UB-612

CAPE CANAVERAL, Fla., March 27, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update. “2024 will prove to be a critical year for Vaxxinity as we refocus our efforts on our neurodegeneration programs and move closer to obtaining our company’s first approval,” said Mei Mei Hu, CEO of Vaxxinity. “Just this month, we presented exploratory biomarker data from our Phase 1 trial of UB-312 in Parkinson’s patients: a first of its kind demonstrating target engagement of toxic alpha-synuclein in the CNS and a potential correlation with clinical efficacy. This represents a major step for our platform in neurodegeneration where the safe engagement of aberrant protein targets in the CNS remains critical, and new hope for the Parkinson’s community. We also seek to advance UB-311, our anti-Aβ Alzheimer’s candidate, as we resume dialogue with regulatory authorities and partners. Finally, we’re looking forward to the readout from the Phase 1 trial of VXX-401, our vaccine candidate for hypercholesterolemia, as well as the potential marketing authorization of UB-612, our heterologous booster vaccine candidate for COVID-19.” 2023 and Recent Clinical Pipeline Developments UB-312 in Parkinson’s disease (PD) and other synucleinopathies UB-312 targets toxic forms of aggregated α-synuclein (aSyn). Two exploratory CSF biomarkers show promise as measures of disease progression: aggregated aSyn, as measured by an aSyn Seed Amplification Assay developed in collaboration with Mayo Clinic, UTHealth Houston, and Amprion, with funding from The Michael J. Fox Foundation. phosphorylated aSyn (pS129-aSyn). PD patients with UB-312-induced antibodies in CSF had significantly less aSyn aggregation (p = 0.0183) and pS129-aSyn (p = 0.0351) as compared to placebo. PD patients with UB-312-induced antibodies in CSF showed significant improvement in the clinical MDS-UPDRS II activities of daily living scale as compared to placebo (p = 0.0062). Anti-aSyn antibody titer levels in CSF correlate with reduction in aggregated aSyn, which correlated with improvement in MDS-UPDRS II. In March 2024, JC Dodart, Chief Scientific Officer, presented these exploratory analyses at AD/PD 2024 in Lisbon, Portugal. VXX-401 in hypercholesterolemia VXX-401 targets proprotein convertase subtilisin/kexin type 9 (PCSK9) to reduce LDL cholesterol. All six cohorts of the Phase 1 trial of VXX-401 are fully enrolled. In February 2024, results from multiple preclinical studies of VXX-401 in non-human primates, demonstrating robust, sustained reduction in LDL-C, were published in the Journal of Lipid Research. The company anticipates topline Phase 1 data by mid-2024. UB-612 COVID-19 booster UB-612 employs a “multitope” approach to neutralizing the ancestral SARS-CoV-2 virus and its variants. In November 2023, Vaxxinity presented data from its head-to-head Phase 3 trial of UB-612 at Vaccines Summit in Boston, MA, and published a peer-reviewed article about UB-612 in Vaccine reporting antibody response against SARS-CoV-2 in cynomolgus macaques. 2023 and Recent Corporate Updates Academic Collaborations & State of Florida Grant. In January 2024 Vaxxinity announced a collaboration with the University of Central Florida to conduct research funded by the state of Florida to further the development of our active immunotherapies against myostatin and activin A to prevent and mitigate muscle and bone wasting, well-known health challenges related to long-term spaceflight. These targets share biological mechanisms implicated in obesity, diabetes, and highly prevalent age-related diseases. In the same month, Vaxxinity announced a collaboration with the University of Florida’s Center for Translational Research in Neurodegenerative Disease (CTRND) to support our development of vaccines for neurodegenerative diseases. Fourth Quarter and Year End 2023 Financial Results As of December 31, 2023, Vaxxinity had $30.4 million of highly liquid assets, including $4.9 million of cash and cash equivalents and $25.5 million of short-term investments, compared to $86.8 million as of December 31, 2022. Comparison of three months ended December 31, 2023 to three months ended December 31, 2022 Research and development expenses were $8.2 million and $13.1 million for the three months ended December 31, 2023 and 2022, respectively. The $4.9 million decrease in research and development expenses was primarily due to decreases in program-related costs of $0.6 million for our UB-313 migraine program, $0.4 million for our VXX-401 hypercholesterolemia program, and $0.4 million for our UB-312 Parkinsons program, as well decreases in personnel and consulting costs totaling $2.1 million. General and administrative expenses were $3.4 million and $7.7 million for the three months ended December 31, 2023, and 2022, respectively. The $4.3 million decrease was primarily due to a decrease in personnel costs of $1.7 million, consulting and professional services totaling $0.9 million, and travel expenses of $0.5 million. Net loss for the three months ended December 31, 2023, was $11.4 million or $0.09 per share compared to $20.5 million or $0.16 per share for the three months ended December 31, 2022. Comparison of the year ended December 31, 2023 to the year ended December 31, 2022 Research and development expenses were $35.9 million and $47.6 million for the years ended December 31, 2023 and 2022, respectively. The $11.7 million decrease in research and development expenses was primarily due to decreases in program-related costs of $4.3 million for our UB-612 Covid-19 program and $1.0 million for our UB-312 Parkinson’s Disease program, as well decreases in personnel costs of $4.2 million and consulting costs of $1.8 million. General and administrative expenses were $22.4 million and $28.4 million for the years ended December 31, 2023, and 2022, respectively. The $6.0 million decrease was primarily due to a decrease in personnel costs of $2.0 million, D&O insurance premiums of $1.8 million, and consulting and professional services costs of $1.2 million. Net loss for the year ended December 31, 2023, was $56.9 million or $0.45 per share compared to $75.2 million or $0.60 per share for the year ended December 31, 2022. VAXXINITY, INC. Statement of Operations (In thousands, except number of shares and per share amounts) Three Months Ended Years Ended December 31, December 31, 2023 2022 2023 2022 Operating expenses: Research and development 8,220 13,018 35,899 47,627 General and administrative 3,430 7,806 22,386 28,352 Total operating expenses 11,650 20,824 58,285 75,979 Loss from operations (11,650 ) (20,824 ) (58,285 ) (75,979 ) Other (income) expense: Interest and other expense 182 250 696 514 Interest and other income (433 ) (634 ) (2,090 ) (1,259 ) (Gain) loss on foreign currency transactions, net (7 ) 16 43 (12 ) Other (income) (258 ) (368 ) (1,351 ) (757 ) Net loss $ (11,392 ) $ (20,456 ) $ (56,934 ) $ (75,222 ) Net loss per share, basic and diluted $ (0.09 ) $ (0.16 ) $ (0.45 ) $ (0.60 ) Weighted average common shares outstanding, basic and diluted 126,736,784 126,056,241 126,508,917 125,939,050 VAXXINITY, INC. Selected Balance Sheet Data (in Thousands) December 31, December 31, 2023 2022 Cash and cash equivalents $ 4,931 $ 33,475 Short term investments 25,464 53,352 Total assets 44,311 106,399 Total liabilities 30,902 44,222 Total stockholder's equity 13,409 62,177 About Vaxxinity Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of synthetic, peptide-based active immunotherapy medicines aimed at disrupting the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration. The company’s proprietary technology platform has enabled the innovation of novel pipeline candidates designed to bring the efficiency of vaccines to the treatment of chronic diseases, including Alzheimer’s, Parkinson’s, migraine, and hypercholesterolemia. The technology is also implemented as part of a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on human health. For more information about Vaxxinity, Inc., visit and follow us on social media @vaxxinity. Forward-looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe," "may," "continue," "advancing," "will" and similar expressions, are intended to identify forward-looking statements. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, initiation, duration, enrollment, results or timing for availability of results of, development of any of Vaxxinity’s product candidates or programs; the target indication(s) for development or approval, the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or completion of or availability or reporting of results from any clinical trial; the potential future regulatory authorization or approval and commercialization of Vaxxinity’s product candidates; the potential benefits or competitive position of any Vaxxinity product candidate or program or the commercial opportunity in any target indication; and Vaxxinity’s plans, expectations or future operations, financial position, revenues, costs or expenses. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Vaxxinity’s management about the development of a new class of immunotherapeutic vaccines and the innovation and efficacy of Vaxxinity’s product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements, including, but not limited to: whether UB-311, UB-312, UB-313, VXX-401, UB-612 or any other current or future product candidate of Vaxxinity will be approved or authorized by any regulatory agency for the indications that Vaxxinity targets; any potential negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of Vaxxinity’s business; Vaxxinity’s product candidates may not be successful or clinical development may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety or efficacy in larger-scale or later clinical trials or in clinical trials for other indications; the timing for initiation or completion of, or for availability of data from, clinical trials for UB-311, UB-312, UB-313, VXX-401 or UB-612, and the outcomes of such trials; Vaxxinity’s reliance on collaborative partners and other third parties for development of its product candidates; Vaxxinity’s ability to obtain coverage, pricing or reimbursement for any approved products and acceptance from patients and physicians for any approved indications; delays or other challenges in the recruitment of patients for, or the conduct of, Vaxxinity’s clinical trials; challenges associated with supply and manufacturing activities; and Vaxxinity’s accounting policies. These and other important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Vaxxinity’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 27, 2024. The forward-looking statements are made as of this date and Vaxxinity does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Investor Contact Mark Joinnides ir@vaxxinity.com Press Contact Ali Nagy / McKenna Miller anagy@kcsa.com / mmiller@kcsa.com

UB-312 is first immunotherapy to show reduction of pathological alpha-synuclein in cerebrospinal fluid of Parkinson’s patientsLISBON, Portugal, March 07, 2024 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (NASDAQ: VAXX), a U.S. company pioneering the development of a new class of medicines, announced positive clinical data from its UB-312 program in Parkinson’s disease (PD) presented by Jean-Cosme Dodart, PhD, SVP of Research at Vaxxinity in an oral session at the AD/PD™ 2024 International Conference on Alzheimer’s and Parkinson’s Disease, held virtually and in Lisbon, Portugal from March 5 to March 9, 2024. UB-312 is the first active immunotherapy candidate to show reduction of pathological alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of PD patients. UB-312 is designed to target aggregated forms of aSyn, the toxic species that underlies PD and other synucleinopathies. As part of the randomized, double-blind, placebo-controlled Phase 1 clinical trial, The Michael J. Fox Foundation (MJFF) funded a 2-year collaborative project between Vaxxinity, the Mayo Clinic, and UTHealth Houston to analyze CSF collected from patients, and to conduct exploratory research to assess target engagement. The UB-312-induced antibodies showed preferential binding to aggregated aSyn and almost no binding to normal monomeric aSyn, as measured by dot blot. After a single priming regimen, those treated with UB-312 in the 300/100/100µg dosing group showed a 20% decrease from baseline in aggregated aSyn in the CSF compared to a 3% increase in the placebo group (p<0.05), as measured by a Seed Amplification Assay (SAA). Further, a post hoc analysis showed that patients with detectable UB-312-induced antibodies in the CSF exhibited improvement in activities of daily living as measured by the MDS-UPDRS II clinical scale (p<0.01). These data also suggest a correlation between reduction in aggregated aSyn in the brain and change in MDS-UPDRS II (R=0.52, p=0.001). “What we see from our UB-312 program is the potential to change the whole conversation around Parkinson’s treatment and prevention,” says Lou Reese, Co-Founder and Executive Chairman of Vaxxinity. “Our findings suggest UB-312 could transform Parkinson’s care, offering hope for improved outcomes with a disease-modifying treatment. The future isn’t decades away: today’s Parkinson’s patients may have hope for the near, not distant future.” The aforementioned results come from Part B of the Phase 1 clinical trial in 20 PD patients. Vaxxinity expects to publish these results in a peer reviewed scientific journal soon. Results from Part A of the trial in healthy volunteers were published in Movement Disorders in 2022 (Yu et al.). Both parts of the trial showed UB-312 to be generally well tolerated (most adverse events were mild and transient) and immunogenic, with antibodies detectable in serum and CSF. “Currently, there are no treatments that address the underlying conditions of Parkinson’s, and we are very excited about this target engagement data. This provides us confidence that we are going after the right target and in a way that is statistically and clinically relevant to patients. There is new hope on the horizon,” said Jean-Cosme Dodart, PhD, SVP Research at Vaxxinity. “With Parkinson’s being the fastest growing neurodegenerative disease in the world, Vaxxinity remains committed to developing safe, convenient, and effective disease-modifying active immunotherapies for all.” For more information about Vaxxinity, Inc., visit http://www.vaxxinity.com and follow us on social media @vaxxinity. About Vaxxinity Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of medicines aimed at disrupting the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration. The company’s proprietary technology platform has enabled the innovation of novel synthetic peptide immunotherapy candidates designed to bring the efficiency of vaccines to the treatment of chronic diseases, including Alzheimer’s disease, Parkinson’s disease, migraine, and hypercholesterolemia. The technology is also implemented as part of a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on human health. Forward-looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe," "may," "continue," "advancing," "will" and similar expressions, are intended to identify forward-looking statements. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, initiation, duration, enrollment, results or timing for availability of results of, development of any of Vaxxinity’s product candidates or programs; the target indication(s) for development or approval, the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or completion of or availability or reporting of results from any clinical trial; the potential future regulatory authorization or approval and commercialization of Vaxxinity’s product candidates; the potential benefits or competitive position of any Vaxxinity product candidate or program or the commercial opportunity in any target indication; and Vaxxinity’s plans, expectations or future operations, financial position, revenues, costs or expenses. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Vaxxinity’s management about the development of a new class of immunotherapeutic vaccines and the innovation and efficacy of Vaxxinity’s product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements, including, but not limited to: whether UB-311, UB-312, UB-313, VXX-401, UB-612 or any other current or future product candidate of Vaxxinity will be approved or authorized by any regulatory agency for the indications that Vaxxinity targets; any potential negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of Vaxxinity’s business; Vaxxinity’s product candidates may not be successful or clinical development may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety or efficacy in larger-scale or later clinical trials or in clinical trials for other indications; the timing for initiation or completion of, or for availability of data from, clinical trials for UB-311, UB-312, UB-313, VXX-401 or UB-612, and the outcomes of such trials; Vaxxinity’s reliance on collaborative partners and other third parties for development of its product candidates; Vaxxinity’s ability to obtain coverage, pricing or reimbursement for any approved products and acceptance from patients and physicians for any approved indications; delays or other challenges in the recruitment of patients for, or the conduct of, Vaxxinity’s clinical trials; challenges associated with supply and manufacturing activities; and Vaxxinity’s accounting policies. These and other important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Vaxxinity’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 27, 2023. The forward-looking statements are made as of this date and Vaxxinity does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Investor ContactMark Joinnidesir@vaxxinity.com Press ContactAlessandra Nagyvaxxinity@kcsa.com