AGM 2020

Jun 8, 2020

Good morning. We'll immediately please come to order. My name is Ian Dukes and I'm the Chairman and Board of Directors of Ionac Biotherapeutics Incorporated. I'm pleased to welcome all of you to this annual meeting of stockholders for BioBalance Biotherapeutics. In light of the public health impact of the coronavirus outbreak and in order to help protect the health and well-being of our shareholders and employees, this meeting is being held virtually through a live webcast. I'd like to introduce you to Ionances' directors and officers who are attending today's meeting. Maria Faris, Athena Kuntakuris, Ryan Maynard, Merrill A. McKee, Wayne P. Rothbaum and Michael Weiser are all directors of the company. Doctor. Parnes is also the company's President and Chief Executive Officer. 2 of our other officers, Timothy Morris, our Chief Financial Officer and Trent Voytes, our General Counsel are also in attendance. Also present is Alan Margarits, a representative of Marcom LLP, the company's independent registered public accounting firm. Alan is available to respond to appropriate questions regarding the company's audited financial statements. Isaac Kagan of Continental Stock Transfer and Trust Company, the company's transfer agent, has been appointed to serve as Inspector of the Election for the Annual Meeting and will deliver a report about the results of the stockholders' votes on the matters that will be considered at today's meeting. Mr. Kagan has signed an oath to serve as the Inspector of Election, which will be filed with the Minister of the meeting. Isaac, do we have a quorum and please explain the procedures for voting today. Good morning. As the Inspector of Elections, I hereby confirm that at least 113,000,000 543,749 of the 126,000,000 846,818 shares of our common stock that were outstanding on the record date are represented at this meeting. I therefore declare that Aquarum is present and that this meeting is duly and properly convened. The polls are now open for voting online. If you are a stockholder of record and wish to vote online, please do so by following the instructions in the online meeting portal. As a reminder, you will need your 12 digit control number in order to access the meeting and vote your shares through the online portal. If you require any assistance or experience any technical difficulties, please contact the Continental Stock Transfer and Trust technical support team by following the instructions in the online portal. If you have any questions, you may use the online portal to submit them at any time. At the conclusion of the legal portion of the meeting, Doctor. Fardis will give a brief presentation on the company's business. Following the presentation, approximately 15 minutes has been set aside for question and answer session. If you have already voted by proxy and do not wish to change your vote, you do not need to cast the vote today. Iovance's proxy statement and notice of meeting were made available on April 27, 2020 to persons holding our shares as of the record date, April 16, 2020. Thank you. We will now discuss and vote upon each of the proposals scheduled to come before the meeting. I'd like to introduce Fred Voyage, IRMAD's General Counsel, who has been appointed to serve as the Secretary of the Annual Meeting and will conduct this powerful meeting. Fred? Good morning. We will now answer any questions from the floor regarding the proposals before we close the polls and proceed to a vote on the proposals. We will address any other questions during the question and answer session following Doctor. Flores' presentation. As a reminder, please refer to our rules of conduct to the meeting, a copy of which has been posted on the online meeting portal. Stockholders are generally limited to one question each and because our time is limited, we may not be able to answer all of your questions during each question and answer session. As there are no questions, the polls are now closed. We will now proceed to a vote on the proposals. The first matter on which stockholders are voting is the election of 7 directors to serve until the 2021 Annual Meeting of our stockholders. Our Nominating Committee has recommended and our Board of Directors has approved the following 7 nominees for election as Maria Fardis, Ian Dukes, Athena Contreiotis, Brian Maynard, Marolline McPeek, William P. Waltham and Mike Weiser. Information about all the director nominees is contained in our proxy statement. The 2nd matter on which stockholders are voting is the approval on a nonbinding advisory basis of the compensation of our named executive officers of IVANX Biotherapeutics is disclosed in our proxy statement. The 3rd matter on which stockholders are voting is the approval on a nonbinding advisory basis of the frequency of our future votes in the compensation of our named executive officer compensation of Avance Biotherapeutics as disclosed in the proxy statement. 4th matter on which stockholders are voting is for the approval of an amendment to the company's 2018 Equity Incentive Plan, increase the number of shares of the company's common stock authorized for issuance thereunder from 6,000,000 shares to 14,000,000 shares as disclosed in the proxy statement. The 5th matter on which stockholders are voting is for the approval of the company's 2020 employee stock purchase plan as disclosed in the proxy statement. The final matter on which stockholders are voting is the ratification of our appointment of Markham LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2020. As described in our proxy statement, the Board of Directors recommends that stockholders ratify the appointment of Mark and LLP. You will now hear from Isaac, who will read the preliminary report of the Inspector of Elections at each of the proposals in which the stockholders are voted. Based on the preliminary reports, Maria Fardis, Ian Dukes, Athena Kuntrijades, Ryan Maynard, Merrill A. McTic, Wayne P. Rothbaum and Michael Weiser have been elected as directors to serve until the 2021 Annual Meeting of Stockholders. 2, the stockholders have approved the compensation of the named executive officers as disclosed in the proxy statement. 3, the stockholders have approved that future votes on the compensation of our named executive officer compensation of the named executive officers of Iovance Biotherapeutics shall be held on an annual basis. 4, the stockholders have approved the amendment to the company's 2018 Equity Incentive Plan. 5, the stockholders have approved the company's 2020 employee stock purchase plan. And 6, the stockholders have ratified the appointment of Marcom LLP as Iovance's independent registered public accounting firm for the fiscal year ending December 31, 2020. The final results will be disclosed in the company's current report on Form 8 ks that the company expects to file no later than tomorrow. Thank you. The Inspector's report indicates that all the proposals before the meeting have passed. Our next order of business is to adjourn the meeting and hereby declare the quarterly meeting adjourns. I'd like to take this opportunity to thank you for your attendance and interest. I would now ask Doctor. Faris to give a presentation about Iovance's business and operations, and there will be an opportunity for questions from stockholders after her presentation. At the outset, I would like to note that during the course of Doctor. Fardis' presentation and the question and answer session, Doctor. Fardis or other representatives of the company may make forward looking statements regarding future events or future financial performance of the company. Such statements are predictions only, and actual events or results could differ materially from those made in any forward looking statements due to a number of risks and uncertainties, including assumptions about future events based on current expectations, planned business development efforts, near and long term objectives, potential new business strategies, organization changes, changing markets, marketing efforts, future business performance and outlook. I refer you to the company's most recent filings with the Securities and Exchange Commission, which contain and identify additional information covering factors as a cause or result to differ materially from those contained in our projections or forward looking statements. As is required by law, the company does not assume any responsibility for updating any forward looking statements, and the company claims the protection of the Safe Harbor are forward looking statements contained in the Private Securities Litigation Reform Act of 1995. Thank you so much. Good morning. I will be speaking about investigating the power of tumor and cell targeting lymphocytes for treatment of cancer. Next slide please. I'm on Slide 2. Thank you. I want to welcome you to the presentation. And on Slide 3, I draw your attention to forward looking statements. On Slide 4, I will be speaking about what tumor infiltrating lymphocytes are and what their unique mechanism of action is in cancer and treatment of cancer. This is a highly personalized therapy. This is our immune system amplified and rejuvenated and responding to various diseases in certain studies of cancer. The process involves excision of a tumor from a patient. About 1 centimeter cube is removed. It is then fragmented, placed in media and the two cells that are our own immune system in the setting of a tumor, departs the tumor. They start expanding and replicating in media. And once we have billions of cells, we then infuse those cells back into the patient. So it's a method of replicating our own immune system and activity of our immune system. I'm now moving to Slide 5, please. On Slide 5, I show the process by which we actually generate the Till. The top of this slide is a patient journey and the bottom of this slide is a tumor journey. So when we receive a patient, the patient is received at a clinical site, they are resected in order for them to give us about a centimeter cube of a tumor. The patient then goes home, so that's step 2 above. And now the tumor is shipped to our manufacturing site. Just to highlight that the tumor can be removed from any lesion, it can be from undemphloan, liver, lung, peritoneal or other organs of the body. Once the tumor is received at a manufacturing facility, so at step 2 below, The tumor is fragmented. It is placing media and 2 things start happening. The Till and other cells leave the tumor while they're replicating. And the first 11 days of the process allows for all the TILs to depart the tumor. The second 11 days is called the rapid expansion protocol, where we rapidly expand the TILs that are present to multiple billions. At the end of the process, we then wash the cells, put them in an infusion bag and cryopreserved them. And at this at the end of the 22 day manufacturing process, which we call a Gen 2 process at iovance, the company is ready to have the product infused back to the patient. When the patient and the clinical site are ready, they bring the patient back. And now we are at step 3 above. The patient is put through a 7 day chemotherapy, which is called non myelobulated lymphadenylation. On after the 7 days, the 2 are infused into the patient. We follow that infusion with up to 6 doses of IL-two, which takes approximately 3 days, and the regimen is then over. This is a onetime treatment. And once the patient has recovered from any adverse events that they may have, they'll visit this from the hospital. I'm now moving to Slide 6. Once the product is infused into the patient, the mechanism of action is shown on Slide 6. The cells start circulation. They are, of course, in the blood, in the peripheral blood. You can see the cells then migrate to the tumor when they detect the tumor through a chemokine that is sort of released from the tumor. So migration of TILs occurs toward the tumor bed at that point. These tells recognize the tumor very well. Recall that they came from the tumor and that they have the recognition component in order to see the tumor. Upon the recognition and engagement, T cell receptor engages to MHC I. And a lysis process starts where these TILs kill the tumor cells via various components of the daily release and it involves preference, granzyme, interferon gamma. On Slide 7, I am showing what the process the growth of the company and the process has been to date, and we have made significant progress, we feel. In 2011, we took a license of this technology from NCI. In 2016, we filed an orphan drug designation for the product, which is now called Dicelucel. In 2016, we had dosed our first patient in melanoma. Carrying on the melanoma story, in 2017, we had developed this new Gen 2 manufacturing process that I spoke to you just a moment ago. And we started dosing patients in melanoma with the GEN-two process. In 2018, we engaged the agency at CorMeda Phase 2 meeting. The agency agreed that the patient population is clearly in unmet medical need and that a cohort in the existing study could be sufficient for registration of this product. As part of this interaction, we received an RMAT designation from FDA in recognition of the patient population and the potential benefit that Till or Lisoleucil co add to this patient population. In 2019, we initiated our pivotal program after receiving FDA guidelines, which is cohort 4. And in 2020, we completed dosing patients into the pivotal program. We are in follow-up, and we released our very early preliminary data as part of the financing we just conducted regarding from Cohort 4, and we are hoping to file our BLA in late 2020. Going back for a moment on our other indications. In 2018, we met with FDA as part of an initiated patient dosing in cervical. In 2019, we met with FDA as part of under Phase II for cervical. We received a breakthrough designation indication for cervical cancer, and we continue enrolling patients into our pivotal program in the cervical indication. We have a very active research program. In fact, we have filed an IND for a new product called PBL, or peripheral blood lymphocyte to be initiated with patient dosing in 2020. As I mentioned before, we have conducted multiple rounds of financing. Our latest one was just a couple of weeks ago where we raised EUR 567,000,000 net proceeds for the company in order to conduct our research activities. Our focus very much remains in 2020 in submission of the BLA for melanoma and with FDA consultation, of course, a cervical indication. On Slide 8, I'll show some of our investment highlights. We are addressing a highly unmet medical new patient population. The market itself is quite large. We are dealing with solid tumor patients. And these patients, the specific subpopulations we have focused on are late time patients, specifically post checkpoint inhibitor therapies. We have the potential to be the 1st cell therapy to get approval for solid tumors, specifically melanoma and cervical. We have an efficient and scalable proprietary manufacturing process that involves a 22 day Gen 2 manufacturing process. This is over 90% success rate in over 300 patients that we have treated to date. And we have a very broad platform and wide applications are being explored through partnerships. We have partnerships with a number of different institutions. Obviously, we work very closely with NIH or NCI, Moffett Cancer Centre, MD Anderson, Yale and University of Montreal SHUM. Moving to Slide 9. We have a very broad IP, intellectual property rights on our product. We have 12 granted or allowed U. S. Patents for composition and methods of treatment in a broad range of cancers relating to Gen 2 manufacturing process in combination including combinations with anti PD-one. We also have patent applications that have been filed for a number of different technologies, narrow infiltrating lymphocytes or peripheral blood lymphocytes or PDLs are among them. Moving to Slide 10. As part of the proceeds for this round of financing and a previous one, we have announced that we have started Iovance commercial manufacturing facility. This manufacturing facility is being built in Philadelphia Navy Yard in Philadelphia. It is 136,000 square feet and expected to have about $85,000,000 investment from company's funds behind it. We have almost completed our core and shell of the 2 facilities, it's Suites 1 and Part A and Part B sort of of the building. You're looking at Part A being completed. And the clean rooms are being initiated already started in April of 2020, well in advance of our initial plans. We expect the facility to be completed by later 2020 to initial to start initial clinical manufacturing and commercial GMP production is expected to be commenced in 2022. We expect the facility for Ayovans to significantly reduce the cost of goods that are associated with build up tills, and we're very excited about completion of the facility and having our own access to the till manufacturing product. On Slide 11, I'll show you what the potential market in solid tumors is. On the left hand side, the market opportunity is shown. About 90% of the cancers that are developed are solid tumors, and about 1,700,000 cases are diagnosed annually, unfortunately, just in U. S. On the right hand side, you're looking at a table with indications that Iovance is interested in pursuing immediately or in long term. We obviously have a pivotal program in melanoma. Cervical, we are pursuing non small cell lung cancer very heavily. We are looking at head and neck, and we certainly are pursuing breast cancer indications, for example, as well as pancreatic through collaborations with academic institutions. Looking on Slide 12, you're looking at our pipeline. At the top of the table shows company sponsored studies and the bottom of the table is showing a few selected investigator initiated programs that are in collaboration with Iovance. As you can see, we have company sponsored studies in melanoma, cervical cancer, head and neck. We have a basket study and a study in hematologic malignancies with our own in house developed PDL. I do want to go back to the Basket study we call IOVACOM2002. I'll highlight that there is a multiple number of indications we are pursuing in that part of the basket study. Melanoma head and neck and non small cell lung cancer are noteworthy to highlight. In non small cell, we have 2 different cohorts, one of them in PD-one naive patient population where we are combining LN-one hundred and forty five company products with pembrolizumab and one is a relapsedrefractic muscle lung cancer patient population, which the patients are only receiving LN-one hundred and forty five irovance tail. We intend to expand our non small cell lung cancer program as a part of this financing we just conducted, and we intend to start a registration directed on small cell program as part of that. Moving to Slide 13, please. I highlight the research focus in terms of our next generation Till. We are a very active group of researchers. We pursue looking at, of course, a brand new product called PBL for CLL. We also have our own IL-two analog called IL-three thousand and one, which we licensed from Novartis. We have mentioned that we intend to be in IND enabling activities in 2021. We pursue selecting more potent Till. We have a PD-one positive selected Till by Iovaz that has been developed and has been initiated into clinic. We also have pursued various other manufacturing optimization methods that we have now introduced into clinic, including GEN-three. As part of our research program, we also consider genetic modification of Till, and we have a license to talent technology from Selective in order to conduct a collaborative agreement to support a clinical program. And we talked about additional collaborations, including PD-one positive selection with a collaboration with an institution in Canada called Schuh. Moving to Slide 14. I'll show you a global footprint of the company and where we are and the size of the organization. Iovance Biotherapeutics has around 190 employees. We are headquartered in San Carlos, California, about 20 minutes south of San Francisco. We have 3 additional offices in New York, Philadelphia and Florida. Our research team is out in Tampa, Florida, very much collaborating with Moffitt Cancer Center. And we also have a presence in Switzerland in Europe as well. Because it's Switzerland only. Moving to Slide 15 to show you our financials. We are, at this point, very well capitalized in order to pursue Till in the commercial landscape. We are very focused in filing our BLA and making sure the product reaches the patients. From a financial perspective, we had reported $251,000,000 cash and cash equivalents. As part of the net proceeds from our May 2020 equity offering, we also now have $567,000,000 in bank and we have zero debt at this time. Moving to Slide 16. The milestones for 2020 are shown on Slide 16. We had initially targeted to complete our patient enrollment in the pivotal cohort 4 by around Q1. We were ahead of schedule and completed that in January of 2020, as I noted before, and we are now in a follow-up period. We also disclosed a very preliminary early read of this data as part of the financing, and we noted that the response rate as of now appears to be quite parallel to the court, 2 that we have disclosed before. We were looking forward to presenting that data. And in fact, we had an oral presentation at ASCO just about a week ago with long term follow-up patients in melanoma. What we showed at the start of this presentation is that median duration of response was not reached after 18.7 months of study follow-up, which is quite remarkable in my opinion. We also have still in our plan to continue dosing in the cervical cancer indication. We intend to complete enrollment by around mid year. We intend to have a pre BLA meeting with FDA to discuss our submission of lifileucel for a BLA later part of this year as well as data from cervical. And we are very focused in the submission of the BLA. In fact, we have started preparing the modules that are required for BLA submission already, and we are well underway towards that. With that, I want to open the floor for questions and see if there's any questions that I can address. Okay. If there are no questions, thank you for your time. Ladies and gentlemen, this concludes our meeting. Thank you for your continued support of ILS. Have a good day.