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 completion of enrollment announced January 18, 2017. Data due early 2Q 2017. April 15, 2017 noted as last possible date given guidance of "early 2Q".

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
Adult patients with facioscapulohumeral muscular dystrophy (FSHD)

Phase 1/2 Data from first four patients released December 13, 2016.

LIFE
Resolaris
Limb girdle muscular dystrophy (LGMD) 2B

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 to be completed early 2017. Safety data readout due 2H 2017.

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

Phase 2 Phase 2 final readout due mid 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 due 1H 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.