Infinity Pharmaceuticals Inc (INFI) 2018 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the Infinity Pharmaceuticals' conference call to discuss the company's financial results for the first quarter of 2018. My name is Jimmy and I'll be your operator for today's call. (Operator Instructions) Please be advised that this call is being recorded at Infinity's request.

Now I would like to introduce your host for today's call, Jayne Kauffman. Please go ahead.

Thank you, Jimmy, and good afternoon, everyone. Welcome to today's call to discuss our recent business progress and review of our first quarter 2018 financial results. With me here today are: Adelene Perkins, Chief Executive Officer; Larry Bloch, President; and Dr. Jeff Kutok, our Chief Scientific Officer. The press release, issued this afternoon, details our results, and is available on our website at infi.com.

Please note that during this call, we make forward-looking statements about our future expectations and plans, including clinical development objectives, the therapeutic potential of our product candidates, our strategic plans and strategies and financial projections. Our actual results may differ materially from what we project today, due to a number of important factors, including the considerations described in the Risk Factors section of our quarterly report on Form 10-Q for the first quarter 2018 and in other filings we make with the SEC. These forward-looking statements represent our views only as of today, and we caution you that we may not update them in the future, whether as a result of new information, future events or otherwise.

Now I would like to turn the call over to Adelene.

Good afternoon, everyone. Today we're pleased to report on our continued progress at Infinity, including the development we are making with IPI-549, our first-in-class oral selective PI3-kinase-gamma inhibitor. IPI-549 targets and plays a unique role in reprogramming macrophages from pro-tumor to an anti-tumor function, thus, reducing immune-suppression and increasing immune-activation. We are evaluating IPI-549, both as a monotherapy and in combination with nivolumab, a PD-1 immune checkpoint inhibitor, in a robust Phase Ib clinical study in approximately 200 patients with advanced solid tumors.

We're very encouraged by the IPI-549 monotherapy data we shared at the Society of Immunotherapy in Cancer, or SITC, meeting in the fourth quarter last year, which demonstrated 3 important features of IPI-549. First, IPI-549 is clinically active as a monotherapy, having shown an objective and durable response in a patient with mesothelioma. This is significant as aside from checkpoint inhibitors, very few immuno-oncology agents have demonstrated the ability to achieve an objective response as a monotherapy. Second, IPI-549 is very well tolerated with the maximum tolerated dose having not been reached as a monotherapy. Third, IPI-549's activities on mechanism. We showed in our monotherapy dose escalation data at SITC that IPI-549 decreases pro-tumor immune suppression and increases antitumor immune activation. This is particularly meaningful given the heavily pretreated and heterogeneous nature of the all-comer solid tumor patient population treated in this portion of the trial.

At ASCO, we will share initial data from the monotherapy expansion portion of the trial, which includes pre-treatment and on-treatment biopsies, to evaluate IPI-549's induced changes in the tumor microenvironment. This monotherapy translational data will provide a valuable foundation for the evaluation of IPI-549-induced changes in patients in the combination expansion cohort. Our primary focus at ASCO will be on the combination dose escalation portion of the trial, which will be presented in a poster and associated poster discussion session on novel combination immune checkpoint therapies. At ASCO and throughout the remainder of 2018, we look forward to showing combination data that builds upon the 3 key features of IPI-549 demonstrated as a monotherapy.

First, that IPI-549 is active in combination therapy. And that, for patients who benefit from treatment with this combination, the benefit is durable. Durability is an important measure of the benefit of immuno-oncology therapies, particularly in an all-comer dose-escalation patient population where response rates cannot meaningfully assessed. Our combination cohort, with a more homogeneous patient population, will enable a more comprehensive assessment of patient benefit in the second half of 2018.

Second, that IPI-549 continues to be well tolerated in combination with nivolumab. This is particularly important given the expectation that immuno-oncology drugs will be most effective when administered as combination therapies.

Third, from a mechanism perspective, we look forward to sharing translational data that supports the complementary nature of the mechanisms of IPI-549 and PD-1 inhibition.

At ASCO, we will also share initial data from patients enrolled in the combination expansion cohort, which were initiated in early 2018 in 6 pre-defined disease-specific patient population. These cohorts are enrolling well and we expect to have mature data from these patients in the second half of the year.

Furthermore, in the second half of this year, we look forward to reporting data from a cohort of 20 patients pre-screened for high baseline blood levels of myeloid-derived suppressor cells or MDSCs, which opens for enrollment at the end of the first quarter.

Finally, all 7 combination expansion cohorts require a mandatory pre-treatment and on-treatment biopsies, which will allow us to develop and correlate clinical and translational insights across several distinct hypotheses, which Jeff will now detail.

Thank you, Adelene. In addition to Adelene's summary of the data we expect to show at ASCO next month, we are also looking forward to reporting more data on the combination expansion cohort, and particularly, the data from the MDSC high cohort in the second half of this year. Taking together, these cohorts evaluate several distinct and exciting hypotheses of IPI-549 in combination with nivolumab.

One hypothesis is based on our preclinical studies that demonstrated IPI-549's ability to overcome resistance to checkpoint blockade. This is being tested in 3 distinct cohorts in patients with non-small cell lung cancer, melanoma and head and neck cancer that have documented progression on a PD-1 and PD-L1 inhibitor in their most recent cryotherapy.

Another hypothesis that is being evaluated is IPI-549's ability to enhance the response to checkpoint inhibition in indications where checkpoint inhibition has had limited activity. This is being tested in patients with triple-negative breast cancer , who have not previously been exposed to checkpoint inhibitors.

In addition, we are seeking to confirm IPI-549 activity from clinical signals we have seen in our dose-escalation studies by expanding in patients with mesothelioma, adrenocortical carcinoma and high baseline blood levels of MDSCs, which are known to suppress immune responses.

The cohort of patients being screened for high MDSCs is significant for 3 reasons: First, high pretreatment levels of MDSCs are correlated with poor response to checkpoint inhibitor therapy. Second, IPI-549 can reduce MDSCs in patients. An in vitro data shows that IPI-549 can overcome the suppressive effects of MDSCs on T-cells. Third, translational data from the IPI-549 dose escalation cohorts suggested an association between high baseline MDSCs and response to IPI-549, both alone and in combination with nivolumab.

In addition to high MDSCs as an enrollment criteria in this cohort. We are also evaluating MDSCs in the disease-specific cohorts, such that we expect to have data on the MDSC levels in approximately 100 patients to correlate with patient benefit later this year.

Importantly, we will be able to evaluate the relationship between MDSCs in the blood and tumor-associated macrophages in biopsies across multiple tumor types.

We have a significant opportunity with IPI-549, which represents a novel approach within immuno-oncology and is the only selective PI3K-gamma inhibitor in clinical development.

The infinity team and our investigators are advancing the clinical development of IPI-549 with a great sense of urgency to bring this potentially transformative treatment forward for patients.

With that, I'll turn the call over to Larry.

Thank you, Jeff. As you can see, 2018 will be a year of important progress for Infinity and IPI-549, made possible by extraordinary commitment by the team at Infinity, the dedicated investigators and staff at our sites, patients who have enrolled in the trial and the families as well as continued support from the shareholders. From a financial perspective, we are pleased to have extended our cash runway from the first quarter 2019 into the third quarter 2019, thereby enabling and ensuring that we have the key resources in place to execute our development plan for IPI-549.

As of March 31, 2018, we had total cash, cash equivalents and available-for-sale securities of $47.8 million compared to $57.6 million at December 31, 2017.

R&D expense for the first quarter of 2018 was $5.9 million compared to $4 million for the same period in 2017. The increased R&D expense was primarily due to higher clinical development expenses for IPI-549.

General and administrative expense was $3.6 million for the first quarter of 2018 compared to $6.4 million for the same period in 2017. The decrease in G&A expense was primarily due to reduction in bonus and stock compensation.

Net loss for first quarter of 2018 was $9.5 million, or basic and diluted loss per common share of $0.18, compared to net loss of $10.5 million, or basic and diluted loss per common share of $0.21 to the same period in 2017.

Our 2018 financial guidance remains unchanged. We expect 2018 net loss to range from $35 million to $45 million, and we expect to end 2018 with cash, cash equivalents and available-for-sale securities balance ranging from $15 million to $25 million.

Based on our current operating plans, which exclude additional funding for business development activities, we anticipate our existing cash, cash equivalents and available-for-sale securities will provide cash runway into the third quarter of 2019.

We should deliver important data from several distinct clinical hypotheses being evaluated in our approximately 200-patient Phase Ib clinical study of IPI-549 within our current cash runway.

Importantly, this cash runway does not include the potential $22 million payment from Verastem, upon the first regulatory approval of duvelisib, which was recently given high review by the FDA with a PDUFA date of October 5, 2018. This cash runway also does not include a potential $2 million payment from PellePharm, a private company, upon initiation of a Phase III study for the hedgehog inhibitor program, which we licensed to them in 2013.

With continued rigorous financial management and potential duvelisib approval milestone, we expect our cash runway to extend into 2020.

We're very pleased with the progress we've made so far with IPI-549, and we look forward to updating you throughout the year as we report safety and activity data from the program.

At this time, we can open the call for questions. Operator?

(Operator Instructions) Our first question comes from Katherine Xu with William Blair.

This is Audrey on for Katherine. I just had a couple of quick follow-ups about what we might see at ASCO. Could you let us know, like, how many patient and at which dose levels we'll see for the combination dose-escalation cohort? And then from the 6 disease-specific combination expansion cohort, like, how much might we expect to see there?

Sure, Audrey. So we have in the combination dose-escalation a total of 31 patients who are enrolled that we'll be reporting on. And on the combination expansion cohort, one of the key things we'll be sharing is what the enrollment is, what -- which of those 6 specific -- disease-specific cohorts, what the status of enrollment is. Because we're actively enrolling now, many of those patients will not yet have reached their first assessment point. But we'll provide data on how many patients are on study by cohort.

And for the MSDC high, I know you guys just started enrolling that.

Yes. We -- we've provided guidance, we will not have because we've just began enrollment. We won't have data on those patients. We can tell you though, that we have begun screening patients and we have several who have satisfied the criteria for having MDSC -- high circulating baseline levels of MDSCs who are now continuing matriculating through the rest of the screening process. So...

You -- I don't know, if you can share, like, what types of patients, like, what types of cancers those might...

Not for that MDSC high cohort. That's still very early.

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

Thank you, Jimmy. We're excited about the opportunity we have with IPI-549, and we look forward to updating you throughout the year. Have a good day, everyone, and thanks for joining the call today.

Ladies and gentlemen, this does conclude your program and you may all disconnect. Everyone, have a great day.