Upcoming Milestones

CD38 CAR-T

  • 1H18 = IND filing
  • 1H18 = Phase 1 and First in Human

ZTlido™ (lidocaine topical system) 1.8%

  • 1Q18 = PDUFA (02/28/18)

RTX (resiniferatoxin)

  • 1Q18 Phase 1 intractable cancer pain (epidural) First in Human
  • 1Q18 IND filing (Phase 1) and 2Q18 (First in Human) for osteoarthritis pain (intra-articular)

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%*

Seprehvir® (Solid Tumors)

75%*

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

ZTlido (lidocaine topical system) 1.8% 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%*

RTX (resiniferatoxin) – moderate to severe osteoarthritis pain – intra-articular 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*

Seprehvir®(Solid Tumors) Ph 1*

Key Program Phase
Pain Management

ZTlido (lidocaine topical system) 1.8% 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*

RTX (resiniferatoxin) – moderate to severe osteoarthritis pain – intra-articular 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.