Upcoming Milestones

Immuno-Oncology Platform

  • IND Filing CD38 CAR-T (Phase I): 2H17
  • IND Filing CD38 ADC (Phase I): 2018

Pain Management Platform

  • FDA Review of ZTlido completed submission: 1Q18
  • Phase IB completion RTX intractable cancer pain trials (resiniferatoxin): 2Q18

Pipeline

Portfolio Key Program IND Enabling Phase 1 Phase 2 Phase 3 BLA/NDA Submission
Immuno-Oncology

CD38 CAR-T (Multiple Myeloma)

50%*

CEA CAR-T (Metastatic Liver Tumors)

75%*

CD38 ADC

50%*

PD-L1

25%

Seprehvir® (Solid Tumors)

75%*

Combination Therapies (synergistic potential under evaluation)

25%

Portfolio Key Program IND Enabling Phase 1 Phase 2 Phase 3 NDA Submission
Pain Management

ZTlido™ (1.8% lidocaine patch) relief of pain associated with PHN

100%

RTX (resiniferatoxin) – terminal cancer pain – intrathecal route (NIH)

40%

RTX (resiniferatoxin) – terminal cancer pain – epidural route (SRNE)

40%*

Portfolio Key Program IND Enabling Phase 1 Phase 2 Phase 3 NDA Submission
Ark Animal Health

Neuroclastin™ (resiniferatoxin) – epidural – canine bone cancer pain

80%*

Neuroclastin™ (resiniferatoxin) – articular – canine osteoarthritis pain

60%*

Key Program Phase
Immuno-Oncology

CD38 CAR-T (Multiple Myeloma) IND Enabling*

CEA CAR-T (Metastatic Liver Tumors) Ph 1*

CD38 ADC IND Enabling*

PD-L1 IND Enabling

Seprehvir®(Solid Tumors) Ph 1*

Combination therapies (synergistic potential under evaluation) IND Enabling

Key Program Phase
Pain Management

ZTlido™ (1.8% lidocaine patch) relief of pain associated with PHN NDA Sub-mission

>

RTX (resiniferatoxin) – terminal cancer pain – intrathecal route (NIH) Ph 1

RTX (resiniferatoxin) – terminal cancer pain – epidural route (SRNE) IND Enabling*

Key Program Phase
Ark Animal Health

Neuroclastin™ (resiniferatoxin) – epidural – canine bone cancer pain Ph 2*

Neuroclastin™ (resiniferatoxin) – articular – canine osteoarthritis pain Ph 1*

*
* Program ready to move to next phase. No additional studies required at this point.