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. And sort of you know what weve seen historically in this space, whether there has been good correlations between some of these PD markers and ultimately the monotherapy clinical activity thats observed. All forward-looking statements included in this presentation are made as of today, and involve assumptions, risks and uncertainties and actual results could differ materially from those anticipated in the forward-looking statements. And now Id like to recap our progress in 2021 and look ahead to milestones expected during 2022. Narula, who has been with Pfizer for 16 years, is currently CFO of Upjohn. Meineke franchisor Driven Brandsnamed Tiffany Masonas chief financial officer. Or do you have a plan maybe an agent in mind that you think makes sense alongside as part of a combination? So just as a reminder, the first patient was dosed in May of last year. We hypothesize that this combination will enable a greater percentage of patients to benefit from immunotherapy and have the potential to move into earlier lines of therapy as a chemotherapy-free regimen. 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. Thanks, Jonathan. Thank you. And also the potent effect on T cells could work really well with things like cellular therapy. Sure. Neoleukin Therapeutics, Inc. SEATTLE, Feb. 25, 2020 (GLOBE NEWSWIRE) -- Neoleukin Therapeutics, Inc. (Neoleukin) (Nasdaq: NLTX), a biopharmaceutical company utilizing sophisticated computational methods to designde novoprotein therapeutics, today announced the appointment of Robert Ho as Chief Financial Officer, effective March 16, 2020. Our next question comes from Joe Catanzaro with Piper Sandler. Presently, Jonathan G. Drachman holds the position of President, Chief Executive Officer, CFO & Director at Neoleukin Therapeutics, Inc. Dr. Drachman is also on the board of Harpoon Therapeutics, Inc. Our preclinical data suggests that NL-201 could benefit patients broadly across many indications and in combination with a wide variety of standard of care agents. And how is the current systemic trial informing whether thats an approach thats worth pursuing? Sign up to receive CFOs The Balance in your inbox. Stocks: Real-time U.S. stock quotes reflect trades reported through Nasdaq only; comprehensive quotes and volume reflect trading in all markets and are delayed at least 15 minutes. Neoleukin undertakes no obligation to update or revise any forward-looking statements. Thank you. Net loss in 2021 was $60.7 million, compared to $33.3 million in 2020. Comericas interim chief financial officer, James Herzog, will assume the role permanently.
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Id now like to turn the call over to Jonathan Drachman. 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. For starters, we added several key leaders to our Executive Team. Okay, got it. 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. And last to fall, Bill Arthur joined us as Vice President and Head of Research. Good afternoon and welcome to Neoleukin Therapeutics year end 2021 conference call. Thomson Reuterssaid Mike Eastwood, senior vice president and head of corporate finance, will succeed Stephane Bello as chief financial officer on March 15. This will be an important year for Neoleukin, as we learn about how our lead molecule performs in patients and continue to focus on extending the potential of our technology. 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. About Neoleukin Therapeutics, Inc.Neoleukin is a biopharmaceutical company creating next generation immunotherapies for cancer, inflammation and autoimmunity usingde novoprotein design technology. Sun succeeds Laurie Stelzer, who has resigned from the role after five years to become CFO at Arena Pharmaceuticals. Priti, you want to take that? Your line is open. This is [Neil] [ph] on for Ben. Now obviously the selection of RP2D will be you know multifactorial base off of safety. Operator, we can now open the call up for questions. We also demonstrated that Neo-5171 can be fused to a life half-life extending domain and administered systemically with improved survival of immunosuppressed mice in a graft versus host disease model. I think you know at the end of 2022, there will be some preliminary efficacy for monotherapy that well take a look at. Any copying, republication or redistribution of Lipper content, including by caching, framing or similar means, is expressly prohibited without the prior written consent of Lipper. And similar to that, how should we also think about the potential patient follow-up that youll have, especially given that immuno-oncology approaches? The increase in G&A expenses in 2021 was primarily due to increases in personnel-related costs. Thanks. We have good investigator engagements and are enrolling patients quickly. His knowledge and insights have been invaluable, and we wish him well in his future endeavors.. But were not expecting that to have a big impact at this point. Neoleukins lead product candidate, NL-201, is a combined IL-2 and IL-15 agonist designed to eliminate alpha receptor binding. Priti, you want to comment about the plans for the pembrolizumab combination? Copyright FactSet Research Systems Inc. All rights reserved. Today, Id like to discuss our progress with the first-in-human Phase 1 clinical trial of NL-201. Thanks, Jonathan and good afternoon, everyone. Change value during the period between open outcry settle and the commencement of the next day's trading is calculated as the difference between the last trade and the prior day's settle. So I think you know it is we are trying to get a dose and schedule as quickly as possible and as a result, its all relapse and refractory tumor types in this trial. Thank you for participating. Were looking for further opportunities to explore this. We expect to be able to use information from the solid tumor trial to guide the starting dose and initiate dose escalation plan. Sources: FactSet, Dow Jones, ETF Movers: Includes ETFs & ETNs with volume of at least 50,000. This business guide shares how CFOs from mCloud Technologies, Pact and Quatris Healthco are raising their finance teams profiles and shaping future business decisions. Prior to Morgan Stanley, he was an associate in the healthcare investment banking division at Merrill Lynch. Both Priti and Bill are great additions to our Neoleukin team and are making significant impacts, leading our clinical and research efforts. Thanks, Priti. So there it took a little while to get up and running. Learn how Precision Medical leveraged OneWorld to cut the cost of billing in half and added $2.5M in annual revenue. Thanks, Sean. Cortenbach shares how he begins his day with meditation, the Robert Frost quote that inspires him, and his favorite leadership lesson. And finally, we anticipate providing further information on progress with the research pipeline. Next, we plan to initiate a combination of NL-201 and pembrolizumab in patients with advanced solid tumors. FDICs Message to Crypto Investors: Digital Assets Arent Insured, Troubled Crypto Lender Babel Lost Big While Trading Client Funds, Ex-Voyager Executive Explores Competing Restructuring Plan for Crypto Lender, Former Chief Financial Officer, Neoleukin Therapeutics Inc.
Thanks. In January of this year, we announced a clinical trial collaboration and supply agreement with Merck.
There will be some renal cell and melanoma in that mix but theres a wide variety of tumor types in dose escalation.
He became CFO in September 2019 to replace outgoing finance chief Muneera Carr. You know I think were really interested in the scientific approach of intratumoral dosing and this is what were hoping to learn. Dukes will remain deputy chief financial officer through Aug. 1, 2020, and then will become senior managing director and CFO. He has built a strong finance department in his time with us and leaves us with an excellent team that will be led by Sean Smith who is joining me on the call today. The science underlying our technology has been published in the prestigious journals, Nature and Science. The increase was also due to facility-related costs associated with the build out of Neoleukins new laboratory and headquarters in Seattle, Washington. 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. And so its a method of delivery that we think could be suited very well for our drug and were exploring opportunities to look at to look at that. Before we start, Id like to remind you that todays call will include forward-looking statements based on current expectations. As a reminder, todays conference call is being recorded. NL-201 was designed using computational methods and then refined through directed evolution and extensive testing in the laboratory. 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. 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. Yeah. Thats great question. So youre asking specifically about renal cell and melanoma within our dose escalation and that sort of mix of patients. We have been extremely fortunate to have Kams guidance these past months after the merger of the two companies. We are testing two schedules, day 1 every three weeks and day 1 and 8 schedules as monotherapy. 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. Perhaps you know like we have this extreme clinical benefit longer-term, but may not be as obviously observed early on in something like in early response? We'll provide strategies for finance teams to proactively prepare. So I would really think about the data were going to be presenting this year as preliminary and early and really informing what is the potential for NL-201. Such statements represent managements judgments, intentions, beliefs and expectations about future events, strategies, product candidates and operating plans. In addition, we showed that an NL-201 can turn cold tumors hot, expanding both the absolute number and clonal diversity of tumor-infiltrating T cells and increasing the amounts of interferon gamma and granzyme B produced in the tumor microenvironment. Sure. Thanks for the question. And that requires a lot of follow-up. The Coca-Cola Company, MariaDB, Vistra, Kirklands, Evelo Biosciences, Dynex Capital, Hammitt, Ra Medical Systems. Elaine Sunhas been appointed chief financial officer at Halozyme Therapeutics. Okay, great. As there are no more questions, Id like to turn the call back to Jonathan Drachman for closing remarks. Great. Good afternoon. International stock quotes are delayed as per exchange requirements. 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. Your line is open. We ended 2021 with cash and cash equivalents of $142.5 million, compared to $192.6 million at the end of 2020. Our next question comes from Charles Zhu with Guggenheim. 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. Herzog joined Comerica in 1984 and was most recently executive vice president and treasurer. Copyright 2022 CFO. Thank you for taking the questions. With that, now Im going to turn the call over to Sean Smith to discuss our year end 2021 financials. Bill is a skilled research leader who has guided research efforts on therapeutic candidates from discovery through clinical development utilizing novel platform technologies. Before joining TaylorMade, Paschal spent three years as CFO for sports equipment company Varsity Brands. Perhaps just one more, if you dont mind. There is no residual or potential bias towards T-regs and no other high affinity sites that need to be saturated in order to activate potential cancer-fighting immune cells. For more information, please visit the Neoleukin website:www.neoleukin.com. February 25, 2020 08:00 ET
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Hi there. Before that, he was vice president in the investment banking division of Morgan Stanley. Great, thanks for that color. 2021 was a busy year for Neoleukin. Will Restaurant Week Be the Ticket? MediaJulie Rathbun206-769-9219jrathbun@neoleukin.com, InvestorsSolebury TroutBrian Korb646-378-2923bkorb@troutgroup.com, A photo accompanying this announcement is available at:https://www.globenewswire.com/NewsRoom/AttachmentNg/136c9211-7534-4b2c-af0c-d9f8dc6c195e, https://www.globenewswire.com/NewsRoom/AttachmentNg/136c9211-7534-4b2c-af0c-d9f8dc6c195e. Sources: CoinDesk (Bitcoin), Kraken (all other cryptocurrencies), Calendars and Economy: 'Actual' numbers are added to the table after economic reports are released. 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. Sure. 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? In addition, we plan to use information obtained from our solid tumor trial, as well as preclinical data to begin evaluation of NL-201 in hematologic malignancies. That is helpful and I think I understand that. Thank you. FactSet (a) does not make any express or implied warranties of any kind regarding the data, including, without limitation, any warranty of merchantability or fitness for a particular purpose or use; and (b) shall not be liable for any errors, incompleteness, interruption or delay, action taken in reliance on any data, or for any damages resulting therefrom. So we actually see the opportunities is very broad and were starting off with monotherapy activity to see what the data look like. You know we expect dose escalation to start at a dose level, and these are learnings from what weve learned in monotherapy. Because a portion of the protein scaffold that normally interacts with the alpha subunit, also known as CD25, has been completely replaced. And weve seen that in our preclinical data. Before joining the drug maker, he held financial and operational leadership roles at American Express and Xerox. What level of monotherapy activity for NL-201 in solid tumors would be clinically meaningful to you? Well, Ill start with the answer. [Operator Instructions] Our first question comes from Greg Harrison with Bank of America. 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. 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. Robert Howill become CFO at biopharmaceutical company Neoleukin Therapeuticson March 16. Well, I think that NL-201 could be a really interesting monotherapy in both in solid tumors and in hematologic malignancies. Priti previously served as Vice President, Head of Hematology Clinical Development at AstraZeneca and brings extensive experience in clinical development strategy and trial execution of investigational therapeutics with a specific expertise in oncology and hematologic malignancies. Good afternoon, everyone and thanks for taking my questions. So as we discussed NL-201 is currently in a Phase 1 clinical trial with all-comers in solid tumors, relapsed and refractory. And there is a long history of people using IL-2 as intratumoral treatment, local treatment for melanomas and other accessible tumors. Neoleukin Therapeutics, Inc. (NASDAQ:NLTX) Q4 2021 Earnings Conference Call March 1, 2022 4:30 PM ET, Julie Rathbun - Communications, Investor Relations. Mason has more than two decades of finance experience, most recently assenior vice president, corporate finance and treasurer at home improvement retailer Lowes. So with theres a lot of interest obviously in this space. Mutual Funds & ETFs: All of the mutual fund and ETF information contained in this display, with the exception of the current price and price history, was supplied by Lipper, A Refinitiv Company, subject to the following: Copyright Refinitiv. So were opening that trial as part of the monotherapy trial. This concludes the conference call. In addition to Neo-5171, our current discovery stage pipeline includes a T-reg agonist program targeting autoimmune and inflammatory conditions and a next-generation IL-2, IL-15 agonists for oncology indications. We know there are other companies in the space are looking, for instance, at the intravesical approach in bladder cancer. 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. 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. Wirth, who has been with the bank for 15 years, will stay on as a senior adviser through the end of the year. Fundamental company data and analyst estimates provided by FactSet. And as weve mentioned previously, due to the pandemic, particularly in 2021, there was some delays at some of the sites in getting it opened. We believe this will be the first data of a fully de novo protein in patients. Dukes most recently served as CFO of SunTrust Banks. Please disable your ad-blocker and refresh. NYC Wants In-Person Dining Back. At this time, all participants are in listen-only mode. Thanks for taking our question. 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. Our plans for further development of this program and our early stage pipeline that we are advancing toward potential future clinical evaluation. And so we may not have to go to the very high doses that for example, Aldesleukin does in order to have a favorable immune activation versus immunosuppressive ratio. In this executive brief based on CFO's June 2022 webinar, you'll learn about the actionable insights CFOs can use to overcome workforce planning challenges amid economic volatility. Sanjeev Narulawas appointed CFO of pharmaceutical companyViatris, a new company that combines Pfizers Upjohn and Mylan. 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. Priti, anything that youd add to that? 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. Your next question comes from Benjamin Burnett with Stifel. In May of last year, we treated our first patient in a Phase 1 clinical trial for NL-201, officially making the transition to become a clinical stage company. Well provide future updates regarding the status of Neo-5171 and potential development plans. In regards to approaching the NL-201 monotherapy readout expect in the second half of this year. Experimental results indicate that NL-201 causes expansion of cytotoxic memory CD8 T cells and a decrease in T-regulatory CD4 cells in the murine bone marrow. Meredithnamed Jason Frierottas the publishing companys new chief financial officer, effective March 9. I think its really hard to look at biomarkers, because although we have a good sense of what a our molecule can do pre-clinically there isnt good correlation with high dose IL-2 or prior experiments or prior studies to predict pharmacodynamics with clinical outcomes. You may now disconnect. First, Id like to take a moment to acknowledge that Bob Ho will be leaving Neoleukin after two years as our CFO to pursue another opportunity. As you look towards potential single agent expansion cohorts, I think you mentioned in RCC as well as melanoma. Im very pleased to announce that we also have a new Member of our Board of Directors, Rohan Palekar, who is currently the CEO of 89bio. During our three-year history, Neoleukin has built a state-of-the-art computational and protein engineering research organization. All rights reserved. We use cookies to optimize your experience on our website and for analytics and advertising purposes. Please. Jonathan will now provide a brief update on our pipeline effort. 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. We plan to present interim dose escalation data at an appropriate time in the second half of 2022. Our future efforts are focused on modifying the biodistribution of this molecule via targeting and/or conditional activation. And now turning to our clinical program NL-201. He has served as chief financial officer Jonathan Pruzans right hand since 2009. Is this happening to you frequently? So maybe not having to start at the very beginning of dose escalation, theres a lot of interests among investigators to start this combination in various tumor types. Ask an AI, I Got a Crash Course in Rodent Control atD.C.s RatAcademy. Previously, she served as managing director and head of West Coast Healthcare for Evercore Partners and managing director at Merrill Lynch. 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. Thanks, everybody for joining our call today. We submitted our first IND at the end of 2020 and began a Phase 1 clinical trial in May of 2021. The fact that we have such potent IL-15 activity on NK cells suggests that NL-201 could work really well with monoclonal antibodies. 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. And so were having a good enrollment and investigator engagement. Eastwood has worked at Thomson Reuters for over 20 years, most recently as senior vice president and head of corporate finance since 2016.Eastwood was formerly chief operating officer of Thomson Reuters Latin America, CFO of the intellectual property and science business, and has also held several senior roles within the finance organization. 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 also spent eight years in an executive role on GEs corporate audit staff. Miralles succeeds James Anderson, who was appointed CFO in 2018. 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. These statements are subject to numerous risks and uncertainties, including market conditions, that could cause actual results to differ materially from what Neoleukin expects. 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. Insight and analysis of top stories from our award winning magazine "Bloomberg Businessweek". Most recently, Ho served as senior finance director at health care company DaVita. It will be available for replay on the Investor Relations section of the Neoleukin website approximately two hours after the call for at least 30 days. In November of 2021, we disclosed Neo-5171 at the American College of Rheumatology Annual Meeting. We also moved into our new headquarters in Seattle, with expanded lab and office space for our team.
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