PolyPid Ltd.

Thank you all for participating in PolyPID's fourth quarter and full year 2020 earnings conference call. Joining me on the call today will be Dikla Chachkas-Oxobrod, Executive Vice President and Chief Financial Officer of PolyPID, and Dr. Noam Emanuel, Founder and Chief Scientific Officer. Earlier today, PolyPID released results for the three and 12 months ended December 31st, 2020. A copy of the press release is available on the Investors section of the company's website. I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the federal securities laws. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Results may differ materially from those projections. These statements involve material risks and uncertainties that can cause actual results or events to differ materially. Accordingly, you should not place undue reliance on these statements. I encourage you to review the company's filings with Securities and Exchange Commission, including without limitation the company's forms F-1 and 6-K, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Hollypeat claims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference hall contains time-sensitive information and speaks only as of the live broadcast today, December 10th, 2021. With the completion of those prepared remarks, it's my pleasure to turn the call over to Dikla Chastas. Dikla, go ahead.

Thank you, Bob. On behalf of our team at PolyPede, I would like to welcome everyone to our fourth quarter and full year 2020 earning call. I will begin today with an overview of our accomplishments in 2020, and then we will provide a detailed update of our business. Dr. Emmanuel, our founder and chief scientist officer, will review our recent progress with our Oncoplex oncology program. Finally, I will review our financial results, after which we will open the call for questions. Unfortunately, Amir Weisberg, our Chief Executive Officer, is having a medical procedure and cannot be with us today. We wish Amir well and expect him to be back at work shortly. As we enter what we expect to be an exciting year, I would like to take a moment to reflect on what was truly a remarkable 2020 for PolyPID. Most importantly, we have achieved significant progress in advancing our development programs and in continuing our evolution towards becoming a commercial company. Our Phase III program for our lead asset, DIPLEX-100, for the prevention of surgical site infection, or SSI, is well underway. Our ongoing SHIELD-1 trial is enrolling well, and our second Phase III trial in abdominal surgery, SHIELD-2, was recently initiated. We are thrilled to have both Phase III trials now opened an enrolling patient in the US, Europe, and Israel. The execution of these two clinical trial will be a core focus for polypids in 2021. As a reminder, these two phase three clinical trial will serve as the basis for polypids first new drug application or NDA submission. Beyond our lead indication, we also have an ongoing clinical development program for DIPLEX100 for the prevention of SSI in bone tissue, such as the sternum in open heart surgeries. In addition, our promising Oncoplex local intratumoral therapy preclinical program, for which we recently announced promising preclinical data, continues to advance as planned. From a regulatory standpoint, we were excited in the fourth quarter to have received breakthrough therapy designation for DPLEX-100 from the FDA for the prevention of SSIs in patients undergoing elective colorectal surgery. DIPLEX-100 previously received two FAST-TRACK designations from the FDA for the prevention of post-abdominal surgery, incisional infections, and for the prevention of sternal wound infections, post-cardiac surgery, as well as two Qualified Infectious Disease Program designations, or QIDPs, in the same indication. We close the year by hosting a well-attended KOL call on DIPLEX-100 that featured presentation by Dr. Herschel Schaaf of the Mayo Clinic, Dr. Anthony Senegor, formerly of UTMB at Gavelstone, and Dr. Oded Zmora from Shamir Medical Center Israel, who discussed the burden and challenges related to SSIs in post-colorectal and cardiovascular surgeries and the opportunity of DIPLEX-100 to change the current treatment landscape. Polypid's robust ongoing development program for our innovative Plex technology is supported by a strong balance sheet, which was further strengthened by the successful completion of our IPO on the NASDAQ in June 2020. We raised $62.8 million in net proceeds from the IPO and added several well-respected new investors. We continue to expect that our current cash position will be sufficient to complete the SHIELD1 study and to conduct SHIELD2, as well as prepare for the submission of an NDA to the FDA. Let's shift gears, and I would like to provide a brief discussion on the status of our pipeline. Following the enrollment of our first patient in the SHIELD1 trial in July 2020, and the initiation of the SHIELD II trial in December, we have continued to open clinical trial centers at an impressive pace. I'm pleased to report today that we have now enrolled a total of 100 patients in our two Phase III studies, with the vast majority of those subjects in our ongoing SHIELD I trial. As we have said previously, for SHIELD I, our plan is to enroll 600 to 900 patients within 60 centers in the US, EU, and Israel. Following the enrollment of 500 patients, the study design provides for a blinded sample size re-estimation based on the overall infection rate observed in the study in order to determine final target enrollment for the study. We continue to anticipate the top line results for SHIELD1 will be available by year end 2021. Late in 2020, we were pleased to initiate SHIELD2, which has broader eligibility criteria, including minimally invasive surgical procedures. This is important because it will provide additional clinical evaluation of the potential of DPLEX-100 to prevent SSIs in broader surgical populations. This second trial will enroll approximately 900 to 1400 patients across the same number of centers as Shield 1. Enrollment in Shield 2 is advancing as anticipated. From a commercial perspective, to reiterate what we have said previously, in order to maximize our commercial success, we have began to establish our own footprint in the U.S. to initiate commercial preparation activities while also exploring potential partnering opportunities with leading pharmaceutical companies. We are in discussion with potential partners for the US, EU, and Asian market. In the US, we are thoroughly evaluating the market access and reimbursement landscape, as well as key hospital economic parameters to ensure optimal positioning and coverage of DIPLEX-100. As part of this work, we are conducting extensive market research with surgeons, pharmacists, and hospital administrators to further assess the attractiveness of DIPLEX-100. This research will help us identify critical opportunities and any potential challenges for adoption. Through those initiatives and our clinical trial, our goal is to generate data that demonstrate positive clinical outcome for DIPLEX-100 as well as favorable health economics for hospitals to drive the commercial potential of our drug candidate. For the prevention of SSI in bone tissue, as you know, we initiate our phase three bone model trial in open heart surgery earlier last year. We focused on bone tissue due to the high risk of morbidity and mortality in cases of deep surgical site infection in these procedures. We are currently evaluating next clinical steps for an open heart surgery phase three trial while we ensure that the SHIELD1 and SHIELD2 trial continue to progress as planned. The company intends to submit the bone surgery data as a supplement after the approval of the NDA for abdominal soft tissue surgery. From a regulatory perspective, we received breakthrough therapy designation for DIPLEX100 from the FDA for the prevention of SSI in patient undergoing elective colorectal surgery. Of significance, breakthrough therapy designation for anti-infective drug is relatively rare, and we believe is indicative of the urgency to adopt new innovative therapies to prevent surgical site infection. It is also important to note that breakthrough therapy designation is granted based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvements over existing therapies on one or more clinically significant endpoints. At this point, I'd like to turn the call over to Noam, our chief scientist officer, to discuss our OncoPlex program. Noam?

Thank you, Dikla. It is my pleasure to join this quality call, especially following the informative KOL call in which I participated with three KOLs in mid-December. As a background, I am the founder of Polyped and serve as the chief scientific officer. Now, I would like to further elaborate on the potential of Oncoplex, our intratumoral chemotherapy product candidate, to overcome tumors, including those that are chemotherapeutic resistant. Oncoplex is controlling the local exposure of tumor cells to docetaxel, one of the most widely used chemotherapy agents. As you know, systemic chemotherapeutic treatment is significantly limited in eradicating solid tumors, mainly due to the limited penetration and the high toxicity to non-involved tissues. Uncomplex utilized the polypid's novel PLEX technology to provide prolonged and controlled local exposure to docetaxel in the intraoperative tumor resection setting. The control over the exposure to chemotherapy will have critical impact on both the efficacy and the safety of the treatment. The release of the drug is immediate after the surgery and continue over weeks to follow with minimal systemic and toxic exposure. These combined attributes may become critical to overcoming tumor reoccurrence and to prevent spreading of cancer cells during the post-operative periods. You will recall that late in 2020, we announced positive preclinical data from this program. In the syngenic mouse model for solid tumors of colon carcinoma using cancer cells highly resistant to docetaxel, among the most treatment-resistant tumor cell type, a single local application of Oncoplex generated significantly better results compared to the group treated with six cycles of systemic docetaxel treatment in multiple K measures, including overall tumor reoccurrence, overall survival, and overall tumor-free survival. Based on these compelling preclinical results in chemotherapeutic-resistant tumor models, we intended to conduct additional preclinical safety studies of Oncoplex in various types of solid tumors in order to complete preclinical package for the filing of pre-IND meeting requests with the FDA later this year and potentially initiate a phase one clinical trial in 2022. We believe Oncoplex could have the potential to become part of the standard of care in the resection setting with multiple solid cancer types, including glioblastoma, prostate cancer, and head and neck cancer. With that, Dikla will now review our recent financial results. Dikla?