PYPD PolyPid Ltd.

7.46
-0.18  -2%
Previous Close 7.64
Open 7.48
52 Week Low 6.95
52 Week High 16.5
Market Cap $139,997,163
Shares 18,756,570
Float 15,682,034
Enterprise Value $93,765,103
Volume 10,634
Av. Daily Volume 25,309
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Upcoming Catalysts

Drug Stage Catalyst Date
D-PLEX100 - SHIELD I
Abdominal (soft tissue) sternal surgical site infections
Phase 3
Phase 3
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D-PLEX100 (SHIELD II)
Surgical Site Infection
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
D-PLEX100
Sternal (bone) sternal surgical site infections
Phase 3
Phase 3
Phase 3 trial initiated December 2019. Enrolment paused due to COVID-19.

Latest News

  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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