ICVX Icosavax Inc.

16.64
-0.01  0%
Previous Close 16.65
Open 15.66
52 Week Low 14.915
52 Week High 49.99
Market Cap $649,655,635
Shares 39,041,805
Float 24,215,854
Enterprise Value $641,488,635
Volume 40,084
Av. Daily Volume 91,948
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Upcoming Catalysts

Drug Stage Catalyst Date
IVX-411
COVID-19 vaccine
Phase 1/2
Phase 1/2
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IVX-121
Respiratory syncytial virus (RSV) vaccine
Phase 1b
Phase 1b
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Drug Pipeline

Drug Stage Notes
IVX-A12
RSV/human Metapneumovirus (hMPV)
Phase 1
Phase 1
IND submission Sep 13, 2021. VLP vaccine candidate expected in 2H 2022.

Latest News

  1. SEATTLE, Jan. 07, 2022 (GLOBE NEWSWIRE) -- Icosavax, Inc. (NASDAQ:ICVX), a biopharmaceutical company leveraging its innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, today provided a corporate update and shared anticipated milestones for 2022.

    Pipeline Updates:

    • Exercised option for patent license for influenza vaccine from the University of Washington (UW) and U.S. Department of Human and Health Services (HHS). Icosavax has exercised its option for a non-exclusive patent license granted by UW and HHS for use of its computationally designed, two component VLP platform in the influenza field, as the company executes on its strategy to develop combination VLP vaccines targeting the viral…

    SEATTLE, Jan. 07, 2022 (GLOBE NEWSWIRE) -- Icosavax, Inc. (NASDAQ:ICVX), a biopharmaceutical company leveraging its innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, today provided a corporate update and shared anticipated milestones for 2022.

    Pipeline Updates:

    • Exercised option for patent license for influenza vaccine from the University of Washington (UW) and U.S. Department of Human and Health Services (HHS). Icosavax has exercised its option for a non-exclusive patent license granted by UW and HHS for use of its computationally designed, two component VLP platform in the influenza field, as the company executes on its strategy to develop combination VLP vaccines targeting the viral causes of pneumonia in older adults. A precursor vaccine candidate on the two-component VLP platform is currently being investigated in a Phase 1 study being run by the NIH, having previously been tested preclinically, including in non-human primates. Icosavax looks forward to providing future updates on its influenza program and development strategy. 
    • Evaluating IVX-411, a SARS-CoV-2 VLP vaccine candidate, against the Omicron variant. As part of its ongoing response to emerging variants, the company plans to evaluate preclinical and clinical sera to determine whether antibodies from animals and subjects immunized with IVX-411 neutralize the SARS-CoV-2 Omicron variant. In addition, Icosavax has initiated preclinical development of a potential Omicron VLP vaccine candidate, for evaluation as a possible back-up COVID-19 vaccine candidate.
    • Completed dosing of younger adults in the Phase 1 portion of the Phase 1/1b clinical trial for IVX-121. Icosavax has completed dosing in the Phase 1 (younger adults) portion of its ongoing Phase 1/1b clinical trial of IVX-121, a VLP vaccine candidate displaying the prefusion stabilized respiratory syncytial virus (RSV) F antigen, and the Phase 1b (older adults) portion of this trial has been initiated. Additionally, the company has completed its pre-IND meeting for the IVX-A12 combination bivalent RSV and human Metapneumovirus (hMPV) VLP vaccine candidate and is on track to begin its Phase 1 trial for IVX-A12 in 2H 2022.

    Corporate Updates:

    • Appointed Robin Robinson, Ph.D., to Scientific Advisory Board (SAB). Icosavax has expanded its SAB with the appointment of Dr. Robinson, who previously served for eight years as the first Director for the Biomedical Advanced Research and Development Authority (BARDA) and, prior to public service, was Head of Vaccines at Novavax, Inc. As the company advances its VLP vaccine candidates, Dr. Robinson brings significant experience interacting with government agencies during pandemic response.
    • Recently appointed John Shiver, Ph.D., to Board of Directors. As announced on January 5, 2022, Icosavax has appointed John Shiver, Ph.D., to its Board. Dr. Shiver has more than 30 years of experience in vaccine and pharmaceutical research and development, including at two of the most prominent vaccine companies in the world, Sanofi Pasteur and Merck & Co., Inc. He has guided scientific teams to create novel vaccine and monoclonal antibody candidates to prevent or treat more than 40 infectious and non-infectious diseases, including RSV, influenza, pneumococcus, CMV, HIV, HPV, cancer, and asthma, and contributed to the licensure of 14 products.
    • Expanded Seattle headquarters. The company recently signed a lease on a new facility of approximately 25,000 square feet, which provides substantially greater research and development capabilities to support the expansion of Icosavax's computationally designed VLP technology including antigen design capabilities and potential additional indications.

    "As we enter 2022, Icosavax has several near-term, anticipated clinical milestones, including top-line data readouts from our IVX-411 program in SARS-CoV-2 as well as our IVX-121 program in RSV. We are also pleased to have exercised our option for influenza, which is another step in our strategy to develop combination and pan-respiratory vaccines using our VLP technology," said Adam Simpson, Chief Executive Officer of Icosavax. "I am thrilled with the company's accomplishments and execution in 2021 and look forward to providing further updates over the course of the coming year."

    Near-Term Milestone Expectations

    • IVX-411 (COVID-19) Phase 1/2 interim, top-line data in 1Q 2022
    • IVX-121 (RSV) Phase 1/1b interim, top-line data in 2Q 2022 
    • IND submission for IVX-A12 (RSV+hMPV) and initiation of a Phase 1 trial for IVX-A12 in 2H 2022
    • Subject to positive data from the IVX-411 (COVID-19) Phase 1/2 trial, initiation of an additional Phase 2 trial for IVX-411, co-administered with a licensed influenza vaccine, in previously vaccinated SARS-CoV-2 subjects, in 2H 2022

    Preliminary Cash Position

    • Icosavax has an unaudited preliminary cash position, including restricted cash, of $281 million as of December 31, 2021. The company currently expects its cash balance to be sufficient to fund operations through at least 2024.

    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.

    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 goal to progress its preclinical and clinical programs including an influenza candidate for use as part of a pan respiratory vaccine, the timing of company milestone achievement, the company's cash balance and the potential of the company's VLP technology. 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 novel and unproven technology and the uncertainties associated with the development of an influenza candidate for use as part of a pan respiratory vaccine; 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 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. In addition, the company's preliminary cash balance reported in this press release reflects only information available to the company at this time, has not been reviewed or audited by the company's independent registered public accounting firm and may differ from the final audited cash balance. 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.



    +1.858.344.8091

    Investor Contact: 

    Laurence Watts

    Gilmartin Group, LLC



    +1.619.916.7620



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  2. SEATTLE, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Icosavax, Inc. (NASDAQ:ICVX), a biopharmaceutical company leveraging its innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, today announced the appointment of John Shiver, Ph.D., to its Board of Directors. Dr. Shiver has more than 30 years of experience in vaccine and pharmaceutical research and development, including at two of the most prominent vaccine companies in the world, Sanofi Pasteur and Merck & Co., Inc. He has guided scientific teams to create novel vaccine and monoclonal antibody candidates to prevent or treat more than 40 infectious and non-infectious diseases, including RSV, influenza, pneumococcus, CMV, HIV, HPV, cancer, and asthma…

    SEATTLE, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Icosavax, Inc. (NASDAQ:ICVX), a biopharmaceutical company leveraging its innovative virus-like particle (VLP) platform technology to develop vaccines against infectious diseases, today announced the appointment of John Shiver, Ph.D., to its Board of Directors. Dr. Shiver has more than 30 years of experience in vaccine and pharmaceutical research and development, including at two of the most prominent vaccine companies in the world, Sanofi Pasteur and Merck & Co., Inc. He has guided scientific teams to create novel vaccine and monoclonal antibody candidates to prevent or treat more than 40 infectious and non-infectious diseases, including RSV, influenza, pneumococcus, CMV, HIV, HPV, cancer, and asthma, and contributed to the licensure of 14 products.

    "I am pleased to welcome John to our Board during an important time in Icosavax's continued growth as we work to advance clinical development of our RSV and SARS-CoV-2 vaccine candidates based on our VLP platform technology," said Adam Simpson, Chief Executive Officer of Icosavax. "John's extensive experience in successfully advancing products to market from novel platform technologies as well as his deep understanding of infectious diseases will be invaluable as Icosavax works to progress its vision of a multivalent VLP vaccine targeting the viral causes of pneumonia in older adults."

    "Naturally occurring virus-like particles have been successfully harnessed for effective vaccines, but constructing and manufacturing VLPs displaying complex antigens has been a major hurdle," said Dr. Shiver. "That's why Icosavax's VLP platform technology is so interesting as it enables the creation of precision-designed VLP vaccine candidates for complex antigens, like RSV, as well as multivalent vaccine candidates with the potential to protect against two or more respiratory diseases and streamline vaccine regimens. I look forward to providing my expertise and working closely with Icosavax's leadership team and Board to advance the company's VLP technology against life-threatening respiratory diseases."

    Currently, Dr. Shiver is Chief Strategy Officer, leader of the scientific advisory board, and member of the Board of Directors at IGM ID, a wholly owned subsidiary of IGM Biosciences. Prior to IGM ID, he was the Global Head of Vaccines R&D and a member of the Executive Leadership team at Sanofi Pasteur, the largest company in the world devoted entirely to vaccines. While at Sanofi, Dr. Shiver championed three major collaborations and an acquisition, including Sanofi's collaboration with Translate Bio for access to the company's mRNA platform, its alliance with MedImmune (now AstraZeneca) for nirsevimab, a monoclonal antibody being developed for the prevention of RSV in infants, and its acquisition of Protein Sciences Corporation, which developed and commercialized a recombinant protein-based influenza vaccine. Prior to Sanofi, Dr. Shiver led vaccine research at Merck and served in the experimental immunology branch of the National Institutes of Health. Dr. Shiver is a fellow of the American Academy of Microbiology and the International Society for Vaccines. He is the author of more than 150 articles in top-tier journals and is a co-author of 68 awarded patents.

    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. 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 Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases. Icosavax exclusively licensed the VLP technology for use in several fields, including RSV and hMPV, from the University of Washington. For SARS-CoV-2, Icosavax has a non-exclusive, worldwide (excluding South Korea) license from the University of Washington that will convert to an exclusive license in North America and Europe in 2025. 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 our current beliefs and expectations and include, but are not limited to: our goal to progress our clinical candidates including our RSV and SARS-CoV-2 vaccine candidates in clinical development and the potential of our VLP technology to create differentiated vaccine candidates for complex antigens and multivalent vaccine candidates with the potential to protect against two or more respiratory diseases and streamline vaccine regimens. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: the early stage of our development efforts; our approach to the discovery and development of vaccine candidates, which is a novel and unproven approach; potential delays in the commencement, enrollment, and completion of clinical trials; the inherent difficulty and uncertainty of vaccine development including the possibility that vaccine candidates that appear promising in non-clinical testing could fail in clinical trials; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our 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 we undertake 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.



    +1.858.344.8091

    Investor Contact: 

    Laurence Watts

    Gilmartin Group, LLC



    +1.619.916.7620



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  3. BOSTON, Dec. 17, 2021 /PRNewswire/ -- Omega Funds, a leading international healthcare venture capital firm focused on delivering impactful medicines to patients, today announced it has closed its seventh and largest fund with $650 million in limited partner capital commitments. The new fund, Omega Fund VII, L.P. ("Fund VII"), was oversubscribed, exceeding the firm's targeted raise of $500 million, and included strong support from both new and existing limited partners. With Fund VII, the firm will continue to execute on its strategy of creating and investing in life sciences companies in the US and Europe that target severe, unmet medical needs. Since its inception in 2004, Omega Funds has raised close to $2 billion to invest in exceptional…

    BOSTON, Dec. 17, 2021 /PRNewswire/ -- Omega Funds, a leading international healthcare venture capital firm focused on delivering impactful medicines to patients, today announced it has closed its seventh and largest fund with $650 million in limited partner capital commitments. The new fund, Omega Fund VII, L.P. ("Fund VII"), was oversubscribed, exceeding the firm's targeted raise of $500 million, and included strong support from both new and existing limited partners. With Fund VII, the firm will continue to execute on its strategy of creating and investing in life sciences companies in the US and Europe that target severe, unmet medical needs. Since its inception in 2004, Omega Funds has raised close to $2 billion to invest in exceptional entrepreneurs developing innovative products across multiple therapeutic areas, including oncology, immunology, rare diseases, and precision medicine.

    "We appreciate the trust from both our longstanding and new investors and their support of our differentiated model, which leverages our broad investment toolkit and data-driven approach to target transformative innovation," said Otello Stampacchia, Ph.D., Founder and Managing Director of Omega Funds. "We look forward to contributing our conviction-building processes and network connectivity, in addition to capital, to the many entrepreneurs and founders intent on transforming existing standards of care for severe diseases. We believe this is the most exciting time to invest in healthcare, due to the accelerating pace of development in biotechnology and the fact that the COVID-19 pandemic has led to many novel discoveries about the human immune system."

    Fund VII builds upon the success of Omega Funds' $438M Fund VI and previous funds, which have supported portfolio companies that have brought 46 new products to market. The firm's investments have contributed to 39 successful portfolio company public listings and 35 portfolio company exits via M&A. Omega Funds' recent public offerings and exits include Theseus Pharmaceuticals (NASDAQ:THRX), Adagio Therapeutics (NASDAQ:ADGI), Icosavax (NASDAQ:ICVX), Imago BioSciences (NASDAQ:IMGO), Ikena Oncology (NASDAQ:IKNA), Nuvation Bio (NYSE:NUVB), Sana Biotechnology (NASDAQ:SANA), Prevail Therapeutics (acquired by Eli Lilly) and Kronos Bio (NASDAQ:KRON).

    Fund VII is stage-agnostic and is expected to be deployed across companies in the U.S. and Europe. Similar to past funds, Fund VII investments will include a variety of investment approaches, from company creation to early venture rounds and later-stage financings.

    "We are delighted to announce with the closing of Fund VII, the addition of Mike Powell as Executive Partner and the promotion of Francesco Draetta to Partner" added Dr. Stampacchia. "We have thoughtfully built our investment team to have the diverse capabilities required to successfully identify, support and construct biotech companies that can bring novel therapies to patients. We look forward to Francesco's continued contribution and Mike's complimentary additions to the team."

    Mike Powell, Ph.D., joined Omega Funds in August 2021 from Sofinnova Investments, where he served as Managing General Partner since 1997. Previously, he was Group Leader at Genentech, where his focus was on drug delivery, CMC, and formulation of both small molecule and protein drug entities. He was previously Board President of the AIDS Vaccine Advocacy Coalition, and past advisor to the Institute for One World Health, the International AIDS Vaccine Initiative (IAVI), and the Bill and Melinda Gates Foundation. Dr. Powell is currently an Adjunct Associate Professor in the Department of Pharmaceutical Chemistry at the University of Kansas, and also serves on the Board of Trustees at Washington University in St. Louis. Dr. Powell has authored or co-authored 90 peer-reviewed publications, numerous book chapters, and the textbook, Vaccine Design. He holds a PhD in Physical Chemistry from the University of Toronto, and completed his postdoctoral studies in BioOrganic Chemistry at the University of California.

    Francesco Draetta, CFA, CAIA, began his career at Omega Funds, as an Analyst from 2008 to 2012, and then rejoined in 2016 as a Principal. He focuses on private company investments and  fundraising for the firm. Mr. Draetta currently serves on the board of Chord Therapeutics and is Chief Financial Officer of Omega Alpha SPAC (NASDAQ:OMEG). Prior to rejoining Omega, Mr. Draetta was part of the investment team at Brookside Mezzanine Partners and at Commonfund Capital. Mr. Draetta graduated cum laude from the Isenberg School of Management at the University of Massachusetts Amherst with a BBA in Finance and Operations Management.

    About Omega Funds

    Founded in 2004, Omega Funds is a leading international venture capital firm that creates and invests in life sciences companies that target our world's most urgent medical needs. Omega focuses on identifying and supporting companies through value inflection points across the full arc of innovation, from company formation through clinical milestones and commercial adoption. Omega Funds' portfolio companies have brought 46 products to market in multiple therapeutic areas, including oncology, rare diseases, precision medicine and others. Please visit www.omegafunds.com for additional information.

    Media Contact:

    Michael Beyer

    The Harbinger Group

    Tel: 312-961-2502

    E-mail:

    Omega Contact:

    Katie Kerfoot

    Tel: 857-332-4495

    E-mail:

    Cision View original content:https://www.prnewswire.com/news-releases/omega-funds-closes-oversubscribed-650-million-fund-vii-to-invest-in-transformative-life-science-companies-301446687.html

    SOURCE Omega Funds

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  4. - Initiated a Phase 1/1b clinical trial for IVX-121, a virus like particle (VLP) vaccine candidate displaying the prefusion stabilized Respiratory Syncytial Virus (RSV) F antigen -

    - Completed dosing in ongoing Phase 1/2 clinical trial for IVX-411, a VLP vaccine candidate displaying the SARS-CoV-2 receptor-binding domain -

    SEATTLE, Nov. 15, 2021 (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, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.

    "I am pleased with…

    - Initiated a Phase 1/1b clinical trial for IVX-121, a virus like particle (VLP) vaccine candidate displaying the prefusion stabilized Respiratory Syncytial Virus (RSV) F antigen -

    - Completed dosing in ongoing Phase 1/2 clinical trial for IVX-411, a VLP vaccine candidate displaying the SARS-CoV-2 receptor-binding domain -

    SEATTLE, Nov. 15, 2021 (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, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.

    "I am pleased with the progress that Icosavax has made in the third quarter, highlighted by our successful IPO in July, the initiation of a Phase 1/1b clinical trial for IVX-121 in September, and the continued progression of a Phase 1/2 clinical trial for IVX-411," said Adam Simpson, Chief Executive Officer of Icosavax. "As we near the end of the year and look ahead to 2022, we have several anticipated clinical milestones in the next few quarters including interim, top-line data readouts from both our IVX-411 Phase 1/2 and IVX-121 Phase 1/1b clinical trials. I look forward to providing updates on our clinical programs in the coming months."

    Third 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 vaccine candidate displaying the prefusion stabilized RSV 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 vaccine candidate, Icosavax plans to thereafter initiate a Phase 1 clinical trial of its IVX-A12 combination bivalent RSV and hMPV vaccine candidate.



    • Progressed a Phase 1/2 clinical trial of IVX-411. Icosavax progressed its Phase 1/2 clinical trial to assess the safety and immunogenicity of IVX-411, the company's VLP vaccine candidate displaying the SARS-CoV-2 receptor-binding domain antigen. Part 1 of this trial is in adults who have neither had COVID-19 nor been vaccinated with a licensed COVID-19 vaccine, and Part 2 of this trial is in adults who have previously completed a vaccine regimen using a licensed COVID-19 vaccine. Both parts of this trial have completed dosing.



    • Completed successful IPO; listed on Nasdaq. In July, Icosavax successfully closed its initial public offering raising gross proceeds of $209.3 million prior to deducting underwriting fees, commissions and offering expenses. Icosavax's common stock began trading on the Nasdaq Global Select Market under the ticker symbol "ICVX" on July 29, 2021.



    • Made key appointments to Executive Team and Board. In July, Ann Veneman was appointed to Icosavax's Board of Directors. In August, Mark McDade was appointed to chair the Board. In September, Icosavax appointed Elizabeth Bekiroglu as the company's General Counsel.

    Near-Term Milestone Expectations

    • Phase 1/2 interim, top-line data for IVX-411 in 1H 2022



    • Phase 1/1b interim, top-line data for IVX-121 in 1H 2022



    • IND submission for IVX-A12, a combination bivalent RSV and hMPV VLP vaccine candidate, in 1H 2022

    Third Quarter 2021 Financial Results

    • Cash, cash equivalents and short-term investments as of September 30, 2021 were $293.9 million, compared to $15.5 million for the period ended December 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 months ended September 30, 2021 were $10.9 million, compared to $4.8 million for the same period in 2020. The increase was primarily driven by increased clinical development and manufacturing costs, increased stock-based compensation expense, growth in the number of R&D employees, and increased non-clinical development and manufacturing activity. Research and development expenses include non-cash stock-based compensation expense of $0.9 million for the three months ended September 30, 2021, versus an immaterial amount for the prior year period.



    • General and administrative (G&A) expenses for the three months ended September 30, 2021 were $25.4 million, compared to $0.7 million for the same period in 2020. The increase was primarily due to increased stock-based compensation expense, increased professional services and other operating expenses to support the company's growth, and growth in the number of G&A employees. General and administrative expenses include non-cash stock-based compensation expenses of $22.7 million for the three months ended September 30, 2021, versus an immaterial amount for the prior year period. This is inclusive of $21.0 million in one-time, non-cash stock-based compensation expense from the acceleration of options in connection with the death of the company's former co-founder and Chairman (Tachi Yamada).



    • Net loss for the three months ended September 30, 2021 was $34.4 million, or a basic and diluted net loss per share attributable to common stockholders of $1.30. This includes non-cash stock-based compensation expense of $23.7 million. Net loss for the same period in 2020 was $5.6 million, or basic and diluted net loss per share attributable to common stockholders of $2.40.

    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

    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 Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases. Icosavax exclusively licensed the VLP technology for use in several fields, including RSV and hMPV, from the University of Washington. For SARS-CoV-2, Icosavax has a non-exclusive, worldwide (excluding South Korea) license from the University of Washington that will convert to an exclusive license in North America and Europe in 2025. Icosavax is located in Seattle. 

    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 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 June 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.



    858.344.8091

    Investor Contact:

    Laurence Watts

    Gilmartin Group, LLC



    619.916.7620



    ICOSAVAX, INC.

    Condensed Balance Sheets

    (Unaudited)

    (in thousands, except share and par value data)

      September 30,  December 31,
        2021  2020 
    Assets     
    Current assets:     
    Cash $291,271  $13,114 
    Restricted cash  2,652   2,384 
    Prepaid expenses and other current assets  6,353   662 
    Total current assets  300,276   16,160 
    Property and equipment, net  548   10 
    Total assets $300,824  $16,170 
    Liabilities, convertible preferred stock, and stockholders' equity (deficit)     
    Current liabilities:     
    Accounts payable $3,049  $1,918 
    Accrued and other current liabilities  2,487   1,532 
    Deferred revenue  2,652   2,384 
    Total current liabilities  8,188   5,834 
    Long-term convertible promissory note     4,947 
    Embedded derivative liability     1,604 
    Other noncurrent liabilities  197   426 
    Total liabilities  8,385   12,811 
    Convertible preferred stock   30,062 
    Total stockholders' equity (deficit) 292,439  (26,703)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit) $300,824  $16,170 
             

    ICOSAVAX, INC.

    Condensed Statements of Operations and Comprehensive Loss

    (Unaudited)

    (in thousands, except share and per share data)

      Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
      2021  2020  2021  2020
    Grant revenue $1,827  $  $5,732  $
    Operating expenses:           
    Research and development  10,883   4,752   24,713   12,338 
    General and administrative  25,357   704   28,669   1,857 
    Total operating expenses  36,240   5,456   53,382   14,195 
    Loss from operations  (34,413)  (5,456)  (47,650)  (14,195)
    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)  27   (121)  (180)  (51)
    Total other income (expense)  27   (121)  (1,139)  (51)
    Net loss and comprehensive loss $(34,386) $(5,577) $(48,789) $(14,246)
    Net loss per share, basic and diluted $(1.30) $(2.40) $(4.50) $(6.66)
    Weighted-average common shares outstanding, basic and diluted  26,494,914   2,321,765   10,836,894  2,139,768 


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  5. SEATTLE, Nov. 11, 2021 (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, today announced that Adam Simpson, Chief Executive Officer of Icosavax, will participate in two upcoming investor conferences.

    Details of the events are below:

    • Jefferies London Healthcare Conference: Icosavax will participate in a fireside chat that will be available at 3:00 AM ET on Thursday, November 18, 2021.

    • Evercore ISI 4th Annual HealthCONx Virtual Conference: Icosavax will participate in a fireside chat on Thursday, December 2, 2021, at 4:20 PM ET.

    The…

    SEATTLE, Nov. 11, 2021 (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, today announced that Adam Simpson, Chief Executive Officer of Icosavax, will participate in two upcoming investor conferences.

    Details of the events are below:

    • Jefferies London Healthcare Conference: Icosavax will participate in a fireside chat that will be available at 3:00 AM ET on Thursday, November 18, 2021.



    • Evercore ISI 4th Annual HealthCONx Virtual Conference: Icosavax will participate in a fireside chat on Thursday, December 2, 2021, at 4:20 PM ET.

    The webcasts of the Jefferies London fireside chat and the Evercore ISI fireside chat will be available on the Events page of the Investor Relations section of Icosavax's website, ir.icosavax.com. The webcast replays will be available on the website for approximately 30 days.

    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. 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 Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases. Icosavax exclusively licensed the VLP technology for use in several fields, including RSV and hMPV, from the University of Washington. For SARS-CoV-2, Icosavax has a non-exclusive, worldwide (excluding South Korea) license from the University of Washington that will convert to an exclusive license in North America and Europe in 2025. Icosavax is located in Seattle. 

    Forward-Looking Statements

    Statements by the company 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 the forward-looking statements 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 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 June 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 they are made, and the company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after such date. 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.



    +1.858.344.8091

    Investor Contact: 

    Laurence Watts

    Gilmartin Group, LLC



    +1.619.916.7620



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