Q2 2020 Oncternal Therapeutics Inc Earnings Call
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Greetings and welcome to our terminals Q2 financial results call. At this time all participants are in listen only mode. A question and answer session will follow the formal presentation.
If anyone should require operator assistance. During this conference. Please press star zero on your telephone keypad.
Please note that this conference call is being recorded.
I'll now turn the conference over to our host Richard Vincent CFO of alternate therapeutics. Thank you you may begin.
Thank you operator go.
Good afternoon, everyone and thank you for joining us today.
Joining me on the call this afternoon, or our president and CEO Dr., James Bright Meyer and our Chief Medical Officer Dr. Frank SRIO.
We welcome all appeal.
Today's call includes a business update and discussion of our 2022nd quarter financial results, which will be followed by Q1 <unk>.
Earlier today, we filed our 10-Q four the second quarter 2020.
Please note that today's press release and a replay of today's earnings call will be available on the Investor Relations section of our turns web site for at least the next 30 days.
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.
We will be making forward looking statements. During this call about future events, such as our business and product development strategies and future financial and operating performance.
Our actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with our business.
These forward looking statements should be considered in conjunction with and our qualified by the cautionary statements contained in todays press release, and our SEC filings, including our form 10-Q for the quarter ended June 32020.
This conference call contains a time sensitive.
Information that is accurate only as of the date of the slight broadcast August six 2020.
We undertake no obligation to revise or update any forward looking statements to reflect events or circumstances occurring after the date of this conference call.
With that it's my pleasure to hand, the call over to our CEO Dr., Jim Bright Meyer.
Yes.
Thank you. Thank you rich and good afternoon, everyone and I turn a we're 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 the target several such cancer indications.
Development efforts focus on untapped biological pathways implicated in cancer, Genesis and or progression.
In the second quarter of 2020, we continued to make steady progress on the development of Teekay Twosixty, our investigational potentially first in class targeted small molecule inhibitor of the 26 transformation specific or E. T. S family of Oncoprotein Teekay to 16 is being evaluated.
In a phase one clinical trial for patients with relapsed refractory Ewing's sarcoma in fact, after we reported too deep responses in patients with Ewing's sarcoma, there's been so much interest in T.K. to 16, among the investigators and in the Ewing's sarcoma patient community that enrollment of patients.
The expansion cohort of our clinical trial has actually accelerated despite the cobot pandemic.
As a result, we are increasing our guidance and now expect to announce clinical data for 12 to 16 patients dosed in the expansion cohort in the fourth quarter of 2020.
During the second quarter of 2020, we also made significant progress in the development of CIRM choose a math or investigational potentially first in class humanized monoclonal antibody that binds with high affinity to a biologically important apatow on ror, one or receptor tyrosine kinase like orphan.
Receptor one.
In May of 2020, we provided a data update from the ongoing phase one two clinical trial upstream choosing map in combination with Ibrutinib at the American Society of clinical oncology or ASKO 2020, virtual annual meeting showing a 58% complete response rate and 83% overall bill.
First objective response rate or O R. R for patients with relapsed refractory mantle cell lymphoma, or Mcl importantly, the combination of some choose a man has also been well tolerated with no significant adverse events above those reported for Bruton therapy alone.
Based on these encouraging data presented at ASCO, We recently announced that Mcl is our lead indication horse from choosing that.
We're recruiting new investigative sites and will increase enrollment of patients with mcl in our phase two expansion cohorts to at least 20 patients.
Based on the interesting observation that patients with MTL, who had previously received to Britain them.
Subsequently did well on the combination of searches amount plus ibrutinib. We are also reaching enrollment of patients with a broader range of prior a burden of treatments.
We have requested a meeting with the U.S. food and drug administration or F.D.A. to seek guidance on a potential accelerated approval pathway fortune twos amount plus ibrutinib in patients with relapsed refractory mcl.
We are pleased to see Sta also granted the company orphan drug designations Horsham choose a mab for treatment of mcl and for treatment of chronic lymphocytic leukemia or CLL.
I'm terminal strengthened its balance sheet over the last few months by raising an aggregate $11.2 million in gross proceeds from to register direct offerings. This is expected to support our operations into the second quarter of 2021.
He also hosted a very well attended virtual kao alcohol on the current treatment landscape of Mcl, along with a discussion of the CIRM choose a man mcl clinical results. This involve dr., Michael Wong President of a professor of lymphoma in myeloma at the University.
<unk> of Texas, MD Anderson Cancer Center.
Dr. Wang with particularly impressed by the strong complete response rate team for patients with Mcl in our phase one two trial.
The combination of searches amount plus or the neb, along with its well tolerated safety profile.
You noted that if approved searches amount plus ibrutinib could be attractive to physicians for patients with mcl either prior to its car T therapy or for those who progress following car T therapy.
Dr. One was impressed that a patient on her study who had relapsed following cdnineteen car T therapy achieved a rapid complete response when treated with certain choose a mad plus ibrutinib.
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Finally, even though the social distancing related to covert 19 created a significant patient enrollment headwind across the country I am pleased to report that our programs remain on track and our dedicated employees continue to successfully manage the challenges related to depend.
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We reaffirm that we have adequate supplies of teekay to 16 and certain choose a mab clinical trial period through at least mid 2021 [noise].
We do still expect some delays in generating preclinical data for Teekay to 16, and CIRM choose a man for potential new indications, which we first noted last quarter.
Overall I'm happy to report that on turn was making steady progress toward our previously disclosed clinical data milestones for 2020, which I will review for you shortly.
In the meantime, let me turn the call over to our Chief Medical Officer, Dr., Frank shoots who will provide more detail on the clinical programs.
Thank you Jim I'll spend the next few minutes updating you on the progress of our clinical programs and filling in more detail about each product.
In April 2020, we announced an interim critical data update for Teekay to 16, which is a novel investigational small molecule inhibitor. Their targets you 26 transformation specific where each yes family Echo approaches.
And our ongoing multi center phase one clinical trial, we've been investigating the effect.
This agents in patients with relapsed or refractory ewing's sarcoma viewing it's a it's a second most common type of bone cancer affecting children.
It is an orphan indication as highly difficult to treat.
As we recorded 70 patients treated at the recommended phase two dose of Teekay to 16, 200 milligrams per meter square per day for 14 days with or without and Christian.
Work valuable clinical response.
With the seven or 28.5% had a cheap deep partial responses or PR.
You had stable disease, and three had progressive disease.
As we given.
Both patients achieving a PR remain on track and are doing well one patient had complete regression all target metastatic lung patients after receiving single agent Teekay to 16.
After maintaining its response on T.K. to 16 and that Teekay to 16 course, and Christian for about six months, a small residual non target long lease with surgically removed indication achieved a surgical complete remission.
That young patient remains on study for more than 12 months now and still has no weapons disease.
The second responding patients, who initially presented with multiple longer because he's our chief you're 90% reduction target lesions and resolution of non target leases falling two cycles are teekay to 16 in combination with and Christian.
Overall.
Key events associated <unk> 16, Ekern manageable.
For instance related events or neutral junior had been transformed and reversible and need to have responded quickly.
Our two growth factory sectors do you see yourself.
Our investigators are their physicians patients and caregivers have reacted very positively usage data because you really sarcoma hurts you treatment options in this advanced as he said.
Enrollment in the expansion cohort in security has accelerated and we now anticipate announcing critical data for 12 to 16 patients goes its expansion cohort in the fourth quarter 2020.
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47 to 12 patients.
Now switching discussion of course are choosing that program, which is an investigational <unk>.
Turn to reverse inquiries humanized monoclonal antibody to find high affinity.
As a buyer large degree important temperature.
On our a war one also known as <unk>.
At this year's ASKO meeting, we announced upgraded critical bigger for certain fuse map in combination with <unk> and approve bruton tyrosine kinase or BTK inhibitor.
In patients with relapsed refractory m. skill in ruled in our ongoing phase one two clinical trial.
Your data card or.
It was capable third year Easter you indicated that 712 are valuable patients were 58%.
Achieved a complete response, our chests and correct here one of which was a complete metabolic response as determined by pet scan.
That's objective response complete or partial response rate.
Was 83%.
For the 70 patients achieved complete responses rapidly after three to four months it starting served to snap.
We are investigators have particularly impressed.
Hi, good responses in heavily pretreated patients.
Five patients with Mcl.
Who had relapse trawling pry recall get stem cell transplants were enrolled in our study all five of them responded to the combination of searches map and improve.
For keeping a complete response and one achieving a partial response.
One patients who had relapse following both in a color because transplant and then allogeneic transplant or cheeks, a complete response on the combination of certainties in that kind of Berger.
[laughter] car T therapies are becoming more widely used for patients with mcl Cartus, which recently at the proof and is encouraging.
One patient honors study, who had relapse following boats and their colleagues transplant and prior Cdnineteen car T therapy or cheaper complete response on the combination of CIRM twos mapping of Britain.
And the treatments well tolerated.
In addition for patients with Mcl enrolled and study had been previously treated with a prudent and later relapse halt for these patients responded to the combination like searches and lab and <unk> and our trial to retrieve can complete responses and to achieving partial responses.
Progression pre survival 17.5 months with the median follow up okay.
Thanks.
The combination of certainties map, plus Ingredion has world color with no new or accentuate adverse events compared to the known safety profile of a burden up alone.
For patients with Mcl, who are older or have co morbidities and cannot tolerate aggressive treatment regimens safety and tolerability are particularly important.
We believe that these results compare favorably to the reported outcomes situation of <unk> and similar.
Mcl patient population.
Based on to publish pooled analysis threep prior clinical trials of simulation of <unk> in patients with relapsed or refractory mcl summarized in the 2019 paper by Simon rule for patients with more than one prior lines of therapy. The complete response rate was 23% <unk> Oh are was.
67% and the PFS was 10.3 months.
Based on the strength that these results presented at ASCO. In me alternate has made a strategic decision to amend or ongoing phase one two study and to increase the number of patients with relapsed refractory mcl to be enrolled in the phase two expansion cohort two leased 20 patients and to allow enrollment.
To patients with a broader.
Range of prior treatments.
The company. It's also requested nifty a means to discuss the results of the interim.
The recent interim analysis and to seek guidance on potential accelerated approval pathway for searches and that plus or burden in patients with relapsed refractory mcl.
We also reported an update on CLL portion of our ongoing study.
Hub certainties map and the burden of at ASCO.
34 patients were enrolled into the dose escalation and expansion portions of the trial.
And dirty at 34 valuable patients achieved a complete response or partial response for an overall best objective response rate of 88%.
One patient or 3% achieved.
A complete response and 29 patients are 85% achieved.
A partial response with the median follow up with 12.8 months no patients with CLL progressed wireline study.
Question free survival was 100%.
Now, while the 100% progression free survival rate is encouraging we believe the M.C.L. indication may offer a more rapid path to potential regulatory approval.
Based on these interim results on kind of will continue.
Treatment and follow up up the patients with COO, who already enrolled in our study after two years or until disease progression, but we'll limit the total enrollment of patients in the randomized phase two obviously, a low cohort to approximately 30 patients in order to folks are resources on the I'm still portion of the study.
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We're also pleased that the FDA.
Granted to accompany orphan drug designations for service using that for the treatment of NCL and for the treatment to see alone.
We are playing to update both mcl, one siloed data from our ongoing phase one two trial at an scientific conference I.
In Q4 2020.
Sure to snap is also being investigated for treatment of patients with breast cancer.
Patient enrollment continues in assays wouldn't be investigator sponsored studies searches map plus paclitaxel in patients with her to negative breast cancer.
Previously presented results showed an objective response rate of 57% with no new core accentuate adverse events compared to the known safety profile Paclitaxel alone. We expect additional clinical data from this trial to be available in the first half the 2021.
Which is a slight delay from prior guidance.
Now work continues on our ROI or one car T cell therapy program together with our collaborators at the University of California, San Diego under Grant from the California Institute, a regenerative medicine and through a partnership.
With Shanghai pharma.
Our goal is to initiate a first in human study and 2021.
I'll now turn over to call to Richard Vincent our CFO to review our financial results.
Thank you Frank.
In October 2017 server awarded an 18.3 million dollar grant to the researchers at the you see San Diego School of Medicine to advance our phase one two clinical trial evaluating some twos AMAP in combination with Ibrutinib for the treatment of patients would be fell employed malignancies.
Including Mcl and CLL.
We are conducting that study in collaboration with you see San Diego and expect to receive approximately $14 million and development milestones under a research sub awards throughout the award period.
In conjunction with this award our Gretton revenue was <unk> point Sixmillion. The second quarter ended June 32020.
Our total operating expenses for the quarter ended June 32020, or 6.2 million.
Research and development expenses totaled 3.8 million in general and administrative expenses totaled 2.3 million.
Net loss for the quarter was 5.5 million or a loss of 34 cents per share basic and diluted.
As of June 32020, we had 16.6 million in cash and cash equivalents.
In May and July 2020 alternate strengthened its balance sheet, raising an aggregate 11.2 million in gross proceeds from two registered direct offering.
Including a 6.2 million dollar offering in July.
Existing investors represented approximately half of the invested capital.
We believe these funds will be sufficient to support our operations into the second quarter of 2021.
Following the July offering we had 19.9 million shares of common stock outstanding.
Now I will turn the call back to our CEO, Jim Ryan Meyer.
Thank you rich that summary of our financial results.
Now close the call by highlighting the upcoming milestones that we expect to reach over this next several months as I mentioned, despite the disruptions related to covert 19 pandemic. We remain on track to achieve the key clinical data read outs for Susan them and Teekay 16 that we have planned for this year.
Specifically, we expect present clinical data from 12 to 16 patients with relapsed refractory Ewing's sarcoma, who have been treated with Teekay to 16, plus been Christie in the expansion card to the study at a scientific conference in the fourth quarter of 2020, a larger number than our pre.
Previous guidance, we expect to present, a clinical data update for my face to one two trial for patients with mcl treated with soon choose a math plus ibrutinib and a scientific conference in the fourth quarter of 2020.
We also expect to present, a clinical trial data update from our phase one two trial for patients with CLL treated with Demcizumab plus ibrutinib as a scientific conference in the fourth quarter of 2020.
We expect to clinical updates to be available from the phase one be investigator sponsored study I assume choose amount plus paclitaxel in patients with hertwo negative breast cancer in the first half of 2021 [noise].
Lastly, we are targeting to treat the first patient with a lower one car T cell therapy in 2021 in a collaboration with Shanghai Fund the limited.
In closing we have a focused business plan ahead of us with multiple potential catalyst in 2020 and beyond and a clear priority of deploying our financial and operating resources against promising product candidates in rare cancers. We look forward to updating you three new manger of 22.
Randy.
So thank you for calling us joining us today I will turn the call back over to Diego for the Q in a portion of this afternoons call.
Thank you.
At this time will be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad a confirmation total indicate that your line is in the question Q.
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Our first question comes from Robert Burns with H.C. Wainwright. Please state your question.
Hi, guys. Thanks for taking my questions and congrats on the progress I just a couple from me if I may so could you help frame expectations around what you believe potential accelerated approval pathway looks like for sandwiches Mad plus the Britain and M.C.L. with regard to possible trial design sample sizes and overall timing.
And I know that you might not want to comment a you know what are the FDIC I just wanted to get your thoughts as to what you think it would be.
And then my second question is since we shall now see clinical data for Teekay to Onesix in 12 to 16 patients from the expansion cohort I was curious as to what you do you is it goes flashing no go ethic efficacy signal. Thank you.
Thank you Rob. This is this is Jim and we appreciate your question [noise].
So so where we're going to the F.D.A. taking note of the fact that there have now been for recent approvals from the FDIC for mantle cell lymphoma based on single arm trials.
Have a of modest numbers of patients and specifically Bruton 111 patients calibre NIM hundred 24, Jana Bruton and the most recent 186 patients and then a among the BTK inhibitors and that's part of this recent party.
Approval single arm study with only 60 patients.
So so we're we're optimistic.
That there may be a pathway for some twos in them with a with a similar similar approach and so.
Hey, let's let's use as around number.
100 patient single arm, a registration study and that would and then we would of course work out the details or would the F.D.A. about patient population and a other design elements. So so we think that.
We're well aware of the fact that mantle cell lymphoma is is not the most common form of malignant lymphoma.
And we would expect that we would run a registration study internationally in the U.S. and in China with our partner Shanghai farm at a minimum but we're also considering other countries and.
And so.
If we look at if we look at other pivotal studies. They typically take in around a two to three years to enroll and within this rare disorder and competition from other studies in M.C.L. to the going on right now.
We think that that's that's a reasonable timeframe we use benchmark.
Numbers of around $100000 per patient than plus manufacturing costs. Then you can imagine what what are all in costs for such a study my my to my my cost and so before I go onto your T.K. to 16 question. Let me let me ask you. If you have a any follow up.
Question on that.
No that was crystal clear thank you.
Sure. So then teekay to 16.
When we we are as I as I think you can tell we're very excited that this targeted agent is showing activity in patients with advanced metastatic ewing's sarcoma, and and we believe that the bar.
For Sta approval for this kind of sarcoma.
Is very low specifically, we've taken no or they have an approval that epizyme achieved four tas barrick in a in a similar sarcoma apathy only OID sarcoma in which a pivotal trial had 62 patients with only one complete response.
So we've we've already seen to near complete responses with our first few patients and so at this point, we are where we are still encouraged that the T.K. to 16 program is likely to go forward a with.
These would you seek responses that we that we've already seen under such circumstances, where we believe the bar is pretty low to bring there are some some activity to a genuinely desperate patients and their families.
So I'll stop there and ask if you have a follow up on Teekay to 16.
No. That's all from me. Thank you so much.
Thank you Rob.
Thank you there no further questions at this time I'll turn it back to management for closing remarks. Thank you.
So thank you everybody for joining us today for our our Q2 Investor call. We appreciate your 10 your attention and look forward to keeping you updated in the future I. Thank you very much and goodbye for now.
Thank you. This concludes todays conference all parties may disconnect have a great day.