ENGLEWOOD, Colo., Nov. 5, 2020 /PRNewswire/ -- Ampio
Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company
focused on the advancement of immunology based therapies for
prevalent inflammatory conditions, today, at 4:30pm EST, will provide an update and overview
of its clinical development pipeline / activities and its financial
results for the third quarter ended September 30, 2020.
Attending the webinar from Ampio will be, Mr. Michael Macaluso (President and CEO), Dr. David
Bar-Or (Director and Founder), Ms. Laura
Goldberg (Vice President) and Mr. Daniel Stokely (CFO). The key areas of
focus will be as follows:
COVID-19 Platform / Pipeline Overview and Update
- AP-014 (inhaled) and AP-016 (intravenous) clinical trial
update
- Possibility of obtaining an Emergency Use Authorization (EUA)
from the FDA for inhaled Ampion
- Discussion of the differences between Ampion vs. other
therapeutic options for COVID-19
OAK Clinical Trial 2020 Timeline / Update
- Ampio's Osteoarthritis of the Knee (OAK) Phase III trial being
conducted under a Special Protocol Assessment (SPA) with the FDA
has been paused as a result of COVID-19
- FDA released "FDA Guidance on Conduct of Clinical Trials of
Medical Products during the COVID-19 Pandemic" in April 2020
- FDA released "Statistical Considerations for Clinical Trials
During the COVID-19 Public Health Emergency" in June 2020
- Ampio harmonizes steps for OAK Phase III trial with the FDA
guidance and submitted an SPA amendment to the FDA
Financial Update
As of September 30, 2020, Ampio had $9.4 million of cash and cash equivalents, as
compared to cash and cash equivalents of $6.5 million as of December 31, 2019.
For the third quarter of 2020,
research and development costs were $1.7
million, down 52% from $3.4
million for the same period in 2019. This decrease was
primarily attributable to a decrease in clinical trial and
sponsored research costs. Ampio expects clinical trial and
sponsored research costs to increase during the fourth quarter of
fiscal 2020 due to the AP-014 inhaled Ampion study.
Operations / manufacturing
expenses increased $190,000 in the
current quarter, when compared to the same period in 2019.
General and administrative costs
decreased $98,000, or 5.6%,
from $1.7 million for the same period
in 2019.
Ampio reported a net loss for the
third quarter of $3.4 million
compared to a net loss of $7.2
million for the same period in 2019.
To access the webinar, please log in to
https://www.webcaster4.com/Webcast/Page/2569/38512 approximately 10
minutes prior to the start of the call. To ask a question,
please dial in to 888-632-3385 (U.S.) or 785-424-1673
(International) and use the Participant Entry Code: 47668. Please
note that you can also ask a question through the webinar
platform.
A replay of this presentation will be available two hours after
the end of the call by dialing 877-481-4010 (U.S.) or 919-882-2331
(International). Replay Passcode: 38512
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 United States Private Securities Litigation Reform
Act of 1995, as amended to date. 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 the safety and efficacy of Ampion and its
classification, as well as those associated with regulatory
approvals and other FDA decisions, the Biologics License
Application (BLA), the ability of Ampio to enter into
partnering or licensing arrangements, current or future clinical
trials, changes in business conditions and similar events
(including currently unforeseen risks associated with COVID-19),
the possibility that Ampion may be used to treat ARDS induced by
COVID-19, Ampio's ability to continue as a going concern and its
ability to continue to raise funds using its "at-the-market" equity
offering or otherwise, 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, in Ampio's Annual Report on Form 10-K for the
period ended December 31, 2019, and
in subsequent reports on Forms 10-Q and 8-K and other filings made
by Ampio with the Securities and Exchange Commission. Accordingly,
you should not place undue reliance on these forward-looking
statements. 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
Investor Relations
Joe Hassett
joeh@gregoryfca.com
484-686-6600
View original content to download
multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-inc-provides-business-update-and-reports-third-quarter-2020-financial-results-301167439.html
SOURCE Ampio Pharmaceuticals, Inc.