- Completed dosing in older adults portion of Phase 1/1b clinical trial for IVX-121, a VLP vaccine candidate displaying the prefusion stabilized Respiratory Syncytial Virus (RSV) F antigen -
- Company anticipates topline, interim data for RSV lead program IVX-121 in 2Q 2022 -
- Announced emerging program in flu, as part of strategy to develop combination VLP vaccines targeting the viral causes of pneumonia in older adults -
- Reported topline Phase 1/2 results for IVX-411 Against SARS-CoV-2 -
“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
Fourth Quarter 2021 and Subsequent Highlights
- Announced topline interim Phase 1/2 data for IVX-411 against SARS-CoV-2. In March,
Icosavax reported topline, interim data for IVX-411, a VLP vaccine candidate displaying the SARS-CoV-2 receptor-binding domain (RBD). Immunologic response was observed in both SARS-CoV-2 naive and previously vaccinated subjects, but at lower than expected levels that were inconsistent with known data about VLPs, including from clinical studies in COVID-19 and the company’s own preclinical data. As a result, the company is conducting an end-to-end drug product investigation to better understand the results and determine a path forward for the COVID-19 program. - Initiated influenza program.
Icosavax licensed the rights to develop and commercialize an influenza VLP vaccine from theUniversity of Washington , as the company executes on its strategy to develop combination VLP vaccines targeting the viral causes of pneumonia in older adults. The company has initiated preclinical development of a quadrivalent, VLP influenza vaccine candidate. - Appointed
John Shiver , Ph.D., to Board of Directors, andRobin Robinson , Ph.D. toScientific Advisory Board (SAB). In January,Dr. Shiver was appointed to Icosavax’s Board of Directors.Dr. Shiver has more than 30 years of experience in vaccine and pharmaceutical research, having guided scientific teams to create novel vaccine and monoclonal antibody candidates to prevent or treat more than 40 infectious and non-infectious diseases.Icosavax also expanded itsSAB with the addition ofDr. Robinson , who previously served for eight years as the first Director for theBiomedical Advanced Research and Development Authority (BARDA) and before that was Head of Vaccines at Novavax, Inc. - Data published on prefusion hMPV antigen being advanced as part of IVX-A12, a combination bivalent RSV and human Metapneumovirus (hMPV) VLP vaccine candidate.
Nature Communications published new data showing that a prefusion form of the hMPV antigen elicits a six-fold greater immune response in mice versus the postfusion form.Icosavax has exclusively licensed rights to this prefusion stabilized F antigen (except for one mRNA license that may be granted) and incorporated the stabilizing mutations into a VLP-based antigen.
Near-Term Milestone Expectations
- IVX-121 (RSV) Phase 1/1b topline interim data expected in 2Q 2022
- Provide update on IVX-411 (Covid) following company’s end-to-end investigation
- IND submission for IVX-A12 (RSV+hMPV) and initiation of a Phase 1 trial for IVX-A12 expected in 2H 2022
Fourth Quarter and Full Year 2021 Financial Results
- Cash and restricted cash as of
December 31, 2021 was$280.7 million , compared to$15.5 million for the period endedDecember 31, 2020 .Icosavax currently expects its cash balance to be sufficient to fund operations through at least 2024. - Research and development (R&D) expenses for the three and twelve months ended
December 31, 2021 were$14.1 million and$38.8 , respectively, compared to$5.2 million and$17.7 for the same period in 2020, respectively. The increase was primarily driven by increased clinical development and manufacturing costs, growth in the number of R&D employees, including increased stock-based compensation expense, and increased preclinical development and manufacturing activity. Research and development expenses include non-cash stock-based compensation expense of$1.2 million and$2.7 million for the three and twelve months endedDecember 31, 2021 , respectively. - General and administrative (G&A) expenses for the three and twelve months ended
December 31, 2021 were$6.2 million and$34.9 , respectively, compared to$0.8 million and$2.7 for the same period in 2020, respectively. The increase was primarily due to growth in the number of G&A employees, including increased stock-based compensation expense, and increased professional services and other operating expenses to support the company’s growth. The increased stock-based compensation for the twelve months endedDecember 31, 2021 is inclusive of$21.0 million in one-time, non-cash expense from the acceleration of options in connection with the death of the company’s former co-founder and Chairman (Tachi Yamada ). General and administrative expenses include non-cash stock-based compensation expense of$2.4 million and$26.3 million for the three and twelve months endedDecember 31, 2021 , respectively. - Net loss for the three and twelve months ended December 31, 2021 was
$18.2 million and$67.0 million , respectively, or a basic and diluted net loss per share attributable to common stockholders of$0.46 and$3.73 , respectively. This includes non-cash stock-based compensation expense of$29.0 million . Net loss for the same period in 2020 was$4.6 million and$18.9 million , respectively, or a basic and diluted net loss per share attributable to common stockholders of$1.28 and$8.40 , respectively.
About
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
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Balance Sheets
(in thousands)
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 | |||
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
Three Months Ended | Year Ended | ||||||||||||||
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 |
Source:
2022 GlobeNewswire, Inc., source