BPC June 23 update

Translate Bio TBIO expands deal with Sanofi +47%; Myovant MYOV hits late-stage endpoints +14%

Price and Volume Movers

Translate Bio (NASDAQ:TBIO) shares closed up 47% to $23.87 on news it has expanded their existing collaboration and license agreement with Sanofi to develop mRNA vaccines for infectious diseases. Translate Bio will receive a total upfront payment of $425m, consisting of a $300m cash payment and a private placement common stock investment of $125m at $25.59 per share representing a 50% premium to the 20-day moving average share price prior to signing. Translate Bio will also be eligible for potential future milestones and other payments up to $1.9b.

Myovant Sciences (NYSE: MYOV) shares closed up 14% to $19.90 on news its second Phase 3 trial of once-daily relugolix combination therapy in women with pain associated with endometriosis, met the co-primary efficacy endpoints and all seven key secondary endpoints.

INOVIO (NASDAQ:INO) shares rose 41% to $21.57 following its announcement it has received $71m funding from the U.S. Department of Defense (DoD) to support the large-scale manufacture of devices used to deliver INO-4800, currently in development for COVID-19. Interim data from the Phase 1 vaccine trial will be available later this month. A Phase 2/3 efficacy trial is planned to begin this summer (July/August).

Millendo Therapeutics, Inc. (Nasdaq: MLND) announced that it will not continue development of nevanimibe in patients with congenital adrenal hyperplasia. The decision was made following an interim review of Phase 2b data. Shares closed down 17% to $1.99.

Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) shares fell 43% to $0.35 following its announcement that it will not advance its current Phase 1/2 trial of vecabrutinib for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL) into the planned Phase 2 portion.

Kitov Pharma Ltd. (NASDAQ: KTOV) announced a registered direct offering for the sale of 38,888,892 of its ordinary shares represented by American Depositary Shares (ADSs) and warrants to purchase 19,444,446 ADSs, at a combined price of $0.90 per ADS and associated warrant, for gross proceeds of $35m. After hitting an intra-day high of $1.35, shares fell following the offering to close at $0.82, for a 7% day-on-day gain.

Outlook Therapeutics, Inc. (NASDAQ:OTLK) announced a registered direct offering of 8,407,411 shares at a purchase price of $1.215 per share, for gross proceeds of $10.2m. Shares fell 5% to $1.29.

Editas Medicine, Inc. (NASDAQ:EDIT) announced after hours that it intends to sell 4m shares of its common stock in an underwritten public offering. Shares are trading down 8% to $31.51 after hours.

Soleno Therapeutics, Inc. (NASDAQ:SLNO) also announced after hours an underwritten public offering to sell shares of its common stock. Shares are trading down 6% to $1.70 after hours.

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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:

Cyclerion Therapeutics, Inc. (CYCN): $7.14; +37%.

Hepion Pharmaceuticals, Inc. (HEPA): $3.09; +24%.

KalVista Pharmaceuticals, Inc. (KALV): $12.89; +18%.

Curis, Inc. (CRIS): $1.36; +14%.

Kadmon Holdings, Inc. (KDMN): $5.23; +13%.

DECLINERS:

Seelos Therapeutics, Inc. (SEEL): $1.23; -19%.

Miragen Therapeutics (MGEN): $1.22; -14%.

Aeglea BioTherapeutics, Inc. (AGLE): $9.78; -11%.

Arcutis Biotherapeutics, Inc. (ARQT): $32.50; -11%.

Revolution Medicines, Inc. (RVMD): $35.04; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADMP – Adamis Pharmaceuticals Corporation
ZIMHI (naloxone HCI Injection)
Opioid overdose

PDUFA CRL announced November 25, 2019. NDA resubmitted with new PDUFA date of November 15, 2020.
$39.8 million

FGEN – FibroGen Inc
Pamrevlumab
COVID-19

Phase 2 Phase 2 commencement of enrolment announced June 23, 2020.
$3.9 billion

INO – Inovio Pharmaceuticals Inc.
INO-4800
Coronavirus COVID-19 vaccine

Phase 1 Phase 1 interim data released June 30, 2020. 94% of Phase 1 trial participants demonstrated overall immune responses at Week 6 but no data on how many patients produced antibodies. Phase 2/3 trial to commence July/August 2020.
$3.4 billion

KDMN – Kadmon Holdings Inc.
KD033
Advanced Solid Tumors

Phase 1 Phase 1 dosing of first patient announced June 23, 2020.
$755.3 million

KRTX – Karuna Therapeutics Inc.
KarXT
Acute psychosis in patients with schizophrenia

Phase 2 Phase 3 trial to be initiated in 2020. Additional Phase 3 trial to be initiated 1H 2021.
$2.9 billion

MLND – Millendo Therapeutics Inc.
Nevanimibe
Congenital adrenal hyperplasia (CAH)

Phase 2b Phase 2b interim review completed. Development to be discontinued - June 23, 2020.
$32.7 million

MLND – Millendo Therapeutics Inc.
MLE-301
Vasomotor symptoms (VMS)

Phase 1 Phase 1 trial to commence 3Q 2020.
$32.7 million

MYOV – Myovant Sciences Ltd.
Relugolix - SPIRIT 1
Endometriosis-associated pain

Phase 3 Phase 3 data met co-primary endpoints June 23, 2020.
$1.8 billion

ONCY – Oncolytics Biotech Inc.
Pelareorep, paclitaxel and avelumab - BRACELET-1
HR+ / HER2- breast cancer

Phase 2 Phase 2 dosing of first patient announced June 23, 2020.
$75.3 million

PTN – Palatin Technologies Inc.
PL8177
COVID-19

Phase 2 Phase 2 trial to be initiated 4Q 2020.
$109.7 million

SNSS – Sunesis Pharmaceuticals Inc.
Vecabrutinib (SNS-062)
Advanced B-Cell Malignancies

Phase 1/2 Phase 1/2 program will not be advanced into the Phase 2 part of the trial - June 23, 2020.
$32.2 million

SNY – Sanofi
SAR442168 (PRN2246)
Multiple sclerosis

Phase 3 Phase 3 commencement of enrolment announced June 23, 2020.
$129.7 billion

SNY – Sanofi
mRNA vaccine
Coronavirus COVID-19

Phase 1b Phase 1 trial to commence by the end of 2020.
$129.7 billion