BPC April 02 update

Sangamo SGMO shares rally 29% on hemophilia data; Evoke EVOK issued CRL -47%; ADMA FDA Approval +24%

Price and Volume Movers

Sangamo Therapeutics, Inc. (NASDAQ: SGMO) shares rallied to close up 29% to $12.29 following promising interim data from the Phase 1/2 Alta trial evaluating SB-525 gene therapy for severe hemophilia A. While the data are preliminary and covering only two patients, those dosed demonstrated Factor III levels of 140% and 94% of normal (as measured by one-stage clotting assay) and 93% and 65% (as measured by chromogenic assay).

ADMA Biologics, Inc. (NASDAQ: ADMA) announced late yesterday evening, around the close of the after-hours session, that the FDA approved Asceniv (RI-002) for the treatment of Primary Humoral Immunodeficiency Disease. Shares closed up 24% to $5.06 after opening at $6.26.

Evoke Pharma, Inc. (NASDAQ: EVOK) shares slid to close down 47% to $0.90 following news it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Gimoti for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. The company said the CRL noted issues related to clinical pharmacology and product quality/device quality.

Can-Fite BioPharma Ltd.(NYSE American: CANF) shares closed down 26% to $0.63 on news it will issue 4,923,078 registered American Depository Shares (ADSs) at a purchase price of $0.65 per ADS, for gross proceeds of approximately $3.2m. Additionally, unregistered warrants to purchase one ADS, with an exercise price of $0.86 per ADS, are attached to the offering.

Advaxis, Inc. (Nasdaq: ADXS) shares are trading down 17% after hours to $4.87, adding to its 9% loss during normal trading hours. The company announced that it intends to offer shares of its common stock in an underwritten public offering.

-

Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume

ADVANCERS:

AVEO Pharmaceuticals, Inc. (AVEO): $1.58; +42%.

EDAP TMS S.A. (EDAP): $4.25; +42%.

Zynerba Pharmaceuticals, Inc. (ZYNE): $6.48; +20%.

Conatus Pharmaceuticals Inc. (CNAT): $1.36; +17%.

TRACON Pharmaceuticals, Inc. (TCON): $1.70; +16%.

DECLINERS:

NewLink Genetics Corporation (NLNK): $1.76; -14%.

TrovaGene, Inc. (TROV): $4.12; -13%.

Akebia Therapeutics, Inc. (AKBA): $7.00; -13%.

Pulmatrix, Inc. (PULM): $2.02; -13%.

Ironwood Pharmaceuticals, Inc. (IRWD): $12.31; -12%.


Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADMA – ADMA Biologics Inc
RI-002
Primary Immune Deficiency Diseases

Approved FDA Approval announced April 1, 2019.
$245 million

ALDX – Aldeyra Therapeutics Inc.
ADX-102 - topical ocular reproxalap - RENEW
Dry eye syndrome

Phase 3 Phase 3 initiation announced April 2, 2019.
$157 million

CBIO – Catalyst Biosciences Inc.
Dalcinonacog alfa – DalcA
Hemophilia B

Phase 2b Phase 2b data due 4Q 2019.
$103.1 million

CLVS – Clovis Oncology Inc.
Rucaparib
Platinum-sensitive pancreatic cancer

Phase 2 Phase 2 data presented at AACR April 2019. PFS 9.1 months.
$718.1 million

CTMX – CytomX Therapeutics Inc.
CX-2009 - PROCLAIM
Solid tumors

Phase 2 Phase 1/2 updated data at AACR April 2, 2019. 7/71 partial responses.
$536.9 million

EVOK – Evoke Pharma Inc.
Gimoti - EVK-001
Female diabetic gastroparesis

NDA Filing CRL issued April 2, 2019. Meeting with FDA regarding NDA resubmission potentially to be held around July 26, 2019.
$24.7 million

IDRA – Idera Pharmaceuticals Inc.
Tilsotolimod - ILLUMINATE 101
Solid tumors

Phase 1 Phase 1b data at AACR April 2019 noted 45% disease control rate.
$70.3 million

IOVA – Iovance Biotherapeutics Inc.
LN-144 - lifileucel
Refractory metastatic melanoma

BLA Filing Phase 2 updated data noted ORR 38 percent (2 CRS; 23 PRs). BLA filing due 2H 2020.
$3 billion

JNCE – Jounce Therapeutics Inc.
JTX-2011
Solid tumors - Cancer

Phase 1/2 Phase 1/2 data at AACR - PFS: median 6.2 months for patients with ICOS hi CD4 T cells.
$144.1 million

MTNB – Matinas Biopharma Holdings Inc.
MAT9001
Severe hypertriglyceridemia

Phase 1 28-day comparative bridging toxicology trial to commence 2Q 2019.
$123.1 million

MTNB – Matinas Biopharma Holdings Inc.
Cryptococcal meningitis
Cryptococcal meningitis

Phase 2 Phase 2 trial to be initiated 2H 2019.
$123.1 million

NLNK – NewLink Genetics Corporation
NLG207 (CRLX101) and paclitaxel
Platinum-resistant ovarian cancer

Phase 2 Phase 2 data presented at AACR April 2, 2019. ORR 27%.
$54.1 million

OCUL – Ocular Therapeutix Inc.
DEXTENZA
Post-surgical ocular inflammation and pain

Approved FDA Approval June 21, 2019.
$232.6 million

SGMO – Sangamo Therapeutics Inc.
SB-913 - CHAMPIONS
MPS Type 2

Phase 1/2 Phase 1/2 updates during 2019.
$1.4 billion

SGMO – Sangamo Therapeutics Inc.
ST-400
beta-thalassemia

Phase 1/2 Phase 1/2 further data due 4Q 2019.
$1.4 billion

SGMO – Sangamo Therapeutics Inc.
SB-525
Hemophilia A

Phase 1/2 Phase 1/2 data due presented ISTH July 5, 2019 noted first two patients achieved normal, sustained Factor VIII levels.
$1.4 billion

TORC – resTORbio Inc.
RTB101
Parkinson's disease

Phase 2 Phase 2 data due 2020.
$371.4 million

TROV – TrovaGene Inc.
Onvansertib (PCM-075) and Zytiga
Prostate cancer

Phase 2 Phase 1/2 presentation at ESMO September 27, 2019.
$11.5 million