PYPD PolyPid Ltd.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
D-PLEX100 - SHIELD I
Abdominal (soft tissue) sternal surgical site infections
|
Phase 3
Phase 3
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|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
D-PLEX100 (SHIELD II)
Surgical Site Infection
|
Phase 3
Phase 3
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Phase 3 trial initiation announced December 16, 2020.
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|
D-PLEX100
Sternal (bone) sternal surgical site infections
|
Phase 3
Phase 3
|
Phase 3 trial initiated December 2019. Enrolment paused due to COVID-19.
|
Latest News
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PETAH TIKVA, Israel, Feb. 23, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharmaceutical company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today announced that it will present at the Raymond James 42nd Annual Institutional Investors Conference and the Barclays Global Healthcare Conference in March. The Company will also participate in one-on-one investor meetings during both events.
Please find presentation details below:
Raymond James 42nd Annual Institutional Investors Conference
Date: Wednesday, March 3, 2021 Time: 8:20 AM Eastern Time Webcast: https://kvgo.com/rjinstitutionalinvestors/polypid-march-2021 Barclays Global Healthcare Conference
Date: Tuesday, March 9, 2021 Time: 7:30 AM Eastern Time Webcast: https://kvgo.com/2021-global-healthcare-conference/polypid-march-2021 Replays of the conferences will be available following each live event using the webcast links above. Each presentation will also be accessible in the Investor Relations section of the PolyPid website at http://www.polypid.com
About PolyPid
PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).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 "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal 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. Because such statements deal with future events and are based on PolyPid's current expectations, they are subject to various risks and uncertainties. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission (SEC), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. 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. Dikla Czaczkes Akselbrad EVP & CFO Tel: +972-747195700 Investors: Bob Yedid LifeSci Advisors 646-597-6989 [email protected]
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Top-line Data Anticipated by Year End 2021
Enrollment Also Continues to Progress in Company's Second Phase 3 Clinical Trial, SHIELD II
PETAH TIKVA, Israel, Feb. 16, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharmaceutical company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today announced that the 100th patient has been enrolled and randomized in the SHIELD I (Surgical site Hospital acquired Infection prEvention with Local D-plex) trial, the Company's first of two Phase 3 clinical trials for its lead product candidate, D-PLEX100, for the prevention of post-abdominal surgery incisional infections (soft tissue).
"Enrollment in our first Phase 3 clinical trial, SHIELD I, continues to progress as expected, and we are excited to have now enrolled and randomized the 100th patient into this important study," said Amir Weisberg, PolyPid's CEO. "We continue to anticipate the availability of top-line results from SHIELD I by end of this year. Moreover, enrollment in our second Phase 3 trial, SHIELD II, which has broader eligibility criteria than SHIELD I with the inclusion of minimally invasive surgical procedures, commenced in late 2020 and also continues to advance as expected."
SHIELD I is a prospective, multinational, multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX100 in the prevention of incisional surgical site infections (SSIs) post-abdominal surgery. The primary endpoint of the trial is the combination of incisional SSIs and mortality rate as measured by the proportion of subjects with either an SSIs event, as determined by a blinded and independent adjudication committee, or mortality for any reason within 30 days post-surgery. The trial will enroll a minimum of 616 patients, with a maximum of about 900 patients, as defined by the adaptive study design, in more than 60 centers in the United States, Europe and Israel.
About D-PLEX100
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 U.S. Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.
About PolyPid
PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).
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 statements relating to the expected timing of trials and release of the results thereof, 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 Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's prospectus filed pursuant to Rule 424(b)(4), filed with the SEC on June 29, 2020. 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.
Company contact: PolyPid, Ltd. Dikla Czaczkes Akselbrad EVP & CFO Tel: +972-747195700 [email protected] Investors contact: Bob Yedid LifeSci Advisors 646-597-6989 [email protected]
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- 100 Patients Enrolled into Phase 3 SHIELD I and SHIELD II Trials of D-PLEX100 in Abdominal Surgery
- Recently Initiated Phase 3 SHIELD II Trial
- Granted Breakthrough Therapy Designation from FDA for D-PLEX100 for Prevention of SSIs in Patients Undergoing Elective Colorectal Surgery
- Conference Call Scheduled for Today at 8:30 AM ET
PETAH TIKVA, Israel, Feb. 10, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics, today provided a corporate update and reported financial results for the three months and full-year ended December 31, 2020.
Recent Corporate Highlights:
- Enrolled 100 patients in total into the two ongoing Phase 3 trials, SHIELD I and SHIELD II. SHIELD I (Surgical site Hospital-acquired Infection PrEvention with Local D-plex) trial is the first of two Phase 3 clinical trials of D-PLEX100, the Company's lead product candidate, for the prevention of surgical site infections (SSIs) in abdominal surgery (soft tissue). The Company plans to enroll 600-900 patients undergoing high priority operations in 60 centers in the United States, Europe and Israel. Following the enrollment of approximately 500 patients, the study design provides for a blinded sample size re-estimation.
- SHIELD II, the second of two Phase 3 clinical trials for D-PLEX100 in abdominal surgery (soft tissue), will enroll approximately 900-1,400 patients across the same number of centers as SHIELD I, and has broader eligibility criteria, including minimally invasive surgical procedures.
- Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for D-PLEX100 for the prevention of SSIs in patients undergoing elective colorectal surgery.
- Announced positive 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 the local tumor reoccurrence and the potential spreading of cancer cells. In a syngeneic mouse model for solid tumors of colon carcinoma using cancer cells highly resistant to docetaxel, a single local application of OncoPLEX at the intra-operative setting post tumor resection showed improved overall survival and significantly less tumor recurrence, and reduced systemic toxicity compared to the group treated with six subsequent cycles of systemic docetaxel treatment with 2-4 days gap between cycles.
- Hosted a key opinion leader webinar on D-PLEX100 for the prevention of SSIs. The webinar featured Hartzell V. Schaff, MD, Mayo Clinic, Anthony J. Senagore, MD, formerly of UTMB at Galveston, and Oded Zmora, MD, Shamir Medical Center, Israel, who discussed the burden and challenges related to SSIs post- colorectal and cardiovascular surgeries and the opportunity for D-PLEX100 to change the current therapeutic landscape. A recording of the KOL event can be found on PolyPid's website http://www.polypid.com
"2020 was truly a transformative year for PolyPid," said Amir Weisberg, Chief Executive Officer. "Most importantly, our Phase 3 program for D-PLEX100 for the prevention of SSIs is progressing as planned. We are excited to report that we have now enrolled 100 patients collectively in our two Phase 3 programs, with the vast majority of those subjects in our ongoing SHIELD I trial. We continue to anticipate top-line results from SHIELD I by year-end 2021. Moreover, our second Phase 3 trial in abdominal surgery, SHIELD II, which was recently initiated, is advancing as anticipated. We also received regulatory validation of the potential of D-PLEX100 to demonstrate substantial improvement in the prevention of SSIs in complex surgical settings when we were granted Breakthrough Therapy Designation from the FDA for D-PLEX100 in late 2020.
"We believe our innovative PLEX technology has potential in multiple areas of medicine where locally administered extended-release and controlled therapies are most beneficial, including oncology," continued Mr. Weisberg. "To this end, the positive preclinical data demonstrated with OncoPLEX support our belief that direct local application of this promising adjuvant therapy in the intra-operative tumor resection setting has the potential to overcome the chemotherapeutic drug resistance seen in many cancer patients across different solid tumors. We look forward to further advancing our OncoPLEX development program and potentially initiating a Phase 1 clinical trial in 2022.
"We also continue to operate from a position of significant financial strength. Our successfully completed IPO on the Nasdaq in June 2020 that generated $62.8 million in net proceeds helped extend our cash runway into 2022. We are well-positioned to complete the SHIELD I study and conduct SHIELD II, as well as prepare for the submission of a New Drug Application to the FDA. Lastly, we are proud and delighted to update that PolyPid recently joined the ARK Israeli Innovative Technology ETF designed to track listed Israeli companies who are causing disruptive innovation in their field, including life sciences," concluded Mr. Weisberg.
Financial results for three months ended December 31, 2020
- Research and development (R&D) expenses for the three months ended December 31, 2020 were $5.0 million, compared to $3.3 million in the same three-month period of 2019, as spending increased due to the initiation of SHIELD I and SHIELD II Phase 3 clinical trials in abdominal surgery.
- General and administrative (G&A) expenses for the three months ended December 31, 2020 were $2.2 million, compared to $0.8 million for the same period of 2019, as costs increased due to being a publicly-traded company with higher D&O insurance costs, and an increase in non-cash share-based compensation.
- Marketing and Business Development expenses for the three months ended December 31, 2020 were $0.7million, compared to $0.3 million for the same period of 2019, as spending increased mainly due to an increase in marketing and business development personnel in our new offices in New Jersey.
- For the three months ended December 31, 2020, the Company had a net loss attributable to ordinary shares of $7.5million, compared to a net loss of $3.9 million, in the three-month period ended December 31, 2019.
Financial results for the full-year ended December 31, 2020
- R&D expenses for the year ended December 31, 2020 were $17.0 million, compared to $14.1 million in the same period of 2019, as spending increased due to the initiation of SHIELD I and SHIELD II Phase 3 clinical trials in abdominal surgery.
- G&A expenses for the year ended December 31, 2020 were $7.7 million, compared to $3.6 million for the same period of 2019, as costs increased due to being a publicly-traded company with higher D&O insurance costs, and an increase in non-cash share-based compensation.
- Marketing and Business Development expenses for the year ended December 31, 2020 were $1.6 million, compared to $0.9 million for the same period of 2019, as spending increased due to the establishment of our new offices in New Jersey, United states, with senior marketing and business development personnel.
- For the year ended December 31, 2020, the Company had a net loss attributable to ordinary shares of $39.0 million, or ($4.07) per diluted share, compared to a net loss of $6.9 million, or ($23.69) per diluted share, for the year ended December 31, 2019.
Balance Sheet Highlights
- As of December 31, 2020, the Company had cash and cash equivalents, short-term deposits and long-term deposits in the amount of $66.6 million, compared to $26.6 million at December 31, 2019. This reflects the completion of the Company's IPO in June 2020, which raised net proceeds of $62.8 million, after underwriting fees and offering expenses. PolyPid expects that this cash balance will be sufficient to fund operations into 2022.
Conference Call Dial-In & Webcast Information: Date: Wednesday, February 10, 2021 Time: 8:30 AM Eastern Time United States: +1 877-870-9135 Israel: +972 1809 213-985 International: +44 (0) 2071 928338 Conference ID: 1468387 Webcast: https://edge.media-server.com/mmc/p/cx5so6fj About D-PLEX100
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 U.S. Food and Drug Administration (FDA) for the prevention of SSIs in patients undergoing elective colorectal surgery. D-PLEX100 has also received two Qualified Infectious Disease Product (QIDP) designations as well as two Fast Track designations for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.About PolyPid
PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).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 statements relating to the expected timing of trials and release of the results thereof, 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 Securities and Exchange Commission ("SEC"), including, but not limited to, the risks detailed in the Company's prospectus filed pursuant to Rule 424(b)(4), filed with the SEC on June 29, 2020. 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.CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands December 31,
2020
2019
(Unaudited)
(Audited)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
4,319
$
3,924
Restricted cash
390
375
Short-term deposits
40,157
22,685
Prepaid expenses and other receivables
2,729
417
Total current assets
47,595
27,401
Long-term assets:
Property and equipment, net
5,890
6,121
Long-term deposits
22,120
-
Other long-term assets
242
230
Total long-term assets
28,252
6,351
Total assets
$
75,847
$
33,752
CURRENT LIABILITIES:
Trade payables
$
974
$
1,581
Other payables and accrued expenses
1,903
998
Total current liabilities
2,877
2,579
Long-term liabilities:
Other liabilities
193
251
Warrants to convertible preferred shares
-
12,241
Total long-term liabilities
193
12,492
Commitments and Contingencies
Convertible preferred shares:
Preferred A, A-1, B, B-1, C-1, C-2, D-1, D-3, E and E-1 shares with no par value - Authorized: 0 and 17,916,412 shares at December 31, 2020 and 2019, respectively; Issued and outstanding: 0 and 12,520,977 shares at December 31, 2020 and 2019, respectively.
-
106,313
Shareholders' equity (deficit):
Share capital -
Ordinary shares with no par value - Authorized: 47,800,000 and 22,520,977 shares at December 31, 2020 and 2019, respectively; Issued and outstanding: 18,494,739 and 562,748 shares at December 31, 2020 and 2019, respectively.
-
-
Additional paid-in capital
205,063
5,671
Accumulated deficit
(132,286
)
(93,303
)
Total shareholders' equity (deficit)
72,777
(87,632
)
Total liabilities, convertible preferred shares and shareholders' equity (deficit)
$
75,847
$
33,752
CONSOLIDATED STATEMENTS OF OPERATIONS U.S. dollars in thousands (except share and per share data) Year ended
December 31,2020
2019
(Unaudited)
(Audited)
Operating expenses:
Research and development, net
$
16,954
$
14,083
Marketing and business development expenses
1,614
887
General and administrative
7,704
3,590
Operating loss
26,272
18,560
Financial (income) expense, net
10,597
(11,655
)
Net loss
$
36,869
$
6,905
Deemed dividend
2,114
-
Net loss attributable to Ordinary shares
$
38,983
$
6,905
Basic and Diluted net loss per Ordinary share
$
4.07
$
23.69
Weighted average number of Ordinary shares used in computing basic and diluted net loss per share
9,582,405
562,451
CONSOLIDATED STATEMENTS OF OPERATIONS U.S. dollars in thousands (except share and per share data) Three Months Ended
December 31,2020
2019
(Unaudited)
(Unaudited)
Operating expenses:
Research and development, net
$
5,006
$
3,314
Marketing and business development expenses
710
316
General and administrative
2,172
778
Operating loss
7,888
4,408
Financial income, net
339
548
Net loss
$
7,549
$
3,860
Deemed dividend
-
-
Net loss attributable to Ordinary shares
$
7,549
$
3,860
Basic and Diluted net loss per Ordinary share
$
0.41
$
6.86
Weighted average number of Ordinary shares used in computing basic and diluted net loss per share
18,494,773
562,748
Contacts: PolyPid, Ltd. Dikla Czaczkes Akselbrad EVP & CFO Tel: +972-747195700 Investors: Bob Yedid LifeSci Advisors 646-597-6989 [email protected]
- 100 Patients Enrolled into Phase 3 SHIELD I and SHIELD II Trials of D-PLEX100 in Abdominal Surgery
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PETAH TIKVA, Israel, Jan. 27, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced that it will report its fourth quarter and full year 2020 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, February 10, 2021. 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.
Conference Call Dial-In & Webcast Information:
Date: Wednesday, February 10, 2021 Time: 8:30 AM Eastern Time United States: +1 877 870 9135 Israel: +972 1809 213-985 International: +44 (0) 2071 928338 Conference ID: 1468387 Webcast: https://edge.media-server.com/mmc/p/cx5so6fj About PolyPid
PolyPid Ltd. (NASDAQ:PYPD) is a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise delivery of drugs at effective release rates, over durations ranging from several days to months. PolyPid's lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of sternal and abdominal surgical site infections (SSIs).For additional company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.
Forward-looking Statements
This press release contains projections and other forward-looking statements regarding future events or our future financial performance. All statements other than present and historical facts and conditions contained in this release are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. Actual events or results may differ materially from those contained in the projections or forward-looking statements. Forward-looking statements in this release are made pursuant to the safe harbor provisions contained in the Private Securities Litigation Reform Act of 1995. 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. Dikla Czaczkes Akselbrad EVP & CFO Tel: +972-747195700 Investors: Bob Yedid LifeSci Advisors 646-597-6989 [email protected]
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Single Local Treatment of OncoPLEX Showed Improved Overall Survival and Significantly Less Tumor Recurrence, and Reduced Systemic Toxicity Compared to Multiple Injections with Standard Systemic Chemotherapy in a Syngeneic Mouse Model for Solid Tumors of Colon Carcinoma
Company Intends to Complete an IND Package with Additional Preclinical Studies in Various Solid Tumor Types, Followed by the Initiation of a Phase 1 Clinical Trial in 2022
PETAH TIKVA, Israel, Dec. 22, 2020 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX technology, today announced positive preclinical data from its OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes the Company's novel PLEX technology to provide prolonged and controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, in the intra-operative tumor resection setting. OncoPLEX is designed for the delivery of sustained, significant concentrations of docetaxel locally within the tumor site for a few weeks, potentially reducing local tumor recurrence and tumor metastatic spreading.
In a syngeneic mouse model for solid tumors of colon carcinoma, a single local application of OncoPLEX at the intra-operative setting post tumor resection compared to the group treated with six cycles of systemic docetaxel treatment with 2-4 days gap between cycles, generated the following key results:
- OncoPLEX arm showed 25% overall tumor recurrence at the end of the study (day 39 post-surgery) compared to 75% in the systemic treatment arm, and 100% in the untreated control arm.
- OncoPLEX arm demonstrated 75% overall tumor free survival at the end of the study (day 39 post-surgery), compared to 25% in the systemic treatment arm, and 0% in the untreated control arm.
- OncoPLEX arm demonstrated 75% overall survival at the end of the study (day 39 post-surgery), compared to 50% in the systemic treatment arm, and 0% in the untreated control arm.
Dose response was also demonstrated for OncoPLEX in these studies.
Systemic toxicity was lower following the local application of OncoPLEX versus systemic docetaxel. Additional data in a pharmacokinetic model showed that the maximal plasma concentration of docetaxel was >10 times lower with OncoPLEX than with systemic docetaxel.
"We believe the benefits of our PLEX platform, including the ability to generate constant and high local concentration of drug over a prolonged period, can also potentially be leveraged as an anti-cancer therapy," said Dr. Noam Emanuel, PolyPid's Chief Scientific Officer. "We are very encouraged by these preclinical data, as they support our belief that direct local application of OncoPLEX in the intra-operative tumor resection setting has the potential to be a promising new type of adjuvant therapy to reduce local tumor recurrence and to prevent postoperative metastatic spreading by cancer cells that escape resection, as seen in many oncology patients across different solid tumors."
Based on these compelling preclinical results, PolyPid intends to conduct additional preclinical safety studies of OncoPLEX in various type of solid tumor resections, in order to complete a preclinical package for the filing of pre-Investigational New Drug meeting request with the U.S. Food and Drug Administration in 2021 and potentially initiate a Phase 1 clinical trial in 2022.
About PolyPid
PolyPid is a Phase 3 clinical-stage biopharmaceutical company focused on developing targeted, locally administered and prolonged-release therapeutics using its proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology. PolyPid's product candidates are designed to address diseases with high unmet medical needs by pairing PLEX with drugs to deliver them directly to precise sites in the body at predetermined release rates and over durations ranging from several days to several months. PolyPid's lead product candidate, D-PLEX100, is in Phase 3 clinical trials for the prevention of sternal SSIs and abdominal SSIs. PolyPid's technology and products are based on the inventions and the professional leadership of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.
For additional company information, visit www.polypid.com.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal 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, PolyPid is using forward-looking statements in this press release when it discusses the potential of its products and that it intends to conduct additional preclinical safety studies of OncoPLEX in various type of solid tumor resections, in order to complete a preclinical package for the filing of pre-Investigational New Drug meeting request with the U.S. Food and Drug Administration in 2021 and potentially initiate a Phase 1 clinical trial in 2022. Actual results, performance or achievements of PolyPid could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in PolyPid's final prospectus dated June 25, 2020, filed pursuant to Rule 424(b)(4) with the Securities and Exchange Commission (SEC), and in any subsequent filings with the SEC. Except as otherwise required by law, PolyPid undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. 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.
Company contact: PolyPid, Ltd. Dikla Czaczkes Akselbrad EVP & CFO Tel: +972-747195700 [email protected] Investors contact: Bob Yedid LifeSci Advisors 646-597-6989 [email protected]