Q1 2024 Aptose Biosciences Inc Earnings Call
Okay.
Josh: Good afternoon. My name is Josh and I will be your conference operator today I would like to welcome everyone to the <unk> Biosciences conference call for the first quarter ended March 31st 2024 at this time all participants are in a listen only mode. After the Speakers' remarks, there'll be a question and answer session.
Speaker Change: If you would like to ask a question. During this time you will need to press star one one on your telephone you will then hear an automated message advising your hand is raised if you would like to withdraw your question. Please press star one again. Thank you as a reminder, this conference call may be recorded I would like to introduce MS. Susan Petro Paolo. Please go ahead.
Josh: Yeah.
Josh: Thank you Josh good afternoon, and welcome to the Atlas Biosciences conference call to discuss financial and operational results for the first quarter ended March 31st 2024 earlier today, absolutely issued a press release relating to these financial results news release as well as related SEC filings are accessible and apoptosis web.
Speaker Change: Joining me on today's call are Dr. William Rice, Chairman, President and CEO, Dr. Rafael Bejar, Senior Vice President Chief Medical Officer, and Mr. Fletcher Payne Senior Vice President Chief Financial Officer, and Chief Business Officer before we proceed I would like to remind everyone that certain statements made during this call will include forward looking statements within the meaning of U S.
Josh: And Canadian Securities laws forward looking statements reflect current expectations regarding future events. They are not guarantees of performance and it is possible that actual results and performance could differ materially from these stated expectations. They involve known and unknown risks uncertainties and assumptions that may cause actual results performance.
Josh: And achievement to differ materially from those expressed.
Josh: More about these risks and uncertainties. Please read the risk factors set forth in autos as most recent quarterly report on Form 10-Q and S. E. T. S Theater filings all forward looking statements made during this call speak only as of the date, they're made I took undertakes no obligation to revise or update the statements to reflect events or circumstances. After the date of this call.
Josh: As required by law, we encourage you to refer to today's press release and the 10-Q for additional information and disclosures regarding today's announcement I will now turn the call over to Dr. Right.
Dr. Right: Thank you Susan I want to welcome everyone to our call first quarter ended March 31 2024.
Dr. Right: Our last call was only about a month and a half ago. So we've decided to switch off our conference call format today.
Dr. Right: Select some slides that can provide you with a better understanding of our clinical strategy to focus the development of <unk>.
Speaker Change: That's a triple drug combination of our triplet frontline therapy to treat newly diagnosed AML patients.
Dr. Right: Our tests as we referred to it because that person to lead clinical asset.
Dan: <unk> is being combined with another clocks or Dan and I'll hop off just for HMA.
Dan: This forms the Tuxpan HMA triplet drug combination.
Dan: <unk> developed for frontline therapy to treat newly diagnosed AML patients.
Dan: HMA is currently the standard of care therapy for newly diagnosed AML patients.
Dan: <unk> is being bolted on.
Speaker Change: Thanks generative care.
Speaker Change: The activity and to do so safely.
Dan: And importantly, we expect to report clinical data with the Tustin HMA triplet in the newly diagnosed AML patients during the second half of this year.
Dan: We all know AML is a highly aggressive cancer of the blood and bone.
Speaker Change: The unmet need still exist for the relapsed or refractory patient population.
Speaker Change: For the newly diagnosed population.
Speaker Change: I'll remind you when we began clinical trials with <unk> as a single agent and with the co spin doublet in the relapsed or refractory AML population.
Dan: Case with many other cash new cancer drugs, yet, we've always planned to move into frontline therapy for newly diagnosed AML patients.
Dan: Our trials with a single agent and with the Tustin doublet and relapsed or refractory patients are now completed a single agent and the doublet demonstrate excellent safety protocols and distinguish us from other agents.
Speaker Change: Just as important we observed responses in patients with wild type with three patients with mutated split three patients with mutated <unk> 53 in Ras genes patients who failed prior therapy with another class of <unk> agents flit, three inhibitors and chemotherapy.
Speaker Change: Those who had failed prior stem cell transplants illustrated to us.
Speaker Change: These responses across a remarkable diversity of AML populations.
Speaker Change: During Q1 of this year, we presented our clinical findings to the FDA as part of our protocol amendment to allow for evaluation of the cost and the HMA Triple drug combination for the frontline therapy of newly diagnosed AML patients.
Speaker Change: Protocol for the triplet in frontline therapy is now open and our clinical team is engaging clinical sites and preparing to initiate dosing of patients on the study.
Speaker Change: I want to explain why we've accelerated our strategy to focus on the frontline triplet and newly diagnosed AML patients.
Speaker Change: As we began to share safety and efficacy data from the test and Thats been trials and relapsed or refractory AML patients with our Kols and pharma it became clear that the greatest unmet medical need and greatest opportunity in AML.
Speaker Change: Is the development of a superior frontline therapy for the treatment of newly diagnosed AML patients.
Speaker Change: It also became clear that the unique unique safety and broad efficacy properties of tests.
Speaker Change: Fifth the desired profile of a third agent.
Speaker Change: <unk> plus HMA standard of care backbone and assemble a spirit triplet for frontline therapy.
Speaker Change: Before we go further let's first recognize that progress had been made with the introduction of <unk> to defend the HMA government.
Speaker Change: And this was a major advancement in the treatment of AML.
Speaker Change: However, the complete remission response rates are still too low a survival is still too short and frontline therapy.
Speaker Change: And we all want to see a more effective frontline therapy.
Speaker Change: But there was another important factor, leading our leading our kols pharma and our internal team to focus on frontline therapy.
Speaker Change: Paul Bernardo Cox treatment has resulted in more responses in frontline therapy. There is a double edged sword with vanilla class. It turns out that relapsed or refractory patients who have failed prior <unk> treatment respond poorly to salvage therapies and even if they achieve a response or survival timeline as grip on the order of a few months.
Speaker Change: This tells us we need a new frontline strategy.
Speaker Change: May be able to help avoid rapid failure of a <unk> based therapies.
Speaker Change: So what we need is an exceptional third agent that can boost response rates of Gen plus HMA prolong the duration of responses and survival improve quality of life treater.
Speaker Change: Treat a broad spectrum of AML genetic subpopulations and minimize the likelihood of patients becoming resistant to genetic clients. This is a tall order and other potential third agents in development may only address specific genetic subpopulations.
Speaker Change: Other agents bring their own complicating toxicities for the triplet.
Speaker Change: This has opened the door for us to address the greatest single opportunity.
Speaker Change: What is the development of a superior frontline therapy to treat newly diagnosed AML.
Speaker Change: <unk> is a natural third agent for addition to Vanadic box in Hma's.
Speaker Change: <unk> has been an excellent safety profile.
Speaker Change: <unk> agent and in combination with <unk> and Hma's and with other drugs.
Speaker Change: Nope enhances anti leukemic activity, when combined with <unk> and Hma's.
Speaker Change: It's a very broad scope of activity across genetic subgroups of AML, even those who have high risk mutations in the <unk> three and Ras genes.
Speaker Change: <unk> targets known banana clocks resistance mechanisms and may help minimize the rapid onset of drug resistance.
Speaker Change: Because of this unique safety activity mechanistic profile a testbed for.
Speaker Change: We're developing that husky on HMA tripling to become a new standard of care therapy to address the safety scope and survival.
Speaker Change: Of newly diagnosed AML patients.
Speaker Change: And I want to present, just one more slide because it's important to understand our perspective works and how tough task plus again show a mechanistic complementarity and maybe minimize drug resistance and I'll illustrate these mechanistic interactions the cartoon on the right side of the slide.
Speaker Change: As you can see AML cells up regulate key oncogenic signal transduction pathways to drive excessive proliferation and cell division at.
Speaker Change: At the same time AML cells avoids cell death by modifying the expression of anti apoptotic proteins, such as Mcl, one and Bcl two.
Speaker Change: Often in AML the Bcl two protein is up regulated.
Speaker Change: <unk>.
Speaker Change: Is administered to patients to target the Bcl two.
Speaker Change: The AML cells to Diamond power.
Speaker Change: However, the net o'clock alone as minimal efficacy in AML.
Speaker Change: Ed classes combined with our harp I'm escalating agents to achieve clinical remission.
Speaker Change: Unfortunately overtime the sales can modify a number of key pathways to generate resistance to venetic clients multiple mutations can occur simultaneously and the flip <unk>.
Speaker Change: Scepter card basis, and then Jeff Carney says of JAK stat pathway and in the Ras map kinase pathway.
Speaker Change: All leading to up regulation of the Mcl, one anti product protein collectively these operations allow AML cells to drive cell division and avoid cell death, even in the presence of an owner clients.
Speaker Change: Now, let's look at the effects of <unk>.
Speaker Change: No directly inhibit <unk> kinase the mutant form of kit.
Speaker Change: Nick and JAK kinases in the JAK stat pathway and RFK two kinase downstream in the Ras map kinase pathway and indirectly reduces mcl one expression.
Speaker Change: Mechanistic complementarity.
Speaker Change: That can make <unk> and vanilla clock, such a powerful combination tool against AML and Dr. Bejar will describe how we plan to use these agents together more effectively treat AML.
Speaker Change: With that I'll now turn it over to Dr. Bexar apoptosis, Chief Medical officer, and resin Kols for his insights into the AML patient journey and take you through our clinical plan that is already well in place.
Speaker Change: Thanks Bill.
Speaker Change: So to follow up on what you just said I would like to describe a little bit about the context in which we're developing suspected namely the AML landscape today and how it is that patients are treated so in newly diagnosed AML patients would likely receive some form of therapy on rare occasions patients who have too many comorbidities may elect for palliative care, but the Ms.
Speaker Change: You already have patients receive some sort of therapy in first line.
Speaker Change: Younger individuals generally patients younger than age 70 will receive a form of intensive chemotherapy. If they are fit enough to tolerate this kind of therapy.
Speaker Change: Central for carrying a subset of patients and has a very high complete remission rate. However, the average age of patients with AML is about 68 being the majority of patients may not be great candidates for high intensity chemotherapy and instead, what are we seeing lower intensity therapy in the frontline consisting of the head.
Speaker Change: Cloud backup methods.
Speaker Change: We have become the standard of care in the past few years.
Speaker Change: The complete remission rate of about 37% and our composite complete remission rate that includes incomplete count recovery of about 66% and with two thirds of patients achieving some form of complete remission and median overall survival for the therapy in the frontline setting is about 15 months.
Speaker Change: Now what can happen to individuals' after they achieved complete remission ideally a candidate who might be able to receive an allogeneic stem cell transplants would do though is that as potentially curative therapy, and then may receive maintenance therapy. After that kind of treatment alternative of patients who achieved complete remission is not a candidate.
Speaker Change: So transplant.
Speaker Change: Everything's maintenance therapy alone or no therapy as they are hopefully in a deep remission.
Speaker Change: However, patients may be primarily refractory to initial treatment, meaning they never achieve a complete remission and are immediately considered therapeutically refractory or they may achieve a remission and even undergo transplant in some cases and yet still relapse and have what we can consider therapeutic failure.
Speaker Change: <unk> outcomes in patients, who have refractory or relapsed disease is quite dead loss and therefore, it is really important to try to prevent this outcome.
Speaker Change: The words try to improve the likelihood that patients remaining remission for longer with frontline therapy, because the best way to treat relapsed refractory disease is to make sure that it doesn't happen in the first place.
Speaker Change: So why do I say that we still can improve upon HMA event as it has become the new standard for the treatment of older individuals unfit for induction of intensive induction chemotherapy.
Speaker Change: Well from the Alta <unk> trial that led to the approval of HMA plus fanatical acts as the frontline standard for older unfit individuals we can break down the benefit and different subpopulations. Those individuals that have a more favorable genetic profile, namely they could not have mutations in <unk> three split three or <unk>. They have the greatest.
Speaker Change: Benefits from this kind of therapy in fact that meeting overall survival is over two years how.
Speaker Change: However, there were some patients that do have some high recommendations they might be in the intermediate benefit category.
Speaker Change: As individuals with flip the ITD mutations or mutations downstream, if it's <unk> and K Ras or interest in your benefit wasn't even half as good a median overall survival was only about 12 months.
Speaker Change: And then there was about a quarter of patients who have a <unk> three mutation.
Speaker Change: Those patients have the worst outcomes. The median overall survival of less than six months and apparently had little benefit with the addition of <unk> over an HMA alone. So there is substantial room for improvement, particularly in the patients that have these proliferative signaling mutations in <unk>, three and <unk> to improve upon the outcomes that they see.
Speaker Change: HMA or <unk> and that is where I think we have a prime opportunity for death benefits.
Speaker Change: So let's talk about that what are the opportunities for the drug.
Speaker Change: That in AML and <unk>.
Speaker Change: <unk> that has about 21000 cases annually in the U S and with more than half the patients are coming to the disorder. Each year as I mentioned, the median age of 68 being the majority of patients are close to that age where induction chemotherapy is not a comment option.
Speaker Change: And survival is still relatively poor, especially for those older individuals where five year overall survival rates are estimated to be less than 10%.
Speaker Change: Now frontline therapy have made improvements in the last few years.
Rice: Thank you Rice mentioned I mentioned that the combination of HMA have about two thirds overall response rate for <unk> and a 15 month median overall survival, but there are the subset of patients that haven't carrier outcomes.
Rice: We have seen several studies that are combining three agents venetic lacks HMA and novel agents.
Rice: To improve outcomes and thus frontline patients and we have seen successes there in particular trials with kinase inhibitors have shown composite complete remission rate of 80, or even 90% in the frontline setting which is very promising unfortunately.
Rice: Do have their own liabilities in part they tend to be more toxic when combined in that triplet agent requiring dose reductions not just of the third novel agent, but of the standard of care backbone of the hyper messaging agents and <unk>, meaning that the combined therapy is fall short of the standard of care, where you did give a placebo instead of the third agent.
Speaker Change: And of course, many of these trials have used targeted agents, meaning that they are not applicable to the broader range of AML patients only a subset defined by either genetic or other biomarker.
Speaker Change: So there is an urgent need for a safe and more effective first line triplet to improve outcomes for AML patients of all genetic subtypes.
Speaker Change: So how does that fit into the model right before that.
Speaker Change: <unk> as an ideal <unk> agent with a very favorable safety profile could be combined both with intensive chemotherapy in the frontline setting at other kinase inhibitors have done and has been approved.
Speaker Change: Or it could be combined with a third agent with fanatical acts on HMA and the low intensity treatment option.
Speaker Change: Yes, I think provides the front.
Speaker Change: A broad frontline opportunity.
Speaker Change: And we have chosen as our first steps in the frontline setting to focus on those low intensity therapy patients where there are no. Other drugs currently approved as an applicable triplet for this patient population.
Speaker Change: Doing so allows us to potentially increase the complete remission rates and survival of patients with <unk> mutations in such a way that doesn't require the reduction of the standard of care. This would permit for example, a randomized clinical study placebo controlled it would get standard of care can both arms without having to dose reduce them in the treatment arm.
Speaker Change: As far as we are aware this is the only agent being developed in combination with men HMA that includes three wild type patients are generally patients without mutational biomarker, which represent the majority of AML patients of course.
Speaker Change: It's the only agent that probably includes patients with <unk> 53, and <unk> K Ras mutations in this frontline triplet paradigm.
Speaker Change: We hope that based on its safety profile to date that the dispersion of inadequate to HMA combination will be a safer therapy for unfit patients than other triplets and Mike brings additional toxicity to the table.
Speaker Change: So.
Speaker Change: <unk> express the landscape of downtown and the rationale for a third agent I wanted to talk about why that isn't ideal for agents as we mentioned drug like gilt. The retina have been combined with Vanessa clocks, and HMA and it boosted the complete remission rate substantially in the <unk> mutant population. So the proof of principle in there that this class of drug can make important.
Speaker Change: Yes.
But we have seen a limitation that I mentioned that required the dose reductions.
Speaker Change: I think has an ideal profile as a third agent that might make a superior can these other agents in that frontline setting and we've learned this from the extensive clinical data we've generated to date with the drug.
Speaker Change: We've done extensive testing both with the spend that as a monotherapy and with the spending in combination with <unk> that tells us that <unk> does not have several of the side effects that could impair its further clinical development, including no Qt prolongation related to drug differentiation syndrome evidence of muscle damage or even prolonged minus depression in patients.
Speaker Change: So which information where patients need.
Speaker Change: I need to take the drug.
<unk> and maintain blood counts.
Speaker Change: By combining it with venetic wax in the relapsed refractory setting in a large number of patients. We now understand that there aren't significant drug interactions that would require dramatic dose ranges of either agent.
Proceed developing them at their established doses.
Speaker Change: And importantly.
Speaker Change: We have favorable comparisons indirect of course with other agents out there. We believe that we can see we have demonstrated we can see responses in patients who have had prior for <unk> inhibitors.
Speaker Change: We don't need to inhibit the pathway substantially as other agents do perhaps because of the multi kinase activity of the drug and that we have seen responses in a large proportion of <unk> mutated patients, which really differentiates.
From other agents like gilt Britain.
Speaker Change: Importantly, we have the superior safety profile, where we are targeting began resistance mechanisms that may potentially help prevent then resistance or potentially even re sensitize them based on preclinical studies and by suppressing more oncogenic pathways may be able to alleviate other potential mechanisms of resistance from a rising.
Therefore, we believe there's a strong rationale for combining <unk> with <unk> in the frontline setting, particularly where patients are like the natives. All agents. So what are we done to get there. We've completed the single agent dose exploration, where we treated a large number of patients of Australia. We've demonstrated the activity of the drug as a single agent.
Speaker Change: Select populations, both with and without <unk> mutations and we've demonstrated superior safety profile of the drug in that context in the doublet study you've learned about the safety of <unk> plus <unk>, how could things be given without substantial modification and we've characterized the PK of both agents and it does not put us in a position to submit a triple.
Speaker Change: <unk> to the FDA, where.
Speaker Change: Where we've also achieved.
Speaker Change: Orphan drug designation and fast track status for patients with <unk> mutations in this drug.
So the trip of a pilot study has already been implemented and clinical sites are now being prepared to enroll the first patients later this year.
And we hope to select the optimal dose that will allow us to maintain the standard of care dosing of the other agents, which will then enable a randomized placebo controlled Registrational study.
Speaker Change: We will learn about how best to give these drove combinations safely and mitigate myeloid suppression and will characterize the activity in this difficult to treat or less likely to benefit subgroups of patients that have P. 53 mutations in Ras K Ras mutations as well as several kinds of for three mutations will further characterize the PK and establish the safety and efficacy profile.
And finally look at what impact we might be having on overall survival before we take our next steps.
Speaker Change: I want to spend a little bit if I'm just sharing sharing how we are actually going to be giving these three drugs together and how it compares to other aging mixes that are out there for the pilot study our first triplet in the frontline setting.
Speaker Change: Proposing to treat about 20% to 36 patients total because there are patients that are going to be older.
<unk> for induction chemotherapy, either because of age over 75 or because of comorbidities that would prevent that kind of more intensive therapy.
For 50% of the patients having a instrumentation. So we havent understanding productivity both in our fleet <unk> mutant and <unk> wild type groups and.
We will look at all those other factors that I've just described earlier.
Speaker Change: The way, we're going to get the drugs together is by giving the Ven and Asia together as a standard of care Dublin with the addition of daily to Sputnik as shown in the top graph here.
You can see that at day, 18 will perform a bone marrow biopsy and <unk>.
Speaker Change: If patients have achieved remission, we will hold a at nine o'clock starting on day 22, and this is consistent with the <unk> label. It suggests that you'll be getting for 'twenty, one to 28 days per cycle.
We then will allow patients to recover their accounts and monitor how long it takes to do so making adjustments along the way if necessary and of course, if a patient has not achieved a remission and they would continue to take them. Another class along with it just betting through day 28, when a second bone marrow biopsy will be formed.
Seem to remission and if they have then allow additional time for their blood count recovery to occur before they move on to the second cycle I don't think in the second cycle will be adjusted based on the patient's experience with the first patients who have no significant mileage suppression would go on to receive the same type of cycle has a second cycle. Those that do will have adjustments to their drugs made according to the <unk> label.
So now let's talk about milestones and when we are likely to have data.
Coming up very shortly we'll be meeting in Madrid.
There, we will present, a summary of our.
Single agent and doublet data.
Speaker Change: Really.
Providing an update to what we presented at Ash earlier, along these lines in our oral presentation given by Dr novel, daughter.
Shortly after that meeting.
We expect to have our first patient enrollment.
Frontline triplet study.
<unk> will begin treatment in the frontline patient population with continued accrual hopefully the presentation of several patients worth of data at the society for Hematology meeting here in San Diego at the edge.
End of near the end of Q4.
The trial will continue of course, we will have to have a more mature suddenly at next year's DHA meeting in 2025, as we meet with the FDA and prepare for the regulatory steps with multiple milestones for adding additional data along the way.
So I'll briefly go into some of the frontline and some of that monotherapy data and doublet data.
That gave us the understanding about how to proceed in the frontline.
So to summarize to spending because a single agent has now been given to over 91 patients as a monotherapy.
And it has a very clean safety profile with no drug related milestone crushing in patients who achieved remission at GTC prolongation or CDK elevation that can be evidenced of muscle damage and in fact in the single agent no drug related discontinuation or deaths.
Here you can see the percentage of the patients with adverse events related to <unk> and the most frequent.
A relatively mild nausea, and fatigue with very few grade three or larger related adverse events.
Speaker Change: Similar profile occurs when we combined with <unk> and the doublet with no new or unexpected safety signals, arriving and very similar rates of adverse events higher rates of neutropenia and other myeloid suppressive markers as would be expected with the addition of an eight o'clock, but very much in.
In line with what we would expect to have an adequate containing regimens in fact.
Lower rates of febrile neutropenia and unexpected.
And here is the evidence of that single agent activity.
Here shows evidence of bone marrow blast reductions in patients treated with the spending by the single agent you can see that more than half the patients to some degree of bone marrow blast reduction.
And you can see that that's occurred in a variety of different dose levels as shown by the different colors.
I think I would point out is that patients that had a prior for <unk> inhibitor are marked with the red triangle and you can see that patients had prior <unk> inhibitors were just as likely if not more likely to show a bone marrow blast reduction.
However, patients with prior <unk> shown by the Black triangles are less represented in the far right of the graph.
System with our knowledge than resistant patients are less likely to respond to practically any other therapy as a monotherapy for that reason we performed the doublet study.
Ah patients with relapse refractory disease, we can get started and venetic wax and again sunglass reductions in more than half of the patients and in contrast that the figure on the left we now see many more black triangles on the far right of the graph showing that even been pretreated patients can have significant loss reductions when treated with the combination of <unk> in the relapsed refractory setting.
Speaker Change: And once more multiple red triangles on the rate, indicating prior for <unk> inhibitor are still more likely to respond and patients don't likely because of their prior to the <unk> mutation status.
So.
Now I will pass on it talks to the Fletcher Payne, who will talk more about the investment thesis and some of the near term milestones for the drug pleasure.
Thanks, Ralph Good afternoon Al Yah three.
Three key points to the test investment thesis first it's a very high unmet medical need in frontline AML, it's been discussed before to increase <unk>.
Across all genetic subtypes.
Yes.
The Kols support test is the ideal third agent for Triple study in the frontline patients.
<unk> test is emerging as an ideal agent to combine with then HMA. This is due to the safety profile the productivity across let three mutated.
Split between wild type patients as well as activity against difficult to treat vacated key P 53, and the Ras genes subtypes.
The design of the <unk> study and the data readouts lineup well to generate several near term value, creating milestones. The first milestone will be at <unk> in June 2024, where we will report single agent and double agent activity, which supports our contention can move into the frontline and the trip.
What study.
The second milestone will be in the summer of 2024, we'll start dosing newly diagnosed patients in a separate study.
The third milestone at Ash 2024, we will report complete responses Mardi negativity and safety data from the triplet study.
During the first half of 2025, we expect to complete enrollment of the study.
Speaker Change: Our fourth milestone will be at IHA in the summer of 2024 25, when we will report data readout from the triplet study.
So as you can see the Triple study provides for a number of value, creating inflection points over the coming year.
Before I cover the first quarter financial highlights I would like to start by saying that our comments in this call additional information may be found in today's press release, and the 10-Q filed with SEC.
During the first quarter of 2024, we continued our disciplined financial management of operations, we've reduced spending on several fronts and prioritize our investments in our clinical programs as always we continue to evaluate ways to reduce operating expenses.
The total outstanding share count as of today may 14th.
$16 million 393393 shares.
Yes.
Based on current operations the company expects the cash on hand, plus our ATM will provide sufficient resources to fund planned operations, including research and development activities through August of 2024.
Last quarter, we informed you that.
A 2024 deficient deficiency letter from NASDAQ regarding the private placement with Hanmi wasn't that was announced which was announced in January.
After this has submitted a plan to NASDAQ to regain compliance.
On April 25 of this year. The company received a letter from NASDAQ listing qualifications Department notifying the company. The company had regained compliance with the NASDAQ listing rules.
635, D and determined that the matter is now closed.
Under the company's plan to regain compliance on April 26, 2024, the company announced that it has amended the warrant agreement with Hanmi to prohibit the exercise from Hanmi warrants and access.
NASDAQ $19, 99% limitation and less shareholder approval is first obtain.
Speaker Change: On April two 2024, we received a second modification from NASDAQ.
<unk> that the company was not in compliance with the NASDAQ listing rules, because our stockholders' equity as of December 31, 2023 was below the minimum $2 5 million.
We intend to submit a compliance plan on or before May 17 to 2024 monitor our stockholders' equity and if appropriate consider further available options to evidence compliance with stockholder equity requirement.
I would like to direct you to review the Companys risk factors and discussions regarding the NASDAQ ladder going concern footnote in our 10-Q and our 10-K filings now lets review the first quarter financials.
We ended the first quarter of 2024 with approximately $9 3 million in cash cash equivalents investments.
Approximately equal to the December 31 2023.
The $11 8 million in <unk>.
Speaker Change: Net financing proceeds in January two terrorists in 'twenty four was offset by $11 8 million used to fund our operations for the quarter, including our activate clinical study participants.
As seen in the income statement, we had no revenues during 2024 or in the first quarter of 2020.
Speaker Change: Four.
During the first quarter of 2024, the net loss was approximately $9 6 million translating into 73 cents loss per share compared to $13 $7 million loss or two to $2 <unk> loss per share from the first quarter of 2023.
Hi.
Speaker Change: As of May 14, 2024 actors had.
$16 million three.
93 <unk>.
Shares outstanding.
All references to losses per share in shares outstanding had been presented to reflect the 15th for one reverse split completed on June six 2023.
Research and development expenses were approximately $6 $4 million for the quarter ended March 31, 2024, compared to $8 8 million for the first quarter of 2023.
Program cost purchased Sep or.
Speaker Change: Were $3 $9 million for the first quarter of 2024 compared to $4 8 million for the first quarter of 2023 lower program costs were to supplement.
Speaker Change: In the current period represent the completion of patient enrollment window test then.
Speaker Change: Program and reduced manufacturing costs.
Speaker Change: Program costs for <unk> were 208000 for the first quarter and decreased by approximately $1 1 billion compared to $1 3 million.
Speaker Change: First quarter of 2023, primarily due to lower clinical trial costs and lower manufacturing costs.
Speaker Change: G&A expenses were $3 3 million for the first quarter of 2024 and decreased by $2 million compared to $5 $3 million for the corresponding period of 2023. The decrease was primarily due to lower professional fees are stock based compensation in the current period now let me turn it back.
William G. Rice: Dr Rice.
Thank you pleasure.
Speaker Change: Now we will open the call for questions and please feel free to pose the questions.
Speaker Change: Operator, if you could please introduce the questions.
William G. Rice: Thank you.
Speaker Change: A reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment for questions.
Our first question comes from Joe <unk> genius with HC Wainwright you May proceed.
Speaker Change: Good afternoon, gentlemen, thanks for taking the questions.
Speaker Change: Start with two if you don't mind so first.
Speaker Change: On slide number 10, when you presented the.
Speaker Change: The trial design for the triplet combination I'm just curious if there was what level of before and after was there. So you met with the FDA.
Speaker Change: In the first quarter as you said.
Speaker Change: How much does slide 10 align with what you originally wanted with them.
Speaker Change: So Rob perhaps talk about how perhaps you can answer that one and put it in <unk>, yes of course.
Speaker Change: So this was developed in conjunction with.
David: Experts in the field, including our lead <unk> novel, David We've done several of these frontline triplet studies and it really reflects.
Speaker Change: Both his experience and then as a label and it isn't really a consequence of a back and forth with the FDA on this we did submit a protocol amendment to our existing study that includes protocol more than 45% to 50 days ago now.
Speaker Change: But yes.
This is really a function of our discussions with our experts not a consequence of discussions with the FDA.
Speaker Change: That makes sense, thanks, and then.
Speaker Change: I guess as we look to the triplet study now everyone is going to be highly looking forward to the year end data. So I guess internally what do you view as the benchmark for success to be able to move beyond the pilot.
Speaker Change: So I can take that to bill.
Bill: There is a couple of opportunities I think to show benefit here. The expectations are based on prior data that the frontline triplet with a kinase inhibitor like <unk> can substantially increase the response rate of course, I think that really the metric that really matters is overall survival and that is not data that we expect to have in the short term.
But the expectation with the BLA study is that you see about two thirds of the patients responding I think if we would see something closer to 75% I think we'd be comfortable that we are at least meeting that if not exceeding it.
Speaker Change: Given the number of patients we expect at Ash I wouldn't expect to see a robust value there, but by the time that study is complete and we've treated enough patients I think will have a very good understanding based on the response metrics.
Speaker Change: What we're doing.
Yes, perhaps.
Sorry go ahead Paul.
Speaker Change: Joe I'll add a little bit to that because it also relates back to the trial design, while we hope to see and we expect to see by year end.
Good complete remissions in these patients we expect to see the robust safety, which we've continued to see.
All the way through even the doublet.
But another card and we're hoping that allows us to maintain the standard of care dosing the doctor a bit hard mentioned, because it's really important to be able to maintain the expected levels of <unk> as well as the heartworm alkylating agents.
According to the label of the drug FDA wants to see that we want to see that.
That's been a real problem with many of the other drugs out there, perhaps Dr. Bejar wants to add to that.
That's exactly right Bill.
Thank you.
Okay. Thanks, guys. Appreciate it thank you Chuck.
Thank you and as a reminder, if you would like to ask a question. Please press star one on your telephone one moment for questions.
Speaker Change: And I'm currently showing no further questions I would now like to turn the call back over to Dr. Rice for closing remarks.
Alright, well. Thank you everyone for joining us this afternoon for general exciting Steakhouse.
William G. Rice: Frontline triplet therapy for newly diagnosed AML patients and we hope that we have related to <unk>.
English from other AML compounds in development not only because of its safety profile because it has shown activity across a broad set of mutations even ballpark beam mill potentially addressing the largest markets in AML not just a subset as always we thank our patients investigators and employees for their important role in this effort our clinical team.
<unk> has been achieved in developing our pilot triplet study prepared to getting it prepared I want to recognize them for their execution. We appreciate our shareholders and analysts who continue to support us and we look forward to keeping you updated on our progress today and we really do appreciate the questions that came to us today.
Thank you and have a good evening.
Thank you ladies and gentlemen that concludes today's conference you may all disconnect and have a wonderful day.
William G. Rice: Okay.
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