Q1 2025 Oncolytics Biotech Inc Earnings Call
Operator: Good afternoon and welcome to Oncolytics Biotech's first quarter conference call. All participants are now in listen-only mode. There will be a question and answer session at the end of this call. Please be advised that this call is being recorded at the company's request.
Good afternoon, and welcome to unclear they expired Thats first quarter conference call. All participants are in listen only mode. There will be question and answer session. At the end of this call. Please be advised that this call is being recorded at the company's request I would now like to turn the call over to John Batten direct.
Jon Patton: I would now like to turn the call over to Jon Patton, Director of Investor Relations and Communication. Please go ahead. Thank you, Operator.
Of Investor Relations and communications. Please go ahead.
Speaker Change: Thank you operator today, we'll provide an update on the quarter and a review of our financials.
Jon Patton: Today, we'll provide an update on the quarter and a review of our FinEx. As a reminder, various remarks made during this call contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of Palo Verde. including statements regarding the company's ongoing CEO search, our mission, strategies, and milestones, the company's belief as to the potential and mechanism of action of Pella ReRep as a cancer therapeutic, our potential registrational opportunities for Pella ReRep, and our plans and strategies related thereto, our plans to continue enrollment in Goblet Cohort 5, our ongoing business development initiatives, and other statements related to anticipated developments in the company's business.
Speaker Change: As a reminder, various remarks made during this call contains certain forward looking statements relating to the company's business prospects and the development and commercialization of television right.
Speaker Change: Any statements regarding the company's ongoing CEO search for emission strategies and milestones because these beliefs as to the potential and mechanism of action all over Europe, as a cancer therapeutics or potential registrational opportunities recalibrate right.
Speaker Change: It hasn't strategies related there too.
Speaker Change: To continue enrolment and Gaba cohort five our ongoing business development initiatives and other statements related to anticipated developments and the company's business. These statements are based on management's current expectations and beliefs.
Jon Patton: These statements are based on management's current expectations and beliefs and are subject to a number of factors which involve unknown and unknown risk delays, uncertainties, and other factors not under the company's control that may cause actual results, performance, or achievements of the company to be materially different from the results, performance, or expectations implied by these four leading statements. In any forward looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith, and our beliefs have a reasonable basis, but there can be no assurance that the statement, expectation, or belief will be achieved.
Speaker Change: To a number of factors, which involve known and unknown risks uncertainties and other factors not under the company's control that may cause actual results performance or achievements of the company to be materially different from the results performance expectations implied by these forward looking statements.
And any forward looking statement on page, especially.
Speaker Change: Especially <unk> expectation or belief as to future results, such expectations or beliefs expects to see everybody's had reasonable basis, but there can be no assurance that these statements of expectations or beliefs will be achieved.
Jon Patton: These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions by regulatory agencies, and those other factors detailed in the company's filings with CDAR and the SEC.
Speaker Change: Factors include results of current or pending clinical trials.
Associated with intellectual property protection and initial projections actually state regulatory agencies and those other factors detailed in the company's filings with SEDAR and the SEC.
Jon Patton: Oncolytics does not undertake any obligation to update these forward-looking statements except as required by applicable law.
Speaker Change: I'm, Greg does not undertake any obligation to update these forward looking statements, except as required by applicable laws.
Jon Patton: On today's call, I'm joined by Chair of Oncolytics Board of Directors and Interim CEO, Wayne Pisano, Chief Medical Officer, Dr. Tom Heineman, VP Business Development, Christophe Degois, and Chief Financial Officer, Kirk Look. The team will be available for Q&A at the end of this call.
Speaker Change: On today's call I'm joined by tariff I'm clinics board of directors.
Cassandra: C E O N Cassandra.
Speaker Change: Chief Medical Officer, Dr. Tom High demand.
Chris: P business development, Chris South Dakota, and Chief Financial Officer.
Chris: The team will be available for Q&A at the end of this call.
Wayne Pisano: And with that, I'll hand it over to Wayne. Good afternoon, everyone. And thank you, Jon. I know it's only been a short time since we last provided a corporate update, so today's call will be relatively brief. I'll run through the important developments from the quarter and then ask Tom to discuss our clinical progress and Christophe to share a business development update. Then Kirk will say a few words about our financial.
Wade: And with that I'll hand, it over to Wade.
Wade: Good afternoon, everyone and thank you John.
Wade: I know, it's only been a short time, so if you actually provided a corporate update.
Wade: This call will be relatively brief.
Speaker Change: I'll run through the important developments from the quarter and then ask Tom to discuss our clinical progress and Christophe the share of business drove an upbeat and Kirk will say a few words about our financials.
Wayne Pisano: To start, I want to let you know that our CEO search is active and we've met several excellent candidates. With an asset like Pella Rio Rep, which has potential in numerous consequential indications, we are aiming to find a leader who can steward Pella with a laser focus on clinical trial execution. Our clinical data continues to exceed expectations, and we believe the further development of Pella will allow it to fulfill its potential as a valuable treatment option for patients with several difficult-to-treat malignancies, including pancreatic cancer, breast cancer, and anal carcinoma. all of which have a high unmet medical need.
Speaker Change: To start I want to let you know that our CEO searches active and we've met several excellent candidates.
Speaker Change: With an asset light colored real rep, which has potential in numerous consequential indications we are aiming to find a leader who can steward pillar with a laser focus on clinical trial execution.
Critical data continues to exceed expectations and we believe the further development of pillow, well I went to fulfill its potential as a valuable treatment option for patients with several difficult to treat malignancy, including pancreatic cancer breast cancer and anal carcinoma.
Speaker Change: All of which have a high unmet medical need.
Wayne Pisano: Additionally, the new CEO will provide invaluable leadership and strategic decision-making surrounding our planned registration-enabling study evaluating Pella and taclotaxel in advanced hermetostatic, HR-positive, HR-2-negative breast cancer.
Speaker Change: Additionally, the new CEO will provide invaluable leadership and strategic decision, making is surrounding our planned registration enabling study.
Speaker Change: Value, adding color and paclitaxel in advanced or metastatic HR positive <unk> negative breast cancer.
Wayne Pisano: And I hope to be able to announce our new CEO in the near future.
Speaker Change: And I hope to be able to announce our new CEO in the near future.
Wayne Pisano: Pella-Riorette, or Pella as we often call it, is a unique and versatile immunotherapeutic agent that we believe has tremendous potential to help a wide range of cancer patients. As discussed during a key opinion leader event in March, Professor Alexander Eggermont described Pella's benefits, including intravenous administration, the ability to be taken to tumor sites via monocytes and lymphocytes, and that it doesn't create anti-aging antibodies, allowing T cells to reach the tumor for long-lasting responses, all without infecting normal, healthy cells. During the same call, Professor Martine Picard, a leading expert in breast cancer, shared her experience in the clinic and confirmed intravenous administration is much preferred to any intratumoral intervention.
Speaker Change: Hello, Rio Rep or pillar as we often quote because of unique and versatile immuno therapeutic agent that we believe has tremendous potential to help a wide range of cancer patients.
Speaker Change: As discussed during our key opinion leader event in March Professor Alexander Eckermann describe colors benefits, including intravenous administration.
Speaker Change: We need to be taken to tumor sites, you might've sites and look for sites and that it doesn't create anti aging antibodies, allowing T cells to reach the tumor for long lasting responses or without affecting normal healthy cells.
Speaker Change: During the same call professor of morphine for card a leading expert in breast cancer shared her experience in the clinic and confirmed intravenous administration is much preferred to any intra tumoral interventions.
Wayne Pisano: She also discussed Pella's opportunity in breast cancer and the multitude of registrational opportunities for an asset like Pella. She confirmed support for the continued advancement of Pella based on two randomized studies confirming its ability to provide an overall survival benefit in breast cancer. She also discussed her belief that there could be an opportunity for Pella to benefit patients at an earlier stage of treatment, possibly in a curative setting. Additionally, in the first quarter, we were able to showcase the versatility of Pella in gastrointestinal cancers when we presented data at ASCO GI in both pancreatic and anal cancer.
Speaker Change: Also discuss pillows opportunity in breast cancer, and the multitude of registrational opportunities for an asset like pillar.
Speaker Change: She confirmed support for the continued advancement of Tullow based on two randomized studies confirming its ability to provide an overall survival benefit in breast cancer.
You also discussed your belief that there could be an opportunity for color to benefit patients at an earlier stage of treatment, possibly the curative setting.
Speaker Change: Additionally, in the first quarter, we were able to showcase the first utility power and gastrointestinal cancers, where we presented data at ESMO Gi in both pancreatic and anal cancers.
Wayne Pisano: Tom will lead the discussion of that clinical data shortly. Looking forward, we'll be sharing pancreatic cancer data at this year's ESCO meeting, highlighting Pella's unique mechanism of action, which stimulates both innate and adaptive immune response.
Speaker Change: Tom will lead the discussion that clinical data shortly.
Looking forward, we'll be sharing pancreatic cancer data at this year's Astro meeting highlighting Cola is unique mechanism of action, which stimulates both innate and adaptive immune responses.
Tom Heineman: I'd now like to turn the call over to Tom for an update on our clinical progress and plans. Thanks, Wayne, and thanks for teeing up the data that we have shared and will be sharing this year at medical conferences such as ASCO and ASCO-GI. The impactful data that Wayne mentioned was presented in January of this year at the ASCO GI conference. Interim results from Goblet Cohort 4 which investigates Pella and atezolizumab in relapsed anal carcinoma showed a 33% objective response rate, including one patient with a complete response that lasted more than 15 months. We have expanded this cohort to Stage 2, in which an additional 18 patients will be enrolled.
Speaker Change: I'd now like to turn the call over to Tom for an update on our clinical progress and plans.
Tom High: Uh huh.
Tom High: Thanks Wayne.
Tom High: Thanks for teeing up the data that we have shared and will be sharing this year at medical conferences, such as Astro and <unk> G I.
Tom High: The impactful data I think Wayne mentioned, what's presented in January of this year, if you ask a Gi conference.
Tom High: Interim results from goblet cohort four.
Tom High: Which investigates pillar and a T cell leukemia, and relapsed anal carcinoma.
Tom High: So the 33% objective response rate, including one patient with a complete response with lasted more than 15 months.
Tom High: We have expanded this cohort to stage two in which an additional 18 patients will be enrolled.
Tom Heineman: If the efficacy signal in this cohort persists, we will engage in discussions with our scientific advisory board and key opinion leaders to optimize the development of PELA in this indication. While anal carcinoma is not as large a commercial opportunity as breast or pancreatic cancer, achieving regulatory approval in this indication would serve as an important validation of Pell's potential in gastrointestinal cancers and could greatly benefit patients with a very high medical need.
Tom High: If the efficacy signal in this cohort persist.
Tom High: We're engaged with discussions with our scientific advisory Board and key opinion leaders to optimize the development of pillar in this indication.
Tom High: Well, we know carcinoma is not as larger commercial opportunity expressed or pancreatic cancer, achieving regulatory approval in this indication.
Tom High: Which serve as an important validation of pellets potential in gastrointestinal cancers and could greatly benefit patients with a very high unmet medical need.
Tom Heineman: In addition, Goblet Cohort 5, which is funded by a $5 million grant from the Pancreatic Cancer Action Network, or PAMCAN, is currently enrolling newly diagnosed metastatic pancreatic cancer patients. This cohort is evaluating Pella combined with modified fulfirinox with or without atezolizumab. Enrollment into the safety run-in phase of this cohort was recently completed. After review of the safety data by an independent data safety monitoring board and the German regulatory authorities, we received all necessary permissions to proceed with full enrollment, which is ongoing. This cohort has enrolled more than half of the patients required to complete stage one of the study, which requires a total of 30 valuable patients, 15 each in the arm with the tesolizumab and the arm without the tesolizumab.
Tom High: In addition, goblet cohort five which was funded by a 5 million dollar grant from the pancreatic cancer action network, where pan cancer is currently enrolling newly diagnosed metastatic pancreatic cancer patients.
Tom High: This cohort is evaluating power combined with modified fulfill remarks with or without a teaser lose Ya man.
Tom High: Enrollment into the safety run in phase of this cohort was recently completed.
Tom High: After a review of the safety data by an independent data safety monitoring board in the German regulatory authorities.
Tom High: We received all necessary permissions proceed with full enrollment which is ongoing.
Tom High: This cohort is enrolled more than half of the patients required to complete stage one of the study which requires a total of 30 evaluable patients.
Tom High: <unk> each in the arm with a pizza with Ya man and the arm without teach them as you lap.
Tom Heineman: Upon completion of Stage 1 enrollment, a decision will be made whether to advance either one or both arms to Stage 2 enrollment. If the efficacy data are encouraging, this study could lead to yet another registration opportunity. We expect to review initial efficacy data from this cohort later this year and share it publicly next year.
Tom High: Upon completion of stage one enrollment the decision will be made whether to advance either one or both arms to stage two enrollment.
Tom High: If the efficacy data are encouraging this study could lead to yet another registrational opportunity. We expect to review initial efficacy data from this cohort later this year and share it publicly next year.
Tom Heineman: In addition to the exciting progress in our gastrointestinal cancer studies, I'd also like to remind you of the compelling breast cancer results from two randomized phase two studies in which Pella-based combination therapy substantially outperformed standard of care treatment. The first of these was the IND213 study in metastatic breast cancer in which median overall survival in the pellet group was nearly double that in the control line. We followed IND2 and IND3 with the BRACEL1 study to confirm the efficacy signal. In BraceLive1, we evaluated patients with advanced or metastatic HR-positive or 2-negative breast cancer who had progressed on hormonal therapy, including a CDK4-6 inhibitor.
Tom High: In addition to the exciting progress in our gastrointestinal cancer studies I'd also like to remind you of the compelling breast cancer results from two randomized phase II studies, which pellet based combination therapy substantially outperformed standard of care treatment.
Tom High: The first of these was the IMT 213 study in metastatic breast cancer and <unk>.
Tom High: Which median overall survival in the power group was nearly double that in the control arm.
Tom High: We followed IMD, two and three with the bracelet one study to confirm the efficacy signal.
Tom High: And Bruce with one we evaluated patients with advanced or metastatic HR positive <unk> negative breast cancer, who had progressed on for mono therapy, including CDK four six inhibitor.
Tom Heineman: The Bracelet1 data became available last fall and showed a substantial clinical benefit for Pella combined with Paclitaxel compared to Paclitaxel monotherapy. This was based on a near doubling of both the median progression-free survival and the two-year survival rate, a near tripling of the confirmed objective response rate, and a median overall survival more than a year longer than that in the control line. With two randomized phase two studies pointing to a meaningful clinical benefit, as well as supportive mechanism of action data from several studies, including the AWARE-1 breast cancer trial, we believe we have largely de-risked this program, setting the stage for continued development of Pella in breast cancer.
Tom High: Bracelet, one data became available last fall and showed a substantial clinical benefits for pelican binds with paclitaxel compared to Paclitaxel monotherapy.
Tom High: This was based on a near doubling of both the median progression free survival and the two year survival rate a.
Tom High: A near tripling of the confirmed objective response rate.
Tom High: And the median overall survival of more than a year longer than that in the control arm.
Tom High: With two randomized phase III studies, pointing to a meaningful clinical benefit as well as supportive mechanism of action data from several studies, including the aware one breast cancer trial.
Tom High: We believe we have largely derisked. This program setting the stage for continued development appellate in breast cancer.
Tom Heineman: In the evolving breast cancer treatment landscape, we have a number of attractive options for the continued development of PELLA. These include a potential registration-enabling study designed to take advantage of the accelerated approval pathway, which was successfully utilized by breast cancer drugs such as Pfizer's Ibrant and Daiichi's and HER2. We also have the option to conduct studies in patients at different stages in the breast cancer treatment path, including patients with an operable disease who have failed antibody drug conjugate therapy and early stage patients utilizing a neoadjuvant approach.
Tom High: In the evolving breast cancer treatment landscape, we have a number of attractive options for the continued development of pillar. These include a potential registration enabling study designed to take advantage of the accelerated approval pathway, which was successfully utilized by breast cancer drugs, such as Pfizer's ice Brent and Daiichi.
Tom High: Her too.
Tom High: We also have the option to conduct studies in patients at different stages in the breast cancer treatment path, including patients with an operable disease, who have failed antibody drug conjugate therapy and early stage patients utilizing a new agile approach.
Tom Heineman: This latter is one of the pathways suggested by key opinion leaders, including Professor Martine Picard, who spoke at the KOL event Wayne mentioned at the start of this call.
Speaker Change: This ladder is one of the pathways suggested by key opinion leaders, including Professor Martijn Burkhardt, who spoke at the Q I wasn't Wayne mentioned have to start a good call.
Christophe Degois: Next, I'd like to introduce Christophe, who will comment on our ongoing business development activities. Christophe? Thanks, Tom. I'm happy to share an update on our BD activities in addition to development involving our current collaboration. As we discussed, the data presented at ASCO-GI continue to show the versatility of Pella in multiple indications, specifically pancreatic and anal cancer. One underappreciated aspect is a remarkable safety profile of pellets. Pellad has been administered to over 1,100 patients over the course of its development. While we're encouraged to see there remain no safety concern in anal cancer, where PELA is being evaluated with a checkpoint in emitters at Eszoluzumab, it is now being tested in combination with modified Folfrenox in pancreatic cancer.
Christophe: Next I would like to introduce Christophe who will comment on our ongoing business development activities.
Christophe: Christoph.
Christophe: Thanks Todd.
Speaker Change: I'm happy to share an update on our BD activities. In addition to developing involving eikon collaboration.
Speaker Change: As we discuss the data presented at the ESMO Gi continued to show the versatility of paid out in multiple indications, specifically pancreatic and <unk> cancer.
Speaker Change: One underappreciated aspect is a remarkable safety profile of sped up.
Speaker Change: And that has been happening.
Speaker Change: Easter to over 1100 patients over the course of its development. While we're encouraged to see that remained no safety concern and annual cancer, where <unk> been given they treated with a checkpoint inhibitors I think originally mab.
Speaker Change: Now being tested in combination with modified <unk> in pancreatic cancer.
Christophe Degois: This chemotherapy regimen has a different safety profile than Jebcitabine plus NAPAKITAXEL, the chemotherapy regimen from Court 1 of the Goblet. The fact that we are able to combine Pella with multiple chemotherapies and checkpoint inhibitors while maintaining a favorable safety profile in pancreatic cancer makes it easier to engage in productive BD conversation.
Speaker Change: These chemotherapy regimen as a different safety profile and Gemcitabine, plus Nab paclitaxel chemotherapy regimen from call. It one of the goblet study.
Speaker Change: The fact that we're able to combine Taylor with multiple chemotherapy and checkpoint inhibitors, while maintaining a favorable safety profile in pancreatic cancer makes it easier to engage in productive BD conversation.
Christophe Degois: We are encouraging business development interaction in January at the J.P. Morgan Conference and will continue to meet with potential biopharma partners at ASCO in Chicago and Bio in Boston. We're also supported by key opinion leaders like Professor Martin Picard and Professor Lex Eggerman, who continue to be enthusiastic supporters of TELUS potential. During the previously discussed KOL event organized by the H.U.N. White, both Professor Picard and Professor Eggermont highlighted the need for new treatment innovations such as PELA that work to activate the immune system to recognize and kill cancer. Furthermore, we already have support from advocacy groups like PANCAN, who are funding Quad Five as a goblet.
Speaker Change: We had an encouraging business development interaction in January at the Jpmorgan Conference and we've continued to meet with potential Biopharma partners at the Astro in Chicago and bio in Boston.
Speaker Change: Well I suppose supported by key opinion leaders like profits was Martin P chord and profits with like segment will continue to be enthusiastic supporters of pent up potential.
Speaker Change: During the previously discussed carefully vetted organized by C. H U N wide, both professor P cards and popular Agamont I liked to the need for new treatment innovations such as paid out that's what to activate the immune system to recognize and kill cancer.
Speaker Change: The more we already have support from advocacy groups like Penn cabin was funding caught five other doublet study.
Christophe Degois: As I mentioned on a previous call, the compelling data PELAS generated across multiple indications serves us well. We have two randomized Phase II studies showing PELAS benefits in HR-positive, O2-negative metastatic breast cancer, multiple pancreatic studies pointing to PELAS meaningful impact, and an emerging efficacy signal that has continued to persist in anal cancer. In summary, this continues to be an exciting time for Pella as we evaluate the most efficient way to pursue regulatory approval and further demonstrate the potential our unique immunotherapeutic asset has in helping improve the lives of cancer patients.
Speaker Change: As I mentioned on our previous calls the accompanying data payless generated across multiple innkeep vacation serves us well.
Speaker Change: We have two randomized phase two studies, showing pellets benefits and HR positive <unk> negative metastatic breast cancer multiple pancreatic studies punting to panoz meaningfully impact and an emerging efficacy signal that's continued to persist in anal cancer.
Speaker Change: In summary, this continues to be an exciting time for pillar as we evaluate the most efficient way to pursue regulatory approval and further demonstrate the potential of our unique email therapeutic asset as in helping improve the lives of cancer patients I look forward to our next chance to update you on our BD opportunities.
Christophe Degois: I look forward to our next chance to update you on our video opportunities and activities.
Speaker Change: And activities.
Kirk Look: I now turn the presentation over to Kirk, who will discuss our financial for the quarter. Thanks, Christophe, and good afternoon, everyone. I'd like to discuss our financial results for the first quarter of 2025, which will be provided in Canadian dollars, unless otherwise noted. A full summary of our financial results can be found on the investors section of our website under filings and reports, or in the press release issued earlier this afternoon. Turning to our financial results for the first quarter, as of March 31st, 2025, we reported cash and cash equivalents of $15.3 million, providing runway through key value driving milestones and through the third quarter of 2025.
Speaker Change: I'll now turn the presentation over to Kirk will discuss our financial for the quarter.
Speaker Change: Okay.
Kirk: Thank you Christophe and good afternoon, everyone.
Kirk: I'd like to discuss our financial results for the first quarter of 2025, which will be provided in Canadian dollars unless otherwise noted.
Kirk: A full summary of our financial results can be found on the investors section of our website under filings and reports.
Kirk: The press release issued earlier this afternoon.
Kirk: Turning to our financial results for the first quarter as of March 31, 2025, we reported cash and cash equivalents of $15 $3 million, providing runway through key value driving milestones and through the third quarter of 2025.
Kirk Look: Net cash used in operating activities for the quarter was $6.5 million compared to $7.5 million in the same period last year. The decrease reflects lower net operating expenditures, partially offset by changes in non-cash working capital. General and administrative expenses were $3 million for the first quarter, consistent with the prior year. Research and development expenses totaled $4.1 million, down from $5.7 million in Q1 of 2024. This decrease is primarily driven by reduced manufacturing and clinical trial costs, partially offset by increased personal-related and share-based compensation expenses associated with leadership transition. The net loss for the quarter was $6.7 million, or $0.08 per basic and diluted share, compared to a net loss of $6.9 million, or $0.09 per share, in Q1 of 2024.
Kirk: Net cash used in operating activities for the quarter was $6 5 million compared to seven five.
Kirk: The same period last year.
Kirk: The decrease reflects lower net operating expenditures, partially offset by changes in non cash working capital.
Kirk: General and administrative expenses were $3 million for the first quarter consistent with the prior year.
Kirk: Research and development expenses totaled $4 1 million down from $507 million in Q1 of 2024.
Kirk: This decrease was primarily driven by reduced manufacturing and clinical trial costs, partially offset by increased personnel related and share based compensation expenses associated with leadership transition activities.
Kirk: The net loss for the quarter was $6 $7 million or <unk> <unk> per basic and diluted share compared to a net loss of $6 $9 million or <unk> <unk> per share in Q1 of 2024.
Kirk Look: Finally, following the end of our quarter, we were pleased to announce a $20 million U.S. dollar share purchase agreement with Alumni Capital. This agreement provides the company with access to capital solely at our discretion, helping us extend our financial runway.
Kirk: Finally, following the end of our quarter, we were pleased to announce a 20 million U S. Dollar a share purchase agreement with a light capital. This agreement provides the company with access to capital solely at our discretion, helping us extend our financial runway.
Kirk Look: Well, this includes our financial review. We look forward to providing further updates throughout the year and encourage you to watch for our upcoming poster presentation on Pella's Mechanism of Action at ASPR. On behalf of the entire Oncolytics team, I'd like to thank our patients, caregivers, healthcare providers, employees, and shareholders for their ongoing support.
Kirk: Well. This concludes our financial review, we look forward to providing further updates throughout the year and encourage you to watch for upcoming poster presentation on pillows mechanism of action that hospital.
Kirk: On behalf of the entire Iconix team I'd like to thank our patients caregivers healthcare providers employees and shareholders for their ongoing support.
Operator: Now, I would like to open the call for a Q&A. Operator. Thank you.
Kirk: Now I would like to open the call for Q&A operator.
Speaker Change: Thank you ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press star followed by the one on your telephone keypad.
Operator: Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star, followed by the 1 on your telephone keypad. You will hear a prompt that your hand has been raised. And should you wish to cancel the request, please press star, followed by the 2. If you are using a speakerphone, please lift the handset before pressing any key.
Kirk: To hear a problem that you had has been raised and should you wish to cancel your request. Please press star followed by the two.
Kirk: If you're using a speaker phone please lift the handset before pressing any keys one moment. Please for your first question.
Operator: One moment, please, for your first question.
Patrick Truschel: Your first question comes from the line of Patrick Truschel from HC Wainwright, please go ahead. Thanks. Good afternoon, and congrats on all the progress. Just first, regarding the anticipated start of the registrational trial in HR-positive, HER2-negative metastatic breast cancer, what can you share about the potential trial design for the study? Will PFS be a primary endpoint, and how are you incorporating feedback from regulatory agencies? And then separately, have there been any recent interactions with the and what feedback, if any, have you received concerning potential registrational pathways?
Speaker Change: Your first question comes from the line of Patrick <unk> from H C. Wainwright. Please go ahead.
Speaker Change: Thanks, and good afternoon, and congrats on all the progress just first regarding the anticipated start of the Registrational trial and HR positive hurts your negative metastatic breast cancer, what can you share about the potential trial design for the study will PFS primary endpoint and how are you incorporating feedback from.
Speaker Change: Regulatory agencies.
Kirk: And then separately has there been any recent interactions with the FDA or other regulatory bodies regarding the pancreatic cancer program and what feedback if any of you received concerning potential registrational pathways.
Tom Heineman: Hi, Patrick.
Speaker Change: Yeah, Hi, Patrick Tom item in here, maybe I can answer those and others step in if I, yes, there is more to say regarding the on the breast cancer side.
Tom Heineman: Tom Heineman here. Maybe I can answer those, and others can step in if there's more to say. Regarding on the breast cancer side, we, as you know, have discussed this study with the FDA at a Type C meeting in the second or third quarter of last year. We continue to work towards the initiation of our next study in breast cancer. At the time that we discussed this with the FDA, we obviously discussed many elements of the study design, including the primary endpoint, which we do anticipate will be progression-free survival in our next breast cancer study.
Speaker Change: We as you know have discussed this study with the FDA at a type C meeting.
Speaker Change: In the second or third quarter of last year.
Speaker Change: We continue to.
Speaker Change: Thank you pardon, we continue to work towards the initiation of our next study in breast cancer.
Speaker Change: At the time that we discussed this with the FDA, we obviously discussed many elements of the study design, including the.
Speaker Change: Primary end point, which we.
Speaker Change: Do you anticipate will be progression free survival when our next breast cancer study.
Tom Heineman: So, that's on the breast cancer side. On the pancreatic cancer side, We have not had, I mean, we have, the FDA is aware of our pancreatic cancer program, including having granted us fast-track approval in pancreatic cancer. We have been. GCAR, as you as you may be aware, to develop a protocol in pancreatic cancer and and those the that activity is ongoing. Of course, we're talking to key opinion leaders and exploring. All the best options for moving our pancreatic cancer program forward, but we have not had any additional discussions with the FDA recently. If we were to move forward with a registrational study through any means, that would require an FDA meeting before we initiated that study, however.
Speaker Change: So that's on the breast cancer side on the pancreatic cancer side.
Speaker Change: Hum.
Kirk: We have not had I mean, we have the FDA is aware of our pancreatic cancer program, including having granted us fast track approval in pancreatic cancer.
Kirk: We have been.
Kirk: Working with <unk>.
Kirk: <unk> as you may be aware to develop a protocol in pancreatic cancer and.
Kirk: Yeah.
Kirk: That activity is ongoing.
Kirk: Of course, we're talking to key opinion leaders and exploring.
Kirk: All the best options for moving our pancreatic cancer program forward.
Kirk: But we have not had any additional discussions with the FDA recently, if we were to move forward with a registrational study through any means.
Kirk: Would require an FDA meeting before we.
Kirk: That study however.
Patrick Truschel: I hope that answers your question. If I forgot anything, let me know. Yeah, that's helpful.
Kirk: Hope that answers your question, maybe I have forgotten anything let me know.
Kirk: That's helpful. And then just a follow up if I may on the development activities. I'm wondering if there are specific areas like regional rights or co development opportunities or other areas that are being prioritized and then just given <unk> mechanism of action are there plans to explore additional combination approaches.
Patrick Truschel: And then just to follow up, if I may, on the business development activities, I'm wondering if there's specific areas like regional rights or co-development opportunities or other areas that are being prioritized.
Christophe Degois: And then just, you know, given Pella Rear-Rep's mechanism of action, are there plans to explore additional combination approaches, you know, maybe with immune checkpoint inhibitors or in other tumor types?
Kirk: Maybe with immune checkpoint inhibitors or in other tumor types.
Tom Heineman: Hi, Patrick. This is Christophe. Yeah, I'm happy to answer the first question. I think Tom can comment on the second part of the question because we're already doing that. Yeah, what we're doing right now, you know, as we mentioned, you know, we've been busy at J.P. Morgan, we'll be at ASCO, we'll be at Bio. We're looking at different possible potential, different partnership for us. You know, what's very important is, as we discussed during this call, Peli, you know, has potential multiple indications. So we'd like to have, obviously, breast and pancreatic being our top priorities. So we'd like a partner that could help us, you know, maximize the value of the asset in this multiple indication.
Patrick Tom: Hi, Patrick Cisco based off a yeah I'm happy to try and so the first question I think Tom Tom can comment on the second part of the question because we're already doing that.
Patrick Tom: Yeah, what what we're doing right now you know as we mentioned you know we've we've been busy at Jpmorgan, we'd be at the high school, we'd add bio.
Patrick Tom: We're looking at the different possible potential different partnership for us to know what's very important is as we just discussed during this call Paolo you know as a potential in multiple indications so we'd like we'd like to obviously breast and pancreatic b being a top priorities. So we'd like to partner that could help us maximize the value of it.
Patrick Tom: The asset in these multiple vacation and that could be done you know either through a global partnership or more regional like Europe.
Christophe Degois: And that could be done, you know, either through a global partnership or a more, you know, regional like Europe, European partnership. So we're looking at both avenues right now. Does that answer your question? Yes, that's helpful.
Patrick Tom: You're up in partnership. So we were looking we are looking at both both avenues right now does that answer your question.
Yes, that's helpful.
Tom Heineman: Tom, do you want to comment on the combination? Yeah, yeah, sure. If you don't mind, Patrick, I'll just mention the combination with checkpoint inhibitors specifically. So, we've done a lot of work, translational work, based on samples from clinical trials in a number of different indications, including breast and pancreatic cancer, and have shown, particularly in pancreatic cancer, but also in breast cancer, that Pella clearly potentiates the activity of checkpoint inhibitors, right? Now, in breast cancer, we have seen very strong efficacy data with Pella without a checkpoint inhibitor, so it's not necessarily essential in every context, but in pancreatic cancer specifically, we have really solid clinical and translational data indicating a synergy with checkpoint inhibitors, so this is something that we will continue to explore and leverage on an indication-by-indication basis.
Patrick Tom: Uh Huh, Patrick can comment yeah, do you want to comment on the combination.
Patrick Tom: Yes, yes sure. If you if you don't mind, Patrick I'll, just mention the combination with checkpoint inhibitors specifically.
Patrick Tom: So we've done a lot of work translational work based on samples from our clinical trials.
Patrick Tom: A number of different indications, including breast and pancreatic cancer.
Patrick Tom: We have shown particularly in pancreatic cancer, but also in breast cancer that pellet.
Patrick Tom: Clearly potentiate the activity of checkpoint inhibitors right now in breast cancer, we have seen very strong efficacy data with power without a checkpoint inhibitor. So it's not necessarily a central in every context, but in pancreatic cancer, specifically, we have really solid clinical and translational data.
Patrick Tom: Indicating.
Patrick Tom: Indicating a <unk>.
Patrick Tom: Synergy with checkpoint inhibitors. So this is something that we will continue to explore and leverage on a indication by indication basis.
Patrick Tom: Yeah.
Patrick Truschel: Okay, thanks so much. Thank you.
Patrick Tom: Great. Thanks, so much.
Patrick Tom: Okay.
Patrick Tom: Okay.
Operator: Once again, should you have a question, please press star 4 by the 1 on your telephone keypad.
Speaker Change: Thank you once again should you have a question. Please press star followed by the one on your telephone Keypad. Your next question comes from the line of Michael <unk> from Raymond James. Please go ahead.
Michael Freeman: Your next question comes from the line of Michael Freeman from Raymond James. Please go ahead.
Michael Freeman: Hey, good afternoon, Wayne, Kirk, Tom, Christophe. Just a few questions here. You mentioned, you know, on the Metastatic Breast Program, you know, you've previously discussed a registration path that might enable accelerated approval. And then, you know, I think I'm hearing for the first time discussion of treatment of patients at different stages of the treatment journey and leaning toward, you know, earlier stage patients, if I'm hearing it, if I heard it right. I wonder if you could discuss, just like dive into that a little more. Would this be an alternative to a registration-enabling trial, or would this be like a separate cohort along the treatment journey?
Tom Christoph: Hey, Good afternoon, Wayne correct, Tom Christoph.
Speaker Change: So a few questions here you mentioned.
Tom Christoph: On the metastatic breast program.
If you previously discussed a registration.
Tom Christoph: Registration path.
Tom Christoph: That made it an accelerated approval.
Tom Christoph: And then.
Tom Christoph: I think I'm hearing for the first time discussion of treatment of patients with different different stages of their treatment journey and leaning toward early earlier stage patients. If I'm hearing you if I heard it right I.
Speaker Change: I Wonder if you could discuss that.
Speaker Change: I didn't spend a little more is this would this be an alternative to a registration enabling trial or would this be like a separate cohort are along the treatment journey.
Michael Freeman: If you could just discuss the rationale and different potential registration paths.
Speaker Change: <unk> be the rationale and different potential registration paths.
Tom Heineman: Yeah, Tom here. So just to be clear, we're not, we're not trying to imply that we would be shifting towards earlier stage necessarily. I'm just trying to indicate that there are a lot of different. populations in the breast cancer treatment path that could provide valuable information and advance the overall program. And one of those may be an earlier stage study in neoadjuvant patients. But the other thing to consider is that the antibody drug conjugates, as you're certainly aware, are changing the landscape in breast cancer. This provides us with a real opportunity because following antibody drug conjugate therapy, the treatment for these patients is much less clear and is wide open for agents like pellet-based combination therapy to step in.
Tom: Yeah, Tom here, so just to be clear we're not.
Speaker Change: Not trying to imply that we would be shifting towards earlier stage nessus.
Tom: Necessarily where I'm just.
Tom: Trying to.
Tom: Indicate that there are a lot of different.
Tom: Populations in the breast cancer.
Tom: Treatment path that could provide valuable information in advance the overall program and one of those maybe in earlier stage study in neo adjuvant patients, but the other the other the other.
Speaker Change: Thing to consider is that the antibody drug conjugates, such as you're certainly aware are changing the landscape in breast cancer.
Tom: This is it provides us with a real opportunity.
Tom: Does following antibody drug conjugate therapy the treatment for these patients is much less clear.
Tom: And it's wide open for agents like <unk> based combination therapy to step in.
Tom Heineman: And so in discussing with key opinion leaders, there is a sense that One potential way to advance the program and de-risk it and move it forward efficiently would be to specifically generate data in patients who have, who are, these are not earlier stage patients, but these are patients who have failed hormonal therapy and then also failed an antibody drug conjugate. We have every reason to believe that Pella would be a successful agent in this, in that patient population, and generating direct data in that population could be a very nice way to further de-risk the program and also stimulate additional interest by potential partners, investors, and so forth, who are looking to understand as well as possible where Pella could fit into the overall treatment path.
Tom: And so they're discussing with key opinion leaders there there is a.
Tom: Since that.
Tom: One potential way to advance the program and Derisk, it and move it forward efficiently.
Tom: Would be to specifically generate data in patients who have who are these are not earlier stage patients. But these are patients who have failed hormonal therapy and then also fail to antibody drug conjugate. We have every reason to believe that pellet would be a successful agent in this.
Tom: In that patient population and generating direct data in that population.
Tom: Could be a very nice way to further.
Tom: Further derisked the program and also stimulate additional.
Tom: The interest by potential partners investors and so forth who are.
Tom: I'm looking to understand as well as possible, where how it could fit into the overall treatment path I.
Tom Heineman: I hope that answers your question, and I don't know if anyone else on the call may want to contribute to that answer. Yeah, that's helpful. I just a little more on that. I'm curious, like, was that was that not similar to the What you contemplated for the original registration-enabling trial, that it would line up after ADCs, or are you now considering a smaller cohort study that would exclusively look at post-ADC, or patients that had failed hormonal therapy and ADCs? Yeah, we had anticipated that before. The reality of the matter is that at that time, it was more hypothetical, because the ADCs had not yet been approved.
Tom: I hope that answers your question and I don't know if anyone else on the call them they want to contribute to that answer.
Yes.
Speaker Change: Helpful. I, just need a little more on that I'm curious like what was that not similar to the.
What you had contemplated for the.
Speaker Change: Original registration, enabling trial that it would lineup after after adcs or is or are you now considering.
Speaker Change: Smaller cohort study.
Speaker Change: That would exclusively look at post data you hear like the patients that had failed hormonal therapy.
Speaker Change: The agencies.
Speaker Change: We had anticipated that before.
Speaker Change: The reality of the matter is that's not yet at that time it was more hypothetical because the adcs had not yet been approved.
Tom Heineman: as the first-line therapy immediately following failure on hormonal therapy, right? Now with that approval, I don't remember when that was, but first quarter of this year, with that approval now on the books, that opens up a slightly different population and leads us to expect that the ADCs are going to be used even earlier in the treatment path than had been obvious before, right? And so provides us with some additional opportunity and motivation to further... solidify the appellate's efficacy in that population. You see what I'm saying? Yes. And if we were to go down that path, we certainly would do it in a smaller study, but we wouldn't do it in a tiny study.
Speaker Change: That's the first line therapy immediately following failure on hormonal therapy right now without approval I don't remember when that was with first quarter of this year with that approval now on the books that opens up a slightly different population.
Speaker Change: And leads the.
Speaker Change: Leads us to expect.
Speaker Change: Is that the adcs are gonna be used even earlier in the treatment paths and then had been obvious before right and so provides us with some additional opportunity and motivation to further.
Speaker Change: Solidify that.
Speaker Change: Power has efficacy in that population.
Speaker Change: I'm, saying.
Speaker Change: Yes, and if we if we were to go down that path, we certainly would do it in a smaller study.
Speaker Change: But we wouldn't do it in a tiny study we definitely want to make sure that the data that were generated there are are robust enough to really move the program.
Michael Freeman: We definitely want to make sure that the data that were generated there are robust enough to really move the program forward as rapidly and with as little risk as possible. Okay, all right, great. I appreciate you guys being dynamic to the landscape.
Speaker Change: Florida's rapidly.
Speaker Change: There's little risk as possible.
Speaker Change: Okay, Alright, great I appreciate you guys being a dynamic landscape.
No.
Kirk Look: Now, I have a question for Kirk on the on the share purchase agreement, you know, congratulations on on finding that access to capital, I wonder if you could describe just like the basic structure of this agreement, any terms, conditions, benefits to alumni capital. And just like the flexibility that offers Yeah, for sure, Michael. I think essentially, this share purchase agreement does provide us with access to capital at our discretion. Importantly, the minimum purchase notice is set at $750,000. Often what we see are smaller purchase notices moving forward, so we felt that that was important. The structure in terms of commitment fees, there was an upfront commitment fee that was granted and then there is an additional fee that is attached on a pro rata basis as well in an effort to reduce the cost of capital, which we were pleased with.
Speaker Change: A question for Kirk on the on the share purchase agreement congratulations on them on.
Speaker Change: Finding that access to capital I Wonder if you could describe.
Speaker Change: Just like the basic structure of this agreement any terms conditions benefits to alumni capital.
Speaker Change: And just like the flexibility offered to you.
Speaker Change: Yeah.
Speaker Change: Yes for sure Michael.
Speaker Change: I think essentially the share purchase agreement.
Speaker Change: <unk> does provide us with access to capital at our discretion.
Speaker Change: Importantly, the minimum purchase.
Speaker Change: Notice is.
<unk>.
Speaker Change: Got it.
Speaker Change: 750000.
Speaker Change: Often what we see are smaller purchase notices.
Speaker Change: Looking forward, we felt that that was important.
Speaker Change: The structure in terms of of.
Speaker Change: Commitment fees there was an upfront commitment fee that was granted and then there is an additional fee. That's that's attached on a pro rata basis.
Speaker Change: Well in an effort to.
Speaker Change: To reduce the cost of capital, which we were which we were pleased with.
Kirk Look: And so it really allows us to, based on the market dynamics of the time, allows us a source of capital that we can, at our discretion, take advantage of and allows us to move the programs forward, get us through our milestones, especially around the Goblet Study that is coming up here and get through this CEO transition. And importantly, move the runway forward. Okay, all right. That's helpful.
Speaker Change: So it really allows us to you know based on kind of the.
Speaker Change: <unk>.
Speaker Change: Okay dynamics at the time.
Speaker Change: Allows.
Speaker Change: It allows us.
A source of capital that we can.
Speaker Change: At our discretion tick.
Speaker Change: Take advantage of it.
Speaker Change: And it allows us to move the programs forward get us through our milestones, especially around the the goblet study that's coming up here.
Speaker Change: And and get through this CEO transition.
Speaker Change: And.
Speaker Change: And importantly.
Speaker Change: Moving the runway forward.
Speaker Change: Okay.
Speaker Change: Okay, Alright, that's helpful.
Michael Freeman: Um, yeah, have you have you tapped that since since announcing Yes, we've topped it a little bit, but again, we're just making sure that it works as described and we're doing it in a strategic manner. Okay. Thank you. That's all for me. Congratulations. Thank you.
Speaker Change: Have you have you tapped that since our since announcing here.
Speaker Change: We earned yes, we've tapped it.
Speaker Change: A little bit.
Speaker Change: But again, we're just.
Speaker Change: Making sure that.
Speaker Change: Works works as described.
Speaker Change: We're doing it or not.
Speaker Change: Strategic manner.
Speaker Change: Okay. Thank you that's all from me congratulations.
Speaker Change: Thank you there are no further questions at this time I would now hand, the call back to Mr. Clark for any closing remarks.
Operator: There are no further questions at this time.
Kirk Look: I would now hand the call back to Mr. Kirk Look for any closing remarks. Well, thanks, Operator. Once again, I would like to thank everyone for taking the time to hear about our recent progress and plans for the future. We continue to be excited about 2025 and how Pella is positioned to positively impact the lives of cancer patients. Wishing everyone a great day. Thanks very much.
Speaker Change: Okay.
Clark: Well, thanks, operator, and once again I would like to thank everyone for taking the time to hear about our recent progress and plans for the future. We continue to be excited about 2025, and how <unk> positioned to positively impact the lives of cancer patients wishing everyone. A great day, thanks very much.
Operator: And this concludes today's call. Thank you for participating. You may all disconnect.
Clark: And this concludes today's call. Thank you for participating you may all disconnect.