Greetings, and welcome to Oncternal's Therapeutics Incorporated Fourth Quarter 2020 Financial Results Call. As a reminder this conference is being recorded. It is now my pleasure to introduce your host Richard Vincent, Chief Financial Officer of Oncternal Therapeutics. Thank you sir. You may begin..

Thank you, Victor. Good afternoon, everyone, and thank you for joining us today. Joining me on the call this afternoon are our President and CEO, Dr. James Breitmeyer; and Acting Chief Medical Officer, Dr. Edwina Baskin-Bey who has been working with us as a consultant for the past several months. We welcome all of you.

Today's call includes a business update and discussion of our 2020 fourth quarter and full year financial results, which will be followed by Q&A. Today’s press release and replay of today’s earnings call will be available on the Investor Relations section on our Oncternal's website for at least the next 30 days.

We filed our 10-K for the full year 2020 earlier today. Please also note that certain information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act..

Thank you, Rich, and good afternoon, everyone. At Oncternal, we are committed to developing novel treatments for patients with cancer who have critical unmet medical needs. We are advancing a robust product pipeline with clinical and preclinical product candidates that target several such cancer indications.

Our development efforts focus on biological pathways implicated in cancer genesis and/or progression.

During the fourth quarter of 2020, we further advanced the development of cirmtuzumab, our investigational, potentially first-in-class humanized monoclonal antibody that binds with high affinity to a biologically important epitope on ROR1 or Receptor-tyrosine kinase-like Orphan Receptor 1.

We have been working on the ROR1 target in several cancer indications for a number of years. At the end of 2020 two major acquisitions took place involving companies who were developing drugs targeting ROR1 with the Merck and Company acquisition of VelosBio Ag. and the Boehringer Ingelheim acquisition of NBE-Therapeutics.

The VLS-101 antibody-drug conjugate was initially developed at Oncternal's and spun out of VelosBio, and it incorporates the cirmtuzumab antibody. These events certainly raised the general awareness of ROR1 as an interesting cancer target.

In December 2020, we provided a data update from the ongoing Phase I/II clinical trial of cirmtuzumab in combination with ibrutinib at the American Society of Haematology or ASH 2020 virtual annual meeting.

The data from 15 valuable patients with relapsed or refractory mantle cell lymphoma or MCL showed a 47% complete response rate and 87% overall best objective response rate or ORR, which is an improvement from the 83% ORR we had previously reported at ASCO 2020..

The TK216 treatment was generally well tolerated with dose limiting toxicity of manageable with myelosuppression and no obvious off target toxicity.

The continuing durability of the two complete responses in these patients who had advanced and heavily pre-treated relapsed refractory Ewing sarcoma is quite encouraging, along with the increased number of patients experiencing stable disease..

Thank you, Jim. In October 2017, CIRM awarded an $18.3 million grant to the researchers at the UC San Diego School of Medicine to advance our Phase I/II clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with B-Cell Lymphoid Malignancies, including MCL and CLL.

We are conducting this study in collaboration with UC San Diego and expect to receive approximately $14 million in development milestones under research subawards throughout the award period. In conjunction with this award, our grant revenue was $1.6 million for the fourth quarter ended December 31, 2020 and $3.4 million for the full year 2020.

Our total operating expenses for the quarter ended December 31, 2020 were $4.5 million and were $20.9 million for the full year 2020. Research and Development expenses in the fourth quarter totaled $3 million and general and administrative expenses totaled $1.5 million.

For the full year 2020, we spent $12.5 million on R&D expenses, and $8.5 million on G&A expenses. Net loss for the fourth quarter was $2.6 million or a loss of $0.09 per share basic and diluted. For the full year 2020, our net loss was $17.2 million or $0.85 per share basic and diluted.

As of December 31 2020, we had $116.7 million in cash and cash equivalents, which includes the $109 million in gross proceeds raised in fourth quarter of 2020. As Jim mentioned, we believe these funds will be sufficient to support our operations into 2023. As of December 31, 2020, we had 48.8 million shares of common stock outstanding.

Now, I will turn the call over to Edwina..

Thank you, Rich. I've been working with Oncternal as a consultant for several months, and I'm delighted to continue to support the team as Chief Medical Officer. I would now like to highlight the upcoming milestones that we expect to reach over the next several months.

We expect to present a clinical data update from our ongoing Phase I/II trial of cirmtuzumab plus ibrutinib for patients with MCL and CLL in the second quarter of 2021..

Jim?.

Yeah. Thank you. Thank you very much. So first of all, Edwina it's a delight to have you working with us as CMO. We're very happy to have you as part of the team. In closing Oncternal has a strong balance sheet and multiple potential catalysts in 2021.

As well as a clear priority of deploying our financial and operating resources toward promising product candidates in rare and underserved cancers. We look forward to updating you during the remainder of 2020. With that, I will turn things back to Victor for the Q&A portion of this afternoon's call..

Thank you. . One moment, please. Well, we now call for questions. Our first question comes from Carl Byrnes with Northland Securities. Please proceed with your question..

Great, thanks for the questions. And congratulations on the progress. Jim, regarding the interactions with the FDA for potential accelerated pathway to approval for CIRM plus ibrutinib for MCL.

Is that something that you think might be possible that we've seen this year? Or would that be more of a 2022 potential event? And then I have a follow up as well. Thanks..

Thank you for the question, Carl. As you as you know, the FDA is difficult to predict. But if we can complete our discussions and negotiations with them relatively quickly, we might be in a position to announce a regulatory fast forward during this calendar year. Time will tell though..

Right, I was thinking you know, assuming that the data that we expect Are you expect to present in the second quarter is compelling. That was sort of help with those conversations I would imagine, just and then a follow up and related.

Do you have any feel and this is more of a question for Richard, with respect to the timing of the CIRM grant recognition throughout 2021, and what the total R&D spend may be for the year? Thanks..

Thanks, Carl. As you know, we have not been historically providing and don't plan to provide any specific quarterly or annual guidance on our spend, or on the grant revenue on an annual basis. Now, I would say -- state that with the $14 million in total subaward proceeds, we have about five quarters left under that subaward.

We expect the studies -- the study portion to be completed relative to the grant requirements by March of 2022..

Great. Thanks so much..

Thank you. Our next question comes from with Brookline Capital Markets. Please proceed with your question..

Hi, I'm on behalf of Kumar Raja from Brookline. Really appreciate the business update. Thank you. And just a couple of questions.

Now, given the initial results, with solid cancers with cirmtuzumab are you planning to further explore the drug for liquid hematologic malignancies?.

Thank you for the question. The answer is yes. And so, we are -- one of the compelling things about ROR1 is expressed on both human logical malignancies and solid tumors diffuse large B-cell lymphoma or DLBCL is one cancer that we haven't started working on yet. And we're interested in it and are doing some preclinical work..

Okay, thank you. Just one more general question regarding enrolment for the ongoing crisis as well as these expansion cohorts that are planned. Can you just give a flavor of how that is growing given the pandemic are there any difficulties or it's all like -- it's all okay.

It's going well?.

Yeah, so of course, look like every biotech company, we were, we wanted to make sure that our clinical programs remained robust, despite the COVID pandemic. And I'm happy to say that they have. In particular, enrolment of Ewing sarcoma patients remained quite strong.

And in fact, enrollment during the pandemic was higher than it was prior to the pandemic. We believe that has been driven by these strong results that that we were pleased to announce including the complete responses, mantle cell lymphoma, enrollment has slowed down a bit.

And it's easy to imagine that because patients with MCL are older, they have comorbidities diseases, and they're exactly those patients that might be at risk of developing severe COVID. If they did catch it. And so there is a certain reluctance to travel to the Medical Centre for MCL patients.

However, we have continued to enrol, and we will be announcing results on additional patients above those that we last updated you on at the ASH meeting..

Great, thank you. Just one last one. With regards to the exciting collaboration with Karolinska Institutet.

I was just wondering if there are any more recent updates on that front?.

So what I can say is that that collaboration is active, where we're doing work together exchanging information and materials. And I think as you know the Karolinska has particular depth in the natural killer space.

In fact, NK cells were discovered there and they have developed very deep experience and expertise with both T-cell and NK based cellular immunotherapy. So it is active and moving along.

We look forward to finding opportunities to keep you updated about our CAR-T program over the course of the year because we think that it's really one of the most important things that we're doing right now. And we're emphasising accelerating that program..

Sounds great. Thank you so much for taking my questions..

Thank you, ..

Thank you. There are no further questions at this time, I'd like to turn the floor back over to management for any closing remarks..

So everybody, thank you very much for joining us on our quarterly update call today. We appreciate your attention and your interest in Oncternal and we look forward to staying in touch with you over the course of this year. With that we will sign-off Thank you..

Ladies and gentlemen, this concludes today's web conference. You may not disconnect your lines at this time. Thank you for your participation. And have a great day..