AMPE Ampio Pharmaceuticals Inc.

1.82
-0.02  -1%
Previous Close 1.84
Open 1.82
52 Week Low 0.45
52 Week High 2.98
Market Cap $356,045,013
Shares 195,629,128
Float 193,016,078
Enterprise Value $343,820,595
Volume 837,047
Av. Daily Volume 3,149,438
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Drug Pipeline

Drug Stage Notes
Ampion
COVID-19
Phase 1
Phase 1
Phase 1 trial 55% enrolled as of January 14, 2021.
Ampion
Osteoarthritis of the Knee
Phase 3
Phase 3
Phase 3 enrolment has been suspended - noted March 24, 2020.
Optina
Diabetic Macula Edema
Phase 2b
Phase 2b
Phase 2b data released May 2015 did not meet endpoints

Latest News

  1. ENGLEWOOD, Colo., April 6, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced the results of a pre-clinical study demonstrating that Ampion inhibits an important pro-inflammatory pathway in the types of immune cells implicated in COVID-19 and Lupus Nephritis.

    The aim of the investigation was to evaluate the ability of Ampion to suppress TLR7 signaling and, thereby, reduce the pro-inflammatory chemokine, CXCL10. Toll-like receptors (TLR) are one of the primary mechanisms by which innate immune cells detect and acutely respond to microbial infection. Dysregulation of these signaling pathways has been implicated in the pathology of a variety of inflammatory and autoimmune diseases.

    TLR7 normally serves to detect viral single-stranded RNA (like SARS-Cov-2), but it is also linked to cytokine storm development and acute kidney injury in sepsis and lupus. Previous in vitro laboratory investigations have demonstrated that Ampion inhibits activity of pro-inflammatory transcription factors (NF-κB and STAT) and pro-inflammatory cytokine release (such as TNFα, IL1β, IL6, and CXCL10) in a variety of immune cells.

    "Recent evidence from our laboratory demonstrates that Ampion treatment of macrophages and peripheral blood monocytes stimulated with a specific TLR7 activator significantly inhibits the release of CXCL10, the chemokine associated with the dysregulated immune response seen in COVID-19," said David Bar-Or, M.D., Director and Founder of Ampio Pharmaceuticals and a co-investigator in the study. "Ampion reduced CXCL10 up to 92 percent compared to a saline solution (p<0.05). This result also implies a role for Ampion in inhibiting the upregulated TLR7 signaling shown in the devastating kidney complication of systemic lupus erythematous, lupus nephritis, for which no specific treatment is available."

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2035 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contacts

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Katie Kennedy



    610-731-1045

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-study-shows-ampion-inhibits-a-key-inflammatory-pathway-in-covid-19-and-lupus-nephritis-301262974.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  2. ENGLEWOOD, Colo., March 29, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a clinical stage biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced the company will present its findings on a poster entitled, "Regulatory decisions during COVID-19: Efficient nonclinical inhalation toxicology for a clinical program," at the upcoming 23rd International Congress of the International Society for Aerosols in Medicine (ISAM).

    The ISAM Congress, which aspires to bring together over 400 attendees at one of the world's largest pulmonary drug delivery and respiratory health conferences, will be held in Boise, Idaho, May 22 to 26, 2021 with an agenda focused on: Medical Aerosols in the Age of COVID and other pandemics, acute and critical care, the developing world, pulmonary disease, inhaled viruses and viral transmission, health risks from environmental aerosols and emerging aerosol technologies.

    In addition to its poster presentation, number 070, the company has been invited to present at the Regulatory/Standardization issues networking group, which recently published an appeal on the urgent need to accelerate the development of inhaled therapies for COVID-19. Presentation date and time has not yet been determined.

    In addition, Ampio recently completed enrollment in its AP-014 Phase I clinical trial utilizing inhaled Ampion in treating respiratory distress in patients as a result of COVID-19. Prior to launching the trial, Ampio undertook pre-clinical research to establish the safety of its Ampion anti-inflammatory therapy in an inhaled format. Ampion, a novel biologic drug containing a blood-derived cyclized peptide and other small molecules, with the potential for treating a variety of serious and often life-threatening inflammatory conditions, had previously demonstrated its safety utilizing injection and intravenous (IV) delivery formats in other trials.

    The FDA identified a need to assess the no-observed adverse effect level (NOAEL) in animals with Ampion via inhalation as the intended route of administration. Ampio designed a study with FDA feedback to assess the potential local toxicity to the lung and other respiratory tissues at a range of inhalation doses. The company's presentation will highlight the program as an example of efficient development that is responsive to both the COVID-19 pandemic and FDA requirements.

    The 23rd ISAM Congress is being held as a hybrid event. All posters will be posted both on the website – along with a short 2-to-5-minute oral presentation – and printed for display at the Boise Conference Center. For more details on the ISAM Congress and the timing of Ampio's presentation, visit: www.isam.org

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2035 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act ("BPCIA").

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contacts

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Katie Kennedy



    610-731-1045

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-to-present-at-the-international-society-for-aerosols-in-medicine-isam-23rd-international-congress-301257174.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  3. ENGLEWOOD, Colo., March 19, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a clinical stage biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced that it has been invited to present at the Benzinga Biotech Small Cap Conference being held virtually on March 24 & 25, 2021.

    Details are as follows:

    Corporate Overview

    Title: Ampio – Business & Pipeline Update

    Date: March 24, 2021

    Time: 
    2:00-2:20pm EDT on Track 2

    Registration Link: https://www.benzinga.com/events/small-cap/biotech/

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company primarily engaged in the development of AmpionTM, our lead anti-inflammatory drug, which is currently undergoing clinical trials focused on the treatment of patients afflicted with COVID-19 induced acute respiratory distress syndrome (ARDS) as well as patients suffering from severe (KL-4) osteoarthritis of the knee (OAK).  Both conditions impact a significant percentage of the population and due to the lack of any FDA approved drugs for treatment, there exists a significant unmet medical need.  Ampion is backed by an extensive global patent portfolio with intellectual property protection extending through 2035.  In addition, Ampion will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application ("BLA"), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contacts

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Katie Kennedy



    610-731-1045

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-to-present-at-benzinga-biotech-small-cap-conference-301250887.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  4. ENGLEWOOD, Colo., March 16, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, recently revealed preliminary positive results in its AP-014 Phase I clinical trial utilizing inhaled Ampion in treating respiratory distress in patients as a result of COVID-19. The Company also outlined its progress toward initiating a Phase I clinical trial using inhaled Ampion for treating those suffering lingering respiratory effects after COVID-19 infection, the so-called COVID-19 "long haulers," as well as its continued research focusing on the use of Ampion in kidney and pediatric diseases.

    ENGLEWOOD, Colo., March 16, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, recently revealed preliminary positive results in its AP-014 Phase I clinical trial utilizing inhaled Ampion in treating respiratory distress in patients as a result of COVID-19. The Company also outlined its progress toward initiating a Phase I clinical trial using inhaled Ampion for treating those suffering lingering respiratory effects after COVID-19 infection, the so-called COVID-19 "long haulers," as well as its continued research focusing on the use of Ampion in kidney and pediatric diseases.

    "We shared these promising results with the FDA in our recent request to expand that trial. The FDA's response recommended that we forego our planned unblinded expansion of the current trial and move directly to a randomized, double-blinded, placebo-controlled Phase II study of inhaled Ampion in COVID-19," said Michael Macaluso, Chairman and Chief Executive Officer of Ampio Pharmaceuticals. "It is also important to note that the data was presented to the FDA for guidance as a potential Emergency Use Authorization (EUA) therapy."

    Preliminary results from the AP-014 Phase I trial of inhaled Ampion indicate:

    • Ampion demonstrated an improvement in all-cause mortality in COVID-19 patients compared to standard of care (SOC). A lower all-cause mortality rate of 8% is observed for the Ampion treatment group, compared to 21% in standard of care alone.
    • Patients who received Ampion required less hospitalization time. The average hospital length of stay was 7 days for the Ampion group compared to 11 days for standard of care patients.
    • Patients who received Ampion required less oxygen than standard of care alone, and 86% of Ampion patients were stable or had improvement compared to 75% of SOC patients.
    • More patients who received Ampion were stable or had improvement on a scale of clinical improvement compared to standard of care alone. By day 5, 86% of patients who received Ampion were stable or had improvement compared to 75% of standard of care patients. This trend in improvement with Ampion treatment is noted as early as day 2 and continues to day 5.
    • Adverse events were the same between Ampion and standard of care, and no drug-related serious adverse events have been reported.

    In commenting on the preliminary positive results in the AP-014 Phase I clinical trial of inhaled Ampion, Dr. David Cornutt, MD, Chairman, Department of Emergency Medicine, Regional West Health Services, and a Medical Monitor on the study, said, "The scientific findings we have reviewed thus far are fascinating and very encouraging. While we are still looking at preliminary data from a small sample size, the safety signals look strong, and I look forward to moving into the efficacy phases to come."

    Initiating trial in "long hauler" COVID-19

    Ampio also provided details on its forthcoming Phase I clinical trial utilizing inhaled Ampion with patients exhibiting "long hauler" COVID-19 symptoms, now known clinically as Post-Acute Sequelae of SARS-CoV-2, or PASC. A significant percentage of the millions of people who have contracted COVID-19 over the past year – even those with mild or asymptomatic cases – continue to suffer effects from the disease long after there is no detectable virus in their system.

    "The complications from COVID-19 stem not from the virus but from the out-of-control inflammatory immune response it triggers, which remains a problem long after the infection is over. We believe that inhaled Ampion could provide a significant therapeutic benefit for those patients plagued by PASC ("long haul symptoms")," continued Macaluso. "And, because Ampion is a platform biologic, what we learn in our upcoming trial could be applicable to a significant number of diseases displaying similar inflammatory-type characteristics, not just COVID-19."

    The trial design will deal specifically with respiratory distress-related symptoms and will involve an "at home" treatment, where patients will receive a nebulizer and a five-day supply of inhaled Ampion. The trial protocol is currently being finalized, with commencement of the study expected by mid-Q2 2021.

    Update on research into kidney and pediatric diseases

    In collaboration with physician scientists at Vanderbilt University, Ampio is studying the effects of Ampion on inflammation in kidney function, as most kidney disorders involve inflammation. The preclinical research is being done in vitro on renal endothelial cells as well as on proximal tubular epithelial cells of the kidney, all cells involved in the pathophysiology of kidney inflammation.

    "The results so far are promising," commented David Bar-Or, MD, Director and Founder of Ampio Pharmaceuticals, "as Ampion's method of action aligns both theoretically and is confirmed by initial in vitro experiments on those cells."

    Ampio is also conducting research into the potential use of Ampion in treating post-Fontan protein-losing enteropathy in conjunction with clinicians and scientists at a major children's hospital based in Philadelphia. The Fontan procedure is a cardiac surgery performed on children born with a single chamber in their heart. Essentially, the procedure involves separating the venous from the arterial blood. Some of these children develop a post-procedure condition termed protein-losing enteropathy, which can be so severe that it necessitates a heart transplant.

    "The cause of this condition is unclear and involves several theories," continued Dr. Bar-Or. "One theory involves inflammation, and we are studying this angle by performing complex in silico work on available genomics, micro-RNA, and other data sets to determine the potential molecular pathways involved. We are also undertaking in vitro experiments on lymphatic endothelial cells permeability, intestinal epithelial cells and others to demonstrate the potential beneficial effect of Ampion in this condition. This may lead to a treatment option for this dreadful condition affecting young children."

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2035 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Company Contacts

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Katie Kennedy



    610-731-1045

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-details-early-positive-results-for-inhaled-ampion-in-covid-19-respiratory-distress-301248333.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  5. ENGLEWOOD, Colo., March 10, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced that it has been invited to participate in the 33rd Annual ROTH Growth Conference being held virtually on March 15-17, 2021.

    The conference will feature presentations from public and private companies across a variety of industry sectors, followed by one-on-one and small group meetings, as well as expert panels and fireside chats. Past events have featured more than 550 participating companies and drawn more than 5,000 attendees, including institutional investors, analysts, family offices and high-net-worth investors.

    The Ampio management team will participate in one-on-one meetings with investors and analysts during the conference.  In addition, Dr. David Bar-Or, Ampio's Founder, Director and member of the Scientific Advisory Board, will participate as an expert on a panel discussion on Monday, March 15, 2021 (12:00pm EST) titled "Therapeutics Against SARS-CoV-2 – Viral Variants Will Not Fade Away".  This meeting will represent a panel discussion of the various developmental therapeutics for SARS-CoV-2 infection.  Please note that this conference is not open to the public and, as such, if you would like to schedule a one-on-one meeting with Ampio / attend the conference, please contact your ROTH representative here.

    About ROTH Capital Partners

    ROTH Capital Partners, LLC "ROTH" is a relationship-driven investment bank focused on serving emerging growth companies and their investors. As a full-service investment bank, ROTH provides capital raising, M&A advisory, analytical research, trading, market-making services and corporate access. Headquartered in Newport Beach, CA, ROTH is privately held, and employee owned. For more information on ROTH, please visit www.roth.com.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2035 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

    Forward Looking Statements

    Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter  into partnering arrangements,  clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

    Investor Relations

    Joe Hassett



    484-686-6600

    Media Contact

    Katie Kennedy



    610-731-1045

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-to-participate-in-the-33rd-annual-virtual-roth-conference-on-march-15-17-2021-301244844.html

    SOURCE Ampio Pharmaceuticals, Inc.

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