BPC July 23 update

Biotech earnings and catalysts for the week ahead; Week in Review

Weekly watchlist

With the third-quarter earnings season underway we turn our focus to key companies reporting next week. The majority of biotech and pharma companies covered by BioPharmCatalyst are in the clinical trial phase process of drug development and have little revenue to speak of so one normally sees little share price impact from earnings reports. However, for large cap companies that are fortunate to have drugs on the market, earnings season presents a major catalyst.

We list top revenue-earning companies set to report next week below. First, however, let’s review the week that was with price-moving events.

REGULATORY:

Ardelyx, Inc. (Nasdaq: ARDX) announced the FDA has identified deficiencies with its New Drug Application for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, with the FDA noting the size of the treatment effect and its clinical relevance as one of the key issues. Shares closed the week down 78% to $1.68.

CLINICAL UPDATES:

Cytokinetics, Incorporated (NASDAQ:CYTK) shares closed the week up 51% to $29.04 following the announcement of positive data from its Phase 2 REDWOOD-HCM trial of CK-274 for the potential treatment of hypertrophic cardiomyopathy (HCM). 92.9% of patients in the high dose cohort met the set left ventricular outflow tract pressure gradient (LVOT-G) level, the target goal of treatment, compared to 7.7% in the placebo arm.

Seres Therapeutics, Inc. (NASDAQ:MCRB) shares dropped 64% to close the week down at $7.39 on news its Phase 2b ECO-RESET trial of SER-287 in patients with mild-to-moderate ulcerative colitis (UC), did not meet its primary endpoint of improving clinical remission rates compared to placebo.

Lumos Pharma, Inc. (NASDAQ:LUMO) announced that the release of data from its Phase 2 OraGrowtH210 trial has been delayed to 2H 2023. Shares closed the week down 20% to $7.69.

Magenta Therapeutics, Inc. (NASDAQ:MGTA) announced the FDA has placed a clinical hold on its Investigational New Drug Application (IND) to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Shares closed the week down 16% to $7.40.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced after hours Friday that it will stop enrollment in its Phase 3 RALLY trial of TNX-102 SL for the management of fibromyalgia. The decision follows interim analysis by the Independent Data Monitoring Committee (IDMC) which recommended stopping the trial for futility. Shares traded after hours Friday down 37% to $0.62 on the news.

OTHER:

Endo International plc (NASDAQ:ENDP) announced that it will pay $35m to settle an opioid-related case involving counties and cities in Tennessee, and one individual infant who was allegedly born with Neonatal Abstinence Syndrome. The lawsuit initially sought over $2 billion in damages following the abuse effects of its painkiller Opana ER, which was withdrawn from the market in 2017. Shares closed the week up 41% to $5.00.

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Selection (15) of top revenue earning companies scheduled to report earnings week of July 26-30, 2021 (PREMIUM members see BioPharmCatalyst earnings calendar for full list and details)

Wed: ALKS BMRN BMY EXAS GSK PFE TEVA

Thu: EBS GILD MRK SGEN SNY OPK VRTX

Fri: ABBV

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Other catalysts penned in for next week:

Drug Price Stage Catalyst Market Cap

ALEC – Alector Inc.
AL001 (INFRONT-2)
Frontotemporal Dementia

$26.81
+1.35  +5%
Phase 2 Phase 2 open-label data presented at AAIC meeting July 29 2021 - slowed clinical progression by 47%.
$2.2 billion

ALEC – Alector Inc.
AL002 (INVOKE-2)
Alzheimer’s disease

$26.81
+1.35  +5%
Phase 2 Phase 2 trial ongoing. Dosing commenced January 2021.
$2.2 billion

ANVS – Annovis Bio Inc.
ANVS401
Alzheimer’s disease (AD) and Parkinson’s disease (PD)

$33.50
+2.26  +7%
Phase 2a Phase 2a completion of dosing announced August 11, 2021 full data due early Fall 2021. Phase 3 trial to be initiated 1Q 2022.
$271.4 million

ARDX – Ardelyx Inc.
Tenapanor
Serum phosphorus - chronic kidney disease (CKD) on dialysis

$1.31
-0.03  -2%
CRL FDA issued CRL on July 29 2021.
$135.1 million

BCEL – Atreca Inc.
ATRC-101
Solid tumors

$6.29
+0.18  +3%
Phase 1b Phase 1b initial data released July 29, 2021. 20/50 (40%) of patients exhibited stable disease.
$232.1 million

INFI – Infinity Pharmaceuticals Inc.
Eganelisib (IPI-549) + TECENTRIQ (atezolizumab) and ABRAXANE (nab-paclitaxel) and IPI-549 + TECENTRIQ (atezolizumab) and AVASTIN (Bevacizumab) - (MARIO-3)
Front-line triple negative breast cancer (TNBC); Renal cell cancer (RCC)

$3.63
+0.21  +6%
Phase 2 Phase 2 updated data released July 27, 2021. Overall response rate 55% in patients. PFS was extended as compared to benchmark data for atezolizumab and nab-paclitaxel alone, increasing from 7.2 months to 7.4 months.
$322.1 million

IONS – Ionis Pharmaceuticals Inc.
IONIS-MAPTRx (ISIS 814907; BIIB080)
Alzheimer's disease

$37.21
+0.78  +2%
Phase 1/2 Phase 1/2 trial met its primary objective of safety and tolerability. Further data due later in 2021.
$5.3 billion

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

$0.63
+0.02  +4%
CRL CRL announced July 26, 2021.
$114.3 million

MDWD – MediWound Ltd.
EscharEx
Venous leg ulcers (VLU’s)

$3.56
+0.06  +2%
Phase 2 Phase 2 trial to continue as planned as per Independent Data Monitoring Committee’s (IDMC) recommendation - July 28, 2021. Data due 1H 2022.
$97 million

SAVA – Cassava Sciences Inc.
Simufilam (PTI-125)
Alzheimer’s disease

$48.51
+4.56  +10%
Phase 2 Phase 2b trial did not meet primary endpoint - May 15, 2020. Noted improvements in biomarkers of disease pathology September 14, 2020. Phase 2 open-label data 9-month data released July 29, 2021. 12-month data due 4Q 2021. Separate Cognition Maintenance Study (CMS) trial ongoing. Phase 3 trial to be initiated Fall 2021.
$1.9 billion