PolyPid Ltd. Provides Corporate Update and Reports Third Quarter 2020 Financial Results
• Over 50% of planned 60 centers for ongoing Phase 3 SHIELD I trial of D-PLEX100 in abdominal surgery have received IRB approval
• Phase 3 SHIELD II trial advanced; preparations underway to initiate by year-end 2020
• Conference Call Scheduled for today at 8:30 a.m. ET
PETAH TIKVA, Israel,
Recent Corporate Highlights:
- Over 50% of planned 60 centers have received institutional review board (IRB) approval for ongoing Phase 3 SHIELD I (Surgical site Hospital-acquired Infection PrEvention with Local D-plex) trial for D-PLEX100 in abdominal surgery (soft tissue). This is the first of two planned 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.
- Advanced preparations are underway to initiate
SHIELD II, a second Phase 3 trial for D-PLEX100 in abdominal surgery, by year-end 2020. This second trial will have broader eligibility criteria, including minimally invasive surgical procedures, and will enroll approximately 900 - 1,400 patients across approximately 60 centers.
- Evaluating EU commercial partnership opportunities for D-PLEX100 as part of the Company’s stated commercial strategy.
“We are very encouraged with our strong progress to date, especially readying additional sites to enroll patients in our lead Phase 3 trial, and remain on track for our planned milestones,” said
“We continue to operate from a strong financial position,” continued
Financial results for three months ended
- Research and development (R&D) expenses for the three months ended
September 30, 2020were $4.2 million, compared to $3.8 millionin the same three-month period of 2019, as spending increased due to the initiation of the Phase 3 SHIELD I clinical trial and preparations for the Phase 3 SHIELD II clinical trial.
- General and administrative (G&A) expenses for the three months ended
September 30, 2020were $2.2 million, compared to $1.2 millionfor the same period of 2019, as costs increased due to becoming a publicly-traded company with higher D&O insurance costs and due to an increase in non-cash share-based compensation.
- For the three months ended
September 30, 2020, the Company had a net loss attributable to ordinary shares of $6.5 million, compared to a net loss of $2.1 millionin the three-month period ended September 30, 2019.
Financial results for nine-months ended
- R&D expenses for the nine months ended
September 30, 2020were $11.9 million, compared to $10.8 millionin the same nine-month period of 2019, as spending increased due to the initiation of the Phase 3 SHIELD I clinical trial and preparations for the Phase 3 SHIELD II clinical trial.
- G&A expenses for the nine months ended
September 30, 2020were $5.5 million, compared to $2.8 millionfor the same nine-month period of 2019, as costs increased due to becoming a publicly-traded company with higher D&O insurance costs and due to an increase in non-cash share-based compensation.
- For the nine months ended
September 30, 2020, the Company had a net loss attributable to ordinary shares of $31.4 million, compared to a net loss of $3.0 million, for the nine-month period ended September 30, 2019.
Balance Sheet Highlights
- As of September 30, 2020, the Company had cash and cash equivalents, short-term deposits and long-term deposits in the amount of
$71.8 million, compared to $26.6 millionas of December 31, 2019. This increase 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. PolyPidexpects that this cash balance will be sufficient to fund operations into 2022.
Conference Call Dial-In & Webcast Information
Wednesday, November 11th at
|+1 877 870 9135|
|+972 1809 213-985|
|International:||+44 (0) 2071 928338|
PolyPid’s lead product candidate, D-PLEX100, is a novel product candidate designed to provide local prolonged 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 up to four weeks for the prevention of SSIs, with additional potential to treat antibiotic-resistant bacteria at the surgical site. D-PLEX100 has received two Qualified Infectious Disease Product (QIDP) designations, as well as two Fast Track designations from the FDA for the prevention of post-abdominal surgery incisional infection and for the prevention of sternal wound infection post-cardiac surgery.
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 SSIs in different type of surgeries, including abdominal and open-heart surgery. PolyPid’s technology and products are based on the inventions of Dr. Noam Emanuel, the Founder and the Chief Scientific Officer of the company.
For additional company information, visit www.polypid.com.
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 its objectives, milestones, plans, and strategies, the expected timing of trials and release of the results thereof, the expected timing of an NDA and other regulatory matters, the research, development, the sufficiency of the Company’s cash and use of the Company’s platform technologies, technologies, products and product candidates, 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
|CONSOLIDATED BALANCE SHEETS|
|U.S. dollars in thousands|
|Cash and cash equivalents||$||9,665||$||3,924|
|Prepaid expenses and other receivables||2,504||417|
|Total current assets||46,627||27,401|
|Property and equipment, net||6,182||6,121|
|Other long-term assets||221||230|
|Total long-term assets||34,471||6,351|
|CONSOLIDATED BALANCE SHEETS|
|LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' DEFICIENCY|
|Other payables and accrued expenses||1,112||998|
|Total current liabilities||1,685||2,579|
|Convertible preferred shares warrant liability||-||12,241|
|Total long-term liabilities||180||12,492|
|COMMITMENTS AND CONTINGENT LIABILITIES|
|CONVERTIBLE PREFERRED SHARES:|
|Preferred A, A-1, B, B-1, C-1, C-2, D-1, D-3, E and E-1 shares of
|SHAREHOLDERS' EQUITY (DEFICIENCY):|
|Share capital -|
|Ordinary shares with no par value - Authorized: 47,800,000 and 22,466,000 shares at
|Additional paid-in capital||203,970||5,671|
|Total shareholders' equity (deficiency)||79,233||(87,632||)|
|Total liabilities, convertible preferred shares and shareholders' equity (deficiency)||$||81,098||$||33,752|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three months ended
||Nine months ended
|Research and development, net||$||4,176||$||3,789||$||11,948||$||10,769|
|Marketing and business development expenses||323||274||904||571|
|General and administrative||2,177||1,190||5,532||2,812|
|Financial (income) expense, net||(218||)||(3,145||)||10,936||(11,107||)|
|Net loss (profit)||$||6,458||$||2,108||$||29,320||$||3,045|
|Net loss (profit) attributable to Ordinary shares||$||6,458||$||2,108||$||31,434||$||3,045|
|Basic and diluted net loss per Ordinary share||$||0.35||$||6.94||$||4.78||$||13.38|
|Weighted average number of Ordinary shares used in computing basic and diluted net loss per share||18,415,231||562,597||6,578,969||562,354|
PolyPid, Ltd. Dikla Czaczkes Akselbrad EVP & CFO Tel: +972-74-719-5700 firstname.lastname@example.org Investor contact: Bob Yedid LifeSci Advisors646-597-6989 email@example.com
Source: PolyPid Ltd.