Full Press Release Details
Ltd. Provides Corporate Update and Reports Third Quarter 2020 Financial Results
Over 50% of planned 60 centers for ongoing Phase 3 SHIELD I trial of D-PLEX100 in abdominal surgery have received IRB approval
Phase 3 SHIELD II trial advanced; preparations underway to initiate by year-end 2020
Conference Call Scheduled for today at 8:30 a.m. ET
TIKVA, Israel, November
11, 2020 -- PolyPid Ltd. (Nasdaq:
PYPD) (the "Company"), a Phase 3 clinical-stage 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 and nine months ended September 30, 2020.
Corporate Highlights:
are very encouraged with our strong progress to date, especially readying additional sites to enroll patients in our lead Phase
3 trial, and remain on track for our planned milestones," said Amir Weisberg, Chief Executive Officer. "We continue
to anticipate that top-line results from SHIELD I will be available in the second half of 2021. Moreover, we expect that the initiation
of our second Phase 3 pivotal trial, SHIELD II, will occur in late 2020. SHIELD I and SHIELD II will serve as the basis for PolyPid's
first New Drug Application (NDA) submission and, we believe, will support a broad label for D-PLEX100 in the prevention of SSIs."
continue to operate from a strong financial position," continued Mr. Weisberg. "We expect that our current cash balance
will be sufficient to complete SHIELD I and to initiate and conduct SHIELD II, as well as prepare for the submission of an NDA
to the U.S. Food and Drug Administration."
results for three months ended September 30, 2020
results for nine-months ended September 30, 2020
Call Dial-In & Webcast Information
November 11th at 8:30 am Eastern Time
| United States: | +1 877 870 9135 |
| Israel: | +972 1809 213-985 |
| International: | +44 (0) 2071 928338 |
| Conference ID: | 4557195 |
| Webcast: | https://edge.media-server.com/mmc/p/u49mfor4 |
lead product candidate, D-PLEX100, is a novel product candidate designed to provide local prolonged 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 up to four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant
bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (QIDP) designations, as well
as two Fast Track designations from the FDA for the prevention of post-abdominal surgery incisional infection and for the prevention
of sternal wound infection post-cardiac surgery.
a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release
therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are
designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites
in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead
product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of SSIs in different type of surgeries, including
abdominal and open-heart surgery. PolyPid's technology and products are based on the inventions of Dr. Noam Emanuel,
the Founder and the Chief Scientific Officer of the company.
additional company information, visit www.polypid.com.
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 its objectives, milestones, plans, and strategies, the expected timing of trials and release of the results thereof,
the expected timing of an NDA and other regulatory matters, the research, development, the sufficiency of the Company's
cash and use of the Company's platform technologies, technologies, products and product candidates, 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 prospectus filed pursuant to Rule 424(b)(4), filed with the SEC on June 29, 2020. 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.
| September 30, 2020 | December 31, 2019 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 9,665 | $ | 3,924 | ||||
| Restricted cash | 378 | 375 | ||||||
| Short-term deposits | 34,080 | 22,685 | ||||||
| Prepaid expenses and other receivables | 2,504 | 417 | ||||||
| Total current assets | 46,627 | 27,401 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 6,182 | 6,121 | ||||||
| Long-term deposits | 28,068 | - | ||||||
| Other long-term assets | 221 | 230 | ||||||
| Total long-term assets | 34,471 | 6,351 | ||||||
| Total assets | $ | 81,098 | $ | 33,752 |
dollars in thousands (except share and per share data)
| September 30, 2020 | December 31, 2019 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' DEFICIENCY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 573 | $ | 1,581 | ||||
| Other payables and accrued expenses | 1,112 | 998 | ||||||
| Total current liabilities | 1,685 | 2,579 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Other liabilities | 180 | 251 | ||||||
| Convertible preferred shares warrant liability | - | 12,241 | ||||||
| Total long-term liabilities | 180 | 12,492 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| CONVERTIBLE PREFERRED SHARES: | ||||||||
| Preferred A, A-1, B, B-1, C-1, C-2, D-1, D-3, E and E-1 shares of NIS 0 par value - Authorized: 0 and 17,916,412 shares at September 30, 2020 (unaudited) and December 31, 2019, respectively; Issued and outstanding: 0 and 12,520,977 shares at September 30, 2020 (unaudited) and December 31, 2019, respectively | - | 106,313 | ||||||
| SHAREHOLDERS' EQUITY (DEFICIENCY): | ||||||||
| Share capital - Ordinary shares with no par value - Authorized: 47,800,000 and 22,466,000 shares at September 30, 2020 (unaudited) and December 31, 2019, respectively; Issued and outstanding: 18,494,344 and 562,748 shares at September 30, 2020 (unaudited) and December 31, 2019, respectively | - | - | ||||||
| Additional paid-in capital | 203,970 | 5,671 | ||||||
| Accumulated deficit | (124,737 | ) | (93,303 | ) | ||||
| Total shareholders' equity (deficiency) | 79,233 | (87,632 | ) | |||||
| Total liabilities, convertible preferred shares and shareholders' equity (deficiency) | $ | 81,098 | $ | 33,752 |
STATEMENTS OF OPERATIONS
dollars in thousands
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Unaudited | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 4,176 | $ | 3,789 | $ | 11,948 | $ | 10,769 | ||||||||
| Marketing and business development expenses | 323 | 274 | 904 | 571 | ||||||||||||
| General and administrative | 2,177 | 1,190 | 5,532 | 2,812 | ||||||||||||
| Operating loss | 6,676 | 5,253 | 18,384 | 14,152 | ||||||||||||
| Financial (income) expense, net | (218 | ) | (3,145 | ) | 10,936 | (11,107 | ) | |||||||||
| Net loss (profit) | $ | 6,458 | $ | 2,108 | $ | 29,320 | $ | 3,045 | ||||||||
| Deemed dividend | - | - | 2,114 | - | ||||||||||||
| Net loss (profit) attributable to Ordinary shares | $ | 6,458 | $ | 2,108 | $ | 31,434 | $ | 3,045 | ||||||||
| Basic and diluted net loss per Ordinary share | $ | 0.35 | $ | 6.94 | $ | 4.78 | $ | 13.38 | ||||||||
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 18,415,231 | 562,597 | 6,578,969 | 562,354 |