Pyxis Oncology, Inc. (PYXS)
NASDAQ: PYXS · Real-Time Price · USD
1.760
-0.140 (-7.37%)
Apr 27, 2026, 4:00 PM EDT - Market closed
← View all transcripts

M&A Announcement

May 24, 2023

Operator

Good day, and thank you for standing by. Welcome to the Pyxis Oncology Corporate Update conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question- and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Lara Sullivan, CEO. Please go ahead.

Lara Sullivan
CEO, Pyxis Oncology

Thank you. Good morning, thank you for joining us today. My name is Lara Sullivan, and I'm the CEO of Pyxis Oncology. Thank you for joining us to discuss Pyxis Oncology's acquisition of Apexigen and the tremendous value we believe it can create for patients and investors. Joining me on today's call is Dr. Xiaodong Yang, Founder and CEO of Apexigen, and Pamela Connealy, CFO and COO of Pyxis Oncology. Next slide, please. Please note that today's presentation includes forward-looking statements. We encourage you to review these statements, which are available on our website. Moving to slide two. I'm pleased to tell you why we're excited about our acquisition of Apexigen. This transaction is complementary to Pyxis Oncology in three ways.

First, we are acquiring an antibody discovery platform that can provide a backbone to use with our internal stacked antibody-drug conjugate or ADC toolkit, which was licensed from Pfizer. This commercially and clinically validated antibody creation engine, called APXiMAB, can be used to accelerate our own internal ADC initiative. With the addition of APXiMAB, Pyxis Oncology is uniquely positioned at the forefront of ADC innovation with an unmatched end-to-end capability for creating next generation ADC candidates. Second, this acquisition brings us a promising immuno-oncology clinical asset in sotigalimab, or Sotiga, which may have broad potential utility across multiple oncology indications. Sotiga is, in our view, a potentially best and first in class phase II CD40 agonist that has demonstrated compelling efficacy and a favorable tolerability profile.

Clinical results presented to date show that Sotiga drives rapid, deep and durable responses in patients with a variety of difficult to treat solid tumors, including those relapsed or refractory to other immunotherapies. We look forward to seeing updated duration of response and progression-free survival or PFS data in patients with Dedifferentiated liposarcoma or DDLPS, a tumor with few viable treatment options at the upcoming ASCO this June. Third, from a financial perspective, this is an excellent deal. APXiMAB generates an annual royalty stream which totaled approximately $4 million in 2022, and has the potential to increase as the assets advance through their own clinical and commercial pathways. This acquisition is structured as an all-stock transaction, which is, in our view, reasonably valued at approximately $15 million.

It leverages our team's decades of oncology clinical development experience and the IO heritage upon which Pyxis Oncology was initially founded. Importantly, while maintaining our cash runway into the first half of 2025 and keeping our PYX-201 and PYX-106 programs on track. Let's turn to slide three. Pyxis Oncology's acquisition of Apexigen is structured as an all-stock transaction, which is expected to close in mid-2023. In total, Pyxis will issue approximately 4 million shares for total valuation of approximately $15 million. Pyxis shareholders will own 90% of the combined company upon closing.

The Pyxis Oncology executive team will lead the organization. As mentioned, we continue to expect our cash balance to provide runway into the first half of 2025, while the combined entity will continue to be eligible for royalty streams and potential milestone payments from APXiMAB license agreements previously arranged by Apexigen. Closing is subject to standard regulatory approvals and customary conditions, including approval by a majority of Apexigen outstanding common shareholders. Turning now to slide four. The FACT platform we licensed from Pfizer equips Pyxis to develop next generation ADCs with improved plasma stability, better potency, and improved tumor permeability due to optimized payloads, improved linker technology, and site-specific conjugation chemistry. Adding the APXiMAB platform to our toolkit will enhance our ability to generate novel antibodies against the library of targets with high affinity and unique binding epitopes.

With these two platforms, Pyxis Oncology is uniquely positioned with an end-to-end system for creating novel next-generation ADCs. Moving now to slide five. We intend to leverage the APXiMAB platform to generate antibodies to use as the backbone of our ADC generation platform. With proprietary cell lines and humanization technology, APXiMAB can create diverse rabbit-derived antibodies. The advantages of this platform include a higher likelihood of identifying a candidate for any given target, finding the best antibody for a particular use, and creating antibodies with high specificity and affinity. Turning now to slide six. I'd like to share the story of a patient who participated in the phase II Melanoma study. This is a 54-year-old patient with melanoma who was initially treated with surgery and radiation, followed by treatment with ipilimumab, or Ipi, and nivolumab, or Nivo.

After three cycles of combination treatment, the patient had to stop Ipi due to poor tolerability. The patient remained on nivo maintenance and after 10 months developed rapid progression of metastatic disease at multiple sites, including the liver. The prognosis was poor, and this individual had limited effective treatment options available. Discussions with the patient's caregivers mentioned hospice as a possible next step. This patient enrolled in the phase two trial evaluating Sotiga in combination with nivo. Please turn to slide seven. Soon after beginning treatment, this patient responded. Just two months after starting therapy, the patient was able to tolerate the combination of Sotiga plus nivo, even though the patient had previously not been able to tolerate Ipi. This individual completed 15 cycles of Sotiga plus nivo and achieved a partial response, including resolution of all lesions.

The response lasted for 25+ months on study following the conclusion of treatment, and this response was maintained for nearly an additional two years after study completion based on investigator observation. Clearly, this patient has had a rapid, deep, and durable response to Sotiga therapy. We believe this experience illustrates the incredible potential for Sotiga, and we are excited about the possibilities it may offer for patients. Moving now to slide eight. Sotiga is a CD40 agonist antibody. CD40 is a cell surface receptor that plays an important role in the control and regulation of the immune system's ability to mount antitumor immune responses. Targeting the CD40 pathway is a promising approach that may be able to efficiently initiate, stimulate, and reactivate T cell responses.

CD40 activation may generate both innate and adaptive immune activity across dendritic cells, macrophages, and T cells, leading to broad and powerful antitumor immune responses that may synergize with existing approaches and potentially help to overcome checkpoint inhibitor resistance. Please turn to slide nine. Sotiga was rationally designed to be differentiated and best in class with two key modifications to increase potency and tolerability compared to other CD40 agonists. First, Sotiga binds with high affinity to the native CD40 ligand binding domain to closely mimic natural CD40 ligand signaling, which may lead to higher potency. This enables Sotiga to uniquely activate dendritic cells, which are the most important antigen-presenting cells, and to stimulate robust production of the cytokine IL-12, which activates naive T cells more effectively than other CD40 agonists.

Second, the Fc region of the antibody was designed to maximize activity through receptor clustering and improve tolerability by reducing immune cell effector function. Importantly, the goals of these design features are being demonstrated by the emerging differentiated clinical profile. Next slide, please, phase II data demonstrate the activity and prolonged responses of the combination of Sotiga plus nivo generated in melanoma patients who are refractory to anti-PD-L1. This study enrolled patients with relapsed or refractory metastatic melanoma who had confirmed progressive disease on anti-PD-1 treatment. Approximately 1/4 of these patients had also received prior anti-CTLA-4 therapy. Results showed strong activity in this difficult-to-treat group of patients, with a 15.2% partial response or PR rate and a 30.3% stable disease or SD rate. Importantly, responses were rapid, deep, and durable, and the combination of Sotiga plus nivo was very well tolerated.

Turning to slide 11. Tolerability is important and can be very differentiating, particularly for therapeutics that are part of a combination regimen and for more fragile treatment experienced patients who often struggle to remain on therapy. The safety profile of Sotiga in combination with nivo in patients with melanoma was in line with expectations for each drug independently. Reported Grade 3 or greater related treatment emergent adverse events consisted of increases of alanine aminotransferase in two patients and increase of aspartate aminotransferase also in two patients. In this and other previously reported studies in which Sotiga was administered in combination with an anti-PD-1 or chemotherapy in patients with melanoma or esophageal GEJ cancers, no additive or synergistic toxicities were observed. On to slide 12.

Although immune checkpoint inhibitors are among the most recently approved options for patients with melanoma, unfortunately, the majority of patients, 60%-70%, do not respond to treatment. For those who do respond, 20%-30% will eventually relapse. The result of these dynamics is a growing population of second-line and later patients who are immune checkpoint inhibitor refractory or resistant. This group, for whom no other good treatment options exist, numbers approximately 9,000+ today in the U.S. There is no approved standard of care for melanoma patients who have failed both anti-PD-1 and anti-CTLA-4 therapy. Based on the emerging clinical data, we believe Sotiga has the potential to change the treatment paradigm for metastatic melanoma. Please turn now to slide 13.

Results from an ongoing investigator-initiated phase II trial of Sotiga plus doxorubicin showed meaningful clinical benefit with robust, durable responses and a high rate of durable disease control across multiple liposarcoma subtypes. These results suggest that Sotiga may have value in this setting, particularly in certain subtypes of liposarcoma. In a subset of 10 DDLPS patients, the interim median PFS was 12.45 months. This initial result is more than double the historical median PFS of less than five months for these patients. The 10 DDLPS patients enrolled in this cohort were heavily pretreated, in some cases with other IO therapies. We are encouraged by these results and look forward to seeing updated duration and PFS data from the 10 DDLPS patient cohort at this year's upcoming ASCO annual meeting in June. Moving to slide 14.

Liposarcomas are a rare tumor type, affecting approximately 3,000 patients per year in the United States. There have been few new treatment options introduced for these patients in recent years, and the current standard of care is doxorubicin chemotherapy. DDLPS is an aggressive subtype of liposarcoma with an incidence of about 300 patients per year, with high levels of recurrence and metastasis. It is often radiation and chemotherapy insensitive, and responses to first-line doxorubicin chemotherapy are typically less than 15%, with a median PFS of just two to five months. Patients are limited in the number of doxorubicin cycles they can receive due to cumulative cardiotoxicity. Clearly, there is a significant need for new treatment options in this setting, and importantly, Sotiga has received orphan drug designation in soft tissue sarcoma, which may enable a fast to patient development approach. Please turn to slide 15.

In summary, Sotiga may be a best and first in class CD40 agonist, and we are excited about the potential it offers for patients. Emerging clinical data show that Sotiga drives rapid, deep and durable responses in patients with a variety of difficult to treat solid tumors, including those relapsed or refractory to other immunotherapies. We believe this strong activity, combined with a favorable tolerability profile, may position Sotiga to be the backbone of many combination therapy regimens. We look forward to quickly advancing this innovative candidate for patients who currently have limited treatment options and believe we may have an opportunity to implement a faster to patient approach with Sotiga, particularly in the DDLPS setting. Beyond melanoma and liposarcoma, we believe Sotiga may have applicability across a variety of tumor types, given its powerful mechanism of action, potential for synergy with other therapies and favorable tolerability profile.

We may look for opportunities to work with partners to drive development of Sotiga in additional tumor types. Moving now to slide 16. Following this transaction close, Pyxis Oncology will have a pipeline focused on ADC and IO-based approaches to solid tumors that is balanced across modalities, stages of development and risk. Two of our pipeline candidates have received orphan drug designation. For Sotiga and second-line melanoma, we plan to begin a phase II dose-finding study in 2024. In DDLPS, we look forward to seeing more data at ASCO. We plan to expand the ongoing study to add an additional cohort of 10 patients to inform next steps in this indication. Our phase I trial of PYX-201, our ADC targeting EDB fibronectin, is off to a great start.

PYX-201 is a novel ADC licensed from Pfizer that targets extra Domain B or EDB of fibronectin. We continue to expect to see preliminary data from this study, including biomarker results and potential early signs of clinical activity in early 2024. PYX-106 is a fully human immunotherapy antibody candidate that blocks activity of Siglec-15, an immune suppressor expressed across a broad range of tumors. Our clinical trial incorporates a biomarker analysis that will provide meaningful insights into potential patient populations that may benefit from PYX-106 and lay the foundation for future studies. We remain on track to see preliminary data from this phase I trial, including biomarker results and potential early signs of clinical activity in the late 2023 timeframe.

Finally, we can use the commercially and clinically validated APXiMAB platform, which will enable production of novel antibodies in combination with our proprietary FACT ADC platform from Pfizer to generate a steady stream of development candidates going forward. Please turn to slide 17. The Pyxis Oncology executive team is extremely experienced across both pharma and biotech. Each of our executives is passionate about building companies and creating value for patients and shareholders. We have the experience to execute across all corporate functions and understand the processes necessary for success in business development, portfolio management, and company and product acquisition. I'm pleased that Xiaodong Yang, Founder and CEO of Apexigen, will join Pyxis Oncology to support the R&D transition activities. This team is well-positioned to lead the combined organization and deliver our programs for patients. Now moving to slide 18.

Our organization is comprised of highly experienced drug developers, and we have deliberately assembled a team across all levels with extensive backgrounds in oncology. We believe that putting great science into the hands of an experienced team is the fastest route to value creation for both shareholders and patients. We know what successful drug development looks like, having participated in more than 150 drug approvals and launches over the course of our careers across both pharma and biotech before joining Pyxis. The breadth and depth of our team's oncology experience and the pharma-trained, biotech-seasoned approach we've employed to build our organization both uniquely differentiate Pyxis from its biotech peers. Please turn now to slide 19. At Pyxis Oncology, our goal is to liberate science to improve and extend the lives of patients with cancer.

We employ a multi-modality approach to innovation across immuno-oncology, ADCs, and adjacent approaches, and are interested in the best science regardless of whether it is sourced internally or externally. Our programs have multiple potential clinical and data catalysts over the next 12-18 months. Our team is uniquely experienced to deliver on our pipeline, and we have a strong balance sheet that will provide runway into the first half of 2025. We will be at the Jefferies conference in New York City in early June and hope to see many of you there. Thank you for joining us today. We are excited about the transformative potential of this transaction for Pyxis Oncology, and we appreciate your interest. We'll move to Q&A. Operator, can you please provide instructions for participants to ask questions?

Operator

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes in the line of Yuan Zhi from B. Riley. Your line is now open.

Brandon Carney
Senior Research Associate, B. Riley

Hi, this is Brandon Carney on for Yuan. Congratulations on the acquisition and thanks for taking our questions. I guess first of all for STS, for the Sotiga data, I'm just wondering how the data compares to the data being generated by next gen CTLA-4-based regimens, which was highlighted at the recent CTOS conference and may also be showcased at the upcoming ASCO alongside the Sotiga dataset.

Lara Sullivan
CEO, Pyxis Oncology

Yeah. Thank you very much for your interest and for the question. I'll ask Xiaodong to respond to that, please.

Xiaodong Yang
Founder and CEO, Apexigen

I'm sorry, I missed first part of the question. Can you repeat it a comparison with which, data?

Brandon Carney
Senior Research Associate, B. Riley

Yeah. Just the next gen CTLA-4, like a ipilimumab data that was highlighted at CTOS and I believe we have other CTLA-4 data coming up at ASCO that should be presented alongside the sotigalimab dataset.

Xiaodong Yang
Founder and CEO, Apexigen

For which indication? Sorry, I'm not too familiar with the new generation CTLA-4 data. In which indication?

Brandon Carney
Senior Research Associate, B. Riley

Yeah, they presented sarcoma data at CTOS. I think we saw 46% response rate, 69% DCR. Just wondering if you've had a chance to maybe look at that and then how Sotiga might compare to that data set.

Xiaodong Yang
Founder and CEO, Apexigen

Yeah. Certainly we will review the data more carefully about the new CTL-4 antibody sarcoma. I think in our case, we have a very well-defined mechanism action for combining Sotiga with doxorubicin. As you know very well, doxorubicin is a well-known immunogenic chemotherapy. The idea, the rationale for combining Sotiga with doxorubicin is that doxorubicin can generate immunogenic tumor death and tumor antigen release. You come with Sotiga, which can activate APC to lead to T-cell activation, eventually leading to a more effective antitumor response. As you probably know very well, for sarcoma, the approval endpoint is the PFS and overall survival.

We will provide more updates on the liposarcoma and also on the efficacy data on the all three subtype of soft tissue sarcoma in the ASCO meeting, I think in early June. You will see the data, we can compare our updated data with the other new CTL-4 antibody data. We can see where the differences and where maybe the different line of therapies or different combination.

Brandon Carney
Senior Research Associate, B. Riley

Okay. Yeah, thanks for that. Maybe also just wanted to ask on potential registration enabling study. Do you think it will be in melanoma or STS, or is it too soon to tell right now? You know, in that kind of study, how would you manage liver enzyme signals?

Lara Sullivan
CEO, Pyxis Oncology

Thank you for that question. We are actually going to be sort of working together with Xiaodong and his team to define the next steps of the path forward on the asset. At this juncture today, we're not commenting on what the regulatory strategy will be, but we do commit to come back to the street, to the analysts, investors on that later this summer following the transaction close.

Brandon Carney
Senior Research Associate, B. Riley

Sure. Understandable. okay. Well, thanks for taking our questions.

Lara Sullivan
CEO, Pyxis Oncology

Thank you.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Andy Hsieh from William Blair. Your line is now open.

Andy Hsieh
Biotech Research Analyst, William Blair

Oh, great. Thanks for taking our questions. Regarding the CD40 agonist program, I'm just curious if there are any plans for biomarkers or any investigational, you know, biomarkers that could help you identify patients who otherwise, you know, might benefit the most, just to enrich the signal there a little bit. My second question has to do with potential synergy with, you know, your ADCs or antibodies in house. Are there any scientific rationale to look at, you know, combinations there? I know, Xiaodong, you basically talked about immunogenic cell death, which is kind of a hot topic for the ADC field these days. Just curious about your thoughts there.

Thank you.

Lara Sullivan
CEO, Pyxis Oncology

Sure. In terms of the first question with respect to biomarker strategy, you know, we do have a strong translational capability within Pyxis already. You know, we see kind of the integration of our capabilities and the capabilities that Xiaodong has built to be very complementary. Again, we're going to be really putting heads together over the next few weeks or months to best define the optimal path forward for all elements of the development approach for the asset. Andy, we'll come back to you further on the biomarker strategy as we do that work together.

Secondly, in terms of the synergy with the ADC, the FACT platform that we had licensed in from Pfizer, you know, as you know, Xiaodong has been quite successful in building this antibody platform within Apexigen as well as antibody work that he's done in past lives. We're particularly enthusiastic now about the ability to have antibody creation owned within the combined entity that fits in quite nicely with the conjugation chemistry, the linkers, the payloads that we brought over from Pfizer. Xiaodong, I don't know if you want to comment any further about kind of your enthusiasm around the integration of the two platforms.

Xiaodong Yang
Founder and CEO, Apexigen

Sure. I think Laura, you elegantly illustrated the potential and also the rationale for potential combination of ADC approach with also before the agonist. I think quite honestly, one of the rationale and motivation for the business combination is the combination of the ADC platform that Pyxis has developed. The first candidate is PYX-201. I think that's a perfect candidate combination with sotigalimab because the potential release of tumor antigens after the ADC killing tumor cells or tumor stromas. I think we have a huge potential to explore that one PYX-201 finish phase I, we can immediately start a combination of sotigalimab with PYX-201.

That's kind of my thinking about. Of course, we'll discuss together with Laura and her team to make sure that these we can actually implement a combination trial in the future.

Andy Hsieh
Biotech Research Analyst, William Blair

That's very helpful. Thank you.

Operator

Thank you. One moment for our next question. Our next question comes in the line of Sam Slutsky from Life Sci Capital. Your line is now open.

Sam Slutsky
Senior Research Analyst, LifeSci Capital

Hey, good morning, everyone. Thanks for taking the questions. Couple from me. I guess, in terms of making new ADCs via Apexigen's antibody platform and then your ADC tech, what might those timelines look like in terms of when we might see new targets coming to the pipeline or hear about them, et cetera?

Lara Sullivan
CEO, Pyxis Oncology

Yeah. Thanks, Sam. It's always great to connect with you. You know, we are pretty enthusiastic, given the advanced nature of the antibody platform that Xiaodong is bringing over that will be able to, impact the, in a, in a positive way, the timelines for us to create new ADCs. Right now, we don't want to give specific guidance yet on the timelines around kind of the next wave, of the pipeline. As we come back, post the transaction close, we'll make sure to provide guidance around our thoughts on, the ADC creation engine as well as Sotiga.

Sam Slutsky
Senior Research Analyst, LifeSci Capital

Okay. Then for the royalty streams on the outlicensed assets or partnered ones, just remind me what those terms look like, across the pipeline.

Lara Sullivan
CEO, Pyxis Oncology

Sure. Pam or Xiaodong, do you want to comment on that?

Xiaodong Yang
Founder and CEO, Apexigen

Pam, do you want to?

Pam Connealy
CFO and COO, Pyxis Oncology

Yeah, I'm happy to take it. Good morning, Sam. The company today receives royalties from Novartis for their Beovu that was commercialized back in 2019. Today they get about 1% royalty on worldwide net sales, and it goes into perpetuity. Right now, between 2020 and 2022, they've averaged about $2 million a year for a total of $6.2 million. The other license agreements have, you know, kind of 3% on the [Simcere] collaboration, annual sales below CNY 100 million and then 4% for anything above. Again, just, you know, kind of your typical, you know, royalty streams coming out of the other three opportunities there.

That is part of, as Lara mentioned in the call, that is really the third leg of the stool of why this was a, you know, meaningful acquisition for us, is to be able to get these royalty streams in as well, along with the platform and the CD40 asset.

Sam Slutsky
Senior Research Analyst, LifeSci Capital

Okay. Just last question from me. For the 10 patients with dedifferentiated liposarcoma presented on, were those patients naive to prior doxorubicin, or what was their prior treatment status?

Lara Sullivan
CEO, Pyxis Oncology

Xiaodong, do you want to comment on that?

Xiaodong Yang
Founder and CEO, Apexigen

Yeah. It's mixed. I think probably 50/50. Half of them are treatment naive patients, half of them receive multiple round of prior therapy, up to six round of prior therapy.

Sam Slutsky
Senior Research Analyst, LifeSci Capital

Got it. Okay. Thank you.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Charles Tony Butler from EF Hutton Group. Your line is now open.

Charles Tony Butler
Senior Managing Director, EF Hutton Group

Thanks very much. So the Lara and maybe Xiaodong, this question may be a tad unfair, except that I want to focus on the DDLPS patient group with Sotiga. The additional extension of 10 patients will occur. I guess I'm asking maybe how rapidly post-close that you may be able to enroll those patients. I say this because the PFS was extraordinarily positive on certainly the first 10, especially given the competitive landscape. As you know, the milademetan trial failed most recently. Certainly not only given the PFS, but certainly seeing an additional 10 patients would, I guess, lead to a perfectly rational registrational trial post that. I didn't know if you wanted to expand a little bit on that timing. Thank you.

Lara Sullivan
CEO, Pyxis Oncology

Thanks. Thanks, Tony. Appreciate the question. We at Pyxis have built a, you know, fully skilled and capable clinical organization, you know, as we've progressed into the clinic now having dosed our first patient in PYX-201 and the imminent dosing with PYX-106. Our team is ready to go as we absorb sotigalimab and the assets from Apexigen. To your point, I think the patient interest and the unmet need is there. The infrastructure is there on our side. The relationships with the KOLs and the PIs are in place from the Apexigen side.

Really, all the elements are in place, and we are sort of going forward, you know, as appropriate within kind of SEC guidelines of how we're able to work together during this interim period prior to the close. We don't intend to have, you know, anything slow down, but we are very careful about, you know, continuing to operate as independent entities until the close. I think we'll be providing, again, further guidance on the specifics around the timelines after the close. That being said, I just want to provide reassurance that all the elements that are in place that enable sort of swift e-execution are there on both sides.

Charles Tony Butler
Senior Managing Director, EF Hutton Group

Thank you, Lara.

Operator

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Our next question comes from the line of Aydin Huseynov from Ladenburg.

Aydin Huseynov
Managing Director, Senior Analyst, and Biotechnology Analyst, Ladenburg

Good morning, everyone. Congratulations with the deal, and thank you for taking. What I have is regarding the agent activity of sotigalimab. Provide any comments, any thoughts about potential signals from single agent activity or in any cancer type? Maybe you could comment on single agent activity of other CD40 agents that you may cite as an example.

Lara Sullivan
CEO, Pyxis Oncology

Yeah. Xiaodong, would you like to take that?

Xiaodong Yang
Founder and CEO, Apexigen

Sure. I'm glad. For sotigalimab, we have ongoing phase two trial evaluating sotigalimab as a monotherapy in immunotherapy naive patient, naive melanoma patients. So far we have seen two patients had a complete response over one year, and we are about to finish this study, and we'll present data in the near future. Regarding other CD40 agonist antibody, because the change of standard of care for different indications, it's going to it has been very challenging to do a single agent activity trials. It has been reported the Roche antibody when it was developed by Pfizer had showed 27% response rate again in immunotherapy naive melanoma patients.

That was reported a few years ago. I don't recall I have seen any other CD40 agonist antibody have shown... They have some single agent activity, but it's not a trial that many of these cases actually is data that's in the dose escalation phase I trial.

Aydin Huseynov
Managing Director, Senior Analyst, and Biotechnology Analyst, Ladenburg

Understood. Thank you. Generally speaking, do you think CD40 agents would first come to the market as a single agent drug, or that would be a combination trial? I'm just thinking of general regulatory path for all CD40 agents, not necessarily just yours.

Xiaodong Yang
Founder and CEO, Apexigen

Laura, do you want me to take or you want to start?

Lara Sullivan
CEO, Pyxis Oncology

Yeah, I think why don't you go ahead?

Xiaodong Yang
Founder and CEO, Apexigen

I think based on the change of landscape of standard of care for almost all solid tumor indications, it's going to be very challenging to do a single agent phase III trials. I think it has to be a combination, even in the first line or even the last line. I mean, the last line you can do a single agent trial. I think my thinking is that for most of the CD40 agonists, probably the most productive phase III development strategy is going to be a combination with the standard of care.

Aydin Huseynov
Managing Director, Senior Analyst, and Biotechnology Analyst, Ladenburg

Okay. Okay, understood. All right. One on liposarcoma data. You have pretty encouraging data PFS, 12.5 months. Could you remind us what was the 95% confidence interval in prior doxorubicin, which is standard of care trial? What's just to try to sort of, you know, to see how it compares to the combination.

Xiaodong Yang
Founder and CEO, Apexigen

Yeah, I do have that number. Maybe I'll give you later on. It's not top of mind, I think I will find that information, provide to you later.

Aydin Huseynov
Managing Director, Senior Analyst, and Biotechnology Analyst, Ladenburg

Okay, no problem. One last one on monetization, sorry, on royalties. The question is, have you thought about monetization, the royalties, for Beovu, for with AMD indication? If you do think about it, how much would you value that potential monetization deal?

Lara Sullivan
CEO, Pyxis Oncology

We are certainly open to considering all forms of business development transactions as well as ways to increase the cash balance of the company. Royalty monetization is something we do think about, you know, at the macro level across the pipeline, not just for this asset. Obviously these royalty streams are in place right now. It's something we're continuing to evaluate, to monitor. I think that it's premature for us to provide any sort of guidance or speculation around what the value of that could be. You know, having that optionality with respect to receiving the royalties as well as potentially monetizing them is certainly helpful from our, you know, cash management and financing strategy.

Aydin Huseynov
Managing Director, Senior Analyst, and Biotechnology Analyst, Ladenburg

Okay. This is very helpful. Congratulations with the deal and thanks for taking the questions.

Lara Sullivan
CEO, Pyxis Oncology

Thank you.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Eun Yang from Jefferies. Your line is now open.

Speaker 10

Hi, this is [Hellen] on for Eun, and thank you very much for taking our question. Was wondering if you could please provide some guidance on how OpEx is expected to increase from the deal. Thank you.

Lara Sullivan
CEO, Pyxis Oncology

I'm sorry, I missed the middle part of the question. How what is expected to increase?

Speaker 10

On how OpEx is expected to increase from the deal.

Lara Sullivan
CEO, Pyxis Oncology

Okay. Pam, do you want to comment on that?

Pam Connealy
CFO and COO, Pyxis Oncology

I'm sorry. I still couldn't hear. Lara, would you-

Lara Sullivan
CEO, Pyxis Oncology

The question was to comment on how OpEx may increase as a result of the deal.

Pam Connealy
CFO and COO, Pyxis Oncology

Great. Thanks for the question, good to see you on the call. We don't expect operating expenses to increase in any significant way. We have a very scalable infrastructure, both on the G&A side as well as within R&D to be able to support this anti-CD40 asset coming in. We don't expect any real appreciable increase in operating expenses. The Apexigen team has done a great job of already getting clinical materials ready for even phase III. That expense has already been undertaken. We feel very confident in our ability to absorb this asset and with the current team in place.

Speaker 10

Thank you.

Operator

Thank you. At this time, I would now like to turn the conference back over to Lara Sullivan for closing remarks.

Lara Sullivan
CEO, Pyxis Oncology

Perfect. Thank you. Thanks to all who participated in the conference today and for your questions. We very much appreciate your interest in the combined company going forward. We're excited about the potential to support patients, both with the current clinical pipeline that we have and the potential future pipeline that we'll be building by bringing our capabilities together. Thank you, and we're also happy to take any one-to-one follow-up meetings as interest dictates. We look forward to continuing to share this story with you, and hope you have a great rest of your day.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

Powered by