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Exhibit 99.1
Ampio Pharmaceuticals Provides Regulatory Update
ENGLEWOOD, Colo., April 29, 2019, /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that it has received comments from the U.S. Food and Drug Administration (FDA) regarding their Special Protocol Assessment (SPA). The FDA recommended the Company not start their confirmatory trial without obtaining FDA concurrence on the trial design. The Company agreed with the comments they received from the FDA and immediately sent a revised SPA to the FDA for review.
“While we will not officially start the trial until the SPA is approved,” said CEO Michael Macaluso, “extensive preparatory work is already underway. We hope to start the trial in May.”
About Osteoarthritis
Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company focused on the development of Ampion to treat prevalent inflammatory conditions for which there are limited treatment options.
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 such as the SPA, whether the FDA will approve the same and the timing thereof, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements for any of its products, including Ampion and Optina, clinical trials and decisions and changes in business conditions and similar events, 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 Contact
Phone: (720) 437-6500
info@ampiopharma.com
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Ampio Pharmaceuticals, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2019 10-K Annual Report includes:
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Consultants and other related costs decreased for the 2019 quarter compared to the 2018 quarter as we finalized a quality control project related to the manufacturing of Ampion.
During the 2018 period, we received gross proceeds from the sale of common stock in a confidentially marketed public offering of $8.0 million, which was offset by offering related costs of $844,000.
An SPA is a process in which sponsors may ask to meet with the FDA to reach agreement with the FDA on the design and size of certain clinical trials to determine if they adequately address scientific and regulatory requirements for a study that could support regulatory submission.
The operating expenses increased $2.8 million from the 2018 period to the 2019 period primarily due to a $1.8 million increase in research and development costs and a $1.0 million increase in general and administrative costs, which is further explained below.
Patent costs for the 2019 quarter decreased compared to the 2018 quarter as we continued to allow non-essential patents to lapse and discontinue prosecution of patent applications that are non-essential to our future commercialization of Ampion.
The operating expenses increased $3.2...Read more
The Company?s projection also reflects...Read more
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Consulting and other costs decreased...Read more
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Financial Statements, Disclosures and Schedules
Inside this 10-Q Quarterly Report
Material Contracts, Statements, Certifications & more
Ampio Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits
Ticker: AMPE
CIK: 1411906
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-19-010403
Submitted to the SEC: Thu Nov 07 2019 11:32:23 AM EST
Accepted by the SEC: Thu Nov 07 2019
Period: Monday, September 30, 2019
Industry: Pharmaceutical Preparations