BPC June 17 update

Key catalysts left for June; Biotech week in review

Weekly watchlist

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To enter in our weekly trading competition “Stock of the Week '' submit your stock on our Discord server here.

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While the markets have officially entered bear territory this week and the Federal Reverse announced a 75 basis point hike, biotech has had some green shine through this week with both data catalysts and rumors of future M&A deals. As we are coming to the end of the second quarter we return to our watchlist, and highlight the catalyst we are still awaiting. We will continue our catalyst watch until the start of the third quarter and refresh our list with new catalysts of note.

First, let’s review the week that was with notable price-moving events in the healthcare sector.

REGULATORY

The FDA rebutted proposed outcome measures for 180 Life Sciences Corp’s (NASDAQ: ATNF) planned Phase 2b trial of adalimumab to treat Dupuytren's disease. The FDA noted that the outcome measure did not meet the requirement for the demonstration of efficacy in registrational studies. Shares closed the week down 45% at $0.84.

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) shares were halted after market close following the FDA Advisory Committee’s vote of 9 to 3 that the evidence does not support the conclusion that NUPLAZID (pimavanserin) is effective for the treatment of hallucinations and delusions in the ADP population.

CLINICAL

Optinose (NASDAQ: OPTN) shares closed the week up 59% at $3.42 after its Phase 3 ReOpen2 trial of XHANCE to treat chronic sinusitis met both co-primary endpoints.

Clovis Oncology (NASDAQ: CLVS) shares closed the week up 79% at $1.18 after it reported Phase 1 data for its radionuclide therapy FAP-2286 in solid tumors noting a confirmed partial response. Buyout rumors were also spread this week, floating that Sanofi (NYSE: SNY) may be considering a bid for Clovis.

OTHER

Acorda Therapeutics, Inc. (NASDAQ: ACOR) shares closed the week up 60% at $0.64 after it launched its Parkinson's disease product, INBRIJA, in Germany.

Rigel Pharmaceuticals, Inc’s (NASDAQ: RIGL) President, Raul Rodriguez bought $688,000 worth of stock, at $0.69 earlier this week. Shares closed the week up 69% at $1.10.

The Florida Medicaid Pharmaceutical & Therapeutics Committee added Evoke Pharma, Inc’s (NASDAQ: EVOK) treatment for diabetic gastroparesis, GIMOTI, to the Florida Medicaid Preferred Drug List (PDL). Shares closed the week up 43% at $3.23.

Mereo BioPharma Group plc (NASDAQ: MREO) shares closed the week up 120% at $1.30, following buyout rumors were published by The Times that AstraZeneca (NASDAQ: AZN) may be considering a bid for the company.

Akero Therapeutics, Inc. (NASDAQ: AKRO) announced two deals this week, including a $25 million investment by Pfizer Inc. (NYSE: PFE) and a $100 million loan from Hercules Capital, Inc. Shares closed the week up 47% at $12.16.

Drug Price Stage Catalyst Market Cap

ATRA – Atara Biotherapeutics Inc.
ATA188 - (EMBOLD)
Multiple sclerosis

$8.30
+0.51  +7%
Phase 1/2 Phase 2 interim analysis due in 2022. Phase 3 trial planned.
$775.3 million

AXSM – Axsome Therapeutics Inc.
Dextromethorphan-bupropion (AXS-05)
Major Depressive Disorder

$40.64
+2.34  +6%
PDUFA Company received proposed labeling from FDA, is reviewing and will reply to the FDA to secure final labeling agreement, noted June 27, 2022.
$1.6 billion

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Piclidenoson - (COMFORT)
Psoriasis

$0.90
-0.02  -2%
Phase 3 Phase 3 top-line data reported that trial met primary endpoint, noted June 29, 2022.
$24.5 million

CFRX – ContraFect Corporation
Exebacase - (DISRUPT)
Serious infections caused by Staph aureus including MRSA

$3.10
+0.03  +1%
Phase 3 Phase 3 interim futility analysis due in first week of July. BLA planned.
$121.9 million

CYCC – Cyclacel Pharmaceuticals Inc.
Fadraciclib (CYC065-101)
Advanced cancers

$1.11
+0.03  +3%
Phase 1/2 Phase 1/2 initiation of dosing announced July 13, 2021. Data due to be presented in fall 2022.
$11.1 million

EPIX – ESSA Pharma Inc.
EPI-7386
Castrate resistant prostate cancer

$2.82
-0.33  -10%
Phase 1a Phase 1a data reported that treatment was well-tolerated, exhibited a favorable pharmacokinetic profile, and demonstrated initial anti-tumor activity in a heavily pretreated group of patients, noted June 27, 2022. Phase 1b trial to be initiated in 3Q 2022.
$81.8 million

ERYP – Erytech Pharma S.A.
GRASPA (Eryaspase)
Acute lymphoblastic leukemia (ALL)

$1.12
0.00  0%
BLA Filing BLA filing planned.
$34.7 million

ETNB – 89bio Inc.
BIO89-100 - (ENTRIGUE)
Severe hypertriglyceridemia

$3.24
+0.02  +1%
Phase 2 Phase 2 top-line data reported that trial met primary endpoint, noted June 28, 2022. Phase 3 trial to be initiated in 1H 2022.
$65.9 million

EVLO – Evelo Biosciences Inc.
EDP1815 - (TACTIC-E)
COVID-19

$2.15
+0.04  +2%
Phase 2/3 Phase 2/3 review from Independent Data Monitoring Committee noting that the progressive mildness of the COVID-19 pandemic makes yielding a meaningful outcome for EDP1815 in TACTIC-E unlikely, noted May 12, 2022.
$232 million

HGEN – Humanigen Inc.
Lenzilumab - (ACTIV-5/BET-B)
COVID-19

$1.64
-0.13  -7%
Phase 2/3 Phase 2/3 target enrollment achieved, noted January 5, 2022. Phase 2/3 top-line data due in July 2022. If successful data can be used for EUA submission.
$115.8 million

NMTR – 9 Meters Biopharma Inc.
Larazotide
Celiac disease

$0.22
-0.04  -14%
Phase 3 Phase 3 interim analysis reported that the additional number of patients needed to determine a significant clinical outcome between placebo and larazotide is too large to support trial continuation, noted June 21, 2022.
$58.3 million

NMTR – 9 Meters Biopharma Inc.
Vurolenatide - (VIBRANT)
Short bowel syndrome

$0.22
-0.04  -14%
Phase 2 Phase 2 top-line results expected in 2022. Phase 3 trial to be initiated in 2H 2022.
$58.3 million