Full Press Release Details
PolyPid Ltd. Provides Corporate Update
and Reports Fourth Quarter and Full-Year 2020 Financial Results
TIKVA, Israel, February 10, 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 and full-year ended December 31, 2020.
Recent Corporate Highlights:
"2020 was truly a transformative
year for PolyPid," said Amir Weisberg, Chief Executive Officer. "Most importantly, our Phase 3 program for D-PLEX100
for the prevention of SSIs is progressing as planned. We are excited to report that we have now enrolled 100 patients collectively
in our two Phase 3 programs, with the vast majority of those subjects in our ongoing SHIELD I trial. We continue to anticipate
top-line results from SHIELD I by year-end 2021. Moreover, our second Phase 3 trial in abdominal surgery, SHIELD II, which was
recently initiated, is advancing as anticipated. We also received regulatory validation of the potential of D-PLEX100
to demonstrate substantial improvement in the prevention of SSIs in complex surgical settings when we were granted Breakthrough
Therapy Designation from the FDA for D-PLEX100 in late 2020.
"We believe our innovative PLEX technology
has potential in multiple areas of medicine where locally administered extended-release and controlled therapies are most beneficial,
including oncology," continued Mr. Weisberg. "To this end, the positive preclinical data demonstrated with OncoPLEX
support our belief that direct local application of this promising adjuvant therapy in the intra-operative tumor resection setting
has the potential to overcome the chemotherapeutic drug resistance seen in many cancer patients across different solid tumors.
We look forward to further advancing our OncoPLEX development program and potentially initiating a Phase 1 clinical trial in 2022.
"We also continue to operate from a position of significant
financial strength. Our successfully completed IPO on the Nasdaq in June 2020 that generated $62.8 million in net proceeds helped
extend our cash runway into 2022. We are 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. Lastly, we are proud and delighted to update that PolyPid recently joined
the ARK Israeli Innovative Technology ETF designed to track listed Israeli companies who are causing disruptive innovation in their
field, including life sciences," concluded Mr. Weisberg.
Financial results for three months ended
Financial results for the full-year
ended December 31, 2020
Balance Sheet Highlights
Conference Call Dial-In & Webcast
| Date: | Wednesday, February 10, 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: | 1468387 |
| Webcast: | https://edge.media-server.com/mmc/p/cx5so6fj |
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 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
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.
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
| December 31, | ||||||||
| 2020 | 2019 | |||||||
| (Unaudited) | (Audited) | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 4,319 | $ | 3,924 | ||||
| Restricted cash | 390 | 375 | ||||||
| Short-term deposits | 40,157 | 22,685 | ||||||
| Prepaid expenses and other receivables | 2,729 | 417 | ||||||
| Total current assets | 47,595 | 27,401 | ||||||
| Long-term assets: | ||||||||
| Property and equipment, net | 5,890 | 6,121 | ||||||
| Long-term deposits | 22,120 | - | ||||||
| Other long-term assets | 242 | 230 | ||||||
| Total long-term assets | 28,252 | 6,351 | ||||||
| Total assets | $ | 75,847 | $ | 33,752 | ||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 974 | $ | 1,581 | ||||
| Other payables and accrued expenses | 1,903 | 998 | ||||||
| Total current liabilities | 2,877 | 2,579 | ||||||
| Long-term liabilities: | ||||||||
| Other liabilities | 193 | 251 | ||||||
| Warrants to convertible preferred shares | - | 12,241 | ||||||
| Total long-term liabilities | 193 | 12,492 | ||||||
| Commitments and Contingencies | ||||||||
| Convertible preferred shares: | ||||||||
| Preferred A, A-1, B, B-1, C-1, C-2, D-1, D-3, E and E-1 shares with no par value - Authorized: 0 and 17,916,412 shares at December 31, 2020 and 2019, respectively; Issued and outstanding: 0 and 12,520,977 shares at December 31, 2020 and 2019, respectively. | - | 106,313 | ||||||
| Shareholders' equity (deficit): | ||||||||
| Share capital - | ||||||||
| Ordinary shares with no par value - Authorized: 47,800,000 and 22,520,977 shares at December 31, 2020 and 2019, respectively; Issued and outstanding: 18,494,739 and 562,748 shares at December 31, 2020 and 2019, respectively. | - | - | ||||||
| Additional paid-in capital | 205,063 | 5,671 | ||||||
| Accumulated deficit | (132,286 | ) | (93,303 | ) | ||||
| Total shareholders' equity (deficit) | 72,777 | (87,632 | ) | |||||
| Total liabilities, convertible preferred shares and shareholders' equity (deficit) | $ | 75,847 | $ | 33,752 |
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share
| Year ended December 31, | ||||||||
| 2020 | 2019 | |||||||
| (Unaudited) | (Audited) | |||||||
| Operating expenses: | ||||||||
| Research and development, net | $ | 16,954 | $ | 14,083 | ||||
| Marketing and business development expenses | 1,614 | 887 | ||||||
| General and administrative | 7,704 | 3,590 | ||||||
| Operating loss | 26,272 | 18,560 | ||||||
| Financial (income) expense, net | 10,597 | (11,655 | ) | |||||
| Net loss | $ | 36,869 | $ | 6,905 | ||||
| Deemed dividend | 2,114 | - | ||||||
| Net loss attributable to Ordinary shares | $ | 38,983 | $ | 6,905 | ||||
| Basic and Diluted net loss per Ordinary share | $ | 4.07 | $ | 23.69 | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 9,582,405 | 562,451 |
CONSOLIDATED STATEMENTS
U.S. dollars in thousands (except share and per share
| Three Months Ended December 31, | ||||||||
| 2020 | 2019 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Operating expenses: | ||||||||
| Research and development, net | $ | 5,006 | $ | 3,314 | ||||
| Marketing and business development expenses | 710 | 316 | ||||||
| General and administrative | 2,172 | 778 | ||||||
| Operating loss | 7,888 | 4,408 | ||||||
| Financial income, net | 339 | 548 | ||||||
| Net loss | $ | 7,549 | $ | 3,860 | ||||
| Deemed dividend | - | - | ||||||
| Net loss attributable to Ordinary shares | $ | 7,549 | $ | 3,860 | ||||
| Basic and Diluted net loss per Ordinary share | $ | 0.41 | $ | 6.86 | ||||
| Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 18,494,773 | 562,748 |