News Release
Dr.
Dr. Carlo added, “The successful underwritten public offering of common stock has provided the necessary resources to advance our pipeline. We were fortunate to have had multiple fundamental health care funds lead that offering. These recent advancements have put Adamis in a strong position for growth.”
Company Highlights and Product Updates
Some of the company’s product updates and accomplishments since the beginning of the second quarter of 2018 include the following:
- Symjepi (epinephrine) Injection 0.30mg – The company entered into a commercialization and distribution agreement with
Sandoz , a division ofNovartis , to market and sell Symjepi in the U.S. Key terms include:Sandoz to pay a supply price to Adamis for product, Adamis 50% profit split andSandoz right of first negotiation for territories outside the U.S.; - APC-8000 (sublingual tadalafil) – The company is developing a new fast-dissolving sublingual tablet containing tadalafil (Cialis®) and intends to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (
FDA ) with the goal of filing a New Drug Application (NDA) before year-end; - APC-6000 (naloxone) – We continue to advance our naloxone product candidate for opioid overdose, and plan to file an NDA with the
FDA before year-end. This is our second product using ourFDA -approved injection device; - APC-1000 (beclomethasone) – The
FDA cleared Adamis to begin Phase 3 pivotal studies with our beclomethasone metered dose inhaler and we are planning to begin patient recruitment in Q4; - APC-4000 (fluticasone) – Fluticasone will be our first product candidate using our patented dry powder inhaler device platform purchased from
3M . We continue to work on proof of concept studies with the objective of demonstrating proper dosing of the steroid; - Balance sheet – We strengthened our cash position with an underwritten equity offering that raised net proceeds of approximately
$37.6 million .
Second Quarter Financial Results
Revenues were approximately
Net loss from operations for the three months ending
SG&A expenses for the three months ended June 30, 2018 and 2017 were approximately
R&D expenses were approximately
At
Future Milestones for 2018
- Commercial launch of Symjepi (epinephrine) Injection 0.3mg in the U.S. – timing of launch and commercial strategy will be at Sandoz’s sole discretion;
FDA approval of lower dose Symjepi (epinephrine) Injection 0.15mg;- Announcement of ex-U.S. strategy for Symjepi;
- Filing an NDA for naloxone injection;
- Filing an NDA for the sublingual tadalafil (Cialis®) tablet;
- Commencement of Phase 3 studies for beclomethasone in asthmatics;
- Growing net revenue of outsourcing facility (U.S. Compounding) by 30% over 2017.
About
Adamis Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the following statements: the company’s beliefs concerning anticipated commencement and completion dates for clinical trials; the company’s beliefs concerning the timing and outcome of commercialization arrangements for its Symjepi (epinephrine) Injection 0.3mg product; the company’s beliefs concerning achievement of goals or milestones during the 2018 year; the company’s beliefs concerning the timing of commencement of and outcome of the FDA’s review of the company’s supplemental New Drug Application (sNDA) relating to the lower dose Symjepi (epinephrine) Injection 0.15mg product candidate, any Investigational New Drug Application that the company may file in the future relating to its sublingual tadalafil product candidate or other product candidates, or other regulatory filings relating to the company’s product candidates; the timing and outcome of any further studies or trials relating to the company’s product candidates; statements about strategies, objectives and our future goals and achievements; the company’s ability to commercialize its product and product candidates; the company’s beliefs concerning the ability of its products and product candidates to compete successfully in the market; the company’s beliefs concerning the safety and effectiveness of its products and product candidates; expectations and goals for future growth; current or planned clinical trials or research and development activities; product development timelines; anticipated dates for commercial introduction of products; guidance regarding future periods; the company's beliefs concerning the safety and effectiveness of its products and product candidates; and other statements concerning our future operations and activities. There can be no assurances regarding the timing of outcome of the FDA’s review of our sNDA. In addition, product development time is subject to a number of risks and uncertainties which can delay the actual development time beyond our expectations. The timing of any NDA filing relating to any of our products candidates could be affected by a number of factors, including, without limitation, the availability of adequate funding, the presence or absence of unexpected regulatory issues or delays, negotiation of any required agreements with third parties, the time period required to enroll a sufficient number of patients in studies, results of trials or studies, the time required to complete and analyze the results of the studies, and
Contacts:
Senior Director, Investor Relations
& Corporate Communications
(858) 412-7951
mflather@adamispharma.com
Source: Adamis Pharmaceuticals Corporation