Q2 2022 Affimed NV Earnings Call

August 11, 2022

Good day, everyone and welcome to the <unk> second quarter 2022 financial results and corporate update conference call. My name is Vanessa and I will be your operator for today's call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer.

Our session. During the question and answer session. If you have a question you can enter the queue by pressing zero then one on your Touchtone phone as a reminder, this conference is being recorded.

I would now like to introduce your host for today's call Mr. Alex <unk> head of Investor Relations at Ashland that Sir you may begin.

Thank you Vanessa and thank you all for joining us today for our call.

Before we begin I'd like to remind everyone that we issued the relevant press release earlier today, which can be found on the Investor Relations section of our website.

The call today, we have members of our management team, including our Chief Executive Officer, Andreas <unk>, Our Chief Medical Officer, Orange to Julien <unk>, Our Chief Scientific Officer, Denise Mueller, Chief Business Officer, and Angus Smith, our Chief Financial Officer.

The team will be available for the Q&A session. After the prepared remarks before we start I'd like to remind you that today's presentation contains projections and forward looking statements regarding future events.

These statements represent our beliefs and assumptions only as of the date of this call except as required by law, we assume no obligation to update these forward looking statements publicly or to update the reasons why actual results could differ materially from those anticipated in the forward looking statements even if new.

New information becomes available in the future.

These forward looking statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied in these statements due to various factors, including but not limited to those identified under the section entitled risk factors in our <unk>.

Filings with the SEC and those identified under the section entitled forward looking statements in the press release that we issued today and filed with the SEC.

With that I'll turn the call over to Audi Audi.

Thank you Alex.

Thank you everyone and thanks for joining our second quarter.

2022 of the financial results and operational progress update call.

We estimate we have a clear vision and goal to be the leading in nature.

In the age of the company.

And to stop content from derailing patients' lives.

And then beyond this year.

We presented groundbreaking data from.

From the combination of <unk> with NK cells in relapsed refractory Hodgkin lymphoma patients.

Having achieved 100% objective response rate.

Clearly impressive given the fact that these patients had undergone.

Median number of seven prior lines of therapy.

And in most cases had exhausted all approved an experimental therapy.

Since the data were presented the study has continued to enroll well underscoring the high need for novel options for these patients.

We believe our <unk> engage technology through its bispecific tetravalent structure.

We have a very high affinity binding to <unk> on natural killer cells and macrophages.

Without the competition from circulating immunoglobulin.

At the core of these impressive results.

The unique attributes of our technology has enabled us to demonstrate meaningful anti.

Antitumor activity for our independent getting two molecules as monotherapy.

And in combinations, including a strong synergy with.

PD, one PD lone checkpoint inhibitor trials and most recently in combination with metrics that footprint.

We are indeed very excited about the many upcoming data readouts across the three pronged strategy approach and today I will summarize our expectations for the remainder of this year.

Moving to slide four place in 13, we show that we have two ongoing studies.

For the registration directed study for <unk> as monotherapy in relapsed and refractory peripheral T cell lymphoma.

Also known as redirect.

We remain on track to deliver top line data in the fourth quarter.

Yeah.

The study enrolled more than 100.

Perhaps in refractory <unk> patients.

And the focus of the initial data release will be on the overall response rate as assessed by a blinded Independent review Committee.

<unk> assessment of the duration of this.

Just as a reminder, PTC L is a disease with significant unmet needs there.

Nearly 1500 patients just in the U S.

Each year with representing with relapsed or refractory to treatment.

Treatment options are very limited.

The prognosis for these patients remains very cool.

The secondary <unk> study is the phase one flash to study in collaboration with the MD Anderson.

Cancer Institute.

Evaluating blood derived natural killer cells pre complex with <unk>.

Followed by.

<unk> treatment.

Again in patients with relapsed refractory <unk> <unk> positive.

Data presented at this year's <unk>.

Conference trying doctoring youre going to get the lead investigator of the trial at MD Anderson.

Demonstrated that after a second talking of treatment. The complete response rate at the recommended phase II dose.

Increased from 38%.

As reported in December 2021% to 62%.

This was achieved in 13 patients the overall response rate.

100%.

And the treatment once determined phase.

And very well tolerated by patients.

Which is now, allowing MD Anderson continue to treat patients with up to four cycles.

Durability of response data presented for patients treated at the recommended phase two dose.

Also promising.

Of the eight patients who achieved a complete response seven remained in complete response at a median follow up of fixing a half months.

Including two patients who had remained in response after 10 months.

And two who received a consolidation autologous stem cell transplant.

Indeed enrollment in this study is progressing very well.

As of July 31st.

30 patients have now been treated including 24 at the recommended phase two dose.

Of one times tend to be a cord blood derived NK cells per kilogram.

Which represents an additional 11 patients treated at that dose.

Since our latest state to updated Haynesville.

Important to note here is that based on the amended protocol. Some patients have now received up to <unk> of treatment.

And new patients are being enrolled at the recommended phase II dose.

Spectrum that Dr. Nieto will report updated data from this study at a major scientific conference in the fourth quarter.

We're also progressing very well with our NK cell strategy to ensure access to an off the shelf cryopreserved NK cell portfolio development.

With our in attending nature molecules.

We expect to announce a development cost of our <unk> with a specific one closed in the second half of 2012.

Now, let me jump to <unk> 24.

As shown on slide five.

We continue to enroll patients in all three ongoing studies in.

Including the expansion cohort.

Our monotherapy study.

In the dose escalation for the combination studies, one with <unk> and the other one with the NK one autologous NK cell program from <unk>.

As we discussed on our last call. We completed the dose escalation part of the monotherapy study and determined and confirmed the 480 milligram weekly dose with our recommended phase II dose.

We're continuing to enroll patients in the expansion phase of the mono therapy.

At the recommended phase two dose.

The expansion cohort includes patients with renal cell carcinoma, non small cell lung cancer and colorectal cancer.

I think from the monotherapy study, including clinical data from the dose escalation phase will be presented at ESMO.

And you've heard the update with correlated science data is expected to be presented at a scientific conference later this year.

We are also continuing to enroll patients in the dose escalation phase of the two combination studies.

The primary purpose of the dose escalation case studies to establish the safety of the two combination and identify the recommended phase two dose for the dose expansion phase.

In a year from 'twenty one two.

The combination of <unk> 'twenty four with lease them up.

We are treating patients with non small cell lung cancer.

Gastric cancer.

And a basket comprising pancreatic cancer cell going to retract.

In this study we have completed the first dose cohort and are enrolling into the second cohort at 480 milligram, which is the recommended phase II dose of <unk> 24.

A presentation of such data.

From this study is expected at the at the scientific conference in the fourth quarter of this year.

Now a second combination study called anything 20, 413 is investigating the combination of April 24.

I think one.

Which is autologous NK cells.

Company called encouraging biotech. This is investigated in patients with non small cell lung cancer squamous cell carcinoma of the head and neck colorectal.

In this study we are nearing completion of cohort, one which is treating patients at the 160 milligram of <unk> from 24.

Fixed dose of <unk>, one and then update this plant based on frankly.

Moving to Asia from 2008, our third wholly owned in Italy engaged targeting CD 123 in patients with AML.

As planned we submitted an IND to the FDA in June .

Following this special Ricky.

The R&D.

Specifically the design of the dose escalation.

We have taken a strategic deal.

Fishing to focused Ellington energy development of 28 outside the U S.

We believe this decision will enable us to conduct the dose escalation.

You probably have a recommended phase two dose as well.

And we now expect to initiate the clinical study in the first half of 2023.

We intend to Reengage with FDA after they get in terms of dose escalation has been China.

As we've mentioned the email is one of the worst blood cancer patient.

Patient.

Prognosis.

Especially in the relapsed or refractory setting with no standard of care salvage regime.

Currently available.

Given the aggressive nature of the disease in desperate need for a viable treatment option. It is a high priority for a permit to be able to offer this treatment option.

AML patients as quickly as possible. We believe this strategy will help to achieve this goal.

Finally, we're also advancing our work with existing partners.

In the case of <unk>, we've made good progress in various preclinical programs and handed over several programs to them for some of the preclinical development.

Our partnership with ROI event.

<unk> hundred 32.

For coal plant Robin asked me.

21 O. One dash 33 is currently being investigated in.

R&D, enabling studies.

We arent electrical for additional proceeds from these key collaborations in the near term.

Including preclinical milestone as well as milestones based on regulatory issues.

We're continuing to build on our core strength and comprehensive to deliver on the goals that you've set.

For hotels for the next few months and we are building the foundation to drive value for shareholders and patients.

For 2022 and beyond.

With that I'm, turning over the call to Anders.

Give you an update on the financials.

Yes.

Thank you Robyn.

Balance sheet and income statement highlights are shown on slides six and seven of the presentation.

<unk> consolidated financial statements have been prepared in accordance with IRS as issued by the international accounting standard board or <unk>.

The consolidated financial statements are prepared in euros, which is the companys functional and presentation currency.

Therefore, all financial numbers are presented in this call unless otherwise noted will be in euros.

As of June 32022, cash and cash equivalents totaled $237 2 million compared to a $197 6 million on December 31 2021.

Based on our current operating plan and assumptions, we anticipate that our cash and cash equivalents will support operations into mid 2024.

Net cash used in operating activities for the quarter ended June 32022 was $26 5 million euros, compared with $17 3 million euros for the quarter ended June 32021.

Total revenue for the quarter ended June 32022 was $7 3 million compared with $9 7 million.

For the quarter ended June 30 of 2021.

Revenue predominantly relates to the genentech and ROI that collaborations.

R&D expense decreased by 4% from $21 8 million in the quarter ended June 32021 to $20 8 million for the quarter ended June 32022.

The decrease was primarily due to lower expenses associated with the development of <unk>.

<unk> and AFM 24 programs.

Largely a result of the decrease in the procurement of clinical trial material.

General and administrative expenses increased 54% from $5 4 million in the quarter ended June 32021 to $8 4 million in the quarter ended June 32022.

Increased predominantly relates to higher personnel and share based payment expenses and an increase in insurance premiums.

Net finance income or cost increase from costs of $1 6 million euros for the quarter ended June 32021 to income of $2 3 million for the quarter ended June 32022.

Net finance income or cost is largely due to foreign exchange gains and losses related to assets denominated in U S dollars as a result of currency fluctuations between the U S dollar and the euro during the year.

Net loss for the quarter ended June 32022 was $19 4 million or <unk> 13 per common share compared with a net loss of $18 8 million or <unk> 16 per common share for the quarter ended June 32021.

The weighted number of common shares outstanding for the quarter ended June 32020 to about $147 3 million.

Additional information regarding these results is included in the notes to the consolidated financial statements as of June 32022, which will be included in <unk> filings with the U S Securities and Exchange Commission.

I will now turn the call back to <unk> for closing remarks.

Yes, thanks, a lot anchors as well.

So on slide eight we are continuing to advance.

Programs forward with a focus on delivering many meaningful updates for our key programs in the second half of this year.

I'd like to thank you for all your continued support in particular patients and their families.

And quality employees in the U S. In Europe , who are continuing to do the best they can in supporting our efforts to move things forward.

Well now open to take questions.

Operator.

Thank you we will now begin our question and answer session. If you have a question. Please press star one.

One on your Touchtone phone, if you wish to be removed from the queue. Please press zero, then too if you're using a speaker phone. Please pick up the handset first before pressing the numbers. Once again, if you have a question. Please press <unk> and then one on your Touchtone phone. Please standby, while we assemble our queue.

Yeah.

Once again that zero.

And then wanted to queue up with your question. Please.

Yeah.

We have our first question from Diana great spot with SBB security.

Hi, Thanks for the question.

Regulatory questions one on core.

Can you talk more about the feedback from FDA, whether it's paying announced specific or excuse me 123 or molecule specific.

Hi.

Their reservations that would lead to an escalation.

Marcelo.

Then sort of second regulatory question wondering if you've had a chance.

Further for a meeting or you can talk about future meeting with FDA on all of a sudden 13.

Alright, thank you.

Yes, Dana thanks for the questions I will hand over to Andrea <unk>.

Hi, Dana.

Just to be sure I think your first question was relating to 2008 and $2 24 right.

On the stock.

Yes.

No.

As we said we made a strategic discussion after discussions with FDA.

We cannot share a lot of details about this discussion message they're confidential this with regulators what we can say, though is that there was no specific concerns.

About CD 123 as a target.

Yeah.

And to the second question.

As we have stated previously our intention is to have a.

Regulatory interaction.

Our meeting with FDA concerning the next steps forwards for the development of AFM 13 in combination with NK cells. This years and we are sticking to this guidance. This is our intention.

Yes, Sir.

I mean, it hasnt happened and you're not guiding to a specific timeframe for that.

Other than probably this year.

Yes, so it will <unk>.

And this helps us meetings this year, but we have not guided to a specific timeframe.

Obviously has not happened yet.

Alright, Thank you very much.

Thank you we have our next question from Chris <unk> with curious securities.

Hi, Thanks for taking the questions with Alex on for Chris.

And I had a question about.

Third party manufacturing, which is a question we get a lot from investors.

Can you talk a little bit about the challenges of considerations that go into finalizing the third party manufacturer what metrics Youre looking at and also how that might affect different partnerships that you have going on with other NK cell company.

Yes, thanks for this.

Question on the NK cell products as we've been.

Stated recently.

<unk> has been.

<unk>.

A number of manner.

To understand the.

Partners.

Manufacturing.

And the next call it NK cell quality, so we have a number of internal.

Assays established that we feel we have that.

That allows us to.

Can you identify the best partners.

In terms of NK cell products, we have in China, where it would seem that that was a good number of NK cell program.

With that.

Similar ties well with that.

Turning data.

Almost independent of source, so cord blood derived peripheral blood.

<unk> and Paypal and they're trying to work with our independent agents.

And.

What we have been focusing on recently in terms of.

Now moving forward is to be able to entertain a registration directed study.

So that requires a partner to have.

Essential.

Substantially and made progress in terms of NK cell manufacturing so that.

Only the quality to be.

Provided but also the quantity.

<unk> identified such Rfps.

And are in the process of finalizing the business agreements.

Okay.

One follow up on the <unk>.

Okay.

<unk> hundred 13 monotherapy trial.

What's the bar for the monotherapy duration.

Efficacy, how youre thinking about it and then also remind us about the development strategy.

After you get the topline data readout later this year.

Yes, I'll hand, this over to Andrea.

Yes, so for the efficacy bar again, we looked at.

Drugs that have received accelerated approval.

PTC all setting.

Our our sweet drugs.

Which would have with the response rate was remarkably similar for all three drugs or <unk>, 27% to 28%.

So this gives us a certain guidance about <unk> response rate.

<unk> responses in these trials were in Z.

And the range around eight months, plus or minus months, which again is the guidance for us for what we're looking for in terms of duration of responses.

Of course, the FDA will never give you a concrete number so that all of us.

Correct.

It will be a review issue but.

The consistency of data was all III trucks okay.

<unk> reached accelerated approval provides us with a pretty good guide rail I would say.

And what was your second question.

Okay.

What does that next steps following the top line data readout later this year.

With monetary.

Of course, we actually as we said we will provide the top line.

Data from the study and then of course, the next step is to enter into interactions with regulatory agencies, primarily with the FDA to discuss next steps as we said our intention is such a study should be registration with directly to them. So we will have discussions with our regulators about that.

Alright, Thanks for taking the question and congrats on the progress.

We have our next question from Maury Raycroft with Jefferies.

Hi, Thanks for taking my questions.

I was going to ask one on.

Manufacturing partner <unk> combo as well is is this something that you need to have in hand are figured out when you meet with FDA later this year to discuss the combo.

What sort of evidence would you need to bring to the FDA with regard to.

This potential NK cell combo partner in order to move directly into a Registrational study.

So we have.

Thanks, Martin for the question.

Obviously, we can appreciate.

Uh huh.

There are a lot of questions.

Questions out there.

That needs to be evaluated and then.

This cost we have taken the position that we have gained a substantial amount of know how.

Our own brands and also what partners do and.

The Knowhow we have.

What could consolidate them now to move forward.

<unk> costs.

Composite with FDA. So we are.

And then expecting that feedback on the details at the moment, what we can say is that we.

Hearts and our minds identified a partner that can grow.

This requirement.

Unfortunately, I cannot go into any further detail along this as obviously the meeting with FDA.

Which are already.

In preparing in advance in preparation.

We will then give us Neil.

A resolution that we can share with you.

Later on.

Got it that's helpful and so it sounds like you have identified a partner then is that fair just to clarify here.

Well again without going into detail.

Yes.

We said we are in.

The execution of our business agreements.

Okay.

Is confirming that we have we have identified if its one partner multiple partners whoever it is that remains to be discussed at the time when Dr. When we're finished with it but we have seen in the field that there are companies out there that can portfolio requirements that I just mentioned.

Got it okay makes sense and.

I also wanted to ask a question on AFM 24, so we see that youre going to have a poster at ESMO.

Just wanted to clarify on that one whether you could potentially include some expansion monotherapy data in that poster or.

If you can talk more about what that update is going to be.

Andreas can you take this question.

Absolutely.

Further I think during the presentation at the ESMO poster will.

Mainly focus on the additional data from the dose escalation part so the 720 milligram cohort.

Which was snow.

Sufficient degree of follow up.

And then data from the expansion cohorts will be released as they become available but estimate will mainly focus on Z.

Dose escalation part.

Got it Okay, and then for the <unk>.

The Io combo update in the fourth quarter can you talk about how much data, we could see for that update.

Again, it's an ongoing study is already set.

Because it is a much study we have completed the dose escalation part one.

Without <unk>, we are actively recruiting at 480 milligram.

And we'll be able if we confirm that.

Also in combination with the recommended phase II dose, we will be able then to open expansion cohorts.

Obviously dataset that we will have most likely towards the end of the year.

Mainly from the dose escalation part.

Got it okay. Thanks for taking my questions.

Thank you. Our next question comes from Lee <unk> with Cantor.

Hey, guys. Thanks for taking my question.

I guess first just on <unk> combo.

Hey, guys.

Or the data that you are going to sit down later this year.

I guess what are you looking to learn from that data set and things like you have 24 solution.

Sure.

Patients can receive up to four.

Maybe just talk about what would be difficult for investors there.

Okay.

I can take this question again.

We will have much more patients.

And of course, we will also report on the patients that were part of <unk>.

See our disclosure earlier this year now all of these patients will have a significantly longer follow ups. Please for the first.

Let's say 12 patients or so we will have really long follow up which I think will allow a significantly better estimate of duration of responses.

In addition to of course response data from the newly recruited patients.

The other thing that I know, there's always a lot of discussion about doing multiple lymphoid depletions.

I thought you said, we have patients who have now received suite enforced cycles.

So there will also be a safety update on multiple them to depletion country feasibility of this approach, which we think is quite feasible.

Approach.

Okay got it.

And then just one question on anthem plenty for the combination with the keys, though.

And in Q completed I guess in the first cohort.

160.

So I wonder if you can just comment a little bit on the safety side.

Have you observed anything.

That said there and also can you remind us what what.

Is that a therapeutic range in a combination setting.

Yeah.

So as we said we have completed about 60 milligram cohort was standard dose of T cells.

Not see dose limiting toxicity, which allowed us to escalate up to 480 milligrams.

And as we said we will provide a much more granular data updates towards the end of the year.

Which will include all of the safety profile.

Okay.

I guess just.

Last one on <unk> 28, so in terms of the phase one study.

And just sort of discuss the design of the dose escalation and then can we just walk us to the timelines here.

And when we might see the data from the dose escalation portion.

What would be the plan I.

I guess after the phase one.

So we made the strategic decision to focus initially on.

Yes, we have outside of the U S. As we have guided in our document we expect.

Patient enrollment will start our first half.

Of next year first half of 2023.

And as you know for dose escalation studies, it's always difficult to predict.

It is a dose escalation studies at <unk> to identify a recommended phase II dose.

Pharmacodynamics active dose.

As soon as possible.

And beyond that our intention is to look at two.

<unk> 2008.

As a mono therapy for patients with refractory AML, but also to combine.

With allogeneic NK cells.

As soon as possible. So this would be a two pronged approach for the military.

Okay got it thank you.

And thank you we have our next question from Bradley <unk> with Stifel.

Hey, this is John on for Brad Canino, Thanks for taking our question.

The upcoming FDA meeting on the if Im 13, NK cell combo, what are some of the key points you intend to communicate with the agency now there are other steps that need to be finalized prior to a pivotal trial start.

Andrew do you want to take that.

Yes, I can start and you can also chime in.

If needed so yes.

Yes.

Has it seems is unprecedented activity.

<unk> NK cells in combination with IL from certain especially in Hodgkin lymphoma patients.

Our intention is to bring this treatment to patients and make it broadly available as soon as possible. So.

Our focus in discussions with the FDA, it will really be to align or agree on.

<unk> passed that.

Ideally.

Enable.

Let's see most expedited approval.

Approval of <unk>.

Something that's a certain combination.

So which kind of trial with us today are and whats the FDA expectations would be.

We believe they're going to be very high activity.

Yes.

Unmet medical need of these refractory patients.

Development costs.

Excellent.

Approval process by the piece will be somewhat sequentially that we will address with FDA.

Yeah.

Okay, perfect and are there other steps that need to be finalized prior to a pivotal trial start with manufacturing et cetera.

Well in terms of manufacturing I think we have outlined.

Sure.

Through the <unk>.

The earlier questions that we have been eight.

<unk> able to accumulate accumulate a lot of know how within SMS and understanding what we believe their requirements are.

Manufacturing and we have clients, who have identified companies that can provide satisfying answers.

And as Sundar.

We are ready to disclose.

Like when we are.

Are there behind the meeting we can then provide the granularity.

At the moment.

<unk>.

Let me put it this way a question to be addressed nevertheless.

We have.

Basically you're learning in the past.

Months and quarters.

That there is substantial quantity in terms of NK cell manufacturing available.

We've been testing.

Reconciles, our internal engagement and generate the confidence.

These preclinical data already.

Comprehensive presentation that showed that there was substantial activity with crop presents itself, we can increase their sales when loaded with ADP <unk>.

And then after following they are they are active.

There is a.

Good part of rock that we have to invest in order to make sure that.

The NK cells.

Labour irrespective of activity. In addition, we have learned from clinical data presented by other.

There are different NK cells that seem too.

It's very similar.

If we could see in particular in non Hodgkin lymphoma, either cost <unk> 19, or and so combined with Rituximab.

So that is a.

A lot of.

Additional information in the meantime available that hasnt been available a year ago interest accumulated in the past.

Months.

So thats, how we have been.

<unk> learning and creating confidence on our part so that there is now the right time to bring the parkland ultimate together and move forward with a with a discussion at the meeting next year, that's correct and preparedness.

<unk>.

Got it thanks for taking the question.

We have our next question from Yale Jen with Laidlaw <unk> company.

Good morning, and thanks for taking the questions.

First from the <unk>.

<unk> and NK combos.

For the 24 patients so far you've treated could.

Could you give us a breakdown in terms of the tumor types.

Moment.

Congrats.

Okay.

Yeah.

So.

The majority is.

Still Hodgkin's lymphoma, we cannot give hub.

Detailed numbers as this will be part of the disclosure, but since the initial 11 patients were already hodgkins, but we are actively also recruiting non hodgkin lymphoma patients now.

Okay, Great. That's very helpful and one more question here to follow the previous one.

In terms of the monotherapy <unk> in monotherapy and you guys say, what the bar of efficacy and the DLR.

It will be and what could be the minimum performance in your opinion that will provide greater commercial viability.

Addressing one of the regulator on this.

No.

I only can reiterate what I said.

In terms of regulatory we have a couple of precedent. So with response rates in the high 20% 27, 28% duration of response of around <unk> eight.

<unk>.

So this is our.

Our I.

Would say internal benchmark.

And then we will have discussions with FDA I definitely cannot comment on the commercial.

That's what we know though is that this is a patient population with very high unmet medical need.

Treatment options are very very limited.

So I think it would offer a treatment option for patients who basically.

Our strengthened by debt immediately.

Okay, Great that's helpful and thanks Paul.

Good luck.

We have our next question from Sean <unk> with Baird Burke.

Great. Thank you.

I wanted to ask about the <unk>.

I think 11 additional patients and had been treated.

Evan Theres, an NK cell combo.

Post ACR I Wonder if you are willing to provide a bit of detail in terms of efficacy and safety there.

Also included in this one particular patient I guess first patient we've.

<unk> seen four cycles.

I Wonder if you are willing to provide a bit of more granularity around the.

The disease progression and responses here.

Yes.

I'll hand over to Andreas in a minute that opex would be we remain very excited.

Obviously very positively in the price book.

<unk>.

Very positive about this.

A good number of recruitment that we're seeing here. So you can also go into into social media, where people are reporting about.

The experiences with with this therapy. So there is since.

Since AUC ought to have been nearly a year.

A good amount of inflammation that was spread so that.

Patients have been brought onto onto such therapy.

As we've said we have now 11 additional patients that were recruited.

And treated as of as of.

End of July so listen to our minds indicate.

Ohio can demand, we really are seeing for this patient population.

Obviously regarding reporting data.

We've been.

Very focused on.

But basically following the rules by the respective by the respective organized in order to secure permanent.

Presentation slides.

Andrea.

Yeah.

Yes.

I cannot add significantly more as we said we were expecting.

To have an update of <unk> data in collaboration with our investigators from MD Anderson.

At a major scientific meeting towards the end of the year. So before is that we cannot give any more detailed data onto new patients or on the ongoing patients beyond what we have already disclosed in our remarks.

Okay. Thank you and maybe just a follow up on your business development strategy can you talk about some without giving.

Given you have.

<unk> differentiated platform I E.

To extend some of the partnerships in the near future and what our potential.

Potential.

Thank you.

Okay.

Yeah at this at this moment.

I do not want to comment specifically on business development, we've beaten up.

So almost we've been focusing obviously on the execution of our three program.

That's why we have done.

Really invested our most emphasis we have in fact, we've we've been and are receiving.

Continuous inbound requests.

Valuing those against what are what we want to achieve on ourselves equilibrium to partnership. So this ongoing dialogues.

And.

We have we pay attention to this.

At the same time in particular with <unk> and 'twenty four we have been progressing in the clinic to now.

I'll be able to present updates in the second half, but also continuously but we're generating value by progressing the programs. We have we're well funded indeed. So can proceed with with this strategy until we may decide to have identified them.

Great partner.

But it remains at the moment.

I want to remind you have already paid.

I should mentioned that there is a good number of interest in partnering up with estimates on.

Some of the specific current programs and our earlier pipeline.

Great. Thank you.

Thank you that concludes our first round of questions. If you have follow up questions. Please press zero then one on your Touchtone phone.

Standing by for questions.

And I see we have no further questions at this time I would like to thank everyone for your participation in the call. Today. This concludes our conference and you may now disconnect.

Okay.

[music].

Okay.

[music].

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During the question and answer session. If you have a question you can enter the queue by pressing zero then one on your Touchtone phone as a reminder, this conference is being recorded.

I would now like to introduce your host for today's call Mr. Alex <unk> head of Investor Relations, Sir you may begin.

Thank you Vanessa and thank you all for joining us today for our call before we begin I'd like to remind everyone that we issued the relevant press release earlier today, which can be found on the Investor Relations section of our website.

On the call today, we have members of our management team, including our Chief Executive Officer, Andreas <unk>, Our Chief Medical Officer, Orange to <unk>, Our Chief Scientific Officer, Denise Mueller, Chief Business Officer, and Angus Smith, our Chief Financial Officer, the team will be available.

For the Q&A session. After the prepared remarks before we start I'd like to remind you that today's presentation contains projections and forward looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date of this call except as required by law, we assume no.

Obligation to update these forward looking statements publicly or to update the reasons why actual results could differ materially from those anticipated in the forward looking statements, even if new information becomes available in the future.

Under the section entitled forward looking statements in the press release that we issued today and filed with the SEC.

With that I'll turn the call over to Audi Audi.

Thank you Alex good.

Good day, everyone and thanks for joining our second quarter.

2022 of the financial results and operational progress update call.

And I think that we have a clear vision and goal to be the leading in a data company.

And to stop content from derailing patients' lives.

And then just beyond this year.

We presented groundbreaking data from.

From the combination of <unk> with NK cells in relapsed refractory Hodgkin lymphoma patients.

Having achieved 100% objective response rate.

Particularly impressive given the fact that these patients had undergone.

Median number of seven prior lines of therapy.

And in most cases had exhausted all approved an experimental therapy.

Since the data were presented the study has continued to enroll well underscoring the high need for novel options for these patients.

We believe our <unk> technology.

<unk> Bispecific tetravalent structure.

With a very high affinity binding to <unk> on natural killer cells and macrophages without the competition from circulating immunoglobulin is at the core of these impressive results.

The unique attributes of our technology.

As to demonstrate meaningful.

Antitumor activity.

Pending data molecule as mono therapy.

And in combinations.

Leaving a strong synergy with <unk>.

PD, one PDL, one checkpoint inhibitor trials and most recently in combination with metrics that footprint.

We are indeed very excited about the many upcoming data readouts across the three pronged strategy.

Liturgy approach and today I will summarize our expectations for the remainder of this year.

Moving to slide four place in 13, we show that we have two ongoing studies.

For the registration directed study for <unk> as monotherapy in relapsed and refractory peripheral T cell lymphoma.

Known as redirect.

Remain on track to deliver top line data in the fourth quarter.

Steve.

The study enrolled more than 100.

Perhaps in refractory <unk> patients.

And the focus of the initial data release will be on the overall response rate as assessed by a blinded Independent review Committee.

Eminem reassessment of the duration of fiscal <unk>.

Just as a reminder, PTC L is a disease with significant unmet needs there.

Nearly 1500 patients just in the U S.

Each year, representing with relapsed or refractory pizza.

The options are very limited.

Prognosis for these patients remains very cool.

The secondary <unk> study is the phase one slash two study in collaboration with the MD Anderson.

And cancer Institute.

Evaluating blood derived natural killer cells pre complex with <unk>.

Followed by <unk>.

<unk> treatment.

Again in patients with relapsed refractory <unk> positive lymphoma.

Data presented at this year's conference by Dr. <unk>, the lead investigator of the trial at MD Anderson.

Demonstrated that after a second talking of treatment. The complete response rate at the recommended phase II dose.

Increased from 38%.

Pointed in December 'twenty, two 'twenty, 1% to 62%.

This was achieved in 13 patients the overall response rate.

We remain 100%.

And the treatment once determined faith and very well tolerated by patients.

Which is now, allowing MD Anderson to continue to treat patients with up to 4%.

Okay.

Durability of response data percentage for patients treated at the recommended phase two dose.

Also promising.

Of the eight patients who achieved a complete response seven remained in complete response at a median follow up of fixing a half months.

Including two patients who had remained in response after 10 months.

And two who received a consolidation autologous stem cell transplant.

Indeed enrollment in this study is progressing very well.

As of July 31st.

30 patients have now been treated including 24 at the recommended phase II dose.

Of one times tend to be a cord blood derived NK cells can be real quick.

Which represent an additional 11 patients treated at that dose.

Since our latest state to updated Haynesville.

Important to note here is that based on the amended protocol. Some patients have now received up to two cycles of treatment.

And new patients are being enrolled at the recommended phase II dose, we aren't expecting that Dr. <unk> will report updated data from this study at a major scientific conference in the fourth quarter.

We're also progressing very well with our NK cell strategy to ensure access to an off the shelf cryopreserved NK cell portfolio development.

With our entertainment nature molecules.

And we expect to enhance the development, possibly some 13 with a specific one peso against in the second half of 2022.

Okay.

Now, let me jump to <unk> 24.

As shown on slide five.

We continue to enroll patients in all three ongoing studies in <unk>.

The expansion cohort for our monotherapy study and the dose escalation for the combination studies, one with <unk> and the other one with the <unk>.

Autologous NK cells trained them from <unk>.

As we discussed on our last call. We completed the dose escalation part of the monotherapy study and determined and confirmed the 480 milligram weekly dose as our recommended phase II dose.

We're continuing to enroll patients in the expansion phase of the mono therapy.

At the recommended phase two dose.

The expansion cohort includes patients with renal cell carcinoma, non small cell lung cancer and colorectal cancer.

Data from the monotherapy study, including clinical data from the dose escalation phase will be presented at ESMO.

And you've heard the update with correlated science data is expected to be presented at a scientific conference later this year.

Okay.

We are also continuing to enroll patients in the dose escalation phase of the two combination studies.

The primary purpose of the dose escalation phase of these studies is to establish the safety of the two combination and identify the recommended phase two days.

Those expansion pace.

In a year from 'twenty one two.

The combination of <unk>, 'twenty, four with Ses and lease them up.

We are treating patients with non small cell lung cancer.

Gastric cancer.

And a basket comprising pancreatic cancer cell didn't retract.

In this study we have completed the first dose cohort and are enrolling into the second cohort at 480 milligram, which is the recommended phase II dose of between two four.

A presentation of such data from this study is expected at the at the scientific conference in the fourth quarter of this year.

Now a second combination study called anything 24, one is investigating the combination of <unk> 2004 with S&P one.

Which is.

While I'm guessing takes a company.

Company called anchor trained biotech. This is investigated in patients with non small cell lung cancer squamous cell carcinoma of the head and neck and colorectal.

In this study we are nearing completion of cohort, one which is treating patients at 60 milligram of <unk> from two to four and a fixed dose of <unk>.

In Q1, and then update as planned.

Great.

Moving to our April 28, our third wholly owned in it and engage your targeting CD 123 in patients with AML.

As planned we submitted an IND to the FDA in June .

Following the special with the FDA regarding the R&D.

Specifically the design of the dose escalation.

We have taken a strategic.

Decision two focused Ellington development of 28 outside the U S.

We believe this decision will enable us to conducting the dose escalation.

Probably the recommended phase two dose.

And we now expect to initiate the clinical study in the first half of 2023.

We intend to Reengage with FDA. After they continued dose escalation has been China.

Okay.

As we've mentioned the email is one of the worst bluffton.

Patient.

Prognosis.

Especially in the relapsed or refractory setting with no standard of care salvage regime.

Currently available.

Given the aggressive nature of the disease in desperate need provided with treatment options. It is a high priority for us to be able to offer this treatment option.

Such AML patients as quickly as possible. We believe this strategy will help to achieve this goal.

Finally, we're also advancing our work with existing partners.

In the case of <unk>, we've made good progress in various preclinical programs and handed over several programs to them for some of the preclinical development.

And our partnership with Royal Bank.

And a year from 32.

For corporate <unk>, asking the T 21 O. One dash 33 is currently being investigated in.

It links that as well.

We arent a literal.

Additional proceeds from these key collaborations in the near term, including preclinical milestone as well as milestones based on regulatory achievements.

We're continuing to build on our core strengths and competencies.

Deliver on the goals that we've spent more hotels for the next few months and we are building the foundation to drive value for shareholders and patients alike 2022 and beyond.

With that I'm, turning over the call to Angus.

To give you an update on the financials Angus.

Thank you Ari.

Balance sheet and income statement highlights are shown on slides six and seven of the presentation.

<unk> consolidated financial statements have been prepared in accordance with IRS has issued by the international accounting standard board or <unk>.

The consolidated financial statements are prepared in euros, which is the companys functional and presentation currency. Therefore, all financial numbers are presented in this call unless otherwise noted will be in euros.

As of June 32022, cash and cash equivalents totaled $237 2 million compared to $197 6 million on December 31 2021.

Based on our current operating plan and assumptions, we anticipate that our cash and cash equivalents will support operations into mid 2024.

Net cash used in operating activities for the quarter ended June 32022 was $26 5 million euros compared with $17 3 million for the quarter ended June 32021.

Total revenue for the quarter ended June 32022 was $7 3 million compared with $9 7 million euros for the quarter ended June 32021.

Revenue predominantly relates to the Genentech, an ROI that collaborations.

R&D expense decreased by 4% from $21 8 million in the quarter ended June 32021 to $20 8 million for the quarter ended June 32022.

The decrease was primarily due to lower expenses associated with the development of <unk>.

<unk> and AFM 24 programs.

Largely a result of the decrease in the procurement of clinical trial material.

General and administrative expenses increased 54% from $5 4 million in the quarter ended June 32021 to $8 4 million in the quarter ended June 32022.

The increase predominantly relates to higher personnel and share based payment expenses and an increase in insurance premiums.

Net finance income or cost increase from cost of $1 6 million euros for the quarter ended June 32021 to income of $2 3 million for the quarter ended June 32022.

Net loss for the quarter ended June 32022 was $19 4 million or <unk> 13 per common share compared with a net loss of $18 8 million or <unk> 16 per common share for the quarter ended June 32021.

The weighted number of common shares outstanding for the quarter ended June 32020 to about $147 3 million.

I will now turn the call back to <unk> for closing remarks.

Yes, Thanks, a lot Angus.

We show on slide eight we are continuing to advance key programs forward with a focus on delivering many meaningful updates for our key programs in the second half of this year.

I'd like to thank you all.

Your continued support in particular patients and their families.

And for our employees in the U S and Europe , who are continuing to do the best they can in supporting our efforts to move things forward.

Well now open to take questions. Thank you operator.

Thank you we will now begin our question and answer session. If you have a question. Please press star.

One on your Touchtone phone.

We wish to be removed from the queue. Please press Star then two.

Using a speakerphone please pick up the handset first before pressing the numbers. Once again, if you have a question. Please prestero then one on your Touchtone phone. Please standby, while we assemble our queue.

Yeah.

Once again that does.

Then wanted to queue up with your question. Please.

Yeah.

We have our first question from Diana great spot with SBB security.

Yeah.

Hi, Thanks for the question.

Regulatory questions one on.

Or can you talk more about the feedback from FDA, whether it's paying announced specific or excuse me 123 or molecule specific.

Right.

Their reservation is that related or escalation.

Slow and then sort of second regulatory question wondering if you've had a chance.

Further offline meeting or you can call.

Talk about future meeting with FDA on <unk>.

All right. Thank you.

Okay.

Yes, Dana thanks for the questions I will hand over to Andrea <unk>.

Hi, Dana.

Just to be sure I think your first question was relating to 2008 and $2 24 right.

Okay.

Just wondering on the stock.

Okay.

No.

As we said we made a strategic decision after discussions with FDA.

We cannot share a lot of details about these discussions.

And those are confidential this with regulators what we can say, though is that there was no specific concerns.

About CD 123 as a target.

And to the second question.

As we have stated previously our intention is to have.

Regulatory interaction.

Our meeting with FDA.

<unk> the next steps forwards for the development of AFM 13 in combination with NK cells. This years and we are sticking to this guidance.

Sure.

Okay.

At that meeting.

It Hasnt happened and you're not guiding to a specific timeframe for that.

Other than probably this year.

Yes, so it will.

<unk> discussed this meetings this year, but we have not guided to a specific timeframe on it obviously has not happened yet.

Alright, Thank you very much.

Thank you we have our next question from Crippa Debenture Kara with curious securities.

Hi, Thanks for taking the question is Alex in for Chris.

I had a question about <unk>.

Third party cane manufacturing, which is a question we get a lot from investors.

Can you talk a little bit about the challenges of considerations that go into finalizing a third party manufacturer what metrics Youre looking at and also how that might affect different partnerships that you have going on with other NK cell company.

Sure.

Yes, thanks for that.

Question on the NK cell products as we've done.

Stated recently.

Ultimate has been addressing.

And number of manner.

To understand the partners.

Manufacturing and you can call it NK cell quality. So we have a number of internal.

<unk> established that.

We feel we have that.

That allows us to.

Can you identify the best partners.

In terms of NK cell products, we have in China, where it would seem that that was a good number of NK cell program out there.

Well with that.

Turning data.

Almost independent of source, so cord blood derived peripheral uneven.

M <unk> and Paypal choice with with our independent agents.

And.

What we have been focusing on recently in terms of.

Now moving forward is to be able to entertain a registration directed study.

So that requires a partner to have a substantial.

Substantially and made progress in terms of NK cell manufacturing so that.

Not only the quality to be provided but also the quantity.

<unk> touch Rfps.

And are in the process of finalizing the business agreements.

Yeah.

Okay, and one follow up on the <unk>.

813 monotherapy trial.

What's the bar for the monotherapy duration.

Efficacy, how youre thinking about it and then also remind us about the development strategy.

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