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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Icosavax Inc | NASDAQ:ICVX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 15.31 | 15.15 | 15.31 | 0 | 01:00:00 |
“Despite the recent readout for IVX-411, I am pleased with the progress we achieved in 2021, including our successful initial public offering and advancing two programs into the clinic,” said Adam Simpson, Chief Executive Officer of Icosavax. “We continue to progress and evaluate our VLP vaccine candidates for multiple indications, and in particular look forward to the 2Q 2022 topline interim data from our lead program, IVX-121 against RSV. RSV represents a significant commercial opportunity, and the readout provides the company with a near-term potential milestone that may also serve as clinical proof of concept for our VLP platform. Contingent on positive data from that trial, we plan to then initiate a Phase 1 study of our first combination vaccine candidate, IVX-A12, for RSV and human metapneumovirus during 2H 2022.”
Fourth Quarter 2021 and Subsequent Highlights
Near-Term Milestone Expectations
Fourth Quarter and Full Year 2021 Financial Results
About Icosavax
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 and a vision for combination and pan-respiratory vaccines. 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), and an emerging program in influenza. 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 is located in Seattle.
For more information, visit www.icosavax.com.
Forward-Looking Statements
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 immunogenicity or efficacy of the company’s product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for the end-to-end drug product investigation relating to IVX-411 to produce inconclusive results; the potential that, even if the investigation identifies a root cause or contributing factors for the lower than expected IVX-411 interim topline immunogenicity data, the company may be unable to resolve all ambiguity; the potential for the investigation into IVX-411 interim results to impact the results of the company’s ongoing trial for IVX-121; the possibility of disappointing results in later clinical trials despite promising results in earlier preclinical research or clinical trials; 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 quarterly report on Form 10-Q for the quarter ended September 30, 2021 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.
Media Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc. jessica@litldog.com858.344.8091
Investor Contact:Laurence WattsGilmartin Group, LLClaurence@gilmartinir.com619.916.7620
ICOSAVAX, INC.Balance Sheets(in thousands)
December 31, | |||||||
2021 | 2020 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash | $ | 279,082 | $ | 13,114 | |||
Restricted cash | 1,642 | 2,384 | |||||
Prepaid expenses and other current assets | 5,829 | 662 | |||||
Total current assets | 286,553 | 16,160 | |||||
Property and equipment, net | 1,076 | 10 | |||||
Total assets | $ | 287,629 | $ | 16,170 | |||
Liabilities, convertible preferred stock, and stockholders' equity (deficit) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,899 | $ | 1,918 | |||
Accrued and other current liabilities | 4,757 | 1,532 | |||||
Deferred revenue | 582 | 2,384 | |||||
Total current liabilities | 9,238 | 5,834 | |||||
Long-term convertible promissory note | — | 4,947 | |||||
Embedded derivative liability | — | 1,604 | |||||
Other noncurrent liabilities | 171 | 426 | |||||
Total liabilities | 9,409 | 12,811 | |||||
Convertible preferred stock | — | 30,062 | |||||
Stockholders' equity (deficit): | |||||||
Preferred stock | — | — | |||||
Common stock | 5 | 2 | |||||
Additional paid-in capital | 372,284 | 393 | |||||
Accumulated deficit | (94,069 | ) | (27,098 | ) | |||
Total stockholders' equity (deficit) | 278,220 | (26,703 | ) | ||||
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ | 287,629 | $ | 16,170 | |||
ICOSAVAX, INC.Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
(unaudited) | |||||||||||||||
Grant revenue | $ | 2,070 | $ | 1,616 | $ | 7,802 | $ | 1,616 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 14,063 | 5,329 | 38,776 | 17,667 | |||||||||||
General and administrative | 6,218 | 802 | 34,887 | 2,659 | |||||||||||
Total operating expenses | 20,281 | 6,131 | 73,663 | 20,326 | |||||||||||
Loss from operations | (18,211 | ) | (4,515 | ) | (65,861 | ) | (18,710 | ) | |||||||
Other income (expense): | |||||||||||||||
Change in fair value of embedded derivative liability | — | 187 | (205 | ) | 187 | ||||||||||
Loss on extinguishment of convertible promissory note | — | — | (754 | ) | — | ||||||||||
Interest and other expense | 29 | (280 | ) | (151 | ) | (331 | ) | ||||||||
Total other expense | 29 | (93 | ) | (1,110 | ) | (144 | ) | ||||||||
Net loss and comprehensive loss | $ | (18,182 | ) | $ | (4,608 | ) | $ | (66,971 | ) | $ | (18,854 | ) | |||
Net loss per share, basic and diluted | $ | (0.46 | ) | $ | (1.28 | ) | $ | (3.73 | ) | $ | (8.40 | ) | |||
Weighted-average common shares outstanding, basic and diluted | 39,139,724 | 3,596,936 | 17,965,894 | 2,245,223 |
1 Year Icosavax Chart |
1 Month Icosavax Chart |
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