ARPO Aerpio Pharmaceuticals Inc.

1.6
-0.23  -13%
Previous Close 1.83
Open 1.79
52 Week Low 0.42
52 Week High 1.9
Market Cap $64,940,806
Shares 40,588,004
Float 39,811,486
Enterprise Value $32,241,171
Volume 3,952,212
Av. Daily Volume 2,139,727
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Upcoming Catalysts

Drug Stage Catalyst Date
Razuprotafib (AKB-9778)
Open-angle glaucoma (OAG)
Phase 2
Phase 2
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Razuprotafib
Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
AKB-4924 (GB004) - SHIFT-UC
Ulcerative Colitis
Phase 2
Phase 2
Phase 2 trial to commence 2H 2020.
AKB-9778 - TIME 2B
Non-Proliferative Diabetic Retinopathy
Phase 2
Phase 2
Phase 2 data released March 18, 2019 did not meet primary endpoint.

Latest News

    • Initiated a Phase 2 Open Angle Glaucoma Trial; Recruiting Ahead of Schedule
    • Announced Partnership with I-SPY to Participate in a Clinical Trial to Treat ARDS in COVID-19 Patients
    • Announced a Second Clinical Trial Funded in Part by the U.S. Military to Prevent ARDS in COVID-19 Patients
    • Ended Second Quarter 2020 with $44.9 Million in Cash

    Conference Call Today, August 12, 2020 at 8:30 a.m. EDT

    CINCINNATI, Aug. 12, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc. ("Aerpio") (NASDAQ:ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, as well as other indications in which the Company believes that activation of Tie2 may have therapeutic potential…

    • Initiated a Phase 2 Open Angle Glaucoma Trial; Recruiting Ahead of Schedule
    • Announced Partnership with I-SPY to Participate in a Clinical Trial to Treat ARDS in COVID-19 Patients
    • Announced a Second Clinical Trial Funded in Part by the U.S. Military to Prevent ARDS in COVID-19 Patients
    • Ended Second Quarter 2020 with $44.9 Million in Cash

    Conference Call Today, August 12, 2020 at 8:30 a.m. EDT

    CINCINNATI, Aug. 12, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc. ("Aerpio") (NASDAQ:ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, as well as other indications in which the Company believes that activation of Tie2 may have therapeutic potential, including acute respiratory distress syndrome ("ARDS") associated with COVID-19 infections, today reported financial results for the second quarter ended June 30, 2020 and provided a business update.

    Recent Company Highlights

    • In June 2020, we initiated a Phase 2 clinical trial designed to assess the therapeutic potential of the Company's lead candidate, razuprotafib (AKB-9778) in the form of topical ocular drops, for patients with Open Angle Glaucoma (OAG) and ocular hypertension (OH).  Patients are being dosed for 28 days after a one month "wash-out" period from their current treatments with the goal to enroll 195 patients. To date, 189 patients have been screened with over 170 enrolled (either in "wash out" or being dosed).  Based on current projections, the study may be fully enrolled by mid-October with top-line data available by the end of the year.
    • In May 2020, we were selected by Quantum Leap Healthcare Collaborative to participate in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with biomarker Integration and Adaptive Learning) to evaluate razuprotafib for the treatment of  COVID-19-related ARDS in adult patients with critical COVID-19. The I-SPY trial is a "platform study" currently planned to evaluate four drug candidates.  The goal of the study is to identify agents with the potential to result in substantial improvements to the clinical condition of participants with critical COVID-19.  Patients to be included in the study will be critical COVID-19 patients who are already intubated or receiving high flow oxygen. For more details about this trial, please click here.
    • On August 4, 2020, we announced funding of up to $5.1 million from MTEC (Medical Technology Enterprise Consortium) to initiate a second clinical trial with razuprotafib, which is designed to assess its potential to prevent the ARDS in patients with moderate-to-severe COVID-19 infections.  The MTEC trial is a stand-alone study managed by Aerpio that will evaluate earlier stage patients (moderate-to-severe COVID-19) prior to initiating high flow oxygen or intubation.  Endpoints will include proportion of subjects alive and respiratory failure-free at Day 28; length of hospitalization from baseline to Day 7; and baseline to Day 28, or death. Trial start up activities are progressing rapidly.
    • In May 2020, we received a one-time payment of $15.0 million pursuant to an amendment to our license agreement with Gossamer Bio for GB004 resulting in a reduction in future potential milestone payments and tiered royalty rates over the life of the agreement.  

    "Our Phase 2 glaucoma study is recruiting ahead of schedule and remains on track to report top-line results in the fourth quarter of 2020," said Joseph Gardner, President and Founder. "We are encouraged by the progress made by the I-SPY network and the Aerpio team in starting up clinical trial sites in areas with a growing number of COVID-19 cases and we expect patient enrollment in both the ARDS treatment and prevention trials to begin imminently."

    Second Quarter 2020 Financial Highlights

    As of June 30, 2020, cash and cash equivalents totaled $44.9 million, compared to $38.5 million as of December 31, 2019. Shares outstanding as of June 30, 2020 totaled approximately 40.6 million.

    Revenue of $15.0 million for the three months ended June 30, 2020 was related to a one-time payment in connection with the amendment to our license agreement for GB004 (formerly AKB-4924) with Gossamer Bio. 

    For the three months ended June 30, 2020, operating expenses totaled $5.7 million, a decrease of 4.0% compared to $6.0 million for the same period in 2019.

    Research and development expenses for the three months ended June 30, 2020, increased approximately $1.3 million, or 56.7%, to $3.6 million from $2.3 million in the three months ended June 30, 2019. This increase was primarily the result of increased expenses associated with our clinical programs. 

    General and administrative expenses for the three months ended June 30, 2020, decreased approximately $0.6 million, or 21.6%, to $2.2 million from $2.8 million, in the three months ended June 30, 2019. This decrease was primarily attributable to lower personnel related expenses and stock-based compensation expenses.

    Net income attributable to common stockholders for the three months ended June 30, 2020, was $9.3 million, or $0.23 per share, compared to a net loss attributable to common stockholders of $5.7 million, or ($0.14) per share, for the three months ended June 30, 2019.

    Conference Call and Webcast

    Aerpio management will host a live conference call at 8:30 a.m. EDT today to discuss Aerpio's financial results and provide a general business update. Please call (877) 407-9716 (U.S.) or (201) 493-6779 (international) to listen to the live conference call. The conference ID number for the live call is 13707708. Please dial in approximately 10 minutes prior to the call.

    A live audio webcast will be accessible here

    To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the start time. An archived version of the audio webcast will be available for replay on the Company's Archived Events page here

    About Aerpio Pharmaceuticals

    Aerpio Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, as well as other indications in which the Company believes that activation of Tie2 may have therapeutic potential, including acute respiratory distress syndrome ("ARDS") associated with COVID-19 infections. Recently published mouse and human genetic data implicate the Angpt/Tie2 pathway in maintenance of Schlemm's canal, a critical component of the conventional outflow tract. The Company's lead compound, razuprotafib (formerly AKB-9778), a first-in-class small molecule inhibitor of vascular endothelial protein tyrosine phosphatase ("VE-PTP"), is being developed as a potential treatment for open angle glaucoma, and the Company intends to investigate the therapeutic potential of razuprotafib in other indications.. The Company is also evaluating development options for ARP-1536, a humanized monoclonal antibody, for its therapeutic potential in the treatment of diabetic vascular complications including nephropathy and diabetic macular edema ("DME"). The Company's third asset is a bispecific antibody that binds both VEGF and VE-PTP which is designed to inhibit VEGF activation and activate Tie2. This bispecific antibody has the potential to be an improved treatment for wet age-related macular degeneration and DME via intravitreal injection. Finally, the Company has exclusively out-licensed AKB-4924 (now called GB004), a first-in-class small molecule inhibitor of hypoxia-inducible factor-1 (HIF). GB004 is being developed by AKB-4924's exclusive licensor, Gossamer Bio, Inc. (NASDAQ:GOSS). For more information, please visit www.aerpio.com.

    About Razuprotafib (formerly known as AKB-9778)

    Razuprotafib binds to and inhibits vascular endothelial protein tyrosine phosphatase (VE-PTP), an important negative regulator of Tie2. Decreased Tie2 activity contributes to vascular instability in many diseases including diabetes and more recently has been shown to contribute to the development of increased IOP and glaucoma. Razuprotafib activates the Tie2 receptor irrespective of extracellular levels of its binding ligands, angiopoietin-1 (agonist) or angiopoietin-2 (antagonist) and may be the most efficient pharmacologic approach to maintain normal Tie2 activation. Aerpio is studying a topical ocular formulation of razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy.  In addition, a subcutaneous formulation of razuprotafib is being explored for its therapeutic potential in treating or preventing ARDS associated with COVID-19. 

    Forward Looking Statements

    This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the Company's product candidates, including razuprotafib, ARP-1536 and the bispecific antibody asset, the clinical development plan therefor and the therapeutic potential thereof, the Company's plans and expectations with respect to razuprotafib and the development therefor and therapeutic potential thereof in addressing COVID-19 and the intended benefits from the Company's collaboration with Gossamer Bio for GB004, including the continued development of GB004 and the milestone and royalty payments related to the collaboration. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, the continued development of GB004 and maintaining and deriving the intended benefits of the Company's collaboration with Gossamer Bio; ability to continue to develop razuprotafib or other product candidates, including in indications related to COVID-19; the inherent uncertainties associated with the drug development process, including uncertainties in regulatory interactions, the design of planned or future clinical trials, commencing clinical trials and enrollment of patients in clinical trials; obtaining any necessary regulatory clearances in order to commence and conduct planned or future clinical trials; the impact of the ongoing COVID-19 pandemic on the Company's business operations, including research and development efforts and the ability of the Company to commence, conduct and complete its planned clinical activities; and competition in the industry in which the Company operates and overall market conditions; and the additional factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q and our other subsequent filings with the SEC.

    These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the Company files with the SEC available at www.sec.gov.

         
    AERPIO PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (In thousands)
         
      June 30, December 31,
       2020   2019 
    Assets       
    Current assets:       
     Cash and cash equivalents$44,864  $38,525 
     Prepaid research and development contracts 307   311 
     Other current assets 264   735 
    Total current assets 45,435   39,571 
    Furniture and equipment, net 146   164 
    Operating lease right-of-use asset 115   162 
    Deposits 20   40 
    Total assets$45,716  $39,937 
             
    Liabilities and shareholders' equity       
    Current liabilities:       
     Accounts payable and accrued expenses$2,994  $3,232 
     Current portion of operating lease liability 111   103 
    Total current liabilities 3,105   3,335 
    Operating lease liability, net of current portion 10   67 
    Total liabilities 3,115   3,402 
             
    Stockholders' equity:       
     Capital 179,479   178,771 
     Accumulated deficit (136,878)  (142,236)
    Total stockholders' equity 42,601   36,535 
    Total liabilities and stockholders' equity$45,716  $39,937 
             



     AERPIO PHARMACEUTICALS, INC.
     CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
     (In thousands, except per share amounts)
                 
       Three months ended Six months ended
       June 30, June 30,
        2020  2019   2020  2019 
                    
    License revenue, and other $15,000 $  $15,000 $ 
                    
    Operating expenses:              
     Research and development  3,548  2,264   5,378  7,850 
     General and administrative  2,196  2,800   4,481  6,055 
     Restructuring expense  -  915   -  915 
     Total operating expenses  5,744  5,979   9,859  14,820 
    Income (loss) from operations  9,256  (5,979)  5,141  (14,820)
                    
    Interest and other income  20  295   216  644 
    Net and comprehensive income (loss) $9,276 $(5,684) $5,357 $(14,176)
                    
    Net income (loss) per common share basic and diluted $0.23 $(0.14) $0.13 $(0.35)
    Weighted average common shares outstanding              
     Basic  40,588  40,588   40,588  40,588 
     Diluted  40,905  40,588   40,748  40,588 
               

    Contacts

    Investor & Media:

    Aerpio Pharmaceuticals, Inc.

    Joseph Gardner

    President & Founder

     

    Gina Marek

    VP Finance

     

    Or

    Investors:

    Irina Koffler

    LifeSci Advisors

     

    Source: Aerpio Pharmaceuticals, Inc.

    Primary Logo

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  1. CINCINNATI, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc. ("Aerpio") (NASDAQ:ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases, ARDS associated with COVID-19, and diabetic complications, will release its financial results for the second quarter ended June 30, 2020, before the market open on Wednesday, August 12, 2020, and host a webcast and conference call at 8:30am ET.

    Wednesday, August 12th @ 8:30amET

    Investors:                                877-407-9716

    International Investors:           201-493-6779

    Conference ID:                       13707708

    Audio-Only Webcast:              http://public.viavid.com/index.php?id=141035 

    About Aerpio Pharmaceuticals

    Aerpio Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications. Recently published mouse and human genetic data implicate the Angpt/Tie2 pathway in maintenance of Schlemm's canal, a critical component of the conventional outflow tract. The Company's lead compound, razuprotafib (formerly AKB-9778), a first-in-class small molecule inhibitor of vascular endothelial protein tyrosine phosphatase ("VE-PTP"), is being developed as a potential treatment for open angle glaucoma, and the Company intends to investigate the therapeutic potential of razuprotafib in other indications. The Company is also evaluating development options for ARP-1536, a humanized monoclonal antibody, for its therapeutic potential in the treatment of diabetic vascular complications including nephropathy and diabetic macular edema ("DME"). The Company's third asset is a bispecific antibody that binds both VEGF and VE-PTP which is designed to inhibit VEGF activation and activate Tie2. This bispecific antibody has the potential to be an improved treatment for wet age-related macular degeneration and DME via intravitreal injection. Finally, the Company has exclusively out-licensed AKB-4924 (now called GB004), a first-in-class small molecule inhibitor of hypoxia-inducible factor-1 (HIF). GB004 is being developed by AKB-4924's exclusive licensor, Gossamer Bio, Inc. (NASDAQ:GOSS). For more information, please visit www.aerpio.com.

    Investors & Media:

    Gina Marek

    VP Finance

    Or

    Investors:

    Irina Koffler

    LifeSci Advisors

    Primary Logo

    View Full Article Hide Full Article
  2. CINCINNATI, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc. ("Aerpio") (NASDAQ:ARPO) and The U.S. Government operating through the Medical Technology Enterprise Consortium (MTEC) announced today that an agreement has been reached to evaluate razuprotafib in a new randomized, investigational trial for the prevention and treatment of Acute Respiratory Distress Syndrome (ARDS) in adult patients with moderate to severe COVID-19 as part of MTEC-20-09-COVID-19 Treatment Military Infectious Disease Research Program (MIDRP) "Development of Treatments for COVID-19."  MTEC will provide up to $5.1 million in funding toward the clinical trial.  Aerpio will support the trial with "in kind" spending in the amount of $2.8 million. MTEC is…

    CINCINNATI, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc. ("Aerpio") (NASDAQ:ARPO) and The U.S. Government operating through the Medical Technology Enterprise Consortium (MTEC) announced today that an agreement has been reached to evaluate razuprotafib in a new randomized, investigational trial for the prevention and treatment of Acute Respiratory Distress Syndrome (ARDS) in adult patients with moderate to severe COVID-19 as part of MTEC-20-09-COVID-19 Treatment Military Infectious Disease Research Program (MIDRP) "Development of Treatments for COVID-19."  MTEC will provide up to $5.1 million in funding toward the clinical trial.  Aerpio will support the trial with "in kind" spending in the amount of $2.8 million. MTEC is a 501(c)3 non-profit organization constructed by the U.S. Army Medical Research and Development Command (USAMRDC). The Medical Technology Enterprise Consortium (MTEC) was established as an enterprise partnership including industry and academia to facilitate research and development activities. Protecting U.S. forces from COVID-19 is a key priority for the U.S. military. The partnership between Aerpio and MTEC will provide resources to support a second COVID-19 Phase 2 clinical trial with razuprotafib, a drug candidate being investigated for its potential to prevent and treat the severe respiratory distress observed in COVID-19 patients.

    Aerpio Pharmaceuticals is developing a potent and selective small molecule inhibitor of vascular endothelial protein tyrosine phosphatase (VE-PTP), razuprotafib (AKB-9778), that restores Tie2 pathway activation in endothelial cells to stabilize blood vessels during vascular injury and inflammation. Emerging data indicate that SARS-Cov2, the virus that causes COVID-19, may attack vascular endothelium and destabilize blood vessels in multiple organs including the lung, kidneys and heart leading to substantial morbidity and mortality. Based on these findings, Aerpio and a distinguished team of clinical investigators have developed a plan to investigate the therapeutic potential of subcutaneous razuprotafib for the prevention and treatment of ARDS in patients with moderate to severe COVID-19. 

    Wesley H. Self, MD, MPH Associate Professor and Vice Chair for Research in the Department of Emergency Medicine at Vanderbilt University Medical Center and Aerpio COVID-19 Steering Committee stated, "A Tie2 activator that can be administered without an IV to stabilize the pulmonary vasculature would be a breakthrough for reducing the devastating effects of COVID‐19 associated pulmonary pathology. This therapeutic could result in fewer COVID-19 patients requiring mechanical ventilation, earlier recovery with decreased time in the hospital and ICU and an overall reduction in morbidity and mortality".

    Jeff Sabados MPP MBA, member of Aerpio's COVID-19 Steering Committee, who served for 20 years in both Active and Reserve Duty in the U.S. Navy, commented, "The subcutaneous administration of razuprotafib to activate Tie2 makes this particularly attractive to active duty military personnel around the globe because razuprotafib has the potential to save lives in the next pandemic and return soldiers back to the front lines.  I am very proud to be a part of this effort."

    About the MTEC Trial

    We hypothesize that razuprotafib, a first-in-class Tie2 activating compound, will exhibit an acceptable safety profile and show efficacy for treatment of ARDS in patients with moderate to severe COVID-19 and be a life-saving therapeutic for service members in the field suffering from the devasting respiratory and vascular effects of COVID-19.  Aerpio, through the support of MTEC will conduct a Phase 2 clinical trial of subcutaneous razuprotafib for the treatment of patients with moderate to severe COVID-19The Phase 2 trial will be conducted at approximately 10 clinical sites and is expected to be completed in the first quarter of 2021.

    About MTEC

    The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation.

    About Razuprotafib (previously AKB-9778)

    Razuprotafib binds to and inhibits vascular endothelial protein tyrosine phosphatase (VE-PTP), an important negative regulator of Tie2. Decreased Tie2 activity contributes to vascular instability in many diseases including diabetes. Razuprotafib activates the Tie2 receptor irrespective of extracellular levels of its binding ligands, angiopoietin-1 (agonist) or angiopoietin-2 (antagonist) and may be the most efficient pharmacologic approach to maintain normal Tie2 activation.  As seen preclinically, activation of Tie2 by razuprotafib stabilizes vasculature which may have beneficial effects in a variety of disease states, including COVID-19.

    About Aerpio Pharmaceuticals

    Aerpio Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications. Recently published mouse and human genetic data implicate the Angpt/Tie2 pathway in maintenance of Schlemm's canal, a critical component of the conventional outflow tract. The Company's lead compound, razuprotafib (formerly AKB-9778), a first-in-class small molecule inhibitor of vascular endothelial protein tyrosine phosphatase ("VE-PTP"), is being developed as a potential treatment for open angle glaucoma, and the Company intends to investigate the therapeutic potential of razuprotafib in other indications. The Company is also evaluating development options for ARP-1536, a humanized monoclonal antibody, for its therapeutic potential in the treatment of diabetic vascular complications including nephropathy and diabetic macular edema ("DME"). The Company's third asset is a bispecific antibody that binds both VEGF and VE-PTP which is designed to inhibit VEGF activation and activate Tie2. This bispecific antibody has the potential to be an improved treatment for wet age-related macular degeneration and DME via intravitreal injection. Finally, the Company has exclusively out-licensed AKB-4924 (now called GB004), a first-in-class small molecule inhibitor of hypoxia-inducible factor-1 (HIF). GB004 is being developed by AKB-4924's exclusive licensor, Gossamer Bio, Inc. (NASDAQ:GOSS). For more information, please visit www.aerpio.com.

    Forward Looking Statements

    This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the Company's product candidates, including razuprotafib, ARP-1536 and the bispecific antibody asset, the clinical development plan therefor and the therapeutic potential thereof, the Company's plans and expectations with respect to razuprotafib and the development therefor and therapeutic potential thereof in addressing COVID-19 and the intended benefits from the Company's collaboration with Gossamer Bio for GB004, including the continued development of GB004 and the milestone and royalty payments related to the collaboration. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, the continued development of GB004 and maintaining and deriving the intended benefits of the Company's collaboration with Gossamer Bio; ability to continue to develop razuprotafib or other product candidates, including in indications related to COVID-19; the inherent uncertainties associated with the drug development process, including uncertainties in regulatory interactions, the design of planned or future clinical trials, commencing clinical trials and enrollment of patients in clinical trials; obtaining any necessary regulatory clearances in order to commence and conduct planned or future clinical trials; the impact of the ongoing COVID-19 pandemic on the Company's business operations, including research and development efforts and the ability of the Company to commence, conduct and complete its planned clinical activities; and competition in the industry in which the Company operates and overall market conditions; and the additional factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q and our other subsequent filings with the SEC.

    These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the Company files with the SEC available at www.sec.gov.

    Contacts for Aerpio Pharmaceuticals, Inc: 

    Investors & Media:

    Gina Marek

    VP Finance



    Or

    Investors:

    Irina Koffler

    LifeSci Advisors

    Primary Logo

    View Full Article Hide Full Article
  3. CINCINNATI, June 24, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc. ("Aerpio") (NASDAQ:ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases, ARDS associated with COVID-19, and diabetic complications, today announced that it has commenced patient enrollment in its double-blind, placebo-controlled Phase 2 trial in patients with elevated intraocular pressure (IOP) associated with open angle glaucoma (OAG) or ocular hypertension (OHT). There are now 20 clinical sites actively enrolling patients and 30 patients have been screened and enrolled.

    The study is designed to evaluate the safety and efficacy of a topical formulation of razuprotafib in approximately 195 patients followed…

    CINCINNATI, June 24, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc. ("Aerpio") (NASDAQ:ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases, ARDS associated with COVID-19, and diabetic complications, today announced that it has commenced patient enrollment in its double-blind, placebo-controlled Phase 2 trial in patients with elevated intraocular pressure (IOP) associated with open angle glaucoma (OAG) or ocular hypertension (OHT). There are now 20 clinical sites actively enrolling patients and 30 patients have been screened and enrolled.

    The study is designed to evaluate the safety and efficacy of a topical formulation of razuprotafib in approximately 195 patients followed over a 28-day period. Patients enrolled in the trial will be administered a baseline of latanoprost ophthalmic solution 0.005%, and then randomized in a 1:1:1 fashion to receive adjunctive therapy consisting of placebo, 40 mg/ml razuprotafib once-daily, or 40 mg/ml razuprotafib twice-daily. The primary endpoint of the study will be mean diurnal IOP at 28 days in the razuprotafib treated groups compared to the latanoprost monotherapy group.

    "We are extremely pleased by the enthusiasm and productivity of the ophthalmology clinics participating in this trial," said Kevin Peters, M.D., Chief Scientific Officer and Chief Medical Officer of Aerpio. "We are now likely to have topline data in Q4 2020, in spite of potential slowdowns in clinic visits associated with the COVID-19 pandemic.  We also attribute the rapid pace of patient enrollment to heightened interest from patients and healthcare providers as a result of the differentiated and novel mechanism of action of razuprotafib."  The Company will provide another update on enrollment during its second quarter earnings call in August.

    About Razuprotafib

    Razuprotafib binds to and inhibits vascular endothelial protein tyrosine phosphatase (VE-PTP), an important negative regulator of Tie2. Decreased Tie2 activity contributes to vascular instability in many diseases including diabetes and more recently has been shown to contribute to the development of increased IOP and glaucoma. Razuprotafib activates the Tie2 receptor irrespective of extracellular levels of its binding ligands, angiopoietin-1 (agonist) or angiopoietin-2 (antagonist) and may be the most efficient pharmacologic approach to maintain normal Tie2 activation. Aerpio is studying a topical ocular formulation of razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy.

    About Aerpio Pharmaceuticals

    Aerpio Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications. Recently published mouse and human genetic data implicate the Angpt/Tie2 pathway in maintenance of Schlemm's canal, a critical component of the conventional outflow tract. The Company's lead compound, razuprotafib (formerly AKB-9778), a first-in-class small molecule inhibitor of vascular endothelial protein tyrosine phosphatase ("VE-PTP"), is being developed as a potential treatment for open angle glaucoma, and the Company intends to investigate the therapeutic potential of razuprotafib in other indications. The Company is also evaluating development options for ARP-1536, a humanized monoclonal antibody, for its therapeutic potential in the treatment of diabetic vascular complications including nephropathy and diabetic macular edema ("DME"). The Company's third asset is a bispecific antibody that binds both VEGF and VE-PTP which is designed to inhibit VEGF activation and activate Tie2. This bispecific antibody has the potential to be an improved treatment for wet age-related macular degeneration and DME via intravitreal injection. Finally, the Company has exclusively out-licensed AKB-4924 (now called GB004), a first-in-class small molecule inhibitor of hypoxia-inducible factor-1 (HIF). GB004 is being developed by AKB-4924's exclusive licensor, Gossamer Bio, Inc. (NASDAQ:GOSS). For more information, please visit www.aerpio.com.

    Forward Looking Statements

    This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the Company's product candidates, including razuprotafib, ARP-1536 and the bispecific antibody asset, the clinical development plan therefor and the therapeutic potential thereof, the Company's plans and expectations with respect to razuprotafib and the development therefor and therapeutic potential thereof in addressing COVID-19 and the intended benefits from the Company's collaboration with Gossamer Bio for GB004, including the continued development of GB004 and the milestone and royalty payments related to the collaboration. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, the continued development of GB004 and maintaining and deriving the intended benefits of the Company's collaboration with Gossamer Bio; ability to continue to develop razuprotafib or other product candidates, including in indications related to COVID-19; the inherent uncertainties associated with the drug development process, including uncertainties in regulatory interactions, the design of planned or future clinical trials, commencing clinical trials and enrollment of patients in clinical trials; obtaining any necessary regulatory clearances in order to commence and conduct planned or future clinical trials; the impact of the ongoing COVID-19 pandemic on the Company's business operations, including research and development efforts and the ability of the Company to commence, conduct and complete its planned clinical activities; and competition in the industry in which the Company operates and overall market conditions; and the additional factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q and our other subsequent filings with the SEC.

    These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the Company files with the SEC available at www.sec.gov.

    Investors & Media:

    Gina Marek

    VP Finance



    Or

    Investors:

    Irina Koffler

    LifeSci Advisors

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  4. CINCINNATI, June 08, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc. (the "Company") (NASDAQ:ARPO), today announced that, due to the public health and safety concerns related to the novel coronavirus (COVID-19) pandemic and recommendations and orders from federal and state authorities, the location of its 2020 annual meeting has been changed to a virtual-only format. There is no change to the items of business to be addressed at the meeting, which are described in the original proxy materials previously distributed on or about May 8, 2020.

    The virtual annual meeting will be held on Wednesday, June 24, 2020 at 10:30 a.m., Eastern Time ("ET"), the same date and time as originally scheduled and communicated. Online access to the virtual…

    CINCINNATI, June 08, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc. (the "Company") (NASDAQ:ARPO), today announced that, due to the public health and safety concerns related to the novel coronavirus (COVID-19) pandemic and recommendations and orders from federal and state authorities, the location of its 2020 annual meeting has been changed to a virtual-only format. There is no change to the items of business to be addressed at the meeting, which are described in the original proxy materials previously distributed on or about May 8, 2020.

    The virtual annual meeting will be held on Wednesday, June 24, 2020 at 10:30 a.m., Eastern Time ("ET"), the same date and time as originally scheduled and communicated. Online access to the virtual annual meeting will begin at 10:15 a.m. ET. The virtual annual meeting will be presented in audio-only format and stockholders will not be able to attend the annual meeting in person.

    Only stockholders of record as of April 27, 2020 will be allowed to vote and ask questions during the virtual annual meeting. Guests may access the virtual annual meeting in listen-only mode by visiting the virtual meeting site provided below but will not be able to vote or submit questions during the meeting.

    Instructions to Attend the Virtual Annual Meeting. As described in the proxy materials for the annual meeting previously distributed, stockholders as of the close of business on April 27, 2020, the record date, are entitled to participate in and vote at the virtual annual meeting by accessing https://web.lumiagm.com/247499396 and selecting the button "I have a Control Number." You will then be directed to a screen where you will enter: (i) the 11-digit control number found on the proxy card, voting instruction form, notice of internet availability of proxy materials or email, as applicable, previously sent or made available to stockholders; and (ii) the meeting password "aerpio2020". Please note the meeting password is case sensitive. Once you have completed these steps, select the "login" button, which will take you to the virtual annual meeting page where you can vote, submit written questions and listen to the meeting.

    Guest Access to the Audio Webcast of the Virtual Annual Meeting. If you are a record holder and would like to enter the virtual annual meeting as a guest in listen-only mode, go to https://web.lumiagm.com/247499396 and select the button "I am a guest." Please note you will not have the ability to ask questions or vote during the meeting if you participate as a guest.

    The live audio webcast of the virtual annual meeting will begin promptly at 10:30 a.m. ET. Online access to the audio webcast will open 15 minutes prior to the start of the virtual annual meeting to allow time for you to log-in and test your device's audio system. We encourage you to access the meeting in advance of the designated start time.

    Beneficial Owners. If you were a beneficial owner as of April 27, 2020 (i.e., you hold your shares in "street name" through an intermediary, such as a bank, broker or other nominee), you must register in advance in order to attend the virtual annual meeting. To register, please obtain a legal proxy from the bank, broker or other nominee that is the record holder of your shares and then submit the legal proxy, along with your name and email address, to AST to receive an 11-digit control number that may be used to access the virtual annual meeting site provided above. While AST will continue to accept registrations up until the annual meeting, to facilitate registration for the virtual annual meeting, we ask and encourage you to send requests for registration and submission of legal proxies, labeled as "Legal Proxy," so that they are received by AST no later than 5 p.m., ET, on June 17, 2020. All such requests should be submitted (1) by email to , (2) by facsimile to (718) 765-8730, or (3) by mail to American Stock Transfer & Trust Company, LLC, Attn: Proxy Tabulation Department, 6201 15th Avenue, Brooklyn, NY 11219. Obtaining a legal proxy may take several days and shareholders are advised to register as far in advance as possible. Once you have obtained your 11-digit control number from AST, please follow the steps set forth above for "Record Holders" to attend the virtual annual meeting.

    Asking Questions. If you are attending the virtual annual meeting as a stockholder of record you can ask questions by clicking the messaging icon on the right side of the toolbar appearing at the top of the Meeting Page and then typing and submitting your question.

    Voting Prior to or at the Virtual Annual Meeting. An online portal is available to stockholders at www.proxyvote.com where you can view and download our proxy materials and 2019 annual report and vote your shares in advance of the virtual annual meeting. If you are attending the virtual annual meeting as a stockholder of record you can vote during the meeting by clicking the link "Proxy Voting Site" on the Meeting Page and following the prompts.

    Record holders and beneficial owners should call AST at (877) 773-6772 with any questions about attending the virtual annual meeting. If you encounter any difficulty accessing the virtual annual meeting, please visit https://go.lumiglobal.com/faq for assistance.

    Whether or not you plan to attend the virtual annual meeting, we urge you to vote and submit your proxy in advance of the meeting using one of the methods described in the proxy materials.

    The proxy card included with the proxy materials previously distributed (if you received a printed copy) will not be updated to reflect the change in location and may continue to be used to vote your shares in connection with the virtual annual meeting. Stockholders who have already voted do not need to vote again.

    About Aerpio Pharmaceuticals, Inc.

    Aerpio Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications. Recently published mouse and human genetic data implicate the Angpt/Tie2 pathway in maintenance of Schlemm's canal, a critical component of the conventional outflow tract. The Company's lead compound, razuprotafib (formerly AKB-9778), a first-in-class small molecule inhibitor of vascular endothelial protein tyrosine phosphatase ("VE-PTP"), is being developed as a potential treatment for open angle glaucoma, and the Company intends to investigate the therapeutic potential of razuprotafib in other indications. The Company is also evaluating development options for ARP-1536, a humanized monoclonal antibody, for its therapeutic potential in the treatment of diabetic vascular complications including nephropathy and diabetic macular edema ("DME"). The Company's third asset is a bispecific antibody that binds both VEGF and VE-PTP which is designed to inhibit VEGF activation and activate Tie2. This bispecific antibody has the potential to be an improved treatment for wet age-related macular degeneration and DME via intravitreal injection. Finally, the Company has exclusively out-licensed AKB-4924 (now called GB004), a first-in-class small molecule inhibitor of hypoxia-inducible factor-1 (HIF). GB004 is being developed by AKB-4924's exclusive licensor, Gossamer Bio, Inc. (NASDAQ:GOSS). For more information, please visit www.aerpio.com.

    Investors & Media:

    Gina Marek

    VP Finance



    Or

    Investors:

    Irina Koffler

    LifeSci Advisors

    Primary Logo

    View Full Article Hide Full Article
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