- 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
“The second quarter and recent period has been a transformational time for
Second Quarter 2021 and Subsequent Highlights
- Initiated a Phase 1/1b clinical trial of IVX-121. In September,
Icosavax initiated a Phase 1/1b clinical trial to assess the safety and immunogenicity of IVX-121, the company’s VLP displaying an RSV stabilized pre-fusion F antigen, in healthy adults (Phase 1), including older adults (Phase 1b). Assuming favorable results from the IVX-121 Phase 1/1b clinical trial and favorable preclinical data from its human Metapneumovirus (hMPV) VLP candidate,Icosavax plans to thereafter initiate a Phase 1 clinical trial of its IVX-A12 bivalent RSV/hMPV vaccine candidate. - Completed successful IPO; listed on Nasdaq. In July,
Icosavax successfully priced its initial public offering raising gross proceeds of$209.3 million prior to deducting underwriting fees, commissions and offering expenses, expected to enable the company to fund its operations through at least 2024. Icosavax’s common stock began trading on the Nasdaq Global Select Market under the ticker symbol “ICVX” onJuly 29, 2021 . - Initiated a Phase 1/2 clinical trial of IVX-411. In June,
Icosavax initiated a Phase 1/2 clinical trial to assess the safety and immunogenicity of IVX-411, the company’s VLP displaying the SARS-CoV-2 receptor-binding domain. Part 1 of this trial, in adults who have neither had COVID-19 nor been vaccinated with a licensed COVID-19 vaccine, has completed dosing, and Part 2 of this trial, in adults who have previously completed a vaccine regimen using a licensed COVID-19 vaccine, has now been initiated. - Appointed
Elizabeth Bekiroglu as General Counsel. In September,Icosavax appointedElizabeth Bekiroglu as the company’s General Counsel.Ms. Bekiroglu has over 15 years of experience advising pharmaceutical and biotechnology companies on a broad range of legal matters.Ms. Bekiroglu most recently served as Associate General Counsel for Seagen, where she helped lead and build the legal affairs group as Seagen transformed into a multi-product, multinational company. - Appointed
Thomas Russo as Chief Financial Officer. In June,Thomas Russo was appointed as Chief Financial Officer.Mr. Russo is a seasoned financial executive who joins the company with more than 25 years of diverse industry experience across finance, operations and sell-side equity research for public biotechnology companies. Prior toIcosavax ,Mr. Russo most recently served as Chief Financial Officer of Assembly Biosciences, where he contributed to financings both through the capital markets and non-dilutive sources. - Appointed additional Board members.
Icosavax appointedHeidi Kunz andAnn Veneman to the Board of Directors in May andJuly 2021 , respectively.Ms. Kunz is a seasoned healthcare executive who sits on the Boards of several healthcare companies and most recently served as Executive Vice President and CFO ofBlue Shield of California .Ms. Veneman has a distinguished career in public service, most recently serving as the Executive Director of the United Nations Children’s Fund (UNICEF ). Additionally,Mark McDade , who has served on Icosavax’s Board of Directors sinceAugust 2019 , was elected to chair the Board inAugust 2021 following the sudden passing of the company’s co-founder and former Board Chair,Tadataka (Tachi) Yamada .Icosavax paid tribute toTachi Yamada and his impact on public health during a Nasdaq closing bell ceremony inAugust 2021 . - Completed successful Series B financing. In April,
Icosavax announced closing of a$100 million Series B financing led byRA Capital Management and joined byJanus Henderson Investors ,Perceptive Advisors ,Viking Global Investors , Cormorant Asset Management, Omega Funds, andSurveyor Capital (aCitadel company) as well as existing investors. In conjunction with the financing,Peter Kolchinsky , Ph.D., founder and managing partner ofRA Capital Management , joined the company’s Board of Directors.
Near-Term Milestone Expectations
- Phase 1/2 interim/topline data for IVX-411, in 1H 2022
- Phase 1/1b interim/topline data for IVX-121, in 1H 2022
- IND submission for IVX-A12, a combination bivalent RSV/human Metapneumovirus (hMPV) VLP vaccine candidate, in 1H 2022
Second Quarter 2021 Financial Results
- Cash, cash equivalents and short-term investments as of
June 30, 2021 were$111.8 million , compared to$15.5 million for the period endedDecember 31, 2020 . Subsequently, in July, the company raised$190.6 million in net proceeds from its initial public offering.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 months ended
June 30, 2021 were$8.3 million , compared to$4.7 million for the same period in 2020. The increase was primarily driven by increased clinical development and manufacturing costs, growth in the number of R&D employees, non-clinical development and manufacturing activity, and stock-based compensation expense. Research and development expenses include non-cash stock-based compensation expense of$0.4 million for the three months endedJune 30, 2021 versus an immaterial amount for the same period in 2020. - General and administrative expenses for the three months ended
June 30, 2021 were$2.2 million , compared to$0.5 million for the same period in 2020. The increase was primarily due to increased stock-based compensation expense, growth in the number of G&A employees, and professional services including legal fees to support the company’s growth. General and administrative expenses include non-cash stock-based compensation expenses of$0.9 million for the three months endedJune 30, 2021 versus an immaterial amount for the same period in 2020. - Net loss for the three months ended June 30, 2021 was
$8.6 million , or a basic and diluted net loss per share attributable to common stockholders of$2.86 . Net loss for the same period in 2020 was$5.2 million , or basic and diluted net loss per share attributable to common stockholders of$2.45 .
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.
About
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
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 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
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Condensed Balance Sheets
(in thousands, except share and par value data)
(Unaudited)
2021 | 2020 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash | $ | 110,585 | $ | 13,114 | ||||
Restricted cash | 1,179 | 2,384 | ||||||
Prepaid expenses and other current assets | 4,119 | 662 | ||||||
Total current assets | 115,883 | 16,160 | ||||||
Property and equipment, net | 561 | 10 | ||||||
Deferred offering costs | 2,265 | — | ||||||
Total assets | $ | 118,709 | $ | 16,170 | ||||
Liabilities, convertible preferred stock, and stockholders' deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 3,111 | $ | 1,918 | ||||
Accrued and other current liabilities | 1,825 | 1,532 | ||||||
Deferred revenue | 1,179 | 2,384 | ||||||
Total current liabilities | 6,115 | 5,834 | ||||||
Long-term convertible promissory note | — | 4,947 | ||||||
Embedded derivative liability | — | 1,604 | ||||||
Other noncurrent liabilities | 279 | 426 | ||||||
Total liabilities | 6,394 | 12,811 | ||||||
Convertible preferred stock, | 151,613 | 30,062 | ||||||
Total stockholders' deficit | (39,298 | ) | (26,703 | ) | ||||
Total liabilities, convertible preferred stock and stockholders' deficit | $ | 118,709 | $ | 16,170 | ||||
Condensed Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share data)
Three Months Ended | Six Months Ended | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Grant revenue | $ | 1,904 | $ | — | $ | 3,905 | $ | — | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 8,277 | 4,666 | 13,830 | 7,586 | ||||||||||||
General and administrative | 2,221 | 541 | 3,312 | 1,153 | ||||||||||||
Total operating expenses | 10,498 | 5,207 | 17,142 | 8,739 | ||||||||||||
Loss from operations | (8,594 | ) | (5,207 | ) | (13,237 | ) | (8,739 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Change in fair value of embedded derivative liability | — | — | (205 | ) | — | |||||||||||
Loss on extinguishment of convertible promissory note | — | — | (754 | ) | — | |||||||||||
Interest and other income (expense) | 42 | 9 | (207 | ) | 70 | |||||||||||
Total other income (expense) | 42 | 9 | (1,166 | ) | 70 | |||||||||||
Net loss and comprehensive loss | $ | (8,552 | ) | $ | (5,198 | ) | $ | (14,403 | ) | $ | (8,669 | ) | ||||
Net loss per share, basic and diluted | $ | (2.86 | ) | $ | (2.45 | ) | $ | (5.00 | ) | $ | (4.23 | ) | ||||
Weighted-average common shares outstanding, basic and diluted | 2,985,183 | 2,119,312 | 2,878,163 | 2,047,803 |
Source:
2021 GlobeNewswire, Inc., source