Ampio Pharmaceuticals, Inc. announced their 2017 financial results during a conference call hosted on Wednesday, March 7th at 5:00 pm EST. Included below are highlighted disclosures from the corporate update and filed Annual report on Form 10K.
ENGLEWOOD, Colo., March 15, 2018 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced their 2017 financial results during a conference call hosted on Wednesday, March 7th at 5:00 pm EST. Included below are highlighted disclosures from the corporate update and filed Annual report on Form 10K.
Year End and Fourth Quarter 2017 Highlights
- Pivotal trial, AP-003-C, demonstrated positive results for both primary and secondary endpoints with Ampion™ treatment in severe osteoarthritis of the knee (OAK)
- Primary endpoint achieved statistical significance when 71% of Ampion-treated patients met the OARSI responder criteria, which exceeded the historically based standard control for a meaningful treatment in severe OAK (p < 0.001).
- Ampion was statistically superior to the historic saline control group in a composite endpoint of pain and function at 12 weeks (p < 0.001).
- Quality of life measures demonstrated statistically significant improvement at 12 weeks with Ampion treatment compared to the historically based standard (p < 0.001).
- Ampion was safe and well tolerated with no drug-related serious treatment-emergent adverse events (TEAEs).
- The Open Label Extension (OLE) study to support the long-term continuous use of Ampion with up to five injections a year began following the completion of pivotal trial AP-003-C.
- Peer-reviewed publication of severely diseased osteoarthritis of the knee (OAK) patients in Ampion clinical trials, the largest report of severely diseased patients to date, was published as a feature article in Orthopedics. https://doi.org/10.3928/01477447-20171114-05
Management Comments
Michael Macaluso, Ampio’s CEO and chairman of the board, commented, “We are excited about the positive pivotal trial read-out at the end of 2017 and look forward to continuing to advance the Ampion program. The improvements patients recognize in both pain and function were supported by the safety and tolerability of the product. With a serious and chronic condition like OAK, safety and continuous long-term use are critical. We are pleased to report the continued safety and tolerability of the product following three injections of Ampion with no drug-related TEAEs or serious TEAEs reported in the OLE study.”
Michael continued, “As a novel biologic, Ampion will be identified as a ‘reference product’ upon FDA approval. Reference products are granted twelve years of exclusivity under the PHS Act, 42 U.S.C. § 262(k)(7). Specifically, FDA is not permitted to approve an application for a biosimilar or interchangeable product until 12 years after the date of the first licensure of the reference product. Ampion is also supported by global patent coverage in all major jurisdictions for pharmaceutical compositions and methods of treating a range of conditions. The portfolio includes 125 issued patents and 85 pending patent applications throughout seven primary patent families having expiration dates that extend to 2035. This patent coverage and 12 years market exclusivity provide a strong runway for commercial market entry.”
Receipt of Audit Opinion with Going Concern Qualification
The Company is required under the NYSE MKT Company Guide Sections 401(h) and 610(b) to publish certain disclosures. As previously disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission on March 6, 2018, the Company’s audited financial statements contained a going concern explanatory paragraph in the audit opinion from its independent registered public accounting firm. This announcement does not represent any change or amendment to the Company’s financial statements or to its Annual Report on Form 10-K for the fiscal year ended December 31, 2017.
As announced during the March 7, 2018, conference call, the company received an additional $2.8M in the first two months of 2018 from the exercise of options and warrants. This increased cash on the balance sheet without any further dilution to our shareholders. The company has reduced the warrant position from 17.5M outstanding warrants at December 1, 2017, to 7.8M warrants outstanding as of February 28, 2018.
