PYPD PolyPid Ltd

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the Month of: November 2023 (Report No. 2)

 

Commission File Number: 001-38428

 

PolyPid Ltd.

(Translation of registrant’s name into English)

 

18 Hasivim Street

Petach Tikva 495376, Israel

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

☒ Form 20-F         ☐ Form 40-F

 

 

 

CONTENTS

 

Attached hereto and incorporated herein is PolyPid Ltd.’s (the “Registrant”) press release issued on November 8, 2023, titled “PolyPid Provides Corporate Update and Reports Third Quarter 2023 Financial Results.”

 

The bullet points under the section titled “Recent Corporate Highlights,” the sections titled “Financial results for the three months ended September 30, 2023,” “Financial results for the nine months ended September 30, 2023,” “Balance Sheet Highlights,” and “Forward-looking Statements” and the financial statements in the press release are incorporated by reference into the Registrant’s registration statements on Form F-3 (File No. 333-257651) and Form S-8 (File No. 333-239517 and File No. 333-271060), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

 

EXHIBIT INDEX

 

Exhibit No.
99.1		Press Release issued by PolyPid Ltd. on November 8, 2023, titled “PolyPid Provides Corporate Update and Reports Third Quarter 2023 Financial Results.”

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

	POLYPID LTD.
Date: November 8, 2023	By:	/s/ Dikla Czaczkes Akselbrad
		Name:	Dikla Czaczkes Akselbrad
		Title:	Chief Executive Officer

 

 

3

Exhibit 99.1

 

PolyPid Provides Corporate Update and Reports Third Quarter 2023 Financial Results

 

Total of 20 Centers Currently Open with Approximately 40 Expected by End of 2023 in SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections

 

Completed Production and Release of Three Process Validation Batches of D-PLEX₁₀₀

 

Successful Completion of Good Manufacturing Practice Audit of Company’s Manufacturing Facility

 

Conference Call Scheduled for Today at 8:30 AM ET

 

PETACH TIKVA, Israel, November 8, 2023 -- 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.

 

Recent Corporate Highlights:

 

●

A total of 20 centers are currently open in the ongoing SHIELD II Phase 3 trial that is recruiting patients undergoing open colorectal abdominal surgery with large incisions.

 

o

Approximately 40 centers are expected to be open by the end of 2023.

 

o

Unblinded interim analysis is planned to be conducted once approximately 400 patients complete their 30-day follow-up.

 

o

Top-line results are expected in the second half of 2024.

 

●

Achieved significant D-PLEX100 manufacturing-related milestones.

 

o

Production and release of three process validation batches of D-PLEX100.

 

o

Good Manufacturing Practice (GMP) audit of the Company’s manufacturing facility completed without any critical or major findings.

 

●

Published positive preclinical results demonstrating, for the first time, the safety profile of D-PLEX100 and the PLEX technology platform in juvenile animals in the peer-reviewed journal, International Journal of Toxicology.

 

●

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.

 

 

●

Appointed Nurit Tweezer-Zaks, MD, MBA, to Board of Directors following the retirement of Anat Tsour Segal.

 

o

Dr. Tweezer-Zaks is a biopharmaceutical industry veteran with extensive executive business development, clinical, and R&D expertise. She is an experienced sector investor and was a practicing physician for nearly 15 years.

 

●

Regained compliance with Nasdaq’s Minimum Closing Bid Price Rule.

 

“Our ongoing SHIELD II Phase 3 trial for our promising lead product candidate, D-PLEX₁₀₀, is progressing as anticipated,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “We currently have 20 centers open, many of which have just recently begun recruiting patients, and we expect enrollment to ramp-up shortly. We anticipate having approximately 40 centers open by the end of 2023. Importantly, we continue to expect top-line results from SHIELD II in second half of 2024.”

 

“While we focus on enrollment into SHIELD II, we have also recently achieved several key D-PLEX₁₀₀ manufacturing-related milestones that have helped evolve PolyPid into a fully-integrated biopharmaceutical company,” continued Ms. Czaczkes Akselbrad. “First, we successfully completed the production and release of three process validation batches of D-PLEX₁₀₀, thus completing a substantial requirement toward our planned submission of D-PLEX₁₀₀’s New Drug Application and EU Marketing Authorization Application regulatory filings. In addition, a successful Good Manufacturing Practice audit of our manufacturing facility was completed without any critical or major findings, and the Company can now produce D-PLEX₁₀₀ at scale to meet the expected commercial demand for the product.”

 

As to the current situation in Israel, our immediate focus is to support our employees and their families while staying focused on running the business. As of today, there has been no material impact on our operations and business activity.

 

Financial results for three months ended September 30, 2023

 

●

Research and development (R&D) expenses for the three months ended September 30, 2023, were $3.8 million, compared to $6.2 million in the same three-month period of 2022. The decrease in R&D expenses resulted primarily from the completion of the SHIELD I Phase 3 clinical trial.

 

●

General and administrative (G&A) expenses for the three months ended September 30, 2023, were $1.2 million, compared to $1.7 million for the same period of 2022.

 

●

Marketing and business development expenses for the three months ended September 30, 2023, were $0.3 million, compared to $0.8 million for the same period of 2022.

 

●

For the three months ended September 30, 2023, the Company had a net loss of $5.6 million, or ($3.40) per share, compared to a net loss of $9.3 million, or ($14.19) per share, in the three-month period ended September 30, 2022.

 

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.

 

●

G&A expenses for the nine months ended September 30, 2023, were $4.3 million, compared to $6.4 million for the same period of 2022.

 

 

●

Marketing and business development expenses for the nine months ended September 30, 2023, were $1.0 million, compared to $2.5 million for the same period of 2022.

 

●

The decreases in G&A and marketing and business development expenses were primarily due to the Company’s cost reduction plan announced in October 2022 and further cost savings initiatives implemented during the first nine months of 2023.

 

●

For the nine months ended September 30, 2023, the Company had a net loss of $17.5 million, or ($13.59) per share, compared to a net loss of $33.0 million, or ($51.15) per share, in the nine-month period ended September 30, 2022.

 

Balance Sheet Highlights

 

●

As of September 30, 2023, the Company had cash and cash equivalents and deposits in the amount of $10.2 million. PolyPid expects that this cash balance will be sufficient to fund operations into late first quarter of 2024.

 

Conference Call Dial-In & Webcast Information:

 

	Date:	Wednesday, November 8, 2023
	Time:	8:30 AM Eastern Time
	Q&A Participants:	https://register.vevent.com/register/BIbd0a9baa57b1427e809302152ba58bd3
	Webcast:	https://edge.media-server.com/mmc/p/r9ot5d24

 

About D-PLEX₁₀₀

 

D-PLEX_100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (SSIs). Following the administration of D-PLEX₁₀₀ into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX₁₀₀ received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX₁₀₀  is currently in Phase 3 SHIELD II trial for the prevention of surgical site infections in patients undergoing open abdominal colorectal surgery with large incisions (>20cm).

 

 

About PolyPid

 

PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX₁₀₀ is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.

 

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 the number of centers expected to open by the end of 2023, the expected timing of top-line data, the planned submission of a New Drug Application and EU Marketing Authorization Application regulatory filings, potential commercial demand for D-PLEX₁₀₀ and the expected sufficiency of the Company’s cash balance. 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 31, 2023. 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. 

Ori Warshavsky

COO – US

908-858-5995

IR@Polypid.com

 

Investors:

Brian Ritchie

LifeSci Advisors

212-915-2578

britchie@lifesciadvisors.com

 

 

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

 

		September 30,				December 31,
		2023				2022
		Unaudited				Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	1,353			$	8,552
Short-term deposits			8,801				4,042
Restricted cash			495				511
Prepaid expenses and other current assets			473				1,089
Total current assets			11,122				14,194
LONG-TERM ASSETS:
Property and equipment, net			8,077				9,247
Operating lease right-of-use assets			1,632				2,431
Other long-term assets			101				99
Total long-term assets			9,810				11,777
Total assets		$	20,932			$	25,971

 

 

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

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

 

		September 30,				December 31,
		2023				2022
		Unaudited				Audited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Current maturities of long-term debt		$	2,859			$	4,024
Accrued expenses and other current liabilities			2,024				2,429
Trade payables			529				1,141
Current maturities of operating lease liabilities			486				959
Total current liabilities			5,898				8,553
LONG-TERM LIABILITIES:
Long-term debt			7,665				7,574
Deferred revenues			2,548				2,548
Long-term operating lease liabilities			832				1,173
Other liabilities			451				294
Total long-term liabilities			11,496				11,589
COMMITMENTS AND CONTINGENT LIABILITIES
SHAREHOLDERS’ EQUITY:
Ordinary shares with no par value -
Authorized: 107,800,000 and 47,800,000 shares at September 30, 2023 (unaudited) and December 31, 2022, respectively; Issued and outstanding: 1,653,559 and 669,605 shares at September 30, 2023 (unaudited) and December 31, 2022, respectively *)			-				-
Additional paid-in capital			235,491				220,273
Accumulated deficit			(231,953	)			(214,444	)
Total shareholders’ equity			3,538				5,829
Total liabilities and shareholders’ equity		$	20,932			$	25,971

 

*)	On September 18, 2023, the Company affected a 1-for-30 reverse share split (the “Reverse Share Split”)

 

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

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

 

		Nine Months Ended								Three Months Ended
		September 30,								September 30,
		2023				2022				2023				2022
Operating expenses:
Research and development, net		$	11,560			$	23,335			$	3,806			$	6,240
Marketing and business development			1,003				2,538				261				840
General and administrative			4,305				6,403				1,193				1,680
Operating loss			16,868				32,276				5,260				8,760
Financial expense, net			581				640				319				437
Loss before income tax			17,449				32,916				5,579				9,197
Income tax expenses			60				74				25				74
Net loss		$	17,509			$	32,990			$	5,604			$	9,271
Basic and diluted loss per ordinary share *)		$	13.59			$	51.15			$	3.40			$	14.19
Weighted average number of ordinary shares used in computing basic and diluted loss per share			1,288,678				644,958				1,650,259				653,240

 

*)

On September 18, 2023, the Company affected a 1-for-30 reverse share split (the “Reverse Share Split”)

 

 

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