FDA Accepted D-PLEX NDA with Priority Review; PDUFA Goal Date of November 28, 2026, Approximately One Quarter Ahead of Previously Communicated Guidance
Exclusive U.S. and Canada Commercialization Partnership with Azurity Pharmaceuticals; $30 Million in Upfront and Near-Term Milestones Achieved Following NDA Acceptance, with Over $290 Million in Additional Milestones Plus Tiered Royalties Up to Mid-Twenties Percentages
Potential U.S. Commercial Launch of D-PLEX by Azurity Targeted for Early 2027
Conference Call Scheduled for Today at 8:30 AM ET
PETACH TIKVA, Israel, Aug. 12, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today provided a corporate update and reported financial results for the three and six months ended June 30, 2026.
Recent Corporate Highlights:
-- Completed NDA Submission for D-PLEX and Received FDA Acceptance with
Priority Review:
-- Completed its New Drug Application ("NDA") submission to the U.S.
Food and Drug Administration ("FDA") for D-PLEX for the prevention
of surgical site infections ("SSIs") in patients undergoing
abdominal colorectal surgery, supported by positive results from
the pivotal Phase 3 SHIELD II trial, which met its primary
endpoint and all key secondary endpoints and demonstrated a 60%
relative risk reduction in SSIs compared to standard of care
(p=0.0013).
-- Subsequent to quarter end, on July 27, 2026, the FDA accepted
D-PLEX NDA submission and granted Priority Review, with a
Prescription Drug User Fee Act ("PDUFA") goal date of November 28,
2026, approximately one quarter ahead of the Company's previously
communicated first quarter 2027 guidance. The FDA did not identify
any filing review issues in its acceptance communications.
-- Exclusive U.S. and Canada Commercialization Partnership with Azurity
Pharmaceuticals:
-- Following the end of the quarter, on July 17, 2026, PolyPid
entered into a commercial partnership agreement with Azurity
Pharmaceuticals ("Azurity"), a privately held global specialty
pharmaceutical company with a first-in-class commercial model,
deep experience in specialty and hospital-based therapies with
more than 50 medicines across 10 therapeutic areas. Azurity has an
experienced commercial launch and execution team launching more
than one product each year on average in the last several years.
-- Following the FDA's July 27, 2026 NDA acceptance, PolyPid has
achieved the milestones required for the $30 million in upfront
and near-term milestone payments from Azurity.
-- Under the partnership, PolyPid is eligible to receive up to
approximately $320 million in total upfront and milestone payments,
inclusive of the $30 million confirmed to date, structured across
a defined series of regulatory, launch, and sales milestones
aligned with the anticipated U.S. and Canada commercialization of
D-PLEX .
-- In addition to and separate from the milestone payments, PolyPid
is entitled to tiered royalties from mid-teen to mid-twenties
percentages on sales in the U.S. and Canada. Additionally, PolyPid
will manufacture and supply D-PLEX to Azurity for an agreed
transfer price, further strengthening the Company's expected
revenues from product sales.
-- As part of the collaboration, Azurity will fund clinical
development to support potential label expansion of D-PLEX in the
U.S. and Canada to additional SSI indications beyond abdominal
surgery, potentially expanding the future addressable market.
-- PolyPid retains commercial rights outside the U.S. and Canada,
manufacturing rights worldwide, and full ownership of its
Kynatrix$(TM)$ technology and associated pipeline.
-- Advancing EU Regulatory Submission:
-- PolyPid remains on track for the previously announced third
quarter 2026 submission of its Marketing Authorization Application
("MAA") to the European Medicines Agency ("EMA") for D-PLEX under
the Centralized Procedure on the basis of therapeutic innovation.
During the second quarter of 2026, the Company held productive and
positive meetings with the EMA Rapporteur and Co-Rapporteur,
aligning on the timeline and requirements for the planned MAA
submission.
-- Advancing Kynatrix(TM) Pipeline Beyond D-PLEX :
-- Beyond D-PLEX , PolyPid continues to advance its proprietary
Kynatrix(TM) technology through additional pipeline programs,
including its long-acting metabolic program and additional
infection opportunities beyond prevention. These programs are
being designed to leverage the Company's established Kynatrix(TM)
technology capabilities, existing clinical and chemistry,
manufacturing and controls ("CMC") foundation, and known active
pharmaceutical ingredient safety profile.
-- Upcoming Expected Milestones:
-- PDUFA goal date for the D-PLEX NDA of November 28, 2026.
-- MAA submission to the EMA for D-PLEX under the Centralized
Procedure in the third quarter of 2026.
-- Potential U.S. commercial launch of D-PLEX in early 2027.
"The second quarter of 2026 and the first few weeks of the third quarter completed PolyPid's transition into a commercial-stage company, with the acceptance by the FDA with Priority Review of our NDA submission for D-PLEX , with no filing review issues and a PDUFA goal date meaningfully ahead of the guidance we have previously communicated," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. "In parallel, the U.S. and Canada commercial partnership we entered into in July, together with the immediate $30 million from the partnership, places PolyPid in potentially the strongest financial position in the Company's history, with no immediate financing needs. With the NDA review process on track, our substantially strengthened financial position, and our U.S. and Canada commercial partnership with Azurity, we believe PolyPid is well positioned to advance D-PLEX for abdominal colorectal surgery and, over time, additional broader surgical indications."
Financial Results for the Three Months Ended June 30, 2026
-- Research and development expenses for the three months ended June 30,
2026, were $6.1 million, compared to $6.2 million in the same three-month
period of 2025. Research and development activity in the second quarter
of 2026 primarily reflects ongoing NDA-related activities and continued
commercial readiness preparation.
-- General and administrative expenses for the three months ended June 30,
2026, were $1.3 million, compared to $2.5 million for the same period of
2025. The decrease was primarily due to the decrease of non-cash expenses
related to performance-based options ("PSUs") following the positive
Phase 3 SHIELD II topline results, which triggered the vesting of those
PSUs.
-- Marketing and business development expenses for the three months ended
June 30, 2026, were $0.5 million, compared to $0.7 million for the same
period of 2025.
-- For the three months ended June 30, 2026, the Company had a net loss of
$7.8 million, or $(0.35) per share, compared to a net loss of $10.0
million, or $(0.78) per share, in the three-month period ended June 30,
2025.
Financial Results for the Six Months Ended June 30, 2026
-- Research and development expenses for the six months ended June 30, 2026,
were $11.9 million, compared to $12.3 million in the same six-month
period of 2025. The decrease primarily reflects the completion of the
SHIELD II Phase 3 trial and the Company's transition toward regulatory
submission and commercial readiness activities.
-- General and administrative expenses for the six months ended June 30,
2026, were $2.9 million, compared to $3.7 million for the same period of
2025. The decrease was primarily due to the decrease of non-cash PSU
vesting expenses.
-- Marketing and business development expenses for the six months ended June
30, 2026, were $0.9 million, compared to $1.0 million for the same period
of 2025.
-- For the six months ended June 30, 2026, the Company had a net loss of
$15.6 million, or $(0.70) per share, compared to a net loss of $18.2
million, or $(1.48) per share, in the six-month period ended June 30,
2025.
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