Q3 2020 Onconova Therapeutics Inc Earnings Call
Ladies and gentlemen, please standby yeah, Q3, 2014 and can affect their PD Inc. earnings conference call will be keyed momentary me.
Hi, Dad PC standby your conference call.
We'll begin momentarily.
[music].
Ladies and gentlemen, thank you for standing by welcome to the unplanned move outs are up uniques third quarter financial results and business update conference call.
At this time all.
I'm, sorry, you know even on the board.
Oh, they need money too much if you have your marks yeah hold a question answer session.
Basketball.
Followed by wanting I pad drilling fluids.
If anyone has difficulty hearing time frames and expenses.
Audio for operator assistance other reminder, let's call it used to be on Florida Today November 12 2010.
At this time I would like to turn the whole over to Abbvie, all their senior Vice President of corporate development and general constant.
Thank you operator good afternoon.
You mean, everyone and welcome to OCC Inovas third quarter, 2020 financial results and business Big Conference call earlier.
Earlier. This afternoon, we issued a press release reporting our financial results and business progress during the quarter.
If you have not seen this press release it is available in the investors and media section of our website.
Www Dot Onconova dotcom.
On today's call Dr., Steve Rothman.
President and CEO will discuss the company's recent highlights and anticipated clinical and business milestones and then Mark Gehring, Our Chief Financial Officer will review third quarter financial results.
Following Marcia report, we'll move to the Q and a portion of the call and we'll be joined by Dr., Rick Woodman, Our Chief Medical Officer before.
Before we begin I'd like to remind everyone that statements made during this conference call by management will include forward looking statements under the Safe Harbor provisions of the private securities.
Really the litigation Reform Act of 1995, which.
Which involve risks and uncertainties that can cause actual results to differ materially.
Forward looking statements speak only as of the date. They are made as the underlying facts and circumstances may change, except as required by law Onconova disclaims.
Any obligation to update these forward looking statements to reflect future information events or circumstances. Please see the forward looking statements disclaimer in the press release issued this afternoon.
Risk factors and the company's current and future filings with the SEC with that it's my pleasure now to turn the call over to Steve.
[laughter] back you Robby.
Good afternoon, everyone and thank you for joining us this afternoon.
We hope.
You and your loved ones I say.
Remain healthy.
To cope with 19 pandemic.
Certainly impacted us all.
And how we live and work together.
And I think you know.
We are still awaiting word are not funding requests to the National Institute of allergy and infectious diseases branch.
On the National Institutes of health.
And the biomedical advanced research and development authority also known as <unk>.
The possible funding.
Clinical trials.
The girls or did in patients.
<unk> COVID-19 disease.
However.
Cancer.
And the development of effective new anti cancer therapies.
Means a significant health issue.
And is our corporate focus.
We believe our.
Thank you know <unk> is well positioned to play an important role in it.
Developing differentiated therapeutics for cancer care.
During the third quarter, our product pipeline advance nicely.
Oh in 123 300.
Entering the clinic.
In a phase one study in China.
And oral rigosertib.
Entering a phase one investigator initiated study.
In combination.
The PD one inhibitor Novolen bad.
K Ras mutated non small cell lung cancer.
The senior management team and I'm getting over brings substantial drug development expertise.
And they.
Previous string of successes and anti cancer drug development.
To our company are no.
Our core expertise.
Just to identify promising drug candidates.
Develop and test.
I am an.
And ultimately to commercialize them.
Both Dr., Rick would admit and our.
Medical oncologist by training.
With careers in academia.
Prior to joining industry.
And the.
I've got to know the team has developed and brought to market numerous successful oncology products during our careers to date.
I don't know.
Our lead pipeline product.
Oh and 1233 on.
Which is a proprietary first in class multi kinase inhibitor targeting.
Okay War sick.
All five.
Oh and 123 300.
Eli Motamed easily inhibits both cell cycle and cellular metabolism.
Through CDK and ALKS five respectively.
And in vitro has been shown to be cyto toxic to cancer cells.
The us killing cancer cells.
Rather than Cyto static.
Or merely inhibiting the growth of cancer cells.
The currently commercially available CDK inhibitors.
Typically.
Great site static.
Regionally with its mechanism of action hog.
Targeting CDK four six and ALKS five Oh.
Oh in 123 300.
We sense and innovative.
Henshall approach to treating solid tumors and hematologic malignancies that a refractory or have become resistant.
She likes commercially available CDK four six inhibitors.
Based on pre clinical.
Local models.
Oh in one Q3 300 may have utility for patients with certain types of breast cancer and non Hodgkin's lymphoma.
And based on these preclinical models all in 123 300.
They also have broader utility utility potentially for advanced mantle cell lymphoma, multiple myeloma colorectal cancer panel cellular carcinoma and in approval real Blackstone.
Due to the preclinical.
Evidence that all in 123 300 can cross the blood brain barrier.
We are particularly pleased.
During the third quarter all in 123 300 entered the clinic in China.
Right.
Our partner Kinect bio pharmaceuticals.
The Hornets phase one dose escalation study began in September.
As of today.
The first cohort of three patients.
Each who has.
Breast cancer.
Been enrolled.
The phase one study in China as they expanded three by three dose escalation study.
With each cohort requiring.
Three or six patients depending on the number.
Dose limiting toxicity observed.
If any are observed.
This phase one study is expected to enroll patients with advanced relapsed refractory cancer at two sites in China.
And together with.
Our planned phase one study in the U.S. real in the fall.
The future development.
Oh and 123 300.
In the U.S., we are preparing to file an investigational new drug.
Drug application with the FDA by the end of this year.
With patient enrollment.
But I think to begin in the first half of 2021.
We expect that our phase one dose escalation and those expenses.
Finishing study will differ from the high next study.
In both dosages and treatment cycles, but the lead the data from these two studies will generate important information to inform anticipated later.
Later stage studies.
Our current plan.
As for the Phase one trial in the U.S. to assess safety Tolerability.
Tolerability and far more co kinetic Oh and went to three 300 administered or.
Badly and increasing doses, starting at 40 milligrams daily or higher.
Four consecutive 28 day cycles in patients with relapsed or refractory advanced cancer.
Including but not limited to patients.
Growth hormone receptor positive and here too negative metastatic breast cancer with clinical resistance to the approved second generation.
CDK four six inhibitors.
Once the recommended.
This phase two dose is this.
Our plan is to enroll.
These 36 hormone receptor positive had two negative postmenopausal metastatic breast cancer patients with resistance to.
The approved.
Second generation CDK, four six inhibitors as well as patients diagnosed with advanced non Hodgkin's lymphoma.
It was a special interest based on preclinical studies in mantle cell.
[noise].
This trial design differences.
From the study in China, and that had an ex those patients daily for 21 days and in the U.S.. We will study continuous daily dose daily dosing for a 28 day cycle.
Notably of the three currently approved CDK four six inhibitors to were tested and used for dosing in 21 day cycles and one was tested in a 28 day cycle.
All three.
Our blockbuster drugs.
Marketing.
Well no I mean.
Companies.
We expect these two phase one studies.
The one in China and the one in the U.S. Q collectively increased the number of patients studied and us to augment.
Our understanding of the safety profile of Oh in 123 300.
Although design is a classical phase one study to establish fate to establish safety.
These studies May also provide.
Preliminary important efficacy signals.
We believe the results of two simultaneous phase one studies will also inform and enhance the development of subsequent latest stage study.
To be conducted.
Let me now turn to our second pipeline product.
Oral rigosertib right.
Which is directed to patients with cancer, who may carry a K Ras mutation.
Following the negative overall survival data readout.
Phase three inspired trial testing intravenous rigosertib in higher risk mild this plastic syndromes we're encouraged.
By investigator initiated.
It's studies aimed at alternative diseases characterized by K Ras mutations that are underway or proposed with oral rigosertib.
On our last call we shared with you.
During the third quarter of phase one dose escalation study had been already initiated and a leading medical center in New York City.
Exploring the use of oral rigosertib in progressive K Ras mutated non small.
Small cell lung cancer patients.
In combination with a PD one inhibitor more specifically the immune checkpoint inhibitor nivolumab or opdivo.
As of today. This study has enrolled five patients.
It is designed to identify the recommended phase two Dallas too.
To further study the combination in future studies.
Add to characterize the safety profile of the combination treatment.
Dosing results of this phase one trial are expected in 2021.
No.
The most recent recent dosing cohort has already received.
The 560 milligram twice daily dose.
Of oral Rigosertib rich.
Which is the highest dose their current protocol is designed to deliver.
It is likely this will be the dose we are taking into phase two testing.
However.
If no dish.
Yeah.
Dose limiting toxicities are observed with additional patients and get into the current trial.
Service those increases.
Sorry go to surgeon may be considered it within the amended protocol.
More than half of non small cell lung cancers are classified as lung adenocarcinoma. This.
Oh please.
The largest subset has a K ras mutation as the predominant genetic driver.
The cancer.
Given their utility and multiple cancer settings.
Point inhibitors are among the world's top selling pharmaceutical products.
And they continue to gain FTC approval for a new indication.
Yes.
In our view this makes our novel combination approach risk vigorous surgeon.
Potentially meaningful option to pursue in lung cancer and other disorders with K Ras mutations.
He's managed with immuno oncology therapies.
We hope these studies will offer patients who have progressed on first line therapy with a potential efficacious second line approach.
In addition.
A multi site.
Investigator initiated phase one b two study.
Where do we go sort of model therapy has opened.
This is studying patients with advanced squamous cell carcinoma.
And associated with.
To answer this traffic epidermolysis below us.
And in extremely rare genetic mutation Ras an area of high unmet medical need.
The first patient is expected to be enrolled in 2021.
These additional investigator initiated preclinical studies with oral rigosertib are being proposed.
Including melanoma and renal cell carcinoma rich.
Which we expect will also be in combination with a PD one inhibitor.
As I mentioned.
Our focus at no.
Is on advancing our cancer therapeutic pipeline.
To help patients.
Based on robust preclinical data we.
We are keen to investigate the protests.
10 show, Oh, and 123 300 in the clinic.
And to further the promise of oral rigosertib for new indications.
We are also actively evaluating strategic opportunities to further advance.
And enhance our portfolio.
Proprietary anti cancer agents.
We look forward to keeping all of you updated on our progress with these very important initiatives.
And now.
I'd like to turn.
On the call with me Mark Garrett.
She financial officer for a discussion of our financial results.
Third quarter of 2020.
Mark please.
Thanks, Steve and good afternoon, everyone I.
I plan to start with a quick review of our.
Third quarter expenses, and then I'll discuss our cash position and cash runway.
Research and development expenses for the third quarter of 2020 were 4.2 million and this compares with 3.5 million for the third quarter of 2019.
The increase was primarily related to higher consulting fees and Manny.
Actually in costs related to clinical supply for Olin 123, 300, partially offset by lower expenses for the oral Rigosertib combination program and the phase three inspire study.
We announced the phase three inspire results on August 24th and we expect modest wind down costs for this trial to continue late into the year.
In the quarter.
General and administrative expenses for the third quarter of 2020 were $2.1 million compared with $1.6 million for the third quarter of 2019.
The increase was due to higher Precommercialization insurance and corporate legal and stockholder meeting expenses.
We reported.
The net loss for the third quarter 2020 of $6.2 million compared to a net loss for the prior year third quarter up 4.6 million.
Cash and cash equivalents as of September Thirtyth, 2020 were $24.2 million compared to 22.7 million as of December 30, Onest 2019.
During the third quarter of 2020, we raised $2.7 million from the exercise of warrants.
The company expects that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations into the first quarter of 2022.
This completes my financial review I'll now turn the call back to Steve.
Thank you Mark.
So with that review of our product pipeline and our financial results, we'd like to open up this call for Q.
Questions.
Operator please.
Ladies and gentlemen, if you wish to register for a question for todays question and answer session. You will need to profit Star then the number one I'd like telephone if.
If your question has to do I'm, sorry are you Mr. He Diana Ross you may be still be pressing the keys.
If you are using.
Speakerphone, please pick up your handset before answering your request.
One moment for the first question.
Our first question comes from Joe Pantginis.
HM.
Right. Your line is open.
Hey, guys. Good afternoon, Thanks for taking the question and hope you're all doing well.
So a couple of questions I'm going to go backwards in the chronology of you. The way you described them. So first with regard to the lung cancer study.
You may.
Mentioned, obviously, there's five patients enrolled and we've already hit the top dose for the protocol. So just curious besides 2021 since there is a I'll call. It relatively decent number of patients in this study for an iced tea.
By the time ASCO or other conferences roll around would we be targeting.
Those types of releases or is this really up to the investigator.
Joe. Thank you for that question and I'll ask Rick to take it please correct.
Thank you Stephen Thank you Joe for the question.
I think there was a couple of considerations first is.
The practical one.
That ASCO abstracts at Ash.
Email today announced that abstract deadline is February 17th.
And so to.
Have an abstract submitted for the what I assume will be a virtual meeting next may June timeframe.
That's the timeline by which we would be operating I.
I think to submit an abstract there is also an important consideration of what is the information we would provide in it.
I think that if there was a recommended phase two dose identified.
And all.
Dl Tees and a maximum tolerated dose identified that would be.
Important information worthy of submitting an abstract.
Whether that happens before February 17th is entirely unknown.
Certainly in addition.
On to that if you had any early signals, it's unlikely that we'd have any given the short timeframe patients would be on treatment.
But that would be another important typical inclusion for an abstract on a study like this so.
So I.
I think certainly the investigator would.
I'd be interested it is his final decision.
And I think some of the things I've described to you would be something that I'm sure. He will discuss with us in his decision.
Great. Thanks for that Rick and then going backwards. So it's very intriguing this new investigators study.
I'd and squamous cell carcinoma for our debt patients. So I think one of the I.
I think intriguing things to me as well sorry to keep using that word word but it really applies is the safety profile of rigosertib to date, because the patients for its hard to have our predominantly pediatrics. So I think to be able to move this.
S.T. forward in this patient population that literally spends about $10000 a month just on bandages is very intriguing and exciting. So I don't know if you have any additional comments about the conduct of the study.
Sure I think Joe it's very impressive first of all they you know so.
Talking about is very rare disease that is amazing, but Rick why don't you take that as well.
Yes at Joe I'm also impressed.
I'm not sure from what I've learned about this rare disease $10000 a year might be under estimate.
No amount unless I'm mistaken.
Sorry, thank you.
I think that first of all let me clarify this phase one study we're doing is in adults age 18 and over.
At this point in time its it.
It's unknown.
Well bill to move into a pediatric population.
I think the important thing to consider is that not only do these patients have.
Terrible skin disease and risk for squamous cell carcinoma, but they also have apathy failure.
The web form in there throughout their gastrointestinal track and so in this particular study we have the need to investigate either oral or intravenous based on individual clinical circumstances for each patient.
So I think.
Okay.
Again, it won't be a pediatric study initially, but certainly if there is benefit demonstrated that's a possibility.
Got it very helpful again, and then I guess.
More quickly because it really did Steve delineate the types of dosing.
Thanks, as you are going to be looking at for one to three 300.
As you know I guess based on again.
Yeah, let's ask this way based on the preclinical profile for the drug do you believe you'll see a particular.
Seeing regimen or beating the other one the or you just need to.
Do the experiment at this point.
Yeah, I think Joe and thank you again for the question I think that's why we're doing that experiment to determine if.
But a 21 day cycle or the 28 day cycle is preferable.
As we mentioned the commercially available.
Different has either.
Regimen, depending on which drug we're talking about so we think we're going again.
Very interesting data both from the patients in China, and the patients and the U.S. and that the study in China is going to help us greatly because they started at low dose of.
40 milligrams in cohort.
Does not have any dose limiting toxicities when we open a U.S. trial, we can already start at the next cohort and after we put all the data together then we'll determine what is the best safety approaches into 21 day regimen or the 20.
Eight day regimen and until we have the data I can add we can't answer your question Joe. Thank you and understood. Thanks for the added detailed guys.
Thank you.
Next question comes from Jason Mccarthy from Maxim Group. Your line is open.
Hi.
We want it or are they on the line for Jason. Thanks for taking my question. So one can expect a data readout from the phase one Chinese <unk> and do you guys plan on exploring any potential combination trials 123 300.
Thank you for that.
Yeah.
To handle that.
Yes, Thank you Steve.
Thank you, Jason I think that.
To answer your question I think it depends on what you called data read out.
I think that.
No we aren't.
Anticipating.
For one or both studies.
But fourth quarter 2021.
You would have an understanding of maximum tolerated dose and recommended phase two dose as well as the safety profile.
Well in the monotherapy.
These setting.
I think it's it's a it will be difficult to have final readout on any efficacy signals.
Given that patients who may be benefiting or maybe on study for a several months or longer hopefully.
And then depending on the last patients come into the study on the expansion phases.
It will also determine you know.
What we know about efficacy.
You know I want to emphasize again.
This is a phase both studies or phase one.
And obviously.
Reading efficacy signals with these studies.
Can be challenging and that's certainly not the primary objectives of the study.
Okay and Frac it expand on Rick's comments regarding the combination approaches as a second part of your question.
Just to highlight to you.
You probably know the commercially available CDK four six inhibitors have limited.
Efficacy as single agents typically that given not typically always given was an Arab emirates ace inhibitor in combination.
Because oh, we want you to be 300.
Targets oxide.
UK for six hours on the PCB side of toxic refractory.
CDK four six inhibitor refractories breast cancer cell lines.
So it is possible have efficacy as a single agent, but perhaps in combination with her now imitation hibbett or some other cost that we'll have even greater efficacy and clearly those studies will have to be conducted after ricks team determines what the match.
Somebody tolerated dose for the phase two Shelby.
I would.
I would just add it also depends what disease, we see a response in.
You know what Steve just described.
Described is for metastatic breast cancer, but if we had a real.
Response, and another tumor type, which there may be because of the arc five that may dictate.
The feasibility of doing combinations and it's hard to know what those combinations might be until we understand which tumor types.
Our in fact responding.
Great. Thanks for the additional color guys appreciate it.
Thank you.
Our next question comes from Oslo demand from Noble capital markets. Your line is open.
Good afternoon team. Thanks, Thanks for taking my question I wanted to follow up on the TDK Force.
Thanks, Dan Arsfive targeting so I am really two years.
Arc five amtrust.
Amplified in any other cancers do you believe a one off the cancers will respond better as Rick's comments and if so what are the indications you might consider going after stronger than others.
Do you have any strategies or any idea of how about that.
To start with.
Thank you our who are Rick would you like to take that please.
Sure.
Yes, there are a number of other tumors that have increased expression.
Of arc five such as.
Mantle cell lymphoma.
A part of cellular carcinoma multiple myeloma.
And obviously, there's some increased expression in breast cancer.
Over the last film as another example, and this compound does cross the blood brain barrier.
So there are a number of tumors.
Potentially.
Have up regulation of the targets and so we'll be of interest as we move through the clinical studies to see what kind of safety and efficacy we observe in those diseases.
And.
In addition on.
Fortunately women with metastatic breast cancer.
Frequently have metastatic disease to their brain.
We hope they somewhat Rick said and evidence of efficacy targeting arc five and us.
Forcing all said the blood brain barrier.
That could be a great benefit to women with metastatic breast cancer, who are at risk.
CNS disease.
Thank you very very excited.
Yes, we're very excited about the future development of ore and one too.
Between.
So I mean, they sell my second question will be about the partnership that was mentioned in the previous quarter earnings call. So are you still only seeking for additional access saying have you made any doubled up any additional progress in.
And if so then should we expect any new phones a partnership.
Thank you I know RV would you like to handle that.
Sure. Thanks Sohu.
Thanks, Steve.
I joined docking over because even Rick has a tremendous track record of developing oncology trucks.
And we're very excited about all in once you through 300 and oral Regal as well.
We are actively looking for opportunities to enhance our portfolio and when there are future developments. We will certainly report them. We are actively looking.
Okay. Thank you very much for taking my question.
Thanks.
Thank you Rocco.
Thank you.
And our next question comes from Yale Jen from Laidlaw <unk> Company. Your line is open.
Oh, good afternoon baseball, taking my questions.
Oh. The first question is going to be clarified that for the ones that we can.
When you get into the expenses since stage are you mentioned 36 patients are those the only for the breast cancer or the breast cancer and the NHL combined.
Rick what are the plans once you get.
Maximally tolerated dose.
Right. So I think that's for both diseases.
And and so I I don't know how they would be evenly distributed in terms of enrollment.
There is also going to be in the Haneke study.
Ah and enrichment in their expansion phase for patients with breast cancer.
So.
The advantages of this study are the simultaneous konjac uptake.
Two phase one studies.
In advanced cancer with the same agent App.
And I think that the data is likely to be very complementary, but also we'll have more data than we might typically see.
Develop in the same timeframe with most agents. So we're very excited about this opportunity of two simultaneous.
Phase one studies.
Okay, Great. That's helpful and maybe just tag on that a little bit which is that the core the phase one dose finding study in the United States.
Oh, the patient on metastatic breast cancer patients, but not necessarily all patients TV.
Currency to pay for the resistant patients at least so we'll be close by Dupont, Okay correct.
Ah, Yes, I mean, the patients with advanced phase disease that are hormone receptor positive her two negative.
Standard of care is generally that these.
Patients will have received a CDK four six.
It's possible they might come into our study after third line therapy.
With some form of chemotherapy as well as part of their prior treatment.
And certainly those patients would be Ellis.
It's terrible.
And so I I I'm, a little hesitant to say that they would only be following CDK four six.
He might have also had other therapies.
And I think it's important to emphasizing that you know the commercially available CD four okay.
Our CDK four six inhibitors are not curative.
And so the need Theres a high need for these patients continuing despite the.
Advances and standard of care that they have made.
Okay.
That's very helpful and I feel good that goes Youre Enzo here, maybe the final question here is that.
You mentioned.
On the toxic where's the others the.
Marketed focus.
Static.
Could you explain the reason in terms.
So the mechanism of actions why.
Is that just because you are talking one more medical pocket to cause that or.
Any other comments on that.
Well I think my comment is the cytotoxicity it.
It's due to the arc.
Five inhibition that occurs with CD with oil at one to three 300.
Remember that this is a dual inhibitor in contrast to the other CDK inhibitors.
And it is the arc five.
Inhibition at sorry, yeah.
Ambition of arc five there's disrupt cellular energy metabolism in the cancer cell and that's what causes to cytotoxicity.
And this is what we think is also particularly advantageous aspect of this drug in these patients.
Okay, Great that's very.
Illuminating and congrats on the progress on this number.
Thank you.
Back to you.
Thank you and I'm showing no further questions at this time I'd like to turn the call back over to the speakers for any closing remarks.
Okay.
Thank you all for participating in todays update call we greatly appreciate it.
Were very excited and aren't getting over to pivot to the development of a new lead product Oh in 123 300.
And look forward to.
Uh huh.
Me important milestones in the near future as follows.
One.
We plan to file U. S I N D.
Oh and went to three 300 in the coming weeks.
Followed by a clinical trial.
While initiation with patient enrollment.
Backed into began in the first half of <unk> E G box.
Two.
The pipeline of investigator sponsored studies.
With all Rigosertib is advancing.
And further progress is anticipated in Twentytwenty one income.
Including establishing.
Jos will further study of the combination of Riga, all regus or the end of all the math.
K Ras mutated non.
Small cell lung cancer.
And we will establish dose of the combination and other solid tumor Ras driven cancers.
And three.
We are actively evaluating strategic opportunities.
To enhance.
Our product portfolio.
We truly appreciate.
Your continued interest in the programs of Onconova.
Should you have any additional questions.
Please feel free to contact any of us.
Thank you.
And have a nice and enjoyable evening.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and you may now disconnect everyone have a wonderful day.
[music].