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Edited Transcript of SNSS earnings conference call or presentation 7-May-20 8:30pm GMT

·12 min read

Q1 2020 Sunesis Pharmaceuticals Inc Earnings Call SOUTH SAN FRANCISCO May 14, 2020 (Thomson StreetEvents) -- Edited Transcript of Sunesis Pharmaceuticals Inc earnings conference call or presentation Thursday, May 7, 2020 at 8:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Dayton Misfeldt Sunesis Pharmaceuticals, Inc. - Principal Financial Officer, Secretary, Interim CEO & Director * Judith A. Fox Sunesis Pharmaceuticals, Inc. - Chief Scientific Officer and Executive VP of Research & Development * Parvinder S. Hyare Sunesis Pharmaceuticals, Inc. - SVP of Commercial ================================================================================ Conference Call Participants ================================================================================ * Justin Alexander Kim Oppenheimer & Co. Inc., Research Division - Associate * Marc Alan Frahm Cowen and Company, LLC, Research Division - Director ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Ladies and gentlemen, thank you for standing by, and welcome to the Quarter First 2020 Sunesis Pharmaceuticals, Inc. Earnings Conference Call. (Operator Instructions) I would now like to hand the conference over to your speaker today, Mr. Par Hyare. Please, sir, go ahead. -------------------------------------------------------------------------------- Parvinder S. Hyare, Sunesis Pharmaceuticals, Inc. - SVP of Commercial [2] -------------------------------------------------------------------------------- Welcome, everyone, and thank you for joining us. With me today are Dayton Misfeldt, interim CEO; and Judy Fox, CSO, EVP, Research and Development. Dayton will review recent corporate events, Judy will provide more details on our pipeline, and then Dayton will provide a brief financial overview of the first quarter of 2020. We will then open the call for questions for which we will all be available. Before we begin, let me remind you that today's conference call, we will be making forward-looking statements that represent the company's intentions, expectations or beliefs concerning future events. These forward-looking statements are qualified by important factors set forth in today's press release and company's filings with the SEC, which could cause actual results to materially differ from those in such forward-looking statements. Information discussed on today's call is accurate as of today and we do not intend to update. With that, let me turn the call over to Dayton. -------------------------------------------------------------------------------- Dayton Misfeldt, Sunesis Pharmaceuticals, Inc. - Principal Financial Officer, Secretary, Interim CEO & Director [3] -------------------------------------------------------------------------------- Thanks, Par. Good afternoon, and thank you for joining us. First and foremost, we hope everyone is staying healthy, and we would like to extend our gratitude to everyone who's working so hard to address the COVID-19 pandemic both on the front lines as well as those working to develop treatments and vaccines. We are working in unprecedented times, presenting us and companies around the globe with unique challenges. At Sunesis, we are prioritizing the safety of our employees and the patients in our ongoing vecabrutinib trial while maintaining business continuity. As you know, shelter-in-place orders were mandated in the San Francisco Bay Area in mid-March, and as such, our employees have been working from home. And we have worked closely with our sites and CRO to ensure that our Phase Ib/II vecabrutinib trial activities are in line with the FDA issued guidance on the conduct of clinical trials during this pandemic. Throughout this time, we continue to make progress on both our vecabrutinib and PDK1 programs. We still expect initial response assessments for the 500-milligram cohort in the Phase Ib study of vecabrutinib this quarter as well as follow-up assessments from patients from lower dose cohorts who remain on treatment. However, there is potential for delays in vecabrutinib development due to the impact from COVID-19 that we will work to address. We will assess next steps and provide updates as the COVID-19 situation evolves and data from the Phase Ib portion of the trial emerge. We continue to advance our proprietary PDK1 inhibitor, SNS-510. In March, we reported encouraging results from an in vitro combination study indicating that SNS-510 can combine synergistically with several drug classes. We are completing IND-enabling studies for SNS-510 with a target to file an IND by the end of 2020. With that, I will turn the call over to Judy to go into more detail on our current progress. -------------------------------------------------------------------------------- Judith A. Fox, Sunesis Pharmaceuticals, Inc. - Chief Scientific Officer and Executive VP of Research & Development [4] -------------------------------------------------------------------------------- Thanks, Dayton. We are currently in the seventh cohort of the Phase Ib/II trial of vecabrutinib. 7 patients are on treatment across 3 cohorts, 300, 400 and 500 milligram. We see evidence of clinical benefit. And as Dayton mentioned, we will have results of the 500-milligram cohort first response assessment this quarter. In the 300-milligram cohort, stable disease was observed in 3 of 5 patients. One CLL patient is continuing on treatment and is currently completing cycle 10. This patient had a second response assessment of stable disease with a 47% reduction in tumor burden improving from their initial 41% reduction in normalized hem parameters. The patient is currently scheduled for a third response assessment in June. In cohort 6, 2 of the 3 CLL patients have stable disease upon first response assessment, including a patient with a 48 reduction in tumor burden. One patient has aggressive disease that remains on treatment by investigator request as the patient is receiving benefits. All 3 patients remain on treatment and are in cycle 7. We expect second response assessment for the cohort to be available this quarter. In cohort 7, the 500-milligram cohort, 6 patients, 4 with CLL and 2 with mantle cell lymphoma, cleared the safety evaluation period, and 3 of these patients remain on treatment. Vecabrutinib has been very well tolerated in the higher dose levels, and we have seen an increase in exposure, and decreases in cytokines remain consistent. Of note, patients in the higher-dose cohorts 300 mgs to 500 milligrams have generally stayed on treatment longer than those in the lower-dose cohorts. We have taken actions to respond to the challenges posed by the COVID-19 pandemic. Patient safety and trial conduct are paramount, and we are taking the appropriate steps to ensure our study meets these aims. COVID-19 has necessitated changes based on protocols implemented at sites that minimize risk to patient and site personnel. Some study visit assessments are being conducted locally and by telemedicine. Site staff are working remotely as possible, and remote study monitoring has been implemented. There are accommodations for study drug distribution directly to patients from sites rather than requiring patients to come in to receive drugs. Remote visits have had an impact on timeliness of data collection, and we are working with sites to address these challenges. As we receive additional clinical data from the Phase Ib study, we will evaluate next steps in conjunction with how the pandemic evolves. We will be providing updates as we move forward. Turning to our other program. SNS-510 is a novel potential first-in-class inhibitor of PDK1, a target of long-standing interest in the oncology community. SNS-510's interaction with PDK1 inhibits both PI3K signaling and PI3K independent pathways integral to many malignancies. And PDK1 can also be overexpressed in breast, lung, prostate, hematologic and other cancers. We recently reported that tumors with mutations or deletions in the CDKN2A gene were particularly sensitive to SNS-510 in vitro. Aberrations in CDKN2A are associated with many different cancer types. SNS-510 also shows synergistic activity when combined with inhibitors of CDK46, KRAS G12C, RBCL2 in breast cancer, KRAS mutant and lymphoma cell lines. We are progressing SNS-510 through the IND-enabling program and are in discussions with a number of KOLs as we establish preclinical collaborations to further characterize SNS-510 and develop clinical plans for solid tumor and hematologic malignancies. The investigators we approached have universally expressed enthusiasm for the program, and we look forward to assembling our clinical advisory boards in the coming months. We plan to present preclinical findings in the second half of the year. I will now turn the call over to Dayton to review financial results. -------------------------------------------------------------------------------- Dayton Misfeldt, Sunesis Pharmaceuticals, Inc. - Principal Financial Officer, Secretary, Interim CEO & Director [5] -------------------------------------------------------------------------------- Thank you, Judy. In the first quarter, we continued vecabrutinib and SNS-510 development while operating within our budget. Cash used in operating activities was $5.7 million in the first quarter of 2020 as compared to $6.1 million for the same period in 2019, resulting primarily from the net loss of $5.8 million and changes in operating assets and liabilities. Our cash position at the end of the first quarter was $28.9 million sufficient to get us through our next milestones. As you may have seen, our Chief Financial Officer, Willie Quinn, left the company recently to pursue another opportunity. We thank him for his efforts here at Sunesis and wish him the best of luck in his future endeavors. Our existing leadership team remains strong, and we have appointed Tina Gullotta as our principal Accounting Officer and promoted her to Vice President, Finance. Tina joined Sunesis nearly 2 years ago with extensive experience in accounting and finance in the biotech industry. I would like to conclude these remarks, acknowledging the industry-wide impact of COVID-19, and I am proud of the flexibility and commitment that our entire team has demonstrated to maintain business continuity during this unprecedented time. With that, let's open the call to your questions. Operator? ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) Our first question comes from the line of Justin Kim from Oppenheimer. -------------------------------------------------------------------------------- Justin Alexander Kim, Oppenheimer & Co. Inc., Research Division - Associate [2] -------------------------------------------------------------------------------- The progress on escalation seems to be trending well, and we're certainly looking forward to the initial scans at 500 mgs. But before you sort of get those results, I was just sort of curious. I appreciate the need to progress the study once reaching a clinically effective dose. But are there any paths by which you would be able to expand the study while also exploring further dose escalation, either through sort of protocol changes that enable escalation or additional cohort? -------------------------------------------------------------------------------- Dayton Misfeldt, Sunesis Pharmaceuticals, Inc. - Principal Financial Officer, Secretary, Interim CEO & Director [3] -------------------------------------------------------------------------------- Yes. No, thanks for your question. I'll have Judy answer that. -------------------------------------------------------------------------------- Judith A. Fox, Sunesis Pharmaceuticals, Inc. - Chief Scientific Officer and Executive VP of Research & Development [4] -------------------------------------------------------------------------------- Yes. Thanks for the question. So the protocol, as it currently stands, allows us to expand 1 or more dose cohorts to confirm a recommended dose. And we have made plans if the decision is made to allow for dose escalation. So we have amended the protocol. -------------------------------------------------------------------------------- Justin Alexander Kim, Oppenheimer & Co. Inc., Research Division - Associate [5] -------------------------------------------------------------------------------- Okay. Great. And then maybe can you just walk us through the dose expansion process and what work might need to be done follow identification of the Phase II dose, whether it's sort of increasing the number of clinical sites. I know currently, there's 11 listed. Any IRB approvals, et cetera? -------------------------------------------------------------------------------- Judith A. Fox, Sunesis Pharmaceuticals, Inc. - Chief Scientific Officer and Executive VP of Research & Development [6] -------------------------------------------------------------------------------- Yes. So we currently have 11 sites, and we feel that's enough to complete a dose expansion. So all that's really required to go to that step would be to hold a safety review committee meeting with our investigators and get approval to expand and at what doses that expansion might occur. -------------------------------------------------------------------------------- Justin Alexander Kim, Oppenheimer & Co. Inc., Research Division - Associate [7] -------------------------------------------------------------------------------- Okay. Got it. And then my last question is just maybe on sort of the patient baseline characteristics. For those that weren't included in the ASH update, can you give us a sense of maybe the baseline characteristics of the recent -- more recently added patients whether by disease severity or prior lines of treatment? Maybe on a high level, were they more or less consistent with the prior population? -------------------------------------------------------------------------------- Judith A. Fox, Sunesis Pharmaceuticals, Inc. - Chief Scientific Officer and Executive VP of Research & Development [8] -------------------------------------------------------------------------------- So we'll give more details on patient population. We did note that we had or have 4 CLL and 2 MCL patients. And we've seen a similar mix of a few patients that are more heavily pretreated and then a number of patients who are less heavily pretreated. -------------------------------------------------------------------------------- Operator [9] -------------------------------------------------------------------------------- Our next question comes from the line of Marc Frahm from Cowen. -------------------------------------------------------------------------------- Marc Alan Frahm, Cowen and Company, LLC, Research Division - Director [10] -------------------------------------------------------------------------------- Maybe just to follow up on that last one. You mentioned the protocol has been amended to potentially allow higher doses. I guess first, what doses are now contemplated within the protocol? And then second, I guess, what will you be looking for from cohort 7 that would mature you to want to pursue those higher doses? -------------------------------------------------------------------------------- Judith A. Fox, Sunesis Pharmaceuticals, Inc. - Chief Scientific Officer and Executive VP of Research & Development [11] -------------------------------------------------------------------------------- Yes. I think a few clarifications. So the protocol will need to go through some additional processes in order to open an additional cohort, but we're in that process. I think when we see the data and have the discussion with the investigators, we'll better understand whether escalation is warranted. Certainly, the safety profile would support additional dose exploration if that's what we choose to do. Did I answer everything? Was there more to your question? Sorry. -------------------------------------------------------------------------------- Marc Alan Frahm, Cowen and Company, LLC, Research Division - Director [12] -------------------------------------------------------------------------------- Yes. Well, I guess, what's kind of the scenario that would lead you to want to go higher? Is it that you've seen -- do you feel you need to see a response in cohort 7 to want to keep going further? Or is it just the fact that you've now -- I mean as you said in your prepared comments, you've seen increased exposures at Cohort 7, therefore, you pretty much want to go to a higher dose no matter what because you haven't capped out on exposure? -------------------------------------------------------------------------------- Judith A. Fox, Sunesis Pharmaceuticals, Inc. - Chief Scientific Officer and Executive VP of Research & Development [13] -------------------------------------------------------------------------------- Yes. I think it's going to be a number of different factors that will feed into any decision to dose escalate. And I think some of that will be from us, and some of that will come from discussion with investigators. So it's not -- there aren't definitive criteria at the moment. -------------------------------------------------------------------------------- Operator [14] -------------------------------------------------------------------------------- There are no further questions at this time. Please continue. -------------------------------------------------------------------------------- Parvinder S. Hyare, Sunesis Pharmaceuticals, Inc. - SVP of Commercial [15] -------------------------------------------------------------------------------- Well, thank you, everyone, for participating on our call today. Stay well, and we look forward to providing an update on our vecabrutinib trials this quarter. Good afternoon. -------------------------------------------------------------------------------- Operator [16] -------------------------------------------------------------------------------- Thank you for participating on today's call. This concludes today's conference. You may now disconnect.