BPC November 13 update

​Marker Therapeutics MRKR shares lower following clinical hold; Offerings DFFN KDMN LPCN PHIO

Price and Volume Movers

Marker Therapeutics (Nasdaq:MRKR) shares closed Wednesday down 25% to $2.93. The company announced in its earnings release that its planned Phase 2 trial of Marker AML in post-allogeneic hematopoietic stem cell transplant patients with acute myeloid leukemia, has been placed on clinical hold in both the adjuvant and active disease setting until response to manufacturing questions from the FDA have been made. The company also noted it will be suspending its Phase 2 trial of TPIV200 in patients with platinum-sensitive advanced ovarian cancer due to insufficient efficacy.

GlaxoSmithKline plc (NYSE: GSK) announced that its Phase 3 trial of Nucala (mepolizumab) in the treatment of patients living with Hypereosinophilic Syndrome (HES), met its primary endpoint, demonstrating a statistically significant result with 50% fewer patients experiencing a HES flare when treated with mepolizumab, compared to placebo (56% vs 28%; p=0.002).

Clovis Oncology, Inc. (NASDAQ:CLVS) announced that the Italian Medicines Agency (AIFA) has approved rucaparib for reimbursement in Italy. Shares closed up 20% to $6.55.

Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) shares closed down 53% to $0.25 on news of a public offering of 11,428,572 shares together with accompanying common warrants, at a public offering price of $0.35 per share and associated warrants for gross proceeds of $4m.

Lipocine Inc. (NASDAQ:LPCN) also announced a public offering of units consisting of shares of its common stock and warrants to purchase its common stock. Shares, which closed down 13% during normal hours, fell a further 23% to $0.53 after hours.

Kadmon Holdings, Inc. (NYSE:KDMN) announced after hours its intention to offer and sell shares of its common stock in a public offering. Shares closed down 8% after hours to $3.27.

Phio Pharmaceuticals Corp. (NASDAQ:PHIO) shares closed down 25% after hours to $0.20 on news that it also has commenced a proposed public offering of shares of its common stock.

Therapix Biosciences Ltd. (Nasdaq: TRPX) shares closed up 19% to $1.72. The company announced its single-arm, open-label, Phase 2 trial of THX-110 in patients with obstructive sleep apnea (OSA), met the primary endpoint of the trial.

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

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

ADVANCERS:

IDEAYA Biosciences, Inc. (IDYA): $8.50; +47%.

Mersana Therapeutics, Inc. (MRSN): $2.78; +21%.

Caladrius Biosciences, Inc. (CLBS): $2.67; +18%.

AC Immune SA (ACIU): $6.53; +17%.

Kazia Therapeutics Limited (KZIA): $3.30; +15%.

DECLINERS:

Melinta Therapeutics, Inc. (MLNT): $1.36; -32%.

Replimune Group, Inc. (REPL): $13.61; -19%.

Molecular Templates, Inc. (MTEM): $7.18; -18%.

Viela Bio, Inc. (VIE): $28.08; -13%.

Neon Therapeutics, Inc. (NTGN): $1.65; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACER – Acer Therapeutics Inc.
ACER-001
Urea cycle disorder (UCD)

Phase 2 Pivotal bioavailability and bioequivalence trial Part B due 1Q 2020 with NDA filing 1Q 2021.
$45 million

ACST – Acasti Pharma Inc.
CaPre (TRILOGY 1 and 2)
Hypertriglyceridemia

Phase 3 Phase 3 TRILOGY 1 data did not meet primary endpoint - January 13, 2020. TRILOGY 2 data due mid-February 2020.
$60.9 million

ALT – Altimmune Inc.
NASOSHIELD
Anthrax

Phase 1b Phase 1b trial to be initiated in 1Q 2020.
$30.8 million

ARDS – Aridis Pharmaceuticals Inc.
AR-301 (Salvecin)
Staphylococcus aureus

Phase 3 Phase 3 interim data due 1Q 2020 with final data due early 2021.
$66 million

BCYC – Bicycle Therapeutics plc
BT5528
Solid tumors

Phase 1/2 Phase 1/2 interim data due 2020.
$193.4 million

GMDA – Gamida Cell Ltd.
NiCord (omidubicel)
Acute myeloid leukemia

Phase 3 Phase 3 completion of enrolment announced December 2, 2019 with top-line data due 1H 2020.
$153.9 million

LQDA – Liquidia Technologies Inc.
LIQ861 - INSPIRE
Pulmonary arterial hypertension

NDA Filing NDA filing due 1Q 2020.
$184.6 million

MIST – Milestone Pharmaceuticals Inc.
Etripamil - NODE-301
Paroxysmal supraventricular tachycardia (PSVT)

Phase 3 Phase 3 top-line data due around end of 1Q 2020.
$526.1 million

MTNB – Matinas Biopharma Holdings Inc.
MAT9001
Severe hypertriglyceridemia

Phase 2 Phase 2 trial against Vascepa to commence 1Q 2020 with top-line data due 2H 2020.
$245.7 million

NCNA – NuCana plc
NUC-1031 (Acelarin)
Front-Line Treatment of Advanced Biliary Tract Cancer

Phase 3 Phase 3 update due 2020.
$165.5 million

PTN – Palatin Technologies Inc.
PL-8177
Ulcerative colitis

Phase 2 Phase 2 trial to commence mid-2020 with data due mid-2021.
$163 million

SLGL – Sol-Gel Technologies Ltd.
Twyneo
Acne

NDA Filing Phase 3 data met co-primary endpoints - December 30, 2019. NDA filing due 2H 2020.
$273.8 million

SLNO – Soleno Therapeutics Inc.
Diazoxide Choline Controlled-Release (DCCR) - DESTINY PWS
Prader-Willi syndrome (PWS)

Phase 3 Phase 3 data due 1H 2020.
$171.7 million