Invivyd Reports Third Quarter 2024 Financial Results and Recent Business Highlights
Invivyd reported Q3 2024 financial results with PEMGARDA™ net product revenue of $9.3 million, up from $2.3 million in Q2 2024. The company ended Q3 with $106.9 million in cash and expects to end 2024 with at least $65 million. The quarter saw a net loss of $60.7 million ($0.51 per share). R&D expenses increased to $57.9 million, while SG&A expenses remained stable at $13.0 million. The PEMGARDA Fact Sheet was updated to reflect neutralization activity against current COVID-19 variants, including KP.3, KP.3.1.1, and LB.1. The company initiated Phase 1 trials for VYD2311, their next-generation COVID-19 antibody.
Invivyd ha riportato i risultati finanziari del terzo trimestre 2024, con entrate nette da prodotto PEMGARDA™ di 9,3 milioni di dollari, in aumento rispetto ai 2,3 milioni di dollari del secondo trimestre 2024. L'azienda ha chiuso il terzo trimestre con 106,9 milioni di dollari in cassa e prevede di chiudere il 2024 con almeno 65 milioni di dollari. Nel trimestre si è registrata una perdita netta di 60,7 milioni di dollari (0,51 dollari per azione). Le spese per ricerca e sviluppo sono aumentate a 57,9 milioni di dollari, mentre le spese SG&A sono rimaste stabili a 13,0 milioni di dollari. Il Fact Sheet di PEMGARDA è stato aggiornato per riflettere l'attività di neutralizzazione contro le attuali varianti del COVID-19, tra cui KP.3, KP.3.1.1 e LB.1. L'azienda ha avviato gli studi di Fase 1 per VYD2311, il loro anticorpo di nuova generazione contro il COVID-19.
Invivyd reportó los resultados financieros del tercer trimestre de 2024, con ingresos netos por producto PEMGARDA™ de 9,3 millones de dólares, en comparación con 2,3 millones de dólares en el segundo trimestre de 2024. La compañía cerró el tercer trimestre con 106,9 millones de dólares en efectivo y espera cerrar 2024 con al menos 65 millones de dólares. En el trimestre se registró una pérdida neta de 60,7 millones de dólares (0,51 dólares por acción). Los gastos en I+D aumentaron a 57,9 millones de dólares, mientras que los gastos de SG&A se mantuvieron estables en 13,0 millones de dólares. La hoja informativa de PEMGARDA se actualizó para reflejar la actividad de neutralización contra las variantes actuales de COVID-19, incluyendo KP.3, KP.3.1.1 y LB.1. La compañía inició ensayos de Fase 1 para VYD2311, su anticuerpo de nueva generación contra el COVID-19.
Invivyd는 2024년 3분기 재무 결과를 보고했으며, PEMGARDA™의 순 제품 수익이 930만 달러로 2024년 2분기 230만 달러에서 증가했습니다. 이 회사는 3분기를 1억 690만 달러의 현금으로 마감했으며 2024년에는 최소 6500만 달러로 마감할 것으로 예상하고 있습니다. 이번 분기 동안 순손실은 6070만 달러(주당 0.51달러)였습니다. 연구개발(R&D) 비용은 5790만 달러로 증가했으며, 판매 및 관리(SG&A) 비용은 1300만 달러로 안정세를 유지했습니다. PEMGARDA 팩트 시트는 현재 COVID-19 변종에 대한 중화 활동을 반영하기 위해 업데이트되었으며, 여기에는 KP.3, KP.3.1.1 및 LB.1이 포함됩니다. 이 회사는 차세대 COVID-19 항체 VYD2311의 1상 시험을 시작했습니다.
Invivyd a annoncé les résultats financiers du troisième trimestre 2024, avec des revenus nets de produits PEMGARDA™ de 9,3 millions de dollars, contre 2,3 millions de dollars au deuxième trimestre 2024. L'entreprise a terminé le troisième trimestre avec 106,9 millions de dollars en liquidités et s'attend à terminer 2024 avec au moins 65 millions de dollars. Le trimestre a enregistré une perte nette de 60,7 millions de dollars (0,51 dollar par action). Les dépenses de recherche et développement ont augmenté à 57,9 millions de dollars, tandis que les dépenses SG&A sont restées stables à 13,0 millions de dollars. La fiche d'information sur PEMGARDA a été mise à jour pour refléter l'activité de neutralisation contre les variantes actuelles de COVID-19, y compris KP.3, KP.3.1.1 et LB.1. L'entreprise a lancé des essais de Phase 1 pour VYD2311, son anticorps de nouvelle génération contre le COVID-19.
Invivyd hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht, mit Nettoverkäufen des Produkts PEMGARDA™ von 9,3 Millionen Dollar, ein Anstieg von 2,3 Millionen Dollar im zweiten Quartal 2024. Das Unternehmen beendete das dritte Quartal mit 106,9 Millionen Dollar in bar und erwartet, 2024 mit mindestens 65 Millionen Dollar abzuschließen. Im Quartal wurde ein Nettoverlust von 60,7 Millionen Dollar (0,51 Dollar pro Aktie) verzeichnet. Die F&E-Ausgaben stiegen auf 57,9 Millionen Dollar, während die SG&A-Ausgaben stabil bei 13,0 Millionen Dollar blieben. Das PEMGARDA-Factsheet wurde aktualisiert, um die Neutralisierungsaktivitäten gegen aktuelle COVID-19-Varianten, einschließlich KP.3, KP.3.1.1 und LB.1, widerzuspiegeln. Das Unternehmen hat Phase-1-Studien für VYD2311, ihren Antikörper der nächsten Generation gegen COVID-19, initiiert.
- PEMGARDA revenue increased to $9.3M in Q3 from $2.3M in Q2 2024
- Strong cash position of $106.9M as of September 30, 2024
- PEMGARDA showed 84% risk reduction from symptomatic COVID-19 in Phase 3 trial
- 64% risk reduction maintained during 6-month follow-up period
- Net loss increased to $60.7M in Q3 2024 from $39.4M in Q3 2023
- R&D expenses nearly doubled to $57.9M from $30.2M year-over-year
- PEMGARDA revenue growth not meeting previously anticipated rates
- Expected cash reduction to $65M by year-end 2024
Insights
The Q3 results reveal mixed signals for Invivyd. While
The updated PEMGARDA Fact Sheet with validated neutralization data against variants KP.3, KP.3.1.1 and LB.1, coupled with
- Q3 2024 PEMGARDA™ (pemivibart) net product revenue of
$9.3 million ; Invivyd ended Q3 2024 with$106.9 million in cash and cash equivalents - Targets near-term (1H 2025) profitability with existing cash and cash equivalents, anticipated growth of net product revenue, and various operational efficiency improvements
- PEMGARDA Fact Sheet updated to properly reflect neutralization activity of PEMGARDA against current circulating variants tested; on track for continued growth now reflective of ongoing commercial optimization
- Next generation molecule VYD2311 first-in-human clinical trial dosing began in August 2024 with anticipated preliminary data readout late Q4 2024
- Management to host conference call today at 8:30AM ET
WALTHAM, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced financial results for the quarter ended September 30, 2024, and recent business highlights.
With the September 26, 2024 update, the PEMGARDA™ (pemivibart) Fact Sheet for Healthcare Providers (Fact Sheet) now includes validated data for pemivibart’s neutralization activity against the latest circulating COVID-19 variants tested, including KP.3, KP.3.1.1 and LB.1. This Fact Sheet update aligns with exploratory clinical efficacy data from the CANOPY Phase 3 clinical trial that demonstrated substantial protection from symptomatic COVID-19 versus placebo in immunocompetent participants across a broad spectrum of viral strains including KP.3 and KP.3.1.1. By ensuring that healthcare providers and other stakeholders have access to accurate information, Invivyd aims to reinforce confidence in the therapeutic potential of PEMGARDA for immunocompromised people needing pre-exposure prophylaxis of COVID-19, as authorized. Invivyd reported
“With the current Fact Sheet that accurately reflects the neutralization activity of PEMGARDA against KP.3.1.1, the exploratory clinical efficacy data reconfirming a substantial level of relative risk reduction of developing symptomatic COVID-19 versus placebo during the KP.3 and KP.3.1.1 wave, and with our predicted continued neutralization activity of pemivibart against the XEC variant, we are confident in the growth potential for PEMGARDA,” said Marc Elia, Chairman of the Invivyd Board of Directors.
“We are excited about the potential of PEMGARDA to address the significant unmet need of COVID-19 pre-exposure prophylaxis for certain immunocompromised people and expect that ongoing commercial execution will drive substantial revenue growth and market expansion,” said Tim Lee, Chief Commercial Officer of Invivyd. “We have expanded our outreach efforts - driving awareness of PEMGARDA in the healthcare providers community, increasing our ability to reach to additional points of care, and adding new programs to support patients.”
Recent Business Highlights
- Submitted Emergency Use Authorization (EUA) amendment request to U.S. Food & Drug Administration (FDA) for PEMGARDA for the treatment of mild-to-moderate COVID-19 in certain immunocompromised patients
- Announced 180-day exploratory clinical efficacy data from the company’s ongoing CANOPY Phase 3 clinical trial showing PEMGARDA™ (pemivibart) demonstrated
84% relative risk reduction from symptomatic COVID-19 versus placebo through month 6 in Cohort B, a placebo-controlled cohort of all-comer immunocompetent individuals, with safety profile reported as remaining consistent with previously disclosed CANOPY clinical trial data - Reported CANOPY Phase 3 long-term exploratory clinical efficacy data showing PEMGARDA™ (pemivibart) provided
64% relative risk reduction from symptomatic COVID-19 versus placebo in Cohort B over six-month off-drug follow-up period (months 7-12), with no new safety observations occurring during months 7-12 - U.S. FDA has updated the PEMGARDA™ EUA Fact Sheet with accurate SARS-CoV-2 variant susceptibility information and PEMGARDA in vitro neutralization activity data
- Announced preprint conveying CANOPY Phase 3 clinical trial data including long-term protection versus recent JN.1 sublineages at low residual titers uploaded in MedRxiv; manuscript conveying pivotal safety, immunobridging, and exploratory clinical efficacy results from the CANOPY clinical trial will be submitted to a major scientific journal shortly
- Announced preprint describing Invivyd scientists’ novel method for predicting the activity of a monoclonal antibody in the face of variant evolution uploaded in BioRxiv; method predicts continued neutralization activity for pemivibart against SARS-CoV-2 variant XEC, with formal assay assessment pending
Recent Pipeline Highlights
- Initiated dosing of first participants in Phase 1 clinical trial of VYD2311, a next generation monoclonal antibody candidate for COVID-19, building on the success of PEMGARDA
Third Quarter 2024 Financial Results
- Revenue: Reported
$9.3 million of net product revenue of PEMGARDA in Q3 2024 as compared to$2.3 million in Q2 2024. - Cash Position: Cash and cash equivalents were
$106.9 million as of September 30, 2024. - Projected 2024 Year-End Cash Position: Based on current operating plans, Invivyd expects to end 2024 with at least
$65 million in cash and cash equivalents, based on anticipated growth of net product revenue and various operational efficiency improvements. - Research & Development (R&D) Expenses (including In-Process R&D): R&D expenses were
$57.9 million for the quarter ended September 30, 2024, compared to$30.2 million for the comparable period of 2023. This increase is primarily attributable to an increase in VYD2311 manufacturing as compared to lower manufacturing costs of PEMGARDA during the same period in 2023. - Selling, General & Administrative (SG&A) Expenses: SG&A expenses remained relatively consistent at
$13.0 million for the quarter ended September 30, 2024 and$12.9 million for the comparable period of 2023. - Net Loss and Net Loss per Share: Net loss was
$60.7 million for the quarter ended September 30, 2024, compared to$39.4 million for the comparable period in 2023. Basic and diluted net loss per share was$0.51 for the quarter ended September 30, 2024, compared to$0.36 for the comparable period in 2023.
Conference Call & Webcast
Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.
About PEMGARDA
PEMGARDA™ (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in a global Phase 2/3 clinical trial for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3, KP.3.1.1, and LB.1. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
PEMGARDA is not authorized for use for treatment of COVID-19 or post-exposure prophylaxis of COVID-19. Pre-exposure prophylaxis with PEMGARDA is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccinations, should receive COVID-19 vaccination. In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination.
Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse events (all grades, incidence ≥
To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Further, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges. Additionally, certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA, and PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants.
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to
About CANOPY
The ongoing CANOPY Phase 3 clinical trial is designed to evaluate the safety and tolerability of pemivibart and to assess immunobridging from pemivibart to certain historical data from the company’s previous Phase 2/3 clinical trial of adintrevimab (ADG20) for the prevention of symptomatic COVID-19 (EVADE). Additionally, there are pre-specified exploratory endpoints through three, six and twelve months to evaluate clinical efficacy of pemivibart compared to placebo in the prevention of RT-PCR-confirmed symptomatic COVID-19. The latest analysis from the Phase 3 CANOPY clinical trial includes 365-day data. The CANOPY clinical trial enrolled participants in two cohorts: Cohort A is a single-arm, open-label trial in adults who have moderate-to-severe immune compromise including complex underlying medical conditions. Cohort B is a randomized, placebo-controlled cohort that enrolled adults without moderate-to-severe immune compromise who are at risk of acquiring COVID-19 due to regular unmasked face-to-face interactions in indoor settings.
About VYD2311
VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new therapeutic options for vulnerable populations, including immunocompromised people. Globally, there are millions of immunocompromised people, with an estimated 8 million in the U.S. alone, who may not adequately respond to COVID-19 vaccination, increasing their risk for severe outcomes from COVID-19.
VYD2311 was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 3 clinical trials for both the prevention and treatment of COVID-19. The pharmacokinetic profile of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. The company’s proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to address evolving viral threats. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for its first mAb in a planned series of innovative antibody candidates. Visit https://invivyd.com/ to learn more.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “intends,” “potential,” “predict,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the company’s expectation regarding its cash and cash equivalents balance at the end of 2024; the company’s aim for near-term profitability; the company’s belief that its existing cash and cash equivalents, anticipated growth of net product revenue and various operational efficiency improvements will be sufficient to fund operations through profitability; the company’s expectations regarding the commercialization of PEMGARDA; the company’s ongoing research and clinical development activities, as well as future potential research and clinical development efforts; anticipated timing of a preliminary data readout from the company’s VYD2311 first-in-human clinical trial; the company’s EUA amendment request to the FDA for PEMGARDA for the treatment of mild-to-moderate COVID-19 in certain immunocompromised patients; the company’s expectations regarding the neutralization activity of pemivibart against SARS-CoV-2 variants, including XEC; the company’s expectation that the preprint conveying CANOPY clinical trial data will be submitted to a major scientific journal shortly; the company’s expectation that PEMGARDA is the first mAb in a planned series of innovative antibody candidates; the potential of PEMGARDA as a mAb for pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise; the company’s devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; the design of the company’s INVYMAB platform approach to facilitate the rapid, serial generation of new mAbs to address evolving viral threats; the company’s business strategies and objectives; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: uncertainties regarding the company’s expectations, projections and estimates regarding future costs and expenses, future revenue, capital requirements, and the availability of and the need for additional financing; whether the company’s cash and cash equivalents are sufficient to support its operating plan for as long as anticipated; uncertainties regarding market acceptance, payor coverage or future sales and revenue generated by PEMGARDA; uncertainties regarding the potential advantages from the company’s planned operational efficiency improvements; how long the EUA granted by the FDA for PEMGARDA for COVID-19 PrEP in certain immunocompromised patients will remain in effect and whether such EUA is revised or revoked by the FDA; the potential negative impacts on Invivyd’s business of any virologic activity data in the public domain that creates doubt regarding the neutralization activity of pemivibart or any other of Invivyd’s product candidates that is generated by academic or other third-party labs and not as part of Invivyd’s ongoing industrial-grade virology efforts; the company’s ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize PEMGARDA; changes in expected or existing competition; the outcome of the company’s EUA amendment request for PEMGARDA for treatment of mild-to-moderate COVID-19 in certain immunocompromised patients, and the timing thereof; uncertainties related to the regulatory authorization or approval process; changes in the regulatory environment; the timing, progress and results of the company’s discovery, preclinical and clinical development activities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of any product candidate following regulatory authorization or approval; the predictability of clinical success of the company’s product candidates based on neutralizing activity in nonclinical studies; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; the company’s reliance on third parties with respect to virus assay creation and product candidate testing and with respect to its clinical trials; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; formal assay assessment results in comparison to predictions made using Invivyd’s molecular panel approach with respect to neutralization activity of pemivibart; whether PEMGARDA, VYD2311, or any other product candidate is able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the complexities of manufacturing mAb therapies; the company’s dependence on third parties to manufacture, label, package, store and distribute clinical and commercial supplies of its product candidates; the company’s ability to leverage its INVYMAB platform approach to facilitate the rapid, serial generation of new mAbs to address evolving viral threats; any legal proceedings or investigations relating to the company; the company’s ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, each filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.
This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.
Contacts:
Media Relations
(781) 208-1747
media@invivyd.com
Investor Relations
(781) 208-1747
investors@invivyd.com
| INVIVYD, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (In thousands, except share and per share amounts) | |||||||
| September 30, 2024 | December 31, 2023 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 106,869 | $ | 200,641 | |||
| Accounts receivable, net | 8,154 | — | |||||
| Inventory, net | 27,067 | — | |||||
| Prepaid expenses and other current assets | 9,011 | 24,240 | |||||
| Total current assets | 151,101 | 224,881 | |||||
| Property and equipment, net | 1,640 | 1,896 | |||||
| Operating lease right-of-use assets | 1,729 | 2,229 | |||||
| Other non-current assets | 7,452 | 175 | |||||
| Total assets | $ | 161,922 | $ | 229,181 | |||
| Liabilities, Preferred Stock and Stockholders’ Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 17,707 | $ | 7,953 | |||
| Accrued expenses(1) | 59,401 | 40,860 | |||||
| Operating lease liabilities, current | 1,414 | 1,443 | |||||
| Other current liability | 20 | 35 | |||||
| Total current liabilities | 78,542 | 50,291 | |||||
| Operating lease liabilities, non-current | 219 | 722 | |||||
| Other non-current liability | — | 700 | |||||
| Total liabilities | 78,761 | 51,713 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity (deficit): | |||||||
| Preferred stock (undesignated), authorized and no shares issued and outstanding at September 30, 2024 and December 31, 2023 | — | — | |||||
| Common stock, 119,604,035 shares issued and outstanding at September 30, 2024; 110,160,684 shares issued and outstanding at December 31, 2023 | 12 | 11 | |||||
| Additional paid-in capital | 966,718 | 909,539 | |||||
| Accumulated other comprehensive loss | (18 | ) | (13 | ) | |||
| Accumulated deficit | (883,551 | ) | (732,069 | ) | |||
| Total stockholders’ equity | 83,161 | 177,468 | |||||
| Total liabilities, preferred stock and stockholders’ equity | $ | 161,922 | $ | 229,181 | |||
| (1) | Includes related-party amounts of |
| INVIVYD, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (In thousands, except share and per share amounts) | |||||||||||||||||
| Three Months Ended September 30, | Three Months Ended September 30, | Nine Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||
| Revenue: | |||||||||||||||||
| Product revenue, net | $ | 9,300 | $ | — | $ | 11,564 | $ | — | |||||||||
| Total revenue | 9,300 | — | 11,564 | — | |||||||||||||
| Operating costs and expenses: | |||||||||||||||||
| Cost of product revenue(1) | 806 | — | 894 | — | |||||||||||||
| Research and development (2) | 57,850 | 25,574 | 119,344 | 96,393 | |||||||||||||
| Acquired in-process research and development (3) | — | 4,600 | — | 5,575 | |||||||||||||
| Selling, general and administrative | 12,955 | 12,886 | 48,973 | 34,038 | |||||||||||||
| Total operating costs and expenses | 71,611 | 43,060 | 169,211 | 136,006 | |||||||||||||
| Loss from operations | (62,311 | ) | (43,060 | ) | (157,647 | ) | (136,006 | ) | |||||||||
| Other income: | |||||||||||||||||
| Other income, net | 1,572 | 3,620 | 6,165 | 11,017 | |||||||||||||
| Total other income, net | 1,572 | 3,620 | 6,165 | 11,017 | |||||||||||||
| Net loss | (60,739 | ) | (39,440 | ) | (151,482 | ) | (124,989 | ) | |||||||||
| Other comprehensive income (loss) | |||||||||||||||||
| Unrealized (loss) gain, net of tax | (6) | 20 | (5) | 270 | |||||||||||||
| Comprehensive loss | $ | (60,745 | ) | $ | (39,420 | ) | $ | (151,487 | ) | $ | (124,719 | ) | |||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.51 | ) | $ | (0.36 | ) | $ | (1.28 | ) | $ | (1.14 | ) | |||||
| Weighted-average common shares outstanding, basic and diluted | 119,495,284 | 109,754,812 | 118,163,599 | 109,333,684 | |||||||||||||
| (1) | Includes related-party amounts of |
| (2) | Includes related-party amounts of |
| (3) | Includes no related-party amounts for both the three and nine months ended September 30, 2024, and related party amounts of |
FAQ
What was Invivyd's (IVVD) Q3 2024 revenue for PEMGARDA?
What was Invivyd's (IVVD) net loss in Q3 2024?
What efficacy did PEMGARDA show in Invivyd's (IVVD) CANOPY Phase 3 trial?
