Q3 2021 Ampio Pharmaceuticals Inc Earnings Call
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Speaker 1: will be the event specialist running today's event. If you would like to ask a question today, please submit your questions on the webcast platform via the Ask a Question widget on the top right hand corner of your
Speaker 1: As a reminder, this call is being recorded and all listeners will be on a listen only mode. At this time I would like to turn the call.
Speaker 1: MPOs Chief Financial Officer. Dan please go ahead when you are ready.
Speaker 3: Hi everyone, thank you very much and I hope everyone's having a great day. It's our pleasure for me and certain members of the executive management team to be present today and would like to thank each one of you for attending our third quarter, 2021 earnings and business update call.
Speaker 3: Prior to reading the same Harbor Ford looking statement, I would like to introduce you to the members of the executive team who will be presenting and or participating on the call today. First is Holly Shurefka, the company's president and chief operating officer.
Speaker 3: We also have President Howard Levy, the company's Chief Medical Officer, Dr. David Baror, Director and Founder, and myself, Dan Stokely, the Chief Financial Officer.
Speaker 3: I'd like to start out by first reading our Safe Harbor statement. The presentation and any follow-up responses to Q&A may contain forward-looking statements about our business. You should not place undue reliance on forward-looking statements as these statements are based upon our current expectations, forecasts and assumptions and are subject to significant risks and uncertainties.
Thank you for your patience the M. P. A pharmaceuticals 2021 third quarter earnings and corporate update call you seemed to begin shortly if you would like to ask the question stay piece of met your question on the webcast platform via the ask a question, which is on the top right.
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Speaker 3: These statements may be identified by words such as may, will, should, could, expect, intend, plan, anticipate, believe, estimate, predict, potential, forecast, continue, or the negative of these terms or other words or terms of similar meaning.
Speaker 3: Risk and uncertainties that could cause are actual results to differ materially from those at fourth and any four-licking statements include or but are not limited to the matters listed under the heading risk factors in our annual report.
Speaker 3: on form 10k for the year ended December 31, 2020, which is on file with the Securities and Exchange Commission, as well as other rest details subsequent filings with the Securities and Exchange Commission.
Speaker 3: These reports are available at www.scc.gov.
Thank you for your patience the M P. A pharmacy to cruise 2021 third quarter earnings results and corporate update call is due to begin shortly.
Speaker 3: Statements and information in this presentation include forward-looking statements, speak only as of the date they are made or provided unless earlier data is indicated, and we do not undertake any obligation to publicly update any statements or information including forward-looking statements whether as a result of new information, future events, or otherwise except as required by law. Now I would like to provide a brief overview of the
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Speaker 3: I would like to discuss our financial results for the three and nine month period ending September 30th, 2021. Cash and cash equivalents told 17.1 million as of September 30th, 2021 compared to 17.3 million on December 31, 2020.
Good afternoon, and welcome to M. P. A pharmacy each cruise 2021 third quarter earnings we vote on corporate update call.
Speaker 3: The net decrease of .2 million is attributable to cash required to fund the operating activities of the company totaling 10.4 million, which was partially offset by net proceeds received from the utilization of our at the market equity offering program and stock options last of 10 million and .2 million respects.
The event specialist running today's event, if you would like to ask a question today. Please submit your questions on the webcast platform via the ask a question with you on the top right hand corner of your screen.
As a reminder, this call is being recorded and all listeners will be on a listen only mode.
At this time I would like to turn the call David to Mr. Downstate clean M P as Chief Financial Officer, Don. Please go ahead, when you're ready.
Speaker 3: We recognize a net loss of $3.6 million for the three months ended September 30, 2021, or the 2021 quarter, compared to a net loss of $3.4 million for the three months ended September 30, 2020, or the 2020 quarter.
Hi, everyone. Thank you very much and I hope everyone is having a great day, its our pleasure for me and certain members of the executive management team to be present today and we'd like to thank each one of you for attending our third quarter 2021 earnings and business update call.
Speaker 3: The net loss during the 2021 quarter was attributable to operating expenses of $3.8 million, partially offset by the non-cast derivative gain of.2 millimeters.
Prior to reading the safe Harbor and forward looking statement I would like to introduce you to the members of the executive team, who will be presenting an we're participating on the call today.
Speaker 3: The net loss during the 2020 quarter was attributable to operating expenses of 3.3 million and the non-cast derivative loss of 0.1 million.
First is Holly sure ask are the company's president and Chief operating Officer, We also have present.
Speaker 3: Operating expenses increased 0.5 million for the 2021 quarter as compared to the 2020 quarter primarily due to a 0.9 million increase in research and development costs, which was driven primarily by an increase in clinical trial expense, partially offset by a 0.4 million decrease in general administrative costs, which was driven primarily by a decrease in legal and commercial insurance costs.
Levi the company's Chief Medical Officer, Dr. David Borrower director and founder and myself, Dan Stokely. This chief financial Officer, I'd like to start out by first reading our safe Harbor statement. The presentation on any follow up responses to Q&A may contain forward looking statements about our bid.
You should not place.
Reliance on forward looking statements as these statements are based upon our current expectations forecasts and assumptions and are subject to significant risks and uncertainties. These statements maybe identified by words, such as May will should could expect in <unk>.
Speaker 3: We recognize the net loss of 10.8 million for the nine months in its September 30th, 2021, or the 2021 period.
Speaker 3: compared to a net loss of $3.3 million for the nine months ended September 30, 2020 or the 2020 period. The net loss during the 2021 period was primarily attributable to operating expenses of $11.3 million partially offset by a non-cash derivative gain of $0.5 million.
<unk> plan anticipate believe estimate predict potential forecasts continue or the negative of these terms or other words or terms of similar meaning risk and uncertainties that could cause our actual results to differ materially.
Speaker 3: The net loss during the 2020 period was primarily attributable to operating expenses of $11.9 million.
Those set forth in any forward looking statements include but.
Speaker 3: partially offset by the gain realized from the PPP loan forgiveness of $0.5 million and a non-cash derivative gain of 0.1.
But are not limited to the matters listed under the heading risk factors in our annual report.
Speaker 3: The operating expenses decreased 0.6 million for the 2021 period as compared to the 2020 period to do a decrease in administrative cost.
And Form 10-K for the year ended December 31, 2020, which is on file with the Securities and Exchange Commission as well as other risks detailed in subsequent filings with the Securities and Exchange Commission. These reports are available at Www Dot S. E C Dot Gov Star.
Speaker 3: On September 30th, 2021, there were 200.5 million common shares outstanding compared to approximately 193.4 million shares on December 31, 2020.
Statements and information in this presentation may include forward looking statements speak only as of the date. They are made or provided unless earlier data has indicated and we do not undertake any obligation to publicly update any statements or information, including forward looking statements.
Speaker 3: The increase during the nine months ended September 30th, 2021, is attributable to issuance of shares under the ATM equity offering program, which approximated about $6.3 million, and an average price of $1.67 a share. And...
Whether as a result of new information future events or otherwise.
Speaker 3: Also, warrant and stock option exercises accounted for about 0.8 min.
Except as required by law.
Speaker 3: And lastly, based on our current projection, which includes what's not limited to access to the residual capacity under the ATM of approximately 13.3 million. Ampio expects to have cash and cash equivalence sufficient to fund research and development programs and business operations through the first quarter of 2023.
Now I'd like to provide a financial update.
I would like to discuss our financial results for the three and nine month period, ending September 30th 2021 cash and cash equivalents totaled $17 1 million as of September 30th 2021 compared to $17 3 million on December 31 2012.
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Speaker 3: And now I'll turn the call over to Holly Turevka, Ampio's president and chief operating officer who will provide a business update on the company's clinical and research pipeline and other business.
The net decrease of <unk> 2 million is attributable to cash required to fund the operating activities of the company totaling $10 4 million.
Which was partially offset by net proceeds received from the utilization of our at the market equity offering program and stock options slash warrant exercises of 10 million and point 2 million respectively.
Speaker 4: Thank you, Dan. Thank you, everyone, for joining the call today. This has been an active quarter, and we are excited to provide corporate updates.
Speaker 4: First, we have strengthened our executive board and executive management team. It is our pleasure to welcome Michael Martino, Kevin Bucci, and Dr. Howard Levy to the team. Mr. Martino has nearly four decades of pharmaceutical experience. He has led the development of drugs and devices to treat and diagnose inflammatory autoimmune and oncology diseases.
We recognized a net loss of $3 6 million for the three months ended September 32021, or the 2020, one quarter compared to a net loss of $3 4 million for the three months ended.
September 30 of 2020, or the 2020 quarter, but net loss during the 2021 quarter was attributable to operating expenses of $3 8 million, partially offset by the noncash derivative gain a point 2 million. The net loss during the 2020 quarter was attributable to operating expenses of three.
Speaker 4: He has filled roles at multi-billion dollar specialty pharmaceutical companies in finance, marketing, strategic planning, business development, and general management. He has served as CEO of both private and public small drug development companies where he has led development from pre-clinical through phase three clinical trials, transacted mergers, and raised nearly one billion in capital through collaborative R&D agreements and financing with institutional investors.
$3 million and the noncash derivative loss of $1 million.
Operating expenses increased <unk> 5 million for the 2021 quarter as compared to the 2020 quarter, primarily due to a point 9 million increase in research and development cost, which was driven primarily by an increase in clinical trial expense, partially offset by a point 4 million decrease.
Speaker 4: Mr. Bucci brings a breadth of public company pharmaceutical experience and a history of driving shareholder value.
Speaker 4: He notably progressed from Chief Financial Officer to Chief Operating Officer and ultimately Chief Executive Officer at F1.
And general administrative cost, which was driven primarily by a decrease in legal and commercial insurance got us.
Speaker 4: Under his tutelage, Mr. Bucci successfully secured a multi-billion dollar exit for the company shareholders by executing a transaction that included therapeutic areas in pain management, respiratory, CNS, oncology, and a biologic candidate in inflammatory disease.
We recognized a net loss of $10 8 million for the nine months ended September 30 of 2021 or the 2021 period compared to a net loss of $3 3 million for the nine months ended September 30th 2020, or the 2020 period. The net loss during the 2021 period.
Speaker 4: Dr. Levy brings an added layer of regulatory, medical, and scientific knowledge as an MD-PhD pulmonologist with over a decade as hospital chief of critical care medicine, along with a wealth of US federal drug administration or FDA experience. Most duplicively, with significant experience in drug development in the Center for Biologics, Evaluation and Research, or SEBER, Division of the FDA.
It was primarily attributable to operating expenses of $11 3 million, partially offset by a noncash derivative gain of <unk> 5 million. The net loss. During the 2020 period was primarily attributable to operating expenses of $11 9 million, partially offset by the gain realized from the Pea.
Speaker 4: Dr. Levy's past experiences as the chief medical officer of catalyst biosciences incorporated, a bio-pharmaceutical company focused on developing novel therapies, targeting the innate immune system to treat unmet medical needs.
P P loan forgiveness of point $5 million and a noncash derivative gain of <unk> 1 million.
The operating expenses decreased <unk> 6 million for the 2021 period as compared to the 'twenty 'twenty period due to a decrease in administrative costs.
Speaker 4: And as the senior global medical program director at CSL Bering, a multi-billion dollar pharmaceutical company focused on plasma derived and recombinant therapies, provide unique and specific insight into successful medical development under the direction and review of the Seabird Division of the FDA.
On September 30th 2021, there were 205 million common shares outstanding compared to approximately 193 4 million shares on December 31, 2020. The increased during the nine months ended September 30 of 2021 is attributable to.
Speaker 4: Dr. Levy brings with him to the role of chief medical officer at Ampio Pharmaceuticals Expertise in Critical Illness, particularly in multiple organ failure with emphasis in respiratory viruses and pneumonia and a robust background developing blood products.
Issuance of shares under the ATM equity offering program, which approximated about $6 3 million at an average price of $1 67 a share.
Speaker 4: Adding to the executive management team at this time is critical, as we believe the company is in the latest phase of development for Ampion, a groundbreaking therapy as the first novel mechanism of action for osteoarthritis patients in nearly a quarter of a century.
And.
Also warrant and stock option exercises accounted for about 8 million shares.
And lastly, based on our current projection, which includes but is not limited to access to the rigid residual capacity under the ATM of approximately $13 3 million.
Speaker 4: Oster arthritis patients desperately need a novel approach to the unturable disease paradigm.
Speaker 4: To that end, the FDA has provided written agreement that Pivotal Study AP3A is an adequate and well-controlled clinical trial that provides evidence of effectiveness of Ampion and can contribute to the substantial evidence of effectiveness necessary for approval of a Biologics License Application known as a BLA.
<unk> expects to have cash and cash equivalents sufficient to fund research and development programs and business operations through the first quarter of 2023.
And now I'll turn the call over to Holli drug <unk>, President and Chief operating Officer, who will provide a business update on the company's clinical and research pipeline and other business matters.
Speaker 4: The company has received a special protocol assessment known as a spa agreement from the FDA on the AP13 study with concurrence on the trial design as a confirmatory study of ampion in offshore thridic patients.
Thank you Dan. Thank you everyone for joining the call. Today. This has been an active quarter and we are excited to provide corporate updates.
First we have strengthened our executive board and executive management team. It is our pleasure to welcome Michael Martino, Kevin Buchi, and Doctor Howard Levy to the team. Mr. Martino has nearly four decades of pharmaceutical experience. He has led the development of drugs and devices to treat and diagnose inflammatory autoimmune and <unk>.
Speaker 4: This study was initiated in June of 2019 prior to the onset of the COVID-19 pandemic. During the conduct of the AP-13 study, the FDA recognized the January 2020 Health and Human Service Declaration of a public state of emergency due to COVID-19 and its impact on clinical trials, which the agency addressed in guidance for industry.
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He has filled roles at multibillion dollar specialty pharmaceutical companies and finance marketing strategic planning business development and General management. He has served as CEO of both private and public small drug development companies, where he has led development from preclinical through phase III clinical trials transacted merge.
Speaker 4: In addition to the guidance for industry, the FDA has provided the company with guidance on the AP-13 clinical program and light of the COVID-19 health emergence.
Speaker 4: The company has closed the AP 13 clinical database and is currently analyzing the data from the study. These stun both public guidance and specific guidance from the FDA on the Ampion, Australorathritis program with a goal to have a meeting with the FDA in the first half of 2022.
<unk> and raised nearly 1 billion in capital through collaborative R&D agreements and financing with institutional investors.
Mr. Buchi brings a breadth of public company pharmaceutical experience and a history of driving shareholder value. He notably progressed from Chief Financial Officer to Chief operating officer, and ultimately and Chief Executive Officer at Cephalon under his tutelage. Mr. Buchi successfully secured a multibillion dollar exit for the company's shareholders.
Speaker 4: In addition to providing evidence of safety and efficacy in pain and function, pre-clinical and early clinical studies have shown that ampion impacts multiple genes related to repair and regeneration of cartilage.
Speaker 4: These published findings suggest that ampion treatment may prime stem cells for both mobilization and contra-genic differentiation, potentially explaining some of the beneficial effects achieved in clinical trials with ampion treatment.
By executing a transaction that included therapeutic areas in pain management, respiratory CNS oncology, and a biologic candidate and inflammatory disease.
Speaker 4: For example, data published in the peer review journal titled Patient Safety and Surgery showed a significant reduction in pain and a lower rate of total knee replacement with ampion treatment compared to saline control and osteoarthritis of the knee patients and a phase one, two study with long-term follow-up for more than three years.
Dr. Levi brings an added layer of regulatory medical and scientific knowledge as an M. D ph D pulmonologist with over a decade as hospital chief of critical care medicine, along with a wealth of U S. Federal drug administration or FDA experience, most applicable each with significant experience in drug development and the <unk>.
Speaker 4: MRI analysis of these patients demonstrated potential cartilage preservation with ampion treatment compared to saline, representing potential for disease modification.
For biologics evaluation and research or Seeber division of the F D a dr.
Dr. Lee these past experiences as the Chief Medical officer of catalyst Biosciences incorporated a biopharmaceutical company focused on developing novel therapies targeting the innate immune system to treat unmet medical need and as the senior Global Medical program director at CSL Behring, a multibillion dollar pharmacy.
Speaker 4: Patients treated with ampion had less cartilage loss than patients treated with saline in all pre-specified and anatomically defined regions of the knee. Ampion also showed increased cartilage thickness in two lateral sub-regions.
Speaker 4: Ampion's positive impact on pain and functionality, including in patients with severe disease, may be driven in part by these regenerative effects of ampion on cartilage, deposition, and restoration in the joint.
Medical company focused on plasma derived and recombinant therapies provide unique and specific insight into successful medical development under the direction and review of the Sea Bird Division of the F. D. A.
Speaker 4: In addition to this osteoarthritis program, the ability to successfully demonstrate strong and vitro data has supported an expedited regulatory path into human clinical trials for respiratory distress due to COVID-19.
Dr. Levi brings with him to the role of Chief Medical Officer at <unk> Pharmaceuticals expertise in critical illness, particularly in multiple organ failure with emphasis in respiratory viruses in pneumonia and a robust background developing blood products.
Speaker 4: This was presented in a scientific forum at the International Society for Aerosols and Medicines, also known as ISAM, in a report titled, Regulatory Decisions During COVID-19, Efficient Non-Clinical Inhalation Toxicology for a Clinical Program, which supports the Ampion Inhalation Program for the treatment of respiratory distress due to COVID-19.
Adding to the executive management team at this time is critical as we believe the company is in the latest phase of development for Amp Young a groundbreaking therapy as the first novel mechanism of action for osteoarthritis patients and nearly a quarter of a century.
Osteoarthritis patients desperately need a novel approach to be Uncurable disease paradigm.
That ends the FDA has provided written agreement the pivotal study a P. Three a is an adequate and well controlled clinical trial that provides evidence of the effectiveness of an P on and can contribute to the substantial evidence of effectiveness necessary for approval of a biologics license application known as a b L. A.
Speaker 4: This study protocol was reviewed by the FDA for consideration in support of a potential emergency use authorization or EUA for the treatment of COVID-19 patients.
Speaker 4: The first patient in the AP-19 study was enrolled and treated in the United States. And following the regulatory approval from the drugs controller general of India, enrollment and patient treatment has commenced in India starting in October of this year.
But the company has received a special protocol assessment known as a spa agreement from the FDA on the AP 13 study with concurrence on the trial design as a confirmatory study of Amp yarn in osteoarthritis patients.
Speaker 4: The clinical trial is currently designed to enroll 200 patients with an interim analysis after 150 patients have been enrolled and completed the 28-day visit to allow for evaluation and sample size re-estimation as appropriate. It is anticipated that enrollment for the interim analysis will be completed in the second Narrated for the 25-qi-shoe evaluation process, 250 participants were currently in the laboratory.
This study was initiated in June of 2019 prior to the onset of the COVID-19 pandemic during the conduct of the AP 13th study. The FDA recognized the January 2020 health and human service Declaration of a public state of emergency due to COVID-19, and its impact on clinical trials, which the.
Speaker 4: Also evaluated by the FDA for consideration as a potential EUA treatment in the fight against COVID-19 is the phase two AP-17 clinical study for the intravenous treatment of Ampion and hospitalized COVID-19 patient.
Agency addressed in guidance for industry.
In addition to the guidance for industry. The FDA has provided the company with guidance on the AP 13 clinical program in light of the COVID-19 health emergency.
Speaker 4: This study is currently designed to enroll 200 patients with an intra-menalysis designed to evaluate 40 patients and include sample size re-estimation as applicable.
The company has closed the a P 13 clinical database and is currently analyzing the data from this study at least on both public guidance and specific guidance from the FDA on the Empire on osteoarthritis program with a goal to have a meeting with the FDA in the first half of 2022.
Speaker 4: The company believes the intra-menalysis population will be enrolled by early first quarter. Additionally, the inhaled treatment of ampion is being investigated in a randomized controlled phase one study for at-home use among probation.
And in addition to providing evidence of safety and efficacy in pain and function preclinical and early clinical studies have shown that amtrust impacts multiple genes related to repair and regeneration of cartilage.
Speaker 4: This study aims to evaluate ampion treatment compared to control in 31 COVID patients. The company believes enrollment for this study will be completed by the end of the year.
These published findings suggest that Amgen treatment may prime stem cells for both mobilization and contract genic differentiation potentially explaining some of the beneficial effects achieved in clinical trials with MTN treatment.
Speaker 4: The clinical trials and the investigation of Ampion is a possible treatment for respiratory distress in COVID-19 patients, is supported by Ampion data and supplementary publications in peer-reviewed scientific journals. Most recently, the data from a randomized controlled phase one trial, which was conducted to evaluate hospitalized patients with respiratory distress due to COVID-19, was published in the peer-reviewed journal titled Insexious Diseases and Therapy.
For example data published in a peer reviewed journal titled Patient Safety and surgery showed a significant reduction in pain and a lower rate of total knee replacement with an P on treatment compared to sailing control and osteoarthritis of the knee patients and a phase one two study with long term follow up for more than three years.
Speaker 4: Patients in this study received the standard of care for COVID-19, including respiratory therapy, corticosteroids, and antiviral therapies. Patients were randomized one-to-one to inhalation treatment with ampion as an adjunct to standard of care or to standard of care alone as control. Ampion was administered via inhalation daily for five days. Safety and clinical efficacy endpoints were evaluated.
Morai analysis of these patients demonstrated potential cartilage preservation with amgen treatment compared to ceiling representing potential for disease modification.
Patients treated with <unk> had less cartilage loss in patients treated with sailing in all pre specified anatomically defined regions of the knee.
Speaker 4: Forty subjects were enrolled and randomized in the study, and it was observed that antiviral therapy was required in fewer ampion treated subjects, 26%, compared to 52% in control, and steroids were administered for most subjects.
Amgen also showed increased cartilage thickness and two lateral sub regions.
Amgen's positive impact on pain and functionality, including in patients with severe disease may be driven in part by these regenerative effects of Amp you on cartilage deposition and restoration in the joint.
Speaker 4: The study met its primary endpoint with no Ampion treatment related adverse events and the incidents and severity of adverse events were comparable between groups. Notably, compared to control, subjects treated with Ampion had fewer deaths.
In addition to this osteoarthritis program the ability to successfully demonstrates strong in vitro data has supported an expedited regulatory path into human clinical trials for respiratory distress due to COVID-19.
Speaker 4: 5% compared to 24% in the control arm.
This was presented in a scientific forum at the International Society for Aerosols and medicines also known as I Sam in a report titled regulatory decisions. During COVID-19 efficient non clinical inhalation toxicology for a clinical program, which supports the Amgen inhalation program for the treatment of respiratory distress due to COVID-19.
Speaker 4: Short or hospital stay eight days versus 12 days.
Speaker 4: Fewer ICU admissions, 21% versus 33%, and a greater proportion of patients treated with ampion had improved clinical outcomes compared to control.
Speaker 4: The Phase 1 clinical results indicate inhaled ampion is safe, well tolerated, and could lead to fewer patients experiencing deterioration or death due to COVID-19.
Currently MTN is being investigated as a potential inhalation treatment for patients with severe COVID-19 in a hospital setting and the a P 19 clinical study under a U S. F D. A I N D.
Speaker 4: In addition to the ongoing clinical investigations for ampion treatment and inflammatory disease, the company has continued to strengthen the ampion platform technology research development pipeline, most recently presenting pre-clinical data and potential application for ampion in acute kidney injury, known as AKI, and Lupus nephritis in scientific forums.
This study protocol was reviewed by the FDA for consideration in support of a potential emergency use authorization or EUA for the treatment of COVID-19 patients.
The first patient in the 18 19 study was enrolled and treated in the United States and following the regulatory approval from the drugs controller General of India enrollments and patient treatment has commenced in India. Starting in October of this year. The clinical trial is currently designed to enroll 200 patients with an inch.
Speaker 4: This clinical and pre-clinical activity is supported by robust, in-house manufacturing.
Speaker 4: The manufacturing team recently delivered a presentation titled Pivoting from one to multiple production platforms to treat COVID-19.
Analysis. After 150 patients have been enrolled and completed the 28 day visit to allow for evaluation and sample size re estimation as appropriate. It is anticipated that enrollment for the interim analysis will be completed in the second quarter of 2022.
Speaker 4: at the 2021 International Society for Pharmaceutical Engineers.
Speaker 4: known as the ISPE at the annual meeting in Expo in Boston, Massachusetts this November . The presentation reports Ampio's innovative work, which has significantly and rapidly expanded the capabilities of its wholly owned automated drug manufacturing facility that was initially focused on producing four CC vials of the platform Immunomodulatory Drug Ampion.
Also evaluated by the FDA for consideration as a potential <unk> treatment in the fight against COVID-19 is the phase two AP 17 clinical study for the intravenous treatment of <unk> in hospitalized COVID-19 patients.
Speaker 4: for interarticular injections into patients with osteoarthritis of the knee.
Speaker 4: And less than four months, the manufacturing facility was reprogrammed to manufacture ampion products to support clinical development in osteoarthritis, along with development in COVID-19 and pre-clinical applications.
This study is currently designed to enroll 200 patients with an interim analysis designed to evaluate 40 patients and includes sample size re estimation as applicable.
The company believes the interim analysis population will be enrolled by early first quarter <unk>.
Speaker 4: With these updates and the continued progress and forward momentum from the company, it is my pleasure to introduce you to Dr. Levy for an update from our Chief Medical Officer.
Additionally, the inhaled treatment of implant is being investigated in a randomized controlled phase one study for at home use among COVID-19 patients.
This study aims to evaluate amtrust treatment compared to control and 30 long Covid patients. The company believes enrollment for this study will be completed by the end of the year.
Speaker 5: Thank you so much Holly. You know, firstly I'm delighted to be in the point to the role of Chief Medical Officer Dan.
Speaker 5: We have three clinical trials underway that you've just heard that are evaluating the safety and efficacy of ampion delivered by either the intravenous infusion root or inhalation for five days, due to the onset of severe cold.
The clinical trials and the investigation of Amazon as a possible treatment for respiratory distress in COVID-19 patients is supported by an P on data and supplementary publications in peer reviewed scientific journals. Most recently the data from our randomized controlled phase <unk> trial, which was conducted to evaluate hospitalized patients with respiratory distress due to COVID-19.
Speaker 5: as well as using inhaled ampion for the longfall COVID, particularly difficult proof.
<unk> was published in the peer reviewed journal titled Infectious diseases and therapy page.
Speaker 5: Exituting a clinical trial is always a complex undertaking and needs to be formed with strict adherence to GCP. That's good clinical practice.
Patients in this study received the standard of care for Covid, 19, including respiratory therapy, corticosteroids and anti viral therapies patients were randomized one to one to inhalation treatment with <unk> as an adjunct to standard of care or to standard of care alone as control and Penn was administered via inhalation daily for five days.
Speaker 5: This means frequent participants, participant interactions, 100% data capture and monitoring of that day.
Speaker 5: Clinical trials in the age of COVID, where there is competition for physician and nursing time and strict enforcement of safety protocols as well as strain supply lines has added additional additional complexion.
Safety and clinical efficacy endpoints were evaluated 40 subjects were enrolled and randomized in the study and it was observed that anti viral therapy was required and fewer M. P. Untreated subjects, 26% compared to 52% and control and steroids were administered for most subjects.
Speaker 5: We've added India sites to the Protocol AP 019, starting nebulous and beyond versus placebo to accelerate enrollment in the trial. And enrollment and treatment in India is currently underway.
The study met its primary endpoint with no M. P untreated treatment related adverse events and incidents and severity of adverse events were comparable between groups, notably compared to control subjects treated with MTN had fewer deaths, 5% compared to 24% in the control arm shortfall shorter hospital stay.
Speaker 5: So preclinical dates provide robust evidence of Ampion's inhibition of pro-inflammatory cytokine.
<unk> eight days versus 12 days fewer ICU admissions, 21% versus 33% and a greater proportion of patients treated with <unk> had improved clinical outcomes compared to control.
Speaker 5: Accurregulation of transcription of the anti-inflammatory factors Enhance to lease of pro-resolving lipid mediators and enhance in the philial barrier function.
The phase one clinical results indicate inhaled MTN is safe well tolerated and could lead to fewer patients experiencing deterioration or deaths due to COVID-19.
In addition to the ongoing clinical investigations for Amgen treatment and inflammatory disease. The company has continued to strengthen the MP on platform technology research and development pipeline. Most recently presenting preclinical data and potential application for <unk> in acute kidney injury, known as 8-K, I and lupus.
Speaker 5: Additional therapies are required to provide weapons against the devastating respiratory failure inside a storm provoked by the devastating respiratory failure.
Writers in scientific forums.
Speaker 5: and are often not prescribed because of delayed recognition of the diagnosis.
This clinical and preclinical activity is supported by robust in house manufacturing the manufacturing team recently delivered a presentation titled pivoting from one to multiple production platforms to treat COVID-19 at the 2021 International Society for pharmaceutical engineers known as the I S. T E at the annual meeting.
Speaker 5: So our trials target a stablished mile to severe poem recompromised to prevent progression to respiratory failure and death.
Speaker 5: In addition, as Holly previously noted, we are finalizing the analysis of AP13 study and preparing the copious documentation that is required for a meeting with FDA, which we expect will be in the first half of 2022.
Expo in Boston, Massachusetts. This November.
The presentation reports mto's innovative work, which is significantly and rapidly expanded the capabilities of its wholly owned automated drug manufacturing facility that was initially focused on producing for CZ vials of the platform immuno modular Tory drug amp yawn for intra articular injections into patients with osteoarthritis of the knee.
Speaker 5: So with that, I'll now turn the call over to Dan, who will moderate the question and ask and support.
In less than four months the manufacturing facility was reprogrammed to manufacturer MTN products to support clinical development in osteoarthritis, along with development in COVID-19, and preclinical application.
Speaker 3: Thank you very much, Howard. Before I go into the Q&A section, I'd first like to tell everyone that effective immediately, the company is going to disseminate all not financial information, information not requiring disclosure of an 8K. That's going to be done going forward utilizing media communications provided.
With these updates and the continued progress and forward momentum from the company. It is my pleasure to introduce you to Dr. Levi for an update from our Chief Medical Officer.
Thank you so much Holly alright.
Speaker 3: So with that said, I'll go into the Q&A and there's been quite a few questions here. And let me see the first question.
I'm delighted to have been appointed to the role of Chief Medical Officer, Dan here.
We have three clinical trials underway that you've just heard that are evaluating the safety and efficacy of <unk> delivered more onto the intravenous infusion route all inhalation for five days juvenile onset of severe COVID-19 as well as using inhaled <unk>.
Speaker 3: What would be the most accurate way to characterize your discussions with potential part?
Speaker 3: You know, as we've, I'll take that one, but as we previously discussed.
Speaker 3: You know, it's an active and ongoing process. You know, we are, as we said before, we're very pleased with the level of interest and we'll disclose more, you know, at such time when it's appropriate. Next.
<unk> for the long for Covid.
Particularly difficult.
To treat.
Executing a clinical trial is always a complex undertaking and needs to be fooled strict adherence to ggp's, that's good clinical practice.
Speaker 3: How has the new data affected their interest levels? I'm assuming partnership or partnering interest levels. Holly, do you want to-
This means frequent participant participant interactions are 100% data capture and monitoring of that data.
Speaker 4: Sure, thank you, Dan. We believe the company is in the latest phase of development on Ampion, as mentioned, a groundbreaking therapy with the first novel mechanism of action in osteoarthritis drug development in nearly a quarter of a century. This is an ongoing process and interest has been expressed both before and after the database lock for the AP-13 study. We're not going to speculate beyond that.
The controls and the age of Covid, where there's.
Competition for physician and nursing tonne and strict enforcement of safety protocols as well as strange supply lines has added additional complexity.
We've added India shocks to the protocol AP 019, studying net realized and beyond versus placebo to accelerate enrollment in the trial and enrollment and treatment in India is currently underway.
Speaker 3: The next question is, do the Merck and Pfizer COVID result?
So preclinical data provides robust evidence of npls inhibition of pro inflammatory cytokine release.
Speaker 3: Do they incline you to rethink how your COVID program is prioritized? David, do you want to take that one? Sure. So both of the
On regulation of transcription pro inflammatory shonda contractors.
Regulation of transcription of the anti inflammatory factors.
Speaker 6: targeted for patients who have initial symptoms.
In Holland to lease a pro resolving mediators and into homes endothelial barrier function.
Speaker 6: which is very different a population from the Ampion program.
Speaker 6: The Ampion program is targeting to provide benefits in clinical outcomes.
All of these are desirable pharmaceutical properties for the prevention of progression as well as the treatment of moderate and severe COVID-19.
Speaker 6: for patients with moderate to severe respiratory distress.
Speaker 6: who are hospitalized and in the inflammatory phase of the disease were a limited treatment option success.
Additional therapies are required to provide weapons against the devastating respond to failure and Charlotte climbed storm provoked sponsored borrowers steroids and other approved therapies based administered in a narrow window alien COVID-19 and.
Speaker 6: These patients have already failed to respond adequately to antiviral therapies, to steroids and antibody infusions.
Speaker 6: which highlights the opportunity for Ampion to provide treatment in addition to this regiment.
And are often not discount because of delayed recognition of the diagnosis.
So our trials target established mild to severe pulmonary compromise to prevent progression to respond to failure and death.
Speaker 6: Empium addresses the inflammatory stage of the disease in hospitalized patients. So no, under the answer to your question, it will not affect the prioritization of our drug program. Okay. Thank you. Next one. Yes. Okay.
In addition.
Holly previously noted we are finalizing the analysis of AP three study and preparing the crude peers documentation that is required for a meeting with the FDA, which we expect will be in the first half of 2022.
Speaker 3: has a significant probability of compromising your trial.
So with that I'll now turn the call over to Dan who will moderate the question and Austin to support them.
Speaker 3: and or the SPA in relation to your position with the FDA.
Speaker 4: The reality is that we will not know the full answer to this question until we meet with the FDA, of course. What we do know is that under FDA guidance, including direct discussion, our clinical trial was sensitive to the impact of the COVID-19 health emergency. We believe we have followed the guidance and have a regulatory path forward, which we plan to discuss with the FDA in the first half of 2020.
Thank you very much hours before I go into the Q&A section I would first like to tell everyone.
That so effective immediately.
The company is going to disseminate all mall financial information information not requiring disclosure of an 8-K, that's going to be done going forward utilizing media communications provided by tumors.
Speaker 3: It looks like more of a general question, but can you describe, generally, the process for meeting with the FDA? All you want to do?
So with that said.
I'll go into the Q&A and Theres been quite a few questions here and.
Speaker 4: Of course, there is published guidance on the process for formal meetings between the FDA and sponsors. We will be following the process outlined in this guidance. In general, FDA meeting scheduling timeframes are related to the type of meeting requested. For example, a meeting may be requested to occur within 60 to 75 calendar days from receipt of the request, with the expectation the FDA will respond, either accepting or rejecting the meeting within 14 to 21 calendar days of said request.
Let me see the first question is.
What would be the most accurate way to characterize your discussions with potential partners.
You know as we've I'll take that one but as we previously discussed.
It's an active and ongoing process.
We are as we said before we're very pleased with the level of interest and we will disclose more.
Such time, when it's appropriate.
Next question is.
Speaker 3: This will be the last one. What is the capacity of your manufacturing facility?
All of the new data affected are their interest levels I'm, assuming partnership are partnering interest levels. Holly do you want to take that sure. Thank you Dan We believe the company is in the latest phase of development on Amgen as mentioned a groundbreaking therapy with the first novel mechanism of action.
Speaker 3: and the equivalent of 4 CC vials.
Speaker 3: I'll take that with our manufacturing facility can produce.
Speaker 3: in the range of about 8 to 10 million vials annually. And based upon this projected share, or the projected share in osteoarthritis, from this one facility, keep in mind, it can be easily replicated in other locations, other geographies. We feel that this capacity that we have here in Colorado on a standalone basis is certainly sufficient for the company to be able to do.
In osteoarthritis drug development and nearly a quarter of a century. This is an ongoing process and interest has been expressed both before and after the database lock for the E. P. 13th study, we're not going to speculate beyond that at this time.
Okay.
Next question is.
Do the Merck and Pfizer Covid poll results.
Do they incline you to rethink how your Covid program is prioritized.
Speaker 3: Paulie, did you want to provide some closing remarks? Yes, thank you, Dan, and thank you to the entire team. It certainly has been an unprecedented time on a global scale. We are incredibly encouraged by the progress to move the Oak program forward, launch a program in the fight against COVID-19, and demonstrate additional pre-clinical applications in the autoimmune space for Ampion.
David do you want to take that one sure.
So both of those fields.
Speaker 4: Severe Oak remains an unmet medical need and we are focused on delivering value to shareholders by realizing an asset for this underserved patient population.
Speaker 4: Additionally, due to its unique mechanism of action as a biologic drug, we have been able to move swiftly and efficiently through the regulatory process for ampion treatment, investigation, and COVID-19 patients with respiratory distress.
Speaker 4: This regulatory cadence allowed for early demonstration of safety and efficacy in severe critical COVID-19 patients, which has been presented to the FDA for guidance on potential U.A. We are excited to announce this publication of this data in the peer reviewed scientific journal titled Infectious Diseases and Therapy, as mentioned earlier. The scientific team remains active and hard at work to continue research on pre-clinical and label expanding applications in the anti-inflammatory immunomodulation space.
The drug.
Speaker 4: This is supported by our robust in-house manufacturing. The manufacturing team continues to efficiently and effectively support the clinical and preclinical development of Ampeon. The company remains focused on the advancement of immunology-based therapies to treat prevalent inflammatory conditions for which there are limited treatment options to provide value to patients and shareholders alike. We look forward to providing continued progress and updates each quarter. Thank you again, everyone, for tuning in today.
Program.
Thank you next.
Next one.
Is do you feel the pandemic.
Has a significant probability is compromising your trial and or or the S. P. A in relation to your position with the F D. A holly.
The reality is that we will not know the answer to this question until we meet with the F. D. A of course, what we do now is it under F. D. A guidance, including direct discussion are clinical trial was sensitive to the impact of the COVID-19 health emergency. We believe we have followed the guidance and have a regulatory path forward, which we plan to discuss with the F.
Speaker 1: Thank you ladies and gentlemen at this concludes today's course. Thank you for joining. You may now disconnect your lines.
Speaker 2: yo
And the first half of 2022.
Okay.
It looks like more of a general question, but can you describe generally the process for meeting with the F. D. A all you want to take that one of course, there's published guidance on the process for forma meetings between the F. D. A and sponsors we will be following the process outlined in this guidance in general.
Meeting scheduling timeframes are related to the type of meeting requested for example, a meeting may be requested to occur within 60 to 75 calendar days from receipt of the request with the expectation FTA will respond either accepting or rejecting the meeting within 14 to 21 calendar days of said request.
Okay.
This will be the last one what is the capacity of your manufacturing facility and the and the equivalent of <unk> vials I'll.
I'll take that with.
Manufacturing facility can produce and.
In the range of about eight to 10 million vials annually.
And based upon this projected share or the projected Sharon osteoarthritis.
From this one facility keeping.
Keep in mind that can be easily replicated.
And other locations other geographies.
We feel that this capacity that we have here in Colorado on a standalone basis, but certainly sufficient.
Company.
Marcus.
Probably.
Probably did you want to provide some closing remarks, yes. Thank you Dan and thank you to the entire team. It certainly has been an unprecedented time on a global scale. We're incredibly encouraged by the progress to move the Oak program forward launch a program in the fight against COVID-19, and demonstrate additional preclinical applications and the auto immune.
Face for MPR severe.
Severe oak remains an unmet medical need and we are focused on delivering value to shareholders by realizing an asset for this underserved patient population.
Additionally, due to its unique mechanism of action is a biologic drug we have been able to move swiftly and efficiently through the regulatory process for M. P. On treatment investigation in COVID-19 patients with respiratory distress. This regulatory cadence allowed for early demonstration of safety and efficacy and severe and critical COVID-19 patients which has been <unk>.
<unk> to the FDA for guidance on potential E Bay, we are excited to announce this publication of this data in a peer reviewed scientific journal titled Infectious diseases in therapy as mentioned earlier the scientific team remains active and hard at work to continue research on preclinical and label expanding applications and the anti inflammatory immunomodulation space.
Yeah.
This is supported by a robust in house manufacturing the manufacturing team continues to efficiently and effectively support the clinical in preclinical development of MPR. The company remains focused on the advancement of immunology based therapies to treat prevalent inflammatory conditions for which there are limited treatment options to provide value to patients.
And shareholders alike, we look forward to providing continued progress in updates each quarter.
Thank you again, everyone for tuning in today.
While further name of a gentleman.
Thank you ladies and gentlemen. This concludes today's cool. Thank you for joining you may now disconnect your lines.
Uh-huh.
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