Vaxcyte Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Vaxcyte (PCVX) reported its Q4 and full year 2024 financial results, highlighting significant progress in its pneumococcal conjugate vaccine (PCV) programs. The company completed a successful VAX-31 Phase 2 adult program and plans to initiate Phase 3 studies by mid-2025.
Key financial highlights include:
- Cash position of $3.1 billion as of December 31, 2024
- Raised $2.2 billion in net proceeds from two equity offerings in 2024
- R&D expenses increased to $476.6 million for full year 2024
- Net loss of $463.9 million for 2024
The company expects multiple clinical milestones in 2025-2026, including topline data from VAX-24 infant Phase 2 study by Q1 2025 end and VAX-31 Phase 3 adult study results in 2026. Vaxcyte also received Breakthrough Therapy Designation from FDA for VAX-31 in November 2024.
Vaxcyte (PCVX) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando progressi significativi nei suoi programmi di vaccini coniugati contro il pneumococco (PCV). L'azienda ha completato con successo il programma VAX-31 di Fase 2 per adulti e prevede di avviare gli studi di Fase 3 entro metà del 2025.
Le principali evidenze finanziarie includono:
- Posizione di cassa di $3,1 miliardi al 31 dicembre 2024
- Raccolti $2,2 miliardi in proventi netti da due offerte di equity nel 2024
- Le spese per R&S sono aumentate a $476,6 milioni per l'intero anno 2024
- Perdita netta di $463,9 milioni per il 2024
L'azienda prevede molteplici traguardi clinici nel 2025-2026, inclusi i dati principali dallo studio di Fase 2 VAX-24 sui neonati entro la fine del primo trimestre 2025 e i risultati dello studio di Fase 3 VAX-31 per adulti nel 2026. Vaxcyte ha anche ricevuto la Designazione di Terapia Innovativa dalla FDA per VAX-31 nel novembre 2024.
Vaxcyte (PCVX) reportó sus resultados financieros del cuarto trimestre y del año completo 2024, destacando un progreso significativo en sus programas de vacunas conjugadas contra el neumococo (PCV). La compañía completó con éxito el programa VAX-31 de Fase 2 para adultos y planea iniciar estudios de Fase 3 para mediados de 2025.
Los aspectos financieros clave incluyen:
- Posición de efectivo de $3.1 mil millones al 31 de diciembre de 2024
- Recaudó $2.2 mil millones en ingresos netos de dos ofertas de acciones en 2024
- Los gastos en I+D aumentaron a $476.6 millones para el año completo 2024
- Pérdida neta de $463.9 millones para 2024
La compañía espera múltiples hitos clínicos en 2025-2026, incluidos los datos principales del estudio de Fase 2 VAX-24 en infantes para finales del primer trimestre de 2025 y los resultados del estudio de Fase 3 VAX-31 en adultos en 2026. Vaxcyte también recibió la Designación de Terapia Innovadora de la FDA para VAX-31 en noviembre de 2024.
Vaxcyte (PCVX)는 2024년 4분기 및 연간 재무 결과를 발표하며, 폐렴구균 결합 백신(PCV) 프로그램에서의 중요한 진전을 강조했습니다. 이 회사는 성인을 위한 VAX-31 2상 프로그램을 성공적으로 완료하였으며, 2025년 중반까지 3상 연구를 시작할 계획입니다.
주요 재무 하이라이트는 다음과 같습니다:
- 2024년 12월 31일 기준 현금 보유액 $31억
- 2024년 두 번의 주식 공모를 통해 $22억의 순수익을 올림
- 2024년 전체 연도 연구 및 개발 비용이 $4억 7660만으로 증가
- 2024년 순손실 $4억 6390만
회사는 2025-2026년 동안 여러 임상 이정표를 기대하고 있으며, 2025년 1분기 말까지 VAX-24 유아 2상 연구의 주요 데이터와 2026년 VAX-31 성인 3상 연구 결과를 포함합니다. Vaxcyte는 또한 2024년 11월 FDA로부터 VAX-31에 대한 혁신 치료제 지정을 받았습니다.
Vaxcyte (PCVX) a publié ses résultats financiers pour le quatrième trimestre et l'année complète 2024, mettant en avant des progrès significatifs dans ses programmes de vaccins conjugués contre le pneumocoque (PCV). L'entreprise a achevé avec succès le programme VAX-31 de phase 2 pour adultes et prévoit de commencer les études de phase 3 d'ici mi-2025.
Les principaux points financiers incluent :
- Position de trésorerie de $3,1 milliards au 31 décembre 2024
- Récupération de $2,2 milliards de produits nets issus de deux offres d'actions en 2024
- Les dépenses en R&D ont augmenté à $476,6 millions pour l'année complète 2024
- Perte nette de $463,9 millions pour 2024
L'entreprise s'attend à plusieurs jalons cliniques en 2025-2026, y compris des données principales de l'étude VAX-24 phase 2 chez les nourrissons d'ici la fin du premier trimestre 2025 et les résultats de l'étude VAX-31 phase 3 chez les adultes en 2026. Vaxcyte a également reçu la désignation de thérapie innovante de la FDA pour VAX-31 en novembre 2024.
Vaxcyte (PCVX) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei bedeutende Fortschritte in seinen Programmen für pneumokokkenkonjugierte Impfstoffe (PCV) hervorgehoben. Das Unternehmen hat das VAX-31 Phase-2-Programm für Erwachsene erfolgreich abgeschlossen und plant, bis Mitte 2025 Phase-3-Studien zu starten.
Wichtige finanzielle Highlights umfassen:
- Liquiditätsposition von $3,1 Milliarden zum 31. Dezember 2024
- Erzielte $2,2 Milliarden an Nettoerlösen aus zwei Aktienplatzierungen im Jahr 2024
- F&E-Ausgaben stiegen auf $476,6 Millionen für das gesamte Jahr 2024
- Nettoverlust von $463,9 Millionen für 2024
Das Unternehmen erwartet mehrere klinische Meilensteine in den Jahren 2025-2026, darunter die Hauptdaten aus der VAX-24 Phase-2-Studie bei Säuglingen bis Ende des ersten Quartals 2025 und die Ergebnisse der VAX-31 Phase-3-Studie bei Erwachsenen im Jahr 2026. Vaxcyte erhielt außerdem im November 2024 die Breakthrough Therapy Designation von der FDA für VAX-31.
- Secured $2.2B in new capital through successful equity offerings
- Strong cash position of $3.1B to fund operations
- Received FDA Breakthrough Therapy Designation for VAX-31
- Positive Phase 1/2 results for VAX-31 in adults aged 50+
- Net loss increased to $463.9M in 2024 from $402.3M in 2023
- R&D expenses rose 43% to $476.6M in 2024
- G&A expenses increased 53% to $92.9M in 2024
Insights
Vaxcyte's Q4 and full year 2024 results reveal a company strategically positioning itself for potential market disruption in the pneumococcal vaccine space, backed by robust clinical progress and an exceptionally strong balance sheet. The company has achieved several critical milestones that substantially de-risk its clinical programs while simultaneously building infrastructure for potential commercialization.
The $3.1 billion cash position (representing approximately 31% of Vaxcyte's current market cap) provides an estimated 4-5 year runway, likely extending well beyond pivotal data readouts for both adult and pediatric programs. This financial strength enables Vaxcyte to pursue an aggressive development strategy without near-term capital constraints, a significant competitive advantage in the capital-intensive vaccine development landscape.
The FDA Breakthrough Therapy Designation for VAX-31 represents regulatory validation of the platform's potential and could accelerate the approval timeline. This designation, combined with positive Phase 1/2 data showing favorable comparisons to Pfizer's Prevnar 20, positions Vaxcyte's 31-valent candidate as potentially best-in-class with broader serotype coverage than currently marketed products.
The company's
The
Key near-term catalysts include VAX-24 infant data expected by Q1-end 2025 and the initiation of the VAX-31 adult Phase 3 program by mid-2025. These events could significantly impact Vaxcyte's valuation as they will provide critical insights into the potential approvability and competitive positioning of the company's lead assets.
The global pneumococcal vaccine market, projected to reach
While execution risks remain, including potential clinical setbacks, regulatory hurdles, and competitive responses from established players like Pfizer and Merck, Vaxcyte has assembled the financial resources, manufacturing infrastructure, and leadership team necessary to navigate these challenges and potentially emerge as a major player in the vaccine market.
Vaxcyte's clinical progress with its pneumococcal conjugate vaccine candidates represents a potential paradigm shift in the prevention of pneumococcal disease. The company's carrier-sparing platform appears to have successfully overcome one of the most significant technical barriers in PCV development - the ability to include additional serotypes without compromising immunogenicity due to carrier protein suppression.
The Phase 1/2 results for VAX-31 in adults are particularly impressive from an immunological perspective. Generating robust opsonophagocytic activity (OPA) responses - the accepted correlate of protection - across all 31 serotypes challenges the conventional wisdom about the practical limits of PCV valency. For context, when earlier-generation PCVs expanded from 7 to 13 serotypes, developers faced significant challenges with immune interference. Vaxcyte's ability to achieve strong functional antibody responses with 31 serotypes represents a remarkable technical achievement.
The clinical significance of this expanded coverage cannot be overstated. We've observed consistent serotype replacement following the introduction of each generation of PCVs, where non-vaccine serotypes gradually increase in prevalence. VAX-31 addresses many of these emerging serotypes, potentially providing more comprehensive and durable protection against pneumococcal disease. This explains the FDA's decision to grant Breakthrough Therapy Designation, which acknowledges both the unmet medical need and VAX-31's potential to address it substantially better than existing therapies.
Vaxcyte's pediatric development strategy demonstrates thoughtful risk management. By advancing VAX-24 ahead of VAX-31 in infants, the company can establish the safety and immunogenicity profile of their platform in this vulnerable population before testing their most advanced candidate. The imminent readout from the VAX-24 infant study will be particularly informative, as the immune response in infants can differ substantially from adults due to their developing immune systems.
The company's
From a competitive standpoint, VAX-31 would represent a substantial advance over currently marketed PCVs from Pfizer (20-valent) and Merck (15-valent). The additional 11 serotypes in VAX-31 not covered by Prevnar 20 could translate to meaningful clinical differentiation, especially as these serotypes continue to emerge as significant causes of disease following widespread use of current vaccines.
The upcoming clinical milestones - particularly the VAX-24 infant data expected by the end of Q1 2025 and the initiation of the VAX-31 adult Phase 3 program - will be critical in validating the platform's potential. If the infant data demonstrates safety and immunogenicity profiles comparable to those observed in adults, it would substantially de-risk the entire platform and strengthen the case for VAX-31 as a potentially best-in-class PCV across all age groups.
-- Completed Successful VAX-31 Phase 2 Adult Program; Company Remains on Track to Initiate VAX-31 Adult Phase 3 Pivotal, Non-Inferiority Study by Mid-2025 and Announce Topline Safety, Tolerability and Immunogenicity Data in 2026 --
-- Company Expects to Announce Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series of VAX-24 Infant Phase 2 Study by the End of First Quarter, Followed by Topline Data from Booster Dose by the End of 2025 --
-- Initiated Second and Final Stage of VAX-31 Infant Phase 2 Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series Expected in Mid-2026, Followed by Topline Data from Booster Dose Approximately Nine Months Later --
-- Raised Approximately
-- Company to Host Webcast/Conference Call Today at 4:30 p.m. ET / 1:30 p.m. PT --
SAN CARLOS, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update.
“We continue to make meaningful progress across the adult and infant clinical programs for our broad-spectrum pneumococcal conjugate vaccine (PCV) candidates, and based on the positive results from the VAX-31 and VAX-24 adult studies, we believe that our carrier-sparing platform has the potential to set a new standard in disease coverage,” said Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte. “For the adult indication, we remain on track to initiate the VAX-31 adult Phase 3 pivotal, non-inferiority study by mid-2025, with topline data expected in 2026. For the pediatric indication, we expect to announce the topline safety, tolerability and immunogenicity data from the VAX-24 infant Phase 2 study primary immunization series by the end of the first quarter, followed by topline data from the booster dose by the end of 2025. We also recently advanced the VAX-31 infant Phase 2 study to the second and final stage and expect topline data for the primary immunization series in mid-2026.”
“Vaxcyte’s financial position has been further strengthened with the completion of two follow-on equity offerings last year that generated
Key 2024 and 2025 to Date Highlights
PCV Franchise Adult Indication:
- Reported Positive Topline Data from Phase 1/2 Study of VAX-31, Company’s 31-Valent PCV Candidate, in Adults Aged 50 and Older: In September 2024, Vaxcyte announced positive topline results from the Phase 1/2 study evaluating the safety, tolerability and immunogenicity of VAX-31 in 1,015 healthy adults aged 50 and older. Based on the strength of the results from this study, the Company selected VAX-31 to exclusively advance to an adult Phase 3 program.
In the Phase 1/2 study, VAX-31 was observed to be well tolerated and demonstrated a safety profile at all doses studied through the full six-month evaluation period similar to Prevnar 20® (PCV20). VAX-31 showed robust opsonophagocytic activity (OPA) immune responses for all 31 serotypes at all doses studied. For all 11 incremental serotypes unique to VAX-31, and not in PCV20, all three doses met the superiority criteria(1). At the middle and high doses, VAX-31 met or exceeded the OPA response non-inferiority criteria(2) for all 20 serotypes common with PCV20. At the VAX-31 high dose, average OPA immune responses were greater for 18 of 20 serotypes compared to PCV20 (geometric mean ratio (GMR) greater than 1.0), with seven of these serotypes achieving statistically higher immune responses(3) compared to PCV20. At the middle dose, 13 of 20 serotypes had a GMR greater than 1.0 and five serotypes achieved statistically higher immune responses compared to PCV20. - VAX-31 Granted Breakthrough Therapy Designation from the FDA for the Prevention of IPD in Adults: In November 2024, Vaxcyte announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) for VAX-31 for the prevention of IPD in adults. The FDA’s decision was informed by the positive topline results from the VAX-31 Phase 1/2 study in adults. With BTD, Vaxcyte has access to all the elements of the FDA’s Fast Track program, as well as the ability to receive guidance and support from the FDA on an efficient drug development program and an organizational commitment from senior managers within the FDA.
- Positive Results from VAX-24 Phase 2 Study in Adults Aged 65 and Older Published in the Journal Vaccine Add to Body of Evidence Validating the Potential of the Company’s Carrier-Sparing Platform: In July 2024, the safety, tolerability and immunogenicity results from the VAX-24 Phase 2 study in adults aged 65 and older were published in the journal Vaccine. In the study, VAX-24, the Company’s 24-valent PCV candidate, demonstrated a safety and tolerability profile similar to PCV20 across all doses studied. VAX-24 also demonstrated robust OPA immune responses for all 24 serotypes at all doses studied, confirming the prior VAX-24 study results in adults 50 to 64 years of age.
PCV Franchise Infant Indication:
- Completed Enrollment of Phase 2 Study Evaluating VAX-24 for the Prevention of IPD in Infants: In March 2024, Vaxcyte announced the completion of enrollment in its Phase 2 clinical study evaluating VAX-24 in 802 healthy infants. The ongoing Phase 2 clinical study is evaluating the safety, tolerability and immunogenicity of VAX-24 compared to PCV20 in Stage 2 of the study, following the evaluation of VAX-24 compared to VAXNEUVANCE™ (PCV15) in Stage 1, which was the broadest-spectrum PCV at the time of study initiation. Additional information about the study can be found at www.clinicaltrials.gov under the identifier NCT05844423.
- Initiated Phase 2 Study Evaluating VAX-31 for the Prevention of IPD in Infants and Advanced to Second and Final Stage:
- In November 2024, Vaxcyte announced FDA clearance of the VAX-31 Investigational New Drug application for the prevention of IPD in infants. The FDA’s decision was supported by the positive topline safety, tolerability and immunogenicity results from the VAX-31 adult Phase 1/2 study.
- In December 2024, Vaxcyte announced the initiation of the first stage of the VAX-31 Phase 2 study in healthy infants. This study is evaluating the safety, tolerability and immunogenicity of VAX-31 compared to PCV20.
- In February 2025, Vaxcyte announced that the VAX-31 infant study had progressed to the second and final stage. Advancement to Stage 2 followed a blinded assessment of the Stage 1 safety and tolerability data per the study protocol. Additional information about the study can be found at www.clinicaltrials.gov under the identifier NCT06720038.
Equity Financings:
- Completed Two Successful Follow-On Financings Totaling Approximately
$2.4 Billion in Gross Proceeds, Further Strengthening Vaxcyte’s Balance Sheet:- In September 2024, Vaxcyte completed an underwritten public offering of 12,087,378 shares of common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,893,203 shares, at a public offering price of
$103.00 per share and pre-funded warrants to purchase 2,427,184 shares of common stock at a public offering price of$102.99 9 per pre-funded warrant. The aggregate gross proceeds to Vaxcyte from this offering were approximately$1.5 billion , before deducting underwriting discounts and commissions and other offering expenses payable by Vaxcyte. - In February 2024, Vaxcyte completed an underwritten public offering of 12,695,312 shares of its common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,757,812 shares, at a public offering price of
$64.00 per share and pre-funded warrants to purchase 781,250 shares of common stock at a public offering price of$63.99 9 per underlying share. The aggregate gross proceeds to Vaxcyte from this offering were approximately$862.5 million , before deducting underwriting discounts and commissions and other offering expenses payable by Vaxcyte.
- In September 2024, Vaxcyte completed an underwritten public offering of 12,087,378 shares of common stock, which included the full exercise of the underwriters’ option to purchase an additional 1,893,203 shares, at a public offering price of
Executive Leadership Team and Board of Directors Appointments:
- Strengthened Leadership Team and Board of Directors:
- In January 2025, Vaxcyte appointed two leaders.
- Harp Dhaliwal was named the Company’s Chief Technical Operations Officer. Mr. Dhaliwal has more than 25 years of experience in engineering, operations strategy, manufacturing and supply chain to establish launch and global supply capacity for multiple major biopharmaceutical products. During his tenure with Vaxcyte, Mr. Dhaliwal’s leadership and expertise have been instrumental in scaling the organization to prepare for the potential global commercialization of the Company’s PCVs.
- Roger Nosal was appointed as Vaxcyte’s Head of Global Regulatory and Quality Assurance. Mr. Nosal brings over 40 years of expertise focused on chemistry, manufacturing and controls product development and global regulatory product approvals across many therapeutics and vaccines, including PCVs. He will provide vital insights to optimize the Company’s late-stage, global clinical trial development and execution.
- In January 2024, Vaxcyte announced the appointment of Whitney Jones as Chief People Officer. Ms. Jones is a seasoned executive with over 20 years of experience spanning biotech, healthcare diagnostics, financial technology and retail with extensive expertise in human resources strategy and operations.
- In July 2024, Vaxcyte appointed John Furey to its Board of Directors. Mr. Furey is an accomplished executive with over 30 years of experience in operational strategy, commercial and technical leadership and vaccine development. He brings a wealth of biopharmaceutical expertise, including the manufacture, supply and commercialization of PCVs. Mr. Furey currently serves as Chief Executive Officer of Imvax, a clinical-stage biotechnology company developing novel immunotherapies for cancer.
- In January 2025, Vaxcyte appointed two leaders.
Anticipated Key Milestones
Vaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones:
PCV Franchise Adult Indication
VAX-31
- Following an FDA End-of-Phase 2 meeting, initiate a Phase 3 pivotal, non-inferiority study by mid-2025 and announce topline safety, tolerability and immunogenicity data in 2026.
- Initiate the remaining Phase 3 studies in 2025 and 2026 and announce data from these studies in 2026 and 2027.
PCV Franchise Infant Indication
VAX-24
- Announce topline safety, tolerability and immunogenicity data from the primary three-dose immunization series of the Phase 2 study, which is fully enrolled with 802 healthy infants, by the end of the first quarter of 2025, followed by topline data from the booster dose by the end of 2025.
VAX-31
- Announce topline safety, tolerability and immunogenicity data from the ongoing VAX-31 infant Phase 2 study primary three-dose immunization series in mid-2026, followed by topline data from the booster dose approximately nine months later.
Upcoming Investor Conferences
Company management will participate in fireside chats and host one-on-one meetings at the following investor conferences. A live webcast of the fireside chats will be accessible through the Investors & Media section of the Company’s website at http://investors.vaxcyte.com for approximately 30 days following each conference.
- Cowen 45th Annual Health Care Conference, March 3-5, 2025: Fireside Chat will take place live on Tuesday, March 4 at 1:50 p.m. ET.
- Leerink Global Healthcare Conference, March 10-12, 2025: Fireside Chat will take place live on Tuesday, March 11 at 2:20 p.m. ET.
- Jefferies Biotech on the Beach Summit, March 11-12, 2025: One-on-one investor meetings will be held on Wednesday, March 12.
- Needham 24th Annual Virtual Healthcare Conference, April 7-10, 2025: Fireside Chat will take place live on Monday, April 7 at 1:30 p.m. ET.
Fourth Quarter and Full Year 2024 Financial Results
- Cash Position: Cash, cash equivalents and investments were
$3,134.7 million as of December 31, 2024, compared to$1,242.9 million as of December 31, 2023. The increase was primarily due to the$2.2 billion in net proceeds from two follow-on financings in 2024. - Research & Development (R&D) Expenses: R&D expenses were
$133.6 million for the three months ended December 31, 2024 and$476.6 million for the full year 2024 as compared to$104.1 million and$332.3 million , respectively, for the same periods in 2023. The increase for the year ended December 31, 2024 was due primarily to increased development and manufacturing activities in connection with the adult and infant PCV programs, including to support the potential future commercial launches, as well as an increase in personnel expenses related to the growth in R&D employees. - General & Administrative (G&A) Expenses: G&A expenses were
$28.5 million for the three months ended December 31, 2024 and$92.9 million for the full year 2024 as compared to$17.5 million and$60.7 million , respectively, for the same periods in 2023. The increase for the year ended December 31, 2024 was due primarily to higher personnel expenses related to the growth in G&A employees. - Net Loss: For the three months and year ended December 31, 2024, net loss was
$137.1 million and$463.9 million , respectively, compared to$180.8 million and$402.3 million for the same periods in 2023. - Commercial Manufacturing Suite: For the three months and year ended December 31, 2024, Vaxcyte incurred an additional
$33.0 million and$127.8 million in capital and facility buildout expenditures, respectively, related to the ongoing construction of the dedicated manufacturing suite at Lonza intended to support the potential global commercialization of the Company’s PCV programs. As of December 31, 2024, Vaxcyte had incurred$214.3 million in total capital and facility buildout expenditures that were reflected on the Company’s balance sheet as of that date.
Conference Call and Webcast
Vaxcyte will host a conference call and webcast to discuss this announcement today, February 25, 2025, at 4:30 p.m. ET / 1:30 p.m. PT. To participate in the conference call, please dial 800-225-9448 (domestic) or 203-518-9708 (international) and refer to conference ID PCVXQ424. A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.vaxcyte.com. After the live webcast, the event will remain archived on Vaxcyte’s website for 30 days.
About Vaxcyte
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. VAX-31, a 31-valent PCV candidate advancing to a Phase 3 adult clinical program and currently being evaluated in a Phase 2 infant clinical program, is being developed for the prevention of IPD in adults and infants and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, the Company’s 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is currently being evaluated in a Phase 2 infant study. Both VAX-31 and VAX-24 are designed to improve upon the standard-of-care PCVs by covering the serotypes in circulation that are responsible for a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice.
Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company’s system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte’s pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine candidate designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.vaxcyte.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of VAX-24 and VAX-31, including breadth of coverage, the ability to deliver potentially best-in-class PCVs, improve upon the standard-of-care and set a new standard for immunogenicity and disease coverage; the process and timing of anticipated future development of Vaxcyte’s vaccine candidates; the initiation of VAX-31 adult Phase 3 studies and the timing of such studies and their data readouts; the timing and availability of data for the VAX-24 and VAX-31 infant Phase 2 studies; the ability to maintain continued positive momentum across the PCV franchise; the potential of the Company’s site-specific, carrier-sparing platform; the demand for Vaxcyte’s vaccine candidates; Vaxcyte’s ability to establish global commercial manufacturing capacity for its PCV candidates; and other statements that are not historical fact. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “on track,” “potential,” “should,” “would” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte’s current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte’s product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses. These and other risks are described more fully in Vaxcyte’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K filed with the SEC on February 25, 2025 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date.
(1) Lower bound of the 2-sided
(2) Lower bound of the 2-sided
(3) Lower bound of the 2-sided
Contacts:
Patrick Ryan, Executive Director, Corporate Communications
Vaxcyte, Inc.
415-606-5135
media@vaxcyte.com
Jennifer Zibuda, Senior Director, Investor Relations
Vaxcyte, Inc.
860-729-8902
investors@vaxcyte.com
Vaxcyte, Inc. | ||||||||||||
Condensed Statements of Operations | ||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||
Year Ended December 31, | ||||||||||||
2024 | 2023 | 2022 | ||||||||||
Operating expenses: | ||||||||||||
Research and development (1) | $ | 476,644 | $ | 332,341 | $ | 169,451 | ||||||
Acquired manufacturing rights | - | 75,000 | 22,995 | |||||||||
General and administrative (1) | 92,902 | 60,700 | 39,810 | |||||||||
Total operating expenses | 569,546 | 468,041 | 232,256 | |||||||||
Loss from operations | $ | (569,546 | ) | $ | (468,041 | ) | $ | (232,256 | ) | |||
Other income (expense), net | ||||||||||||
Interest expense | - | - | (2 | ) | ||||||||
Interest income | 109,994 | 62,907 | 8,356 | |||||||||
Other income (expense) | (4,375 | ) | 2,868 | 417 | ||||||||
Total other income (expense), net | 105,619 | 65,775 | 8,771 | |||||||||
Net loss | $ | (463,927 | ) | $ | (402,266 | ) | $ | (223,485 | ) | |||
Net loss per share, basic and diluted | $ | (3.80 | ) | $ | (4.14 | ) | $ | (3.44 | ) | |||
Weighted-average shares outstanding, basic and diluted | 121,997,348 | 97,157,690 | 64,877,988 | |||||||||
(1) Amounts include stock-based compensation expense as follows: | ||||||||||||
Research and development | $ | 42,819 | $ | 23,275 | $ | 9,899 | ||||||
General and administrative | 42,003 | 25,485 | 13,751 | |||||||||
Total stock-based compensation expense | $ | 84,822 | $ | 48,760 | $ | 23,650 | ||||||
Vaxcyte, Inc. | ||||||||||||
Summary Balance Sheet Data | ||||||||||||
(in thousands) | ||||||||||||
December 31, | ||||||||||||
2024 | 2023 | |||||||||||
Cash, cash equivalents and investments | $ | 3,134,718 | $ | 1,242,902 | ||||||||
Total assets | 3,511,318 | 1,407,917 | ||||||||||
Total stockholders' equity | 3,305,819 | 1,240,468 | ||||||||||

FAQ
What are the key milestones expected for Vaxcyte's VAX-31 program in 2025-2026?
How much cash does PCVX have after its 2024 equity offerings?
What was Vaxcyte's net loss for full year 2024?
When will PCVX announce VAX-24 infant Phase 2 study results?