PolyPid Ltd. (NASDAQ:PYPD) Q4 2023 Earnings Call Transcript
PolyPid Ltd. (NASDAQ:PYPD) Q4 2023 Earnings Call Transcript February 14, 2024
PolyPid Ltd. misses on earnings expectations. Reported EPS is $-3.97 EPS, expectations were $-2.17. PolyPid Ltd. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Greeting morning and welcome to the PolyPid Fourth Quarter and Full Year 2023 Conference Call. At this time, all participants are in a listen-only mode. As a reminder, this call is being recorded. And I would now like to introduce your host for today's conference, Brian Ritchie from LifeSci Advisors. Mr. Ritchie, you may begin.
Brian Ritchie: Thank you all for participating in PolyPid's fourth quarter and full year 2023 earnings conference call. Joining me on the call today will be Frank Laukien, Chief Executive Officer of PolyPid; Gerald Herman, PolyPid's Chief Financial Officer; and Gerald Herman, Chief Operating Officer of PolyPid. Earlier today, PolyPid released financial results for the 3 and 12 months ended December 31, 2023. A copy of the press release is available in the Investors section on the company's website, www.polypid.com. I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the federal securities laws. For example, management is making forward-looking statements when it discusses the expected timing for recruitment and top line results from the SHIELD II trial and of the unblinded interim analysis, the planned new drug application 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 subject to numerous risks and uncertainties and many of which are beyond our control, including the risks described from time to time in our SEC filings. Our results may differ materially from those projections. These statements involve material risks and uncertainties that could cause actual results or events to materially differ. Accordingly, you should not place undue reliance on these statements. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's Form 20-F, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. PolyPid disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.
This conference call contains time-sensitive information and speaks only as of the live broadcast today, February 14, 2024. With the completion of these prepared remarks, it is my pleasure to turn the call over to Dikla Czaczkes Akselbrad, CEO of PolyPid. Dikla?
Dikla Czaczkes Akselbrad: Thank you, Brian. On behalf of our team at PolyPid, I would like to welcome everyone, including our new shareholders to our fourth quarter and full year 2023 earnings call. We are thrilled with a significant progress recently achieved throughout our business. As we expected, enrollment in our ongoing SHIELD II pivotal trial for D-PLEX100 for the prevention of dominant colorectal surgical site infection has begun to ramp up. We have also generated some new highly compelling preclinical data with OncoPLEX that demonstrates its potential in oncology. 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.
I will discuss all of this in greater detail shortly but let's begin with the status of SHIELD II. The study has now enrolled more than 100 subjects and approximately 40 centers are currently open. As a reminder, we intend to conduct an unblinded interim analysis once approximately 400 patients of a planned total of 600 subjects complete the 30-day follow-up, which is expected to occur in mid-2024. Top line results are anticipated in the second half of this year. With respect to the expected recruitment rate, as we said on our last call, once the site is fully up and running, which takes several weeks following its being formally opened, we anticipate approximately 1.5 patients being recruited into the trial per center per month, and we expect to overall approximately 60 centers opened and recruiting patients.
Moving on, to reiterate what we have said previously, we have a clear regulatory pathway for the potential NDA submission for D-PLEX100 in the U.S. Last year, the FDA acknowledged not only that the SHIELD I result may provide supportive evidence of the safety and efficacy of D-PLEX100 in patients with large surgical incision, but also confirmed that if successful, SHIELD II is sufficient to support a potential NDA submission. We continue to strongly believe that SHIELD II is a derisked stage for each trial giving the more focused patient population in which we have already generated highly positive data in SHIELD I and the fact that it will not be conducted within the tight COVID-related restrictions that were in place during the pandemic and throughout the duration of SHIELD I, we are also leveraging key learnings from SHIELD I related to the sites involved in the study.
While we are targeting approximately 60 centers for SHIELD II around the same number as SHIELD I, we now have firm knowledge of the best-performing sites from SHIELD I in terms of recruitment, patient monitoring and good clinical practice. We believe this to be essential in the execution of SHIELD II. We have also enhanced our clinical operations team another key step towards supporting the successful study. Moving on, I'm excited to report today some new preclinical data generated with our OncoPLEX product candidate. We have recently demonstrated the ability of OncoPLEX to be injected intratumorally, while having effective and prolonged antitumor impact. A single intratumoral injection of OncoPLEX significantly reduced tumor growth and increased survival in 2 well-established and commonly used tumor animal models, murine melanoma and murine called carcinoma.
OncoPLEX has now shown a CTC in all models it has been tested and across the various therapeutic approaches. Hydro is a neoadjuvant via intratrial injection or is an adjuvant via post-resection application in the tumor bed. To date, OncoPLEX has been tested in 6 different models and applications, all with highly effective results. The effect of OncoPLEX is attributable to the PLEX Technologies' unique mechanism of action that allows constant and prolonged release of the therapy hemotherapytic drug, docetexia. The locality, combined with the prolonged and constant release rate can promote deep penetration of the drug into the tumor with minimal systemic exposure to the chemotherapeutic agent. The intratumoral injection of the PLEX platform could enable it to be used as an interventional oncology treatment not only with docetaxel, but also with additional chemotherapietics or other types of molecules, such as antibodies, the specifics and no clicks assets.
Shifting gears. We were pleased to recently significantly prodify our balance sheet by successfully closing a private placement financing or pipe for $16 million of gross proceeds. The pipe syndicate was comprised of new and existing investors, including participation from U.S. life science-focused investors, Dafna Capital Management and Roslin advancer. But due to the pipe, the investor purchased $3,371,312 of the company's ordinary share, all prefunded words in Lea thereof at a purchase price of $4.81 per share for gross proceeds of $16 million and received warrants to purchase up to the same amount of shares of common stock with an exercise price of $5.5 per share for rotor exercise price of $19 million. The warrants expired upon the earlier of 2 years from the date of issuance and 10 trading days following PolyPid's announcement of a positive recommendation by the data safety monitor Board regarding the company's unlined interim analysis in its SHIELD II Phase III trial of D-PLEX100 resulting in the stopping of the trial due to positive efficacy.
The initial $16 million extended our cash runway until late in the third quarters of 2024 and behind the anticipated timing of SHIELD II planned unlined interim analysis. If the result of the unblinded interim analysis are positive and all warrants issued in the financing are exercised, the additional $19 million would fund PolyPid to the start of the planned new drug application submission for D-PLEX100. I'd like to take the opportunity to thank all of the investors who participated in this financing for their confidence and support. With that, it is my pleasure to turn the call over to Jonny. Jonny?
Jonny Missulawin: Thank you, Dikla. As of December 31, 2023, the company had cash and short-term deposits of $5.3 million as compared to $12.6 million at the end of 2022. This does not include the net proceeds of approximately $15 million generated from the pipe financing closed in January 2024. As Dikla noted, we expect that our pro forma cash balance will be sufficient to fund operations into late third quarter of 2024. Now let's turn to our income statement. Research and development expenses for the 3 months ended December 31, 2023, were $4.6 million compared to $4.7 million in the same 3-month period of 2022. R&D expenses in the most recently completed fourth quarter were driven by the ramp-up of the ongoing SHIELD II Phase III trial.
For the full year ended December 31, 2023 and 2022, R&D expenses were $16.1 million and $28 million, respectively. Marketing and business development expenses for the fourth quarter of 2023 were $193,000 compared to $350,000 during the prior year period. General and administrative expenses for the fourth quarter of 2023 were $1.2 million compared to $1.6 million recorded in the same 3-month period of 2022. For the fourth quarter of 2023, the company had a net loss of $6.4 million as compared to $6.6 million in the fourth quarter of 2022. For calendar year 2023, the company had a net loss of $23.9 million compared to a loss of $39.6 million in the full year 2022. Finally, we continue to execute well on our cost containment initiatives. As such, our net cash used in operating activities for full year 2023 decreased by $17 million as compared to calendar year 2022 from $34.3 million to $17.3 million.
With that, we will now open the call to your questions. Operator?
See also Top 15 Electric Bike Brands According to Reddit and 30 Highest-Grossing Media Franchises of All Time.
To continue reading the Q&A session, please click here.
