Polypide

PolyPid Provides Corporate Update and Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 8, 2023
SHIELD, Research, American College, Good, Financial result, Good manufacturing practice, MD, G&A, Conference, MBA, Polypide, R, Canadian International Council, Marketing, Animal, GMP, Patient, PLEX, International Journal of Toxicology, Rare-earth element, Pharmaceutical industry, Nursing, Medical device, Fine chemical, Clothing, Cryptocurrency, Toxicology, EU

PETACH TIKVA, Israel, Nov. 08, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three and nine months ended September 30, 2023.

Key Points: 
  • PETACH TIKVA, Israel, Nov. 08, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three and nine months ended September 30, 2023.
  • Presented the results of the SHIELD I Phase 3 trial for the first time at a medical meeting, the American College of Surgeons Clinical Congress 2023.
  • Financial results for nine months ended September 30, 2023
    R&D expenses, net for the nine months ended September 30, 2023, were $11.6 million, compared to $23.3 million for the same nine-month period of 2022.
  • PolyPid expects that this cash balance will be sufficient to fund operations into late first quarter of 2024.

PolyPid Announces the Addition of Dr. Nurit Tweezer-Zaks to its Board of Directors

Retrieved on: 
Tuesday, November 7, 2023
M.B.A, Perioperative, International, Kellogg-HKUST Executive MBA Program, Christianity in Singapore, Sheba Medical Center, Tel Aviv University, Polypide, R, Business administration, Partnership, Internal medicine, Medical device, Management, Sanofi

“We are thrilled to welcome Dr. Tweezer-Zaks to the PolyPid Board.

Key Points: 
  • “We are thrilled to welcome Dr. Tweezer-Zaks to the PolyPid Board.
  • She has had a distinguished career as a practicing physician, biopharmaceutical industry executive and sector investor,” said Jacob Harel, PolyPid’s Chairman.
  • I would also like to thank Anat for her distinguished service and counsel as a member of PolyPid’s Board since April 2008.
  • In her most recent role at Sanofi, she served as Global Established Products Medical Lead – Strategic Decision for Portfolio Enhancement.

PolyPid to Report Third Quarter 2023 Financial Results and Operational Highlights on November 8, 2023

Retrieved on: 
Wednesday, November 1, 2023
Conference, Webcast, Polypide, Broadcasting

PETACH TIKVA, Israel, Nov. 01, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will report its third quarter 2023 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, November 8, 2023.

Key Points: 
  • PETACH TIKVA, Israel, Nov. 01, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will report its third quarter 2023 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, November 8, 2023.
  • 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.
  • To ensure you are connected prior to the beginning of the call, PolyPid suggests registering a minimum of 5 minutes before the start of the call.
  • For those not planning to ask a question of management, the Company recommends listening via the webcast.

PolyPid Regains Compliance with Nasdaq Minimum Closing Bid Price Rule

Retrieved on: 
Wednesday, October 11, 2023
Polypide, Cryptocurrency, Auction

PETACH TIKVA, Israel, Oct. 11, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has received a written notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the minimum bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2), which requires listed securities, including the Company's ordinary shares, to maintain a minimum bid price of $1.00 per share.

Key Points: 
  • PETACH TIKVA, Israel, Oct. 11, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has received a written notice from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the minimum bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2), which requires listed securities, including the Company's ordinary shares, to maintain a minimum bid price of $1.00 per share.
  • The Nasdaq staff made this determination of compliance after the closing bid price of the Company's ordinary shares was at $1.00 per share or greater for the 11 consecutive business days prior to the date of the notice.
  • Accordingly, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), and Nasdaq considers the prior bid price deficiency matter now closed.

PolyPid Announces Publication of Preclinical Data Further Supporting the Good Safety Profile of D-PLEX₁₀₀ and PLEX Technology Platform

Retrieved on: 
Wednesday, October 4, 2023
SHIELD, PLEX, Christianity in Singapore, Polypide, Safety, Toxicokinetics, International Journal of Toxicology, Animal, Patient, Canadian International Council, Pig, Toxicology

PETACH TIKVA, Israel, Oct. 04, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced the publication of positive preclinical results demonstrating, for the first time, the safety profile of D-PLEX100 and the PLEX technology platform in juvenile animals. These preclinical data were published in the peer-reviewed journal, International Journal of Toxicology, in a paper titled, “Preclinical In-Vivo Safety and Toxicokinetics of D-PLEX100 in an Abdominal Surgery Incision Model in Juvenile Miniature Swine,” which can be found here.

Key Points: 
  • PETACH TIKVA, Israel, Oct. 04, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced the publication of positive preclinical results demonstrating, for the first time, the safety profile of D-PLEX100 and the PLEX technology platform in juvenile animals.
  • These preclinical data were published in the peer-reviewed journal, International Journal of Toxicology, in a paper titled, “Preclinical In-Vivo Safety and Toxicokinetics of D-PLEX100 in an Abdominal Surgery Incision Model in Juvenile Miniature Swine,” which can be found here .
  • The safety and toxicokinetics of D-PLEX100 were tested following its administration via an abdominal incision to juvenile swine.
  • The animals were evaluated for a period of nine months and no treatment-related adverse events were observed during this period.

PolyPid Announces Successful Commercial Good Manufacturing Practice (GMP) Audit by Israeli Ministry of Health

Retrieved on: 
Thursday, September 21, 2023
Agreement, GMP, Acceptance, Good manufacturing practice, Ministry of Health and Medical Education, ACAA, Polypide, Ministry, European, Test management, Medical device, Health

PETACH TIKVA, Israel, Sept. 21, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that the Israeli Ministry of Health has completed a successful Good Manufacturing Practice (GMP) audit of the Company's manufacturing facility without any critical or major findings.

Key Points: 
  • PETACH TIKVA, Israel, Sept. 21, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that the Israeli Ministry of Health has completed a successful Good Manufacturing Practice (GMP) audit of the Company's manufacturing facility without any critical or major findings.
  • The audit was conducted as part of the Ministry of Health's routine evaluation of PolyPid’s manufacturing process for D-PLEX100.
  • The audit concluded that PolyPid’s manufacturing facility, process and quality system conform to the requirements of current GMP for medicinal products.
  • This successful audit underscores the viability, quality and high standards that PolyPid upholds in the manufacturing of D-PLEX100 for clinical and commercial use in compliance with rigorous international standards.”

PolyPid Announces Successful Completion of Manufacturing Process Validation for D-PLEX₁₀₀

Retrieved on: 
Tuesday, September 19, 2023
SHIELD, GMP, NDA, MAA, Polypide, Patient, Christianity in Singapore, Marketing, Fine chemical, EU

PETACH TIKVA, Israel, Sept. 19, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced the successful completion of the production of three process validation batches of D-PLEX100 which have started stability program. This successful production process validation completes a substantial requirement toward the Company’s planned submission of D-PLEX100 New Drug Application (NDA) and Marketing Authorization Application (MAA) regulatory filings.

Key Points: 
  • PETACH TIKVA, Israel, Sept. 19, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced the successful completion of the production of three process validation batches of D-PLEX100 which have started stability program.
  • This successful production process validation completes a substantial requirement toward the Company’s planned submission of D-PLEX100 New Drug Application (NDA) and Marketing Authorization Application (MAA) regulatory filings.
  • “The successful validation of the production process at commercial scale is the result of a significant facility expansion and scale-up that more than tripled the Company’s capacity to manufacture D-PLEX100 for the U.S., EU and global markets,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer.
  • “Our in-house state-of-the-art GMP sterile production facility provides us with full control of D-PLEX100 manufacturing from clinical stage to commercial supply and serves as a key competitive advantage going forward.

PolyPid Provides Corporate Update and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023
SHIELD, Pharmacy, Marketing, Polypide, G&A, Patient, Financial result, Bacteria, R, European Journal, Conference, End, Food, European Journal of Pharmaceutical Sciences, Rare-earth element, Medical imaging, Pharmaceutical industry, Clothing, Fine chemical, Cryptocurrency

PETACH TIKVA, Israel, Aug. 09, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three and six months ended June 30, 2023.

Key Points: 
  • Resumed recruitment in late June 2023 with a total of 40 patients already recruited into SHIELD II trial.
  • Total recruitment time into the trial is anticipated to be approximately 12 months and top-line results are expected in mid-2024.
  • Financial results for six months ended June 30, 2023
    R&D expenses, net for the six months ended June 30, 2023, were $7.8 million, compared to $17.1 million for the same six-month period of 2022.
  • PolyPid expects that this cash balance will be sufficient to fund operations into late first quarter of 2024.

PolyPid to Report Second Quarter 2023 Financial Results and Operational Highlights on August 9, 2023

Retrieved on: 
Wednesday, July 26, 2023
Webcast, Polypide, Conference, Broadcasting

PETACH TIKVA, Israel, July 26, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will report its second quarter 2023 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, August 9, 2023.

Key Points: 
  • PETACH TIKVA, Israel, July 26, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will report its second quarter 2023 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, August 9, 2023.
  • 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.
  • To ensure you are connected prior to the beginning of the call, PolyPid suggests registering a minimum of 5 minutes before the start of the call.
  • For those not planning to ask a question of management, the Company recommends listening via the webcast.

PolyPid Announces New Publication Highlighting Potent Antibacterial Activity of D-PLEX₁₀₀ against Susceptible and Resistant Bacteria for the Prevention of Surgical Site Infections

Retrieved on: 
Thursday, June 29, 2023
SHIELD, Antimalarial medication, Pharmacy, Christianity in Singapore, Polypide, Infection, Trial of the century, European Journal of Pharmaceutical Sciences, Doxycycline, Bacteria, European Journal, Safety, Vaccine, Pharmaceutical industry

PETACH TIKVA, Israel, June 29, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced a new publication highlighting the potent antibacterial activity of D-PLEX100 and its potential as an effective prophylactic drug against the most prevalent bacteria causing surgical site infections (SSIs), including resistant strains. The paper, entitled, “Potent antibacterial activity in surgical wounds with local administration of D-PLEX100” was recently published in the European Journal of Pharmaceutical Sciences and can be found here.

Key Points: 
  • Potent Antibacterial Efficacy of D-PLEX100 in In-vivo and Phase 2 Clinical Studies against a Wide Range of Bacteria Tested, including Resistant Strains
    PETACH TIKVA, Israel, June 29, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced a new publication highlighting the potent antibacterial activity of D-PLEX100 and its potential as an effective prophylactic drug against the most prevalent bacteria causing surgical site infections (SSIs), including resistant strains.
  • The paper, entitled, “Potent antibacterial activity in surgical wounds with local administration of D-PLEX100” was recently published in the European Journal of Pharmaceutical Sciences and can be found here .
  • “This publication highlights the tremendous potential of D-PLEX100 in addressing the persistent challenge of surgical site infections, especially in an era of increased multidrug-resistant bacteria” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer.
  • “The data showed the significant antibacterial activity of D-PLEX100 in pre-clinical and phase 2 clinical studies against a wide range of bacteria tested, including resistant ones.