Full Press Release Details
PolyPid Provides Corporate
Update and Reports Fourth Quarter and
Full-Year 2021 Financial Results
PETACH TIKVA, Israel, February 9, 2022
-- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a Phase 3 biopharmaceutical company focused
on developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology, today provided
a corporate update and reported financial results for the three months and full-year ended December 31, 2021.
Recent Corporate Highlights:
"Our team is achieving rapid progress in
advancing our multiple development programs, as well as executing on the activities related to our commercial preparations
for D-PLEX100 for prevention of abdominal soft tissue SSIs," stated Amir Weisberg, PolyPid's Chief Executive Officer.
"We are very pleased with the interim analysis in SHIELD I that will strengthen the adaptive design of the study so we can more
precisely define the targeted patient enrollment range. It can also potentially allow for stopping the trial earlier than planned, if
the efficacy results on SSIs are above expectations. We are also very satisfied with the study enrollment which continues at a strong
pace, as we now have approximately 680 patients enrolled into the study, as compared to about 480 patients announced on our November
2021 conference call."
"We believe PolyPid is in the strongest
operational position in its history, and we are well-positioned for long-term success. We continue to anticipate that our current balance
sheet will be sufficient to complete the SHIELD I study and prepare for the submission of an NDA to the FDA, as well as further advancement
of our OncoPLEX development platform," concluded Mr. Weisberg.
Financial results for three months ended December
Financial results for the full-year ended
Balance Sheet Highlights
Conference Call Dial-In & Webcast Information:
| Date: | Wednesday, February 9, 2022 | |
| Time: | 8:30 AM Eastern Time | |
| United States: | +1 877-870-9135 | |
| Israel: | +972 1809 213-985 | |
| International: | +44 (0) 2071 928338 | |
| Conference ID: | 6092321 | |
| Webcast: | https://edge.media-server.com/mmc/p/fxz7727t |
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
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, its expectations regarding the interim analysis and its
timing, that interim analysis could potentially allow for an early trial stopping if the efficacy results on SSIs exceed the expectations,
the pace of enrollment in SHIELD I and SHIELD II trials, the timing of top-line results of the SHIELD I trial, the IND meeting with the
FDA supporting a Phase 1/2 clinical trial of OncoPLEX as a potential part of first-line combination therapy for patients newly diagnosed
with Glioblastoma Multiform (GBM), the potential of OncoPLEX to help treat brain tumors and have substantial commercial benefit, the
Company's belief that PolyPid is in the strongest operational position in its history, its anticipation that its current balance
sheet will be sufficient to complete the SHIELD I study and prepare for the submission of an NDA to the FDA, as well as further advance
its OncoPLEX development platform and fund operations through the end of 2022. 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
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
Tel: +972-74-719-5700
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| (Unaudited) | (Audited) | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 9,819 | $ | 4,319 | ||||
| Restricted cash | 397 | 390 | ||||||
| Short-term deposits | 22,384 | 40,157 | ||||||
| Prepaid expenses and other current assets | 2,211 | 2,334 | ||||||
| Total current assets | 34,811 | 47,200 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 8,761 | 5,890 | ||||||
| Long-term deposits | - | 22,120 | ||||||
| Other long-term assets | 663 | 637 | ||||||
| Total long-term assets | 9,424 | 28,647 | ||||||
| Total assets | $ | 44,235 | $ | 75,847 |
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| (Unaudited) | (Audited) | |||||||
| LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 4,136 | $ | 974 | ||||
| Other payables and accrued expenses | 3,670 | 1,903 | ||||||
| Total current liabilities | 7,806 | 2,877 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Other liabilities | 199 | 193 | ||||||
| Total long-term liabilities | 199 | 193 | ||||||
| Commitments and Contingencies | ||||||||
| Shareholders' equity (deficit): | ||||||||
| Share capital - | ||||||||
| Ordinary shares with no par value - Authorized: 47,800,000 shares at December 31, 2021 and 2020; Issued and outstanding: 18,756,570 and 18,494,739 shares at December 31, 2021 and 2020, respectively | - | - | ||||||
| Additional paid-in capital | 210,847 | 205,063 | ||||||
| Accumulated deficit | (174,617 | ) | (132,286 | ) | ||||
| Total shareholders' equity | 36,230 | 72,777 | ||||||
| Total liabilities shareholders' equity | $ | 44,235 | $ | 75,847 |
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share
| Year ended December 31, | ||||||||||||
| 2021 | 2020 | 2019 | ||||||||||
| (Unaudited) | (Audited) | (Audited) | ||||||||||
| Operating expenses: | ||||||||||||
| Research and development, net | $ | 30,423 | $ | 16,954 | $ | 14,083 | ||||||
| Marketing and business development | 2,973 | 1,614 | 887 | |||||||||
| General and administrative | 9,479 | 7,704 | 3,590 | |||||||||
| Operating loss | 42,875 | 26,272 | 18,560 | |||||||||
| Financial (income) expense, net | (544 | ) | 10,597 | (11,655 | ) | |||||||
| Loss | $ | 42,331 | $ | 36,869 | $ | 6,905 | ||||||
| Deemed dividend | - | 2,114 | - | |||||||||
| Loss attributable to Ordinary shares | $ | 42,331 | $ | 38,983 | $ | 6,905 | ||||||
| Basic and diluted loss per Ordinary share | $ | 2.26 | $ | 4.48 | $ | 23.69 | ||||||
| Weighted average number of Ordinary shares used in computing basic and diluted loss per share | 18,721,528 | 9,582,405 | 562,451 |
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
| Three Months Ended December 31, | ||||||||
| 2021 | 2020 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Operating expenses: | ||||||||
| Research and development, net | $ | 9,487 | $ | 5,006 | ||||
| Marketing and business development expenses | 1,137 | 710 | ||||||
| General and administrative | 2,760 | 2,172 | ||||||
| Operating loss | 13,384 | 7,888 | ||||||
| Financial income, net | 152 | 339 | ||||||
| Loss | $ | 13,232 | $ | 7,549 | ||||
| Loss attributable to Ordinary shares | $ | 13,232 | $ | 7,549 | ||||
| Basic and Diluted loss per Ordinary share | $ | 0.71 | $ | 0.41 | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted loss per share | 18,756,570 | 18,494,773 |