PolyPid Provides Corporate Update and Reports Second Quarter 2022 Financial Results
- Signed Exclusive Licensing Agreement for Commercialization of D-PLEX100 in
Europe for Potentially Over$110 Million in Upfront and Milestone Payments, Plus Royalties on Net Sales - Independent Data Safety Monitoring Board Recommended Concluding Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Soft Tissue Surgery Following Enrollment of the Minimum Number of Targeted Patients
- Concluded Enrollment in Phase 3 SHIELD I Trial
- Top-line Results from the Phase 3 SHIELD I Trial Anticipated by End of Q3 2022
- Conference Call Scheduled for Today at 8:30 AM ET
PETACH TIKVA, Israel,
Recent Corporate Highlights:
- Entered into exclusive licensing agreement with ADVANZ PHARMA for the commercialization of D-PLEX100 for the prevention of surgical site infections (“SSIs”) in abdominal and cardiac surgeries in
Europe for potentially over$110 million in upfront and milestone payments, plus transfer price and royalties on net sales in double-digit percentages of up to the mid-twenties. - Independent Data Safety Monitoring Board, or DSMB, recommended concluding SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX100) study evaluating D-PLEX100 for the prevention of abdominal soft tissue SSIs subsequent to the enrollment of 950 patients, which is the minimum number of targeted patients in the study protocol.
- Concluded enrollment in SHIELD I trial in late
May 2022 , the largest Phase 3 trial conducted in infection prevention in abdominal surgery in over a decade. Top-line results are expected by the end of the current quarter, followed by potential NDA submission to the FDA and a European Union MAA filing. Based on prior receipt of breakthrough therapy designation, D-PLEX100 is eligible for a rolling NDA submission, which is targeted to be initiated in early 2023. - Published OncoPLEX animal model studies in 2022 ASCO annual meeting abstract book.
- Dikla Czaczkes Akselbrad, Chief Executive Officer, was appointed to the Board of Directors, effective
August 8, 2022 . Additionally, Jonny Missulawin has been promoted to Senior Vice President of Finance.
“As we rapidly approach top-line results for SHIELD I, which are anticipated by the end of the current quarter,
Financial results for three months ended
- Research and development (R&D), net expenses for the three months ended
June 30, 2022 , were$8.4 million , compared to$7.4 million for the same three-month period of 2021, as spending increased due to the expedited recruitment of the final patients in the SHIELD I Phase 3 clinical trial in abdominal surgery. - General and administrative (G&A) expenses for the three months ended
June 30, 2022 , were$2.2 million , compared to$2.4 million for the same period of 2021. - Marketing and business development expenses for the three months ended
June 30, 2022 , were$0.9 million , compared to$0.7 million for the same period of 2021. - For the three months ended
June 30, 2022 , the Company had a loss of $11.8 million, compared to a loss of$10.5 million for the same three-month period endedJune 30, 2021 .
Financial results for six months ended
- R&D expenses, net for the six months ended
June 30, 2022 , were$17.1 million , compared to$13.5 million for the same six-month period of 2021, as spending increased due to the expedited recruitment of the final patients in the SHIELD I Phase 3 clinical trial in abdominal surgery. - G&A expenses for the six months ended
June 30, 2022 , were$4.7 million , compared to$4.6 million for the same period of 2021. - Marketing and business development expenses for the six months ended
June 30, 2022 , were$1.7 million , compared to$1.4 million for the same period of 2021. - For the six months ended
June 30, 2022 , the Company had a loss of $23.7 million, compared to a loss of$19.2 million for the same six-month period endedJune 30, 2021 .
Balance Sheet Highlights
- As of June 30, 2022, the Company had cash and cash equivalents and deposits in the amount of
$23.8 million , not including the second tranche of$2.5 million from the Kreos Capital VI (Expert Fund ) LP (“Kreos”) loan, which was drawn inJuly 2022 .PolyPid expects that its cash balance, together with the upfront payment from ADVANZ PHARMA and the proceeds from the Kreos loan, will be sufficient to fund operations through the end of the second quarter of 2023. This estimated cash runway does not include the potential milestone payment of up to$12.5 million from ADVANZ PHARMA that is contingent upon positive top-line results from the SHIELD I Phase 3 study, or additional development-related milestone payments of up to$8.4 million .
Conference Call Dial-In & Webcast Information:
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Date: |
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Time: |
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Q&A Participants: |
https://register.vevent.com/register/BI985b31488d2141f99e4e9db5d66810fd |
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Webcast: |
About
For additional Company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.
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.
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 its ongoing clinical trials, its expectations regarding the timing of top-line results from the SHIELD-I study and potential NDA submission and MAA filing, potential milestone payments under the license agreement with ADVANZ PHARMA, the strength of its financial position and its expectation that its cash balance, together with the upfront payment from ADVANZ PHARMA and the proceeds from the Kreos loan, will be sufficient to fund operations through the end of the second quarter of 2023. 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 February 28, 2022. 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.
Contacts:
PolyPid Ltd.
COO – US
908-858-5995
IR@Polypid.com
Investors:
646-597-6989
Bob@LifeSciAdvisors.com
Media Contact:
551-444-0784
Nechama.Feuerstein@finnpartners.com
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
|
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2022 |
2021 |
|||||
Unaudited |
Audited |
|||||
ASSETS |
||||||
CURRENT ASSETS: |
||||||
Cash and cash equivalents |
$ |
11,640 |
$ |
9,819 |
||
Restricted cash |
576 |
397 |
||||
Short-term deposits |
12,139 |
22,384 |
||||
Prepaid expenses and other current assets |
661 |
2,211 |
||||
Total current assets |
25,016 |
34,811 |
||||
LONG-TERM ASSETS: |
||||||
Property and equipment, net |
9,183 |
8,761 |
||||
Other long-term assets |
618 |
663 |
||||
Total long-term assets |
9,801 |
9,424 |
||||
Total assets |
$ |
34,817 |
$ |
44,235 |
The accompanying notes are an integral part of the interim condensed consolidated financial statements.
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
|||||||
2022 |
2021 | |||||||
Unaudited |
Audited |
|||||||
LIABILITIES AND SHAREHOLDERS' EQUITY |
||||||||
CURRENT LIABILITIES: |
||||||||
Current maturities of long-term debt |
$ |
2,168 |
$ |
- |
||||
Trade payables |
2,430 |
4,136 |
||||||
Accrued expenses and other current liabilities |
4,106 |
3,940 |
||||||
Total current liabilities |
8,704 |
8,076 |
||||||
LONG-TERM LIABILITIES: |
||||||||
Long-term debt |
6,919 |
- |
||||||
Other liabilities |
84 |
199 |
||||||
Total long-term liabilities |
7,003 |
199 |
||||||
COMMITMENTS AND CONTINGENT LIABILITIES |
||||||||
SHAREHOLDERS' EQUITY: |
||||||||
Ordinary shares with no par value - |
- |
- |
||||||
Additional paid-in capital |
217,716 |
210,847 |
||||||
Accumulated deficit |
(198,606 |
) |
(174,887 |
) |
||||
Total shareholders' equity |
19,110 |
35,960 |
||||||
Total liabilities and shareholders' equity |
$ |
34,817 |
$ |
44,235 |
||||
|
|
|
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The accompanying notes are an integral part of the interim condensed consolidated financial statements.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Six Months Ended |
Three Months Ended |
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2022 | 2021 | 2022 | 2021 | |||||||||||
Operating expenses: |
||||||||||||||
Research and development, net |
$ |
17,095 |
$ |
13,460 |
$ |
8,398 |
$ |
7,442 |
||||||
Marketingand business development |
1,698 |
1,391 |
923 |
739 |
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General and administrative |
4,723 |
4,576 |
2,243 |
2,449 |
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Operating loss |
23,516 |
19,427 |
11,564 |
10,630 |
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Financial expense (income), net |
203 |
(263 |
) |
281 |
(153 |
) |
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Loss |
$ |
23,719 |
$ |
19,164 |
$ |
11,845 |
$ |
10,477 |
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Basic and diluted loss per Ordinary share |
$ |
1.23 |
$ |
1.03 |
$ |
0.61 |
$ |
0.56 |
||||||
Weighted average number of Ordinary shares used in computing basic and diluted loss per share |
19,222,423 |
18,685,906 |
19,505,246 |
18,747,967 |
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The accompanying notes are an integral part of the interim condensed consolidated financial statements.
PolyPid Ltd.