AMPE Ampio Pharmaceuticals Inc.

1.21
-0.11  -8%
Previous Close 1.32
Open 1.33
52 Week Low 0.6209
52 Week High 2.98
Market Cap $238,185,047
Shares 196,847,146
Float 194,234,096
Enterprise Value $262,892,475
Volume 4,135,701
Av. Daily Volume 2,037,375
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Drug Pipeline

Drug Stage Notes
Ampion
COVID-19
Phase 1
Phase 1
Phase 2 trial to commence 2Q 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., July 29, 2021  /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced details on the Company's poster presentation, "Efficient Applied Toxicology during COVID-19: A Preclinical Study that Advanced Clinical Use of Ampion," being given virtually at the American College of Toxicology 42nd Annual Meeting, November 14 to 17, 2021, at the Gaylord National Harbor in Washington, DC.

    Ampio's poster is based on the Company's preparations for its recently completed AP-014 Phase I clinical trial utilizing an inhaled form of Ampio's drug, Ampion™, for treatment of respiratory distress in patients as a result of COVID-19. The study showed inhaled Ampion significantly reduced all-cause mortality for patients suffering from COVID-19 induced respiratory distress by 78% over the Standard of Care (SOC) alone. Based on those strong positive results, Ampio has recently undertaken a Phase II trial.

    Prior to launching the initial AP-014 trial, Ampio undertook pre-clinical research to establish the safety of its Ampion anti-inflammatory therapy whereby the method of use would be through inhaled delivery. 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 previously completed 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 presentation will be given by Laura Goldberg and Holli Cherevka, both of Ampio Pharmaceuticals based in Englewood, CO, and Philip J. Kuehl of Lovelace Biomedical based in Albuquerque, NM.

    For more information on the abstract presentation or American College of Toxicology 42nd Annual Meeting, visit https://www.actox.org/am/am2021/.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies 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 2037 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 using 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.

    Media Contact

    Katie Kennedy



    610-731-1045

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ampio-pharmaceuticals-to-present-at-the-american-college-of-toxicology-42nd-annual-meeting-301344198.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  2. ENGLEWOOD, Colo., July 28, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced details on the Company's abstract presentation, "Significant Inhibition of the TLR7/CXCL10 Signaling Axis by LMWF5A in Monocytic Lineages; Implications for COVID-19 and Lupus Nephritis," being given virtually at the 14th International Congress on Systemic Lupus Erythematosus (LUPUS 2021) & 6th International Congress on Controversies in Rheumatology and Autoimmunity (CORA) on October 6-9, 2021.

    Ampio's presentation is based on the Company's analysis that Ampio's drug candidate, Ampion™, currently under clinical investigation for the treatment of osteoarthritis and the hyper-inflammation observed with severe COVID-19, inhibits pro-inflammatory cytokine release, also known as the cytokine storm.

    The presentation will summarize evidence that treatment utilizing Ampion suppresses Toll Like Receptor 7/8 (TLR7/8) signaling in monocytic/macrophage lineages and suggests a role for Ampion in treating the dysregulation of these pathways observed in lupus nephritis as well as in COVID-19. Toll Like Receptors are fundamental, innate mechanisms to detect and respond to pathogens (pathogen-associated molecular patterns, PAMPs, including viruses such as SARS-Cov2) or damaged cells (damage-associated molecular patterns, DAMPs) by activating a proinflammatory cascade in immune cells. Such dysregulated hyperactivation of these pathways is associated with the cytokine/chemokine storm observed in severe COVID-19 patients.

    Ampio recently announced early positive data in its AP-014 Phase I clinical trial, utilizing Ampion in treating respiratory distress in patients as a result of COVID-19. The study showed inhaled Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78% over the Standard of Care (SOC) alone.

    For more information on the abstract presentation or LUPUS 2021 and CORA, visit https://lupus2021.kenes.com/.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies 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 2037 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 using 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.

    Media Contact 

    Katie Kennedy 

     

    610-731-1045

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ampio-pharmaceuticals-to-present-at-the-14th-international-congress-on-systemic-lupus-erythematosus-lupus-2021--6th-international-congress-on-controversies-in-rheumatology-and-autoimmunity-cora-301343031.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  3. ENGLEWOOD, Colo., July 27, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced details on the Company's poster presentation, "Inflammation and COVID Induced ARDS: Inhaled Ampion™ as a Therapeutic Option," being given at the 63rd annual Thomas L. Petty Aspen Lung Conference, September 20 to 23, 2021, at the Gant Conference Center in Aspen, Colorado. Elevated levels of inflammatory cytokines indicative of an uncontrolled immune response have been found in COVID-19 patients with ARDS, and in vitro studies indicate Ampion regulates cellular transcription to reduce inflammatory cytokines (TNFα, IL-1β, IFNγ…

    ENGLEWOOD, Colo., July 27, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced details on the Company's poster presentation, "Inflammation and COVID Induced ARDS: Inhaled Ampion™ as a Therapeutic Option," being given at the 63rd annual Thomas L. Petty Aspen Lung Conference, September 20 to 23, 2021, at the Gant Conference Center in Aspen, Colorado. Elevated levels of inflammatory cytokines indicative of an uncontrolled immune response have been found in COVID-19 patients with ARDS, and in vitro studies indicate Ampion regulates cellular transcription to reduce inflammatory cytokines (TNFα, IL-1β, IFNγ, IL-6, IL-12, IP-10).

    Ampio's poster highlights the Company's recently completed AP-014 Phase I clinical trial utilizing an inhaled form of Ampio's drug, Ampion, for treatment of respiratory distress in patients as a result of COVID-19. The study showed inhaled Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78% over the Standard of Care (SOC) alone.

    In addition, the poster further highlights that patients who received inhaled Ampion had shorter hospital stays (8 days for Ampion vs. 12 days for control) and shorter ICU stays (8 days for Ampion vs. 11 days for control). Remdesivir was also used at a lower rate (26% of patients) in the Ampion group vs. the control group (52% of patients).

    The poster is led by Michael Roshon, M.D., Ph.D., of the Emergency Department, Penrose Hospital (Colorado Springs, CO) and Luciano Lemos-Filho, M.D., of the National Jewish Division of Pulmonary Medicine at Swedish Medical Center (Englewood, CO).

    The theme of this year's Aspen Lung Conference will be "ARDS in the 21st Century: New Insights into Clinical and Mechanistic Heterogeneity," providing an international forum bringing together leading basic, translational, and clinical ARDS researchers while welcoming trainees in pulmonology and critical care medicine. The conference will be a hybrid event, mixing in-person and virtual sessions, with all poster sessions being held virtually.

    For more information on the poster presentation or the Aspen Lung Conference, visit https://medschool.cuanschutz.edu/aspen.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies 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 2037 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 using 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 because of new information, future events or otherwise.

    Media Contact 

    Katie Kennedy 

     

    610-731-1045

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ampio-pharmaceuticals-to-present-at-aspen-lung-conference-301341959.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  4. ENGLEWOOD, Colo., July 14, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced it will host a conference call to discuss financial results for the quarter ended June 30, 2021, and provide a corporate business update on Wednesday, August 4, 2021, at 4:30 pm EDT/ 2:30 pm MT.

    Conference Call & Webcast:

    Wednesday, August 4, 2021, 4:30 pm EDT / 2:30 pm MT



    Domestic:    

    888-506-0062 - Conference ID# 469825

    International: 

    973-528-0011 - Conference ID# 469825

    Webcast Link: 

    https://www.webcaster4.com/Webcast/Page/2569/42087

    The conference call will also be available from the Investor Relations section of the Company's website at www.ampiopharma.com and will be archived there shortly after the live event.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies 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 2037 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.

    Media Contact

    Katie Kennedy

     

    610-731-1045

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ampio-pharmaceuticals-inc-to-report-fiscal-2021-second-quarter-financial-results-and-provide-corporate-business-update-301328721.html

    SOURCE Ampio Pharmaceuticals, Inc.

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  5. ENGLEWOOD, Colo., June 25, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE:AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced randomization and dosing of patients in its multi-center AP-019 Phase II clinical trial, using inhaled Ampion™ in the treatment of respiratory distress due to COVID-19, is underway.

    "We saw strong, positive results in our Phase I trial, reducing all-cause mortality in COVID-19 respiratory distress by 78%. If this Phase II study further confirms the efficacy results seen in our Phase I  study, I can envision moving forward quickly with an application for Emergency Use Authorization for Ampion in treating patients suffering from respiratory distress due to COVID-19," said Michael Macaluso, President and CEO of Ampio.

    As an immunomodulatory agent with anti-inflammatory effects, Ampion interrupts the hyperactive immune response associated with COVID-19 and may improve the clinical outcome for patients suffering from its complications.

    The company initiated the AP-019, double-blind, placebo-controlled Phase II trial, utilizing inhaled Ampion following the strong top-line results achieved from its AP-014 Phase I trial. On April 27, 2021, the company reported the earlier Phase I study not only met its primary endpoint of safety and tolerability, but top-line results also showed that Ampion reduced all-cause mortality in patients suffering from COVID-19 respiratory distress by 78% over the Standard of Care (SOC). Specifically, mortality in the SOC group was 24%, while in the group treated with Ampion, mortality was only 5%.

    "Roughly 300 people per day are dying of COVID-19 in the U.S.," Macaluso continued, "with a seven-day average of 10,000 per day worldwide. There is a perception the vaccine rollout has ended the pandemic, but COVID-19 is likely to remain a concern for some time to come, and physicians need tools to treat it."

    Ampio also recently received approval from the FDA to expand the AP-019 study to India, which has recently seen a dramatic surge in COVID-19 cases.

    About Ampio Pharmaceuticals

    Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies 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 2037 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.

    Media Contact

    Katie Kennedy



    610-731-1045

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-announces-patient-randomization-and-dosing-in-ap-019-phase-ii-study-of-inhaled-ampion-in-covid-19-respiratory-distress-301320070.html

    SOURCE Ampio Pharmaceuticals, Inc.

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