LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve

Inclusion Criteria:

BCG-unresponsive Patients:

1. BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without coexistingpapillary Ta/T1 tumors who are ineligible for or have elected not to undergocystectomy, and have experienced CIS disease within 12 months of treatment where:adequate BCG regimen consists of at least 2 courses of BCG where the first course (induction) must have included at least 5 or 6 doses and the second course may haveincluded a re-induction (at least 2 treatments) or maintenance (at least 2 doses),and Cis must be documented or indicated by pathology Phase 2 Only:

2. BCG-Naïve or BCG-incompletely treated Patients with CIS or BCG-unresponsive, HGTa/T1 papillary disease without CIS:

-NMIBC with current Cis of the bladder, with or without coexisting papillary Ta/T1NMIBC tumor(s), who are ineligible for or have elected not to undergo cystectomy,where: either: cohort 2a) no treatment with BCG but may have previously been treatedwith at least 1 dose of intravesical chemotherapy following transurethral resectionof bladder tumor (TURBT) and Cis must be documented or cohort 2b) indicated bypathology incomplete BCG treatment (at least 1 dose and less than the 5+2 dosesrequired for adequate dosing per Cohort 1) or cohort 3) patients who areBCG-unresponsive following adequate treatment, with HG Ta/T1 papillary diseasewithout CIS. All Patients:

3. Patients who have previously been treated with a checkpoint inhibitor and failedtreatment are eligible for inclusion 30 days post-treatment (Phase 1) or 3 monthspost-treatment (Phase 2).

4. Male or non-pregnant, non-lactating female, 18 years or older.

5. Women of childbearing potential must have a negative pregnancy test at Screening.

6. Female patients of childbearing potential must be willing to consent to using highlyeffective birth control methods; Male patients are required to utilize a condom forthe duration of the study treatment through 3 months post-dose.

7. In Phase 2, for patients with T1 lesions may be eligible after repeat TURBT ifpathology shows non-invasive (Ta or less) or no disease.

8. Performance Status: Eastern Cooperative Oncology Group 0, 1, and 2.

9. Hematologic inclusion: a. Absolute neutrophil count >1,500/mm3. b. Hemoglobin >9.0g/dL. c. Platelet count >100,000/mm3.

10. Hepatic inclusion: a. Total bilirubin must be ≤1.5 x the upper limit of normal (ULN). b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) andalkaline phosphatase ≤2.5 x ULN.

11. Adequate renal function with creatinine clearance >30 mL/min

12. Prothrombin time and partial thromboplastin time ≤1.25 x ULN or within thetherapeutic range if on anticoagulation therapy.

13. Must have satisfactory bladder function with ability to retain study drug for 60minutes.

Exclusion Criteria:

1. Active malignancies (i.e., progressing or requiring treatment change in the last 24months). Exceptions allowed under Sponsor review.

2. Concurrent treatment with any chemotherapeutic agent.

3. History of partial cystectomy.

4. Treatment with last therapeutic agent (including intravesical chemotherapypost-TURBT) within 30 days of Screening (prior to the screening biopsy).

5. Patients who have received systemic immunosuppressive medication including high-dosecorticosteroids.

6. History of severe asthma or other respiratory diseases.

7. History of unresolved vesicoureteral reflux or an indwelling urinary stent.

8. History of unresolved hydronephrosis due to ureteral obstruction.

9. Participation in any other research protocol involving administration of aninvestigational agent within 30 Days prior to screening or any prior treatment ofNMIBC with any investigational gene or immunotherapy agent.

10. History of external beam radiation to the pelvis or prostate brachytherapy withinthe last 12 months.

11. History of interstitial lung disease and/or pneumonitis in patients who havepreviously received a PD-1 or PD-L1 inhibitor therapy.

12. Evidence of metastatic disease.

13. History of difficult catheterization that in the opinion of the Investigator willprevent administration of EG-70.

14. Active interstitial cystitis on cystoscopy or biopsy.

15. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemictherapy.

16. Known human immunodeficiency virus, Hepatitis B, or Hepatitis C infection.

17. Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardialinfarction within 6 months).

18. Hypersensitivity to any of the excipients of the study drug.