Sellas Life Sciences Group Inc (SLS) 2015 Q2 法說會逐字稿

Hello, and welcome to the Galena Biopharma second-quarter 2015 earnings conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time.

I would now like to introduce your host for today's call, Remy Bernarda, Senior Vice President, Investor Relations and Corporate Communications. You may begin.

Good afternoon, everyone, and thank you for joining our call today. For those of you listening via telephone, I would encourage you to visit our website and log into our webcast presentation.

For this quarterly call, we will again be using slides to enhance our information flow. The slides can be accessed on our website in the Investors section under Events and Presentations. These slides are posted both as a PDF document and will also be available on the webcast. The slides are viewer-controlled, meaning that you, the viewer, will need to advance the slides. Our speakers will alert you to the slides they are addressing.

As listed on slide 2 on our presentation, during today's discussion, we may make forward-looking statements about our programs. Such statements include, but are not limited to, statements about our commercialization strategy, operations and plans, and the development progress of our clinical product candidates, including patient enrollment, trial initiations and collaborations.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under Risk Factors in our Annual Report on Form 10-K; Quarterly Reports on Form 10-Q; and other documents filed with the SEC and available on our website. Actual results may differ materially from those contemplated by those forward-looking statements.

Please now turn to slide 3, as I would like to introduce the members of management presenting on today's call. Dr. Mark Schwartz, our President and CEO; Dr. Gavin Choy, Senior Vice President, Clinical Sciences and Operations, who will discuss our clinical programs; Christopher Lento, Senior Vice President of Commercial, who will discuss our Commercial business; and Ryan Dunlap, our Vice President and Chief Financial Officer.

Please now turn to slide number 5, and Dr. Schwartz will begin our discussion.

Thank you, Remy, and welcome, everyone, to our second-quarter earnings conference call. I am pleased to report our progress today, as the last four months have been extremely productive for us.

On this slide, slide 5, I have highlighted in red the major milestones that we've completed, and I am grateful to our entire Galena team for their efforts to reach these accomplishments. I will briefly review each of these, and then turn the call over to Gavin, Chris and Ryan to elaborate further.

On the clinical side, as we stated last quarter, we accomplished a critical milestone with the completion of over-enrollment in our PRESENT trial for NeuVax. And we look forward to the interim analysis, which we expect to be later this year or early next year.

In total, we have three ongoing breast cancer trials with this agent. As a drug candidate, NeuVax falls into the exciting and dynamic landscape known as immuno-oncology, where new approvals and breakthroughs in this area continue to improve the lives of cancer patients. We plan to continue to expand the utility of NeuVax in diseases where patients may benefit from our immunotherapy. To date, we have been successful in expanding our portfolio, and have garnered funding from partners and government agencies to help us expand the use of NeuVax. We are constantly evaluating the immuno-oncology landscape and opportunities where NeuVax may contribute, and expect to initiate additional trials in the future. Gavin will elaborate on this in more detail.

We also had two meaningful data presentations on our earlier-stage assets -- GALE-301, also known as folate binding protein or FBP; and GALE-401 -- with both assets demonstrating efficacy, safety and tolerability.

Our second immunotherapy asset, GALE-301, or FBP, is in a Phase IIa trial treating women with ovarian and endometrial cancers. The preliminary results were quite promising with a reduction in the relative risk of recurrence of 78%. We continue to treat the patients in this trial as we look to reach our two-year endpoint, and will report our one-year data at the upcoming ESMO conference in September.

GALE-401 also produced positive preliminary results from the Phase II pilot study in patients suffering from thrombocythemia associated with myeloproliferative neoplasms, demonstrating an overall response rate of 78%. Patients continue to be treated, and we expect to present the final efficacy data by the end of the year.

I would now like to take a moment to discuss the state of our commercial business. First, as I hope you saw last week, we announced the launch of Zuplenz, our antiemetic for the prevention of nausea and vomiting for patients undergoing chemotherapy, radiation and surgical treatments. As we noted in our press release, we recorded net revenue of $6.1 million thus far this year from Abstral sales, and are very proud of our Commercial team for bringing in our highest quarterly net revenue to date of $3.4 million in Q2.

Abstral is part of the transmucosal immediate release fentanyl, or TIRF, market that is very competitive, and has received a great deal of press this year. As Chris will go into in more detail, our metrics for Abstral are trending in the right direction, although our sales growth has fluctuated quarter-over-quarter based on field demand and wholesaler inventory levels.

Because of the ongoing market dynamics, the quarterly variability around our reported sales, and the fact that we've just launched Zuplenz and have yet to recognize revenue to date for that product, it is appropriate for us to guide to a lower end of our range with the expected full-year revenue of around $15 million for both products. We continue to work to make our Commercial business accretive, and we are evaluating our commercial options and strategy to achieve long-term profitability and maximize the value of our commercial assets, with a goal of building shareholder value.

I will now have the team walk you through our progress in detail, beginning with our Head of Clinical Operations, Gavin Choy. Please turn to slide 6. Gavin?

Thank you, Mark. As Mark mentioned, our clinical team made terrific progress in the second quarter, and we are looking forward to several additional clinical data presentations over the remainder of the year.

As I mentioned on our last call, we successfully completed enrollment in our Phase III PRESENT clinical trial with our lead cancer immunotherapy asset, NeuVax. The study scheme is depicted on slide 7. And reaching this significant milestone was critical for our Company and the overall clinical development of NeuVax for the prevention of breast cancer recurrence. NeuVax is a peptide derived from the HER2 protein that binds to the human leukocyte antigen, or HLA. PRESENT is a multi-center, multi-national prospective double-blind study enrolling lymph node positive breast cancer patients with HER2 1+ 2+ tumors in the adjuvant setting. NeuVax is used for these women who have no evidence of disease after their standard of care treatment, otherwise known as secondary prevention. Because there are no treatments currently approved in this setting, there exists a critical unmet medical need for these patients, and unfortunately, if these patients' disease reoccurs, it is most often fatal.

Our next major clinical milestone for this trial will be achieving a positive readout on our event-driven interim analysis, which will occur when we reach 70 events, defined as recurrence or death from any cause. We believe this would be a significant de-risking event for the trial. As a reminder, this is a safety and futility analysis, and based on our current event rate, we expect to reach this milestone by the end of this year or in the first quarter of 2016.

I would now like to take some time to discuss our NeuVax franchise and where we see potential for the program. In addition to the PRESENT trial, we also have two ongoing trials in combination with trastuzumab that are currently active across multiple sites in the United States. These trials are summarized on slide 8. And I have also included their respective trial design schemas for your reference on slides 9 and 10. Although trastuzumab is an effective drug and has been life-changing for thousands of women, there are still significant breast cancer patient populations who are not adequately addressed by the current HER2 directed therapies. In our combination trials, we are looking to broaden the utility of NeuVax in the HER2 low to intermediate expressors, or 1+ and 2+, where trastuzumab is currently not approved, as well as in high risk 3+ patients.

Turning to slide 11, I have provided a schematic broadly outlining the additional therapeutic opportunities in breast cancer for NeuVax. Currently with PRESENT and our combination trials, we are targeting secondary prevention for women, as depicted in the top blue box. In this setting, we are evaluating whether NeuVax can prevent their cancer from returning after their initial standard of care therapies.

To date, we have only studied NeuVax in the adjuvant breast cancer setting. But within breast cancer, we are also assessing additional areas where NeuVax could be a viable treatment option. Given the deepening understanding of the role of immunology in cancer biology, and the broadening array of cancer immunotherapy treatments in the metastatic setting, we are assessing opportunities where the mechanism of action of NeuVax could be complementary and effective in combination with agents such as checkpoint inhibitors or other immune modulators.

In addition, we are evaluating other diseases -- areas where NeuVax could have an impact as a monotherapy, moving NeuVax earlier in the treatment paradigm towards breast cancer primary prevention.

Given HER2 is expressed in gastric carcinomas, and trastuzumab is approved in HER2 3+ gastric cancer, there's a strong rationale to evaluate NeuVax in this tumor type. In partnership with Dr. Reddy's, we plan to initiate a Phase II single-arm clinical proof-of-concept trial next year. In preparation for this trial, Dr. Reddy's is conducting an epidemiological study to ascertain the rate of HLA A2 and A3, HER2 1+, 2+ and 3+ status in gastric resected tumors. Results of this study will be presented at a scientific congress in early 2016, and will inform the rate of enrollment, given the protocol defined targeted population.

Moving now to our second immunotherapy asset on slide 12. GALE-301 is a peptide vaccine derived from folate binding protein, and is targeting the prevention of recurrence in ovarian and endometrial cancers -- diseases where the recurrences are high and the outcomes are often quite poor, with a reported 44.6% five-year survival rate upon diagnosis. GALE-301 is in the Phase IIa portion of the Phase I/II trial, with the optimal dose carried forward from the Phase I. The trial is evaluating women who have no evidence of disease after undergoing their primary first-line therapy.

Turning now to slide 13, the trial is ongoing and is designed as a safety and dose optimization trial that is not powered for a disease-free survival efficacy endpoint. The preliminary data, as presented at the ASCO 2015 annual meeting, demonstrated that GALE-301 is well-tolerated, and elicits a strong and dose-dependent in vivo immuno response. The preliminary efficacy results from the IIa portion of the trial are promising. In the 1,000 microgram optimal dose cohort, at 9.8 months median follow-up, the data demonstrated that the vaccine group only had one clinical recurrence in 15 patients dosed, while there were 11 recurrences in 22 patients dosed in the control group. Based on the data, the estimate for disease-free survival at two years is 85.7% in the 1,000 mcg dose vaccinated group compared to 19.2% for the control group, with a P value of 0.09. This is a 78% reduction of relative risk of recurrence. A more mature data set from this trial will be presented at the European Society for Medical Oncology Congress in September.

In June, we also presented the Phase II proof-of-concept data on our hematology asset, GALE-401 at the European Hematology Association Congress, and I have summarized the data on slide 14. GALE-401 is our controlled release formulation of anagrelide in development to reduce the elevated platelet counts in patients with thrombocythemia, secondary to myeloproliferative neoplasms. In the trial, GALE-401 has been shown to be well-tolerated, with primarily grade 1 and 2 toxicities in 16 of the 18 patients studied. Our efficacy data compares favorably to anagrelide immediate release in terms of platelet response, with an overall response rate of 78%, and both complete and partial response rates of 39%, respectively. The median time to response was five weeks, which is comparable to the IR formulation. Because the trial is ongoing, we have not yet reached our median duration of response. We expect to present the final efficacy and safety data for this trial at the end of the year.

The first half of the year has produced several positive clinical readouts, as well as reaching the most critical milestone for our NeuVax program thus far. We have the right team in place to advance our clinical programs and evaluate opportunities to expand our development pipeline. We look forward to the additional data presentations during the second half of 2015, and remain optimistic about the prospects of our ongoing development programs.

I would like now to hand over the call to Chris Lento to review our Commercial programs. Please turn to slide 15.

Thank you, Gavin. And good afternoon, everyone. I'll start my discussion with Abstral. As a reminder, Abstral is indicated for the treatment of breakthrough cancer pain in opioid-tolerant adult cancer patients, and falls under the TIRF REMS Access program. I am pleased to report Abstral net revenue of $3.4 million for the second quarter of 2015 -- our highest net revenue quarter since launch.

This is a result of our team adding new prescribers and the continued adoption of our Galena patient services, or GPS program. On slide 16, you can see this trajectory. In addition, our gross to net deduction improved to 77% this quarter compared to 65% in Q1 2015. Ryan will discuss this in more detail later in the call.

Turning to slide 17, this graph shows the number of Abstral units dispensed per paid transaction. As shown, we continue to trend positively at around 80 to 85 tablets per transaction versus 55 tablets per transaction in June of last year. This has resulted in more profitable transactions, and is directly related to our providers becoming more comfortable prescribing Abstral, and adopting the benefits of our GPS programs.

Our current market share in the branded TIRF market remained steady at around 4% to 5% of total prescription dollars on a monthly basis according to Wolters Kluwer. More importantly on slide 18, you can see that our average transaction price reached an all-time high in June at $5,673 per transaction.

Our focus remains on growing our oncology prescriber base. Slide 19 illustrates the fact that we are maintaining about 34% of our Abstral business through oncology-focused providers and palliative care specialists. As a reminder, this is up from 1% when we launched Abstral. We anticipate this number to continue to grow over time, and expect that with the promotion of Zuplenz, we will further increase our footprint in the oncology arena.

Our Managed Markets group has made significant progress in 2015 to expand our Managed Care coverage for both Abstral and Zuplenz. For Abstral, as we mentioned last quarter, we secured exclusive or co-preferred status as of April 1st with Caremark. This improved our coverage and access for approximately 32 million commercial lives. In addition, Prime Therapeutics has added Abstral to its Medicare Part D formulary, effective August 1, 2015, providing coverage for an additional 1.2 million lives.

As we have mentioned on previous calls, the growth of Abstral will continue to fluctuate quarter-over-quarter. But as you have seen, the underlying metrics are all trending upwards.

Please now transition to slide 21 for a screenshot from our Zuplenz website showing our product branding. As we announced last week, we officially launched Zuplenz, and it is now available nationwide, and is supplied in both 4 milligram and 8 mg strengths. Zuplenz is approved by the FDA for the treatment of patients with chemotherapy, radiation and postoperative-induced nausea and vomiting, otherwise known as CINV, RINV, and PONV.

The active pharmaceutical ingredient in Zuplenz is ondansetron, and it's considered the gold standard treatment option for patients suffering from emesis as a result of their cancer and surgical treatments. Zuplenz is bioequivalent to ondansetron orally disintegrating tablets, or ODT. In fact, the 2014 NCCN guidelines recommend the use of ondansetron in patients with highly and moderately emetogenic CINV and in RINV.

We believe the product attributes of Zuplenz highlighted on slide 22 will differentiate us from the competition, and allow us to penetrate the 5-HT3 antiemetic market. Zuplenz utilizes the novel, PharmFilm oral soluble film technology, which provides for convenient delivery and several key patient benefits: The film rapidly dissolves in the mouth in about 10 seconds. This dissolution illuminates the burden of swallowing pills during emesis and in cases of oral irritation. Zuplenz does not require water to administer. It can be taken with or without food. There is a pleasant peppermint flavor with no gritty aftertaste. And, it is non-sedating.

Moving to slide 23, this graphic shows the specialists targeted by our field sales team for both Abstral and Zuplenz. The dark blue triangles on the graph are the specialists our team is currently calling upon, and where we have established strong relationships. This is where we have added Zuplenz to our promotional mix. The lighter triangle in the non-oncology specialties is an area of expansion for Zuplenz promotion. We have implemented our launch with our customer base existing of targeted oncology clinics and high decile non-oncology specialists, including surgeons and emergency medicine providers.

We will use Wolters Kluwer to track our market share progress, and IMS to track prescriber level prescription activity and trends. The branded 5-HT3 market is growing and will exceed $1 billion in 2015 according to data sources. With our current sales force, we will strategically target a subset of this market focused on the non-injectable, branded 5-HT3 therapies, representing a market of around $100 million.

In addition to the field sales team, we are leveraging our established account management and managed market teams, as well as our GPS program. Our account management team has secured product availability with all of our distribution partners, assuring product access for all healthcare providers and their appropriate patients. On the managed market side for Zuplenz, we have increased our Medicare Part D coverage from 1% at product acquisition to approximately 50% at launch, and we expect to be at or near parity with the branded competition in 2016.

We offer patient assistance programs for both Abstral and Zuplenz. And on slide 24, I have provided a screenshot from our GPS website. As a reminder, GPS is an outsourced, third party vendor that helps both our physician offices and pharmacies to verify benefits, administer prior authorizations, manage denials and appeals, as well as other support services. To date we have had tremendous success with our patient assistance program with Abstral, which has improved both our gross to net deductions, as well as our revenue per transaction. We have launched our co-pay assistance program for Zuplenz to support our healthcare providers and their patients, and we are confident the program will be instrumental in the success of Zuplenz.

In summary, our Abstral business is growing, and we are enthusiastic about selling Zuplenz where our very early reception of the product has been positive.

I will now turn the call over to Ryan for a review of our numbers for the quarter.

Thank you, Chris. And good afternoon, everyone. Please refer to slide 26, as I walk you through the highlights of our 2015 P&L, starting with revenue. And, of course, all amounts mentioned will be in US dollars.

Net revenue from the sale of Abstral for the second quarter of 2015 was $3.4 million, up 48% from the $2.3 million reported for the same quarter of last year. Net revenue for the first half of the year was $6.1 million, up 36% from the $4.5 million reported for the first half of last year.

Gross to net deductions continue to improve, as Chris mentioned, moving below 25% during Q2, as we gain more utilization of our various patient assistance programs, and our account management and managed care teams strengthen relationships with our distributors, pharmacies and commercial payors. We expect Abstral gross to net deduction percentages to remain at these low levels moving forward, which reflects the significant progress our team has made in this area.

Last week, we launched our second product, Zuplenz, and we expect to begin recognizing revenue moving forward. While we are optimistic about our sales for this product, we expect to report initially high gross to net deduction at around 60% to 70%, due to the lack of any historical sales demand and product return information. As a result, our revenue recognition for Zuplenz will be deferred until the product is sold through, or when the right of return from our customers no longer exists.

Also, as we mentioned before, after we purchased Zuplenz, we worked closely with certain distributors to replace the outdated product sold by the previous licensee with our new, longer-dated, Galena-labeled product. These agreements will delay our revenue recognition for Zuplenz. As we get through the first couple quarters after launch, and have a clearer picture of the channel inventory, we will be able to provide more refined guidance into 2016. In the meantime, I reiterate our full-year 2015 net revenue guidance at the low end of our range at around $15 million for both products, with between $1 million and $2 million attributed to Zuplenz.

Moving into the expense results, please refer to slide 27. Operating expenses for the second quarter of 2015 were $14.7 million compared to $18.1 million for the second quarter of last year. To break down the key expense components, SG&A expense for the second quarter was $6.5 million, down 33% from $9.6 million for the second quarter of last year. The decrease in SG&A costs has resulted from the reduction in nonrecurring legal fees related to the ongoing civil litigation and SEC activities. While we have no updates as to timing or potential resolution on these proceedings, our expectation continues to be that the associated costs will be predominantly covered by our D&O insurance.

R&D expenses were $7.3 million for the second quarter of 2015, down 10% from the $8.1 million reported for the second quarter of last year. The decrease in R&D costs is a result of completing the enrollment period for our NeuVax Phase III PRESENT trial, as the costs during the enrollment period are much higher than the post-enrollment maintenance phase. Moving forward, based on our current programs, we expect these costs to remain in the $6 million to $7 million range throughout the rest of 2015.

Our overall operating loss improved to $11.3 million in the second quarter of 2015, which was $4.5 million better than that reported for the same quarter last year. Our loss per share for the second quarter of 2015 was $0.10 compared to a loss per share of $0.17 for the same quarter last year. The current-quarter loss per share was negatively impacted by a $4.3 million non-cash expense from the increase in our warrant liability, compared to a $3.3 million non-cash expense for the same quarter last year.

Moving to our cash flow, slide 28. We have $45.3 million in cash and cash equivalents at the end of the quarter compared to $23.7 million at the end of 2014. The roughly $30 million increase in cash during the first half the year represents the $47.4 million raised in equity financings, offset by $23.4 million in cash used in operations, $1.9 million in principal payments on long-term debt, and a $500,000 milestone payment on the Zuplenz asset.

Moving to slide 29, I will now turn the call back over to Mark for closing remarks.

Thank you, Ryan. Galena had a successful first half of the year, and we remain focused on our cancer immunotherapy programs, led by our PRESENT trial with NeuVax and the potential for future trials in additional indications. Our employees companywide worked diligently to achieve several of our major milestones and we look forward to continuing to advance under our commercial programs and our clinical data readouts over the remainder of this year.

We will now open the call for questions.

(Operator Instructions). Mara Goldstein, Cantor Fitzgerald.

Thanks for taking the question. I was hoping that maybe you could walk us a little bit through the results for 301. I mean, understanding that you are showing the optimal dose group, but the broader study showed a higher -- if I understand and read it correctly -- response rate in the non-treated group. So maybe you can help me with that.

So, Mara, let me take the first crack at that, and then Gavin can jump in. So the trial was set up as a dose escalation trial. So we essentially started at a low-dose and migrated our way up to the optimal dose -- the maximum dose that didn't have any safety or tolerability issues. And that was the 1,000 micrograms.

I think what we saw isn't -- I don't have all the data plots right in front of me from the published data, but the non-optimal dose groups, the dose groups below the 1,000 micrograms, did not show really a measurable improvement over the placebo. But 1,000 micrograms showed a very measurable -- I don't want to use the word significant -- but a very measurable improvement over placebo. In fact, depending on the specifics -- the statistics, it was statistically significant.

So I think the data indicates that there is a very dramatic dose response curve, a dose response mechanism taking place. And that the 1,000 micrograms does represent a dose in which the immune system is responding very strongly. And, in fact, is strong enough to represent a clinical response.

Right. I guess my question is -- but why then would the complete response rate be lower? Is it just a function of chance that you had such poor responders in the sub-optimal group?

So, Mara, we are not looking at complete response. We are looking at clinical recurrence. And so --

Well, I am reading your press release. So I apologize.

Yes, yes. So, I think the press release may have stated it incorrectly. It's actually the CR is actually a clinical recurrence. And -- yes. So in this setting, we are looking in the adjuvant setting where patients were -- there's no evidence of disease. And then came onto our trial.

And as Mark mentioned, it was a dose escalation of 1,000 micrograms at the top dose. The two lower doses were 500 and 100 micrograms of E39. And just to add on to what Mark has said, we also showed, in the abstract, that there was a pre- and post-DTH immunological response as well. And the clinical recurrence corroborated with the DTH reaction, showing that the 1,000 microgram dose cohort had a statistically significant increase -- or decrease -- or the millimeters of DTH was significant compared to the lower, less than 1,000 microgram dose cohort.

Okay. Okay. You should look at your press release, because you do have clinical response and complete response. So I apologize for my confusion, but it does exist in that press release. So -- thanks. Oh, if I could --

Is that -- Mara, is this for 301 or 401?

301.

Just -- just -- okay.

So. And if I could just ask a financial question on the financing vehicle with Lincoln Park. I think that there was a set amount in that $50 million or so. So, can you just let us know how much you have -- what is left in that funding vehicle?

Sure, Mara. This is Ryan. Thanks for the question. We have about $42 million left on the Lincoln Park --.

Okay, thank you.

You bet.

Jason Kolbert.

It's actually Jason McCarthy for Jason Kolbert. Just kind of a broad question. We see Galena, you're looking at -- you have a fully enrolled or over-enrolled, actually, PRESENT trial for NeuVax. You have several other vaccine studies going on.

Could you guys elaborate a little bit on the potential of expanding the NeuVax and the vaccine platform possibly as a combination studies with like a checkpoint modulator, or even with a partner? And the reason I'm asking is that we are beginning to see more of the big pharma companies gravitating to cancer vaccines, almost like they gravitated to CAR T. And we think that's a space -- the vaccine space, in particular, is very undervalued right now, relative to the CAR T space. And it might be starting to catch up. And I just wondered if that's something that you guys are thinking about?

So, Jason, I would agree with you that it's very undervalued. So I think we have a common vision there. And thanks for the question. The short answer is yes. We are very actively looking at -- in fact, if you go to slide 11 in the presentation, if you happen to be in front of your computer -- we are very actively engaged in discussions with different folks to understand what the possibilities are in terms of using NeuVax across the range of settings.

In particular, let's talk about breast cancer, although we could certainly go into any HER2 expressing solid tumor. But we are very active in investigating the opportunities for NeuVax in combination with immune modulators, whether it's a checkpoint inhibitor or another immune modulator moving down -- downstream into the metastatic area, or moving, I guess, what you might call upstream or earlier into the cancer prevention side.

And so I can't -- there's nothing specific that I can talk to at the moment. But it is an area that's of very active interest to us. And we are working on opportunities that we can jump into here over the next period of time.

Oh, great. Yes, because we do see like the CAR T space -- yes, everything is moving toward solid tumors. You're already there with your vaccine for NeuVax. And we think that the heterogeneity of those tumors, it's going to be a stumbling block for CAR T. And this is where you could see vaccines maybe even in the next year start to break through and become a little bit more relevant, or a lot more relevant. And that was the reason for my question.

Because you do have data coming. It could be a critical inflection point for the Company. But thank you for taking my question.

Oh, you're welcome. And we agree with you completely. I think the T cell data of NeuVax and E39 could be very pivotal in a combination setting.

Great. Thanks, guys.

Rahul Jasuja, Global Life Science.

Thanks for taking my question. So just sticking with the combination approach for potentially NeuVax there, so as I understand it, I guess breast cancers are naturally immunogenic and they're PD1, PDL1 low. So, unless you're talking about triple negative, which doesn't really qualify for the HER2 high expressors. Could you comment on that?

And so -- Rahul, I'm sorry. Restate your question, because -- yes, I'm sorry, I didn't quite catch the key questions.

Yes, yes. No, absolutely. So it's very exciting that there is an opportunity here, as the previous caller said, to combine -- to look at combination study, just because in the context of the modern immunotherapy approach where you're reversing the NEO suppression, at in presentation and the vaccines would play a big part.

So in relevance to that, my question is for breast cancer in particular, HER2 expressing breast cancer, my understanding is that PD1 and PDL1 are not expressed, and therefore are not already highly expressed. Therefore, using a PD1 approach is not appropriate. But potentially using maybe a co-stimulator -- a T cell co-stimulator may work. Is that the right thinking there?

I think it is. I know that people have done a lot of work in looking at the PD1 and PDL1 markers. I don't know how consistently, though, that they have been indicative of the action of those compounds that, as a biomarker, I don't know that they always predicted the outcome of those inhibitors in various trials.

I think as NeuVax's ability to stimulate a significant T cell response, that any removal of the brakes, any added support we can give to that T cell activity could be enough to overcome the suppressive effect of even a very low expression of PD1, PDL1, could be very useful. I guess I'm not convinced that people really understand enough of the biology to know what's really going to work in each individual setting. Each tumor is different. The biology varies radically. The immune system adapts and changes. And while I think the checkpoint inhibitors have had a dramatic effect in melanoma, there is still a lot of biology we don't understand to know what the combination of these agents are really going to -- where they are going to result in success.

Fair enough. Yes. And there's more than just the PD1 and PDL1's that could sort of harness adaptive and innate immunity to help the vaccine studies. That's helpful.

Let me move on to Zuplenz now. And just to get some clarification there, really the major thrust for CINV, at least, is driven by intravenous antiemetic drugs, 5HT-3 antagonist, or IV. How much of a play does the oral space have, which you are in? And also, the other part of my question is, it's for acute and for -- sorry, it's for HEK and for MEK. Is it also for delayed (inaudible)-- is part of a delayed regimen too?

So thank you for the questions. This is Chris. You're correct on the intravenous market. If you separated out the 5-HT3 market, the overall market in the branded segment is around $1.1 billion, $1.2 billion. $1 billion of that is made up by the injectables, which leaves roughly $100 million in the oral or non-injectable segment. So Zuplenz will play in that space. But it could also be used with the injectable products as well. And there's another $5 billion sitting out in the generic space as well. So the product has opportunity to pull market share from each of those segments.

Okay. And then Zuplenz would be used, at least in the HEK setting, I would think, in combination with dexamethasone and NK-1 receptor antagonist? Right?

That is correct.

Okay. Great. That's all I had, guys. Thanks.

There are no other questions in the queue. I will now turn it back over to Mark Schwartz.

Thank you very much, everybody. Appreciate your time this evening, and look forward to talking to you next quarter.

Ladies and gentlemen, that concludes today's conference. You may now disconnect.