Q3 2023 Celcuity Inc Earnings Call
Speaker 1: Greetings and welcome to the Selcurity Third Quarter 2023 Financial Results Conference Call.
Greetings and welcome to the show QED third quarter 'twenty to 'twenty three financial results Conference call.
Speaker 1: At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation.
At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation.
Speaker 1: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.
Anyone should require operator assistance during the conference. Please press star zero on your telephone keypad as a reminder, this call is being recorded.
Speaker 1: It is now my pleasure to introduce your host, Maria Jankowski, with ICR. Thank you, ma'am. You may begin.
It is now my pleasure to introduce your host Maria Young Koskey with ICR. Thank you Ma'am you may begin.
Speaker 2: Thank you, Operator, and good morning to everyone on the call. Thank you for joining us to review Selcuity's third quarter 2023 financial results and business update. Earlier this morning, Selcuity released financial results for the third quarter ending September 30, 2023.
Thank you operator, and good morning to everyone on the call. Thank you for joining us to review so acuity third quarter 2023 financial results and business update earlier. This morning, So acuity released financial results for the third quarter ending September 30th 2023.
Speaker 2: The press release can be found on the investors section of the website.
The press release can be found on the investors section of the website joining me on the call today are Brian Sullivan, So acuity, Chief Executive Officer, and co founder and Vicki Hahn Chief Financial Officer.
Speaker 2: Joining me on the call today are Brian Sullivan, Selkiewicz's Chief Executive Officer and Co-Founder, and Vicky Hahn, Chief Financial Officer.
Speaker 2: Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements.
Before we begin I would like to remind listeners that our comments today will include some forward looking statements.
Speaker 2: These statements involve a number of risks and uncertainties, which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results may differ materially from those projected in the forward-looking statement.
These statements involve a number of risks and uncertainties, which are outlined in today's press release and in our reports and filings with the SEC actual events or results may differ materially from those projected in the forward looking statements such forward looking statements and their implications involve known and unknown risks.
Speaker 2: Such forward-looking statements and their implications involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected.
Uncertainties and other factors that may cause actual results or performance to differ materially from those projected.
Speaker 2: On this call, we will also refer to Nod GAAP financial measures.
On this call. We will also refer to non-GAAP financial measures. These non-GAAP measures are used by management to make strategic decisions forecast future results and evaluate the company's current performance.
Speaker 2: These non-GAAP measures are used by management to make strategic decisions, forecast future results, and evaluate the company's current performance.
Speaker 2: Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future.
Management believes the presentation of these non-GAAP financial measures is useful for investors understanding and assessment of the company's ongoing core operations and prospects for the future you can find a table reconciling the non-GAAP financial measures to GAAP measures in today's press release and with that I would now like to.
Speaker 2: you can find the table reconciling the non-GAAP financial measures to GAAP measures in today's press release.
Speaker 2: And with that, I would now like to turn the call over to Brian Sullivan, CEO of Cellcuity. Please go ahead.
Turn the call over to Brian Sullivan CEO I still QED. Please go ahead.
Speaker 3: Thank you, Maria, and good morning to everyone joining us on today's call. Our current focus at Telcuity is to develop treatments for patients who have cancers involving the PI3K mTOR or PAM signaling pathway. The PAM pathway is one of the most important oncogenic pathways. It regulates key metabolic functions, cross-regulates other oncogenic pathways and affects the tumor microenvironment, which can directly affect how a patient's immune system responds to a tumor.
Thank you Maria and good morning to everyone joining us on today's call.
Our current focus and tell QED is to develop treatments for patients with cancers involving the <unk> K EMCORE or Pam signaling pathway. The Pan pathway is one of the most important oncogenic pathways. It regulates came out of barley functions cross regulates other oncogenic pathways and effects of the tumor microenvironment, which can directly affect.
Hello, patient's immune system response to whatsoever.
Speaker 3: It is also the most highly mutated by a significant margin of all signaling pathways.
It is also the most highly mutated by significant margin are all signaling pathways.
Speaker 3: 38% of solid tumors have a PAM-related mutation or alteration.
38% of solid tumors have a pam related mutation or alteration.
Speaker 3: Mutations obviously serve as potential targets, but the overall proportion of pathway alterations in a tumor highly correlates to its overall role as a cancer driver.
Mutations, obviously serve as potential targets, but the overall proportion of pathway alterations in a tumor highly correlates to its overall role of the cancer driver.
Speaker 3: Despite its importance as a cancer driver, the number of patients treated today with a PAM inhibitor is trivial compared to the number who could potentially benefit from them. And this is why we think the PAM pathway represents the largest drug development opportunity in solid tumors.
Despite its importance to the cancer driver the number of patients treated today with a pan inhibitor, it's trivial compared to the number who could potentially benefit from them.
This is why we think the Pam pathway represents the largest drug development opportunity in solid tumors.
Speaker 3: The primary reason why PAM inhibitors have not become standard of care drugs, despite the importance of the PAM pathway.
The primary reason why pan inhibitors have not become standard of care drugs. Despite the importance of the pan pathway.
Speaker 3: is because it is very difficult to safely and efficaciously inhibit this path.
It's because it is very difficult to safely and efficacious they inhibit this pathway.
Speaker 3: Unlike most pathways, where inhibition of a single kinase may induce the desired activity, the PAM pathway involves multiple nodes. Each of them must be targeted because of the complex interaction that takes place between them. Otherwise, uninhibited nodes may be activated and compensatory resistance may be induced, which in turn compromises efficacy.
Unlike most pathways, where inhibition of the single kinase may induce the desired activity.
Pam pathway involves multiple nodes each of them must be targeted because of the complex interaction that takes place between them otherwise.
Otherwise uninhibited nodes may be activated and conference Torry resistance, maybe induced switch interim compromises efficacy.
Speaker 3: The available therapies that target this pathway only target a single node, such as mTORC1 or PI3K-alpha, and have only reported limited improvements in patient outcomes.
The available therapies that target this pathway only target a single node such as M torque, one or pediatric alpha have only reported limited improvements in patient outcomes.
Speaker 3: That is why we believe development of an optimized PAM inhibitor, like Getatilicin, that targets all class 1 PI2K isoforms and mTORC1 and mTORC2, represents one of the most important opportunities to improve the standard of care in these cancers.
That's why we believe development of an optimized pan inhibitor might get us a lesson that targets all class one P. S. Okay isoforms and them talk one and <unk> two.
It represents one of the most important opportunities to improve the standard of care in these cancers.
Speaker 3: With our phase 3 program and HR positive for 2 negative advanced breast cancer and our newly initiated phase 1 B 2 program and metastatic castration resistant prostate cancer.
With our phase III program in HR positive <unk> negative advanced breast cancer, and our newly initiated phase one b two program in metastatic castration resistant prostate cancer.
Speaker 3: We hope to eventually impact over 500,000 patients globally who have one of these tumor
We hope to eventually impact over 500000 patients globally, who have one of these tumor types.
Speaker 3: Our Phase 3, Victoria 1 clinical trial is evaluating Getatelicib in combination with Fulvistrin with and without Powasiclib in adults with HR positive, HER2 negative, advanced breast cancer, who have progressed on prior treatment with a CDK4-6 inhibitor.
Our phase III, Victoria, one clinical trial is evaluating go to solicit in combination with full dose strength with and without power cyclic and adults with HR positive <unk> negative advanced breast cancer, who have progressed on prior treatment with the CDK four six inhibitor.
Speaker 3: We are now recruiting patients at nearly 220 sites in 23 countries in North and South America, Europe , and Asia.
Now recruiting patients at nearly 220 sites in 23 countries in North and South America, Europe and Asia.
Speaker 3: The trial remains on track to provide initial data and analysis of the PIK3CA wild-type patient subgroup in the second half of 2024, and the data for the PIK3CA mutated patient subgroup in the first half of 2025.
The trial remains on track to provide initial data and analysis of the pits, we see a wild type patient subgroup in the second half of 'twenty 'twenty four and the data for the picture, we see a mutated patient subgroup in the first half of 2025.
Speaker 3: In August , we announced our plans to initiate the clinical development of getatelicid in patients with metastatic castration-resistant prostate cancer, whose disease progressed while receiving treatment with an androgen receptor inhibitor.
In August we announced our plans to initiate the clinical development of get up to listen and patients with metastatic castration resistant prostate cancer, whose disease progressed, while receiving treatment with an androgen receptor inhibitor.
Speaker 3: Treatment options for these patients are limited, and there's an urgent need for new drugs to treat this patient population.
Treatment options for these patients are limited and there is an urgent need for new drugs to treat this patient population.
Speaker 3: Numerous preclinical studies have demonstrated interaction between the antigen receptor and PAM pathways suggest that combining a PAM inhibitor with an antigen receptor inhibitor may induce a synergistic antitumor effect in patients with prostate.
Numerous preclinical studies have demonstrated interaction between the androgen receptor and pan pathways suggest that combining a pan inhibitor with an androgen receptor inhibitor may induce a synergistic antitumor effect in patients with prostate cancer.
Speaker 3: There's also compelling clinical evidence with an earlier generation PAM inhibitor providing a proof of concept of our hypothesis that combining gettatilicin with an androgen receptor inhibitor may be efficacious.
There's also a compelling clinical evidence with an earlier generation Pan inhibitor, providing a proof of concept of our hypothesis that combining data to listen and androgen receptor inhibitor may be efficacious.
Speaker 3: The FDA cleared our IND and gave us allowance to proceed with our Phase 1b2 trial to evaluate Gettysilicium in combination with Duralutamate.
The FDA cleared our IND and gave us allow us to proceed with a phase one b two trial to evaluate got caught off.
Get us a lesson in combination with garlic Tonight.
Speaker 3: which is a potent androgen receptor inhibitor. In patients with metastatic castration-resistant prostate
Which is a potent androgen receptor inhibitor in patients with metastatic castration resistant prostate cancer we.
Speaker 3: We expect to activate this trial in the first quarter of 2024 and report initial data in the first half of 2025.
We expect to activate this trial in the first quarter of 'twenty 'twenty four and report initial data in the first half of 2025.
Speaker 3: In the phase 1b portion of the study, the acuity expects that up to 42 participants will be randomly assigned to receive 600 milligrams of darolutamide combined with either 120 milligrams of getophilicin in arm 1 or 180 milligrams of getophilicin in arm 2.
And the phase one portion of the study the acuity expects it up to 42 participants will be randomly assigned to receive 600 milligrams of <unk> combined with either 120 milligrams and get it for less of an arm, one or 180 milligrams and get us a lesson in arm two.
Speaker 3: An additional 12 participants will then be enrolled in the phase 2 portion of the study at the recommended phase 2 dose level to enable evaluation of a total of 30 participants treated with a phase 2 dose of Geta-Telizumab.
An additional 12, just Vince will then be enrolled in the phase II portion of the study at the recommended recommended phase two dose level to enable evaluation of a total of 30 participants treated with the phase two dose and get them to listen.
Speaker 3: The primary objectives of the Phase I-B portion of the trial include assessment of the safety and tolerability of getatelizumab in combination with theralutamide and determination of the recommended Phase II dose of getatelizumab.
The primary objectives of the phase <unk> portion of the trial include assessment of the safety and Tolerability of Gotta go lives have been combination, but theyre alluded, Mike and determination of the recommended phase two dose of get its a lesson.
Speaker 3: The primary objective of the Phase II portion of the trial is to assess the six-month radiographic progression-free survival rate of patients who received the Phase II dose.
Primarily primary objective of the phase two portion of the trial is to assess the six month radiographic progression free survival rate of patients who received the phase two dose.
Speaker 3: We're excited that Bayer agreed to enter into a clinical trial collaboration and supply agreement to provide darolutamide, their approved androgen receptor inhibitor, for this trial at no cost. Darolutamide is structurally unique to other androgen receptor inhibitors with an excellent efficacy and differentiated tolerability profile coupled with minimal drug-drug interactions, making it an ideal combination partner for Geta to listen to.
We're excited that bear agreed to enter into a clinical trial collaboration and supply agreement to provide Darling they're approved androgen receptor inhibitor for this trial at no cost Theyre alert them I just structurally you need two other androgen receptor inhibitors with an excellent efficacy and differentiated tolerability profile, coupled with minimal drug drug interactions.
It's an ideal combination partner forgot to listen.
Speaker 3: And finally, in September , we hosted a virtual science day where we provided an in-depth overview of the scientific and strategic rationale supporting our clinical development strategy.
And finally in September we hosted a virtual science day, where we provided an in depth overview of a scientific and strategic rationale supporting our clinical development strategies.
Speaker 3: We reviewed how getatolysib's differentiated mechanism of action, safety profile, and potency solves the riddle of comprehensively inhibiting the PAM pathway without inducing unacceptable levels of toxin.
We reviewed how get to listen to a differentiated mechanism of action safety profile and potency solve the riddle of comprehensively inhibiting the Pam pathway without inducing unacceptable levels of toxicity.
Speaker 3: We then characterize the significant unmet needs in breast and prostate cancer, and why GADF-ELISAB is uniquely positioned to potentially improve the outcomes for the hundreds of thousands of patients with these tumors.
We then characterize the significant unmet needs in breast and prostate cancer and why it got us unless a is uniquely positioned to potentially improve the outcomes for the hundreds of thousands of patients with these tumors.
Speaker 3: For nearly 20 years, the PAM pathway has confounded drug developers. This has led many drug developers and investors to question the relevance of the pathway as a cancer.
For nearly 20 years, the Pan pathway has confounded drug developers.
Like many drug developers and investors to question the relevance of the pathway is a cancer target. We think that that amount is misguided we blamed the drugs not the pathway.
Speaker 3: we think that settlement is misguided. We blame the drugs, not the path.
Speaker 3: We're excited about the opportunity to potentially offer breast and prostate cancer patients effective treatment for their PAM pathway-involved tumors, and we look forward to updating you on our progress over the coming quarter.
We're excited about the opportunity to potentially offer breast and prostate cancer patients effective treatment for their pan pathway and ball tumors and we look forward to updating you on our progress over the coming quarters.
Speaker 3: With that, I'll turn now the call over to Vicky Han, our CFO , to review our financial results.
I'll turn now the call over to Vicki Hall, our CFO to review our financial results.
Speaker 4: Thank you, Brian , and good morning, everyone. I'll provide a brief overview of our third quarter 2023 financial results.
Thank you, Brian and good morning, everyone I'll provide a brief overview of our third quarter 2023 financial results.
Speaker 4: Net loss for the third quarter of 2023 was $18.4 million, or $0.83 loss per share, compared to a net loss of $10.9 million, or $0.75 loss per share, for the third quarter of 2022. We also included in our press release non-GAAP-adjusted net loss for the quarter ending September 30, 2021.
Net loss for the third quarter of 2023, with $18 4 million or 83 cents loss per share compared to a net loss of $10 9 million or <unk> 75 cents loss per share for the third quarter of 2022.
We also included in our press release non-GAAP adjusted net loss for the quarter ending September 30th 2023.
Speaker 4: Our non-GAAP-adjusted net loss for the third quarter of 2023 was $17.3 million, or $0.78 loss per share, compared to non-GAAP-adjusted net loss for the third quarter of 2022 of $9.5 million, or $0.63 loss per share.
non-GAAP adjusted net loss for the third quarter of 'twenty to 'twenty, three with $17 3 million or 78 cents loss per share compared to non-GAAP adjusted net loss for the third quarter of 2022 of $9 5 million or 63 cents loss per share.
Speaker 4: Research and development expenses were $17.5 million for the third quarter of 2023 compared to $9.6 million for the third quarter of 2022.
Research and development expenses were $17 5 million for the third quarter of 2023 compared to $9 6 million for the third quarter of 2022.
Speaker 4: Of the approximately $7.9 million increase in research and development expenses, $7.5 million was due to an increase in expenses related to the Victoria I Phase III clinical trial and $0.4 million was related to increased employee-related expenses.
Of the approximately $7 9 million increase in research and development expenses $7 5 million was due to an increase in expenses related to the Victoria, one phase III clinical trial.
In point 4 million, which related to increased employee related expenses.
Speaker 4: General and administrative expenses were $1.4 million for the third quarter of 2023 compared to $1 million for the third quarter of 2022. Employee-related expenses accounted for $0.3 million of the income.
General and administrative expenses were $1 4 million for the third quarter of 2023 compared to 1 million for the third quarter of 2022.
Employee related expenses accounted for a point 3 million of the increase.
Speaker 4: The remaining $0.1 million increase resulted from professional fees and other expenses associated with being a public company.
Remaining <unk> 1 million increase resulted from professional fees and other expenses associated with being a public company.
Speaker 4: Net cash used in operating activities for the third quarter of 2023 was $12.7 million compared to $9.3 million for the third quarter of 2022.
Net cash used in operating activities for the third quarter 2023 was $12 7 million compared to $9 3 million for the third quarter of 2022.
Speaker 4: This was the result of non-GAAP adjusted net loss of approximately $17.3 million offset by working capital changes of approximately $4.6 million in accounts payable and accrued expenses and partially offset by other assets.
This was the result of non-GAAP adjusted net loss.
Approximately $17 3 million offset by working capital changes of approximately $4 6 million.
In accounts payable and accrued expenses and partially offset by other assets.
Speaker 4: We ended the quarter with cash, cash equivalents, and short-term investments of $133.9 million.
We ended the quarter with cash cash equivalents and short term investments.
133 million $133 9 million.
Speaker 4: On October 20th, we closed on a $50 million private placement, which is not reflected in the September 30th cash and investment amount.
On October 20th we closed on a $50 million private placement, which is not reflected in the September 30th cash in investment amount.
Speaker 4: We believe this will extend our cash runway into mid-2026 and fund us through multiple critical milestones. With that, I will now hand the call back over to you.
We believe this will extend our cash runway into mid 2026 and fund us through multiple critical milestones.
With that I will now hand, the call back to Brian.
Yeah.
Speaker 3: Thank you, Vicky. Operator, could you please open the call for questions?
Thank you Vicky operator could you. Please open the call for questions.
Speaker 1: Sure, thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key.
Sure. Thank you.
We will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue for participants using speaker equipment it may be necessary.
Sorry to pick up your handset before pressing the star keys.
Speaker 1: Our first question comes from Mari Raycroft with Jefferies, please go ahead.
Our first question comes from Maury Raycroft with Jefferies. Please go ahead.
Speaker 5: Hi, good morning. Thank you for taking our questions. This is Yao on the call for Morrie.
Okay.
Hi, Good morning, Thank you for taking our questions.
Yeah, all on the call for Maury.
Speaker 5: Our first question is on the phase three trial regarding the primary analysis between arm B and arm C.
Our first question morning.
Our first question is on the phase III trial regarding the primary analysis between RMB and the arm C.
Speaker 5: which compares GATA plus Fulvestrin versus Fulvestrin alone, what kind of Delta was
Which compares get a plus well vast friend versus foe veteran alone.
What kind of Delta was.
Speaker 5: went into the powering assumptions. We assume falvestrin alone has maybe four to five months of PFS, so what does GATA and falvestrin combo need to show to be statistic? And similarly, between RMD and RME in mutant patients, what kind of
Went into the powering assumptions are.
We assume that shouldn't allow it has maybe four to five months of PFS. So what does get out and go faster in a combo and need to show to them to be static and similarly between arm D and army in mutant patients what kind of.
Speaker 5: Delta went into the powering assumptions there. That would be
Delta went into the powering assumptions there that would it be.
Yeah.
Speaker 5: versus a Palisade plus Fulvestrum combo in that comparison.
Versus Oh palace at plus five Ashwin commvault in that comparison.
Speaker 5: And I have a follow up. Yep. Thank you. Oh, go ahead.
And I have all thanks for the question Paul off Yeah, Oh go ahead.
Speaker 3: No, thanks for the question. We powered this study with traditional powering assumptions, which are typically 90 percent, and so we have sufficient sample size to detect an effect size difference that's statistically significant with that.
Oh, yeah. Thanks for the question.
We powered the study with traditional powering assumptions.
Which are typically 90%.
And so we have sufficient sample size to detect an effect size difference.
Physically significant with that.
Speaker 3: And so, we haven't disclosed the specific effect size difference that we're assuming, but given the low...
And so we haven't disclosed the specific effect size difference that we're assuming.
But given the low oh.
Speaker 3: median PFS rate that's been reported for clovestrain, one could deduce.
Median PFS rate that's been reported for investment.
One can deduce that the.
Speaker 3: level of improvement or the effect size difference doesn't have to be significant to be statistically significant. For just as an example, a two-month
Level of improvement or the effect size difference it doesn't have to be significant to be statistically significant you know for just as an example.
A two months improvement in PFS.
Speaker 3: which would translate to 100% improvement relative to what's been reported in full vestment recently, two months to median PFS for them, it would represent an HR of 0.5. And that would A, be statistically significant and B, would be on the edge of being clinically
Which would translate to a 100% improvement relative to what's been reported for best friend recently, two months median PFS for them.
Would represent a and H are.
0.5, and that would be statistically significant and b, what would be on the edge of being clinically meaningful.
Speaker 6: And a similar analysis was done with our assumptions for RMD versus RME, we power the studies.
And a similar analysis was done with our assumptions for R&D versus army, we power the study.
Speaker 6: ninety percent, and derive our sample size accordingly.
90%.
Drive our sample size accordingly.
Got it that makes sense.
And I guess.
Speaker 7: Maybe move on to the prostate cancer study.
Maybe move on to the prostate cancer study.
Uh huh.
Speaker 7: There, we know dilutamide seems to have pretty low drug-drug interactions, but still there are some reports that seems to suggest dilutamide can reduce CMAX or AOC for some other drugs that...
There.
We know it.
Duluth, Matt it seems to have pretty low drug drug interactions, but still there are some reports that seems to suggest Duluth mad Ken can reduce C match or AUC for some other drugs that.
Speaker 7: had been administered together in the past. I guess, can you maybe clarify if you are going to do very detailed PK monitoring? Or do you think your trial design is sufficient for you to find the optimum dose? And do you have any plans to maybe look at other different dose combos?
Had it been administered together in the past I guess can you maybe.
Clarify.
If you are going to do very detailed PK monitoring or do you think your trial design is sufficient 240 to find the optimal optimum dose and do you have any plans to maybe look at other different dose com.
Both.
Speaker 6: Okay. Well, thanks for the question. Well, two things. We have evaluated the DDI profile of darlutamide and assess that relative.
Okay, well thanks for the question.
Thanks.
<unk> evaluated the DDI profile of dialogue on my end.
Assess that relative to the.
Speaker 6: interactions with Getta. But Getta is very stable. It doesn't metabolize. It metabolizes at a very, very low rate. And so we don't anticipate any drug-drug interaction between the two drugs, just based on their respective PK profiles. We will be doing PK analysis so that we'll confirm that as part of our study. You know, our
Interactions with would get it but yet it's very stable it.
It doesn't metabolized at where metabolize it had a very very low rate and so we don't anticipate any drug drug interaction between the two drugs in this based on their respective PK profile, we will be doing PK analysis, so that will confirm that as part of our study.
You know our focus right now is demonstrating proof of concept of combining.
Speaker 6: focus right now is demonstrating the proof of concept that combining a PAM-PI3K inhibitor like Erythrolysis with an androgen receptor inhibitor like Ferrolizumab.
Pam Pietro can inhibit or like Atlas said with an androgen receptor inhibitor like her remarks.
Speaker 6: very potent, will induce a treatment effect in these patients.
It's a very potent.
We will induce a treatment effect in these patients.
Speaker 6: that could be significant and advance the standard of care.
But there could be significant and advance the standard of care.
Speaker 6: The steps that follow that, there's a lot of potential different steps and we will start discussing those as we begin reporting.
The steps to follow that there's a lot of potential different steps and we will start discussing those as we begin reporting data.
Speaker 7: Got it. That makes sense. Thank you so much. I'll hop back in the queue.
Got it that makes sense.
Thank you so much I'll hop back in the queue.
Speaker 1: Our next question comes from Boris Becker with Cowen. Please go ahead.
Our next question comes from Boris Becker with Cowen. Please go ahead.
Speaker 8: Yes, hi. A couple of questions here. So, just for Geta in general, what's responsible for the drug's tolerability when we compare it...
Yes, Hi, a couple of questions here, So I'll just forget it in general what's responsible for the drug's tolerability when we compare it to some prior attempts at targeting Torre M. P. I, three K and specifically kind of an extension of that into Victoria trial, what's the algorithm for dose reduction and do we have a sense of.
Speaker 8: prior attempts at targeting mTOR and PI3K, and specifically kind of an extension of that in the Victoria trial, what's the algorithm for dose reduction and do we have a sense of fraction of patients that have had a dose reduction?
Fraction of patients that have had a dose reduction.
Speaker 6: Great. Well, thanks. So, so get a tolerability profile as a function of two features of the drug. One is that it's administered.
Great well. Thanks, so so again its tolerability profile as a function of two features of the drug one is that it's it's administered.
Speaker 6: IV intravenously, which means it avoids the GI tract and the liver. Because PI3K-alpha, which is one of the targets of GEDA and which is one of the targets of available therapy,
IV.
Intravenously, which means it's avoids oh, the Gi tract and in the liver.
Because <unk> Alpha which is one of the targets are to get out and which is one of the targets are.
Available therapy.
Speaker 6: regulates glycolic activity.
Regulates glycolic AR activity.
Speaker 6: which takes place in the liver, avoiding the liver allows you to avoid...
Which takes place in liver.
Avoiding the liver allows you to avoid.
Speaker 6: essentially inducing high levels of hypoglycemia, which is one of the primary adverse reactions associated with PI3K drugs.
Essentially inducing high levels of hyperglycemia, which is one of the primary adverse reactions associated with a P. S. Okay drugs.
And the second.
Speaker 6: feature of the drug relates to its PK profile, and that's a function of its chemical structure, which is that it has a very balanced volume of distribution of around 40 liters. And what that essentially means is that it doesn't get retained excessively in the liver.
Feature of the drug.
Two its PK profile and that's a function of its chemical structure, which is that it has a very balanced volume of distribution of around 40 meters and what that essentially means is that it doesn't get retained excessively in the liver.
Speaker 6: Which is in comparison to some other drugs that have been ID administered which had very high volumes of distribution and were retained in the liver 50-fold 50-fold higher concentrations than in plasma. So it's a combination of the route of administration, which is a necessary but not sufficient condition to minimize the toxicity It's also a feature of the PK profile and it's balanced a volume of
Which is in comparison to some other drugs that have been IV administered which had very high volumes with distribution and were retained in the liver a 50 fold 50 fold higher concentrations in plasma. So it's a combination of the route of administration, which is a necessary, but not sufficient condition to minimize Ah Ah the toxicity.
It's also a feature of the PK profile and it's a balance of volume of distribution.
Speaker 3: As far as dose reductions, you know, in our phase 1B study, we had dose...
As far as a dose reductions on a phase one b study we.
We had those Uh huh.
Speaker 6: Intensity levels of roughly 90% so so there'll be you know very structured approach to dose reductions, but overall you know patients
Yes.
Intensity levels of roughly 90%. So so there'll be you know a very structured approach to a dose reductions but overall.
Uh huh.
Speaker 6: stay on the drug, for the most part, at the 180 milligram dose level. The dosing density was comparable to palvocyclin. So we think that...
Stay on the drug at that are for the most part at the 180 milligram dose level.
The dosing.
Density was comparable to Paolo cyclic so we think that.
Speaker 6: Essentially, the drugs are somewhat equally tolerable as a result.
Essentially the drugs are somewhat equally tolerable as a result.
Speaker 6: There's nothing that would expect us to see anything different in this phase 3 study.
There's nothing that would expect us to see anything different in this phase II phase III study.
Great and maybe if I could squeeze in one more just on prostate cancer. Obviously, there's a lot of discussion I'm curious somebody targeting therapies, particularly in the pre chemo setting. We just saw some data in asthma, we're expecting all the data.
Speaker 8: Actually, there's a lot of discussion on PSMA targeting therapies, particularly in the pre-chemo setting. We just saw some data in asthma.
Speaker 8: How do you see that impacting kind of your development pathway to get a pleasant result?
How do you see that impacting kind of your development pathway forget a plus non dilutive.
In these patients.
Speaker 3: Sure. Well, we'll see. I mean, it's a function of the data that we report. If the data that we report is consistent with what's been reported in clinical studies that
Sure well, we'll see I mean, it's a function of the data that we report if if the data that we report.
It is consistent with what's been reported in our clinical studies that.
Speaker 6: were done with an earlier generation PAM inhibitor that is no longer under development, then we think Getta would be on track to potentially offering a standard of care that was superior to PSMA-targeted therapies, even if it was just comparable. And, again, I'm just...
We're done with our.
Earlier generation Pam inhibitor that is no longer under development.
And then we think get a would be on track to potentially offering a standard of care that was superior.
P S M a targeted therapies.
Even if it was just comparable and again I'm, just describing scenarios not projecting anything but even if it was just comparable with the radiographic progression free survival was just comparable to the P. S. M. A.
Speaker 6: describing scenarios, not projecting anything, but even if it was just comparable, the rate of graphic progression to survival was just comparable to the PSMA, we think that we would have an advantage relative to the challenges involved in administering that class of drugs. But it's early days, but ultimately, as is the case in most of these settings, the efficacy will really determine the strategy going forward and the penetration.
Yeah, we think that we would have an advantage relative to the challenges involved in administering.
But that class of drugs, but.
But it's it's early early days, but ultimately is as is the case in most of these settings the efficacy really determined.
You know the strategy going forward and the penetration that you could hope to expect.
Speaker 6: But we don't think that the bar is raised to a level with those drugs that will create an impediment for us to be successful.
But we don't think that the bar is raised.
Two a level with those drugs that will create a impediment for us to be successful.
Great. Thanks for taking my questions.
Hello.
Speaker 1: Our next question comes from Gil Blum with Needham & Co. Please, go ahead.
Our next question comes from Gil Blum with Needham and co. Please go ahead.
Speaker 9: Hey, good morning, everyone. Thanks for taking our question. Just a quick one on use of proceeds. You guys recently had the financing. We're just trying to understand if you expect the majority of these proceeds to be used to maybe extend the cash runway, or is it more to expand the footprint than invest in the prostate cancer program? Thanks.
Hey, good morning, everyone. Thanks for taking our question just a quick one on use of proceeds you guys.
Recently, the financing, but just trying to understand it.
You expect the majority of these proceeds to be used to maybe extend the cash runway or is it more to expand.
The footprint.
Invest in our.
Prostate cancer program. Thank you.
Right.
Thanks Neil.
Speaker 6: We raised the incremental $50 million, which really came over the threshold. It was an unsolicited inquiry, and we concluded that it would be favorable for us to
We raised the incremental $50 million, it's really came over the threshold at was was an unsolicited inquiry.
And you know we we we concluded that it was would be favorable for us to extend the runway.
Speaker 6: You know the money we've raised and had on our balance sheet prior factored in Development costs associated with the phase 1b to study and so for the most part this incremental
The money, we've raised and had on our balance sheet prior factored in development costs associated with phase two study.
So for the most part this incremental infusion.
Infusion of cash will primarily extend our cash run rate, which again in this environment.
Speaker 6: will primarily extend our cash runway, which, again, in this environment, having additional runway we think is just very prudent. And so we concluded that it was an opportunity for us to bolster the balance sheet and really make the most of it. Thank you.
Additional runway, we think is it's just very prudent and so we concluded that it was an opportunity for us to bolster the balance sheet and you know really.
Speaker 6: say eliminate, but certainly reduce the potential balance sheet risk associated with our programs.
Can't say eliminate but certainly reduce the potential balance.
Balance sheet risk associated with our programs.
Hello.
Speaker 1: Our next question comes from Alex Nowak with Craig Holland. Please go ahead.
Our next question comes from Alex Nowak with Craig Hallum. Please go ahead.
Speaker 10: Okay, great. Good morning, everyone. You know, with the enrollment ramping here, 220 sites, multiple countries, you're now looking, you're doing the indication expansion into Prostate, you know, what additional investment in the townside resources, whether it be in Minnesota or, you know, other geographies, do you need to plan for here?
Okay, great. Good morning, everyone, you know what the enrollment ramping here 220 sites multiple countries, you're now look and you did the indication expansion into prostate you know what additional investment in the talent side resources, whether it be in Minnesota or other geographies do you need to plan for here.
Speaker 3: We're adding, you know, staff to our team.
We're adding staff to our team.
Speaker 3: you know, throughout, you know, we have added people to our team, we'll continue to add people to our team that typically will not be at the senior executive level. And, you know, those those folks are
Yep throughout you know we have added people to our team will continue to add people to our team. They typically will not be at the senior executive level.
And you know those those folks are.
Speaker 6: there to support just the day-to-day activities of managing a study as significant as Victoria 1, but also to help us prepare ourselves for a new drug application, our NDA. And so we have to simultaneously execute our phase 3 study while also preparing for an eventual NDA submission. And so as we get closer to that NDA submission, that activity starts to ramp up.
There to support just the day to day activities of managing a study is a significant victory I want but also to help us prepare ourselves for new drug application R&D, yet and so we have to simultaneously execute our phase III study while also preparing.
For an eventual NDA submission and so as we get closer to that NDA submission that activity starts to ramp up.
Speaker 6: we'll add staff accordingly. But the investments, you know, from a G&A standpoint will still be, you know, relatively modest, but there'll be some increase in headcount as a result of, you know,
We will add staff accordingly.
But the investments you know from a G&A standpoint, what will still be relatively modest, but there'll be some increase in head count as a result of.
Our progress towards the NDA.
Speaker 10: Got it. No, it makes sense. And then the R&D expense pickup this quarter, I mean, is that a, is it fair to say that's a direct indication that the enrollment for the trial is going, let's say, better than initially expected?
Got it that makes sense and then the R&D expense pick up this quarter. I mean is that a is it fair to say that's a direct indication that the enrollment for the trial, it's going lets say better than initially expected.
Speaker 3: I would say it's just in line with what we expected. So as you enroll more patients, there's certainly expenses associated with that. As more patients are on the drug, there's more expenses associated with that. And so I think what we've reported is pretty consistent with what the expectations have been for our.
I would say, it's just in line with what we expected. So as you enroll more patients you are certainly expenses associated with that as more patients are on on the drug there's more expenses associated with that and so I think what we've reported is pretty consistent with what the expectations have been for our expenses.
Speaker 10: Okay, makes whole sense. And then just lastly, you know, with enrollment creeping higher here, has there been any major kind of recruitment protocol changes that have been made to the study?
Okay makes total sense and then just lastly, you know with enrollment creeping I here has there been any major kind of recruitment political changes that are out of the amazing. This study.
Speaker 6: No. So far, so good. You know, it clearly requires a lot of very hands-on work with the sites, ensuring that, you know, the trial has visibility, not only with the principal investigator, but the typically multiple investigator sub-DIs that can enroll patients.
So so far so good.
It clearly requires a lot of very.
Hands on work with the sites ensuring that the trial has visibility not only with the principal investigator, but they're typically multiple investigator sub T is.
Can enroll patients.
Speaker 6: And so we have a very deliberate approach to stay in contact with, you know, the multiple individuals involved with the study. We're constantly assessing, you know, the patients they may have who could potentially be eligible for the study down the road if they progress on their current CDK-4-6 therapy. And so we have multiple ways of...
So we have a very deliberate approach to stay in contact with you know the multiple individuals involved with the study where we're constantly assess.
Assessing the patients they may have who could potentially be eligible for the study.
On the road.
They are progressing their car.
Current CDK four six therapy, and so we have multiple ways of.
Speaker 6: gauging what the potential activity could be at the site and also just multiple ways of ensuring that we're as top of mind as we can. And so far, so good. But we have roughly 220 sites, so that means we have to stay in touch with a lot of...
Gauging, what the potential activity it could be at the site and also just multiple ways of ensuring that we're is top of mind as we can.
And so far so good but we have roughly 220 sites. So that means we have to stay in touch with a lot of.
Speaker 6: lot of individuals, but we think we have a very good approach to not only execute that, but also keep track of it, and then to the extent that we see any sites that may be not living up to our expectations, we're following up with them and digging into any potential obstacles that they may think they have that could be preventing them from.
A lot of individuals' end up but we think we have a very good approach to not only execute that but also keep track of it and then to the extent that we see any sites, but maybe not living up to our expectations are we're following up with them and and digging into any potential obstacles that they may think they have that could be preventing them from.
Screening patients.
Speaker 10: All right. Well, great to hear. Appreciate the update. Thank you. You're welcome.
Alright, well great to hear I appreciate the answer thank you.
Youre welcome.
Speaker 1: There are no further questions at this time, so that concludes our Q&A session. I would like to turn the floor back over to Brian Southerland, CEO , for closing comments.
There are no further questions at this time, so that concludes our Q&A session I would like to turn the floor back over to Brian Sullivan CEO for closing comments.
Speaker 3: Well, thanks again for participating in our call today and for your ongoing support. We'll be participating in the upcoming Stiefel Healthcare Conference and Jeffrey's London Healthcare Conference next week, and look forward to hopefully seeing many of you there.
Well, thanks again for participating in our call today and for your ongoing support we'll be participating in the upcoming Stifel Healthcare Conference and Jefferies London Healthcare Conference next week next week.
And look forward to hopefully seeing many of you there.
Goodbye.
Speaker 1: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Yeah.
Okay.
[music].
Yeah.
[music].
Yeah.
Yeah.
Yeah.
Yeah.
Okay.
Yeah.
Hum.
Hum.
Yeah.
Hum.
[music] mhm.
Uh huh.
Hum.
Hum.
Speaker 11: What.
Uh huh.
Hum.
Hum.
Hum.
[music].
Hum.
[music].
Hum.
Hum.
[music].
Yeah.
Uh huh.
Hum.
[music].
Speaker 11: Oh.