Ampio Pharmaceuticals, Inc.

AMPE Details

Ampio Pharmaceuticals, Inc. (NYSE: AMPE) is a biopharmaceutical company focused on advancing immunology-based therapies to treat inflammatory conditions with limited treatment options. The company's primary product is Ampion, an anti-inflammatory biologic therapy, which will be eligible for 12-year market exclusivity approval by the US Food and Drug Administration (FDA) as a novel biologic under the Biologics Price Competition and Innovation Act (BPCIA).

Positive Research Outcome: On August 13, 2021, APME announced that the preprint version of the "LMWF5A Demonstrates an Anti-Inflammatory Mode of Action and Similar Drug Targets to Dexamethasone in Activated PBMC" manuscript mentioned the preclinical research done on Ampion, highlighting that it showed fewer harmful side effects while treating conditions that are supported for dexamethasone.

Beginning AP-014 Phase II trial:  On June 25, 2021, the company stated that it had commenced the double-blind, placebo-controlled AP-019 Phase II clinical trial for treating respiratory distress due to COVID-19 using inhaled Ampion. This follows the solid top-line results observed during the AP-014 Phase I trial. It is on track to initiate patient randomizing and dosing for the Phase II study.

Q2FY21 Results: The company reported no revenue for Q2FY21 (ended June 30, 2021). Total operating expenses for the quarter amounted to USD 3.67 million, representing a 47.21% increase from USD 2.60 million reported in Q2FY20, owing to 103.31% higher research & development (R&D) expenses. Net loss for Q2FY21 was USD 3.56 million vs. USD 2.73 million in Q2FY20. The company exited the quarter with a cash balance of USD 20.55 million and no outstanding debt.

Key Risks: AMPE initiated various clinical trials in June 2020 to determine the efficacy of Ampion as a treatment for COVID-19, which are currently in the early stages. While the company has invested substantial resources in its R&D, it may be unable to produce a drug that successfully treats COVID-19 related illness promptly or at all. In addition, the biopharmaceutical industry is extensively regulated, and any changes in regulations could increase the costs for the company.

Outlook: In its Q2FY21 press release, AMPE stated that it expects to have sufficient cash (including access to external sources of liquidity) to fund its R&D expenses and general corporate operations through Q4FY22.

AMPE Daily Technical Chart (Source: REFINITIV)

Stock Recommendation: AMPE's stock price has risen 18.23% in the last month and 123.79% in the past twelve months. It is currently trading close to the mid-point of the 52-weeks range of USD 0.62 to USD 2.98. In addition, the stock is trading above its 50 and 200 DMA levels, and its RSI Index is at 62.85. Considering the significant rise in the stock price, we believe the meagre business fundamentals are factored in at current trading levels. Hence, we recommend a "Sell" rating on the stock at the current price of USD 1.67, up 7.00% as of August 30, 2021, at 11:49 AM ET.

* The reference data in this report has been partly sourced from REFINITIV.

*All forecasted figures and industry information have been taken from REFINITIV.  

Disclaimer - This report has been issued by Kalkine Pty Limited (ABN 34 154 808 312) (Australian financial services licence number 425376) (“Kalkine”) and prepared by Kalkine and its related bodies corporate authorised to provide general financial product advice. Kalkine.com.au and associated pages are published by Kalkine.

Any advice provided in this report is general advice only and does not take into account your objectives, financial situation or needs. You should therefore consider whether the advice is appropriate to your objectives, financial situation and needs before acting upon it.

There may be a Product Disclosure Statement, Information Statement or other offer document for the securities or other financial products referred to in Kalkine reports. You should obtain a copy of the relevant Product Disclosure Statement, Information Statement or offer document and consider the statement or document before making any decision about whether to acquire the security or product.

You should also seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice) as necessary before acting on any advice in this report or on the Kalkine website. Not all investments are appropriate for all people.

The information in this report and on the Kalkine website has been prepared from a wide variety of sources, which Kalkine, to the best of its knowledge and belief, considers accurate. Kalkine has made every effort to ensure the reliability of information contained in its reports, newsletters and websites. All information represents our views at the date of publication and may change without notice.

Kalkine does not guarantee the performance of, or returns on, any investment. To the extent permitted by law, Kalkine excludes all liability for any loss or damage arising from the use of this report, the Kalkine website and any information published on the Kalkine website (including any indirect or consequential loss, any data loss or data corruption). If the law prohibits this exclusion, Kalkine hereby limits its liability, to the extent permitted by law, to the resupply of services.

Please also read our Terms & Conditions and Financial Services Guide for further information.

On the date of publishing this report (referred to on the Kalkine website), employees and/or associates of Kalkine and its related entities do not hold interests in any of the securities or other financial products covered on the Kalkine website.

Kalkine Media Pty Ltd, an affiliate of Kalkine Pty Ltd, may have received, or be entitled to receive, financial consideration in connection with providing information about certain entity(s) covered on its website.