To are of of recent everyone we behalf would with quarter we begin, I we a like our the the review in team submitted at call. FDA On have will to including for our you, revised later perspective, the welcome the From first thrilled business, our clinical earnings to feedback. my Thank II Brian. protocol our which throughout await PolyPid, strengthening I have remarks. achieved a progress and to balance sheet, XXXX significant their bit SHIELD
Assuming patients recruiting patients. approximately enrolled comments XX in II, agency, has begin from no date major to to expect be target the into very new to we position soon SHIELD a which
for a As reminder, we for the now a US. regulatory clear submission D-PLEXXXX have pathway the potential in NDA
recommended result could conduct Earlier also population and acknowledged to that support provide the submission the agency I SHIELD than efficacy II planned. the of FDA in SHIELD XX on D-PLEXXXX potential focus greater an centimeters. this a as confirmed safety may The patients additional study with evidence the and such incisions surgical NDA year, supportive company serve this of that patient
additional an total resumed expected said more. or Total SHIELD we to XX months II recruited be into subjects into our XXX the XXX intend we to call, what approximately time from reiterate the is approximately To study already recruit and on time a of patients the beyond we XX last recruitment patients II. SHIELD
Top are year. next mid line expected results
approximately sites on one in of SHIELD prepare II, SHIELD the unblinded resume recruiting as XX-day an I conduct to to plan interim the once key follow-up, XXX their patients also study. we involved complete the is analysis learnings We a total of from for
in performing believe knowledge we of site of monitoring clinical the good the While We number be in SHIELD recruitment, best of now have I we XX for SHIELD targeting patient same are essential around approximately II. practice. II, from centers terms and I, execution the firm SHIELD this SHIELD to
We successful the study. also clinical have another our supporting stream, towards operation step key enhanced
we made the I the SHIELD results, and in the terms endpoints. SHIELD I to study SHIELD the based to SHIELD II design is on of protocol modest II modifications trial primary similar have very secondary While of the
on combination the of standard intervention CDC will alone. index post in of as will arm endpoint XX defined the days rate primary reintervention trial subject SSI in the The Patients arm guidelines. SSI. and will the in receive and receive top be D-PLEXXXX of control standard at mortality care care surgery of a of
will place for will an the take monitored additional study be XX days. Europe the safety Israel. Patient in and And U.S.
we focused emphasize in patient generated data a SHIELD II previously, giving said in population entry that have I like we as which trial would highly positive de-risked I. SHIELD As we already view more to the have
the be during will in pandemic of within restrictions not tight COVID were that it I. And that the conducted the the related throughout fact SHIELD and place duration
noted ago, moment key study. as leveraging In I learnings addition, I a we are SHIELD from the
in feedback the D Agency meeting Advice from was Products following we National the Swedish Type that a Medical Swedish In the MPA line in with from or Europe, recently FDA the Scientific received Meeting. feedback we received
additional the support MAA Swedish submission. result X company patients evidence the study supportive that that large Specifically, recommended in Phase an the acknowledged provide FDA, with confirm MPA similar incision the surgical may to I to results with the and SHIELD an
safety solution. data MPA sufficient an for obtained to-date MAA also noted clinical Swedish The that is
Advance we with the strategy our including European Importantly, our regulatory for Swedish this to the with and recent aligned Pharma, closely fully development work on partner preparation surrounding the to with region, the MPA. pathway continue meetings are respect European
packaging in validation I should few next process to add months. complete we D-PLEXXXX that expect manufacturing the the commercial for and
NDA CMC continue top support results. to to well line data needed preclinical submission in advance the expect an have the of and We to
completed a of to quarter our series first our late transaction, further strength, we regard the position. financial financial In in financial solidify to
certain full with existing on warrants a public total additional closed shareholders option concurrent the of underwritten for a, shares proceeds of $XX.X First, ordinary that approximately offering purchase the an underwriters' placement million. to gross we included, exercise pre-funded and private of
with secured our Kreos in $X from with timing restructured in the August expected of line will we SHIELD over results resulting top be Capital, agreement repayments from XXXX addition, million of line paid deferred II. loan which our onwards, In existing
The transactions, the late-QX proceeds cash the financing with extend deferred our combined next into of runway loan from repayment year.
number anticipate further ahead, compelling our Looking balance II having financing XXXX additional to opportunities, we sheet to of a to completion. in enhance SHIELD fund order a in successful later
who are as public the we said, shareholders the by that offering. in new shown March participated our institutional, With grateful as continued support for well investors our largest
we to Moving development initiatives. continue our business on, also advance
As a reminder we are two key areas. on focused
strong in D-PLEXXXX additional for targeting geographies U.S. like are we different the partners and First, Asia.
in becoming oncology. as in collaboration areas nature, platform-related such more focused specific are therapeutic PLEX pursuing are we Second, that,
As is formalize we in pace planned XXXX, difficult two our although, objective partnership discussions last said our on exact predict. to of inherently call, is the to partnerships
it turn the is pleasure to that, financials. my call Jonny, over our With to to review Jonny? current
