PolyPid Ltd. Reports First Quarter 2021 Financial Results and Provides Corporate Update
• Recruitment Progressing as Planned with Nearly 200 Patients Enrolled into Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery
• Recruitment Rate in SHIELD I trial Doubled in the Last Three Weeks
• Manufacturing Facility Now Fully Scaled Up and Capable of Supporting at Least First 30 Months of Anticipated Commercial Demand for D-PLEX100
• Conference Call Scheduled for Today at
PETAH TIKVA, Israel,
Recent Corporate Highlights:
- Recruitment progressing as planned with nearly 200 patients enrolled into the ongoing Phase 3 SHIELD I (Surgical site Hospital-acquired Infection PrEvention with Local D-plex) study, the first of two ongoing Phase 3 clinical trials of the Company’s lead product candidate D-PLEX100, for the prevention of surgical site infections (SSIs) in abdominal surgery (soft tissue).
- The Company plans to enroll 616-900 patients undergoing high priority operations in 60 centers in the United States,
Europeand Israel. Following the enrollment of approximately 500 patients, the study design provides for a blinded sample size re-estimation.
- Enrollment is also advancing as anticipated in
SHIELD II, the second of two Phase 3 clinical trials for D-PLEX100 in abdominal surgery (soft tissue). SHIELD IIwill enroll approximately 900-1,400 patients across 60 centers in the United States, Europeand Israel and has broader eligibility criteria, including minimally invasive surgical procedures.
- Manufacturing facility is now fully scaled up and capable of producing the first 30 months of anticipated commercial demand for D-PLEX100.
- Continued to generate compelling preclinical data from the Company’s new OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes PolyPid’s PLEX technology in the intra-operative tumor resection setting to provide prolonged and controlled exposure to docetaxel within the tumor resected site, which is important to prevent local tumor recurrence and the potential spreading of cancer cells.
“We have made significant progress advancing our promising development programs and continuing our evolution towards successful commercialization,” said
“We also continue to generate additional compelling preclinical data with OncoPLEX, including positive safety data in a promising solid tumor indication,” continued
“Our strong balance sheet continues to drive our robust clinical development program. Our cash runway extends into 2022 and we remain well-positioned to complete the SHIELD I study and conduct
Financial results for three months ended
- Research and development expenses for the three months ended
March 31, 2021were $6.0 million, compared to $3.4 millionin the same three-month period of 2020, as spending increased due to the ongoing SHIELD I and SHIELD II Phase 3 clinical trials in abdominal surgery.
- Marketing and business development expenses for the three months ended
March 31, 2021were $0.7 million, compared to $0.3 millionfor the same period of 2020, as spending increased primarily due to additional marketing and business development personnel hired in the Company’s New Jerseyoffices.
- General and administrative expenses for the three months ended
March 31, 2021were $2.1 million, compared to $0.7 millionfor the same period of 2020. This increase was due to the increase in costs due to the Company’s status as a publicly traded company with higher D&O insurance costs and an increase in non-cash share-based compensation.
- For the three months ended
March 31, 2021, the Company had a net loss attributable to ordinary shares of $8.7 million, compared to a net loss of $5.9 million, in the three-month period ended March 31, 2020.
- As of March 31, 2021, the Company had cash and cash equivalents, short-term deposits and long-term deposits in the amount of
$61.4 million, compared to $66.6 millionat December 31, 2020. PolyPidcontinues to expect that this cash balance will be sufficient to fund operations into 2022.
|Conference Call Dial-In & Webcast Information:|
|+972 1809 213-985|
|International:||+44 (0) 2071 928338|
PolyPid’s lead product candidate, D-PLEX100, is a novel drug product candidate 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 technology enables a prolonged and constant release of the broad-spectrum antibiotic doxycycline, resulting in high local concentration of the drug for a period of four weeks for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received Breakthrough Therapy Designation from the
For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.
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 statements relating to the expected recruitment for trials, timing of trials and release of the results thereof, the capacity of the Company’s manufacturing facility, the potential benefits of PLEX and OncoPLEX, the sufficiency of the Company’s cash to fund future operations, and all statements (other than statements of historical facts) that address activities, events, or developments that the Company intends, expects, projects, believes, or anticipates will or may occur in the future. 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
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.
Dikla Czaczkes Akselbrad
EVP & CFO
|CONSOLIDATED BALANCE SHEETS|
|U.S. dollars in thousands|
|Cash and cash equivalents||$||5,993||$||4,319|
|Prepaid expenses and other receivables||1,286||2,334|
|Total current assets||50,943||47,200|
|Property and equipment, net||6,023||5,890|
|Other long-term assets||773||637|
|Total long-term assets||18,896||28,647|
|CONSOLIDATED BALANCE SHEETS
|LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY|
|Other payables and accrued expenses||2,038||1,903|
|Total current liabilities||3,506||2,877|
|Total long-term liabilities||186||193|
|Commitments and Contingencies|
|Share capital -|
|Ordinary shares with no par value - Authorized: 47,800,000 shares at
|Additional paid-in capital||207,120||205,063|
|Total shareholders' equity||66,147||72,777|
|Total liabilities, convertible preferred shares and shareholders' equity||$||69,839||$||75,847|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three months ended
|Research and development, net||$||6,018||$||3,433|
|Marketing and business development expenses||652||276|
|General and administrative||2,127||727|
|Financial expense (income), net||(110||)||1,433|
|Net loss attributable to Ordinary shares||$||8,687||$||5,869|
|Basic and diluted net loss per Ordinary share||$||0.47||$||13.90|
|Weighted average number of Ordinary shares used in computing basic and diluted net loss per share||18,623,154||562,748|
Source: PolyPid Ltd.