PolyPid Provides Corporate Update and Reports Fourth Quarter and Full-Year 2024 Financial Results
PolyPid reported its Q4 and full-year 2024 financial results, highlighting significant progress in its SHIELD II Phase 3 trial of D-PLEX₁₀₀. The trial has enrolled over 700 patients, with completion expected in March 2025 and top-line results in Q2 2025. The DSMB recommended concluding the trial at 800 patients.
The company secured a private placement financing of $14.5 million, with potential additional proceeds of $27.0 million through warrants. Financial results showed R&D expenses of $7.0 million for Q4 2024 and $22.8 million for the full year. Net loss was $8.5 million for Q4 and $29.0 million for 2024. Cash position stood at $15.6 million as of December 31, 2024, expected to fund operations into Q3 2025.
PolyPid ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando progressi significativi nel suo trial di fase 3 SHIELD II per D-PLEX₁₀₀. Lo studio ha arruolato oltre 700 pazienti, con completamento previsto per marzo 2025 e risultati preliminari nel secondo trimestre del 2025. Il DSMB ha raccomandato di concludere lo studio a 800 pazienti.
L'azienda ha ottenuto un finanziamento tramite collocamento privato di 14,5 milioni di dollari, con potenziali proventi aggiuntivi di 27,0 milioni di dollari attraverso warrant. I risultati finanziari hanno mostrato spese per R&D di 7,0 milioni di dollari per il quarto trimestre del 2024 e 22,8 milioni di dollari per l'intero anno. La perdita netta è stata di 8,5 milioni di dollari per il quarto trimestre e 29,0 milioni di dollari per il 2024. La posizione di cassa era di 15,6 milioni di dollari al 31 dicembre 2024, prevista per finanziare le operazioni fino al terzo trimestre del 2025.
PolyPid informó sus resultados financieros del cuarto trimestre y del año completo 2024, destacando un progreso significativo en su ensayo de fase 3 SHIELD II de D-PLEX₁₀₀. El ensayo ha inscrito a más de 700 pacientes, con la finalización esperada en marzo de 2025 y resultados preliminares en el segundo trimestre de 2025. El DSMB recomendó concluir el ensayo con 800 pacientes.
La empresa aseguró un financiamiento de colocación privada de 14,5 millones de dólares, con posibles ingresos adicionales de 27,0 millones de dólares a través de warrants. Los resultados financieros mostraron gastos de I+D de 7,0 millones de dólares para el cuarto trimestre de 2024 y 22,8 millones de dólares para el año completo. La pérdida neta fue de 8,5 millones de dólares para el cuarto trimestre y 29,0 millones de dólares para 2024. La posición de efectivo era de 15,6 millones de dólares al 31 de diciembre de 2024, prevista para financiar las operaciones hasta el tercer trimestre de 2025.
PolyPid는 2024년 4분기 및 연간 재무 결과를 보고하며, D-PLEX₁₀₀의 SHIELD II 3상 시험에서 중요한 진전을 강조했습니다. 이 시험은 700명 이상의 환자를 모집했으며, 2025년 3월에 완료될 것으로 예상되며, 2025년 2분기에 주요 결과가 나올 예정입니다. DSMB는 800명의 환자로 시험을 종료할 것을 권고했습니다.
회사는 1,450만 달러의 사모펀드 조달을 확보했으며, 워런트를 통해 추가로 2,700만 달러의 수익이 발생할 가능성이 있습니다. 재무 결과에 따르면 2024년 4분기 R&D 비용은 700만 달러, 연간 비용은 2,280만 달러였습니다. 순손실은 4분기에 850만 달러, 2024년에는 2,900만 달러였습니다. 2024년 12월 31일 기준 현금 보유액은 1,560만 달러로, 2025년 3분기까지 운영 자금을 지원할 것으로 예상됩니다.
PolyPid a annoncé ses résultats financiers du quatrième trimestre et de l'année 2024, mettant en avant des progrès significatifs dans son essai de phase 3 SHIELD II de D-PLEX₁₀₀. L'essai a recruté plus de 700 patients, avec une finalisation prévue en mars 2025 et des résultats préliminaires au deuxième trimestre 2025. Le DSMB a recommandé de conclure l'essai à 800 patients.
L'entreprise a sécurisé un financement par placement privé de 14,5 millions de dollars, avec des revenus supplémentaires potentiels de 27,0 millions de dollars grâce à des bons de souscription. Les résultats financiers ont montré des dépenses de R&D de 7,0 millions de dollars pour le quatrième trimestre 2024 et de 22,8 millions de dollars pour l'année entière. La perte nette s'est élevée à 8,5 millions de dollars pour le quatrième trimestre et à 29,0 millions de dollars pour 2024. La position de trésorerie s'élevait à 15,6 millions de dollars au 31 décembre 2024, prévue pour financer les opérations jusqu'au troisième trimestre 2025.
PolyPid berichtete über die finanziellen Ergebnisse des 4. Quartals und des gesamten Jahres 2024 und hob dabei erhebliche Fortschritte in seiner SHIELD II Phase 3 Studie zu D-PLEX₁₀₀ hervor. In der Studie wurden über 700 Patienten eingeschlossen, mit einem Abschluss, der für März 2025 erwartet wird, und den ersten Ergebnissen im 2. Quartal 2025. Das DSMB empfahl, die Studie bei 800 Patienten abzuschließen.
Das Unternehmen sicherte sich eine private Platzierungsfinanzierung in Höhe von 14,5 Millionen Dollar, mit möglichen zusätzlichen Einnahmen von 27,0 Millionen Dollar durch Warrants. Die finanziellen Ergebnisse zeigten Forschungs- und Entwicklungskosten von 7,0 Millionen Dollar für das 4. Quartal 2024 und 22,8 Millionen Dollar für das gesamte Jahr. Der Nettoverlust betrug 8,5 Millionen Dollar im 4. Quartal und 29,0 Millionen Dollar für 2024. Die Liquiditätsposition betrug zum 31. Dezember 2024 15,6 Millionen Dollar und wird voraussichtlich die Betriebe bis zum 3. Quartal 2025 finanzieren.
- DSMB's positive recommendation to conclude SHIELD II trial at 800 patients
- Secured $14.5M private placement with potential additional $27M from warrants
- Cash runway extended into Q3 2025
- Strong trial enrollment with over 700 patients to date
- Increased net loss to $29.0M in 2024 from $23.9M in 2023
- R&D expenses increased to $22.8M in 2024 from $16.1M in 2023
- Quarterly net loss increased to $8.5M from $6.4M year-over-year
Insights
The latest financial results and corporate update from PolyPid presents a strategically orchestrated position ahead of important clinical milestones. The DSMB's recommendation to conclude SHIELD II at 800 patients - the lowest sample size reassessment stop - strongly suggests positive efficacy signals, as DSMBs typically recommend larger sample sizes when interim data is inconclusive.
The company's recent
Financial metrics reveal strategic resource allocation:
- R&D expenses increased
52% YoY to$7.0 million in Q4, reflecting accelerated SHIELD II enrollment - G&A expenses decreased
17% YoY to$1.0 million , demonstrating effective cost management - Cash position strengthened to
$15.6 million , providing runway into Q3 2025
The collaboration with ImmunoGenesis represents a strategic expansion of PLEX Technology beyond surgical applications into oncology, potentially creating additional value streams. The appointment of Yitzchak Jacobovitz, with his dual expertise in healthcare investment and board governance, strengthens oversight during this pivotal commercialization preparation phase.
The convergence of Fast Track and Breakthrough Therapy designations could accelerate the regulatory timeline post-positive data, potentially reducing time to market by several months. With trial completion expected in March 2025 and top-line results in Q2 2025, PolyPid has structured its financial and operational resources to maintain momentum through potential NDA submission.
Positive Recommendation by DSMB to Continue Enrollment of Phase 3 SHIELD II Trial of D-PLEX₁₀₀ to 800 Patients
SHIELD II Enrolled more than 700 Patients to Date; Enrollment Completion Expected in March 2025, with Top-Line Results Anticipated in Second Quarter of 2025
Company Completed Private Placement of Up to
Conference Call Scheduled for Today at 8:30 AM ET
PETACH TIKVA, Israel, Feb. 12, 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 and full year ended December 31, 2024.
Recent Corporate Highlights:
- The independent Data Safety Monitoring Board (“DSMB”) recommended to conclude the SHIELD II Phase 3 trial of D-PLEX100 upon enrollment of 800 patients in the study , which is the lowest sample size reassessment stop after the minimum planned number of patients.
- The study has enrolled more than 700 patients to date and enrollment of the last patient is expected to occur in March 2025.
- The Company anticipates reporting top-line results in the second quarter of 2025.
- Upon potential positive Phase 3 data, PolyPid expects to submit a New Drug Application (“NDA”) with the advantages of the Fast Track and Breakthrough Therapy designations.
- The study has enrolled more than 700 patients to date and enrollment of the last patient is expected to occur in March 2025.
- Concurrent with the DSMB’s positive recommendation, as previously reported, PolyPid entered into a securities purchase agreement for a private placement financing (“PIPE”) led by existing institutional shareholders for
$14.5 million in gross proceeds.
- Under the securities purchase agreement, the investors also received warrants which will expire upon the earlier of nine months from the date of issuance and 10 trading days following PolyPid’s announcement of top-line results from its SHIELD II Phase 3 trial. Exercise of the warrants in full would result in an additional
$27.0 million in gross proceeds to the Company. - The gross proceeds from the financing extend PolyPid’s cash runway into the third quarter of 2025, beyond expected top-line results from SHIELD II.
- Proceeds of all warrants issued in this transaction, if exercised, would provide the Company with capital beyond NDA approval.
- Under the securities purchase agreement, the investors also received warrants which will expire upon the earlier of nine months from the date of issuance and 10 trading days following PolyPid’s announcement of top-line results from its SHIELD II Phase 3 trial. Exercise of the warrants in full would result in an additional
- Announced a research and development collaboration with ImmunoGenesis, Inc. which focuses on the development of novel formulations utilizing PolyPid’s experience with its proprietary PLEX Technology and ImmunoGenesis’ potent STimulator of INterferon Genes (“STING”) agonist drug candidate to potentially enhance treatment for solid tumors.
- Appointed Mr. Yitzchak Jacobovitz, CFA, to the Board of Directors, effective as of February 10, 2025. Mr. Jacobovitz is a partner and lead healthcare analyst at AIGH Capital Management and affiliates. Mr. Jacobovitz is also a board member at Myomo, Inc. He earned his MBA from Johns Hopkins University and is a Chartered Financial Analyst.
“We are thrilled with the impressive clinical and operational progress achieved in 2024 and believe that we are well-positioned for a potentially transformational year in 2025,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “Importantly, we remain confident that the DSMB’s recent recommendation to conclude SHIELD II upon the enrollment of 800 patients is suggestive of positive efficacy signals from D-PLEX100. Moreover, the sample size reassessment was an opportunity to 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. We continue to focus on completing the trial, while advancing our planned NDA and Marketing Authorization Application (“MAA”) submissions, preparing pre-launch activities, and expediting partnership discussions in and outside of the United States. We are also excited to welcome Mr. Jacobovitz to the Board of Directors and are pleased that AIGH was the lead investor in our most recent equity offering. Mr. Jacobovitz brings extensive healthcare investment experience to our board and we look forward to his contributions.”
Financial results for three months ended December 31, 2024
- Research and development (“R&D”) expenses for the three months ended December 31, 2024, were
$7.0 million , compared to$4.6 million in the same three-month period of 2023. 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 December 31, 2024, were
$1.0 million , compared to$1.2 million for the same period of 2023. - Marketing and business development expenses for the three months ended December 31, 2024, were
$0.2 million , compared to$0.2 million for the same period of 2023. - For the three months ended December 31, 2024, the Company had a net loss of
$8.5 million , or ($1.13) per share, compared to a net loss of$6.4 million , or ($3.97) per share, in the three-month period ended December 31, 2023.
Financial results for the full year ended December 31, 2024
- R&D expenses, net for the twelve months ended December 31, 2024, were
$22.8 million , compared to$16.1 million for the same twelve-month period of 2023. The increase in R&D expenses was driven by the ramp up of the ongoing SHIELD II Phase 3 trial. - G&A expenses for the twelve months ended December 31, 2024, were
$4.3 million , compared to$5.5 million for the same period of 2023. - Marketing and business development expenses for the twelve months ended December 31, 2024, were
$0.9 million , compared to$1.2 million for the same period of 2023. - The decreases in G&A and marketing and business development expenses were primarily due to the Company’s ongoing cost savings initiatives.
- For the twelve months ended December 31, 2024, the Company had a net loss of
$29.0 million , or ($4.91) per diluted share, compared to a net loss of$23.9 million , or ($16.93) per diluted share, in the twelve-month period ended December 31, 2023.
Balance Sheet Highlights
- As of December 31, 2024, the Company had cash and cash equivalents in the amount of
$15.6 million , compared to$5.3 million on December 31, 2023. 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, February 12, 2025 |
| Time: | 8:30 AM Eastern Time |
| Conference Call: | https://register.vevent.com/register/BI4e72dffa5a7b4167a28a33a6b3097df3 |
| Webcast: |
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, Fast Track and Qualified Infectious Disease Product (QIDP) Designations 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 expected timing for completion of enrollment of the SHIELD II trial, expected timing for top-line results from the SHIELD II trial, potential NDA and MAA submissions, potential clinical benefits of D-PLEX100, including safety and efficacy, and potential success of the trial, pre-launch activities and partnership discussions, that the gross proceeds from the financing extend the Company’s cash runway into the third quarter of 2025, that proceeds from the exercise of all warrants issued in the financing transaction would provide the Company with capital beyond NDA approval, that the Company is well-positioned for a potentially transformational year in 2025, the potential of the Company’s collaboration with ImmunoGenesis to enhance treatment for solid tumors, and the expectation that the Company’s current cash balance will be sufficient to fund operations into the third quarter of 2025. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission, including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed on March 6, 2024. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.
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
| CONSOLIDATED BALANCE SHEETS | ||||||
| U.S. dollars in thousands | ||||||
| December 31, | ||||||
| 2024 | 2023 | |||||
| (Unaudited) | ||||||
| ASSETS | ||||||
| CURRENT ASSETS: | ||||||
| Cash and cash equivalents | $ | 15,641 | $ | 5,309 | ||
| Restricted deposits | 168 | 300 | ||||
| Prepaid expenses and other current assets | 764 | 458 | ||||
| Total current assets | 16,573 | 6,067 | ||||
| LONG-TERM ASSETS: | ||||||
| Property and equipment, net | 6,075 | 7,621 | ||||
| Operating lease right-of-use assets | 2,295 | 1,597 | ||||
| Other long-term assets | 277 | 87 | ||||
| Total long-term assets | 8,647 | 9,305 | ||||
| Total assets | $ | 25,220 | $ | 15,372 | ||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| U.S. dollars in thousands (except share and per share data) | ||||||||
| December 31, | ||||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 2,409 | $ | 772 | ||||
| Accrued expenses and other current liabilities | 2,566 | 1,971 | ||||||
| Current maturities of long-term debt | 6,787 | 4,003 | ||||||
| Current maturities of operating lease liabilities | 919 | 540 | ||||||
| Total current liabilities | 12,681 | 7,286 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Long-term debt | 634 | 6,379 | ||||||
| Deferred revenues | 2,548 | 2,548 | ||||||
| Long-term operating lease liabilities | 1,277 | 857 | ||||||
| Other liabilities | 396 | 398 | ||||||
| Total long-term liabilities | 4,855 | 10,182 | ||||||
| COMMITMENTS AND CONTINGENT LIABILITIES (NOTE 8) | ||||||||
| SHAREHOLDERS' EQUITY (DEFICIT): | ||||||||
| Ordinary shares, no par value - Authorized: 107,800,000 shares at December 31, 2024 and 2023, respectively; Issued and outstanding: 10,190,904 and 1,653,559 shares at December 31, 2024 and 2023, respectively | - | - | ||||||
| Additional paid-in capital | 275,015 | 236,213 | ||||||
| Accumulated deficit | (267,331 | ) | (238,309 | ) | ||||
| Total shareholders' equity (deficit) | 7,684 | (2,096 | ) | |||||
| Total liabilities and shareholders' equity (deficit) | $ | 25,220 | $ | 15,372 | ||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
| U.S. dollars in thousands (except share and per share data) | |||||||||
| Year Ended December 31, | |||||||||
| 2024 | 2023 | 2022 | |||||||
| (Unaudited) | |||||||||
| Operating expenses: | |||||||||
| Research and development, net | $ | 22,811 | $ | 16,148 | $ | 27,990 | |||
| Marketing and business development | 945 | 1,196 | 2,888 | ||||||
| General and administrative | 4,273 | 5,523 | 8,010 | ||||||
| Operating loss | 28,029 | 22,867 | 38,888 | ||||||
| Financial expense, net | 951 | 929 | 540 | ||||||
| Loss before income tax | 28,980 | 23,796 | 39,428 | ||||||
| Income tax expense | 42 | 69 | 129 | ||||||
| Net loss | $ | 29,022 | $ | 23,865 | $ | 39,557 | |||
| Loss per share *): | |||||||||
| Basic | $ | 4.91 | $ | 16.99 | $ | 61.09 | |||
| Diluted | $ | 4.91 | $ | 16.93 | $ | 61.09 | |||
| Weighted-average Ordinary shares outstanding *): | |||||||||
| Basic | 5,912,890 | 1,404,368 | 647,556 | ||||||
| Diluted | 5,912,890 | 1,421,308 | 647,556 | ||||||
*) Results for the year ended December 31, 2022, have been retroactively adjusted to reflect the 1-for-30 reverse share split affected on September 18, 2023.
FAQ
When will PolyPid (PYPD) complete enrollment for the SHIELD II Phase 3 trial?
What is the total potential funding from PolyPid's (PYPD) recent private placement?
What was PolyPid's (PYPD) net loss for full-year 2024?
How long will PolyPid's (PYPD) current cash balance last?
When will PolyPid (PYPD) announce top-line results for SHIELD II trial?
