Icosavax Reports Second Quarter 2021 Financial Results and Provides Corporate Update
- Initiated a Phase 1/2 clinical trial for IVX-411, a virus-like particle (VLP) displaying the SARS-CoV-2 receptor-binding domain -
- Initiated a Phase 1/1b clinical trial for IVX-121, a VLP displaying a Respiratory Syncytial Virus (RSV) stabilized pre-fusion F antigen -
- Raised $209.3 million in gross proceeds from an upsized IPO, funding operations through at least 2024 -
SEATTLE, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Icosavax, Inc. (Nasdaq: ICVX), a biopharmaceutical company leveraging its innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.
“The second quarter and recent period has been a transformational time for Icosavax thanks to our initiation of two clinical trials, one in RSV and one in SARS-CoV-2, as well as our successful initial public offering and listing on the Nasdaq stock exchange. I would like to thank the entire Icosavax team for their hard work during this period, and I believe our company is now well-positioned to further advance the development of our VLP vaccine pipeline,” said Adam Simpson, Chief Executive Officer of Icosavax. “Our novel VLP platform has shown promise to drive a robust, broad, and durable protective immune response to complex antigens. To this end, we are delighted to have recently initiated the Phase 1/1b trial of our RSV VLP vaccine candidate, IVX-121, in addition to the Phase 1/2 trial of our COVID-19 VLP vaccine candidate, IVX-411, and we look forward to providing future updates on these and our other programs.”
Second Quarter 2021 and Subsequent Highlights
Near-Term Milestone Expectations
Second Quarter 2021 Financial Results
About Icosavax’s Virus-Like Particle (VLP) Vaccines
VLPs enable multivalent display of antigens in a manner that closely resembles viruses but contain no genetic material. Approved vaccines that are derived from naturally occurring VLPs have shown efficacy when formulated as combination vaccines and have shown the ability to induce high and sustained levels (titers) of neutralizing antibodies (nAbs) in adults, which have generally been associated with protective immunity. However, VLPs engineered to display complex viral antigens have in general been difficult to develop or successfully manufacture at scale, limiting the pathogens that can be addressed by this approach. Icosavax’s VLP vaccine technology is designed to enable robust, durable and broad immune responses against a broader array of pathogens than has been possible with naturally occurring VLPs and to overcome the manufacturing challenges experienced with other VLP technologies.
Icosavax is a biopharmaceutical company leveraging its innovative VLP platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases. Icosavax’s VLP platform technology is designed to enable multivalent, particle-based display of complex viral antigens, which it believes will induce broad, robust, and durable protection against the specific viruses targeted. Icosavax’s pipeline includes vaccine candidates targeting respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Icosavax was formed in 2017 to advance the breakthrough VLP technology from the Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases. Icosavax exclusively licensed the VLP technology for use in several fields, including RSV and hMPV, from the University of Washington. For SARS-CoV-2, Icosavax has a non-exclusive, worldwide (excluding South Korea) license from the University of Washington that will convert to an exclusive license in North America and Europe in 2025. Icosavax is located in Seattle.
Statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on the company’s current beliefs and expectations and include, but are not limited to: the company’s expectation regarding the opportunities for, and the therapeutic and commercial potential of, its vaccine product candidates; the company’s ability to advance its development program and achieve the noted development milestones in 2022; and the sufficiency of the company’s current cash, cash equivalents, and investments to fund its operations through at least 2024. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the company’s business, including, without limitation: the early stage of the company’s development efforts; the company’s approach to the development of vaccine candidates, including its plan to pursue a combination bivalent RSV/hMPV VLP vaccine candidate, which is a novel and unproven approach; potential delays in the commencement, enrollment, and completion of clinical trials and preclinical studies; the company’s dependence on third parties in connection with manufacturing, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval, and/or commercialization; results from preclinical studies or early clinical trials not necessarily being predictive of future results; competing approaches limiting the commercial value of the company’s vaccine candidates; regulatory developments in the United States and other countries; the company’s ability to obtain and maintain intellectual property protection for its product candidates and maintain its rights under intellectual property licenses; the company’s ability to fund its operating plans with its current cash, cash equivalents, and investments; the company’s ability to maintain undisrupted business operations during the COVID-19 pandemic, including with respect to clinical trials, manufacturing, and supply chain; and other risks described in the company’s prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the company’s Registration Statement on Form S-1 and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Condensed Balance Sheets
Condensed Statements of Operations and Comprehensive Loss
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