PolyPid Provides Corporate Update and Reports Third Quarter 2022 Financial Results
- Company Intends to Meet with
U.S. and EU Regulatory Authorities to Discuss Data from SHIELD I Phase 3 Study and Regulatory Pathway for D-PLEX100 in First Quarter of 2023 - Implemented a Cost Reduction Plan, Including a 20% Decrease in Headcount Across All Departments
- Conference Call Scheduled for Today at
8:30 AM ET
PETACH TIKVA, Israel,
Recent Corporate Highlights:
- Announced top-line results from SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-PLEX100) study evaluating D-PLEX100 for the prevention of abdominal soft tissue surgical site infections (SSIs).
PolyPid intends to discuss the SHIELD I study outcomes and potential next steps with U.S. and EU regulatory authorities in the first quarter of 2023.
- Continued data analysis of SHIELD I study showed encouraging results in certain subpopulations:
- 54% reduction in the primary endpoint in complex surgeries with large incisions (>20cm) pre-specified subgroup (p=0.0032; n=423) compared to standard of care.
- 34% reduction in the primary endpoint in patients with one or more personal risk factors (post hoc analysis; p=0.047; n=680) compared to standard of care.
- SHIELD I study demonstrated a good safety profile of D-PLEX100 with no increase in serious or severe treatment emergent adverse events compared to standard of care.
- Received confirmation from the European Medicines Agency (EMA) that D-PLEX100 is eligible for submission of a Marketing Authorization Application under the EMA’s centralized procedure in the European Union (EU).
- Positive clinical data from the previously completed Phase 2 study of D-PLEX100 for the prevention of superficial and deep SSIs in abdominal surgery published in peer-reviewed publication, Techniques in Coloproctology.
- Implemented a cost reduction plan, including a 20% decrease in headcount across all departments, which is expected to extend available cash into the third quarter of 2023 in support of the Company’s long-term growth strategy.
“Since the top-line results were announced, we have continued to gather and analyze additional data from SHIELD I,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “These data have been increasingly encouraging. While SHIELD I did not meet its primary endpoint, the significant reduction in SSIs in complex surgeries with large incisions and in high-risk patients, as well as the safety data, are very compelling. As such, we are in the process of preparing a comprehensive package of D-PLEX100 data for a planned meeting with the
“In parallel to preparing for these important regulatory interactions, we recently implemented a cost reduction plan, including a 20% decrease in headcount across all departments,” continued Ms. Czaczkes Akselbrad. “We expect that these significant measures will extend our cash runway into the third quarter of 2023 in support of the Company’s long-term growth strategy.”
Financial results for three months ended
- Research and development, net (R&D) expenses for the three months ended
September 30, 2022 , were$6.2 million , compared to$7.5 million for the same three-month period of 2021, as spending decreased due to the completion of the SHIELD I Phase 3 clinical trial. - General and administrative (G&A) expenses for the three months ended
September 30, 2022 , were$1.7 million , compared to$2.1 million for the same period of 2021. - Marketing and business development expenses for the three months ended
September 30, 2022 , were$0.8 million , compared to$0.4 million for the same period of 2021. - For the three months ended
September 30, 2022 , the Company had a net loss of $9.3 million, compared to a net loss of$9.9 million for the same three-month period endedSeptember 30, 2021 .
Financial results for nine months ended
- R&D expenses, net for the nine months ended
September 30, 2022 , were$23.3 million , compared to$20.9 million for the same nine-month period of 2021. The increase in spending was due to the accelerated recruitment of the final patients in the SHIELD I Phase 3 clinical trial in abdominal surgery. - G&A expenses for the nine months ended
September 30, 2022 , were$6.4 million , compared to$6.7 million for the same period of 2021. - Marketing and business development expenses for the nine months ended
September 30, 2022 , were$2.5 million , compared to$1.8 million for the same period of 2021. - For the nine months ended
September 30, 2022 , the Company had a net loss of $33.0 million, compared to a net loss of$29.1 million for the same nine-month period endedSeptember 30, 2021 .
Balance Sheet Highlights
- As of September 30, 2022, the Company had cash and cash equivalents and deposits in the amount of
$18.1 million , including the$2.6 million upfront payment from ADVANZ PHARMA received during the third quarter. Following the recently announced cost reduction plan,PolyPid expects that its current cash balance will be sufficient to fund operations into the third quarter of 2023.
Conference Call Dial-In & Webcast Information:
| Date: | |
| Time: | |
| Q&A Participants: | https://register.vevent.com/register/BI5e06285152a24249a0330f025cefc01e |
| Webcast: | https://edge.media-server.com/mmc/p/c6nr79zi |
About
For additional Company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.
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 and the increasing encouragement from data analysis of the SHIELD I study outcome, its expectation to extend the Company’s available cash into the third quarter of 2023, its intention to meet with
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:
212-915-2578
britchie@lifesciadvisors.com
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| 2022 | 2021 | |||||
| Unaudited | Audited | |||||
| ASSETS | ||||||
| CURRENT ASSETS: | ||||||
| Cash and cash equivalents | $ | 16,108 | $ | 9,819 | ||
| Restricted cash | 394 | 397 | ||||
| Short-term deposits | 2,003 | 22,384 | ||||
| Prepaid expenses and other current assets | 1,297 | 2,211 | ||||
| Total current assets | 19,802 | 34,811 | ||||
| LONG-TERM ASSETS: | ||||||
| Property and equipment, net | 8,976 | 8,761 | ||||
| Other long-term assets | 603 | 663 | ||||
| Total long-term assets | 9,579 | 9,424 | ||||
| Total assets | $ | 29,381 | $ | 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 | $ | 3,132 | $ | - | |||
| Trade payables | 1,031 | 4,136 | |||||
| Accrued expenses and other current liabilities | 2,722 | 3,940 | |||||
| Total current liabilities | 6,885 | 8,076 | |||||
| LONG-TERM LIABILITIES: | |||||||
| Long-term debt | 8,354 | - | |||||
| Deferred revenues | 2,548 | - | |||||
| Other liabilities | 91 | 199 | |||||
| Total long-term liabilities | 10,993 | 199 | |||||
| COMMITMENTS AND CONTINGENT LIABILITIES | |||||||
| SHAREHOLDERS' EQUITY: | |||||||
| Ordinary shares with no par value - Authorized: 47,800,000 shares at |
- | - | |||||
| Additional paid-in capital | 219,380 | 210,847 | |||||
| Accumulated deficit | (207,877 | ) | (174,887 | ) | |||
| Total shareholders' equity | 11,503 | 35,960 | |||||
| Total liabilities and shareholders' equity | $ | 29,381 | $ | 44,235 | |||
The accompanying notes are an integral part of the interim condensed consolidated financial statements.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Nine Months Ended | Three Months Ended | ||||||||||||
| September30, | September30, | ||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||
| Operating expenses: | |||||||||||||
| Research and development, net | $ | 23,335 | $ | 20,936 | $ | 6,240 | $ | 7,476 | |||||
| Marketing and business development | 2,538 | 1,836 | 840 | 445 | |||||||||
| General and administrative | 6,403 | 6,719 | 1,680 | 2,143 | |||||||||
| Operating loss | 32,276 | 29,491 | 8,760 | 10,064 | |||||||||
| Financial expense (income), net | 640 | (392 | ) | 437 | (129 | ) | |||||||
| Net loss before income tax | 32,916 | 29,099 | 9,197 | 9,935 | |||||||||
| Income tax expense | 74 | - | 74 | - | |||||||||
| Net loss | $ | 32,990 | $ | 29,099 | $ | 9,271 | $ | 9,935 | |||||
| Basic and diluted loss per Ordinary share | $ | 1.71 | $ | 1.56 | $ | 0.48 | $ | 0.53 | |||||
| Weighted average number of Ordinary shares used in computing basic and diluted loss per share | 19,348,725 | 18,709,719 | 19,597,212 | 18,756,570 | |||||||||
The accompanying notes are an integral part of the interim condensed consolidated financial statements.
Source: PolyPid Ltd.
