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Verastem Inc (VSTM -2.60%)
Q1Â 2019 Earnings Call
May. 09, 2019, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good afternoon, and welcome to the Verastem Oncology Investor Conference Call on Thursday, May 9, 2019. At this time, all participants are in a listen-only mode. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the Company's request and will be available on the Company's website for a period of 90 days from today.
At this time, I would like to introduce Mr. John Doyle, Vice President of Investor Relations and Finance at Verastem Oncology. Please go ahead.
John Doyle -- Vice President, Investor Relations & Finance
Welcome everyone and thank you for joining us this afternoon to discuss Verastem Oncology's financial results and corporate highlights for the first quarter of 2019. I'm joined today by Robert Forrester, our President and Chief Executive Officer; Joe Lobacki, our Chief Commercial Officer; Dan Patterson, our Chief Operating Officer; and Rob Gagnon, our Chief Financial Officer.
During today's call, Robert will provide some introductory comments. Joe will provide an update on the commercial COPIKTRA program. Dan will review a few clinical development highlights, and Rob will discuss the highlights from our first quarter financial results. Robert will then provide a brief closing summary before opening the call up for your questions.
Earlier today, we issued a press release detailing our first quarter 2019 financial results. The release is available on our website at verastem.com.
Before we begin our formal comments, a reminder that we will be making forward-looking assertions during today's call that represent the Company's intentions, expectations or beliefs concerning future events which constitute forward-looking statements for the purpose of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995.
All forward-looking statements are subject to factors, risks and uncertainties such as those detailed in today's press release announcing this call and in our filings with the SEC which may cause actual results to differ materially from the results expressed or implied by such statements. In addition, any forward-looking statements represent our views only as of the date of this recording and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update any such statements. We refer you to the Disclosure Notice section in our earnings release we issued today and the Risk Factors section of the Annual Report on Form 10K for discussion of important factors that could cause actual results of different materially from these forward-looking statements.
With that, I would now like to turn the call over to Robert Forrester. Robert?
Robert Forrester -- President/Chief Executive Officer
Thanks John. Good afternoon everybody, and thank you all for joining us on today's call.
I'll start today by discussing the COPIKTRA launch. As many of you know, our lead oncology drug COPIKTRA, also known as duvelisib, received its first marketing approval from the US Food and Drug Administration in late September 2018. In the first quarter of 2019, which reflects the second full quarter of sales, COPIKTRA net revenues were $1.7 million, a 38% increase over the fourth quarter of 2018.
As a reminder, COPIKTRA is an oral inhibitor of PI3K and was the first dual inhibitor both PI3K-delta and PI3K-gamma to be approved in the US. It is administered twice daily oral capsule that patients can take at home under the guidance of their physician. COPIKTRA is approved for treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma offer at least two prior therapies. COPIKTRA also received accelerated approval for the treatment of patients with relapsed and refractory follicular lymphoma after at least two prior systemic therapies.
The entire commercial team has been working diligently to overcome certain headwinds in the field, which Joe will discuss in more detail in a few minutes. However, we believe we continue to make substantial progress on the COPIKTRA launch. While we continue to expect 2019 revenues overall to be modest, we believe the groundwork we have laid over the past several months will have an increasingly positive impact through 2019 and into 2020.
Before I turn the call over to Joe to provide a commercial update, I'd like to take a moment to touch on new corporate development. As we announced in our earnings release earlier today, Joe will be stepping down from his current role as Chief Commercial Officer during 2019 to pursue other professional opportunities including Board of Director roles. We have commenced a formal search for his successor, but Joe intends to serve in his current role until replacement is identified and appointed. During his transition, Brian Stuglik who is a member of our Board of Directors and is the former Chief Marketing Officer of Lilly Oncology will be providing strategic oversight and advisory support for the commercial organization. Joe has played an invaluable role in building the commercial organization today including launching COPIKTRA on the same day it was approved and then achieving reimbursement with 92% of targeted health plans. He has played a central role in Verastem Oncology's transition from a development stage R&D company into the commercial organization we are today. Joe's leadership and guidance have been a vital part of our growth as a business and for that we sincerely thank him. His many contributions have created a strong foundation that has well positioned the company for sustainable growth and success. I'll now turn it over to Joe.
Joseph Lobacki -- Chief Commercial Officer
Thank you, Robert, and thank you to everyone who dialed in for today's call. As Robert mentioned, I will be transitioning out of my role as Chief Commercial Officer over the course of this year. This decision was largely driven by my desire to focus on my time and attention on different professional endeavors. I joined Verastem Oncology to build out the commercial and medical affairs teams including the distribution network and foundational systems and policies and to secure payer reimbursement. All of these initiatives are largely complete. In order to continue supporting the ongoing launch and growth of COPIKTRA, I plan to serve in my current role until a successor is identified and appointed. I believe that with the current commercial team in place, the Company is well positioned to deliver on the future success of COPIKTRA in 2019 and into 2020. I am also confident that with the clinical success and new combinations in tumor sizes, COPIKTRA has the potential to grow well beyond the base we are establishing in relapsed or refractory CLL, SLL and FL.
I am very proud of the commercial organization that has been built to support COPIKTRA and I am fortunate to have spent this time working with such a talented and dynamic team. I look forward to closely following the Company's future success.
I'll now provide a brief update on the commercial COPIKTRA program. Today, we're reporting $1.7 million in net COPIKTRA revenue for the first quarter of 2019, an increase of 38% from the prior quarter. We also made substantial progress on the reimbursement front as we are now tracking at over 92% of targeted health plans listing and providing reimbursement for COPIKTRA.
The first two quarters of the launch have been dedicated securing reimbursement and educating physicians about the benefits and safety profile of COPIKTRA. While we are still in the early stages of our first commercial product launch, we continue to receive positive feedback from prescribing physicians including their support for new treatment options with novel mechanisms of action for patients with relapsed or refractory CLL, SLL and FL who are intolerant to other available drug classes such as BTK and BCL-2 inhibitors, have comorbidities that preclude them from receiving those other classes or who have failed previous therapies.
A key differentiating benefit of COPIKTRA is that is a convenient oral at-home monotherapy with a convenient safety profile that is manageable following dosing guidelines. As Robert mentioned earlier, we have been diligently working to overcome certain headwinds in the field. Some headwinds include negative historical perceptions regarding PI3K and limited clinical experience using COPIKTRA. We continue to see evidence that we are overcoming such challenges with our ongoing physician education and patient identification efforts.
COPIKTRA fills an important gap in the CLL, SLL and FL treatment landscape, when patients cannot tolerate a therapy or their disease stops responding to a therapy options, for treating CLL and FL become very limited. COPIKTRA is differentiated by its novel mechanism of action as a dual inhibitor, PI3K-delta and PI3K-gama, and by its attractive profiles of chemo-free oral monotherapy that can be conveniently administered at home. As a reminder, although our sales team has been actively promoting the FL message since COPIKTRA approval in September 2018, due to the nature of the accelerated approval COPIKTRA received in FL, the sales team has been limited to only the package insert for their promotional efforts.
As of March this year, we launched our physician education and marketing campaign providing the sales team with additional materials to promote the efficacy and safety of COPIKTRA in FL post two therapies. Now armed with these new materials, our sales representatives can have fuller and more engaged conversations with healthcare professionals. We have also added the FL indication to our speaker slide deck enabling peer-to-peer exchanges on the efficacy and safety of COPIKTRA in treating FL patients.
Additionally, we have included information on COPIKTRA in treating FL to our physician and patient websites. We believe these new promotional efforts will lead to increased understanding by physicians for managing patients will support sales of COPIKTRA in FL. Collectively, across CLL, SLL, and FL, we estimate that the patient population in need of these new therapeutic options is approximately 20,000 patients per year.
In summary, despite some of the challenges we have faced during this early stage of the commercial launch of COPIKTRA, we continue to make progress with our physician education, patient identification and reimbursement efforts. We believe the groundwork we have laid over the past several months will have an increasingly positive impact through 2019 and into next year.
With that, I'll turn the call over to Dan.
Dan Paterson -- Chief Operating Officer
Thanks Joe. Now I'd like to briefly summarize certain first quarter items from the clinical development front. In March, four abstracts were presented at the 23rd Annual International Congress on hematologic malignancies that build upon the growing body of data in support of COPIKTRA om CLL, SLL and FL. A key abstract at the meeting highlighted data from the Phase 3 DUO study evaluating COPIKTRA compared to ofatumumab in patients with relapsed or refractory CLL, SLL after at least two prior therapies. This is the labeled indication for which COPIKTRA received approval in September 2018. In this analysis, COPIKTRA demonstrated progression-free survival of 16.4 months compared to PFS of 9.1 months for patients treated with ofatumumab. COPIKTRA also demonstrated an overall response rate of 78% compared to 39% for patients treated with ofatumumab.
The other three COPIKTRA posters from ICHM, which were previously presented at the American Society of Hematology 2018 Annual Meeting, featured long-term efficacy and safety data from patients treated with COPIKTRA for greater than two years, data from the Phase 3 DUO crossover extension study in patients with relapsed or refractory CLL, SLL, and data describing certain prognostic and immune-related factors associated with response to COPIKTRA from the Phase 2 DYNAMO study in indolent non-Hodgkin's lymphoma . In the pooled long-term efficacy and safety analysis, the subset of 46 patients who received duvelisib monotherapy achieved an overall response rate of 89% with a median PFS of 40 months.
In general, the AE profile for patients treated for greater than two years was similar to the profile on patients on treatment for less than two years and we were able to manage most adverse events through dose reductions and dosing holds which allowed these patients to continue deriving benefit from treatment. In the DUO crossover extension study, the 90 patients who crossed over to duvelisib once they progressed following treatment with ofatumumab achieved an overall response rate of 77%, and a median PFS 15.2 months. The median time to response was 2.6 months and the median exposure to duvelisib in the crossover study was 9.8 months with a median total follow-up of 12.5 months.
Another highlight from the quarter was the publishing of the Phase 2 DYNAMO study in the peer reviewed Journal of Clinical Oncology. The DYNAMO study evaluated COPIKTRA in patients with indolent non-Hodgkin's lymphoma, who were refractory to both rituximab and chemotherapy or radioimmunotherapy, and are the data that are -- the COPIKTRA approval in FL was based on.
I'd next like to mention some additional studies that we remain very excited about. First is the Company-sponsored PRIMO study, an open-label, multi-center, Phase 2 clinical evaluating the efficacy and safety of duvelisib monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma, an aggressive type of non-Hodgkin's lymphoma. We expect to be expanding this study to include more patients this year with data from the initial phase of PRIMO study also expected later this year.
The other ongoing trial of note is an investigator-sponsored Phase 1/2 study evaluating duvelisib in combination with venetoclax, an oral selective inhibitor of BCL-2 in patients with relapsed or refractory CLL, SLL. The primary objectives of the Phase 1 portion of this trial are to determine the maximum tolerated dose and the recommended Phase 2 dose of venetoclax for this combination regimen.
In addition to these ongoing trials, we're working with the FDA on finalizing the design and the confirmatory Phase 3 trial aimed at converting the accelerated approval of COPIKTRA in FL into a full approval. We look forward to initiating that confirmatory trial later this year.
With that, I'd like to turn the call over to Rob.
Rob Gagnon -- Chief Financial Officer
Thank you, Dan. Since we issued a press release earlier today outlining our first quarter financial results, I'll just review the highlights beginning with our cash position. As of March 31st 2019, Verastem Oncology had cash and investments of $211.7 million compared to $249.7 million of cash and investments as of December 31st 2018. In April 2019, we announced an amendment to refinance our existing loan and security agreement with Hercules Capital, changing key terms to our agreement including a lower overall interest rate and extended principal repayment timeline and an increase to the borrowing limit from $50 million to $75 million of which $35 million has been drawn to date.
Net product revenue for the first quarter 2019, as Robert and Joe mentioned, was $1.7 million, which resulted from the commercial launch of COPIKTRA following receipt of FDA marketing approval on September 24, 2018.
Research and development expense for the first quarter 2019 was $9.8 million compared to $10.9 million for the first quarter of 2018. The $1.1 million decrease or 11% was primarily related to lower consulting fees associated with activities to file a new drug application for COPIKTRA in the 2018 quarter, and the site closures from the Phase 3 DUO and Phase 2 DYNAMO studies. All of these lower costs were partially offset by an increase in costs related to our Phase 2 PRIMO study for the treatment of patients with relapsed or refractory PTCL.
Selling, general and administrative expense for the first quarter 2019 was $26 million compared to $9.8 million for the first quarter 2018. The increase of $16.2 million or 165% between these two periods was primarily due to higher personnel and related costs, as well as promotional and consulting costs in support of the commercial launch of COPIKTRA. Interest expense for the first quarter 2019 was $4.9 million which includes a full quarter of interest related to the convertible notes.
Net loss for the first quarter 2019 was $38.1 million or $0.52 per share compared to a net loss of $21.1 million or $0.41 cents per share for the first quarter 2018.
Now that we have seven months of COPIKTRA launch behind us and greater visibility into the product adoption and uptake, we believe we are in a position to provide revenue guidance for the current fiscal year. For 2019, we expect net product revenue from sales of COPIKTRA to be in the range of $10 million to $12 million. This estimate is based on product revenue to date, current run rates, and near-term expectations. Please note we will not be providing guidance for metrics related to the COPIKTRA launch including patient numbers, prescription numbers et cetera.
With that, I will now turn the call back to Robert for closing remarks.
Robert Forrester -- President and Chief Executive Officer
Thanks Rob. I will now review our key upcoming goals and priorities for 2019 before opening up the call to Q&A. Looking ahead, our key priorities include, one, continuing to execute on the commercial launch ofCOPIKTRA in CLL, SLL, and FL. Two, identifying a Chief Commercial Officer to succeed Joe. Three, initiating a confirmatory Phase 3 study evaluating duvelisib for the treatment of patients with relapsed or refractory or refractory FL. The confirmatory study is expected to start later this year. Four, initiating additional investigational studies on duvelisib as a monotherapy and in combination with other anticancer agents such as checkpoint inhibitors in both heme and solid tumor malignancies. Five, expansion on the Phase 2 PRIMO study for patients with PTCL, which preliminary data is expected by the end of this year. Six, executing another ex-US partnership for duvelisib. Seven, advancing our focal adhesion kinase inhibitor defactinib, which is currently being evaluated in four separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic, non-small cell lung, ovarian and mesothelioma and finally presenting and publishing additional duvelisib anddefactinib data.
As a convenient oral monotherapy with a novel mechanism of action, we believe that COPIKTRA is an attractive treatment option for patients with CLL, SLL, and FL, and we plan to advance the drug into other high unmet need lymphoid malignancies.
We look forward to providing you with further updates on our ongoing progress with the commercial launch of COPIKTRA.
With that, we will now open the call out for your questions. Operator?
Questions and Answers:
Operator
(Operator Instructions) Your first question comes from the line of Robert Hazlett from BTIG. Please ask your question.
Jake Colby -- BTIG -- Analyst
Hi guys, this is Jake Colby on the line for Bert. Thanks for the question. I guess -- I was just wondering on the guidance, I mean, it's a bit lower than what we were looking for. Is there any any additional color you can provide on the pushes and pulls that went into this range?
Robert Forrester -- President/Chief Executive Officer
Yeah I'll ask Rob to address that. We just thought this was the right time now to provide that guidance. So Rob, over to you.
Rob Gagnon -- Chief Financial Officer
Yeah. So this -- you're right. This is the first time we're providing guidance as a company on revenue, and now that we're seven months into the launch, we felt that it was the right time to comment on what we're seeing for the full year 2019. There certainly have been headwinds that we've been facing which we outlined in the prepared remarks and our estimate for this year is really based on the traction that we're currently seeing in the market and our plans to continue the acceleration of the commercial rollout over the coming months.
It's also based on the revenues to date what we're seeing in run rates and our near-term expectations. If you look at other drugs within this indication, for example, I'll mention venclexta, they had $30 million of sales in the first 12 months post launch and the second year was $114 million. So we also looked at other drugs in the space as a reference point. And I'll just -- I'll end it by saying we remain very confident in the unmet need of third line treatment for CLL, SLL and FL. There are approximately 20,000 patients in those indications. We believe COPIKTRA can achieve sales of between $200 million and $300 million per year. And as we've discussed previously, the ramp to peak sales in these third line indications would be around the four- to five-year timeline.
Jake Colby -- BTIG -- Analyst
Okay, thanks. That's really helpful, and I guess it's kind of following up on sort of that I guess the confidence and maybe overcoming some of this headwinds with the groundwork you're laying. Can you just provide any sort of qualitative or quantitative metrics you're tracking and I guess in physician awareness and overcoming that PI3-K headwind.? Thank you.
Robert Forrester -- President/Chief Executive Officer
Yes. Know that it's an important question, Jake, and none of this was unexpected. The headwinds that we're really seeing, the negative perceptions around the PI3-K, and the lack of clinical experience here in the US particularly among the community where many of the patients are residing. So we see 2019 as the sort of foundation year, we're doing all the fundamental work we need to do and then to lead into a much more important 2020.
But we are seeing green shoots. And let me just talk about a couple of those. First of all, we're seeing increased podium presence. PI3-K is back on the podium as a point of discussion and totally relevant to many different disease types, So that -- that's good news. We're seeing increased K1 engagements and that's across the board. And that's really coming through things like IST proposals, we have had significant number of IST proposals. Dan talked about some of ISTs that are ongoing, you should expect to see some additional ISTs starting shortly and over the rest of this year. So across the board, we are seeing signs of evidence that we are actually making good progress with our educational programs to address some of these headwinds.
And then hopefully, this will then begin to translate into sales as we move into starting the next year and we hope to report toward the latter part of this year.
Jake Colby -- BTIG -- Analyst
Thank you.
Operator
Your next question comes from the line of Sean Lee from H.C. Wainwright. Please ask your question.
Sean Lee -- H.C. Wainwright & Co. -- Analyst
Hi guys. Thanks for taking my question. My first one is, you mentioned -- in the prepared remarks you mentioned you would be looking to explore ex-US opportunities. Could you provide us with a little bit more color on that?
Robert Forrester -- President/Chief Executive Officer
Yeah, so, as you know, Sean, great to hear from you. Thank you for your question. We have worldwide rights to duvelisib and we're very focused on the US of course as the primary market for us. We already have partners I think you know in China and Japan with CSPC and Yakult, maybe I can ask Dan to comment about the rest of the territories ex-US.
Dan Paterson -- Chief Operating Officer
Yes. So we have a number of discussions ongoing. We would anticipate having at least one other partnership by the end of the year. And I will comment on both Yakult and CSPC. We've been working very closely with them on advancing duvelisib in both of those territories.
Sean Lee -- H.C. Wainwright & Co. -- Analyst
Just a follow-up. Could you provide maybe a bit of a timeline on those?
Robert Forrester -- President/Chief Executive Officer
You mean for Yakult and CSPC?
Sean Lee -- H.C. Wainwright & Co. -- Analyst
Yes, for China and Japan.
Robert Forrester -- President/Chief Executive Officer
Obviously, I mean those -- we work very closely and we also don't have control of what they do, but maybe Dan, you can provide a bit more color on that.
Dan Paterson -- Chief Operating Officer
Yeah, but we -- we neither have control -- direct control over what they're doing or necessarily going to give guidance on what they're doing, where they necessarily haven't given guidance. So we'll probably give guidance later this year.
Robert Forrester -- President/Chief Executive Officer
I would say that they both are highly motivated and they're moving swiftly from what we can tell, they're very, very engaged. We certainly see that on a daily basis here. So they're very motivated to bring duvelisib to patients in China and Japan.
Sean Lee -- H.C. Wainwright & Co. -- Analyst
Great. Thanks for the additional color. My second question is on the defactinib program. Could you provide us with a bit of an update on that? When can we expect to see some more clinical results?
Robert Forrester -- President/Chief Executive Officer
Yeah, so defactinib, I think you know is in four separate programs all of which are funded largely by our collaborators. So you've got the program going on in the UK with Cancer Research UK in non-small cell lung cancer, pancreatic and meso. We also have another pancreatic study going on here with Wash U and Merck with Pembro. And then there's an advanced tumor -- solid tumor program going on with Chugai (ph), Royal Marsden in London. And then there's an ovarian program going on with platinum and taxane out in UC San Diego.
So that's the sort of -- those are the four programs that we have going on. So maybe, Dan, you want to comment on how they are progressing and what can we expect from them?
Dan Paterson -- Chief Operating Officer
They are all progressing, and we would expect data from a number of those programs at medical meetings later this year.
Sean Lee -- H.C. Wainwright & Co. -- Analyst
Thank you for taking my questions. That's all I have.
Robert Forrester -- President/Chief Executive Officer
Thanks Sean.
Operator
Your next question comes from the line of George Zavoico from B. Riley. Please ask your question.
George Zavoico -- B. Riley. -- Analyst
Hi everyone. Good afternoon. Thanks for taking my questions. My first question is about the overall landscape in this space, in the relapsed refractory CLL/SLL space, in particular. And in particular, I mentioned venetoclax because it's a drug that's seen a lot of increased penetration. So I'm very intrigued by the trial that's going on in combination. Can you comment a little bit about how that might impact where COPIKTRA might be used? I mean, it seems like that would at least advance it into second line, perhaps. What -- how are you thinking about that strategically?
Robert Forrester -- President/Chief Executive Officer
As you know, we have long patent life on duvelisib. We have probably, effectively, 13 years to 14 years of patent life with extensions. So we have time to really broaden the clinical utility of duvelisib, to bring duvelisib to patients who can really benefit. We obviously have to move quickly because the time goes fast and the patients are waiting. And one of the ways of moving forward is in combination with standard of care and novel therapies. And one of the most important combinations is with venetoclax. We have the strongest synergy pre-clinically that we have seen with all of the combinations that we're looked at with venetoclax. It is a critical combination. And I think it allows us the opportunity to move into many different tumor types, starting CLL, but beyond that, we can imagine moving into different tumor types beyond that too. But with that, maybe we'll allow Joe to comment a bit further.
Joseph Lobacki -- Chief Commercial Officer
Sure. Thank you, George, for the questions. Thank you, Robert. Yes, so for the CLL/SLL landscape, what we're seeing is oral therapies are moving kind of upfront. So we're starting to see ibrutinib as a first-line agent; venetoclax as a second line agent. And that really leaves a third line space wide open. There aren't a lot of a lot of other choices. And we see physicians now using -- going back to chemotherapy, doing the CD20 by itself. And there are better options there. So that's a lot of what our oncology account managers, our sales force, is doing right now to identify -- help physicians identify that there's a need in the third line space and how COPIKTRA can fill that need. So the market is changing. I think that's to the benefit, as you mentioned, to COPIKTRA going forward. And I agree with Robert. I think the -- as the market looks at it, combinations is the way to go with an oncology.
They're starting to look at combining the various agents together. I agree, I think the combination we have with venetoclax is extremely interesting and showing synergy. And I think showing something different about the mechanism of action of COPIKTRA as well. So that helps. Any of that data really gets out and differentiates the product for us. So CLL is a great spot, but don't forget FL as well. So there's still a high unmet need within the third line, FL. And that's a place where right now only PI3Ks exist for treatment. So ibrutinib is not active in FL. Venetoclax hasn't been active in FL through group studies. So a lot of that is the physician's choices around PI3K. So this new launch that we have -- or going in with more materials for physicians around this post 2 prior therapies with the FL has been very well received. So we continue to see growth in that as well. So this opening it up of CLL and identifying this third line need, as well as the need that is already identified by physicians from PI3K and FL are really adding to our growth.
George Zavoico -- B. Riley. -- Analyst
Okay, by the way thanks Joe and good luck in your next endeavor.
Joseph Lobacki -- Chief Commercial Officer
Thank you, George.
George Zavoico -- B. Riley. -- Analyst
Venetoclax, are you getting -- are you working with a -- is there a sponsor? Are you working with a developer on this? Or is it independent of them?
Robert Forrester -- President/Chief Executive Officer
I'll let Dan comment (multiple speakers) trial.
Dan Paterson -- Chief Operating Officer
Yes. So this is an investigator-sponsored study, so the relationship is between us and the investigator and the investigator and the other company. That's with Dana.
Robert Forrester -- President and Chief Executive Officer
And that's with Dana-Farber.
Dan Paterson -- Chief Operating Officer
Yeah. Dana-Farber with Matt Davidson.
Robert Forrester -- President/Chief Executive Officer
Matt Davidson, he's making good progress obviously, it's within his control as to when he will provide an update on that trial because because I mean, it's an important trial, it allows us to get into probably some more aggressive tumor types too and subtypes, and I think that's important.
George Zavoico -- B. Riley. -- Analyst
Okay. And then one quick question about defactinib. It sounds like some of these ISTs that you've got going are going to deliver some important data by the end of the year. Will that put you in a position, say, sometime in the first half of next year to develop a strategy for perhaps picking which indication you'd like to go after first, and then taking over sponsorship of those trials. Do you expect that to happen next year?
Robert Forrester -- President/Chief Executive Officer
That's a really important question. And we see this as a wonderful way to bring forward the development of this drug in collaboration with our partners. And you're right, as we see data from these trials, it will allow us to start to make decisions on how we best proceed. And that's likely to be the latter part of this year, bumping into next year, depending on the trials. They're obviously going on different timelines, but we do see them as important proof of concept studies. Dan, is there anything else you want to add in addition to that?
Dan Paterson -- Chief Operating Officer
No. I mean, by doing these as ISTs, it allowed us to place more bets than if we'd fully funded these studies themselves, so we're looking at them as signal generation. For each of them, we have a sense of where we're going next with a positive signal.
George Zavoico -- B. Riley. -- Analyst
Okay. And the most advanced of those is actually-what? A couple of them are Phase 2s, right? They're not all Phase 1s?
Robert Forrester -- President and Chief Executive Officer
I would describe them as of sort of proof of concept Phase 1/Phase 2s. I wouldn't put too much store on one being ahead of the other. I think they're all proof of concept within the different disease types. So I think over the next 12 months, we will hope to have some data from these that will allow us to start to make some decisions on whether we should be investing further or not.
George Zavoico -- B. Riley. -- Analyst
Okay, great. All right. Thank you very much.
Robert Forrester -- President/Chief Executive Officer
Thanks George.
George Zavoico -- B. Riley. -- Analyst
That's all for me.
Operator
(Operator Instructions) We have a question from Matthew Cross from Jones trading. Please ask your question.
Matthew Cross -- Jones Trading -- Analyst
Hey guys. Good afternoon and thanks for taking my questions. I just wanted to ask here, you mentioned expanding PRIMO with some additional patients and I was wondering if you could give a little bit more detail around the criteria for these additional enrollments and any changes to the existing protocol and then kind of rationale for this? I guess, particularly also interested in learning how you may square this with potential combination work with romidepsin. Thanks.
Robert Forrester -- President/Chief Executive Officer
Now that's an important question. Well, as you know, we and our collaborators are excited about the activity we've seen with duvelisib in PTCL. As you know, this is an aggressive tumor with a large unmet need. And thinking of the relapsed refractory patients, they unfortunately don't do well. And so far, the data has been encouraging both for the PRIMO study and also in the combination study with romidepsin. So we will continue to report data from both those trials and from our collaborator, of course, probably the latter part of this year. But with that, maybe we can let Dan comment a little bit further, about PRIMO in particular.
Dan Paterson -- Chief Operating Officer
Yes. So as you know, our approved dose is 25 milligram BID in CLL/SLL and FL. In our Phase 1 experience where we saw the original signal for PTCL, the majority of those patients were treated at 75 milligram BID. We believe based on the PK, 25 milligram should be sufficient. But what we did in the PRIMO study is the initial phase of the study was looking at 25 milligram BID and 75 milligram BID and the expansion will be choosing a dose to go forward in a potential registration-directed study. And so we're hoping to report the initial phase at a medical meeting later this year and then open the expansion at that single-dose that we choose at a larger number of studies -- study sites.
Matthew Cross -- Jones Trading -- Analyst
Okay. Great. No, that's very helpful; I appreciate the color. And then just I also wanted to ask if you could comment on some of your optionality here regarding utilization of your existing cash balance. I guess what are your latest thoughts on potentially in-licensing, any additional pipeline assets or -- and/or retiring any portion of the outstanding convert?
Robert Forrester -- President/Chief Executive Officer
That's a really broad question. So thank you, Matt. First of all, we're delighted with where our cash position is right now. And as Rob talked about in his prepared comments earlier, as we think about building a business, I mean, that's really what, I think, you're talking about -- the three top priorities for us. One is the launch, making sure that we do the launch to a world-class level. We get the drug to the patients who could benefit from it and we are early into that and we see 2019 as being that foundation year to really sort of takeoff latter part of the year into 2020.
Second, because of the long IP that we have on the drug and the potential for duvelisib to help patients with other tumor types where you're going to see from us and you're already beginning to see from us a development plan that takes the drug into new tumor types both the single agent and in combinations, may go into earlier stage patients, may go into higher risk patient populations like Richter's or transformed follicular -- PTCL, obviously you know about already, TL PTCL, mantle cell marginal zone, even possibly into solid tumors in combination with some of the IO drugs, both in heme and potentially in solid tumors. As well as also maybe around CAR-T, pre- and post- CAR-T may be another area of interest for our drug. So job number two is to maximize the potential for duvelisib. As you know, getting a drug approved is a tricky process. You've got to get -- run the gauntlet with the biology and then run the gauntlet with the FDA. Duvelisib has survived both of those challenges. And it now being an approved drug, that makes it a lot easier now to do the expansion of the drug into additional indications.
Then the third area is, what else? What other drugs can we bring forward that can benefit from both our developments, our regulatory and our now -- our commercial capabilities? Already we have in the portfolio defactinib and there were a couple of questions earlier about defactinib and we'll see whether that is a drug that deserves further investment. And then there could be new drugs that we can bring it at some point in the near term or in the medium or late -- longer term. We are actively looking for things, but I'm not going to give any guidance around whether we found anything or whether we'd like to do something shortly or not. But we have a high bar in terms of what we're looking for, and we will be patient to make sure we find something that really fits in well with our skill sets.
Matthew Cross -- Jones Trading -- Analyst
Okay fair enough and I appreciate the detailed answer on on as you put it a pretty broad question, looking forward to seeing what the future looks like for the pipeline. Thanks guys.
Robert Forrester -- President/Chief Executive Officer
Thanks, Matt.
Operator
There are no further questions at this time. I'll turn the call back to CEO, Robert Forrester.
Robert Forrester -- President/Chief Executive Officer
Thank you very much indeed for joining us today. We look forward to updating you soon. Bye-bye.
Operator
This concludes today's conference call. Thank you everyone for your participation, you may now disconnect.
Duration: 54 minutes
Call participants:
John Doyle -- Vice President, Investor Relations & Finance
Robert Forrester -- President/Chief Executive Officer
Joseph Lobacki -- Chief Commercial Officer
Dan Paterson -- Chief Operating Officer
Rob Gagnon -- Chief Financial Officer
Robert Forrester -- President and Chief Executive Officer
Jake Colby -- BTIG -- Analyst
Sean Lee -- H.C. Wainwright & Co. -- Analyst
Dan Paterson -- Chief Operating Officer
George Zavoico -- B. Riley. -- Analyst
Matthew Cross -- Jones Trading -- Analyst
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