Sentiment Analysis of the earnings transcript to help figure out if there are any bullish or bearish sentiments that could be gathered from it. We're doing ML and AI based analysis on the earnings call to get some more insights.
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| With the promising pipeline and capital to support our near-term development plans, we're excited about the potential to create stockholder value and deliver improved therapeutic options for patients |
| Voruciclib has a favorable PK and PD profile that allow its use orally because it's bioavailable |
| In short, MEI's pipeline is promising and presents substantial opportunity for delivering novel therapeutics for patients and creation -- and value creation for MEI stockholders |
| Both voruciclib and ME-344 have the potential in combination with current standards of care therapies to overcome known resistance mechanisms and improve patient outcomes |
| This novel approach to treatment has also generated enthusiasm among our investigators in the ongoing study |
| We're pleased with how the study is enrolling |
| 2022 worldwide Avastin and bevacizumab biosimilar sales reached $2 billion in 2022 and are expected to grow to $3.3 billion by 2028 |
| Looking ahead over the next few quarters, we see important opportunities in the continued progress of our two clinical stage oncology programs, voruciclib and ME-344 |
| We're working with some of the leading oncologists in the country in both of our clinical studies, and we're pleased with their level of engagement and interest in our programs |
| The results further demonstrate encouraging early clinical activity in heavily pre-treated patients that progressed on venetoclax who were administered voruciclib monotherapy and at the initial dose level in combination with venetoclax |
| And 20% to 30% response rate in that -- in this relapse population, I think would get everybody excited |
| Venetoclax sales are continuing to grow and are expected to generate $3.4 billion by 2028 |
| In earlier clinical studies, ME-344 was generally well tolerated at the dose we're currently investigating, and there was evidence of clinical activity as a single agent |
| He was just appointed our CFO as of August 1st, so this is his first earnings call at MEI, and we're very happy to have him on the team |
| Richard will provide more detail shortly, but in brief, voruciclib alone and in combination with venetoclax has been generally well tolerated in the Phase 1 study to date with no significant myelosuppression in patients with B-cell malignancies or AML |
| I would like to use this call to provide an update on the status of these programs and why we're optimistic about their potential |
| We believe that the potential value of both programs is notable given that the addressable market opportunities for voruciclib in combination with venetoclax and ME-344 in combination with bevacizumab are significant |
| Regarding that proposed transaction, while we believe the potential upside of the Infinity merger was compelling for MEI stockholders, we value the perspective of our stockholders |
| With respect to voruciclib, as previously reported, we've seen promising data from our ongoing Phase I study |
| So overall, voruciclib as a monotherapy at a dose of up to 200 milligram on a 14 days on, 14 days off schedule, was well tolerated, had no DLT, we did not see drug-related neutropenia, we did not see Grade 3 or higher drug-related toxicity, and no patients were discontinued due to drug-related toxicity |
| As you've heard today, I believe we have two exciting programs with expected data readouts beginning with voruciclib early in calendar 2024 and the first half of 2024 for ME-344 |
| We chose these combination approaches based on clear hypotheses to address known resistance mechanisms of each standard of care therapy, clear medical need, and significant commercial opportunities |
| Our hypothesis is voruciclib combined to venetoclax has the potential to restore sensitivity to venetoclax and therefore improve durability of response |
| 20 patient will be enrolled, and the readout will be that four months after the patients -- last patient is enrolled and considering the positive outcome is a PFS at four months of 20% or higher |
| And that corresponds to an improvement in survival in the model depicted here in AML |
| Combining ME-344 to block the mitochondrial energy and a VEGF inhibitor like Avastin would now have a possibility of synthetic lethality and therefore improving anti-tumor control |
| The PK analysis of the earlier dose level do not show drug-drug interactions, and we are seeing evidence of clinical activity at the low dose evaluated today, manifested by a reduce in transfusions, improved counts, response observed in some patients, and over 85% of the patients continuing beyond cycle 1 of the DLT windows |
| Focusing now on the subset of patients in this study who had a tumor normalization vascular -- vascularization normalization by PET, this effect is further enhanced |
| We need to see at least something better than to go to Phase 2 -- to the cohort 2 |
| This is a very interesting and novel mechanism of action where the inhibition on the mitochondria is a dual effect |
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| Independently and separately, we also know that MYC is overexpressed in a variety of cancers and tend to be associated with poor prognosis |
| So should we anticipate there's some top line coming just because of the amortization or we should anticipate that to be stopped, at least in the near term? David Urso I'm sorry, could you repeat? We were having a little bit of trouble following the question |
| As mentioned, MYC is over expressed in a variety of cancers and tend to be associated with poor prognosis |
| And then just lastly, I guess when you look at the 4Q R&D number implied from what you reported year end, it looks to be demonstrably down sequentially, I think sub $3 million |
| The protein MCL-1, it is known that its increase is associated with poor prognosis in patients with acute myeloid leukemia or AML and in a variety of B-cell malignancies |
| Then, in addition to some of the other cost reductions that we've made throughout the second half of the year, overall R&D, yeah, you're right, it'll be down significantly from the prior year |
| You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including but not limited to, our failure to successfully commercialize our product candidates, the availability or appropriateness of utilizing the FDA's accelerated approval pathway for our product candidates, final data from our preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials, costs and delays in the development and/or FDA approval or the failure to obtain such approval of our product candidates, uncertainties or differences in interpretation in the clinical trial results, uncertainty regarding the impact of rising inflation and the increase in interest rates as a result, potential economic downturn, activist investors, our inability to maintain or enter into and the risks resulting from our dependence upon collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales, and distribution of any product, competitive factors, our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business, our inability to operate our business without infringing the patents and property proprietary rights of others, general economic conditions, the failure of any products to gain market acceptance, our inability to obtain any additional required financing, technological changes, government regulation, changes in industry practice, and one-time events |
| Importantly, we have seen in our collaborative laboratory studies done with collaboration at academic centers, a decrease in MCL-1 and MYC using a single-cell RNA sequencing from three patients with CLL and two patients with AML |
| We do know that that trial continues to wind down |
| We have seen a decrease in c-MYC expression in 60% of the patients tested in that study |
| Purine are essential to cell proliferation, and blocking purine biosynthesis could lead to a decrease in cell growth and proliferation |
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