Q2 2024 Summit Therapeutics Inc Earnings Call
Unknown Executive: Manmeet Soni, Carter Gould, Allen Yang, Bradley Canino, Daniel Delfico, Ankur Dhingra, Dara Azar, Mahkam Zanganeh, Daniel Delfico, Hartaj Singh, Dave Gancarz, Dara Azar, Ankur Dhingra, Hartaj Singh, Summits to multi-regional registration of Phase 3 non-small cell lung cancer trials, Harmony and Harmony Harmony remains on track to complete its planned enrollment later this year.
Unknown Executive: 200 million, Adipremium, over the then current market price, extended our cash runway, and increasing our resources to execute our expansive goals.
Over the then current market price, extending our cash runway and increasing our resources to execute our expansive goals man.
Manmeet Soni: Manmeet will provide more details about our financial position in a few minutes.
Speaker Change: <unk> will provide more details about our financial position in a few minutes.
Unknown Executive: Some of the two multi-regional registrational phase three non-small cell lung cancer trials, Harmony and Harmony Three, continue to enroll. Harmony remains on track to complete its planned enrollment later this year. Alongside our partners at Akessa, having this map data was featured at ASCO, as well as Harmony A data being published in JAMA, Journal of the American Medical Association. This, in addition to smaller conferences and best of ASCO follow-up meetings, have been excellent in fostering KOL discussions regarding the future of cancer therapy, including the potential for evidence map. These efforts were further bolstered as we continue to ramp our Investigator-Sponsored trial or our IST program.
Speaker Change: Some astute multi regional Registrational phase III non small cell lung cancer trials harmony in harmony III continued to enroll harmony remains on track to complete its planned enrollment later this year alongside our partners at a castle, our munis and <unk> data was featured at <unk> as well as harmony a data being published in Jama.
Unknown Executive: Alongside our partners at Acesso, iVanissimab data was featured at ASCO, as well as Harmony A data being published in JAMA, the Journal of the American Medical Association. This, in addition to smaller conferences and Best of ASCO follow-up meetings, has been excellent in fostering KOL discussions regarding the future of cancer therapy, including the potential for iVanissimab. These efforts will be further bolstered as we continue to scale up our Investigator Sponsored Trial, or IST, program.
Journal of American Medical Association. This in addition to smaller conferences and best of ESCO follow up meetings have been excellent and fostering kols discussions.
Regarding the future of cancer therapy, including the potential for Evan Smith.
These efforts were further bolstered as we continue to ramp our investing investigator sponsored trial or ISG program last month, we announced a five year strategic collaboration with MD Anderson to accelerate development of <unk> to the opportunity to conduct multiple clinical trials with one of the world's most respected medical.
Unknown Executive: Last month we announced a five-year strategic collaboration with MD Anderson to accelerate development of Openism map through the opportunity to conduct multiple clinical trials with one of the world's most respected medical health care institutions. These efforts are in addition to our continued collaboration with our partners at Akessa, who continue to generate patient-positive data in phase two settings in both lung cancer and solid tumors outside of lung cancer. Data which can help support additional late-stage clinical trials. These accomplishments have been foundational to our 2024 goals of successfully executing on our registration phase three trials while expanding our clinical development program.
Unknown Executive: Last month, we announced a five-year strategic collaboration with MD Anderson to accelerate the development of ibuprofen through the opportunity to conduct multiple clinical trials with one of the world's most respected medical healthcare institutions. These efforts are in addition to our continued collaboration with our partners at Acaso, who continue to generate patient-positive data in Phase II settings in both lung cancer and solid tumors outside of lung cancer, data that can help support additional late-stage clinical trials.
<unk> health care institutions. These efforts are in addition to our continued collaboration with our partners at <unk>.
We will continue to generate patient positive data in phase II settings in both lung cancer and solid tumors outside of lung cancer data, which can help support additional late stage clinical trials. These accomplishments have been foundational to our 2024 goals of successfully executing on our Registrational phase III trials.
Unknown Executive: These accomplishments have been foundational to our 2024 goals of successfully executing on our registrational Phase III trials while expanding our clinical development program. MACI will further expound upon these accomplishments, including additional strides we have made to drive our firm, continued belief and conviction in Team Summit and the potential of avinicimab in non-small-cell lung cancer and beyond. We are an experienced, mission-driven organization with a collective goal to improve quality of life, increase potential duration of life, and resolve serious medical needs. We believe we have the right team and the right molecule in avinicimab to help us achieve this goal. With that, I will turn the call over to MACI for additional context and recent highlights for consideration.
While expanding our clinical development program.
Unknown Executive: Mackie will further expound upon these accomplishments, including additional strides we have made to drive our firm continued belief in conviction and team summit and the potential of Openism map in non-small cell lung cancer and beyond. We are an experienced mission-driven organization with a collective goal to improve quality of life, increase potential duration of life, and resolve serious medical needs. We believe we have the right team and the right molecule in Openism Map to help us realize this goal.
Maggie: Maggie will further expound upon these accomplishments, including additional strides we have made to drive our firm continued belief and conviction and team summit and the potential of <unk> in non small cell lung cancer and beyond we are an experienced mission driven organization with a collective goal to improve quality of life.
Increased potential duration of life and resolve serious unmet medical needs. We believe we have the right team and the right molecule in a position to help us realize this scope with that I will turn the call over to Maggie for additional context and recent highlights for consideration.
Unknown Executive: With that, I will turn the call over to Mackie for additional context and recent highlights for consideration.
Mackie: Thank you, Bob, and good morning, everyone. As Bob mentioned, I remain incredibly enthusiastic about the accomplishments of Team Summit and our partnership with Akessa. Before touching on the clinical highlights of Openism map, I would like to speak to the expansive clinical development work we have conducted with Openism map. Between Summit and Akessa, over 1,800 patients have been treated with Openism map in clinical studies to date worldwide. There have been 20 clinical trials around the globe evaluating Openism Map. While our phase three programs across Summit and Akessa are currently focused in non-small cell lung cancer, there are seven of the clinical trials for Openism map or evaluating or lead candidate in solid tumor settings beyond non-small cell lung cancer.
Maggie: Thank you Bob and good morning, everyone as Bob mentioned.
Maggie: Thank you Billy and <unk> about the accomplishments our team summit and our partnership with Aircastle before touching on the clinical highlight <unk> I would like to speak to the expansive clinical development work, we have conducted with Humana.
Speaker Change: Between summit on AK steel or 1800 patients have been treated with our lithium app in clinical studies to date worldwide. There have been 20 clinical trials around the globe evaluating abernethy map.
Maggie: While our phase III programs across semi and AK steel are currently focused in non small cell lung cancer setting of the clinical trials for the island as Cmos are evaluating our lead candidate in solid tumor settings beyond non small cell lung cancer of course, we are sponsoring tutoring cartwright, both of which are phase III study harmony.
Mackie: Of course, we are sponsoring two clinical trials, both of which are Phase Three studies, Harmony and Harmony Three. As a reminder, Openism map is the only PD1 VJF by specific antibody in phase three in our license territories. Openism map brings these two highly validated mechanisms of action together into one novel molecule targeting simultaneously both PD1 and VJF.
Maggie: Harmony.
Unknown Executive: As a reminder, abonisimab is the only PD-1 VGEF bispecific antibody in phase 3 in our licensed territories. Abonisimab brings these two highly validated mechanisms of action together into one novel molecule, targeting simultaneously both PD-1 and VGEF. We also announced that Harmony 2 met its primary endpoint of progression-free survival in pre-specified interim analysis, in which Ibanezibab monotherapy in a head-to-head trial against Pembrolizumab monotherapy achieved a statistically significant and clinically meaningful benefit in patients in China with first-line non-small cell lung cancer whose tumors were positive for PD-L1 expression. This path in PFS was observed broadly across subgroups, including PD-L1 low and PD-L1 high expressing tumors, as well as squamous and non-squamous histologies.
Maggie: As a reminder, <unk> is the only PD one VEGF bispecific antibody in phase III in our license territory.
Speaker Change: Matt brings these two highly validated mckenney Smith action together into one novel molecule targeting simultaneously, both PD, one and VEGF.
Mackie: Next, I would like to review our recent achievement, as well as touch on some upcoming catalysts for the remainder of this year. As a reminder, our partnership with AKSO became effective at the beginning of 2023. At the time, AKSO was enrolling or completing enrollment in two Phase Three clinical trials. We immediately got to work and enrolled our first patient in Harmony in the first half of 2023, began Harmony three enrollment in the fourth quarter of 2023, and helped to ensure Ivone Simab was featured at several medical conferences. The second quarter of 2024 was a pivotal moment for Ivone Simab and its development, with two major catalyst events occurring around the time of the ASCO 2024 conference.
Speaker Change: Next I would like to review, our recent achievements as well as touch on some upcoming catalysts for the remainder of this year.
Speaker Change: As a reminder, our partnership with <unk> became effective at the beginning of 2023 at the time I guess, it was enrolling or completing enrollment in two phase III clinical trial with <unk>.
Speaker Change: <unk> actually got toward an enrolled our fares first patient in harmony in the first half of 2023 began harmony tree enrollment in the fourth quarter of 2023 and helped to ensure our nissim App was featured at several medical conferences.
Speaker Change: The second quarter of 2024 was a pivotal moment for <unk> and its development with two major catalyst events occurring around the time of the <unk> 2024 contracts.
Mackie: Ivone Simab received marketing approval in China, supported by AKSO Harmony A phase three clinical trial for patients with advanced non-small cell lung cancer, who progressed following an EGF or TKI. This data was subsequently featured in an oral presentation at ASCO, and the Harmony A study was published in the Journal of the American Medical Association or JAMA. We also announced that Harmony 2 met its primary end point of progression-free survival in press-visified interim analysis in which Ivone Simab Monotaurabine in a head-to-head trial against Pembro, Lizumab Monotaurabine achieved a statistical significance and clinically meaningful benefit in patients in China, with first-line non-small cell lung cancer patients whose tumors were positive for PDL-1 expression.
Speaker Change: I've only seen <unk> received marketing approval in China supported by AK, So harmony, a phase III clinical trial for patients with advanced non small cell lung cancer, who progress following an Egfr T. Kat. These data was subsequently featured in an oral presentation at <unk> and Eharmony. A study was published in the journal of American Medical.
Speaker Change: Association or Jama.
Speaker Change: We also announced that harmony to met its primary endpoint of progression free survival in pre specified interim analysis in which I have understood that monotherapy in a head to head trial against Pembroke lithium monotherapy achieved statistically significant and clinically meaningful benefit in patients in China with first line non small cell lung cancer.
Speaker Change: <unk>, whose tumors were positive for PDL one expression in.
Mackie: Improvements in PFS was observed broadly across subgroups, including PDL-1 low and PDL-1 high, expressing tumors, as well as comments and non-small-small-estologies. We look forward to having additional Harmony 2 data presented at a major medical conference this quarter. Looking to the remainder of 2024, in addition to the Harmony 2 data readout, we plan to complete enrollment in our multi-regional Harmony trial later this year and expect additional Phase Two data. In addition, in long and non-long indications to be presented at multiple medical conferences in the coming months, including the World Conference on Lung Cancer and ESMO. ESMO recently released abstract titles featuring Ivone Simab in phase two studies in triple-negative breast cancer, colorectal cancer, and head-and-neck cancer.
Unknown Executive: We look forward to having additional Harmony 2 data presented at a major medical conference this quarter. Grade 3 or higher potential VJF-related adverse events were reported in 3.1% of patients in the treatment arm versus 2.5% of patients in the placebo arm. However, there were no grade 3 or higher bleeding events observed in either arm.
Mackie: We are fortunate to have created such a strong partnership in our ongoing collaboration with ECSO, as we leveraged data from multiple solid tumor studies supporting and informing some of its own late-stage clinical development strategy in our license territories.
Mackie: With meaningful updates from ECSO Harmony A and Harmony 2, occurring this past quarter, we wanted to take the opportunity on this quarter's earning call to review both phase three study design and highlight some key results. Starting with Harmony A, this is a double-blinded, placebo-controlled, single-region, randomized phase three trial evaluating Ivone Simab plus chemotherapy versus placebo-plus chemotherapy for patients with advanced or metastatic EDFR mutant non-small results. This month's long cancer and disease progression after EDFR TKI treatment. 322 patients were enrolled across 55 study sites in China, and patients were stratified for exposure to third-generation EDFR TKI treatment and the presence of brain metastasis.
Mackie: As a reminder, approximately 85% of Harmony A patients are intended to be included in our own Harmony Study Analysis, representing those patients in Harmony A who receive a third-generation EGFR TKI prior to entering the trial. In Harmony A, the primary endpoint of progression-free survival per independent radiologic review committee was met, achieving a PFS hazard ratio of 0.46, representing a 54% reduction in the risk of disease progression or death compared to chemotherapy. Additionally, the subgroup of patients receiving a third-generation EGFR TKI, like Aussie Mertonib, experienced reduced risk of disease progression or death of 52% or hazard ratio of 0.48, as our Harmony trial enrollment is expected to complete in the second half of this year.
Mackie: We remain strongly encouraged by the opportunity for Ivone Sima. In addition, an overall survival analysis of the Harmony A data was requested by the Chinese regulatory authority as a part of its review of Ivone Sima for more getting approval in China. At 52% data maturity, median overall survival in the Ivone Sima form showed a positive survival trend, with a hazard ratio of 0.80. Ivone Sima was well-to-related and demonstrated a manageable safety profile. Treatment-related adverse events leading to this continuation were 5.6% in the treatment arm compared to 2.5% in the placebo arm, and there were no deaths reported in either arm.
Mackie: Moving to Harmony 2, this ECSO-sponsored study in a single-region, multi-center, double-blinded, randomized phase retrial evaluating monoterapia Ivone Sima, head to head against monoterapia, parabolezema as first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors have positive PDL1 expression or a TPS score of greater than 1%. Patient in the study are stratified by PDL1 low or TPS scores for 1 to 49% and PDL1 high or TPS score of 50% or greater, scramas versus non-scramas histology and stage of disease. Harmony 2 primary input is progression-free survival as measured by independent radiologic review committee.
Mackie: In high-level results for Harmony 2, Ivone Sima demonstrated statistically significant clinical meaningful improvement in progression-free survival over Pembrolizumab. This benefit was observed across patients' subgroup including PDL1 low, PDL1 high, scramas and non-scramas histologies, as well as other high-risk patients. Notably, no other randomized phase retrial, in contrast, in non-small cell lung cancer, have demonstrated statistically significant improvement in progression-free survival in a head-to-head setting versus pembrolizumab. Dismap. As mentioned previously, we are eager to share more information when the Harmony 2 interim analysis data set is presented at an upcoming major medical conference this quarter. The PDL1 subgroups, as well as the subgroups by histology, are important in terms of informing next steps in our clinical development pathway for indication both within long and beyond long.
Speaker Change: P J on one high squamous and non squamous histology as well as other high risk patients.
Speaker Change: Notably no other randomized phase III clinical trial in non small cell lung cancer, who have demonstrated a statistically significant improvement in progression free survival in head to head setting versus parallelism up.
Speaker Change: As mentioned previously we are eager to share more information when the harmony two interim analysis dataset is presented at an upcoming major medical conference. This quarter, the PD lone subgroups as well as the subgroups by histology are important in terms of informing next steps in our clinical development pathway for indication both within <unk> and beyond.
Mackie: We had many highlights this past quarter and touched on most of them already, but would like to mention our five-year strategic collaboration with the MD Anderson Cancer Center that was announced last month, in which the development of the iPhone Ximab will be accelerated in several solid two more types across multiple studies. MD Anderson will lead this clinical choice to evaluate the safety and potential clinical benefit of the iPhone Ximab, including the possibility of identifying biomarkers through additional research activities. Early work may include renal cell carcinoma, colorectal cancer, skin cancer, breast cancer, and glioblastoma. The partnership has the potential to rapidly expand iPhone Ximab's development program.
Speaker Change: Long.
Speaker Change: We had many highlights this past quarter and touch on most of them already but would like to mention our five year strategic collaboration with the MD Anderson cancer Center that was announced last month in which the development of <unk> will be accelerated in several solid tumor types across multiple studies MD Anderson will lead this clinical trial to evaluate the safety.
Speaker Change: <unk> potential clinical benefit of <unk>, including the possibility of identifying biomarkers through additional research activities. Early work may include renal cell carcinoma, colorectal cancer, a skin cancer breast cancer and Glioblastoma.
Speaker Change: Partnership has the potential to rapidly expand our new Sim ops development program with.
Mackie: We expanded our license territories to include Latin America, including Mexico, and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa, in addition to our original license territories, which include the US, Europe, Canada, and Japan. We are excited to expand open our existing territories as we seek to bring iPhone Ximab to as many people around the globe as possible.
Speaker Change: We expanded our license territories to include Latin America, including Mexico, and all countries in Central America, South America, and the Caribbean, The Middle East and Africa. In addition to our original license territories, which include the U S Europe, Canada and Japan.
Speaker Change: Cited to expand up in our existing territories as we seek to bring <unk> to as many people around the globe as possible.
Mackie: In addition, I would like to take a moment to acknowledge that we straighten our greater team recently with two new appointments to our board of directors. In every 2024, we now executive and genomic said Dr. Mustafa Ronari joined our board. He has played a leading role in the development of technology which have helped improve the odds for patients with cancer, including biomarker driven diagnostics such as next generation sequencing technology and platforms. He has co-founded several companies as well as being Luminous Shift Technology Officer from 2008 to 2021. In June, Mr. Jeff Hoover, the transformational Google and Grail executive, joined our board as well.
Speaker Change: In addition, I would like to take a moment to acknowledge that'd be straighten our greater team recently with two new appointment to our board of directors.
Speaker Change: In February 2024, renown executive and genome Me said Dr. Mostafa <unk> joined our board has played a leading role in the development of technology, which have helped improve the odds for patients with cancer, including biomarker driven diagnostics, such as next generation sequencing technology and platforms.
Mostafa Ronaghi: Yes, cofounded several companies as well as being Illumina as Chief Technology Officer from 2008 to 2021.
Speaker Change: In June Mr. Jeff Huber, the transformational Google and Grail Executive joined our board as well.
Mackie: Prior to his current role leading Tritomy Capital ABC firm, Jeff was the founding CEO and vice chairman of Grail, a mission-driven company seeking to detect cancer early when it can be cured. Prior to Grail, he was a Senior Vice President at Alphabet Inc., formerly known as Google Inc. Over 30 years at Google, he co-founded Google's life sciences effort in Google X, and he led development and scaling of Google Maps, Google apps such as Gmail, Google Calendar, Google Docs, as well as Google Ads. Jeff managed a team of over 5,000 employees and five billion PNL during his time at Google.
Speaker Change: <unk> current role leading try told me capital a VC firm, Jeff was the founding CEO and Vice Chairman of grade and mission driven company seeking to detect cancer early when it can be cured.
Speaker Change: Great. He was a senior vice President at Alphabet, Inc. Formerly known as Google in over 30 years at Google He Cofounded, Google Life Sciences efforts, and Google X and he led the development and scaling of Google maps, Google apps, such as Gmail, Google calendar, Google Docs as well as Google ads, just manage a team of over 5000 employ.
Speaker Change: And 5 billion P&L during his time at Google. In addition, Jeff is also a board member at several other cutting edge company.
Mackie: In addition, Jeff is also a board member at several other cutting-edge companies. We are fortunate to have Mustafa and Jeff's perspectives and expertise as they join us in our mission to make a significant positive difference in the lives of patients with serious unmet medical needs.
Speaker Change: We are fortunate to have more stuff on Jeff perspectives and expertise as they join us in our mission to make a significant positive difference in the lives of patients with serious unmet medical need.
Mackie: Finally, I would like to take a moment to thank Team Summit as well, and I have described all of the accomplishments we have achieved over the past year and a half. With Ivone Simap, this team has done a remarkable job across every team in making our goals a reality. It is a tremendous honor and privilege to work with each member of Team Summit, and I would like to express my heartfelt thanks to each and every one of our great team members.
Speaker Change: Finally, I would like to take a moment to thank team summit as Bob and I have described all of the accomplishments we have achieved over the past year and a half with eyewitness mob. This team has done a remarkable job across every team and are making our goals a reality.
Speaker Change: It is tremendous honor and privilege to work with each member of team summit and I would like to express my heartfelt. Thanks to each and every one of our great team members with that update I will now asthma and me to provide details on our financial position and outlook.
Manmeet Soni: With that update, I will now ask Manmy to provide details on our financial position and outcomes.
Manmeet Soni: Look, Manmeet. Thank you, Miki, and good morning, everyone. We filed this morning at 10-Q for the second quarter of 2024.
Unknown Executive: Thank you, Mickey, and good morning, everyone.
Speaker Change: Yeah.
Speaker Change: Thank you Mickey and good morning, everyone.
Me: We filed this morning, our 10-Q for the second quarter of 2024.
Manmeet Soni: Today, I'll provide you with an update on three items: our cash position after our recent $200 million financing, our updated cash runway guidance, and second quarter operating expenses. Let me start with cash position. We entered the second quarter of 2024 with a cash position of $325.8 million. This cash position was strengthened at the end of second quarter with the closing of a $200 million unsolicited private placement from a single institutional investor in June 2024. This morning, we also filed a Form S-3 in order to register the shares, which were issued in the private placement on June 6, 2024.
Speaker Change: Today I'll provide you with an update on three items, our cash position after our recent $200 million financing.
Speaker Change: Our updated cash runway guidance.
Me: Second quarter operating expenses.
Speaker Change: Let me start with cash position.
Speaker Change: The second quarter of 2024, with a cash position of $325 8 million.
Speaker Change: This cash positions warfarin strengthen at the end of second quarter with the closing of our 200 million dollar <unk> private placement from a single institutional investor in June 2024.
Speaker Change: This morning, we also filed a form S. Three in order to register the shares which were issued in the private placement on June six 2024.
Manmeet Soni: Moving to updated cash runway guidance based on our planned operations, including our two Facebook clinical trials, we updated our cash runway guidance and now expect that we have sufficient cash to run our operations into the fourth quarter of 2025.
Speaker Change: Moving to our updated cash runway guidance.
Speaker Change: Based on our plant operations, including our two phase three clinical trials, we updated our cash runway guidance.
Speaker Change: Now I expect that we have sufficient cash to run our operations and to fourth quarter of 2025.
Manmeet Soni: Turning to operating expenses, I'll provide details to both gap and non-gap numbers. You can refer to our press release issued this morning for a reconciliation of GAAP to non-GAAP financial measures. Non-GAAP expenses exclude stock-based compensation and one-time charges related to acquired in-process R&D expenses. Our gap R&D expenses during the second quarter were $30.8 million compared to $30.9 million for the first quarter of 2024. And non-GAAP R&D expenses were $27.3 million in the second quarter of 2024 compared to $28.5 million for the first quarter of 2024. Our gap acquired IP R&D expenses during the second quarter were $15 million compared to $0 for the first quarter of 2024.
Speaker Change: Turning to operating expenses I will provide details to both GAAP and non-GAAP numbers you can refer to our press release issued this morning for a reconciliation of GAAP to non-GAAP financial measures.
Speaker Change: non-GAAP expenses exclude stock based compensation and onetime charges related to acquired in process R&D expenses.
Speaker Change: Our GAAP R&D expenses during the second quarter were $30 8 million compared.
Speaker Change: Compared to $30 9 million for the first quarter of 2024.
Speaker Change: Our non-GAAP R&D expenses were $27 3 million in the second quarter of 2024 compared to $28 5 million for the first quarter of 2024.
Speaker Change: Our GAAP acquired IP R&D expenses during the second quarter were $15 million compared to zero for the first quarter of 2024.
Manmeet Soni: This $15 million expense is related to our upfront consideration for adding territories of Latin America, Africa, and the Middle East as for the June 2024 license agreement amendment with a case of. Turning to GNA, gap GNA expenses for our second quarter to 2024 total to $14 million compared to $11.7 million for the first quarter of 2024. And non-GAAP GNA expenses were $6.4 million during the second quarter of 2024 compared to $4.6 million for the first quarter of 2024. Overall, our non-GAAP operating expenses during the second quarter of 2024 were $33.7 million, consistent with $33.1 million for the first quarter of 2024.
Speaker Change: This $15 million expense is related to our upfront consideration for adding that increase of Latin America Africa, and middle East as for the June 2024 license agreement Amendment with our queso.
Speaker Change: Yes.
Speaker Change: Turning to G&A GAAP G&A expenses for our second quarter 2024, total to $14 million compared to $11 7 million for the first quarter of 2024.
Speaker Change: Our non-GAAP G&A expenses were $6 4 million during the second quarter of 2024 compared to $4 $6 million for the first quarter of 2024.
Speaker Change: Overall, our non-GAAP operating expenses during second quarter of 2024 were $33 7 million consistent with $43 1 million for the fourth quarter of 2024.
Unknown Executive: And with that, I will hand it back over to Dave.
Speaker Change: And with that I will hand, it back over to Dave.
Unknown Executive: Thank you, Bob McKee, and my mate. We'll now see if there are any questions that our team can help answer. Christina, if you could please open the line for questions. Yes, thank you. And at this time, I'd like to remind everyone that in order to ask a question, please press star, then the number one on your telephone keypad. Again, please press star one to ask a question. We'll pause for a moment to compile the Q&A roster.
Dave: Thank you Bob Mickey in Miami.
Dave: We will now see if there are any questions that our team can help answer.
Speaker Change: Kristina if you could please open the line for questions.
Kristina: Yes, Thank you and at this time I would like to remind everyone in order to ask a question. Please press Star then the number one on your telephone keypad again. Please press star one to ask a question, we'll pause for a moment to compile the Q&A roster.
Bradley Canino: And your first question comes from the line of Brad Canino from Stifel. Your line is open. Great. Thanks for taking our question. This is Dara Azar on for Brad.
Speaker Change: And your first question comes from the line of Brad Canino from Stifel. Your line is open.
Speaker Change: Great. Thanks for taking our question. This is <unk> on for Brad.
Dara Azar: Could you be able to walk through the puts and takes of data disclosure? If Harmony 2 is at Wart Long, when is it that title allowance or things like should we expect an abstract tax before the presentation to have a lifted embargo? And if so, what data could be included in the abstract? Sure. Thanks, Dara. I appreciate the question. This is Dave responding. So, as you can imagine, our Harmony 2 data is considered a breaker abstract at the World Conference for Lung Cancer or World Lung. So, our partners at a KESO previously announced their intention to submit the Harmony 2 data to the World Lung Conference.
Speaker Change: Could you.
Speaker Change: We were able to walk through the puts and takes of data disclosure.
Speaker Change: <unk> two is that we're long one is at the title allowance.
Speaker Change: Sure. Thanks, Mike should we expect from the abstract tax before the presentation to have it lifted the embargo.
Speaker Change: And if so.
Speaker Change: What data could be included in the abstract.
Speaker Change: Sure. Thanks, Terry I. Appreciate the question this is Dave responding so.
Dave: As you can imagine our harmony to data is considered a late breaker abstract.
Speaker Change: At the World gas conference for lung cancer or worldwide.
Speaker Change: Our partners at a cost so previously announced their intention to submit the harmony to data to the world Lung conference and so the deadline for abstracts for World Lung where July 31.
Dave Gancarz: And so, the deadline for abstracts for World Lung was July 31st. Notifications to the primary authors of each of those abstracts that are late breakers are provided early in August, but generally between the 7th and 10th of August. Traditionally, what our understanding of what World Lung does is around August 15th releases the titles and abstracts from most of the remaining, so they release some of the original titles already. But for the remaining titles and abstracts released around August 15th, however, what they do is they withhold the number of what they consider presidential symposium or otherwise larger presentations until the actual conference itself, at which point they only release the title, but the abstract is held until the conference itself.
Speaker Change: Notifications to the primary authors of each of those abstracts that are late breakers are provided.
Speaker Change: Early in August, but generally between the seventh in the 10th of August.
Speaker Change: Traditionally what our understanding of what world lung does is.
Speaker Change: Around August 15th releases, the titles and abstracts for most of the remaining so they've released some of the original.
Speaker Change: Titles already but for the remaining.
Speaker Change: <unk> and abstracts released around August 15th However, what they do is they.
Speaker Change: With hold a number of what they consider presidential symposium or otherwise larger presentations until the actual conference itself at which point they only released title, but but the abstract is held until the conference itself. So at this point, because we havent yet technically hit the acceptance time period of August 7th.
Dave Gancarz: So, at this point, because we haven't yet technically hit the acceptance time period of August 7th to 10th, we're not yet made aware in terms of whether our abstract will be held back or not. So, Dara, I appreciate the question. It's a very good question in terms of exactly the timeline of when things will come up, but until we hit the approval date for World Lung between the 7th and 10th of August, and then they announce what they will and won't hold back until the conference itself. You know, we'll need to wait patiently alongside you in terms of those details.
Speaker Change: We're not yet made aware in terms of whether our abstract will be held back or not so I. Appreciate the question. It's a very good question in terms of exactly the timeline of when things will come up but until we hit the approval date from world lung between the seventh and 10th of August and then they announce what they will and won't.
Speaker Change: Back until the conference itself.
Speaker Change: We will need to wait patiently alongside you in terms of those details.
Dave Gancarz: Yeah, very helpful overview. If I may ask a follow-up, what is your latest view on OS maturity, if it's going to be return up to for inclusion the presentation, if not, would there be any language in the abstract to describe the trend observed, and if there's time I'll come back for another follow-up? Sure, Dara. So, this is Dave again. I'll start and then I'll let Alan add in the additional context that he'd like to, but if you recall from the earlier trials that were run with Pemberlismab as a monotherapy in the setting, the Keynote 024 and the Keynote 042 settings, what the time period by which they reached their survival maturity was a little bit longer than the time period on which this trial has matured from last patient.
Speaker Change: Yeah very helpful overview, if I may ask a follow up.
Speaker Change: What is your latest view on OS maturity, if it's kind of a mature enough to for inclusion in the presentation and if not what the.
Speaker Change: Would there be any language in the <unk>.
Speaker Change: Abstract describes as trying to observe.
Speaker Change: Yeah.
Speaker Change: And if there's time I'll come back for another follow up.
Speaker Change: Sure. Darren This is Dave again, I'll start and then I'll I'll I'll, let Alan add any additional context that he'd like to but if you recall.
Alan: From the earlier trials that were run with <unk> as a monotherapy in this setting the keynote <unk> four and the keynote <unk> four two settings.
Speaker Change: What's the time period by which they reached there.
Speaker Change: <unk> maturity.
Speaker Change: It was a little bit longer than the time period in which this trial has matured from from last patient and so as a reminder.
Dave Gancarz: And so, as a reminder, Harmony 2 completed enrollment around the end of the 3rd quarter, beginning of the 4th quarter of 2023. And so is it that interim analysis was run and ultimately the IDMC met and then we released the top line data along with our partners at a KESO in May, not a lot of time from an overall survival perspective had transpired from when the trial completed enrollment. And so, as a result, anything that we have at this point will be early. So we haven't made definitive announcements or decisions on exactly what will be presented with respect to overall survival, but what I would say is we're not holding anything back at this point as much as news, time needs to take place for these patients to remain on trial and study to get them mature enough, read out for overall survival at a mature level.
Speaker Change: Harmony to completed enrollment around the end of the third quarter beginning of the fourth quarter of 2023.
Speaker Change: So is that interim analysis was run and ultimately the DMC met and then we released the top line.
Speaker Change: Data along with our partners at <unk> in May.
Speaker Change: Not a lot of time from an overall survival perspective had transpired from when the trial completed enrollment and so as a result.
Speaker Change: Anything that we have at this point will be early so we havent made definitive announcements or decisions on exactly what will be presented with respect to overall survival, but what I would say is we're not holding anything back at this point as much as <unk>.
Speaker Change: Time needs to take place for these patients to remain on trial and study to get a mature enough.
Speaker Change: Readout for overall survival at a mature level.
Allen Yang: Yeah, not much to add, Dave, except that it is very early in this study. Remember, they just completed enrollment. This study hit its first primary or interim analysis very early. So the data were very immature at the time, and I think that those are the strengths of the PFS data today. Yeah, thank you.
Speaker Change: Yes, not much to add David It is very early in this study remember.
Speaker Change: Completed enrollment the study hit its first primary our interim analysis very earliest the data over very immature.
David: At the time and I think that does to the strength of the PFS data to date.
David: Yes. Thank you makes a lot of sense.
Dave Gancarz: It makes a lot of sense, and there's a last two-parter. Without OAS, how do you think about what constitutes a good PFS result in isolation? And finally, how should we think about additional phase three plans, perhaps announcement in relation to harmony to medical meeting update? That's it from me. Thank you. Yeah, so I'll take the first question. In terms of the PFS, we're not going to comment on that. You'll have to come see us at that meeting, and then you'll see the results there. And I understand why everybody's interested in that. We're just not going to disclose it at this time.
Speaker Change: And as the last two parter.
Speaker Change: How do you think.
Speaker Change: How do you think about what constitutes too.
David: Good PFS result in isolation.
Speaker Change: And finally, how should we be thinking about additional phase III plans.
Speaker Change: Perhaps announcement in relation to harmony to medical meeting update.
David: That's it from me thank you.
Speaker Change: Yes, so I'll take the first question in terms of the PFS, we're not going to comment on that Youll have to come see us at that meeting and then youll see the results there and I understand why everybody is interested in that we just not going to disclose it at this time in terms of additional phase III programs, you've probably why making outlets at world lung, but you'll see some data maturing and lung.
Dave Gancarz: In terms of additional phase three programs, you probably won't make announcements at World Lung, but you'll see some data maturing in Lung and some other lung indications as well. And the development title will be fairly obvious in terms of recreating sort of key studies that Merck or AstraZeneca has done in the past, and will probably prioritize based on unmet need. Thank you. Okay, great, thank you.
Speaker Change: And some other lung indications as well and the development of time that will be fairly obvious and in terms of recreating sort of key studies that Merck or astrazeneca has done in the past and we will probably prioritize based on unmet need.
Speaker Change: Thank you Sir.
Speaker Change: Okay, Great. Thank you and your next question comes from the line of your gallon Chavez from Citigroup. Your line is open.
Yigal Nochomovitz: And your next question comes from the line of Yackel, Notromovix, from City Group. Your line is open. Hi, great. Thanks so much for taking the questions. Obviously, a very key one for investors. I've received a lot of questions on is the read through from Harmony 2 to Harmony 3.
Ygal Chavez: Hi, great. Thanks, so much for taking the question, obviously, a very key one for investors.
Speaker Change: We received a lot of questions on is the read through from harmony to to harmony <unk> III.
Yigal Nochomovitz: So I'm curious, given the appearance strength of the PFS data in Harmony 2, could you comment as to how you're thinking about the addition of the chemo backbone in terms of extracting the relative benefit of Ivan Eskimab over Katrina in squamous in Harmony 3. Now, if you follow up, thanks. Yeah, you go. Thanks for the question. So, you know, we're very confident for Harmony 3. I think the strength of the Harmony 2 data is giving us more confidence. I mean, remember, we decided to do Harmony 3 before the Harmony 2 data were available. So we thought that squamous was an unmet need.
Speaker Change: So I am curious given the apparent strength of the PFS data in harmony to could you comment as to how Youre thinking about the addition of chemo chemo backbone in terms of.
Speaker Change: Tracking the relative benefit of Ivan estimate over Keytruda in squamous and harmony theory.
Speaker Change: Follow ups. Thanks, Yes, yigal thanks for the question so.
Yigal: We're very confident for harmony three I think the strength of the harmony to data has given us more confidence I mean, remember we decided to do harmony three before the harmony to data were available. So we thought that squamous was an unmet need we thought that VEGF targeted agents were never developed and Squame because of safety concerns we did not see those safety <unk>.
Yigal Nochomovitz: We thought that VHS-targeted agents were never developed in squam because of safety concerns. We did not see those safety concerns in the development of Ivan Eskimab. And that's why we thought Harmony 3 was low-hanging fruit for Ivan Eskimab, given the strength of the Harmony 2 data; we were even more confident.
Speaker Change: <unk> and the development by Vanessa Nab and that's why we thought <unk> was low hanging fruit private SM out given the strength of the harmony to data, we're even more confident.
Yigal Nochomovitz: You know, the addition of chemotherapy may change things in terms of, you know, reduction of tumors, but I don't think it will change biologically the importance of Ivan Eskimab for this population. And then the second question was on, sorry, could you repeat the second question? I didn't ask it yet. The second one was; the second one was just to confirm. So for Harmony 2, it's TPS greater than 1 percent. For Harmony 3, is it all TPS scores? And does that make any notable difference in your mind? We're not really. Yeah, it's for all TPS scores, and it did, you know, going into this study in terms of the Harmony 3 before we had the Harmony 2 results, I was actually more confident in the lower TPS expressing or the lower PDL 1 expressing patients because of the VHS component.
Speaker Change: The addition of chemotherapy may change things in terms of reduction of the tumors, but.
Speaker Change: But I don't think it'll change biologically the importance of <unk> for this population.
Speaker Change: And then the second question was on.
Speaker Change: Sorry could you repeat the second question.
Speaker Change: I didn't ask it yet.
Speaker Change: Second one was.
Speaker Change: The second one was just to confirm so for harmony to its TTS greater than 1% for harmony three is it all TPS scores and does that make any notable difference in your mind I'm not really.
Speaker Change: Yes, it's for all TPS scores than it did going into this study in terms of the harmony <unk> before we had the harmony to results I was actually more confident in the lower TPS.
Speaker Change: Expressing or the lower PD lone expressing patients because of that Jeff components, but looking at the harmony to date as we said publicly we seem to see a benefit across.
Yigal Nochomovitz: But looking at the Harmony 2 data, as we said publicly, we seem to see a benefit across PDL 1 expression levels. So we don't think it matters what patients will come onto the study.
Speaker Change: PD lone expression level. So we don't think it matters what patients will come on to the study.
Yigal Nochomovitz: Okay, another key question in terms of the catalyst path for the company is potential interim readouts for Harmony 3, and I understand they're built into the protocol. Could you comment it all as to what might be in store as far as potential interim readouts for Harmony 3 of the next several quarters. Yeah, you go. That's a great question, and we can't really disclose that, and we haven't disclosed that at this time. I will say that our Akeso partners are running a parallel study called the 306 study, which is actually in the same similar population, which is Ivan S.
Speaker Change: Okay.
Speaker Change: Another key question in terms of the catalyst path for the company is potential interim readouts for harmony, three and I understand there.
Speaker Change: Built into the protocol could you comment at all as to what might be in store as far as potential interim readouts for Hanmi three over the next several several quarters yes.
Speaker Change: Yes.
Speaker Change: Great question, and we can't really disclose that and we haven't disclosed that at this time I will say that our castle partners are running a parallel study called the 300 <unk> study, which is actually in a similar population, which is <unk> against <unk>, which is the standard of care in China. So those results.
Yigal Nochomovitz: Mab against Tizzle Tuzumab, which is the standard of care in China. So those results won't be out earlier as well, but we haven't disclosed, nor has our Akeso partner disclosed any timelines around that.
Speaker Change: Be out earlier as well, but we haven't disclosed nor ISR accursed, a partner disclosed any timelines around that.
Yigal Nochomovitz: Okay, and then the last question is I think Mickey mentioned that there were some abstract titles for some of these other solid tumors in phase two triple negative, press, colorectal, head and neck. But then you also are starting the MD Anderson partnership. So can you just kind of comment on how those two work streams are going to intersect between your own phase two work as well as what MD Anderson is doing with respect to tumors outside of long. Hey, you go. Thanks for the question. Yeah, so first of all, the MD Anderson collaboration is very exciting. You know, speaking with physicians and experts at MD Anderson gives us access to, you know, a treasure trove of scientific and clinical expertise.
Speaker Change: Okay.
Speaker Change: And then the last question is I think I'm, Mike you mentioned that there were some abstract titles for some of these other solid tumors and phase two triple negative breast colorectal head and neck.
Speaker Change: Then you also are starting to MD Anderson partnerships. So can you just kind of comment on how those two work streams are going to intersect between your own phase two work.
Speaker Change: As well as what MD Anderson is doing with respect to tumors outside of lung.
Speaker Change: Hey, Yigal. Thanks for the question, yes, So first of all the MD Anderson collaboration is very exciting.
Speaker Change: Speaking with physicians and experts at MD Anderson gives us access to.
Eric: A treasure trove of scientific and clinical expertise I think if you look at the way the two programs interact with Eric <unk> is doing.
Yigal Nochomovitz: I think if you look at the way the two programs interact, remember Kesso is doing a lion's share of the phase two work, and they've done quite a lot of phase two work. However, there might be some minor gaps in the sense that the standard care in China is different, or certain tumor types are not as prevalent in China. And this is where MD Anderson can help us get quick signals, some phase two data as well. And then again, the scientific expertise. So when we have a question around a certain tumor type or certain subsets of tumor types that they're not interested in China, this is where the gap will be filled with MD Anderson.
Speaker Change: The lion's share of the phase two work and they've done quite a lot of phase two work. However, there might be some minor gaps in the sense that the standard of care in China is different or certain tumor types are not as prevalent in China and this is where MD Anderson can help us get quick signals.
Speaker Change: Some phase II data as well and then again the scientific expertise. So when we have a question around certain tumor type or certain subsets of tumor types that they're not.
Speaker Change: Interested in China.
Speaker Change: This is where the gap will be filled with MD Anderson without specific questions do you have specific questions on specific tumor types.
Yigal Nochomovitz: Without specific questions, do you have specific questions on specific tumor types? Oh, no, not at this point, but that's helpful. Thank you. Yeah. Thanks, you go.
Speaker Change: No not at this point that's helpful. Thank you.
Heiko: Thanks Heiko.
Mitchell Kapoor: Your next question comes from the line of Mitchell Kapoor from 8C Wainwright. Your line is open. Everyone, thanks for taking our questions, and congrats on the recent data.
Speaker Change: Your next question comes from the line of Mitchell Kapoor from H C. Wainwright. Your line is open.
Mitchell Kapoor: Everyone. Thanks for taking our questions and congrats on the recent data.
Mitchell Kapoor: The first question I have here is just given the fact that most of the 420 Harmony patients will be bundled from Harmony A, would you potentially envision something similar for leveraging the Harmony 2 data in the US? Possibly. And so we're in the midst of sort of discussions with the agency. It's clear that we won't be able to file on the Harmony 2 data in all regions. And so that's something that we're going to try to address. However, there is an opportunity to leverage the Harmony 2 data in future studies. Chiefs as well, without disclosing more than that.
Mitchell Kapoor: First question I have here is just given the fact that most of the 420 harmony patients will be bundled from harmony, a would you potentially envision something similar for leveraging the harmony to data in the U S.
Speaker Change: Possibly and so we're in the midst of nickel sort.
Speaker Change: Discussions with the agency, it's clear that we won't be able to file on the harmony to data in all regions and so that's something that we're going to try to address however, there is a opportunity to leverage the harmony to data in future studies as well.
Speaker Change: Without disclosing more than that.
Allen Yang: Okay, great, thank you. And then just broadly on the use of Ivan S. Mab in lower PDL-1 TPS scores, thinking like closer to one versus the 49 range. Is there a threshold where Ivan S. Mab becomes more clearly effective? Yeah, well, so I think the best data results are from the 201 and the 202 study of the phase 2 data. And you see a clear trend where the response rate does increase as PDL-1 expression increases. And in the opposite direction, as PDL-1 expression decreases, the level activity drops off, but not as sharply as other PD-1 or PDL-1 agents.
Speaker Change: Okay, great. Thank you and then.
Speaker Change: Just broadly on the use of <unk> and lower PD Lone TPS scores.
Speaker Change: Like closer to one versus the 49 range is there a threshold where IMS mat becomes more clearly effective.
Speaker Change: Yeah.
Speaker Change: So I think the best data results are from the tier one and the 202 study the phase II data and you see a clear trend where the response rate does increase as PDL one expression.
Speaker Change: The expression increases than in the opposite direction as PDL, one expression decreases the level of activity drops off but not as stark.
Speaker Change: Sharply as other PD, one or PD lone agents. So I think this is probably the VEGF effect and you know there are other bi specific immuno therapies out there like PD one <unk> four that are looking at the PD one negatives.
Allen Yang: So I think this is probably the veg effect. And you know, there are other by specific immunotherapies out there, like PD-1, CTLA-4, that are looking at the PD-1 negatives. So the question is, how good will we be there? And I think we'll be pretty strong there as well. So I get the question; we see the benefit across the whole spectrum. The benefit seems to be greater in the high PD-1 and relative to PD-1s. Where is that relative benefit? The relative benefit is actually greater, even though the overall response rate is a little bit lower in the low PD-1 expression.
Speaker Change: So the question is is how good will be there and I think will be pretty strong there as well. So I get the question, we see the benefit across the whole spectrum the benefit seems to be greater in the high PD, one and relative to PD ones, where is that relative benefit the relative benefit of actually greater even though the overall risk.
Dave Mitchell: <unk> is a little bit lower in the low PD lone expression I noticed kind of confusing, but again I think we see good activity across all PD lone expression. There is a slight increase fry Vanessa maps for the PD ones of high expressing PD lone high expressing as well as a reference point. This is Dave Mitchell that you can go back to is the <unk> 2020.
Allen Yang: I know it's kind of confusing, but again, I think we see good activity across all PD-1 expressions. There's a slight increase for Ivan S. Mab for the PD-1s, high expressing PD-1, high expressing as well. There's a reference point.
Mitchell Kapoor: This is Dave Mitchell that you can go back to is the ASCO 2023 poster, which actually kind of lays out by PD-L1 expression status. In the Phase 2 trials, as Alan mentioned, especially in combination with chemo, the relative benefit and the by PD-L1 expression. Great. Thank you, David Allen. Really appreciate it. It makes a lot of sense. And once again, if you... Thank you.
Speaker Change: Three.
Speaker Change: Poster, which actually kind of lays out by PD L. One expression status in the phase two trials.
Speaker Change: As Alan mentioned, especially in combination with chemo.
Speaker Change: Relative benefit in the PD lone expression.
Speaker Change: Yeah.
David: Great. Thank you David Allen really really appreciate it makes a lot of stones.
Speaker Change: And once again if you.
Unknown Executive: Once again, if you do have a question, please press star 1 on your telephone keypad. Again, if you do have a question, please press Star 1.
Speaker Change: Once again, if you do have a question. Please press star one on your telephone keypad again, if you do have a question. Please press star one.
Unknown Executive: Thank you with no further questions.
Speaker Change: Thank you with no further questions, Dave I will turn the floor back over to you.
Unknown Executive: Dave, I'll turn the floor back over to you. Thank you very much. We appreciate everyone taking the time to join us this morning for our quarterly earnings call.
Dave: Thank you very much we appreciate everyone taking the time to join US. This morning for our quarterly earnings call. We appreciate your continued support and we wish you a great day. Thank you very much.
Unknown Executive: We appreciate your continued support, and we wish you a great day. Thank you very much. Thank you.
Speaker Change: Thank you once again this does conclude today's conference call. You may now disconnect have a great day.
Unknown Executive: Once again, this does conclude today's conference call. You may now disconnect. Have a great day.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].