Full Press Release Details
PolyPid Ltd. Provides Corporate Update
and Reports Second Quarter 2020 Financial Results
Phase 3 SHIELD I Trial for D-PLEX100 in Abdominal Surgery and Received Fast Track Designation for D-PLEX100
Positive Phase 2 Results of D-PLEX100 for Prevention of Surgical Site Infections in Abdominal Surgery at ASCRS Meeting
Initial Public Offering in U.S., Raising Net Proceeds of $62.8 Million
Conference Call scheduled for Wednesday,
August 19 at 8:30 AM Eastern Time
TIKVA, Israel, August 19, 2020 (GLOBE
NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD), 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 six months ended June 30, 2020.
Recent Corporate Highlights:
"We have recently completed a truly
transformational period in PolyPid's corporate evolution," said Amir Weisberg, Chief Executive Officer. "We made
significant progress in advancing our promising clinical development program for D-PLEX100 as highlighted by the initiation
of our first Phase 3 clinical trial in abdominal surgery. This key milestone represented a significant step toward
furthering our U.S. regulatory approval strategy and our objective to provide a novel solution for surgeons and their patients
as expeditiously as possible. Moreover, we were excited to recently receive Fast Track Designation for D-PLEX100,
an important regulatory validation of our innovative PLEX technology and the high clinical
unmet need that currently exists in preventing surgical site infections in complex surgical settings, such as abdominal surgeries."
Mr. Weisberg added, "We were also
proud to complete our IPO on the Nasdaq Global Market in June, successfully raising $62.8 million of net proceeds. Our IPO and
listing increase our visibility in the U.S. capital markets, and provides us with critical growth capital to continue the clinical
development of D-PLEX100 through both Phase 3 trials in abdominal surgery, begin our rolling New Drug Application submission
and initiate our commercial preparations for this compelling asset."
Financial results for three months ended
Financial results for six months ended
Balance Sheet Highlights
Conference Call & Webcast
Wednesday, August 19th
@ 8:30 am Eastern Time
| Domestic: | 877-870-9135 | |
| International: | 44 (0) 2071 928338 | |
| Passcode: | 6389197 | |
| Webcast: | https://edge.media-server.com/mmc/p/v669bncn |
PolyPid's 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 from
the FDA for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac
PolyPid is 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 sternal SSIs and abdominal SSIs. PolyPid's technology and products are
based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.
For additional company information,
visit www.polypid.com.
CONSOLIDATED BALNCE SHEET
(U.S. dollars in thousands)
| June 30, 2020 | December 31, 2019 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 69,282 | $ | 3,924 | ||||
| Restricted cash | 376 | 375 | ||||||
| Short-term deposits | 12,054 | 22,685 | ||||||
| Prepaid expenses and other receivables | 430 | 417 | ||||||
| Total current assets | 82,142 | 27,401 | ||||||
| LONG-TERM ASSETS: | ||||||||
| Property and equipment, net | 6,231 | 6,121 | ||||||
| Other long-term assets | 227 | 230 | ||||||
| Total long-term assets | 6,458 | 6,351 | ||||||
| Total assets | $ | 88,600 | $ | 33,752 | ||||
| LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY (DEFICIENCY) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 630 | $ | 1,581 | ||||
| Other payables and accrued expenses | 3,312 | 998 | ||||||
| Total current liabilities | 3,942 | 2,579 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Other liabilities | 179 | 251 | ||||||
| Convertible preferred shares warrant liability | - | 12,241 | ||||||
| Total long-term liabilities | 179 | 12,492 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| CONVERTIBLE PREFERRED SHARES: | - | 106,313 | ||||||
| SHAREHOLDERS' EQUITY (DEFICIENCY): | ||||||||
| Share capital | - | - | ||||||
| Additional paid-in capital | 202,758 | 5,671 | ||||||
| Accumulated deficit | (118,279 | ) | (93,303 | ) | ||||
| Total shareholders' equity (deficiency) | 84,479 | (87,632 | ) | |||||
| Total liabilities, convertible preferred shares and shareholders' equity (deficiency) | $ | 88,600 | $ | 33,752 |
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands (except share
and per share data))
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Unaudited | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 4,339 | $ | 3,503 | $ | 7,772 | $ | 6,980 | ||||||||
| General and administrative | 2,933 | 1,199 | 3,936 | 1,919 | ||||||||||||
| Operating loss | 7,272 | 4,702 | 11,708 | 8,899 | ||||||||||||
| Financial (income) expense, net | 9,721 | (4,995 | ) | 11,154 | (7,962 | ) | ||||||||||
| Net loss (profit) | $ | 16,993 | $ | (293 | ) | $ | 22,862 | $ | 937 | |||||||
| Deemed dividend | 2,114 | - | 2,114 | - | ||||||||||||
| Net loss (profit) attributable to Ordinary shares | $ | 19,107 | $ | (293 | ) | $ | 24,976 | $ | 937 | |||||||
| Basic profit (net loss) per Ordinary share | (25.30 | ) | 0.52 | (37.87 | ) | (6.43 | ) | |||||||||
| Diluted net loss per Ordinary share | (25.30 | ) | (1.10 | ) | (37.87 | ) | (6.43 | ) | ||||||||
| Weighted average number of Ordinary shares used in computing basic net loss per share | 755,289 | 562,270 | 659,551 | 562,229 | ||||||||||||
| Weighted average number of Ordinary shares used in computing diluted net loss per share | 755,289 | 614,515 | 659,551 | 562,229 |
RECONCILIATION OF GAAP TO NON-GAAP NET
LOSS (INCOME) AND NET LOSS (INCOME) PER SHARE
(U.S. dollars in thousands (except per
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Unaudited | ||||||||||||||||
| GAAP net loss (profit) attributable to Ordinary shares: | $ | 19,107 | $ | (293 | ) | $ | 24,976 | $ | 937 | |||||||
| Add: | ||||||||||||||||
| Deemed dividend | 2,114 | - | 2,114 | - | ||||||||||||
| Depreciation and amortization | 254 | 208 | 498 | 398 | ||||||||||||
| Share-based compensation | 2,068 | 204 | 2,257 | 391 | ||||||||||||
| Warrants change in fair value | 9,861 | (4,991 | ) | 11,373 | (7,933 | ) | ||||||||||
| Non-GAAP net loss attributable to Ordinary shares | $ | 4,810 | $ | 4,286 | $ | 8,734 | $ | 8,081 | ||||||||
| Basic and diluted net loss per Ordinary share | 6.37 | 7.62 | 13.24 | 14.37 | ||||||||||||
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 755,289 | 562,270 | 659,551 | 562,229 |
Use of Non-GAAP Financial Results
In addition to disclosing financial
results calculated in accordance with United States generally accepted accounting principles (GAAP), this press release contains
non-GAAP financial measures of net loss for the period that excludes the effect of stock-based compensation expenses, change in
fair value of warrant liability, deemed dividend and depreciation and amortization. The company's management believes the
non-GAAP financial information provided in this release is useful to investors' understanding and assessment of the company's
ongoing operations. Management also uses both GAAP and non-GAAP information in evaluating and operating business internally and
as such deemed it important to provide all this information to investors. The non-GAAP financial measures disclosed by the company
should not be considered in isolation or as a substitute for, or superior to, financial measures calculated in accordance with
GAAP, and the financial results calculated in accordance with GAAP and reconciliations to those financial statements should be
carefully evaluated.
Forward-looking Statements
This press release contains forward-looking
statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995
and other Federal 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, PolyPid is using forward-looking statements in this press release when it
discusses the expected timing of Phase 3 trials, potential of D-PLEX100 to prevent SSIs, furthering U.S. regulatory
approval strategy, ability to provide a novel solution for surgeons and their patients as expeditiously as possible, sufficiency
of capital to continue the clinical development of D-PLEX100 through both Phase 3 trials and through the second half
of 2022, to begin a rolling New Drug Application submission and advance commercial preparations. Because such statements deal with
future events and are based on PolyPid's current expectations, they are subject to various risks and uncertainties. Also,
while PolyPid has received Fast Track Designation for D-PLEX100 for the prevention of SSIs, it cannot guarantee
that it will be able to maintain such designation due to reasons within our outside of its control. Actual results, performance
or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release.
The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including
those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant
to Rule 424(b)(4) with the Securities and Exchange Commission ("SEC"), and in any subsequent filings with the SEC.
Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking
statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. 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