Y-mAbs Therapeutics, Inc. (YMAB) Earnings Call Transcript & Summary

Hello, and welcome to the Annual Meeting of Stockholders of Y-mAbs Therapeutics Annual Meeting 2020. Please note that today's meeting is being recorded. During the meeting, we will have a question and answer session. [Operator Instructions] Please note that your registered name will be announced along with your question during the Q&A session following the formal portion of the meeting. Guests will not be able to submit questions. [Operator Instructions] It is now my pleasure to turn today's meeting over to Mr. Thomas Gad. The floor is yours.

Thank you very much. Good morning, ladies and gentlemen, and welcome to the 2020 Annual Meeting of Stockholders of Y-mAbs Therapeutics, Inc. My name is Thomas Gad, and I'm the Chairman of the Board. We had expected an in-person meeting this year, however, COVID-19 pandemic caused us to host a virtual meeting for the health and safety of our stockholders, employees and other stakeholders. We appreciate your flexibility in accommodating this format of the meeting. Also on behalf of the entire Y-mAbs team, I would like to pause and take a moment to commend the members of our community, including doctors, nurses and other health care professionals that are fighting this pandemic on the front line every day for the benefit of all of us. Thank you. This meeting is being held via live webcast. No one attending via the webcast is permitted to use any recording audio device. I would like to introduce the other directors of the company who are joining us today on our line: Dr. Claus Møller, our Chief Executive Officer; Johan Wedell-Wedellsborg; Dr. Ashu Tyagi; Dr. James Healy; Mr. David Gill; and our new Class II Director Nominee, Laura Hamill. Also joining us today is Dwight Kinsey, Esq. of Duane Morris LLP, our outside Counsel, and he has been appointed the inspector of elections by the Board of Directors. In the interest of having a fair and constructive meeting, please note the following voting procedures. If you have submitted your vote prior to this meeting, whether by mail, phone or online, you do not need to take any further actions. However, if you wish to revoke your proxy and vote now or if you have not voted, you will be given the opportunities to submit a virtual ballot to the vote before polls are closed. If you have an 11-digit voting control number issued by AST, our company's transfer agent and wish to vote during this meeting, you may do so by clicking the proxy voting link on the left-hand panel of your screen. You may also ask questions during the meeting if you register with your 11-digit voting control number. Please refer to the chat box icon located on the top of the left-hand panel of your screen to submit a written question. A digital copy of the notice and proxy statements is also available for your review. You may access the document by clicking on the link named annualreport/proxystatement. On the left-hand side of your screen, an agenda that outlines the order of business for today's meeting is displayed on the screen. The matters to be considered at this meeting today are described in the company's proxy statement dated April 28, 2020, and I'll review these in a few minutes. But for now, I'd like to turn the meeting over to Mr. Kruse to act as the secretary of the meeting and will report on the notice for this meeting. Go ahead, Bo.

I would like to state for the record that on or about April 28, 2020, the notice of this meeting was made available to all stockholders of record as of April 17, 2020, the record date for this meeting. I have proof by an affidavit from AST that notice of Internet availability of proxy materials was mailed on or about April 28, 2020, to all of the company's stockholders of record determined as of the close of business on the record date. The affidavit will be incorporated into the minutes of this meeting. I have a list of the stockholders entitled to vote at this meeting, which is available for inspection by any stockholder present or by any proxy holder representing a stockholder and which will be filed with the records of this meeting. The registered stockholder list is available for the duration of the meeting and is available during this meeting by e-mailing us at [email protected] with a control number or other evidence of stock ownership. We expect to close the polls approximately 1 minute after the presentation of matters to be voted on at the meeting and the question-and-answer session on the proposals. We'll answer questions regarding matters to be voted on at the meeting after all matters have been presented, as appropriate. Stockholders are limited to one question each. Though we may not be able to answer every question, we'll do our best to respond to as many as possible in the time permitted. The time permitting -- permitted for this first question-and-answer session will be limited to 10 minutes following the formal meeting -- portion of the meeting and the presentation of the CEO's report on the status of the company's business who will answer appropriate business related questions. The time permitted for the second question-and-answer session will be limited to 10 minutes, and stockholders will be limited to one question each.

Thank you, Bo. The inspector of elections has already taken his oath. Inspector, do we have a quorum for this meeting?

At this virtual meeting, we have represented in person or by proxy, shares of common stock, representing more than majority of the voting power entitled to vote at the virtual meeting, and therefore in accordance with the company's bylaws, a quorum is present. This virtual meeting is authorized to transact business. Polls are now open for voting.

Thank you, inspector. This takes us to the first item of business, the election of 3 Class II directors nominated by our Board of Directors, each to serve for a 3-year term to expire 2023. The names of the nominees for Class II directors are: Dr. James Healy, Dr. Ashu Tyagi and Laura Hamill. Will the holder of common stock move for the election of the 3 Class II directors, each to be elected by the holders of common stock, please?

I move for the election of the named directors.

I second the motion.

Thank you. The persons just nominated for election as Class II directors are the same as the persons included in the notice of meeting sent to all stockholders of record. No other nominations for director to serve for a term to expire in 2021 or 2022 have been received from any stockholder of the company in accordance with our bylaws. The second and last item of business is the ratification of our Board's appointment of PricewaterhouseCoopers LLP, an independent registered public accounting firm to audit the accounts of the company for the fiscal year ending December 31, 2020. Mr. Kruse, will you read the resolution, please?

Sure. Result that the appointment by the Board of Directors of PricewaterhouseCoopers LLP, an independent registered public accounting firm, to audit the financial statements of the company for the fiscal year ending December 31, 2020, be and the same here by is ratified and approved.

Thank you. For the ratification of appointment of the independent registered public accounting firm, the holders of common stock will vote as one class with each share of common stock having one vote per share. Will someone please move the resolution?

I move that the resolution be adopted.

I second the motion.

Thank you. Mr. Bay and Mr. Philip of PricewaterhouseCoopers LLP are present, if there are any questions for them. Are there any questions on these proposals? We will now open the floor for discussions concerning the proposals. Please note that we will not address any questions that are irrelevant to the matters presented at this meeting today. If you registered with your 11-digit voting control number and wish to submit a question, please refer to the chat box icon located on the top left-hand panel of your screen. Though we may not be able to answer every single question, we'll do our best to certainly answer as many as possible in the time permitted. The time permitted for the question-and-answer session on the proposals is limited to 10 minutes. If we do not receive any relevant questions, we'll conclude the question-and-answer session early. We'll now pause for a minute to allow stockholders to submit any questions. Okay. So that was a minute, and I don't hear we have any questions. So we do not see any questions, and we'll conclude the question-and-answer session here for this part of the meeting. As noted earlier, voting today is by proxy and digital ballot, each share of common stock is entitled to one vote. Let me remind you that if you've already sent in your signed proxy or previously voted by phone or online, there's no need for you to cast a ballot now unless you wish to change the vote that you've put on the proxy. The individuals named in the proxy or any of them will vote your shares as indicated on the proxy that you already mailed or delivered to us. If there's any stockholder present at this virtual meeting who has not returned a proxy or desires to revoke a proxy and vote now, please make sure you have your 11-digit voting control number issued by AST and click the vote link on the left-hand side of your screen. We expect to leave the polls open for approximately one minute to allow anyone who chooses to vote now to cast digital ballots. Ballot will be tallied after we have voted on all matters on the agenda. Upon receipt of all ballots, the polls will officially be closed. The digital votes cast today will be counted in the final tally along with the proxies previously received. Again, we'll leave the polls open for approximately one more minute to allow anyone who chooses to vote here to cast ballots. So remaining 1 minute allotment will begin now. Thank you. [Voting]

Thank you. The polls for voting at this meeting are now closed at 10:14 a.m., and no further proxies or digital ballots will be accepted. Since all the votes have been cast and since at least a majority of the votes were cast by a proxy encountered prior to this virtual meeting, we will now hear the report from the inspector of elections of the meeting regarding the preliminary results of the voting. Now please will the inspector of elections report on the results of the balloting. Thank you.

Mr. Chairman, each of the 3 persons named in the ballot for election as Class II directors, each to serve for a 3-year term to expire in 2023, has received a vote of more than 80% of the shares voted at the meeting, constituting a plurality of the votes cast at the meeting on this matter. I, therefore, declare that such persons are duly elected as directors of Y-mAbs Therapeutics, Inc. Mr. Chairman, the results of the balloting on the resolution to ratify the appointment of PricewaterhouseCoopers LLP, an independent registered public accounting firm, for the fiscal year ending December 31, 2020, are as follows: more than 90% of the total of the votes cast at the meeting are for; against are less than 1%; and abstained are less than 1%. This resolution was approved by a majority of the votes cast at the meeting on this matter. I, therefore, declare the appointment ratified. Please note that the exact tally of the election of the directors and for the other matters voted on will be recorded in the Inspector Certificate of Elections, which will be available following the meeting.

Thank you. I direct that the inspectors' oath and Certificate of Elections be affixed to the minutes of this meeting. At this time, I'd like to call upon Dr. Claus Møller, our Chief Executive Officer of the company to report of the status of the company. At the end of Dr. Møller's presentation, stockholders may ask questions regarding the company and its business. Due to the time constraint, we ask that each stockholder limit his or her remarks to no more than 2 minutes. Please go ahead, Dr. Møller.

Thank you, Thomas. Let me start by saying that we continue to closely monitor the impact of COVID-19 on our businesses. We have implemented a number of measures to protect the health and safety of our employees while also taking steps to advance our operations. These include efforts to mitigate disruptions to any of our supply chain and continued clinical trial planning and commercial activities. While we expect some near-term impact on clinical trials, site initiation and patient enrollment due to the unprecedented challenges posed by the COVID-19 pandemic, we have not changed our overall expectations for key anticipated 2020 clinical data [ recounts ]. During the first part of 2020, we have continued to work hard to ensure that our 2 lead product candidates, naxitamab and omburtamab advance towards the market. In March, we submitted the final portion of our rolling BLA for omburtamab in relapsed/refractory neuroblastoma. And recently, we received the PDUFA date from the U.S. FDA, it's November 30 this year. The BLA submission is based on the safety and efficiency results of the pivotal -- 2 pivotal Phase II studies, Study 201, Study 12-230. And we presented overall investigator reported response rates at ASCO a few weeks ago this year, showing an overall 79% response rate from the pivotal Study 201. In addition to the BLA for naxitamab, we have trials ongoing for first-line neuroblastoma as well as chemo combination trials for refractory neuroblastoma patients at MSK and in Barcelona. During the remainder of 2020, we expect to initiate international Phase II multicenter clinical trials, both in frontline and with chemo combination treatments. For omburtamab, we had a pre-BLA meeting with the FDA in February, and we were very pleased to have our rolling BLA plans confirmed by the agency for the treatment of patients with CNS leptomeningeal metastasis from neuroblastoma. In addition to our U.S. development program, we are making good progress in Europe. In December, EMA agreed to our proposed pediatric investigational plan for omburtamab, and an approved PIP or Pediatric Investigational Plan is a prerequisite for filing for a marketing authorization in Europe for a new product. And we believe that we now have a clear path for registration in Europe of omburtamab for the treatment of pediatric patients with CNS leptomeningeal metastasis from neuroblastoma. We plan to submit a marketing authorization application in November this year in Europe. And this is a vital step forward in our efforts to bring omburtamab to the market in Europe in 2021. As previously disclosed, we are also developing omburtamab for diffuse intrinsic pontine glioma, known as DIPG in a Phase I study at MSK, where we are now planning also to open a multicenter Phase II study for DIPG patients later in 2020. For desmoplastic small round cell tumors also known as DSRCT, we have recently opened a Phase II study at MSK. Our lutetium-177 labeled omburtamab-DTPA construct we filed an IND back in December, and we expect to open 2 multi-center Phase I/II studies later this year. One study is in pediatric medulloblastoma and the other study is a basket study for B7-H3 positive CNS leptomeningeal metastases in adult patients. For both studies, we hope to utilize our prior experience of treating patients with these indications with the iodine-labeled omburtamab. In terms of launch planning, we are very focused on the execution and intend to drive a rapid uptake of both products upon approval and to ensure that we get the optimal pricing and reimbursement coverage. Our commercial team is largely in place. As many of you know, we hired our Chief Commercial Officer, Phil Herman, more than 2 years ago. And we have been building his team ever since making us believe that we will be positioned for the potential launch of naxitamab and omburtamab in the U.S. On April 15, this year, we announced that we have had entered into an agreement with Memorial Sloan Kettering Cancer Center in Massachusetts Institute of Technology also called MIT for a worldwide exclusive license and research collaboration to develop and commercialize antibody construct based on what's called SADA, self-assembly, disassembling antibody constructs, a radioimmunotherapy platform, we also call Liquid Radiation. We intend to initiate development of a number of SADA-based constructs created by MSK and MIT, including GD2 SADA for GD2 positive solid tumors, a GPA33 SADA for potential use in colon cancer, and a HER2 SADA for potential use in breast cancer. We also expect to advance a series of proprietary constructs as well. We are targeting to file our first IND next year for a SADA construct and hope to start treating patients with this exciting technology shortly thereafter. We continue to believe that we are well positioned to become a commercial stage biotech company in late 2020, and concurrently increase our focus on the SADA technology and the earlier stage product candidates in our pipeline, including the lutetium labeled omburtamab, the bispecific programs and the GD2-GD3 vaccine as well as the next in line indications for naxitamab and omburtamab. Thank you very much.

Thank you very much, Claus. So if anyone have any business-related questions, please use our chat box to submit relevant questions at this time. The time permitted for this question-and-answer session is limited to 10 minutes. Stockholders are limited to one question each. Please note that we will not be answering any questions irrelevant to the business of the company related to material nonpublic information or questions related to personal stockholder matters or any questions that do not otherwise -- that are not otherwise suitable for this meeting as determined by a reasonable judgment. If you do not receive any appropriate questions, we'll conclude the question-and-answer session early. We'll now pause for a minute to allow stockholders to submit any questions. Thank you. We do not see any questions, and we will conclude the question-and-answer session and this virtual meeting. The time permitted for question-and-answer session has ended. We will not be answering any additional questions, and we will end the virtual meeting now. May I hear a motion for adjournment of this meeting?

I move that the meeting be adjourned.

I second the motion.

All in favor of the meeting. Thank you, Andy. All in favor, the meeting is hereby adjourned. Thank you, everyone.

Thank you.

This concludes the meeting. You may now disconnect.