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AIM ImmunoTech Inc. (AIM)

Q3 2016 Earnings Call· Tue, Nov 15, 2016

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen and welcome to the Hemispherx Biopharma Conference Call. At this time, all lines have been placed on a listen-only mode. Before management begins speaking, the Company has the following statements. To the extent that statements on this conference call are not strictly historical, as such statements are forward-looking, are based upon the current beliefs and expectations of the Company's management, are subject to significant risks and uncertainties, and are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. We are obliged by law to provide certain legal and binding disclaimers before we begin. Words such as intends, plans, potential, beliefs, potentially, possible and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from these contemplated in these forward-looking statements. For example, because numerous risks and uncertainties exists despite our efforts and belief regarding approvals, we cannot assure Ampligen will ever be commercially approved for any treatment, or that Alferon N Injection will ever be commercially approved for potential new treatment indications, or for the new manufacturing procedures underway. Examples of such risks and uncertainties include the risks described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q, and 8-K. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligations to update or revise the information discussed on this conference call, whether as a result of new information, future events or circumstances or otherwise revised or update this release to reflect events or circumstances after the date hereof. With that covered, it is now my pleasure to turn the floor over to your host, Mr. Thomas Equels, President and Chief Executive Officer of Hemispherx Biopharma. Sir, the floor is yours.

Thomas Equels

Management

Good morning welcome to Hemispherx's third quarter 2016 conference call. We have made significant progress on a number of initiates this past quarter. The new Hemispherx has begun to lay the groundwork for long-term success in our belief. Thank you to those of you who have submitted questions in advance as requested in our press release. We have received many questions and many of you had the same or similar questions. Accordingly we have grouped them into three sections. First I will discuss the progress we have made with Ampligen. Second I will review our corporate and business highlights. And finally I will give you a financial overview for the third quarter. As to Ampligen on August 23, this quarter we announced a major breakthrough. Ampligen was approved by ANMAT. ANMAT is the FDA of the Republic of Argentina. It was approved for the treatment of severe cases of Chronic Fatigue Syndrome. This is the first commercial approval for Ampligen and it also represents a significant milestone for our Company. Ampligen is the first drug to receive approval for CFS anywhere in the world. Since the ANMAT of Argentina is a well respected regulator in South America the approval of Ampligen opens new pathways for potential new drug approvals in other South American countries. We are now working closely with our partner GP Pharm in order to move forward with the necessary post approval steps to initiate a commercial launch of Ampligen in Argentina and then in other countries as approved in South America. We expect this process to take approximately 12 months to 18 months. In Europe we are aggressively moving our early access programs forward. The first shipment of Ampligen was sent to myTomorrows and we are currently working closely with our European partner myTomorrows. A top priority…

Q - Dianne Will

Operator

Thank you Tom, your first question is what is the latest information about the subgroup that could serve as an endpoint for the new Phase 3 trial for Chronic Fatigue Syndrome?

Thomas Equels

Management

Okay. Well first let me respond by saying that this concept of a subgroup, a high responder subgroup is not intended to set an endpoint what it's intended to do is help design a study protocol regarding inclusion and exclusion criteria for the clinical trials. And to follow-up on that we've recently received an indication from the FDA that the subset that we're proposing is acceptable. Now the reason this is important is because when we apply the data from the prior Phase 3 trial to this narrower subgroup it demonstrates an extremely robust response in terms of the efficacy of Ampligen for that subset of CFS sufferers.

Dianne Will

Analyst

Thank you. And the next question is on the subject of selling the warehouse. Is the warehouse already sold and if so for how much?

Thomas Equels

Management

Okay, with regard to that question it's first important that I point out when we talk about the warehouse, we're talking about an unused building on a separate lot that we own. It is not the manufacturing facility, which is adjacent to it now with regard to that we have currently signed a letter of intent with a bonafide purchaser to purchase this spare asset and we are working as we speak on finalizing a sales agreement.

Dianne Will

Analyst

Okay thank you. The next question is can you provide insight into progress made on potential partnerships?

Thomas Equels

Management

Yes, I assure you we are working very diligently with Huron Consulting and are using our own internal resources to reach out to potential partners. We are currently providing these with potential partners with additional requested information. However this is a long process and it may take some time before we are able to announce a deal that would be beneficial for the company and its shareholders. Not every deal is the right deal and we're going to take our time and try our very best as we reach partnerships in the future to make sure they're in the best interest of the Company.

Dianne Will

Analyst

Okay, thank you. When do you anticipate generating revenues from Ampligen in Europe?

Thomas Equels

Management

Well. We have a sequence of events for Europe that is very close at hand. We are currently manufacturing Ampligen and we're in the final stages of that manufacturing process creating new lots of Ampligen. We are also currently working on reimbursement processes in multiple countries in Europe through our partner in Europe myTomorrows. And additionally there are potential patients that are able to privately fund treatment or have other resources to fund treatment. So it is our expectation as the new lots of Ampligen are produced that we will begin sales under early access programs in Europe as well as working towards various clinical initiatives in the United States. And supplying the necessary Ampligen from that manufacturing process for testing and approvals in Argentina.

Dianne Will

Analyst

Okay, thank you and the next question is when do you expect sales in South America for Ampligen.

Thomas Equels

Management

Well I think I've already mentioned that while we have the commercial approval of the new drug application in Argentina the Argentine FDA called the ANMAT has certain things that it has to do subsequent to that approval before we can commence sales. That includes the inspection of manufacturing processes, testing, various testing in technical matters. Additionally we are in discussions with the government of Argentina. We will be seeking to reach agreement on pricing before the commercial launch as well, so that the reimbursement system in Argentina is complied with an all material respect before we begin our commercial launch. We anticipate this process could take as long as 12 months to 18 months to complete.

Dianne Will

Analyst

Thank you. And the next question is what is the $5 million raised in the recent financing used for?

Thomas Equels

Management

The money raised in this recent financing is being used for general operational activities research and development purposes the accelerated manufacturing activities to create new lots of Ampligen and create revenues in the future through our early access programs.

Dianne Will

Analyst

Thank you. And the next question is can we expect a reverse split in the near future or in the future I am sorry.

Thomas Equels

Management

Well I want to emphasize that we undertook the reverse split, that we did to resolve a particular listing requirement of the New York Stock Exchange because we were trading below $0.20 a share. There are no plans to initiate another reverse split and we believe an additional reverse split would not be necessary in the foreseeable future.

Dianne Will

Analyst

Thank you. Do you think the identification of a high responder subgroup can help to obtain a special protocol assessment with the FDA?

Thomas Equels

Management

We're currently working with the FDA on such questions and we’ll update you once we have a clear path forward. However I want to say that the identification of this subgroup. Does give us a confidence that we’ve established parameters for an extremely robust response with Ampligen, with CFS suffers in that subgroup.

Dianne Will

Analyst

Thank you. And the last question I have for you Tom is. the Company disclosed a schedule with the FDA concerning the additional Phase 3 trial requested. Can you discuss in general what kind of timeline we are looking at for the trial design and an [indiscernible].

Thomas Equels

Management

Well as mentioned earlier we're working with the FDA and it is too early to say what that timeline might be. The early protocol design elements are currently being worked out with the FDA and we would like to move the ball forward as quickly as possible.

Dianne Will

Analyst

And that was the last question I had for you Tom.

Thomas Equels

Management

Well thank you very much and I would like to emphasize to our stockholders. Who are attending this call and have stuck with us for many years. That the new Hemispherx is focused on building us into a successful biopharmaceutical company. On one side we're working to try and leverage our existing clinical and early access programs to facilitate future growth. On the other hand we are aggressively working both internally and externally with partners and regulators to move our programs forward. I look forward to speaking to you next quarter. And I want to thank you for attending. I also want to thank you for supporting us. And I wish you a happy holiday.

Dianne Will

Analyst

We can now disconnect all lines. Thank you.