PolyPid

PolyPid Ltd. operates as a phase 3 biopharma company. Its proprietary PLEX technology pairs with medications, enables precise delivery of drugs at effective release rates, over pre-determined durations ranging from several days to months. The firm's product candidates are designed to address unmet medical needs by delivering active pharmaceutical ingredients, or APIs, locally at predetermined release rates and durations over extended periods ranging from days to several months. The company was founded by Noam Emanuel in 2008 and is headquartered in Petach Tikva, Israel.

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PolyPid advances SHIELD II trial, secures financing for growth

PolyPid's Q2 2024 earnings call showcased progress in the SHIELD II trial and financial resilience through secured financing.
Strong leadership appointments and positive feedback on D-PLEX100's potential highlight the company's strategic strengths.
While facing timeline risks and financial challenges, PolyPid remains focused on advancing D-PLEX100 and seizing growth opportunities.
Overall, PolyPid's performance reflects a balanced approach to innovation, financial management, and commitment to achieving key milestones.

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PolyPid Ltd. operates as a phase 3 biopharma company. Its proprietary PLEX technology pairs with medications, enables precise delivery of drugs at effective release rates, over pre-determined durations ranging from several days to months. The firm's product candidates are designed to address unmet medical needs by delivering active pharmaceutical ingredients, or APIs, locally at predetermined release rates and durations over extended periods ranging from days to several months. The company was founded by Noam Emanuel on February 28, 2008 and is headquartered in Petach Tikva, Israel.

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.

PolyPid Regains Compliance with Nasdaq Minimum Closing Bid Price Rule

PETACH TIKVA, Israel, Oct. 09, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that SHIELD I Phase 3 clinical data for D-PLEX100 will be highlighted in a presentation at the American College of Surgeons Clinical Congress 2023, to be held on October 22-25, 2023, in Boston, MA.

PolyPid Announces Presentation at the American College of Surgeons Clinical Congress 2023

Safety Profile of D-PLEX 100 and PLEX Platform Shown in Juvenile Animals for the First Time

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

PETACH TIKVA, Israel, Sept. 22, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD), (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that Company's management will present at the Cantor Global Healthcare Conference taking place on September 26-28, 2023, in New York City, New York.

PolyPid to Present at the 2023 Cantor Fitzgerald Global Healthcare Conference

Successful Audit of the Company's State-of-the-Art Manufacturing Facility Represents a Key Milestone Toward Plan to Commercialize D-PLEX₁₀₀ Globally Successful Audit of the Company's State-of-the-Art Manufacturing Facility Represents a Key Milestone Toward Plan to Commercialize D-PLEX₁₀₀ Globally

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

PETACH TIKVA, Israel, Sept. 20, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announces a reverse share split (the “Reverse Split”) of the Company's issued and outstanding ordinary shares, no par value (“Ordinary Shares”), at the ratio of 1-for-30, such that each thirty (30) Ordinary Shares, shall be consolidated into one (1) Ordinary Share.

PolyPid Announces Reverse Share Split

Company has Successfully Completed the Production of Three Process Validation Batches at Commercial Scale Completes a Substantial Requirement Toward the Planned Submission of D-PLEX 100 NDA and MAA Regulatory Filings PETACH TIKVA, Israel, Sept. 19, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd.

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

PolyPid Ltd (NASDAQ:PYPD ) Q2 2023 Earnings Conference Call August 9, 2023 8:30 AM ET Company Participants Brian Ritchie - LifeSci Advisors Dikla Akselbrad - CEO & Director Jonny Missulawin - CFO Ori Warshavsky - COO Conference Call Participants Douglas Buchanan - JMP Securities Operator Greetings, and welcome to the PolyPid Second Quarter 2023 Conference Call. [Operator Instructions].

PolyPid Ltd (PYPD) Q2 2023 Earnings Call Transcript

Reached Agreement with U.S. FDA on Design of SHIELD II Phase 3 Trial E valuating D-PLEX 100  for the Prevention of Abdominal Colorectal Surgical Site Infections

PolyPid Provides Corporate Update and Reports Second Quarter 2023 Financial Results

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.

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

Potent Antibacterial Efficacy of D-PLEX100 in In-vivo and Phase 2 Clinical Studies against a Wide Range of Bacteria Tested, including Resistant Strains

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

Company Recently Reached Agreement with FDA on Design of Trial Top-line Results Expected in Mid-2024 PETACH TIKVA, Israel, June 22, 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 first patient has been recruited and is scheduled for surgery in its revised SHIELD II Phase 3 trial evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs).

PolyPid Announces Recruitment of First Patient in Revised SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for Prevention of Abdominal Colorectal Surgical Site Infections

PETACH TIKVA, Israel, June 05, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced it has received an extension of the period to regain compliance with The Nasdaq Stock Market LLC's ("Nasdaq") minimum bid price rule and approval from Nasdaq to transfer the listing of the ordinary shares of the Company (the “Ordinary Shares”) from The Nasdaq Global Market to The Nasdaq Capital Market. The transfer will become effective at the opening of business on June 6, 2023.

PolyPid Announces 180-Day Extension to Regain Compliance with Nasdaq Minimum Bid Requirement and Transfer of its Listing to the Nasdaq Capital Market

Recruitment to Resume Imminently Top-line Results Expected in Mid-2024 PETACH TIKVA, Israel, May 22, 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 U.S. Food and Drug Administration (FDA) agreed to Company's SHIELD II Phase 3 trial design evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs).

PolyPid Announces FDA Agreement on the Design of SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for Prevention of Abdominal Colorectal Surgical Site Infections

PolyPid Ltd. (NASDAQ:PYPD ) Q1 2023 Earnings Conference Call May 10, 2023 8:30 AM ET Company Participants Brian Ritchie - LifeSci Advisors Dikla Czaczkes Akselbrad - Chief Executive Officer Jonny Missulawin - Chief Financial Officer Ori Warshavsky - Chief Operating Officer Conference Call Participants Brandon Folkes - Cantor Fitzgerald Roy Buchanan - JMP Securities Operator Greetings, and welcome to the PolyPid First Quarter 2023 Conference Call.

PolyPid Ltd. (PYPD) Q1 2023 Earnings Call Transcript

Submitted Revised Protocol for SHIELD II Phase 3 Trial to FDA to Evaluate D-PLEX 100  for Prevention of Abdominal Colorectal Surgical Site Infections ; Recruitment Expected to Re sume Imminently

PolyPid Provides Corporate Update and Reports First Quarter 2023 Financial Results

PETACH TIKVA, Israel, April 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 first quarter 2023 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, May 10, 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.

PolyPid to Report First Quarter 2023 Financial Results and Operational Highlights on May 10, 2023

PETACH TIKVA, Israel, April 24, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that members of management will participate in the following upcoming investor conferences:

PolyPid to Participate in Upcoming Investor Conferences

PETACH TIKVA, Israel, April 14, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced it has received a letter from the Listing Qualifications staff of The Nasdaq Stock Market (“Nasdaq”) notifying the Company that it is no longer in compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Global Market. Nasdaq Listing Rule 5450(b)(1) requires listed companies to maintain stockholders' equity of at least $10,000,000, and the Company's stockholders' equity was $5,829,000 as of December 31, 2022. In accordance with Nasdaq rules, the Company has 45 calendar days, or until May 25, 2023, to submit a plan to regain compliance. If the plan is accepted, Nasdaq can grant an extension of up to 180 calendar days from the date of the letter to evidence compliance. The notification letter has no immediate effect on the Company's listing on the Nasdaq Capital Market, and during the grace period, as may be extended, the Company's ordinary shares will continue to trade on Nasdaq under the symbol “PYPD”.

PolyPid Announces Receipt of Nasdaq Notification of Minimum Stockholders' Equity Non-Compliance

PETACH TIKVA, Israel, March 31, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, announced today the closing of an underwritten public offering (the “Public Offering”) of ordinary shares, no par value, (“Ordinary Shares”) with gross proceeds of approximately $7.1 million, which includes the full exercise of the underwriter's option to purchase additional Ordinary Shares. The Company also announced the closing of a concurrent private placement of pre-funded warrants with certain of its existing shareholders with gross proceeds of $4.35 million.

PolyPid Announces Closing of Underwritten Public Offering, Including Full Exercise of Overallotment Option, and Concurrent Private Placement with $11.4 Million in Aggregate Gross Proceeds

PETACH TIKVA, Israel, March 29, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, announced today the pricing of an underwritten public offering of 14,660,000 ordinary shares, no par value (the “Ordinary Shares”) at a public offering price of $0.42 per share (the “Public Offering”). The gross proceeds to PolyPid from the Public Offering, before deducting underwriting commissions and other estimated offering expenses payable by PolyPid, are expected to be approximately $6.2 million. In addition, PolyPid has granted the underwriter a 30-day option to purchase up to an additional 2,199,000 Ordinary Shares at the public offering price, less underwriting discounts and commissions, to cover over-allotments in connection with the Public Offering. All of the Ordinary Shares in the Public Offering were offered by PolyPid. The Public Offering is expected to close on or about March 31, 2023, subject to the satisfaction of customary closing conditions.

PolyPid Announces Pricing of $6.2 Million Underwritten Public Offering of Ordinary Shares and Concurrent $4.4 Million Private Placement of Pre-Funded Warrants

PETACH TIKVA, Israel, March 28, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, announced today that it has commenced an underwritten public offering of its ordinary shares, no par value (the “Ordinary Shares”). In addition, PolyPid intends to grant the underwriter a 30-day option to purchase up to an additional 15% of the number of Ordinary Shares offered in the offering at the public offering price, less underwriting discounts and commissions. All of the Ordinary Shares in the offering are being offered by PolyPid. The final terms of the proposed offering will depend on market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

PolyPid Announces Proposed Underwritten Public Offering of Ordinary Shares

PETACH TIKVA, Israel, March 07, 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 present at the Barclays Global Healthcare Conference, which is being held in Miami, Florida, on March 14-16, 2023.

PolyPid to Present at the Barclays Global Healthcare Conference

PolyPid Ltd (NASDAQ:PYPD ) Q4 2022 Earnings Conference Call February 8, 2023 8:30 AM ET Company Participants Brian Ritchie - LifeSci Advisors Dikla Akselbrad - CEO Ori Warshavsky - COO, US Jonny Missulawin - SVP, Finance Conference Call Participants Brandon Folkes - Cantor Fitzgerald Douglas Buchanan - JMP Securities Operator Greetings, and welcome to the PolyPid Fourth Quarter and Full Year 2022 Conference Call. [Operator Instructions].

PolyPid Ltd (PYPD) Q4 2022 Earnings Call Transcript

Following Positive Communication with the FDA , Regulatory Pathway Clarified for D-PLEX 100  for Prevention of Abdominal Colorectal Surgical Site Infections

News for PolyPid Stock (PYPD)