Full Press Release Details
Ltd. Reports Third Quarter 2021 Financial Results and Provides Corporate Update
Progressing as Planned with Approximately
480 Patients Enrolled in Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery
FDA Agreement 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, Company Intends to Target Higher
End of Patient Enrollment Range in SHIELD I to Leverage Key Clinical, Commercial and Financial Benefits
Cash Runway Extends to Year-End 2022, ahead of Prior Forecast of Q2 2022
Conference Call Scheduled for Today
PETACH TIKVA, Israel, November 10, 2021 --
PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a phase 3 biopharmaceutical company focusing
on developing targeted, locally administered, and prolonged-release therapeutics to improve surgical outcomes, today provided a
corporate update and reported financial results for the three and nine months ended September 30, 2021.
Recent Corporate Highlights:
"We continue to expeditiously advance our
multiple development programs, as well as our commercial preparations," said Amir Weisberg, PolyPid's Chief Executive Officer.
"Most importantly, the pace of enrollment in the SHIELD I trial has continued to increase over the last several months and we expect
an even greater acceleration in the months ahead. Having now passed the mid-point in our planned enrollment for SHIELD I, and with over
600 patients now enrolled in both SHIELD I and SHIELD II studies combined, we are well-positioned to leverage the expected clinical, commercial
and financial benefits of targeting the higher end of our patient enrollment range for SHIELD
I. Additionally, we are having ongoing discussions with commercialization partners in the United States, Europe and Asia, based upon the
anticipated data from our Phase 3 trial in 2022."
"We continue to be excited about the compelling
preclinical data being generated by our promising OncoPLEX development platform initially targeting brain tumors. The most recent results
further support our work toward the completion of a preclinical package for the filing of an Investigative New Drug application with the
FDA to potentially initiate a Phase 1/2 clinical trial. We look forward to meeting with the Agency later this month to discuss the clinical
and non-clinical development plan for OncoPLEX in GBM," continued Mr. Weisberg.
"In addition, we are progressing our robust
clinical development program from a position of financial strength. Our cash runway now extends to year-end 2022, a significant improvement
over our prior target of the second quarter of 2022. We continue to have sufficient cash resources to complete the SHIELD I study, prepare
for the submission of a New Drug Application to the FDA and further advance our OncoPLEX program," concluded Mr. Weisberg.
Financial results for the three months ended
Research and development expenses for the three
months ended September 30, 2021 were $7.5 million, compared to $4.2 million in the same three-month period of 2020, as expenses 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 September 30, 2021 were $0.4 million, compared to $0.3 million for the same period in 2020, as 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 three
months ended September 30, 2021 were $2.1 million, consistent with $2.2 million in the prior year period. The decrease was due to lower
non-cash share-based compensation expenses.
For the three months ended September 30, 2021,
the Company had a net loss attributable to ordinary shares of $9.9 million, compared to a net loss of $6.5 million in the three-month
period ended September 30, 2020.
As of September 30, 2021, the Company had cash,
cash equivalents, short-term deposits, and long-term deposits in the amount of $42.0 million, compared to $67.0 million at December 31,
2020. PolyPid expects that its cash on hand will be sufficient to fund operations until the end of 2022.
Financial results for the nine months ended
Research and development expenses for the nine
months ended September 30, 2021 were $20.9 million, compared to $11.9 million in the same nine-month period of 2020, as expenses increased
due to the ongoing SHIELD I and SHIELD II Phase 3 clinical trials in abdominal surgery.
Marketing and business development expenses for
the nine months ended September 30, 2021 were $1.8 million, compared to $0.9 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 nine
months ended September 30, 2021 were $6.7 million, compared to $5.5 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 nine months ended September 30, 2021,
the Company had a net loss attributable to ordinary shares of $29.1 million, as compared to a net loss of $31.4 million in the nine months
ended September 30, 2020.
Conference Call Dial-In & Webcast
| Date: | Wednesday, November 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: | 4585862 |
| Webcast: | https://edge.media-server.com/mmc/p/5rbkqsbe |
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
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 cash runway and sufficiency of its cash resources, ongoing
clinical trials, plans to use the guidance provided by the FDA to progress with its SHIELD I program, the pace of enrollment in the SHIELD
I trial, the timing of last-patient-in or of top-line results of the SHIELD I trial, the size and design of the SHIELD I trial, potential
initiation of Phase 1/2 clinical trial of OncoPLEX in GBM in 2022 and D-PLEX100 NDA submission timelines. 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.
Dikla Czaczkes Akselbrad
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Unaudited | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 9,217 | $ | 4,319 | ||||
| Restricted cash | 390 | 390 | ||||||
| Short-term deposits | 32,375 | 40,157 | ||||||
| Prepaid expenses and other current assets | 3,335 | 2,334 | ||||||
| Total current assets | 45,317 | 47,200 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 5,717 | 5,890 | ||||||
| Long-term deposits | - | 22,120 | ||||||
| Other long-term assets | 2,425 | 637 | ||||||
| Total long-term assets | 8,142 | 28,647 | ||||||
| Total assets | $ | 53,459 | $ | 75,847 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 1,656 | $ | 974 | ||||
| Other payables and accrued expenses | 3,488 | 1,903 | ||||||
| Total current liabilities | 5,144 | 2,877 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Other long-term liabilities | 192 | 193 | ||||||
| Total long-term liabilities | 192 | 193 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Share capital - | ||||||||
| Ordinary shares with no par value - Authorized: 47,800,000 shares at September 30, 2021 and December 31, 2020; Issued and outstanding: 18,756,570 and 18,494,739 shares at September 30, 2021 and December 31, 2020, respectively | - | - | ||||||
| Additional paid-in capital | 209,508 | 205,063 | ||||||
| Accumulated deficit | (161,385 | ) | (132,286 | ) | ||||
| Total shareholders' equity | 48,123 | 72,777 | ||||||
| Total liabilities and shareholders' equity | $ | 53,459 | $ | 75,847 |
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and