1. DALLAS, Jan. 12, 2022 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (NASDAQ:VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today announced that the first patient with Parkinson's disease (PD) has been dosed with UB-312 in Part B of a double-blinded, placebo-controlled Phase 1 clinical trial, following completion of Part A of the Phase 1 trial in healthy volunteers.

    UB-312 is a synthetic peptide vaccine targeting toxic forms of aggregated α-synuclein (aSyn), a protein that plays a central role in synaptic functions and regulation of neurotransmitter release at the synapse. Mutations of aSyn increase the risk of developing PD and other synucleinopathies, including dementia with Lewy bodies (DLB) as well…

    DALLAS, Jan. 12, 2022 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (NASDAQ:VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today announced that the first patient with Parkinson's disease (PD) has been dosed with UB-312 in Part B of a double-blinded, placebo-controlled Phase 1 clinical trial, following completion of Part A of the Phase 1 trial in healthy volunteers.

    UB-312 is a synthetic peptide vaccine targeting toxic forms of aggregated α-synuclein (aSyn), a protein that plays a central role in synaptic functions and regulation of neurotransmitter release at the synapse. Mutations of aSyn increase the risk of developing PD and other synucleinopathies, including dementia with Lewy bodies (DLB) as well as multiple system atrophy (MSA). UB-312 was granted an orphan designation for MSA by the European Medical Agency (EMA).

    "We are delighted to achieve another milestone for Vaxxinity as we initiate the next part of our clinical program in Parkinson's, an indication with clear unmet needs for a large patient population," said Mei Mei Hu, Chief Executive Officer of Vaxxinity. "Part A of our Phase 1 study demonstrated that UB-312 was generally safe and well tolerated at multiple dose levels, and that it successfully generated robust levels of titers against aggregated aSyn that crossed the blood brain barrier at meaningful levels of approximately 0.2%. Developing vaccines that target chronic and difficult-to-treat diseases like Parkinson's are integral to our vision of providing cheaper, safer and more effective medicines to the world."

    The study is enrolling up to 20 patients with PD, Hoehn and Yahr stage ≤ III, at the Center for Human Drug Research in the Netherlands. Patients will be enrolled in one of two dosing cohorts with the primary objectives of safety and immunogenicity. The study will also assess exploratory biomarker endpoints for target engagement including Protein Misfolding Cyclic Amplification, supported by a grant from the Michael J. Fox Foundation, and in collaboration with Mayo Clinic and University of Texas.

    More information about the trial is available at https://clinicaltrials.gov/ct2/show/NCT04075318.

    About Parkinson's Disease

    Parkinson's disease currently affects approximately one million people in the United States and more than 10 million people worldwide. PD is a chronic and progressive neurodegenerative disorder that affects predominately dopamine-producing ("dopaminergic") neurons in the substantia nigra area of the brain. While today's approved products are aimed at providing symptomatic relief, they often produce significant side effects and lose their beneficial effects over time. There are no currently approved disease-modifying therapeutics for PD. Alpha-synuclein is a protein highly expressed in neurons, mostly at presynaptic terminals, suggesting a role in synaptic vesicle trafficking, synaptic functions and in regulation of neurotransmitter release at the synapse. Mutations in the gene encoding aSyn are known to cause or increase the risk of developing PD or DLB and have been shown to alter the secondary structure of aSyn, resulting in misfolded and aggregated forms of the protein (i.e., pathological forms). While mutations in the aSyn gene are rare, aggregates of aSyn in the form of Lewy bodies ("LB") and Lewy neurites are common neuropathological hallmarks of both familial and sporadic PD, suggesting a key role of aSyn in PD neuropathogenesis. Immunotherapy approaches targeting aSyn have been shown to ameliorate aSyn pathology as well as functional deficits in mouse models of PD and are now being investigated in the clinic.

    About UB-312

    UB-312 is a vaccine candidate targeting pathological forms of aSyn for the disease-modifying treatment of PD and other synucleinopathies such as DLB and MSA. Preclinical data indicated that UB-312 elicits antibodies that preferentially recognize pathological forms of aSyn, and improves motor performance in mouse models of synucleinopathies. Clinical data from Part A of the Phase 1 trial indicate that UB-312 elicits antibody levels sufficient to cross the BBB (i.e., detectable in CSF). The European Medical Agency ("EMA") has granted UB-312 orphan designation for MSA.

    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 immunotherapeutic vaccines 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 www.vaxxinity.com and follow us on social media @vaxxinity.

    Forward-looking Statement

    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," and "will" and similar expressions, are intended to identify forward-looking statements. 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. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on December 23, 2021. 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.

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  2. DALLAS, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (NASDAQ:VAXX), a clinical-stage biotech company pioneering a new class of immunotherapeutic vaccines to treat and prevent chronic neurological diseases, including Alzheimer's and Parkinson's, has announced that the company has been awarded a grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) for the exploration of markers for target engagement in individuals with Parkinson's disease (PD).

    Vaxxinity is developing its PD vaccine candidate UB-312, which has completed Part A of a first-in-human study in healthy volunteers and is advancing to Part B in Parkinson's patients. This award from MJFF will support the discovery and development of relevant pharmacodynamic…

    DALLAS, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (NASDAQ:VAXX), a clinical-stage biotech company pioneering a new class of immunotherapeutic vaccines to treat and prevent chronic neurological diseases, including Alzheimer's and Parkinson's, has announced that the company has been awarded a grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) for the exploration of markers for target engagement in individuals with Parkinson's disease (PD).

    Vaxxinity is developing its PD vaccine candidate UB-312, which has completed Part A of a first-in-human study in healthy volunteers and is advancing to Part B in Parkinson's patients. This award from MJFF will support the discovery and development of relevant pharmacodynamic markers. Specifically, the funds will be used to investigate whether Protein Misfolding Cyclic Amplification (PMCA) could be implemented as a robust method to assess target engagement in subjects immunized with UB-312. In recent years, PMCA has demonstrated excellent sensitivity and specificity for the detection of pathological forms of α-synuclein (aSyn) in the cerebrospinal fluid (CSF) of PD patients and has been shown to discriminate accurately between those with synucleinopathies, including PD and Multiple System Atrophy (MSA), versus healthy individuals.

    UB-312 is designed to target pathological forms of aSyn for the treatment and prevention of synucleinopathies, including PD. UB-312 was selected as a clinical candidate through a comprehensive screening and profiling campaign, and demonstrated strong immunogenicity and efficacy in preclinical studies.

    In the healthy volunteer portion of a first-in-human Phase 1 trial (Part A), UB-312 was found to be generally well tolerated at multiple dose levels. Serum and CSF anti-aSyn antibody titers were dose-dependent and indicated that antibodies crossed the blood-brain barrier (BBB) with a CSF:Serum ratio up to 0.2%.

    Vaxxinity plans to initiate Part B of the Phase 1 trial later this month to assess the safety, tolerability, and immunogenicity of UB-312 in PD patients. Vaxxinity's senior vice president of preclinical R&D, Jean-Cosme Dodart, PhD, will serve as principal investigator of the exploratory project funded by MJFF.

    "By essentially turning the body into its own antibody manufacturer, our technology platform has the potential to truly disrupt and displace traditional biologics and mAbs with something that is accessible to everyone globally," says Lou Reese, Executive Chairman of Vaxxinity. "With respect to neurodegenerative diseases, a vaccine approach further allows us to more efficiently go earlier into disease, halting progression before symptoms start or deteriorate."

    Mark Frasier, PhD, Co-Chief Scientific Officer of MJFF adds, "MJFF is proud to award this grant to Vaxxinity as they begin Part B of their Phase 1 trial of UB-312 in Parkinson's patients. This trial of UB-312 presents an exciting opportunity to investigate PMCA as a method to assess the neutralization of alpha-synuclein, a potentially critical contribution to the advancement of our understanding of target engagement in Parkinson's."

    About the Michael J. Fox Foundation (MJFF)

    As the world's largest nonprofit funder of Parkinson's research, MJFF is dedicated to finding a cure for Parkinson's disease through an aggressively funded research agenda and to ensuring the development of improved therapies for those living with Parkinson's today. The Foundation has funded nearly USD $1.5 billion in research to date. Operating at the hub of worldwide Parkinson's research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders, increases the flow of participants into Parkinson's disease clinical trials with its online tool, Fox Trial Finder, promotes Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.

    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 immunotherapeutic vaccines 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 www.vaxxinity.com and follow us on social media @vaxxinity.

    Forward-looking Statement

    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," and "will" and similar expressions, are intended to identify forward-looking statements. 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. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on December 23, 2021. 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.

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  3. DALLAS, Jan. 04, 2022 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (NASDAQ:VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today announced the appointment of Jason Pesile, MBA, CPA, as Senior Vice President, Finance & Accounting. The Company also announced today the appointment of George Hornig, Chairman of Xometry, to its Board of Directors.

    Mr. Hornig will be the new independent director to chair the Audit Committee, with current Board members Greg Blatt and Peter Diamandis moving to chair the Compensation Committee and Nominating and Governance Committee, respectively.

    "We are thrilled to welcome Jason to our management team and George to the Vaxxinity Board," said Mei Mei Hu, Chief Executive Officer…

    DALLAS, Jan. 04, 2022 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (NASDAQ:VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today announced the appointment of Jason Pesile, MBA, CPA, as Senior Vice President, Finance & Accounting. The Company also announced today the appointment of George Hornig, Chairman of Xometry, to its Board of Directors.

    Mr. Hornig will be the new independent director to chair the Audit Committee, with current Board members Greg Blatt and Peter Diamandis moving to chair the Compensation Committee and Nominating and Governance Committee, respectively.

    "We are thrilled to welcome Jason to our management team and George to the Vaxxinity Board," said Mei Mei Hu, Chief Executive Officer of Vaxxinity. "Jason is a well-regarded financial industry leader with expertise managing financial functions within the biopharmaceutical sector and will undoubtedly help us operationally as we continue advancing multiple vaccine candidates through clinical development. The addition of George to our Board of Directors further strengthens our leadership team by bringing nearly 40 years of senior executive-level experience at large, global financial institutions to Vaxxinity."

    Mr. Pesile is a seasoned finance executive with 20 years of experience in the biopharmaceutical space and most recently served as Vice President Finance, Corporate Controller at BeyondSpring Pharmaceuticals. He has worked at multiple biopharma companies in the past 10 years, where he led various aspects of financial operations, including accounting, financial reporting, audit and financial planning. Earlier in his career, Jason worked in management consulting and as a global project manager at Schering-Plough and Merck focused on post-merger integration. Jason graduated from the Wharton School of the University of Pennsylvania with a B.S. degree in Finance and holds an MBA from Columbia Business School. He is a certified public accountant in the State of New Jersey.

    Mr. Hornig is currently Chairman of Xometry (NASDAQ:XMTR), an AI-driven platform for on-demand manufacturing of industrial parts, and Co-Chairman (and Audit Chairman) of Healthwell Acquisition Corp., a special purpose acquisition company. Mr. Hornig is also Managing Partner and Co-Founder of The Seed Lab, an early-stage venture fund. From 2010-2016, Mr. Hornig was Senior Managing Director and COO of PineBridge Investments (formerly AIG Investment Management). Prior to joining PineBridge, Mr. Hornig spent 11 years at Credit Suisse Asset Management as Managing Director and Global COO. From 1993-1999, Mr. Hornig was Executive Vice President of Deutsche Bank Americas. Earlier in his career Mr. Hornig was Managing Director and COO of Wasserstein Perella & Co., worked in the M&A group of First Boston and was an Associate with the law firm of Skadden, Arps, Slate, Meagher & Flom LLP. During his career, Mr. Hornig has served as a Director of Forrester Research, Unity Mutual Life, Veridian Group, KBL Merger Corp IV, Office Tiger, Daily Candy and Merchants Preferred. Mr. Hornig received his A.B., J.D. and M.B.A. from Harvard University.

    About Vaxxinity

    Vaxxinity, Inc. is purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of synthetic, peptide-based immunotherapeutic vaccines 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.

    Forward-looking Statement

    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," "potentially," and "will" and similar expressions, are intended to identify forward-looking statements. 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. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on December 23, 2021. 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.

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    Claudia Styslinger

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  4. DALLAS, Dec. 23, 2021 (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 third quarter ended September 30, 2021.

    "The completion of our recent initial public offering is an important milestone in Vaxxinity's mission to democratize health," said Mei Mei Hu, CEO of Vaxxinity. "With the goal to disrupt the existing antibody therapy paradigm and improve the quality of chronic disease treatments while increasing their convenience and meaningfully lowering their cost, we believe we have the opportunity to profoundly impact the lives of countless patients across the globe. The funds raised in our recent IPO are critical…

    DALLAS, Dec. 23, 2021 (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 third quarter ended September 30, 2021.

    "The completion of our recent initial public offering is an important milestone in Vaxxinity's mission to democratize health," said Mei Mei Hu, CEO of Vaxxinity. "With the goal to disrupt the existing antibody therapy paradigm and improve the quality of chronic disease treatments while increasing their convenience and meaningfully lowering their cost, we believe we have the opportunity to profoundly impact the lives of countless patients across the globe. The funds raised in our recent IPO are critical to advancing our potentially transformative vaccine candidates toward approval."

    Recent Pipeline Developments

    • UB-311 targets toxic forms of aggregated amyloid-β in the brain to fight Alzheimer's disease (AD). Phase 1, Phase 2a and Phase 2a Long Term Extension trials have shown UB-311 to be well tolerated in mild-to-moderate AD patients over three years of repeat dosing, with a safety profile comparable to placebo, and immunogenic, with a high responder rate and antibodies that bind to the desired target. We currently expect to initiate the Phase 2b portion of the study in the second half of 2022.
    • UB-312 targets toxic forms of aggregated α-synuclein in the brain to fight Parkinson's disease (PD) and other synucleinopathies, such as dementia with Lewy Body and multiple system atrophy. Part A of a Phase 1 trial has shown UB-312 to be well tolerated in healthy volunteers, with no significant safety findings or serious adverse events, and immunogenic, with a high responder rate and antibodies that cross the blood-brain barrier. We have initiated enrollment of Parkinson's patients for Part B of the Phase 1 trial; however, due to the requirement of booster shots against COVID-19 before participating in the clinical trial, initial dosing is now expected to occur in Q1 2022.
    • UB-313 targets calcitonin gene-related peptide to fight migraines. Investigational new drug application (IND)-enabling studies are ongoing and we anticipate submitting a clinical trial application ("CTA") or an IND in 2022.
    • UB-612 employs a "multitope" approach to neutralizing the SARS-CoV-2 virus. Phase 1 and Phase 2 trials of UB-612 have shown UB-612 to be well tolerated with no significant safety findings to date, while observing UB-612 generated antibodies that can bind to the S1-RBD protein and neutralize SARS-CoV-2, in addition to driving a T-lymphocyte response. Following immunogenicity data from Phase 1 trial subjects who received two prime doses plus one booster dose of UB-612, we are exploring paths for authorization for UB-612 as a heterologous boost and a three-dose regimen.
    • Our anti-PCSK9 vaccine candidate will target hypercholesterolemia to reduce the risk of cardiac events. We plan to select a lead candidate and initiate IND-enabling studies in 2022.

    Recent Corporate Updates

    Completed Initial Public Offering (IPO). On November 15, 2021, the Company closed its IPO of Class A common stock at a public offering price of $13.00 per share. Including shares issued pursuant to the exercise of the underwriters' option, the Company issued 6,537,711 shares of Class A common stock, and received aggregate proceeds, net of underwriting discounts and commissions and other offering expenses, of approximately $71.1 million. Vaxxinity's class A common stock began trading on The Nasdaq Global Market on November 11, 2021, under the ticker symbol "VAXX."

    Third Quarter 2021 Financial Results

    As of September 30, 2021, cash and cash equivalents were $89.4 million. Research and development (R&D) expenses for the three months ended September 30, 2021 were $23.6 million, compared with $7.8 million for the three months ended September 30, 2020. The $15.8 million increase consisted primarily of an increase of $12.7 million related to our UB-612 clinical trial in Taiwan (primarily consisting of materials and manufacturing costs as well as increases in CRO costs), increased personnel costs of approximately $1.8 million, and increased UB-311 costs (primarily production related) of approximately $0.9 million.

    General and administrative expenses for the three months ended September 30, 2021 were $6.7 million, compared with $5.1 million for the three months ended September 30, 2020. The $1.6 million increase was related to our continued organizational growth to support our ramp-up in research and development efforts, as well as increased costs for preparations for being a public company.

    Net loss for the three months ended September 30, 2021 was $30.4 million, compared with $16.5 million for the three months ended September 30, 2020.

    About Vaxxinity

    Vaxxinity, Inc. is purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of synthetic, peptide-based immunotherapeutic vaccines 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.

    Forward-looking Statement

    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," and "will" and similar expressions, are intended to identify forward-looking statements. 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. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on December 23, 2021. 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.

     VAXXINITY, INC.
     Statement of Operations
     (In Thousands)
         
      Three Months Ended

    September 30,
     Nine months ended

    September 30,
      2020  2021  2020  2021 
             
     Revenue$117  $50  $557  $67 
     Cost of revenue (178)  9   52   1,937 
     Gross profit/loss 295   41   505   (1,870)
     Operating expenses:           
     Research and development 7,867   23,616   12,109   54,221 
     General and administrative 5,122   6,700   9,453   21,130 
     Total operating expenses 12,989   30,316   21,562   75,351 
     Loss from operations (12,694)  (30,275)  (21,057)  (77,221)
     Other expense:           
     Interest expense, net 331   109   737   493 
     Change in fair value of convertible notes 2,786      4,781   2,667 
     Change in fair value of warrant liability          214 
     Change in fair value of simple agreements for future equity 615      615   8,365 
     Foreign currency loss, net 39   5   48   24 
     Other expense, net 3,771   114   6,181   11,763 
     Loss before income taxes (16,465)  (30,389)  (27,238)  (88,984)
     Provision for income taxes           
     Net loss$(16,465) $(30,389) $(27,238) $(88,984)
     Net loss per share, basic and diluted (0.24)  (0.44)  (0.47)  (1.30)
     Weighted average common shares outstanding, basic and diluted 68,138,651   68,728,509   58,154,956   68,667,682 
                 





           
           
    VAXXINITY, INC. 
    Selected Balance Sheet Data 
    (In Thousands) 
           
     December 31, September 30, 
     2020  2021 
       
    Cash and cash equivalents$31,143  $89,375 
    Total assets 50,141   134,916 
    Total liabilities 75,041   41,286 
    Total stockholders' equity (24,900)  93,630 
           
           



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  5. DALLAS, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. ("Vaxxinity"), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today announced the closing of its initial public offering of 6,000,000 shares of class A common stock at a public offering price of $13.00 per share on November 15, 2021 as well as the subsequent closing on November 18, 2021 of the issuance of an additional 537,711 shares of class A common stock, pursuant to a 30-day option granted to the underwriters to purchase up to an additional 900,000 shares of class A common stock at the initial public offering price, less underwriting discounts and commissions. The gross proceeds from the offering and the partial exercise of the underwriters…

    DALLAS, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. ("Vaxxinity"), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today announced the closing of its initial public offering of 6,000,000 shares of class A common stock at a public offering price of $13.00 per share on November 15, 2021 as well as the subsequent closing on November 18, 2021 of the issuance of an additional 537,711 shares of class A common stock, pursuant to a 30-day option granted to the underwriters to purchase up to an additional 900,000 shares of class A common stock at the initial public offering price, less underwriting discounts and commissions. The gross proceeds from the offering and the partial exercise of the underwriters' option to purchase additional shares of class A common stock, before deducting underwriting discounts and commissions and other offering expenses payable by Vaxxinity, were approximately $85.0 million. Vaxxinity's class A common stock began trading on The Nasdaq Global Market on November 11, 2021, under the ticker symbol "VAXX." All shares in the offering were offered by Vaxxinity.

    BofA Securities, Jefferies and Evercore ISI are acting as lead book-running managers for the offering.

    A registration statement on Form S-1 relating to the shares being sold in this offering was declared effective by the Securities and Exchange Commission on November 10, 2021. The offering is being made only by means of a prospectus, copies of which may be obtained, when available, from: BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001 or by email ; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 1-877-821-7388 or by email at ; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at 1-888-474-0200, or by email at . Copies of the final prospectus related to the offering are available at www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Vaxxinity

    Vaxxinity, Inc. is a U.S.-based global biotechnology company pioneering a new class of immunotherapeutic vaccines to democratize health. The company's proprietary technology platform has enabled the innovation of synthetic peptide-based 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.

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    Claudia Styslinger

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    Diane Murphy



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