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.


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INOVIO (NASDAQ:INO) announced it has had its U.S. funding for its Phase 3 COVID-19 vaccine trial withdrawn.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.


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.


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).


Biotech earnings calendar:

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





Phase 1 events to watch for second quarter 2021:

Drug Stage Catalyst Market Cap

ALT – Altimmune Inc.
COVID-19 vaccine

Phase 1 Phase 1 data due June 2021.
$526.8 million

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

Phase 1a Phase 1a/b trial initiation announced October 19, 2020. Complete response reported March 23, 2021. Updated data at EHA June 9-17, 2021.
$430.4 million

BCEL – Atreca Inc.
Solid tumors

Phase 1b Phase 1b initial data due July 2021.
$350.5 million

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

Phase 1/2 Phase 1 dose-escalation initial PK, safety, and preliminary efficacy data to be presented at ASCO June 4, 2021. Dose-escalation portion on track to complete in 1H 2021. Phase 2 portion to begin 2H 2021.
$906.2 million

FMTX – Forma Therapeutics Holdings Inc.
Sickle cell disease

Phase 1 Phase 2/3 trial has been initiated. Phase 1 open label extension data due at EHA meeting June 9-17, 2021.
$1.4 billion

FREQ – Frequency Therapeutics Inc.
Age-Related Hearing Loss

Phase 1b Phase 1b data showed treatment effect was not significant compared to placebo.
$300.4 million

GNCA – Genocea Biosciences Inc.
Various cancers

Phase 1/2 Phase 1/2 long-term follow-up clinical and immunogenicity data to be presented at ASCO June 4, 2021.
$121.4 million

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

Phase 1b Phase 1b data due 2Q 2021.
$3.3 billion

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

Phase 1b Phase 1b data to be presented at ASCO June 4, 2021.
$917.4 million

RAPT – RAPT Therapeutics Inc.
Atopic dermatitis

Phase 1b Phase 1b data due 1H 2021.
$515.4 million

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

Phase 1b Phase 1 data from second cohort due mid-2021.
$67.8 million

SURF – Surface Oncology Inc.
Solid tumors

Phase 2 Phase 1 data due at ASCO June 4, 2021.
$337.6 million

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

Phase 1 Phase 1 TTI-621 monotherapy showed 18-29% ORR in R/R T- and B-cell lymphomas.
$778.6 million

XFOR – X4 Pharmaceuticals Inc.
Mavorixafor and ibrutinib
Waldenström macroglobulinemia

Phase 1b Phase 1b initial data due at EHA meeting June 11, 2021.
$177.2 million