BPC July 31 update

​Sanofi SNY and Glaxo GSK COVID vaccine added to Operation Warp Speed

Price and Volume Movers

Sanofi (NASDAQ:SNY) and GlaxoSmithKline plc (NYSE:GSK) announced that the U.S, government will provide up to $2.1b for the development and manufacture of their potential COVID-19 vaccine, the sixth drug to be included in the U.S. government Operation Warp Speed program following AstraZeneca, Johnson & Johnson, Moderna, Novavax and Pfizer. Sanofi expects a Phase 1/2 trial to start in September, followed by a Phase 3 trial by the end of 2020. If the data are positive, the companies will seek regulatory approval in the first half of 2021.

Tiziana Life Sciences plc (NASDAQ:TLSA) shares closed up 41% to $6.99. The company announced it has submitted a patent application for the potential use of nasally administered Foralumab for the treatment of COVID-19 either alone or in combination with other anti-viral drugs.

VistaGen Therapeutics, Inc. (NASDAQ:VTGN) announced after hours it has commenced an underwritten public offering of shares of its common stock. Shares are trading down 20% to $0.74 after hours.

Emergent BioSolutions Inc.(NYSE:EBS) shares closed up 15% to $111.24 following its report of second quarter earnings. Revenues of $394.7m were recorded in the quarter, an increase of 62% from the same quarter a year ago. It also revised upward full year 2020 guidance, noting expected revenues of $1.5b-$1.6b compared with previous guidance of $1.175b - $1.275b.

Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) shares closed down 9% to $4.30 on news that the Magistrate Judge considering its lawsuit against the FDA, has recommended the District Judge deny Catalyst's lawsuit against the FDA regarding the marketing approval issued to Jacobus Pharmaceutical for its drug for patients with Lambert-Eaton myasthenic syndrome. Catalyst’s approved drug in adult patients, Firdapse, was thought to have seven years orphan drug marketing exclusivity. However, the FDA awarded Jacobus approval in children, allowing the much less costly drug to be prescribed by doctors to adults off label.

-

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

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

ADVANCERS:

Sonnet BioTherapeutics Holdings, Inc. (SONN): $4.11; +41%.

Achieve Life Sciences, Inc. (ACHV): $13.63; +14%.

IDEAYA Biosciences, Inc. (IDYA): $12.61; +12%.

SELLAS Life Sciences Group, Inc. (SLS): $3.56; +11%.

Alpine Immune Sciences, Inc. (ALPN): $11.50; +11%.

DECLINERS:

Edesa Biotech, Inc. (EDSA): $6.85; -28%.

Spring Bank Pharmaceuticals, Inc. (SBPH): $1.55; -20%.

Genocea Biosciences, Inc. (GNCA): $2.85; -17%.

NantKwest, Inc. (NK): $11.18; -17%.

Adial Pharmaceuticals, Inc. (ADIL): $1.61; -15%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

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 on OR about August 31, 2020,
$70.5 million

APLS – Apellis Pharmaceuticals Inc.
APL-2 OAKS
Geographic atrophy (GA) associated with age-related macular degeneration (AMD)

Phase 3 Phase 3 top-line data due 3Q 2021.
$2.1 billion

APLS – Apellis Pharmaceuticals Inc.
APL-2 (pegcetacoplan) - DERBY
Geographic atrophy (GA)

Phase 3 Phase 3 data due 3Q 2021.
$2.1 billion

ARQT – Arcutis Biotherapeutics Inc.
ARQ-151
Plaque psoriasis

Phase 2 Phase 2 long-term safety top-line data due 1H 2021.
$949.5 million

BNTX – BioNTech SE
BNT111 and Libtayo
Melanoma

Phase 2 Phase 2 trial to be initiated 4Q 2020.
$16.5 billion

BSGM – BioSig Technologies Inc.
Merimepodib and remdesivir
COVID-19

Phase 2 Phase 2 update provided August 4, 2020.
$205.9 million

GLYC – GlycoMimetics Inc.
Uproleselan (GMI-1271)
Acute myeloid leukemia (AML) newly diagnosed and refractory - cancer

Phase 3 Phase 3 enrolment to be completed 2H 2021.
$177.8 million

IMGN – ImmunoGen Inc.
Mirvetuximab soravtansine - FORWARD II
Ovarian cancer and relapsed endometrial cancer

Phase 1/2 Phase 1b/2 data from platinum-sensitive triplet cohort due at ESMO September 19-21, 2020.
$659.8 million

MRK – Merck & Company Inc. (new)
V591 (Themis)
COVID-19 vaccine

Phase 1 Phase 1 trial to commence 3Q 2020.
$209.4 billion

MRK – Merck & Company Inc. (new)
V590 (IAVI)
COVID-19 vaccine

Phase 1 Phase 1 trial to commence 2H 2020.
$209.4 billion

TAK – Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)
CoVIg-19
COVID-19

Phase 1 Registration-enabling trial to commence in the coming weeks - noted July 31, 2020.
$58.7 billion

TAK – Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)
Pevonedistat (TAK-924)
Higher-risk myelodysplastic syndromes (HR-MDS)

Phase 3 Phase 3 data due 4Q 2020 / 1Q 2021.
$58.7 billion

TAK – Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)
TAK-609
Hunter Syndrome

NDA Filing Currently in preparatory stages for a NDA submission - noted July 31, 2020.
$58.7 billion

UBX – Unity Biotechnology Inc.
UBX0101
Osteoarthritis of the knee

Phase 2 Phase 2 top-line data due 3Q 2020.
$600.5 million