PolyPid Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results
PolyPid Ltd. (PYPD) updates on SHIELD II Phase 3 trial for D-PLEX100, reports positive preclinical data, successful financing, and strong financial results. The company aims to improve surgical outcomes and expects top-line results in the second half of 2024.
Positive
More than 100 patients enrolled in ongoing SHIELD II Phase 3 trial for D-PLEX100.
Unblinded interim analysis planned once around 400 patients complete 30-day follow-up.
Top-line results expected in the second half of 2024.
New preclinical data shows OncoPLEX injected intratumorally reduces tumor volume.
$16 million financing extends cash runway through late third quarter 2024.
Potential additional $19 million if warrants are exercised to fund NDA submission for D-PLEX100.
Positive financial results for three months and full year ended December 31, 2023.
Net loss decreased for both three months and full year compared to previous periods.
Cash and cash equivalents of $5.3 million as of December 31, 2023, expected to fund operations into late third quarter 2024.
The enrollment of over 100 patients in the SHIELD II Phase 3 trial for D-PLEX100 marks a significant progression in PolyPid's clinical development program. The interim analysis, scheduled after 400 patients complete their 30-day follow-up, will provide crucial data that could influence the future of D-PLEX100 as a preventive treatment for abdominal colorectal surgical site infections. The outcome of this analysis could have a substantial impact on the company's valuation, as positive results may lead to increased investor confidence and potentially, a surge in stock price. These developments are particularly noteworthy considering the high costs and morbidity associated with surgical site infections, which represent a significant market need.
Furthermore, the preclinical success of OncoPLEX in reducing tumor volume and improving survival rates in animal models suggests a promising expansion of PolyPid's portfolio into oncology. If the technology translates effectively to human trials, it could position the company as a key player in the interventional oncology space, potentially disrupting current treatment paradigms with its PLEX platform technology.
The recent $16 million financing is a strategic move by PolyPid, extending its cash runway and providing stability through key upcoming milestones. This financial cushion is essential for maintaining investor confidence, especially in the volatile biotech sector. The potential additional $19 million from warrant exercises would further bolster the company's financial position, supporting its operations until the New Drug Application submission for D-PLEX100. Investors should closely monitor the cash burn rate and the results of the interim analysis, as these will be critical indicators of the company's financial health and its ability to continue funding its clinical programs without the need for immediate additional capital.
The reduction in R&D, G&A and marketing expenses as reported in the financial results suggests PolyPid's commitment to cost efficiency, which is essential for a late-stage biopharma company. The year-over-year decrease in net loss is a positive signal to the market, reflecting better financial management and potentially increasing the attractiveness of the company to investors. However, the true test will come with the results of the SHIELD II Phase 3 trial, as the market potential for D-PLEX100 is contingent on its clinical efficacy and safety profile. With the global surgical site infection control market projected to grow, PolyPid's advancements could capture a significant market share if D-PLEX100 is successful.
02/14/2024 - 07:00 AM
More Than 100 Patients Enrolled in Ongoing SHIELD II Phase 3 Trial of D-PLEX 100 for the Prevention of Abdominal Colorectal Surgical Site Infections
Unblinded Interim Analysis to be Conducted Once Approximately 400 Patients Complete Their 30-Day Follow-up; Top-line Results Expected in Second Half of 2024
New Preclinical Data Showed OncoPLEX Injected Intratumorally Reduc ed Tumor Volume and Improv ed Survival in New Animal Models
Recent Successful $16 Million Financing Extends Company’s Cash Runway Through Late Third Quarter 2024 and Beyond Expected Timing of Unblinded Interim Analysis; Potential Additional $19 Million if Warrants are Exercised to Fund PolyPid to the Start of a Planned New Drug Application Submission for D-PLEX100
Conference Call S cheduled for Today at 8:30 AM ET
PETACH TIKVA, Israel, Feb. 14, 2024 (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, 2023.
Recent Corporate Highlights:
More than 100 patients have been enrolled to date in the ongoing SHIELD II Phase 3 trial that is recruiting patients undergoing colorectal abdominal surgery with large incisions.Approximately 40 centers are currently open. Unblinded interim analysis is planned to be conducted once a total of approximately 400 patients complete their 30-day follow-up, which is expected to occur in mid-2024. Top-line results are anticipated in the second half of 2024. Generated new preclinical data with OncoPLEX injected intratumorallyOncoPLEX single intratumoral injection significantly reduced tumor growth and increased survival in two well established and commonly used tumor animal models: murine melanoma and murine colon carcinoma. The intratumoral injection of the PLEX platform could be used as an interventional oncology treatment with additional chemotherapies or other types of molecules, such as monoclonal antibodies, bispecific antibodies and nucleic acids. Closed a private placement financing (the “PIPE”) for $16 million of gross proceeds, which extends the Company’s cash runway through late in the third quarter of 2024 and beyond the expected timing of the planned unblinded interim analysis.PIPE syndicate was comprised of new and existing investors, including participation from new U.S. life sciences-focused investors, DAFNA Capital Management and Rosalind Advisors. Company has the potential to secure an additional $19 million if the results of the unblinded interim analysis are positive and all warrants issued in the recent financing are exercised, which would fund PolyPid to the start of a planned New Drug Application (“NDA”) submission for D-PLEX100 . “We are thrilled with the significant progress recently achieved throughout our business,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “As we expected, enrollment in our ongoing SHIELD II Phase 3 pivotal trial for D-PLEX100 has begun to ramp up, and we continue to anticipate top-line results from this study in the second half of 2024. We have also generated new highly compelling preclinical data with OncoPLEX that demonstrate its potential in oncology and beyond.”
“Moreover, in order to support our robust clinical development efforts, we successfully completed a $16 million financing that included participation from multiple new U.S. life sciences-focused investors,” continued Ms. Czaczkes Akselbrad. “Importantly, we also have the potential to secure an additional $19 million if the warrants associated with this transaction are exercised, which would fund PolyPid to the start of a planned New Drug Application submission for D-PLEX100 . ”
Financial results for three months ended December 31 , 202 3
Research and development (R&D) expenses, net for the three months ended December 31, 2023, were $4.6 million , compared to $4.7 million in the same three-month period of 2022. R&D expenses in the most recently completed quarter were 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, 2023, were $1.2 million , compared to $1.6 million for the same period of 2022. Marketing and business development expenses for the three months ended December 31, 2023, were $0.2 million , compared to $0.4 million for the same period of 2022. For the three months ended December 31, 2023, the Company had a net loss of $6.4 million , or ($3.97) per diluted share, compared to a net loss of $6.6 million , or ($9.90) per diluted share, in the three-month period ended December 31, 2022. Financial results for the full year ended December 31 , 202 3
R&D expenses, net for the year ended December 31, 2023, were $16.1 million , compared to $28 million in 2022. The decrease in R&D expenses resulted primarily from the completion of the SHIELD I Phase 3 clinical trial. G&A expenses for the year ended December 31, 2023, were $5.5 million , compared to $8.0 million for 2022. Marketing and business development expenses for the year ended December 31, 2023, were $1.2 million , compared to $2.9 million for 2022. The decreases in G&A and marketing and business development expenses were primarily due to the Company’s cost reduction plan announced in October 2022 and further cost savings initiatives implemented during full year 2023. For the year ended December 31, 2023, the Company had a net loss of $23.9 million , or ($16.93) per diluted share, compared to a net loss of $39.6 million , or ($61.09) per diluted share, for 2022. Balance Sheet Highlights
As of December 31, 2023, the Company had cash and cash equivalents in the amount of $5.3 million . This does not include the net proceeds of approximately $15 million generated from the PIPE financing closed in January 2024. PolyPid expects that its pro forma cash balance will be sufficient to fund operations into late third quarter 2024. Conference Call Dial-In & Webcast Information:
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 top-line results from the SHIELD II trial and of the unblinded interim analysis, the planned NDA submission for D-PLEX100 , the potential impacts and uses for OncoPLEX and the PLEX platform, the Company’s expected cash runway, and the potential to receive additional funds if warrants are exercised. 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 SEC, including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed on March 31, 2023. 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: IR@Polypid.com
Investors: britchie@lifesciadvisors.com
CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands December 31, 2023 2022 (Unaudited) ASSETS CURRENT ASSETS: Cash and cash equivalents $ 5,309 $ 8,552 Restricted deposits 300 511 Short-term deposits - 4,042 Prepaid expenses and other current assets 458 1,089 Total current assets 6,067 14,194 LONG-TERM ASSETS: Property and equipment, net 7,621 9,247 Operating lease right-of-use assets 1,597 2,431 Other long-term assets 87 99 Total long-term assets 9,305 11,777 Total assets $ 15,372 $ 25,971
CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (except share and per share data) December 31, 2023 2022 (Unaudited) LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Current maturities of long-term debt $ 4,003 $ 4,024 Accrued expenses and other current liabilities 1,971 2,429 Trade payables 772 1,141 Current maturities of operating lease liabilities 540 959 Total current liabilities 7,286 8,553 LONG-TERM LIABILITIES: Long-term debt 6,379 7,574 Deferred revenues 2,548 2,548 Long-term operating lease liabilities 857 1,173 Other liabilities 398 294 Total long-term liabilities 10,182 11,589 COMMITMENTS AND CONTINGENT LIABILITIES SHAREHOLDERS' EQUITY: Ordinary shares, no par value *)- - - Authorized: 107,800,000 and 47,800,000 shares at December 31, 2023 and 2022, respectively; Issued and outstanding: 1,653,559 and 669,605 shares at December 31, 2023 and 2022, respectively Additional paid-in capital 236,213 220,273 Accumulated deficit (238,309 ) (214,444 ) Total shareholders' equity (deficit) (2,096 ) 5,829 Total liabilities and shareholders' equity (deficit) $ 15,372 $ 25,971
*) Prior period results have been retroactively adjusted to reflect the 1-for-30 reverse share split affected on September 18, 2023.
CONSOLIDATED STATEMENTS OF OPERATIONS U.S. dollars in thousands (except share and per share data) Year Ended December 31, 202 3 202 2 2021 (Unaudited) Operating expenses: Research and development, net $ 16,148 $ 27,990 $ 30,553 Marketing and business development 1,196 2,888 2,983 General and administrative 5,523 8,010 9,609 Operating loss 22,867 38,888 43,145 Financial (income) expense, net 929 540 (544 ) Loss before income tax 23,796 39,428 42,601 Income tax expense 69 129 - Net loss $ 23,865 $ 39,557 $ 42,601 Loss per share: Basic $ 16.99 $ 61.09 $ 68.27 Diluted $ 16.93 $ 61.09 $ 68.27 Weighted-average Ordinary shares outstanding: Basic 1,404,368 647,556 624,051 Diluted 1,421,308 647,556 624,051
CONSOLIDATED STATEMENTS OF OPERATIONS U.S. dollars in thousands (except share and per share data) Three Months Ended December 31, 2023 2022 (Unaudited) (Unaudited) Operating expenses: Research and development, net $ 4,588 $ 4,655 Marketing and business development expenses 193 350 General and administrative 1,218 1,607 Operating loss 5,999 6,612 Financial expense (income), net 348 (100 ) Loss before income tax 6,347 6,512 Income tax expense 9 55 Net loss $ 6,356 $ 6,567 Loss per share: Basic $ 3.84 $ 9.90 Diluted $ 3.97 $ 9.90 Weighted average number of Ordinary shares used in computing basic and diluted loss per share 1,653,559 663,145
How many patients are enrolled in the ongoing SHIELD II Phase 3 trial for D-PLEX100?
More than 100 patients have been enrolled to date in the ongoing SHIELD II Phase 3 trial.
When are the top-line results of the SHIELD II Phase 3 trial expected?
Top-line results are anticipated in the second half of 2024.
What does the new preclinical data show about OncoPLEX?
New preclinical data shows OncoPLEX injected intratumorally reduces tumor volume and improves survival in new animal models.
How much financing did PolyPid secure recently?
PolyPid secured $16 million in financing recently.
What is the potential additional funding PolyPid could secure?
PolyPid has the potential to secure an additional $19 million if warrants are exercised to fund NDA submission for D-PLEX100.
What were the net losses for the three months ended December 31, 2023?
For the three months ended December 31, 2023, the net loss was $6.4 million.
What were the net losses for the full year ended December 31, 2023?
For the full year ended December 31, 2023, the net loss was $23.9 million.
How much cash and cash equivalents did PolyPid have as of December 31, 2023?
PolyPid had cash and cash equivalents of $5.3 million as of December 31, 2023.
