Xenia - Polypid - Update

מ"עב לטיפק ר'צנו הינסק

)"הרבחה"(

2021 רבמבונב 11
דובכל	דובכל
א"תב ךרע תוריינל הסרובה	ךרע תוריינ תושר
www.tase.co.il	www.isa.gov.il

ישילשה ןועברל תויפסכ תואצות לע חוויד - )"דיפילופ" :ןלהל( מ"עב דיפילופ:עוריאה תוהמ

2021 תנשל

,2021 תנש לש ישילשה ןועברל תויפסכה היתואצות תא המסרפ דיפילופ יכ חוודל תדבכתמ הרבחה :םינותנה ירקיע ןלהל .התוליעפ יבגל עדימ ןכו )"חודה תפוקת"(

:2021 רבמטפסב 30 םויב ומייתסהש םישדוח השולשל תויפסכה תואצותה

הפוקתב רלוד ןוילימ 6.5 לש ךסב יקנ דספהל האוושהב ,רלוד ןוילימ 9.9 לש ךסב יקנ דספה	•
.דקתשא הליבקמה
רלוד ןוילימ 4.2 לש ךסב פ"ומ תואצוהל האוושהב ,רלוד ןוילימ 7.5 לש ךסב פ"ומ תואצוה	•

• ו ,SHILD I םייוסינהמ האצותכ העבנ חודה תפוקתב היילעה .דקתשא הליבקמה הפוקתב
  .תישילשה הזאפב SHILD II

ךסב תויללכו הלהנה תואצוהל האוושהב ,רלוד ןוילימ 2.1 לש ךסב תויללכו הלהנה תואצוה	•
.דקתשא הליבקמה הפוקתב רלוד ןוילימ 2.2 לש
:2021 רבמטפסב 30 םויב ומייתסהש םישדוח העשתל תויפסכה תואצותה
רלוד ןוילימ 31.4 לש ךסב יקנ דספהל האוושהב ,רלוד ןוילימ 29.1 לש ךסב יקנ דספה	•
.דקתשא הליבקמה הפוקתב
ןוילימ 11.9 לש ךסב פ"ומ תואצוהל האוושהב ,רלוד ןוילימ 20.9 לש ךסב פ"ומ תואצוה	•
SHILD םייוסינהמ האצותכ העבנ חודה תפוקתב היילעה .דקתשא הליבקמה הפוקתב רלוד
.תישילשה הזאפב SHILD II - ו ,I
ךסב תויללכו הלהנה תואצוהל האוושהב ,רלוד ןוילימ 6.7 לש ךסב תויללכו הלהנה תואצוה	•
האצותכ העבנ תיחכונה הפוקתב היילעה .דקתשא הליבקמה הפוקתב רלוד ןוילימ 5.5 לש
.תירוביצ הרבח דיפילופ לש התויהמ האצותכ םירוטקריד חוטיב לש תויולעמ

:םינמוזמ תורתילש ךורא ןמזלו רצק ןמזל תונודקיפ ,םינמוזמ הוושו םינמוזמה תרתי 2021 רבמטפסב 30 םויל ןוכנ 31 םויב רלוד ןוילימ 67 לש ךסב תורתיל האוושהב ,רלוד ןוילימ 42 לש ךס לע הדמע דיפילופ

.2020 רבמצדב

.2022 תנש ףוסל דע הלש תוליעפה ןומימ תא רשפאת הלש םינמוזמה תרתי יכ הכירעמ דיפילופ :דיפילופ תוליעפ לע יתיצמת עדימ

480 - כ וסיוג הכ דעו ,ןנכותמכ םדקתמ תישילשה הזאפב SHILD I יוסינב םילוחה סויג	•
.םילוח
יושע )SHILD I( תישילשה הזאפה בלשב דחא רקחמש ךכל FDA -ה תויושר תמכסה רואל	•
,סגה יעמה יחותינב םימוהיז תעינמל D-PLEX100 - ה רצומל רושיא תלבקל קיפסהל
.םילוח 900 - כ ,ןנכותש םילוחה חווטב יברימה םילוחה רפסמ תא סייגל תנווכתמ דיפילופ
,2022 תנש לש ינשה ןועברב סייוגמ תויהל יופצ SHILD יוסינב ןורחאה לפוטמה	•
.ןכמ רחאל םיישדוחכ לבקתהל תורומא תואצותהו
מ הלעמל וסיוג הכ דעו ,ןנכותמכ םדקתמ תישילשה הזאפב SHILD II יוסינב םילוחה סויג	•
.םילוח 130 -
םדקל הנווכב FDA - ה תויושר םע המידקמ החיש ,שדוחה ךלהמב ,םייקל היופצ דיפילופ	•
.2022 תנש ךלהמב הלש יגולוקנואה רצומב הנושאר הזאפב יוסינ תליחת

תרשפאמ רשא PLEX םשב תופורת תלבוה תיגולונכט תחתפמ דיפילופ ,הרבחה תעידי בטימל אוה דיפילופ לש לגדה רצומ .ןמז ךרואל םיליעי הפורת ינונימ לש רקובמו ההשומ ,ימוקמ רורחש םימוהיז עונמל ידכב ,הקיטויביטנא לש ןמז ךרואלו רקובמ רורחש רשפאמ רשא ,D-PLEX100 לש תישילשה הזאפה בלשב תואצמנ D-PLEX100 לש תויצקילפאה יתש .ןטבו הזח יחותינ רחאלש

.ינילקה רקחמה םויב םסרופש הרבחה לש יתפוקתה חודל 'א קרפל 9.3 ףיעס ואר ,דיפילופ תודוא םיפסונ םיטרפל

.)הינפהה ךרד לע הללכה הווהמ הז עדימ( 2021-01-048501 אתכמסא 'סמ ,2021 ץרמב 26

.NASDAQ -ה רתאב דיפילופ המסרפש חווידה ,הז חווידל ב"צמ

,בר דובכב

מ"עב לטיפק ר'צנו הינסק

םיפסכ ל"כנמסו ל"כנמ ,ןוזרוס ילא :תועצמאב

PolyPid Ltd. Reports Third Quarter 2021 Financial Results and Provides Corporate Update

Recruitment Progressing as Planned with Approximately 480 Patients Enrolled in Phase 3 SHIELD I Trial of D-PLEX100 in Abdominal Surgery

Following FDA Agreement that a Single Pivotal Phase 3 Study is Sufficient for Potential Approval of D-PLEX100 for the Prevention of Surgical Site Infections in Colorectal Surgery, Company Intends to Target Higher End of Patient Enrollment Range in SHIELD I to Leverage Key Clinical, Commercial and Financial Benefits

Company's Cash Runway Extends to Year-End 2022, ahead of Prior Forecast of Q2 2022

Conference Call Scheduled for Today at 8:30 AM ET

PETACH TIKVA, Israel, November 10, 2021 -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a phase 3 biopharmaceutical company focusing on developing targeted, locally administered, and prolonged-release therapeutics to improve surgical outcomes, today provided a corporate update and reported financial results for the three and nine months ended September 30, 2021.

Recent Corporate Highlights:

• Recruitment progressing as planned with approximately 480 patients enrolled in the ongoing Phase 3 SHIELD I study.
• Following an agreement with the U.S. Food and Drug Administration (FDA) that a single pivotal Phase 3 study is sufficient, provided the study results are adequate, for potential approval of D-PLEX100 for the prevention of SSIs in colorectal surgery, the Company determined that it is in the best interests of the development program to target the higher end of its planned patient enrollment range in SHIELD I.
• Targeting approximately 900 patients for enrollment in SHIELD I is not expected to modify D-PLEX100 NDA submission timelines and will help ensure that the study is well powered and will provide additional data that will potentially be used to further demonstrate the medical and health economic benefits of D-PLEX100.
• FDA agreement that a single pivotal Phase 3 study is sufficient for potential approval will extend PolyPid's cash runway to year end 2022.
• Last-patient-infrom SHIELD I is expected to enroll during the second quarter of 2022 with top line results 2 months thereafter.
• Patient enrollment is also advancing as anticipated in SHIELD II, the second Phase 3 clinical trials for D-PLEX100 in abdominal surgery (soft tissue), with over 130 patients enrolled to date. SHIELD II has broader eligibility criteria than SHIELD I, including minimally invasive surgical procedures.

• Positive preclinical data from Company's intra-tumoral OncoPLEX cancer therapy program in two animal models of Glioblastoma Multiform (GBM) showed that single local treatment of OncoPLEX significantly inhibited tumor growth and prolonged survival. The Company will conduct a Pre-IND meeting with the FDA later this month to potentially initiate a Phase 1/2 clinical trial of OncoPLEX in GBM in 2022.

"We continue to expeditiously advance our multiple development programs, as well as our commercial preparations," said Amir Weisberg, PolyPid's Chief Executive Officer. "Most importantly, the pace of enrollment in the SHIELD I trial has continued to increase over the last several months and we expect an even greater acceleration in the months ahead. Having now passed the mid-point in our planned enrollment for SHIELD I, and with over 600 patients now enrolled in both SHIELD I and SHIELD II studies combined, we are well-positioned to leverage the expected clinical, commercial and financial benefits of targeting the higher end of our patient enrollment range for SHIELD I. Additionally, we are having ongoing discussions with commercialization partners in the United States, Europe and Asia, based upon the anticipated data from our Phase 3 trial in 2022."

"We continue to be excited about the compelling preclinical data being generated by our promising OncoPLEX development platform initially targeting brain tumors. The most recent results further support our work toward the completion of a preclinical package for the filing of an Investigative New Drug application with the FDA to potentially initiate a Phase 1/2 clinical trial. We look forward to meeting with the Agency later this month to discuss the clinical and non- clinical development plan for OncoPLEX in GBM," continued Mr. Weisberg.

"In addition, we are progressing our robust clinical development program from a position of financial strength. Our cash runway now extends to year-end 2022, a significant improvement over our prior target of the second quarter of 2022. We continue to have sufficient cash resources to complete the SHIELD I study, prepare for the submission of a New Drug Application to the FDA and further advance our OncoPLEX program," concluded Mr. Weisberg.

Financial results for the three months ended September 30, 2021

Research and development expenses for the three months ended September 30, 2021 were $7.5 million, compared to $4.2 million in the same three-month period of 2020, as expenses increased due to the ongoing SHIELD I and SHIELD II Phase 3 clinical trials in abdominal surgery.

Marketing and business development expenses for the three months ended September 30, 2021 were $0.4 million, compared to $0.3 million for the same period in 2020, as expenses increased primarily due to an increase in marketing and business development personnel hired in the Company's New Jersey offices.

General and administrative expenses for the three months ended September 30, 2021 were $2.1 million, consistent with $2.2 million in the prior year period. The decrease was due to lower non-cashshare-based compensation expenses.

For the three months ended September 30, 2021, the Company had a net loss attributable to ordinary shares of $9.9 million, compared to a net loss of $6.5 million in the three-month period ended September 30, 2020.

As of September 30, 2021, the Company had cash, cash equivalents, short-term deposits, and long-term deposits in the amount of $42.0 million, compared to $67.0 million at December 31, 2020. PolyPid expects that its cash on hand will be sufficient to fund operations until the end of 2022.

Financial results for the nine months ended September 30, 2021

Research and development expenses for the nine months ended September 30, 2021 were $20.9 million, compared to $11.9 million in the same nine-month period of 2020, as expenses increased due to the ongoing SHIELD I and SHIELD II Phase 3 clinical trials in abdominal surgery.

Marketing and business development expenses for the nine months ended September 30, 2021 were $1.8 million, compared to $0.9 million for the same period of 2020. These expenses increased primarily due to an increase in marketing and business development personnel hired in the Company's New Jersey offices.

General and administrative expenses for the nine months ended September 30, 2021 were $6.7 million, compared to $5.5 million in the prior year period. The increase in general and administrative expenses was due to the increase in costs associated with the Company's status as a publicly traded company with higher D&O insurance costs.

For the nine months ended September 30, 2021, the Company had a net loss attributable to ordinary shares of $29.1 million, as compared to a net loss of $31.4 million in the nine months ended September 30, 2020.

Conference Call Dial-In & Webcast Information:

Date:	Wednesday, November 10, 2021
Time:	8:30 AM Eastern Time
United States:	[phone]
Israel:	[phone]