PolyPid Provides Corporate Update and Reports First Quarter 2025 Financial Results
- DSMB recommended lowest sample size for trial completion, suggesting positive efficacy signals
- Fast Track and Breakthrough Therapy designations could accelerate regulatory pathway
- Potential $27.0M additional capital from warrant exercises upon Phase 3 data announcement
- Multiple potential U.S. partnership discussions in progress
- Net loss increased to $8.3M in Q1 2025 from $6.4M in Q1 2024
- Cash position decreased to $8.0M from $15.6M in December 2024
- Current cash only sufficient until Q3 2025, requiring additional funding
- R&D expenses increased to $6.1M from $5.1M year-over-year
Insights
PolyPid's SHIELD II trial completion signals potential near-term catalyst with readout expected this quarter; FDA submission planned for early 2026.
The completion of enrollment in the SHIELD II Phase 3 trial represents a critical milestone for PolyPid's lead candidate D-PLEX100. Most notably, the independent Data Safety Monitoring Board's recommendation to conclude the study at the lowest sample size reassessment option (800 patients) is particularly encouraging and suggests potential positive efficacy signals. This is not a guarantee of success, but typically DSMBs recommend lower enrollment numbers when treatment effects appear stronger than initially projected.
The expected data readout within the current quarter (Q2 2025) positions this as an imminent binary catalyst that could dramatically alter the company's trajectory. D-PLEX100 targets abdominal colorectal surgical site infections, a significant clinical challenge with substantial healthcare costs and patient morbidity implications.
The regulatory strategy leverages Fast Track and Breakthrough Therapy designations, which could accelerate approval timelines if data are positive. The company's readiness with Chemistry, Manufacturing, and Controls (CMC) and non-clinical modules indicates appropriate preparation for a potential NDA submission in early 2026.
From a clinical development perspective, this is a focused approach targeting a well-defined medical need with a product that has already secured important FDA designations, suggesting the agency recognizes its potential importance. The explicit mention of derisking in the trial design indicates careful statistical planning to maximize chances of demonstrating efficacy while maintaining scientific rigor.
The financial position reveals both challenges and opportunities. PolyPid reported
The company's quarterly net loss widened to
The current cash runway extending only into Q3 2025 creates a tight timeline, but the company has a potential funding solution through warrant exercises. If trial results are positive, warrants from recent financing would generate an additional
This creates an unusual but potentially efficient financial structure - the company has sufficient funds to reach the binary data readout event, after which either: 1) positive results trigger warrant exercises providing needed capital to reach approval, or 2) negative results would likely render additional funding moot. This approach aligns shareholder and company incentives, as funding availability is directly tied to clinical success.
The parallel pursuit of strategic partnerships could provide an alternative or complementary funding path while potentially maximizing the commercial opportunity for D-PLEX100 in the U.S. market.
PolyPid Successfully Completed Enrollment in Phase 3 SHIELD II Trial of D-PLEX100, with Top-Line Results Anticipated in Current Quarter
Company Continues to Advance Regulatory Submission Preparations, Commercial Launch Preparations and Partnering Discussions
Conference Call Scheduled for Today at 8:30 AM ET
PETACH TIKVA, Israel, May 14, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today provided a corporate update and reported financial results for the three months ended March 31, 2025.
Recent Corporate Highlights:
- Clinical Development: Successfully completed enrollment of 800 patients in the SHIELD II Phase 3 trial of D-PLEX100 for the prevention of abdominal colorectal surgical site infections. This major achievement follows the independent Data Safety Monitoring Board’s (“DSMB”) recommendation to conclude the study at the lowest sample size reassessment option, potentially suggestive of positive efficacy signals from D-PLEX100.
- Near-term Catalyst Timeline: Top-line results from SHIELD II remain on track and expected to be announced by the end of the current quarter (the second quarter of 2025), representing a potentially transformative milestone for the Company.
- Regulatory Pathway: Following potential positive Phase 3 data, PolyPid plans to leverage its Fast Track and Breakthrough Therapy designations to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in early 2026, with a Marketing Authorization Application (“MAA”) in the EU to follow shortly thereafter. Key regulatory components, including Chemistry, Manufacturing, and Controls (“CMC”) and non-clinical modules, are being finalized to support this timeline.
- Commercial Strategy: The Company continues to advance its commercialization preparations while simultaneously advancing strategic partnership discussions and due diligence with multiple potential partners in the United States to maximize D-PLEX100’s market potential.
- Strong Financial Position: Upon announcement of Phase 3 top-line data, warrants from the Company’s recent financing would be eligible for exercise, potentially generating an additional
$27.0 million in capital. The Company anticipates that with such additional funding, PolyPid’s runway would be extended beyond anticipated NDA approval.
“PolyPid is on track for a transformational year in 2025. We continue to view the SHIELD II Phase 3 trial as a derisked study. This assessment has been further strengthened by the 800-patient sample size reassessment which helps ensure the study has sufficient power to conclusively confirm D-PLEX100’s treatment benefit and we believe this increases the trial’s overall probability of success,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “As we await the top-line results from SHIELD II later this quarter, we continue to advance our preparations for NDA and MAA submissions in 2026. Moreover, we continue to progress our commercial plans, as well as engage in partnership discussions with multiple potential partners in the United States.”
Financial results for three months ended March 31, 2025
- Research and development (“R&D”) expenses for the three months ended March 31, 2025, were
$6.1 million , compared to$5.1 million in the same three-month period of 2024. The increase in R&D expenses in the most recently completed quarter was driven by the ramp up of the ongoing SHIELD II Phase 3 trial. - General and administrative (“G&A”) expenses for the three months ended March 31, 2025, were
$1.2 million , compared to$1.0 million for the same period of 2024. - Marketing and business development expenses for the three months ended March 31, 2025, were
$0.3 million , compared to$0.2 million for the same period of 2024. - For the three months ended March 31, 2025, the Company had a net loss of
$8.3 million , or ($0.70) per share, compared to a net loss of$6.4 million , or ($1.37) per share, in the three-month period ended March 31, 2024.
Balance Sheet Highlights
- As of March 31, 2025, the Company had cash and cash equivalents and short-term deposits in the amount of
$8.0 million , compared to$15.6 million on December 31, 2024. PolyPid expects that its current cash balance will be sufficient to fund operations into the third quarter of 2025.
Conference Call Dial-In & Webcast Information:
| Date: | Wednesday, May 14, 2025 |
| Time: | 8:30 AM Eastern Time |
| Conference Call: | https://register-conf.media-server.com/register/BI326905131be34ceda978c4ff2ca7a54d |
| Webcast: | https://edge.media-server.com/mmc/p/bqgwfbps |
About SHIELD II
SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 administered concomitantly with standard of care (“SoC”), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing abdominal colorectal surgeries with large incisions. The primary endpoint of the trial is measured by the proportion of subjects with either a surgical site infection (“SSI”) event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the United States, Europe and Israel.
About D-PLEX100
D-PLEX100, PolyPid’s lead product candidate, is 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 (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 is currently in Phase 3 SHIELD II trial for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery with large incisions.
About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX100 is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.
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 the potential efficacy and benefits of D-PLEX100 and the probability of success of the trial, that the current cash balance will be sufficient to fund the operations into the third quarter of 2025, the expected timing for completion of enrollment of the SHIELD II trial, the expected timing for top-line results from the SHIELD II trial, potential NDA and MAA submissions and the timing thereof, finalization of CMC and non-clinical modules, potential clinical benefits of D-PLEX100, the potential to receive up to an additional
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.
Ori Warshavsky
COO – US
908-858-5995
IR@Polypid.com
Investors:
Brian Ritchie
LifeSci Advisors
212-915-2578
britchie@lifesciadvisors.com
| INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
| U.S. dollars in thousands | |||||
| March 31, | December 31, | ||||
| 2025 | 2024 | ||||
| Unaudited | Audited | ||||
| ASSETS | |||||
| CURRENT ASSETS: | |||||
| Cash and cash equivalents | $ | 2,272 | $ | 15,641 | |
| Restricted deposits | 165 | 168 | |||
| Short-term deposits | 5,767 | - | |||
| Prepaid expenses and other current assets | 568 | 764 | |||
| Total current assets | 8,772 | 16,573 | |||
| LONG-TERM ASSETS: | |||||
| Property and equipment, net | 5,705 | 6,075 | |||
| Operating lease right-of-use assets | 2,088 | 2,295 | |||
| Other long-term assets | 284 | 277 | |||
| Total long-term assets | 8,077 | 8,647 | |||
| Total assets | $ | 16,849 | $ | 25,220 | |
| INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
| U.S. dollars in thousands (except share and per share data) | |||||
| March 31, | December 31, | ||||
| 2025 | 2024 | ||||
| Unaudited | Audited | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | |||||
| CURRENT LIABILITIES: | |||||
| Trade payables | $ | 2,016 | $ | 2,409 | |
| Accrued expenses and other current liabilities | 2,967 | 2,566 | |||
| Current maturities of long-term debt | 6,498 | 6,787 | |||
| Current maturities of operating lease liabilities | 905 | 919 | |||
| Total current liabilities | 12,386 | 12,681 | |||
| LONG-TERM LIABILITIES: | |||||
| Long-term debt | 381 | 634 | |||
| Deferred revenues | 2,548 | 2,548 | |||
| Long-term operating lease liabilities | 1,044 | 1,277 | |||
| Other liabilities | 404 | 396 | |||
| Total long-term liabilities | 4,377 | 4,855 | |||
| SHAREHOLDERS' EQUITY: | |||||
| Ordinary shares with no par value - | - | - | |||
| Authorized: 107,800,000 shares at March 31, 2025 (unaudited) and December 31, 2024; Issued and outstanding: 10,190,904 shares at March 31, 2025 (unaudited) and December 31, 2024, respectively | |||||
| Additional paid-in capital | 275,685 | 275,015 | |||
| Accumulated deficit | (275,599) | (267,331) | |||
| Total shareholders' equity | 86 | 7,684 | |||
| Total liabilities and shareholders' equity | $ | 16,849 | $ | 25,220 | |
| INTERIM CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||
| U.S. dollars in thousands (except share and per share data) | |||||
| Three Months Ended | |||||
| March 31, | |||||
| 2025 | 2024 | ||||
| Unaudited | |||||
| Operating expenses: | |||||
| Research and development | $ | 6,117 | $ | 5,050 | |
| Marketing and business development | 289 | 236 | |||
| General and administrative | 1,173 | 1,015 | |||
| Operating loss | 7,579 | 6,301 | |||
| Financial expense, net | 678 | 140 | |||
| Loss before income tax | 8,257 | 6,441 | |||
| Income tax expense | 11 | 7 | |||
| Net loss | $ | 8,268 | $ | 6,448 | |
| Basic and diluted loss per ordinary share | $ | 0.70 | $ | 1.37 | |
| Weighted average number of ordinary shares used in computing basic and diluted loss per share | 11,751,622 | 4,691,445 | |||
FAQ
When will PolyPid (PYPD) announce SHIELD II Phase 3 trial results?
What is PolyPid's (PYPD) cash runway as of Q1 2025?
How many patients were enrolled in PolyPid's (PYPD) SHIELD II Phase 3 trial?
What was PolyPid's (PYPD) net loss in Q1 2025?
When does PolyPid (PYPD) plan to submit its NDA to the FDA?
