Apollomics, Inc. (NASDAQ:APLM) Q4 2023 Earnings Conference Call March 28, 2024 8:00 AM ET
Company Participants
Guo Liang Yu – Chairman and Chief Executive Officer
Sanjeev Redkar – Co-founder, Executive Director and President
Matthew Plunkett – Chief Financial Officer
Conference Call Participants
Tim Moore – EF Hutton
Operator
Good morning ladies and gentlemen. Welcome to the Apollomics Full Year 2023 Results Conference Call. Before we begin, we want to advise you that over the course of the call and question and answer session, forward- looking statements will be made regarding events, trends, business prospects and financial performance which may affect Apollomics future operating results and financial position.
All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section, including an Apollomics annual report on form 20-F, registration statement on Form F1, and other reports filed with the securities and Exchange Commission. Apollomics advises you to review these risk factors in considering such statements. Apollomics assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the dates they are made.
It is now my pleasure to turn the floor over to Dr. Guo Liang Yu, Apollomics Chairman and Chief Executive Officer. Sir, you may begin.
Guo Liang Yu
Thank you Shannon. Good morning, everyone and thank you for taking the time to join us today as we provide an overview of recent business highlights and discuss our full year 2023 financial results.
Joining me for the call today is Dr. Sanjeev Redkar, our President, Dr. Peony Yu, our Chief Medical Officer and Dr. Matthew Plunkett, our recently appointed Chief Financial Officer who joined us earlier this month. Matt brings to Apollomics an outstanding track record of executive leadership in financial strategy and business development. We look forward to his contributions as we continue to execute on our vision of bringing Vebreltinib or APL-101 APL 101 and our other pipeline candidates towards regulatory approvals to better serve patients with a number of and the under serve indications.
I’ll begin the call with some introductory remarks which will be followed by a review of our recent corporate and development progress by Sanjeev. Matt will also cover our full year 2023 financials and then we’ll open the call for Q&A.
We recently reviewed interim data from our global SPARTA Trial and KUNPENG a trials with FDA in February 2024 and received informative and encouraging feedback on our lead product candidate vebreltinib.
But first, before we go into that, I want to remind everyone our strategic focus and what were accomplished in 2023. 2023 was a year of significant accomplishment as we made substantial progress in our two lead drug candidates, vebreltinib and ophthalescelen [ph] Both have shown promising clinical results.
First, we substantially advanced our phase two registrational trial of our lead product candidate vibratinib in non small cell lung cancer and other solid tumors with Met dysregulation. Vibratinib is a novel oroactive brain penetrate highly specific CMAD inhibitor being evaluated in global clinical trials including the US, Europe and China.
Dysregulation in CMAT signaling can play an essential role in the development, progression and the survival of cancer. Vibratinib has the potential to treat cancers with MeT or HGF dysregulations beyond MET Exon 14 skipping.
Our multicohort global SPARTA Trial, which includes over 90 clinical sites in North America, Europe and Asia. Together with our partner Evanstone Pharmaceutical technology company known as Everstone, more than 500 patients have been treated to date and have observed encouraging efficacy from vibratim in clinical trials.
The safety profile is generally similar to other met tyrosine kinase inhibitors on the market at this time given our encouraging clinical data on vibratinib monotherapy to date, we are focused on three initial indications. We expect the first to be non small cell lung cancer with Mad exon 14 skipping mutation, for which vibratinib has the potential to be best in class to further improve patient treatment beyond available therapies. The other two indications are expected to be first in class targeted treatments including non small cell lung cancer with CMAD amplification and glioblastoma metaphor with PTPRZ-MET Fusion. Sanjeev will provide further update on where we are in clinical and regulatory development with each of the indication in a moment.
In December 2023, we reported the overall response rate of vibratinib by gene, carbon number or GCN subgroup analysis in 83 non small cell lung cancer patients from the ongoing multicohort phase two KUNPENG trial in China and the ongoing global multicohort phase two SPARTA Trial.
The interim data, demonstrated by broadening efficacy in non small cell lung cancer patients with MET Exon 14 skipping a patient, provide a robust overall response rate and an acceptable safety profile in patient with and without co occurring mat amplification.
In November 2023, Evanstone received conditional approval from the National Medical Products Administration of China for the commercialization of vibratin to treat patients with Mad Exon 14 skipping non small cell lung cancer cancer. Note under our partnership agreement, Everstone holds the exclusive rights to vibratinib in Greater China, while Apollomics retain the exclusive rights in the US, Europe and the rest of the world, and partners have access to each other’s data.
In addition, in January 2024, we announced the completion of patient enrollment for our phase three bridging study in China for Apollomics or APL 106 in patients with relapsed or refractory acute myeloid leukemia or AML. Apollomics licensed apolecylin from glycomimetics including the right to clinical development, production and commercial cells in greater China market. Apollomics is a first in class e selectin inhibitor being used in combination with standard of care chemotherapy in patients with AML.
It has the potential to improve efficacy and tolerability of chemotherapy. Epilepsy has been granted breakthrough therapy designation by both the FDA and the NMPA. Glycomatics US and the global phase three epolicide study in the reflexed and the refractory AMR patient was fully enrolled as of November 2021. Glycomimetics expects top line results from this trial in the second quarter of 2024.
Finally, in March 2023, we successfully transitioned to a public company by completing our business combination and listing on NASDAQ. With that, I will turn the call over to Sanjeev.
Sanjeev Redkar
Thank you, Guo Liang. In February 2024 we sought feedback from the FDA in a type c meeting with the objectives to review our development plan as well as our registration pathway of federal vebreltinib for the treatment of three conditions.
The first was non small cell lung cancer with medoxone 14 skipping mutation, the second non small cell lung cancer with CMAT amplification and the third glioblastoma or GBM with PTPRZ-MET fusions.
Now the interim results in the first indication, Medoxon 14 skipping mutation included 107 non small cell lung cancer patients with centrally confirmed Medexon 14 skipping mutations. Now of the 107 patients, 71 were treatment naive and 36 previously treated patients with no prior met inhibitor and no immune checkpoint inhibitor treatment immediately prior to webrathen.
Now in the 71 treatment, naive small cell lung cancer patients, about half are from Sparta and half are from the KUNPENG trial. The objective response rate was 66.2%, supported by median duration of response of 16.5 months. In the 36 previously treated patients, of which 19 are from Sparta and 17 from KUNPENG, the ORR was 61.1% with a median duration of response of 16.7 months.
An updated efficacy analysis by Gene Copy Number or GCN subgroup continues to show similar webraltinib activity in the treatment of non small cell lung cancer patient with medexon protein skipping mutation regardless of overlapping met amplification, that is, in the absence of overlapping C Net amplification with GCN gene copy number less than four the ORR was 67% in a pooled analysis of 86 patients from the Sparta and KUNPENG trials.
Now in the treatment, naive patients with GCN less than four. The ORR was 64.3% in 28 Sparta patients and the ORR was 71.4 in 28 KUNPENG patients. Based on the feedback from the FDA from this type C meeting, we will continue to enroll in these Sparta cohorts and review additional information on patients from the Sparta and KUNPENG trials with the FDA on the NDA readiness for this indication. We will analyze data after all patients have achieved a 12v month follow up to support a traditional approval.
Now, based on the discussions with the FDA, we believe that pre treated non small cell lung cancer patients with CMAT amplification may remain an unmet medical need and that the preliminary data presented could represent an improvement over available therapy.
We’ll continue to enroll non small cell lung cancer patients with CMR amplification in this Sparta study to increase the precision around the point estimate for the ORR and provide geographic diversity in the NDA package for supporting an accelerated approval. The primary efficacy analysis could potentially be based on the single on trial results from KUNPENG and Sparta.
We expect enrollment of these incremental patients in Sparta will continue into 2025 and if these results are positive, we could potentially submit an NDA in 2026 to seek accelerated approval of fibrelative as a second line treatment for non small cell lung cancer patients with CMET amplification.
Now for patients with GBN with PDPR Z one Med fusions the agency acknowledged that PDPR Z one med fusion positive high grade glioma is a serious illness with an unmet medical need. We do need additional study data and additional to determine if the randomized phase two three study completed by Avistone, which showed a 48% reduction in risk of death supported by data from the Sparta study, could support a marketing authorization for this indication in the US,
For the remainder of 2024 and into 2025, we look forward to the following milestones and updates. We look forward to disclosing exciting new preclinical data on webraltinib at the AACR meeting in San Diego next week. We are planning to present results from multiple preclinical studies in two posters.
Now on APL 106 at upper Lasland. Apollomics, partner in the US, Glycomimetics expects to report top line results from its pivotal phase three study of April Esalan in the relapsed refractory AML in the second quarter of 2024. Our phase three bridging study in relapse refractory AML in China was fully enrolled at the end of 2023 while waiting for data to mature in this event driven study we expect to report top line data in the first half of 2025.
I’ll now turn the call over to Matt who will review the financials.
Matthew Plunkett
Thank you, Sanjeev. Please refer to our press release issued earlier this morning, March 28, 2024, for a summary of our financial results for the year ended December 31, 2023. As of December 31, 2023, cash, cash equivalents, bank deposits and money market funds were $37.8 million, as compared to $58.9 million as of December 31, 2022.
In March 2023, the company raised $23.7 million before transaction expenses in a pipe financing in conjunction with the business combination and listing on Nasdaq. Based on current projections, we believe our cash position is sufficient to fund planned operations through the first quarter of 2025.
For the year ended December 31, 2023, research and development expenses were $34.2 million, including stock based compensation, of $5.9 million. This compares to $35.4 million, including stock based compensation, of $2.4 million for the full year 2022.
General and administrative expenses were $20.6 million, including stock based compensation of $6.8 million for the full 2023 year. This compares to $9.9 million, including stock based compensation of $0.6 million for the full year 2022. The increase was primarily from administrative expenses related to our business combination in 2023, directors and officers insurance as a result of being a publicly listed company, and an increase in employee stock based compensation.
Net loss for full 2023 was $172.6 million, or $2.32 per diluted share, as compared to a net loss of 240.8 million, or $8.44 per diluted share, for the full year 2022. The net loss includes a non cash expense for change in fair value of convertible preferred shares of $76.4 million in 2023 and $189.6 million in 2022 and also includes expenses related to capital markets activities of $46.0 million in 2023 and $6.6 million in 2022.
For the year ended December 31, 2023, net cash used in operating activities was approximately $43.2 million, as compared to $42.8 million in the prior year. At this point, I’ll now turn it back over to the operator for our Q&A session.
Question-and-Answer Session
Operator
Thank you [Operator Instructions] Our first question comes from the line of Tim Moore with EF Hutton. Your line is now open.
Tim Moore
Thanks for your press release and your prepared comments on the call. It’s great that you want to move forward with enrolling the Sparta cohorts. So I just want to maybe clarify the timing you need to reach the 12 month follow up period. It sounds like you will expect the enrollment to be finished by maybe early 2025. So does that mean you’d have more data that you’re pretty confident on submitting to the FDA sometime? I guess it would be early 2026. Does that timeline make sense?
Guo Liang Yu
Maybe. Puny. Would you be able to answer Tim’s question here?
Operator
Peony, your line may be on mute.
Guo Liang Yu
I can do another question if you want. Come back to that one. Sure. Yep.
Tim Moore
Great. So that’s good that you might seek the NDA application route. And that was good news. And is there anything else you can maybe share feedback from the FDA meeting there? Anything that they want you to do or follow up on or any kind of request that they had?
Guo Liang Yu
Yeah, so I think the key message is that FDA basically we need continue to enroll more patients to kind of specify result that we already have. So we will just continue what we’re doing. I think Peony is on. Could you answer the previous question Tim has asked? Puny, are you on? If he’s not. Okay. Yeah, so actually maybe I’ll give you a high level answer.
I think the timeline might be a little shorter than what you think. With the current patient that we have presented to FDA, the 12 months follow up time will coming up in the summer, but if we need additional patient to be enrolled, that will basically extend another 12 months. So we are thinking of in the year of 2025 rather than 2026. That answer your question? That’s why I was curious because these extra patients might push out that timeline a bit. Right. For the 12 month. I’m just wondering if the FDA is going to redefine the twelve month follow up. If it’s not this summer and it gets moved out to early 2026.
Yeah. So for the non small cell lung cancer with Exxon 14 [ph] skipping because we’re going after the traditional approval. Therefore 12 months follow up is required.
Tim Moore
Okay. Okay, I got it then. One other question I had was you added the CFO role last week. Doctor Plunkett spoke a bit. I just love to hear from him. What is he expected to enhance and improve at the company? Is he bringing over some best practices of commercialization, regulatory approval learned at Imago and Carta Therapeutics?
Unidentified Company Speakerm
Great question. Matt, would you able to share your thoughts? Yes, I certainly can, Tim, thanks for, thanks for the question. Near term focus here is really to help the existing team with our 20 f filing, which you’ll see come out later today. As you’ve seen, I do have some extensive experience in a variety of finance and business roles in various small biopharma companies, ranging from capital formation to strategic collaborations. And those are some of the things that I’ll be looking to work on in the coming months. So stay tuned there.
Tim Moore
Great, great. Not to put Matt on the spot, but whoever wants to answer financial expense questions, I’m just trying to update my model for this year, and I got to imagine that your R&D expense climbs I think it was 34 million for 2023. Is it reasonable for me to expect because you got enrollments and other expenses and clinical trials going on, is 50 million this year maybe too much and just kind of curious about the R&D number?
Unidentified Company Speaker
Yeah. Happy to answer that for you. What I would really do is look at our guidance for cash Runway and kind of back into it from there. So 37.8 million in cash, bank deposits and mutual fund balances at the beginning of 2024. And we said we’ve got cash through the first quarter of 2025. So five quarters there. So basically you can just do the math there and kind of get a total expense number.
I would point out that with the completion of enrollment in the Aprilisin phase three trial, obviously those expenses one would expect are not going to be as great in 2024 as 2023. So hopefully that gives you a little bit of help there. And then obviously, with some significant one time expenses related to the de SPAC transaction in 2023, 1st time ever, public reporting, etcetera, we’re going to expect some of those G&A things not to be as large in 24 as 23, but really the best thing to do is just look at the overall cash burn guidance and Runway guidance. So I think that should get you where you need to go.
Tim Moore
Yeah, that’s what I was thinking originally. It’s just I was kind of curious. You know, it was really helpful to say through the first quarter next year. Makes you feel comfortable on the cash burn, but I didn’t know how much that does. That factor in the additional patients enrollment, if that’s the route you’re going to go, you know, the extra patience.
Unidentified Company Speakerm
It sure. It sure does, Tim. Okay, good, good, good. Anything else to add on the rest of the pipeline? I know you touched on, you know, a couple other indications. Anything else going on with some of the other drug candidates? Not really. We try to stay focused with vibratinib and plessant at this time, especially with limited cash that we have. So we really kind of try to stay focused and get our first drug approved.
Tim Moore
Good. No, I like the focus. I think that’s very good. Too many biotechs try to fund five or six things at once, and you’re focusing on your two top ones. So I appreciate it. And that’s it for my questions. Thanks.
Operator
Thank you. [Operator Instructions] Thank you, Tim. Thank you. As a reminder to ask a question at this time, I’d like to hand the call over to Dr. Guo Liang Yu for closing remarks.
Guo Liang Yu
Okay, thank you, everyone, for joining today. We appreciate your interest in the company and thank you for the questions. I look forward to updating you on our business in the near future.
Operator
This concludes today’s conference call. Thank you for your participation. You may now disconnect.+
