Full Press Release Details
POLYPID LTD. AND ITS SUBSIDIARY
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. DOLLARS IN THOUSANDS
| Page | ||
| Condensed Consolidated Balance Sheets | 2 - 3 | |
| Condensed Consolidated Statements of Operations | 4 | |
| Condensed Consolidated Statements of Changes in Shareholders' Equity | 5 - 6 | |
| Condensed Consolidated Statements of Cash Flows | 7 | |
| Notes to Condensed Consolidated Financial Statements | 8 - 18 |
- - - - - - - - - - -
POLYPID LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Unaudited | ||||||||
| 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 |
The accompanying notes are an integral part of
the interim condensed consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Unaudited | ||||||||
| LIABILITIES 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 long-term 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 |
The accompanying notes are an integral part of
the interim condensed consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and
| 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 |
The accompanying notes are an integral part of
the interim condensed consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES
IN CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY
U.S. dollars in thousands (except share data)
| Convertible Preferred shares | Shareholders' equity | |||||||||||||||||||||||||||
| Number of Preferred shares | Amount | Total | Number of Ordinary Shares | Additional paid-in capital | Accumulated deficit | Total shareholders' equity | ||||||||||||||||||||||
| Balances as of January 1, 2021 | - | $ | - | $ | - | 18,494,739 | $ | 205,063 | $ | ( 132,286 | ) | $ | 72,777 | |||||||||||||||
| Share-based compensation | - | - | - | - | 2,238 | - | 2,238 | |||||||||||||||||||||
| Exercise of Warrants | - | - | - | 184,473 | 632 | - | 632 | |||||||||||||||||||||
| Exercise of options | - | - | - | 77,358 | 402 | - | 402 | |||||||||||||||||||||
| Net loss | - | - | - | - | - | ( 19,164 | ) | ( 19,164 | ) | |||||||||||||||||||
| Balances as of June 30, 2021 (unaudited) | - | $ | - | $ | - | 18,756,570 | $ | 208,335 | $ | ( 151,450 | ) | $ | 56,885 |
| Convertible Preferred shares | Shareholders' equity | |||||||||||||||||||||||||||
| Number of Preferred shares | Amount | Total | Number of Ordinary Shares | Additional paid-in capital | Accumulated deficit | Total shareholders' equity | ||||||||||||||||||||||
| Balances as of January 1, 2020 (audited) | 12,520,977 | $ | 106,313 | $ | 106,313 | 562,748 | $ | 5,671 | $ | ( 93,303 | ) | $ | ( 87,632 | ) | ||||||||||||||
| Share-based compensation | - | - | - | - | 2,257 | - | 2,257 | |||||||||||||||||||||
| Deemed dividend related to Series E-1 Preferred shares | - | - | - | 158,967 | 2,114 | ( 2,114 | ) | - | ||||||||||||||||||||
| Issuance of Ordinary Shares in connection with IPO, net of issuance costs of $ 6,224 (see note 1e) | - | - | - | 4,312,500 | 62,776 | - | 62,776 | |||||||||||||||||||||
| Conversion of Convertible Preferred shares to Ordinary Shares | ( 12,520,977 | ) | ( 106,313 | ) | ( 106,313 | ) | 12,520,977 | 106,313 | - | 106,313 | ||||||||||||||||||
| Exercise of Warrants | - | - | - | 528,824 | 13 | - | 13 | |||||||||||||||||||||
| Reclassification of Warrants into equity | - | - | - | - | 23,614 | - | 23,614 | |||||||||||||||||||||
| Net loss | - | - | - | - | - | ( 22,862 | ) | ( 22,862 | ) | |||||||||||||||||||
| Balances as of June 30, 2020 (unaudited) | - | $ | - | $ | - | 18,084,016 | $ | 202,758 | $ | ( 118,279 | ) | $ | 84,479 |
The accompanying notes are an integral part of
the interim condensed consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES
IN CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY
U.S. dollars in thousands (except share data)
| Convertible Preferred shares | Shareholders' equity | |||||||||||||||||||||||||||
| Number of Preferred shares | Amount | Total | Number of Ordinary Shares | Additional paid-in capital | Accumulated deficit | Total shareholders' equity | ||||||||||||||||||||||
| Balances as of January 1, 2020 (audited) | 12,520,977 | $ | 106,313 | $ | 106,313 | 562,748 | $ | 5,671 | $ | ( 93,303 | ) | $ | ( 87,632 | ) | ||||||||||||||
| Share-based compensation | - | - | - | - | 4,577 | - | 4,577 | |||||||||||||||||||||
| Issuance of Ordinary Shares in connection with IPO, net of issuance costs of $ 6,243 (see Note 1e) | - | - | - | 4,312,500 | 62,757 | - | 62,757 | |||||||||||||||||||||
| Conversion of Convertible Preferred shares to Ordinary Shares | ( 12,520,977 | ) | ( 106,313 | ) | ( 106,313 | ) | 12,520,977 | 106,313 | - | 106,313 | ||||||||||||||||||
| Deemed dividend related to Series E-1 Preferred shares | - | - | - | 158,967 | 2,114 | ( 2,114 | ) | - | ||||||||||||||||||||
| Reclassification of Warrants into equity | - | - | - | - | 23,614 | - | 23,614 | |||||||||||||||||||||
| Exercise of Warrants | - | - | - | 939,152 | 13 | - | 13 | |||||||||||||||||||||
| Issuance of Warrants | - | - | - | - | 1 | - | 1 | |||||||||||||||||||||
| Exercise of options | - | - | - | 395 | 3 | - | 3 | |||||||||||||||||||||
| Net loss | - | - | - | - | - | ( 36,869 | ) | ( 36,869 | ) | |||||||||||||||||||
| Balances as of December 31, 2020 (audited) | - | $ | - | $ | - | 18,494,739 | $ | 205,063 | $ | ( 132,286 | ) | $ | 72,777 |
The accompanying notes are an integral part of
the interim condensed consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
| Six months ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| Unaudited | ||||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( 19,164 | ) | $ | ( 22,862 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 547 | 498 | ||||||
| Remeasurement of warrants | - | 11,373 | ||||||
| Share-based compensation | 2,238 | 2,257 | ||||||
| Changes in assets and liabilities: | ||||||||
| Decrease (increase) in receivables and prepaid expenses | 1,397 | ( 13 | ) | |||||
| Decrease (increase) in other long-term assets | ( 10 | ) | 3 | |||||
| Increase (decrease) in trade payables | 782 | ( 951 | ) | |||||
| Increase in other payables and accrued expenses and other liabilities | 659 | 2,242 | ||||||
| Net cash used in operating activities | ( 13,551 | ) | ( 7,453 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchase of property and equipment | ( 391 | ) | ( 608 | ) | ||||
| Short-term deposits, net | ( 242 | ) | 10,631 | |||||
| Long-term deposits, net | 17,061 | - | ||||||
| Pre-payment for equipment | ( 787 | ) | - | |||||
| Net cash provided by investing activities | 15,641 | 10,023 | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from exercise of Warrants | 632 | 13 | ||||||
| Proceeds from exercise of options | 402 | - | ||||||
| Proceeds from issuance of Ordinary Shares in connection with IPO, net | - | 62,776 | ||||||
| Net cash provided by financing activities | 1,034 | 62,789 | ||||||
| Increase in cash, cash equivalents and restricted cash | 3,124 | 65,359 | ||||||
| Cash, cash equivalents and restricted cash at the beginning of the period | 4,908 | 4,498 | ||||||
| Cash, cash equivalents and restricted cash at the end of the period | $ | 8,032 | $ | 69,857 | ||||
| Reconciliation of cash, cash equivalents and restricted cash as shown in the condensed consolidated statements of cash flow: | ||||||||
| Cash and cash equivalents | 7,448 | 69,282 | ||||||
| Restricted cash and restricted cash included in long-term assets | 584 | 575 | ||||||
| Total cash, cash equivalents and restricted cash | $ | 8,032 | $ | 69,857 |
The accompanying notes are an integral part of
the interim consolidated financial statements.
POLYPID LTD. AND ITS SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and
The Company wholly-owns subsidiaries in the Unites States of
America and Romania.
Through June 30, 2021, the Company has been primarily engaged
in research and development.
The Company expects to continue to incur
substantial losses over the next several years during its clinical development phase. To fully execute its business plan, the Company
will need to complete phase III clinical studies and certain development activities as well as manufacture the required clinical and commercial
production batches in the pilot manufacturing plant. Further, the Company's product candidates will require regulatory approval
prior to commercialization and the Company will need to establish sales, marketing and logistic infrastructures. These activities may
span over many years and require substantial expenditures to complete and may ultimately be unsuccessful. Any delays in completing these
activities could adversely impact the Company.
As of June 30, 2021, the Company's
had cash, cash equivalents, short-term deposits and long-term deposits of $52,906. During the six months ended June 30, 2021, the
Company incurred a net loss of $19,164 and had negative cash flows from operating activities of $13,551. In addition, the Company had
an accumulated deficit of $151,450 as of June 30, 2021. Management plans to seek additional equity financing through private and
public offerings or strategic partnerships and, in the longer term, by generating revenues from product sales.
| POLYPID LTD. AND ITS SUBSIDIARY |
| NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
| U.S. dollars in thousands (except share and per share data) |
The Company's future operations
are highly dependent on a combination of factors, including (i) the timely and successful completion of additional financing discussed
above; (ii) completion of all required clinical studies; (iii) the success of its research and development; activities; (iv) the manufacture
of all required clinical and commercial production batches; (v) marketing approval by the relevant regulatory authorities; and (vi) market
acceptance of the Company's product candidates.
There can be no assurance that the Company
will be successful in obtaining additional financing on favorable terms, or at all or will succeed in achieving the clinical, scientific
and commercial milestones as detailed above.
| POLYPID LTD. AND ITS SUBSIDIARY |
| NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS |
| U.S. dollars in thousands (except share and per share data) |
NOTE 2:- SIGNIFICANT
The unaudited interim consolidated financial
statements should be read in conjunction with the audited consolidated financial statements and notes for the year ended December 31,
These unaudited interim consolidated financial
statements of the Company as of June 30, 2021 and for the six months then ended, have been prepared in accordance with accounting
principles generally accepted in the United States of America ("US GAAP").
The unaudited interim consolidated financial
statements have been prepared in accordance with generally accepted accounting principles for interim financial information. Accordingly,
they do not include all the information and footnotes required by generally
accepted accounting principles for annual
consolidated financial statements. In the opinion of our management, all material adjustments considered necessary for a fair presentation
of the financial information as of and for the periods presented have been included.
The significant accounting policies followed
in the preparation of these unaudited interim consolidated financial statements are consistent to those applied in the preparation of
the latest annual consolidated financial statements.
The preparation of financial statements
in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts
reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
As an "emerging growth company",
the Jumpstart Our Business Startups Act ("JOBS Act") allows the Company to delay adoption of new or revised accounting pronouncements
applicable to public companies until such pronouncements are made applicable to private companies. The Company has elected to use this
extended transition period under the JOBS Act. The adoption dates discussed below reflect this election.
In February 2016, the Financial Accounting
Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2016-02, "Leases," which would
require lessees to recognize assets and liabilities on the balance sheet for most leases, whether operating or financing, while continuing
to recognize the expenses on their income statements in a manner similar to current practice. Under the guidance, the Company would also