H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory, and related services to public and private companies across multiple sectors and regions. We have a total of 24 publishing senior analysts and over 650 companies covered across all sectors. If you would like more information, please visit hcwco.com. From a logistics standpoint, please make sure to reference your online conference portal that provides your individual links to your meetings and all presentations. With that being said, we wish you a productive and enjoyable day. Now, I will hand it off to Peter Nielsen, the CEO of Bio-Path Holdings.
Thank you. Hello, everyone. I'm Peter Nielsen. I am President and CEO of Bio-Path Holdings. Today, I will be talking to you about our company. First, I'd like to remind everyone there are forward-looking statements in this presentation. Investors should evaluate those statements using their own judgment. Introducing Bio-Path Holdings, we are developing advanced oligonucleotide therapeutics with high-efficiency systemic delivery. We are traded on the Nasdaq under the symbol BPTH. Currently, we utilize 14 employees and consultants. We were established in 2007 and became a public company, Bio-Path Holdings, in 2008. Our technology highlights feature DNAbilize technology, our next-generation single-stranded DNA antisense. We have a robust clinical pipeline with novel oncology targets. Our investment highlights, we believe we are positioned to achieve multiple value-creating milestones.
First, we just did a recent interim update from our Phase 2 AML clinical trial in prexigebersen, our lead drug, which demonstrated strong efficacy and safety tolerability compared to current available therapies. These results further enhanced by the high-risk rating of evaluable patients and inclusion of secondary AML patients in our study, which are both classes of patients with very difficult-to-treat disease. This challenging population in which current treatment options are suboptimal and outcomes are very poor. We're developing molecular biomarkers for prexigebersen and are expected to potentially accelerate time to registration. Inclusion of biomarkers derived from analysis of previous patient treatments are designed to significantly improve patient selection and treatment effectiveness.
We also have patient response in a Phase 1/1b clinical trial of BP1001-A in solid tumors, which supports BP1001-A's compelling potential as a treatment for advanced solid tumors. Our first solid tumor patient treated with the second higher dose of 90 milligrams per square meter in the Phase 1/1b BP1001-A clinical trial experienced tumor reduction, stable disease, and allows rigorous exercise program and improved quality of life. We also have Phase 1/1b clinical trial in BP1002 in relapsed refractory AML, and this opens its third higher 60 milligrams per square meter dose cohort. FDA review of the first two dose cohorts was approved, allowing advancement to the next higher dose cohort.
Finally, we just want to note we have platform technology with composition of matter patents, which enable access for us to multiple of new patented drug products. Our robust oncology pipeline, prexigebersen, our lead drug, BP1001. This is in a Phase 2 in AML. That drug has orphan drug status in the U.S. and the EU. We have BP1001-A, which is a Phase 1/1b solid tumors in ovarian, endometrial, and pancreatic. We have BP1002 in a Phase 1 trial in lymphoma, CLL, and we have that same drug in a separate trial, Phase 1/1b in AML, venetoclax failures. Finally, BP1003, targeting the STAT3 protein, and that's in the final preclinical stages and will be targeting pancreatic and non-small cell lung cancer.
The highlights of DNAbilize technology. It's proven a safe, robust, and targeted method of treating diseases after many years of development. There's no toxicity. That's the most exciting feature, and this is with human patients to date in prexigebersen and other clinical trials. The DNAbilize liposome structure is similar to the cellular membrane and enhances uptake and safety. Our P-ethoxy DNA does not induce bleeding toxicity like other antisense. These are systemic treatments, so we have IV delivery to the main organs of our drug product via blood flow. We have high cellular uptake. Our liposome structure allows us to have compatibility with the cell membrane, enhancing cellular uptake. These are nanoparticles. They enable penetration into tumors for delivery of drug substance through the vascular pore spaces. Finally, we have proven target inhibition.
We've used patient blood samples and submitted them to analysis, and it's clearly demonstrated high levels of inhibition against the target protein. The efficacy trial design of the AML prexigebersen combination therapy. This trial was conducted at several leading cancer centers. The primary endpoint is the number of patients who achieve a complete remission. It's using a triple combination treatment of prexigebersen with the frontline treatment of decitabine venetoclax. There's two cohorts in this trial, with newly diagnosed AML and a second cohort with refractory relapsed AML. They're both being treated with triple combination. A third cohort was added to treat AML refractory relapsed patients who are venetoclax intolerant with prexigebersen and decitabine alone.
Trial design has a safety segment, which we're through, phase 2, which we're halfway in, and the pivotal trial. An interim analysis is done 2/3 of the way. Use of this will be to discuss the pivotal trial with the FDA. The results have been good, and these are targeting patients that, again, they really can't tolerate frontline treatment, have very poor outlooks, 5- 10 months, and so, this is a high-need situation. The Phase 2 interim analysis of the prexigebersen AML, encouraging results. From the Phase 2 trial, data show signs of safety and efficacy in high-risk AML patients with adverse risk and secondary AML. These are the toughest patients to treat. Data was reported from two cohorts, with previously untreated AML and relapsed refractory AML. Primary endpoint, again, complete remission.
In cohort one, 20 new diagnosed patients were evaluable. 15, or 75%, achieved complete remission, two achieved 10% partial remission, and two achieved stable disease. In total, evaluable patients had 95% response to treatment. The complete remission of 75% in the evaluable patients is significantly higher than the complete remission rate of 62% in the frontline combination treatment without the venetoclax or without prexigebersen. This is a real strong combination, because particularly since all BioPath patients had adverse risk or secondary AML, the most difficult to treat patients. 23 refractory relapsed evaluable AML patients were in cohort two. 12 of the 23, or 55%, had complete remission, one or 4% partial remission, and eight patients, or 35%, achieved stable disease. In total, evaluable patients had a 94% response to treatment.
The complete remission rate of 55% for the evaluable refractory relapse patients in cohort two is higher than the complete remission rate of 12%-52% for refractory relapse patients treated with combination treatment of decitabine and venetoclax. This is particularly important since BioPath patients all had adverse risk or secondary AML. Again, the most difficult to treat patients. Moving on to BP1001-A, the Phase 1b study in solid tumors. BP1001-A, again, is it's a modified product that incorporates the drug substance of prexigebersen, but has a modified formulation designed to enhance nanoparticle properties for penetrating solid tumors. It's shown efficacy against ovarian tumors and against pancreatic tumors. Clinical plans, Phase 1/1b study of BP1001-A in patients with advanced or recurrent solid tumors, including in ovarian and endometrial, pancreatic, and breast cancers.
The second step would then move to the phase 1b, which would be a combination trial. So you'd have 1001-A plus paclitaxel in recurrent ovarian and endometrial tumors, and 1001-A plus gemcitabine in patients with metastatic pancreatic tumors. The Phase 1/1b trial is open. First dosing cohort was successfully completed. The second higher dosing cohort at 90 milligram per square meter is open and enrolling patients. Importantly, the first solid tumor patient treated with the second higher dose of 90 milligram per square meter experienced tumor reduction, stable disease, which has allowed for rigorous exercise program and improved quality of life. We're very excited about that first result in that higher dose. BP1002. This is a Phase 1 study in lymphoma and CLL. Again, this is a drug targeting the BCL-2 protein.
It's shown in preclinical work to decrease viability in lymphoma cells, and by blocking BCL-2 protein, BP1002 allows chemotherapy and radiation to activate apoptosis. The Phase 1 clinical trial is open for lymphoma and CLL. The first dose cohort was successfully completed, and now we're in the second cohort, enrolling and treating one, at least one patient. Same drug, BP1002, Phase 1/1b study in relapse refractory AML, with a focus on patients who have relapsed on venetoclax. This is a trial that's open for refractory relapsed AML and two dose cohorts have been completed. The FDA-approved results of the first two cohorts and the third higher dosing cohort is approved for testing and is enrolling. High expression of BCL-2 has been correlated with adverse prognosis for patients diagnosed with AML.
Studies have shown that BP1002 in RNAi to block cell production of BCL-2 is a potent inhibitor of that BCL-2 target. Venetoclax frontline treatment targets the BCL-2 activity of the protein. AML patients, though, fail frontline venetoclax therapy and have very poor prognosis, with median overall survival of less than three months. The focus in BP1002 is in AML and on those patients, and this is clearly a high-need situation. BP1003, targeting STAT3. This is a very high importance protein. It's a regulating protein, regulates, I think, up to five cancer processes. We've shown our drug BP1003 efficacy against non-small cell lung cancer, AML, pancreatic cancer cells, and solid tumors. BP1003 plus gemcitabine combination is efficacious in pancreatic cancer-derived tumors in animals.
We've been working on finishing up our IND studies, and our goal is to submit the IND and conduct a Phase 1 study of BP1003 in patients with refractory metastatic solid tumors, including pancreatic and non-small cell lung cancer. We've got an experienced leadership team. I've been working in biotech companies 24 years, co-founder, President, CEO. I do a lot of work also besides strategy and manufacturing and development. Dr. Ana Tari, former Associate Professor, MD Anderson, was a key member of the research team that developed this liposomal delivery technology. Mike Hickey, our VP, Clinical, comes out of big pharma. He spent 10 years, for example, in with Amgen in clinical management. And Anthony Price, our Senior VP, Finance and Accounting, was formerly Accounting and Finance Associate Director at Lexicon.
Our intellectual property and financial snapshot. We have a real strong intellectual property position. Original patents licensed from MD Anderson, they've since been surpassed. We now have new composition and methods of use patent, really more for commercialization now that covers DNAbilize technology, solely owned by BioPath. Six patents issued in the United States, 59 foreign patents issued across 22 countries, four additional foreign patent applications allowed. Four applications pending in the U.S., along with 30+ applications pending in foreign jurisdictions. So we're rounding out these intellectual property to be candidates for licensing of pharma, for Big Pharma. Financial snapshot on the Nasdaq, BPTH symbol, $4 million cash end of June, approximately $3 million market cap as of June, and average second quarter burn rate was around $3 million. That completes my presentation.
Appreciate your interest in the company. Thank you.
Great. Thank you, Peter, and thank you to Bio-Path Holdings for leading a very productive and informative presentation. The H.C. Wainwright team is grateful for your presence at the Annual Global Investment Conference and for your efforts in preparing for your session.
Thank you for having me.
Of course.