Good day, and welcome to the MediWound First Quarter 2022 Financial Results and Presentation of the EscharEx phase II clinical trial results conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press the star key followed by one on your touchtone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. At this time, I would like to turn the conference over to Monique Kosse of LifeSci Advisors. Please go ahead.
Thank you, operator, and welcome everyone. Earlier today, MediWound issued a press release announcing its first quarter 2022 financial results and provided a corporate update. We will be reviewing those results with the management team in addition to hearing from two KOLs on the results of the EscharEx U.S. phase II trial, which were announced in a press release issued on May 12, 2022. You may access both releases on the company's website under the Investors tab. With us today from management are Sharon Malka, Chief Executive Officer of MediWound; Ofer Gonen, Board Member; and Boaz Gur-Lavie, Chief Financial Officer. Also joining us are Professor Lior Rosenberg, Chief Medical Officer, and Dr. Cyaandi Dove from Advanced Wound & Ankle Center, Las Vegas, and an investigator in the EscharEx phase II studies.
Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session relating to MediWound's expected future performance, future business prospects or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecasts due to the impact of many factors beyond the control of MediWound. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events or otherwise.
Participants are directed to cautionary notes set forth in today's press release, as well as the risk factors set forth in MediWound's annual report filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. At this time, I would like to turn the call over to Sharon Malka, Chief Executive Officer of MediWound. Sharon?
Thank you, Monique. Good morning to our listeners in the U.S., and good afternoon to those joining us from Israel. Welcome to our first quarter 2022 conference call to discuss our financial and recent operational highlights. We are very pleased to have two esteemed key opinion leaders with us on the call today. Professor Lior Rosenberg, Chief Medical Officer of MediWound, and Dr. Cyaandi Dove, a principal investigator in both our EscharEx phase II studies and the pharmacology study from the Advanced Wound & Ankle Center in Las Vegas. They will share their insights on our EscharEx trial and data and also provide some perspective on the overall wound care practices. After our data discussion, we will hear a quick review of the financials from Boaz before opening the call for Q&A.
First, let me provide a quick review of our quarter and recent updates before taking a deeper dive with our KOL into the clinical data for EscharEx. Starting with EscharEx, we were excited to report positive data from the U.S. phase II clinical study of EscharEx for the debridement of venous leg ulcers. The study met its primary and its key secondary endpoint with statistically significant results compared to the control arm. The study demonstrated significant improvement over the current standard of care and no observed deleterious effects on wound closure and no safety issues were observed. We highlighted some of these results at the SAWC Spring 2022 symposium in April and received a very warm welcome and high interest by the top wound care specialists from around the globe.
The interest was very encouraging, and we were very pleased to have received recognition for our poster, which was selected as one of the top 10 posters out of the 235 posters at the conference. In our NexoBrid program, we continue to partner with BARDA and Vericel for the approval of NexoBrid and look forward to bringing this innovative product to the U.S. market. We remain on track for a mid-year resubmission of the NexoBrid BLA, and we anticipate a six-month review process which will position NexoBrid for a potential approval by year-end and a commercial launch in the U.S. in the first half of 2023.
To that end, BARDA expanded its contract, providing us with supplemental funding of $9 million to support the NexoBrid BLA resubmission and the ongoing expanded access protocol, which will run through approval. Lastly, on NexoBrid, we are proud to have started the project with the U.S. Department of Defense for the development of NexoBrid for the U.S. Army as a non-surgical solution for field care burn treatment. This research project, if successful, could open the gates for armies all over the world, as well as simplify our supply chain costs and administration. Let me now provide a quick review of EscharEx's phase II study design and the key results before handing the call to our esteemed KOLs.
The study was a multicenter prospective randomized placebo-controlled adaptive design study evaluating the safety and efficacy of EscharEx in debridement of VLUs compared to gel vehicle as a placebo control and compared to the non-surgical standard of care of either enzymatic or autolytic debridement. The study enrolled 120 patients, with 119 treated at approximately 20 clinical sites, primarily in the United States. Study participants were treated by either EscharEx, 46 patients, gel vehicle, 43 patients, or non-surgical standard of care, another 30 patients, with a three-month follow-up. The single primary endpoint was incidence of complete debridement, clinically assessed within up to eight treatment applications during an assessment period of 14 days compared to the gel vehicle placebo control as agreed with the FDA.
Secondary and exploratory endpoints assess time to achieve complete debridement, reduction of pain, reduction of wound area, granulation tissue, and quality of life, enabling evaluation of clinical benefit compared to both gel vehicle and the standard of care. Incidence and time to achieve wound closure were assessed at safety measurement. Turning now to the study results. The study met its primary endpoint with a high degree of statistical significance, demonstrating that patients treated with EscharEx had a statistically significant higher incidence of complete debridement compared to the gel vehicle. More specifically, 63% of the patients treated with EscharEx, 93 patients out of 46, achieved complete debridement by the eighth treatment, and this compares with only 30% of the patients treated with hydrogel vehicle, which is about 13 patients out of 43, with a P value of 0.004.
EscharEx efficacy superiority remains statistically significant compared to the gel vehicle, also after adjusting for pre-specified covariates ascribed to patient baseline characteristics, wound size, wound age, and region. The study also met its key secondary and exploratory endpoints that provide further insight on additional efficacy parameters and can establish clinical benefits. Starting with head-to-head comparison with the non-surgical standard of care, including enzymatic debridement or autolytic debridement. 63 of the patients treated with EscharEx achieved complete debridement compared to only 13% of patients treated with standard of care, 4 patients out of 30 patients, within the 14 days assessment period. The time to achieve complete debridement was significantly shorter. The estimated median time to complete debridement was 9 days for patients treated with EscharEx compared to 59 days for patients treated with the non-surgical standard of care, with a P value of 0.01.
Moreover, on average, complete debridement was achieved after less than four applications with EscharEx compared to almost 13 applications with the non-surgical standard of care. This significant improvement over the current standard of care is important when you consider that the non-sharp debridement agents, enzymatic or other, currently available on the U.S. market require daily application for several weeks to achieve complete debridement, yet still generates hundreds of millions of dollars every year. Patients treated with EscharEx demonstrated significantly higher incidence of at least 75% granulation tissue at the end of the treatment period compared to the gel vehicle, with a P value lower than 0.001, which is required for wound healing. Finally, favorable trend were observed in wound area reduction and reduction of pain compared to gel vehicle. The above efficacy results achieved our key goals in this study.
One, to demonstrate that EscharEx efficacy in debridement of chronic wounds. Two, to establish a clear improvement over the current standard of care. Three, to give us a clear guidance for future pivotal studies in the indication of our interest. In addition, the study showed that EscharEx was safe and well-tolerated, and the overall safety was comparable between all arms. Importantly, there were no observed deleterious effects on wound closure and no material differences in reported adverse events. Actually, the estimated time to complete wound closure was 64 days for patients treated with EscharEx, compared to 78 days for patients treated with standard of care. With that, we achieved additional goal for this phase II study, which was to assess the EscharEx safety and tolerability and show that it's a well-tolerated treatment for debridement of chronic wounds.
Let me now turn the call over to Professor Rosenberg, our Chief Medical Officer, to provide us with some color regarding the unmet need, the role of debridement in wound management, the robust clinical evidence generated to date, and how a product like EscharEx would fit the current treatment paradigm. Professor Rosenberg, please.
Thank you very much, Sharon, and good morning, everybody. First, I would like to thank our partners, the investigative staff, and especially the patients and their families for their commitment and perseverance in completing the study in the face of all the challenges posed by the COVID-19 pandemic. Let me start with a brief overview of the debridement role as a critical component of the wound management. Efficient debridement is an essential step in the acute and chronic wound management. Debridement is involving the removal of non-viable tissue from chronic wounds to stimulate the granulation tissue and epithelialization. The underlying pathogenic abnormalities in chronic wounds cause a continual build-up of necrotic tissue, and regular debridement is necessary to reduce the necrotic burden and achieve healthy granulation tissue. Debridement also reduces wound contamination and therefore assists in reducing tissue destruction.
Dead spaces that may otherwise harbor bacterial growth must be exposed during debridement. Routine care of non-healing chronic wounds starts with debridement, the necessity to induce the functional process of tissue repair. Five methods of debridement, selective and non-selective, are available, each with its own advantages and limitations. The choice of debridement techniques is highly dependent on the site of care, wound characteristics, and patient. Sharp debridement is the dominant debridement method used. Non-sharp debridement techniques, mainly autolytic or enzymatic debridement, are primarily used adjunctive to sharp or reserved for patients considered ineligible for sharp debridement. There is a great unmet need to effectively debride chronic wounds in an easy-to-use, non-surgical, and prompt manner to enable wound healing. Moving to the EscharEx clinical evidence, I continue to be impressed by the compelling clinical data generated to date in EscharEx clinical trials.
In the first phase II randomized control study, evaluating EscharEx safety and efficacy in several etiologies, including DFU, diabetic foot ulcer, and venous leg ulcer, and post-traumatic wound. Patients treated with EscharEx demonstrated a significantly higher incidence of complete debridement compared to patients treated with gel vehicle. EscharEx 55% versus gel vehicle 29%, with the P value of 0.047. Complete debridement was achieved earlier in patients treated with EscharEx. The effect was even greater in diabetic lower extremity ulcers and in venous leg ulcers, and EscharEx was safe and well-tolerated in all tested doses and dosing regimens. The robust results across multiple endpoints in the U.S. phase II randomized controlled study for the debridement of VLU corroborated the results from the first phase II study and demonstrated the potential significant clinical and patient beneficial impact that EscharEx may have on patients' lives.
EscharEx demonstrated significant higher incidence of complete debridement within up to eight applications, and that's compared for both gel vehicles and non-surgical standard of care. The time to achieve complete debridement was significantly shorter compared to the control arm with significant lower number of daily applications. In addition, EscharEx demonstrated higher incidence of at least 75% granulation tissue post debridement, which is critical for wound bed preparation toward wound healing with no deleterious effect on wound healing. Lastly, data from our ongoing phase II pharmacology study, EscharEx demonstrated safe and effective debridement of lower leg ulcers, both diabetic foot ulcers and venous leg ulcers, with few daily application. EscharEx demonstrated significant debridement of wound during the treatment period, average of 84% non-viable tissue, percent non-viable tissue removed, and significant decrease in wound size by the end of the two-week follow-up.
In addition, an evaluation of the tissue samples and fluorescence images indicated a reduction of biofilm. Score reduced from 2.44 at baseline to 0.7 post-treatment. Bacterial load following treatment with EscharEx, red fluorescence intensity reduced from 1.72 of baseline to 0.7 after debridement. The product like EscharEx fits into the unmet need for a fast and effective non-surgical debridement for chronic and wounds. It is an easy to use daily topical gel that, as documented in the study, significantly improves the rate of complete debridement after a few applications, thus facilitating wound debridement. I believe that EscharEx holds great potential to be a significant contributor in this market and welcome addition to our armamentarium for chronic wound care.
Let me turn the call over to Dr. Cyaandi Dove, who treated more than 10 patients with EscharEx as a principal investigator in both phase II studies, to share her clinical experience with EscharEx and how a product like EscharEx would fit within the current wound management practice. Dr. Dove?
Thank you, Doctor, and good morning, everyone. It's my pleasure and privilege to join in this call and share my hands-on experience with EscharEx. My name is Dr. Cyaandi Dove, and I am the owner and Chief Medical Officer at Advanced Wound & Ankle Center in Las Vegas, Nevada, for the past 16 years. In our clinical practice, we deal with chronic non-healing wounds on a daily basis. A chronic wound, as we all know, is debilitating, both physically and physiologically. It also serves as a point of entry for local and systemic infections. It is a huge financial burden on patients, caregivers, and society. The data that we're talking about today is very positive and encouraging in a disease where we really have very few treatment options that are effective and really work.
Despite the growing number of new and innovative wound-healing products on the market, why does the treatment of chronic wounds still continue to be such a great problem? For non-healing wound products to work, you initially have to have a wound bed that is clean and physiologically ready for these products. Effective debridement is a critical first step for wound bed preparation in order to facilitate effective wound management. As described by the doctor previously, the most commonly used non-surgical debridement methods include enzymes. We have hydrogels and other topical dressings, which require quite a long time to achieve a clean wound bed, if they achieve this at all. I've had the privilege of treating several patients suffering from either venous leg ulcers or diabetic foot ulcers with EscharEx.
In my experience, after several applications of EscharEx, usually two to six applications, what we'll find is that the wound has a very vibrant, healthy, robust, and uniform granulation tissue. Granulation tissue that is ready to move on to negative pressure therapy or cellular therapy or even closed secondarily. The level of debridement achieved via EscharEx is very precise and not something that I can replicate with traditional debridement methods, especially sharp debridement, which is typical. That is why it reinforces my belief that EscharEx has the potential to become a best-in-class topical debridement product for the treatment of chronic wounds. We encourage MediWound to move forward with its continued clinical development, and I look forward to the day that EscharEx becomes available. I really appreciate the opportunity to speak to all of you today.
Now I will turn things back to Sharon. Thank you.
Thank you very much, Dr. Dove, and thank you, Dr. Rosenberg. Your insights underscore the great need for a product that can effectively debride chronic wounds. In a non-surgical, effective, and prompt manner. Chronic wounds represent a significant burden to patients, healthcare professionals, and the healthcare system. They affect millions of patients, and the cost of treatment runs into billions of dollar annually. We are excited to bring the EscharEx clinical development plan forward, given the magnitude of its commercial opportunity. In summary, debridement is a critical component of wound care.
There are about 2 million patients with venous leg ulcers and diabetic foot ulcers that undergo debridement every year in the U.S. alone. The two most commonly used non-surgical debridement methods, enzymatic or autolytic, generate several hundred of million in sales every year, yet can take weeks to show effect, leaving much room for improvement. With EscharEx, on the other hand, we've shown to be safe and effective in debridement of hard-to-heal wounds with a few daily applications.
Looking now to our plan for development, we believe the data from this study and the clinical evidence generated to date provides further insight on the additional efficacy parameters and can establish clinical benefits. This enables us to better design the pivotal study. We plan to file that clinical data with the FDA and to request an end of phase II meeting in the second half of 2022. Our goal is to work with the FDA on establishing a plan for a potential phase III pivotal plan for EscharEx as soon as possible. EscharEx clearly has the potential to become a game-changing therapy, and we are committing to bringing it to the market. We believe EscharEx is well-positioned to potentially become a best-in-class debridement option for millions of patients suffering from hard-to-heal wounds and transforming wound management.
Before turning the call over to Boaz for a summary of our financials, I want to address the news announced today of my transition to the board and the appointment of Ofer Gonen as the CEO. I have accomplished my goal as CEO of positioning the company for long-term success and strong future. MediWound is on the cusp of a very exciting chapter. The company's pipeline portfolio is in a strong position for continued advancement, including market expansion for our successful commercial product, NexoBrid, a potential near-term launch in the U.S. for this product, and a promising best-in-class therapy for wound care. It has been an honor to lead this company and the entire team at MediWound, and I look forward to supporting Ofer in my new role as a member of the board of directors and helping the company realize the tremendous opportunities that lay ahead.
Ofer brings more than 20 years of experience in managing life science investment and global businesses. His extensive managerial experience in leading companies, global network, and deep understanding of MediWound's strengths and potential position him uniquely to lead MediWound in its next phase of success. I will continue supporting the company as a board member, ensuring success with our BLA process and reinforcing our strategic alliances and collaborations. We are positioned for success and poised for our transformational year. Now let me turn the call to Ofer, please.
Thank you. Good morning, everyone. I'm honored and excited to assume the role of MediWound's chief executive officer. Thanks to the strong foundation built by Sharon and his team, as well as the experience and ongoing support of our board of directors, MediWound has tremendous potential to grow into a leading global biopharmaceutical company. I look forward to driving the next phase of MediWound. We will continue to advance our lead program to expand patients' access to our technologies and increase the value to our shareholders. Let me turn the call back to Sharon.
Thank you, Ofer. Now, let me turn the call to Boaz for a brief look at our financials. Boaz?
Thank you, Sharon, and good morning, everyone. As we have started what we believe to be an eventful year, we recently raised $10 million net. These funds, along with our NexoBrid commercialization efforts and the expected upcoming BLA approval, provide us with a solid balance sheet to meet the upcoming milestones and activities throughout the next 24 months. Let me now review the financial statement of the quarter. Total revenues for the first quarter of 2022 was $4.4 million, compared to $5.8 million for the same period last year. The decrease this quarter on a comparable basis was mainly related to product revenues due to a decrease in BARDA's emergency stockpile procurement of $1.2 million.
Gross profit was $1.5 million, with a gross margin of 33%, compared to a gross profit of $2.4 million and gross margin of 41% for the same period last year. Operating loss was $3.3 million, compared with $1.9 million in the first quarter of 2021. This resulted primarily from a decrease in product revenues to BARDA. Net loss was $3.6 million or $0.012 per share compared to a net loss of $2.9 million or 10 cents per share for the first quarter of 2021. Adjusted EBITDA was a loss of $2.6 million compared to a loss of $1.3 million for the first quarter last year. Moving to our balance sheet highlights. As of March 31, 2022, cash and short-term investment were $16.8 million.
We remained on budget, utilizing $4 million in the first quarter of 2022 for operational activities. Again, our cash position is expected to be sufficient to support the anticipated operating activities for the next 24 months. For the full year of 2022, we expect cash use to be in the range of $11 million-$13 million. With that, I have concluded the financial overview. I will now turn the call back over to Sharon. Sharon?
Thank you, Boaz. I'd like to thank the investigators and the KOL and patients who participated in this study, and especially to thank Professor Rosenberg and Dr. Dove for joining us this morning. Naturally, we are grateful for their participation in our study and for giving us their time this morning, but we also appreciate their ability to view the clinical data and place it into a context of its ultimate objective, which is helping patients in real-world clinical practices. Thank you. In closing, we are very well positioned. We are on track to resubmit our NexoBrid BLA by mid-year and continue to anticipate approval by the end of the year.
We are preparing to meet with the FDA in the second half of this year to discuss EscharEx and gain clarity on path towards approval, and we are welcoming Ofer Gonen to take the company to the next level of success. I look forward to continuing to support the company as a board member, and I'm certain we will enjoy a smooth transition. With that, I would like to turn the call to the operator to open the line for questions. Operator?
If you'd like to ask a question at this time, please press the star, then the number one key on your touchtone telephone. To withdraw your question, press the pound key. Again, that is star, then one if you'd like to ask a question. Our first question comes from Josh Jennings with TD Cowen.
Hi, this is Brian here for Josh. Thank you for taking my questions. I want to ask about the comment in today's press release about realizing the potential of your assets. Can you address your interest in looking for a partnership for either EscharEx or NexoBrid outside the U.S.? I guess maybe more plainly, given the strength of the phase II data we've seen for EscharEx, what's your commitment to independently completing the phase III program?
Good morning, Brian, and thank you for the question. As communicated previously, I think that now we are even better positioned for the next stage in terms of flexibility. We have the financial injection or the cash injection we had in the first quarter to strengthen our cash position. Now we have additional clinical data, very robust clinical data, providing us with the ability to establish a improvement over all current non-surgical standard care. This provide us to explore all alternatives, which are taking the product to the finish line by ourselves or exploring any other potential collaboration. It's premature now to discuss the alternative, but I can share with you as you really frame it, we have now the opportunity to explore all options given the robust data that we have on hand. Thank you.
Okay, thanks for that. I guess on the NexoBrid BLA, you've outlined a timeline to approval that matches what you'd face in a typical Class 2 resubmission. My question is, has the FDA definitively indicated that this is a Class 2 resubmission? If so, can you discuss where you stand with factors such as the inspections and your preparedness for a potential AdCom panel, if that's requested?
Again, we remain on track for a mid-year resubmission for the NexoBrid BLA, and we anticipate a six-month review process. The six-month review process is by law. Usually it takes either two to six months. Given the COVID and the backlog FDA has since the COVID, we know that it will take six months of review, and which position NexoBrid for a potential approval by year-end and commercial launch in the beginning of 2023, in the first half of 2023. We can't speak on behalf of the FDA regarding the ability to get for pre-approval inspection in our facilities. That being said, we have been aware that the FDA inspected facilities outside the U.S., both in Europe and in Israel, and we are encouraged by that. Looking forward to get the FDA response while we submit the FDA.
As you know, within 30 months from resubmission, we expect to get the FDA acceptance and timeline for the review as well as for the potential pre-approval inspection. Thanks.
Okay, thank you.
Our next question comes from Kevin DeGeeter with Oppenheimer.
Hey, thanks for taking our questions. First I wanna thank Sharon for all his help and feedback, you know, for several years. Our question, I don't know whether Dr. Dove is here for Q&A, but, you know, I guess we're primarily interested in better understanding, you know, how nonsurgical debridement is used in VLU and DFU patients who, you know, specifically circumstances under which it's used as a standalone versus, you know, an adjunct to sharp debridement.
Sure. Thank you very much for the question, Kevin. I can share with the audience that you were joining me in the last SAWC, in the last conference, and we did see that usually the nonsurgical means for debridement is used in conjunction with sharp as a maintenance debridement. This is what we know about the market. Let's leverage the fact that Dr. Dove is available and provide you with her perspective from her experience. Dr. Dove, can you share your view at that point?
Yes, I can. With the EscharEx, clinically, when we applied it as per the parameters of the trial, this was applied, and there was no adjunctive sharp debridement, even in patients who had fairly deep wounds for the diabetic foot ulcers. Traditionally, in my private practice, it is some type of enzymatic debridement, but almost always in conjunction with sharp debridement. The use of the EscharEx, again, to reiterate, was very precise, much more precise than what I can replicate by a traditional sharp debridement with a 15 blade in my office. I hope that gives some clarification to you.
Thank you, Dr. Dove.
Maybe building on that, I mean, based on, you know, the phase II data, you know, and I guess this is for either the company or Dr. Dove. Do you envision, you know, an evolution of standard of care potentially where EscharEx, you know, replaces the nonsurgical debridement, but, you know, where most patients continue to get surgical debridement, you know, and thus, you know, the nonsurgical essentially in adjunctive you know, process? Or do you anticipate or envision, essentially, a reduction in the volume of sharp debridement and more, you know, standalone nonsurgical only debridement technique?
Thank you for that, Kevin. I will start to provide you what we know about this and what we expect, and then Dr. Dove can add her perspective. Giving the feedback that we have, which comprise of a thorough market research we conducted in the U.S. and in Europe. Giving the feedback we get just in the last conference in the U.S., the SAWC, we believe that giving this efficacy of EscharEx, providing an effective and prompt debridement, clear debridement, and preparing the wound bed for the next stage of healing, we believe EscharEx can be positioned as a first-line therapy, not only replacing the current enzymatic standard of care, but rather take also chunk from the autolytic as well as from the sharp debridement. This is exactly what the market research indicated and what we got as a feedback.
The best benchmark for that, I think, to the ones of us that had some history in the wound care industry, is the Papain-Urea. Papain-Urea was a mixture of autolytic enzymes, a product by Healthpoint, that was dominant in the market and used as a first-line therapy because it was effective. When I say effective, it debrided wound in about two to three weeks. We are talking now based on the clinical data on this product that can provide a precise debridement, clear debridement in less than four applications, on average, four applications. With that, I would like to turn the call to Dr. Dove to share her perspective. Please, Dr. Dove.
Yes. As a principal investigator in the trial and as a physician who sees private practice patients, I think that there is nothing on the market like this product because it is standalone without surgical debridement. Because of the speed and the precision of EscharEx, I think that this will become standard of care therapy on the market. I think that for the large wound care centers and private practice physicians, this will be the first-line therapy because it was incredibly effective at debriding and incredibly fast as well for the patients who were treated with it. Yes, this will become. In my opinion, it will become the standard of care first-line therapy.
Thank you very much.
Thanks for taking our questions.
Thank you, Kevin.
As a reminder, if you'd like to ask a question at this time, that's star then one. Our next question comes from Arthur He with H.C. Wainwright.
G ood morning, everyone. This is Arthur in for RK. Thanks for taking my question, and congratulations on the robust data from the phase II study. My first question is for the doctors. Within these, the secondary and the exploratory endpoint from the phase II study, which endpoint is more, in your view, is important in terms of medical perspective?
Thank you for your question, Arthur. I will turn the call to Professor Rosenberg to share his view and then to Dr. Dove to share her view regarding what is the meaning of the second day endpoint in terms of wound bed preparation. Please, Dr. Rosenberg.
Wound bed preparation is really the first step and the necessary step for wound healing. What we found it was that the granulation tissue was much more abundant and much more, shall we say, kicking and living than what we saw in the standard of care. The meaning of having such a granulation tissue is that one can really either heal the wound by grafting it, and this is an immediate closure, or healing it by spontaneous epithelialization will take a bit longer. The granulation tissue means that the wound bed is alive. The model for wound care is what we call TIME. It stands for tissue, inflammation, et cetera, et cetera. This means that we really kind of having the key to open the wound care to much faster and much more efficient way of treating it.
Thank you, Professor Rosenberg. Dr. Dove, can you provide your follow-up?
Yes. You know, I would really build on what Dr. Rosenberg said. If you do not have a clean wound bed with healthy granulation tissue that is robust, you have nothing because the wound will never proceed past that inflammatory stage. You will never have a decrease in size. You will not have a decrease in pain. You'll never have a improvement in quality of life. You have to have that initial healthy wound bed before you can even contemplate moving on to means of closure. In my perspective, the primary endpoint of healthy, complete debridement and getting a healthy wound bed is the most vital endpoint that we have.
Thank you very much, Dr. Dove.
Thank you. Thank you very much for both. Follow-up on that for Sharon and the team. I guess based on this robust data from the phase II study, could you guys give us more commentary on the potential, the pivotal study design and the potential costs related to that? Thank you.
Yes. Thank you for your question. As I said, first of all, it's premature yet to provide a clear data on the next stage of development in terms of size, extent of the studies, number of studies, et cetera, given the fact that we did not yet discuss with the FDA. We expect to continue analyze the data. As you know, we provide a robust data set, but we will continue to analyze the data, subpopulation and others, to establish additional benefit of EscharEx compared to both gel vehicle and, of course, the standard of care. We also expect final data from the ongoing phase II pharmacology study, which is conducted with VLU and DFU, where the initial data demonstrated, in addition to rapid debridement, also reduction in biofilm and microbial load.
We want to gather all this information, integrate the data from the first phase II study from Europe and Israel, the current phase II study from the U.S., and the pharmacology phase II study, integrate the data, establish a plan for the next stage, and share it with the FDA. Once we'll have more clarity on that, of course, we'll communicate this plan with the Street. Thank you.
Thank you. Thank you very much for the additional color, and thanks for taking my question.
I'm showing no further questions in queue at this time. I'd like to turn the call back to Sharon Malka for closing remarks.
Thank you very much. We look forward to updating you again on our next earnings call. Have a great day. Thank you.
This concludes today's conference call.