BPC April 23 update

Biotech earnings calendar for the week ahead; Biotech week in Review

Weekly watchlist

The first full week of first-quarter earnings kicks off this coming week. Typically, the top revenue-generating biotech and pharma companies report earnings during the first week and are regarded as key price moving catalysts due to their high revenue flows. We highlight key companies reporting below, while also including a selection of Phase 1 catalysts to watch for this quarter, rounding out our catalyst preview for the quarter following previous lists of Phase 2, Phase 3 and FDA events.

First, let’s review the week that was.

COVID-19:

Ocugen (NASDAQ:OCGN) announced its partner, Bharat Biotech, released data from a second interim analysis of its Phase 3 trial for its COVID-19 vaccine candidate, Covaxin. The data exhibited vaccine efficacy in mild, moderate, and severe COVID-19 disease of 78% with efficacy against severe COVID-19 disease of 100%. Ocugen is eligible for 45% of profits in the US market should it receive marketing approval. Shares closed the week up 67% to $9.63.

Emergent BioSolutions Inc. (NYSE: EBS) shares closed the week down 20% to $61.94 on news that the FDA has requested it halt the manufacture of the Johnson & Johnson COVID-19 vaccine at one of its main plants. The pause will allow the FDA to investigate further an error which caused the spoiling of millions of doses in March.

INOVIO (NASDAQ:INO) announced it has had its U.S. funding for its Phase 3 COVID-19 vaccine trial withdrawn. The company cited increased availability of vaccines authorized for emergency use for the withdrawal of funding. The company still plans to initiate a Phase 3 trial but predominantly outside of the US. Shares closed Friday down 25% to $6.85.

EARNINGS:

Biogen Inc. (NASDAQ:BIIB) shares closed Thursday down 4% to $259 following its report of first quarter earnings, with revenues falling 24% compared with the previous year. All eyes will be on what is arguably the FDA approval event of the year, for the potential marketing approval of Aducanumab for the treatment of Alzheimer’s disease. The PDUFA date for a decision by the FDA is June 7, 2021.

CLINICAL DATA:

Syndax Pharmaceuticals, Inc. (Nasdaq:SNDX) announced Phase 1 dose escalation data from its Phase 1/2 AUGMENT-101 trial of SNDX-5613 in patients with mixed lineage leukemia rearranged (MLLr) and nucleophosmin (NPM1c) mutant relapsed/refractory (R/R) acute leukemias. The overall response rate (ORR) among evaluable patients was 48% (15/31). Shares, however, closed the week down 24% to $15.47 with investors likely focussing on data which showed of the 15 responses just five CR/CRh were noted (complete remission or complete remission with partial hematological recovery).

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Biotech earnings calendar:

Selection of key earnings dates below. Full list available for premium members.

Tue: AMGN LLY NVS

Wed: ALKS TEVA

Thu: AGIO ALNY AMRN BMRN BMY EBS GILD MRK SGEN VRTX

Fri: ABBV

Phase 1 events to watch for second quarter 2021:

Drug Price Stage Catalyst Market Cap

ALT – Altimmune Inc.
AdCOVID
COVID-19 vaccine

$9.07
+0.01  +0%
Phase 1 Phase 1 data released June 29, 2021 did not stimulate an adequate immune response. Development to be discontinued.
$348.3 million

APTO – Aptose Biosciences Inc.
Luxeptinib (CG-806)
Acute myeloid leukemia

$2.69
+0.08  +3%
Phase 1a Phase 1a/b trial initiation announced October 19, 2020. Complete response reported March 23, 2021.
$235.3 million

BCEL – Atreca Inc.
ATRC-101
Solid tumors

$5.49
+0.58  +12%
Phase 1b Phase 1b initial data released July 29, 2021. 20/50 (40%) of patients exhibited stable disease.
$202.5 million

BDTX – Black Diamond Therapeutics Inc.
BDTX-189 (MasterKey-01)
Solid tumors

$9.56
+0.21  +2%
Phase 1/2 Dose-escalation portion on track to complete in 1H 2021. Phase 2 portion to begin 2H 2021.
$345.7 million

FMTX – Forma Therapeutics Holdings Inc.
FT-4202
Sickle cell disease

$22.89
-1.33  -5%
Phase 2/3 Phase 2/3 trial has been initiated.
$1.1 billion

FREQ – Frequency Therapeutics Inc.
FX-322
Age-Related Hearing Loss

$8.33
+0.32  +4%
Phase 1b Phase 1b data showed treatment effect was not significant compared to placebo.
$285 million

GNCA – Genocea Biosciences Inc.
GEN-009
Various cancers

$2.02
-0.02  -1%
Phase 1/2 Phase 1 long-term follow-up clinical and immunogenicity data presented at ASCO June 4, 2021. 4/9 checkpoint inhibitor-sensitive patients experienced responses post vaccination.
$110 million

KRTX – Karuna Therapeutics Inc.
KarXT
Healthy elderly volunteers / dementia-related psychosis

$114.22
+0.81  +1%
Phase 1b Phase 2 trial to commence 1H 2022.
$3.4 billion

ORIC – Oric Pharmaceuticals Inc.
ORIC-101 and ABRAXANE (nab-paclitaxel)
Solid tumors

$16.65
-0.56  -3%
Phase 1b Phase 1b data presented at ASCO June 4, 2021.
$654.2 million

RAPT – RAPT Therapeutics Inc.
RPT193
Atopic dermatitis

$30.67
-0.52  -2%
Phase 1b Phase 1b data released June 14, 2021 - 42.9% of patients treated with RPT193 achieved a 50% improvement in EASI score (EASI-50) compared with 10.0% in the placebo group.
$900.6 million

RGLS – Regulus Therapeutics Inc.
RGLS4326
Autosomal dominant polycystic kidney disease (ADPKD)

$0.70
-0.01  -1%
Phase 1b Phase 1 data from second cohort due 3Q 2021.
$52.7 million

SURF – Surface Oncology Inc.
SRF388
Solid tumors

$6.01
-0.06  -1%
Phase 2 Phase 1 data at ASCO June 4, 2021 noted stable disease of 6 of 18 (33%) patients.
$239.8 million

TRIL – Trillium Therapeutics Inc.
TTI-621-01
Diffuse Large B-cell Lymphoma (DLBCL), Cutaneous T-cell lymphoma (CTCL)

$6.53
-0.12  -2%
Phase 1 Phase 1 TTI-621 monotherapy showed 18-29% ORR in R/R T- and B-cell lymphomas.
$579.1 million

XFOR – X4 Pharmaceuticals Inc.
Mavorixafor and IMBRUVICA (ibrutinib)
Waldenström macroglobulinemia

$5.75
-0.27  -4%
Phase 1b Phase 1b initial data released at EHA meeting June 11, 2021. At 6 months, patients achieved median IgM level reductions of 60%-75%.
$142.4 million