BPC June 10 update

Key catalysts left for the quarter; Biotech week in review

Weekly watchlist

Congrats to this week’s winner @Freshy! Your pick of IMPP ended the week up 60%. Imperial Petroleum Inc (NASDAQ: IMPP) is an international shipping transportation company specialized in the transportation of various petroleum and petrochemical products in liquefied form.

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Now that we have entered into June we will start our countdown to the end of the quarter by revisiting catalysts that have yet to read out, and other notable events to remember. We will continue this until the end of the quarter and the release of our new list for the third quarter.

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

REGULATORY

Bluebird Bio, Inc. (NASDAQ:BLUE) had two positive recommendations from an FDA’s Advisory committee regarding its biologics licensing applications (BLAs) for betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel). Shares were trading up 63% at $5.30 for the week after the trading halt was removed during after-hours Friday.

The FDA agreed to consider a De Novo pathway for Bluejay Diagnostics, Inc’s (NASDAQ: BJDX) Symphony IL-6 Test. Symphony is a testing system to measure specific biomarkers. Shares closed the week up 19% at $1.23.

CLINICAL

Cogent Biosciences, Inc. (NASDAQ: COGT) released data from its Phase 2 APEX trial of bezuclastinib to treat advanced systemic mastocytosis (AdvSM), noting that 100% of patients achieved ≥50% reduction in serum tryptase levels. Shares closed the week up 77% at $7.87.

DBV Technologies (NASDAQ: DBVT) had an eventful week after its Phase 3 trial EPITOPE of Viaskin Peanut to treat peanut-allergy met its primary endpoint. Later in the week it also announced a $194 million private placement of shares and pre-funded warrants. Shares closed the week up 83% at $2.76.

Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) had a disappointing readout from its Phase 3 FORWARD trial of ostamatinib to treat warm autoimmune hemolytic anemia (wAIHA). The trial did not meet its primary endpoint. Shares closed the week down 62% at $0.67.

Praxis Precision Medicines (NASDAQ: PRAX) announced a corporate realignment plan after its Phase 2/3 Aria trial of PRAX-114 to treat major depressive disorder did not meet the primary endpoint. To maintain cash flow Praxis will reduce its employees. Shares closed the week down 44% at $1.78.

Fulcrum Therapeutics, Inc (NASDAQ: FULC) released data from its Phase 1b trial of FTX-6058 to treat sickle cell disease (SCD) noting a positive response to treatment, however 3 of the 6 patients were not included in evaluation due to being non-adherent or discontinued due to protocol deviation. Shares closed the week down 41% at $4.92.

Caribou Biosciences (NASDAQ: CRBU) shares closed the week down 22% at $6.94, after it released data from its Phase 1 ANTLER trial of CB-010 to treat relapsed or refractory B cell non-Hodgkin lymphoma, noting that after 6 months the complete response (CR) rate decreased from 100% at the first dose to 40%.

OTHER

Kiromic BioPharma, Inc. (NASDAQ: KRBP) announced a research deal to conduct in vivo preclinical research using its Gamma Delta T cell (GDT) allogeneic therapies with the primary investigator at The University of Texas MD Anderson Cancer Center. Shares closed the week up 67% at $0.55.

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

OPTN – OptiNose Inc.
XHANCE - (ReOpen2)
Chronic sinusitis

$3.64
-0.02  -1%
Phase 3 Phase 3 top-line data reported statistically significant benefits for both the symptoms co-primary endpoint and the CT scan co-primary endpoint, noted June 13, 2022.
$301 million

RYTM – Rhythm Pharmaceuticals Inc.
IMCIVREE (setmelanotide)
Bardet-Biedl Syndrome

$4.30
+0.15  +4%
Approved Approved June 16, 2022.
$216.7 million