Influenza Virus Like Particle Vaccines(University Of Washington)

- Positive topline interim Phase 1 results for bivalent VLP vaccine candidate IVX-A12 against RSV and hMPV in older adults - - Positive twelve-month immunogenicity data and initial proof-of-concept for revaccination with IVX-121 against RSV - - Initiation of Phase 2 Trial of IVX-A12 with topline interim results now expected by end 2023 - - Closed $67.8 million registered direct offering of common stock; extended cash runway into 2H 2025 - SEATTLE, Aug. 14, 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 second quarter ended June 30, 2023 and provided a corporate update. “The first half of 2023 has been particularly productive for Icosavax, highlighted by our positive topline interim Phase 1 data and the initiation of a Phase 2 trial for IVX-A12, our potential first-in-class bivalent vaccine candidate for RSV and hMPV,” said Adam Simpson, Chief Executive Officer of Icosavax. “From our Phase 1b extension trial of IVX-121 in RSV, we recently announced positive 12-month immunogenicity and initial revaccination data; these were exciting because better durability and improved response to boosting are potential opportunities for differentiation of our VLP technology. Looking ahead we have additional near-term clinical milestones, including topline interim data from our Phase 2 study of IVX-A12 by the end of the year.” Second Quarter 2023 and Subsequent Highlights Reported positive topline interim phase 1 results for bivalent VLP vaccine candidate IVX-A12 against RSV and hMPV in older adults. In May 2023, Icosavax announced positive topline interim results from a Phase 1 clinical trial of IVX-A12 against respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) in older adults. IVX-A12 is comprised of IVX-121, Icosavax’s RSV prefusion F protein VLP vaccine candidate, and IVX-241, Icosavax’s hMPV prefusion F protein VLP vaccine candidate. In this Phase 1 trial, IVX-A12 induced robust immune responses against both RSV and hMPV at day 28 in older adults, with no evidence of immune interference between RSV and hMPV VLPs administered in combination, and was generally well-tolerated across all dosage groups. Initiated Phase 2 clinical trial of IVX-A12 against RSV and hMPV in older adults. In June 2023, Icosavax announced the initiation of a Phase 2 clinical trial of IVX-A12 in older adults. Dosing has been completed and topline interim data is now expected by the end of 2023. Reported positive 12-month durability data for IVX-121 against RSV and initial evidence for revaccination potential. In August 2023, Icosavax provided a 12-month immunogenicity update from its Phase 1b extension trial of IVX-121 against RSV in older adults. These data demonstrate substantial durability of neutralizing antibody (NAb) response against RSV at twelve months after a single administration of IVX-121. The company also reported initial evidence for revaccination potential with its VLP-based vaccines, including robust immune responses against RSV-A in Phase 1b extension trial participants who received 75 µg unadjuvanted IVX-121 at one year after their first dose. Completed a $67.8 million registered direct offering of common stock. In May 2023, Icosavax closed a registered direct offering of 8,369,754 shares of its common stock at a purchase price of $8.10 per share. The $67.8 million financing was led by new investor TCGX with participation by additional new investors including Logos Capital and Vivo Capital. Appointed Dr. M. Amin Khan, PhD as Executive Vice President, Head of Research and Development. During the quarter, Icosavax appointed Dr. M. Amin Khan as the company’s Head of Research and Development. Dr. Khan has more than 30 years’ experience in vaccine and pharmaceutical R&D, including senior scientific and executive leadership roles at Eli Lilly, Novartis and GlaxoSmithKline. He has guided scientific and technical teams to develop novel vaccines for infectious diseases including targets for RSV, influenza, meningitis, group B streptococcus, S. aureus, COPD, CMV, herpes zoster and SARS-Cov-2, and has contributed to the licensure of four vaccines. Near-Term Milestone Expectations IVX-A12 (RSV + hMPV) Phase 2 topline interim data expected by end 2023 IVX-A12 (RSV+ hMPV) Phase 1 six-month immunogenicity data expected in 1Q 2024 Other indications: no changes to milestones related to Flu and COVID-19 programs Second Quarter Financial Results Cash and cash equivalents and short-term investments as of June 30, 2023 was $246.9 million, compared to $219.4 million for the period ended December 31, 2022. Icosavax currently expects its cash balance to be sufficient to fund operations into 2H 2025. Research and development (R&D) expenses for the three months ended June 30, 2023 were $19.9 million, compared to $15.8 million for the same period in 2022. The increase was primarily driven by increased clinical development activity, increased personnel related expenses and stock-based compensation expense, increased expenses primarily related to facilities costs, and increased development-related consulting costs, partially offset by decreased preclinical development and manufacturing activity. Research and development expenses include non-cash stock-based compensation expenses of $2.4 million for the three months ended June 30, 2023. General and administrative (G&A) expenses for the three months ended June 30, 2023 were $9.1 million compared to $7.3 million for the same period in 2022. The increase was primarily due to increased expenses related to facilities costs to support the company’s growth, increased stock-based compensation expense, increased professional services, and growth in the number of G&A employees. General and administrative expenses include non-cash stock-based compensation expenses of $3.9 million for the three months ended June 30, 2023. Net loss for the three months ended June 30, 2023 was $26.5 million, or a basic and diluted net loss per share of $0.59. This includes non-cash stock-based compensation expense of $6.3 million. Net loss for the same period in 2022 was $22.6 million or a basic and diluted net loss per share of $0.57. 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 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, including the potential for IVX-A12 to be a first-in-class vaccine; 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 into 2H 2025. 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 development of 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 the commencement, enrollment, conduct of, and receipt of data from, clinical trials; difficulties in developing an hMPV challenge model and the risk that the planned challenge study may produce negative or inconclusive results based on such model or otherwise; 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; the company’s dependence on third parties in connection with manufacturing, research, and clinical testing; the risk that approved third party RSV vaccines may make conducting clinical trials more difficult and costly and otherwise adversely affect the company’s ability to successfully develop, obtain regulatory approval of and commercialize its vaccine candidates; approved vaccines and 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 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, 2023 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. Icosavax’s Contacts Media Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc. jessica@litldog.com 858.344.8091 Investor Contact: Laurence Watts Gilmartin Group, LLC laurence@gilmartinir.com 619.916.7620 ICOSAVAX, INC. Condensed Balance Sheets (Unaudited) (in thousands) June 30, December 31, 2023 2022 Assets Current assets: Cash and cash equivalents $ 155,073 $ 58,846 Restricted cash - 1,061 Short-term investments 91,860 159,461 Prepaid expenses and other current assets 4,766 4,545 Total current assets 251,699 223,913 Right-of-use assets - operating leases 3,072 3,247 Property and equipment, net 12,131 11,517 Other noncurrent assets 2,124 - Total assets $ 269,026 $ 238,677 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 1,547 $ 2,892 Accrued and other current liabilities 11,298 8,759 Current portion of operating lease liabilities 2,169 2,137 Total current liabilities 15,014 13,788 Operating lease liabilities, net of current portion 6,272 6,658 Other noncurrent liabilities 18 69 Total liabilities 21,304 20,515 Stockholders' equity: Common stock 7 6 Additional paid-in capital 484,666 404,386 Accumulated other comprehensive loss (66 ) (403 ) Accumulated deficit (236,885 ) (185,827 ) Total stockholders' equity 247,722 218,162 Total liabilities and stockholders' equity $ 269,026 $ 238,677 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, 2023 2022 2023 2022 Grant revenue $ - $ - $ - $ 582 Operating expenses: Research and development 19,826 15,820 37,183 33,733 General and administrative 9,129 7,311 18,294 13,633 Total operating expenses 28,955 23,131 55,477 47,366 Loss from operations (28,955 ) (23,131 ) (55,477 ) (46,784 ) Other income: Interest and other income 2,458 495 4,419 615 Total other income 2,458 495 4,419 615 Net loss $ (26,497 ) $ (22,636 ) $ (51,058 ) $ (46,169 ) Other comprehensive (loss) income: Unrealized (losses) gains on available-for-sale debt securities (3 ) (275 ) 337 (275 ) Comprehensive loss $ (26,500 ) $ (22,911 ) $ (50,721 ) $ (46,444 ) Net loss per share, basic and diluted $ (0.59 ) $ (0.57 ) $ (1.19 ) $ (1.17 ) Weighted-average common shares outstanding, basic and diluted 44,770,820 39,594,028 43,042,461 39,524,408

- In new data from Icosavax’s IVX-121 Phase 1b extension trial in older adults, GMTs against RSV through day 365 persisted at ~45-70% of the GMTs at day 28 (for 75 and 250 µg unadjuvanted dosages) - - Data provide additional clinical evidence of potential differentiation on durability with company’s VLP platform technology - - Robust immune response against RSV-A observed in Phase 1b extension trial participants who were revaccinated with IVX-121 twelve months following initial dose - - IVX-121 continues to be generally well tolerated with no additional safety concerns observed with longer-term follow up or revaccination - - IVX-A12 (a potential-first-in-class bivalent combination of IVX-121 for RSV and IVX-241 for hMPV) currently in a Phase 2 trial; Phase 2 topline interim data now expected by end 2023 - SEATTLE, Aug. 08, 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 provided a 12-month immunogenicity update from its Phase 1b extension trial of IVX-121 against Respiratory Syncytial Virus (RSV) in older adults. These data demonstrate substantial durability of neutralizing antibody (NAb) response against RSV at twelve months after a single administration of IVX-121. The company also reported initial evidence for revaccination potential with its VLP-based vaccines, including robust immune responses against RSV-A in Phase 1b extension trial participants who received 75 µg unadjuvanted IVX-121 at one year after their first dose. “We continue to believe that there is a need for long-lasting, well-tolerated vaccines, particularly in combinations. These 12-month immunogenicity data from our Phase 1b extension trial of IVX-121 provide additional clinical evidence of a potentially differentiated durability pro our VLP-based technology, as well as initial data supporting the potential for revaccination to boost immune responses in the second year,” said Adam Simpson, Chief Executive Officer of Icosavax. IVX-121 (RSV) Phase 1b extension 12-month immunogenicity update Icosavax has previously reported day 28 and day 180 data from the IVX-121 Ph 1/1b trial, which followed young and older adult subjects through six months after administration of either IVX-121 or placebo. Older adult subjects had the opportunity to participate in a Phase 1b extension trial that allowed continued evaluation through 12 months following their initial dose of vaccine. IVX-121 continued to be generally well-tolerated with no safety concerns observed in this 12-month follow up. No vaccine related serious adverse events (SAEs) were observed. Data described below refer to RSV neutralizing antibody (NAb) responses to a single administration of IVX-121 at the 75 and 250 µg unadjuvanted dosage levels or placebo in older adults at the designated timepoints. Geometric mean neutralizing antibody titers (GMTs) were measured in international units (IU/mL) using the WHO international reference standard. GMTs for RSV-A at day 365 were maintained within a range of ~45-50% relative to the GMTs at day 28 for the same group of subjects. RSV-B titers were also durable, persisting at ~65-70% of the GMTs at day 28 for the same dosage groups. IVX-121 (RSV) Phase 1b extension trial revaccination data The Phase 1b extension trial also evaluated immune responses one month after revaccination, in older adult participants who received IVX-121 (75 µg without adjuvant) approximately 12 months after their initial dose of vaccine or placebo in the Phase 1b trial. Revaccination with IVX-121 was generally well tolerated. At one month after revaccination (month 13 overall), IVX-121 induced robust RSV-A immune responses with GMTs for RSV-A NAbs increased to a range of ~70-115% of the GMTs observed one month after the initial dose for the same subset of participants. RSV-B titers did not increase following revaccination but remained at ~40-60% of the GMTs observed 28 days after the initial dose. "Recent data and the initial ACIP recommendation for RSV vaccines highlight potential opportunities for improvements in durability and revaccination,” said Niranjan Kanesa-thasan, M.D., Chief Medical Officer of Icosavax. “I am pleased with these data for IVX-121 and their support of potential differentiation of our VLP technology." Update on IVX-A12 (RSV/hMPV) Phase 2 topline interim data milestone timing IVX-121 is a component of Icosavax's lead vaccine candidate IVX-A12, a potential first-in-class bivalent combination in Phase 2 for RSV and hMPV in older adults. Icosavax is pleased to report that dosing has been completed in its Phase 2 trial of IVX-A12, and the company now expects to announce topline interim data by the end of 2023 versus the prior guidance of 1Q 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 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 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, including the potential for IVX-A12 to be a first-in-class vaccine; and the company’s planned development activities, including clinical trials and data readouts, and the timing thereof. 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 risk that results of a clinical trial at a particular time point may not predict final results and that an outcome may materially change as follow-up of subjects continues and following more comprehensive reviews of the data; the possibility of disappointing results in later clinical trials despite promising results in earlier preclinical research or clinical trials; potential unexpected adverse side effects or inadequate immunogenicity or efficacy of IVX-121 or IVX-A12 that may limit their development, regulatory approval, and/or commercialization; the company’s approach to the development of vaccine candidates, including its IVX-A12 combination bivalent RSV/hMPV VLP vaccine candidate, which is a novel and unproven approach; potential delays in the development process including without limitation in the enrollment, conduct of, and receipt of data from, clinical trials; the company’s dependence on third parties in connection with manufacturing, research, and clinical testing; the risk that approved third party RSV vaccines may make conducting clinical trials more difficult and costly and otherwise adversely affect the company’s ability to successfully develop, obtain regulatory approval of and commercialize its vaccine candidates; approved vaccines and competing approaches limiting the commercial value of the company’s vaccine candidates; regulatory developments in the United States and other countries; 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, 2023 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. Icosavax’s Contacts Media Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc. jessica@litldog.com 858.344.8091 Investor Contact: Laurence Watts Gilmartin Group, LLC laurence@gilmartinir.com 619.916.7620