BPC October 22 update

Upcoming COVID-19 vaccine catalysts; Biotech week in Review

Weekly watchlist

The next couple months will see the first key data readouts from Phase 3 COVID-19 vaccine trials. These feature among other key COVID vaccine catalysts in this week’s list below.

First, let’s review the week that was with notable healthcare news.

COVID-19:

Gilead Sciences, Inc. (NASDAQ:GILD) announced Thursday that the FDA has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization, making it the first FDA-approved treatment in the U.S. for COVID-19. Previously, the FDA had issued an Emergency Use Authorization (EUA) which meant that while Gilead was not given permission to market the product, hospital doctors were be able to obtain and use it in a stated dosage regimen for patients with COVID-19.

Moderna, Inc., (Nasdaq: MRNA) announced that it has completed enrolment of 30,000 participants for its Phase 3 trial of mRNA-1273, its vaccine candidate against COVID-19. Interim data are expected in November.

CLINICAL DATA:

CRISPR Therapeutics (NASDAQ:CRSP) closed Wednesday down 14% to $92.22 following the release of initial data from its Phase 1 trial evaluating the safety and efficacy of CTX110 in relapsed or refractory non-Hodgkin lymphoma. Complete responses (CRs) were achieved in 4 out of 11 patients across four dose levels with 2/4 CRs at the third-highest dose. However, the single patient to receive the highest dose died 52 days after receiving treatment.

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) shares closed Friday down 86% to $5.20 following news its Phase 3 trial of M-001, its universal flu vaccine candidate, failed to meet both the primary and secondary efficacy endpoints.

REGULATORY

Zosano Pharma Corporation (NASDAQ:ZSAN) shares closed Wednesday down 28% to $0.44 on news it received a complete response letter (CRL) from the FDA for its New Drug Application (NDA) for Qtrypta. The FDA has recommended that the company conduct a repeat bioequivalence study before resubmitting its NDA.

BUYOUT RELATED

Endo International plc (NASDAQ:ENDP) announced it will acquire all of the outstanding shares of BioSpecifics Technologies Corp. (NASDAQ:BSTC) for $88.50 in cash per share, or an estimated enterprise value of approximately $540m. BioSpecifics shares closed Monday up 45% to $88.69, while Endo shares closed up 13% to $5.64.

Cleveland BioLabs, Inc., (NASDAQ:CBLI) announced a reverse merger with Cytocom. Cleveland shareholders will own approximately 39% of the newly merged company. Cleveland shares closed the week up 14% to $2.60.

Upcoming COVID-19 vaccine catalysts:

Drug Price Stage Catalyst Market Cap

ALT – Altimmune Inc.
AdCOVID
COVID-19 vaccine

$15.56
-0.08  -1%
Phase 1 Phase 1 data due June 2021.
$597.5 million

ARCT – Arcturus Therapeutics Holdings Inc.
ARCT-021
COVID-19 vaccine

$33.02
+0.22  +1%
Phase 2 Phase 2 data due 2H 2021. Phase 3 trial planned.
$869.1 million

AZN – AstraZeneca PLC
AZD1222
COVID-19 vaccine

$57.89
-0.42  -1%
Phase 3 Phase 3 data exhibited 70% efficacy (90% and 60% across two dosing regimens) - UK and Brazil trial. Data from U.S. trial noted 76% efficacy rate - March 24, 2021.
$152 billion

CVAC – CureVac N.V.
CVnCoV
COVID-19 vaccine

$58.10
-1.57  -3%
Phase 2/3 Phase 2b/3 trial did not meet prespecified statistical success criteria - June 16, 2021.
$10.8 billion

GSK – GlaxoSmithKline PLC
Adjuvanted COVID-19 vaccine
COVID-19 vaccine

$39.08
-0.70  -2%
Phase 3 Phase 3 trial initiation announced May 27, 2021 with data due around 4Q 2021.
$98.3 billion

IMV – IMV Inc.
DPX-COVID-19
COVID-19 vaccine

$2.32
0.00  0%
Phase 1/2 Phase 1/2 trial planned.
$157.3 million

INO – Inovio Pharmaceuticals Inc.
INO-4800
COVID-19 vaccine

$8.70
+0.06  +1%
Phase 2 Phase 2 data released May 10, 2021 - generally safe and well-tolerated. Phase 3 trial to commence 2Q 2021.
$1.8 billion

JNJ – Johnson & Johnson
JNJ-78436735 (Ad26.COV2-S) - (ENSEMBLE)
COVID-19 vaccine (single dose)

$163.62
-0.22  -0%
Approved Phase 3 data released January 29, 2021. Efficacy rate 66% in overall population, 72% effective in U.S. and 57% in South Africa. EUA Approval by FDA announced February 27, 2021.
$430.9 billion

MRNA – Moderna Inc.
mRNA-1273
COVID-19 vaccine

$221.36
+13.12  +6%
Approved FDA approval (EUA) announced December 18, 2020. Initiation of rolling BLA filing announced June 1, 2021.
$88.9 billion

NVAX – Novavax Inc.
NVX-CoV2373
COVID-19 vaccine

$194.37
+13.38  +7%
Phase 3 Phase 3 U.S. trial data released June 14, 2021. 90.4% efficacy overall, 100% protection against moderate and severe disease.
$14.4 billion

PFE – Pfizer Inc.
BNT162b2
COVID-19 vaccine

$39.61
+0.19  +0%
BLA Filing FDA EUA approval announced December 11, 2020. Rolling BLA filing has been submitted - May 7, 2021.
$221.7 billion

SNY – Sanofi
MRT5500
COVID-19 vaccine

$52.30
-0.32  -1%
Phase 1/2 Phase 1/2 interim data due 3Q 2021.
$130.8 billion

VXRT – Vaxart Inc.
VXA-CoV2-1
COVID-19 Vaccine

$7.89
-0.01  -0%
Phase 1 Phase 2 trial to commence mid-2021.
$964.7 million