ARDS Aridis Pharmaceuticals Inc.

7.68
+0.45  (+6%)
Previous Close 7.23
Open 7.61
52 Week Low 3.8
52 Week High 12.4
Market Cap $68,531,512
Shares 8,923,374
Float 6,593,198
Enterprise Value $48,191,994
Volume 1,843
Av. Daily Volume 10,822
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Upcoming Catalysts

Drug Stage Catalyst Date
AR-301 (Salvecin)
ventilator associated pneumonia (VAP) / Staphylococcus aureus
Phase 3
Phase 3
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AR-501
Chronic bacterial lung infections in patients with cystic fibrosis (CF)
Phase 2a
Phase 2a
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Drug Pipeline

Drug Stage Notes
AR-105 (Aerucin)
Pseudomonas aeruginosa
Phase 2
Phase 2
Phase 2 trial did not met primary endpoint - September 3, 2019.

Latest News

  1. SAN JOSE, Calif., June 26, 2020 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, today announced that Vu Truong, Ph.D., Chief Executive Officer, will participate in Cantor Fitzgerald's Virtual Symposium: "Winning Ways to Treat Infections and COVID-19" being held on Tuesday, June 30, 2020.

    Symposium Details:
    Panel: Winning Ways to Treat Infections and COVID-19
    Date: Tuesday, June 30, 2020 
    Time: 11:00AM ET

    To register for the virtual symposium, please click here: Virtual Symposium Registration.

    About Aridis Pharmaceuticals, Inc.
    Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives…

    SAN JOSE, Calif., June 26, 2020 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, today announced that Vu Truong, Ph.D., Chief Executive Officer, will participate in Cantor Fitzgerald's Virtual Symposium: "Winning Ways to Treat Infections and COVID-19" being held on Tuesday, June 30, 2020.

    Symposium Details:

    Panel: Winning Ways to Treat Infections and COVID-19

    Date: Tuesday, June 30, 2020 

    Time: 11:00AM ET

    To register for the virtual symposium, please click here: Virtual Symposium Registration.

    About Aridis Pharmaceuticals, Inc.

    Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is utilizing its proprietary /\PEX and MabIgX® technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture mAbs for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized for high potency by the donor's immune system; hence, they do not require genetic engineering or further optimization to achieve full functionality.

    The Company has generated multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company's pipeline is highlighted below:

    Aridis' Pipeline

    AR-301 (VAP). AR-301 is a fully human immunoglobulin 1, or IgG1, mAb currently in Phase 3 clinical development targeting gram-positive S. aureus alpha-toxin in VAP patients.

    AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting P. aeruginosa liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide.

    AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients.  This program is currently in a Phase 1/2a clinical study in healthy volunteers and CF patients.

    AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.

    AR-701 (COVID-19). AR-701 is a fully human mAb cocktail discovered from convalescent COVID-19 patients that are directed at multiple envelope proteins on SARS-CoV-2. 

    AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV).

    For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/.

    Contact:

    Investor Relations

    Jason Wong

    Blueprint Life Science Group



    (415) 375-3340 Ext. 4

     

    Aridis Pharmaceuticals, Inc. Logo (PRNewsfoto/Aridis Pharmaceuticals, Inc.)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/aridis-pharmaceuticals-to-participate-in-cantor-fitzgerald-virtual-symposium-winning-ways-to-treat-infections-and-covid-19-301084143.html

    SOURCE Aridis Pharmaceuticals, Inc.

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  2. SAN JOSE, Calif., June 22, 2020 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, announced today positive results from the Phase 1 portion of its Phase 1/2a clinical trial of AR-501, an inhaled formulation of gallium citrate being developed for the treatment of chronic lung infections in patients with cystic fibrosis (CF). The Phase 1/2a clinical trial, which is being funded by the Cystic Fibrosis Foundation, is a randomized, double blinded, placebo-controlled study evaluating the safety and pharmacokinetics in healthy volunteers and Pseudomonas aeruginosa infected CF patients. AR-501 is being…

    SAN JOSE, Calif., June 22, 2020 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, announced today positive results from the Phase 1 portion of its Phase 1/2a clinical trial of AR-501, an inhaled formulation of gallium citrate being developed for the treatment of chronic lung infections in patients with cystic fibrosis (CF). The Phase 1/2a clinical trial, which is being funded by the Cystic Fibrosis Foundation, is a randomized, double blinded, placebo-controlled study evaluating the safety and pharmacokinetics in healthy volunteers and Pseudomonas aeruginosa infected CF patients. AR-501 is being developed as a once-per-week dosing regimen that is self-administered using a hand-held nebulizer device.

    Key findings:

    - AR-501 aerosols were well tolerated

    - No serious adverse events (SAEs), no Grade 3 or Grade 4 adverse events (AEs) reported over the 28 day study period for the single ascending dose cohort, or 56 day study period for the multiple ascending dose cohort

    - All AEs were Grade 1 or Grade 2 in severity that resolved

    - Most common AEs were respiratory and were balanced between AR-501 and placebo recipients

    - Transient incremental changes in airflow as measured by spirometry were observed in both AR-501 and placebo recipients that were not dose related

    - The SMC and DSMB support all doses to proceed to the Phase 2a portion of the Phase 1/2a trial in adult subjects with CF

    "We know that a recent Phase 2 clinical study showed that intravenous, 5-day continuous infusion of gallium is safe and effective in improving lung functions of cystic fibrosis patients. Our current data is extremely exciting as it shows that gallium is also well tolerated when delivered directly to the lungs in a more convenient, once-per-week, inhaled form that is likely capable of achieving substantially higher lung exposure than the intravenous route," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "We look forward to advancing to the Phase 2a stage of the study evaluating adult cystic fibrosis patients, with results expected in 2H 2021."

    About the Phase 1/2a Clinical Trial

    The study was designed to enroll 48 healthy adult volunteers (Phase 1) and 48 cystic fibrosis patients (Phase 2a) from approximately 18 sites in the U.S. In the now-completed Phase 1 arm, 48 healthy adults were randomized and treated in 6 cohorts (of 8 subjects each) to receive either a single ascending dose (SAD, Cohorts 1, 2, and 3 [N=24]) or weekly multiple ascending doses (MAD, Cohorts 4, 5, and 6 [N=24]) of active drug at 6.4 mg gallium (Ga+3), 20 mg Ga+3 and 40 mg Ga+3 or placebo. Phase 1 participants were randomized within each cohort in a 3:1 ratio of active drug to placebo. Subjects were followed for 28 days after study dose for safety and PK of inhaled AR-501 in HV subjects. AR-501 or placebo was delivered by a nebulizer device. For additional information about this study, please visit https://clinicaltrials.gov/ct2/show/NCT03669614?term=ar-501&rank=1

    About AR-501 and Cystic Fibrosis

    AR-501 is an inhaled formulation of gallium citrate that is being developed to treat chronic lung infections in cystic fibrosis patients. It is a non-antibiotic, broad acting antimicrobial with a mechanism of action involving interference with iron and disruption of microbial iron-dependent metabolic pathways distinct from current antibiotics. AR-501 acts as an iron analog and is believed to disrupt multiple iron dependent pathways in microbes, leading to growth inhibition. AR-501 has antimicrobial activities against a number of gram-negative and gram-positive bacteria, including antibiotic resistant strains. Preclinical studies have shown that mice infected with P. aeruginosa bacteria can be rescued from mortality with a single inhalation exposure of aerosolized AR-501. 

    Cystic fibrosis patients often suffer from severe, persistent secondary bacterial lung infections due to their underlying lung disease which results in an immune-compromised state. Preclinical efficacy and safety data have demonstrated that AR-501 works synergistically with multiple antibiotics, is effective against antibiotic resistant strains, and has a low intrinsic resistance profile. AR-501 is being developed as a self-administered, inhaled weekly treatment. Separately, an intravenous formulation of gallium nitrate citrate has been evaluated in Phase 1 and Phase 2 clinical studies as a single, 5-day infusion in moderate and severe cystic fibrosis patients by researchers at the University of Washington (Seattle, WA). Both clinical studies of IV gallium demonstrated safety and efficacy as measured by improvement in lung function. AR-501 received Orphan Drug, Fast-Track, and QIDP (Qualified Infectious Diseases Product) designations for the treatment of lung infections in patients with CF by the US FDA. The European Medicines Agency (EMA) also awarded AR-501 with Orphan Drug designation.

    About Aridis Pharmaceuticals, Inc.

    Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is utilizing its proprietary /\PEXTM and MabIgX® technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture mAbs for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized for high potency by the donor's immune system; hence, they do not require genetic engineering or further optimization to achieve full functionality.

    The Company has generated multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company's pipeline is highlighted below:

    Aridis' Pipeline

    AR-301 (VAP). AR-301 is a fully human immunoglobulin 1, or IgG1, mAb currently in Phase 3 clinical development targeting gram-positive S. aureus alpha-toxin in VAP patients.

    AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting P. aeruginosa liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide.

    AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients.  This program is currently in a Phase 1/2a clinical study in healthy volunteers and CF patients.

    AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.

    AR-701 (COVID-19). AR-701 is a fully human mAb cocktail discovered from convalescent COVID-19 patients that are directed at multiple envelope proteins on SARS-CoV-2. 

    AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV).

    For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/.

    Forward-Looking Statements

    Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties.  These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially.  There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements.  These factors include, but are not limited to, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations.  While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2019 and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

    Contact:

    Investor Relations

    Jason Wong

    Blueprint Life Science Group



    (415) 375-3340 Ext. 4

    Aridis Pharmaceuticals, Inc. Logo (PRNewsfoto/Aridis Pharmaceuticals, Inc.)

     

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    SOURCE Aridis Pharmaceuticals, Inc.

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  3. SAN JOSE, Calif., June 18, 2020 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, announced today that it will participate in a Cantor Fitzgerald hosted Virtual Fireside Chat on Thursday, June 25, 2020 at 11:00 AM ET.

    The event, entitled "APEXTM, a technology platform geared to rapidly discover new treatments for emerging pulmonary pathogens," will be moderated by Louise Chen, Senior Research Analyst and Managing Director of Cantor Fitzgerald and feature Aridis' Dr. Vu Truong, Chief Executive Officer and Dr. Hasan Jafri, Chief Medical Officer. The discussion is intended to provide a…

    SAN JOSE, Calif., June 18, 2020 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, announced today that it will participate in a Cantor Fitzgerald hosted Virtual Fireside Chat on Thursday, June 25, 2020 at 11:00 AM ET.

    The event, entitled "APEXTM, a technology platform geared to rapidly discover new treatments for emerging pulmonary pathogens," will be moderated by Louise Chen, Senior Research Analyst and Managing Director of Cantor Fitzgerald and feature Aridis' Dr. Vu Truong, Chief Executive Officer and Dr. Hasan Jafri, Chief Medical Officer. The discussion is intended to provide a comprehensive profile of the Company's CRISPR based, new platform technology APEX™. A particular emphasis will be placed on addressing how APEXTM can be rapidly customized to future COVID strains as well as any emerging viral or bacterial pathogens.

    Aridis will also provide an update on lead programs AR-301 which is in a Phase 3 clinical trial for the treatment of ventilator associated pneumonia (VAP) and is open to all patients, including those with COVID-19, who demonstrate S. aureus pneumonia secondary to ventilator placement. Further, Drs. Truong and Jafri will also discuss development plans for AR-501, a non-antibiotic, small molecule, inhalable therapy for chronic pulmonary infections in cystic fibrosis patients.

    To register for the event please visit the following link: Fireside Chat Registration

    About Aridis Pharmaceuticals, Inc.

    Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is utilizing its proprietary APEXTM and MabIgX® technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture mAbs for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized for high potency by the donor's immune system; hence, they do not require genetic engineering or further optimization to achieve full functionality.

    APEX™ is a platform for the unbiased discovery of new and highly potent antibodies against pathogens and a methodology to maximize the production/yield of selected antibodies on commercial scale. The platform technology is comprised of a silicon wafer-based array of nanoliter sized tissue microculture wells that enable rapid screening of antibody secreting cells, enabling discovery of potent antibodies against targets such as viruses within one day of a pandemic outbreak. It also features CRISPR enabled activation of endogenous genetic control elements that dramatically increase the yield of biotherapeutic drugs from manufacturing production cell lines, and a proprietary production cell line that is designed to rapidly manufacture multiple monoclonal antibody therapeutics at approximately half the manufacturing cycle time than current available manufacturing technologies. 

    The Company has generated multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as VAP and hospital acquired pneumonia (HAP). The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company's pipeline is highlighted below:

    Aridis' Pipeline

    AR-301 (VAP). AR-301 is a fully human immunoglobulin 1, or IgG1, mAb currently in Phase 3 clinical development targeting gram-positive S. aureus alpha-toxin in VAP patients.

    AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting P. aeruginosa liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide.

    AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients.  This program is currently in a Phase 1/2a clinical study in healthy volunteers and CF patients.

    AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.

    AR-701 (COVID-19). AR-701 is a cocktail of fully human IgG1 mAbs which are directed at several envelope proteins and designed to neutralize diverse clinical isolates of SARS-CoV-2.

    AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV).

    For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/.

    Forward-Looking Statements

    Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties.  These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially.  There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements.  These factors include, but are not limited to, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations.  While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2019 and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

    Contact:

    Investor Relations

    Jason Wong

    Blueprint Life Science Group



    (415) 375-3340 Ext. 4

    Aridis Pharmaceuticals, Inc. Logo (PRNewsfoto/Aridis Pharmaceuticals, Inc.)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/aridis-pharmaceuticals-to-discuss-apex-in-virtual-fireside-chat-hosted-by-cantor-fitzgerald-on-june-25th-301079155.html

    SOURCE Aridis Pharmaceuticals, Inc.

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  4. SAN JOSE, Calif., June 15, 2020 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, announced today that it has appointed Dr. Hasan Jafri as Chief Medical Officer (CMO). Dr. Jafri replaces Dr. Paul Mendelman who has been serving as the Company's interim CMO since October, 2019 and will transition to the role of senior medical advisor to the Company.

    "It is a pleasure to welcome Dr. Jafri to the Aridis team as he brings extensive clinical, research and industry experience across the full spectrum of the infectious disease treatment landscape, especially in anti-infective immunotherapies…

    SAN JOSE, Calif., June 15, 2020 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, announced today that it has appointed Dr. Hasan Jafri as Chief Medical Officer (CMO). Dr. Jafri replaces Dr. Paul Mendelman who has been serving as the Company's interim CMO since October, 2019 and will transition to the role of senior medical advisor to the Company.

    "It is a pleasure to welcome Dr. Jafri to the Aridis team as he brings extensive clinical, research and industry experience across the full spectrum of the infectious disease treatment landscape, especially in anti-infective immunotherapies," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "I also wish to extend gratitude to Dr. Mendelman for his tremendous contribution in helping maintain the development pace of our clinical programs and implementation of the Company's APEX™ technology platform used in the discovery of COVID-19 mAbs and other antibodies against lung disease pathogens." 

    Dr. Jafri comes to Aridis from AstraZeneca, where he most recently served as Senior Medical Director, Clinical Research and Development, Microbial Sciences, Clinical Head of Antibacterial mAb Program, and Coordinator of the European Public-Private COMBACTE-NET & COMBACTE-MAGNET consortia focused on antibacterial drug development supported by the Innovative Medicines Initiative (IMI). During his tenure at AstraZeneca, he led the clinical development of the anti-bacterial monoclonal antibodies within the Serious Bacterial Infections Franchise, including its Phase 2 programs MEDI4893 (anti-S. aureus alphatoxin mAb) and MEDI3902 (anti-P. aeruginosa Psl/PcrV mAb). He also served as the AstraZeneca representative on the Infection Control Strategic Governance Group (SGG), an industry committee tasked with advising the European Commission and IMI on R&D priorities. In addition to the antibacterial programs, Dr. Jafri has been a leader in respiratory syncytial virus (RSV) R&D. Dr. Jafri has over 25 years of experience in clinical practice and research, especially in the area of serious healthcare associated and community acquired infections, respiratory viral infections and invasive fungal infections (in immunocompromised and immunocompetent hosts), and biomarker and translational research. He has been involved in the design and conduct of multiple Phase 1–4 clinical studies to assess novel small and large molecules against bacterial, viral and fungal pathogens. Prior to joining AstraZeneca, Dr. Jafri served as a Professor in the Department of Pediatric Infectious Diseases and the Department of Clinical Science Research at the University of Texas Southwestern Medical Center at Dallas. He was the Chief of Division of Clinical Pharmacology, Director of the Pediatric Infectious Diseases fellowship program, and Director of the NICHD Pediatric Pharmacology Research Center. Dr. Jafri has authored over 70 peer reviewed journal articles and presented over 100 original research abstracts at National and International Conferences.

    "I'm excited to join Aridis especially at such a critical time within the infectious disease arena given the COVID-19 pandemic, the global antibiotic resistance challenges and the need for new innovative antibacterial therapies. I look forward to playing an integral role in advancing our pipeline of differentiated anti-infective treatments for multiple indications and bringing these novel and potentially lifesaving medicines to patients," commented Dr. Hasan Jafri, Chief Medical Officer of Aridis Pharmaceuticals. "I'm particularly passionate about antiviral and antibacterial immunotherapy using monoclonal antibodies after having spent the past decade working on this area at AstraZeneca/MedImmune and have helped advance multiple programs through global Phase 3 clinical studies."

    About Aridis Pharmaceuticals, Inc.

    Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is utilizing its proprietary APEX and MabIgX® technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture mAbs for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized for high potency by the donor's immune system; hence, they do not require genetic engineering or further optimization to achieve full functionality.

    The Company has generated multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as VAP and hospital acquired pneumonia (HAP). The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company's pipeline is highlighted below:

    Aridis' Pipeline

    AR-301 (VAP). AR-301 is a fully human immunoglobulin 1, or IgG1, mAb currently in Phase 3 clinical development targeting gram-positive S. aureus alpha-toxin in VAP patients.

    AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting P. aeruginosa liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide.

    AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients.  This program is currently in a Phase 1/2a clinical study in healthy volunteers and CF patients.

    AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.

    AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV).

    For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/.

    Forward-Looking Statements

    Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties.  These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially.  There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements.  These factors include, but are not limited to, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations.  While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2019 and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

    Contact:

    Investor Relations

    Jason Wong

    Blueprint Life Science Group



    (415) 375-3340 Ext. 4

     

    Aridis Pharmaceuticals, Inc. Logo (PRNewsfoto/Aridis Pharmaceuticals, Inc.)

     

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  5. SAN JOSE, Calif., May 12, 2020 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, today reported financial and corporate results for the first quarter ended March 31, 2020. 

    First Quarter Highlights and Recent Developments

    • Enrolled the first patient with COVID-19 in AR-301 Phase 3 trial for patients with ventilator associated pneumonia (VAP)
    • Initiated dosing of the last dose cohort in the healthy volunteer portion of the AR-501 Phase 1/2a clinical trial with top-line data provisionally expected in 1H 2020 (healthy subjects), and in 2H 2021 (cystic fibrosis subjects)
    • Commenced COVID-19…

    SAN JOSE, Calif., May 12, 2020 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening bacterial infections, today reported financial and corporate results for the first quarter ended March 31, 2020. 

    First Quarter Highlights and Recent Developments

    • Enrolled the first patient with COVID-19 in AR-301 Phase 3 trial for patients with ventilator associated pneumonia (VAP)
    • Initiated dosing of the last dose cohort in the healthy volunteer portion of the AR-501 Phase 1/2a clinical trial with top-line data provisionally expected in 1H 2020 (healthy subjects), and in 2H 2021 (cystic fibrosis subjects)
    • Commenced COVID-19 monoclonal antibody and vaccine discovery activities utilizing the APEX™ platform technology

    "While the COVID-19 pandemic has provided significant headwinds to patient trial enrollment across therapeutic indications including our own ongoing studies, we were still able to advance our lead programs and in fact, enrolled our first patient diagnosed with COVID-19 and on a ventilator into the AR-301 Phase 3 VAP study," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "Furthermore, the pandemic provided a unique opportunity to leverage our APEX platform technology for the rapid discovery and development of highly potent monoclonal antibodies from convalescent COVID-19 patients."

    During the quarter, Aridis initiated COVID-19 monoclonal antibody and vaccine discovery activities utilizing its APEX™ technology platform for the unbiased discovery of new and highly potent antibodies against pathogens. The APEX™ platform is comprised of a silicon wafer-based array of nanoliter sized tissue micro-culture wells that enable rapid screening of antibody secreting cells, enabling discovery of potent antibodies against targets such as the virus that causes COVID-19 disease (called 'SARS-CoV-2') within a few days of patient sample availability. It also features CRISPR enabled activation of endogenous genetic control elements that dramatically increase the yield of bio-therapeutic drugs from manufacturing production cell lines. The technology also features a proprietary production cell line that is designed to rapidly manufacture multiple monoclonal antibody therapeutics at approximately half the manufacturing cycle time than currently available manufacturing technologies. 

    Clinical Program Update

    AR-301: In April, Aridis enrolled its first COVID-19 patient in the Company's ongoing Phase 3 clinical trial of AR-301. COVID-19 patients on prolonged mechanical ventilation in the intensive care unit (ICU) are prone to secondary infections (also called 'superinfections') by opportunistic pathogens such as bacteria. Superinfection is a reported complication in COVID-19 patients, which exacerbates morbidity and rate of mortality. The Company's ongoing AR-301 Phase 3 study allows for the enrollment of patients with baseline characteristics which are inclusive of certain COVID-19 patients. While AR-301 is not an agent to treat SARS-CoV-2 virus itself, it can potentially reduce the morbidity associated with secondary S. aureus pneumonia, which is a coronavirus complication and a contributing cause of death in such patients.

    The trial, which was initiated in the first quarter of 2019, is expected to enroll 240 patients at approximately 160 clinical centers in 22 countries.  However, the advent of coronavirus infections which became apparent during the fourth quarter of 2019, impacted the global patient enrollment rate, and delayed further clinical site activations in regions with large number of clinical sites, such as in China and India. Contingent upon the evolution of the coronavirus pandemic, Aridis is provisionally expecting interim data to be reported in 2H 2020, and top line data in 2H 2021. Participating clinical centers that are activated continue to follow the same stringent clinical protocols and procedures for critically ill VAP patients, as is standard in the U.S. and Europe. The trial represents the first ever Phase 3 superiority clinical study evaluating immunotherapy with a fully human monoclonal antibody to treat acute pneumonia in the intensive care unit setting. Details of the study can be viewed on www.clinicaltrials.gov using identifier NCT03816956.

    AR-301 is a fully human monoclonal IgG1 antibody specifically targeting gram-positive S. aureus alpha-toxin. It has been shown in vitro to protect against alpha-toxin mediated destruction of host cells, thereby potentially preserving the human immune response. AR-301's mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA (methicillin resistant S. aureus) and MSSA (methicillin sensitive S. aureus).

    AR-501: During the first quarter, Aridis initiated dosing of the last dose cohort in healthy volunteer portion of the AR-501 Phase 1/2a clinical trial of this inhalable formulation of gallium citrate being evaluated for the treatment of chronic lung infections associated with cystic fibrosis. The single ascending dose cohorts of healthy subjects have completed dosing and the safety monitoring committee has recommended proceeding into the multiple ascending dose cohorts. The Company expects to report data from the Phase 1 portion of the trial which consists of healthy subjects provisionally in 1H 2020 and the Phase 2a segment with cystic fibrosis subjects in 2H 2021. 

    AR-501, which is being developed in collaboration with the Cystic Fibrosis Foundation (CFF), has been granted Orphan Drug Designation (ODD), Fast Track and Qualified Infectious Disease Product (QIDP) designations by the U.S. Food and Drug Administration (FDA). In addition, the European Medicines Agency (EMA) granted ODD to AR-501. Details of the Phase 1/2a clinical trial, which is a randomized, double-blinded, placebo controlled single and multiple dose-ascending trial investigating the safety and pharmacokinetics of inhaled AR-501 in healthy volunteers and cystic fibrosis patients with chronic bacterial lung infections, can be viewed on www.clinicaltrials.gov using identifier NCT03669614. The study is expected to accrue 48 healthy adult volunteers and 48 cystic fibrosis patients from approximately 15 sites in the U.S.

    Corporate Update

    During the first quarter, Aridis continued to present at leading investor and medical conferences, which due to the COVID-19 pandemic have been transitioned to virtual forums. The Company participated in Maxim Group's Infectious Disease Virtual Conference held on May 5, 2020. The event consisted of four panels of companies in various stages of development, from early stage to near commercialization, that represent the next wave of innovation in the infectious disease sector. Vu Truong, Ph.D., Aridis' Chief Executive Officer, was a speaker on two panels entitled "Non-antibiotic Anti-infectives" and "COVID-19 (Therapeutics)." The presentation slides can be found at https://investors.aridispharma.com/publications-and-posters

    Fiscal 2020 First Quarter Results:

    • Cash: Total cash and cash equivalents as of March 31, 2020 was $16.3 million.
    • Revenues: Grant revenue decreased from approximately $1.0 million for the quarter ended March 31, 2019 to zero for the quarter ended March 31, 2020 primarily due to the recognition of revenue related to a milestone under the grant award from the CFF during the first quarter of 2019 and none during the first quarter of 2020.
    • Research and Development Expenses: Research and development expenses incurred in the quarter ended March 31, 2020 were $4.9 million, a decrease of approximately $2.2 million over the same period in 2019 due primarily to a decrease in spending on clinical trial activities for the AR-105 Phase 2 program, which was completed in 2019, and a decrease in drug manufacturing expenses related to the AR-301 Phase 3 program. These decreases were partially offset by an increase in spending on clinical trial activities for both the AR-301 Phase 3 and the AR-501 Phase 1/2a programs.
    • General and Administrative Expenses: There was no material difference in general and administrative expenses for the quarter ended March 31, 2020 when compared to the same period in 2019.
    • Interest and Other Income, net: Interest and other income, net was $61,000 for the quarter ended March 31, 2020, a decrease of approximately $55,000 over the same period in 2019. These decreases were due primarily to a lower average cash balance and lower interest rates.
    • Share of Loss from Equity Method Investment: Loss from equity method investment decreased by $433,000 to $9,000 for the quarter ended March 31, 2020 over the same period in 2019 due to our share of loss from our minority interest under the equity method was limited to the book value of the investment.
    • Net Loss: The net loss for the quarter ended March 31, 2020 was $6.5 million, or ($0.73) per share, compared to a net loss of approximately $8.1 million, or ($0.99) per share, for the quarter ended March 31, 2019. The weighted average common shares outstanding was approximately 8.9 million and approximately 8.1 million for the first quarter of 2020 and 2019, respectively.

    About Aridis Pharmaceuticals, Inc.
    Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is utilizing its proprietary APEXTM and MabIgX® technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture mAbs for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized for high potency by the donor's immune system; hence, they do not require genetic engineering or further optimization to achieve full functionality.

    The Company has generated multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as VAP and hospital acquired pneumonia (HAP). The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company's pipeline is highlighted below:

    Aridis' Pipeline
    AR-301 (VAP). AR-301 is a fully human immunoglobulin 1, or IgG1, mAb currently in Phase 3 clinical development targeting gram-positive S. aureus alpha-toxin in VAP patients.

    AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting P. aeruginosa liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide.

    AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients.  This program is currently in a Phase 1/2a clinical study in healthy volunteers and CF patients.

    AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.

    AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV).

    For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/.

    Forward-Looking Statements
    Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties.  These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Aridis' expectations, strategy, plans or intentions. These forward-looking statements are based on Aridis' current expectations and actual results could differ materially.  There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements.  These factors include, but are not limited to, the timing of regulatory submissions, Aridis' ability to obtain and maintain regulatory approval of its existing product candidates and any other product candidates it may develop, approvals for clinical trials may be delayed or withheld by regulatory agencies, risks relating to the timing and costs of clinical trials, risks associated with obtaining funding from third parties, management and employee operations and execution risks, loss of key personnel, competition, risks related to market acceptance of products, intellectual property risks, risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses, risks associated with the uncertainty of future financial results, Aridis' ability to attract collaborators and partners and risks associated with Aridis' reliance on third party organizations.  While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption "Risk Factors" in Aridis' 10-K for the year ended December 31, 2019 and Aridis' other filings made with the Securities and Exchange Commission. Forward-looking statements included herein are made as of the date hereof, and Aridis does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

    Aridis Pharmaceuticals, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)



    March 31,


    December 31,



    2020


    2019



    (unaudited)








    Cash and cash equivalents


    $           16,324


    $           20,897

    Other current and noncurrent assets


    5,683


    7,070

    Total Assets


    $           22,007


    $           27,967






    Total Liabilities


    $           24,384


    $           24,331

    Total stockholders' equity (deficit)


    (2,377)


    3,636

    Total liabilities and stockholders' equity (deficit)


    $           22,007


    $           27,967

     

    Aridis Pharmaceuticals, Inc.

    Condensed Consolidated Statements of Operation

    (in thousands, except share and per share amounts)








    Three Months Ended



    March 31,



    2020


    2019




    (unaudited)







    Revenue


    $             —


    $            1,022






    Operating Expenses*





    Research and development


    4,917


    7,118

    General and administrative


    1,639


    1,641

    Total operating expenses


    6,556


    8,759






    Loss from operations


    (6,556)


    (7,737)

    Other income (expense)





    Interest and other income, net


    61


    116

    Share of loss from equity method investment


    (9)


    (442)






    Net loss


    $           (6,504)


    $           (8,063)






    Weighted-average common shares outstanding, basic and diluted


    8,919,393


    8,105,636






    Net loss per share, basic and diluted


    $             (0.73)


    $             (0.99)






    *Includes stock based-compensation as follows





    Research and development


    $                145


    $                173

    General and administrative


    332


    277



    $                477


    $                450

    Contact:

    Investor Relations
    Jason Wong
    Blueprint Life Science Group

    (415) 375-3340 Ext. 4

    Aridis Pharmaceuticals, Inc. Logo (PRNewsfoto/Aridis Pharmaceuticals, Inc.)

     

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