BPC June 17 update

IDEAYA IDYA adds to Tuesday's gains +43%; Offerings BCDA CBIO ISEE LPTX

Price and Volume Movers

IDEAYA Biosciences, Inc. (NASDAQ:IDYA) shares, which closed up 43% Tuesday following a deal with GlaxoSmithKline plc (NYSE:GSK), added a further 45% Wednesday to close at $18.57. Analysts at H.C. Wainwright, which initiated coverage of the stock in April with a price target of $13, increased their price target of the stock further to $22.

Eloxx Pharmaceuticals, Inc., (NASDAQ:ELOX) shares are trading up 48% to $3.05 after hours. The company announced that enrollment in its Phase 2 clinical trial for ELX-02 in cystic fibrosis has been resumed in Israel and Europe after being temporarily paused in response to the COVID-19 pandemic.

InflaRx (Nasdaq: IFRX) shares closed down 25% to $5.39 following its announcement that interim results its Phase 2/3 trial of IFX-1 in patients with severe COVID-19 pneumonia, did not meet the primary endpoint. Relative change in the oxygenation index at day 5 showed no differences between treatment groups.

Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) confirmed that following an analysis of data from its Phase 3 trial of ADS-5102 in multiple sclerosis patients with walking impairment (MSW), a second Phase 3 trial will not be initiated and will discontinue development in MSW. Shares are trading down 12% to $2.51 after hours.

BioCardia, Inc. (Nasdaq: BCDA) announced the pricing of its public offering of 4,762,000 shares of common stock at a price to the public of $2.10 per share for gross proceeds of $10m. Shares closed down 27% to $2.12.

IVERIC bio, Inc. (NASDAQ:ISEE) shares are trading down 9% to $4.05 after hours on news of a public offering of $50m of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof).

Leap Therapeutics, Inc. (NASDAQ:LPTX) shares have fallen 16% after hours to $2.11 on news it has commenced an underwritten public offering of its common stock and, in lieu of common stock, pre-funded warrants to purchase shares of its common stock.

Catalyst Biosciences, Inc. (NASDAQ:CBIO) also announced that it is offering shares of its common stock in an underwritten public offering. Shares are trading down 8% to $6.67 after hours, adding to a fall of 8% during the normal trading session.

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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:

Millendo Therapeutics, Inc. (MLND): $3.28; +38%.

Miragen Therapeutics (MGEN): $1.26; +34%.

Forward Pharma A/S (FWP): $7.42; +21%.

DiaMedica Therapeutics Inc. (DMAC): $5.96; +19%.

MediWound Ltd. (MDWD): $2.58; +19%.

DECLINERS:

Brickell Biotech, Inc. (BBI): $1.29; -24%.

AVEO Pharmaceuticals, Inc. (AVEO): $5.16; -17%.

Celsion Corporation (CLSN): $4.25; -13%.

Immuron Limited (IMRN): $8.22; -13%.

Annovis Bio, Inc. (ANVS): $5.00; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADMS – Adamas Pharmaceuticals Inc.
GOCOVRI (amantadine)
Multiple sclerosis (MS)

Phase 3 Phase 3 data met primary endpoint at one of two doses. Secondary endpoint in walking impairment not met. Second trial will not be initiated as a result of data - December 17, 2019. Findings were confirmed June 17, 2020.
$72.1 million

AFMD – Affimed N.V.
AFM24
EGFR-expressing solid tumors

Phase 1/2 Phase 1/2a completion of first cohort announced June 17, 2020. Noted no efficacy yet was observed, however, efficacy was not expected at this dose level.
$348.5 million

AKRO – Akero Therapeutics Inc.
AKR-001
Nonalcoholic steatohepatitis (NASH)

Phase 2a Phase 2a dose groups all met primary endpoint - March 31, 2020. Further data released June 30, 2020 noted 48% of patients achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis.
$946.8 million

ATRA – Atara Biotherapeutics Inc.
ATA188
Multiple sclerosis

Phase 1b Phase 1b commencement of enrolment announced June 17, 2020.
$1.1 billion

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

Phase 2 Phase 2 patient enrolment has commenced. Data due in 3Q 2020.
$210 million

ELOX – Eloxx Pharmaceuticals Inc.
ELX-02
Cystic fibrosis

Phase 2 Phase 2 enrolment has resumed following temporary pause due to COVID-19.
$125.6 million

IFRX – InflaRx N.V.
IFX-1
COVID-19

Phase 2 Phase 2 interim analysis noted (primary endpoint) relative change in the oxygenation index at day 5 showed no differences between treatment groups. 28-day all-cause mortality was 13% (2 out of 15) versus 27% (4 out of 15) in the control group.
$123.2 million

KMDA – Kamada Ltd.
Plasma-derived IgG product
COVID-19

Phase 1/2 Phase 1/2 trial to be initiated 3Q 2020.
$393.1 million

MRK – Merck & Company Inc. (new)
Keytruda
Solid tumors - TMB-H ≥10 mutations/megabase

Approved FDA Approval June 17, 2020.
$198.8 billion

OTLK – Outlook Therapeutics Inc.
NORSE 1 (ONS-5010-001)
Wet age-related macular degeneration (wet AMD)

Phase 3 Phase 3 data due August 2020.
$157.8 million

OTLK – Outlook Therapeutics Inc.
NORSE 2 (ONS-5010-002)
Wet age-related macular degeneration (wet AMD)

Phase 3 Phase 3 data due 3Q 2021.
$157.8 million

PDSB – PDS Biotechnology Corporation
Versamune-CoV-2FC (PDS0204)
COVID-19 Vaccine

Phase 1 Phase 1 trial to be initiated in Brazil.
$25.7 million

PTCT – PTC Therapeutics Inc.
PTC299
COVID-19

Phase 2/3 Phase 2/3 initiation announced June 17, 2020.
$3.5 billion

TGTX – TG Therapeutics Inc.
Umbralisib
Marginal zone lymphoma (MZL) and follicular lymphoma (FL)

NDA Filing Rolling NDA has been completed - June 17, 2020.
$2.3 billion