BPC November 10 update

Ten Micro-cap Biotech stock catalysts for 4Q; Biotech week in Review

Weekly watchlist

The last week saw the peak of 3Q earnings news flow with most other companies yet to report scheduled to release next week. While a number of companies reacted positively to earnings, on the clinical data front, many failed to live up to expectations anticipated by investors. 

OncoSec Medical Incorporated (NASDAQ: ONCS) shares closed Tuesday down 50% to $0.87 following the release of preliminary data from KEYNOTE-695, a Phase 2b, open-label trial of Tavo with Keytruda in patients with unresectable, advanced melanoma.  Of nine patients treated, two experienced a partial response and one patient had stable disease, lower than investor expectations. 

Clearside Biomedical, Inc. (NASDAQ:CLSD) shares slumped Monday 63% to $2.07 following news that its Phase 3 Sapphire trial of Xipere for the treatment of retinal vein occlusion (RVO), did not meet its primary endpoint. 

Sangamo Therapeutics, Inc. (NASDAQ: SGMO) announced that it will not submit a late-breaking abstract to the ASH Meeting next month for its Phase 1/2 Alta trial evaluating SB-525 for hemophilia A. Shares closed Friday down 18% to $11.15 in reaction to the delay. The company instead noted that it will continue with an additional dose escalation and data from the Alta trial will be presented after the dose escalation is complete and the trial has progressed to the cohort expansion phase. 

TESARO, Inc. (NASDAQ: TSRO) announced data from its Phase 1 Amber trial of TSR-022 in combination with TSR-042 in patients who have progressed following anti-PD-1 therapy treatment. 1 of 11 patients showed a partial response in the 100mg dose cohort while 3 of 20 patients showed a partial response in the 300mg cohort. Shares closed Friday down 19% to $25.10 in reaction to the data. 

Asterias Biotherapeutics, Inc. (NYSE American: AST) shares closed Thursday up 25% to $1.32 following news that BioTime, Inc. (NYSE American: BTX) will acquire all of the remaining shares of Asterias.  

 

Last week we looked ahead at small cap stocks with Phase 3 catalysts. For the upcoming week we look at TEN nano and micro-cap (sub-$300m) stocks with catalysts slated for this quarter:


Drug Stage Catalyst Market Cap

ADMA – ADMA Biologics Inc
BIVIGAM
Primary humoral immunodeficiency

PDUFA PDUFA date delayed two months to December 18, 2018.
$210 million

ALDX – Aldeyra Therapeutics Inc.
Reproxalap (ADX-102)
Allergic conjunctivitis

Phase 3 Phase 3 data due early 2019.
$248.3 million

CPRX – Catalyst Pharmaceuticals Inc.
Firdapse
Lambert-Easton Myasthenic Syndrome (LEMS)

Approved FDA approval announced November 28, 2018.
$240.4 million

EVFM – Evofem Biosciences Inc.
Amphora - AMPOWER
contraceptive vaginal gel

Phase 3 Phase 3 data due late-2018.
$91.6 million

HSGX – Histogenics Corporation
NeoCart
Cartilage defects in the knee

Phase 3 Phase 3 data released September 5, 2018. Primary endpoint not met. Update regarding possibility of filing BLA expected by end 2018 or early 2019.
$34 million

MDWD – MediWound Ltd.
NexoBrid
Severe burns

Phase 3 Phase 3 data due January 2019.
$131 million

OCUL – Ocular Therapeutix Inc.
DEXTENZA
Ocular inflammation and pain following cataract surgery

Approved FDA approval announced December 3, 2018.
$219 million

RDHL – Redhill Biopharma Ltd.
RHB-105 - ERADICATE Hp 2
H. pylori

Phase 3 Phase 3 trial met primary endpoint. NDA filing 1H 2019.
$173.5 million

SCYX – SCYNEXIS Inc.
SCY-078 - oral (FURI)
Invasive candidiasis

Phase 3 Phase 3 open label trial commenced 3Q 2017. Preliminary data review 4Q 2018.
$23.5 million

SESN – Sesen Bio Inc.
Vicinium
Non-muscle invasive bladder cancer (NMIBC)

Phase 3 Phase 3 12-month data due mid-2019. 6-month data due December 2018.
$108.4 million