1. PETAH TIKVA, Israel, Sept. 20, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a phase 3 biopharmaceutical company focused on developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology, today announced its participation in the Cantor Fitzgerald Virtual Global Healthcare Conference on September 29 at 02:00 pm EDT.

    In her presentation, Dikla Czaczkes Akselbrad, Polypid's EVP and CFO will provide corporate highlights and discuss recent developments.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a phase 3 biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid…

    PETAH TIKVA, Israel, Sept. 20, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a phase 3 biopharmaceutical company focused on developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology, today announced its participation in the Cantor Fitzgerald Virtual Global Healthcare Conference on September 29 at 02:00 pm EDT.

    In her presentation, Dikla Czaczkes Akselbrad, Polypid's EVP and CFO will provide corporate highlights and discuss recent developments.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a phase 3 biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its ongoing clinical trials, plans to use the guidance provided by the FDA to progress with its SHIELD I program, the timing of top-line results of the SHIELD I trial, and the size and design of the SHIELD I trial. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 5, 2021. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Corporate Contact

    PolyPid, Ltd.

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Investor Contact

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    bob@lifesciadvisors.com

    Media Contact

    Nechama Feuerstein

    FINN Partners

    551-444-0784

    Nechama.Feuerstein@finnpartners.com



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    • Positive Results in Two Animal Models of Glioblastoma Multiform (GBM) demonstrated that Single Local Treatment of OncoPLEX Significantly Inhibited Tumor Growth and Prolonged Survival

    • Company Expects a Pre-IND Meeting with the U.S. FDA by Year End and Potential Initiation of Phase 1/2 Clinical Trial of OncoPLEX in Brain Tumors in 2022

    PETAH TIKVA, Israel, Sept. 13, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a phase 3 biopharmaceutical company focused on developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology, today announced positive preclinical data in two key Glioblastoma Multiform (GBM) animal models of its OncoPLEX intra-tumoral cancer therapy program.

    OncoPLEX utilizes…

    • Positive Results in Two Animal Models of Glioblastoma Multiform (GBM) demonstrated that Single Local Treatment of OncoPLEX Significantly Inhibited Tumor Growth and Prolonged Survival



    • Company Expects a Pre-IND Meeting with the U.S. FDA by Year End and Potential Initiation of Phase 1/2 Clinical Trial of OncoPLEX in Brain Tumors in 2022

    PETAH TIKVA, Israel, Sept. 13, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a phase 3 biopharmaceutical company focused on developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology, today announced positive preclinical data in two key Glioblastoma Multiform (GBM) animal models of its OncoPLEX intra-tumoral cancer therapy program.

    OncoPLEX utilizes the Company's novel PLEX technology to provide controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, for a few weeks in the intra-operative tumor resection setting, to potentially reduce local tumor recurrence, tumor spreading and prolong patient survival.

    The OncoPLEX intra-tumoral cancer therapy program was evaluated in brain tumors for tumor growth and survival in two Glioblastoma Multiform (GBM) animal models. Key results included:

    • OncoPLEX induced strong inhibition of tumor growth and recurrence in a partially resected human glioblastoma subcutaneous mouse model. A single local OncoPLEX application induced 98% tumor growth inhibition (day 41 post operation) compared to the untreated control (p<0.001), and 66% compared to multiple injections of systemic chemotherapy treatment arm (p=0.0165). The day 41 survival rate for OncoPLEX was much higher than the systemic treated mice, or untreated with 60%, 20%, and 10% survival, respectively.
    • OncoPLEX was also tested in a GBM brain rat model. OncoPLEX, applied locally next to the non-resected tumor in the brain, showed a 40% survival rate at day 23 following the beginning of treatment, as compared to a 0% survival rate in the standard systemic treatment arm (Temozolomide 33.5 mg/kg, 5 treatment days), the placebo arm (OncoPLEX without Docetaxel) and in the untreated control arm. Only OncoPLEX significantly enhanced the overall survival compared to both the placebo arm and to the untreated arm (p<0.02).
    • Dose response was demonstrated for OncoPLEX in the different animal models.
    • Local application of OncoPLEX in a rat brain model evidenced good safety profile at the different doses studied.

    "The growing set of data from our OncoPLEX preclinical studies continue to look promising," said Dr. Noam Emanuel, PolyPid's co-founder and Chief Scientific Officer. "GBM is one of the most aggressive forms of brain cancer which carries a poor prognosis with current therapy, mainly due to the limited ability of existing approaches to penetrate the blood brain barrier. The novel prolonged intra-tumoral OncoPLEX treatment could provide substantial benefit for patients with these devastating tumors that often cannot be fully resected surgically. Based on the encouraging anti-cancer results of OncoPLEX in various animal models generated to date, including in tumors that are highly resistant to docetaxel, we believe that OncoPLEX warrants further evaluation in the clinical setting. As such, we intend to conduct a pre-Investigational New Drug (IND) meeting with the U.S. FDA by year-end with the objective of initiating a Phase 1/2 clinical trial in 2022."

    About OncoPLEX

    OncoPLEX is PolyPid's lead intra-tumoral product candidate in Oncology. OncoPLEX utilizes the Company's novel PLEX technology to provide controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, directly at the tumor site for few weeks to potentially reduce local tumor reoccurrence, the potential spreading of cancer cells, and ultimately improve the overall survival rate of cancer patients. Local delivery of drugs directly into the tumor site, especially in difficult to access tumors such as in the brain, may significantly improve the clinical outcome. The OncoPLEX intra-tumoral cancer therapy program has been evaluated successfully in various animal tumor models, including colon carcinoma and glioblastoma.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a phase 3 biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over pre-determined durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of abdominal and sternal surgical site infections (SSIs).

    For additional company information, please visit polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses statements relating to the timing of a pre-IND Meeting with the U.S. FDA, the timing of trials, and the potential benefits of OncoPLEX, and all statements (other than statements of historical facts) that address activities, events, or developments that the Company intends, expects, projects, believes, or anticipates will or may occur in the future. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 5, 2021. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    References and links to websites and social media platforms have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Contacts:

    PolyPid, Ltd.

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Investors:

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Bob@LifeSciAdvisors.com

    Media:

    Nechama Feuerstein

    551-444-0784

    Nechama.Feuerstein@finnpartners.com



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  2. PETACH TIKVA, Israel, Aug. 17, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma focusing on developing targeted, locally administered and prolonged-release therapeutics to improve surgical outcomes, announced today that its Co-Founder and Chief Scientific Officer Dr. Noam Emanuel, will deliver a virtual presentation at the first World Association against Infection in Orthopaedics and Trauma (WAIOT) Congress on August 28, 2021.

    The virtual presentation will be a part of the Septic Non-Union and Bone Loss Management session. The presentation details can be found below:

    Location: Room 3
    Lecture Number: 0 41
    Time: 16:11 – 16:16 CEST
    Presentation Title:
        Improved Healing of Gustilo Type IIIA and IIIB Open Long…

    PETACH TIKVA, Israel, Aug. 17, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma focusing on developing targeted, locally administered and prolonged-release therapeutics to improve surgical outcomes, announced today that its Co-Founder and Chief Scientific Officer Dr. Noam Emanuel, will deliver a virtual presentation at the first World Association against Infection in Orthopaedics and Trauma (WAIOT) Congress on August 28, 2021.

    The virtual presentation will be a part of the Septic Non-Union and Bone Loss Management session. The presentation details can be found below:

    Location: Room 3

    Lecture Number: 0 41

    Time: 16:11 – 16:16 CEST

    Presentation Title:

        Improved Healing of Gustilo Type IIIA and IIIB Open Long Bone Fractures Treated with Local Biodegradable Prolonged Release Antibiotic Formulated Bone Graft During the First Surgical Intervention Post-Surgery: A Prospective, Randomized Clinical Trial

    Presenter:

        Dr. Noam Emanuel, PolyPid

    WAIOT is the first and the largest worldwide scientific association, focused on bone, joints, biofilms- and implant-related infections. The event will be attended by 1,700 members coming together virtually from 101 countries.

    About PolyPid

    PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharmaceutical company focusing on developing targeted, locally administered and prolonged-release therapeutics to improve surgical outcomes. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its ongoing clinical trials, plans to use the guidance provided by the FDA to progress with its SHIELD I program, the timing of top-line results of the SHIELD I trial, and the size and design of the SHIELD I trial. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 5, 2021. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Corporate Contact

    PolyPid, Ltd.

    Dikla Czaczkes Akselbrad

    EVP & CFO

    +972-747195700

    Investor Contact

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    bob@lifesciadvisors.com

    Media Contact

    Nechama Feuerstein

    551-444-0784

    Nechama.Feuerstein@finnpartners.com 



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  3. •  Recruitment Progressing as Planned with Over 300 Patients Enrolled into Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery

    •  FDA Agreed that a Single Pivotal Phase 3 Study is Sufficient for Potential Approval of D-PLEX100 for the Prevention of Surgical Site Infections in Colorectal Surgery

    •  Brain Tumors Selected as the Initial Indication for Company's OncoPLEX Intra-tumoral Cancer Therapy Program

    •  Conference Call Scheduled for Today at 8:30 AM ET

    PETACH TIKVA, Israel, Aug. 11, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today provided a corporate update and reported financial…

    •  Recruitment Progressing as Planned with Over 300 Patients Enrolled into Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery

    •  FDA Agreed that a Single Pivotal Phase 3 Study is Sufficient for Potential Approval of D-PLEX100 for the Prevention of Surgical Site Infections in Colorectal Surgery

    •  Brain Tumors Selected as the Initial Indication for Company's OncoPLEX Intra-tumoral Cancer Therapy Program

    •  Conference Call Scheduled for Today at 8:30 AM ET

    PETACH TIKVA, Israel, Aug. 11, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today provided a corporate update and reported financial results for the three and six months ended June 30, 2021.

    Recent Corporate Highlights:

    • Recruitment progressing as planned with over 300 patients enrolled into the ongoing Phase 3 SHIELD I (Surgical site Hospital-acquired Infection PrEvention with Local D-plex) study, the first of two ongoing Phase 3 clinical trials of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery (soft tissue).
    • The Company plans to enroll 616-900 patients in 60 centers in the United States, Europe and Israel. Following the enrollment of approximately 500 patients, the study design provides for a blinded sample size re-estimation.
    • Received written responses from the U.S. Food and Drug Administration (FDA) to a Type B meeting request submitted following receipt of Breakthrough Therapy Designation for D-PLEX100, regarding the development plan for the Company's lead product candidate, D-PLEX100. The FDA indicated that PolyPid's proposal for a single Phase 3 pivotal study, SHIELD I, provided the study results are adequate, would provide sufficient evidence of clinical efficacy and safety to support approval of D-PLEX100 for the prevention of SSIs in colorectal surgery.
    • Enrollment is also advancing as anticipated in SHIELD II, the second of two Phase 3 clinical trials for D-PLEX100 in abdominal surgery (soft tissue). SHIELD II will enroll approximately 900-1,400 patients across 60 centers in the United States, Europe and Israel and has broader eligibility criteria than SHIELD I, including minimally invasive surgical procedures.
    • The Company identified brain tumors as the initial target indication for OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes PolyPid's PLEX technology in the intra-operative tumor resection setting to provide local, prolonged and controlled exposure to docetaxel within the residual tumor site, which is important to potentially reduce local tumor recurrence, the potential spreading of cancer cells to other organs and ultimately improve overall survival of the patients.
    • Appointed leading colorectal surgeon, Anthony J. Senagore, M.D., as Senior Medical Director. Dr. Senagore has a long track record of academic surgery practice and significant experience in healthcare start-up companies. He will be responsible for developing PolyPid's medical infrastructure in the United States, and will contribute to the Company's NDA submission and commercial launch of D-PLEX100.

    "We have recently achieved significant progress in advancing our multiple development programs, and in continuing our evolution towards becoming a commercial stage company," said Amir Weisberg, PolyPid's Chief Executive Officer. "Most importantly, the recent communication from the FDA regarding SHIELD I reduces our anticipated costs for the program, and provides us with additional financial flexibility overall. In addition, we are excited to report that we have now enrolled over 300 patients in the SHIELD I trial."

    "We are also diligently working to further progress our promising OncoPLEX platform in oncology applications, which continues to advance expeditiously," continued Mr. Weisberg. "Our initial target indication for OncoPLEX will be brain tumors, the most aggressive and deadly type of cancer for which patients currently have almost no meaningful treatment options."

    "Our vigorous clinical development program continues to be supported by a strong balance sheet. With a cash runway that extends into the second half of 2022, we remain well-positioned to complete the SHIELD I study, prepare for the submission of an NDA to the FDA and further advance our OncoPLEX program with our current cash resources," concluded Mr. Weisberg.

    Financial results for three months ended June 30, 2021

    • Research and development expenses for the three months ended June 30, 2021 were $7.4 million, compared to $4.3 million in the same three-month period of 2020, as spending increased due to the ongoing SHIELD I and SHIELD II Phase 3 clinical trials in abdominal surgery.



    • Marketing and business development expenses for the second quarter of 2021 were $0.7 million, compared to $0.3 million for the same period of 2020, as spending increased primarily due to an increase in marketing and business development personnel hired in the Company's New Jersey offices.



    • General and administrative expenses for the second quarter of 2021 were $2.4 million, compared to $2.6 million in the prior year period. The decrease was due to lower non-cash share based compensation expenses.



    • For the three months ended June 30, 2021, the Company had a net loss attributable to ordinary shares of $10.5 million, compared to a net loss of $19.1 million in the three-month period ended June 30, 2020.



    • As of June 30, 2021, the Company had cash, cash equivalents, short-term deposits, and long-term deposits in the amount of $52.9 million, compared to $66.6 million at December 31, 2020. PolyPid continues to expect that its cash on hand will be sufficient to fund operations into the second half of 2022.

    Financial results for the six months ended June 30, 2021

    • Research and development expenses for the six months ended June 30, 2021 were $13.5 million, compared to $7.8 million in the same six-month period of 2020, as spending increased due to the ongoing SHIELD I and SHIELD II Phase 3 clinical trials in abdominal surgery.



    • Marketing and business development expenses for the six months ended June 30, 2021 were $1.4 million, compared to $0.6 million for the same period of 2020. These expenses increased primarily due to an increase in marketing and business development personnel hired in the Company's New Jersey offices.



    • General and administrative expenses for the six months ended June 30, 2021 were $4.6 million, compared to $3.4 million in the prior year period. The increase in general and administrative expenses was due to the increase in costs associated with the Company's status as a publicly traded company with higher D&O insurance costs.



    • For the six months ended June 30, 2021, the Company had a net loss attributable to ordinary shares of $19.2 million, as compared to a net loss of $25.0 million in the six months ended June 30, 2020.

    Conference Call Dial-In & Webcast Information:

    Date: Wednesday, August 11, 2021
    Time:8:30 AM Eastern Time
    United States:+1 877 870 9135
    Israel:+972 1809 213-985
    International:+44 (0) 2071 928338
    Conference ID:1663949
    Webcast:https://edge.media-server.com/mmc/p/2eu7k7nj

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of abdominal and sternal surgical site infections (SSIs).

    For additional company information, please visit polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses statements relating to the expected recruitment for trials, timing of trials and release of the results thereof, the potential benefits of PLEX and OncoPLEX, the sufficiency of the Company's cash to fund future operations, and all statements (other than statements of historical facts) that address activities, events, or developments that the Company intends, expects, projects, believes, or anticipates will or may occur in the future. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 5, 2021. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Contacts:

    PolyPid, Ltd.

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Investors:

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Bob@LifeSciAdvisors.com

    Media :

    Nechama Feuerstein

    551-444-0784

    Nechama.Feuerstein@finnpartners.com



     
    CONSOLIDATED BALANCE SHEETS
    U.S. dollars in thousands
     June 30, December 31,
      2021  2020
     Unaudited Audited
    ASSETS   
        
    CURRENT ASSETS:   
    Cash and cash equivalents$        7,448 $        4,319
    Restricted cash 388  390
    Short-term deposits 40,399  40,157
    Prepaid expenses and other current assets 937  2,334
        
    Total current assets 49,172  47,200
        
    LONG-TERM ASSETS:   
    Property and equipment, net 5,734  5,890
    Long-term deposits 5,059  22,120
    Other long-term assets 1,431  637
        
    Total long-term assets 12,224  28,647
        
    Total assets$        61,396 $        75,847

     

        
     June 30, December 31,
      2021   2020 
     Unaudited Audited
    LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY   
        
    CURRENT LIABILITIES:   
    Trade payables$        1,756  $        974 
    Other payables and accrued expenses 2,565   1,903 
        
    Total current liabilities 4,321   2,877 
        
    LONG-TERM LIABILITIES:   
    Other liabilities 190   193 
        
    Total long-term liabilities 190   193 
        
    COMMITMENTS AND CONTINGENCIES   
        
    SHAREHOLDERS' EQUITY:   
    Share capital -   
    Ordinary shares with no par value - Authorized: 47,800,000 shares at June 30, 2021 (unaudited) and December 31, 2020; Issued and outstanding: 18,756,570 and 18,494,739 shares at June 30, 2021 (unaudited) and December 31, 2020, respectively -   - 
    Additional paid-in capital 208,335   205,063 
    Accumulated deficit (151,450)  (132,286)
        
    Total shareholders' equity 56,885   72,777 
        
    Total liabilities and shareholders' equity $61,396  $        75,847 
            



    CONSOLIDATED STATEMENTS OF OPERATIONS
    U.S. dollars in thousands (except share and per share data)
     

    Six months ended

    June 30,

     

    Three months ended

    June 30,

      

    2021

       

    2020

      

    2021

       

    2020

     

    Unaudited

            

    Operating expenses:

           

    Research and development, net

    $

            13,460

      

    $

            7,772

     

    $

            7,442

      

    $

            4,339

    Marketing and business development expenses

     

    1,391

       

    581

      

    739

       

    305

    General and administrative

     

    4,576

       

    3,355

      

    2,449

       

    2,628

            

    Operating loss

     

    19,427

       

    11,708

      

    10,630

       

    7,272

    Financial (income) expense, net

     

    (263

    )

      

    11,154

      

    (153

    )

      

    9,721

            

    Net loss

     

    19,164

       

    22,862

      

    10,477

       

    16,993

            

    Deemed dividend

     

    -

       

    2,114

      

    -

       

    2,114

            

    Net loss attributable to Ordinary shares

    $

            19,164

      

    $

            24,976

     

    $

            10,477

      

    $

            19,107

            

    Basic and diluted net loss per Ordinary share

    $

            1.03

      

    $

            37.87

     

    $

            0.56

      

    $

            25.30

            

    Weighted average number of Ordinary shares used in computing basic and diluted net loss per share

     

    18,685,906

       

    659,551

      

    18,747,967

       

    755,289



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  4. PETAH TIKVA, Israel, July 28, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today announced that it will report its second quarter 2021 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, August 11, 2021. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date: Wednesday, August 11, 2021
    Time:8:30 AM Eastern Time
    United States:+1 877 870 9135
    Israel:+972 1809 213-985
    International:+44 (0) 2071 928338
    Conference

    PETAH TIKVA, Israel, July 28, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today announced that it will report its second quarter 2021 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, August 11, 2021. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date: Wednesday, August 11, 2021
    Time:8:30 AM Eastern Time
    United States:+1 877 870 9135
    Israel:+972 1809 213-985
    International:+44 (0) 2071 928338
    Conference ID:1663949
    Webcast:https://edge.media-server.com/mmc/p/2eu7k7nj

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains projections and other forward-looking statements regarding future events or our future financial performance. All statements other than present and historical facts and conditions contained in this release are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. Actual events or results may differ materially from those contained in the projections or forward-looking statements. Forward-looking statements in this release are made pursuant to the safe harbor provisions contained in the Private Securities Litigation Reform Act of 1995. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Contacts: 

    PolyPid, Ltd. 

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Investors:

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Bob@LifeSciAdvisors.com

    Media Contact:

    Nechama Feuerstein

    551-444-0784

    Nechama.Feuerstein@finnpartners.com



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  5. TEL AVIV, Israel and RADNOR, Pa., July 12, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NASDAQ:NRXP), a clinical stage pharmaceutical company announced today that it has signed a Memorandum Of Understanding with the Government of Israel to license exclusive worldwide development, manufacturing, and marketing rights to a novel Coronavirus vaccine developed by the Israel Institute for Biological Research (IIBR).

    The BriLife™ vaccine (technical name VSV ΔG1) is based on a previous, FDA-approved vaccine platform that was further optimized by IIBR and targeted towards COVID-19. Because BriLife™ is a self-propagating, live-virus vaccine, NRx anticipates rapid and affordable industrial scaleup and manufacturing. The vaccine will initially be delivered by traditional injection. 

    The initiative will be led by NRx Chairman and CEO Jonathan Javitt, together with NRx Director Chaim Hurvitz, who chairs CH Health, an Israeli Private Equity group.

    "We at NRx are honored to have been selected by the Government of Israel to carry forward this life-saving mission," said Mr. Hurvitz.  As the first generation COVID vaccines are increasingly challenged by rapid mutation of the Coronavirus, we aim to develop a vaccine that can rapidly scale at low cost to serve the needs of both the developed and the developing world."

    "As a physician and public health professional, I am inspired by the privilege of collaborating with an institution whose scientific roots date to Jonas Salk and the fight against Polio," said Prof Jonathan C Javitt, MD, MPH, CEO and Chairman of NRx, who has been involved in the fight against Coronaviruses since the 2002 SARS epidemic. "In its first year, the COVID pandemic has killed four million people worldwide, constituting the worst public health catastrophe since the 1918 Influenza epidemic. As the virus mutates and challenges the immunity we have built through first-generation vaccines, we are excited to expand our focus on COVID by including a vaccine platform that has potential to scale at high speed and low cost."

    In its collaboration with NRx, the IIBR will provide technical assistance, while receiving customary royalty and milestone payments for its intellectual property.  NRx has further committed to supplying all required doses of the vaccine for the population of Israel.

    About NRx Pharmaceuticals

    NRx (www.nrxpharma.com) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration, (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, and the Medical Countermeasures program of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation and a Special Protocol Agreement to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof. Jonathan Javitt, MD, MPH (Adj. Professor, Johns Hopkins School of Medicine), who serves as a Senior Fellow in the National Security Health Policy Center of the Potomac Institute for Policy Studies. In addition to 30 years of experience in drug development, Dr. Javitt has been appointed to leadership roles under Presidents Reagan, Bush ('41), Clinton, and Bush ('43), where he served as a Special Employee of the Undersecretary of Defense. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General HR McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor. NRx is publicly traded on the Nasdaq Global Select Exchange under the stock ticker NRXP.

    About CH Health

    CH Health is a Tel Aviv-based private equity group that has played a key role in the founding and advancement of a series of pharmaceutical companies including Kite Pharmaceuticals (Nasdaq:KITE, now owned by Gilead Sciences (Nasdaq: GILD), Urogen (NASDAQ:URGN), Polypide (NASDAQ:PYPD), Galmed (NASDAQ:GLMD), and NRx (NASDAQ:NRXP). CH Health is led by Mr. Chaim Hurvitz, former director of Teva Pharmaceuticals (NASDAQ:TEVA) and former President of the Teva International Group, where he led global development and sales of Copaxone throughout its life cycle. Mr. Hurvitz is a graduate in political science from Tel Aviv University and serves as President of the pharmaceutical section of the Israel Manufacturer's Organization. As Chairman of the Tel-Aviv Yafo Foundation, he plays an active philanthropic role in the community.

    About the Israel Institute for Biological Research

    The IIBR is a center for research and development in the fields of biology, chemistry and the environment. Its mission is to strengthen the capabilities and resilience of the State of Israel. The scientists at IIBR have accumulated extensive knowledge and expertise over the decades in areas including: the development and implementation of advanced methods for detection and identification, research of disease processes, planning and development of vaccines and diverse therapeutic methods and more. The institute employs hundreds of scientists, some of them leaders in their fields in Israel and around the world.  They work in laboratories and biotechnological facilities that enable the development and production of advanced products and vaccines, under strict regulatory conditions.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.   

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise.    Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. 

    1 Pronounced "VSV delta G"

    CORPORATE CONTACT                                                      

    INVESTOR RELATIONS





    Jack Hirschfield                                                                                  

    John Mullaly

    Head of Corporate Communications, NRx                             

    LifeSci Advisors

    jhirschfield@nrxpharma.com                                                 

    jmullaly@lifesciadvisors.com

    512-674-5163                                                                                     

    617-429-3548

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-announces-partnership-with-the-israel-institute-for-biological-research-to-complete-development-and-commercialization-of-brilife-covid-vaccine-301331618.html

    SOURCE NRx Pharmaceuticals

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  6. PETAH TIKVA, Israel, July 12, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company focusing on developing targeted, locally administered and prolonged-release therapeutics to improve surgical outcomes, today announced that it has appointed leading colorectal surgeon Anthony J. Senagore, M.D., as its Senior Medical Director.

    In his position, Dr. Senagore will be responsible for developing PolyPid's medical infrastructure in the United States, and will contribute to the Company's NDA submission, approval and commercial launch of its lead product candidate, D-PLEX100, a novel drug product candidate designed to prevent surgical site infections (SSIs) by providing local prolonged and controlled anti-bacterial activity…

    PETAH TIKVA, Israel, July 12, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company focusing on developing targeted, locally administered and prolonged-release therapeutics to improve surgical outcomes, today announced that it has appointed leading colorectal surgeon Anthony J. Senagore, M.D., as its Senior Medical Director.

    In his position, Dr. Senagore will be responsible for developing PolyPid's medical infrastructure in the United States, and will contribute to the Company's NDA submission, approval and commercial launch of its lead product candidate, D-PLEX100, a novel drug product candidate designed to prevent surgical site infections (SSIs) by providing local prolonged and controlled anti-bacterial activity directly at the surgical site.

    "I am delighted to welcome Dr. Senagore to the PolyPid team as we continue to advance toward commercialization of D-PLEX100," stated Amir Weisberg, CEO of PolyPid. "With near-term clinical and regulatory milestones ahead, Dr. Senagore's experience as a practicing surgeon and biopharmaceutical innovator, as well as his unique understanding of the budgeting process of hospital systems, will prove invaluable to our pursuit to reduce the clinical and financial burden of surgical site infections."

    Anthony J. Senagore, M.D., is a colorectal surgeon with a long track record of academic surgery practice and significant experience in healthcare start-up companies. He has served as Professor of Surgery at several prestigious academic medical centers, including University of Texas Medical Branch at Galveston, Central Michigan University College of Medicine, the University of Southern California, Keck School of Medicine, Cleveland Clinic Foundation, and Spectrum Health/Michigan State University. Dr. Senagore has experience with payment policy and health care economics with service on the AMA/CMA Relative Value Update Committee for 16 years and as Chair of the Practicing Physicians Advisory Committee for the Centers for Medicaid Services. In addition, Dr. Senagore has edited five textbooks in colon and rectal surgery and authored over 230 peer-reviewed publications and 25 textbook chapters.

    Commenting on his appointment, Dr. Senagore said, "Despite advancements in health technologies, SSIs remain the most prevalent type of surgery related healthcare acquired infection, burdening our economy and reducing the quality of care. I am thrilled to join PolyPid and help lead the company toward its goal of preventing the risk of SSIs to protect patients, facilitate the recovery journey, and alleviate unnecessary healthcare costs."

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a Phase 3 biopharmaceutical company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    About Dr. Anthony J. Senagore

    Anthony J. Senagore, M.D., is a colorectal surgeon with a long record of academic surgery practice. In his previous roles, Dr. Senagore served as the Chief Strategy Officer for Genetesis, a privately-held medical technology company, and consulted for several healthcare start-up companies. He has also served as Professor of Surgery at several prestigious academic medical centers, including the University of Texas Medical Branch at Galveston, Central Michigan University College of Medicine, University of Southern California's Keck School of Medicine, Michigan State University's Spectrum Health and the Cleveland Clinic Foundation. Dr. Senagore has served as Chair of the Colorectal Surgery Residency Review Committee for the Accreditation Council for Graduate Medical Education, President of the Board of Colon and Rectal Surgery. Dr. Senagore is the past President of the American Society of Colon and Rectal Surgeons and Midwest Surgical Association. He also served on the Relative Value Update Committee for 16 years and as Chair of the Practicing Physicians Advisory Committee for the Centers for Medicaid Services. Dr. Senagore has significant experience in revenue cycle and capacity management for healthcare. In addition, during his career, he was involved in the development of many innovations in laparoscopic colorectal surgery and the field of enhanced recovery. Dr. Senagore earned his medical degree from Michigan State University (MSU), East Lansing, MI. He completed his residency in General Surgery at the Butterworth Hospital/MSU program. Dr. Senagore then completed a research fellowship and colon and rectal surgery residency at Ferguson Hospital on the Grand Rapids and East Lansing campuses of MSU. He later received his Master of Science degree in physiology from MSU and a Master of Business Administration from the University of Phoenix, San Francisco, CA campus. Dr. Senagore has edited five textbooks in colon and rectal surgery and authored over 230 peer-reviewed publications and 25 textbook chapters.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its ongoing clinical trials and plans. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 5, 2021. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Corporate Contact

    PolyPid, Ltd.

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Investor Contact

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    bob@lifesciadvisors.com

    Media Contact

    Nechama Feuerstein

    551-444-0784

    Nechama.Feuerstein@finnpartners.com

     



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  7. PETAH TIKVA, Israel, June 23, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, announced that Dikla Czaczkes Akselbrad, Executive Vice President and Chief Financial Officer will present today at The Raymond James Human Health Innovation Conference at 9:20 am EDT.

    The presentation will be webcast live and archived 90 days on PolyPid's Investor Relations website, which can be found at: https://investors.polypid.com/events-and-presentations/events.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled…

    PETAH TIKVA, Israel, June 23, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, announced that Dikla Czaczkes Akselbrad, Executive Vice President and Chief Financial Officer will present today at The Raymond James Human Health Innovation Conference at 9:20 am EDT.

    The presentation will be webcast live and archived 90 days on PolyPid's Investor Relations website, which can be found at: https://investors.polypid.com/events-and-presentations/events.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its ongoing clinical trials, plans to use the guidance provided by the FDA to progress with its SHIELD I program, the timing of top-line results of the SHIELD I trial, and the size and design of the SHIELD I trial. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 5, 2021. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Corporate Contact

    PolyPid, Ltd.

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Investor Contact

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    bob@lifesciadvisors.com

    Media Contact

    Nechama Feuerstein

    551-444-0784

    Nechama.Feuerstein@finnpartners.com



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  8. FDA Agreed that a Single Pivotal Phase 3 Study is Sufficient for Potential Approval of D-PLEX100for the Prevention of Surgical Site Infections in Colorectal Surgery.

    • Enrollment in Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery Continues to Advance; Over 200 Patients Enrolled to Date

    • Top-line Results Expected by Year-end

    PETAH TIKVA, Israel, May 19, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, announced today it has received written responses from the U.S. Food and Drug Administration (FDA) to a Type B meeting request that the Company submitted regarding its development plan for D-PLEX…

    FDA Agreed that a Single Pivotal Phase 3 Study is Sufficient for Potential Approval of D-PLEX100 for the Prevention of Surgical Site Infections in Colorectal Surgery.

    • Enrollment in Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery Continues to Advance; Over 200 Patients Enrolled to Date



    • Top-line Results Expected by Year-end

    PETAH TIKVA, Israel, May 19, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, announced today it has received written responses from the U.S. Food and Drug Administration (FDA) to a Type B meeting request that the Company submitted regarding its development plan for D-PLEX100.

    The FDA indicated that PolyPid's proposal for a single Phase 3 pivotal study (SHIELD I), provided the study results are adequate, would provide sufficient evidence of clinical efficacy and safety to support approval of D-PLEX100 for the prevention of surgical site infections (SSIs) in colorectal surgery. The Type B meeting was requested following PolyPid's receipt of Breakthrough Therapy Designation from the FDA for D-PLEX100 for the prevention of SSIs in patients undergoing elective colorectal surgery.

    "We appreciate the thoughtful feedback from the FDA regarding our clinical program, and we are thrilled with the acceptance of our proposed development plan for the potential approval of D-PLEX100, which also reduces overall anticipated costs for the program," said Amir Weisberg, PolyPid's CEO. "PolyPid is dedicated to tackling the issue of SSIs that accounts for 20 percent of all healthcare-acquired infections in the U.S., resulting in extended hospital stays and readmission, costing up to $10 billion in annual medical costs. We will use the responses provided to progress our SHIELD I trial which continues to enroll patients at the expected rate, with over 200 patients enrolled to date, and we anticipate the availability of top-line results by the end of 2021."

    Launched in July 2020, SHIELD I is a prospective, multinational, multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 for the prevention of incisional SSIs post-abdominal surgery. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSI event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients, as defined by the adaptive study design, in more than 60 centers in the United States, Europe and Israel.

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its ongoing clinical trials, plans to use the guidance provided by the FDA to progress with its SHIELD I program, the timing of top-line results of the SHIELD I trial, and the size and design of the SHIELD I trial. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 5, 2021. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Corporate Contact

    PolyPid, Ltd.

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Investor Contact

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    bob@lifesciadvisors.com

    Media Contact

    Nechama Feuerstein

    551-444-0784

    Nechama.Feuerstein@finnpartners.com



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  9. • Recruitment Progressing as Planned with Nearly 200 Patients Enrolled into Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery

    • Recruitment Rate in SHIELD I trial Doubled in the Last Three Weeks

    • Manufacturing Facility Now Fully Scaled Up and Capable of Supporting at Least First 30 Months of Anticipated Commercial Demand for D-PLEX100

    • Conference Call Scheduled for Today at 8:30 AM ET

    PETAH TIKVA, Israel, May 12, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today provided a corporate update and reported financial results for the three months ended March 31, 2021.

    Recent Corporate

    • Recruitment Progressing as Planned with Nearly 200 Patients Enrolled into Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery

    • Recruitment Rate in SHIELD I trial Doubled in the Last Three Weeks

    • Manufacturing Facility Now Fully Scaled Up and Capable of Supporting at Least First 30 Months of Anticipated Commercial Demand for D-PLEX100

    • Conference Call Scheduled for Today at 8:30 AM ET

    PETAH TIKVA, Israel, May 12, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today provided a corporate update and reported financial results for the three months ended March 31, 2021.

    Recent Corporate Highlights:

    • Recruitment progressing as planned with nearly 200 patients enrolled into the ongoing Phase 3 SHIELD I (Surgical site Hospital-acquired Infection PrEvention with Local D-plex) study, the first of two ongoing Phase 3 clinical trials of the Company's lead product candidate D-PLEX100, for the prevention of surgical site infections (SSIs) in abdominal surgery (soft tissue).
    • The Company plans to enroll 616-900 patients undergoing high priority operations in 60 centers in the United States, Europe and Israel. Following the enrollment of approximately 500 patients, the study design provides for a blinded sample size re-estimation.
    • Enrollment is also advancing as anticipated in SHIELD II, the second of two Phase 3 clinical trials for D-PLEX100 in abdominal surgery (soft tissue). SHIELD II will enroll approximately 900-1,400 patients across 60 centers in the United States, Europe and Israel and has broader eligibility criteria, including minimally invasive surgical procedures.
    • Manufacturing facility is now fully scaled up and capable of producing the first 30 months of anticipated commercial demand for D-PLEX100.
    • Continued to generate compelling preclinical data from the Company's new OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes PolyPid's PLEX technology in the intra-operative tumor resection setting to provide prolonged and controlled exposure to docetaxel within the tumor resected site, which is important to prevent local tumor recurrence and the potential spreading of cancer cells.

    "We have made significant progress advancing our promising development programs and continuing our evolution towards successful commercialization," said Amir Weisberg, PolyPid's Chief Executive Officer. "Our robust Phase 3 trials for D-PLEX100 for the prevention of SSIs, SHIELD I and SHIELD II, continue to enroll patients at the expected rate. To this end, we are thrilled to report that the recruitment rate in SHIELD I trial doubled in the last three weeks and that we have now enrolled nearly 200 patients in the trial. We continue to anticipate the availability of top-line results for SHIELD I by year-end 2021 and top-line results from SHIELD II by the end of next year."

    "We also continue to generate additional compelling preclinical data with OncoPLEX, including positive safety data in a promising solid tumor indication," continued Mr. Weisberg. "We are excited to further progress our OncoPLEX development program and potentially initiate a first-in-man Phase 1 clinical trial in 2022."

    "Our strong balance sheet continues to drive our robust clinical development program. Our cash runway extends into 2022 and we remain well-positioned to complete the SHIELD I study and conduct SHIELD II, as well as prepare for the submission of a New Drug Application to the FDA with cash on hand," concluded Mr. Weisberg.

    Financial results for three months ended March 31, 2021

    • Research and development expenses for the three months ended March 31, 2021 were $6.0 million, compared to $3.4 million in the same three-month period of 2020, as spending increased due to the ongoing SHIELD I and SHIELD II Phase 3 clinical trials in abdominal surgery.
    • Marketing and business development expenses for the three months ended March 31, 2021 were $0.7 million, compared to $0.3 million for the same period of 2020, as spending increased primarily due to additional marketing and business development personnel hired in the Company's New Jersey offices.
    • General and administrative expenses for the three months ended March 31, 2021 were $2.1 million, compared to $0.7 million for the same period of 2020. This increase was due to the increase in costs due to the Company's status as a publicly traded company with higher D&O insurance costs and an increase in non-cash share-based compensation.
    • For the three months ended March 31, 2021, the Company had a net loss attributable to ordinary shares of $8.7 million, compared to a net loss of $5.9 million, in the three-month period ended March 31, 2020.
    • As of March 31, 2021, the Company had cash and cash equivalents, short-term deposits and long-term deposits in the amount of $61.4 million, compared to $66.6 million at December 31, 2020. PolyPid continues to expect that this cash balance will be sufficient to fund operations into 2022.

    Conference Call Dial-In & Webcast Information:
     Date:Wednesday, May 12, 2021
     Time:8:30 AM Eastern Time
     United States:+1 877-870-9135
     Israel:+972 1809 213-985
     International:+44 (0) 2071 928338
     Conference ID:7258907
     Webcast:https://edge.media-server.com/mmc/p/j63c5h43

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses statements relating to the expected recruitment for trials, timing of trials and release of the results thereof, the capacity of the Company's manufacturing facility, the potential benefits of PLEX and OncoPLEX, the sufficiency of the Company's cash to fund future operations, and all statements (other than statements of historical facts) that address activities, events, or developments that the Company intends, expects, projects, believes, or anticipates will or may occur in the future. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 5, 2021. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Contacts:

    PolyPid, Ltd.

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Investors:

    Bob Yedid

    LifeSci Advisors

    646-597-6989

    Bob@LifeSciAdvisors.com



    CONSOLIDATED BALANCE SHEETS
    U.S. dollars in thousands
     
     March 31,

     December 31,

     
            
            
      2021  2020

     
            
            
     Unaudited

     Audited

     
     U.S. dollars in thousands 
         
    ASSETS    
         
    CURRENT ASSETS:    
    Cash and cash equivalents$ 5,993 $ 4,319 
    Restricted cash 385  390 
    Short-term deposits 43,279  40,157 
    Prepaid expenses and other receivables 1,286  2,334 
         
    Total current assets 50,943  47,200 
         
    LONG-TERM ASSETS:    
    Property and equipment, net 6,023  5,890 
    Long-term deposits 12,100  22,120 
    Other long-term assets 773  637 
         
    Total long-term assets 18,896  28,647 
         
    Total assets 69,839  75,847 
           



    CONSOLIDATED BALANCE SHEETS

    U.S. dollars in thousands (except share and per share data)
     
      March 31,

     December 31,

       2021 2020
      Unaudited

     Audited

       U.S. dollars in thousands

             
    LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY        
             
    CURRENT LIABILITIES:        
    Trade payables $1,468  $ 974 
    Other payables and accrued expenses  2,038   1,903 
             
    Total current liabilities  3,506   2,877 
             
    Long-term liabilities:        
    Other liabilities  186   193 
             
    Total long-term liabilities  186   193 
             
    Commitments and Contingencies        
              
    Shareholders' equity:        
    Share capital -        
    Ordinary shares with no par value - Authorized: 47,800,000 shares at March 31, 2021 (unaudited) and December 31, 2020; Issued and outstanding: 18,745,142 and 18,494,739 shares at March 31, 2021 (unaudited) and December 31, 2020, respectively.  -   - 
    Additional paid-in capital  207,120   205,063 
    Accumulated deficit  (140,973)  (132,286)
             
    Total shareholders' equity  66,147   72,777 
             
    Total liabilities, convertible preferred shares and shareholders' equity $69,839  $75,847 
             



    CONSOLIDATED STATEMENTS OF OPERATIONS
    U.S. dollars in thousands (except share and per share data)
     
      Three months ended



    March 31,

     
      2021 2020

     
        
      Unaudited

     
      U.S. dollars in thousands  
             
    Operating expenses:        
    Research and development, net $6,018  $3,433 
    Marketing and business development expenses  652   276 
    General and administrative  2,127   727 
          
    Operating loss  8,797   4,436 
    Financial expense (income), net  (110)  1,433 
          
    Net loss $8,687  $5,869 
          
    Net loss attributable to Ordinary shares $8,687  $5,869 
          
    Basic and diluted net loss per Ordinary share $0.47  $13.90 
          
    Weighted average number of Ordinary shares used in computing basic and diluted net loss per share  18,623,154   562,748 
          


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  10. PETAH TIKVA, Israel, April 29, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today announced that it will report its first quarter 2021 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, May 12, 2021. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date: Wednesday, May 12, 2021
    Time:8:30 AM Eastern Time
    United States:+1 877 870 9135
    Israel:+972 1809 213-985
    International:+44 (0) 2071 928338
    Conference ID:

    PETAH TIKVA, Israel, April 29, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today announced that it will report its first quarter 2021 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, May 12, 2021. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date: Wednesday, May 12, 2021
    Time:8:30 AM Eastern Time
    United States:+1 877 870 9135
    Israel:+972 1809 213-985
    International:+44 (0) 2071 928338
    Conference ID:7258907
    Webcast:https://edge.media-server.com/mmc/p/j63c5h43

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains projections and other forward-looking statements regarding future events or our future financial performance. All statements other than present and historical facts and conditions contained in this release are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. Actual events or results may differ materially from those contained in the projections or forward-looking statements. Forward-looking statements in this release are made pursuant to the safe harbor provisions contained in the Private Securities Litigation Reform Act of 1995. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.



    Contacts: 
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    
    Investors:
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    Bob@LifeSciAdvisors.com

    Primary Logo

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  11. PETAH TIKVA, Israel, Feb. 23, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharmaceutical company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today announced that it will present at the Raymond James 42nd Annual Institutional Investors Conference and the Barclays Global Healthcare Conference in March. The Company will also participate in one-on-one investor meetings during both events.

    Please find presentation details below:

    Raymond James 42nd Annual Institutional Investors Conference

    Date:Wednesday, March 3, 2021
    Time:8:20 AM Eastern Time
    Webcast:https://kvgo.com/rjinstitutionalinvestors/polypid-march-2021

    Barclays Global Healthcare Conference…

    PETAH TIKVA, Israel, Feb. 23, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharmaceutical company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today announced that it will present at the Raymond James 42nd Annual Institutional Investors Conference and the Barclays Global Healthcare Conference in March. The Company will also participate in one-on-one investor meetings during both events.

    Please find presentation details below:

    Raymond James 42nd Annual Institutional Investors Conference

    Date:Wednesday, March 3, 2021
    Time:8:20 AM Eastern Time
    Webcast:https://kvgo.com/rjinstitutionalinvestors/polypid-march-2021

    Barclays Global Healthcare Conference

    Date: Tuesday, March 9, 2021
    Time:7:30 AM Eastern Time
    Webcast:https://kvgo.com/2021-global-healthcare-conference/polypid-march-2021

    Replays of the conferences will be available following each live event using the webcast links above. Each presentation will also be accessible in the Investor Relations section of the PolyPid website at http://www.polypid.com

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. Because such statements deal with future events and are based on PolyPid's current expectations, they are subject to various risks and uncertainties. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission (SEC), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.



    Contacts: 
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    
    Investors:
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    Bob@LifeSciAdvisors.com

    Primary Logo

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  12. Top-line Data Anticipated by Year End 2021

    Enrollment Also Continues to Progress in Company's Second Phase 3 Clinical Trial, SHIELD II

    PETAH TIKVA, Israel, Feb. 16, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharmaceutical company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today announced that the 100th patient has been enrolled and randomized in the SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company's first of two Phase 3 clinical trials for its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infections (soft tissue).

    "Enrollment in our first…

    Top-line Data Anticipated by Year End 2021

    Enrollment Also Continues to Progress in Company's Second Phase 3 Clinical Trial, SHIELD II

    PETAH TIKVA, Israel, Feb. 16, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharmaceutical company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today announced that the 100th patient has been enrolled and randomized in the SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company's first of two Phase 3 clinical trials for its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infections (soft tissue).

    "Enrollment in our first Phase 3 clinical trial, SHIELD I, continues to progress as expected, and we are excited to have now enrolled and randomized the 100th patient into this important study," said Amir Weisberg, PolyPid's CEO. "We continue to anticipate the availability of top-line results from SHIELD I by end of this year. Moreover, enrollment in our second Phase 3 trial, SHIELD II, which has broader eligibility criteria than SHIELD I with the inclusion of minimally invasive surgical procedures, commenced in late 2020 and also continues to advance as expected."

    SHIELD I is a prospective, multinational, multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 in the prevention of incisional surgical site infections (SSIs) post-abdominal surgery. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSIs event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients, as defined by the adaptive study design, in more than 60 centers in the United States, Europe and Israel.

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses statements relating to the expected timing of trials and release of the results thereof, the potential benefits of PLEX and OncoPLEX, the sufficiency of the Company's cash to fund future operations, and all statements (other than statements of historical facts) that address activities, events, or developments that the Company intends, expects, projects, believes, or anticipates will or may occur in the future. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's prospectus filed pursuant to Rule 424(b)(4), filed with the SEC on June 29, 2020. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.



    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    ir@polypid.com
    
    Investors contact:
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    Bob@LifeSciAdvisors.com

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    • 100 Patients Enrolled into Phase 3 SHIELD I and SHIELD II Trials of D-PLEX100 in Abdominal Surgery

    • Recently Initiated Phase 3 SHIELD II Trial

    • Granted Breakthrough Therapy Designation from FDA for D-PLEX100 for Prevention of SSIs in Patients Undergoing Elective Colorectal Surgery

    • Conference Call Scheduled for Today at 8:30 AM ET

    PETAH TIKVA, Israel, Feb. 10, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today provided a corporate update and reported financial results for the three months and full-year ended December 31, 2020.

    Recent Corporate Highlights:

    • Enrolled 100 patients in total into the two…
    • 100 Patients Enrolled into Phase 3 SHIELD I and SHIELD II Trials of D-PLEX100 in Abdominal Surgery



    • Recently Initiated Phase 3 SHIELD II Trial



    • Granted Breakthrough Therapy Designation from FDA for D-PLEX100 for Prevention of SSIs in Patients Undergoing Elective Colorectal Surgery



    • Conference Call Scheduled for Today at 8:30 AM ET



    PETAH TIKVA, Israel, Feb. 10, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today provided a corporate update and reported financial results for the three months and full-year ended December 31, 2020.

    Recent Corporate Highlights:

    • Enrolled 100 patients in total into the two ongoing Phase 3 trials, SHIELD I and SHIELD II. SHIELD I (Surgical site Hospital-acquired Infection PrEvention with Local D-plex) trial is the first of two Phase 3 clinical trials of D-PLEX100, the Company's lead product candidate, for the prevention of surgical site infections (SSIs) in abdominal surgery (soft tissue). The Company plans to enroll 600-900 patients undergoing high priority operations in 60 centers in the United States, Europe and Israel. Following the enrollment of approximately 500 patients, the study design provides for a blinded sample size re-estimation.
    • SHIELD II, the second of two Phase 3 clinical trials for D-PLEX100 in abdominal surgery (soft tissue), will enroll approximately 900-1,400 patients across the same number of centers as SHIELD I, and has broader eligibility criteria, including minimally invasive surgical procedures.
    • Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for D-PLEX100 for the prevention of SSIs in patients undergoing elective colorectal surgery.
    • Announced positive preclinical data from the Company's new OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes PolyPid's PLEX technology in the intra-operative tumor resection setting to provide prolonged and controlled exposure to docetaxel within the tumor resected site, which is important to prevent the local tumor reoccurrence and the potential spreading of cancer cells. In a syngeneic mouse model for solid tumors of colon carcinoma using cancer cells highly resistant to docetaxel, a single local application of OncoPLEX at the intra-operative setting post tumor resection showed improved overall survival and significantly less tumor recurrence, and reduced systemic toxicity compared to the group treated with six subsequent cycles of systemic docetaxel treatment with 2-4 days gap between cycles.
    • Hosted a key opinion leader webinar on D-PLEX100 for the prevention of SSIs. The webinar featured Hartzell V. Schaff, MD, Mayo Clinic, Anthony J. Senagore, MD, formerly of UTMB at Galveston, and Oded Zmora, MD, Shamir Medical Center, Israel, who discussed the burden and challenges related to SSIs post- colorectal and cardiovascular surgeries and the opportunity for D-PLEX100 to change the current therapeutic landscape. A recording of the KOL event can be found on PolyPid's website http://www.polypid.com

    "2020 was truly a transformative year for PolyPid," said Amir Weisberg, Chief Executive Officer. "Most importantly, our Phase 3 program for D-PLEX100 for the prevention of SSIs is progressing as planned. We are excited to report that we have now enrolled 100 patients collectively in our two Phase 3 programs, with the vast majority of those subjects in our ongoing SHIELD I trial. We continue to anticipate top-line results from SHIELD I by year-end 2021. Moreover, our second Phase 3 trial in abdominal surgery, SHIELD II, which was recently initiated, is advancing as anticipated. We also received regulatory validation of the potential of D-PLEX100 to demonstrate substantial improvement in the prevention of SSIs in complex surgical settings when we were granted Breakthrough Therapy Designation from the FDA for D-PLEX100 in late 2020.

    "We believe our innovative PLEX technology has potential in multiple areas of medicine where locally administered extended-release and controlled therapies are most beneficial, including oncology," continued Mr. Weisberg. "To this end, the positive preclinical data demonstrated with OncoPLEX support our belief that direct local application of this promising adjuvant therapy in the intra-operative tumor resection setting has the potential to overcome the chemotherapeutic drug resistance seen in many cancer patients across different solid tumors. We look forward to further advancing our OncoPLEX development program and potentially initiating a Phase 1 clinical trial in 2022.

    "We also continue to operate from a position of significant financial strength. Our successfully completed IPO on the Nasdaq in June 2020 that generated $62.8 million in net proceeds helped extend our cash runway into 2022. We are well-positioned to complete the SHIELD I study and conduct SHIELD II, as well as prepare for the submission of a New Drug Application to the FDA. Lastly, we are proud and delighted to update that PolyPid recently joined the ARK Israeli Innovative Technology ETF designed to track listed Israeli companies who are causing disruptive innovation in their field, including life sciences," concluded Mr. Weisberg.

    Financial results for three months ended December 31, 2020

    • Research and development (R&D) expenses for the three months ended December 31, 2020 were $5.0 million, compared to $3.3 million in the same three-month period of 2019, as spending increased due to the initiation of SHIELD I and SHIELD II Phase 3 clinical trials in abdominal surgery.
    • General and administrative (G&A) expenses for the three months ended December 31, 2020 were $2.2 million, compared to $0.8 million for the same period of 2019, as costs increased due to being a publicly-traded company with higher D&O insurance costs, and an increase in non-cash share-based compensation.
    • Marketing and Business Development expenses for the three months ended December 31, 2020 were $0.7million, compared to $0.3 million for the same period of 2019, as spending increased mainly due to an increase in marketing and business development personnel in our new offices in New Jersey.
    • For the three months ended December 31, 2020, the Company had a net loss attributable to ordinary shares of $7.5million, compared to a net loss of $3.9 million, in the three-month period ended December 31, 2019.

    Financial results for the full-year ended December 31, 2020

    • R&D expenses for the year ended December 31, 2020 were $17.0 million, compared to $14.1 million in the same period of 2019, as spending increased due to the initiation of SHIELD I and SHIELD II Phase 3 clinical trials in abdominal surgery.
    • G&A expenses for the year ended December 31, 2020 were $7.7 million, compared to $3.6 million for the same period of 2019, as costs increased due to being a publicly-traded company with higher D&O insurance costs, and an increase in non-cash share-based compensation.
    • Marketing and Business Development expenses for the year ended December 31, 2020 were $1.6 million, compared to $0.9 million for the same period of 2019, as spending increased due to the establishment of our new offices in New Jersey, United states, with senior marketing and business development personnel.
    • For the year ended December 31, 2020, the Company had a net loss attributable to ordinary shares of $39.0 million, or ($4.07) per diluted share, compared to a net loss of $6.9 million, or ($23.69) per diluted share, for the year ended December 31, 2019.

    Balance Sheet Highlights

    • As of December 31, 2020, the Company had cash and cash equivalents, short-term deposits and long-term deposits in the amount of $66.6 million, compared to $26.6 million at December 31, 2019. This reflects the completion of the Company's IPO in June 2020, which raised net proceeds of $62.8 million, after underwriting fees and offering expenses. PolyPid expects that this cash balance will be sufficient to fund operations into 2022.

    Conference Call Dial-In & Webcast Information:

     Date:Wednesday, February 10, 2021
     Time:8:30 AM Eastern Time
     United States:+1 877-870-9135
     Israel:+972 1809 213-985
     International:+44 (0) 2071 928338
     Conference ID:1468387
     Webcast:https://edge.media-server.com/mmc/p/cx5so6fj

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses statements relating to the expected timing of trials and release of the results thereof, the potential benefits of PLEX and OncoPLEX, the sufficiency of the Company's cash to fund future operations, and all statements (other than statements of historical facts) that address activities, events, or developments that the Company intends, expects, projects, believes, or anticipates will or may occur in the future. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's prospectus filed pursuant to Rule 424(b)(4), filed with the SEC on June 29, 2020. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.



    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    CONSOLIDATED BALANCE SHEETS   
    U.S. dollars in thousands 



     
      

    December 31,

     
       

    2020

       

    2019

      
      

    (Unaudited)

     

    (Audited)

     
          

    ASSETS

         
          

    CURRENT ASSETS:

         

    Cash and cash equivalents

     

    $

    4,319

      

    $

            3,924

      

    Restricted cash

      

    390

       

    375

      

    Short-term deposits

      

    40,157

       

    22,685

      

    Prepaid expenses and other receivables

      

    2,729

       

    417

      
          

    Total current assets

      

    47,595

       

    27,401

      
          

    Long-term assets:

         

    Property and equipment, net

      

    5,890

       

    6,121

      

    Long-term deposits

      

    22,120

       

    -

      

    Other long-term assets

      

    242

       

    230

      
          

    Total long-term assets

      

    28,252

       

    6,351

      
          

    Total assets

     

    $

            75,847

      

    $

            33,752

      

     

    CURRENT LIABILITIES:

         

    Trade payables

     

    $

            974

      

    $

            1,581

      

    Other payables and accrued expenses

      

    1,903

       

    998

      
          

    Total current liabilities

      

    2,877

       

    2,579

      
          

    Long-term liabilities:

         

    Other liabilities

      

    193

       

    251

      

    Warrants to convertible preferred shares

      

    -

       

    12,241

      
          

    Total long-term liabilities

      

    193

       

    12,492

      
          

    Commitments and Contingencies

         

    Convertible preferred shares:

         

    Preferred A, A-1, B, B-1, C-1, C-2, D-1, D-3, E and E-1 shares with no par value - Authorized: 0 and 17,916,412 shares at December 31, 2020 and 2019, respectively; Issued and outstanding: 0 and 12,520,977 shares at December 31, 2020 and 2019, respectively.

      

    -

       

    106,313

      
          

    Shareholders' equity (deficit):

         

    Share capital -

         

    Ordinary shares with no par value - Authorized: 47,800,000 and 22,520,977 shares at December 31, 2020 and 2019, respectively; Issued and outstanding: 18,494,739 and 562,748 shares at December 31, 2020 and 2019, respectively.

      

    -

       

    -

      

    Additional paid-in capital

      

    205,063

       

    5,671

      

    Accumulated deficit

      

    (132,286

    )

      

    (93,303

    )

     
          

    Total shareholders' equity (deficit)

      

    72,777

       

    (87,632

    )

     
          

    Total liabilities, convertible preferred shares and shareholders' equity (deficit)

     

    $

            75,847

      

    $

            33,752

      



     





      





      



    CONSOLIDATED STATEMENTS OF OPERATIONS   
    U.S. dollars in thousands (except share and per share data) 



      

    Year ended

    December 31,

       

    2020

      

    2019

     
      

    (Unaudited)

     

    (Audited)

    Operating expenses:

        

    Research and development, net

     

    $

            16,954

     

    $

            14,083

     

    Marketing and business development expenses

      

    1,614

      

    887

     

    General and administrative

      

    7,704

      

    3,590

     
         

    Operating loss

      

    26,272

      

    18,560

     

    Financial (income) expense, net

      

    10,597

      

    (11,655

    )

         

    Net loss

     

    $

            36,869

     

    $

            6,905

     
         

    Deemed dividend

      

    2,114

      

    -

     
         

    Net loss attributable to Ordinary shares

     

    $

            38,983

     

    $

            6,905

     
         

    Basic and Diluted net loss per Ordinary share

     

    $

            4.07

     

    $

             23.69

     
         

    Weighted average number of Ordinary shares used in computing basic and diluted net loss per share

      

    9,582,405

      

    562,451

     



      



      



     

     

    CONSOLIDATED STATEMENTS OF OPERATIONS  
    U.S. dollars in thousands (except share and per share data) 



      

    Three Months Ended

    December 31,

       

    2020

      

    2019

      

    (Unaudited)

     

    (Unaudited)

    Operating expenses:

        

    Research and development, net

     

    $

            5,006

     

    $

            3,314

    Marketing and business development expenses

      

    710

      

    316

    General and administrative

      

    2,172

      

    778

         

    Operating loss

      

    7,888

      

    4,408

    Financial income, net

      

    339

      

    548

         

    Net loss

     

    $

            7,549

     

    $

            3,860

         

    Deemed dividend

      

    -

      

    -

         

    Net loss attributable to Ordinary shares

     

    $

            7,549

     

    $

            3,860

         

    Basic and Diluted net loss per Ordinary share

     

    $

            0.41

     

    $

             6.86

         

    Weighted average number of Ordinary shares used in computing basic and diluted net loss per share

      

    18,494,773

      

    562,748



      



      





    Contacts:
    PolyPid, Ltd.
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    
    Investors:
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    Bob@LifeSciAdvisors.com

    Primary Logo

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  13. PETAH TIKVA, Israel, Jan. 27, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will report its fourth quarter and full year 2020 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, February 10, 2021. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

     Date: Wednesday, February 10, 2021
     Time:8:30 AM Eastern Time
     United States:+1 877 870 9135
     Israel:

    PETAH TIKVA, Israel, Jan. 27, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will report its fourth quarter and full year 2020 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, February 10, 2021. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

     Date: Wednesday, February 10, 2021
     Time:8:30 AM Eastern Time
     United States:+1 877 870 9135
     Israel:+972 1809 213-985
     International:+44 (0) 2071 928338
     Conference ID:1468387
     Webcast:https://edge.media-server.com/mmc/p/cx5so6fj

    About PolyPid

    PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).

    For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

    Forward-looking Statements

    This press release contains projections and other forward-looking statements regarding future events or our future financial performance. All statements other than present and historical facts and conditions contained in this release are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. Actual events or results may differ materially from those contained in the projections or forward-looking statements. Forward-looking statements in this release are made pursuant to the safe harbor provisions contained in the Private Securities Litigation Reform Act of 1995. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.



    Contacts: 
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    
    Investors:
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    Bob@LifeSciAdvisors.com

    Primary Logo

    View Full Article Hide Full Article
  14. Single Local Treatment of OncoPLEX Showed Improved Overall Survival and Significantly Less Tumor Recurrence, and Reduced Systemic Toxicity Compared to Multiple Injections with Standard Systemic Chemotherapy in a Syngeneic Mouse Model for Solid Tumors of Colon Carcinoma

    Company Intends to Complete an IND Package with Additional Preclinical Studies in Various Solid Tumor Types, Followed by the Initiation of a Phase 1 Clinical Trial in 2022

    PETAH TIKVA, Israel, Dec. 22, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced positive preclinical data from…

    Single Local Treatment of OncoPLEX Showed Improved Overall Survival and Significantly Less Tumor Recurrence, and Reduced Systemic Toxicity Compared to Multiple Injections with Standard Systemic Chemotherapy in a Syngeneic Mouse Model for Solid Tumors of Colon Carcinoma

    Company Intends to Complete an IND Package with Additional Preclinical Studies in Various Solid Tumor Types, Followed by the Initiation of a Phase 1 Clinical Trial in 2022

    PETAH TIKVA, Israel, Dec. 22, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced positive preclinical data from its OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes the Company's novel PLEX technology to provide prolonged and controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, in the intra-operative tumor resection setting. OncoPLEX is designed for the delivery of sustained, significant concentrations of docetaxel locally within the tumor site for a few weeks, potentially reducing local tumor recurrence and tumor metastatic spreading.

    In a syngeneic mouse model for solid tumors of colon carcinoma, a single local application of OncoPLEX at the intra-operative setting post tumor resection compared to the group treated with six cycles of systemic docetaxel treatment with 2-4 days gap between cycles, generated the following key results:

    • OncoPLEX arm showed 25% overall tumor recurrence at the end of the study (day 39 post-surgery) compared to 75% in the systemic treatment arm, and 100% in the untreated control arm.
    • OncoPLEX arm demonstrated 75% overall tumor free survival at the end of the study (day 39 post-surgery), compared to 25% in the systemic treatment arm, and 0% in the untreated control arm.
    • OncoPLEX arm demonstrated 75% overall survival at the end of the study (day 39 post-surgery), compared to 50% in the systemic treatment arm, and 0% in the untreated control arm.

    Dose response was also demonstrated for OncoPLEX in these studies.

    Systemic toxicity was lower following the local application of OncoPLEX versus systemic docetaxel. Additional data in a pharmacokinetic model showed that the maximal plasma concentration of docetaxel was >10 times lower with OncoPLEX than with systemic docetaxel.

    "We believe the benefits of our PLEX platform, including the ability to generate constant and high local concentration of drug over a prolonged period, can also potentially be leveraged as an anti-cancer therapy," said Dr. Noam Emanuel, PolyPid's Chief Scientific Officer. "We are very encouraged by these preclinical data, as they support our belief that direct local application of OncoPLEX in the intra-operative tumor resection setting has the potential to be a promising new type of adjuvant therapy to reduce local tumor recurrence and to prevent postoperative metastatic spreading by cancer cells that escape resection, as seen in many oncology patients across different solid tumors."

    Based on these compelling preclinical results, PolyPid intends to conduct additional preclinical safety studies of OncoPLEX in various type of solid tumor resections, in order to complete a preclinical package for the filing of pre-Investigational New Drug meeting request with the U.S. Food and Drug Administration in 2021 and potentially initiate a Phase 1 clinical trial in 2022.

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions and the professional leadership of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, PolyPid is using forward-looking statements in this press release when it discusses the potential of its products and that it intends to conduct additional preclinical safety studies of OncoPLEX in various type of solid tumor resections, in order to complete a preclinical package for the filing of pre-Investigational New Drug meeting request with the U.S. Food and Drug Administration in 2021 and potentially initiate a Phase 1 clinical trial in 2022. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission (SEC), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

     



    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    ir@polypid.com
    
    Investors contact: 
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    Bob@LifeSciAdvisors.com

    Primary Logo

    View Full Article Hide Full Article
  15. Enrollment in SHIELD I, the First Phase 3 Clinical Trial Continues to Progress, with Top-line Data Anticipated in Second Half of 2021

    PETAH TIKVA, Israel, Dec. 16, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that the first patient has been enrolled and randomized in the SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company's second of two Phase 3 clinical trials for its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infection (soft tissue).

    "Three…

    Enrollment in SHIELD I, the First Phase 3 Clinical Trial Continues to Progress, with Top-line Data Anticipated in Second Half of 2021

    PETAH TIKVA, Israel, Dec. 16, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that the first patient has been enrolled and randomized in the SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company's second of two Phase 3 clinical trials for its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infection (soft tissue).

    "Three weeks after D-PLEX100 received Breakthrough Therapy Designation from the FDA, the enrollment of the first patient in our second Phase 3 trial is a significant achievement for our D-PLEX100 clinical development program. Importantly, SHIELD II will have broader eligibility criteria than SHIELD I, with the inclusion of minimally invasive surgical procedures, providing additional clinical evaluation of the potential of D-PLEX100 to prevent surgical site infections (SSIs) in broader target populations," said Amir Weisberg, PolyPid's CEO. "Enrollment in our first Phase 3 clinical trial, SHIELD I, continues to progress as expected and we anticipate the availability of top-line results from this study in the second half of next year. SHIELD I and SHIELD II will serve as the basis for our first New Drug Application submission."

    "Based on the compelling data generated to date, D-PLEX100, if approved, has the potential to be a highly effective solution in preventing SSIs, even in the most complex surgical settings such as abdominal surgery with colorectal resection," said Anthony Senagore, M.D., a leading colorectal surgeon, and a medical advisor to PolyPid. "As systemic antibiotic penetration into the surgical wound is significantly limited due to blood flow interruption, a substantial unmet need remains in preventing SSIs. I look forward to the continued clinical assessment of this promising therapeutic candidate in the SHIELD I and SHIELD II studies."

    SHIELD II (NCT04411199) is a prospective, multinational, multicenter, randomized, double-blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with the Standard of Care (SoC), compared to a SoC-treated control arm, for the prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial is the infection rate, as measured by the proportion of subjects with at least one abdominal target incisional infection event within 30 days post-abdominal surgery, determined by a blinded independent adjudication committee. The trial will enroll a minimum of 900 patients, with a maximum of approximately 1,400 subjects, as defined by the adaptive study design, in approximately 60 centers in the United States, Europe and Israel.

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions and the professional leadership of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, PolyPid is using forward-looking statements in this press release when it discusses the potential of D-PLEX100 to prevent SSIs, and the enrollment and timing of clinical trials. Because such statements deal with future events and are based on PolyPid's current expectations, they are subject to various risks and uncertainties. Also, while PolyPid has received Fast Track Designation for D-PLEX100 for the prevention of SSIs, it cannot guarantee that it will be able to maintain such designation due to reasons within our outside of its control. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission (SEC), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

     



    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    ir@polypid.com
    
    Investors contact: 
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    Bob@LifeSciAdvisors.com

    Primary Logo

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  16. PETAH TIKVA, Israel, Dec. 03, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will host a key opinion leader (KOL) call on D-PLEX100 for the prevention of surgical site infections on Tuesday, December 15, 2020, at 8:00 am Eastern Time.

    The call will feature presentations by KOLs Hartzell V. Schaff, MD, Mayo Clinic, Anthony J. Senagore, MD, Formerly of UTMB at Galveston, and Oded Zmora, MD, Shamir Medical Center, Israel, who will discuss the burden and challenges related to surgical site infections (SSIs) post colorectal and cardiovascular…

    PETAH TIKVA, Israel, Dec. 03, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will host a key opinion leader (KOL) call on D-PLEX100 for the prevention of surgical site infections on Tuesday, December 15, 2020, at 8:00 am Eastern Time.

    The call will feature presentations by KOLs Hartzell V. Schaff, MD, Mayo Clinic, Anthony J. Senagore, MD, Formerly of UTMB at Galveston, and Oded Zmora, MD, Shamir Medical Center, Israel, who will discuss the burden and challenges related to surgical site infections (SSIs) post colorectal and cardiovascular surgeries and the opportunity for D-PLEX100 to change the current status quo for the better. Dr. Schaff, Dr. Senagore, and Dr. Zmora will be available to answer questions following the formal presentations.

    PolyPid's management team will also discuss its developmental plans for D-PLEX100.

    To register for the call, please register here.

    Dr. Schaff is the Stuart W. Harrington Professor of Surgery and a consultant in the Division of Cardiovascular Surgery at Mayo Clinic, Rochester, Minnesota. He is a member of major international societies, including the American Association for Thoracic Surgery (2012-2013 President). He has authored or co-authored 784 papers, 94 book chapters, edited or written nine textbooks, and delivered over 500 lectures. He has served or is serving on the editorial boards of 11 journals, including Circulation and the Journal of Thoracic and Cardiovascular Surgery, where he is currently the Associate Editor. Dr. Schaff received his medical degree and training at the University of Oklahoma School of Medicine, where he also completed an NIH Research Fellowship. His surgical training was completed at Johns Hopkins Hospital.

    Anthony J. Senagore, MD, is a colorectal surgeon with a long track record of academic surgery practice. He now serves as the Chief Strategy Officer for Genetesis in Mason, Ohio, and consults several healthcare startup companies. He has served as Professor of Surgery at several prestigious academic medical centers, including UTMB (University of Texas Medical Branch) at Galveston, Central Michigan University, College of Medicine, the University of Southern California, Keck School of Medicine, Cleveland Clinic Foundation, and Spectrum Health/Michigan State University. He has served as Chair of the Colorectal Surgery Residency Review Committee for the ACGME, President of the Board of Colon and Rectal Surgery, and he is a Past President of the ASCRS and Midwest Surgical Association. He also served on the Relative Value Update Committee for 16 years and as Chair of the Practicing Physicians Advisory Committee for the Centers for Medicaid Services. He has significant experience in revenue cycle and capacity management for healthcare. In addition, during his career, he was involved in the development of many innovations in laparoscopic colorectal surgery and the field of enhanced recovery.

    Dr. Senagore earned his medical degree from Michigan State University (MSU), East Lansing, MI. He completed his residency in General Surgery at the Butterworth Hospital/MSU program. Dr. Senagore then completed a research fellowship and colon and rectal surgery residency at Ferguson Hospital on the Grand Rapids and East Lansing campuses of MSU. He continued his education and later received his Master of Science degree in physiology from MSU and a Master of Business Administration from the University of Phoenix, San Francisco, CA campus. He has edited five textbooks in colon and rectal surgery, authored over 230 peer-reviewed publications and 25 textbook chapters.

    Oded Zmora, MD is a Colon and Rectal Surgeon and Chair of the Department of Surgery, Shamir Medical Center, Israel. He is also an associate professor of surgery at the Tel Aviv University School of Medicine. Dr. Zmora's education and training include residency in general surgery at the Sheba Medical Center in Israel and the Mount Sinai Medical Center in New York, followed by two years of clinical and research fellowships at the Cleveland Clinic, Florida. Dr. Zmora is a past president of the Israel Society of Colon and Rectal Surgeons, immediate past chair of the S-ECCO (Surgeons' European Crohn and Colitis Organization), and past co-editor of Techniques in Coloproctology. His main research interests focus on colorectal surgery, including surgical infectious complications, prevention of colorectal cancer metastases, treatment of perineal fistulas, and clinical research in colon and rectal surgery.

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the FDA for the prevention of surgical site infections (SSIs) in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions and the professional leadership of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, PolyPid is using forward-looking statements in this press release when it discusses its development and commercial plans for D-PLEX100 and Phase 3 trials of D-PLEX100. Because such statements deal with future events and are based on PolyPid's current expectations, they are subject to various risks and uncertainties. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission ("SEC"), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.



    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700 
    ir@polypid.com
    
    Investors contact:
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    bob@lifesciadvisors.com

    Primary Logo

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  17. PETAH TIKVA, Israel, Nov. 24, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of surgical site infections (SSIs) in patients undergoing elective colorectal surgery.

    Breakthrough Therapy Designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition so patients may have access to therapies through FDA approval as soon as possible…

    PETAH TIKVA, Israel, Nov. 24, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of surgical site infections (SSIs) in patients undergoing elective colorectal surgery.

    Breakthrough Therapy Designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition so patients may have access to therapies through FDA approval as soon as possible. This designation is granted based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

    "The Breakthrough Therapy Designation in the field of anti-infective drugs is rather rare, and further supports the urgency to develop new innovative therapies to prevent SSIs," said Amir Weisberg, PolyPid's CEO. "It also reflects on the promising clinical data of D-PLEX100 in the prevention of SSIs in complex surgical settings, such as colorectal abdominal surgeries. We are looking forward to working closely with the FDA to make D-PLEX100 available to surgeons and patients as quickly as possible. Our ongoing Phase 3 pivotal studies in abdominal surgery - SHIELD I and SHIELD II - are on track."

    The Breakthrough Therapy Designation for D-PLEX100 is based on conclusive positive results from a Phase 2 clinical trial evaluating D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal colorectal surgery. The Phase 2 clinical trial was a prospective, multicenter, randomized, controlled two arm study in 201 patients and demonstrated that the local administration of D-PLEX100 resulted in a statistically significant decrease in SSIs of 59 percent in the Intent to Treat (ITT) population (p=0.0086), and a decrease of 69 percent in the Per Protocol population (n=179; p=0.0024), as compared to the standard of care alone.

    D-PLEX100 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 Product designations (QIDP's) in the same indications.

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel drug product candidate designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations from the FDA for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions and the professional leadership of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, PolyPid is using forward-looking statements in this press release when it discusses the potential of D-PLEX100 to prevent SSIs, timing, subject matter and frequency of communications with the FDA, and providing a safe and effective solution for surgeons and their patients as quickly as possible. Because such statements deal with future events and are based on PolyPid's current expectations, they are subject to various risks and uncertainties. Also, while PolyPid has received Fast Track Designation for D-PLEX100 for the prevention of surgical site infections, and Breakthrough Therapy Designation for the prevention of SSIs in colorectal surgery, it cannot guarantee that it will be able to maintain such designation due to reasons within our outside of its control. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission ("SEC"), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.



    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    
    Investors contact: 
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    Bob@LifeSciAdvisors.com

    Primary Logo

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  18. •  Over 50% of planned 60 centers for ongoing Phase 3 SHIELD I trial of D-PLEX100in abdominal surgery have received IRB approval 

    •  Phase 3 SHIELD II trial advanced; preparations underway to initiate by year-end 2020

    •  Conference Call Scheduled for today at 8:30 a.m. ET

    PETAH TIKVA, Israel, Nov. 11, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD) (the "Company"), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today provided a corporate update and reported financial results for the three and nine months ended September 30, 2020.

    Recent Corporate Highlights:

    • Over 50% of planned 60 centers have…

    •  Over 50% of planned 60 centers for ongoing Phase 3 SHIELD I trial of D-PLEX100 in abdominal surgery have received IRB approval 

    •  Phase 3 SHIELD II trial advanced; preparations underway to initiate by year-end 2020

    •  Conference Call Scheduled for today at 8:30 a.m. ET

    PETAH TIKVA, Israel, Nov. 11, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD) (the "Company"), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today provided a corporate update and reported financial results for the three and nine months ended September 30, 2020.

    Recent Corporate Highlights:

    • Over 50% of planned 60 centers have received institutional review board (IRB) approval for ongoing Phase 3 SHIELD I (Surgical site Hospital-acquired Infection PrEvention with Local D-plex) trial for D-PLEX100 in abdominal surgery (soft tissue). This is the first of two planned Phase 3 clinical trials of D-PLEX100, the Company's lead product candidate for the prevention of surgical site infections (SSIs) in abdominal surgery (soft tissue). The Company plans to enroll 600 - 900 patients undergoing high priority operations in 60 centers in the United States, Europe, and Israel. Following the enrollment of approximately 500 patients, the study design provides for a blinded sample size re-estimation.



    • Advanced preparations are underway to initiate SHIELD II, a second Phase 3 trial for D-PLEX100 in abdominal surgery, by year-end 2020. This second trial will have broader eligibility criteria, including minimally invasive surgical procedures, and will enroll approximately 900 - 1,400 patients across approximately 60 centers.



    • Evaluating EU commercial partnership opportunities for D-PLEX100 as part of the Company's stated commercial strategy.

    "We are very encouraged with our strong progress to date, especially readying additional sites to enroll patients in our lead Phase 3 trial, and remain on track for our planned milestones," said Amir Weisberg, Chief Executive Officer. "We continue to anticipate that top-line results from SHIELD I will be available in the second half of 2021. Moreover, we expect that the initiation of our second Phase 3 pivotal trial, SHIELD II, will occur in late 2020. SHIELD I and SHIELD II will serve as the basis for PolyPid's first New Drug Application (NDA) submission and, we believe, will support a broad label for D-PLEX100 in the prevention of SSIs."

    "We continue to operate from a strong financial position," continued Mr. Weisberg. "We expect that our current cash balance will be sufficient to complete SHIELD I and to initiate and conduct SHIELD II, as well as prepare for the submission of an NDA to the U.S. Food and Drug Administration."

    Financial results for three months ended September 30, 2020

    • Research and development (R&D) expenses for the three months ended September 30, 2020 were $4.2 million, compared to $3.8 million in the same three-month period of 2019, as spending increased due to the initiation of the Phase 3 SHIELD I clinical trial and preparations for the Phase 3 SHIELD II clinical trial.



    • General and administrative (G&A) expenses for the three months ended September 30, 2020 were $2.2 million, compared to $1.2 million for the same period of 2019, as costs increased due to becoming a publicly-traded company with higher D&O insurance costs and due to an increase in non-cash share-based compensation.



    • For the three months ended September 30, 2020, the Company had a net loss attributable to ordinary shares of $6.5 million, compared to a net loss of $2.1 million in the three-month period ended September 30, 2019.

    Financial results for nine-months ended September 30, 2020

    • R&D expenses for the nine months ended September 30, 2020 were $11.9 million, compared to $10.8 million in the same nine-month period of 2019, as spending increased due to the initiation of the Phase 3 SHIELD I clinical trial and preparations for the Phase 3 SHIELD II clinical trial.



    • G&A expenses for the nine months ended September 30, 2020 were $5.5 million, compared to $2.8 million for the same nine-month period of 2019, as costs increased due to becoming a publicly-traded company with higher D&O insurance costs and due to an increase in non-cash share-based compensation.



    • For the nine months ended September 30, 2020, the Company had a net loss attributable to ordinary shares of $31.4 million, compared to a net loss of $3.0 million, for the nine-month period ended September 30, 2019.

    Balance Sheet Highlights

    • As of September 30, 2020, the Company had cash and cash equivalents, short-term deposits and long-term deposits in the amount of $71.8 million, compared to $26.6 million as of December 31, 2019. This increase reflects the completion of the Company's IPO in June 2020, which raised net proceeds of $62.8 million, after underwriting fees and offering expenses. PolyPid expects that this cash balance will be sufficient to fund operations into 2022.

    Conference Call Dial-In & Webcast Information

    Wednesday, November 11th at 8:30 am Eastern Time

     United States:+1 877 870 9135
     Israel:+972 1809 213-985
     International:+44 (0) 2071 928338
     Conference ID:4557195
     Webcast:https://edge.media-server.com/mmc/p/u49mfor4
       

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel product candidate designed to provide local prolonged anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of up to four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (QIDP) designations, as well as two Fast Track designations from the FDA for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of SSIs in different type of surgeries, including abdominal and open-heart surgery. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses statements relating to its objectives, milestones, plans, and strategies, the expected timing of trials and release of the results thereof, the expected timing of an NDA and other regulatory matters, the research, development, the sufficiency of the Company's cash and use of the Company's platform technologies, technologies, products and product candidates, and all statements (other than statements of historical facts) that address activities, events, or developments that the Company intends, expects, projects, believes, or anticipates will or may occur in the future. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's prospectus filed pursuant to Rule 424(b)(4), filed with the SEC on June 29, 2020. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.



         
    CONSOLIDATED BALANCE SHEETS
    U.S. dollars in thousands
         
      September 30,

    2020
     December 31,

    2019
      Unaudited Audited
    ASSETS    
         
    CURRENT ASSETS:    
    Cash and cash equivalents $9,665  $3,924 
    Restricted cash  378   375 
    Short-term deposits  34,080   22,685 
    Prepaid expenses and other receivables  2,504   417 
         
    Total current assets  46,627   27,401 
         
    LONG-TERM ASSETS:    
    Property and equipment, net  6,182   6,121 
    Long-term deposits  28,068   - 
    Other long-term assets  221   230 
         
    Total long-term assets  34,471   6,351 
         
    Total assets $81,098  $33,752 
             







         
    CONSOLIDATED BALANCE SHEETS
    U.S. dollars in thousands (except share and per share data)
         
      September 30,

    2020
     December 31,

    2019
      Unaudited Audited
    LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' DEFICIENCY    
         
    CURRENT LIABILITIES:    
    Trade payables $573  $1,581 
    Other payables and accrued expenses  1,112   998 
         
    Total current liabilities  1,685   2,579 
         
    LONG-TERM LIABILITIES:    
    Other liabilities  180   251 
    Convertible preferred shares warrant liability  -   12,241 
         
    Total long-term liabilities  180   12,492 
         
    COMMITMENTS AND CONTINGENT LIABILITIES    
         
    CONVERTIBLE PREFERRED SHARES:        
    Preferred A, A-1, B, B-1, C-1, C-2, D-1, D-3, E and E-1 shares of NIS 0 par value - Authorized: 0 and 17,916,412 shares at September 30, 2020 (unaudited) and December 31, 2019, respectively; Issued and outstanding: 0 and 12,520,977 shares at September 30, 2020 (unaudited) and December 31, 2019, respectively  -   106,313 
         
    SHAREHOLDERS' EQUITY (DEFICIENCY):    
    Share capital -    
    Ordinary shares with no par value - Authorized: 47,800,000 and 22,466,000 shares at September 30, 2020 (unaudited) and December 31, 2019, respectively; Issued and outstanding: 18,494,344 and 562,748 shares at September 30, 2020 (unaudited) and December 31, 2019, respectively  -   - 
    Additional paid-in capital  203,970   5,671 
    Accumulated deficit  (124,737)  (93,303)
         
    Total shareholders' equity (deficiency)  79,233   (87,632)
         
    Total liabilities, convertible preferred shares and shareholders' equity (deficiency) $81,098  $33,752 
             





         
    CONSOLIDATED STATEMENTS OF OPERATIONS
    U.S. dollars in thousands
         
      Three months ended

    September 30,
     Nine months ended

    September 30,
       2020   2019   2020  2019 
                    
      Unaudited
             
    Operating expenses:        
    Research and development, net $4,176  $3,789  $11,948 $10,769 
    Marketing and business development expenses  323   274   904  571 
    General and administrative  2,177   1,190   5,532  2,812 
             
    Operating loss  6,676   5,253   18,384  14,152 
    Financial (income) expense, net  (218)  (3,145)  10,936  (11,107)
             
    Net loss (profit) $6,458  $2,108  $29,320 $3,045 
             
    Deemed dividend  -   -   2,114  - 
             
    Net loss (profit) attributable to Ordinary shares $6,458  $2,108  $31,434 $3,045 
             
    Basic and diluted net loss per Ordinary share $0.35  $6.94  $4.78 $13.38 
             
    Weighted average number of Ordinary shares used in computing basic and diluted net loss per share  18,415,231   562,597   6,578,969  562,354 
             













































































































     

    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-74-719-5700 
    ir@polypid.com
    
    Investor contact:
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    bob@lifesciadvisors.com

    Primary Logo

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  19. PETAH TIKVA, Israel, Nov. 04, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will present at two investor conferences in November. Details on the presentations can be found below. The company will also participate in one-on-one investor meetings at the AGP Virtual Healthcare Symposium 2020 on Thursday, November 19.

    H.C. Wainwright 6th Annual Israel Conference

    Date: Thursday, November 12, 2020
    Time:1:30 PM Eastern Time

    Stifel 2020 Virtual Healthcare Conference

    Date: Tuesday, November 17, 2020
    Time:8:00 AM Eastern Time
    Webcast:https://wsw.com/webcast/stifel27/pypd/2115344

    PETAH TIKVA, Israel, Nov. 04, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will present at two investor conferences in November. Details on the presentations can be found below. The company will also participate in one-on-one investor meetings at the AGP Virtual Healthcare Symposium 2020 on Thursday, November 19.

    H.C. Wainwright 6th Annual Israel Conference

    Date: Thursday, November 12, 2020
    Time:1:30 PM Eastern Time

    Stifel 2020 Virtual Healthcare Conference

    Date: Tuesday, November 17, 2020
    Time:8:00 AM Eastern Time
    Webcast:https://wsw.com/webcast/stifel27/pypd/2115344  

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of SSIs in different type of surgeries, including abdominal and open-heart surgery. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses statements relating to our objectives, plans, and strategies, the expected timing of trials, the research, development, and use of our platform technologies, technologies, products and product candidates, and all statements (other than statements of historical facts) that address activities, events, or developments that the Company intends, expects, projects, believes, or anticipates will or may occur in the future. Forward-looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's registration statement filed pursuant to Rule 424(b)(4), filed with the SEC on June 29, 2020. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.

    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-74-719-5700 
    ir@polypid.com
    
    Investor contact:
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    bob@lifesciadvisors.com

    Primary Logo

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  20. PETAH TIKVA, Israel, Oct. 28, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will report its third quarter 2020 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, November 11, 2020. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date: Wednesday, November 11, 2020
    Time:8:30 AM Eastern Time
    United States:+1 877 870 9135
    Israel:+972 1809 213-985

    PETAH TIKVA, Israel, Oct. 28, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will report its third quarter 2020 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, November 11, 2020. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date: Wednesday, November 11, 2020
    Time:8:30 AM Eastern Time
    United States:+1 877 870 9135
    Israel:+972 1809 213-985
    International:+44 (0) 2071 928338
    Conference ID:4557195
    Webcast:https://edge.media-server.com/mmc/p/u49mfor4  

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of SSIs in different type of surgeries, including abdominal and open-heart surgery. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release contains projections and other forward-looking statements regarding future events or our future financial performance. All statements other than present and historical facts and conditions contained in this release are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. Actual events or results may differ materially from those contained in the projections or forward-looking statements. Forward-looking statements in this release are made pursuant to the safe harbor provisions contained in the Private Securities Litigation Reform Act of 1995. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Contacts: 
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    
    Investors:
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    Bob@LifeSciAdvisors.com

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  21. Initiated Phase 3 SHIELD I Trial for D-PLEX100 in Abdominal Surgery and Received Fast Track Designation for D-PLEX100 from FDA

    Presented Positive Phase 2 Results of D-PLEX100 for Prevention of Surgical Site Infections in Abdominal Surgery at ASCRS Meeting

    Completed Initial Public Offering in U.S., Raising Net Proceeds of $62.8 Million

    Conference Call scheduled for Wednesday, August 19 at 8:30 AM Eastern Time

    PETAH TIKVA, Israel, Aug. 19, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today provided a corporate update and reported financial results for the…

    Initiated Phase 3 SHIELD I Trial for D-PLEX100 in Abdominal Surgery and Received Fast Track Designation for D-PLEX100 from FDA

    Presented Positive Phase 2 Results of D-PLEX100 for Prevention of Surgical Site Infections in Abdominal Surgery at ASCRS Meeting

    Completed Initial Public Offering in U.S., Raising Net Proceeds of $62.8 Million

    Conference Call scheduled for Wednesday, August 19 at 8:30 AM Eastern Time

    PETAH TIKVA, Israel, Aug. 19, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today provided a corporate update and reported financial results for the three and six months ended June 30, 2020.

    Recent Corporate Highlights:

    • Enrolled and randomized the first patient in the Phase 3 SHIELD I (Surgical site Hospital-acquired Infection PrEvention with Local D-plex) trial. This is the first of two planned Phase 3 clinical trials of the Company's lead product candidate, D-PLEX100, for the prevention of surgical site infections (SSIs) post-abdominal surgery (soft tissue). The Company plans to enroll 600-900 patients among 60 centers in the U.S., Europe and Israel. Following the enrollment of the first 500 patients, the study design provides for a blinded sample size re-estimation. The second Phase 3 clinical trial in the same indication, SHIELD II, is expected to begin in late 2020.
    • Received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for D-PLEX100 for the prevention of post abdominal surgery incisional infection.
    • Presented positive Phase 2 clinical trial data of D-PLEX100 for the prevention of SSIs in abdominal surgery at the American Society of Colon and Rectal Surgeons (ASCRS) 2020 Annual Scientific Conference Recorded Sessions. The data were presented via a video session based on the accepted abstract entitled, "Local Constant Prolonged Release of an Antibiotic for the Prevention of Surgical Site Infections (SSI) Post Colorectal Resection Abdominal Surgeries."
    • Completed an initial public offering (IPO) on the Nasdaq Global Market through which the Company sold 4,312,500 ordinary shares at a price to the public of $16.00 per share, raising $62.8 million of net proceeds.

    "We have recently completed a truly transformational period in PolyPid's corporate evolution," said Amir Weisberg, Chief Executive Officer. "We made significant progress in advancing our promising clinical development program for D-PLEX100 as highlighted by the initiation of our first Phase 3 clinical trial in abdominal surgery. This key milestone represented a significant step toward furthering our U.S. regulatory approval strategy and our objective to provide a novel solution for surgeons and their patients as expeditiously as possible. Moreover, we were excited to recently receive Fast Track Designation for D-PLEX100, an important regulatory validation of our innovative PLEX technology and the high clinical unmet need that currently exists in preventing surgical site infections in complex surgical settings, such as abdominal surgeries."

    Mr. Weisberg added, "We were also proud to complete our IPO on the Nasdaq Global Market in June, successfully raising $62.8 million of net proceeds. Our IPO and listing increase our visibility in the U.S. capital markets, and provides us with critical growth capital to continue the clinical development of D-PLEX100 through both Phase 3 trials in abdominal surgery, begin our rolling New Drug Application submission and initiate our commercial preparations for this compelling asset."

    Financial results for three months ended June 30, 2020

    • For the three months ended June 30, 2020, the Company had a net loss of $17 million, compared to a net profit of $0.3 million in the three-month period ended June 30, 2019.
    • Research and development (R&D) expenses for the three months ended June 30, 2020 were $4.3 million, compared to $3.5 million in the same three-month period of 2019, as spending increased due to the preparation of the Phase 3 SHIELD I clinical trial of D-PLEX100 for the prevention of SSIs in abdominal surgery.
    • General and administrative (G&A) expenses for the three months ended June 30, 2020 were $2.9 million, compared to $1.2 million for the same period of 2019, as costs increased due to the Company's IPO and an increase in non-cash share-based compensation.
    • GAAP net loss attributable to ordinary shares for the three months ended June 30, 2020 was $19.1 million, compared to GAAP net profit of $0.3 million for the three months ended June 30, 2019.
    • Non-GAAP net loss attributable to ordinary shares for the three months ended June 30, 2020 was $4.8 million compared to non-GAAP net loss of $4.3 million in the prior year period. A reconciliation between GAAP net loss and non-GAAP net loss for the three-month periods ended June 30, 2020 and 2019 is provided in the financial results that are part of this news release. The difference between GAAP to non-GAAP net loss attributable to ordinary shares is mainly due to the revaluation of our convertible preferred share warrant liability following the increase in fair value due to the IPO price.

    Financial results for six months ended June 30, 2020

    • For the six months ended June 30, 2020, the Company had a net loss of $22.9 million, compared to a net loss of $0.9 million for the six-month period ended June 30, 2019.
    • R&D expenses for the six months ended June 30, 2020 were $7.8 million, compared to $7.0 million in the same six-month period of 2019, as spending increased due to the preparation of the Phase 3 SHIELD I clinical trial.
    • G&A expenses for the six months ended June 30, 2020 were $3.9 million, compared to $1.9 million for the same six-month period of 2019, as costs increased due to the Company's IPO and an increase in non-cash share-based compensation.
    • GAAP net loss attributable to ordinary shares for the six months ended June 30, 2020 was $25.0 million, compared to GAAP net loss of $0.9 million for the six months ended June 30, 2019.
    • Non-GAAP net loss attributable to ordinary shares for the six months ended June 30, 2020 was $8.7 million compared to non-GAAP net loss of $8.1 million in the prior year period. A reconciliation between GAAP net loss and non-GAAP net loss for the six-month periods ended June 30, 2020 and 2019 is provided in the financial results that are part of this release. The difference between GAAP to non-GAAP net loss attributable to ordinary shares is mainly due to the revaluation of our convertible preferred share warrant liability following the increase in fair value due to the IPO price.

    Balance Sheet Highlights

    • As of June 30, 2020, the Company had cash and cash equivalents, restricted cash and short-term deposits in amount of $81.7 million, compared to $27.0 million at December 31, 2019. This reflects the completion of the Company's IPO in June 2020, which raised net proceeds of $62.8 million, after underwriting fees and offering expenses. PolyPid expects this cash balance is sufficient to fund operations through the second half of 2022.
    Conference Call & Webcast
    Wednesday, August 19 @ 8:30 am Eastern Time
    Domestic:877-870-9135
    International:44 (0) 2071 928338
    Passcode:6389197
    Webcast:https://edge.media-server.com/mmc/p/v669bncn

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel product candidate designed to provide local prolonged anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of up to four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (QIDP) designations from the FDA for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.



    CONSOLIDATED BALNCE SHEET

    (U.S. dollars in thousands)

      June 30,

    2020
     December 31,

    2019
      Unaudited Audited
         
    ASSETS    
         
    CURRENT ASSETS:    
    Cash and cash equivalents $69,282  $3,924 
    Restricted cash  376   375 
    Short-term deposits  12,054   22,685 
    Prepaid expenses and other receivables  430   417 
         
    Total current assets  82,142   27,401 
         
    LONG-TERM ASSETS:    
    Property and equipment, net  6,231   6,121 
    Other long-term assets  227   230 
         
    Total long-term assets  6,458   6,351 
         
    Total assets $88,600  $33,752 



    LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY (DEFICIENCY)    
         
    CURRENT LIABILITIES:    
    Trade payables $630  $1,581 
    Other payables and accrued expenses  3,312   998 
         
    Total current liabilities  3,942   2,579 
         
    LONG-TERM LIABILITIES:    
    Other liabilities  179   251 
    Convertible preferred shares warrant liability  -   12,241 
         
    Total long-term liabilities  179   12,492 
         
    COMMITMENTS AND CONTINGENT LIABILITIES    
         
    CONVERTIBLE PREFERRED SHARES:  -   106,313 
         
    SHAREHOLDERS' EQUITY (DEFICIENCY):    
         
    Share capital  -   - 
    Additional paid-in capital  202,758   5,671 
    Accumulated deficit  (118,279)  (93,303)
         
    Total shareholders' equity (deficiency)  84,479   (87,632)
         
    Total liabilities, convertible preferred shares and shareholders' equity (deficiency) $88,600  $33,752 



    CONSOLIDATED STATEMENTS OF OPERATIONS

    (U.S. dollars in thousands (except share and per share data))

      Three months ended

    June 30,
     Six months ended

    June 30,
      2020 2019 2020 2019
             
      Unaudited
             
    Operating expenses:        
    Research and development, net $4,339  $3,503  $7,772  $6,980 
    General and administrative  2,933   1,199   3,936   1,919 
             
    Operating loss  7,272   4,702   11,708   8,899 
    Financial (income) expense, net  9,721   (4,995)  11,154   (7,962)
             
    Net loss (profit) $16,993  $(293) $22,862  $937 
             
    Deemed dividend  2,114   -   2,114   - 
             
    Net loss (profit) attributable to Ordinary shares $19,107  $(293) $24,976  $937 
             
    Basic profit (net loss) per Ordinary share  (25.30)  0.52   (37.87)  (6.43)
             
    Diluted net loss per Ordinary share  (25.30)  (1.10)  (37.87)  (6.43)
             
    Weighted average number of Ordinary shares used in computing basic net loss per share  755,289   562,270   659,551   562,229 
             
    Weighted average number of Ordinary shares used in computing diluted net loss per share  755,289   614,515   659,551   562,229 



    RECONCILIATION OF GAAP TO NON-GAAP NET LOSS (INCOME) AND NET LOSS (INCOME) PER SHARE

    (U.S. dollars in thousands (except per share data))

      Three months ended

    June 30,
     Six months ended

    June 30,
      2020

     2019 2020

     2019
             
      Unaudited
             
    GAAP net loss (profit) attributable to Ordinary shares: $19,107  $(293) $24,976  $937 
    Add:        
    Deemed dividend  2,114   -   2,114   - 
    Depreciation and amortization  254   208   498   398 
    Share-based compensation  2,068   204   2,257   391 
    Warrants change in fair value  9,861   (4,991)  11,373   (7,933)
             
    Non-GAAP net loss attributable to Ordinary shares $4,810  $4,286  $8,734  $8,081 
             
    Basic and diluted net loss per Ordinary share  6.37   7.62   13.24   14.37 
             
    Weighted average number of Ordinary shares used in computing basic and diluted net loss per share  755,289   562,270   659,551   562,229 



    Use of Non-GAAP Financial Results

    In addition to disclosing financial results calculated in accordance with United States generally accepted accounting principles (GAAP), this press release contains non-GAAP financial measures of net loss for the period that excludes the effect of stock-based compensation expenses, change in fair value of warrant liability, deemed dividend and depreciation and amortization. The company's management believes the non-GAAP financial information provided in this release is useful to investors' understanding and assessment of the company's ongoing operations. Management also uses both GAAP and non-GAAP information in evaluating and operating business internally and as such deemed it important to provide all this information to investors. The non-GAAP financial measures disclosed by the company should not be considered in isolation or as a substitute for, or superior to, financial measures calculated in accordance with GAAP, and the financial results calculated in accordance with GAAP and reconciliations to those financial statements should be carefully evaluated.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, PolyPid is using forward-looking statements in this press release when it discusses the expected timing of Phase 3 trials, potential of D-PLEX100 to prevent SSIs, furthering U.S. regulatory approval strategy, ability to provide a novel solution for surgeons and their patients as expeditiously as possible, sufficiency of capital to continue the clinical development of D-PLEX100 through both Phase 3 trials and through the second half of 2022, to begin a rolling New Drug Application submission and advance commercial preparations. Because such statements deal with future events and are based on PolyPid's current expectations, they are subject to various risks and uncertainties. Also, while PolyPid has received Fast Track Designation for D-PLEX100 for the prevention of SSIs, it cannot guarantee that it will be able to maintain such designation due to reasons within our outside of its control. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission ("SEC"), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Company contact:
    
    PolyPid, Ltd.
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    ir@polypid.com
    
    Investors contact:
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    bob@lifesciadvisors.com

    Primary Logo

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  22. PETAH TIKVA, Israel, Aug. 05, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will report its second quarter 2020 financial results and operational highlights before the Nasdaq market opens on Wednesday, August 19, 2020. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date: Wednesday, August 19, 2020
    Time:8:30 AM Eastern Time
    United States:+1 (877) 870-9135
    Israel:+972 35308845
    International:+44

    PETAH TIKVA, Israel, Aug. 05, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will report its second quarter 2020 financial results and operational highlights before the Nasdaq market opens on Wednesday, August 19, 2020. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

    Conference Call Dial-In & Webcast Information:

    Date: Wednesday, August 19, 2020
    Time:8:30 AM Eastern Time
    United States:+1 (877) 870-9135
    Israel:+972 35308845
    International:+44 (0) 2071 928338
    Conference ID:6389197
    Webcast:https://edge.media-server.com/mmc/p/v669bncn

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of cardiac and abdominal surgical site infections. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. Because such statements deal with future events and are based on PolyPid's current expectations, they are subject to various risks and uncertainties. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission ("SEC"), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Contacts: 
    
    Company:
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    
    Investors:
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    Bob@LifeSciAdvisors.com

    Primary Logo

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  23. PETAH TIKVA, Israel, Aug. 03, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that D-PLEX100 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the prevention of post abdominal surgery incisional infections.

    The FDA's Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious and life threatening conditions and fill an unmet medical need. Fast Track designation allows for early and frequent communication with the FDA throughout the entire…

    PETAH TIKVA, Israel, Aug. 03, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that D-PLEX100 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the prevention of post abdominal surgery incisional infections.

    The FDA's Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious and life threatening conditions and fill an unmet medical need. Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process, and allows for a rolling review of a D-PLEX100's New Drug Application ("NDA"). It also enables eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.

    "Receiving Fast Track designation from the FDA represents an important achievement for our promising D-PLEX100 development program," said Amir Weisberg, PolyPid's CEO. "We view the Fast Track designation as important regulatory validation of the novelty of our PLEX technology and the high clinical unmet need that currently exists in the ability to prevent surgical site infections in complex surgical settings such as abdominal surgeries. We recently initiated our SHIELD I Phase 3 clinical trial of D-PLEX100 for the prevention of post-abdominal surgery incisional infections, and look forward to the opportunity to provide a safe and effective solution for surgeons and their patients as quickly as possible."

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel product candidate designed to provide local prolonged anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of up to four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (QIDP) designations from the FDA for the prevention of sternal wound infection post-cardiac surgery and for the prevention of post-abdominal surgery incisional infection.

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, PolyPid is using forward-looking statements in this press release when it discusses the potential of D-PLEX100 to prevent SSIs, timing, subject matter and frequency of communications with the FDA, whether D-PLEX100 will be eligible for rolling review of its NDA and/or priority review with the FDA, and providing a safe and effective solution for surgeons and their patients as quickly as possible. Because such statements deal with future events and are based on PolyPid's current expectations, they are subject to various risks and uncertainties. Also, while PolyPid has received Fast Track Designation for D-PLEX100 for the prevention of surgical site infections, it cannot guarantee that it will be able to maintain such designation due to reasons within our outside of its control. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission ("SEC"), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Company contact:
    
    PolyPid, Ltd. 
    Dikla Czaczkes Akselbrad
    EVP & CFO
    Tel: +972-747195700
    
    Investors contact: 
    
    Bob Yedid
    LifeSci Advisors
    646-597-6989
    Bob@LifeSciAdvisors.com

    Primary Logo

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  24. PETAH TIKVA, Israel, July 27, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that Dr. Anthony Senagore, colorectal surgeon and a medical advisor to PolyPid, is presenting a recorded video presentation today highlighting previously presented key results from PolyPid's successfully completed Phase 2 clinical trial of D-PLEX100 for the prevention of surgical site infections in abdominal surgery at the American Society of Colon and Rectal Surgeons (A.S.C.R.S.) 2020 Annual Scientific Conference Recorded Sessions.

    The recorded video session will…

    PETAH TIKVA, Israel, July 27, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that Dr. Anthony Senagore, colorectal surgeon and a medical advisor to PolyPid, is presenting a recorded video presentation today highlighting previously presented key results from PolyPid's successfully completed Phase 2 clinical trial of D-PLEX100 for the prevention of surgical site infections in abdominal surgery at the American Society of Colon and Rectal Surgeons (A.S.C.R.S.) 2020 Annual Scientific Conference Recorded Sessions.

    The recorded video session will be available on the A.S.C.R.S. website beginning today, July 27th, and is based on an accepted abstract entitled, "Local Constant Prolonged Release of an Antibiotic for the Prevention of Surgical Site Infections (SSI) Post Colorectal Resection Abdominal Surgeries". The presentation can be viewed here:

    https://fascrs.org/my-ascrs/meetings-events/ascrs-virtual-scientific-meeting

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100, is a novel product candidate designed to provide local prolonged anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of up to four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (QIDP) designations from the FDA for the prevention of sternal wound infection post-cardiac surgery and for the prevention of post-abdominal surgery incisional infection.

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release contains projections and other forward-looking statements regarding future events or our future financial performance. All statements other than present and historical facts and conditions contained in this release are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. Actual events or results may differ materially from those contained in the projections or forward-looking statements. Forward-looking statements in this release are made pursuant to the safe harbor provisions contained in the Private Securities Litigation Reform Act of 1995. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

    Company contact:
    
    PolyPid, Ltd. 
    
    Dikla Czaczkes Akselbrad
    
    EVP & CFO
    
    Tel: +972-747195700

    Primary Logo

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  25. PETAH TIKVA, Israel, July 1, 2020 /PRNewswire/ -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that  the first patient has been enrolled and randomized in the SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company's first of two Phase 3 clinical trials of its lead product candidate D-PLEX100, for the prevention of post-abdominal surgery incisional infection (soft tissue).

    PolyPid Ltd Logo

    "We are very pleased with the initiation of our SHIELD I trial, one month after the submission of an amendment to our Investigational New Drug application…

    PETAH TIKVA, Israel, July 1, 2020 /PRNewswire/ -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that  the first patient has been enrolled and randomized in the SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company's first of two Phase 3 clinical trials of its lead product candidate D-PLEX100, for the prevention of post-abdominal surgery incisional infection (soft tissue).

    PolyPid Ltd Logo

    "We are very pleased with the initiation of our SHIELD I trial, one month after the submission of an amendment to our Investigational New Drug application to the U.S. Food and Drug Administration (FDA) on May 29, 2020 " said Amir Weisberg, PolyPid's CEO.  "Enrollment of the first patient in this trial represents a significant milestone for our D-PLEX100 development program. Abdominal surgery is the second surgical model to enter Phase 3 development for D-PLEX100.  We believe that this trial, combined with the second Phase 3 clinical trial in this indication that is planned to start approximately 6 months from now, represents a key advancement toward our U.S. regulatory approval strategy and our ability to provide a novel solution for surgeons and their patients as expeditiously as possible."

    "D-PLEX100 has shown promise in a previous Phase 2 clinical trial by significantly decreasing surgical site infections (SSI) in abdominal surgery with colorectal resection, one of the most complex surgical setting for SSIs" said Dr. Anthony Senagore, colorectal surgeon and a medical advisor to PolyPid. "The need for additional preventive solutions is acute, especially with the emergence of antibiotic resistant bacteria, and so we look forward to evaluating D-PLEX100 in the SHIELD-I trial as a potential solution for our surgical patients."

    SHIELD I is a prospective, multinational, multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with the Standard of Care (SoC), compared to a SoC-treated control arm, for the prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial is the infection rate, as measured by the proportion of subjects with at least one abdominal target incisional infection event within 30 days post abdominal surgery, determined by a blinded independent adjudication committee. The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients, as defined by the adaptive study design, in approximately 50 centers in the United States, Europe and Israel.

    About D-PLEX100

    PolyPid's lead product candidate, D-PLEX100 , is a novel product candidate designed to provide local prolonged anti-bacterial activity directly at the surgical site to prevent SSIs. Following the administration of D-PLEX100  into the surgical site, the PLEX technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of up to four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant bacteria at the surgical site. D-PLEX100  has received two Qualified Infectious Disease Product (QIDP) designations from the FDA for the prevention of sternal wound infection post-cardiac surgery and for the prevention of post-abdominal surgery incisional infection.

    About PolyPid

    PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company. 

    For additional company information, visit www.polypid.com.

    Forward-looking Statements

    This press release contains projections and other forward-looking statements regarding future events or our future financial performance. All statements other than present and historical facts and conditions contained in this release, including any statements regarding our future results of operations and financial positions, business strategy, plans and our objectives for future operations, the conduct and timing of our clinical trials, our research, development and regulatory plans for our product candidates and preclinical pipeline, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies and whether, if approved, our product candidates will be successfully commercialized and marketed, are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. Actual events or results may differ materially from those contained in the projections or forward-looking statements. Forward-looking statements in this release are made pursuant to the safe harbor provisions contained in the Private Securities Litigation Reform Act of 1995.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    Company contact:

    PolyPid, Ltd. 

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Cision View original content:http://www.prnewswire.com/news-releases/polypid-initiates-first-phase-3-clinical-trial-of-d-plex100-for-the-prevention-of-post-abdominal-surgery-incisional-infections-301086841.html

    SOURCE PolyPid Ltd.

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  26. PETAH TIKVA, Israel, June 30, 2020 /PRNewswire/ -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage pharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, announced the closing of its initial public offering of 4,312,500 ordinary shares, including the full exercise of the underwriters' option to purchase additional shares, at a price to the public of $16.00 per share, for gross proceeds of $69.0 million. The shares are listed for trading on the Nasdaq Global Market under the symbol "PYPD."

    Barclays and BMO Capital Markets acted as joint book-running managers. Raymond James acted as lead manager. National Securities Corporation, ODDO BHF and A.G.P/Alliance Global Partners acted as co-managers.

    A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on June 25, 2020. The offering was made only by means of a prospectus, copies of which may be obtained from Barclays Capital Inc. c/o Broadridge Financial Solutions by mail at 1155 Long Island Avenue, Edgewood, NY, 11717, by email at barclaysprospectus@broadridge.com, or by calling 888-603-5847 or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, New York, New York 10036, telephone: 1-800-414-3627 or by emailing bmoprospectus@bmo.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    Company contacts:

    PolyPid, Ltd. 

    Dikla Czaczkes Akselbrad

    Chief Financial Officer

    Tel: +972-747195700

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/polypid-ltd-announces-closing-of-initial-public-offering-and-full-exercise-of-underwriters-option-to-purchase-additional-shares-301086240.html

    SOURCE PolyPid Ltd.

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  27. PETAH TIKVA, Israel, June 26, 2020 /PRNewswire/ -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage pharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, announced the pricing of its initial public offering of 3,750,000 ordinary shares at a price to the public of $16.00 per share, for gross proceeds of $60.0 million. All of the ordinary shares are being offered by PolyPid.

    The shares are expected to begin trading on The Nasdaq Global Market under the symbol "PYPD" on June 26, 2020. The offering is expected to close on June 30, 2020, subject to customary closing conditions. In addition, PolyPid has granted the underwriters a 30-day option to purchase…

    PETAH TIKVA, Israel, June 26, 2020 /PRNewswire/ -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage pharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, announced the pricing of its initial public offering of 3,750,000 ordinary shares at a price to the public of $16.00 per share, for gross proceeds of $60.0 million. All of the ordinary shares are being offered by PolyPid.

    The shares are expected to begin trading on The Nasdaq Global Market under the symbol "PYPD" on June 26, 2020. The offering is expected to close on June 30, 2020, subject to customary closing conditions. In addition, PolyPid has granted the underwriters a 30-day option to purchase up to 562,500 additional ordinary shares at the initial public offering price less underwriting discounts and commissions.

    Barclays and BMO Capital Markets acted as joint book-running managers. Raymond James acted as lead manager. National Securities Corporation, ODDO BHF and A.G.P/Alliance Global Partners acted as co-managers.

    A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on June 25, 2020. The offering is being made only by means of a prospectus, copies of which may be obtained from Barclays Capital Inc. c/o Broadridge Financial Solutions by mail at 1155 Long Island Avenue, Edgewood, NY, 11717, by email at barclaysprospectus@broadridge.com , or by calling 888-603-5847 or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, New York, New York 10036, telephone: 1-800-414-3627 or by emailing bmoprospectus@bmo.com .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    Company contacts:

    PolyPid, Ltd. 

    Dikla Czaczkes Akselbrad

    EVP & CFO

    Tel: +972-747195700

    Cision View original content:http://www.prnewswire.com/news-releases/polypid-ltd-announces-pricing-of-initial-public-offering-301084236.html

    SOURCE PolyPid Ltd.

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