Q4 2021 Panbela Therapeutics Inc Earnings Call
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Good day, ladies and gentlemen, and welcome to the PANBELLA 4th Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode, and the floor will be open for your questions and comments following the presentation.
Good day, ladies and gentlemen, and welcome to the Penn below fourth quarter 2021 earnings call. At this time all participants are in a listen only mode and the floor will be opened for your questions and comments. Following the presentation. It is now my pleasure to turn the floor over to your host James Carbonara, Sir the floor is yours.
It is now my pleasure to turn the floor over to your host, James Carbonara. Sir, the floor is yours.
Thank you and once again welcome to <unk> fourth quarter 2021 earnings call with me on the call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath Chief Financial Officer.
James Carbonara: Thank you and once again welcome to Panbello's fourth quarter 2021 earnings call. With me on the call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath, Chief Financial Officer. Before I turn the call over
Before I turn the call over to Dr. Simpson. Please note that statements made on this call that are not historical facts may be forward looking statements.
James Carbonara: Please note that statements made on this call that are not historical facts may be forward-looking statements. Significant risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward-looking statements are detailed in the company's annual report on Form 10-K and supplemented by subsequently filed quarterly reports on Form 10-Q , as well as in other reports that the company has filed with the SEC.
Risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward looking statements are detailed in the Companys annual report on Form 10-K , and supplemented by subsequently filed quarterly reports on Form 10-Q as well as in other reports that the company has filed with the SEC.
James Carbonara: Any forward-looking statements made on this call are made only as of today's date, and the company does not undertake any obligations to update or supplement any such statements to reflect subsequent developments.
Any forward looking statements made on this call are made only as of today's date and the company does not undertake any obligations to update or supplement any such statements to reflect subsequent developments now I would like to turn the call over to Jennifer Simpson CEO 10 Bella Jennifer. Please proceed.
James Carbonara: Now, I would like to turn the call over to Jennifer Simpson, CEO of Panbella. Jennifer, please proceed.
Thank you everyone for joining I'll begin the call by touching on 2021 and recent significant accomplishments.
Jennifer Simpson: Thank you, everyone, for joining. I will begin the call by touching on 2021 and recent significant accomplishments.
Jennifer Simpson: Sue will then follow with a review of the financial results, and then we will open it up for Q&A.
She will then follow with a review of the financial results and then we will open it up for Q&A.
So starting with 2021 and recent highlights as many of you know most recently, we entered into a definitive agreement to acquire cancer cancer Prevention Pharmaceuticals incorporated or C. P. P for short.
Sue Horvath: Starting with 2021 and recent highlights, as many of you know, most recently, we entered into a definitive agreement to acquire Cancer Prevention Pharmaceuticals Incorporated, or CPP for short.
Speaker Change: The agreement consideration is a combination of stock and future contingent milestone payments that Sue will review in greater detail.
The agreement consideration, if a combination of stock and future contingent milestone payments that Sue will review in greater detail.
C. P. P is currently a private clinical stage company developing therapeutics to reduce the risks and recurrence of cancer and rare diseases.
Speaker Change: CPP is currently a private clinical stage company developing therapeutics to reduce the risk and recurrence of cancer and rare diseases.
Speaker Change: Initial areas of focus include familial abnominous polyposis or FAP and colorectal cancer prevention.
Initial areas of focus include familial adenomatous, polyposis or F N P and colorectal cancer prevention.
Speaker Change: The current lead asset for CPP is Flampovi, which is a combination of CPP1X, or a fluoroethene, and Sulindax, and it has a dual mechanism inhibiting polyimine synthesis and increasing polyimine export in catabolism.
The current lead asset for C. P. P is some tobey, which is a combination of CPP onex or floor thing and children back and you'll have the dual mechanism inhibiting timing synthesis and increasing timing export in catabolism.
Speaker Change: As a result of a 2021 North American License Agreement, CPP's FAP registration trial is fully funded and is scheduled to begin by year end.
As a result of a 2021 North American license agreement.
P. P. F E. P registration trial is fully funded and is scheduled to begin by year end.
In addition, a phase III trial in colon cancer survivors is currently underway and is sponsored by the southwest oncology group or swaps.
Speaker Change: In addition, a phase three trial in colon cancer survivors is currently underway and is sponsored by the Southwest Oncology Group or SWOG.
Speaker Change: Several other clinical trials in neuroblastoma, gastric cancer, and early-onset type 1 diabetes are underway in collaboration with various cooperative groups.
Several other clinical trials in neuroblastoma gastric cancer and early onset type one diabetes are underway in collaboration with various cooperative groups.
The combined company will have a much larger pipeline targeting approximately a $5 billion aggregate market opportunity for the areas of initial focus.
Speaker Change: The combined company will have a much larger pipeline targeting approximately a $5 billion aggregate market opportunity for the areas of initial focus. Those include
Those include F E P.
First line metastatic pancreatic cancer Neo adjuvant pancreatic cancer colorectal.
Speaker Change: first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention, and ovarian cancer.
Cancer prevention and ovarian cancer.
With the combined development programs, we will be poised to have a consistent stream of catalysts and news events with programs raging ranging from preclinical to registration studies under the guidance of a veteran management team with a demonstrated track record of drug discovery development and commercialization expertise.
Speaker Change: With the combined development programs, we will be poised to have a consistent stream of catalysts and news events with programs ranging from preclinical to registration studies under the guidance of a veteran management team with a demonstrated track record of drug discovery, development, and commercialization expertise.
Speaker Change: Moreover, acquiring CPP significantly advances our mission of treating diseases where there is an unmet need through a diversified pipeline, addressing numerous targets and thus expanding the potential of the joint company.
Moreover, acquiring CPP significantly advances our mission of treating diseases, where there was an unmet need to a diversified pipeline.
Dressing numerous targets and thus expanding the potential of the joint company.
The combined platforms will be better positioned to treat more patients.
Speaker Change: the combined platforms will be better positioned to treat more patients.
Speaker Change: The transaction is a strategic fit and we feel drives shareholder value.
The transaction is a strategic fit and we feel drive shareholder value.
About a month prior to announcing C. P. P. So at the end of January here in 2022, we announced the initiation of our global randomized trial.
Speaker Change: About a month prior to announcing CPP, so at the end of January here in 2022, we announced the initiation of our global randomized trial.
Speaker Change: This trial is a randomized, double-blind, placebo-controlled trial for SBP 101 in combination with gemcitabine and nabpaclitaxel versus gemcitabine, nabpaclitaxel, and placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma, and is referred to as the ASPIRE trial.
This trial is a randomized double blind placebo controlled trial for SPP, one O one.
In combination with <unk> and Nab Paclitaxel.
<unk> jumped vitamin Nab pocket, Nab paclitaxel and placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma and is referred to as the aspire trial.
The primary endpoint is overall survival with a futility analysis evaluating progression free survival or PFS at 104 events.
Speaker Change: The primary endpoint is overall survival with a futility analysis evaluating progression-free survival, or PFS, at 104 events.
Speaker Change: If the futility analysis is passed, the trial expands to allow for additional subjects so that the full trial could serve for registration.
If the futility analysis of past the trial expands to allow for additional subjects. So that the full trial could serve for registration.
Speaker Change: We are seeking to conduct a trial at leading cancer centers in the United States, Europe , and the Asia Pacific region.
We are seeking to conduct the trial at leading cancer centers in the United States, Europe , and the Asia Pacific region.
Speaker Change: This Phase 2-3 trial is designed as a Phase 3 trial, but with an interim Phase 2 look to assess whether the experimental treatment is active enough to continue the trial to its Phase 3 sample size.
This phase two three trial is designed as a phase III trial, but with an interim phase two look to assess whether the experimental treatments. It's active enough to continue the trial to a phase III sample size.
Speaker Change: We believe the primary advantage of a Phase 2-3 trial over a separate Phase 2 and Phase 3 trial is speed and resource mitigation, and that the Phase 2 patients can be included in the Phase 3 analysis, and one does not have to wait for the Phase 3 protocol development after the Phase 2 results become available.
We believe the primary advantage of a phase two three trial over a separate phase II and phase III trial is speed and resource mitigation and that the phase two patients can be included in the phase III analysis, and one does not have to wait for the phase III protocol development. After the phase II results become available.
Stomach cancer centers in Spokane, Washington was the first clinical site activated with Doctor Arvin Chowdhry, serving as principal investigator.
Speaker Change: Stomach Cancer Centers in Spokane, Washington was the first clinical site activated with Dr. Arvind Chaudhary serving as its principal investigator.
Speaker Change: Approximately 60 to 70 additional sites are expected to be activated in 2022.
Approximately 60 to 70 additional sites are expected to be activated in 2022.
Speaker Change: We have commenced screening for eligible patients, with enrollment expected to complete in approximately 12 months after the first patient enrolled.
We have commenced screening for eligible patients with enrollment expected to complete in approximately 12 months after the first patient enrolled.
Supporting the advancement into the phase two three aspire trial with data announced from our Phase <unk> study at the <unk> annual meeting in 2021 and more recently in January of 2022 at the ESMO Gi meeting.
Speaker Change: Supporting the advancement into the Phase 2, 3 ASPIRE trial was data announced from our Phase 1b study at the ASCO annual meeting in 2021 and more recently in January of 2022 at the ASCO GI meeting.
Interim data from cohort foreign expansion showed an objective response rate of 48% and a median overall survival of 12 months, which at the time of the poster presentation was not yet final.
Speaker Change: Interim data from Cohort 4 and the expansion showed an objective response rate of 48 percent and a median overall survival of 12 months, which at the time of the poster presentation was not yet final.
Speaker Change: Both exceeded historical rates reported for gemcitabine and nabpaclitaxel and supports the continued development of SCP 101 as an addition to first-line treatment for metastatic pancreatic cancer and also for neoadjuvant treatment for patients with potentially resectable disease.
Both exceeded historical rates reported for Gen <unk> and Nab Paclitaxel and supports the continued development of SPP. One O. One as an addition to first line treatment for metastatic pancreatic cancer and also for neo adjuvant treatment for patients with potentially resectable disease.
Since the poster presentation. The median overall survival has reached has been reached at 12.53 months.
Speaker Change: Since the poster presentation, the median overall survival has been reached at 12.53 months.
Speaker Change: This is four months longer than what is typically seen with gemcitabine and nabpaclitaxel.
This is four months longer than what is typically seen with Jim <unk> and Nab Paclitaxel. While this data from our phase one trial. This increase an objective response rate and median overall survival is encouraging.
Speaker Change: While this data is from a phase one trial, this increase in objective response rate and median overall survival is encouraging.
Speaker Change: Lastly, we also have had patients who have demonstrated long-term survival with two patients from Cohort 2, one of which achieved 30.3 months and final and 33 months and still alive.
Lastly, we also have had patients who have demonstrated long term survival with two patients from cohort two one of which achieved 30.3 months and final and 33 months and still alive. There are seven patients one from cohort two and six from cohort foreign expansion that are still in survival follow up.
Speaker Change: There are seven patients, one from cohort two, and six from cohort four in the expansion that are still in survival follow-up.
Speaker Change: We are excited to continue development of SCP-101 and our global randomized phase 2-3 study in metastatic pancreatic cancer, which I spoke about earlier.
We are excited to continue development of S. C. P. One to one and our global randomized phase three study in metastatic pancreatic cancer, which I spoke about earlier.
In addition to SPP one on ones promise in pancreatic cancer, we believe it could be a treatment option for other cancers as well.
Speaker Change: In addition to SBP 101's promise in pancreatic cancer, we believe it could be a treatment option for other cancers as well.
Speaker Change: Thus, early in 2021, we announced a research agreement with the Johns Hopkins University School of Medicine.
Thus early in 2021, we announced a research agreement with the Johns Hopkins University School of Medicine the.
Speaker Change: The collaboration's intended focus was on the further development of PAMBELLA's investigative agent, SCP-101, including activity in cell lines outside of pancreatic cancer, evaluating possible biomarkers which can form diagnostics, and potential combination with.
The collaborations intended focus was on the further development of <unk> investigative agent S. P. P. One O one.
Including activity in cell lines outside of pancreatic cancer.
<unk> possible, my Biomarkers, which can form diagnostics.
And potential combination with checkpoint inhibitors.
Speaker Change: In December , we were pleased to announce positive preclinical data supporting the activity of SVP 101 in ovarian cancer cell lines.
In December we were pleased to announce positive preclinical data supporting the activity of SPP, one O one in ovarian cancer cell line.
We expect to launch a development effort for S. P. P. One O one in ovarian cancer in the first half of this year.
Speaker Change: We expect to launch a development effort for SCP-101 in ovarian cancer in the first half of this year.
Speaker Change: The preclinical results illustrate SCP-101's potential to expand into another area of high unmet need.
The preclinical results illustrate SVP wanna ones potential to expand into another area of high unmet need.
Speaker Change: According to the American Cancer Society, ovarian cancer was the fifth leading cause of cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.
According to the American cancer Society, ovarian cancer with the fifth leading cause of cancer deaths among women accounting for more deaths than any other cancer of the female reproductive system.
In fact, the European Society for medical oncology or ESMO has stated that ovarian cancer represents a significant unmet need and gynecologic cancers.
Speaker Change: In fact, the European Society for Medical Oncology, or ESMO, has stated that ovarian cancer represents a significant unmet need in gynecologic cancers with the absence of a well-defined screening program or programs and inconsistent initial symptoms leading to late diagnosis in most patients.
With the absence of a well defined screening program or programs and inconsistent initial symptoms leading to late diagnosis most patients.
Speaker Change: Considered largely incurable, ovarian cancer typically relapses within three years in 80% of women.
Considered largely incurable ovarian cancer typically relapses within three years and 80% of women.
Speaker Change: with subsequent recurrence arising sooner each time as resistance to chemotherapy develops.
With subsequent recurrence of rising sooner each time is resistant to chemotherapy develops there.
Speaker Change: Therefore, it is vital to progress potential new therapies such as SCP-101 for ovarian cancer.
Therefore, it is vital to progress potential new therapies, such as SVP, one O one for Varian cancer.
Yeah.
Speaker Change: We recently issued a press release that an abstract for SBP 101 had been accepted for poster presentation at the American Association for Cancer Research, or AACR, which will be held April 8th through the 13th of this year.
We recently issued a press release that an abstract for SPP. One O. One had been accepted for poster presentation at the American Association for cancer research or ACR, which will be held April eight through the 13th of this year.
Speaker Change: The work reflects the company's ongoing collaboration with Johns Hopkins University School of Medicine.
The work reflects the company's ongoing collaboration with Johns Hopkins University School of Medicine.
Before the end of 'twenty 'twenty. One we also completed the preclinical work necessary to begin a neo adjuvant trial.
Speaker Change: Before the end of 2021, we also completed the preclinical work necessary to begin a neoadjuvant trial.
Speaker Change: We are working with key opinion leaders to finalize the protocol and obtain the necessary institutional approvals to open this investigator-initiated trial in the second half of this year.
We are working with key opinion leaders to finalize the protocol and obtain the necessary institutional approval to open. This investigator initiated trial in the second half of this year.
Turning to intellectual property in 2021, we announced that we received an issue notification for covering a shorter synthesis of SPP. One O. One that provides many benefits, including the ability to manufacture product with a reduced lead time.
Speaker Change: Turning to intellectual property in 2021, we announced that we received an issue notification for covering a shorter synthesis of SBP 101 that provides many benefits, including the ability to manufacture product with a reduced lead time.
Speaker Change: quicker access to drug supply, which facilitates expansion into additional indications.
Quicker access to drug supply, which facilitates expansion into additional indications.
Speaker Change: and a potentially scalable, efficient, and cost-effective manufacturing process to implement as soon as we are ready to commercialize upon approval.
And Ah potentially scalable efficient and cost effective manufacturing process to implement as soon as we're ready to commercialize upon approval.
Also in terms of the balance sheet recall that in Q3 of 2021, we closed on a 10 million dollar underwritten bought deal offering of our common stock that capital has provided important resources to keep us on the path of further developing and expanding the application of SD 101 and dry.
Speaker Change: Also, in terms of the balance sheet, recall that in Q3 of 2021, we closed on a $10 million underwritten bought deal offering of our common stock. That capital has provided important resources to keep us on the path of further developing and expanding the application of SBP 101 and DRIVE shareholder values.
Shareholder value.
Speaker Change: Another 2021 highlight for us includes joining the Russell Micro-Cap Index.
Another 2021 highlight Prost includes joining the Russell Microcap index.
Speaker Change: Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.
At this point I would like to finish by reiterating our milestones.
Speaker Change: At this point, I would like to finish by reiterating our milestones.
In the first half of this year, we expect to announce the first patient enrolled in our aspire trial as well as expansion outside the U S.
Speaker Change: In the first half of this year, we expect to announce the first patient enrolled in our ASPIRE trial, as well as expansion outside the U.S.
Speaker Change: satisfaction of conditions and closing of the CPP acquisition.
Satisfaction of conditions and closing of the CPP acquisition.
Research call to review the ovarian cancer data in ovarian cancer treatment standards.
Speaker Change: research call to review the ovarian cancer data and ovarian cancer treatment standards.
Speaker Change: The final data from our Phase 1 Firstline Metastatic Pancreatic Cancer Study.
The final data from our phase one first line metastatic pancreatic cancer study.
Speaker Change: initiation of the ovarian cancer program for SCP-101, and in the second half of this year, we expect to open the neoadjuvant pancreatic cancer investigator-initiated trial.
Initiation of the ovarian cancer program for SPP, one on one and in the second half of this year, we expect to open the neo adjuvant pancreatic cancer investigator initiated trial.
Speaker Change: With the expected closing of the CPP transaction, we anticipate that additional milestones for 2022 will increase the flow of plan development activity and data.
With the expected closing of the CPP transaction, we anticipate that additional milestones for 2022, we will increase the flow of planned development activity and data.
In summary, we have made tremendous progress in 2021 and year to date, we are excited too.
Speaker Change: In summary, we have made tremendous progress in 2021 and year-to-date. We are excited to meet shareholder value in 2022 by executing against our stated milestones.
Our whole barrick shareholder value in 2022 by executing against our stated milestones.
Speaker Change: I will stop here and turn it over to Sue to review the financials.
I will stop here and turn it over to Sue to review the financials.
Thank you Jennifer.
General and administrative expenses were $1.3 million in the fourth quarter of 2021 compared to <unk> 9 million in the fourth quarter of 2020, the changes due to expenses, including legal and financial advisory fees associated with the acquisition of CPP.
Sue Horvath: General and administrative expenses were $1.3 million in the fourth quarter of 2021, compared to $0.9 million in the fourth quarter of 2020. The change is due to expenses, including legal and financial advisory fees associated with the acquisition of CPP.
Sue Horvath: Research and development expenses were $2 million in the fourth quarter of 2021, compared to $0.7 million in the fourth quarter of 2020.
Research and development expenses were $2 million in the fourth quarter of 2021 compared to <unk> 7 million in the fourth quarter of 2020 the.
Sue Horvath: The changes due primarily to increased clinical trial and manufacturing costs as we prepare to launch our randomized study in approximately 60 sites around the world.
The change is due primarily to increased clinical trial and manufacturing costs as we prepare to launch our randomized study in approximately 60 sites around the world.
Net loss in the fourth quarter of 2021 was $3 5 million or 26 cents per diluted share compared to a net loss of <unk> 9 million or nine cents per diluted share in the fourth quarter of 2020.
Sue Horvath: Net loss in the fourth quarter of 2021 was $3.5 million or $0.26 per diluted share compared to a net loss of $0.9 million or $0.09 per diluted share in the fourth quarter of 2020.
Sue Horvath: Total cash was $11.9 million as of December 31, 2021. Total current assets were $12.3 million, and current liabilities were $2.7 million as of the same date.
Total cash was $11 9 million as of December 31, 2021, total current assets were $12 3 million and current liabilities were 2.7 million as of the same date.
Sue Horvath: There was no debt on the balance sheet as of December 31st.
There was no debt on the balance sheet as of December 31st.
Looking to the cap table, we had $13 4 million of common shares outstanding at the end of the year and including shares reserved for options and warrants. We were at a total of 21 million shares. These shares reserved numbers include all outstanding equity awards, including stock options, which are high.
Sue Horvath: Looking to the cap table, we had $13.4 million of common shares outstanding at the end of the year. And including shares reserved for options and warrants, we were at a total of 21 million shares.
Sue Horvath: These shares reserved numbers include all outstanding equity awards, including stock options, which are held primarily by insiders, and all warrants to purchase common stock.
Primarily by insiders and all warrants to purchase common stock.
Turning briefly to additional details regarding the definitive agreement to acquire C. P. P.
Sue Horvath: Turning briefly to additional details regarding the definitive agreement to acquire CPP.
Sue Horvath: Under the terms of the agreement and plan of merger, the holders of CPP's outstanding capital stock immediately prior to the merger will receive shares of common stock of Pandela upon closing of the merger.
Under the terms of the agreement and plan of merger the holders of C. P. Pes outstanding capital stock immediately prior to the merger will receive shares of common stock of 10 Bella upon closing of the mergers.
Sue Horvath: On a pro forma and fully diluted basis, holders of Panbella Common Stock are expected to own approximately 59% of the post-merger holding company and holders of CPP securities, including converted indebtedness, are expected to beneficially own approximately 41% of the post-merger holding.
On a pro forma and fully diluted basis holders of pin Bella common stock are expected to own approximately 59% of the post merger holding company.
Holders of C. P P securities, including converted indebtedness are expected to beneficially own approximately 41% of the post merger holding company.
Sue Horvath: CPP stockholders will also be eligible to receive contingent payments totaling a maximum of $60 million from milestones and royalty payments associated with the potential approval and commercialization of the lead asset.
C. P. P. Stockholders will also be eligible to receive contingent payments totaling a maximum of $60 million from milestones and royalty payments associated with the potential approval and commercialization of our lead asset.
We expect to close by the second quarter of 22 subject to approval of the issuance of securities in this transaction by our stockholders and satisfaction of other customary closing conditions.
Sue Horvath: We expect to close by the second quarter of 22, subject to approval of the issuance of securities in this transaction by our stockholders and satisfaction of other customary closing conditions.
Moving back to our balance sheet previously we discussed that our available cash would take us into early 2023.
Sue Horvath: Moving back to our balance sheet. Previously, we discussed that our available cash would take us into early 2023. We now project the cash will take us into Q4 of 2022.
We now project the cash will take us into Q4 of 2022.
Sue Horvath: This difference is related primarily to an increased activity in the randomized trial.
This difference is related primarily to an increased activity in the randomized trial preparation for expansion into the ovarian cancer development program and costs associated with our acquisition of C. P. P.
Sue Horvath: preparation for expansion into the ovarian cancer development program, and costs associated with our acquisition of CPP.
Sue Horvath: We view all three to be positives that will add tremendous value.
We view all three to be positives that will add tremendous value C. P. Pes operations and development activities post closing are not expected to add significantly to our operating burn in 2022.
Sue Horvath: CPP's operations and development activities post-closing are not expected to add significantly to our operating burn in 2022.
Speaker Change: That concludes my prepared remarks. Operator, can you please open the phone lines for Q&A and poll for questions?
That concludes my prepared remarks, operator can you. Please open the phone lines for Q&A and poll for questions.
Speaker Change: Certainly. Ladies and gentlemen, the floor is now open for questions.
Certainly ladies and gentlemen, the floor is now opened for questions. If you have any questions or comments. Please press star one on your phone now.
Speaker Change: If you have any questions or comments, please press star 1 on your phone now. We ask that while posing your question, you please pick up your handset if listening on a speakerphone to provide optimum sound quality. Once again, if you have any questions or comments, please press star 1 on your phone now. Please hold a moment while we poll for questions. Your first question.
We ask that we're posing your question you. Please pick up your handset if a Sam speaker phone to provide optimum sound quality. Once again, if you have any questions or comments. Please press star one on your phone now please hold a moment, while we poll for questions.
Your first question is coming from Jason Mccarthy with Maxim Group.
Your line is live.
Speaker Change: Thanks for taking the questions.
Sure.
Alright, thanks for thanks for taking the questions just briefly on the aspire study.
Speaker Change: Briefly, on the Aspire study.
What is the expectation.
Speaker Change: What is the expectation on PFS in first line and historically with NAV and GEM?
On PFS in first line.
And historically with Nab and Jim.
Speaker Change: And also, at your interim look, it's PFS offense, but that would include.
And also at your interim look.
It's PFS events that would include deaths right would there be any survival.
Speaker Change: debts, right? Would there be any survival, overall survival that you might see a signal for at that interim that you would be sharing with investors?
Overall survival that you might see a signal for.
At that interim that you would be sharing with investors.
Speaker Change: Hi, Jason. Thank you so much. Yeah. So, the PFS, you know, when you look at Gemini-Braxane, you're in the, you know, roughly five-and-a-half-month PFS, give or take, you know, that's pulling from the MPACT trial, and obviously you can see some variation across other trials that have been run. You know, we will be looking, you know, clearly that it will incorporate also of course. We will
Hi, Jason. Thank you so much yeah. So the the PFS you know when you look at some German abroad senior in the roughly five and a half months PFS.
PFS.
Give or take you know that's pulling from the impact trial and obviously you can see some variation across other other trials that have been run.
You know we will be looking you know clearly that it will incorporate also deaths of course, we will.
Speaker Change: have a DSMB and because it's a blinded study, they will certainly be looking at all efficacy parameters. If at that point they were to see a larger split in the survival, that would be something that they would probably certainly flag and we would have to address it at that time.
How did the F&B and because it's a blinded study they will certainly be looking at all efficacy parameters. If at that point they were to see a larger split and survival that would be something that they would probably certainly flag.
And we would have to address it at that time.
Speaker Change: But the way we've structured it is really to make sure that we are seeing the benefits that we believe will translate ultimately into an overall survival as the primary endpoint for the entire trial is overall survival. So that's how we structured it.
But the way we've structured it is really to make sure that we are seeing the benefits that we believe will translate ultimately into an overall survival as the primary endpoint for the entire trial is overall survival. So that's that's how we structured it.
Speaker Change: And can you just review with us.
And can you just review with us.
Speaker Change: what the parameters are going to be for the ovarian cancer program and what potential combinations we'll be looking at.
What the parameters are going to be for the ovarian cancer program and what potential combinations.
Yeah.
Speaker Change: Certainly. So we're working to finalize that right now. We're working with some of the gynecologic oncology KOLs.
Certainly so we're working to finalize that right now we're working with them some of the gynecologic oncology Kols.
Speaker Change: It is not fully defined yet. I think it's a high likelihood that it'll be in the platinum-resistant population because that's where there really truly is a huge unmet need for patients.
It is not fully defined yet and I think it's a high likelihood that it'll be in the platinum resistant population, because that's where they're really truly is a huge unmet need for patients.
Speaker Change: And if you think about what's currently used in that setting, you know, it's Paclitaxel, it's a pegylated lymphosomal doxorubicin, Gemcitabine, Topatecan to a lesser extent. So, we would probably look to combine with one of those agents is my best guess given that that's really all that's been.
If you think about what's currently used in that setting you know with Paclitaxel pegylated.
<unk> like to thermal doxorubicin jumped side of being.
<unk> taken to a lesser extent.
So we would probably look to combine with <unk> with one of those agents Ah is my best guess given that that's really all that's been.
Speaker Change: shown any efficacy and by that it's really not that much unfortunately, so we are looking to see which one makes the most sense and hopefully improve upon that for patients.
As shown any.
Efficacy and by that I, that's really not that much. Unfortunately, so we are looking to see which one makes the most sense and hopefully improve upon that for patients.
And.
Speaker Change: This would exclude, if it's platinum resist, are you excluding use of parts in these populations, or is that the expectation?
This would exclude plot.
Platinum resistant you're excluding.
Use of the parts populations or is that the expectation.
Speaker Change: You know what, I think we have to look at that a little deeper. I know PARP inhibitors are being used especially also in maintenance, so I think that's something that we do have to look at and figure out what makes sense, just to make sure that we can truly identify a signal with the addition of SPP 101. So it's a great question and I don't have a definitive answer yet until we finalize the protocol, but something to consider for sure.
You know what I think we have to look at that little deeper I know I know PARP inhibitors are being used especially often maintenance. So I think that's something that we do have to look at and figure out what makes sense just to make sure that we can truly identify a signal.
With the addition of SPP one O. One so it's a great question and I don't have a definitive answer yet until we finalize the protocol, but something to consider for sure.
Speaker Change: And just a last question. Briefly going back to the aspire you have a 104 PFS events at the futility analysis and you'll make a determination.
And just one last question briefly going back to the aspire you have it.
For PFS events.
The futility analysis.
And Youll make a determination of how.
Speaker Change: of how many patients you would need for the phase 3 based off of that. That's one part. And the second part is, I think I missed it, but you said the first patient is expected to be enrolled by the end of this month.
How many patients you would need for the phase III based off of that that's one part and the second part is I think I missed it but you said the first patients is expected to be enrolled by the end of this month.
Yeah, we're expecting the first quarter of the first patient to be enrolled and then from that point approximately 12 months to complete enrollment and we're estimating roughly 150 to reach the 100 and for PFS events.
Speaker Change: Yes. So, we're expecting the first quarter, the first patient to be enrolled, and then from that point, approximately 12 months to complete enrollment. And we're estimating roughly 150 to reach the 104 PFS events. Okay. And
Okay and the.
Speaker Change: Yes, you are correct. We will, based on that futility analysis, that will drive the final sample size for the phase three portion. Got it, okay.
Yes, you are correct, we will based on that futility analysis that will drive the final sample size.
For the phase III portion.
Got it okay. Thank you very much for taking the questions certainly.
Certainly thank you so much.
Your next question is coming from Tony Butler with Roth Capital. Your line is live.
Speaker Change: Your next question is coming from Tony Butler with Roth Capital. Your line is live.
Tony Butler: Thanks very much. Jennifer, just one question on the ovarian cancer study. Is it, and this actually hits on the PARP part as well, but is it considered?
That's very much Jennifer just just one question on the ovarian cancer study.
And this actually sits on the pork hurt as well but is.
Is it.
Considered.
Broker positive patients for broker.
Tony Butler: BRCA positive patients or BRCA mutant patients or would that be irrelevant? That's question one, if I may. And then question two is, in the neoadjuvant trial, and I
Or would that be irrelevant.
Question, one if I may and then question two is.
In the Neo adjuvant trial.
And I recognize that that's not complete.
Tony Butler: At least trial design time complete, but could you provide a view at what that actually might look like for example? How many days in front of say surgery a or resection a patient may receive a dose of? SPP or would there be several?
At least trial designs are complete but could you provide a view.
That actually might look what for example.
How many days in front of safe surgery or <unk>.
<unk> a patient may receive a dose.
SPP or would there be several doses along some continuum and then would they continue post surgically as well.
Tony Butler: along some, you know, continuum? And then would they continue post-surgically as well? Thank you.
Speaker Change: Okay. Thank you, Tony. So, I will tell you, for the ovarian cancer, I think it's too premature to comment yet on the BRCA status. Again, you know, we'll be meeting with the Guyanat KOLs. I think there's a — but you bring up a great point. There's a couple factors, for sure, that we need to account for. And, again, make sure that the population we pick is as
Okay. Thank you Tony.
So I will tell you for the ovarian cancer.
It's too premature to comment yet on the BRCA status again I you know, we'll be meeting with the guy not Kols I think theirs, but you bring up a great point Theres a couple of factors for sure that we need to account for.
And again make sure that the population we pick is there's alcohol clean as possible to identify a signal so I'm not sure about mixing.
Speaker Change: I'll call it clean as possible to identify a signal. So, I'm not sure about mixing both positive and negative. I think we might stick with more streamlined and pick one subset. So, what I would say is stay tuned and as soon as we have that finalized, we'll certainly put that out in the public. We're very much looking forward to starting this program.
You know both positive and negative I think we might.
Might stick with more streamlined and pick one one subset so.
But I would say is stay tuned and as soon as we have that finalized we'll certainly.
Put that all in the public we're very much looking forward to starting this program Ah So stay tuned on that one for the new adjuvant.
Speaker Change: Stay tuned on that one. For the neoadjuvant, you know, typically you'll see anywhere from two to four cycles
Typically you'll see anywhere from two two to four cycles.
Of chemotherapy, given and then you have a washout period, because you want you know healing from the chemotherapy before you take them to surgery.
Speaker Change: chemotherapy given, and then you have a washout period because you want healing from the chemotherapy before you take them to surgery.
Speaker Change: You bring up a good point, which is, is it just neoadjuvant therapy or do you want to add some adjuvant on the back end after the surgery?
You bring up a good point, which is is it just me or adjuvant therapy or do you want to add some adjuvant on the back end after the surgery.
Speaker Change: And that is something we are discussing with the KOLs that will be running this trial.
And that is something we are discussing with the kols that we'll be running this trial.
Speaker Change: we will be for sure giving at least two cycles of therapy before. It could be up to four cycles before. And then.
We will be for sure, giving you at least two cycles of therapy before it could be up to four cycles before and then we will be discussing as I just mentioned the possibility of getting something in the adjuvant post surgery.
Speaker Change: we will be discussing, as I just mentioned, the possibility of giving something in the adjuvant post-surgery.
So it's a great question. Thanks, Jennifer.
Speaker Change: So it's a great question. Thanks, Jennifer. Yeah, thank you. Really appreciate it.
Really appreciate it.
Sure.
Your next question is coming from Robin Garner with Craig Hallum.
Speaker Change: Your next question is coming from Robin Garner with Craig Hallam.
Your line is live.
Robin Garner: Hi, good evening, and thank you for taking my questions. Just wanted to ask a little bit more on the ASPIRE study and the 104 events. What was the assumption there to get to the 104? And then if we just carry that idea of it would take 150 patients to get to that point, at that point, how many patients would be required in the phase three? Yeah.
Hi, Good evening and thank you for taking my questions just wanted to ask a little bit more on the Etsy buyer study and the 104 events what was the assumption there to get to the 104 and then if we just carry that idea of it would take 150 patients to get to that point.
At that point, how many patients would be required in the phase III.
Yeah. So you know the.
Robin Garner: We're looking, from a PFS, we're looking at, you know, we haven't actually given the exact delta that we're looking for, you know, but obviously we wanna make sure that we've got a delta that we believe will translate into survival. I think probably the more important is that when you look at survival, we'll be looking for at least a three-month benefit.
We're looking at from a PFS, we're looking at.
Haven't actually given the exact delta that we're looking for them.
But obviously, we want to make sure that we've got a delta that we believe will translate into survival.
Probably the more important is that when you look at survival, we'll be looking for at least a three month benefit.
Robin Garner: in survival because that is, especially in this disease, what we believe the FDA will consider meaningful. And so the sample size will be derived based on what we see in that futility analysis. If I had to take a guess right now, I would say you're looking at a total
And survival because that is especially in this disease are what we believe the FDA will consider meaningful.
And so the sample size will be Drived, you know based on what we see in that futility analysis, if I had to take a guess right now I would say youre looking at a total.
Robin Garner: total number of subjects, you know, somewhere in the range of four to 500. And that's really based on the activity that we've seen with the SPP101 combination with geminobraxine in the phase one study. So if that continues to hold, that would be what we would expect.
Total number of subjects, you know somewhere in the in the range of four to 500 mm and that's really based on the activity that we've seen with the SPP Wanna, one combination with chairman of Brac seen in the phase one study. So if that continues to hold that would be what we would expect.
Speaker Change: Okay, thank you for that. And if it were four to 500 patients based on the times required for enrollment, how long would it take to enroll the additional patients to get to that four to 500 number? Yeah, so
Okay. Thank you for that and if it were four to 500 patients based on the time required for enrollment how long would it take to enroll the additional patients to get to that four to 500 number.
Yeah. So you know we will.
Speaker Change: We'll take a look at that, but I will tell you, we would be certainly aiming no longer than 24 months, if at all possible. Could it be upwards of 36 months? The answer is yes, absolutely. But I will say that we have a very,
We'll take a look at that but I will tell you we would be certainly aiming no no longer than 24 months if at all possible could it be upwards of 36 months. The answer is yes, absolutely, but I will say that we have a very.
Aggressive a team a collective team between our internal team on the CRO.
Speaker Change: aggressive team, a collective team between our internal team and the CRO. And if, you know, as you can tell, you know, roughly 150 patients in 12 months, you know, I think we can move pretty quickly. And also, as you probably know, when the investigators are seeing, you know, patients and patients.
And if you know as you can tell you know roughly 150 patients in 12 months you know I think we can move pretty quickly and also as you probably know when the investigators are seeing you.
You know patients and patients.
Potentially doing better or well, obviously there'll be blinded so they won't know.
Speaker Change: potentially doing better or well. Obviously, they'll be blinded, so they won't know. That gets excitement there as well, and so I think we would probably bring on some additional sites to meet our goal.
That gets excitement there as well and so I think we would probably bring on some additional sites to to meet our goal.
Speaker Change: Okay, thank you for that. And for my last question, I wanted to just ask about the neoadjuvant study, the total numbers of patients you expect, and then very specifically, what would you plan to do with the biopsy data that you could have, very special to the design of the neoadjuvant study, how would you be able to use that to your benefit?
Okay. Thank you for that and for my last question I wanted to just ask about the Neo adjuvant study. The total numbers of patients who expect a remember specifically what would you plan to do with the biopsy data that you could have a.
Very special to the design of the Neo Adjuvant study, how would you be able to use that to your benefit.
Speaker Change: That's a great question, Robin. You know, in terms of the sample size, this will be a small phase two, so it's really meant to see the activity, so more of a signal-seeking, if you will.
That's a great question Robin and you know in terms of the sample size. This will be a small phase two so it's really meant to see the activity and so more of a signal seeking if you will.
Speaker Change: So, you know, I expect it will be, you know, in the realm of, you know, a smaller phase 2. Again, we need to finalize that with the KOLs, so I don't have a definitive number yet.
So you know.
It'll be you know in the realm of a smaller phase two again, we need to finalize that with the kols.
So I don't have a definitive number yet.
Speaker Change: But, you know, in terms of the biopsy, you know, I think that's an interesting question. We have our collaboration with Johns Hopkins as well, and so I do think that there may be some
But you know in terms of the the biopsy them you know I think that that's an interesting question. You know we have our collaboration with with Johns Hopkins as well and so I do think that there may be some hum.
Markers that we may be targeting to look at and see if that can.
Speaker Change: markers that we may be targeting to look at and see if that, you know, can inform us about the activity of SPP 101 at the tissue level. So, I think that's a great question, and it's something we just haven't fully fleshed out yet. Okay. Thank you, and congratulations on the quarter. Thank you so much, Robin.
Can inform us.
But the activity of S. P P. One to one.
At the tissue level. So I think that's a great question and it's something we just haven't fully fleshed out yet.
Okay. Thank you and congratulations on the quarter.
Thank you so much robin.
Do you have a follow up question coming from Tony Butler.
Your line is live.
Jennifer apologies, but.
Speaker Change: on the heels of the 104 events in Aspire. And I'm asking you to speculate, you wouldn't necessarily know today, but would you then actually state, I guess, in a press release that you've hit the futility and whatever happened, you're continuing to roll and what that enrollment number would be at that time? Yeah.
On the heels of 104 exempts spire.
And I'm asking you to speculate it in important that's true without today, but would you.
Then actually stake I guess in the press release.
You've hit the futility and whatever happened you're considering to roll what that enrollment number would be.
That car.
Yeah or okay.
Speaker Change: Yes, I think that would be obviously very important, right, because that'll drive to, I believe it was Robin's question, you know, the total number of patients and also that the planned enrollment time as well, which, you know, would be very important for, you know, clinicians, scientists, investors, you know, everyone. Yes, ma'am. Thanks a lot.
Yes, I think that would be obviously very important right because that will drive them to I believe it was Robin's question you know the the total number of patients and also that the planned enrollment time as well, which you know would be very important for you know clinician scientists investors you know everyone.
Thanks, a lot.
Yeah.
We have no further questions coming from the lines at this time. Thank you ladies and gentlemen. This concludes today's event you may disconnect at this time and have a wonderful day. Thank you for your participation.
Speaker Change: Thank you, ladies and gentlemen. This concludes today's event. You may disconnect at this time and have a wonderful day. Thank you for your participation.
Excellent.