AIM ImmunoTech Inc (AIM) 2017 Q2 法說會逐字稿

Good afternoon, everyone, and thank you for joining us today to review Hemispherx 2017 fiscal year-end conference call. Representing the company today is Mr. Thomas Equels, Chief Executive Officer.

We are obliged by law to provide certain legal and binding disclaimers before we begin. Words such as intends, plans, potential, believe, 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 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 exist, despite our efforts and beliefs 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 in 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 obligation to revise -- to update or revise the information discussed on this conference call, whether as a result of new information, future events or circumstances, or otherwise revise or update this information 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.

Good afternoon, everyone. I'm Tom Equels. Welcome to Hemispherx Second Quarter Conference Call. Today, I'll start by summarizing Hemispherx accomplishments since our last conference call, which reviewed our corporate and business highlights. And finally, I'll give a financial overview for the 6 months ended June 30, 2017. I've incorporated the topics of the questions that we have received into my discussion.

We have had some very important events occur at our company during the past year and since our last call. Events that I'm very enthusiastic about. Most our -- overarching of which is our decision to repurposing Ampligen beyond the single indication of ME/CFS so as to maximize the potential of this proven immunotherapeutic in indications in which a healthier and more stimulated immune system can play an important role in successful medical outcomes. This decision was based on reams of scientific data and human trials in oncology, which, frankly, got buried in the company's files some years ago in favor of a once, total focus on ME/CFS. As I will describe later, we have taken Ampligen now into pancreatic cancer, and we are looking closely at opportunities for Ampligen as a vaccine adjuvant.

We are very excited to have been able to announce a few days ago that the study with the Ampligen plus FluMist in human safety trials known as AMP-5 -- AMP-600 has been completed. We know now that like in the intravenous applications of Ampligen, where Ampligen with almost 100,000 doses having been administered, is generally well tolerated in humans. So intranasally, we have every indication that Ampligen is generally well tolerated in humans. This is very important.

We are very encouraged by the outcome of this study because it establishes a foundation for Ampligen as a intranasal adjuvant. This shows Ampligen's potential to take us to the next step in developing Ampligen, either as a strain specific, or more universal influenza intranasal vaccine immune-enhancing adjuvant. This safety study was the first milestone to our ultimate goal, which is to combine Ampligen with a non-live virus vaccine to produce stronger and broader coverage and to confer longer immunity than is possible with the vaccine alone. I firmly believe that Ampligen's multifaceted impact on the immune system will redefine the term adjuvant. Ampligen is a highly selective TLR-3 agonist that induces the innate immune responses required for adaptive protective immunity. For example, monkeys immunized with H5N1 vaccine and Ampligen showed enhanced protection after being challenged with a homologous highly pathogenic H5N1 virus.

Preclinical studies also showed cross protection against H5N1 viruses using trivalent seasonal vaccines in mouse models. In theory, Ampligen-induced cross protection may extend to any vaccine for viruses subject to a high mutation rate and genetic drift.

Another event of particular importance since our last call, we announced last week that we were working in Canada with the Canadian advocacy group called Millions Missing Canada and a Canadian physician representing patients with ME/CFS in support of a collaborative effort to advance ME research and potential treatments in Canada. This joint effort, which includes Dr. Ian Hyams, a leading physician specializing in ME management, is the next step in potentially bringing Ampligen to Canadians suffering from the disease. Hemispherx and Millions Missing Canada will follow the model that Hemispherx successfully used to obtain commercial approval in Argentina. We will seek a local Canadian partner, a Canadian-based pharma, who will file with us for regulatory approval in Canada. The plan is to use existing Ampligen New Drug Application databases to gain approval of Ampligen in severely debilitated ME patients in Canada. We will seek to narrow the label so as to address the patient population most in need and focus on the group that has previously shown the most robust responses.

We are very pleased to be working with Millions Missing Canada and Dr. Hyams on this important issue. Canada has one of the highest worldwide per capita incidences of ME. There is no therapy in the late-stage pipeline there, and these people are completely disabled without any kind of therapy available. It's an unmet medical need that must be addressed without further delay.

While we are on the topic of ME/CFS, there was a new research article published on July 31 in the proceedings of the National Academy of Science, which was widely covered in the news and was even covered in a segment of ABC's Good Morning America. This new study, led by a team of researchers from Stanford University, may provide the basis for a long diagnostic to test for ME/CFS, which is estimated to afflict more than 1 million Americans according to the Center for Disease Control. This new study, led by a team of researchers from Stanford, is basis for prevention effectively. The diagnostic will allow early treatment and allow us to move forward if it's developed successfully. This study, led by Dr. Jose Montoya, found that people with ME/CFS had blood levels of certain protoinflammatory cytokines that correlated with disease symptom severity. These findings suggested a link between excessive inflammation and the disease exists. This further makes it clear that ME/CFS is a devastating biological disorder. When you put this all together, it appears very encouraging that we may be moving closer to having a lab or doctor's office blood test that could not only confirm a ME/CFS diagnosis, but also confirm the stage of progression of the disease.

In January, we announced that an Early Access Program contract with myTomorrows, originally designed to enable Ampligen to be available for European ME/CFS patients, had been extended to pancreatic cancer. MyTomorrows who is our exclusive provider in Europe and Turkey, manages all EAP activities related to the extension for pancreatic cancer patients in addition to activities regarding early access use in ME/CFS. Pancreatic patients generally have a very poor prognosis and very few therapeutic options. This cancer is commonly diagnosed at an advanced stage, and there is a 5-year survival rate of roughly only 7%. We expanded our EAP to a patient population for this devastating malignancy with a clearly unmet medical need and can hopes that Ampligen can become a lifeline for those in desperate need.

At the beginning of the second quarter, we announced that Hemispherx continues to enhance our manufacturing and scientific abilities with the promotion of Carol Smith, Ph. D. to Chief Manufacturing Officer as well as Deputy Chief Science Officer. In this new role, which is critical to our plan to increase Ampligen production, Dr. Smith will be responsible for all manufacturing processes of Ampligen and Alferon to satisfy the Early Access Program for pancreatic cancer and ME/CFS as well as U.S.-based compassionate care programs such as AMP 511. She will work closely with Dr. David Strayer, our Chief Scientific and Medical Officer, to assist in managing the company's scientific, technological and research operations. At the same time as Dr. Smith's promotion, we also appointed Dr. Joseph Horvath as Deputy Chief Medical Officer to oversee the Ampligen EAP pancreatic cancer programs. In this newly created position, Dr. Horvath will assist us on various scientific aspects of development, manufacturing, regulatory and medical affairs with a focus on assisting with the oversight of the current Ampligen EAP program that's in place for pancreatic cancer. Dr. Horvath has considerable experience in immuno-oncology research, which is anticipated to be especially helpful in our expanding efforts in the immuno-oncology as well as our ongoing work in ME/CFS. His experience is expected to ensure a continuation of successful organization and planning for upcoming clinical studies that we expect to conduct in the United States in the immuno-oncology space.

An important step achieved this year is the kickoff of our immuno-oncology programs. We are vigorously repurposing Ampligen as a broadly indicated immuno-oncology agent. By repurposing the experimental drug from a sole focus on ME/CFS, we take advantage of a fully developed safety profile, that has emerged over the years from the approximately 100,000 doses utilized in prior clinical studies showing that Ampligen was generally well tolerated in humans. No other TLR agonist showing the high levels of bioactivity of Ampligen in oncology comes into the cancer space with such a strong and positive safety profile.

Our belief in Ampligen's potential as a therapy in oncology is based not only on its direct antitumor cell activity, but also on its immunomodulatory activities, which may be important in providing a favorable tumor microenvironment for therapy. Our goal is repurposing Ampligen into a serious player in immuno-oncology. We are deeply committed to providing a therapeutic solution to the large unmet medical need in pancreatic cancer, which is one of the leading causes of cancer death in Europe, as research shows as well as other solid tumors where there are unmet medical needs.

I would like to now review our financials for the 6 months ended June 30. We continued to remain committed to preserving capital so that we can better achieve our corporate goals. Our income statement continues to reflect these initiatives as evidenced by the significant reduction in expenses compared to a year ago. The net loss for the 6 months ended June 30, 2017 was approximately $5,014,000 or $0.19 per share as compared to a net loss of $3,467,000 or $0.16 per share for the same 6-month period in 2016. There are factors related to our manufacturing that account for that change. And this expense control is also reflected in our much reduced use of the cash. Cash equivalents and marketable securities were approximately $3,211,000 at June 30, 2017 as compared to $5,868,000 as of December 31, 2016.

So if I may, I'd like to summarize our initiatives and accomplishments in 2017. We have generated the first sales of Ampligen through our Early Access Programs in Europe. We continue discussions with the United States Food and Drug Administration so that we can develop a path forward for the approval of Ampligen in ME/CFS. We are continuing our efforts to secure out-licensing opportunities and/or senior codevelopment partnerships for our products. We are beginning efforts in Canada to secure a partner to gain approval of ME/CFS in Canada, and we continue to adhere to our plan of financial responsibility.

I would like to conclude by saying that we continue to focus the company and believe that the approval of Ampligen in Argentina, the EAP programs, Early Access Programs, our manufacturing progress and capital raises, help position our company for it's success in the future. Again, I want to emphasize to you, our shareholders, that we are focusing on building Hemispherx into a successful biopharmaceutical company. As you can see, we have dramatically cut costs across the board from a few years ago, and yet with a fraction of the resources, we are delivering a spectacular number of tangible results. The team at the new Hemispherx is dedicated. We are all dedicated to achieving results that will ultimately translate into increased stockholder value for you. We are working to leverage our existing clinical and Early Access Programs to facilitate future growth. We are aggressively working both internally and externally with partners and regulators to move our programs forward. We look forward to updating you on our next quarterly call, and we thank you for joining us today. Thank you very much.

Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation.