BPC September 03 update

September biotech catalysts to watch; Biotech week in review

Weekly watchlist

Until the end of the quarter, we will highlight 14-15 key catalysts to watch, refreshing the list each week by replacing completed catalysts with others yet to readout. Catalysts for Apellis Pharmaceuticals, Inc. (NASDAQ: APLS), Evelo Biosciences, Inc. (NASDAQ: EVLO), and Editas Medicine, Inc. (NASDAQ: EDIT) are among the top events to watch, together with presentations at the upcoming ESMO conference.

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

REGULATORY:

Moderna, Inc. (NASDAQ: MRNA) submitted initial data to the FDA for approval of the third dose of its COVID-19 vaccine. The data showed that with an additional shot, antibody responses displayed more than 40x against the delta variant. This followed the publishing of a Belgian researcher’s analysis that Moderna’s mRNA vaccine produced twice as many antibodies as its rival Pfizer and Biontech SE.

NeuroPharma, Inc. (NASDAQ: IMPL) released that the FDA has approved TRUDHESA, a nasal spray for the acute treatment of migraine in adults. The commercial launch of TRUDHESA is planned for early October 2021.

CLINICAL UPDATES:

Forte Biosciences, Inc. (NASDAQ: FBRX) has discontinued its Phase 2 trial of FB-401 for the treatment of atopic dermatitis. The trial failed to meet statistical significance for the primary endpoint. Forte will not continue the development of FB-401. Shares closed the week down 82% at $5.13.

Pliant Therapeutics, Inc. (NASDAQ: PLRX) announced that it will issue a pre-market press release and conduct a conference call on Tuesday, September 7, 2021. During this call, they will release interim clinical data from an ongoing Phase 2a positron emission tomography (PET) imaging trial of PLN-74809 in patients with idiopathic pulmonary fibrosis (IPF).

Assembly Biosciences (NASDAQ: ASMB) announced that the Phase 2 study of ABI-H2158 as a treatment for hepatitis B virus (HBV) will be discontinued. This decision was made after some participants in the study displayed symptoms of drug-induced hepatotoxicity. Assembly will not continue the development of ABI-H2158. Shares closed Friday down 11% at $3.26.

AC Immune SA. (NASDAQ: ACIU) announced that its Phase 2 trial of semorinemab to treat Alzheimer’s disease, has met one of its two co-primary endpoints. Following this announcement, AC noted that they will continue to analyze the data to present at the CTAD conference (Clinical Trials on Alzheimer's Disease) in November 2021. Shares traded as high as $12.61 following the release of data, before retracing gains to close the week up 3% at $7.12.

Drug Price Stage Catalyst Market Cap

ADAP – Adaptimmune Therapeutics plc
ADP-A2M4CD8 (SURPASS)
Solid tumors

$5.40
+0.11  +2%
Phase 1 Phase 1 data released September 13, 2021 - 4% of patients received CR, 28% received PR, 44% received SD, 12% received PD, 3% not evaluable. Additional data due at ESMO September 16-21, 2021.
$842.9 million

ALT – Altimmune Inc.
ALT-801
Non-alcoholic steatohepatitis (NASH) - Healthy Overweight and Obese Volunteers

$15.24
-1.16  -7%
Phase 1 Phase 1 6-week MAD released June 16, 2021. Weight loss of 5.4% achieved at 6 weeks of treatment with 1.8 mg once weekly dose. 12-week data due September 2021. Phase 2 obesity and NASH trials expected to initiate in Q1 2022.
$605.1 million

APLS – Apellis Pharmaceuticals Inc.
EMPAVELI (pegcetacoplan) - OAKS
Geographic atrophy (GA) associated with age-related macular degeneration (AMD)

$34.21
+0.21  +1%
NDA Filing Phase 3 data met primary endpoint September 9, 2021. NDA expected to be filed in the first half of 2022.
$3 billion

APLS – Apellis Pharmaceuticals Inc.
EMPAVELI (pegcetacoplan) - DERBY
Geographic atrophy (GA)

$34.21
+0.21  +1%
Phase 3 Phase 3 data did not meet primary endpoints September 9, 2021.
$3 billion

ASLN – ASLAN Pharmaceuticals Limited
ASLAN004
Atopic dermatitis

$3.22
+0.19  +6%
Phase 1 Phase 1 top-line data due end of 3Q 2021. Phase 2b trial to be initiated 4Q 2021.
$224.2 million

CRDF – Cardiff Oncology Inc.
Onvansertib, FOLFIRI and AVASTIN (bevacizumab)
KRAS-Mutated Colorectal Cancer

$6.86
+0.13  +2%
Phase 1/2 Phase 1b/2 data displayed 42% of patients achieved an initial partial response (PR) as of the data cutoff date, 37% have achieved a confirmed PR. Treatment is shown to be well-tolerated with only 10% of reported treatment-emergent adverse events. - September 8 2021.
$271.3 million

EDIT – Editas Medicine Inc.
AGN-151587 (EDIT-101) - BRILLIANCE
Leber Congenital Amaurosis type 10 (LCA10).

$63.20
+2.20  +4%
Phase 1/2 Phase 1/2 initial data due to be presented at the International Symposium on Retinal Degeneration planned for September 29, 2021.
$4.3 billion

EVLO – Evelo Biosciences Inc.
EDP1815
Mild to moderate psoriasis

$8.34
+1.03  +14%
Phase 2b Phase 2b data due 3Q 2021.
$445.3 million

LIFE – aTyr Pharma Inc.
ATYR1923
Pulmonary sarcoidosis

$10.31
+0.05  +0%
Phase 1/2 Phase 1b/2a trial met primary endpoint September 13, 2021.
$174.4 million

MGNX – MacroGenics Inc.
MGC018
Solid tumors

$20.48
-0.51  -2%
Phase 1 Phase 1 data of mCRPC patients showed 25% (4) achieved partial responses (PR) (two confirmed and two unconfirmed). Of NSCLC patients, 25% (4) achieved unconfirmed partial responses (PR). At least one TRAE of any grade was experienced by 78 of 86 patients (91%), with 43 of 86 patients (50%) experiencing a Grade ≥3 TRAE. There were two Grade 5 fatal events: one from an unknown cause and one due to SARS-CoV-2. Noted September 16, 2021.
$1.3 billion

MRTX – Mirati Therapeutics Inc.
Adagrasib (MRTX-849), Erbitux (cetuximab) and KEYTRUDA (pembrolizumab) - KRYSTAL-01
Solid Tumors

$174.05
+5.03  +3%
Phase 1/2 Phase 1/2 cetuximab data to be orally released at ESMO September 19, 2021.
$9 billion

PLRX – Pliant Therapeutics Inc.
PLN-74809
Idiopathic pulmonary fibrosis

$18.24
-0.76  -4%
Phase 2a Phase 2a PET positive interim data results released September 7, 2021.
$655.5 million

RDHL – Redhill Biopharma Ltd.
YELIVA (Opaganib)
COVID-19

$4.89
+0.07  +1%
Phase 2/3 Phase 2/3 preliminary top-line data results did not meet its primary endpoint September 14, 2021.
$228.5 million

SBTX – Silverback Therapeutics Inc.
SBT6050 (monotherapy and pembrolizumab)
HER2 Positive Solid Tumors

$12.55
+0.05  +0%
Phase 1 Phase 1/1b presented at ESMO September 16, 2021. Among 18 evaluable patients for tumor types of interest, 1 patient had a confirmed partial response (5%). In addition, stable disease was reported in 7 patients (38%).
$439.7 million

SYRS – Syros Pharmaceuticals Inc.
SY-5609
Solid tumors

$5.08
-0.37  -7%
Phase 1 Phase 1 abstract to be released late September 16, 2021. Phase 1 dose-escalation data to be presented at ESMO September 20, 2021.
$314.6 million

TBPH – Theravance Biopharma Inc.
Ampreloxetine
nOH

$7.11
+0.25  +4%
Phase 3 Phase 3 study did not meet its primary endpoint September 15, 2021.
$522.4 million