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Edited Transcript of ONTX earnings conference call or presentation 14-May-19 1:00pm GMT

Q1 2019 Onconova Therapeutics Inc Earnings Call

Newtown May 30, 2019 (Thomson StreetEvents) -- Edited Transcript of Onconova Therapeutics Inc earnings conference call or presentation Tuesday, May 14, 2019 at 1:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Abraham N. Oler

Onconova Therapeutics, Inc. - VP of Corporate Development & General Counsel

* Mark Patrick Guerin

Onconova Therapeutics, Inc. - CFO

* Richard Charles Woodman

Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development

* Steven M. Fruchtman

Onconova Therapeutics, Inc. - CEO, President & Director

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Conference Call Participants

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* Ahu Demir

NOBLE Capital Markets, Inc., Research Division - Biotechnology Research Analyst

* I-Eh Jen

Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst

* Joseph Pantginis

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Naureen Quibria

Maxim Group, LLC - Senior Equity Research Associate

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Presentation

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Operator [1]

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Good morning, and welcome to the Onconova Therapeutics Corporate Update and First Quarter 2019 Financial Results Conference Call. (Operator Instructions) As a reminder, this call may be recorded.

At this time, I'd like to turn the call over to Avi Oler, Vice President of Corporate Development and General Counsel at Onconova.

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Abraham N. Oler, Onconova Therapeutics, Inc. - VP of Corporate Development & General Counsel [2]

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Thank you, operator. Good morning, and welcome to Onconova's Corporate Update and -- First Quarter 2019 Corporate Update and First Quarter Financial Results Conference Call. Earlier this morning, we issued a press release with first quarter 2019 financial results and business updates. If you have not seen this morning's earnings release, you can find it on our Investor Relations page of our website at www.onconova.com.

On today's call, Dr. Steve Fruchtman, President and Chief Executive officer, will review the company's recent business and clinical highlights and milestones and discuss anticipated progress over the remainder of 2019. After that, Mark Guerin, our Chief Financial Officer, will review first quarter 2019 financial results. Steve will then make some final remarks before we hold the Q&A portion of the call. For the Q&A portion of the call, we will be joined by Dr. Rick Woodman, our Chief Medical Officer, who is in meetings in Turkey today.

Before we begin, I remind everyone that statements made during this conference call will include forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, 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 morning and the risk factors in the company's current and future filings with the SEC.

With that, it is my pleasure to turn the call over to Steve.

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [3]

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Thank you so much, Avi. And good morning, everyone, and thank you again for joining today's call. Last year demonstrated important progress and achievements for the company. 2019 has the potential to be even more significant.

First quarter and recent highlights include the following. As I hope you are all aware, we are pleased to announce yesterday that we have entered into a license agreement with HanX Biopharmaceuticals, also known as HanX, to develop and commercialize rigosertib in Greater China. We see this second license agreement with HanX as important to the advancement of the study of rigosertib in high-risk myelodysplastic syndrome and in the future with solid tumor indications such as non-squamous cell lung cancer.

Under terms of this agreement, we have granted HanX an exclusive license to develop and commercialize rigosertib in Greater China. In exchange for these rights, HanX will make a $2 million upfront payment and will make an additional $2 million equity investment in Onconova common stock at a premium to the market. HanX will also dedicate $2 million of Chinese currency in escrow to fund rigosertib development over the next 2 years.

HanX will make additional regulatory developmental and sales-based milestone payments to Onconova of up to $45.5 million on net sales in China. Onconova will initially supply the finished product while HanX will support our clinical trial initiatives in China.

HanX and Onconova will collaborate to advance the drug in China, and together with our other corporate partners globally pursuant to a joint developmental plan we will all participate in. In addition to the financials, this collaboration offers great strategic value to Onconova.

We look forward to our pivotal INSPIRE trial opening in China. Based on their large population, we anticipate robust accrual from this new geographical area. In addition, we will be participating in the Acute Leukemia Forum in Shanghai at the end of May. This will be a meeting attended by MDS and leukemia experts from the U.S. and China, and will give us an opportunity to present the INSPIRE trial and rigosertib at this meeting as well as to meet with potential principal investigators who will conduct the INSPIRE trial in China.

HanX has been an outstanding partner and we are appreciative of their commitment to this important program for patients with high-risk MDS. I would like to commend the business development teams from both HanX and Onconova for successfully completing this latest transaction, which has the potential to be transformative for both of our companies. Business development efforts are continuing and we look forward to additional collaborations for the development of this innovative chemical entity, rigosertib.

As a reminder, in December of 2017 Onconova and HanX entered into a collaborative development agreement for ON 123300, our unique dual inhibitor of CDK4 and 6 and ARK5 for the treatment of a variety of cancers. This program is currently in preclinical development. And following our IND submission to the U.S. FDA, we anticipate opening a Phase I trial in the second half of 2019.

While we have obviously been very active in business development, our clinical focus remains on our late-stage clinical programs which have continued to progress. This includes our pivotal INSPIRE trial, which as you know is a randomized controlled Phase III clinical program and a population of patients with higher-risk MDS after they have failed a hypomethylating agent. The primary endpoint of the INSPIRE trial is overall survival.

As mentioned on our recent call, during the first quarter we passed the 75% enrollment mark of the anticipated requirement on the INSPIRE trial for 360 randomized patients. Currently, more than 140 trial sites in 23 countries across 4 continents are active and enrollment is continuing worldwide. We have recently opened 19 additional new clinical sites in 8 already participating countries, and approximately 25 new sites are being added including sites in Brazil, where we have recently obtained orphan drug designation. We now expect to add sites in China as well, based on our collaboration with HanX.

Our goal continues to be to complete enrollment on the INSPIRE trial in the second half of 2019. We believe that these new regions with large populations, in addition to other regions and new sites in the U.S., will help us reach this goal. As you can see, we remain laser-focused on the INSPIRE trial and its timely completion. I will mention our other programs, which are progressing.

With respect to our Phase II study of oral rigosertib in combination with full-dose azacitidine in patients with high-risk MDS, we have previously reported promising efficacy and a manageable safety profile. We will be presenting the data at the 24th European Hematology Association Annual Congress in June in Amsterdam. The results from the Phase II trial of this combination are expected to form the basis of a new pivotal trial, which is currently under review with the U.S. Food and Drug Administration.

Regarding our special protocol assessment request, or SPA, to the U.S. FDA for a Phase III trial of oral rigosertib and azacitidine combination therapy for the treatment of adult patients with first-line high-risk MDS, we have determined that the primary endpoint will be an overall response endpoint, which will be a composite of complete remission and partial remission based on the IWG response criteria. Both of these endpoints imply a normal complete blood count, and thus normal numbers of circulating blood elements.

We have completed the end of Phase II meeting and our discussions with the FDA are ongoing. Following finalization of the SPA submission, we anticipate opening the Phase III trial of oral rigosertib in combination with azacitidine as early as the second half of 2019, following additional partnerships and funding.

We look forward to filing an IND for ON 123300, which, as I mentioned, is a first-in-class dual inhibitor of CDK4/6 and ARK5. In preclinical studies, ON 123300 has been shown to be very effective against tumors that over-express CDK4/6 with activity in breast cancer cell lines resistant to commercially available CDK4/6 inhibitors, which are used in the clinic for women with hormone receptor-positive metastatic breast cancer, typically in combination with an aromatase inhibitor.

As noted, ON 123300 has already partnered with HanX. Together with our lung cancer experts and our corporate partners, we remain confident that we will initiate a new Phase I trial of rigosertib in combination with an immuno-oncology agent and RAS-mutated non-small cell lung cancer in 2019.

Concurrent with this Phase I trial in the U.S., SymBio Pharmaceuticals, our partner for the commercialization of rigosertib in Japan and Korea, is also working with us to conduct a KRAS-mutated non-small cell lung cancer trial in Japan. Based on the RAS target proteins that rigosertib affects, we believe that in addition to MDS, rigosertib has many potential indications, as RAS is mutated in many solid tumors.

We continue to actively participate and present at major MDS hematology and oncology conferences worldwide. We recently presented information pertaining to rigosertib clinical trials at the American Association for Cancer Research annual meeting, the MDS Symposium recently completed in Copenhagen and the Acute Leukemia Forum in Newport, California. Upcoming presentations, which I hope you will follow, will be made at the 2019 Acute Leukemia Forum in China and the European Hematology Association Congress in Amsterdam. We will also be attending the 2019 American Society of Clinical Oncology Annual Meeting in this upcoming June in Chicago.

With respect to the RASopathies and other pediatric development programs, the National Cancer Institute is conducting pharmacokinetic, pharmacodynamic and dose-escalation studies in preclinical models for possible dosing of pediatric cancer patients with germline RAS mutations with single-agent rigosertib therapy for the first time.

In addition, preclinical studies of rigosertib in juvenile myelomonocytic leukemia, or JMML, again a RAS-driven leukemia, continue at the University of California at San Francisco, a recognized center of excellence for studies in JMML. This preclinical study is being funded by the Leukemia & Lymphoma Society.

We also have numerous investigator-initiated studies ongoing, including a study for patients with myeloproliferative neoplasms, in which the bone marrow produces too many circulating blood cells. Other investigator-initiated studies include a study on RAS-driven rare squamous-cell carcinoma of the skin, which will be conducted at centers of excellence in the U.S. and Europe that have expertise in this rare disease.

As you can see, our focus on advancing earlier-stage programs, while also looking to enhance the potential of rigosertib through existing and new collaborations and partnerships, has resulted in a robust pipeline. Rigosertib, we believe, has the potential for multiple franchises within a single new chemical entity.

With that, I'd like to turn the call over to my colleague, Mr. Mark Guerin, our Chief Financial Officer, for a discussion of our financial results for the first quarter 2019.

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Mark Patrick Guerin, Onconova Therapeutics, Inc. - CFO [4]

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Thanks, Steve, and good morning, everyone. Cash and cash equivalents as of March 31, 2019 totaled $10.4 million compared to $17 million as of March 31, 2018. Based on our current projections with the receipt of upfront funds from the HanX transaction, we expect that our cash will be sufficient to fund ongoing trials and operations into early 2020.

Net loss was $7.6 million for the first quarter ended March 31, 2019, compared to $5.1 million for the comparable 2018 quarter. Research and development expenses were $4.1 million for the first quarter ended March 31, 2019, and $4.6 million for the comparable period in 2018. General and administrative expenses were $3.2 million for the first quarter ended March 31,'19, and $1.9 million for the comparable period in 2018.

We continue to look for ways -- look at ways to reduce our cash burn to focus our resources on the INSPIRE study. Also, as noted in our year-end 2018 call, during the first quarter of 2019, we executed a reduction in our workforce which represents a savings of approximately $500,000 net of severance costs in 2019, and an ongoing annual savings of approximately $1.5 million.

This completes my financial review, I'll now turn the call back to Steve. Steve?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [5]

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Thank you, Mark. We are very excited about the progress we are making both in pipeline and business development, and the momentum continues to build. Our team is operating on all cylinders to complete the INSPIRE trial and to build value for our shareholders by presenting our data to the FDA via the NDA process. If we are successful in these trials, we expect to commercialize the first new therapy for high-risk MDS since Vidaza was approved in 2004.

Thank you, all, for your attention. Operator, please open the call for any questions which we'd be happy to entertain.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from Dr. Joseph Pantginis with H.C. Wainwright.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [2]

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I think my questions are mostly logistical. So the first one is, can you provide a little more color as to what the outstanding questions or discussion points are regarding the SPA? And can you remind us, did the government shutdown impact it at all?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [3]

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Yes. I will ask Dr. Woodman to respond to that question. Rick?

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Richard Charles Woodman, Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development [4]

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Thank you, Steve. I think the most outstanding question is related to starting dose and dose adjustments that we have to finalize with the FDA. Our statistical assumptions, our patient population, those things we're generally very much in agreement with the FDA. I think that the strike did impact us in one way in terms of the SPA review. And that is, typically you would get a rolling feedback from the FDA of x number of questions that you would have an opportunity to answer. With the particular government shutdown, what happened is we got all the questions all at once. And so obviously, we were dealing with all of them at the same time and we continue to finalize our responses to the FDA. Thank you.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [5]

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Got it, Rick. And then just curious with regard to the oral Phase II. With regard to the upcoming EHA update, can you manage some expectations about what we might see? Is it just going to be longer-term follow-up of these patients and how responses might have evolved over time?

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Richard Charles Woodman, Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development [6]

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Yes. That's correct. The Phase II 09-08 study with oral rigosertib in combination of azacitidine will primarily be an update of the few remaining patients who we're continuing to follow and study, as well as additional analyses that we haven't previously looked at, such as response across the various IPSS-R subsets. But generally speaking, the efficacy will be very similar to what we shared at ASH.

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Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [7]

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Got it. And then my last question I think may be for Mark. First, can you just discuss the accounting for the upfront payment from HanX, the $2 million? And then secondly, I know you had some onetimes in the first quarter regarding G&A and the restructuring, so I was just maybe trying to get a sense of maybe a little more color with regard to the new baseline or the run rate going forward for G&A.

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Mark Patrick Guerin, Onconova Therapeutics, Inc. - CFO [8]

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Thanks, Joe. So for the first question, the HanX deal, the upfront $2 million, we are not yet fully through our analysis for the revenue recognition of that. But if it is similar in some ways to transactions done in the past, there will be -- the premium that they paid for the stock would likely be recognized as revenue. And then the $2 million milestone, depending on a number of factors we have yet to go through, some of that could be revenue immediately, and then probably a larger chunk of it would be recognized over the term of the agreement. So hopefully that answers your question for now. Then your second question. You're right, we did have some onetime expenses in the first quarter, specifically the reduction in force that I mentioned, and I would expect that our ongoing burn rate will continue to be what it has been previously, which is in the $5.5 million cash per quarter or so.

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Operator [9]

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And our next question comes from Dr. Jason McCarthy with Maxim.

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Naureen Quibria, Maxim Group, LLC - Senior Equity Research Associate [10]

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This is Naureen on for Jason. I apologize if there's some background noise. So my first question is with regards to your CDK inhibitor program. Now that you're moving closer to an IND, can you talk a little bit about the trial design and the particular patient selection that you might have in the trial? Will it be focused just in breast cancer or other solid tumors?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [11]

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So I'll take that one, and thank you very much Naureen. Our plan, when we submit the IND to the FDA, the Phase I will be an all comer trial because we're eager -- when I say all comer, a solid tumor trial -- we're eager to establish the appropriate dose and mg. Clearly we understand where this unique CDK4/6 and ARK5 inhibitor will ultimately play a clinical role, and that is in metastatic -- in hormone receptor-positive metastatic breast cancer.

So we would like to -- in addition to having all comers, to be at a site where many of these patients are seen because clearly, women who failed, let's say, palbociclib, if we, in the Phase I trial, saw a response with ON 123 for one of these unfortunate women who already failed a commercially approved CDK4/6 inhibitor, that will be a big deal. Because ultimately, you can understand that, that is the indication we'd like to study. But in addition, diseases like multiple myeloma, hepatocellular carcinoma, which are driven by mutations in ARK5, would also be of interest to us in the Phase I study.

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Naureen Quibria, Maxim Group, LLC - Senior Equity Research Associate [12]

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Great. That's helpful. And I was just wondering, pivoting a little bit to your -- one of the data that you presented at ASH regarding your CXCL12 as a potential biomarker for patient response to rigosertib. I was just curious, are you continuing to follow that in any of the trials? And is this something of -- is the biomarker strategy something that you included as part of your SPA package for review?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [13]

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So we continue to study a broad number of genomics and other abnormalities in all of our studies. So right now, it's a broad MDS population, but we will be doing a deep genomic sequencing on all the patients, for instance on the INSPIRE trial. And based on that much larger trial than the one you're referring to, we will make decisions going forward on how best to identify these biomarkers. All the patients on the INSPIRE trial will be having deep genomic sequencing. They've already been run at randomization, but we're waiting to batch them post randomization to repeat those specimens and ultimately correlate with survival on the INSPIRE trial.

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Naureen Quibria, Maxim Group, LLC - Senior Equity Research Associate [14]

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Got it. That's helpful. And one last question from me. Recently at the Acute Leukemia Forum in California, there was a small Phase II study of oral rigo with azacitidine in AML patients. And the responses were pretty impressive, 50% response though the patient number was just 17 patients. Are there any plans to initiate a study in that indication?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [15]

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So I'll let Dr. Woodman, who attended that conference, take that question. Rick?

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Richard Charles Woodman, Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development [16]

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Thank you, Steve. Yes, the AML patients that we presented at the Acute Leukemia Forum in Newport were from 09-08. They represented a small subset of patients who were parts of that Phase I/II study in addition to MDS patients. We plan to explore further the data we have on other studies with patients who have that elevated blast counts. Clearly, we saw responses in a population that's heavily pretreated and has a very poor prognostic outcome. So clearly having an oral agent in patients with elevated blast counts is potentially worthwhile pursuing.

Part of the initial interest we have is related to the fluctuations in how the world is learning to define acute myeloid leukemia based on blast counts. It varies around the world. 20% and above is how they generally define it in Europe, above 30% is how it's defined in some other parts of the world, including the United States. We do have responses in patients who have elevated blast counts. We're going to go back, and the hope is that over the summer we'll do retrospective analysis, because we have a much larger subset of patients in our other studies who have blast counts that would define them as AML. And so understanding clearly the response of both IV and oral rigosertib in these patients will be our first step. And based on that information, we'll then make a decision about how we can proceed with further development of rigosertib in AML setting, as defined by either 20% or 30% blast. Thank you.

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Naureen Quibria, Maxim Group, LLC - Senior Equity Research Associate [17]

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Actually, I do have one last final question. This is regards to your KRAS+ non-small cell lung cancer study that you plan to pursue. Could you clarify with regards to the IST, are they going to be working in coordination with your partner in Japan? Or are they 2 separate studies? I guess a little clarification on that would be helpful.

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [18]

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So we plan to initiate this study at a major medical center in the U.S. And as you pointed out, that study will be for patients with KRAS-mutated lung cancer, who had already progressed on an immuno-oncology drug. Tentatively, the study will be a combination of an alternative immuno-oncology agent. We have, in negotiation, received the ability to get a commercially approved I-O for free to combine with rigosertib. That will be the major focus of the trial in the U.S.

In collaboration with SymBio, we are actually working on how best to combine those trials, and we have not finalized the program with SymBio yet. There's other -- there's also interest in other sites in the U.S. So it could be a variety of approaches to attempt to optimize the rigosertib research that we plan to do in KRAS-mutated non-small cell lung cancer. And again, a lot of this -- how many studies we can do, I want to remind everybody, even though we're very excited about this program, KRAS-mutated lung cancer, our focus will continue to be to complete the INSPIRE trial.

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Operator [19]

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Our next question comes from Dr. Ahu Demir with NOBLE Capital Markets.

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Ahu Demir, NOBLE Capital Markets, Inc., Research Division - Biotechnology Research Analyst [20]

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Congratulations on the partnership and the progression that you made. My first question will be on the data. For the Phase III rigosertib clinical study, I know you will present at EHA, ASCO. When do we expect more patients, like larger patient population? Or do we expect perhaps potential of using PTPN11 mutation as a biomarker? Can you give a little bit color on what do we expect from the data? Or do we just wait for ASH for larger patient population?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [21]

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Rick?

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Richard Charles Woodman, Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development [22]

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Well, I think that the -- it'll probably be -- there'll be 2 areas of focus. One will be continuing to look at the 09-08. I mentioned a moment ago, the use of oral and IV rigosertib in AML. And then finally, looking at genomic profiling, and we'll look at studies other than the INSPIRE study in terms of what information is available in terms of genomic profiling and biomarkers. Establishing some of these biomarkers is going to take some validation studies, and so that's something that we probably would wait and see the initial preliminary data and then move into 2020 with that type of program.

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Ahu Demir, NOBLE Capital Markets, Inc., Research Division - Biotechnology Research Analyst [23]

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Okay, Rick. My following question will be on the CDK4 program, also a follow-up on the Naureen question. So the IND submission will be filling the first half of 2019 and it will be, first, breast cancer and later on you plan to expand on the other indications. Is that correct, Steve? I think that's what you mentioned.

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [24]

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It's the opposite. I'm sorry if I confused you. Yes to your first part of your question, we plan to submit the IND by, hopefully, the end of June. But this is going to be a first in-person trial, so it will be an all comer trial for patients who have no other alternative therapies available to them. So it'd be an all comer trial to establish the dose. But we would clearly like to be at a site, which we've already identified, where -- have a large number of patients with hormone receptor-positive metastatic breast cancer who failed a commercially available CDK4/6 inhibitor.

So it's going to be all comer trial to get the optimal dose, but we'd also like, already in Phase I, to identify certain groups of patients where ultimately we know these are the areas -- the diseases that we also want to study. So it'll be a combination of both, all comers with a bias towards certain indications like recurrent/refractory metastatic breast cancer for patients who failed a commercially available CDK4/6 inhibitor.

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Operator [25]

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(Operator Instructions) And our next question comes from Dr. Yale Jen with Laidlaw & Company.

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I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [26]

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In terms the HanX deals for the rigosertib, is that only include the IV version? Or would that potentially also added the oral ones as well?

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Abraham N. Oler, Onconova Therapeutics, Inc. - VP of Corporate Development & General Counsel [27]

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This is Avi speaking, nice to hear from you, Yale. Yes, it includes both formulations. It includes rigosertib as a whole.

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I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [28]

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Okay. And as you -- in the prepared remarks suggesting that if you have the SPA designation done and depending on the partnership or resources, you could start the first-line combination therapies. Would that be suggesting maybe HanX will be the -- one of the major sources for moving this ball forward?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [29]

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So thank you, Yale, for that important question. The reality is, there is tremendous global interest in the first-line high-risk combination trial that we would like to open. And clearly, HanX is also very interested in participating in that trial, as is SymBio in Japan. So our goal, based on funding, will be to start with a number of sites in the U.S. and also to include -- and that's the value of this new partnership with HanX, to include a site in China and in addition to include a site in Japan. So that is our plan.

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I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [30]

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So let me be clear. So that means that both those companies would not be mainly supporting the U.S. study, but -- I mean there's a study in the U.S. but would support study in their respective countries for a large patient population -- or sort of coverage?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [31]

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That is correct. That is correct, Yale. So they will be responsible under our auspices -- will be participating in the same trial but will be funding the trial in their respective countries.

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I-Eh Jen, Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst [32]

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Okay. Great. That's very helpful. And just one more question. Back to Steve in rigosertib was talking about the KRAS pathway. And there's another RAS -- KRAS focus, the drug called AMG 510 from Amgen. We understood that there are some sort of data readout to come, probably at the ASCO. Do you guys have any comment about that particular program, and what do you think that say about RAS as a target currently?

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [33]

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The comment, Yale, is we look forward to seeing their data at ASCO.

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Operator [34]

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And at this time, I am showing no further questions. I'd like to turn the call back over to Steve for any closing remarks.

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Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [35]

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Thank you. So 2019 continues to advance well, and we look forward to achieving value-enhancing milestones this year, including completion of enrollment in our Phase III INSPIRE trial of intravenous rigosertib. Our Phase II program with oral rigosertib in combination with azacitidine is advancing towards a pivotal Phase III trial in first-line high-risk MDS patients as well. And we are also continuing to execute our partnering strategy, including the additional geographical licensing agreements for our pipeline.

We also look forward to continuing with our scientific rigor by publishing and presenting data in high-quality scientific journals and continuing to present at key medical and scientific conferences that we outlined to you today.

With our strengthened cash position and multiple late-stage clinical programs, we remain optimistic that we will achieve our clinical milestones and advance business development opportunities for our pipeline.

As always, we tremendously appreciate your continued support. We look forward to bringing rigosertib to the help of patients with high-risk MDS. Thank you for your participation on today's call and for your excellent questions. Please feel free to contact us with any additional questions you may have. And thank you, again. Operator?

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Operator [36]

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Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone have a good day.