PYPD

Interested in PolyPid Ltd.? Here are five stocks we like better. PolyPid said it has entered a key regulatory transition for D-PLEX100, with its rolling NDA submission to the FDA underway and the remaining clinical module expected to be filed imminently. The company also plans to seek a European MAA in Q3 2026. Management said U.S. partnership talks are in late stages, as PolyPid looks for a hospital-focused partner to support a commercial launch targeted for Q1 2027. The company is also building commercial readiness through conferences, publications, and clinician engagement. PolyPid reported a narrower Q1 net loss of $7.7 million versus $8.3 million a year earlier, with $10.9 million in cash at quarter-end. Management said current cash should fund operations into the second half of 2026, and the company has since repaid its remaining loan facility. PolyPid (NASDAQ:PYPD) said its first quarter marked a transition from late-stage clinical development toward regulatory submission and commercial preparation for D-PLEX100, its lead product candidate for preventing surgical site infections in abdominal colorectal surgery. Chief Executive Officer Dikla Czaczkes Akselbrad told investors that the company’s priorities are advancing D-PLEX100 toward potential U.S. Food and Drug Administration approval and finalizing a U.S. strategic partnership intended to support a commercial launch in the first quarter of 2027. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? “The first quarter of 2026 was a defining transition for PolyPid,” Czaczkes Akselbrad said. “We moved from late-stage clinical development to final NDA regulatory submission.” PolyPid initiated its rolling new drug application submission to the FDA on March 30, 2026. Czaczkes Akselbrad said the company has submitted the chemistry, manufacturing and controls module, non-clinical modules and administrative components. The remaining components, including the clinical module, are expected to be submitted “imminently,” which would complete the full NDA submission. → MercadoLibre Boldly Invests in Growth: Discount Deepens D-PLEX100 has received Fast Track and Breakthrough Therapy designations, making it eligible for priority review if the FDA accepts the application and grants that status. Czaczkes Akselbrad said priority review would shorten the standard review period from 10 months to six m...

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Initiated a rolling NDA submission for D-PLEX100 in abdominal colorectal surgery, completing CMC and nonclinical modules with clinical components expected imminently. Advanced U.S. commercial partnership discussions to late-stage negotiations, shifting focus from due diligence to finalizing definitive agreement terms. Strengthened the clinical value proposition with new SHIELD II data showing a 64% relative risk reduction in clinically significant wound infection severity. Positioned D-PLEX100 to align with Medicare's new TEAM reimbursement model, which holds hospitals financially accountable for complications within a 30-day post-surgery window. Leveraged Breakthrough Therapy Designation to maintain frequent communication with the FDA regarding CMC processes and development reports prior to formal submission. Maintained operational continuity and manufacturing readiness despite regional conflict, noting that the FDA has recently inspected other Israeli facilities. Anticipates a potential 6-month priority review period if granted by the FDA, which would shorten the standard 10-month review timeline. Plans to submit a Marketing Authorization Application (MAA) to the EMA in Q3 2026 following alignment meetings with European regulators. Targets a formal U.S. commercial launch in the first quarter of 2027, supported by a strategic partner with established hospital sales infrastructure. Expects current cash resources to fund operations into the second half of 2026, covering several significant upcoming milestones. Prepares for a critical FDA pre-approval inspection of the internal manufacturing facility, supported by multiple successful mock audits and external consultants. Received a $4.3 million PDUFA fee waiver from the FDA under small business provisions, preserving capital for commercialization activities. Achieved a debt-free balance sheet following the full repayment of the remaining 2022 loan facility in early May 2026. Reported a narrowed net loss of $7.7 million for Q1 2026, down from $8.3 million in the prior year period, reflecting the completion of Phase III trials. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management emphasized that owning...

Image source: The Motley Fool. Wednesday, May 13, 2026 at 8:30 a.m. ET Chief Executive Officer — Dikla Czaczkes Akselbrad Chief Financial Officer — Jonny Missulawin Chief Operating Officer, U.S. — Ori Warshavsky Head of Investor Relations — Yehuda Leibler Need a quote from a Motley Fool analyst? Email [email protected] Yehuda Leibler: Thank you, operator, and thank you all for joining PolyPid's First Quarter 2026 Earnings Conference Call. Joining me on the call today will be Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid; Jonny Missulawin, PolyPid's Chief Financial Officer; and Ori Warshavsky, Chief Operating Officer, U.S. of PolyPid. Earlier today, PolyPid released its financial results for the 3 months ended March 31, 2026. A copy of the press release is available on the Investors section of the company's website at www.polypid.com. I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the federal securities laws. For example, management is making forward-looking statements when discussing the company's regulatory strategy, including the expected completion of the rolling New Drug Application or NDA submission for D-PLEX100. Management may also discuss the company's planned engagements with the European Medicines Agency, or EMA, including meetings with the Rapporteur and Co-Rapporteur regarding the planned marketing authorization application, or MAA, and the anticipated timing thereof. In addition, management may discuss the company's ongoing U.S. commercial strategic partnership discussions, its belief that those discussions are in late stages and expected launch plans and timing. Other forward-looking statements may relate to the potential clinical and economic value proposition of D-PLEX100. The company's preparations for potential commercialization, the potential for 2026 to be a transformative year for PolyPid and the expectation that current cash resources will be sufficient to fund operations into the second half of 2026 and from several significant upcoming potential milestones. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the company's control, including the risks described from time to time in the company's Securities and Exchange Commission filings. Accordingly, you should not place undue reliance on these statements. I encou...

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. PolyPid Ltd (NASDAQ:PYPD) has initiated the NDA submission for DPLEX-100 to the FDA, with the expectation of completing it imminently. The company received a small business waiver from the FDA for the PDUFA fee, saving approximately $4.3 million. Strategic partnership discussions in the U.S. are in late stages, focusing on definitive agreement terms. PolyPid Ltd (NASDAQ:PYPD) has conducted multiple mock inspections to prepare for FDA inspection, with no major issues identified. The company has fully repaid its outstanding debt obligations, strengthening its balance sheet ahead of potential commercialization. PolyPid Ltd (NASDAQ:PYPD) reported a net loss of $7.7 million for Q1 2026, although this is an improvement from the previous year. General and administrative expenses increased to $1.6 million from $1.2 million in the same period last year. The company's cash reserves decreased from $12.9 million to $10.9 million as of March 31, 2026. There is uncertainty regarding the timeline for FDA inspection due to potential geopolitical issues in the Middle East. The company anticipates some increase in operational expenses as commercialization efforts expand. Warning! GuruFocus has detected 2 Warning Signs with KRNT. Is PYPD fairly valued? Test your thesis with our free DCF calculator. Q: Can you discuss the work done with consultants to submit the CMC module with confidence, particularly around process validation for your differentiated drug product? A: We utilized the breakthrough therapy designation for frequent communication with the FDA, ensuring alignment on expectations. We also engaged experienced teams and regulatory consultants to review and advise on the CMC aspects. Our own manufacturing facility gives us full control over processes, which strengthens our position. Mock inspections have been conducted, and no major issues were identified. (CEO) Q: Have you had any dialogue with the FDA since submitting the first modules of the NDA? A: No formal communication has occurred yet, as the NDA submission is not complete. We expect to receive feedback once the submission is finalized imminently. (CEO) Q: Have your priorities shifted in your commercial partnership discussions? A: Our priorities...

Initiated NDA Submission to the FDA for D-PLEX₁₀₀ ; Completion Expected Imminently U.S. Commercial Partnership Discussions in Late Stages Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, May 13, 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 months ended March 31, 2026. Recent Corporate Highlights: Initiated NDA Submission to the FDA under Rolling Review: On March 30, 2026, the Company initiated a New Drug Application ("NDA") submission to the U.S. Food and Drug Administration ("FDA") for D-PLEX₁₀₀, the Company's lead product candidate for the prevention of surgical site infections ("SSIs") in patients undergoing colorectal surgery. The first modules, including the Chemistry, Manufacturing and Controls ("CMC") and nonclinical sections, were submitted as part of the rolling review, with additional components, including the clinical section, expected to be submitted imminently, marking the completion of the NDA submission. In March 2026, the FDA granted PolyPid a small business waiver of the Prescription Drug User Fee Act ("PDUFA") fee of approximately $4.3 million for the D-PLEX₁₀₀ NDA. This meaningful waiver enables the Company to focus its resources on commercialization preparations. Advancing EU Regulatory Submission: The Company has scheduled meetings in the second quarter of 2026 with the European Medicines Agency (“EMA”) Rapporteur and Co-Rapporteur, which are European regulatory authorities designated to lead the assessment of the planned Marketing Authorization Application ("MAA") for D-PLEX₁₀₀, to align on the content and structure of the planned submission. The MAA, which will be submitted to the EMA under the Centralized Procedure on the basis of therapeutic innovation, is currently planned for the third quarter of 2026. U.S. Commercial Partnership Discussions in Late Stages: The Company's strategic partnership discussions with potential U.S. commercial partner for D-PLEX₁₀₀ have continued to progress and are now in what the Company believes are its late stages. New SHIELD II Phase 3 Data Presented at Two Medical Congresses: At the 45th Annual Meeting of the Surgical Infec...

PolyPid (NASDAQ:PYPD) held its first-quarter earnings conference call on Wednesday. Below is the complete transcript from the call. This content is powered by Benzinga APIs. For comprehensive financial data and transcripts, visit https://www.benzinga.com/apis/. The full earnings call is available at https://edge.media-server.com/mmc/p/w3mvdb4o/ PolyPid reported a net loss of $7.7 million for Q1 2026, an improvement from a loss of $8.3 million in Q1 2025, with operating expenses showing a minor decrease primarily due to the completion of a Phase 3 trial. The company is in the late stages of strategic partnership discussions in the U.S. and is advancing its NDA submission for DPLEx100, which is expected to be completed imminently, aiming for FDA priority review. PolyPid's cash resources are expected to fund operations into the second half of 2026, with an additional strengthening of its balance sheet following the full repayment of a loan facility. The company continues to focus on manufacturing readiness for FDA inspection and commercial readiness, including expanding its presence at major medical conferences and engaging in strategic partnerships. Management remains optimistic about 2026 being a transformative year, with significant milestones anticipated, such as a potential FDA approval and European regulatory advancements. OPERATOR Welcome to Polyped's first quarter 2026 earnings conference call. At this time, participants are in a listen only mode. As a reminder, this call is recorded and I would now like to introduce your host for today's conference, yehuda Libra from ARCS Investor Relations. Mr. Liebler, you may begin. yehuda Libra Thank you Operator and thank you all for joining PolyPid's first quarter 2026 earnings conference call. Joining me on the call today will be Dikla Tchajkas Axelbrad, Chief Executive Officer of Polypid, Johnny Misalawim, Polypid's Chief Financial Officer and Ori Warchevsky, Chief Operating Officer US of PolyPid. Earlier today, Polypid released its financial results for the three months ended March 31, 2026. A copy of the press release is available on the Investors section of the company's website at www.PolyPid.com. I'd like to remind you that on this call management will make forward looking statements within the meaning of the Federal securities laws. For example, management is making forward looking statements when it disc...

PETACH TIKVA, Israel, May 06, 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 announced that it will report its first quarter 2026 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, May 13, 2026. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations. To ensure you are connected prior to the beginning of the call, PolyPid suggests registering a minimum of 5 minutes before the start of the call. For those not planning to ask a question of management, the Company recommends listening via the webcast. Conference Call Dial-In & Webcast Information: About PolyPid PolyPid Ltd. (Nasdaq: PYPD) is an innovative biopharmaceutical company dedicated to elevating treatment effectiveness, right where care begins. The Company develops long-acting, controlled-release drugs designed to deliver therapy precisely at the site of care, addressing critical unmet medical needs across a wide and diverse pipeline spanning surgical care, metabolic diseases, and beyond. PolyPid’s lead product, D-PLEX₁₀₀, successfully met its primary and all key secondary endpoints in the landmark Phase 3 SHIELD II trial for the prevention of surgical site infections. Guided by a commitment to precision and innovation, PolyPid is redefining how therapies perform and raise the standard of patient care. For additional Company information, please visit http://www.polypid.com and follow us on Twitter (X) and LinkedIn. Company Contact: PolyPid Ltd. Ori Warshavsky 908-858-5995 [email protected] Investor Relations Contact: Arx Investor Relations North American Equities Desk [email protected]

Image source: The Motley Fool. Feb. 11, 2026 at 8:30 a.m. ET Chief Executive Officer — Dikla Czaczkes Akselbrad Chief Financial Officer — Jonny Missulawin Chief Operating Officer, U.S. — Ori Warshavsky Investor Relations — Yehuda Leibler Need a quote from a Motley Fool analyst? Email [email protected] Yehuda Leibler: Thank you, operator, and thank you all for joining PolyPid's Fourth Quarter and Full Year 2025 Earnings Conference Call. Joining me on the call today will be Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid; Jonny Missulawin, PolyPid's Chief Financial Officer; and Ori Warshavsky, Chief Operating Officer, U.S. of PolyPid. Earlier today, PolyPid released its financial results for the 3 and 12 months ending December 31, 2025. A copy of the press release is available in the Investors section on the company's website at www.polypid.com. I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the federal securities laws. For example, management is making forward-looking statements when it discusses the company's regulatory strategy and the anticipated timing and structure of the planned new drug application or NDA submission for D-PLEX100, including the rolling submission, the potential regulatory and commercial pathways for D-PLEX100, the company's ongoing partnership discussions, commercialization readiness, transition from a primarily R&D and clinically focused organization into one that is preparing for commercialization, the potential for 2026 to be a transformative year for the company, benefits and advantages of D-PLEX100 that Kynatrix represents a broader long-term opportunity for PolyPid and the expectation that current cash resources will be sufficient to fund operations into the second half of 2026. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the company's control, including the risks described from time to time in the company's SEC filings. The company's results may differ materially from those projections. These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place undue reliance on these statements. I encourage you to review the company's filings with the SEC, including, without limitation, the company's annual report on Form...

Successfully completed the SHIELD II Phase III trial for D-PLEX100, meeting the primary endpoint and all key secondary endpoints for surgical site infection reduction. Secured FDA support for a rolling NDA review process, with the agency confirming that the existing clinical data package from SHIELD II appears adequate for submission. Transitioned the organizational focus from R&D and clinical development toward commercial execution and external stakeholder engagement. Advanced U.S. partnership discussions to detailed operational stages, targeting collaborators with established hospital-based commercial infrastructure and surgical ecosystem presence. Introduced 'Kynatrix' as the next-generation technology brand to encompass expanded capabilities beyond localized small molecule delivery, including systemic therapeutic applications. Appointed Brooke Story as Chairman of the Board to leverage her extensive medical technology leadership experience at Medtronic and Becton Dickinson during the commercialization phase. Expects to initiate the rolling NDA submission for D-PLEX100 by the end of Q1 2026, starting with CMC and non-clinical modules. Anticipates a shortened 6-month priority review period following the final clinical module submission, supported by Breakthrough Therapy and Fast Track designations. Projects current cash resources of $12.9 million, plus $3.7 million from subsequent warrant exercises, will fund operations into the second half of 2026. Plans to submit European regulatory filings approximately one quarter after the completion of the U.S. FDA submission process. Targets additional preclinical data from the ultra-long-acting GLP-1 Receptor Agonist program to support early-stage partnering discussions. G&A expenses increased to $7.2 million for the full year, primarily due to non-cash expenses from the vesting of performance-based options linked to Phase III success. Marketing and business development expenses doubled to $2 million in 2025, reflecting intensified commercial preparation and partnership activities. Strengthened the balance sheet post-quarter with $3.7 million in gross proceeds from long-time shareholders exercising warrants at prices between $3.61 and $4.50. Refreshed the corporate brand to signal a shift in maturity and precision as the company begins engaging hospital administrators and value committees. Our analysts just identif...

This article first appeared on GuruFocus. Release Date: February 11, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. PolyPid Ltd (NASDAQ:PYPD) successfully completed the Shield 2 phase 3 trial, with Duplex 100 meeting its primary and key secondary endpoints, showing a meaningful reduction in surgical site infections. The company received positive feedback from the FDA, supporting a rolling NDA review for Duplex 100, which is expected to begin by the end of Q1 2026. PolyPid Ltd (NASDAQ:PYPD) has advanced to the final stages of partnership discussions in the US, reflecting recognition of Duplex 100's strong clinical profile and unmet needs it addresses. The company has introduced a refreshed corporate brand and new technology platform, Kinnatrix, indicating a strategic shift towards commercialization. PolyPid Ltd (NASDAQ:PYPD) has strengthened its leadership with the appointment of Ms. Brooke Story as Chairman of the Board, bringing extensive experience in medical technology and surgical solutions. Research and development expenses increased to $23.8 million in 2025, up from $22.8 million in 2024, primarily due to regulatory preparation and development program advancements. General and administrative expenses rose significantly to $7.2 million in 2025 from $4.3 million in 2024, driven by non-cash expenses related to performance-based options. The company reported a net loss of $34.2 million for the full year 2025, compared to a net loss of $29 million in 2024. Marketing and business development expenses increased to $2 million in 2025 from $0.9 million in 2024, reflecting higher commercial preparation efforts. Despite progress, the commercialization of Duplex 100 is dependent on successful partnership agreements and regulatory approvals, which carry inherent risks and uncertainties. Warning! GuruFocus has detected 3 Warning Signs with PYPD. Is PYPD fairly valued? Test your thesis with our free DCF calculator. Q: Can you share details on the pre-NDA discussions with the FDA regarding the scope of the label for Duplex 100? A: Diklachat Axelblad, CEO: We are targeting an initial label for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, supported by the Shield 2 phase 3 data. There may be opportunities for label expansion into broader abdominal surgical applic...

FDA-backed rolling NDA path for D-PLEX100: PolyPid received positive FDA feedback supporting a rolling NDA submission for D-PLEX100 with plans to begin by end of Q1 2026, targeting an initial label for prevention of surgical site infections in abdominal colorectal surgery and expecting a ~six-month priority review. U.S. commercial readiness and partnership talks are advancing: Management is in detailed discussions with hospital-focused partners and is building pre-launch activities (KOL engagement, publications, pricing and health-economics work), with a European submission expected roughly one quarter after the FDA filing. Limited cash runway into 2H 2026: As of Dec. 31, 2025 PolyPid had $12.9M in cash plus $3.7M in post-period warrant proceeds, reported a Q4 net loss of $8.5M and a full-year 2025 net loss of $34.2M, and expects existing resources to fund operations into the second half of 2026. Interested in PolyPid Ltd.? Here are five stocks we like better. PolyPid (NASDAQ:PYPD) said 2025 marked a “pivotal year” as the company completed its SHIELD II Phase 3 trial and moved D-PLEX100 into the final stages of regulatory preparation, while also advancing U.S. commercial partnership discussions ahead of a planned new drug application submission in early 2026. Chief Executive Officer Dikla Czaczkes Akselbrad said the company recently received positive written feedback from the U.S. Food and Drug Administration following pre-NDA meeting communications. According to management, the FDA supported PolyPid’s plan to pursue a rolling NDA review for D-PLEX100, and the company expects to begin the rolling submission by the end of the first quarter of 2026. → Once Upon A Farm: Buy the $1B Growth Story? PolyPid also said the FDA agreed that the existing clinical data package, including results from the SHIELD II Phase 3 trial, “appears adequate” to support NDA submission and review. Management described that feedback as providing clarity on submission structure and expectations. During the Q&A, Akselbrad said PolyPid is targeting an initial label focused on prevention of surgical site infections in patients undergoing abdominal colorectal surgery, noting that this indication is directly supported by SHIELD II data and aligns with D-PLEX100’s breakthrough therapy designation. She added that the company expects there “may be an opportunity” to evaluate potential label ex...