BPC December 13 update

Proteon shares tumble 75% as another biotech reports disappointing data

Price and Volume Movers

Achaogen, Inc. (NASDAQ:AKAO), which on Monday saw its shares soar over 148%, continued with its surge on Tuesday, with shares closing up 14% on 18x average volume. The company announced yesterday positive data from both its CARE and EPIC Phase 3 trials of plazomicin. Achaogen plans to submit a New Drug Application (NDA) in 2H 2017.

Proteon Therapeutics, Inc. (Nasdaq:PRTO) shares tumbled 75% on 93x average volume following its release that its first Phase 3 trial of vonapanitase (PATENCY-1) did not meet its primary endpoint of improved primary unassisted patency compared to placebo (p=0.254). Enrollment in its second Phase 3 trial, PATENCY-2, is due to be completed in 1Q 2017, with top-line data due 2Q 2018.

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that its Phase 2b trial of Clonidine Topical Gel for the management of painful diabetic neuropathy did not meet the primary endpoint. As a result, BDSI is discontinuing further development of the product. Shares closed down 2.5% of being down 15% at the opening of today’s session.

Soligenix, Inc. (Nasdaq: SNGX) announced today the pricing of its public offering of 1,670,000 shares and warrants to purchase up to 2,087,500 shares at a combined offering price of $3.16 for gross proceeds of approximately $5,277,200. The company began trading on The Nasdaq Capital Market under the ticker "SNGX" on December 13, 2016. Shares closed down 34%.

Recro Pharma, Inc. (Nasdaq:REPH) also announced the pricing of its offering of 6.5m shares of at a price of $6 per share for net proceeds of $35.9m. After opening lower, shares closed up 9%.

CytRx Corporation (NASDAQ: CYTR) another company to raise cash, announced that it will offer shares at a price of $0.42 per share with gross proceeds of $8.1m. Shares of the company dropped 17% on 3.5x average volume.

Other price movers (+10%):

ADVANCERS:

Sunshine Heart Inc (NASDAQ:SSH): +53%; 6x average volume.

Northwest Biotherapeutics, Inc (NASDAQ:NWBO): +11%; 3x average volume.

Abeona Therapeutics Inc (NASDAQ:ABEO): +10%; 2x average volume.

Cerecor Inc (NASDAQ:CERC): +10%; 13x average volume.


DECLINERS:

aTyr Pharma Inc (NASDAQ:LIFE): -23%; 6x average volume.

Apricus Biosciences Inc (NASDAQ:APRI): -20%; 9x average volume.

Atossa Genetics Inc (NASDAQ:ATOS): -11%.

Fibrocell Science Inc (NASDAQ:FCSC): - 13%; 4x average volume.

Peregrine Pharmaceuticals (NASDAQ:PPHM): -12%; 2x average volume.


Full pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

PRTO
Vonapanitase (PRT-201) PATENCY-2
Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)

Phase 3 Phase 3 enrollment to be completed 4Q 2017. Data due 4Q 2018.

PRTO
Vonapanitase (PRT-201) PATENCY-1
Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)

Phase 3 Phase 3 data released December 13, 2016 - primary endpoint not met.

BDSI
Clonidine gel
Painful diabetic neuropathy (PDN)

Phase 2b Phase 2b data released December 13, 2016 - primary endpoints not met.

ACRX
ARX-04 (SAP303)
Moderate-to-severe acute pain following a surgical procedure

PDUFA PDUFA date October 12, 2017. Advisory Committee meeting planned.

PRTK
Omadacycline
Community-acquired bacterial pneumonia (CABP)

Phase 3 Phase 3 data released April 3, 2017 - all endpoints met.

DMTX
DTX101
Ornithine Transcarbamylase (OTC) Deficiency

Phase 1/2 Phase 1/2 trial initiated December 2016. Initial data due 2H 2017.

MGNX
Margetuximab SOPHIA study
Metastatic breast cancer

Phase 3 Phase 3 enrolling. Enrollment of trial to be completed by end of 2018.

LIFE
Resolaris
Limb girdle muscular dystrophy (LGMD) 2B / Adult patients with facioscapulohumeral muscular dystrophy (FSHD)

Phase 1/2 Phase 1b/2 data released December 13, 2016.

SCYX
Intravenous SCY-078

Phase 1 Clinical hold placed on the initiation of intravenous (IV) SCY-078 until the FDA completes a review of all data. Clinical hold follows three mild-to-moderate thrombotic events in healthy volunteers - announced March 2, 2017. Meeting scheduled with FDA for 2Q 2017.

RDHL
RHB-104 MAP US
Crohn’s disease

Phase 3 Phase 3 DSMB safety analysis released December 13, 2016 - trial to continue as planned. Interim efficacy analysis due mid-2017.

RXII
RXI-109-1501
Retinal scarring

Phase 1/2 Phase 2 enrollment of first two cohorts has been completed. Third cohort ongoing.

RXII
RXI-109-1402
Connective tissue growth factor (CTGF)

Phase 2 Phase 2 final readout due 2H 2017.

RXII
Samcyprone - RXI-SCP-1502
Cutaneous warts

Phase 2 Phase 2 first cohort data due 2Q 2017. Full data due 2H 2017.

PRTK
Sarecycline
Severe acne vulgaris

Phase 3 Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.

SAGE
SAGE-217
Essential tremor

Phase 2 Announced that screening has opened for Phase 2a trial - December 13, 2016. Data due 2H 2017.

SAGE
SAGE-217
Parkinson’s disease (PD)

Phase 2 Phase 2 initiation announced December 13, 2016. Data from Part A of trial due 1H 2017.