Core Insights - Vaxcyte, Inc. is advancing its VAX-31 infant Phase 2 randomized, dose-finding study to the final stage, focusing on a 31-valent pneumococcal conjugate vaccine designed to prevent invasive pneumococcal disease (IPD) in infants [1][2][3] - The VAX-31 Optimized Dose aims to elicit stronger immune responses in infants, with the majority of serotypes dosed at 4.4mcg and the balance at 3.3mcg, potentially covering approximately 92% of IPD and 93% of acute otitis media in U.S. children under five [1][3][6] - The company plans to release topline data from the primary immunization series and booster dose by the end of the first half of 2027 [1][2] Company Overview - Vaxcyte is a clinical-stage vaccine innovation company focused on developing high-fidelity vaccines to combat bacterial diseases [1][8] - The company is also developing VAX-24, a 24-valent PCV candidate, which aims to cover more serotypes than any existing infant PCV on the market [8][9] - Vaxcyte utilizes the XpressCF platform for cell-free protein synthesis, enhancing its ability to produce complex vaccines [9] Study Details - The VAX-31 infant Phase 2 study is a randomized, double-blind, active-controlled trial evaluating safety, tolerability, and immunogenicity compared to Prevnar 20 (PCV20) [4][10] - The study will enroll approximately 900 participants, including those previously in the Low Dose arm, and will assess immune responses through serotype-specific immunoglobulin G (IgG) seroconversion rates [2][10] - The study consists of three stages, with the first stage completed and the second stage modified to include the new Optimized Dose arm [4][10] Disease Context - Pneumococcal disease, caused by Streptococcus pneumoniae, is a leading cause of vaccine-preventable deaths among children under five, with significant morbidity and mortality [5][6] - The disease can lead to severe conditions such as meningitis and bacteremia, highlighting the urgent need for a broader-spectrum vaccine [5][6] Regulatory Status - The FDA has expanded the Breakthrough Therapy designation for VAX-31 to include the prevention of pneumonia caused by Streptococcus pneumoniae, indicating potential substantial improvement over existing therapies [7]

Financial Agreements and Payments - The company entered into an option agreement with Sutro Biopharma in December 2022, paying $22.5 million upfront, which included $10.0 million in cash and $7.5 million in common stock[72][73]. - On November 21, 2023, the company exercised the option, paying $50.0 million in cash as the first installment, with a second installment of $25.0 million due in May 2024[74]. - The company agreed to pay Sutro Biopharma additional milestone payments totaling up to $60.0 million upon achieving certain regulatory milestones[74]. Share Issuance and Stock Options - The company has sold 4,211,367 shares under the Amended ATM Sales Agreement at a weighted average price of $64.19 per share, generating $270.3 million in gross proceeds[81]. - The company completed an underwritten public offering on September 6, 2024, raising $1.4 billion in net proceeds after deducting issuance costs[86]. - As of June 30, 2025, the company had 10,017,589 shares available for issuance under the 2020 Equity Incentive Plan[91]. - The company issued 2,500,000 shares at $20.00 per share in January 2022, resulting in net proceeds of $107.6 million[82]. - The company has 129,816,472 shares of common stock outstanding as of June 30, 2025[80]. - The company has recorded 862,884 shares subject to outstanding options under the 2014 Plan as of June 30, 2025[92]. - As of June 30, 2025, the company had 10,465,014 stock options outstanding with a weighted average exercise price of $44.36 and an intrinsic value of $54,196,000[93]. - For the six months ended June 30, 2025, the company exercised options for 549,602 shares at a weighted average price of $13.00, resulting in an intrinsic value of $33.3 million[94]. - The total stock-based compensation expense for the six months ended June 30, 2025 was $67.5 million, compared to $39.2 million for the same period in 2024[100]. - The unrecognized stock-based compensation cost related to unvested RSUs and PSUs as of June 30, 2025 was $134.9 million, expected to be recognized over a weighted average period of 2.92 years[96]. - The weighted average grant date fair value of options granted for the six months ended June 30, 2025 was $37.66, down from $45.86 in 2024[94]. - The company had 1,964,301 unvested RSUs as of June 30, 2025, with a weighted average grant-date fair value of $66.01[96]. - The total number of stock options outstanding increased from 9,366,936 on December 31, 2024 to 10,465,014 on June 30, 2025[93]. Financial Performance - The net loss for the three months ended June 30, 2025 was $166.6 million, compared to a net loss of $128.7 million for the same period in 2024[106]. - The net loss for the six months ended June 30, 2025, was $307.3 million, compared to a net loss of $223.7 million for the same period in 2024, reflecting a 37% increase[112]. - Total operating expenses for the three months ended June 30, 2025, were $226.2 million, a 48% increase from $153.0 million in the same period of 2024[112]. - Research and development external costs for the three months ended June 30, 2025, were $144.7 million, up 42% from $101.8 million in 2024[112]. Cash and Investments - As of June 30, 2025, the company had approximately $2.8 billion in cash, cash equivalents, and investments, down from $3.1 billion as of December 31, 2024[208]. - The company reported interest income of $31.1 million for the three months ended June 30, 2025[208]. - A hypothetical 10% increase in interest rates would result in a $10.5 million impact on net assets as of June 30, 2025[208]. Foreign Currency and Inflation - Foreign currency denominated accounts payable and accrued expenses were $91.7 million as of June 30, 2025, compared to $72.4 million as of December 31, 2024[210]. - The company had foreign currency denominated property, plant, and equipment valued at $202.9 million as of June 30, 2025, an increase from $157.6 million in 2024[210]. - Inflation has increased costs, particularly in labor and research and development, but the company does not believe it had a material effect on operations during the reported periods[212]. - The company intends to evaluate alternative strategies, including hedging, to mitigate foreign currency exposure as risks increase in the future[210]. Funding and Development Programs - The company has received funding of $11.7 million for its VAX-A1 vaccine development program, with all milestones achieved as of the second quarter of 2024[101].

Financial Performance - Vaxcyte reported approximately $2.8 billion in cash, cash equivalents, and investments as of June 30, 2025, down from $3.1 billion at the end of 2024[11]. - The net loss for Q2 2025 was $166.6 million, compared to a net loss of $128.7 million in Q2 2024[17]. - Total operating expenses for the first half of 2025 reached $407,012,000, compared to $267,453,000 in the same period of 2024, reflecting a 52.3% increase[21]. - Net loss for Q2 2025 was $166,573,000, compared to a net loss of $128,703,000 in Q2 2024, representing a 29.4% increase in losses[21]. - Interest income for Q2 2025 was $31,073,000, an increase from $23,813,000 in Q2 2024, marking a 30.5% rise[21]. - Total stockholders' equity as of June 30, 2025, was $3,071,334,000, down from $3,305,819,000 at the end of 2024[23]. - Total assets decreased to $3,305,363,000 as of June 30, 2025, from $3,511,318,000 at the end of 2024[23]. Research and Development - R&D expenses increased to $194.2 million for Q2 2025, compared to $131.5 million for the same period in 2024, primarily due to development activities for PCV programs[17]. - Research and development expenses for Q2 2025 were $194,179,000, a 47.5% increase from $131,507,000 in Q2 2024[21]. - The company is continuing the VAX-31 infant Phase 2 dose-finding study and plans to initiate VAX-31 adult Phase 3 studies[18]. - The company plans to initiate the Phase 3 pivotal, non-inferiority study for VAX-31 in Q4 2025, with topline data expected in 2026[12]. - Vaxcyte modified the ongoing VAX-31 infant Phase 2 study to include an optimized dose arm, with topline data expected by the end of the first half of 2027[6]. - Multiple Phase 3 data readouts for VAX-31 are anticipated in 2026 and 2027 to support a potential Biologics License Application submission[4]. - Vaxcyte is streamlining its early-stage pipeline to prioritize resources for its PCV programs, pausing development on certain candidates[7]. Expenses - G&A expenses rose to $32.0 million in Q2 2025, up from $21.5 million in Q2 2024, mainly due to higher personnel costs[17]. - The company reported total stock-based compensation expenses of $36,927,000 in Q2 2025, compared to $21,558,000 in Q2 2024, indicating a 71.3% increase[21]. - The company has incurred $290.6 million in capital and facility buildout expenditures for a dedicated manufacturing suite, with total costs expected to reach $300-$350 million[17]. Regulatory and Market Developments - The FDA expanded the Breakthrough Therapy designation for VAX-31 to include the prevention of pneumonia, in addition to invasive pneumococcal disease[5]. - Vaxcyte's management anticipates potential delays in obtaining required regulatory approvals for its vaccine candidates[18].

Core Insights - Vaxcyte is advancing the development of VAX-31, a potential new standard-of-care pneumococcal conjugate vaccine (PCV) for adults and infants, with significant clinical and regulatory progress expected in the coming years [1][2][3] PCV Program Updates - The company is finalizing the Phase 3 clinical program for VAX-31 in adults, with a pivotal, non-inferiority study expected to start in Q4 2025 and topline data anticipated in 2026 [1][4][5] - The FDA has provided input on licensure requirements for the adult program, indicating that the planned immunogenicity and safety assessments align with precedent requirements [4][5] - For the pediatric program, the ongoing Phase 2 dose-finding study has been modified to include an optimized dose arm, with enrollment expected to proceed by the end of Q3 2025 and topline data anticipated by mid-2027 [1][6] Financial Position - As of June 30, 2025, the company reported approximately $2.8 billion in cash, cash equivalents, and investments, down from $3.1 billion at the end of 2024 [1][13][24] - The company expects its cash runway to extend to mid-2028, supporting ongoing development and potential commercialization of its PCV programs [13][24] Research and Development Expenses - R&D expenses for Q2 2025 were $194.2 million, an increase from $131.5 million in Q2 2024, primarily due to development activities related to the adult and infant PCV programs [13][16][20] - General and administrative expenses also increased to $32.0 million in Q2 2025 from $21.5 million in Q2 2024, reflecting higher personnel costs [20] Executive Leadership - Chris Griffith has been appointed as Chief Business and Strategy Officer, bringing over 20 years of experience to support the company's strategic initiatives [8][9] Upcoming Milestones - Key upcoming milestones include the initiation of the Phase 3 pivotal study for VAX-31 in adults in Q4 2025 and the announcement of topline data from the modified Phase 2 study for infants by mid-2027 [10][14][15]

VAX-31 Phase 1/2 Study Results Overview - VAX-31 demonstrated a safety profile similar to Prevnar 20® (PCV20) at all doses studied[14] - VAX-31 induced robust OPA immune responses for all 31 serotypes (STs) at all doses studied, with all three doses advanceable to Phase 3[14] - The VAX-31 data validate the potential of Vaxcyte's carrier-sparing platform to deliver the broadest-spectrum PCVs[15] Immunogenicity Data - High and Middle doses of VAX-31 met or exceeded OPA regulatory immunogenicity criteria for all 31 STs, while the Low dose met the criteria for 29 of 31 STs[17] - For the 20 STs common with PCV20, the High dose had 18 with GMR greater than 10, the Middle dose had 13 with GMR greater than 10, and the Low dose had 8 with GMR greater than 10[17] - For the 11 additional STs unique to VAX-31, all 11 met the superiority criteria at all doses[17] Clinical Development Plan - Vaxcyte plans to initiate a Phase 3 pivotal, non-inferiority study for VAX-31 in adults by mid-2025, with topline results expected in 2026[18] - Vaxcyte plans to initiate a VAX-31 infant Phase 2 study in 1Q:2025 following IND submission and clearance[18] Market Opportunity - The pneumococcal vaccine market is expected to reach approximately $13 billion by 2027[105] - VAX-31 is designed to increase coverage to more than 95% of IPD circulating in U S adults[104]

Summary of Vaxide Conference Call Company Overview - Vaxide was co-founded twelve years ago, based on a proprietary cell-free protein synthesis platform originally developed at Stanford [3][4] - The company holds exclusive rights to this technology for vaccine development, focusing on a 31-valent pneumococcal conjugate vaccine [4][5] Industry Context - The pneumococcal vaccine market is currently valued at $8 billion, with a significant portion of sales historically in the pediatric segment [4][29] - The current standard of care vaccine only covers about 50% of circulating pneumococcal diseases, while Vaxide's 31-valent vaccine aims to cover 95-98% [8][34] Key Developments - Vaxide is preparing to initiate Phase III trials for its 31-valent vaccine for adults, with expectations to start mid-2025 [44][49] - The adult vaccination landscape is evolving, with the U.S. now vaccinating adults starting at age 50 instead of 65, which is expected to drive future growth [30][33] Regulatory Environment - Recent changes in CDC and FDA policies have created uncertainty, but the management believes the underlying substance of these changes is less impactful than the headlines suggest [15][16] - Vaxide has received breakthrough therapy designation from the FDA, allowing for more frequent interactions and potentially accelerated review processes [25][49] Competitive Landscape - Pfizer has historically dominated the pneumococcal vaccine market with its Prevnar franchise, but new entrants like Merck are increasing competition [28][35] - Vaxide's technology allows for higher valency vaccines without the issue of carrier suppression, which has limited competitors [36][39] Clinical Data and Pipeline - Vaxide's VAX 24 showed positive results in pediatric studies, with good immune responses and tolerability, despite some noninferiority misses [57][62] - The company is optimistic about its VAX 31 infant study, which is currently underway, and expects to have data by mid-next year [64][66] Manufacturing and Commercialization Strategy - Vaxide has partnered with Lonza for manufacturing, ensuring commercial-scale production readiness ahead of product launch [55][56] - The company plans to commercialize independently in the U.S. and major markets, with potential partnerships in regions where establishing a commercial presence may be challenging [53][54] Future Opportunities - Vaxide is also exploring other vaccine candidates, with the group A strep vaccine seen as having the most promise due to high unmet need and potential for success [79][80] - The company aims to leverage its technology to address antimicrobial resistance through vaccines, which is a growing global concern [82] Conclusion - Vaxide is positioned to capitalize on the growing pneumococcal vaccine market with its innovative technology and upcoming clinical trials, while also exploring additional vaccine opportunities to address significant health challenges.

Summary of the Conference Call Company Overview - The conference featured Backside, a biotech company focusing on pneumococcal vaccines, with key executives including CEO Grant, CFO Andrew, and COO Jim participating in the discussion [1][2]. Recent Updates - Backside disclosed positive clinical data for its 24-valent vaccine in infants in March, which has been confirmed by external experts [4][5]. - The company is preparing to start its Phase III adult VAX-31 vaccine trial by mid-year, with a focus on non-inferiority immunogenicity as the primary study endpoint [9][10]. Market Insights - The adult pneumococcal conjugate vaccine (PCV) market is valued at $8 billion, with the adult segment currently comprising 15-20% of sales but expected to grow significantly due to recent regulatory changes [14][15]. - The U.S. has expanded its vaccination mandate to include adults aged 50 and above, increasing the addressable population by 65 million [15][16]. Competitive Landscape - Backside is the first company to take a 30+ valent vaccine into clinical trials, positioning itself as a leader in the market [49]. - Competitors like Pfizer, GSK, and Merck are attempting to catch up by developing their own higher-valent vaccines [49][50]. Vaccine Development and Technology - Backside's VAX-31 program aims to achieve over 90% coverage compared to the current standard of care, Prevnar 20, which offers around 69% coverage [31][36]. - The company has demonstrated a unique ability to avoid carrier suppression, allowing for better immune responses with higher doses [19][45]. Regulatory Environment - The FDA has shown consistent support for science-driven vaccine development, and Backside has maintained positive interactions with the agency despite leadership changes [6][11]. - The FDA considers the totality of data, including the magnitude of immune responses and the prevalence of circulating diseases, when evaluating vaccine efficacy [35][38]. Financial Position - Backside reported having nearly $3 billion in cash, which is expected to fund all upcoming Phase III studies and important Phase II readouts [52][53]. - The company is reviewing its capital allocation strategy to enhance its financial position and extend its cash runway [53]. Key Upcoming Events - The next significant data readout for the VAX-24 program is expected by the end of the year, which will provide further insights into the vaccine's efficacy [22][30]. - The VAX-31 program is anticipated to yield data next year, which is critical for the company's future development plans [30][31]. Conclusion - Backside is well-positioned in the pneumococcal vaccine market with promising clinical data, a strong financial position, and a clear strategy for future growth and regulatory engagement [52][53].

Summary of the Conference Call Company Overview - The conference featured Backside, a biotech company focusing on pneumococcal vaccines, with key executives including CEO Grant, CFO Andrew, and COO Jim participating in the discussion [1][2]. Recent Updates and Pipeline - Backside disclosed positive clinical data for its 24-valent vaccine in infants in March, which has been confirmed by external experts [4][5]. - The company is on track to start its Phase III adult VAX-31 pneumococcal vaccine study by mid-year, with data expected next year [9][10]. - Backside has breakthrough therapy designation, allowing for frequent interactions with the FDA, which have remained consistent despite recent leadership changes [9][11]. Market Insights - The adult pneumococcal conjugate vaccine (PCV) market is valued at $8 billion, with the adult segment currently comprising 15% to 20% of sales but expected to grow significantly due to new vaccination guidelines [14][15]. - The recent lowering of the age cutoff for vaccination from 65 to 50 years in the U.S. increases the addressable population by approximately 65 million Americans [15][16]. - Other countries are also beginning to mandate universal vaccination, indicating a potential global market expansion [16]. VAX-31 Program - VAX-31 is positioned to provide over 95% coverage compared to competitors, which offer around 50-60% [19]. - The company has demonstrated a unique ability to avoid carrier suppression, which is a common issue in the development of conjugate vaccines [19][20]. - The upcoming Phase II readout for VAX-24 is expected to provide further insights into the vaccine's efficacy and safety profile [22][30]. Regulatory Environment - The FDA is expected to consider the totality of data when evaluating new vaccines, including the risk-benefit ratio and the magnitude of immune responses [35][36]. - Backside's data shows strong immune responses for serotypes that are circulating, which is a favorable factor in regulatory assessments [36][38]. Competitive Landscape - Backside is the first company to take a 30+ valent vaccine into clinical trials, prompting competitors to adjust their strategies [49]. - The company has observed competitive reactions, with other firms attempting to match their advancements in vaccine coverage [49][50]. Financial Position and Capital Allocation - Backside reported having nearly $3 billion on its balance sheet, allowing it to fund upcoming Phase III studies and important Phase II readouts [52]. - The company is reviewing its investment priorities and capital allocation to enhance its competitive advantage and extend its cash runway [53]. Conclusion - Backside is well-positioned in the pneumococcal vaccine market with a strong pipeline, positive clinical data, and a solid financial foundation, while navigating a supportive regulatory environment and competitive landscape [54][56].

Summary of Vaxcyte (PCVX) Conference Call Company Overview - Vaxcyte is a clinical-stage biotechnology company focused on developing next-generation pneumococcal vaccines, particularly the PPD franchise [2][3][4] Core Points and Arguments Development Programs - The company is preparing to initiate a Phase III program for its adult pneumococcal vaccine, with positive data recently unveiled for the infant indication [4][8] - The Phase III program is expected to start by mid-2025, with a non-inferiority study reading out in 2026 and additional studies concluding by 2027 [8][9] Regulatory Environment - Vaxcyte is operating under a breakthrough therapy designation, allowing for more frequent discussions with the FDA [16][17] - The company does not anticipate the need for placebo-controlled trials for its vaccines, given established safety and efficacy [14][15] Competitive Landscape - Vaxcyte's 31-valent vaccine is positioned to be competitive in the market, with a focus on demonstrating expanded coverage for adults previously vaccinated with other pneumococcal vaccines [11][12][27] - The company believes that having the broadest serotype coverage (95% disease coverage) will provide a competitive advantage [27][30] Financial Position - As of March 31, Vaxcyte reported approximately $3 billion on its balance sheet, which is expected to support key milestones through 2027 [59][61] - The company is evaluating its investment priorities to further strengthen its financial position [61] Manufacturing Readiness - Vaxcyte plans to launch its adult vaccine from existing facilities and is building a new dedicated facility with Lonza, expected to be completed early next year [62][63] Important but Overlooked Content - The company is closely monitoring the macro environment, including potential policy changes in Washington, but asserts that these have not impacted its fundamental mission [5][6] - Vaxcyte is exploring higher doses in its ongoing studies to optimize the immune response for its vaccines [44][45] - The company is addressing enrollment dynamics for its trials, noting a slight decrease in infant enrollment but compensating by increasing the number of sites [57][58] This summary encapsulates the key points discussed during the Vaxcyte conference call, highlighting the company's strategic direction, competitive positioning, and financial health.

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) Vaxcyte's unaudited condensed consolidated financial statements for Q1 2025 show a net loss of $140.7 million, increased R&D expenses, and total assets of $3.38 billion Condensed Consolidated Balance Sheet Highlights (unaudited) | (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $346,850 | $387,878 | | Total current assets | $1,716,563 | $1,787,985 | | Total assets | $3,378,103 | $3,511,318 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $96,996 | $140,180 | | Total liabilities | $178,077 | $205,499 | | Total stockholders' equity | $3,200,026 | $3,305,819 | Condensed Consolidated Statements of Operations Highlights (unaudited) | (in thousands, except per share data) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $148,134 | $94,587 | | General and administrative | $32,659 | $19,885 | | Loss from operations | $(180,793) | $(114,472) | | Interest income | $32,935 | $21,666 | | Net loss | $(140,718) | $(95,020) | | Net loss per share, basic and diluted | $(1.04) | $(0.85) | Condensed Consolidated Statements of Cash Flows Highlights (unaudited) | (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(166,274) | $(159,124) | | Net cash provided by (used in) investing activities | $123,317 | $(451,073) | | Net cash provided by financing activities | $759 | $818,196 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail Vaxcyte's accounting policies, fair value measurements, and significant agreements, including manufacturing commitments with Lonza and Sutro Biopharma - The company entered into a commercial manufacturing and supply agreement with Lonza in October 2023 for its PCV franchise. As of March 31, 2025, Vaxcyte has incurred **$171.3 million** in capital expenditures for its owned facility buildout and equipment[49](index=49&type=chunk)[50](index=50&type=chunk)[53](index=53&type=chunk) - In November 2023, the company exercised its option with Sutro Biopharma, paying **$50.0 million** as a first installment for manufacturing rights. A final installment of **$25.0 million** was paid in May 2024. Additional milestone payments could total up to **$60.0 million**[70](index=70&type=chunk) Non-cancelable Purchase Commitments (as of March 31, 2025) | Years ending December 31, | Amount (in thousands) | | :--- | :--- | | Remainder of 2025 | $265,216 | | 2026 | $111,727 | | 2027 | $733 | | 2028 | $527 | | **Total** | **$378,203** | - As of March 31, 2025, the company had **$356.6 million** of unrecognized stock-based compensation expense, expected to be recognized over a weighted-average period of 2.91 years[95](index=95&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Vaxcyte's financial condition, operational results, and business outlook, highlighting pipeline advancements, increased expenses, and sufficient liquidity for the next 12 months [Overview and Pipeline](index=25&type=section&id=Overview%20and%20Pipeline) Vaxcyte is a clinical-stage company developing broad-spectrum conjugate vaccines using its XpressCF cell-free protein synthesis platform, led by PCV candidates VAX-31 and VAX-24 - **VAX-31 (Adult):** Following positive Phase 1/2 results in September 2024 and receiving FDA Breakthrough Therapy Designation in November 2024, the company plans to initiate a pivotal Phase 3 study by mid-2025[111](index=111&type=chunk)[114](index=114&type=chunk) - **VAX-24 (Pediatric):** Announced positive topline data from the infant Phase 2 dose-finding study in March 2025, showing a safety profile similar to PCV20 and meeting key immunogenicity endpoints[114](index=114&type=chunk)[117](index=117&type=chunk) - **VAX-31 (Pediatric):** Advanced to the second and final stage of its Phase 2 study in infants in February 2025, with topline data from the primary three-dose series expected in mid-2026[116](index=116&type=chunk) - Other pipeline programs include VAX-A1 (Group A Strep), VAX-PG (periodontitis), and VAX-GI (shigellosis), all in preclinical stages[116](index=116&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Vaxcyte's net loss increased to $140.7 million in Q1 2025, primarily due to a 56.6% rise in R&D expenses and a 64.2% increase in G&A expenses Comparison of Operating Results (Three Months Ended March 31) | (in thousands) | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $148,134 | $94,587 | $53,547 | 56.6% | | General and administrative | $32,659 | $19,885 | $12,774 | 64.2% | | **Total operating expenses** | **$180,793** | **$114,472** | **$66,321** | **57.9%** | | Loss from operations | $(180,793) | $(114,472) | $(66,321) | 57.9% | | Total other income, net | $40,075 | $19,452 | $20,623 | 106.0% | | **Net loss** | **$(140,718)** | **$(95,020)** | **$(45,698)** | **48.1%** | - The **$53.5 million** increase in R&D expenses was driven by a **$27.3 million** rise in product manufacturing costs and a **$19.4 million** increase in personnel-related expenses due to headcount growth and activities supporting the PCV programs[164](index=164&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) Vaxcyte holds $3.0 billion in cash, cash equivalents, and investments, sufficient to fund operations for at least the next 12 months, despite an accumulated deficit of $1.5 billion - As of March 31, 2025, the company had **$0.3 billion** in cash and cash equivalents and **$2.6 billion** in investments[167](index=167&type=chunk) - The company believes its existing cash, cash equivalents and investments will be sufficient to fund its operating expenses and capital expenditure requirements through at least 12 months from the filing date of the report[119](index=119&type=chunk)[180](index=180&type=chunk) - Net cash used in operating activities increased to **$166.3 million** in Q1 2025 from **$159.1 million** in Q1 2024, due to higher expenditures supporting business growth and development activities[184](index=184&type=chunk)[185](index=185&type=chunk) - Net cash from financing activities was **$0.8 million** in Q1 2025, a significant decrease from **$818.2 million** in Q1 2024, which included proceeds from a follow-on offering[187](index=187&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Vaxcyte's market risks include interest rate sensitivity on its $3.0 billion investment portfolio and foreign currency exposure from Swiss Franc-denominated contracts with Lonza - A hypothetical 10% change in interest rates would impact net assets by approximately **$11.5 million** and net loss by **$3.1 million** for the quarter[198](index=198&type=chunk) - The company is exposed to foreign currency risk, primarily from contracts with Lonza denominated in Swiss Francs (CHF). As of March 31, 2025, it held **$27.8 million** in CHF cash and had **$47.8 million** in foreign currency denominated payables and accruals[200](index=200&type=chunk) - A hypothetical 10% change in currency exchange rates would impact net assets by approximately **$17.3 million** and net loss by **$15.9 million** for the quarter[200](index=200&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that Vaxcyte's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[203](index=203&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[204](index=204&type=chunk) [PART II. OTHER INFORMATION](index=45&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) Vaxcyte is not currently involved in any legal proceedings that would materially adversely affect its business, financial condition, or operating results - Vaxcyte is not presently a party to any material legal proceedings[207](index=207&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks, including Vaxcyte's clinical-stage status, reliance on lead candidates and novel technologies, intense competition, manufacturing dependence, and regulatory and market challenges [Risks Related to Financial Position and Capital Needs](index=45&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) Vaxcyte, a clinical-stage company with an accumulated deficit of $1.5 billion, anticipates continued losses and will require substantial additional funding to finance operations - The company has incurred significant net losses since inception and had an accumulated deficit of **$1.5 billion** as of March 31, 2025[212](index=212&type=chunk) - Vaxcyte will require substantial additional funding to finance its operations. If unable to raise capital, it could be forced to delay, reduce, or terminate development programs[215](index=215&type=chunk) [Risks Related to Business and Industry](index=47&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) Vaxcyte's success depends on its novel cell-free platform and lead PCV candidates, facing intense competition from major pharmaceutical companies with greater resources - The company's business is highly dependent on the success of its PCV candidates, VAX-31 and VAX-24. Failure to successfully develop and commercialize these candidates would significantly harm the business[227](index=227&type=chunk) - Primary competitors like Pfizer, Merck, and GSK have significantly greater resources, experience, and competing products (e.g., PCV20, PCV15, PCV21), which may make it difficult for Vaxcyte to compete[232](index=232&type=chunk)[233](index=233&type=chunk) - The company's vaccine development approach is based on a novel cell-free protein synthesis platform, which is unproven at a commercial scale and may expose it to unforeseen risks and development delays[219](index=219&type=chunk) [Risks Related to Reliance on Third Parties](index=67&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) Vaxcyte heavily relies on third-party CROs for clinical trials and CMOs like Lonza for manufacturing, where any failure could severely delay development and commercialization - The company relies on third-party CMOs, including a strategic partnership with Lonza, for all manufacturing of its vaccine candidates. Any failure by these partners to supply sufficient quantities at acceptable quality and price would materially and adversely affect the business[250](index=250&type=chunk)[332](index=332&type=chunk) - The company depends on third-party CROs and independent investigators to conduct its clinical trials. If these parties do not perform their duties successfully or meet deadlines, regulatory approval and commercialization could be delayed[328](index=328&type=chunk) [Risks Related to Government Regulation](index=69&type=section&id=Risks%20Related%20to%20Government%20Regulation) Vaxcyte faces extensive, costly, and uncertain government regulation, including lengthy FDA approval processes, ongoing review, and pricing pressures from legislative reforms - The FDA regulatory approval process is lengthy and time-consuming, and there is a risk the FDA may disagree with the company's regulatory plan or that clinical trials may not support approval[340](index=340&type=chunk)[345](index=345&type=chunk) - Healthcare legislative reforms, such as the Inflation Reduction Act (IRA), could increase pricing pressure and negatively impact the business, although the IRA also includes provisions beneficial to vaccines, such as eliminating patient cost-sharing under Medicare Part D[373](index=373&type=chunk)[377](index=377&type=chunk) - The company is subject to numerous evolving data privacy and security laws (e.g., HIPAA, CCPA, GDPR), and failure to comply could lead to significant fines, litigation, and reputational harm[385](index=385&type=chunk)[386](index=386&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=88&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Vaxcyte reported no unregistered sales of equity securities during the three months ended March 31, 2025 - There were no unregistered sales of equity securities in the three months ended March 31, 2025[453](index=453&type=chunk) [Item 3. Defaults Upon Senior Securities](index=89&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable to the company's current financial reporting [Item 4. Mine Safety Disclosures](index=89&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's current operations [Item 5. Other Information](index=89&type=section&id=Item%205.%20Other%20Information) This section discloses that Andrew Guggenhime, President and CFO, terminated his Rule 10b5-1 trading plan on March 17, 2025 - Andrew Guggenhime, President and Chief Financial Officer, terminated his 10b5-1 trading plan on March 17, 2025[458](index=458&type=chunk) [Item 6. Exhibits](index=90&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents and XBRL data