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| Statement |
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| 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 |
| We remain highly confident in our long-term prospects especially the potential of our promising late-stage product candidate, D-PLEX100 |
| And we were very pleased with the results as they repeated also the similar results that we saw as an adjuvant |
| The level of the company that are discussing and showing interest in our approach is encouraging |
| We are thrilled with a significant progress recently achieved throughout our business |
| Finally, we continue to execute well on our cost containment initiatives |
| As always, we are grateful to our team members, existing and new shareholders in all our external partners for their commitment to our mission and their support in continuing to advance towards our goal of bringing D-PLEX100 to healthcare providers and patients as quickly as possible |
| Obviously, the timing of -- the maturity of this discussion is something that we cannot predict and cannot discuss, but we are very pleased with the kind of companies that are discussing with us |
| We have also enhanced our clinical operations team another key step towards supporting the successful study |
| 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 |
| We have also generated some new highly compelling preclinical data with OncoPLEX that demonstrates its potential in oncology |
| 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 |
| 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 |
| We have recently demonstrated the ability of OncoPLEX to be injected intratumorally, while having effective and prolonged antitumor impact |
| 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 |
| Moving on, I'm excited to report today some new preclinical data generated with our OncoPLEX product candidate |
| 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 |
| Boobalan Pachaiyappan And then you mentioned about positive preclinical data in melanoma and colon carcinoma animal models |
| 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 |
| So the idea was here to expand our preclinical data into a naroadjuvant approach in a fast-growing sales model |
| To date, OncoPLEX has been tested in 6 different models and applications, all with highly effective results |
| 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 |
| Statement |
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| So things are progressing and we started to see -- we obviously had some slowdown around end of the year, beginning of the year due to the holidays and the winter break |
| 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 |
| 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 |
| I can tell you that at the end of the day, in SHIELD I, the alpha on the interim was very, very minimal |
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