BPC June 21 update

Biotech stock catalysts likely to readout in June/July

Weekly watchlist

Looking ahead to the final week of June, a larger than normal number of clinical readouts remain on the BioPharmCatalyst FDA Calendar slated for 2Q 2019. It should be noted though that companies do not always announce in advance if they anticipate missing timeline guidance.

In recent watch lists, we have noted catalysts due this quarter, without including companies that are slated to release data during “mid-2019”. Last week we saw a few “mid-2019” catalysts read out data so included in this week’s list are a couple of such catalysts. Once the June readouts have been completed we will add more July and mid-2019 catalysts to the list next week.

First, let’s review the week that was:

AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced that the FDA approved Vyleesi to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. AMAG in-licensed Vyleesi from Palatin Technologies, Inc. (NYSE: PTN) and the approval of triggers a $60m payment to Palatin. Shares of AMAG closed Friday’s after-hours session up 13% to $10.16, while Palatin shares surged 57% to $2.11.

Ocular Therapeutix, Inc. (NASDAQ: OCUL) also received the green light from the FDA on Friday, when it announced it received approval for the Supplemental New Drug Application (sNDA) for Dextenza to include the treatment of ocular inflammation following ophthalmic surgery as an additional indication. The approval was delivered well before its assigned PDUFA date of November 10, 2019. Shares closed Friday up 7% to $4.42.

VBI Vaccines Inc. (Nasdaq: VBIV), one of the companies which guided for a mid-2019 release of data, saw its shares close the week down 46% to $1.01 on the back of data released from its Phase 3 trial evaluating Sci-B-Vac, its hepatitis B vaccine, compared with a comparator vaccine, Engerix-B. While it met the co-primary endpoints, the trial did not meet the key secondary endpoint of non-inferiority of two doses of Sci-B-Vac compared with three doses of Engerix-B.

Pfizer Inc. (NYSE: PFE) announced that it intends to acquire Array BioPharma Inc. (NASDAQ: ARRY) for $48 per share in cash, for a total enterprise value of approximately $11.4b. Pfizer expects to complete the acquisition in 2H 2019. Shares of Array closed the week up 56% to $46.20.

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) shares closed the week down 35% to $41.06 on news of a public offering of $300m of its common shares. While public offerings are common place in the biotech space, what made this news even more newsworthy was the fact that there had been reports that the company was seeking to be acquired, as noted in Bloomberg in April. Given the size of the offering, any potential buyout looks to be off the table, at least for the near future, at least.

Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) shares closed the week up 53% to $9.74 on news that they have expanded their collaboration to discover and develop mRNA, DNA and siRNA therapeutics with Ultragenyx Pharmaceutical, Inc. (Nasdaq: RARE). Ultragenyx will make an upfront payment of $6m to Arcturus and will also purchase 2.4m shares of Arcturus’ common stock at $10 per share.

Melinta Therapeutics, Inc. (NASDAQ: MLNT) announced the FDA accepted its supplemental New Drug Application (sNDA) for Baxdela, in patients with community-acquired bacterial pneumonia (CABP). The PDUFA date under priority review is October 24, 2019. Shares of the micro-cap (borderline nano-cap) surged to close the week up 198% to $5.03.

Drug Stage Catalyst Market Cap

ACER – Acer Therapeutics Inc.
EDSIVO
Vascular Ehlers-Danlos Syndrome

CRL CRL issued June 25, 2019.
$33.5 million

ACRS – Aclaris Therapeutics Inc.
ATI-502 (ATI-50002-AA-201) - dose ranging
Alopecia areata

Phase 2 Phase 2 data did not meet primary endpoint - June 26, 2019.
$60.1 million

AKCA – Akcea Therapeutics Inc.
Volanesorsen
Familial partial lipodystrophy (FPL)

Phase 3 Phase 3 data met primary endpoint - August 6, 2019.
$1.5 billion

DCPH – Deciphera Pharmaceuticals Inc.
Ripretinib
Gastrointestinal Stromal Tumors (GIST) - fourth-line

Approved FDA Approval announced May 15, 2020.
$3.2 billion

ITCI – Intra-Cellular Therapies Inc.
ITI-007 - Monotherapy (Study 401)
Bipolar depression

Phase 3 Phase 3 trial did not meet primary endpoint - July 8, 2019.
$1.4 billion

KPTI – Karyopharm Therapeutics Inc.
Selinexor
Quadruple Refractory Multiple Myeloma

Approved FDA Approval announced July 3, 2019.
$1.3 billion

KRYS – Krystal Biotech Inc.
B-VEC (Beremagene Geperpavec) - KB103
Epidermolysis Bullosa

Phase 3 Phase 3 trial to commence 1H 2020.
$944.7 million

MRKR – Marker Therapeutics Inc.
MultiTAA-Specific T Cells
Pancreatic cancer

Phase 1/2 Phase 1/2 data update at ASCO May 29, 2020. 4/13 overall responses.
$105.2 million

NERV – Minerva Neurosciences Inc
MIN-202 (seltorexant)
Primary insomnia

Phase 2b Phase 2b data June 24, 2019 met primary endpoint.
$154.1 million

PFE – Pfizer Inc.
PF-06939926
Duchenne muscular dystrophy (DMD)

Phase 3 Phase 3 trial to be initiated 2H 2020.
$200.9 billion

SLGL – Sol-Gel Technologies Ltd.
VERED (Epsolay)
Papulopustular rosacea

NDA Filing NDA filing due 2Q 2020.
$184.9 million

TMBR – Timber Pharmaceuticals Inc.
BPX-04
Rosacea

Phase 2b Phase 2b data June 25, 2019 met endpoints.
$50.1 million

VRCA – Verrica Pharmaceuticals Inc.
VP-102
Common warts

Phase 2 Phase 3 trial to be initiated 1H 2020.
$309.8 million