Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Q4 2017 Earnings Conference Call March 6, 2018 5:00 PM ET
Dolly Vance - Executive Vice President, Corporate Affairs and General Counsel
Raul Rodriguez - President and Chief Executive Officer
Anne-Marie Duliege - Executive Vice President and Chief Medical Officer
Eldon Mayer - Executive Vice President and Chief Commercial Officer
Nelson Cabatuan - Vice President, Finance
Kyung Yang - Jefferies LLC
Tessa Romero - J.P. Morgan Securities, LLC
Do Kim - BMO Capital Markets Corp.
Joseph Pantginis - H.C. Wainwright & Co.
Elemer Piros - Cantor Fitzgerald & Co.
Good afternoon, and welcome to Rigel Pharmaceuticals' Financial Conference Call for the Fourth Quarter and Year End of 2017. All participants are in a listen-only mode. We will be facilitating a question-and-answer session at the end of today's conference. [Operator Instructions] I would like to remind you that this call is being recorded for replay purposes from Rigel's website. [Operator Instructions]
And now, I would turn this conference over to our first speaker, Dolly Vance, who is Rigel's Executive Vice President, Corporate Affairs and General Counsel.
Welcome to our financial results and business update conference call. The financial press release for the fourth quarter and year ended 2017 was issued a short while ago and can be viewed in the News & Events section of our Investor Relations page on our website, www.rigel.com.
Joining me on the call today from Rigel are: Raul Rodriguez, our CEO; Anne-Marie Duliege, our Chief Medical Officer; Eldon Mayer, our Chief Commercial Officer; and Nelson Cabatuan, our VP of Finance.
As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook, and our plans and timings for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ than those reported - than those forecasted. A description of these risks can be found in our most recent annual report in Form 10-K and on file with the SEC.
Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances.
At this time, I would like to turn the call over to our CEO, Raul Rodriguez.
Thank you, Dolly. And welcome, everyone. Thank you for your time this afternoon. 2017 was a monumental year for Rigel, and as we worked at potentially new therapeutic options for adult patients with chronic immune thrombocytopenia or ITP.
During today's agenda, we will highlight some of that progress and our plans. First, Anne-Marie will provide an update on our regulatory interactions with the FDA regarding our NDA for fostamatinib in adult patients with chronic ITP as well as our plans for European MAA pilot. In addition, she will discuss the clinical data from Stage 1 of our Phase 2 study of autoimmune hemolytic anemia.
Secondly, we have made substantial progress in putting in place an excellent commercial team and in developing an understanding of the ITP commercial opportunity. Eldon will provide some insights in his presentation.
And lastly, Nelson - welcome, Nelson - will provide a financial update on the last quarter and year end 2017. Slide 8, a number of years ago we made a substantial change to Rigel's strategy; that is to transition from an R&D to a commercial stage company. This strategy was based on fostamatinib as an excellent foundation for this pivot.
In 2017, we continued to execute on that strategy. Utilizing fostamatinib as a cornerstone, we completed Phase 3 studies and filed the U.S. NDA for fostamatinib in adult patients with chronic ITP. We continue to manage that NDA towards an approval. We are also planning on commercializing fostamatinib in the U.S. ourselves and working towards that launch.
However, ITP is not Rigel's sole focus with fostamatinib. We are also broadening the fostamatinib opportunity with autoimmune hemolytic anemia, which is now enrolling Stage 2 of its Phase 2 study after positive Stage 1 results.
Our studies - fostamatinib studies in IgA Nephropathy will have results later this year. Furthermore, we are considering other indications for fostamatinib. Our therapeutic areas of focus are immunology, hematology, oncology and rare diseases.
Immunology is a fundamental expertise at Rigel. And using that knowledge, we have discovered the next product up for Rigel. Up next is an IRAK 1/4 inhibitor R835. And finally, partnerships are an important part of our strategy and we plan on putting partnerships in place for fostamatinib in ex-North-American territories.
On Slide 9 is why we're excited about fostamatinib. Fostamatinib addresses a fundamental target in immune cell signaling and so presents us with a broad opportunity to address numerous immune disorders. Fostamatinib is a SYK kinase inhibitor. SYK is an important underlying - important in the underlying inappropriate antibody destruction of tissues, would characterize many autoimmune diseases; furthermore, as we are the first company to advance a drug to address this key mechanism with a first-in-class drug in fostamatinib. That's a great accomplishment for a small company.
We have chosen three orphan autoimmune diseases as our initial targets due to their pathophysiology. ITP is characterized by antibody mediated destruction of platelets. Autoimmune hemolytic anemia is characterized by antibody mediated destruction of red blood cells. And IgA Nephropathy is characterized by the production of antibodies against the bodies circulating the IgA1 protein, which results in immune complexes that have been captured in the kidney and can result in the impairments of the kidney's ability to filter the blood.
The unique mechanism of fostamatinib may allow us to address each of these autoimmune disorders. Finally, there are numerous other autoimmune disorders, which may also be addressed by fostamatinib. And we are currently evaluating these to further expand the product's potential.
A bit about those autoimmune diseases we just spoke about, the three initial orphan autoimmune diseases we are pursuing are each attractive indications with sufficient patient populations to have an impact, but still addressable by our focus companies such as Rigel, addressable in both in terms of the size of clinical trials necessary and the size of physician prescribing audiences. Each of these indications has significant unmet medical needs are treated by products with significant limitations.
In the case if autoimmune hemolytic anemia or IgA Nephropathy, no treatment options have been approved. And in ITP, only the TPO receptor agonist agents have been approved and they have limitations according to KOLs and especially patients suffering from ITP.
Fostamatinib with its unique mechanism of action may address the underlying autoimmune basis of these autoimmune diseases. And this is different than the currently approved ITP agents. Second, we have shown important patient benefits. In ITP, we have shown in our Phase 3 studies are rapid, are robust and an enduring benefit in platelet responses.
In autoimmune hemolytic anemia, we have shown a 53% response rate in Stage 1 of our Phase 2 study, a remarkable result for patients where nothing is approved. And in IgA Nephropathy, we have shown the trend towards improvement in proteinuria. At the lower dose cohort of this trial, we hope to show even better results at a higher dose of fostamatinib in the second cohort later this year.
All of these indications allow us to build a focused commercial capability, and then to leverage that capability across various disease areas and overlapping physician audiences. I will now turn the call over to Anne-Marie for a regulatory and clinical update.
Thank you, Raul. As always, I want to thank my colleagues for their ongoing hard-work and dedication in support of our NDA submission for the ITP indication. We continue to work closely with the agency and remain hopeful that we will be able to bring this investigational product as a new drug to a patient population with unmet medical need.
In addition, we continue to accumulate data in patients with autoimmune hemolytic anemia. Finally, we're on track for the results of the IgA Nephropathy study in Q2 2018.
Rigel focused on chronic ITP at its first indication for fostamatinib, because there is a significant unmet medical need in this orphan disease. ITP is a rare autoimmune condition with approximately 65,000 adult patients with chronic ITP in the U.S. ITP arises from various disease mechanisms of platelet destruction and in some cases insufficient platelet production.
This disease is characterized by an increased risk of bleeding, often with minor forms of bleeding such as bruising [in particular] [ph]. In addition, patients may also have considerable fatigue and a reduction in the quality of life. Bleeding episodes such as GI or brain hemorrhage can be more severe and potentially lethal.
The physiopathology of ITP is complex and many factors have contributed to the disease may differ from patient to patient, making this a clinically heterogeneous disease. Treatment options exist, but they are limited, often associated with side effects and the response can wane over time. There is no treatment that specifically prevents platelet destruction. SYK kinase is a key player in the immune system's destruction of platelets in ITP, fostamatinib is a SYK inhibitor with a first-in-class unique mechanism of actions.
As a clinical summary of fostamatinib in ITP, the combined Phase 3 studies with fostamatinib demonstrate consistent clinical benefit in treating patients with ITP with a stable response of approximately 18% and a post-hoc overall or clinically relevant platelet response rate of 43%.
Patients with platelet increase had a rapid, robust and enduring response. The safety profile in the studies was consistent with a substantial prior experience in the rheumatoid arthritis population. Adverse events were generally mild or moderate, with diarrhea, hypertension, liver toxicity being the most frequent one. Hence, if approved by the FDA, fostamatinib may be an important new treatment option for patients with chronic ITP.
Slide 14 gives us a quick overview of the U.S. regulatory interactions to date. We submitted the NDA in April 2017, which was accepted for review. We have had positive interactions with the FDA at both the mid-cycle and the late-cycle review meetings. Regular collaborative discussions are ongoing with the FDA, but we will not comment further on the details of these discussions at this time. We can confirm that we're on track for PDUFA date of April 2017.
Regarding the European regulatory path, we've received positive feedback from the MHRA last December with no objection to the filing. Based on this, and the fact that we know the data so well, we have decided to submit an MAA ourselves by the end of 2018. We went with this decision rather than identifying a partner who would then submit dossier in 2019. As we could gain approximately a year in timing, and this could strongly benefit patients in Europe. We're still actively looking at partnership for the product in Europe.
On Slide 16, focusing on our fundamental target fostamatinib we now look at our next indication in the Phase 2 study with this product. Autoimmune hemolytic anemia is a condition associated with increased destruction of red blood cells, in the presence of anti-red blood cells antibodies. There are approximately 40,000 cases of autoimmune hemolytic anemia in the U.S. Symptoms can include fatigue, shortness of breath and reduction of activity in quality of life, all of which can be severe at times.
Currently, other than steroids, there are no approved products in the treatment of warm autoimmune hemolytic anemia and no standard therapeutic approach to its treatment has been developed. The relative rarity as well as the heterogeneity of this disease has make it difficult to conduct randomized clinical trial. Thus, the treatment approach to warm autoimmune hemolytic anemia is largely based on the preferences of the treating physicians.
Hence, autoimmune hemolytic anemia represents an attractive opportunity for the potential extension of fostamatinib usage, with unique mechanism of action potentially addressing the underlying cause of this autoimmune disease.
Slide 17, this Phase 2 study is a Stage 2 study. Patients enrolled are treated with fostamatinib for 12 weeks and can then participate in a long-term extension study. The study design and the definition of the primary endpoint were done in collaboration with key opinion leaders. The primary endpoint is the response rate during the 12-week study. The definition of the response is widely accepted as hemoglobin of greater than 10 gram per deciliter and at least 2 gram per deciliter increase from baseline.
On the next slide, the patient - the next slide, the patient population is also characteristics of the general patient population with moderately severe to autoimmune hemolytic anemia, mostly middle aged women with anemia. The goal in Stage 1 of this Phase 2 study was the enrollment of 17 patients. During the study, two patients discontinued for reasons unrelated to safety or efficacy and were replaced. So we have 17 evaluable patients for efficacy and 19 patients for safety.
On Slide 19, we review the Stage 1 results. Of the 17 patients evaluable for efficacy, 53% of these patients, 9 of 17, have now had a clinical response on fostamatinib. Six patients responded during the 12-week evaluation period, and an additional three patients started to increase their hemoglobin levels during the initial 12 weeks of the trial, and have now met the clinical response criteria in the extension study. And further comprehensive analysis of the Phase 2 data will continue.
The figure on Slide 20 provides the hemoglobin response during the 12-week study by responder status. In green, you see six subjects who responded in the 12-week study at a rapid median hemoglobin increase to over 3 gram per deciliter in the first four weeks. Among the 11 initial non-responders, three patients met the criteria for response in the extension study. These late responders are noted on this graph in blue to show the increase in hemoglobin that happened in these individuals during the first initial 12 weeks, taking them into the extension study, where they achieved a clinical response.
These results are meaningful, because they show that fostamatinib is associated with a hemoglobin response that is generally rapid and sustained in a disease with significant unmet need. There were no new adverse events in the program. Three patients with serious adverse events all assessed are non-treatment related by the investigators.
In summary, on Slide 22, we have had 53% response rate in Stage 1 of this trial. This is a disease with significant unmet medical need. And study investigators, including our lead investigator, David Kuter, are very encouraged by these results, because of the clinically meaningful increase in hemoglobin.
Remember, current treatment options include steroids or Rituxan, treatments that are not approved for this condition, and also splenectomy. Many patients initially respond to this treatment, but either failed to achieve a durable response or find the long-term side effect unacceptable.
Hence, an investigational drug that targets the mechanism of disease is an attractive option that deserves further clinical testing. There were no new safety signals and the primary endpoint was achieved in the Stage 1 portion of the trial. Another exciting news is that we have been granted orphan drug designation for fostamatinib in autoimmune hemolytic anemia The next step is to enroll 20 additional patients onto Stage 2 of this study. We look forward to discussing these results with the FDA and the best regulatory strategy to move this product forward to a potential approval.
Our third indication that is currently completing a Phase 2 clinical study with our fundamental target fostamatinib is IgA nephropathy. IgA nephropathy is a chronic autoimmune disease associated with inflammation in the kidneys that can diminish their ability to filter blood. There are an estimated 82,000 to 165,000 cases in the U.S. with a higher prevalence in Asia.
Outside of angiotensin blockade, primarily for blood pressure control, there are no disease-targeted therapies for IgA nephropathy. Preclinical data show that fostamatinib may decrease SYK activation in the kidney, potentially resulting in the reversal of the inflammation in the glomeruli and improvement in kidney function.
Slide 24 shows the study design for the IgA nephropathy Phase 2 study. Rigel announced results of the first cohort of the Phase 2 study, which used 100 milligram twice a day of fostamatinib in January of last year. The study showed no safety signals and a trend towards greater reduction in proteinuria over 20 weeks compared to placebo.
Rigel expects results of the second cohort evaluating a higher dose of fostamatinib using 150 milligrams bid in Q2 of this year. That concludes our clinical review for this call. And now I would like to introduce Eldon to discuss our commercial readiness. Eldon?
Thank you, Anne-Marie. I'd like to review several aspects of our launch preparation and, in particular, some details on how we view the adult chronic ITP market and the opportunity for TAVALISSE, which is the conditionally accepted proprietary name for this investigational product candidate. On a future call, we will discuss topics such as pricing and market access.
First, I'd like to review the ITP patient landscape. As part of our market assessment, we conducted quantitative market research and evaluated seven years of ITP patient claims data. And from this analysis, we estimate there are approximately 65,000 adult patients in the U.S. with chronic ITP. This analysis also revealed that in any given year, approximately 50% or 32,500 of those patients are not actively treated for their disease. However, over a longer period of time, we expect to see a proportion of those patients join the treated population.
For the other half, the 65,000 patients that are on treatment, we estimate that 15,100 received steroids during a given year. The remaining 17,400 of the treated patients are steroid refractory and received any of the currently available treatment, such as rituximab, TPO agents, splenectomy, et cetera. These patients may need additional treatment options over what is currently available and represent the addressable market for TAVALISSE.
Our analysis also looked at treated ITP patients to see how they typically progress through the lines of therapy. This is shown on Slide 27. And as you can see, the ITP treatment continuum is very fragmented, with no single treatment dominating any line of therapy, all therapies are used across all lines. And there are several factors that contribute to this.
First, as Anne-Marie mentioned, ITP is a heterogeneous disease, so it's difficult for a clinician to predict which patient might respond to a given treatment. Many treatments are used, and the sequencing of treatments is highly variable. In addition, the approach to treating ITP can vary quite a bit from doctor to doctor. In fact, our analysis revealed there are over 300 different treatment combinations used for adult chronic ITP, which supports the level of unmet need that remains for ITP patients.
On the slide, you can also see our estimate of how the 17,400 patients in the steroid refractory market are broken out by the line of therapy, with approximately 7,800 in the first line steroid refractory, 5,300 in second line and so on. And we expect that TAVALISSE will follow a typical pattern of introduction that is seen with most new therapies in this type of chronic market.
For example, during the early stages following launch, we expect that most physicians will prescribe TAVALISSE for refractory or later line ITP patients. However, as prescribers have success with TAVALISSE and become more comfortable and knowledgeable with it, we expect they'll begin using it in earlier lines of therapy. And because this is a chronic disease, once patients experience a group clinical outcome on the product, they are likely to remain on it for years.
Of course, our preparation for launch goes well beyond market analysis. Our commercial team has been very busy with launch preparation. And on this slide, you can see some of our key initiatives. With regard to the commercial team, we have been very successful in attracting and hiring some top talent, with extensive experience in hematology, oncology and rare disease. At launch, we plan to have a team of 50 to 60 individuals, and we are on track to meeting this goal and being ready for launch in the latter part of Q2.
And with that, I'll turn it over to Nelson for a financial update.
Thank you, Eldon. We completed two successful financings this year, with over $108 million in net proceeds. This helped us to extend our runway into 2019, including the potential commercial launch cost for fostamatinib. We ended 2017 with cash and short-term investments of approximately $116 million. In 2017, we invested approximately $10 million in launch preparation costs. We expect these costs to significantly increase in 2018, as we continue to invest for potential launch in Q2 2018, including the hiring of a sales force.
Implementation of financial systems to support a successful launch, including systems for aggregate spend and transparency reporting are underway. Further, on the Q4 2017 financial results, we reported a net loss of $25.9 million or $0.18 per share in Q4 2017, compared to a net loss of $15.6 million or $0.16 per share in Q4 of 2016. There were no contract revenues from collaborations in the fourth quarter of 2017 compared to $3 million in the fourth quarter of 2016, which was related to the payment received pursuant to a collaboration agreement with Bristol-Myers Squibb.
We reported total costs and expenses of $26.2 million in the fourth quarter of 2017 compared to $18.8 million in the fourth quarter of 2016. This was an increase of $7.4 million, primarily due to the launch preparation costs for fostamatinib in chronic ITP as well as cost for managing our NDA submission. Back to you, Raul.
Thank you, Nelson. Let me summarize on Slide 39 for you what we view as the near-term Rigel opportunity. Fostamatinib is a broad opportunity, which provides a foundation for treating a wide range of autoimmune diseases. The orphan autoimmune diseases we have chosen have significant unmet medical need, and fostamatinib SYK inhibition may address the key pathogenesis of these diseases.
We have these indications coming in sequence, led by ITP currently at NDA review, followed by Phase 2 with autoimmune hemolytic anemia with strong proof-of-concept data. And then, Phase 2 in IgA nephropathy and more to come. Fostamatinib in these indications provides the ideal product to pivot to a commercial stage company, including limited clinical trial requirements and focus the physician audiences. This allows us to build and leverage a commercial capability broadly.
Following along the same path is R835, our IRAK 1/4 inhibitor. This molecule may also address a broad fundamental immune signaling mechanism and allow us to address numerous immune diseases or diseases where the immune system is key.
On Slide 32, you see some of the broad range of potential indications for R835. We look forward to introducing R835 into human clinical studies in Q2 of this year.
At this time, we'd like to open up the call for your questions.
Thank you. [Operator Instructions] Please stand by for your first question. And the first question is from the line of Kyung Yang of Jefferies. Your line is open.
Thank you. In terms of fostamatinib, the label, do you expect that it's going to be similar to TPO mimetics such as like in insufficient response to steroids, immunoglobulin or splenectomy? Or do you think that it also include - that this will include patients with a prior TPO mimetic therapy?
Yes, at this point, we're making no comment on the label.
Kyung, as you can understand, we're in that constant negotiation discussion with the FDA. It's all regular type of work. And so at this point, we'll defer on that.
So the 17,400 addressable market for the refractory that you mentioned, does that assume that your label would be similar to TPO mimetics?
The analysis that Eldon showed us shows how those lines break up, but we can't at this point discuss what our label is likely to be.
Okay. And then, second question on R835. Is this same as R509 previously?
It's a different molecule at that. And it has a better profile, and which is why we think it's the right molecule to put into MAB [ph]. But it's similar, similar mechanism - identical mechanism.
Okay. So the going to clinic second quarter this year. But in the past, when you talked about R509 you were thinking about the initial indication of gout. Is that still what you are thinking for R835?
At this point, our initial indication or proof for concept on will probably be psoriasis. And we can tell you in a different call why we think that might be a good starting point for the product. But by no means is that the only point of the product. That's the attractiveness about both fostamatinib and R835, that they address fundamental mechanisms. And as a result, we have the opportunity to use them and explore them across a range of immune disorders.
And - but we probably will start with psoriasis for some very good reasons, including the rather well-established type of trials that we'd have to do and the well-understood endpoints that we might pursue.
Absolutely, and then there is a clear unmet medical need for an oral agent in psoriasis.
Okay. And the last question that I have for you is on warm hemolytic anemia. So, you are enrolling additional 20 patients. Can you give us some update on how many patients have been enrolled? And when you meet with the FDA in the first-half of this year to discuss the regulatory path, do you need all these 20 patients' data to have a conversation? Thank you.
So, thank you. In this we're not making any comments about enrollment in this trial as this is an ongoing process, but we certainly intend to go and talk to the FDA this year. That means that we may not have completed entirely the Stage 2 of the trial.
Okay. Thank you.
It will be - that conversation will be driven by Stage 1, obviously, with all the safety information on the product that we know which is really quite substantial, as you know.
Thank you. Our next question is from the line of Anupam Rama of J.P. Morgan. Your line is open.
Hi, guys. This is Tessa on for Anupam this evening. Thanks for taking our questions. With respect to the updated AIHA data, can you elaborate for us a little bit further on whether there were any corollaries with baseline criteria for the six patients that responded in the first week - first 12 weeks versus the three additional patients that responded in the extension study?
And then, I guess, I had a second related one, on any more details you guys were able to provide on the goals of the Stage 2 study and what overall level of durability of response would warrant moving the program forward. Thanks so much.
Right. So, no, we haven't looked yet at the baseline. We know the baseline criteria of these patients. But we have not compared them with the non-responders simply because their numbers are so small and would not give us any meaningful indication. We intend to do that when we combine Stage 1 and Stage 2 studies together.
In terms of durability of response, very much like for the ITP program, we're looking forward, and so far that seems to be the case of patient to, in general, maintain the response for as long as they were treated. So certainly a minimum of 12 weeks for the duration of the trial, but also as they continue to the long-term extension study.
Okay. Great. Thank you. Thanks very much, guys.
Thank you. Our next question is from the line of Do Kim of BMO Capital Markets. Your line is open.
Hi, thank you for taking my questions. First, on your filing for TAVALISSE in Europe, if you are planning to file in the fourth quarter of this year, does that mean we should expect the partner to be signed until 2019?
Hi, Do. Thank you for your question. We do expect to have the MAA filing in the second half of this year, Q4 is most likely. We will - we're working with exploring potential partners now. I think, as you can imagine, the approval of the product in the U.S. is an important de-risking step, even though we're talking about ex-U.S. territories, Europe specifically.
And so, I think we're really thinking that end of this year, early next year is probably the right time frame for a European partnership. The Asian partnership may take a little bit longer, and that may go into next year. But we don't think that the filing of the MAA will be - any obstacle to that, in fact, just the opposite.
I think it makes the opportunity so much more present. That is we should have an approval, if we're lucky, in Europe maybe in 2019. And the partner would take on the regulatory interactions with the European agencies once we sign that partnership and be there once the product is approved.
Great. Thank you. That's helpful. And for AIHA, could you possibly expand on what the regulatory options you would explore with the FDA, and if there is an accelerated path that you could use if TAVALISSE is approved?
Well, we definitely have these discussions internally, both what are the options in terms of accelerated path and also what would be the basis of our discussion. So we're not making any comment at this point, but later on this year once we have clarified and defined and refined these options.
Okay. And my last question is on the financials. Could you give us a sense of where you think SG&A spending would go this year if you get approval?
So, thank you for that question. The financial plan that we have for 2018 included a full investment into commercial launch. And with that we are still in a good position to have a runway that will bring us into Q1 of 2019.
And do you see the fourth quarter spending as a good proxy for your quarterly run rate?
I would think so.
Okay. Great. Thank you for taking my questions.
Thank you, Do.
Thank you. Our next question is from the line of Joe Pantginis of H.C. Wainwright. Your line is open.
Hi, good afternoon. Thanks for taking the question. A quick question on the commercial readiness, I believe you said that you have all of the internal personnel hired. And I just wanted to confirm and see that you're essentially in the press-play mode with regard to the pending approval with regard to hiring the field-force.
Sure, yeah. Most of the internal payment is in place and had been for a while particularly the management team. With respect to the sales force, our national sales director and sales management is in place. And we are now in the process of hiring some of our sales reps, all of our sales reps, some of which are already hired.
Got it. Thank you very much.
Thank you. [Operator Instructions] Our next question is from the line of Elemer Piros of Cantor. Your line is open.
Thank you. Good afternoon. What I'd like to ask maybe, Anne-Marie, if you could help us understand the purpose and what sort of additional information could be obtained from the Stage 2 of the anemia trial.
Simply confirmation of the overall response rate, the Stage 1 was actually very informative, provided exciting results. But this is a small group of patients and we'd like to be able to reproduce this number in Stage 2.
And observing that about one-third of this small trial of the patients responded beyond the initial 12 weeks, would you consider expanding the treatment period? Or do you just leave it as is and then just like in Stage 1, you just follow patients in the extension phase?
No, we're extending the treatment period from 12 weeks to 24 weeks in Stage 2 and then also offering the option of an extension trial.
Thank you very much, Anne-Marie. And just one financial question to Nelson, Nelson, the non-cash items in the fourth quarter also had a significant jump in parallel with the G&A expenses. Would this also be a good proxy for continuing forward in 2018?
Yes, I would think so.
Okay. That was all. Thank you so much.
Thank you. And this does conclude our Q&A session for today. I would like to turn the conference back over to Mr. Raul Rodriguez for the closing remarks.
Thank you for your time today. 2017 was a very exciting year for Rigel. And honestly, we cannot wait for the year ahead. If all goes according to plan and with all the appropriate caveats and knock on wood, in the near future a patient will for the first time receive TAVALISSE fostamatinib and will benefit from it. And their lives will be better for it.
And importantly, we will be compensated for this. Thank you all for your support in allowing us to make this happen. We look forward to providing you further updates on regulatory commercial milestones in our pipeline. It will be a great year. Thank you.
Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.