Or do you have a plan maybe an agent in mind that you think makes sense alongside as part of a combination? Thank you. As there are no more questions, Id like to turn the call back to Jonathan Drachman for closing remarks. Private Securities Litigation Reform Act of 1995, including, but not limited to, planned development activities and the potential benefits of the companys product candidates and platform. This guide will explore the top risks for your business, including a possible recession, materials shortages and cyber attacks. And the initial data that we plan to present in the second half of 2022, which is what weve guided to, well focus on safety and tolerability, mostly and in addition, well look at PK/PD from that dose escalation data. We designed and NL-201 to be a potent activator of IL-2 and IL-15 responsive cells, without preferentially binding to cells expressing CD25. And now turning to our clinical program NL-201. And as far as the follow-up goes, youre right you know that for immuno-oncology products you know one of the benefits is to have a long-lasting benefit. And you know do you how close do you think youll get to that before you have data to speak of? I will now ask Priti to talk about our clinical plans. Neoleukin Therapeutics, Inc. There will be some renal cell and melanoma in that mix but theres a wide variety of tumor types in dose escalation. Rohan has decades of experience in biotechnology in both small and large companies, and has held key leadership positions at J&J and Medivation before becoming CEO of Avanir and subsequently 89bio. NL-201 was designed using computational methods and then refined through directed evolution and extensive testing in the laboratory. The so you know our dose escalation is going as we would predict, we havent commented on exactly where we are in terms of dose escalation, but given the potency of the molecule, we would not expect to have to go very far through the process to start seeing at least pharmacodynamic effects of NL-201. Thanks for the question, Charles. So as we discussed NL-201 is currently in a Phase 1 clinical trial with all-comers in solid tumors, relapsed and refractory. Research and development expenses for the year were $39.2 million, compared to $24.3 million in 2020. Meredithnamed Jason Frierottas the publishing companys new chief financial officer, effective March 9. Herzog joined Comerica in 1984 and was most recently executive vice president and treasurer. Sources: FactSet, Dow Jones, Bonds: Bond quotes are updated in real-time. TaylorMade Golf Companyappointed Rick Paschalas finance chief. Prior to Morgan Stanley, he was an associate in the healthcare investment banking division at Merrill Lynch. Ask an AI, I Got a Crash Course in Rodent Control atD.C.s RatAcademy. Now, as Priti mentioned in our prepared comments, things are going really well, we got 8 sites open across three countries. This business guide shares how CFOs from mCloud Technologies, Pact and Quatris Healthco are raising their finance teams profiles and shaping future business decisions. Thanks. Such statements represent managements judgments, intentions, beliefs and expectations about future events, strategies, product candidates and operating plans. The Coca-Cola Company, MariaDB, Vistra, Kirklands, Evelo Biosciences, Dynex Capital, Hammitt, Ra Medical Systems. Comericas interim chief financial officer, James Herzog, will assume the role permanently. And weve seen that in our preclinical data. Please. Source: FactSet, Markets Diary: Data on U.S. Overview page represent trading in all U.S. markets and updates until 8 p.m. See Closing Diaries table for 4 p.m. closing data. Bobs deep experience in multiple facets of financial leadership at public companies and financial institutions, including large-scale operations, public offerings, and transactions, will be a great asset to Neoleukin Therapeutics, and we are very pleased to have him join our leadership team, said Jonathan Drachman, M.D., Chief Executive Officer. What level of monotherapy activity for NL-201 in solid tumors would be clinically meaningful to you? NYC Wants In-Person Dining Back. And now Id like to recap our progress in 2021 and look ahead to milestones expected during 2022. Before we start, Id like to remind you that todays call will include forward-looking statements based on current expectations. Sun succeeds Laurie Stelzer, who has resigned from the role after five years to become CFO at Arena Pharmaceuticals. Thomson Reuterssaid Mike Eastwood, senior vice president and head of corporate finance, will succeed Stephane Bello as chief financial officer on March 15. Thanks, Jonathan. News Corp is a global, diversified media and information services company focused on creating and distributing authoritative and engaging content and other products and services. Great. Hi there. And finally, in the second half of 2021, we presented preclinical data at multiple scientific conferences on topics ranging from NL-201 and its effects on the tumor microenvironment to initial data about a novel IL-2 and IL-15 inhibitor molecule. Data are provided 'as is' for informational purposes only and are not intended for trading purposes. The agreement allows for the evaluation of safety and efficacy of NL-201 in combination with Mercks anti-PD-1 therapy, KEYTRUDA or pembrolizumab in our ongoing Phase 1 trial. Cortenbach shares how he begins his day with meditation, the Robert Frost quote that inspires him, and his favorite leadership lesson. Prior to joining CNA, Miralles was the chief financial officer for the investments division of Nationwide Insurance. At this time, we are still testing different disease models and modes of administration. Neoleukin uses sophisticated computational methods to design proteins that demonstrate specific pharmaceutical properties that provide potentially superior therapeutic benefit over native proteins. Before joining Lowes, Mason was vice president, SEC reporting at Bank of America. At the American Society of Hematology Meeting in December, two abstracts reported on preclinical NL-201 antitumor activity, one in non-Hodgkin lymphoma and one in multiple myeloma. Okay. And based on our current operating plan, we believe our cash on hand will be sufficient to fund operations into the second half of 2023. We plan to present interim dose escalation data at an appropriate time in the second half of 2022. Good afternoon, everyone and thanks for taking my questions. This is [Neil] [ph] on for Ben. Source: FactSet, Indexes: Index quotes may be real-time or delayed as per exchange requirements; refer to time stamps for information on any delays. These statements are subject to numerous risks and uncertainties, including market conditions, that could cause actual results to differ materially from what Neoleukin expects. Well, Ill start with the answer. You know the patient number is really based around some expansion groups that we may want to look at in this setting, renal cell, melanoma, et cetera. Fundamental company data and analyst estimates provided by FactSet. Im also kind of wondering, though, to what extent just given based on the inclusion criteria of your dose escalation, will you might you also have you know empirical data specifically within those patients heading into expansion cohorts? 2021 was a busy year for Neoleukin. This guide discusses how to track the correct KPIs based on business needs, how those KPIs impact strategy and how to make sure theyve selected the right KPIs. Because a portion of the protein scaffold that normally interacts with the alpha subunit, also known as CD25, has been completely replaced. I think one of the things thats exciting about NL-201 is that, at low doses, it is immune activating. NL-201 is a highly potent de novo protein that stimulates both the IL-2 and IL-15 receptors. Good afternoon and welcome to Neoleukin Therapeutics year end 2021 conference call. Last year, we presented preclinical data demonstrating that NL-201 has synergistic activity when combined with anti-PD-1 therapy, even in checkpoint refractory cancer models. Source: Kantar Media, President, Chief Executive Officer, CFO & Director, Senior Vice President-Corporate Development, General Counsel & Senior Vice President-Legal, Neoleukin Therapeutics to Host Second Quarter 2022 Financial Results Conference Call and Webcast on August 9, 2022, Neoleukin Therapeutics Announces First Patient Treated in Combination Arm of Phase 1 Trial Evaluating NL-201 in Combination with KEYTRUDA(R) (pembrolizumab), Neoleukin Therapeutics Announces First Quarter 2022 Financial Results and Corporate Update, Neoleukin Therapeutics to Present at Upcoming Investor Conferences. The open label Phase 1 trial of NL-201 is currently active at 8 sites in the United States, Australia and Canada. Sure. I truly value the time Ive spent with Neoleukin and have enjoyed being able to contribute to a successful transition following the merger with Aquinox, said Mr. Alam. Neoleukin undertakes no obligation to update or revise any forward-looking statements. And then we would start to explore a number of different combinations. Data may be intentionally delayed pursuant to supplier requirements. The science underlying our technology has been published in the prestigious journals, Nature and Science. For starters, we added several key leaders to our Executive Team. We appreciate the dedicated efforts of our talented team at Neoleukin and remain focused on our overriding goal to advance our de novo protein technology platform to benefit patients with serious diseases, including cancer, inflammation and autoimmune diseases. He is a former Vice President in the Investment Banking Division of Morgan Stanley & Co., where he managed over $9 billion in financing deals and participated in the completion of more than $5 billion in M&A transactions. Priti, you want to take that? To ensure this doesnt happen in the future, please enable Javascript and cookies in your browser. Our plans for further development of this program and our early stage pipeline that we are advancing toward potential future clinical evaluation. Sources: FactSet, Tullett Prebon, Commodities & Futures: Futures prices are delayed at least 10 minutes as per exchange requirements. And I Im going to ask maybe a question not so much about a competitor, per se, but, you know there is a fair amount of data on [inaudible] due out you know over the next weeks and months, and Im curious as to sort of any type of contingency plan for enrollment that you might make depending on what that data is? The increase in net loss, as mentioned, is primarily driven by increased clinical trial expense related to NL-201, increase in personnel costs and costs related to the build out of our headquarters in Seattle, Washington. Sign up to receive CFOs The Balance in your inbox. Industry Dive, Inc. (c) 2022, All rights reserved, 1255 23rd Street, NW, Suite 550, Washington, DC 20037, Meta, LendingClub, Verisk, Lazard, Berkeley Lights, Avangrid, Timbers Company, Icertis, TaylorMade Golf Company, Invesco, Neoleukin Therapeutics, Meredith, Viatris, CAN, Morgan Stanley, Thomson Reuters, Comerica, Driven Brands. And just to add a little bit to that, because the interim data will be based on dose escalation and not indication-specific cohorts, its going to be hard to have a real estimate of activity. Next, we plan to initiate a combination of NL-201 and pembrolizumab in patients with advanced solid tumors. Perhaps just one more, if you dont mind. Anderson resigned from the company to pursue other opportunities. International stock quotes are delayed as per exchange requirements. Prior to Morgan Stanley, he was an associate in the Healthcare Investment Banking Division at Merrill Lynch & Co. Its a very exciting time to join Neoleukin, as the company continues to advance its novel technology platform, and Im greatly looking forward to working with this dedicated, talented team, said Mr. Ho. You know I think were really interested in the scientific approach of intratumoral dosing and this is what were hoping to learn. Our goal is to show you know to have some monotherapy activity as we think about potential combination strategies. We believe this will be the first data of a fully de novo protein in patients. Thank you, Julie and good afternoon. Well provide future updates regarding the status of Neo-5171 and potential development plans. Neoleukins lead product candidate, NL-201, is a combined IL-2 and IL-15 agonist designed to eliminate alpha receptor binding. Is this happening to you frequently? We showed that Neo-5171 can withstand acidic environments and is resistant to degradation by common proteases, including pepsin and trypsin. You may now disconnect. During 2022, we plan to initiate a new Phase 1 dose escalation trial testing NL-201 monotherapy in patients with relapsed and refractory hematological malignancies, including multiple myeloma and B cell-derived non-Hodgkin lymphoma. Now obviously the selection of RP2D will be you know multifactorial base off of safety. Finally, the potent effect of IL-15 stimulation on NK cell has the potential to increase ADCC activity in future combinations with the rituximab, daratumumab and other monoclonal antibody. Id like to begin with a few recent transitions at Neoleukin. By creating completely new molecules, we can optimize multiple parameters, including potency, affinity, stability, size and exactly which parts of the target receptors are engaged. This trial will evaluate two different schedules, an ascending dose levels of NL-201 in order to assess safety, pharmacokinetics, pharmacodynamics and antitumor activity. Please refer to the companys filings with the SEC which are available from the SEC or in the Neoleukin website for information concerning the risk factors that could affect the company. Net loss in 2021 was $60.7 million, compared to $33.3 million in 2020. Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers business and financial information, news and insight around the world. But its not going to be a complete story, because were not going to have that long follow-up with large numbers of patients with specific indications. So were opening that trial as part of the monotherapy trial. CFOs The Balance brings the most important finance reporting to your inbox. Please disable your ad-blocker and refresh. The increase was also due to facility-related costs associated with the build out of Neoleukins new laboratory and headquarters in Seattle, Washington. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. We are testing two schedules, day 1 every three weeks and day 1 and 8 schedules as monotherapy. But were not expecting that to have a big impact at this point. Learn how Precision Medical leveraged OneWorld to cut the cost of billing in half and added $2.5M in annual revenue. Prior to becoming CFO in February 2018, she served in a series of leadership roles throughout her 20 years with SunTrust, including head of commercial and business banking and CEO of the Atlanta division. We ended 2021 with cash and cash equivalents of $142.5 million, compared to $192.6 million at the end of 2020. And finally, we anticipate providing further information on progress with the research pipeline. Id now like to turn the call over to Jonathan Drachman. I want to follow-up on the last question, maybe Ill ask it in a slightly different way and one I wonder whether you see as some PD markers being more predictive of potential clinical activity, whether thats overall CD8 expansion or CD8 to T-reg ratio. Thats great question. We have been extremely fortunate to have Kams guidance these past months after the merger of the two companies. Dukes will remain deputy chief financial officer through Aug. 1, 2020, and then will become senior managing director and CFO. Our next question comes from Charles Zhu with Guggenheim. Copyright FactSet Research Systems Inc. All rights reserved. His knowledge and insights have been invaluable, and we wish him well in his future endeavors.. With that, now Im going to turn the call over to Sean Smith to discuss our year end 2021 financials. So we actually see the opportunities is very broad and were starting off with monotherapy activity to see what the data look like. Thanks for taking my question. Your line is open. Narula, who has been with Pfizer for 16 years, is currently CFO of Upjohn. Morgan Stanleys deputy chief financial officer Paul Wirthwill step down from his role at the end of May. Thank you. As far as well first of all, were excited to see the data. Download our whitepaper to discover the technical and behavioral skills needed to lead your business forward. Mr. Ho brings two decades of financial experience to Neoleukin. And I think thats because IL-2 is one of the few immunotherapy drugs that has actually been shown to work. Furthermore, T-cells in the murine bone marrow had an increase in granzyme B expression and a decrease in the exhaustion phenotype after NL-201. If you have an ad-blocker enabled you may be blocked from proceeding. Throughout the past year, weve made strides in our research efforts as we explore the range of opportunities that Neoleukins de novo protein technology platform has to offer. Our next question comes from Mara Goldstein with Mizuho. I think you know the purpose of the expansion as we get to RP2D is to select validated tumor types or you know IL-2 has activity, so we get we can get a better sense as what efficacy looks like in those disease phase. This concludes the conference call. Wirth, who has been with the bank for 15 years, will stay on as a senior adviser through the end of the year. Your line is open. Source: FactSet. We know there are other companies in the space are looking, for instance, at the intravesical approach in bladder cancer. Sure. As a reminder, Neoleukin was founded at the end of 2018, went public in August of 2019 through a merger. Bill is a skilled research leader who has guided research efforts on therapeutic candidates from discovery through clinical development utilizing novel platform technologies. CANappointed Al Mirallesas chief financial officer. I let Priti comment on that. You know we expect dose escalation to start at a dose level, and these are learnings from what weve learned in monotherapy. We'll provide strategies for finance teams to proactively prepare. Bill was previously at Seagen, where he served most recently as Senior Director and Head of Cancer Biology and was previously at Merck and Rosetta Inpharmatics, leading the discovery of oncology targets, predictive biomarkers and synergistic drug combinations. And there is a long history of people using IL-2 as intratumoral treatment, local treatment for melanomas and other accessible tumors. Sure. Okay, great. Neoleukin undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Most recently, Mr. Ho served as Senior Finance Director at DaVita, Inc. a publicly held, Fortune 500 company that is a leading provider of kidney care services in the U.S. He received an undergraduate degree from Harvard University and a doctorate from Harvard Medical School. And so were having a good enrollment and investigator engagement. And that requires a lot of follow-up. Before joining TaylorMade, Paschal spent three years as CFO for sports equipment company Varsity Brands. I think you know at the end of 2022, there will be some preliminary efficacy for monotherapy that well take a look at. Allison Dukeswill join Invescoas deputy chief financial officer onMarch 10. Were excited for patients and also for the concept of trying to improve upon a proven mechanism of action in IL-2. After our recommended Phase 2 dose and schedule is identified, we plan to enroll indication-specific expansion cohort, including patients with renal cell carcinoma and melanoma. Most recently, Ho served as senior finance director at health care company DaVita. Following the conclusion of the prepared remarks, we will conduct a question-and-answer session, and instructions will follow at that time. | Source: Thank you for taking the questions. So just as a reminder, the first patient was dosed in May of last year. Sanjeev Narulawas appointed CFO of pharmaceutical companyViatris, a new company that combines Pfizers Upjohn and Mylan. Sean has been with Neoleukin since 2019 as our Controller and will now lead the Finance Team and be our Principal Accounting Officer until we appoint a new CFO. Today, Id like to discuss our progress with the first-in-human Phase 1 clinical trial of NL-201. He became CFO in September 2019 to replace outgoing finance chief Muneera Carr. This included stints as a senior financial executive at GE Transportation, GE Power and Water, and GE Energy. Change value during other periods is calculated as the difference between the last trade and the most recent settle. Our operating cash burn for the year was approximately $50 million after adjusting for non-cash items. How should we think about where you are in your dose escalation relative to where the potential efficacious window may lie? 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Our future efforts are focused on modifying the biodistribution of this molecule via targeting and/or conditional activation. Well we would have to see how that goes. Our approach of designing de novo proteins to improve on native sequences represents an important shift in the way new biological drugs could be developed. Further information on potential risk factors that could affect Neoleukins business and its financial results are detailed under the heading Risk Factors in documents the Company files from time to time with theSecurities and Exchange Commission(SEC), and other reports as filed with theSEC.