Full Press Release Details
Ltd. Reports Second Quarter 2021 Financial Results and Provides Corporate Update
Recruitment Progressing as Planned with Over 300 Patients Enrolled into Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery
FDA Agreed 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
Brain Tumors Selected as the Initial Indication for Company's OncoPLEX Intra-tumoral Cancer Therapy Program
Call Scheduled for Today at 8:30 AM ET
TIKVA, Israel, August 11, 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 and six months ended June 30, 2021.
Corporate Highlights:
have recently achieved significant progress in advancing our multiple development programs, and in continuing our evolution towards becoming
a commercial stage company," said Amir Weisberg, PolyPid's Chief Executive Officer. "Most importantly, the recent communication
from the FDA regarding SHIELD I reduces our anticipated costs for the program, and provides us
with additional financial flexibility overall. In addition, we are excited to report that we have now enrolled over 300 patients
in the SHIELD I trial."
are also diligently working to further progress our promising OncoPLEX platform in oncology applications, which continues to advance
expeditiously," continued Mr. Weisberg. "Our initial target indication for OncoPLEX will be brain tumors, the most aggressive
and deadly type of cancer for which patients currently have almost no meaningful treatment options."
vigorous clinical development program continues to be supported by a strong balance sheet. With a cash runway that extends into the second
half of 2022, we remain well-positioned to complete the SHIELD I study, prepare for the submission of an NDA to the FDA and further advance
our OncoPLEX program with our current cash resources," concluded Mr. Weisberg.
results for three months ended June 30, 2021
results for the six months ended June 30, 2021
Call Dial-In & Webcast Information:
| Date: | Wednesday, August 11, 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: | 1663949 | |
| Webcast: | https://edge.media-server.com/mmc/p/2eu7k7nj |
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 continuous 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.
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 abdominal and sternal surgical site infections (SSIs).
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 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.
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.
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 7,448 | $ | 4,319 | ||||
| Restricted cash | 388 | 390 | ||||||
| Short-term deposits | 40,399 | 40,157 | ||||||
| Prepaid expenses and other current assets | 937 | 2,334 | ||||||
| Total current assets | 49,172 | 47,200 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 5,734 | 5,890 | ||||||
| Long-term deposits | 5,059 | 22,120 | ||||||
| Other long-term assets | 1,431 | 637 | ||||||
| Total long-term assets | 12,224 | 28,647 | ||||||
| Total assets | $ | 61,396 | $ | 75,847 |
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 1,756 | $ | 974 | ||||
| Other payables and accrued expenses | 2,565 | 1,903 | ||||||
| Total current liabilities | 4,321 | 2,877 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Other liabilities | 190 | 193 | ||||||
| Total long-term liabilities | 190 | 193 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Share capital - | ||||||||
| Ordinary shares with no par value - Authorized: 47,800,000 shares at June 30, 2021 (unaudited) and December 31, 2020; Issued and outstanding: 18,756,570 and 18,494,739 shares at June 30, 2021 (unaudited) and December 31, 2020, respectively | - | - | ||||||
| Additional paid-in capital | 208,335 | 205,063 | ||||||
| Accumulated deficit | (151,450 | ) | (132,286 | ) | ||||
| Total shareholders' equity | 56,885 | 72,777 | ||||||
| Total liabilities and shareholders' equity | 61,396 | $ | 75,847 |
STATEMENTS OF OPERATIONS
dollars in thousands (except share and per share data)
| Six months ended June 30, | Three months ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Unaudited | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 13,460 | $ | 7,772 | $ | 7,442 | $ | 4,339 | ||||||||
| Marketing and business development expenses | 1,391 | 581 | 739 | 305 | ||||||||||||
| General and administrative | 4,576 | 3,355 | 2,449 | 2,628 | ||||||||||||
| Operating loss | 19,427 | 11,708 | 10,630 | 7,272 | ||||||||||||
| Financial (income) expense, net | (263 | ) | 11,154 | (153 | ) | 9,721 | ||||||||||
| Net loss | 19,164 | 22,862 | 10,477 | 16,993 | ||||||||||||
| Deemed dividend | - | 2,114 | - | 2,114 | ||||||||||||
| Net loss attributable to Ordinary shares | $ | 19,164 | $ | 24,976 | $ | 10,477 | $ | 19,107 | ||||||||
| Basic and diluted net loss per Ordinary share | $ | 1.03 | $ | 37.87 | $ | 0.56 | $ | 25.30 | ||||||||
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 18,685,906 | 659,551 | 18,747,967 | 755,289 |