Lear Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 9, 2023

There are 13 speakers on the call.

Operator

Afternoon. We will begin the MacroGenics 2023 Second Quarter Corporate Progress and Financial Results Conference Call in just a moment. All participants are in listen only mode at the moment, and we will conduct a question and answer session at the conclusion of the call. At this point, I will turn the call over to Jim Carroll, Senior Vice President, Chief Financial Officer of MacroGenics.

Speaker 1

Thank you, operator. Good afternoon, and welcome to MacroGenics' conference call to discuss our Q2 2023 financial and operational results. For anyone who's not had the chance to review these results, We issued a press release this afternoon outlining today's announcements, which is available under the Investors tab on our website at macrogenics.com. You may also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately 2 hours after the call is completed.

Speaker 2

I would

Speaker 1

like to alert listeners that today's discussion will include statements about the company's future expectations, plans and prospects that constitute forward looking statements for purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the Risk Factors section of our annual quarterly and current reports filed with the SEC. In addition, any forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any While we may elect to update these forward looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change except to the extent required by applicable law. And now, I'd like to turn the call over to Doctor. Scott Koenig, President and Chief Executive Officer of MacroGenics.

Speaker 3

Thank you, Jim. I'd like to welcome everyone participating via conference call and webcast today. This afternoon, I will provide key updates on our clinical programs. But before I do so, let me first turn the call back to Jim, who will review our financial results.

Speaker 1

Thank you, Scott. This afternoon, MacroGenics reported financial results for Quarter ended June 30, 2023, which highlight our financial position. As described in our release this afternoon, MacroGen's total revenue was $13,100,000 for the quarter ended June 30, 2023 compared to total revenue of $26,000,000 for the quarter ended June 30, 2022. Revenue for the quarter ended June 30, 2023 included recognition of $1,600,000 in contract manufacturing revenue And marginza net sales of $5,100,000 compared to net sales of $4,700,000 for the quarter ended June 30, 2022. Our research and development expenses were $43,200,000 for the quarter ended June 30, 2023, compared to $51,700,000 for the quarter ended June 30, 2022.

Speaker 1

The decrease was primarily due to decreased costs Related to discontinued studies, partially offset by increased expenses related to preclinical antibody drug conjugate or ADC molecules and increased clinical expenses related to lorogirlimab and vorbiduo. Our selling, general and administrative expenses were $13,700,000 Each of the quarters added June 30, 2023, 2022. You'll notice approximately $100,000,000 as a component of other income on our income Let me take a moment to explain. Under GAAP guidelines and pursuant to FASB's ASC 4 70 in March 2023, We recorded the $100,000,000 proceeds received from the sale of our royalty interest on global net sales of tZeal To DRI Healthcare Acquisitions LP or DRI as a liability related to future royalties. This liability was to be amortized over the term of the arrangement using the effective interest rate method.

Speaker 1

Sanofi subsequently acquired Both Provention Bio and the tZield royalty interest and milestone obligations from DRI in April 27, 2023, obviating the need for MacroGenics' involvement in the transfer of royalty payments to DRI. This resulted in a change to the arrangement, which was evaluated as a modification under the provisions of ASC 4 70. Accordingly, we recognized approximately $100,000,000 as a component of other income quarter ended June 30, 2023 compared to a net loss of $41,300,000 for the quarter ended June 30, 2022. Our cash, cash equivalents and marketable securities balance as of June 30, 2023 was $240,300,000 compared to $154,300,000 as of December 31, 2022. Our cash balance as of June 30, 2023 did not include a $50,000,000 milestone payment from Sanofi subsequently earned.

Speaker 1

Payment of this milestone was triggered pursuant tesanofi's July 28 announcement that the PRO2TECT placebo controlled study investigating tZeal or tiplizumab in patients with newly diagnosed stage 3 Type 1 diabetes met its primary endpoint, having demonstrated preservation of beta cell function. This milestone was part of the March 2023 agreement originally between MacroGenics and DRI, the royalty interest and milestone payment obligations of which We're sold by DRI to a subsidiary of Sanofi in April 2023. And finally, in terms of our cash runway, We anticipate that our cash, cash equivalents and marketable securities balance of $240,300,000 as of June 30, 2023, The $50,000,000 milestone subsequently earned in addition to projected and anticipated future payments from partners and product revenues should extend our cash runway into 2026. Our anticipated funding requirements reflect expected expenditures related to the Phase 2 Tamarac clinical trial, the Phase 2 study of lorogerlimab in metastatic castration resistant prostate cancer, as well as our other clinical and preclinical studies currently ongoing. And now, I'll turn the call back to Scott.

Speaker 3

Thank you, Jim. We continue to believe our proprietary pipeline of product candidates has great promise, and I will walk you through each of our key programs momentarily as well as tell you about our plans for upcoming clinical programs. But before I do that, I'll quickly remind you that over the past year, Through our business development efforts as well as milestone achievement, we have generated $320,000,000 of non dilutive capital. Ovaritamabduacomizine or VOVR DUO is our ADC designed to deliver DNA alkylating dukomycin cytotoxic to tumors expressing B7 H3. B7 H3 is a member of the B7 family of molecules involved in immune regulation.

Speaker 3

VOBRADUO was designed to take advantage of this antigen's broad expression across multiple solid tumor types. We began enrolling the Tamarac Phase 2 study of VOBER DUO in patients with metastatic castration resistant prostate cancer under a modified study protocol during the Q2. You may recall that we made this modification to address the changing treatment landscape For patients with mCRPC and enrollment has been proceeding nicely. We hope to enroll a majority of the 100 patients across the 2 experimental arms of 2 mgs per kg or 2.7 mgs per kg every 4 weeks in 2023 and provide a clinical update in 2024. Next, I'll update you on lorodirlimab, our bispecific tetravalin PD-onexCTLA-four DART molecule.

Speaker 3

We designed lorajolumab to have preferential blockade on dual PD-one CTLA-four Expressing cells such as tumor infiltrating lymphocytes or TILs, which are most abundant in the tumor microenvironment. You may recall that we presented encouraging preliminary clinical results from a single arm dose expansion study of loradirlimab in patients with advanced solid tumors in a poster session at the ASCO General Urinary Cancer Symposium in February 2023. Based on the strength of the mCRPC data presented, we plan to commence enrollment of a randomized Phase 2 study of loradirlimab In combination with docetaxel versus docetaxel alone and second line chemotherapy naive and CRPC patients in the coming weeks. A total of 150 patients are planned to be treated in the 2:one randomized study. The current study design includes the primary study endpoints of radiographic progression free survival.

Speaker 3

In addition, we continue to enroll patients in the Phase 1 dose escalation study of VOBR Duo in combination with loradirlimab In patients with advanced solid tumors, including renal cell carcinoma, pancreatic cancer, ovarian cancer, expansion portion of the study by year end 2023. Next up, MGD-twenty four It's our next generation bispecific CD123xCD3 DART molecule that incorporates a CD3 component Designed to minimize cytokine release syndrome while maintaining antitumorcytolytic activity and permitting intermittent dosing through a longer half life. Our Phase 1 dose escalation study of MGD-twenty four is ongoing in patients with CD123 positive relapsed or refractory hematologic malignancies, including acute myeloid leukemia And myelodysplastic syndrome. We call that Gilead has the option to license MGD-twenty four at predefined decision points during the Phase 1 study. Finally, enoblituzumab is an Fc optimized monoclonal antibody that targets P7H3.

Speaker 3

3. Based on the recently published results from a Phase 2 investigative sponsored study of enoblituzumab In men with prostate cancer, MacroGenics and collaborators and multiple academic institutions plan to initiate an investigator sponsored, Randomized translationally intense neoadjuvant prostate cancer study in high risk population by early 2024. And now I'd like to give you some perspective on where MacroGenics intends to advance. I'll remind you that over our history, We have maintained our focus in developing innovative antibody based therapeutics, having had a role in the development of 3 products now More recently, as an extension of the synthesis, we've accelerated our ADC efforts. This has been possible through the following.

Speaker 3

First, our technology enabling partnerships, most notably our 2 collaborations with Synaptics, which has recently been purchased by Lonza. We have reviewed multiple linker payload technologies and are pursuing Synapix's approach, which utilizes various linker toxins conjugated to a site specific glycan within the Fc domain of antibodies. This affords us the ability to exploit different cytotoxic mechanisms including Topoisomerase inhibition, microtubule inhibition and DNA damage in up to 7 ADC molecules incorporating Synaprix's technology. The second element we believe allows us to extend our reach into ADCs is leveraging our 20 plus year history of pursuing 1st in class target discovery in addition to our antibody engineering expertise. And finally, the third element is our proven ability to develop product candidates through FDA approval, coupled with our commercial scale manufacturing and external supply chain management capabilities.

Speaker 3

We are very excited about where this could take us in developing ADCs to treat cancer. As previously indicated, We intend to submit an investigational new drug or IND application to the U. S. FDA by the end of this year for the first of potentially multiple new ADC molecules, which incorporate topoisomerase inhibitor payload. To conclude, we believe we have the technical development and clinical expertise and even the necessary financial resources to support execution on our plan of developing and delivering life changing medicines to cancer patients in 2023 and beyond.

Speaker 3

We would now be happy to open the call for questions. Operator? Thank

Operator

you. Our first question comes from Jonathan Chang with Leerink Partners. Your line is open.

Speaker 4

Hi, guys. Thanks for taking my questions. First question, can you give us a sense of how enrollment in the Phase 2 TAMRAC study has progressed? Just trying to get a sense of when in 2024 we might see data.

Speaker 3

Thank you, Jonathan. I'm Very encouraged by the rapidity of enrollment at this point now as And many of these sites have incorporated the amendments to the protocol. We still have Additional site initiation visits to complete on additional sites, but based on what we've been seeing In this group of sites, I stick with what I have said that the majority of patients Should be enrolled in the study this year and we should complete it in the 1st part of 2024.

Speaker 4

Got it. Thank you. And second question, what do you need to see from the either of the Phase 2 prostate cancer studies to support advancing these programs into the next stage of development.

Speaker 3

So with regard to Tamarac, as you know, we had seen very encouraging data with regard to late stage mCRPC patients with regard to PS850 reductions as well as objective responses. The goal of this study, in fact, is to achieve responses in terms of efficacy That were similar to that observed at the doses that we had treated before, As you recall, 3 mgs per kg on a Q3 weekly basis, but which most of those patients had dose reductions during those course. What is more important at this point is to see some improvement in the side effect profile. In particular, the most disconcerting side effect was hand foot syndrome in these patients who develop Grade 2 So we would like to see a reduction obviously in that grade and obviously the incidence as well. With regard to the efficacy parameters, again, just to refresh everybody's memory, we saw approximately half those patients have PSA50 reductions.

Speaker 3

So of course, we would like to see, in the order around 40% to 60% or even better, obviously, if that is achievable in that population with concomitant tumor control and continued treatment. With regard to the loradirlimab study, in terms Of outcomes, obviously, we were looking for an acceptable safety profile. In terms of Efficacy, if you look at the historical data in terms of control groups, which we obviously include here Of patients treating with docetaxel, historical data says an RPFS of 8 months Is what you would like to exceed. So we'll have to see if we're able to achieve that by certainly several months.

Speaker 4

Got it. Thanks for taking the questions.

Operator

Thank you. Our next question comes from Peter Lawson with Barclays. Your line is

Speaker 5

open. Thanks, Scott. I guess initially just as a follow-up to Jonathan's question. The Data that we could see for your B7H3 for the Phase 3 sorry, the Phase 2 data, can we see that in the second half of 24 and for the Phase 1 combination data, is that something like a first half twenty four data sets still?

Speaker 3

So Peter, as things go now, as I said to Jonathan, And the encouragement about where we are enrolling, if this continues at this pace, I think the second half twenty twenty four Presentation of this data is certainly possible for the Tamarac study. So obviously, we'll have to monitor that The rest of the year in terms of enrollment. I should also point out that this is an open study. So we will Take interim looks at that data along the way and may be able to come to some conclusions earlier before we even have the full body of data from that study. So, again, I would be consistent with And we're targeting the second half of the year at this point.

Speaker 3

With regard to the combination study, As we pointed out, we're sort of trying to fine tune the combination of Vobro with lorodjirlibab right Now individually in combination, once we settle on what that dose to use the doses to use Moving forward in combination and expansion studies, we expect that to occur by the end of the year. So again, could it be the first half of the year? Possible. But right now, Let me bring you up to date. Once we have picked those doses And started those expansions, I'll be able to give you a little bit more definition when that will happen.

Speaker 5

Got you. And then on Adam, I know there's an update this year kind of what kind of update would that be? Will we see Data is kind of a go, no go decision and with the data involved the lung cancer data set?

Speaker 3

So as you know and we discussed this before, ImmunoGen is conducting a clinical studies. They're Following through on the patients with lung cancer to identify an appropriate adult making decisions about go forward. We have not discussed with them the specifics about what would be discussed and presented. We should be doing that soon. So again, updates later this year, the nature of what will be contained, I don't have an

Operator

Thank you. Our next question comes from Charles Zhu with Guggenheim. Your line is open.

Speaker 6

Hi, guys. This is Rosie on for Charles Zhu. Thanks for taking our So first question is with regard to the changing landscape in MesoCC CRPC, how are you changing or setting applications with regards to the

Speaker 3

So, if I understand your question, how are we Anticipating the use of these drugs in face of where Plavicto is at this point and in the future. Is that correct?

Speaker 7

Yes.

Speaker 3

Okay. So clearly, Pluvicto has changed the landscape for treatment. It is being used currently right now in major medical centers that have Pet scanning capabilities for PSMA, there has been, as you know, Some limitation in its distribution in terms of supply, which is being addressed By Novartis, so there will be increased use with time. I think at this point, Well, we have to wait to see the data on the results of Plavicta In earlier lines of therapy, so right now it's more in a later line of therapy. When we have completed Our study results, we will evaluate where the appropriate line of therapy will be in which Populations, but right now, it's just too early.

Speaker 3

Also mechanistically, We're talking about completely different mechanisms and also the toxicity profiles are quite different. And so I think that this is an opportunity where different mechanisms of action You have greater number of choices for treating physicians and their patients. So I think it's a good story for patients That new modalities will be available very soon.

Speaker 7

Thank Thank you. And if I can ask

Speaker 6

the second one real quick. This one's regarding the VovaDuO combo. Are there specific histologies that you potentially want to focus on for the dose expansion?

Speaker 3

Well, as we pointed out in today's call and previously, we are looking at 6 Different solid tumor types right now. We have not selected which ones to do yet for the expansion.

Operator

Certainly,

Speaker 3

prostate cancer will be one of them, which Additional others, we will select. We have yet to make that decision. Then we'll again, In the near term, we'll be able to provide that information.

Operator

Thank you. Our next question comes from Etzer Darrout with BMO Capital Markets. Your line is open.

Speaker 8

Great. Thanks for taking the question. First 1, just wondered if, you plan to disclose any of the data from the dose escalation of vorbraduol plus loradrolumab Prior to moving into expansion studies. And then secondly, if you maybe could comment on the progress Are there any other kind of other tumor types, Laurie, sort of monotherapy, maybe any progress there with other tumor types, When we could get an update there or any other tumor types that you would look to explore with FluorA either monotherapy or combinations? Thank you.

Speaker 3

Yes. So, Esther, we'll have to again, as you know, as I've said just earlier today, we're honing in on The specific doses for the individual components of the VovaDuo combo, ultimately, it will be determined of How many patients we have available at the time to assess. My inclination right now is to start and move forward in Expansions in particular types, which I alluded to before, prostate and probably 1 or 2 others. And probably at that time, Once we have that data, we would be in, I think, a better position to present the total data. But again, this is subject to further discussions later this year.

Speaker 3

With regard to other tumor types For Laurie, besides the data we presented at ASCO GU, as you know, we have Previously said that we've had objective responses in 3 other cohorts that we were testing, Including MS Stable colorectal cancer, melanoma And lung cancer, what I've also indicated on previous calls is that For us to move forward into a more wholesome Phase 2 study, I'd like to see Some additional patients being treated as monotherapy to better Determine the activity in particular tumors. I pointed out, for example, In the lung cancer cohort that we had, we lost a lot of that data because of patients that were treated in Ukraine For the case of the MS stable colorectal cancer patients, I pointed out we had very few patients Without liver metastasis, which has been an area being pursued by others, So I'd like to see additional patients being treated as monotherapy before making the decisions going forward. The melanoma data, we're very encouraged by. As you know, historically, we've had We have noted that we've had very significant responses with Vopraduo and melanoma as well. And that is one of the tumor types we're potentially enrolling in The combination study going forward, so.

Speaker 8

Great. Thank you.

Operator

Thank you. Our next question comes from Kaveri Pullman with BTIG. Your line is open.

Speaker 7

Yes. Good evening. Thank you. Thanks for the updates and for taking my questions. Sorry if I missed this, But for lorazolamab and docetaxel combination study, it's a randomized trial for 150 patients.

Speaker 7

Can you give us a sense How long it will take to enroll the study and to get RPSS? Also, do you think that you can just Expanded to a free trial if the interim data looks good. Just want to know how you we are thinking about it?

Speaker 3

Yes. Kuberi, thank you very much. So we're very close to enrolling the first patients. We've initiated sites. Patients are In screen now, the start up of this trial.

Speaker 3

Right now, until you start enrolling, you won't know The rate of enrollment, but right now the anticipation will take us through this year And through a good part of 2024. And so at this point, it would be just too early to Predict when we'd be able to do the readout at the study. Most likely in early 2025, But that's all conjecture at this point.

Speaker 7

Got it. That's very helpful. And then for MGD-twenty four, can you tell us how is the enrollment going? Any feedback you have received from the physicians so far? And Can you accelerate dosing based on your previous clinical experience with flotetuzumab here?

Speaker 3

So As you know, in irrespective of what the product is, any CD3 based, bispecific molecule when interacting with the regulatory Specific molecule when interacting with the regulatory agencies, there is a lot of prudence In terms of the dose escalation speed on which these things can be conducted, despite the fact that we had very Significant data showing dramatic reductions in cytokine production in primate model systems And anticipate that we could move this faster. But having said that, we are following what was Discuss with the FDA, we are right in the middle of dose escalation. The study is going well, and that's all I can say At this point, my sense is that once the dose has been picked From that dose escalation and we go into a more Phase 2 like study, There may be greater opportunities to accelerate the development. But again, that will be with either with Gilead, If they opt into the program after the Phase 1 or during Phase 1 or by ourselves if it warrants it. So Still too early to tell.

Speaker 7

Makes sense. Thank you.

Operator

Thank you. Our next question comes from Yigal Nochomovitz with Citigroup. Your line is open.

Speaker 9

Hi, Scott. Thanks for taking the question. On the Tamarac study in metastatic CRPC and then the Phase onetwo dose escalation with the combo and I think you mentioned CRPC there as well and you want to do an expansion. Can you just comment, are those patients, those prostate patients relatively similar in their Degree of pretreatment, you mentioned advanced solid tumors for CRPCR. So I wasn't clear if it was similar or if the ones in the Phase onetwo were more significantly Pretreated versus Tamarac.

Speaker 9

Thanks.

Speaker 3

So there are some slight differences in eligibility. We have a little bit Wider in Tamarac, but the majority of the patients will be quite similar. We obviously wanted to compare apples to apples with the modification of dose. Obviously, we wanted to get this enrolled quickly. So there was Some minor changes, but I would say they'll be very easily comparable to the previous data.

Speaker 3

And that's the same story with the combo for whatever prostate patients come in, very late stage patients as well, Typically, have advanced on the engine receptor targeting agents on a taxane and often Experimental agents as well. So we think the data set will be we will be able to compare each one.

Speaker 9

The reason I ask is because I mean if you do the prostate expansion in the Phase III with the Vobra and the lerajilimab and that looks really good. I'm just curious how you're thinking about pivotal study and how you would register the product because Whether you'd want to register with the monotherapy, with the roberduo or if the lorazilumab roberduo looks really good in prostate, if That would be the way to go forward, to take the drug to mark the combo to market. That's more of a strategic question, but just curious How are you thinking about that?

Speaker 3

Yes. So obviously, we this is constant discussion. Obviously, we with the data on the lorazirlimab mono Sorry, being so encouraging, we decided to move a little bit up line with now Going into chemo naive patients, but with androgen receptor experienced patients, So that right now there is no other checkpoint that is vying for that population. So this is A great opportunity that we can demonstrate in that line of therapy success. With regard to The Vober story, either as monotherapy or potentially combination with Lori, That's a nice problem to have.

Speaker 3

It both look very successful, both the results from Tamarac and then The combo, so we'll address that as the data comes out next year.

Operator

Thank you. Our next question comes from Stephen Willey with Stifel. Your line is open.

Speaker 10

Yes, good afternoon. Thanks for taking the questions. I guess now that you've removed the control arm from Tamarac, I'm guessing there's going to be more of an emphasis on response rate versus, I guess any kind of event driven efficacy data. So I guess I'm just curious based upon the eligibility criteria of Tamarac, What percentage of patients you're expecting to actually have soft tissue disease that is resist valuable?

Speaker 3

With that from that parameter, I think, our experience in many in the trials to date I believe we have those patients and I would not be surprised given this is an international study Based on actually the results from the LORI trial that we presented, almost all the majority of those patients

Speaker 2

Had

Speaker 3

visceral involvement, it was not only bony involvement. So I'm not At this point, I am not concerned that we will be seeing a tissue limited population. I think there will be enough And then clearly, we'll monitor that going forward and we certainly can add more patients if necessary, but I don't think that's going to be a problem.

Speaker 10

Okay. And I guess just a question on Vovra Duo. So You've pressed the pause button here on single agent dose expansion in other tumor types. I think that's Despite some of the early signs of efficacy that you talked about earlier, are you thinking of reinitiating any of those development efforts Again, once you get confirmation on dosing and scheduling from Tamarac or does this next gen ADC effort now kind of get Prioritized in front of overdue.

Speaker 3

Yes, I mean, my answer to you is, is we certainly are Just given the broad expression of B7 H3, of course, a large number of solid tumors and our experience with them that additional tumor types will be pursued. Clearly, we would like to see With VoverDuo, that improvement in safety, which I discussed earlier. And I mean, I can guess that At this point, or we could forge ahead and just move there, but I think it's more prudent given, as I said earlier today, that Enrollment is going well and we'll have the answers soon, to initiate other At that point, I we feel very strongly that we are building a great Opportunity and franchise within prostate cancer, with the Lori, With the Vobra potential combination and then as we said today, the plans to start With academic collaborators, a neoadjuvant study with enoblituzumab In prostate cancer, so we're trying to really cover the entire landscape for treatment of patients with prostate, But that does not interfere with our enthusiasm for pursuing this in other tumors as well.

Speaker 2

All

Speaker 10

right. Thanks for taking the questions.

Operator

Thank you. Our next question comes from John Miller with Evercore ISI. Your line is open.

Speaker 3

Hi, guys. Thanks for taking

Speaker 11

the question. I would look to ask more about the financials And the runway guidance, so obviously you mentioned that covers Tamarac and Loic Phase 2 and ongoing trials. How much does that cover of a new ADC? How much does that cover for trials that aren't currently running or anticipate to start? And does that count any new indications either for VOBR Duo or for Laurie expansion?

Speaker 3

Yes. Thanks, John. Very good question. Obviously, with today's announcement, we're very excited about getting that additional $50,000,000 milestone from achieving it from achieving it through the results of the PROTECT study, and so obviously, just again to put in context, As we said earlier, with the $320,000,000 in the past year of non dilutive capital, The likelihood of additional milestones goes up Because of the hitting the primary endpoint, of course, it's dependent on the opportunity to get TZeal is approved in the new indication as well as different regions for the original indication that has been already approved in the And U. S.

Speaker 3

FDA, but that increases likelihood there, which means potential increased opportunities for more milestones and as well as royalties. I should also point out that, Incyte announced Last week that they completed enrollment in the 2 registration studies For the anti PD-one Zynas In lung cancer and anal cancer, so again, with those readouts as results accrue, If those are successful, what we have on the table are a potential $320,000,000 of regulatory clinical milestones, Another $330,000,000 in commercial, so over $600,000,000 there and we still have the potential for Another $380,000,000 from Sanofi. So that's over $1,000,000,000 of potential milestones from 2 approved products. So getting back to the essence of your question, just with this additional 50 And the study is ongoing. That does include the new antibody drug conjugate that we will File an IND the Q4 this year, it does include the opportunity To do additional studies, whether it be for new tumor indications or Additional studies in different lines of prostate cancer, those are under discussion right now and it doesn't take away from any of the work Pre clinically for a second ADC from the Synafix that we said is ongoing right now, which we're Hoping to target for an IND in 2024 plus a lot of other preclinical development activity that we have not So we're very, very, very encouraged both with our cash runway and the opportunity to Pursue a very robust clinical and preclinical pipeline.

Speaker 11

Great. That makes sense. I guess, I know you sometimes include risk adjusted future milestones in your cash runway. Can you talk a little bit about how much of that Potential $1,000,000,000 in milestones you're counting on when you give that runway into $26,000,000

Speaker 3

Yes, we haven't broken that down. Clearly, We make those adjustments based on real time results and certainly we have the opportunity to adjust A probability based on the fact that Sanofi has said that they are going for regulatory approval. Obviously, we'd like to see the data. We have not seen the data on the results of the new study. But we are at this point, we're not in a position to break out the specifics there.

Speaker 1

This is Jim, Jonathan. I would just add to that, that historically if we look back at the probabilities that we use For risk adjustment, we've been very conservative.

Speaker 11

Okay, makes sense.

Speaker 2

Thanks so much.

Speaker 3

Thank you.

Operator

Thank you. Our next question comes From Silvan Turkin with JMP Securities. Your line is open.

Speaker 2

Yes. Hi, thanks for taking my question. A couple of questions on Tamarac here. The patients group that you're expecting to enroll by the end of the year or maybe early next year, Will that have sufficient chemo naive patients that, that could be also an option, maybe better than the chemo experienced patient for a registrational study or what are your options after in In terms of patient populations that you have in this Phase 2 to go on?

Speaker 3

No, actually that is One of the several hard fast enrollment criteria, they have to have been exposed to a chemotherapeutic most likely Docetaxel. So in this particular study, we're not we want to really compare The results as I described earlier of our previous experiences with vobra In a later line population that is chemo experience. So not in this study. We are certainly interested in looking at Opportunities in earlier lines of therapy, including hormone sensitive populations, but nothing is on the table right now.

Speaker 2

Great. Thanks. That's very helpful. And then at ASCO, we saw first in human data from ANSOS, ADC, Health Director, BSM H3. Are there any learnings from that that we can apply to VovaDuo?

Speaker 3

Yes. I mean, I would say The most encouraging data was obviously a small data set and they were talking about expansion in other tumor types is that of the 9 patients With small cell lung cancer, 7 had an objective responses, which fits The data that Daiichi has discussed also in the small cell population. So Clearly, this is a histological type that we are certainly considering Adding to the types being tested, we as you may recall, we have only had one patient With small cell cancer in our dose escalation, who actually did very well on bovar at a lower dose. That patient was on treatment for over 6 months with tumor shrinkage, didn't have an objective response, But really responded well to the therapy. So clearly that opens up for us A confirmation that a small cell maybe an indication we should also pursue.

Speaker 2

Great. Well, thanks. Thanks for taking my questions.

Operator

Thank you. Thank you. Our next question comes from Boris Peaker with C. D. Cohen.

Operator

Your line is open.

Speaker 12

Hi. My name is Hansi Fu for Boris Peaker. I would like to ask How confident for vopra do, how confident are you that the 2 doses that you're Testing will give you the ideal dose moving forward. And you think about the registrational trial, Do you expect further dose modification if needed? Thank you.

Speaker 3

So As any experiment being conducted, you go with the data you have and you have a hypothesis and we feel that The doses we selected were the right ones. This was based on a full analysis of the data in all the expansion cohorts with regard to side effect profiles, tumor responses, pharmacokinetics. And so we tried to book in based on what the real exposure was in patients. As I commented on earlier, the majority of patients At dose reduction, so we feel that we've picked the 2 doses that should give us more clarity with regard to And improved safety profile and activity profile. So as much as that can guide us, We're hoping that was the right selection and the right answer.

Speaker 3

And if we have to make modifications In some way, subsequently, once we get the data, we'll do it if the drug looks both Active as well as relatively safe.

Speaker 12

Got it. Thank you for taking my question.

Operator

Thank you. There are no further questions. I'd like to turn the call back over to Doctor. Koenig for closing remarks.

Speaker 3

Well, thank you very much, operator, and thank Thank you everyone for participating in our call today. We look forward to providing further updates both on our clinical and preclinical Pipeline in the coming months. Have a good day.

Operator

Thank you for your participation. This does conclude the program and you may now disconnect. Everyone enjoy the rest of

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Earnings Conference Call
Lear Q2 2023
00:00 / 00:00
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