Call Start: 16:30 January 1, 0000 5:06 PM ET

Ambrx Biopharma Inc. (NASDAQ:AMAM)

Q4 2021 Earnings Conference Call

April 26, 2022, 4:30 PM ET

Company Participants

Feng Tian – Chief Executive Officer

Sonja Nelson – Chief Financial Officer

Laurence Watts – Managing Director, Gilmartin Group

Conference Call Participants

Corinne Jenkins – Goldman Sachs

Tazeen Ahmad – Bank of America

Phil Nadeau – Cowen & Co.

Joel Beatty – Baird

Operator

Welcome to the Ambrx Second Half and Full Year 2021 Financial Results and Corporate Update Conference Call. At this time, all participants are on listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ensure that we have ample time to address everyone's questions during the Q&A session, we would like the limit of one question and one follow-up question per person. [Operator Instructions] As a reminder, this call is being recorded today, Tuesday, April 26, 2022. I would now like to turn the conference over to Laurence Watts, Managing Director at Gilmartin Group. Please go ahead.

Laurence Watts

Thank you, Jason. Joining us on the call today from Ambrx are Chief Executive Officer, Feng Tian, and Chief Financial Officer, Sonja Nelson. During this conference call, management will make forward-looking statements that are subject to risks and uncertainties related to the future events and or financial performance of the company. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties such as but not limited to those discussed in the Risk Factors section of our annual report on Form 20-F for the year ended December 31st, 2021 on file with the SEC. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result. With that, I will turn the call over to Feng Tian, Chief Executive Officer of Ambrx. Tian?

Feng Tian

Thank you. Laurence. Good afternoon, everyone. And thank you all for joining our second half on the full-year 2021 Financial Result Conference Call. I would like to start today's call by thanking the entire Ambrx, our partner in China, NovoCodex. And the physicians and the patients who have participated in our ongoing clinical trials. Without the collective efforts of those groups, the growth that we have experienced throughout the year would not be possible. Cumbersome made great strides in 2021 demonstrated through the expansion of its executive team, as well as a progression of its clinical developed pipeline. Despite ongoing challenges of COVID-19. On this quarter by the recent lockdowns, which are high. We continuing to see positive trends in enrollment in our trials. Before I talk about recent events and the future of Ambrx, I would like to review key milestones achieved in 2021.

Ambrx's successful initial public offering in June of 2021 raised gross proceeds of $142.1 million, which adapts the company well capitalized. Ended the year with $170.1 million in cash and cash equivalents. I expect our cash position to be sufficient to fund operations, our ongoing investments and our clinical pipeline for at least the next 12 months [Indiscernible] of our annual report filed today. In conjuction with our going public and versus scrutineer leadership team, the strategic appointments and information of our Scientific Advisory Board. Following our 2021 IPO, Sonja Nelson was appointed as Chief Financial Officer. Through the year, we then extended the Board of Directors with appointments of Olivia Ware, Katrin Rupalla, and more recently in February 2022, Paul Maier. Turning to our clinical operations, Ambrx made significant progress in its clinical development pipeline. In August, we dosed the first patient in ongoing Phase 1 clinical trial of ARX517 for the treatment of PSMA expressing tumors. This achievement marked an important milestone for Ambrx, as it is the second internal antibody drug conjugate program to enter the clinic. We anticipate announcing initial Phase 1 data from the trial in the coming months. We would now like to focus on our lead asset, ARX788. [Indiscernible] It is being studied in breast, gastric, and other solid tumors.

In early 2021, the U.S. FDA granted ARX788 orphan drug designation for the treatment of gastric cancer and the fast track designation for the treatment of HER2-positive metastatic breast cancer. Carrying our momentum forward into the second half of the year, Ambrx announced the progression of a number of trials involving the ARX788. In October, our partner in China NovoCodex, announced a positive interim data from ACE-Gastric-01 Phase 1 clinical trial for the treatment of HER2-positive metastatic gastric or gastro as effective [Indiscernible]. In the China Society of Clinical Oncology concepts. We're very pleased with the data demonstrated an overall response rate of 44% in responsive, evaluable patients across all cohorts, while remaining generally well-tolerated. AMBRX currently expected intends to participate in ACE Gastric-02 of global flu slash three clinical trial, evaluating the efficacy and safety of ARX788 in patients with peripheral positive at above [Indiscernible], adenocarcinoma, which dose the first patient in August, 2021. In November, AMBRX announced it has built on the first patient in ACE breast. All three are Phase two clinical trial of ARX788 for the treatment of HER2-positive metastatic breast cancer in patients whose disease is resistant or reflect for it to TDM1, TDF D were to [Indiscernible] continuing, we anticipate providing interim data from the ongoing Phase two trial, the first 100 rigs. In December, the presented positive data from an ongoing ACE-Breast-01 clinical trial conducted by NovoCodex. And is a firm full Breast Cancer Symposium. ACE-Breast-01 in the fifth one trial of ARX788 for the treatment of metastatic breast cancer. ARX788 was found to have demonstrated robust anti-tumor activity with an objective response rate of 66% in the evaluable patients in 1.5 mil per people. We anticipate reducing a full clinical trial report later this year.

Most recently, I'm thrilled to announce that Quantum Leap Healthcare Collaborated has included ARX788 in its I-SPY 2.2 Phase 2 clinical trial, evaluating our animated or I conjugate as a monotherapy, or in combination with PD-1 therapy for the treatment of HER2-positive breast cancer in their new adjuvant setting. Outside of ARX788, we have furthered our internal pipeline with the submission of the investigational new drug application to the U.S. FDA for ARX305. Secondly, ARX305 is the third, and whether conjugate developed by Ambrx to receive our 10X clearance. Now, let me turn to the remainder of the year and Ambrx expectations for 2022. Much of our recent progress has been in conjunction with our partnerships utilizing ARX788 and our engineered precision biologics. However, we're now positioned to advise several internal clinical development communities in the coming months. ARX788 continues to be our lead clinical asset with two anticipated data readouts in the second half of the year from the ongoing [Indiscernible] clinical trials. In addition to ARX788 data, we anticipate providing interim free flow system data for ARX517 in the second half of this year. The Phase 1 goal aspirations for -- of our PSMA drug conjugate was initiated in 2021 having demonstrated a promising drug property and toxicity profile in pre -clinical testing. Regarding our earlier stage programs, I look forward to upcoming R&D submission of our ARX102 currently versus conducting IND enabling studies for the program, which will allow us to transition our first immuno oncology candidate into the community. Recently, we're now in acceptance and clearance from the FDA of our IMD for ARX305 for the treatment of RCC and other cancers. We anticipate initiating a first-in-human physical clinical trial in the second half of this year. I'm thankful for the dedication of Ambrx organization to reach our objectives during our first year as a public company. I look forward to executing our strategy through the remainder of the year, and the continuing the success achieved in 2021. With that, I will turn the call over to Sonja to discuss financial results. Sonja, please.

Sonja Nelson

Thank you, Tian. The filling and press release we issued earlier today details our financial results in full, so I will only provide highlights on this call. Revenue for the second half and full-year 2021 were $2.4 million and $7.5 million respectively as compared to $7.2 million and $13.7 million for the same periods in 2020. Operating expenses for the second half and full-year 2021 were $41.5 and $71.9 million respectively, compared to $14.3 million and $26.8 million for the same periods in 2020. The increase in operating costs were mainly related to the increased cost of clinical trials spend primarily driven by ARX788 and professional services and fees associated with the preparation for Ambrx's IPO and operating as a public company. Turning to our balance sheet, cash and cash equivalents as of December 31, 2021 were $170.1 million, which we believe is sufficient to fund our planned operations for at least the next 12 months from the date of our Annual Report filed to-date. Finally, Ambrx's number of ordinary shares outstanding as of December 31, 2021, were approximately $270.1 million or approximately $38.6 million American depositary shares. Now I will turn the call back over to Tian.

Feng Tian

Thank you, Sonja. In closing, we continue to invest all our internal and our partner council development programs, regardless of the disruption which was caused by COVID-19. The remainder of the year caused a lot of potential milestones, opportunities for Ambrx to demonstrate the capabilities of its antibody drug conjugate and Immuno -Oncology Conjugate franchises. As a recap, Ambrx anticipate announcing top loan Phase III data in ACE-Breast - O2, additional Phase I data in ACE-Pan tumor-01, interim Phase 1 50 data in ARX517, the initiation of Phase 1 trial in ARX305, the submission of the R&D ARX102. I want to update that all of our stakeholders for your continued support and look forward to updating you on our progresses through the year. With that, I will now open the call up for questions. Operator?

Question-and-Answer Session

Operator

Thank you. If you'd like to ask a question, please press star followed by one on your telephone keypad. If for any reason you'd like to remove that question, please press star followed by two. Again, to ask a question, press star one. As a reminder if using a speakerphone, please remember to pick up to enhance it before asking the question, will pause your briefly as questions are registered. Our first question is from Corinne Jenkins with Goldman Sachs. Please proceed.

Corinne Jenkins

Good afternoon. Maybe just on the pan-tumor update that we expect later this year. Can you just help us understand what level of incremental detail we should expect from that update? And then how those data should inform the clinical development strategy beyond breast Gastric tumor indications as you get past the readout?

Feng Tian

Sure. Thank you for the question. Regarding our Pan Tumor-01 trial, right now it's ongoing with multiple cohorts, including cohorts for HER2-positive cancer, gastric cancer, and also HER2 -low breast cancer. And we're also testing even two different doses. One is -- for breast cancer is a 1.6 mg/kg and also 1.7 mg/kg. So those Phase 1 data will come out later this year. And also, as you'll see, those are three cohorts right now involved with Pan Tumor-01 or both peripheral positive breast cancer, gastric, and HER2 -low breast cancer. All those will guide us for our future clinical trial design.

Corinne Jenkins

Okay. And then we also expect some Phase 1 data from ARX517 this year. And I'm curious how quickly, once you get this data, can you proceed into additional clinical studies and the Phase 2, etc?

Feng Tian

Yes. Right now, 517 -- ARX 517 that's on time just made ADC is under Kohl's escalation study and the trial's going very well. We anticipate in the middle of the year, we should finish those escalation. And after that, we will quickly turn into a cohort expansion. We're anticipating that happens in second half this year.

Corinne Jenkins

Helpful. Thank you.

Feng Tian

Thank you.

Operator

Our next question is from Tazeen Ahmad from Bank of America. Please proceed.

Tazeen Ahmad

Hi, guys. Good afternoon and thanks for taking my questions. As it relates to the portion of your studies that are being run out of China, can you talk about any delays that you've experienced or could experience as a result of the partial shutdown in the various parts of the country? Specifically right now, the Shanghai shutdown, is that impacting any of the timelines that you have for expectation of data to the end of this year or into next year? And then I have a follow-up.

Feng Tian

Thank you. I think that's a really good question. All our hearts go to people in Shanghai. And it's not easier for them to live through that shutdown. We're talking about just a shutdown, and for them it's a lockdown in their apartments. But regarding how that will impact our trials, first of all, from Ambrx side, we are focusing to deliver data second half this year, mainly ex-China data. As you'll see, our best estimate for ex-China trial so far at the moment is looking very good. It's actually faster than we anticipated. And our Pan Tumor-01 trial is also ex-China trial. So from that point of view, Ambrx ex-China trial we don't think will have any impact -- be impacted by the Shanghai lockdown. Now let's go back to China trial that is run by our China partner, NovoCodex. For Pan Tumor-01, those are just trials ongoing.

We're very lucky we still have, last time I know, is 11 patients still on the trial, which demonstrated how good the drug is. And both are ongoing. I haven't heard from a partner if those -- treatment of those patients are impacted. And they're just trying to finish the trial. Regarding the Pantema Ultema trials ongoing in China. I think we're very close to enroll all the patients anticipated, and I haven't heard really significantly impact on the trials. And we have more story from Shanghai, I'll update you. But overall as a first principle, we all know the lockdown will have a negative impact on patients’ treatment and I cannot say there will be no impact. But how big the impact, we're collecting data, after we hear from our partners, we'll update you.

Tazeen Ahmad

Okay. Thanks for all that color. Now, for the Phase III study you're doing in second line and after breast cancer, will that be at all impacted by enrollment of Chinese patients and how confident are you that that study can still readout by year-end?

Feng Tian

You're talking about Breast-02 trial, right?

Tazeen Ahmad

Yeah.

Feng Tia

Yeah. So the enrollment, actually there is good news until we're almost whatever finished with the enrollment. So it's more of after that to collect all the data. So enrollment is not be concerned from what I know.

Tazeen Ahmad

And then follow up during the study, you don't think will be impact to you?

Feng Tian

Right now, is mainly Shanghai has got knockdown and let's see how big the spread will be. What I heard in Beijing, maybe other cities potentially may be impacted, but so far to for Shanghai, I think Shanghai there's the fuel sites, majority of the feta is across China. From my part the timeline will be impacted so far. Not yet.

Tazeen Ahmad

Good to know. Thank you.

Feng Tian

Thank you.

Operator

Thank you for your question. Our next question is from Phil Nadeau with Cowen and Company. Please proceed.

Phil Nadeau

Good afternoon, congrats on progress and thanks for taking our questions. First, a follow-up to the prior question on Pan tumor-01. Do you have a sense for the H2 update, how many patients will be disclosed for each tumor type in each cohort, and approximately how much follow-up will be available at the time of the data cut?

Feng Tian

Yeah. Sure. Now, for Pan Tumor-01, it's actually in conjunction with our Breast-03, where we're trying to couple all those trials to help us to determine between at 1.6 mg/kg or 1.7 mg/kg early Q3. Regarding the enrollment, we are antici -- we experienced better-than-expected patient enrollment in ex-China, okay. So for breast -- Pan Tumor-01 study, we anticipate by later this year for breast cancer maybe 20 patients in both arm for 1.6 to 1.7. For HER2 -low breast cancer, we are also anticipating that kind of a number. So for both groups. We're also testing in gastric 1.7 and a 1.8 liter of arm to expand to those higher because we observed better safety profiles in ex-China file than in U.S. file as you can see in 20F. You can look at those safety data. For both systemic constantly and also special Interest of target middle AE, ex-China seems much better than China. And that's why we're trying to reach higher dose to give patient better benefit.

Phil Nadeau

That is very helpful. Second question on ACE-Gastric-02 and ACE-Pan tumor-02. In the past, I think you've suggested that data was possible -- interim data was possible for mostly trials also in the second half this year. Based on your press release, it seems like that's now more likely in 2023, data from both those trials is probably more likely next year. Is that fair?

Feng Tian

You're talking about our Gastric O2 trial?

Phil Nadeau

Gastric 02 and tumor O2, I think at one point there was a suggesting that data from either -- either both for this could come of in the second half of this year also, but wasn't mentioned could come today's press release.

Feng Tian

As gas-to-NGL to wrestle too, right?

Phil Nadeau

I think can you mentioned breast or two already but penn tumor to I think at 1 we had on our table that there could be data from that also in the second half this year.

Feng Tian

But a great yes. Gastric onto again, that's starting from China. And we anticipate to become a global trial that's a setup, okay we're expected achieved to join our trial second half this year. The patient enrollment in Gastric O2. So far looks very good. And we anticipate to have a second-half next year to have interim readout [Indiscernible] us so far, the updated next milestone for Gastric O2 regarding [Indiscernible] hole to fill nor to focus our resource of our company to rest Hector and Gastric where we most recently decided to stop pan-tumor ultimate trial to focus all our resource to Breast AWS-3. And also, most recently we announced the adjuvant study for breast cancer.

Phil Nadeau

Got it. Okay. That makes more sense. That is also very helpful. And then last question on ARX102, we've recently seen some disappointing data for the 102 field. Can you talk about how 102 could be differentiated and whether the recent results that were released have in any way informed that program or change your confidence in 102 as a target?

Feng Tian

Absolutely. We are a company we're taking an engineering approach to take our target, actually, our approach is actually using our technologies to enable our target. And we already demonstrated that in ARX788 since our target is normal target. Many people tried different approach but when we just coming in using our technology and we show clear differences in those efficacy in the synfuel. If I haven't touched that synfuel wise compared to other drug is better than [Indiscernible]. And for example, our grace rate officially are [Indiscernible], in the ARX788 is in the two percentage, which has barely seen in chemo or other ADC. Efficacy-wise, and the reason we started focusing on breast cancer, in the ARX788 is because we see early signals in our Breast-03 trials. When we tested even other lower those, if you can refer to our most recent release for the F in the first five patients of post-TDM1.

That's all the data your people are looking because in China, TDM1 is now standard treatment, but in U.S., TDM1 is. So enough patient population, the first five patients received four of them even in the first scale in PR. So it goes for early indication that efficacy is really great with any percent of response rate. Again, we're still waiting for more patients to demonstrate for similar situation in one or two. IL-2 is a great drug. As a wild-type, we all know it works, but it's with great toxicity. The unfortunate result from Nektar's drug will allow people to think about, is this the right approach. Again, with 102 as a proven target, the [Indiscernible] [Indiscernible] is to enable, which means we're doing something that they've never done before. We believe based on clinical data, we have a much better safety profile compared to existing approach and we have a much better efficacy compared with existing or similar IL-2 drug. We observed much wider therapeutic window in our drug. That's why we believe we have a chance of success in one or two. Thank you.

Phil Nadeau

Perfect. Thanks for taking our questions and congrats again on the progress.

Feng Tian

Thank you.

Operator

Thank you for your question. Our next question is from Joel Beatty with Baird. Please proceed.

Joel Beatty

Hi, thanks for taking my questions. The first one is on the Phase III Breast-02 trial being conducted in China. Could you share how much can we learn from that study that could help us with predicting how ARX788 could perform in a China population such as Breast-03 study?

Feng Tian

Joel, thank you for the question. How much we can learn from Breast-02? Well, first of all, that trial is still ongoing, and what we can learn more is really referencing that trial to actually Breast-01 study. Because Breast-01 study with both safety and efficacy data is out. We can reference those two and try to learn. That's how -- if we were trying to learn anything from Breast-02, that's the way how I learn. And how to -- it's more of how I think about U.S. data. As we talked before, I think for Breast-01 study, our efficacy in China might be underestimated, that's my perception, from my point of view, from both patient selection and also from a percentage of IHC 3-plus patient percentage. Safety wise, what I learn is I referenced that across to other anti-HER2 ADC. The other trials with what we know as Asian population and also U.S. population is different.

In other trial from different company, we observed about between five to seven fold, not percentage, five to seven fold higher of non-comps in Asian population compared to the U.S population. So from that what I learned is, likely the 50 data, especially the non-comps data in Asian population, may be overestimated compared to the U.S. population. So from those, that really give me more confidence for our U.S. trial for both efficacy and also safety. As I mentioned earlier, we -- our first of five patients in impose TDM1 patient, four of them, your first upscale they come up TR. So that's 80% compared with 66% or are in China Breast-01. So even though still early, but those are coming together to validate my perception. So hopefully, with more patient data coming up, we'll have more and more evidence to support this notion. Thank you.

Joel Beatty

Thank you for that. And then as a follow-up, the newly announced Eisai trial, could you tell us anything about the trial design there such as how many patients might be treated with ARX788 and when initial data could come?

Feng Tian

Yes. Thank you for the question. The news actually just came up yesterday, I believe. So it's very fresh and we're very excited to join that trial. First of all, that trial is a consortium, deal with multiple drugs as selected by Quantum leap. So they are looking for treatment that is safe and efficacious to replace the current chemotherapy which caused a lot of toxicity for patients. That statement really already validated the Eisai view about [Indiscernible] profile of ARX788. And we're running into arms. One is the ARX788 as a single arm, single agent. And also the second arm will be in combination with Anti-PD-1 antibody. So those will be started in a few weeks to those patients.

And as a trial design actually is an active trial design. It's quite interesting, very complicated. I don't think we can really get a very clear idea how that's done. Basically, if the drug is working, the patient enrollment will getting faster, and certainly the trial will go a little longer. Regarding what kind of data we can get. I think by second half of the year, if the trial is still ongoing, that's a very good sign, which means the drug is working. So if like say, the trials do ongoing and I cannot tell us the data which should be a pilot data. And wouldn't get a readout. We as a company, we can look at our data. Quantum leap, leave themselves will have the data because there's suspicion, we'll look at those and look for the drug is working better, more patient will be enrolled in our [Indiscernible]. The data readout we're expecting sometime next year. So right now the trial design is about a 100 patients for eSharp. So finger crossed.

Joel Beatty

Thank you.

Feng Tian

Thank you.

Operator

Thank you for your question. There are no further questions waiting at this time, so I'll pass the call back over to the management team for closing remarks.

Feng Tian

Thank you, Operator. In the coming weeks, we plan to attend Bank of America and HC Wainwright healthcare investor conferences, as well as the Colon Oncology Summit. We welcome your request for meetings at our events or directly to us. Feel free to reach out to Sonya if you'd like to schedule some time. This concludes our second half and full year 2021 conference call. Thank you again, everyone, for joining us this afternoon.