PolyPid Q2 earnings call highlights. August 12, 2026 Key points. * FDA review advances: PolyPid's NDA for D-PLEX100 was accepted on July 27, 2026, with priority review and a Nov. 28 PDUFA target date. The company is preparing for a pre-approval manufacturing inspection. * Azurity partnership provides funding and commercialization support: The U.S. and Canada agreement includes $30 million in upfront and near-term milestone payments, more than $290 million in potential additional milestones, and tiered royalties. Azurity expects to launch D-PLEX100 in early 2027 if approved. * Financial position improved: PolyPid's second-quarter net loss narrowed to $7.8 million from $10 million a year earlier, while the subsequent Azurity payments strengthened liquidity and are expected to fund operations into 2028. * Five stocks to consider instead of PolyPid. PolyPid NASDAQ: PYPD said its second-quarter 2026 was marked by the FDA's acceptance of its new drug application for D-PLEX100 and a commercialization agreement with Azurity Pharmaceuticals covering the United States and Canada. D-PLEX100 is being developed to prevent surgical site infections in patients undergoing abdominal corrective surgery. CEO Dikla Czaczkes Akselbrad said the FDA accepted the company's NDA for filing on July 27, after the company completed its submission during the second quarter. The agency granted priority review and set a Prescription Drug User Fee Act goal date of Nov. 28, 2026. Akselbrad said the FDA identified no filing review issues in the acceptance notice. Priority review reduces the standard review timeline to six months from 10 months, according to the company. PolyPid expects an FDA pre-approval inspection of its manufacturing facility as part of the review process and continues to prepare for that inspection through mock audits and outside consultants. Azurity partnership adds upfront payments and potential milestones. On July 17, PolyPid entered an exclusive agreement with Azurity Pharmaceuticals to commercialize D-PLEX100 in the U.S. and Canada. PolyPid said it has secured $30 million in aggregate upfront and near-term milestone payments, consisting of a $15 million payment at signing and a further $15 million payment following FDA acceptance of the NDA. The agreement also provides PolyPid eligibility for more than $290 million in additional regulatory, launch and sales milestones. The company is entitled to tiered royalties on Azurity's net sales ranging from the mid-teens to mid-20s percentages. PolyPid will retain global manufacturing responsibility and will receive an agreed transfer price for each unit supplied to Azurity. Chief Operating Officer Ori Warshavsky said Azurity was selected after a competitive partnering process involving multiple prospective commercial partners. He cited Azurity's portfolio of more than 50 medicines, its hospital and surgical-channel presence, and relationships with more than 1,700 hospitals and academic institutions as factors supporting the selection. Azurity will lead commercial activities including sales force development, national account planning, medical affairs and pharmacy-channel work. PolyPid will retain global regulatory strategy and manufacturing responsibilities. The companies have established joint forums for medical, regulatory and commercial launch preparations, management said. Discover more Company News Space stocks report PolyPid expects Azurity to launch D-PLEX100 in the U.S. in early 2027, assuming regulatory approval. Management said the commercial rollout is expected to proceed hospital by hospital and integrated delivery network by integrated delivery network rather than reaching all target institutions immediately. Manufacturing, reimbursement and European plans. The company said its manufacturing site in Israel has passed four consecutive good manufacturing practice inspections, including an inspection by Israel's Ministry of Health in September 2025. Prospective commercial partners, including Azurity, also conducted on-site diligence of the facility during the partnering process, management said. In response to analyst questions, Akselbrad said PolyPid has had several communications with the FDA since filing the NDA, including discussions relating to expected audits, but did not provide a specific date for the agency's pre-approval inspection. Management said commercial launch metrics will include hospital adoption, pharmacy and therapeutics committee approvals, pilot usage by physicians, reimbursement progress and discussions with payers. If D-PLEX100 launches in early 2027, PolyPid expects to recognize revenue as it supplies vials to Azurity under the agreed transfer price, while royalty and milestone revenue would be recognized as applicable. Warshavsky said Azurity is pursuing a New Technology Add-on Payment, or NTAP, application for the next government fiscal year. He said FDA approval is not required before submitting an NTAP application, provided the product is under FDA review, and noted an October deadline. PolyPid also plans to submit a marketing authorization application to the European Medicines Agency during the third quarter of 2026. Akselbrad said the company held meetings during the quarter with the EMA rapporteur and co-rapporteur and characterized them as productive. She said the discussions did not identify issues requiring additional data or changes that would delay the planned submission timeline. Label expansion and pipeline opportunities. The Azurity agreement includes an Azurity-funded joint development framework intended to pursue label expansion opportunities beyond the initial abdominal surgery indication. Management identified cardiac procedures, including coronary artery bypass grafting, orthopedic procedures such as hip and knee replacement, and breast mastectomy and reconstruction as potential areas of interest. PolyPid also cited expansion into territories outside the U.S. and Canada and further development of its PLEX technology platform as longer-term growth drivers. Warshavsky said the company is exploring applications beyond infection prevention, including treatment applications and a long-acting metabolic program, but did not provide specific product details or development timelines. Second-Quarter financial results. Research and development expense was $6.1 million in the second quarter, compared with $6.2 million a year earlier. General and administrative expense fell to $1.3 million from $2.5 million, primarily due to lower non-cash expenses related to performance-based options. Marketing and business development expense was $0.5 million, compared with $0.7 million in the prior-year period. Net loss totaled $7.8 million, or $0.35 per share, compared with a loss of $10 million, or $0.78 per share, in the second quarter of 2025. For the first six months of 2026, net loss was $15.6 million, compared with $18.2 million in the prior-year period. As of June 30, PolyPid had $6.6 million in cash and cash equivalents, compared with $12.9 million in cash equivalents and short-term deposits at Dec. 31, 2025. CFO Jonny Missulawin said the subsequent $30 million in Azurity payments strengthened the company's capital position. Based on current plans and assumptions, PolyPid expects available resources, partnership proceeds and potential future proceeds to fund operations into 2028. About PolyPid (NASDAQ:PYPD). PolyPid Ltd is a clinical-stage biotechnology company focused on polymer-based drug delivery technologies designed to enhance the performance of therapeutic agents at mucosal surfaces. Leveraging its proprietary Mucoadhesive & Mucus-Penetrating (MMP) platform, PolyPid develops long-acting formulations for ocular, oral and pulmonary indications. Its lead candidates include OncoTears and OralTear, therapies targeting dry eye and dry mouth conditions, respectively, as well as Paclical, a polymer-formulated paclitaxel designed to improve tolerability and antitumor activity in oncology patients. Founded in 2003 and headquartered in Jerusalem, Israel, PolyPid has assembled an international patent portfolio covering key markets in North America, Europe and Asia. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Continue following MarketBeat Before you consider PolyPid, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and PolyPid wasn't on the list. While PolyPid currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. The AI boom is creating opportunities across semiconductors, cloud computing, enterprise software, infrastructure, cybersecurity, and automation. 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Press release for Eklira entering China NRDL_AZ 06.23.2026. PP-EKL-7577-CHI-EN-v1 Nang Kuang Medicine Trading Limited and Azurity Pharmaceuticals Announce that Aclidinium Bromide Powder for Inhalation (marketed under the trademark Eklira(R) Genuair(R) is Now Included in China's National Reimbursement Drug List for Chronic Obstructive Pulmonary Disease Treatment [HongKong 7th December] - Nang Kuang Medicine Trading Limited and Azurity Pharmaceuticals announced that aclidinium bromide powder for inhalation (marketed under the trademark Eklira(R) Genuair(R) has been included in China's National Reimbursement Drug List (NRDL), improving patient access to Chronic Obstructive Pulmonary Disease (COPD) treatment. "The strategic partnership between Nang Kuang and Azurity is aimed at bringing important respiratory therapies to patients in China," said Zhao Bing, General Manager at Nang Kuang. "The medicines are specifically for the maintenance treatment of patients with COPD, which is a rapidly growing respiratory condition in China." Through this collaboration, Nang Kuang has also obtained long-term exclusive rights to commercialize aclidinium bromide/formoterol fumarate powder for inhalation (marketed under trademark Duaklir(R) Genuair(R) in the Chinese market. Nang Kuang will lead commercialization to ensure rapid access for patients across China. "Azurity is proud to partner with Nang Kuang to make these treatment options available to more people with COPD," said Ronald van der Rol, Chief Commercial Officer for Europe and International at Azurity Pharmaceuticals. "We strive to transform how medicine is experienced globally and this is an important milestone for expanding access to our growing portfolio of medicines." About Aclidinium Bromide Powder for Inhalation Aclidinium bromide powder for inhalation is an imported original medicine primarily used for long-term maintenance treatment of adult patients with COPD. Positive results from the AVANT Phase 3 clinical trial for aclidinium bromide/formoterol fumarate powder for inhalation were previously reported. The 24-week study achieved statistically significant and clinically important outcomes for all key endpoint measures of efficacy in adult patients with moderate-to-severe COPD. There was no new safety concerns raised in the study and the findings were consistent with the known safety profiles of aclidinium bromide and aclidinium bromide/formoterol fumarate. The study involved 1,060 adult patients with moderate-to-severe COPD, with 70% of participants enrolled from China across 48 local study sites. Aclidinium bromide powder for inhalation was approved in China in 2024. As of January 1, 2026, it is included in the National Reimbursement Drug List (NRDL) as a Category B drug. Core Drug Information - Generic Name: Aclidinium Bromide Powder for Inhalation (imported original) - Indication: For symptom control and reduction of acute exacerbations in patients with COPD. Recommended dosage: one inhalation twice daily. - Drug Category: Category B (effective from 2026) Explanation of Reimbursement Policy As a Category B drug, Aclidinium Bromide requires patients to pay a certain percentage of the cost out-of-pocket before the remainder is reimbursed under the outpatient chronic and special disease policy. The specific reimbursement rate may vary and depends on the hospital level and type of insurance coverage. Application Process for Outpatient Chronic and Special Diseases - As of January 1, 2026 Aclidinium Bromide is reimbursable under the NRDL Category B policy. - Chronic/Special Disease Designation: Patients may be required to provide their ID card, social security card/medical insurance code, and a diagnosis certificate (including lung function report and medical records) from a Grade II or higher hospital. Applications can be submitted online via the National Medical Insurance Service Platform APP, or in person at the medical insurance office of a county-level hospital or a government affairs hall. - Special Drug Registration (if required): Some high-cost drugs may require a "Five-Part Management" system. Patients must visit a designated respiratory specialist at an authorized hospital for assessment and to obtain a designation form. After an initial review by the hospital's medical insurance office and a final review by the medical insurance authority, the patient's record will be flagged in the system to enable direct settlement. - Designated Pharmacy Purchase and Settlement: The product may be dispensed through a designated hospital or specialty pharmacy using your social security card or electronic medical insurance credential. The settlement system is expected to automatically recognize your outpatient chronic/special disease benefits, and you will only need to pay the out-of-pocket portion. References Efficacy and safety of aclidinium/formoterol versus monotherapies and aclidinium versus placebo in Chinese and other Asian patients with moderate-to-severe COPD: The AVANT Phase 3 study. Respiratory Medicine, 2023; 218 https://www.resmedjournal.com/article/S0954-6111(23)00281-0/fulltext European Medicines Agency https://www.ema.europa.eu/en/medicines/human/EPAR/eklira-genuair About Nang Kuang Medicine Trading Co. Nang Kuang Group is a China-based, innovation-driven pharmaceutical company with a global outlook. Dedicated to improving patient care through high-quality therapies, Nang Kuang has built long-term partnerships with leading international pharmaceutical companies. Learn more at www.nangkuang-med.com. About Azurity Pharmaceuticals Azurity Pharmaceuticals is a privately held global pharmaceutical company dedicated to redefining medicine for the real world. Azurity's first-in-class enterprise model challenges the status quo by rethinking how therapies are designed, delivered, and accessed. With more than 50 medicines across 10 therapeutic areas, Azurity's mission is fueled by a growing portfolio that reaches millions of people in more than 50 countries. Learn more at www.azurity.com. Media Contacts Nang Kuang: [email protected] Azurity Pharmaceuticals: [email protected] (C) 2026 Nang Kuang Medicine Trading Co., Ltd. All rights Reserved. This press release contains forward looking statements, including statements regarding anticipated commercialization and patient access in China. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially.