BPC March 20 update

Tentative biotech catalysts left on the table for March; Biotech week in Review

Weekly watchlist

As mentioned last week, many key catalysts remain on the table for release by the end of this month. A selection of such readouts is listed below. The companies concerned have yet to inform investors of any delays, so while one must assume that data will be released on time, caution is still recommended regarding the timing of the events below, in particular taking into account the rapidly changing situation in the U.S.

First, let’s review the week that was, which saw newsflow, in the healthcare sector at least, dominated by COVID-19 coronavirus news.

Several companies noted upcoming delays with their clinical trials due to the coronavirus (COVID-19) pandemic. IVERIC bio, Inc. (Nasdaq: ISEE) announced that enrolment of its pivotal trial of Zimura for the treatment of geographic atrophy (GA) has been delayed while, Provention Bio, Inc. (Nasdaq: PRVB) announced a temporary pause in the randomization of patients in its Phase 3 trial of teplizumab in patients with newly diagnosed type 1 diabetes.

BioNTech SE (Nasdaq: BNTX) announced double collaborations in both China and ex-China to develop its mRNA vaccine candidate BNT162 for the prevention of COVID-19 infections, with trials to commence in late April 2020. Shares closed the week up 50% to $46.50, but well down from its intra-day high of $105 on Wednesday.

Vaxart, Inc. (NASDAQ:VXRT) shares closed the week up 23% to $1.80 following news it has entered into an agreement with Emergent BioSolutions Inc. (NYSE:EBS) to develop and manufacture Vaxart's oral vaccine candidate for COVID-19. A Phase 1 trial is slated to commence in early 2H 2020.

Moderna, Inc., (NASDAQ:MRNA) announced that the first participant has been dosed in its Phase 1 trial of its mRNA vaccine (mRNA-1273) for COVID-19. The company also noted that it expects to initiate a Phase 2 trial in a few months. Shares closed the week up 32% to $28.20.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that its scientists have isolated virus-neutralizing, fully human antibodies from their VelocImmune mice, which have been genetically-modified to have a human immune system. Regeneron will select the top two antibodies for a 'cocktail' treatment for COVID-19 and plans to produce hundreds of thousands of prophylactic doses per month by the end of summer. Clinical testing will also commence at the beginning of the summer.

DBV Technologies (Nasdaq: DBVT) shares closed Tuesday down 56% to $2.33 following news the FDA has identified questions regarding efficacy of its Biologics License Application (BLA) for Viaskin Peanut in patients with peanut allergy. As a result, the Allergenic Products Advisory Committee (APAC) meeting to discuss the BLA will no longer take place as previously scheduled.

Key biotech catalysts slated for March (caution advised with possible delays due to COVID-19 situation).

Drug Stage Catalyst Market Cap

AKRO – Akero Therapeutics Inc.
Nonalcoholic steatohepatitis (NASH)

Phase 2a Phase 2a dose groups all met primary endpoint - March 31, 2020. Top-line safety/tolerability, laboratory measures and paired biopsy data due 2Q 2020.
$653.2 million

ASND – Ascendis Pharma A/S

Phase 2 Phase 2 six-month data from the open-label extension portion due 3Q 2020. Phase 3 trial to commence 4Q 2020.
$7 billion

AXSM – Axsome Therapeutics Inc.
Treatment resistant depression

Phase 3 Phase 3 data did not meet primary endpoint. Secondary endpoints met. Second Phase 3 trial to commence 3Q 2020.
$2.8 billion

AXSM – Axsome Therapeutics Inc.

Phase 3 Phase 3 data met primary endpoints - April 6, 2020.
$2.8 billion

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Migraine - preventative

Phase 3 Phase 3 top-line data met primary endpoint - March 30, 2020.
$3.9 billion

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Namodenoson (CF102)
Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2 endpoints met - April 7, 2020.
$20 million

IGXT – Intelgenx Techs Corp

CRL CRL announced March 27, 2020.
$24.8 million

IMVT – Immunovant Inc.
Graves Ophthalmopathy

Phase 2a Phase 2a initial data March 30, 2020 noted 65% mean reduction in total IgG.
$1.9 billion

ITRM – Iterum Therapeutics plc
Uncomplicated urinary tract infections (uUTI)

Phase 3 Phase 3 data due 2Q 2020.
$22.2 million

MIST – Milestone Pharmaceuticals Inc.
Etripamil - NODE-301
Paroxysmal supraventricular tachycardia (PSVT)

Phase 3 Phase 3 top-line data released March 23, 2020 did not meet primary endpoint.
$86.6 million

MNLO – Menlo Therapeutics Inc.
Pruritus associated with prurigo nodularis

Phase 3 Phase 3 data did not meet primary endpoint - April 6, 2020.
$290.2 million

MYOV – Myovant Sciences Ltd.
Relugolix - SPIRIT 2
Endometriosis-associated pain

Phase 3 Phase 3 data met co-primary endpoints - April 22, 2020.
$1.5 billion

NVAX – Novavax Inc.
NanoFlu vaccine

Phase 3 Phase 3 top-line data met primary endpoints - March 24, 2020.
$2.6 billion

PRQR – ProQR Therapeutics N.V.
Usher Syndrome Type 2

Phase 1/2 Phase 1/2 interim data March 31, 2020. 2/8 patients demonstrated benefit across multiple concordant outcome measures.
$265.8 million