Full Press Release Details
PolyPid Ltd. Reports First Quarter 2021 Financial
Provides Corporate Update
Recruitment Progressing as Planned with Nearly 200 Patients Enrolled into Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal
Recruitment Rate in SHIELD I trial Doubled in the Last Three Weeks
Manufacturing Facility Now Fully Scaled Up and Capable of Supporting at Least First 30 Months of Anticipated Commercial Demand for
Conference Call Scheduled for Today at 8:30 AM ET
TIKVA, Israel, May 12, 2021 -- PolyPid
Ltd. (Nasdaq: PYPD), a late-stage biopharma company aiming to improve surgical outcomes
through locally administered, controlled, extended-release therapeutics, today provided a corporate update and reported financial results
for the three months ended March 31, 2021.
Corporate Highlights:
have made significant progress advancing our promising development programs and continuing our evolution towards successful commercialization,"
said Amir Weisberg, PolyPid's Chief Executive Officer. "Our robust Phase 3 trials for D-PLEX100 for the prevention
of SSIs, SHIELD I and SHIELD II, continue to enroll patients at the expected rate. To this end, we are thrilled to report that the recruitment
rate in SHIELD I trial doubled in the last three weeks and that we have now enrolled nearly 200 patients in the trial. We continue to
anticipate the availability of top-line results for SHIELD I by year-end 2021 and top-line results from SHIELD II by the end of
"We also continue to generate additional
compelling preclinical data with OncoPLEX, including positive safety data in a promising solid tumor indication," continued Mr.
Weisberg. "We are excited to further progress our OncoPLEX development program and potentially initiate a first-in-man Phase 1 clinical
"Our strong balance sheet continues to drive our robust clinical
development program. Our cash runway extends into 2022 and we remain well-positioned to complete the SHIELD I study and conduct SHIELD
II, as well as prepare for the submission of a New Drug Application to the FDA with cash on hand," concluded Mr. Weisberg.
results for three months ended March 31, 2021
Call Dial-In & Webcast Information:
| Date: | Wednesday, May 12, 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: | 7258907 | |
| Webcast: | https://edge.media-server.com/mmc/p/j63c5h43 |
PolyPid's lead product candidate, D-PLEX100, is a
novel drug product candidate designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site
to prevent SSIs. Following the administration of D-PLEX100 into the surgical site, the PLEX technology enables a prolonged
and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four
weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site.
D-PLEX100 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention
of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product
(QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the
prevention of sternal wound infection post-cardiac surgery.
PolyPid Ltd. (Nasdaq: PYPD) is a late-stage 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 information, please visit http://www.polypid.com
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 statements relating to the expected recruitment for trials, timing of trials and release of the results thereof, the
capacity of the Company's manufacturing facility, the potential benefits of PLEX and OncoPLEX, the sufficiency of the Company's
cash to fund future operations, and all statements (other than statements of historical facts) that address activities, events, or developments
that the Company intends, expects, projects, believes, or anticipates will or may occur in the future. 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
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Unaudited | Audited | |||||||
| U.S. dollars in thousands | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 5,993 | $ | 4,319 | ||||
| Restricted cash | 385 | 390 | ||||||
| Short-term deposits | 43,279 | 40,157 | ||||||
| Prepaid expenses and other receivables | 1,286 | 2,334 | ||||||
| Total current assets | 50,943 | 47,200 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 6,023 | 5,890 | ||||||
| Long-term deposits | 12,100 | 22,120 | ||||||
| Other long-term assets | 773 | 637 | ||||||
| Total long-term assets | 18,896 | 28,647 | ||||||
| Total assets | 69,839 | 75,847 |
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Unaudited | Audited | |||||||
| U.S. dollars in thousands | ||||||||
| LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 1,468 | $ | 974 | ||||
| Other payables and accrued expenses | 2,038 | 1,903 | ||||||
| Total current liabilities | 3,506 | 2,877 | ||||||
| Long-term liabilities: | ||||||||
| Other liabilities | 186 | 193 | ||||||
| Total long-term liabilities | 186 | 193 | ||||||
| Commitments and Contingencies | ||||||||
| Shareholders' equity: | ||||||||
| Share capital - | ||||||||
| Ordinary shares with no par value - Authorized: 47,800,000 shares at March 31, 2021 (unaudited) and December 31, 2020; Issued and outstanding: 18,745,142 and 18,494,739 shares at March 31, 2021 (unaudited) and December 31, 2020, respectively. | - | - | ||||||
| Additional paid-in capital | 207,120 | 205,063 | ||||||
| Accumulated deficit | (140,973 | ) | (132,286 | ) | ||||
| Total shareholders' equity | 66,147 | 72,777 | ||||||
| Total liabilities, convertible preferred shares and shareholders' equity | $ | 69,839 | $ | 75,847 |
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
| Three months ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Unaudited | ||||||||
| U.S. dollars in thousands | ||||||||
| Operating expenses: | ||||||||
| Research and development, net | $ | 6,018 | $ | 3,433 | ||||
| Marketing and business development expenses | 652 | 276 | ||||||
| General and administrative | 2,127 | 727 | ||||||
| Operating loss | 8,797 | 4,436 | ||||||
| Financial expense (income), net | (110 | ) | 1,433 | |||||
| Net loss | $ | 8,687 | $ | 5,869 | ||||
| Net loss attributable to Ordinary shares | $ | 8,687 | $ | 5,869 | ||||
| Basic and diluted net loss per Ordinary share | $ | 0.47 | $ | 13.90 | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 18,623,154 | 562,748 |