Q2 2021 Agenus Inc Earnings Call

August 9, 2021

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Operator: Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Agenus second quarter 2021 conference call and webcast. At this time, all participants are in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. Please note that this event is being recorded and may be used in future Agenus promotional material. I would now like to turn the conference over to John Medina, Director of Investor Relations. John, please go ahead. Thank you, Myra.

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Good morning, ladies and gentlemen, thank you for standing by and welcome to day, a genius second quarter 2021 conference call and webcast.

At this time all participants are in a listen only mode.

After todays presentation, there will be an opportunity to ask questions.

Please note that this event is being recorded and may be used in feature of genius promotional material.

I would now like to turn the conference over to John Medina Director of Investor Relations. John. Please go ahead.

John Medina: Thank you, Myra, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory, and commercial plans and timelines, as well as timelines for data release and partnership opportunities. These statements are subject to risks and uncertainties, and we refer you to our SEC filings for more details on these risks. As another reminder, this call is being recorded for audio broadcast.

IRA and thank you all for joining US today today's call is being webcast and will be available on our website for replay.

I'd like to remind you that this call will include forward looking statements, including statements regarding our clinical development regulatory and commercial plans and timelines as well as timelines for data release and partnership opportunities. These statements are subject to risks and uncertainties and we refer you to our SEC filings for more details on these risks.

As a reminder, this call is being recorded for audio rebroadcast joining.

John Medina: Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer, Dr. Jennifer Buell, President and Chief Operating Officer, Andy Hurley, our Chief Commercial Officer, and Christine Klaskin, Vice President of Finance. Now I'll turn the call over to Garo to highlight our progress during 2021 so far.

Joining me today are Dr. Garo, Armen, Chairman and Chief Executive Officer, Dr. Jennifer Buell, President and Chief operating Officer, Andy Hurley, Our Chief commercial officer, and Kristine class skin, Vice President of Finance and now I'll turn the call over to Garo to highlight our progress during 2021, so far Garo.

Garo H. Armen: Thank you very much, John. And thank you everyone for joining us today. In addition to the named officers of the company, we also have Dr. Steven ODay, our chief medical officer, to answer any questions that you may have at the end. I will start by explaining what I did at our shareholders' meeting approximately eight weeks ago. And there, we try to explain our business in simple terms.

Thank you very much on and thank you everyone for joining US today. In addition to the named officers of the company. We also have Dr. Steven on what day, our Chief Medical Officer to answer any questions that you may have it yet.

I will start by displaying a what I did.

At our shareholders for meeting approximately 8 weeks ago.

And there we tried to explain our business in simple terms.

Garo H. Armen: So that there's clarity about what we focus on, our key operational drivers, and some of the supportive programs we have. Starting with our significant value creators, 1181, that's Agen 1181, which is our next generation CTLA-4 compound that is beyond what just the CTLA-4 does. And you'll hear about that on many future occasions, as you have heard before.

Sure that there's clarity about what we focus on on.

Key operational drivers and channel of the supportive programs we have.

Starting with our significant value creators eliminating 1 that's H N 11, 81, which is our next generation she T L. A for a compound.

That is beyond.

What just the city of La for Dash, and you'll hear about debt on many future occasions as you have heard before.

Garo H. Armen: And with our 1181 program, we have already enrolled well over 100 patients in our clinical trial, and the results of updated clinical data will be made available in the second half of this year at major, at least one major clinical company. Our second significant value driver, which we talked about at the shareholders meeting, is our Agent 797 program, which is our INKT cell. Now, we cannot say very much about that because we have filed an S-1 for a proposed public offering. The third major driver is our Agen 2373. Now, this is a 4-1BB Agenus.

And without on 11.81 program, we have already enrolled well over 100 patients in our clinical trials.

And the results of an updated clinical data will be made available in the second half of this year and major at least 1 major clinical conference.

Our second significant value driver, which we talked about at the shareholders' meeting.

As our agent 797 day program, which is our I N. K T cells now we cannot say very much about debt because we have filed an S..1 for our proposed public offering.

Third major driver is our age and 23.73 now.

Now this is a for 1 b b agonist.

Garo H. Armen: We also call it City 137, this compound, which has been tested for the last, who must be here, has shown excellent safety profile, and we're now seeing hints of very early clinical activity. And in the second half of this year, you'll hear more about this compound. And, of course, we have our QS21 program, which has gotten a lot of attention because of COVID and because of what this compound can do for other vaccines beyond what's been in the headlines with COVID prophylaxis.

We also call it C D 137.

This compound which has been tested.

For the last almost.

For a year.

As shown excellent safety profile.

And we're seeing now hence or very early clinical activity and in the second half of this year, you'll hear more about this compound.

And of course, we have on our Qs 21 program, which has gotten a lot of attention because of COVID-19.

And because of what this compound can do for other vaccines beyond.

What's been in the headlines with Covid prophylaxis.

Garo H. Armen: Now, as you know, we often get questions about which programs to prioritize and how we fund these programs. And, of course, early on, in the beginning of this quarter, we closed on a very important transaction. It was the Bristol-Myers in-licensing of our Tidget bi-specific, and the bi-specific arm has not been disclosed yet. Now this is a very exciting compound, we have thought... Bristol is one of the best candidates to advance this program, if not the best candidate.

Now as you know we get questions often about.

Which programs to prioritize and how do we fund these programs.

And of course early on.

On the beginning of this quarter, we closed on a very important transaction.

It was the Bristol Myers in licensing of our ticket by specific.

And the by specific arm has not been disclosed yet.

It is a very exciting compound.

We have thought.

Debt Bristow is 1 of the best candidates to advance this program if not the best candidates and we also disclosed that are at the time of a consummation of this transaction.

Garo H. Armen: And we also disclosed that at the time of our consummation of this transaction, that it was a competitive process. So this transaction allows us to get the $200 million, which we've already received. In addition to that, there are well over a billion dollars worth of contingent milestone payments and royalties upon commercialization. Also, very importantly, we have a number of other potential transactions in the queue, and some may happen during the course of the second half of this year and some beyond.

Debt it was a competitive process.

This transaction allows us to get the $200 million, which we've already received.

In addition to that debt well over $1 billion worth of contingent milestone payments and royalties upon commercialization.

But also very importantly, we have a number on other potential transactions in the queue.

And some may happen during the course of the second half of this year.

And some be on.

Now, we also talked about potential spinout strategies we'd.

Garo H. Armen: Now we also talked about potential spin-out strategies. We talked about the S-1 filing for a proposed IPO for Mink. Mink, by the way, for those of you who may remember, is the original Agentis company.

We talked about the S..1 filing for a proposed for.

IPO for mink make by the way for those of you who may remember is the original Genesis company. This is our cell therapy company.

Garo H. Armen: This is our cell therapy company, and we also anticipate other potential spin-outs from businesses that have been cultivated with Agenus and are ready to be on their own. Now, we've also talked about potential project financing as a strategy to bring in additional cash, particularly for programs that we plan on pursuing ourselves without necessarily having to out-license, and there are a number of such programs in our portfolio. Now, the third category that we mentioned was what we call supportive programs.

And we also anticipate other potential spin average from businesses that have been cultivated with agenda.

Janice.

And are ready to be on their own.

Now we've also talked about potential heidrick financings as.

Strategy to bring in additional cash, particularly for programs that we plan on pursuing ourselves without necessarily having to out license them.

And there are a number of such programs in our portfolio.

Now the third category that we mentioned or what we call support care programs and supported programs certainly include filling map, our PD, 1 antibody and we've said that while our PD 1 antibody on its own may not be a blockbuster.

Garo H. Armen: And supportive programs certainly include Bostelumab, RPD1 antibody. And we've said that while RPD1 antibody, on its own, may not be a blockbuster. It can be a potential blockbuster product in connection with some of the other elements in our portfolio. We've also talked about our Bostelumab plus Zolifilumab. And you will hear more about that very soon at a major medical conference, ESMO, which we announced with our earnings disclosures. Now we've also been in discussions for potential clinical collaborations for some of our earlier assets, meaning Valsfilimab as well as Zolifilimab.

For potential it can be a blockbuster potential product in connection with some of the other elements in our portfolio.

We've also talked about our box filler map plus the other free with map.

And you will hear more about that very soon at a major.

Medical Conference, ESMO, which we announced with our earnings.

This quarter for today.

We've also been in discussions for potential clinical collaborations for some of our earlier assets, meaning while still a map as well as sell with Perla map. These.

Garo H. Armen: These compounds can be very valuable in connection with other people's assets that will benefit from the synergy provided by PD-1 and CTLA-4 combination. And those will benefit us further by expanding the market, with these combinations for our PD-1 and first generation CTLA-4, anybody. The fourth pillar we spoke about is our key operational capabilities, which on the one hand allow us to advance our programs in the clinic very rapidly. On the other hand, they also allow us to... We manufacture our candidates reliably and rapidly, and thirdly, they allow us to be able to launch our own products, as Dr. Andy Hurley will be speaking about briefly today. So with that, I will turn this call over to Dr. Jennifer Buell. Thank you.

These compounds can be very valuable Inc.

Connection with other People's assets that will benefit from the synergy provided by PD, 1 and C. T L. A for a combination.

And those will benefit us further by expanding the market with.

With these combinations for our PD, 1 and first generation suited for antibodies.

The fourth pillar, we spoke about are our key operational capabilities, which on 1 hand to allow us to advance our programs in the clinic very rapidly.

On the other hand, they also allow us to.

Manufacture our candidates are reliably and rapidly.

And thirdly, they allow us to be able to launch our own product as Dr. Andy Hurley today, we'll be speaking about briefly.

So with that I will try on this call to a doctor agenda for you. Thank you Jennifer.

Thank you very much I'll, just build a little bit upon what gum Gareth mentioned, our research and development productivity, which is really unique to each N. S. S. Now become business as usual for us in the past 6 years, we've delivered 17, new discoveries to the clinic.

Jennifer Buell: Thank you very much, Garo. I'll just build a little bit on what Garo has mentioned. Our research and development productivity, which is really unique to Agenus, has now become business as usual for us.

Jennifer Buell: In the past six years, we've made 17 new discoveries.

Which is really remarkable progress, but in addition to those filings on the clinical advancement on these programs who boss al.

On our application for our first program our BLA application. We now have that's still on the harvest Gal mentioned has been accepted for priority review by the FDA with an action date of.

Jennifer Buell: Discoveries to the clinic

Jennifer Buell: which is really remarkable progress. But in addition to those filings and the clinical advancement of these,

December 16th.

So we're quite excited now as Garo mentioned Eddy will tell you about the commercial infrastructure that we're setting up to build for basketball on that and then beyond balance still don't have of course as you hear from Doctor on a day in the upcoming months on data and progress on major and 11.81. It has been quite remarkable so the infrastructure that Andy is going to be.

Jennifer Buell: programs. We've also filed our application for our first program, our BLA application. We now have Balstilamab, as Garo mentioned, has been accepted for priority review by the FDA with an action date.

Well Dang, well supports bell and set us up for the launch of agent 11.81.

In addition to these discoveries on advancements 1 of those 17 announced discoveries entering the clinic advancing to the clinic is H N 17, 77, now that's and pitch it by specific molecule, which is now in a collapsed strategic collaboration with Bristol and a fee.

Jennifer Buell: This is a priority review by the FDA with an action date of December.

Jennifer Buell: I will tell you about the commercial infrastructure that we're setting up to build for Valsilomab and then beyond Valsilomab. Of course, as you hear from Dr. ODay in the upcoming months, data and progress from Agent 1185.

Important components Garo mentioned, Brazil is really the most remarkable company to bring this power and they're committed to advancing at their experience in this space in IL.

And in terms of biology, and they have a very aggressive development plan that we're really quite excited about in addition, the strategic collaboration Max are important differentiators for my prior collaborations in that.

Jennifer Buell: has been quite remarkable. So the infrastructure that Andy is going to be building...

Jennifer Buell: Spell, and set us up for the launch of Agent 1181. In addition to these discoveries and advancements...

We have the opportunity to combine this bi specific with certain agents in our portfolio, which is really exciting for us in addition.

Jennifer Buell: Now that's a tiget by a specific molecule.

And on approval, we have the opportunity to sell per mill. So we're really excited about the fda's recent clearance of the science and we'll be looking forward to making further announcements about the clinical progress for this molecule.

Jennifer Buell: which is now in a strategic collaboration with Bristol. And a few important components, Garo mentioned Bristol is really the most remarkable company to bring this forward. They're committed to advancing it, they're experienced in this space in IO and in tissue biology, and they have a very aggressive development plan that we're really quite excited about.

Now beyond these most recent advancements gala has mentioned.

We expect to present data on H N 11, 81, which is making significant progress on the correct and that data on those data release will be based upon cohorts disease specific cohorts that we've now been expanding upon them. So well certainly we have doctor every day here with us today and we take on.

Jennifer Buell: In addition, the strategic

Jennifer Buell: This strategic collaboration marks some important differences from our prior collaborations in that we have the opportunity to combine this by specific with certain agents in our portfolio.

To answer questions about this program. Additionally, as we have we and others have shown when you ask detailing for the PD..1 when you see this with 11.81, we also see this with balance out, particularly in 1 of our most advanced programs in cervical cancer, we expense response rate and duration of response and we're really excited.

Jennifer Buell: In addition, upon approval, we have the opportunity to co-promote.

Jennifer Buell: Clearance of this IND, and we'll be looking forward to making free

To be presenting an update on our clinical program about floods down in patients with refractory cervical cancer at ESMO. This year. So the titles have been announced and will have on many oral presentation now quite enthusiastic about.

Jennifer Buell: I look forward to making further announcements about the clinical progress of this molecule.

Jennifer Buell: Now, beyond these most recent advancements,

Jennifer Buell: Garo has mentioned that we expect to present data on agent 1181, which is making significant progress in the clinic, and that those data will be released.

Now on me Therapeutics.

I'll introduce that we've submitted a confidential S..1 for <unk>.

For post IPO, well, we can't talk too much about this on this program. These programs what I can say is what we've explained to you before now me therapeutics, formerly intensive.

Jennifer Buell: Those data releases will be based upon cohorts, disease-specific cohorts that we've now been expanding upon. So we'll certainly, we have Dr. ODay here with us today, and he can answer questions about this program.

Advancing invariant natural killer T cells. These are actually a subset of T cells.

Jennifer Buell: Additionally, as we and others have shown, when you add CCLA-4 to PD-1, we see this with 11.

And Theyre allogeneic for them and they carry boat the capacity to modulate innate and adaptive immunity.

Jennifer Buell: We also see this with Bowdell, particularly in one of our most advanced programs for cervical cancer.

He has the ability and cancer to directly kill tumors through tumor lysis. They modulate the tumor microenvironment. They suppressed on my list suppress yourself M. D. S T a.

Jennifer Buell: expand response rates and duration of response. And we're really excited.

Also we crewed and activate T cells and NK cells, we believe that these cells have the potential.

To deliver the durability and memory memory responses of T cells with the state of lytic power of NK cells.

Jennifer Buell: And we're really excited to be presenting an update on our clinical program of valves, blood valves, in patients with refractory cervical cancer at ESMO this year. So the titles have been announced, and we'll have a mini oral presentation now that I'm quite enthusiastic about. Now in May

Multiple clinical trials underway, we've announced those the progress some of those programs and these programs include taking these cells into patients with solid cancers and in addition to exploring these cells alone in solid tumors well also be evaluating these cells in combination with debt.

Jennifer Buell: Now, I'm mini-therapeutic. Garo introduced this. We've submitted a confidential S1 for a proposed IPO. Well, we can't say too much about this program, these programs. What I can say is what we've explained to you before. Now, Mink Therapeutics, formerly Agentes, is advancing invariant natural killer T-cells. These are actually a subset of T-cells.

Holiday to checkpoint modulating antibodies, such as detailing for N. PD..1 we believe that these cells can build on the benefits that we've seen with vitale for on PD, 1 and we have presented data previously demonstrated in preclinical models.

Detailing for on PD, 1 or about 40 to 50 per cent active when you add I N T T cells into that combination you see complete tumor eradication and alumni model for pre clinically. So we will we expect to be presenting data later this year on our ongoing clinical programs in patients with multiple myeloma as well as patients.

Jennifer Buell: in their allogeneic form.

Jennifer Buell: the capacity to modulate innate and adaptive immunity. They have the ability to fight cancer.

T cells in patients with severe and are the other secondary to COVID-19.

And finally, our vision platform, we've presented data on this platform a number of times. This is a tool that enables us to identify how the.

Jennifer Buell: cancer to directly kill tumors through tumor lysis. They modulate the tumor microenvironment. And they suppress myeloid suppressor cells, MDSCs.

The best approaches to design molecules to address biology.

This platform also enables us to interrogate responses and identify ways in which we can predict patient until respond to other therapies.

Jennifer Buell: They also recruit and activate T-cells and NK-cells. We believe that these cells have the potential to deliver the durability and memory response.

We expect the combination of our biologics platform.

Jennifer Buell: responses of T cells with the cytolytic power of NK cells.

And our new and expanding compute capability.

To be able to identify patients with significant probability of determining who will respond to therapy for those patients go on therapy. This is an evolving platform and we look forward to continuing to update you on the promise of this platform.

Jennifer Buell: We have multiple clinical trials underway. We've announced the progress from those programs, and these programs include taking these cells into patients with solid cancers. In addition to exploring these cells alone in solid tumors, we'll also be evaluating these cells in combination with...

Now I'm going to turn it over to Andy Hurley to tell you about our commercial group.

Yes, I'm happy to reported that we were making great progress in planning the U S. Commercial launch of golf's fill them up and advanced cervical cancer ACC for short.

Jennifer Buell: Validated checkpoint modulating antibodies such as CTLA-4 and PD-1.

You have identified and hired a highly experienced leadership team across the key commercial and medical functions.

Jennifer Buell: We believe that these cells can build on the benefits that we've seen with CTLA-4 and PD-1, and we've presented data previously demonstrating in preclinical models where CTLA-4 and PD-1 are about 40 to 50 percent active. When you add INKT cells into that combination, you see complete tumor eradication in a lung mass model preclinically.

I'm very pleased with the collaboration and agility for the team that has shown to develop a well defined strategic and tactical launch plan.

Launch is only as strong as the team driving it and we have attracted top commercial and medical leaders to Genesis from across the industry.

To be a part of the continued build out of the company.

Our launch planning for Bell still them up and HCC has 2 main goals in mind.

Jennifer Buell: ongoing clinical programs in patients with multiple myeloma, as well as these cells in patients with severe ARDS.

Burst.

But every patient that can benefit from bell still amount has access to it with few barriers.

We are leveraging innovative programs that launch to reduce or eliminate normal reimbursement hurdles that physicians often face when trying newly approved medications.

Jennifer Buell: And finally, our vision platform. We've presented data on this platform a number of times. This is a tool that enables us to identify how the best approach is to design molecules to address biology. This platform also enables us to interrogate responses and identify ways in which we can predict patients who will respond to our therapies. We expect the combination of our biologic platform and our vision platform to be very powerful.

And second.

In line with its market potential a cost efficient launch leveraging a targeted personal and non personal promotion approach across medium. Some channels that physicians have told us they prefer an on market research.

Covid challenged every pharma company to rethink how for promote their products and provide medical education of physicians and from this position to determine how they want to receive information now and in the future and we will be leveraging these learnings and how we will bring balance fill them up to the E C.

Jennifer Buell: and our new and expanding compute capability.

Jennifer Buell: to be able to identify patients with a significant probability of determining who will respond to therapy before those patients go on therapy. This is an evolving platform, and we look forward to continuing to update you on the progress of this platform. Now I'm going to turn it over to Andy Hurley to tell you about our commercial group.

C market.

The comment a bit further on the progress made on our launch planning we have hired an experienced team of commercial leaders, including account directors that will be engaging with payers prelaunch to support widespread formulary coverage of bell still amount at March.

Andy Hurley: I'm happy to report that we are making great progress in planning the U.S. commercial launch of Balsilamab, an advanced cervical cancer drug, ACC for short. We have identified and hired a highly experienced leadership team across the key commercial and medical functions. I'm very pleased with the collaboration and agility that the team has shown to develop a well-defined strategic and tactical launch plan. You know, a launch is only as strong as the team driving it, and we have attracted top commercial and medical leaders to Agenus from across the industry to be a part of the continued build-out of the company. Our launch planning for BalstulaMap NACC has two main goals in mind.

We have conducted extensive market research across a wide audience for physicians and payers to determined on product positioning and messaging for all key stakeholders.

We built a data management infrastructure that will allow for deep and fast insights generation to enable us to react in real time.

2 signals that we here at launch.

This is where I've seen a lot of launches fail and not being able to be agile and quickly act on an insight that has happened in our market. We are spending a great deal of time, ensuring that there are no silos and how we support our launch execution.

Andy Hurley: First, that every patient that can benefit from Valstilumab has access to it with few barriers. We are leveraging innovative programs at launch to reduce or eliminate normal reimbursement hurdles that physicians often face when trying newly approved medications. In line with its market potential, a cost-efficient launch, leveraging a targeted personal and non-personal promotion approach across mediums and channels that physicians have told us they prefer in our market research. You know, COVID challenged every pharma company to rethink how to promote their products and provide medical education to physicians. And from this, physicians have determined how they want to receive information, now and in the future.

We have partnered with best in industry vendors and agencies to support our reimbursement hub creative marketing campaigns medical education planning.

CRM platforms and other critical areas and these vendor partners will be embedded within our teams. So they can also support future launches following the bell still amount of margin ACC.

The overarching goal of this launch is for it to be a foundational step for Genesis it.

It will serve as the catalyst to initiate the build of a fully integrated commercial infrastructure, which in turn would allow us to easily scale, our teams and operational systems for future launches maximizing the value of her best pipeline.

Specifically as Garo and Jim mentioned, we are very excited at the possibilities for 11, 81, and big indications with high unmet needs.

Andy Hurley: And we will be leveraging these learnings in how we will bring Valstilumab to the ACC market. To comment a bit further on the progress made in our launch planning, we have hired an experienced team of commercial leaders, including account directors, that will be engaging with payers pre-launch to support widespread formulary coverage of ValstillaMap at launch. We have conducted extensive market research across a wide audience of physicians and payers to determine our product positioning and messaging for all key stakeholders.

As much as they'll still about monotherapy can offer the small population of second line advanced cervical cancer cancer patients a therapeutic option.

We could potentially see 11.81, providing a much broader range of patients life changing outcomes potentially a.

A range of outcomes on.

Matched.

Recent Idaho history.

I've had the good fortune to have led and been a part of over 20 product launches in my career.

I believe that the promise that 11, 81 has clinically and commercially.

Andy Hurley: We built a data management infrastructure that will allow for deep and fast insights generation to enable us to react in real time to signals that we hear at launch. This is where I've seen a lot of launches fail because they weren't able to be agile and quickly act on an insight that had happened in a market. We are spending a great deal of time ensuring that there are no silos in how we support our launch execution. We have partnered with the best in industry vendors and agencies to support our reimbursement hub, creative marketing campaigns, and medical education planning. CRM platforms, and other critical areas.

Seldom seen in her career and it is a big reason on what got me to come to adjust.

There are certainly exciting times ahead for Genesis and the patients we hope to hold on.

I'll now turn it over to Christine <unk> to review our financial results.

Thank you Andy.

We ended the second quarter of 2021, with a cash balance of $74 million as compared to $100 million at December 31, 2020.

Subsequent to the quarter end, we received $200 million related to our BMS partnership.

For the second quarter ended June 32021, our cash used in operations was $56 million and we reported a net loss of 84 million for 37 cents per share.

Andy Hurley: And these vendor partners will be embedded within our teams so they can also support future launches, following the Valstella MAP launch in A.C. However, the overarching goal of this launch is for it to be a foundational step for Agenus. It will serve as the catalyst to initiate the build of a fully integrated commercial infrastructure, which in turn would allow us to easily scale our teams and operational systems for future launches, maximizing the value of our vast pipeline.

This compares to cash used in operations for the same period in 2020 of $37 million on a net loss of $48 million or 28 cents per share.

Noncash operating expenses for the second quarter ended June 32021 for $30 million compared to $18 million for the second quarter of 2020.

Our cash used in operations for the 6 months ended June 32021, with $98 million with a net loss of 138 million for 65 cents per share compared to cash used in operations of $72 million and a net loss for the same period in 2020 of 94 million.

Andy Hurley: Specifically, as Garo and Jen mentioned, we are very excited at the possibilities for 1181 in big indications with high unmet needs. As much as Delph-Philimab monotherapy can offer the small population of second-line advanced cervical cancer patients a therapeutic option, we could potentially see 1181 providing a much broader range of patients with life-changing outcomes. Potentially, a range of outcomes unmatched in recent IO history. I've had the good fortune to have led and been a part of over 20 product launches in my career. I believe that the promise that 1181 has, clinically and commercially, is seldom seen in a career. And it is a big reason why it got me to go to the gym.

<unk> dollars or <unk> 59 per share.

We recognized revenue of $22 million and $42 million for the 6 months ended June 32021, and 2020, respectively. This revenue include related revenue related to noncash royalties earned revenue recognized under our collaboration agreement and in $2020.14 million.

From an upfront license fee we received.

I'll now turn the call back together.

Sure.

Thank you very much Christine and thank you once again for participating in our call.

I will make a few closing remarks before I will turn it to the.

Operator for questions.

Just to summarize some of the highlights for the second half over this year.

You may expect.

As Jim mentioned, we have produced for date for them.

For my monotherapy in December.

And we're diligently working in preparation for all aspects on the final phases.

Christine M. Klaskin: There are certainly exciting times ahead for Agenus and the patients we hope to help. I'll now turn it over to Christine Klaskin to review our financial results. Thank you, Andy.

As required.

As Andy mentioned, we're preparing diligently for a commercial launch.

For second line cervical cancer.

But as you said.

Christine M. Klaskin: We ended the second quarter of 2021 with a cash balance of $74 million, as compared to $100 million at December 31, 2020. Subsequent to the quarter end, we received $200 million related to our BMS partnership. For the second quarter ended June 30, 2021. Our cash used in

We're putting together an infrastructure so that we can capitalize on our leveraging for our future launches.

We're going to be defining our strategy for balance out and as John mentioned, you can expect very exciting presentation.

The upcoming ESMO conference.

We will continue with our development for Asia 11.81.

With a strategy for.

The transition of our studies.

2 an approvable study for 11.81.

Christine M. Klaskin: The cash used in operations was $56 million, and we reported a net loss of $84 million, or $0.37 per share. This compares to cash used in operations for the same period in 2020 of $37 million and a net loss of $48 million, or $0.28 per share. Non-cash operating expenses for the second quarter ended June 30, 2021, were $30 million compared to $18 million for the second quarter of 2020.

And and additional data presentations for our own pipeline on regions and partner agents are also due in the second half.

We won't be advancing our age on 1 triple 7 which was now Bristol Myers is asset.

This program.

Into and through the credit.

We will be completing enrollment or various other programs and I will not give you the specifics on what we expect to put out a I N K T program base.

Based on our confidential S, 1 filing which puts us in a quiet period.

Christine M. Klaskin: Our cash used in operations for the six months ended June 30, 2021, was $98 million.

We will be progressing our commercial manufacturing capabilities for antibodies is very very important aspect of our strategy.

Christine M. Klaskin: with a net loss of $138 million, or $0.65 per share.

Will be critical for us to do this so that we can launch potentially launch 11.81.

Christine M. Klaskin: has used in operations of $72 million and a net loss for the same period in 2020 of $94 million or so.

B the league as possible upon demonstration.

Telling data as Andy said and patient.

Otherwise not benefiting from COVID-19 therapy or for that matter any other therapy.

Christine M. Klaskin: dollars or 59 cents per share. We recognized revenue of $22 million and $42 million for the six months ended June 30, 2021 and 2020, respectively. This revenue includes revenue related to non-cash royalties earned, revenue recognized under our collaboration agreements, and, in 2020, $14 million from an up-front license fee we received. I'll now turn the call back to Garo. Thank you very much.

We're also progressing with our sustainable supply of Qs 21, which we believe is a very very important agent for.

For both prophylactic as well as therapeutic vaccine adjuvant and see.

And as I mentioned earlier, we will be anticipating additional transactions financial Inc, corporate transactions and the share.

I couldn't have for this year.

Thank you again for your attention and now we are open to any questions you may have.

Thanks, Meyer if you could open the Q&A. Please.

Family at this time I would like to take any questions you might have for us today and as a reminder to ask a question you will need to press Star then the number 1 on your telephone keypad. Once again to ask a question. Please press star 1 to enjoy a request you may press the pound or cash.

Garo H. Armen: Thank you very much, Christine, and thank you once again for participating in our call. I will make a few closing remarks before I turn it over to the operator for questions. Just to summarize, some of the highlights for the second half of this year that you may expect.

We'll pause for a moment.

Many of them.

For the only take a few months.

Our first question comes from the line of Kelly <unk> from Jefferies. Your line is open. Please go ahead.

Garo H. Armen: As Jen mentioned, we have a PDUFA date for mastilumab monotherapy in December, and we're diligently working in preparation for all aspects of the final phases of what is required. As Andy mentioned, we're preparing diligently for commercial launch for Second Line Cervical Cancer, but as you said, we're putting together an infrastructure so that we can capitalize on our leveraging for our future launches. We're going to be defining our strategy for BALZAL, and as Jen mentioned, you can expect an exciting presentation at the upcoming ESMO conference.

Congrats on the progress and I. Thank you for taking my questions I have 2 questions. So first of all on and what is on the marketing strategy for <unk>.

<unk> medical monotherapy in second line cervical cancer upon approval given that a combo.

It's probably not too far behind the in the progress and also what are we going to hear on media overall survival data for a monotherapy trial does this data have an impact on your commercial strategy for mono versus combo.

That's my first question on my second question is for them.

Could you give us some color on the combo data at ESMO. Thank you.

Garo H. Armen: We will continue with our development for Agent 1181, with a strategy to transition our studies to an approvable study for 1181. Additionally, additional data presentations for our own pipeline of agents and partnered agents are also due in the second half. We will be advancing our Agen 1777, which is now Crystal Myers' asset, into and through the clinic. We will be completing enrollment in various other programs, and I will not give you the specifics on what we expect with our INKT program based on our confidential S-1 filing, which puts us in a quiet period.

Let me address.

The question on the top line and then I'll try to do my colleagues to get into the specifics, but remember that we cannot say very much about it.

<unk> specifics otherwise will simply be kicked out on the presentation, which other very desirable outcome for us.

So if you're a patient you will see that day that was classified in data has been very exciting.

And and getting back to your first.

Question.

As you know.

Combinations with I O therapies.

Generally.

And when I say generally I'm talking about the great majority of the time certainly with the existing marketed products achieve better results.

Garo H. Armen: We will be progressing our commercial manufacturing capabilities for antibodies. This is a very important aspect of our strategy. It will be critical for us to do this so that we can potentially launch 1181 as speedily as possible upon demonstration of compelling data, as Andy said, in patients who are otherwise not benefiting from immunotherapy or, for that matter, any other therapy. We're also progressing with our sustainable supply of QS21, which we believe is a very, very important agent for both prophylactic as well as therapeutic vaccine adjuvants.

And monotherapy and when I say measured results, we're talking about improved response rates, but also very critically.

Improved duration of responses and that's typically on that so in an ideal world where everybody would accept these facts we.

We would.

Imagine that the combination should be the desired path forward, but there are hurdles.

Quoting regulatory hurdles.

In allowing for these combinations to be practiced and so we will work very respectfully with the regulatory agencies in the U S and elsewhere to make sure that these combinations become.

Garo H. Armen: And, as I mentioned earlier, we will be anticipating additional transactions, financial and corporate transactions, in the second half of this year. Thank you again for your attention, and now we're open to any questions you may have. Thanks, Myra, keep it up.

The best options available for the appropriate patient population.

With that Doug.

Operator: At this time, we would like to take any questions you might have for us today. And as a reminder, to ask a question, you will need to press star, then the number 1 on your telephone to add another question. Once again, to ask a question, please press star 1. To withdraw your request, you may press the pound or hash key.

For you and that's very early if you have any other.

Sure I'm going to turn it over to Andy to get started on your question Kelly question number 1 yeah. So thank you Kelly.

I looked at every launch.

You have to really establish a foundation with the community that youre going to be.

Targeting and bringing our product to and the belt Philomena monotherapy launch allows for us to build those relationships you have to understand the marketplace yet to really understand the dynamics that are going to be needed for subsequent launches in that particular space.

Operator: We'll pause for a moment to compile the Q&A list. This will only take a few moments. Our first question comes from the line of Kelly Shee from Jeffries. Your line is open. Please go ahead. Congratulations on the progress and thank you for taking the time to answer my questions. I have two questions. The first one is, what is our market strategy for bio monotherapy in second-line cervical cancer upon approval given that a combo is probably not too far behind in the progress? And also, are we going to hear media overall survival data from the monotherapy trial? Does this data have an impact on your commercial?

So part of our strategy is really bringing a much needed therapy to that particular wide audience of physicians and then in doing so.

On a get comfort with bell still amount.

Because if youre going to be bringing in combination that has but I'll spell them out in it and they already have comfort with the monotherapy option and seeing it really work where other agents may not have worked in the past that is a good first step for us to really establish credibility in a marketplace that we're gonna be looking to really make a significant impact them.

So I believe that's really what it is and I'll go back to the initial point that I've made is the fact that we're not looking at launches in isolation.

We're not looking at 1 versus another.

As our primary focus our primary focus is to build a fully integrated commercial infrastructure that we can pivot to whatever product, we're looking to bring to market and the combination in cervical cancer. It looks promising and we want to continue to explore it then will have the necessary support both on the.

Kelly Shee: Strategy of Amarna versus Kumble. That's my first question. And my second question.

The in house commercial leadership as well as the field presence to be able to really make that impact.

Kelly Shee: Could you give us some color on the combo data at ASML? Thank you.

Thank you.

Garo H. Armen: Let me address the question briefly, and then I'll turn it over to my colleagues to get into the specifics. But remember that we cannot say very much about the ESMO specifics. Otherwise, we'll simply be kicked out of the presentation, which is not a very desirable outcome.

Excellent.

Our next question comes from the line of me on 1 tiny from B Riley <unk> Securities. Your line is open. Please go ahead.

Good morning team. Thanks for taking my question and congrats on the progress in Goodyear and then particularly on for the New Road men can that'd be great to have you on the call. So maybe for.

Garo H. Armen: Now, so if you're patient, you will see the data. We've classified the data as being very exciting, and getting back to your first question. As you know, combinations with iotherapy... General. And when I say generally, I'm talking about the great majority of the time, certainly with the existing marketed products, achieving better results than monotherapy. And when I say better results, we're talking about improved response rates, but also, very critically, improved duration of response. And that's typical of that.

A couple of questions for the Doctor a day so for 1.1 each 1 can.

Could you just it looks like it's maybe that's more maybe it's just just.

Just curious.

What sort of update.

You would expect in terms of you.

You have a number of different tumor types.

PD, 1 refractory setting versus.

Garo H. Armen: In an ideal world, where everybody would accept these facts, we would imagine that the combination should be the desired path forward, but there are hurdles, including regulatory hurdles, in allowing for these combinations to be practiced. And so we will work very respectfully with the regulatory agencies in the U.S. and elsewhere to make sure that these combinations become the best options available for the appropriate patient population. But with that, Dr. Buell and Dr. Hurley, if you have any other questions...

Doing this in combination.

And also like what.

The number of patients who may have on the MSS colorectal cohort.

It would be question number 1.

Thank you for that question.

Very obviously excited about eliminating 1 program as we are.

Publicly disclosed.

You know this this agent which is a next generation <unk> for its been engineered to be more active both from our prime and in memory point of view as well as depleting T regs in the tumor microenvironment and having a better toxicity profile. So.

Garo H. Armen: Sure, I'm going to turn it over to Andy to get started on your question, Kelly, question number one. Yeah, so thank you.

We continued to advance the phase 1 plus 1 b program.

<unk> said, we now have over 100 patients treated with either single agent 11, I want our combination.

We will.

B hopefully presenting this data by the end of the year at a major conference and we can't say more than that at this point.

Andy Hurley: foundation with the community you're going to be targeting and bringing a product to, and the Bounce Philemab Monotherapy launch allows us to build those relationships, get to understand the marketplace, and get to really understand the dynamics that are going to be needed for subsequent launches in that particular space. So part of our strategy is really bringing a much-needed therapy to that particular wide audience of physicians, and then, in doing so, they're going to get comfort with Bounce Philemab.

Well I think the take home messages from this program to date has been it's been designed to be a next generation seats like for and it's performing as such in the clinic in the sense that tumors that historically have had little to no PD 1 our seats like for activity, we reported responses for.

Particularly in cold solid tumors like M S stable colorectal cancer ovarian as well as PD 1 resistant settings.

So this is all very encouraging to us.

In terms of numbers around cohorts again that debt, we have not publicly released updates on that but look forward to doing that.

Andy Hurley: And because if you're going to be bringing a combination that has Belfast Delta MAP in it, and they already have comfort with the monotherapy option, and seen it really work where other agents may not have worked in the past, that is a good first step for us to really establish credibility in a marketplace that we're going to be looking to really make a significant impact in. So I believe that's really what it is.

At a major meeting, but as you know our colorectal MFS stable cohort is 1 of the cohorts that we are rapidly expanding in this trial and look forward to updating you further.

Later in the year.

Thank you put for all the big debt and then on the bad <unk> monotherapy.

As you prepare for that.

They didn't need to draw from for instance that are depended on that.

<unk> expense with FDA.

Are you expecting an outcome by any chance.

The question is how do we expect engaged an ad com.

Okay, I think I think between.

Between now and the Purdue for a date.

You kind of expect debt, we are going to do a lot of work.

Andy Hurley: And I'll go back to the initial point that I made, which is the fact that we're not looking at launches in isolation. We're not looking at one versus another as our primary focus. Our primary focus is to build a fully integrated commercial infrastructure that we can pivot to whatever products we're looking to bring to market. And if the combination in cervical cancer looks promising, and we want to continue to explore it, then we'll have the necessary support both from in-house commercial leadership as well as from the field presence to be able to really make that impact.

In communication with the agency.

There are.

Mandated inspections in the process, we're going through all of that right now and I think out of respect to the process, we will not disclose the details.

Okay Fair enough and then maybe maybe for Jan and go do I have a I have a follow up for you.

Maybe Jim are you able to comment on.

So out of the.

Patients dosed across solid tumors.

COVID-19, the ideas and what'd setup that I believe have you been enrolling for the for.

Good day and any color there.

Hi, My uncle, we can't say too much right now for our for obvious reasons, given where we are in the process, but but rest assure we will be aggressive with data releases as we have always been across the portfolio.

Operator: Our next question comes from the line of Mayank Mamtani from B. Riley Securities. Your line is open. Please go ahead.

Great. Thank you and maybe for Daniel go as you look at scaling up.

Mayank Mamtani: Good morning team. Thanks for taking our question and congratulations on the progress and N2GN, in particular for the new role with Menk and Andy. Great to have you on the call. So maybe first, a couple of questions for Dr. Oday. So for 1181, can you just, looks like it's not maybe at ESMO, maybe it's after. Just curious what sort of update we should expect in terms of, you have a number of different tumor types, PD-1 refractory setting versus doing this in combination, and also, like how many patients you may have in the MSS colorectal cohort. That would be question number one.

You know garage RMB GMA capex.

Great to see this is active.

For some of the big coming on line here in California, expanding your zone.

Everybody efforts on just give.

Like how should we think about this going forward, especially if.

<unk>.

Become something that would require investment how would you think about expanding GAAP.

Capex and obviously continuing to fund the R&D pipeline.

Sure, let me address that in several ways and I don't mean to be.

Steven J. ODay: Thank you for that question. You know, we're very obviously excited about the 1181 program. Publicly disclosed, this agent, which is a next-generation CTLA-4, has been engineered to be more active, both from a priming and memory point of view, as well as depleting Tregs in the tumor microenvironment and having a better toxicity profile. So we continue to advance the Phase 1s plus 1B program. As Garo said, we now have over 100 patients treated with either single-agent 11A1 or combination.

Complex about my answer but just.

Just bear with me now if you look at the history Mayak.

How we have managed.

Our.

<unk>.

Versus our cash balance.

It has been done in a very orderly way, meaning.

You know in any given quarter.

We have managed our cash outflows and cash inflows very well.

Of course, the Bristow transaction debt brought in $200 million.

And is expected to deliver on another milestone this year in terms of cash infusion.

<unk> has provided.

A bit of a jump into our cash balances and I expect that in the second half for the year, we will have additional jumps in on cash balances.

Steven J. ODay: We will hopefully be presenting this data by the end of the year at a major conference, and we can't say more than that at this point. I think the take-home messages from this program to date have been that it's been designed to be a next-generation CTLA-4, and it's performing as such in the clinic in the sense that tumors that historically have had little to no PD-1 or CTLA-4 activity, we've reported responses, particularly in cold, solid tumors like MS-stable colorectal cancer, ovarian, as well as in PD-1 resistance settings

Where do they come from.

Several sources in addition, true corporate transactions milestones project financing transactions. In addition to those we.

We expect to fund some of our.

Separated subsidiaries.

By means of outside capital infusion.

And that will certainly reduce some of our cash.

Our cash burn associated with those businesses that includes for example, our minc therapeutics fashion.

So <unk>.

Includes our choice for 'twenty, 1 and related assets.

Steven J. ODay: So this is all very encouraging to us. And in terms of numbers around cohorts, again, we have not publicly released updates on that, but look forward to doing that at a major meeting. But as you know, the colorectal MS-stable cohort is one of the cohorts that we are rapidly expanding in this trial, and look forward to updating you further later in the year.

We would also expect to see some asset sales, possibly in the second half of this year.

And so if you add all of those things relative to unusual items that will occur from time to time that will represent jumps I cannot promise you on a quarter to quarter basis, what the impact of that will be but I expect that we'll be able to manage our.

Cash position, so that we are left with a substantial cushion.

Mayank Mamtani: Thank you for all the details. And then on the Val monotherapy, Pradeep, as you prepare for that, are there any parallels to draw from, you know, for instance, the reticulumab, you know, recent experience with FDA, or are you expecting an outcome by any chance?

Cushion at the end of each period.

I'm sure other than that Unfortunately, I cannot give you any more specific dollar guidance.

No. That's helpful got it thanks again for taking the questions.

Yeah.

Once again I would like to remind everyone. If you wish to ask a question. Please press star 1 on your telephone keypad are net.

Mayank Mamtani: The question is, are we expecting a... An adcom. Adcom. Okay, I think between now and the PDUFA date, you can expect that we are going to do a lot of work. In communication with the agency, there are mandated inspections in the process, and we're going through all of that right now.

Question comes from the line of Matt Phillips from William Blair. Your line is open for your feeling.

Good morning, Thanks for taking my questions just a few.

Do you guys have any update on the timing of the Belleville filing that's lined up.

Mayank Mamtani: Okay, fair enough. And then maybe for Jen and Garo, I have a follow-up question for you. But maybe, Jen, are you able to comment on sort of the patients dosed across solid tumors and COVID-19 ARDS? And what sort of territories have you been enrolling for the INKT? Any color there?

Give a little bit more clarity on or ahead of the Paducah for BOE a day, we have to really wait for that particularly clear.

I think on the balance out filings match them.

We've said that we'll provide guidance on this in the second half of this year of course, it's going to be a function of us disclosing the data the final data from that combination trial at ESMO, and then deliberations with the FDA. So.

Jennifer Buell: Hi Mayank, we can't say too much right now.

Bear with us once we get some clarity through both processes will give you a definition on the path forward.

Jennifer Buell: for obvious reasons, given where we are in the process. But rest assured, we'll be aggressive with data.

But with regard to the Peru for a day.

And what was the question again.

No that pretty much answers it.

Then secondly for $13.27 wholly owned.

Jennifer Buell: with Data Releases, as we have always been across the portfolio.

Mayank Mamtani: You know, I'm just curious, like, how should we think about this going forward, especially if, you know, QS21 adjuvant becomes something that would require investment. How would you, you know, think about expanding CAPEX and obviously continuing to fund the R&D pipeline here? Okay.

Is it specific antibody do you still plan to move that into phase 1 this year or just what are kind of the thoughts for the other thought after the outlet for the Bispecific.

So clearly.

The bi specific has advantages over the mine on a specific.

And the data that we've generated so far is very suggested on however, having said that can the mono specific antibody being important reagent just like PD..1 is an important reagent for some of the other combination possibilities portfolio. The answer is mostly.

Garo H. Armen: Okay, so let me address that in several ways, and I don't mean to be complex about my answer, but just bear with me. Now, if you look at the history of how we have managed expenditures versus our cash balance. It has been done in a very orderly way, meaning, you know, at any given quarter, we have managed our cash outflows and cash inflows very well. Of course, the Bristol transaction that brought in $200 million and is expected to deliver another milestone this year in terms of cash infusion has provided a bit of a jump into our cash balances. And I expect that in the second half of the year, we will have additional jumps in our cash balances. Now, where do they come from?

Yes, and so hence we will advance this program with debt in mind.

And we I don't think we've provided guidance on the exact timing on the R&D filing how 'bout bear with us it will be.

Within a reasonable period of time.

Okay. Thanks, and then.

There are as I look at your really kind of earliest stage.

<unk> pipeline.

The disclosures it does seem like there's a bit of a move to buy specific.

Formats or go to therapy is that do you think that it's kind of a direction that you are moving more broadly I mean, obviously.

Does it.

So that gives you a bit of trapped or color on that.

Garo H. Armen: In addition to corporate transactions, milestones, and project financing transactions. In addition to those, we expect to fund some of our separated subsidiaries by means of outside capital infusion, and that will certainly reduce some of our cash burn associated with those businesses. That includes, for example, our Mink Therapeutics asset. It also includes our QS21 and related assets. You could also expect to see some asset sales, possibly, in the second half of this year.

Rob So just curious if that's going on where we should think about for the evolution of your kind of antibody based platform.

I. Thank you for that and that I think that's a pretty sumptuous assumption.

Meaning.

We have bi specifics in our portfolio that have not been disclosed that have.

Very very exciting activity that we're seeing very early on.

But we also have some phenomenal mono specifics that will be announced and what specifically will be filed to enter the clinic. This year and of course with these agents as you know the immune system is like is symphony.

Garo H. Armen: And so if you add all of those things... Relative to unusual items that will occur from time to time that will represent jumps, I cannot promise you on a quarter-to-quarter basis what the impact of that will be, but I expect that we'll be able to manage our cash position so that we are left with a substantial cushion at the end of each period. So other than that, unfortunately, I cannot give you any more specific dollar guidance. Well, that's it.

For a lot of activities.

And yes, certain immuno oncology agents have activity as single agents, but I think it's fair to say that the most exciting activity.

Is being seen with the symphony process of agents and so I think it will be very exciting for us.

Mayank Mamtani: Now, that's helpful, Khaled. Thanks again for taking our questions.

To see from our own portfolio combinations and sue that we'll be generating very exciting data as we have seen using our vision technology and other means in our preclinical development process, so very exciting and very exciting.

Operator: Once again, I would like to remind everyone that if you wish to ask a question, please press star 1 on your telephone keypad. Our next question comes from the line of Matt Phillips from William Bear. Your line is open. Please go ahead.

Particularly because we control the different components of the Symphony if you will.

Matthew Phipps: Morning, thanks for taking my questions. Just a few.

Matthew Phipps: Do you guys have any update on the timing of the bowels coming out?

Great. Thanks Garo.

Yeah.

Yes.

There are no further questions at this time you may continue.

Matthew Phipps: [inaudible] I think of the Bell Cells.

Garo H. Armen: I think on the Belzell filing, Matt, we've said that we'll provide guidance on this in the second half of this year. Of course, it's going to be a function of us disclosing the data, the final data from that combination trial at ESMO, and then deliberations with the FDA. So bear with us. Once we get some clarity on both processes, we'll give you a definition of the path forward. With regard to the PDUFA date, what was the question again?

Thank you very much Raul. Thank you very much for your attendance.

Listening to our updates.

Okay.

This concludes today's conference call you may now disconnect have a great.

[music].

Garo H. Armen: No, that pretty much answers it.

Matthew Phipps: Then secondly, for 1327, you're now wholly owned.

Matthew Phipps: and Tidget, a monospecific antibody. Do you still plan to move that into phase one this year or just what are the kind of thoughts for that after the outlices of the biospecific show?

Garo H. Armen: So, clearly, the bispecific has advantages over the monospecific, and the data that we've generated so far is very suggestive of that. However, having said that, can the monospecific antibody be an important reagent, just like PD-1 is an important reagent, for some of the other combination possibilities in our portfolio? The answer is most likely yes. And so, hence, we will advance this program with that in mind. And I don't think we've provided guidance on the exact timing of the IND filing, but bear with us; it will be within a reasonable period of time.

Matthew Phipps: Okay, thanks, and then... Garo, as I look at your really kind of early stage pipeline... Closures, it does seem like there's a bit of a move to buy specific formats or kinds of therapies. Is that, do you think that is kind of a direction that you all are moving more broadly? I mean, obviously, the TIGIT and then also the TGS-Beta trap are kind of in that realm. So just curious if that's kind of where we should think about for the evolution of your kind of antibody-based platform.

[music].

Garo H. Armen: I thank you for that, Matt. But I think that's a presumptuous assumption. Meaning, we have specifics in our portfolio that have not been disclosed that have... very, very exciting activity that we're seeing very early on, but we also have some phenomenal monospecifics that will be announced, and one specifically will be filed to enter the clinic this year. And of course, with these agents, as you know, the immune system is like a symphony of a lot of activities.

Garo H. Armen: And yes, certain immuno-oncology agents have activity as single agents, but I think it's fair to say that the most exciting activity is being seen with this symphony process of agents. And so, I think it will be very exciting for us to see from our own portfolio combinations ensue that will be generating very exciting data, as we have seen using our vision technology and other means in our preclinical development process. So very exciting, and very exciting particularly because we control the different components of this symphony.

Operator: If there are no further questions at this time, you may continue. Thank you very much, everyone.

Garo H. Armen: Thank you very much, all. Thank you very much for your attendance and listening to our updates.

Operator: This concludes today's conference call. You may now disconnect. Have a great day.

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John Medina: Thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory, and commercial plans and timelines, as well as timelines for data release and partnership opportunities. These statements are subject to risks and uncertainties, and we refer you to our SEC filings for more details on these risks. As another reminder, this call is being recorded for audio broadcast.

Garo H. Armen: So that there's clarity about what we focus on, our key operational drivers, and some of the supportive programs we have. Starting with our significant value creators, 1181, that's Agent 1181, which is our next generation CTLA-4 compound that is beyond what just the CTLA-4 does. And you'll hear about that on many future occasions, as you have heard before.

[music].

Garo H. Armen: This compound, which has been tested, for the last, who must be here, has shown excellent safety profile, and we're now seeing hints of very early clinical activity. And in the second half of this year, you'll hear more about this compound. And, of course, we have our QS21 program, which has gotten a lot of attention because of COVID and because of what this compound can do for other vaccines beyond what's been in the headlines with COVID prophylaxis.

Garo H. Armen: Now, as you know, we get questions often about which programs to prioritize and how we fund these programs. And, of course, early on, in the beginning of this quarter, we closed on a very important transaction. It was the Bristol-Myers in-licensing of our PIDGET bi-specific, and the bispecific arm has not been disclosed yet. But, this is a very exciting compound. We have thought that Bristol is one of the best candidates to advance this program, if not the best candidate.

Good morning, ladies and gentlemen, thank you for standing by and welcome to the a genius second quarter 2021 conference call and webcast.

At this time all participants are in a listen only mode.

After todays presentation, there will be an opportunity to ask questions.

No. That's the figure that is being recorded and may be used in future genius promotional material.

I would now like to trying to conference over to John Medina Director of Investor Relations. John. Please go ahead.

Garo H. Armen: And we also disclosed that at the time of our consummation of this transaction, that it was a competitive process. So this transaction allows us to get the $200 million, which we've already received. In addition to that, there are well over a billion dollars worth of contingent milestone payments and royalties upon commercialization. But also, very importantly... We have a number of other potential transactions in the queue, and some may happen during the course of the second half of this year and some beyond.

Thank you Mara and thank you all for joining US today today's call is being webcast and will be available on our web site for replay.

As another reminder, this call is being reported for audio rebroadcast joining.

Joining me today are Dr. Garo, Armen, Chairman and Chief Executive Officer, Dr. Jennifer Buell, President and Chief operating Officer, Andy Hurley, Our Chief commercial officer, and Kristine class skin, Vice President of Finance now I will turn the call over to Garo to highlight our progress during 2021, so far garo. Thank.

Thank you very much John and thank you everyone for joining US today. In addition to the name the officers of the company. We also have Dr. Stephen All day, our Chief Medical Officer to answer any questions that you may have it yet.

I will start by displaying what I did.

At our shareholders meeting approximately 8 weeks ago.

And there we tried to explain our business in simple terms.

So that there is clarity about what we focus on on.

A key operational drivers and some of the supporting programs we have.

Starting with our significant value creators of eliminating 1 that's H N 11, 81, which is our next generation CTO a for a compound.

That is beyond.

What just Vichy DLA for dash and Youll hear about debt on many future locations as you have heard before.

Garo H. Armen: And supportive programs certainly include Bofillimab, our PD-1 antibody. And we've said that while our PD-1 antibody on its own may not be a blockbuster potential, it can be a blockbuster potential product in connection with some of the other elements in our portfolio. We've also talked about our Bostelumab plus Zoliferumab combination, and you will hear more about that very soon at a major medical conference, ESMO, which we announced with our earnings disclosures. Now, we've also been in discussions for potential clinical collaborations for some of our earlier assets, meaning Valsfilimab as well as Zolifilimab.

And without eliminating 1 program, we have already enrolled well over 100 patients on our clinical trials.

And the results on updated clinical data will be made available in the second half of this year and major at least 1 major clinical conference.

Our second <unk>.

Second value driver, which we talked about at the shareholders' meeting.

As our agent 797 program, which is our I N K T cells now we cannot say very much about that because we have filed an S..1 for our proposed public offering.

Garo H. Armen: These compounds can be very valuable in connection with other people's assets that will benefit from the synergy provided by PD-1 and CTLA-4 combination. And those will benefit us further by expanding the market, with these combinations for our PD-1 and first generation CTLA-4, anybody. The fourth pillar we spoke about is our key operational capabilities, which on the one hand allow us to advance our programs in the clinic very rapidly. On the other hand, they also allow us to... We manufacture our candidates reliably and rapidly, and thirdly, they allow us to be able to launch our own products, as Dr. Andy Hurley today will be speaking about. So with that, I will turn this call over to Dr. Jennifer Buell. Thank you.

Third major driver is our age and 23.73 now.

Now this is a for 1 b b agonist.

We also call it C D 137.

This compound which has been tested.

For the last.

Almost a year.

As shown excellent safety profile and.

And we're seeing now hence on very early clinical activity and in the second half of this year, you'll hear more about this compound.

And of course, we have on Qs 21 program.

She has gotten a lot of attention because on COVID-19.

And because of what this compound can do for other vaccines beyond.

What's been in the headlines weighted COVID-19 prophylaxis.

Now as you know we get questions often about.

Which programs to prioritize and how do we fund these programs.

Jennifer Buell: Thank you very much, Garo. I'll just build a little bit on what Garo has mentioned.

And of course early on.

Beginning on this quarter, we closed on a very important transaction.

Jennifer Buell: Our research and development productivity, which is really unique to Agenus, has now become business as usual for us. In the past six years, we've delivered 17 new discoveries to the clinic, which is really remarkable progress. But in addition to those filings and the clinical advancement of these programs,

It was the Bristol Myers in licensing of our <unk> Bispecific.

The bi specific on has not been disclosed yet and this is a very exciting compound.

We have thought.

Debt Bristow is 1 of the best candidates to advance this program if not the best candidate and we also disclose that at the time of our consummation of this transaction our debt. It was a competitive process. So this transaction.

Jennifer Buell: We've also filed our application for our first program, our BLA application. We now have Valstilumab, as Garo mentioned, has been accepted for priority review by the FDA with an action date of December 16.

Allows us to get the $200 million, which we've already received in addition to that debt.

All over $1 billion worth of contingent milestone payments and royalties upon commercialization.

But also very importantly, we have a number on other potential transactions in the queue.

Jennifer Buell: So we're quite excited now, as Garo mentioned. Andy will tell you about the commercial infrastructure that we're setting up to build for Valsilomab and then beyond Valsilomab. Of course, as you hear from Dr. ODay in the coming months, data and progress from Agent 1181 have been quite remarkable. So the infrastructure that Andy's gonna be...

And some may happen during the course of the second half of this year.

And so on beyond.

Now we also talked about a potential spin out strategies, we talked about the S..1 filing for a proposed for IPO for men make by the way for those of you who may remember is the original agenda.

Company. This is our cell therapy company.

Jennifer Buell: has been quite remarkable. So the infrastructure that Andy's going to be building will support Bell and set us up for the launch of Agent 1181. In addition to these discoveries and advancements, one of those 17 announced discoveries entering the clinic, advancing to the clinic, is Agen 1777. Now that's a tiget by specific molecule.

And we also anticipate other potential spin average from businesses that have been cultivated with.

Janice.

And I are ready to be on their own.

Now we've also talked about potential heidrick financings as a strategy to bring in additional cash, particularly for programs that we plan on pursuing our sales without necessarily having to out license them and.

Jennifer Buell: which is now in a strategic collaboration with Bristol.

Jennifer Buell: Garo mentioned Bristol is really the most remarkable company to bring this forward. They're committed to advancing it, they're experienced in this space in I.O. and in digital biology, and they have a very aggressive development plan that we're really quite excited about. In addition, the strategic collaboration...

There are a number of such programs in our portfolio.

Now the third category that we mentioned or what we call support him programs and supported programs certainly include Bob fill in map, our PD, 1 antibody and we've said that while our PD 1 antibody on it.

On may not be a blockbuster potential.

It can be a blockbuster potential product in connection with some of the other elements in our portfolio.

Jennifer Buell: This collaboration marked some important differences from our prior collaborations in that we have the opportunity to combine this with specific agents in our portfolio, which is really exciting for us. In addition, upon approval, we have the opportunity to co-promote. So we're really excited about the FDA's recent clearance of this IND, and we'll be looking forward to making further.

We've also talked about our vascular map plus zone affluent map.

And you will hear more about that very soon at a major.

Medical conference asthma, which we announced with our earnings.

This quarter today.

Now we've also been in discussions for potential clinical collaborations for some of our earlier assets, meaning while still a map as well as solid thriller map.

Jennifer Buell: We look forward to making further announcements about the clinical progress of this molecule.

Jennifer Buell: Now, beyond these most recent advancements, Garo mentioned that we expect to present data on AGEN 1181, which is making significant progress in the clinic, and that data released will be based upon cohorts, disease-specific cohorts that we've now been expanding upon. So we'll certainly, we have Dr. ODay here with us today, and he can answer questions.

These compounds can be very valuable in connection with other people's assets that will benefit from the synergy provided by PD, 1 and <unk> for combinations and those will benefit us further by expanding the market.

With these combinations for our PD, 1 and for generations to GLA for antibodies.

Jennifer Buell: Additionally, as we and others have shown, when you add CCLA-4 to PD-1, we see this with 1181. We also see this with BALA-1.

The fourth pillar, we spoke about our our key operational capabilities, which on 1 hand to allow us to advance our programs in the clinic very rapidly.

On the other hand, they also allow us to.

Manufacture our candidates are reliably and rapidly.

Jennifer Buell: We also see this with bowel-to-bowel, particularly in one of our most advanced programs in cervical cancer. We're expanding response rates and duration of response, and we're really excited to be presenting an update on our clinical program of Bowel, Blood, and Vowels in Patients with Refractory Cervical Cancer at ESMO this year. So the titles have been announced, and we'll have a mini oral presentation now that I'm

And thirdly day allow us to be able to launch our own products as doctor and inherently today, we'll be speaking about briefly.

So with that I will try on this call to a doctor agenda for you. Thank you for Jennifer.

Thank you very much GAAP I'll, just build a little bit upon what Gareth mentioned, our research and development productivity, which is really unique to <unk>. It's now become business as usual for us in the past 6 years, we've delivered 17, new discoveries to the clinic.

Jennifer Buell: Now on MiniTherapeutics. Garo introduced this. We've submitted a confidential S-1 for a proposed IPO. Well, we can't say too much about this.

Which is really remarkable progress, but in addition to those filings.

On some of these programs evolve zone.

Jennifer Buell: What I can say is what we've explained to you before.

Our application for our first program our BLA application. We now have still on average Gal mentioned has been accepted for priority review by the FDA with an action date of December 16.

Jennifer Buell: Now Mink Therapeutics, formerly Agentes, is advancing invariant natural killer T-cells. These are actually a subset of T-cells in their allogeneic form.

So we're quite excited now as Gal mentioned, Andy will tell you about the commercial infrastructure that we're setting up to build for that format and then beyond bounced around on that of course as you hear from Doctor on a day in the upcoming months on data and progress on Asia and 11.81.

Jennifer Buell: And they carry both the capacity and the margin.

Jennifer Buell: to emulate innate and adaptive immunity. They have the ability and cancer to do so.

Has been quite remarkable so on.

Jennifer Buell: to directly kill tumors through tumor lysis. They modulate the tumor microenvironment. They suppress...

On the infrastructure that Andy is going to be building well support now and set us up for the launch of agent 11.81.

Jennifer Buell: Myeloid Suppressor Cells, MDFCs. They also recruit and activate T-cells and NK-cells. We believe that these cells have the potential to deliver durable immunity.

In addition to these discoveries on advancements 1 of those 17 announced on discoveries entering the clinic advancing to the clinic is H and $17.77, and now that Tidjane bi specific molecule.

Jennifer Buell: Memory Responses of T-Cells with the cytolytic power of NK Cells

She is now in a collapsed strategic collaboration with Bristol and a few important components as Garo mentioned, Brazil is really the most remarkable company to bring this power and they're committed to advancing at their experience in this day in IL and TNF biology, and they have a very aggressive development plan that we're really quite excited about.

In addition, our strategic collaborations and Max are important differentiators for my prior collaborations in that.

Jennifer Buell: Validated checkpoint modulating antibodies such as CTLA-4 and PD-1.

We have the opportunity to combine this bi specific with certain agents in our portfolio, which is really exciting for us. In addition, upon approval we have the opportunity to tell per mill. So we're really excited about the fda's recent clearance of the science and we'll be looking forward to make inc.

Jennifer Buell: We believe that these cells can build on the benefits that we've seen with CTLA-4 and PD-1, and we've presented data previously demonstrating...

There are announcements about the clinical progress for this molecule.

Now beyond.

These most recent advancements gala has mentioned that we expect to present data on H N 11, 81, which is making significant progress on the correct and that data those data release will be based upon cohort disease specific cohorts that we've now been expanding upon.

Jennifer Buell: in preclinical models, where CTLA-4 and PD-1 are about 40 to 50% off.

Jennifer Buell: complete tumor eradication and a lung mass model preclinically. So we expect to be presenting data later this year on our ongoing clinical programs and patients with multiple myeloma as well as these cells in patients with severe ARDS.

Well certainly we have to ask the other day here with us today and he can answer any questions about this for lab. Additionally, as we have we and other income Sean when you ask you Kelly for the PD 1 when you see this with 11.81, we also see those without.

Jennifer Buell: And finally, our vision platform. We've presented data on this platform a number of times. This is a tool that enables us to identify how the best

Particularly in 1 of our most advanced programs in cervical cancer, we expense response rate and duration of response and we're really excited to be presenting an update on our clinical program about plus <unk> in patients with refractory cervical cancer at ESMO. This year. So the titles have been announced and will have on me.

Jennifer Buell: to design molecules to address biology. This platform also enables us to interrogate responses and identify ways in which we can predict patients who will respond to our therapies. We expect the combination of our biological platform and our new and expanding compute capabilities to be able

He went on presentation now quite enthusiastic about.

Now on many therapeutics.

Now I'll introduce that we've submitted a confidential epsilon, whereas for.

For post IPO, well, we can't talk too much about this this program. These programs what I can say is what we explained to you before now Inc. Therapeutics, formerly in Genesis is advancing invariant natural killer T cells. These are actually a subset of T cells.

And the allogeneic form.

And then carrying Butch mea capacity to modulate innate and adaptive immunity.

They have the ability and cash.

Cancer to directly kill tumors through tumor lysis may modulate the tumor microenvironment.

On my list price yourself and DST they.

Andy Hurley: I'm happy to report that we are making great progress in planning the U.S. commercial launch of Valsilinab in advanced cervical cancer, ACC for short. We have identified and hired a highly experienced leadership team across the key commercial and medical functions.

They also recruit and activate T cells and NK cells, we believe that these cells have the potential.

To deliver the durability and memory memory responses of T cells with the site analytic power of NK cells.

For a multiple clinical trials underway, we've announced those the progress from those programs and these programs include taking these cells into patients with solid cancers and in addition to exploring these cells alone in solid tumors, well also be evaluating <unk> in combination with <unk>.

Andy Hurley: I'm very pleased with the collaboration and agility that the team has shown to develop a well-defined strategic and tactical launch plan. You know, a launch is only as strong as the team driving it, and we have attracted top commercial and medical leaders to Agenus from across the industry to be a part of the continued build-out of the company. Our launch planning for BalstulaMap NACC has two main goals in mind.

Holiday to checkpoint modulating antibodies, such as detailing for N. PD..1 we believe that these cells can build on the benefits that we've seen with the hilli for on PD, 1 and we presented data previously demonstrated in preclinical models.

Detailing for on PD, 1 or about 40% to 50% off debt. When you add I N K T cells into that combination you see complete tumor eradication and along that model for pre clinically. So we will we expect to be presenting data on later this year on our ongoing clinical programs in patients with multiple myeloma as well as patients.

Andy Hurley: First, that every patient that can benefit from Valstilumab has access to it with few barriers. We are leveraging innovative programs at launch to reduce or eliminate normal reimbursement hurdles that physicians often face when trying newly approved medications. Second, in line with its market potential, a cost-efficient launch, leveraging a targeted personal and non-personal promotion approach across mediums and channels that physicians have told us they prefer in our market research. You know, COVID challenged every pharma company to rethink how to promote their products and provide medical education to physicians. And from this, physicians have determined how they want to receive information, now and in the future.

These cells and any patients to be on a rds secondary to COVID-19.

And finally, our vision platform, we've presented data on this platform a number of times. This is a tool that enables us to identify the.

For the best approach is to design a molecule to address biology.

This platform also enables us to interrogate responses and identify ways in which we can predict patients who will respond to our therapies.

We expect the combination of our biologics platform.

And our new and expanding compute capability to be able to identify patients with significant probability of determining who will respond to therapy for those patients go on therapy. This is an evolving platform and we look forward to continuing to update you on the promise of the spot for them.

Now I'm going to turn it over to Andy Hurley to tell you about our commercial group.

I am happy to reported that we're making great progress and planning in the U S. Commercial launch results fill them up and advanced cervical cancer ACC for short.

We have identified and hired a highly experienced leadership team across the key commercial and medical functions I'm very pleased with the collaboration and agility for the team that has shown to be well defined strategic and tactical launch plan.

Our launch is only as strong as the team driving it and we have attracted top commercial and medical leaders to adjust from across the industry to be a part of the continued build out of the company.

Our launch planning for Bell still amount and ACC has 2 main goals in mind for.

On that.

Every patient that can benefit from balance still amount has access to it with few barriers. We are leveraging innovative programs that launch to reduce or eliminate normal reimbursement hurdles that physicians often face when trying newly approved medications.

And second.

In line with its market potential.

Andy Hurley: And these vendor partners will be embedded within our teams so they can also support future launches, following the Valstella MAP launch in ACC. However, the overarching goal of this launch is for it to be a foundational step for Agenus. It will serve as the catalyst to initiate the build of a fully integrated commercial infrastructure, which in turn would allow us to easily scale our teams and operational systems for future launches, maximizing the value of our vast pipeline.

Cost efficient launch leveraging a targeted personal and non personal promotional approach across mediums in channels that physicians have told us they prefer and our market research.

Covid Challenge every pharma company to rethink how to promote their products and provide medical education of physicians and from this position to determine how they want to receive information now and in the future and we will be leveraging these learnings and how we will bring balance still a mab to the ACC.

<unk> market.

Andy Hurley: Specifically, as Garo and Jen mentioned, we are very excited at the possibilities for 1181 in big indications with high unmet needs, and as much as Delphi-Philibab monotherapy can offer the small population of second-line advanced cervical cancer patients a therapeutic option. We could potentially see 1181 providing a much broader range of patients with life-changing outcomes. Possibly, a range of outcomes unmatched in recent IO history. I've had the good fortune of... I've been part of over 20 product launches in my career.

The comment on this further on the progress made in our launch planning we have hired an experienced team of commercial leaders, including account directors that will be engaging with payers prelaunch to support widespread formulary coverage of the archstone that at launch.

We have conducted extensive market research across a wide audience for physicians and payers to determine on a product positioning and messaging for all key stakeholders.

We built a data management infrastructure that will allow for deep and fast insights generation to enable us to react in real time.

2 signals that we here at launch.

Andy Hurley: I believe that the promise that 1181 has, clinically and commercially, is seldom seen in a career, and it is a big reason why it got me to come to Agenda. There are certainly exciting times ahead for Agenus and the patients we hope to help. I'll now turn it over to Christine Klaskin to review our financial results. Thank you, Andy.

We have partnered with best in industry vendors and agencies to support our reimbursement hub creative marketing campaigns medical education planning CRM platforms and other critical areas and these vendor partners will be embedded within our teams. So they can.

Christine M. Klaskin: quarter of 2021 with a cash balance of $74 million as compared to $100 million at December 31st, 2020. Subsequent to the quarter end, we received $200 million dollars related to our

Also support future launches following the balance still amount of launch and ACC.

The overarching goal of this launch is for it to be a foundational step for Janice It will serve as the catalyst to initiate the build of a fully integrated commercial infrastructure, which in turn would allow us to easily scale, our teams and operational systems.

Christine M. Klaskin: for VMS Partnership. For the second quarter ended June 30, 2021, our cash used in operations was $56,000.

Christine M. Klaskin: With $56 million, and we reported a net loss of $84 million, or $0.37 per share. This compares to cash used in operations for the same period in 2020 of $37 million and a net loss of $48 million, or $0.28 per share. Non-cash operating expenses for the second quarter ended June 30, 2021, were $30 million compared to $18 million for the second quarter of 2020.

For future launches and maximizing the value of our vast pipeline.

Specifically as Garo and Jim mentioned, we are very excited at the possibilities for 11, 81, and big indications with high unmet needs.

As much as they'll still about monotherapy can offer the small population of second line advanced cervical cancer cancer patients a therapeutic option.

We could potentially see 11.81, providing a much broader range of patients life changing outcomes potentially on.

On a range of outcomes unmatched in the recent Idaho history.

Christine M. Klaskin: Our cash used in operations for the six months...

Christine M. Klaskin: This month ended June 30, 2021, with $98 million and a net loss of $138 million, or $0.65 per share, compared to cash used in operations.

I've had the good for channel.

Sort of over 20 product launches in my career.

I believe that the promise that <unk> has clinically and commercially.

Seldom seen in her career and it is a big reason of what got me to come to adjust.

Christine M. Klaskin: The same period in 2020, of $94 million, or 59 cents per share. We recognized revenue of $22 million and $42 million for the six months ended June 30, 2021, and 2020, respectively. This revenue includes revenue related to non-cash royalties earned, revenue recognized under our collaboration agreements, and, in 2020, $14 million from an up-front license fee we received. I'll now turn the call back to Garo.

There are certainly exciting times ahead for Genesis and the patients we hope to help.

I'll now turn it over to Christine <unk> to review our financial results.

Thank you Andy.

We ended the second quarter of 2021, with a cash balance of $74 million.

<unk> to $100 million at December 31, 2020.

Subsequent to the quarter end, we received $200 million related to our BMS partnership.

For the second quarter ended June 32021, our cash used in operations was $56 million and we reported a net loss of 84 million or <unk> 37 per share.

This compares to cash used in operations for the same period in 2020 of $37 million on a net loss of $48 million or 28 cents per share.

Garo H. Armen: Thank you very much, Christine, and thank you once again for participating in our call. I will make a few closing remarks before I turn it over to the operator for questions. Just to summarize some of the highlights for the second half of this year that you may expect.

Non cash operating expenses for the second quarter ended June 32021 for $30 million compared to $18 million for the second quarter of 2020.

Our cash used in operations for the 6 months ended June 32021, with $98 million with a net loss of $138 million for 65 per share compared to cash used in operations of $72 million and a net loss for the same period in 2020 of 94 million.

Garo H. Armen: As Jen mentioned, we have a PDUFA date for blasto-MAP monotherapy in December, and we're diligently working in preparation for all aspects of the final phases, or what is required. As Andy mentioned, we're preparing diligently for commercial launch for Second Line Cervical Cancer, but as you said, we're putting together an infrastructure so that we can capitalize on our leveraging for our future launches. We're going to be defining our strategy for BALZAL, and as Jen mentioned, you can expect an exciting presentation at the upcoming ESMO conference.

Dollars or <unk> 59 per share.

From an upfront license fee we received.

I'll now turn the call back to Garo.

Yeah.

Thank you very much Christine and thank you once again for participating in our call.

I will make a few closing remarks before I will turn it to Reed.

Operator for questions.

Just to summarize some of the highlights for the second half over this year you may expect.

As John mentioned, we have produced for date for us.

For my monotherapy in this genre.

And we're diligently working in preparation for all aspects of the <unk>.

Final phases always required.

As Andy mentioned, we're preparing diligently for a commercial launch.

For a second line cervical cancer.

But as you said.

We're putting together an infrastructure so that we can capitalize on our leveraging for our future launches.

We're going to be defining our strategy for balance out and as John mentioned, you can expect the exciting presentation at.

The upcoming ESMO conference.

We will continue with our development for Asia 11.81.

With a strategy for.

For the transition of our studies.

2 an approvable study for 11.81.

And and additional data presentations for our own pipeline on regions and partner agents are also.

In the second half.

We will be advancing on a gen..1 triple 7 which was now Bristol Myers for this asset it's a particular program.

And true and through the clinic.

We will be completing enrollment or various other programs and I will not give you the specifics on what we expect for that.

I N K T program based on our confidential S..1 filing which puts us in a quiet period.

Yeah.

We will be progressing our commercial manufacturing capabilities for antibodies is very very important aspect of our strategy.

It will be critical for us to do this so that we can launch potentially launch 11.81.

B the league as possible upon demonstration of compelling data as Andy said in patients who are otherwise not benefiting from immunotherapy or for that matter any other therapy.

We're also progressing with our sustainable supply on Qs 21, which we believe is a very very important agent for.

For both prophylactic as well as therapeutic vaccine adjuvant and see.

And as I mentioned earlier, we will be anticipating additional transactions financial and corporate transactions in the second half for this year.

Thank you again for your attention.

And now we are open to any questions you may have.

Thanks, Meyer if you could open the Q&A. Please.

Operator: At this time, we would like to take any questions you might have for us today. And as a reminder, to ask a question, you will need to press star, then the number 1 on your telephone keypad. Once again, to ask a question, please press star 1. To withdraw your request, you may press the pound or hash key.

Sales at this time I would like to take any questions you might have for us today and as a reminder to ask a question you will need to press Star then the number 1 on your colleagues on Keybank. Once again to ask a question. Please press star 1 to enjoy a request you may press, the pound or hash key.

We'll pause for a moment for <unk>.

Operator: We'll pause for a moment to compile the Q&A list. This will only take a few moments. Our first question comes from the line of Kelly Shee from Jeffries. Your line is open. Please go ahead. Congratulations on the progress and thank you for taking the time to answer my questions. I have two questions. The first one is, what is our market strategy for bio monotherapy in second-line cervical cancer upon approval given that a combo is probably not too far behind in the progress? And also, what are we going to hear the media's overall survival data from the monotherapy trial? Does this data have an impact on

For the Q&A.

For the only thing for people.

Our first question comes from the line of Kelly <unk> from Jefferies. Your line is open. Please go ahead.

Congrats on the progress and thank you for taking my questions I have 2 questions. So first of all on and what is on our market strategy for that.

<unk> America monotherapy in second line cervical cancer El Pas approval, given that a combo.

It's probably not too far behind the in the progress and also what are we going to hear on media overall survival data from monotherapy trial does this data has an impact on your commercial strategy for Manav versus combo.

Kelly Shee: on your commercial strategy for Mona versus Cumbo. That's my first question. And my second question...

That's my first question on my second question is for them.

Kelly Shee: And my second question is... Could you give us some color on the combo data at AdMob? Thank you.

Could you give us some color on the combo data at ESMO. Thank you.

Let me address that.

Our share on top line and then I'll try to do my colleagues to get into the specifics, but remember that we cannot say very much about.

<unk> specifics otherwise will simply be kicked out on the presentation, which other very desirable outcome for us.

Garo H. Armen: Now, so if you're patient, you will see the data; we've classified the data as being very exciting, and getting back to your first question. As you know, combinations with iotherapy... General. And when I say generally, I'm talking about the great majority of the time, certainly with the existing marketed product, achieving better results, and Mano Sir. And when I say better results, we're talking about improved response rates, but also, very critically, improved duration. And that's typical of that.

So if you're a patient you will see that day that we've classified on data as being very exciting.

And and.

And getting back to your first question.

As you know.

Combinations.

<unk> therapies share.

Generally.

When I say generally.

Talking about the great majority of the time certainly.

With the existing marketed products achieve better results.

And mono therapy, and when I say better results.

Talking about improved response rates, but also very critically.

Improved duration of response and Thats typical on that.

Garo H. Armen: In an ideal world where everybody would accept these facts, we would imagine that the combination should be the desired path forward, but there are hurdles, including regulatory hurdles, in allowing for these combinations to be used. And so we will work very respectfully with the regulatory agencies in the U.S. and elsewhere to make sure that these combinations become the best options available for the appropriate patient population. But with that, Dr. Buell and Dr. Hurley, if you have any other questions...

So in an ideal world, where everybody would accept these facts.

Would you imagine that the combination should be the desired path forward.

There are hurdles.

Putting regulatory hurdles.

Allowing for these combinations to be practiced and so we will work very respectfully with the regulatory agencies in the U S and elsewhere to make sure that these combinations.

Hum.

The best options available for the appropriate patient population.

Andy Hurley: Sure. I'm going to turn it over to Andy to get started on your question, Kelly, question number one. Yeah. So, thank you, Kelly. You know, I look at every launch as you have to really establish a foundation with the community. You're going to be...

With that Doug.

You end up for early if you have any other.

Sure I'm going to turn it over to Andy to get started on your question Kelly question number 1 yeah. So thank you Kelly.

I looked at every launch.

You have to really establish a foundation with the community youre going to be.

Andy Hurley: with the community you're going to be targeting and bringing a product to, and the Bounce Philomath Monotherapy launch allows us to build those relationships, get to understand the marketplace, and get to really understand the dynamics that are going to be needed for subsequent launches in that particular space. So part of our strategy is really bringing a much-needed therapy to that particular wide audience of physicians, and then in doing so, they're going to get comfort with Bounce Philomath.

Good day, and bringing our product to and the balance Philomel monotherapy launch allows for us to build those relationships you have to understand the marketplace yet to really understand the dynamics that are going to be needed for subsequent launches in that particular space. So part of our strategy is.

Really bringing a much needed therapy to that particular wide audience of physicians and in doing so they're going to get comfort with bell still amount.

Andy Hurley: And because if you're going to be bringing a combination that has Valsteldamab in it, and they already have comfort with the monotherapy option, and seeing it really work where other agents may not have worked in the past, that is a good first step for us to really establish credibility in a marketplace that we're going to be looking to really make a significant impact in. So I believe that's really what it is.

And because if youre going to be bringing a combination that has bell spell them out and they already have comfort with the monotherapy option and seeing it really work where other agents may not have worked in the past debt is a good first step for us to really establish credibility in a marketplace that we're gonna be looking to really make a significant impact them.

So I believe that's really what it is and I'll go back to the initial point that I made is the fact that we're not looking at launches in isolation without looking at 1 versus another as.

Andy Hurley: And I'll go back to the initial point that I made, which is the fact that we're not looking at launches in isolation. We're not looking at one versus another as our primary focus. Our primary focus is to build a fully integrated commercial infrastructure that we can pivot to whatever products we're looking to bring to market. And if the combination in cervical cancer looks promising and we want to continue to explore it, then we'll have the necessary support both from in-house commercial leadership as well as from the field presence to be able to really make that impact.

As our primary focus our primary focus is to build a fully integrated commercial infrastructure that we can pivot to whatever products, we're looking to bring to market and the combination in cervical cancer. It looks promising and we want to continue to explore then we will have the necessary.

For both on the in house commercial leadership as well as the field presence to be able to really make that impact.

Thank you.

Operator: Our next question comes from the line of Mayank Mamtani from B. Reilly Securities. Your line is open, please go ahead.

Excellent.

Our next question comes from the line of Leo 1 tiny from B Riley Securities. Your line is open. Please go ahead.

Mayank Mamtani: Good morning team. Thanks for taking our question and congratulations on the progress and N2GN, in particular for the new role with men. Can Andy, great to have you on the call. So maybe first, a couple of questions for Dr. Oday. So for 1181, can you just, looks like it's not maybe at Esmo, maybe it's after. Just curious what sort of update we should expect in terms of, you know, you have a number of different tumor types, PD-1 refractory setting versus, you know, doing this in combination, you know, and also like what number of patients you may have in the MSS colorectal cohort. That would be question number one.

Good morning team. Thanks for taking my question and congrats on the progress in <unk> and in particular for the new role that men can that'd be great to have you on the call so maybe flow.

A couple of questions for Doctor day, So for 1.1 each 1.

Can you just it looks like it's Dod maybe that's more maybe it's just.

Just curious.

What sort of update.

You would expect in terms of you.

You have a number a bit for humor dives.

PD, 1 refractory setting versus.

Doing this in combination.

And also like what.

The number of patients who may have on the MSS colorectal cohort that debt.

Would be question number 1.

Steven J. ODay: Thank you for that question. As publicly disclosed, this agent, which is a next-generation CTLA-4, has been engineered to be more active both from a priming and memory point of view as well as depleting Tregs in the tumor microenvironment and having a better toxicity profile. So we continue to advance the phase 1 slash 1B program.

Thank you for that question.

Very obviously excited about Bill every day 1 program as we are.

Publicly disclosed.

You know this this agent which is a next generation <unk> for has been engineered to be more active both from our prime and in memory point of view as well as depleting T regs in the tumor microenvironment and having a better toxicity profile. So.

We continue to advance the phase 1 plus 1 b program as <unk>.

Steven J. ODay: As Garo said, we now have over 100 patients treated with either single agent 11A1 or combination. We will hopefully be presenting this data by the end of the year at a major conference, and we can't say more than that at this point. Well, I think the take-home messages from this program to date have been that it's been designed to be a next-generation CTLA-4, and it's performing as such in the clinic in the sense that tumors that historically have had little to no PD-1 or CTLA-4 activity, we've reported responses, particularly in cold, solid tumors like MS-stable colorectal cancer, ovarian, as well as in PD-1

<unk> said, we now have over 100 patients treated with either single agent elaborate on what our combination.

We will.

B hopefully presenting this data by the end of the year at a major conference and we can't say more than that at this point.

Well I think the.

Take home messages from this program to date has been it's been designed to be a next generation seats like for and it's performing as such in the clinic in the sense that tumors that historically have had little to no PD, 1 or <unk> for activity, we reported responses, particularly in cold solid.

Tumors like MF stable colorectal cancer ovarian as well as PD 1 resistant settings.

Steven J. ODay: So, this is all very encouraging to us. And in terms of numbers around cohorts, again, we have not publicly released updates on that, but look forward to doing that at a major meeting. But as you know, the colorectal MS-stable cohort is one of the cohorts that we are rapidly expanding in this trial, and we look forward to updating you further later in the year.

So this is all very encouraging to us and.

In terms of numbers around cohorts again that we have not publicly released updates on that but look forward to doing that.

At a major meeting, but as you know our colorectal MSS stable cohort is 1 of the cohorts that we are rapidly expanding in this trial and look forward to updating you further.

Later in the year.

Thank you put for other do debt and then on the bad <unk> monotherapy for <unk>.

As you prepare for that.

They don't need to draw from for instance that.

Depending on that.

Recent experience with the FDA.

Mayank Mamtani: Thank you for all the details. And then on the Val Monotherapy Purdue file, you know, as you prepare for that, are there any parallels to draw from, you know, for instance, the Retic-Fenlemab experience, you know, recent experience with FDA, or are you expecting an outcome by any chance?

Are you expecting an outcome by any chance.

The question is how are we expecting day an ad com.

Okay, I think I think.

Between now and the Peru for Dave you kind of expect debt, we are going to do a lot of work.

Mayank Mamtani: The question is, are we expecting a... Adcom. Adcom. Okay. I think between now and the PDUFA date, you can expect that we are going to do a lot of work. In communication with the agency, there are mandated inspections in the process.

In communication with the agency there are.

Mandated.

Corrections in the process and we're going through all of that right now and I think out of respect to the process, we will not disclose the details.

Mayank Mamtani: Okay, fair enough. And then maybe for Jen and Garo, I have a follow-up for you, but maybe Jen, are you able to comment on sort of the patients dosed across solid tumors and COVID-19 ARDS and what sort of territories have you been enrolling for the INKT in any color there?

Okay Fair enough and then maybe maybe for Jan and go a habit I have a follow up for you.

But maybe Jim are you able to comment on.

Out of the debt.

Patients dosed across solid tumors, and COVID-19, the ideas and what sort of debt Adobe's have you been enrolling for the for that.

And good day.

Any color there.

Hi, Langley can't say too much right now for for obvious reasons, given where we are in the process, but but rest assure we will be aggressive with data releases as we have always been across the portfolio.

Jennifer Buell: Hi Mayank, we can't say too much right now for...

Jennifer Buell: For obvious reasons, given where we are in the process, but rest assured, we'll be aggressive with data releases as we have always been across the portfolio.

Great. Thank you.

And maybe for Daniel.

Get go as you look at scaling up.

Lord.

So it'd be GMA capex.

Great to see this activity.

Mayank Mamtani: It's great to see this Vacaville facility coming online here in California, expanding your Zoma antibody efforts. I'm just curious, how should we think about this going forward, especially if QS21 adjuvant becomes something that would require investment? How would you think about expanding CapEx and obviously continuing to fund the R&D pipeline here?

That's a really big coming online here in California expanding yards on the.

Everybody efforts.

Curious like how should we think about this going forward.

Cash needed.

<unk>.

The gum something that would be quite assessment, how would you think about expanding.

Capex and obviously continuing to find that out it would be by plaintiff.

Okay. So let me address that in several ways and I don't mean to be.

Complex about my answer but just.

Just bear with me now if you look at the history My Inc.

How we have managed our.

Expenditures versus our cash balance.

It has been done in a very orderly way, meaning.

In any given quarter.

We have managed our cash outflows and cash inflows very well.

Of course, the Bristow transaction that brought in $200 million.

And is expected to deliver on another milestone this year in terms for cash infusion.

<unk> has provided a bit of a jump into our cash balances and I expect that in the second half for the year. We will have additional jumps in our cash balances are where do they come from several sources. In addition true CT.

Garo H. Armen: Several sources, in addition to corporate transactions, milestones, and project financing transactions. In addition to those, we expect to fund some of our separated subsidiaries by means of outside capital infusion, and that will certainly reduce some of our cash burn associated with those businesses. That includes, for example, our Mink Therapeutics asset. It also includes our QS21 and related assets. You could also expect to see some asset sales, possibly, in the second half of this year.

Current transactions milestones.

<unk> financing transactions in addition to those we.

We expect to fund some of our separated subsidiaries.

By means of outside capital infusion.

And that will certainly reduce some of our cash is true.

Our cash burn associated with those businesses that includes for example, our minc therapeutics asset.

So <unk>.

Includes our <unk> 'twenty, 1 and related assets.

We could also expect to see some asset sales, possibly in the second half of this year.

Garo H. Armen: And so, if you add all of those things... Relative to unusual items that will occur from time to time that will represent jumps, I cannot promise you on a quarter-to-quarter basis what the impact of that will be, but I expect that we'll be able to manage our cash position so that we are left with a substantial cushion at the end of each period. So, other than that, unfortunately, I cannot give you any more specific dollar guidance.

Cash position, so that we are left with a substantial cushion.

Pushing it.

At the end of each period.

So other than that unfortunately, I cannot give you any more specific dollar guidance.

Mayank Mamtani: No, that's...

No.

Mayank Mamtani: Now that's helpful, Khaled. Thanks again for taking our questions.

Helpful color, Thanks, again for taking our questions.

Operator: Once again, I would like to remind everyone, if you wish to ask a question, please press star 1 on your telephone.

Once again I would like to remind everyone. If you wish to ask a question. Please press star 1 on your telephone keypad.

Next question comes from the line of Matt Phillips from William Blair. Your line is open. Please go ahead.

Matthew Phipps: Good morning. Thanks for taking my questions. Just a few. Do you guys have any update on the timing of the Balzac filing?

Good morning, and thanks for taking my questions just a few.

Do you guys have any update on the timing of the bell So filing that's the way that you can.

Garo H. Armen: I think on the Bell-Zell filing, Matt. We've said that we'll provide guidance on this in the second half of this year. Of course, it's going to be a function of us disclosing the data, the final data from that combination trial at ESMO, and then deliberations with the FDA. So bear with us. Once we get some clarity on both processes, we'll give you a definition of the path forward. With regard to the PDUFA date, what was the question again?

Give a little bit more clarity on ahead of the Paducah for BOE, a day, where you have to really wait for that particular to clear.

I think on the balance valve filing match.

We've said that we will provide guidance on this in the second half of this year of course, it's going to be a function of us disclosing the data.

And on the data from that combination trial at ESMO, and then deliberations with the FDA show.

Bear with us a while.

Once we get some clarity through both processes will give you a definition on the path forward.

With regard to the Peru Friday.

And what was the question again.

Matthew Phipps: No, that pretty much answers it.

No.

Matthew Phipps: Then secondly, for 1327, you're...

Then secondly for $13.27, you're now wholly owned.

Matthew Phipps: You're now wholly owned, Pidget, monospecific antibody. Do you still plan to move that into phase one this year or just what are the kind of thoughts for that after the outlices of the biospecific show?

A lot of specific antibody do you still plan to move that into phase 1 this year or just what are kind of the thoughts for the other thought after the outlet for the Bispecific <unk>.

Garo H. Armen: So, clearly, the bispecific has advantages over the monospecific, and the data that we've generated so far is very suggestive of that.

So clearly.

The bi specific has advantages over the mine on a specific.

And the data that we've generated so far is very suggestive however, having said that.

Garo H. Armen: However, having said that, can the monospecific antibody be an important reagent, just like PD-1 is an important reagent, for some of the other combination possibilities you have in your portfolio? The answer is most likely yes. And so, hence, we will advance this program with that in mind. And I don't think we've provided guidance on the exact timing of the IND filing, but bear with us; it will be within a reasonable period of

Can the mono specific antibody being important reagent just like PD..1 is unimportant reagent for some of the other combination possibilities portfolio. The answer is most likely yes, and so hence we will advance this program with debt in mind and.

I don't think we've provided guidance on the exact timing on the R&D filing about bear with us it will be within a reasonable period of time.

Matthew Phipps: Okay, thanks, and then... Garo, as I look at your really kind of early stage pipeline... Closures, it does seem like there's a bit of a move to buy specific formats or kinds of therapies. Is that, do you think that is kind of a direction that you all are moving more broadly? I mean, obviously, the Tidgit and then also the TGS-Beta trap are kind of in that realm. So just curious if that's kind of where we should think about for the evolution of your kind of antibody-based platform.

Okay. Thanks, and then.

There are as I look at your really kind of earliest stage pipeline.

Disclosures it does seem like there's a bit of a move to buy specific.

Formats or go to therapies is that do you think that it's kind of a direction that you are moving more broadly I mean, obviously.

Is it.

So that gives you a bit of trap or color on that.

Relative to just curious if that's going on where we should think about for the evolution of your kind of antibody based.

For them.

I, Thank you for that Matt.

I think that's a presumptuous assumption on.

Meaning we have bi specifics on our portfolio that have not been disclosed that have.

Very very exciting activity that we're seeing very early on.

But we also have some phenomenal mono specifics that will be announced and 1 specifically will be filed to enter the clinic. This year and of course with these agents as you know the immune system is like is symphony.

A lot of activities.

And yes, certain immuno oncology agents have activity as single agents, but I think it's fair to say that the most exciting activity.

Is being seen with the symphony process of agents. So I think it will be.

Very exciting for us.

Particularly because we control the different components of the symphony issue for them.

Great. Thanks, Chris.

Yeah.

There are no further questions at this time you may continue.

Operator: There are no further questions at this time; you may continue. Thank you very much, everyone.

Yes.

Thank you very much Raul. Thank you very much for your attendance.

Listening to our update.

Garo H. Armen: Thank you very much, everyone. Thank you very much for your attendance and listening to our update.

Okay.

[noise].

Operator: This concludes today's conference call. You may now disconnect. Have a great day.

This concludes today's conference call you may now disconnect have a great.

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