SEATTLE, March 30, 2023 (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 and a vision of creating pan-respiratory vaccines for older adults, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update.
“We are proud of the progress we made in 2022, which included announcing positive interim results from our Phase 1/1b IVX-121 monovalent respiratory syncytial virus trial, followed by promising durability data at the six-month timepoint. Additionally, we initiated our Phase 1 trial for IVX-A12, a bivalent respiratory syncytial virus and human metapneumovirus VLP vaccine candidate,” said Adam Simpson, Chief Executive Officer of Icosavax. “We have now completed dosing and plan to announce topline data for this Phase 1 trial in 2Q 2023, followed by the planned initiation of a Phase 2 study in the second half of this year. In February, our IVX-A12 program was further boosted when it was granted Fast Track designation by the FDA. These achieved and prospective milestones, along with a 12-month durability data readout from our IVX-121 Phase 1b extension trial around mid-year, mean that 2023 is shaping up to be an exciting period for Icosavax as we continue to work towards our vision.”
Fourth Quarter 2022 and Subsequent Highlights
Near-Term Milestone Expectations
Fourth Quarter and Full Year 2022 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 lead program is a combination vaccine candidate targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), and its pipeline includes additional programs in influenza 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 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 prophylactic and commercial potential of, its vaccine candidates and technology platform; the company’s ability to advance its development program and achieve the noted development milestones in 2023; 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 develop a combination bivalent RSV/hMPV VLP vaccine candidate, which is a novel and unproven approach; potential delays in the development process including without limitation in candidate development, IND submission, the commencement, enrollment, conduct of, and receipt of data from, clinical trials; unexpected adverse side effects or inadequate immunogenicity or efficacy of the company’s vaccine 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; the company’s dependence on third parties in connection with manufacturing, research, and clinical testing; the potential for challenges encountered in the manufacturing and scale up process, including without limitation challenges that reduce drug product stability or potency; 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 vaccine 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; 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, 2022 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.,
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858.344.8091
Investor Contact:
Laurence Watts
Gilmartin Group, LLC
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619.916.7620
ICOSAVAX, INC
Balance Sheets
(in thousands)
December 31, | ||||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 58,846 | $ | 279,082 | ||||
| Restricted cash | 1,061 | 1,642 | ||||||
| Short-term investments | 159,461 | — | ||||||
| Prepaid expenses and other current assets | 4,545 | 5,829 | ||||||
| Total current assets | 223,913 | 286,553 | ||||||
| Right-of-use assets – operating leases | 3,247 | — | ||||||
| Property and equipment, net | 11,517 | 1,076 | ||||||
| Total assets | $ | 238,677 | $ | 287,629 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,892 | $ | 3,899 | ||||
| Accrued and other current liabilities | 8,759 | 4,757 | ||||||
| Current portion of operating lease liabilities | 2,137 | — | ||||||
| Deferred revenue | — | 582 | ||||||
| Total current liabilities | 13,788 | 9,238 | ||||||
| Operating lease liabilities, net of current portion | 6,658 | — | ||||||
| Other noncurrent liabilities | 69 | 171 | ||||||
| Total liabilities | 20,515 | 9,409 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 6 | 5 | ||||||
| Additional paid-in capital | 404,386 | 372,284 | ||||||
| Accumulated other comprehensive loss | (403 | ) | — | |||||
| Accumulated deficit | (185,827 | ) | (94,069 | ) | ||||
| Total stockholders' equity | 218,162 | 278,220 | ||||||
| Total liabilities and stockholders' equity | $ | 238,677 | $ | 287,629 | ||||
ICOSAVAX, INC.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (Unaudited) | ||||||||||||||||
| Grant revenue | $ | — | $ | 2,070 | $ | 582 | $ | 7,802 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 16,193 | 14,063 | 65,410 | 38,776 | ||||||||||||
| General and administrative | 8,938 | 6,218 | 30,230 | 34,887 | ||||||||||||
| Total operating expenses | 25,131 | 20,281 | 95,640 | 73,663 | ||||||||||||
| Loss from operations | (25,131 | ) | (18,211 | ) | (95,058 | ) | (65,861 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of embedded derivative liability | — | — | — | (205 | ) | |||||||||||
| Loss on extinguishment of convertible promissory note | — | — | — | (754 | ) | |||||||||||
| Interest and other | 1,518 | 29 | 3,300 | (151 | ) | |||||||||||
| Total other income (expense) | 1,518 | 29 | 3,300 | (1,110 | ) | |||||||||||
| Net loss | $ | (23,613 | ) | $ | (18,182 | ) | $ | (91,758 | ) | $ | (66,971 | ) | ||||
| Comprehensive loss: | ||||||||||||||||
| Unrealized losses on available-for-sale debt securities | 206 | — | (403 | ) | — | |||||||||||
| Comprehensive loss | $ | (23,407 | ) | $ | (18,182 | ) | $ | (92,161 | ) | $ | (66,971 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.59 | ) | $ | (0.46 | ) | $ | (2.31 | ) | $ | (3.73 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 39,811,323 | 39,139,724 | 39,725,131 | 17,965,894 | ||||||||||||
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