BPC May 27 update

Key Phase 1/2 catalysts left for the quarter; Biotech week in review

Weekly watchlist

Congrats to this week’s winner IVMathGirl! Your pick of MNKD ended the week up 19%. The FDA approve United Therapeutics' Tyvaso DPI to treat pulmonary arterial hypertension (PAH). MannKind has a worldwide exclusive licensing and collaboration agreement with United Therapeutics. As a biotech stock they won double the prize!

BioPharmCatalyst commenced a weekly trading competition “Stock of the Week '' on our Discord server. Enter your stock pick each week and the biggest gainer wins cash and prizes. Make your account and submit your pick here.

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This week we reanalyze our watchlist for Phase 1 and 2 events for the second quarter, and highlight the catalyst we are still awaiting. Next week we look back at our list of PDUFAs and regulatory events expected for this quarter.

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

REGULATORY

Apyx Medical Corporation (NASDAQ: APYX) received 510(k) clearance from the FDA for the use of the Renuvion Dermal Handpiece for specific dermal resurfacing procedures. Shares closed the week up 77% at $6.27.

Verrica Pharmaceuticals Inc. (NASDAQ: VRCA) received a Complete Response Letter (CRL) for its New Drug Application (NDA) for VP-102 to treat molluscum contagiosum (molluscum). This is the third CRL for this application. Shares closed the week down 66% at $2.

CLINICAL

Oncternal Therapeutics, Inc. (NASDAQ: ONCT) published its ASCO abstract for the Phase 1/2 study of zilovertamab and ibrutinib in mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL). Data reported an ORR of 85% and CR rate of 41%. Shares closed the week up 88% at $1.54.

The Data Safety and Monitoring Board (DSMB) reviewed NRx Pharmaceuticals, Inc’s (NASDAQ: NRXP) Phase 3 ACTIV-3b trial of Remdesivir and ZYESAMI (Aviptadil) to treat COVID-19, and noted that the trial should be stopped after failing to meet futility guidelines. Shares closed the week down 66% at $0.53.

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) shares closed the week down 66% at $0.53 after it reported data from Cohort 4 for its trial of C-144-01 to treat melanoma. The overall response rate (ORR) was 29%, lower than Cohort 2's 35% ORR, with a median duration of response (DOR) of 10 months.

SpringWorks Therapeutics, Inc. (NASDAQ: SWTX) shares closed the week down 51% at $18.36 after a double whammy hit from the released data of its Phase 3 DeFi trial of nirogacestat to treat desmoid tumors and its Phase ½ combination trial of nirogacestat with low-dose BLENREP to treat multiple myeloma. In its Phase ½ trial the objective response rate (ORR) was 38%.

Mirati Therapeutics (NASDAQ: MRTX) released data from its Phase 2 cohort of the KRYSTAL-1 trial of adagrasib to treat non-small cell lung cancer (NSCLC). SVB Leerink also lowered Mirati Therapeutics’ price target to $111 per share from $164. Shares closed the week down 37% at $39.81.

OTHER

Genocea Biosciences, Inc. (NASDAQ: GNCA) announced this week that it will be delisting from the NASDAQ stock market and winding down business operations. Shares closed the week down 71% at $0.06.

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

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

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

FULC – Fulcrum Therapeutics Inc.
FTX-6058
Sickle Cell Disease

$4.92
+0.02  +0%
Phase 1b Phase 1b trial initiated, noted January 10, 2022. Phase 1b initial data reported a rapid and robust induction of HbF, and subjects achieved increases of up to 6.3% over baseline, noted June 10, 2022.
$201 million

GNCA – Genocea Biosciences Inc.
GEN-011 - (TITAN)
Various tumors

$0.02
0.00  -12%
Phase 1/2 Phase 1/2 initiation of dosing announced July 13, 2021, Phase 1 trial data showed consistent pattern of activity in first five heavily pre-treated, checkpoint-refractory patients with advanced solid tumors and progressive disease. Dose escalation continues toward potentially more effective regimen, initial translational data corroborate clinical findings, noted April 8, 2022. Phase 1/2a initial data due 2Q 2022.
$881.8 thousand

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

PMVP – PMV Pharmaceuticals Inc.
PC14586 - (PYNNACLE)
Solid tumors

$15.48
+1.23  +9%
Phase 1/2 Phase 1/2 data released May 26, 2022. ASCO abstract highlights 3/10 (30%) partial responses in patients treated in higher dose cohorts and activity observed in multiple tumor types. In addition, the safety profile was encouraging as PC14586 was well-tolerated. Additional Phase 1/2 reported a ORR of 32% with partial responses seen in 6 tumor types, noted June 7, 2022.
$705.5 million