PolyPid Ltd.

PolyPid Ltd. announced a significant License and Supply Agreement with Azurity Pharmaceuticals Ireland Ltd. for D-PLEX100 in the United States and Canada, including $30 million in upfront and near-term payments and potential milestones exceeding $290 million, plus tiered royalties. This positive development comes alongside the company's interim financial results for the six months ended June 30, 2026, which showed a net loss of $15.58 million and a cash balance of $6.56 million. The company also disclosed substantial doubt about its ability to continue as a going concern.

PolyPid announced that the FDA accepted its D-PLEX₁₀₀ New Drug Application (NDA) for preventing surgical site infections with Priority Review, setting a PDUFA goal date of November 28, 2026. This acceptance triggered $30 million in upfront and near-term milestone payments from its exclusive U.S. and Canada commercialization partnership with Azurity Pharmaceuticals, with potential for over $290 million in additional milestones and tiered royalties. The company reported a Q2 2026 net loss of $7.8 million and expects its current cash, combined with partnership proceeds, to fund operations into 2028.

PolyPid announced that the FDA accepted its New Drug Application (NDA) for D-PLEX₁₀₀ with Priority Review, setting a PDUFA goal date of November 28, 2026, which is ahead of previous guidance. The company also secured an exclusive U.S. and Canada commercialization partnership with Azurity Pharmaceuticals, receiving $30 million in upfront and near-term milestone payments, with potential for over $290 million in additional milestones and tiered royalties. This significantly strengthens PolyPid's financial position, with the company reporting a reduced net loss of $7.8 million for Q2 2026.

PolyPid Ltd. announced it will report its second quarter 2026 financial results and operational highlights before the U.S. financial markets open on Wednesday, August 12, 2026. The company will host a conference call and webcast at 8:30 AM Eastern Time on the same day to discuss the results and provide a business update. Interested parties can register for the conference call or listen via the webcast.

PolyPid Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for D-PLEX100. The FDA granted Priority Review and set a PDUFA target action date of November 28, 2026, which is approximately one quarter ahead of the company's previously communicated guidance. The FDA identified no filing review issues, and this acceptance triggers a $15 million milestone payment from Azurity Pharmaceuticals, completing $30 million in upfront and near-term milestone payments under their commercialization partnership.

PolyPid Ltd. announced an exclusive partnership with Azurity Pharmaceuticals for the commercialization of its product D-PLEX100 in the United States and Canada. Under the agreement, PolyPid will receive an upfront payment of $15 million and an additional $15 million upon U.S. FDA acceptance of the New Drug Application, expected in August 2026. The company is also eligible for up to $300 million in additional milestone payments and tiered royalties from mid-teen to mid-twenties percentages. PolyPid will manufacture and supply the product, while Azurity will fund potential label expansion studies.

PolyPid Ltd. has entered into an exclusive commercial partnership with Azurity Pharmaceuticals for the commercialization of D-PLEX100 in the United States and Canada. PolyPid stands to receive over $320 million in potential payments, including $30 million upfront and near-term milestones, plus tiered royalties. Azurity will commercialize the product and fund its clinical development for potential label expansion, while PolyPid will manufacture and supply D-PLEX100 and retain global rights outside the partnered territories. This collaboration follows positive Phase 3 results for D-PLEX100 and its recent NDA submission to the FDA.

PolyPid Ltd. has filed an Amended and Restated 2012 Share Option Plan, outlining the terms for granting stock options to its employees, officers, directors, consultants, and other service providers. The plan reserves a total of 5,012,403 shares for these options, which are intended to incentivize participants and align their interests with the company's success. The Board retains broad discretion over the administration of the plan, including determining grant terms, vesting schedules, and exercise prices, and has specific provisions for handling options during corporate events like mergers or upon termination of service.

PolyPid Ltd. announced it will hold its Annual and Extraordinary General Meeting of Shareholders on July 15, 2026, in Petach Tikva, Israel. Shareholders will vote on the re-election of the independent registered public accountants and eight board members, as well as approving their compensation. Additionally, proposals include amending non-executive directors' annual options grants and approving an option grant for CEO Ms. Dikla Czaczkes Akselbrad. The meeting will also include a discussion of the financial statements for the fiscal year ended December 31, 2025.

PolyPid Ltd. announced the successful completion of its New Drug Application (NDA) submission to the U.S. FDA for D-PLEX100, its lead product candidate for preventing surgical site infections (SSIs) in colorectal surgery patients. The NDA is supported by positive Phase 3 SHIELD II trial results, which demonstrated a 60% relative risk reduction in SSIs. The company anticipates a potential FDA decision in the first quarter of 2027 under the PDUFA review timeline, with D-PLEX100 having received Breakthrough Therapy, Fast Track, and QIDP designations.