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 second quarter ended June 30, 2022 and provided a corporate update.
“We are pleased with the company’s progress this year - especially the recently announced positive topline interim Phase 1/1b results for our VLP vaccine candidate IVX-121 against RSV - and remain focused on continuing that momentum through the second half of the year,” said Adam Simpson, Chief Executive Officer of Icosavax. “IVX-121 demonstrated a robust immunologic response, consistent across both young and older adults, a favorable tolerability profile, and provided initial validation of our underlying VLP technology. Based on these results, in addition to the body of preclinical data for our hMPV VLP and the RSV/hMPV combination VLP, we now look forward to the near-term initiation of a Phase 1 study for our first combination vaccine candidate, IVX-A12, against both RSV and hMPV.”
Second Quarter 2022 and Subsequent Highlights
Near-Term Milestone Expectations
Second Quarter 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) and human metapneumovirus (hMPV), as well as programs in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and 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 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 2022 and 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 pursue 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 March 31, 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.,
Little Dog Communications Inc.
This email address is being protected from spambots. You need JavaScript enabled to view it.
858.344.8091
Investor Contact:
Laurence Watts
Gilmartin Group, LLC
This email address is being protected from spambots. You need JavaScript enabled to view it.
619.916.7620
ICOSAVAX, INC.
Condensed Balance Sheets
(Unaudited)
(in thousands)
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 108,345 | $ | 279,082 | ||||
| Restricted cash | 1,061 | 1,642 | ||||||
| Short-term investments | 134,459 | — | ||||||
| Prepaid expenses and other current assets | 4,637 | 5,829 | ||||||
| Total current assets | 248,502 | 286,553 | ||||||
| Right-of-use assets – operating leases | 3,227 | — | ||||||
| Property and equipment, net | 7,949 | 1,076 | ||||||
| Total assets | $ | 259,678 | $ | 287,629 | ||||
| Liabilities and stockholders' equity (deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,485 | $ | 3,899 | ||||
| Accrued and other current liabilities | 7,349 | 4,757 | ||||||
| Current portion of operating lease liabilities | 1,061 | — | ||||||
| Deferred revenue | — | 582 | ||||||
| Total current liabilities | 11,895 | 9,238 | ||||||
| Operating lease liabilities, net of current portion | 5,235 | — | ||||||
| Other noncurrent liabilities | 119 | 171 | ||||||
| Total liabilities | 17,249 | 9,409 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock | 5 | 5 | ||||||
| Additional paid-in capital | 382,937 | 372,284 | ||||||
| Accumulated other comprehensive loss | (275 | ) | — | |||||
| Accumulated deficit | (140,238 | ) | (94,069 | ) | ||||
| Total stockholders' equity | 242,429 | 278,220 | ||||||
| Total liabilities and stockholders' equity | $ | 259,678 | $ | 287,629 | ||||
ICOSAVAX, INC.
Condensed Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Grant revenue | $ | — | $ | 1,904 | $ | 582 | $ | 3,905 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 15,820 | 8,277 | 33,733 | 13,830 | |||||||||||
| General and administrative | 7,311 | 2,221 | 13,633 | 3,312 | |||||||||||
| Total operating expenses | 23,131 | 10,498 | 47,366 | 17,142 | |||||||||||
| Loss from operations | (23,131 | ) | (8,594 | ) | (46,784 | ) | (13,237 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Change in fair value of embedded derivative liability | — | — | — | (205 | ) | ||||||||||
| Loss on extinguishment of convertible promissory note | — | — | — | (754 | ) | ||||||||||
| Interest and other | 495 | 42 | 615 | (207 | ) | ||||||||||
| Total other income (expense) | 495 | 42 | 615 | (1,166 | ) | ||||||||||
| Net loss | $ | (22,636 | ) | $ | (8,552 | ) | $ | (46,169 | ) | $ | (14,403 | ) | |||
| Comprehensive loss: | |||||||||||||||
| Unrealized losses on available-for-sale debt securities | (275 | ) | — | (275 | ) | — | |||||||||
| Comprehensive loss | $ | (22,911 | ) | $ | (8,552 | ) | $ | (46,444 | ) | $ | (14,403 | ) | |||
| Net loss per share, basic and diluted | $ | (0.57 | ) | $ | (2.86 | ) | $ | (1.17 | ) | $ | (5.00 | ) | |||
| Weighted-average common shares outstanding, basic and diluted | 39,594,028 | 2,985,183 | 39,524,408 | 2,878,163 | |||||||||||
December 12, 2023 December 12, 2023 November 14, 2023 August 14, 2023 |
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
CLICK TO LEARN MORE
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
CLICK TO LEARN MORE
