912
  1. Commercial Manufacturing and Supply Agreement

On October 13, 2023, we entered into a pre-commercial services and commercial manufacturing supply agreement with Lonza (the “Commercial Manufacturing and Supply Agreement”).

Pursuant to the Commercial Manufacturing and Supply Agreement, Lonza will (i) construct and build out a dedicated suite (the “Suite”) at Lonza’s facilities in Visp, Switzerland to manufacture certain key components (including drug substance) for our proprietary pneumococcal conjugate vaccine (“PCV”) franchise and any other products or intermediates we may choose (collectively, the “Products”) and (ii) maintain and operate the Suite (utilizing Lonza’s employees) to manufacture the Products as a service provided to us, including conducting related quality control and quality assurance operations. Lonza will be a preferred, non-exclusive, supplier of the Products to us, and we retain the right to procure the Products from one or more alternate and/or backup manufacturers of the Products (including at our own facilities).

Under the Commercial Manufacturing and Supply Agreement, prior to completion of construction and certification of the Suite for commercial operation, we will contribute to the capital expenditure costs to construct the Suite (and will own certain equipment in the Suite to be purchased or otherwise acquired by us), and will pay Lonza a fixed-rate monthly service fee for Lonza’s pre-commercial services prior to commencement of commercial operations (which monthly service fee amount is subject to increases in subsequent years). Following commencement of commercial operations of the Suite to manufacture the Products, we will pay Lonza (i) Suite fees based on allocations of certain of Lonza’s costs to maintain the facility in which the Suite is located and to provide shared services to us and Lonza’s other customers in such facility, (ii) service fees based upon Lonza’s actual full-time equivalent employee (“FTE”) costs to operate the Suite to manufacture the Products, and (iii) certain other pass-through costs, including for raw materials. In addition, we may be obligated to pay or reimburse Lonza for certain other fees and expenses under the Commercial Manufacturing and Supply Agreement. Lonza will be eligible for certain financial bonuses, and subject to certain financial penalties, as incentives for the timely completion of certain scale-up activities, receipt of certain regulatory approvals for the Suite and manufacture of the Products in accordance with our commercial requirements.

Unless earlier terminated, the Commercial Manufacturing and Supply Agreement will remain in effect until December 31, 2038, subject to automatic renewal for up tothree additional renewal periods offive years each, unless we elect not to renew (with 24 months advanced notice to Lonza). We are permitted to terminate the Commercial Manufacturing and Supply Agreement for convenience or for Lonza’s uncured material breach, in each case subject to certain notice obligations. Lonza is permitted to terminate the Commercial Manufacturing and Supply Agreement in the event that we commit certain specified material breaches, including uncured failure to pay material and undisputed amounts of money due to Lonza, subject to certain notice obligations. Either party may terminate the Commercial Manufacturing and Supply Agreement in certain circumstances in the event of the other party’s bankruptcy. In the event that we terminate the agreement for convenience, or Lonza terminates the agreement in the event that we commit certain specified material breaches, then certain termination consequences may be triggered, including that (i) we would forfeit any outstanding entitlement to credit from Lonza of the Repurposing Fee (as defined below), and (ii) we would be obligated to pay Lonza a termination penalty equal to the greater of (a) CHF 70.0 million, or (b) a prespecified number of months’ FTE fees for the actual FTEs assigned to us as of the date of termination. Within 30 days of the Effective Date, we paid Lonza a repurposing fee (the “Repurposing Fee”) of CHF 27.0 million that will be credited back to us over a 10-year period starting upon commencement of commercial production. In the event of a termination under certain circumstances, Lonza shall be obligated to provide certain wind-down and transition services to us for up to 12 months and 24 months, respectively.

As of March 31, 2025, we have incurred an accumulated (i) $171.3 million of capital expenditures related to the Vaxcyte owned facility buildout and equipment and (ii) $74.7 million of facility buildout expenditures that are owned and controlled by Lonza, including the Repurposing Fee, which have been accounted for as prepaid lease payments and will be recorded as a right-of-use ("ROU") asset under Accounting Standards Codification (“ASC”) 842 lease accounting when control over the Suite is transferred to us, which we expect to occur when the buildout of the Suite is complete and manufacturing activities commence.

  1. Leases

Operating Lease Obligations

Office Facility

In January 2021, we entered into a lease agreement (the “Original Lease”) for our current corporate headquarters facility located in San Carlos, California (the “Headquarters Facility”). The lease term began on December 3, 2021, as amended on October 17, 2023, and was set to expire on December 31, 2025.

In September 2023, we entered into an assignment and assumption of lease agreement (the “Assignment Agreement”) for an expanded lease space in the same building as our Headquarters Facility (the “Assumed Lease Premises”). The assumed lease had an original contractual term of 10 years, set to expire on November 30, 2031. Pursuant to the Assignment Agreement, the base rent was abated for three full calendar months following the October 1, 2023 effective date of the Assignment Agreement. Thereafter, we were obligated to pay an aggregate of approximately $1.9 million in rent payments for the remaining nine months of the first year, with a 3% rent adjustment (not inclusive of rent abatement) every year thereafter.

In November 2024, we amended and restated the Original Lease (the “Amended and Restated Lease”) as a single, unified lease for our Headquarters Facility which includes the existing space under the Original Lease, Assumed Lease Premises (the “Existing Premises”) and expanded space covering additional floors (the “Additional Premises”), which resulted in a lease modification in accordance with ASC 842. The Amended and Restated Lease has an initial contractual term of 10 years, contains rent-free periods, scheduled rent increases, lease incentives and the option oftwo consecutive rights to extend the term for 60 months each. The effective date of the Amended and Restated Lease was November 15, 2024 which, for the purposes of lease accounting, is the commencement date of the lease of the Existing Premises. The commencement date of the Additional Premises will be when certain leasehold improvements and specifications are substantially complete, the first of which occurred on February 10, 2025, and the rest of which are estimated to occur between November 2025 and June 2026, for certain office and lab spaces on the additional floors. Our Amended and Restated Lease expires on February 28, 2035.

In November 2024, we entered into a sublease agreement, for which we are sublessor, for a portion of our Existing Premises. This sublease has a contractual term oftwo years, expiring on December 12, 2026, unless earlier terminated, withtwo conditional options to extend the term of the sublease for a period of 12 months. The commencement date of this sublease was December 12, 2024.

In July 2024, we entered into a sublease agreement, for which we are sublessee for a new operating lease in the same campus as our corporate headquarters. This sublease has rent-free periods, scheduled rent increases, and a contractual term oftwo years, expiring on June 30, 2026, unless earlier terminated.

Manufacturing Facility

In October 2023, we entered into the Commercial Manufacturing and Supply Agreement with Lonza. We have concluded that this agreement contains an embedded lease and will be accounted for in accordance with ASC 842 Leases upon the commencement date. As of March 31, 2025, the lease had not commenced and, as such, no lease liability or ROU asset was recorded on the condensed consolidated balance sheets andno operating lease expense was recorded on the condensed consolidated statements of operations. See Note 4, “Commercial Manufacturing and Supply Agreement,” for further details.

The following tables present additional information for our operating leases:

March 31,2025December 31,2024
Weighted-average remaining lease term (in years)9.709.60
Weighted-average discount rate7.2%7.2%
Three Months EndedMarch 31,
20252024
(in thousands)
Right-of-use assets obtained in exchange for new operating lease liabilities$17,575$—
Cash paid for operating lease liabilities3,0842,390

Maturities of lease liabilities as of March 31, 2025 were as follows:

Years ending December 31,(in thousands)
Remainder of 2025$8,205
202611,761
202710,826
202811,824
202912,178
Thereafter69,006
Total future undiscounted lease payments123,800
Less: Imputed interest(36,691)
Total lease liabilities$87,109

Rent expense recognized under the leases was $3.6 million and $2.7 million for the three months ended March 31, 2025 and 2024, respectively.

  1. Commitments and Contingencies

Legal Contingencies

From time to time, we may become involved in legal proceedings arising from the ordinary course of business. We record a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated. Significant judgment by us is required to determine both probability and the estimated amount. We do not believe that there is any litigation or asserted or unasserted claim pending that could, individually or in the aggregate, have a material adverse effect on our results of operations or financial condition.

Guarantees and Indemnifications

In the normal course of business, we enter into agreements that contain a variety of representations and provide for general indemnification. Our exposure under these agreements is unknown because it involves claims that may be made against us in the future. To date, we have not paid any claims or been required to defend any action related to our indemnification obligations. As of March 31, 2025, we did not have any material indemnification claims that were probable or reasonably possible and consequently have not recorded related liabilities.

To the extent permitted under Delaware law, we have agreed to indemnify our directors and officers for certain events or occurrences while the director or officer is, or was, serving at our request in such capacity. The indemnification period covers all pertinent events and occurrences during the director’s or officer’s service. The maximum potential amount of future payments we could be required to make under these indemnification agreements is not specified in the agreements; however, we have directors and officers insurance coverage that reduces our exposure and enables us to recover a portion of any future amounts paid. We have not incurred any material costs as a result of such indemnification and are not currently aware of any indemnification claims.

Development and Manufacturing Services Agreements with Lonza

In April 2022, we entered into a non-exclusive development and manufacturing services agreement with Lonza effective as of March 22, 2022, which was subsequently amended on May 12, 2022, November 21, 2022 and October 31, 2023 (as amended, the “2022 Lonza DMSA”). Pursuant to the 2022 Lonza DMSA, Lonza is obligated to perform services including manufacturing process development and clinical manufacture and supply of our proprietary PCV candidates.

In February 2023, we entered into another non-exclusive development and manufacturing services agreement with Lonza effective as of March 1, 2023 (the “2023 Lonza DMSA”). Pursuant to the 2023 Lonza DMSA, Lonza will perform manufacturing process development and the manufacture of components for VAX-31 and VAX-24, including the polysaccharide antigens, our proprietary eCRM protein carrier and conjugated drug substances.

Under each of the 2022 Lonza DMSA and 2023 Lonza DMSA (collectively, the “Lonza Agreements”), we pay Lonza agreed-upon fees for their performance of development and manufacturing services and pass-through expenses incurred by Lonza for raw materials, as well as customary procurement and handling fees. Under each Lonza Agreement, we own all rights, title and interest in and to any and all New Customer Intellectual Property (as defined in each Lonza Agreement), and Lonza owns all rights, title and interest in New General Application Intellectual Property (as defined in each Lonza Agreement). For additional information about the Lonza Agreements, see “Certain Significant Relationships—Lonza—Development and Manufacturing Services Agreements” included in Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations of this Quarterly Report on Form 10-Q.

Commercial Manufacturing and Supply Agreement with Lonza

For details of the Commercial Manufacturing and Supply Agreement with Lonza, see Note 4.

Sutro Option Agreement

In December 2022, we entered into an option agreement with Sutro Biopharma (the “Option Agreement”). Pursuant to the Option Agreement, we acquired from Sutro Biopharma (i) authorization to enter into an agreement with an independent alternate CMO to directly source Sutro Biopharma’s cell-free extract, allowing us to have direct oversight over financial and operational aspects of the relationship with the CMO; and (ii)a right, but not an obligation, to obtain certain exclusive rights to internally manufacture and/or source extract from certain CMOs and the right to independently develop and make improvements to extract (including the right to make improvements to the extract manufacturing process as well as cell lines) for use in connection with the exploitation of certain vaccine compositions(the “Option”). We and Sutro Biopharma agreed to negotiate the terms and conditions of a form definitive agreement to be entered into in the event we exercised the Option, which would include the terms and conditions set forth in an executed term sheet between us (the “Term Sheet”) and such terms that were necessary to give effect to each of the terms and conditions set forth in the Term Sheet (the “Form Definitive Agreement”).

As consideration for the Option and other rights and authorizations granted to us under the Option Agreement, we paid Sutro Biopharma upfront consideration of $22.5 million, consisting of (i) $10.0 million in cash and $7.5 million worth of shares of our common stock (the number of shares calculated based on the arithmetic average of the daily volume weighted average price of our common stock as traded on Nasdaq in the three consecutive trading days immediately prior to the issuance thereof) in December 2022, and (ii) $5.0 million in October 2023 within five business days after we and Sutro Biopharma mutually agreed in writing upon the Form Definitive Agreement on September 28, 2023. The 167,780 shares of common stock issued was recorded at fair value of $8.0 million on the date of settlement, December 22, 2022.

On November 21, 2023 (the “Option Exercise Date”), we exercised the Option by submitting written notice thereof to Sutro Biopharma and concurrently paid Sutro Biopharma $50.0 million in cash as the first of two installment payments for the Option exercise price, followed by the second and final installment of $25.0 million in cash in May 2024. We determined there was no current alternative future use of the acquired manufacturing rights from the Option Agreement and, as a result, the amounts paid were expensed as incurred. Upon the occurrence of certain regulatory milestones, we agreed to pay Sutro Biopharma certain additional milestone payments totaling up to $60.0 million in cash. In the event that we undergo a change of control, certain rights and payments may be accelerated.

Manufacturing Rights Agreement with Sutro Biopharma

Concurrent with the payment of the first installment of the Option exercise price pursuant to the Option Agreement, on November 21, 2023, the manufacturing rights agreement (in the form of the Form Definitive Agreement) between us and Sutro Biopharma (the “Manufacturing Rights Agreement”) became effective. Pursuant to the Manufacturing Rights

Agreement, we obtained exclusive rights to independently, or through certain third parties, develop, improve and manufacture cell-free extract for use in connection with our vaccine candidates.

For additional information about the Manufacturing Rights Agreement, see “Certain Significant Relationships—Sutro Biopharma—Manufacturing Rights Agreement with Sutro Biopharma” included in Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations of this Quarterly Report on Form 10-Q.

Purchase Commitments

We enter into agreements in the normal course of business with CMOs and other vendors for manufacturing services and raw materials purchases. We rely on several third-party manufacturers for our manufacturing requirements. As of March 31, 2025, we had the following amounts of non-cancelable purchase commitments related to manufacturing services and raw materials purchased due to our key manufacturing partners. These amounts represent our minimum contractual obligations, including termination fees. If we terminate certain firm orders with key manufacturing partners, we will be required to pay for the manufacturing services scheduled or raw materials purchased under our arrangements. The actual amounts we pay in the future to our vendors under such agreements may differ from the purchase order amounts.

Years ending December 31,(in thousands)
Remainder of 2025$265,216
2026111,727
2027733
2028527
Total non-cancelable purchase commitments due to our key manufacturing partners$378,203
  1. Stockholders' Equity

Preferred Stock

Our certificate of incorporation authorizes us to issue up to 10,000,000 shares of preferred stock with $0.001 par value per share. There wereno shares of preferred stock issued or outstanding as of March 31, 2025 or December 31, 2024.

Common Stock

Our certificate of incorporation authorizes us to issue up to 500,000,000 shares of common stock with $0.001 par value per share, of which 128,939,412 and 124,893,034 shares were issued and outstanding as of March 31, 2025 and December 31, 2024, respectively.

ATM Program

In July 2021, we entered into an Open Market Sales Agreement SM (the “Original ATM Sales Agreement”) with Jefferies LLC (“Jefferies”), to issue and sell, from time to time at our discretion, shares of our common stock at an aggregate offering price up to $150.0 million through Jefferies acting as our sales agent or principal. As of February 27, 2023, we had sold 4,995,709 shares of our common stock under the Original ATM Sales Agreement at a weighted average price of $27.57 per share for aggregate gross proceeds of $137.8 million. On February 27, 2023, we and Jefferies entered into an amendment to the Original ATM Sales Agreement (as amended, the “Amended ATM Sales Agreement”) to offer and sell additional shares of our common stock with an aggregate offering price up to another $400.0 million, which is in addition to the $150.0 million aggregate offering price under the Original ATM Sales Agreement. We will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any common stock sold through Jefferies under the Amended ATM Sales Agreement; however, we are not obligated to make any sales of common stock. As of March 31, 2025, we have sold 4,211,367 shares of our common stock under the Amended ATM Sales Agreement at a weighted average price of $64.19 per share for aggregate gross proceeds of $270.3 million ($264.2 million net of commissions and offering expenses) with $129.7 million remaining for future sales under the Amended ATM Sales Agreement. We have made no sales under the Amended ATM Sales Agreement since August 2024.

Underwritten Follow-on Public Offerings

On January 13, 2022, we completed an underwritten public offering in which we issued 2,500,000 shares of our common stock at a price of $20.00 per share and pre-funded warrants to purchase 2,500,000 shares of our common stock at a price of $19.999 per underlying share. Each pre-funded warrant has an exercise price of $0.001 per share. In February 2022, the underwriters exercised their option to purchase an additional 750,000 shares of common stock. In aggregate, we received $107.6 million in net proceeds after deducting issuance costs, and excluding the exercise of any pre-funded warrants.

On October 28, 2022, we completed an underwritten public offering of 17,812,500 shares of our common stock, which included the full exercise of the underwriters’ option to purchase an additional 2,812,500 shares, at a price of $32.00 per share and pre-funded warrants to purchase 3,750,000 shares of our common stock at a price of $31.999 per underlying share. Each pre-funded warrant has an exercise price of $0.001 per share. In aggregate, we received $651.6 million in net proceeds after deducting issuance costs, and excluding the exercise of any pre-funded warrants.

On April 21, 2023, we completed an underwritten public offering of 13,030,000 shares of our common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,830,000 shares, at a price of $41.00 per share and pre-funded warrants to purchase 1,000,000 shares of our common stock at a price of $40.999 per underlying share. Each pre-funded warrant has an exercise price of $0.001 per share. In aggregate, we received $545.3 million in net proceeds after deducting issuance costs, and excluding the exercise of any pre-funded warrants.

In February 2024, we completed an underwritten public offering of 12,695,312 shares of our common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,757,812 shares, at a price of $64.00 per share and pre-funded warrants to purchase 781,250 shares of our common stock at a price of $63.999 per underlying share. Each pre-funded warrant has an exercise price of $0.001 per share. In aggregate, we received $816.5 million in net proceeds after deducting underwriting discounts and commissions and other offering expenses payable by us, and excluding the exercise of any pre-funded warrants.

On September 6, 2024, we completed an underwritten public offering of 12,087,378 shares of our common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,893,203 shares, at a price of $103.00 per share and pre-funded warrants to purchase 2,427,184 shares of our common stock at a price of $102.999 per underlying share. Each pre-funded warrant has an exercise price of $0.001 per share. In aggregate, we received $1.4 billion in net proceeds after deducting issuance costs, and excluding the exercise of any pre-funded warrants.

The pre-funded warrants are exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and payment of the exercise price. No fractional shares of common stock will be issued in connection with the exercise of a pre-funded warrant. The holders of the pre-funded warrants may also satisfy their obligation to pay the exercise price through a “cashless exercise,” in which the holder receives the net value of the pre-funded warrant in shares of common stock determined according to the formula set forth in the pre-funded warrant.

The pre-funded warrants will not expire until they are fully exercised. However, we may not effect the exercise of any pre-funded warrants, and a holder will not be entitled to exercise any portion of any pre-funded warrants that, upon giving effect to such exercise, would cause: (i) the aggregate number of shares of our common stock beneficially owned by such holder (together with affiliates) to exceed 4.99% or 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as applicable; or (ii) the combined voting power of our securities beneficially owned by such holder (together with its affiliates) to exceed 4.99% or 9.99% of the combined voting power of all of our securities outstanding immediately after giving effect to the exercise, as applicable, as such percentage ownership is determined in accordance with the terms of the pre-funded warrants. However, any holder of a pre-funded warrant may increase or decrease such percentage to any other percentage not in excess of 19.99% upon at least 61 days' prior notice for the holder to us.

During the three months period ended March 31, 2025,1,000,000 shares and 2,500,000 shares underlying the pre-funded warrants from the January 2022 and October 2022 offerings, respectively, were exercised. As of March 31, 2025, no other shares underlying the pre-funded warrants had been exercised.

  1. Equity Incentive Plans

Equity Incentive Plans

We currently grant stock options and restricted stock units (“RSUs”) under the 2020 Equity Incentive Plan (“2020 Plan”), which became effective in June 2020 and replaced our 2014 Equity Incentive Plan (“2014 Plan”).

Effective January 1, 2025, the number of shares of common stock available under the 2020 Plan increased by 6,244,651 shares pursuant to the evergreen provision of the 2020 Plan. As of March 31, 2025, an aggregate of 9,723,621 shares of common stock were available for issuance under the 2020 Plan.

Our 2014 Plan permitted the granting of incentive stock options, non-statutory stock options, restricted stock and other stock-based awards. Subsequent to the adoption of the 2020 Plan, no additional equity awards can be made under the 2014 Plan. As of March 31, 2025,943,393 shares and 9,723,621 shares of common stock were subject to outstanding options and RSUs under the 2014 Plan and 2020 Plan, respectively.

Stock Option Activity

Stock option activity under our 2020 Plan, including performance contingent stock options ("PCSOs"), and 2014 Plan, which excludes options to purchase 29,638 shares granted outside of the 2020 Plan and 2014 Plan, was as follows:

Options Outstanding · PCSOs Outstanding
(in thousands, except share and per share data)
Stock Option Activity · NumberofOptions · Weighted-AverageExercisePrice PerShare · Weighted-AverageRemainingContractual Term(Years) · AggregateIntrinsicValue · NumberofOptions · Weighted-AverageExercisePrice PerShare · Weighted-AverageRemainingContractual Term(Years) · AggregateIntrinsicValue
Balances — December 31, 20249,366,936$39.407.48$406,730$639,710$102.709.85$—
Options granted1,137,82375.83——
Options exercised (1)(440,454)13.97——
Options forfeited(37,001)62.75——
Balances — March 31, 202510,027,304$44.567.70$78,996$639,710$102.709.60$—
Vested and expected to vest — March 31, 202510,027,304$44.567.70$78,996$639,710$102.709.60$—
Exercisable at March 31, 20255,164,520$29.376.78$68,221$—$—

(1) Shares returned due to net exercises.

During the three months ended March 31, 2025 and 2024, options to purchase 440,454 and 631,287 shares, respectively, were exercised for cash at a weighted-average price per share of $13.97 and $72.85, respectively. The weighted-average grant date fair value of options granted for the three months ended March 31, 2025 and 2024 was $46.04 and $47.28, respectively. The intrinsic value of the stock options exercised was $31.0 million and $38.1 million for the three months ended March 31, 2025 and 2024, respectively.

RSU Activity

RSU activity, including performance-based stock units ("PSUs"), for the three months ended March 31, 2025 was as follows:

Unvested RSUs · Unvested PSUs
(in thousands, except share and per share data)
Number of Shares · Weighted-AverageGrant-DateFair Value · Weighted-Average Remaining Contractual Term · AggregateIntrinsicValue · Number of Shares · Weighted-AverageGrant-DateFair Value · Weighted-Average Remaining Contractual Term · AggregateIntrinsicValue
Unvested at December 31, 20241,241,272$67.321.46$101,611175,513$151.483.85$14,367
Granted696,76373.57——
Vested and released(180,269)52.44——
Cancelled(15,213)70.46——
Unvested at March 31, 20251,742,553$71.331.59$65,799175,513$151.483.61$6,627

The weighted-average grant date fair value of RSUs granted during the three months ended March 31, 2025 and 2024 was $73.57 and $73.42, respectively. The aggregate fair value of unvested RSUs is calculated using the closing price of our common stock on the grant date. As of March 31, 2025 and 2024, the unrecognized stock-based compensation cost of unvested RSUs was $139.3 million and $62.6 million, respectively, which is expected to be recognized over a weighted-average period of 3.06 years and 2.97 years, respectively.

Shares available for grant under our 2020 Plan for the three months ended March 31, 2025 were as follows:

Number of Shares
Balance — December 31, 20246,275,934
Shares authorized6,244,651
Shares expired(166)
Options and RSUs granted(1,834,586)
Shares forfeited (1)53,283
Shares withheld for taxes73,235
Balance — March 31, 202510,812,351

(1) As of March 31, 2025, a total of 1,069 shares were forfeited under the 2020 Plan due to net exercises of stock options.

Stock-based Compensation

The following assumptions were used in the Black-Scholes options pricing model for stock options granted in the respective period of:

Three Months Ended March 31,
20252024
Expected volatility67.3% - 67.5%73.2% - 73.5%
Expected term (in years)5.2 - 5.35.4
Risk-free interest rate4.1% - 4.5%4.0% - 4.3%

Our expected dividend yield is zero as we have not declared and do not anticipate declaring any dividends.

We recorded total stock-based compensation expense for the three months ended March 31, 2025 and 2024 related to the 2014 Plan, the 2020 Plan and the 2020 ESPP in the condensed consolidated statements of operations and allocated the amounts as follows:

Three Months Ended March 31,
20252024
(in thousands)
Research and development$15,925$8,818
General and administrative14,6908,811
Total$30,615$17,629

As of March 31, 2025, there was $356.6 million of unrecognized stock-based compensation expense related to unvested employee and non-employee awards, which is expected to be recognized over a weighted-average period of 2.91 years.

  1. Funding Arrangements

Our vaccine development program for VAX-A1, a novel conjugate vaccine candidate designed to prevent disease caused by Group A Streptococcus, has been funded in part by a grant obtained from Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (“CARB-X”), a global non-profit partnership dedicated to accelerating antibacterial innovation to tackle the rising global threat of drug-resistant bacteria. The CARB-X grant provided funding of $11.7 million upon the achievement of VAX-A1 development milestones through June 2024. As of the second quarter of 2024, all of these milestones had been successfully achieved, and no further amounts will be funded under this CARB-X grant.

Our vaccine development program for VAX-GI, a novel preclinical vaccine candidate being developed as a preventative treatment for dysentery and shigellosis, which is caused by Shigella bacteria, is currently funded in part by two grants obtained from the National Institutes of Health (“NIH”) administered by the University of Maryland, Baltimore. Our first grant from the NIH was awarded in April 2021 and provides for potential funding up tofive years totaling approximately $0.5 million. In June 2023, we received another grant from the NIH that provides for potential funding up tofive years totaling approximately $4.6 million. As of March 31, 2025, we have received and expect to continue to receive funding under each of these grants.

We are currently working on a discovery program with the University of North Carolina at Chapel Hill and the University of Chicago to develop a vaccine candidate for the prevention of Chlamydia, which is funded in part by a grant from the National Institute of Allergy and Infectious Diseases that provides potential funding up tofive years totaling approximately $9.5 million. As of March 31, 2025, we have received and expect to continue to receive funding under this grant.

Income from grants is recognized in the period during which the related specified expenses are incurred, provided that the conditions under which the grants were provided have been met. The amount of grant income wasnot material during the three months ended March 31, 2025 and March 31, 2024. A grant receivable of $0.3 million and $0.4 million representing unreimbursed, eligible costs incurred under the agreements was recorded and included in Prepaid expenses and other current assets in the condensed consolidated balance sheets as of March 31, 2025 and December 31, 2024, respectively.

  1. Net Loss Per Share

The following table sets forth the computation of basic and diluted net loss per share and excludes shares which are outstanding, but subject to repurchase by us:

Three Months Ended March 31,
20252024
Net loss (in thousands)$(140,718)$(95,020)
Weighted-average shares outstanding used in computing net loss per share, basic and diluted(1)135,690,949111,690,951
Net loss per share, basic and diluted$(1.04)$(0.85)

(1) Includes shares of common stock into which pre-funded warrants may be exercised as of March 31, 2025. See Note 7, “Stockholders' Equity.”

The following potentially dilutive securities outstanding as of the periods presented below were excluded from the computation of diluted net loss per share for the three months ended March 31, 2025 and 2024 because including them would have been anti-dilutive:

March 31,
20252024
Stock options10,696,65211,302,590
Restricted stock units1,918,0661,204,939
Employee Stock Purchase Plan shares114,206104,775
Total12,728,92412,612,304
  1. Income Taxes

In determining quarterly provisions for income taxes, we use the annual estimated effective tax rate applied to the actual year-to-date profit or loss, adjusted for discrete items arising in that period. Our annual estimated effective tax rate differs from the U.S. federal statutory rate primarily as a result of changes in our valuation allowance against our deferred tax assets. During the three months ended March 31, 2025 and 2024, we incurred net pre-tax losses in the jurisdictions we operate in and hadno income tax provisions. During the three months ended March 31, 2025, there were no material changes to our unrecognized tax benefits, and we do not expect to have any significant changes to unrecognized tax benefits through the end of the fiscal year. We do not have any tax audits or other issues pending.

  1. Segment Reporting

We operate and manage our business asone reportable and operating segment. Our chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance based on consolidated net loss, as is reported in our condensed consolidated statements of operations.

Our long-lived assets are based in the United States and Switzerland. Long-lived assets are comprised of property and equipment. As of March 31, 2025 and December 31, 2024, property and equipment based in the United States was $40.5 million and $40.8 million, respectively. As of March 31, 2025 and December 31, 2024, property and equipment based in Switzerland was $176.6 million and $157.2 million, respectively.

This following table presents segment operation results for the three months ended March 31, 2025 and 2024:

Three Months EndedMarch 31,
20252024
Operating expenses:
Research and development - external costs (1)$103,806$69,637
Research and development - internal costs (2)44,32824,950
General and administrative32,65919,885
Total operating expenses$180,793$114,472
Total other income, net$40,075$19,452
Net loss$140,718$95,020

(1)Research and development - external costs consist of product manufacturing costs, clinical costs, research and development consumables, lab supplies and equipment, facility and allocated costs, and other external costs.

(2)Research and development - internal costs consist of internal employee costs including stock-based compensation expenses.

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