BPC July 25 update

Key companies reporting earnings this upcoming week; Biotech stock catalysts remaining for mid-2019

Weekly watchlist

The second week of biotech earnings season coupled with a number of key readouts saw steady news flow throughout the week.

The week ahead also sees further price moving earnings events to look forward to. We highlight companies with expected annual revenues of over $100m that are set to report. As noted last week, earnings releases for mid-large cap companies are a significant catalyst, whereas the impact is very limited on smaller cap firms which do not have approved treatments on the market.

We also highlight events which have been signalled as occurring in mid-2019 or in early August. Note this list does not include events slated for “3Q 2019”, which we will highlight next week. First, let’s highlight price moving events from the week that was.

Sanofi (NASDAQ: SNY) announced late-Friday it notified Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) that it is terminating its collaboration to develop Zynquista (sotagliflozin) in all diabetes programs. The news follows mixed data from three Phase 3 trials of sotagliflozin for the treatment of diabetes. Lexicon responded claiming that it considers the notice invalid and Sanofi to be in breach of contract. Shares of Lexicon closed the after-hours session on Friday down 50% to $2.82.

Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN) shares closed the week up 95% to $4.65. The company noted it achieved positive data from its Phase 1 multiple ascending dose (MAD) trial of ACH-5228 in healthy volunteers.

Intec Pharma Ltd. (NASDAQ: NTEC) shares slumped to close the week down 84% to $0.48 on news that it failed to meet the primary endpoint in its pivotal Phase 3 trial evaluating the safety and efficacy of Accordion Pill-Carbidopa/Levodopa (AP-CD/LD) for the symptoms of advanced Parkinson's disease (PD).

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) announced that it did not meet the primary endpoint in its Phase 3 Enhance trial of pimavanserin as an adjunctive treatment in adult schizophrenia patients. Shares closed the week down 9% to $23.34.

Chiasma, Inc. (NASDAQ: CHMA) shares closed Tuesday up 27% to $7.86 following its announcement that it met all primary and secondary endpoints in its pivotal Phase 3 trial evaluating Mycapssa, for the maintenance treatment of adults with acromegaly. However, shares actually closed lower for the week, on the back of a post-data offering of common stock.

Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) announced negative data from its Phase 2 Magnolia clinical trial of ganaxolone in women with postpartum depression (PPD). Shares closed the week down 71% to $1.12.

Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) shares closed the week down 29% to $8.37 on news the the FDA has cancelled the Psychopharmacologic Drugs Advisory Committee meeting for its New Drug Application (NDA) for lumateperone for the treatment of schizophrenia. Originally scheduled for July 31, 2019, the company said the FDA cancelled the meeting to allow sufficient time to review new information regarding non-clinical trials and any forthcoming information, which may result in an extension of the PDUFA date of September 27, 2019.

Key companies reporting 2Q earnings:

M: SNY

T: AMGN EXAS GILD INCY LLY MRK PFE

W: EXEL UTHR VRTX

Th: ACOR BMRN EBS

Key catalysts remaining for July/August (not including catalysts designated as "3Q").

Drug Stage Catalyst Market Cap

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

Phase 3 Phase 3 data met primary endpoint - August 6, 2019.
$2 billion

ALKS – Alkermes plc
Diroximel fumarate (BIIB098) - Head-to-head trial versus Tecfidera -
Relapsing Remitting Multiple Sclerosis (RRMS)

Phase 3 Phase 3 top-line data met primary endpoint - July 30, 2019.
$3.4 billion

ALLK – Allakos Inc.
AK002
Eosinophilic Gastritis

Phase 2 Phase 2 top-line data met primary and secondary endpoints - August 5, 2019. Extension data due 1H 2020. Phase 3 trial to commence 1Q 2020.
$4.3 billion

ATNX – Athenex Inc.
Oraxol
Metastatic breast cancer

Phase 3 Phase 3 top-line data met primary endpoint (ORR), secondary endpoints (PFS/OS) yet to hit.
$1.2 billion

AZRX – AzurRx BioPharma Inc.
MS1819-SD (OPTION)
Cystic fibrosis

Phase 2 Phase 2 data due September 2019.
$25.8 million

DCPH – Deciphera Pharmaceuticals Inc.
Ripretinib DCC-2618 - INVICTUS
Gastrointestinal Stromal Tumors (GIST) - fourth-line

NDA Filing Phase 3 data met PFS primary endpoint - August 13, 2019. Secondary ORR endpoint not achieved. NDA filing due 1Q 2020.
$1.4 billion

GLYC – GlycoMimetics Inc.
GMI-1070 (rivipansel)
Vaso-occlusive crisis of sickle cell disease

Phase 3 Phase 3 data failed to meet endpoints - August 2, 2019.
$146.9 million

KALA – Kala Pharmaceuticals Inc.
KPI‑121 0.25%
Dry eye disease

CRL CRL issued August 8, 2019. Data from Stride 3 trial due 4Q 2019 are required for resubmission.
$136 million

LPTX – Leap Therapeutics Inc.
DKN-01 + KEYTRUDA
Esophagogastric adenocarcinoma

Phase 1/2 Phase 1/2 data August 6, 2019 noted 50% ORR.
$35.1 million

NBRV – Nabriva Therapeutics plc
Lefamulin - Intravenous and Oral
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)

PDUFA priority review PDUFA date under priority review August 19, 2019.
$167.3 million

RARE – Ultragenyx Pharmaceutical Inc.
DTX301
Ornithine Transcarbamylase (OTC) Deficiency

Phase 1/2 Phase 1/2 third cohort data due 3Q 2019.
$3.4 billion

SRPT – Sarepta Therapeutics Inc.
Golodirsen - Exon 53
Duchenne muscular dystrophy

PDUFA priority review PDUFA date under priority review August 19, 2019 .
$9.3 billion