ARDS Aridis Pharmaceuticals Inc.

4.02
+0.13  (+3%)
Previous Close 3.89
Open 3.85
52 Week Low 3.5352
52 Week High 8.5
Market Cap $59,048,317
Shares 14,688,636
Float 13,259,326
Enterprise Value $47,381,794
Volume 43,636
Av. Daily Volume 212,362
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Upcoming Catalysts

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

Drug Stage Notes
Suvratoxumab (AR-320)
Staphylococcus aureus (S. aureus)
Phase 3
Phase 3
Phase 3 trial to commence 4Q 2021.
AR-712
COVID-19
Phase 1
Phase 1
Phase 1/2/3 trial to be initiated end of 2021.
Aerucin (AR-105)
Pseudomonas aeruginosa
Phase 2
Phase 2
Phase 2 trial did not met primary endpoint - September 3, 2019.

Latest News

  1. LOS GATOS, Calif., Aug. 12, 2021 /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, today reported financial and corporate results for its second quarter ended June 30, 2021.

    Second Quarter Highlights

    • Executed and announced in July an agreement with AstraZeneca under which the Company in-licensed the Phase 3-ready monoclonal antibody (mAb) candidate, suvratoxumab, being evaluated for the prevention of pneumonia. AstraZeneca took an equity stake in Aridis as part of the agreement and has first right of negotiation for future licensing of AR-320. Launch of the Phase 3 study, supported by up to €25…

    LOS GATOS, Calif., Aug. 12, 2021 /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, today reported financial and corporate results for its second quarter ended June 30, 2021.

    Second Quarter Highlights

    • Executed and announced in July an agreement with AstraZeneca under which the Company in-licensed the Phase 3-ready monoclonal antibody (mAb) candidate, suvratoxumab, being evaluated for the prevention of pneumonia. AstraZeneca took an equity stake in Aridis as part of the agreement and has first right of negotiation for future licensing of AR-320. Launch of the Phase 3 study, supported by up to €25 million (approximately $30 million) of funding from the EU Commission's Innovative Medicines Initiatives (IMI), is expected in the fourth quarter of 2021.

    Phase 2 data, involving n=196 patients, was recently published in The Lancet Infectious Diseases journal. The data showed that in the overall intent to treat (ITT) study population, mechanically ventilated ICU patients colonized with Staphylococcus aureus (S. aureus) treated with suvratoxumab saw a relative risk reduction of pneumonia of 32%. Importantly, in the pre-specified population under 65 years of age, which is the target population in the planned Phase 3 study, the relative risk reduction was, a statistically significant, 47%.

    Aridis believes that suvratoxumab (also referred to as 'AR-320') will be a first-line, first-to-market, first-in-class pre-emptive treatment of S. aureus colonized patients. The same first-line, first-to-market and first-in-class strategy applies to the company's Phase 3 candidate AR-301, which is being developed for the acute treatment of ventilator associated pneumonia (VAP) patients. AR-320 and AR-301 are highly complementary to each other, as AR-320 is expected to be beneficial in a prevention mode for patients who have been colonized by the S. aureus bacteria but who did not yet progress to VAP, while AR-301 is intended to treat patients who are diagnosed with VAP caused by S. aureus. With these complimentary product candidates, the Company believes it is in a position to be a global leader in the prevention and treatment of VAP caused by S. aureus.

    • Announced on August 4 that it had closed a definitive agreement with a single healthcare-focused institutional investor for the purchase and sale of 4,947,556 shares of the Company's common stock (or common stock equivalents) and warrants to purchase up to an aggregate of 2,473,778 shares of the Company's common stock, at an effective at-the-market purchase price of $5.053 per share, in a registered direct offering priced at a premium to the market under Nasdaq rules. The gross proceeds to the Company from this offering was approximately $25 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for clinical development, working capital and general corporate purposes through early 2022. 
    • Inhaled COVID mAb combination (AR-712) binds and neutralizes SARS-CoV-2 Delta variant at a highly effective level (~20ng/mL). Binding analyses project that AR-712 will be effective against all variants on the U.S. Centers for Disease Control's Variants of Interest and Variants of Concern lists.
    • AR-711, one of two mAbs in the AR-712 cocktail, is confirmed by the Coronavirus Immunotherapeutics Consortium (CoVIC; https://covic.lji.org) to be among the top five most potent when compared to more than 350 COVID-19 mAbs that entered the CoVIC evaluation program.
    • Continued enrolling global Phase 3 clinical trial of AR-301 in patients with S. aureus VAP. Top-line data expected in mid-2022.

    "We are delighted to have been selected by AstraZeneca as the licensee of its Phase 3-ready candidate for the prevention of pneumonia, and with the recent influx of cash from our latest capital raise and the substantial funding by the EU's Innovative Medicines Initiatives, we are in a great position to launch our Phase 3 study for AR-320 in the fourth quarter of this year," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "Multiple near-term clinical milestones from our expanding product pipeline (AR-712 Phase 1 and 2 read-outs in 1H 2022, AR-501 Phase 2a data in Q1 2022 and AR-301 Phase 3 top-line data in mid-2022) should provide a number of strong catalysts to fortify our leadership position in the respiratory health space."

    "I am delighted at the completion of the in-licensing agreement with AstraZeneca to bring suvratoxumab into the Aridis pipeline, as I have been involved in developing this highly promising mAb for almost a decade," commented Hasan Jafri, M.D., Chief Medical Officer of Aridis Pharmaceuticals. "After the favorable results of the Phase 2 study, this agreement enables Aridis to initiate a Phase 3 trial of suvratoxumab in partnership with the COMBACTE Consortium as part of its commitment to bring multiple novel immunotherapeutic molecules targeting antimicrobial resistance (AMR) to critically ill patients with high unmet medical need."

    Clinical Program Update

    AR-301: AR-301 is being evaluated in a Phase 3 clinical study as an adjunctive treatment to standard of care antibiotics in S. aureus VAP patients. The ongoing AR-301 Phase 3 study remains blinded, and the independent Data Monitoring Committee with access to unblinded data continues to monitor study subjects for safety and has not conveyed any safety concerns (i.e., thus far an un-remarkable safety profile). However, the pace of the trial had been affected by the COVID-19 pandemic. The activation of AR-301 clinical trial sites progressed globally during the pandemic, but the patient enrollment slowed due to the prioritization of the intensive care units (ICU) around the world to COVID-19 patients. As countries start to emerge from the pandemic, the company expects patient enrollment to improve, and enrollment completed in late first half of 2022. At this rate, the Phase 3 interim futility analysis would be completed too close to the completion of patient enrollment to be useful. As such, the company will elect to forgo the interim futility analysis and focus on accelerating patient enrollment to deliver top-line data by approximately mid-2022.

    It is important to note that COVID-19 patients on prolonged mechanical ventilation in the 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 the rate of mortality. The 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 likely contributing cause of death in such patients.

    The trial is expected to enroll 240 patients at approximately 160 clinical centers in 22 countries. Participating clinical centers continue to follow standard 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 mAb 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-501: The Company initiated its Phase 2a study to evaluate the safety, pharmacokinetic, and preliminary efficacy evaluation in cystic fibrosis (CF) patients in the first quarter of 2021. The Phase 2a is actively enrolling patients with a goal of 42 cystic fibrosis adult patients at full enrollment. The Company expects to report top-line data from this study during the first quarter of 2022.

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

    AR-712:   AR-712 is a cocktail of two mAbs, AR-711 and AR-720, designed to lower the barrier to treatment coverage of non-hospitalized SARS-CoV-2 (i.e., COVID-19) patients by using a convenient, self-administered inhaled dosage presentation. The two mAbs that comprise AR-712 were discovered from convalescent COVID-19 patients and target the receptor-binding domain (RBD) region of the spike protein of the original SARS-CoV-2 virus. AR-712 binds and neutralizes the SARS-CoV-2 Delta variant virus at a highly effective level (~20ng/mL) and binding analyses project that AR-712 will be effective against all variants on the U.S. Centers for Disease Control's Variants of Interest and Variants of Concern lists. AR-711 is confirmed by the CoVIC consortium (NIAID, Bill and Melinda Gates Foundation, Wellcome Trust, MasterCard Impact Fund and others) to be among the top five most potent mAbs out of over 350 COVID-19 mAbs that entered the CoVIC evaluation program. In a mouse model of SARS-CoV-2 infection, the AR-711 mAb effectively protected infected animals at the lowest parenteral dose tested (0.5 mg/kg).

    In an animal challenge study with golden Syrian hamsters, inhaled AR-711 successfully eliminated all detectable SARS-CoV-2 virus at substantially lower doses than parenterally administered (injected) COVID-19 mAb. The AR-712 mAbs are engineered to be long-acting in blood for up to six to twelve months and are stabilized using a proprietary formulation designed to protect the mAbs from the physical stresses imparted by commercial nebulizer delivery devices on protein drugs. The potency of AR-712 and its direct delivery to the lungs by inhaled administration may facilitate significant dose sparing not achievable by parenteral administration. A proprietary formulation enables AR-712 to be deliverable using a variety of commercially available nebulizers that can be self-administered on an outpatient basis, thus lowering the barrier to COVID-19 therapeutic treatment. Clinical trials for AR-712 are expected to commence towards the end of 2021.

    AR-701: During the quarter, Aridis continued to characterize this cocktail of fully human mAbs discovered from its in-house ʎPEX mAb discovery platform that is directed at multiple envelope proteins of the SARS-CoV-2 virus.  AR-701 is intended to treat hospitalized, moderate to severe patients, which complements AR-712's focus on milder, non-hospitalized patients.

    AR-320 (suvratoxumab): The Company announced the licensing of this Phase 3-ready asset from AstraZeneca in July 2021. A multinational, randomized, double blinded, placebo-controlled Phase 2 study (n=196 patients) showed that mechanically ventilated ICU patients colonized with S. aureus who are treated with suvratoxumab, a fully human mAb, saw a relative risk reduction of pneumonia by 32% in the overall ITT study population, and by 47% in the under 65-year-old population, which is the target population in the planned Phase 3 study. The relative risk reduction in the target population reached statistical significance and was also associated with a substantial reduction in the duration of care needed in the ICU and hospital. The Company expects to launch its Phase 3 study of AR-320 in the fourth quarter of 2021.

    Corporate Update

    A key development was the closing of a $25 million financing which occurred in August 2021. The proceeds from this registered direct offering strengthened the Company's balance sheet subsequent to the second quarter to support the continued advancement of AR-301's Phase 3 VAP treatment clinical trial, while allocating the requisite resources to preparing for the initiation of a Phase 3 clinical evaluating AR-320, recently licensed from AstraZeneca, for the prevention of VAP, AR-501's Phase 2b cystic fibrosis clinical trial and the ongoing development of novel COVID-19 therapies, such as AR-712.

    Fiscal 2021 Second Quarter Results:

    • Cash: Total cash and cash equivalents as of June 30, 2021 were approximately $3.6 million.  
    • Revenues: 
      • Grant revenue decreased to zero for the quarter ended June 30, 2021 from $1.0 million for the quarter ended June 30, 2020 due to the recognition of revenue related to a development-based milestone achieved under the award from the Cystic Fibrosis Foundation (CFF) during the second quarter of 2020 and none during the second quarter of 2021.
      • License revenue increased to approximately $33,000 for the quarter ended June 30, 2021 from zero for the quarter ended June 30, 2020 due to the recognition of revenue related to the out-licensing and product discovery agreement with Kermode Biotechnologies, Inc., which was entered into during the first quarter of 2021. There was no license revenue during the second quarter of 2020.
    • Research and Development Expenses: Research and development expenses increased by approximately $926,000 from approximately $3.6 million for the quarter ended June 30, 2020 to approximately $4.6 million for the quarter ended June 30, 2021. The quarter over quarter increase was primarily due to an increase in spending on research and development activities for our COVID-19 programs, an increase in personnel, consulting and other related costs, and an increase in spending on clinical trial activities and drug manufacturing expenses for AR-301 and AR-501, currently undergoing clinical evaluation.
    • General and Administrative Expenses: General and administrative expenses increased by approximately $111,000 from approximately $1.6 million for the quarter ended June 30, 2020 to approximately $1.7 million for the quarter ended June 30, 2021. This increase was due primarily to increases in professional service fees, personnel related costs, including stock-based compensation, and patent related expenses, partially offset by a decrease in Delaware franchise taxes.
    • Interest Income, net: Interest income, net decreased by approximately $10,000 from approximately $10,000 for the quarter ended June 30, 2020 to approximately less than $1,000 for the quarter ended June 30, 2021, due primarily to lower average cash balances during the second quarter of 2021 as compared to the same period in 2020.
    • Other Income: Other income increased by approximately $22,000 from zero for the quarter ended June 30, 2020 to approximately $22,000 for the quarter ended June 30, 2021, which relates to income from a sublease agreement we entered into with a tenant in March 2021 to sublet a small portion of our Los Gatos facility. There was no sublease agreement or related income during the second quarter of 2020.
    • Gain on Extinguishment of Paycheck Protection Program Loan: Gain on extinguishment of the Paycheck Protection Program loan of approximately $722,000 for quarter ended June 30, 2021 related to the forgiveness of our loan from the Small Business Administration and release of financial obligation from our lender, Silicon Valley Bank, in May 2021. There was no extinguishment of debt in 2020.
    • Share of Loss from Equity Method Investment: Loss from equity method investment was zero for the second quarter of 2021 and the same period in 2020.
    • Net Loss: The net loss available to common stockholders for the quarter ended June 30, 2021 was approximately $5.5 million, or $0.49 net loss per share, compared to a net loss available to common stockholders of approximately $4.2 million, or $0.47 net loss per share, for the quarter ended June 30, 2020. The weighted average common shares outstanding used in computing net loss per share available to common stockholders was approximately 11.2 million and approximately 8.9 million for the second quarter of 2021 and 2020, respectively.

    About Aridis Pharmaceuticals, Inc.

    Aridis Pharmaceuticals, Inc. discovers and develops anti-infectives to be used as first-line treatments to combat antimicrobial resistance (AMR) and viral pandemics. The Company is utilizing its proprietary ʎPEX 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 by the natural human immune system for high potency. Hence, they are already fit-for-purpose and do not require further engineering 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 hospital acquired pneumonia (HAP), in addition to preclinical stage antibacterial and 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 IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus (S. aureus) alpha-toxin in VAP patients.

    AR-320 (S. aureus). AR-320 is a fully human mAb for prevention of pneumonia with statistically significant Phase 2 data in the target population of those ≤ 65 years of age, recently published in Lancet Infectious Diseases journal. A Phase 3 study of AR-320, licensed from AstraZeneca, is expected to begin in the fourth quarter of 2021.

    AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa (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 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 mAbs discovered from convalescent COVID-19 patients that are directed at multiple envelope proteins of the SARS-CoV-2 virus.

    AR-712 (COVID-19). AR-712 is a cocktail of two fully human IgG1 mAbs, AR-711 and AR-720, that are directed against the receptor binding domain of the SARS-CoV-2 virus. AR-712 is being developed to treat non-hospitalized mild to moderate COVID-19 patients by inhalation using a nebulizer.

    AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb directed against the F-protein of diverse clinical isolates of respiratory syncytial virus (RSV). This program is licensed exclusively to the Serum Institute of India.

    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 need for additional financing, 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, 2020 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.









    Consolidated Balance Sheets









    (in thousands)













    June 30,



    December 31,













    2021



    2020













    (unaudited)































    Cash and cash equivalents



    $             3,592



    $             8,232









    Other current and noncurrent assets



    7,795



    6,885









    Total Assets



    $          11,387



    $          15,117



























    Total Liabilities



    $          24,874



    $          23,798









    Total stockholders' deficit



    (13,487)



    (8,681)









    Total liabilities and stockholders' deficit



    $          11,387



    $          15,117















































    Aridis Pharmaceuticals, Inc.

    Consolidated Statements of Operation

    (in thousands, except share and per share amounts)























    Three Months Ended



    Six Months Ended





    June 30,



    June 30,





    2021



    2020



    2021



    2020





    (unaudited)



    (unaudited)



















    Revenue



    $             33



    $       1,000



    $             33



    $       1,000



















    Operating Expenses*

















    Research and development



    4,573



    3,647



    9,528



    8,564

    General and administrative



    1,694



    1,583



    3,638



    3,222

    Total operating expenses



    6,267



    5,230



    13,166



    11,786



















    Loss from operations



    (6,234)



    (4,230)



    (13,133)



    (10,786)

    Other income (expense)

















    Interest income, net





    10



    1



    71

    Other income



    22





    29



    Gain on extinguishment of Payroll Protection Program loan



    722





    722



    Share of loss from equity method investment









    (9)

    Net loss



    $          (5,490)



    $          (4,220)



    $        (12,381)



    $        (10,724)

    Deemed dividends







    (986)



    Net loss available to common stockholders



    $          (5,490)



    $          (4,220)



    $        (13,367)



    $        (10,724)



















    Weighted-average common shares outstanding used in computing net

       loss per share available to common stockholders, basic and diluted



    11,233,572



    8,923,374



    10,734,580



    8,921,383



















    Net loss per share available to common stockholders, basic and diluted



    $             (0.49)



    $             (0.47)



    $             (1.25)



    $             (1.20)



















    *Includes stock based-compensation as follows

















    Research and development



    $                172



    $                130



    $                332



    $                275

    General and administrative



    381



    393



    788



    725





    $                553



    $                523



    $             1,120



    $             1,000



















    Contact:

    Investor Relations

    Dave Gentry, CEO

    RedChip Companies

    Dave@redchip.com

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

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/aridis-pharmaceuticals-announces-second-quarter-2021-results-301354302.html

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  2. LOS GATOS, Calif., Aug. 2, 2021 /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, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the purchase and sale of 4,947,556 shares of the Company's common stock (or common stock equivalents) and warrants to purchase up to an aggregate of 2,473,778 shares of the Company's common stock, at an effective purchase price of $5.053 per share of common stock (or common stock equivalent) and associated warrant, in a registered direct offering priced at-the-market under Nasdaq rules. The…

    LOS GATOS, Calif., Aug. 2, 2021 /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, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the purchase and sale of 4,947,556 shares of the Company's common stock (or common stock equivalents) and warrants to purchase up to an aggregate of 2,473,778 shares of the Company's common stock, at an effective purchase price of $5.053 per share of common stock (or common stock equivalent) and associated warrant, in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about August 4, 2021, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The warrants have an exercise price of $5.00 per share, are exercisable immediately and have a term of seven years.

    The gross proceeds to the Company from this offering are expected to be approximately $25 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for clinical development, working capital and general corporate purposes.  

    The securities described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-233601) previously filed with the Securities and Exchange Commission (the "SEC") on September 3, 2019, and declared effective by the SEC on September 5, 2019. The offering of the securities is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at placements@hcwco.com.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 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 ʎPEXTM 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 monoclonal antibody (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 technically 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 hospital acquired pneumonia (HAP), in addition to 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 IgG1 mAb targeting gram-positive Staphylococcus aureus (S. aureus) alpha-toxin and is being evaluated in a global Phase 3 clinical study as an adjunctive treatment of S. aureus ventilator associated pneumonia (VAP) currently.

    AR-320 (VAP). AR-320 is a fully human IgG1 mAb targeting S. aureus alpha-toxin that is being developed as a pre-emptive treatment of S. aureus colonized mechanically ventilated patients who do not yet have VAP. Phase 3 is expected to be initiated in 4Q21.

    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 Phase 2a clinical development in CF patients.

    AR-712 (COVID-19). AR-712 is a cocktail of fully human mAbs (AR-711 and AR-713) that are directed against the receptor binding domain of the SARS-CoV-2 virus. It is formulated for delivery via inhalation using a nebulizer.

    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 mAbs discovered from convalescent COVID-19 patients that are directed at multiple surface proteins of the SARS-CoV-2 virus.

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

    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, including, without limitation, statements regarding the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering. 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, market and other conditions, the need for additional financing, 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, 2020 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, except as required by law.

    Contact: 

    Investor Relations 

    Dave Gentry

    Redchip 

    Dave@redchip.com 

    1-800-733-2447

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

     

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  3. LOS GATOS, Calif., July 26, 2021 /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 that animal efficacy data reported by the Coronavirus Immunotherapeutics Consortium (CoVIC) showed that the Company's COVID-19 monoclonal antibody (mAb) AR-711, one of two mAbs in the AR-712 cocktail, ranks among the top 5 most potent mAbs that the CoVIC consortium have studied to date.

    Among a panel of more than 350 therapeutic antibodies identified by different discovery efforts that were submitted for side-by-side analyses by CoVIC, AR-711 had neutralization potency that ranked among the top 10…

    LOS GATOS, Calif., July 26, 2021 /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 that animal efficacy data reported by the Coronavirus Immunotherapeutics Consortium (CoVIC) showed that the Company's COVID-19 monoclonal antibody (mAb) AR-711, one of two mAbs in the AR-712 cocktail, ranks among the top 5 most potent mAbs that the CoVIC consortium have studied to date.

    Among a panel of more than 350 therapeutic antibodies identified by different discovery efforts that were submitted for side-by-side analyses by CoVIC, AR-711 had neutralization potency that ranked among the top 10% of the panel (single-digit ng/mL IC50 values in three different neutralization assays). Based on this potency, AR-711 was prioritized for animal efficacy testing by CoVIC. Of the ~75 antibodies tested to date in a mouse model of SARS-CoV-2 infection, the AR-711 mAb was among the top 5 most potent mAbs and effectively protected infected animals at the lowest parenteral dose tested (0.5 mg/kg). The dual antibody cocktail of AR-711 and AR-720 will be delivered as an inhaled treatment, effective against the Delta and Delta Plus variants, and is expected to provide broad coverage of all known high-risk variants.

    About AR-712

    AR-712 is being developed as a self-administered, at-home inhaled treatment for COVID-19 patients who are not yet hospitalized. The product candidate is designed to substantially lower the barrier to treatment of COVID-19 patients and encourage treatment much earlier in the course of their disease within the patients' own homes.

    AR-712 is a cocktail of two fully human immunoglobulin G1 (IgG1) mAbs discovered from screening the antibody secreting B-cells of convalescent SARS-CoV-2 virus infected (COVID-19) patients. These mAbs target the SARS-CoV-2 virus' receptor-binding domain (RBD) region of the spike protein at distinct, unique molecular binding sites. The binding of SARS-COV2 spike protein RBD by AR-712 mAbs lead to effective neutralization of the live SARS-COV2 viruses in all cases tested.  The AR-712 mAbs are also engineered to be active for 6-12 months in the blood and formulated for effective delivery from commercially available nebulizers. Due to its direct delivery to the lungs by inhaled administration, AR-711 and AR-720 may facilitate more rapid, broader treatment coverage, and at a substantially lower dose (>100-fold lower) as compared to parenteral administration. AR-711 was previously shown to be effective in prophylactic as well as therapeutic treatment modes in a SARS-CoV-2 viral challenge pre-clinical study. AR-720 extends the binding of SARS-CoV-2 strains to include the Delta, Delta Plus, Lambda, all others that are listed in the Variant of Interest and Variant of Concern by the U.S. Center for Disease Control (CDC). Recent data from the Texas Biomedical Research Institute showed that AR-720 is highly protective against infections by the original SARS-CoV2 WA-1 strain as well as the B.1.351 (South Africa) variant in animal challenge studies.

    About the CoVIC Consortium

    CoVIC is a global partnership created to accelerate discovery, optimization, and delivery of antibody-based therapeutics against SARS-CoV-2 [see https://covic.lji.org/about/]. It is an academic-industry and non-profit research collaboration that brings together scientists from around the world to study and assess which antibodies are most effective against the coronavirus SARS-CoV-2, and to streamline and accelerate the research pipeline for antibody-based therapeutics needed against SARS-CoV-2. The funders of CoVIC include the Bill & Melinda Gates Foundation, the Wellcome Trust, NIAID (NIH), and MasterCard.

    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 ʎPEXTM 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 monoclonal antibody (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 technically 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 hospital acquired pneumonia (HAP), in addition to 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 IgG1 mAb targeting gram-positive Staphylococcus aureus (S. aureus) alpha-toxin and is being evaluated in a global Phase 3 clinical study as an adjunctive treatment of S. aureus ventilator associated pneumonia (VAP) currently.

    AR-320 (VAP). AR-320 is a fully human IgG1 mAb targeting S. aureus alpha-toxin that is being developed as a pre-emptive treatment of S. aureus colonized mechanically ventilated patients who do not yet have VAP. Phase 3 is expected to be initiated in 4Q21.

    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 Phase 2a clinical development in CF patients.

    AR-712 (COVID-19). AR-712 is a cocktail of fully human mAbs (AR-711 and AR-713) that are directed against the receptor binding domain of the SARS-CoV-2 virus. It is formulated for delivery via inhalation using a nebulizer.

    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 mAbs discovered from convalescent COVID-19 patients that are directed at multiple surface proteins of the SARS-CoV-2 virus.

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

    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 need for additional financing, 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

    Dave Gentry

    Redchip

    Dave@redchip.com

    1-800-733-2447 

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

     

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    SOURCE Aridis Pharmaceuticals, Inc.

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  4. LOS GATOS, Calif., July 19, 2021 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS) today announced that it has entered into an exclusive, worldwide licensing agreement with AstraZeneca (NASDAQ:AZN) to in-license the late stage monoclonal antibody candidate, suvratoxumab.  

    The highlights of the agreement are:

    • Phase 3-ready candidate. Suvratoxumab monoclonal antibody (mAb) for prevention of pneumonia has been licensed from AstraZeneca. Suvratoxumab extends Aridis' pneumonia franchise by complementing the existing AR-301 Phase 3 pneumonia treatment program.
    • Lancet ID publication. Phase 2 data involving n=196 patients recently published in The Lancet Infectious Diseases journal showed safety and a statistically significant (47%) relative…

    LOS GATOS, Calif., July 19, 2021 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS) today announced that it has entered into an exclusive, worldwide licensing agreement with AstraZeneca (NASDAQ:AZN) to in-license the late stage monoclonal antibody candidate, suvratoxumab.  

    The highlights of the agreement are:

    • Phase 3-ready candidate. Suvratoxumab monoclonal antibody (mAb) for prevention of pneumonia has been licensed from AstraZeneca. Suvratoxumab extends Aridis' pneumonia franchise by complementing the existing AR-301 Phase 3 pneumonia treatment program.
    • Lancet ID publication. Phase 2 data involving n=196 patients recently published in The Lancet Infectious Diseases journal showed safety and a statistically significant (47%) relative reduction of pneumonia in S. aureus colonized, mechanically ventilated patients less than 65 years old, with corresponding reduction in the number of days needed in the ICU and hospital.i
    • Up to €25 million Euros funding (approximately $30 million).  EU Commission's Innovative Medicines Initiatives (IMI) funding for suvratoxumab Phase 3 clinical trial
    • AstraZeneca's equity stake in Aridis. AstraZeneca becomes a shareholder of Aridis through the issuance of common stock and has right of first negotiation for future licensing of suvratoxumab.

    Monoclonal

    Antibody

    Targeting

    Disease

    Development

    Status

    Next

    Milestone

    suvratoxumab or

    'AR-320'

    Staphylococcus

    aureus
    alpha

    toxin

    S. aureus colonized

    patients at high risk

    of developing

    pneumonia

    Phase 2

    completed

    Phase 3

    launch

    4Q-2021

     

    Deal Highlights

    • Aridis acquires global exclusive rights for development and commercialization of

      suvratoxumab for all indications
    • AstraZeneca retains rights of first negotiation for future licensing
    • Aridis will make an upfront payment to AstraZeneca of $11m in cash and Aridis common

      stock. AstraZeneca will also receive up to a further $115m on achievement of certain

      development and sales-related milestones, in addition to tiered royalties on net sales
    • Up to €25 million Euros (approximately $30m) from EU Commission's Innovative Medicines

      Initiative (IMI) COMBACTE clinical trial consortium for the Phase 3 trial for suvratoxumab

    Development Overview: Suvratoxumab Phase 3 Clinical Study

    Suvratoxumab and AR-301 are complementary products. Suvratoxumab's focus on preventive treatment of S. aureus pneumonia complements Aridis' AR-301 Phase 3 mAb program which is being developed as a therapeutic treatment of S. aureus pneumonia.

    A multinational, randomized, double blinded, placebo controlled Phase 2 study (n=196 patients) showed that mechanically ventilated ICU patients colonized with S. aureus who are treated with suvratoxumab saw a relative risk reduction of pneumonia by 32% in the overall intend to treat (ITT) study population, and by 47% in the under 65 year old population, which is the target population in the planned Phase 3 study. The relative risk reduction in the target population reached statistical significance, and was also associated with a substantial reduction in the duration of care needed in the ICU and hospital.i [see https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30995-6/fulltext]

    Aridis believes that suvratoxumab (product code name 'AR-320') will be first-line treatment, first to market, first-in-class pre-emptive treatment of S. aureus colonized patients. The same first-line, first to market and first-in-class strategy applies to the acute treatment with the monoclonal antibody AR-301 which the Company believes makes Aridis a globally dominant leader in this space.

    Aridis comments

    "We are pleased to have been selected as AstraZeneca's licensee. The strong data from the Phase 2 trial gives us an advantage to define the patient population, primary endpoint, and the Phase 3 clinical study design to support a clear path to the Phase 3 confirmatory trial," said Vu Truong, Ph.D., Aridis' Chief Executive Officer.

    "We intend to efficiently leverage our collaboration with the globally renowned HAP/VAP experts in the EU Commission's Innovative Medicines Initiative (IMI) COMBACTE consortium and our global network of existing clinical sites to launch the Phase 3 study for AR-320 in the 4th quarter this year," said Hasan Jafri, M.D., Aridis' Chief Medical Officer. "We are delighted that this Phase 3-ready candidate is supported by IMI through the COMBACTE consortium and are excited to demonstrate the potential for suvratoxumab to fulfill an unmet medical need in a highly vulnerable and high-risk population, while also offering substantial pharmacoeconomic benefits," said Dr. Jafri.

    AstraZeneca comments

    Mark Esser, Vice President, Microbial Sciences, BioPharmaceuticals R&D, AstraZeneca said: "Suvratoxumab has the potential to transform pulmonary infection management in ventilated patients. We are pleased to complete this licensing deal with Aridis who we believe are well placed to take suvratoxumab forward."

    IMI's COMBACTE consortium comments

    "On behalf of IMI's COMBACTE consortium, I would like to express our continued support and strong enthusiasm for suvratoxumab," said Dr. Marc JM Bonten, MD/PhD, Managing Entity and Scientific and Academic coordinator of COMBACTE (University Medical Center, Utrecht). "We plan to leverage the consortium's vast network of clinical sites and principal investigators across Europe to facilitate the execution of this important Phase 3 study to its timely completion," said Dr. Bonten.

    Dr. Bruno Francois, a world renowned VAP expert and the Academic COMBACTE Lead for the Phase 3 study (University Hospital of Limoges) further added, "After the very promising SAATELLITE phase 2 trial, starting this phase 3 is very exciting as it could bring a new class of molecules to treat severe bacterial infections, to patients. The COVID pandemic has highlighted the importance of having therapeutic options to address emerging infectious threats and antimicrobial resistance (AMR) remains a serious threat. In this context, the AR-320 study is very timely. Lastly, the public-private partnership approach which made the phase 2 study successful, will undoubtedly be one of the major strengths of the coming phase 3 study."

    About suvratoxumab ('AR-320')

    Suvratoxumab (also referred to as MEDI4893) is a fully human, half-life extended IgG1 monoclonal antibody targeting S. aureus alpha toxin. Alpha-toxin is a key virulence factor that is secreted by both methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA). It is believed that AR-320 protects against alpha-toxin mediated destruction of host cells, preserving the human immune cells. AR-320's mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA and MSSA.

    About IMI's COMBACTE Consortium

    The European Commission's Innovative Medicines Initiative (IMI) is the world's biggest public-private partnership in the life sciences, whose goal is to develop next generation vaccines, medicines and treatments, such as new antibiotics [see https://www.imi.europa.eu/]. The IMI-funded COMBACTE project aims to give antibiotic drug development a much-needed boost by pioneering new ways of designing and implementing efficient clinical trials for novel antibiotics. COMBACTE forms part of the New Drugs for Bad Bugs (ND4BB) initiative, IMI's wider program to tackle AMR. The COMBACTE consortium comprises a large network of over 1,000 hospitals in Europe that are potential clinical sites for clinical trial conduction [see https://www.imi.europa.eu/projects-results/project-factsheets/combacte-net]

    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 monoclonal antibodies (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 technically do not require genetic engineering or further optimization to achieve full functionality.

    The Company has generated multiple clinical stage mAbs targeting bacteria and respiratory viruses that cause life-threatening infections such as pneumonia, bacteremia, and COVID-19. 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 IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus (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 Pseudomonas aeruginosa (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 Phase 2a clinical development in 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 mAbs discovered from convalescent COVID-19 patients that are directed at multiple envelope proteins of the SARS-CoV-2 virus.

    AR-712 (COVID-19). AR-712 is a cocktail of fully human mAbs (AR-711 and AR-720) that are directed against the receptor binding domain of the SARS-CoV-2 virus. It is formulated for delivery via inhalation using a nebulizer.

    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 need for additional financing, 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

    Dave Gentry

    Redchip

    Dave@redchip.com

    1-800-733-2447

    i François B, Jafri HS, Chastre J et al. Efficacy and safety of suvratoxumab for prevention of Staphylococcus aureus ventilator-associated pneumonia (SAATELLITE): a multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2 pilot trial. Lancet Infectious Diseases. 2021. https://doi.org/10.1016/S1473-3099(20)30995-6

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

     

     

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    SOURCE Aridis Pharmaceuticals, Inc.

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  5. LOS GATOS, Calif., July 12, 2021 /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 that its COVID-19 mAb cocktail AR-712 binds and neutralizes the Delta variant virus SARS-CoV-2 at a highly effective level (~20ng/mL). Binding analyses project that AR-712 will be effective against all variants on the U.S. Centers for Disease Control's Variants of Interest and Variants of Concern lists.      

    The dual antibody cocktail will be delivered as an inhaled treatment and is expected to provide broad coverage of all known high-risk variants. In addition, Aridis is pleased to announce the…

    LOS GATOS, Calif., July 12, 2021 /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 that its COVID-19 mAb cocktail AR-712 binds and neutralizes the Delta variant virus SARS-CoV-2 at a highly effective level (~20ng/mL). Binding analyses project that AR-712 will be effective against all variants on the U.S. Centers for Disease Control's Variants of Interest and Variants of Concern lists.      

    The dual antibody cocktail will be delivered as an inhaled treatment and is expected to provide broad coverage of all known high-risk variants. In addition, Aridis is pleased to announce the preclinical development services support from NIAID (NIH) provided further demonstration of strong therapeutic efficacy of inhaled delivery in a SARS-CoV-2 hamster challenge model. This achieved reversal of disease in infected animals at an inhaled dose of 1mg/kg, equivalent to a 10mg dose in humans from a nebulizer. These results confirmed the Company's efficacy studies showing highly efficient dosing by inhalation. For reference purposes, the dose of commercially available COVID antibody therapies is currently in the range of 500mg to 1,200mg.   

    AR-712 is being developed as a self-administered, at-home inhaled treatment for COVID-19 patients who are not yet hospitalized. The product candidate is designed to substantially lower the barrier to treatment of COVID-19 patients and encourage treatment much earlier in the course of their disease within the patients' own homes.

    The Company remains on track to finalize the Phase 1/2/3 design for this program and initiate the clinical study in 2H 2021.

    About AR-712

    AR-712 is a cocktail of two fully human immunoglobulin G1 (IgG1) mAbs discovered from screening the antibody secreting B-cells of convalescent SARS-CoV-2 virus infected (COVID-19) patients. These mAbs target the SARS-CoV-2 virus' receptor-binding domain (RBD) region of the spike protein at distinct, unique molecular binding sites. The binding of SARS-CoV-2 spike protein RBD by AR-712 mAbs lead to effective neutralization of the live SARS-CoV-2 viruses in all cases tested.  AR-712 comprises of AR-711 and AR-720 mAbs. AR-720 mAb is higher in potency than AR-713 and thus has replaced it in the cocktail. The AR-712 mAbs are also engineered to be active for 6-12 months in the blood and formulated for effective delivery from commercially available nebulizers. Due to its direct delivery to the lungs by inhaled administration, AR-711 and AR-720 may facilitate more rapid, broader treatment coverage, and at a substantially lower dose (>100-fold lower) as compared to parenteral administration. AR-711 was previously shown to be effective in prophylactic as well as therapeutic treatment modes in a SARS-CoV-2 viral challenge pre-clinical study. AR-720 extends the binding of SARS-CoV-2 strains to include all that are listed in the Variant of Interest and Variant of Concern by the U.S. Centers for Disease Control (CDC). Both AR-711 and AR-720 were originally discovered through a collaboration with the University of Alabama (Birmingham) and the Texas Biomedical Research Institute.

    About NIAID and CoVIC Consortium

    NIAID (National Institute of Allergy and Infectious Diseases) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services. CoVIC is a global partnership created to accelerate discovery, optimization, and delivery of antibody-based therapeutics against SARS-CoV-2. It is an academic-industry and non-profit research collaboration that brings together scientists from around the world to study and assess which antibodies are most effective against the coronavirus SARS-CoV-2, and to streamline and accelerate the research pipeline for antibody-based therapeutics needed against SARS-CoV-2. The funders of CoVIC include the Bill & Melinda Gates Foundation, the Wellcome Trust, NIAID, and MasterCard. The company's receiving of the preclinical services support from NIAID and CoVIC should not be construed as endorsements of the company's products.

    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 ʎPEXTM 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 monoclonal antibody (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 technically 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 hospital acquired pneumonia (HAP), in addition to 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 IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus (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 Pseudomonas aeruginosa (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 Phase 2a clinical development in 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 mAbs discovered from convalescent COVID-19 patients that are directed at multiple surface proteins of the SARS-CoV-2 virus.

    AR-712 (COVID-19). AR-712 is a cocktail of fully human mAbs (AR-711 and AR-713) that are directed against the receptor binding domain of the SARS-CoV-2 virus. It is formulated for delivery via inhalation using a nebulizer.

    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 need for additional financing, 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, 2020 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

    jwong@bplifescience.com

    (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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