AIM ImmunoTech Inc. logo

AIM ImmunoTech Inc.

AIM UA

AIM ImmunoTech Inc.NYSE MKT LLC

0.39

USD
-0.02
(-4.73%)

Q3 2016 · Earnings Call Transcript

Nov 15, 2016

Executives

Thomas Equels – President and Chief Executive Officer Dianne Will – Investor Relations

Analysts

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

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 is to reach agreement with certain European government authorities to gain early access program reimbursement approvals for the treatment of severe cases of ME/CFS in those countries. We are currently manufacturing, in the process of manufacturing lots of Ampligen now to fill that need which we expect will begin in 2017.

In the U.S., we recently met with the FDA in the first of a series of meetings. In order to identify and develop a path forward for Ampligen in the Chronic Fatigue Space and to confirm and finalize a protocol for any kinds of further confirmatory trials that the FDA may require.

We believe that we have a compelling case for Ampligen and we hope to update you on our discussions with the FDA in the coming months. We have also executed an agreement with Nitto Denko Avecia, which is formally known as Avrio Biopharmaceuticals.

And that's to use them as an additional contract manufacturer for the compounding and fill and finish of sterile clinical and commercial grade Ampligen that process is underway and moving nicely. The addition of Avecia, will help to supply the needs for the Company's ongoing domestic clinical studies as well as the early access programs in Europe and Turkey.

In October, we successfully completed the technology transfer, which is an engineering run basically, of all information necessary for the manufacturing of Ampligen and associated assays. With the test engineering run completed, we anticipate the first lots of Ampligen to be filled and finished this month.

With release in late December or early January for the Early Access Program in Europe and other clinical issues. Finally with regard to Alferon, the flood damage repairs to our Alferon manufacturing facility have been completed.

Currently the manufacturing process is on hold due to the complete shutdowns after the flood that we had in January of this year. We cannot now propose a definitive timetable to have the Alferon facility back online due to the need to rerun all validation lots in the newly upgraded facility and to the high cost estimates related to bringing the facility back on line we will need additional funds to finance the revalidation process in our facility and to initiate commercial manufacturing.

We have to prepare ourselves for the FDA pre-approval inspection for Alferon. Those funds will either come from potential cash flow from sales or from a co-development partner, neither which are currently at hand.

Moving now to our corporate and business highlights for the third quarter as we discussed in our previous call at our Annual Meeting in May stockholders approved an amendment to the – I said Annual Meeting in May I apologize, it was later in the year. Our stockholders approved an amendment to the Company's Certificate of Incorporation to reverse stock split in order to gain compliance with the New York Stock Exchange's listing requirements.

Hemispherx stock began trading on a stock split adjusted basis on August 29. And we were officially informed by the New York Stock Exchange that we have regained compliance with the listing requirements of the Exchange.

During this period we entered into agreements with two health care focused institutional investors for an offering of common stock in a Registered Direct facilitated by Rodman & Renshaw, an H.C. Wainwright.

Gross proceeds from this offering was approximately $5 million and the proceeds will be used for technology transfer opportunities expenses related to new lots of Ampligen being manufactured at Avecia and for other working capital in general and corporate purposes. We have settled this quarter all remaining material litigations this allows us to free up substantial funds and management time to focus on the future of Ampligen and our clinical work.

Now finally I'd like to review the creation this past quarter of our Scientific Advisory Board. The board consists of our Chairman of the Board of Hemispherx Dr.

William Mitchell and Dr. Ronald Brus from Holland.

Dr Neal Burnette, a famous scientist in the United States who invented the Western blot and a well esteemed oncologist Dr. Christopher Nicodemus.

Dr. Mitchell is the Chairman of the Board of Directors of Hemispherx as I mentioned and he is also going to Chair the Scientific Advisory Board.

We believe the Scientific Advisory Board will provide invaluable experience and advice as we continue our discussions with the FDA as well as, as we navigate the Argentinean and European regulatory systems on our path toward global commercialization of Ampligen for ME/CFS and other indications. Now I would like to review our financials with you for the period ended September 30 2016.

In the first quarter when we announced changes in the management team we also committed to preserve capital. So we can better achieve our corporate goals our income statement reflects these initiatives as being successfully implemented.

As evidenced by the significant reduction in expenses compared to a year ago. Total operating expenses for the third quarter in 2016 were $3.248 million, a 19% decrease from the same period in 2015.

This expense control is also reflected in our much reduced use of cash. The cash used for the third quarter was $3.061 million representing a 13% decrease for the same period in 2015.

Importantly no Company funds were used to pay for costs related to the litigation settlements, we previously announced. And cash, cash equivalent and marketable securities were approximately $8.009 million as of September 30, 2016 as compared to $8.910 million as of December 31, 2015.

I would like to conclude by saying that we continue to focus the Company and believe that the approval of Ampligen in Argentina, our manufacturing process and our recent capital raise all help to position the Company for a successful future. I would also like to announce that the Company will be presenting at the LD Micro Conference on Tuesday December 06, at the Luxe Sunset Boulevard Hotel in Los Angeles.

I look forward to seeing many of you there. Now at this time, I'd like to address some of the questions that we've received from investors and stockholders.

Q - Dianne Will

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

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

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

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

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

Thomas Equels

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

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

Thomas Equels

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

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

Thomas Equels

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

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

Thomas Equels

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

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

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

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

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

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

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

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

Thomas Equels

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

We can now disconnect all lines. Thank you.

)