BPC February 12 update

​G1 Therapeutics GTHX FDA approval; Prothena PRTA analyst upgrade +46%

Price and Volume Movers

Mallinckrodt plc (OTC: MNKKQ) announced that the FDA has deferred its decision regarding the Stratatech Biologics License Application (BLA) for StrataGraft, for the treatment of adult patients with deep partial-thickness burns. This is due to COVID-19-related travel restrictions, which are delaying a required manufacturing site inspection. Shares closed down 8% to $0.46.

G1 Therapeutics, Inc. (NASDAQ: GTHX) shares are trading up 9% after hours to $30.89 on news the FDA has approved its regulatory application for Cosela (trilaciclib) to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.

Prothena Corporation (NASDAQ: PRTA) shares closed up 46% to $22.85 following an upgrade from analysts at Jefferies from Hold to Buy, raising its price target from $15 to $30.

Sesen Bio (Nasdaq: SESN) announced that it will host a conference call on Tuesday, February 16, 2021 at 8:00 a.m. ET to provide a business update. No specific details about the nature of the call were provided.

Phio Pharmaceuticals Corp. (NASDAQ:PHIO) shares closed down 5% to $3.43 on news of a registered direct offering for the sale of 2,246,784 shares at a purchase price of $3.42 per share, for gross proceeds of $7.7m.

Caladrius Biosciences, Inc. (NASDAQ:CLBS) announced a registered direct offering for the sale of 24,906,134 shares and warrants to purchase 12,453,067 shares at a purchase price of $2.45 per share and associated warrant. In addition, the company also announced a private placement of 1,632,652 shares and warrants to purchase 816,326 shares in a non-brokered registered direct offering. The gross proceeds from the registered direct offerings are expected to be approximately $65m. Shares fell 15% to $2.33.

Amicus Therapeutics (Nasdaq: FOLD) shares closed Friday down 33% to $12.57 following the release of top-line data from its Phase 3 Propel trial of AT-GAA for the treatment of late-onset Pompe disease (LOPD), released Thursday. As mentioned yesterday, the trial failed to meet the primary endpoint of the change in 6-minute walk distance as compared with baseline measurements. Patients walked on average 21 meters farther compared to 7 meters with those treated with current standard of care alglucosidase alfa but statistical significance for superiority was not achieved (p=0.072). The company still intends to complete its Biologics License Application (BLA) for approval with the FDA next quarter.

Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) announced after hours that it intends to sell shares of its common stock in an underwritten public offering. Shares are currently trading down 14% to $2.56 after hours.

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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

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

ADVANCERS:

ImmunoGen, Inc. (IMGN): $10.53; +30%.

NantKwest, Inc. (NK): $30.92; +19%.

Novan, Inc. (NOVN): $2.55; +19%.

Clene Inc. (CLNN): $12.49; +16%.

Ampio Pharmaceuticals, Inc. (AMPE): $2.49; +15%.

DECLINERS:

Longeveron Inc. Class A Common Stock (LGVN): $7.41; -26%.

Oncorus, Inc. (ONCR): $17.40; -17%.

SQZ Biotechnologies Company (SQZ): $18.56; -16%.

Protalix BioTherapeutics, Inc. (PLX): $4.90; -15%.

4D Molecular Therapeutics, Inc. (FDMT): $44.91; -15%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

GTHX – G1 Therapeutics Inc.
Trilaciclib
Second/third-line small-cell lung cancer

Approved FDA approval announced February 12, 2021.
$981.4 million

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

Phase 1/2 Phase 1b mature data to be presented at ASCO June 4-8, 2021.
$1.8 billion

IMGN – ImmunoGen Inc.
IMGN632 and Venetoclax or Azacitidine (801)
Acute Myeloid Leukemia (AML)

Phase 1 Phase 1 updated data due at ASH December 11-14, 2021.
$1.8 billion

IMGN – ImmunoGen Inc.
Mirvetuximab - SORAYA
Ovarian cancer

Phase 3 Phase 3 trial data due 3Q 2021.
$1.8 billion

IMGN – ImmunoGen Inc.
IMGN632
Relapse/Refractory AML, ALL, BPDCN

Phase 1/2 Phase 1/2 top-line data due 1H 2022.
$1.8 billion

KTRA – Kintara Therapeutics Inc.
VAL-083
Glioblastoma Multiforme (GBM) - Adjuvant

Phase 2 Phase 2 top-line data due 2Q 2021.
$62.8 million

LLY – Eli Lilly and Company
Tanezumab
Osteoarthritis

PDUFA Advisory Committee March 24, 2021; PDUFA date TBA.
$195.7 billion

MACK – Merrimack Pharmaceuticals Inc.
Onivyde - RESILIENT (acquired by Ispen)
Small Cell Lung Cancer

Phase 3 Phase 3 interim data due 1H 2022 (trial conducted by Ispen).
$95.8 million

MDNA – Medicenna Therapeutics Corp.
MDNA11
Cancer Immunotherapies

Phase 1/2 Phase 1/2 trial to be initiated mid-2021 with top-line top-line safety, PK/PD and biomarker data due end of 2021. Efficacy data due 2022.
$195.2 million

MNKKQ – Mallinckrodt plc
StrataGraft skin tissue
Deep partial thickness severe burns - skin defects

PDUFA priority review PDUFA date under priority review February 2, 2021. However, action by the FDA has been deferred due to COVID-19.
$30.9 million

OCUL – Ocular Therapeutix Inc.
OTX-TKI
Wet Age-related Macular Degeneration (AMD)

Phase 1 Phase 1 data presented February 13, 2021. Phase 2 trial to be initiated in Australia mid-2021.
$1.4 billion

PFE – Pfizer Inc.
Panzyga
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Approved FDA approval announced February 12, 2021.
$186.3 billion