VERA Vera Therapeutics Inc.

19.07
-0.53  -3%
Previous Close 19.6
Open 19.03
52 Week Low 11.3
52 Week High 37.11
Market Cap $405,764,099
Shares 21,277,614
Float 10,702,329
Enterprise Value $352,112,098
Volume 47,657
Av. Daily Volume 70,646
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Upcoming Catalysts

Drug Stage Catalyst Date
MAU868
Kidney transplant
Phase 2
Phase 2
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Atacicept (ORIGIN)
IgA Nephropathy
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
Atacicept
Lupus nephritis (LN)
Phase 3
Phase 3
Phase 3 trial planned.
Atacicept - JANUS
IgA nephropathy (IgAN)
Phase 2a
Phase 2a
Phase 2a data released November 4, 2021. Phase 2a JANUS clinical trial showed atacicept administered subcutaneously once weekly demonstrated a durable and substantial reduction in serum galactose-deficient IgA1 (Gd-IgA1) in a dose-dependent manner up to 72 weeks.

Latest News

  1. BRISBANE, Calif., Jan. 18, 2022 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (NASDAQ:VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, announced plans to initiate a Phase 3 clinical trial of its lead product candidate atacicept in lupus nephritis (LN).

    This announcement comes after positive feedback from the U.S. Food and Drug Administration (FDA)'s review of the proposed Phase 3 trial. Lupus nephritis, a severe renal manifestation of systemic lupus erythematosus (SLE), causes kidney inflammation, which leads to blood and protein in the urine, high blood pressure, impaired kidney function, and eventually approximately 25 percent of…

    BRISBANE, Calif., Jan. 18, 2022 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (NASDAQ:VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, announced plans to initiate a Phase 3 clinical trial of its lead product candidate atacicept in lupus nephritis (LN).

    This announcement comes after positive feedback from the U.S. Food and Drug Administration (FDA)'s review of the proposed Phase 3 trial. Lupus nephritis, a severe renal manifestation of systemic lupus erythematosus (SLE), causes kidney inflammation, which leads to blood and protein in the urine, high blood pressure, impaired kidney function, and eventually approximately 25 percent of LN patients develop end stage renal disease.

    "Fewer than half of patients treated for LN have a complete response to current therapies, and among patients without a complete response, more than half will have non-functioning kidneys within five years," said Vera founder and CEO Marshall Fordyce, MD. "Atacicept has the potential to offer a significant improvement over standard of care for patients who currently have limited options. Atacicept has been administered to more than 1,400 patients in clinical studies across different indications. We look forward to initiating this Phase 3 trial and working with the FDA and other regulators to evolve the standard of care for LN patients."

    The Phase 3 randomized, double-blinded, placebo-controlled trial will evaluate the efficacy and safety of atacicept in subjects with LN by assessing 150 milligrams of once-weekly subcutaneous injections of atacicept versus placebo. The clinical trial consists of a 52-week double-blind treatment period, followed by a 104-week open-label treatment period and a 26-week safety follow-up period. The primary endpoint for the trial is complete renal response at 52 weeks.

    Additional Clinical Trials

    Atacicept is also currently being evaluated for the treatment of immunoglobulin A nephropathy (IgAN) in the Phase 2b ORIGIN trial, which Vera expects will complete enrollment in mid-2022. If the data from this trial are positive, Vera plans to seek an accelerated approval path from the FDA and European Medicines Agency (EMA) for IgAN while initiating a pivotal Phase 3 clinical trial in 2023.

    Vera also plans to initiate a Phase 2b or Phase 3 trial for MAU868 in kidney transplant patients with BK virus (BKV) viremia, a potentially first-in-class monoclonal antibody designed to treat BKV infections. In December 2021, Vera obtained worldwide, exclusive development and commercial rights to MAU868 from Amplyx Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer. In an interim analysis of Phase 2 data among kidney transplant recipients, MAU868 was shown to be well-tolerated and showed a greater proportion of subjects with decrease in BK plasma viral load versus placebo. Vera expects to share full results from the interim analysis in mid-2022 and initiate the next clinical trial in 2023.

    About Atacicept

    Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B lymphocyte stimulator (BlyS) and a proliferation-inducing ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgA nephropathy and lupus nephritis. Atacicept showed a dose-dependent effect on key biomarkers and clinical markers in a Phase 2a clinical study. Vera believes atacicept is positioned for best-in-class potential, targeting B cells and plasma cells to reduce autoantibodies and having been administered to more than 1,400 patients in clinical studies across different indications.

    About Vera

    Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger's disease and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit www.veratx.com.

    Forward-looking Statements

    Statements contained in this press release regarding matters, events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the continued tolerability of Vera's product candidates, research and clinical development plans and timing, the scope, progress, and results of developing Vera's product candidates, strategy, and regulatory matters, including the timing and likelihood of success of obtaining drug approvals. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "plans," "will," "expects," "potential," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, risks and uncertainties associated with Vera's business in general, the impact of the COVID-19 pandemic, and the other risks described in Vera's filings with the Securities and Exchange Commission, including in its latest Form 10-Q filed with the Securities and Exchange Commission on November 10, 2021, particularly under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

    Contacts

    Investor Contact:

     

    Media Contact:

    Kathy Vincent

    Greig Communications, Inc.



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  2. BRISBANE, Calif., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (NASDAQ:VERA), a clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that Marshall Fordyce, MD, founder and CEO, will present and participate in one-on-one investor meetings at the 40th Annual J.P. Morgan Healthcare Conference taking place virtually January 10-13, 2022.

    Presentation details:

    Date:January 11, 2022
    Time:3:45-4:25 PM ET
    Webcast:A live audio webcast is available by choosing the following link (click here)

    A replay of the event will be available for 30 days and can be accessed by visiting the "Investor Calendar" section of the Vera Therapeutics…

    BRISBANE, Calif., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (NASDAQ:VERA), a clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that Marshall Fordyce, MD, founder and CEO, will present and participate in one-on-one investor meetings at the 40th Annual J.P. Morgan Healthcare Conference taking place virtually January 10-13, 2022.

    Presentation details:

    Date:January 11, 2022
    Time:3:45-4:25 PM ET
    Webcast:A live audio webcast is available by choosing the following link (click here)

    A replay of the event will be available for 30 days and can be accessed by visiting the "Investor Calendar" section of the Vera Therapeutics website.

    About Vera Therapeutics

    Vera Therapeutics is a clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger's disease. Vera is also developing MAU868, a monoclonal antibody that neutralizes infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit www.veratx.com

    Investor Contact:

    Joyce Allaire

    LifeSci Advisors

    212-915-2569

    Media Contact:

    Kathy Vincent

    Greig Communications, Inc.



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  3. Ongoing Phase 2 clinical trial for MAU868 in kidney transplant patients; potential first-in-class

    MAU868 Phase 2 data for kidney transplant to readout mid-2022

    BK Virus is a leading cause of transplant loss and transplant-associated morbidity

    BRISBANE, Calif., Dec. 17, 2021 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (NASDAQ:VERA), a clinical-stage biotechnology company focused on developing treatments for immunological diseases that improve patients' lives, announced today that it has acquired MAU868, a first-in-class monoclonal antibody to treat BK Virus (BKV) infections, and has entered into a credit facility with Oxford Finance LLC (Oxford) to provide borrowing capacity up to $50 million. MAU868, acquired from Amplyx Pharmaceuticals…

    Ongoing Phase 2 clinical trial for MAU868 in kidney transplant patients; potential first-in-class

    MAU868 Phase 2 data for kidney transplant to readout mid-2022

    BK Virus is a leading cause of transplant loss and transplant-associated morbidity

    BRISBANE, Calif., Dec. 17, 2021 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (NASDAQ:VERA), a clinical-stage biotechnology company focused on developing treatments for immunological diseases that improve patients' lives, announced today that it has acquired MAU868, a first-in-class monoclonal antibody to treat BK Virus (BKV) infections, and has entered into a credit facility with Oxford Finance LLC (Oxford) to provide borrowing capacity up to $50 million. MAU868, acquired from Amplyx Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., has the potential to neutralize infection by blocking BKV virions from binding to host cells.

    "BKV is a leading cause of kidney transplant loss and transplant-associated morbidity, and there are currently no available antiviral treatments in the U.S. We are excited to acquire MAU868 from Pfizer and carry it forward in development," said Vera founder and CEO Marshall Fordyce, MD. "The acquisition of MAU868, a potentially transformative treatment for BKV, is consistent with our strategy to diversify our pipeline with new molecules that leverage our strengths and serve adjacent populations. We believe, based on currently available data, that MAU868 has the potential to significantly impact outcomes for kidney transplant patients and become the first effective therapy for BKV. We look forward to working with regulators to establish a new standard of care for kidney transplant patients."

    MAU868 is currently undergoing a randomized, double-blind, placebo-controlled Phase 2 clinical trial to assess the safety, pharmacokinetics, and efficacy for the treatment of BKV in kidney transplant patients. MAU868 has been shown in an interim analysis of week 12 data from Cohort 1 and 2 of a Phase 2 study to be well tolerated and showed a greater proportion of subjects with decrease in BK plasma viral load versus placebo. Full Cohort 1 and 2 interim analysis results will be submitted for presentation at a conference in mid-2022.

    Up to 90 percent of healthy adults are infected with BKV, but it remains latent in kidney and bladder tissues. Reactivation occurs in the setting of immune suppression, and causes clinical disease in the transplant setting. BKV is a significant cause of complications in these immunocompromised patients, including in kidney transplant and hematopoietic stem cell transplant (HSCT) recipients. In kidney transplant recipients, BKV is a leading cause of allograft loss and poor outcomes, while in HSCT recipients, the virus significantly increases the risk of severe hemorrhagic cystitis, which causes bladder damage. There are currently no approved treatments for BKV in the U.S.

    MAU868 Asset Acquisition

    In partial consideration for the asset acquisition, Vera made an upfront payment of $5.0 million. In addition to the upfront payment, Vera is also obligated to make certain milestone payments in an aggregate amount of up to $7.0 million based on certain regulatory milestones. Further, Vera is required to pay Amplyx low single-digit percentage royalties based on net sales on a country-by-country and product-by-product basis. The rights to MAU868 that Vera acquired from Amplyx are subject to a license agreement by and between Amplyx and Novartis International Pharmaceutical AG, pursuant to which Vera is obligated to make certain milestone payments in an aggregate amount of up to $69.0 million based on certain clinical development, regulatory and sales milestones. Further, the Company is required to pay Novartis mid-to-high single-digit percentage royalties based on net sales on a country-by-country and product-by-product basis.

    Credit Facility

    Vera also announced today that they entered into a credit facility with Oxford Finance. Under the terms of the loan agreement, Oxford will provide Vera with borrowing capacity of up to $50 million. The initial $5 million funded at closing, and an additional $45 million will be available in minimum draws of $5 million, at Vera's option through the end of 2022. The debt facility provides for at least 48-months of interest-only at close. There are no warrants or financial covenants associated with the credit facility. Armentum Partners served as the Company's financial advisor on the debt financing.



    About Vera

    Vera Therapeutics is a clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger's disease. Vera is also developing MAU868, a monoclonal antibody that neutralizes infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit www.veratx.com.

    Forward-looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the potential efficacy of our product candidates, research and clinical development plans, the scope, progress, and results of developing our product candidates, strategy, regulatory matters, including the timing and likelihood of success of obtaining drug approvals, market opportunity and our ability to complete certain milestones, the timing of the expected closing of the debt financing, and the expected use of the net proceeds therefrom. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "plans," "will," "anticipates," "goal," "potential," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period, risks and uncertainties associated with Vera's business in general, the impact of the COVID-19 pandemic, and the other risks described in Vera's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

    Contacts

    Investor Contact:





    Media Contact:

    Greig Communications, Inc.

    Kathy Vincent



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  4. BRISBANE, Calif., Dec. 14, 2021 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (NASDAQ:VERA), a clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced the appointment of Kimball Hall to its board of directors.

    Ms. Hall is a seasoned executive and a chemistry, manufacturing, and controls (CMC) expert. Formerly holding leadership positions at Genentech and Amgen, she is currently president and chief operating officer of Abzena, a biopharmaceutical focused contract development and manufacturing organization (CDMO).

    "We're honored to welcome Kimball to our board of directors," said Marshall Fordyce, MD, founder and CEO of Vera Therapeutics…

    BRISBANE, Calif., Dec. 14, 2021 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (NASDAQ:VERA), a clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced the appointment of Kimball Hall to its board of directors.

    Ms. Hall is a seasoned executive and a chemistry, manufacturing, and controls (CMC) expert. Formerly holding leadership positions at Genentech and Amgen, she is currently president and chief operating officer of Abzena, a biopharmaceutical focused contract development and manufacturing organization (CDMO).

    "We're honored to welcome Kimball to our board of directors," said Marshall Fordyce, MD, founder and CEO of Vera Therapeutics. "Over her decades of pharmaceutical and biotech industry experience, Kimball has shown the leadership required to translate high-level vision into practical and successful business strategies. She has demonstrated success leading cross-functional teams and projects developing novel biologic therapies, including the successful transition from clinical to commercial stage. Kimball's experience and direction will help Vera advance our core objectives and ultimately improve medical treatment for patients suffering from serious immunological diseases. On behalf of the entire Vera board, I look forward to Kimball's contributions."

    Prior to her current role at Abzena, Ms. Hall held several executive positions at Genentech, Inc., a member of the Roche family, most recently as senior vice president, global head of drug substance manufacturing and a member of the Genentech executive committee. Responsible for seven internal sites and 27 external manufacturing locations, she supported five commercial product launches, built a strong quality and safety culture, and established small-volume production. Prior to joining Genentech, Ms. Hall spent 16 years at Amgen, a biotechnology company, most recently as vice president of manufacturing.

    "Vera stands out among the many companies pursuing therapies for immunologic diseases," said Ms. Hall. "The company's lead clinical-stage candidate, atacicept, is potentially disease modifying for people who suffer from kidney disease and lack effective treatments. I'm thrilled to join Vera's board of directors and look forward to working with Vera's management team and the board to grow the company and continue to move atacicept forward for the patients who are waiting for improved medical treatments."

    Ms. Hall has held a variety of board and advisory board positions, including as a member of Genentech's patient access board and as an advisor to Genentech's global women's professional organization. She holds a bachelor's degree in microbiology from the University of Washington.

    About Vera Therapeutics

    Vera Therapeutics is a clinical-stage biotechnology company focused on developing treatments for immunological diseases that improve patients' lives. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful, including lupus nephritis, a severe renal manifestation of systemic lupus erythematosus. For more information, please visit www.veratx.com.

    Investor Contact:

    Joyce Allaire

    LifeSci Advisors

    212-915-2569

    Media Contact:

    Kathy Vincent

    Greig Communications, Inc.

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f96d8e68-65ff-4a18-92e5-148678704f4d



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  5. SOUTH SAN FRANCISCO, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (NASDAQ:VERA), a clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that Marshall Fordyce, MD, Founder and Chief Executive Officer, will present and participate in one-on-one investor meetings at several upcoming investor conferences in November. Details of these presentations and associated conferences can be found below:

    Jefferies London Healthcare Conference (November 16-18, 2021)  
    Format:            Fireside Chat  
    Time and Date: 5:00-5:35 PM GMT (12:00-12:35 p.m. EST) on Tuesday, November 16, 2021
       
    Evercore ISI 4th Annual HealthCONx

    SOUTH SAN FRANCISCO, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (NASDAQ:VERA), a clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that Marshall Fordyce, MD, Founder and Chief Executive Officer, will present and participate in one-on-one investor meetings at several upcoming investor conferences in November. Details of these presentations and associated conferences can be found below:

    Jefferies London Healthcare Conference (November 16-18, 2021)  

    Format:            Fireside Chat  
    Time and Date: 5:00-5:35 PM GMT (12:00-12:35 p.m. EST) on Tuesday, November 16, 2021
       
    Evercore ISI 4th Annual HealthCONx (November 30 – December 2, 2021)  
    Format: Fireside Chat
    Time and Date: 2:40-3:00 PM EST on Tuesday, November 30, 2021
       
    Piper Sandler 33rd Healthcare Conference (November 30 – December 2, 2021)  
    Format: Fireside Chat
    Time and Date: Available on-demand beginning at 10:00 AM EST on November 22, 2021
       

    A replay link of each presentation will be available for 30 days and can be accessed by visiting the "Presentations" section of the Vera Therapeutics website at www.veratx.com.

    About Vera Therapeutics

    Vera Therapeutics is a clinical-stage biotechnology company focused on developing treatments for immunological diseases that improve patients' lives. Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful, including lupus nephritis, a severe renal manifestation of systemic lupus erythematosus. For more information, please visit www.veratx.com.

    Forward-looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "plans," "will", "anticipates," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Vera's business in general, the impact of the COVID-19 pandemic, and the other risks described in Vera's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

    Investor Contact:

    Joyce Allaire

    LifeSci Advisors

    212-915-2569

    Media Contact:

    Greig Communications, Inc.

    Kathy Vincent

    (310) 403-8951

    greigcommunications.com



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