The Week Ahead In Biotech (Nov. 7-Nov. 13): Earnings Taper Off, Multiple Conference Presentations, IPOs And More

Biotech stocks reversed course and closed the week ended Nov. 5 lower, squandering the gains notched early in the week.

What was good news for Pfizer, Inc. PFE turned out to be negative for several others engaged in COVID-19 vaccine and treatment research. Pfizer announced Friday its oral COVID-19 pill Paxlovid reduced the risk of COVID-19-related hospitalization or death by 89%.

Merck & Co., Inc. NYSE, which also has a competing medication in the pipeline, shed close to 10% on Friday.

Stocks also reacted to the earnings, which came in thick and fast during the week. Five stocks belonging to the biotech and diagnostics spaces, debuted on Wall Street during the week.

Here are the key upcoming catalysts that biotech investors are on in the unfolding week:

Health Care Conferences:

• American College of Rheumatology, or ACR, Convergence 2021: Nov. 3-9 (virtual)
• BMO Biopharma Spotlight Series: Emerging Trends and Therapeutics in Oncology: Nov. 8 (virtual event)
• Credit Suisse 30th Annual Virtual Healthcare Conference: Nov. 8-11 (virtual conference)
• 14th Clinical Trial On Alzheimer's Disease, or CTAD, 2021: Nov. 9-12 (in Boston)
• 6th Respiratory Syncytial Virus Network, or RESVINET, Conference: Nov. 10-12 (virtual meeting)
• Society For Immunotherapy of Cancer: Nov. 10-14 (hybrid event, to be held in Washington, D.C. and to be available virtually)
• Connective Tissue Oncology Society, or CTOS, 2021 Annual Meeting: Nov. 10-13 (virtual meeting)
• American Academy of Ophthalmology, or AAO, 2021 Meeting: Nov. 12-13 (in New Orleans)
• American Association for the Study of Liver Diseases, AASLD, The Liver Meeting 2021: Nov. 12-15 (virtual meeting)

Clinical Readouts/Presentations

Liver Meeting Presentations

• Enanta Pharmaceuticals, Inc. ENTA: Phase 1b data for EDP-514 in viremic, chronic hepatitis B infected patients
• Vir Biotechnology, Inc. VIR: Preliminary results from a Phase 1 study evaluating a single dose of VIR-3434, a novel neutralizing, vaccinal monoclonal antibody, for hepatitis B infection (Friday, at 8 a.m.)
• Vaccitech plc VACC: Interim results of HBV001, a Phase 1 study evaluating therapeutic vaccination with ChAdOx1-HBV in healthy volunteers and patients with chronic hepatitis B infection; Phase 1b/2a study of heterologous ChAdOx1/MVA therapeutic vaccination combined with Bristol-Myers Squibb Company's BMY low-dose Opdivo in virally-suppressed patients with CHB under nucleos(t)ide analogues
• Dicerna Pharmaceuticals, Inc. DRNA: results of a subpopulation pharmacokinetic and safety analysis from the Phase 1 trial of RG6346, which Dicerna is developing in collaboration with Roche Holding AG RHHBY for the treatment of chronic hepatitis B virus infection; interim Phase 1 data from Belcesiran in Alpha 1-antitrypsin deficiency-associated liver disease
• Lipocine Inc. LPCN: safety And tolerability Of LPCN 1144 treatment In biopsy confirmed NASH subjects from the Phase 2 LiFT study
• Arbutus Biopharma Corporation ABUS: data on the effects of its GalNAc-siRNA, AB-729, in chronic hepatitis B patients on nucleos(t)ide analogue therapy
• Axcella Health Inc. AXLA: Phase 2 data for AXA1665 in overt hepatic encephalopathy and data from the Phase 2b study of AXA1125 in non-alcoholic fatty liver disease patients
• VBI Vaccines Inc. VBIV: results from a pivotal phase 3 study of 3-antigen HBV vaccine containing pre-S1, pre-S2 and S antigens
• CohBar, Inc. CWBR: data from the Phase 1a/1b clinical study of CB4211 in obese subjects with nonalcoholic fatty liver disease
• Aligos Therapeutics, Inc. ALGS: data on ALG-000184 in treating chronic hepatitis B patients
• Protagonist Therapeutics, Inc. PTGX: Phase 2 data for Rusfertide in patients with hereditary hemochromatosis. (Saturday)

CTAD Presentations

• Alector, Inc. ALEC: Phase 1 data for AL003 in Alzheimer's disease, update on the Phase 2 study of AL001 in frontotemporal dementia patients carrying a granulin mutation
• Annovis Bio, Inc. ANVS: positive clinical outcomes of posiphen in two phase 2a studies - Alzheimer's disease and Parkinson's disease
• AC Immune SA ACIU: topline results from Phase 2 study of Semorinemab in Alzheimer's disease; additional Phase 2 data for ACI-24 in Alzheimer's disease
• Biogen Inc. BIIB: topline results from TANGO, a Phase 2 study of gosuranemab in participants with mild cognitive impairment due to Alzheimer's disease
• Cortexyme, Inc. CRTX: topline results from the Phase 2/3 study of Atuzaginstat in mild to moderate Alzheimer's disease

Related Link: Mirati Therapeutics COO, CMO Exit, Completing Management Overhaul

CTOS Meeting Presentations

• Adaptimmune Therapeutics plc ADAP: Phase 2 data of afamitresgene autoleucel in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma
• Oncternal Therapeutics, Inc. ONCT: interim clinical data update for ONCT-216 in patients with relapsed or refractory Ewing sarcoma
• Inhibrx, Inc. INBX: update from the Phase 2 expansion cohort for INBRX-109 in patients with conventional chondrosarcoma

AAO Meeting Presentations

• Graybug Vision, Inc. GRAY: Phase 2b data for GB-102 in wet age-related macular degeneration
• Ocuphire Pharma, Inc. OCUP: Phase 2 data for oral APX3330 in diabetic retinopathy/diabetic macular edema; Phase 2 data for phentolamine ophthalmic solution and low-dose pilocarpine for treating presbyopia
• REGENXBIO Inc. RGNX/ Clearside Biomedical, Inc. CLSD: two-year results from the Phase 1/2a study of subretinal RGX-314 gene therapy for treating neovascular AMD and an update on suprachoroidal trials
• EyePoint Pharmaceuticals, Inc. EYPT: interim Phase 1 data from DAVIO trial of EYP-1901 for the potential treatment of wet AMD

SITC Meeting Presentations

• Corvus Pharmaceuticals, Inc. CRVS: data from the Phase 1/1b trial of mupadolimab in solid tumors, as well as from the Phase 2 study of mupadolimab in human papilloma virus positive head and neck squamous cell cancers
• Nektar Therapeutics NKTR: Phase 1b data for NKTR-255 plus cetuximab in patients with solid tumors
• Immutep Limited IMMP: results from a Phase 2 study of eftilagimod alpha and Merck & Co., Inc.'s MRK Keytruda in patients with PD-L1 unselected metastatic 2nd line head and neck squamous cell carcinoma; data from Phase 2 study of eftilagimod alpha and Keytruda in patients unselected for PD-L1 expression in first line metastatic head and neck squamous cell carcinoma
• Genmab A/S GMAB & BioNTech SE BNTX: results of the Phase 1/2 trial evaluating investigational bispecific antibody, GEN1042 in patients with advanced solid tumors as well as Phase1/2 data for GEN1046 in solid tumors
• Replimune Group, Inc. REPL: data from the Phase 1 clinical trial of RP2, as a single agent and combined with Opdivo in patients with advanced solid tumors
• Checkmate Pharmaceuticals, Inc. CMPI: final clinical data from the Phase 1b study vidutolimod, in combination with Keytruda or as a monotherapy in melanoma
• NextCure, Inc. NXTC: preclinical data for its lead drug candidate, NC318
• OncoSec Medical Incorporated ONCS: Phase 2b data for TAVO and Keytruda in melanoma patients
• Kadmon Holdings, Inc. KDMN: Phase 1 clinical data for KD033 in patients with metastatic or locally advanced solid tumors

Earnings

Monday

• Editas Medicine, Inc. EDIT (after the close)
• Reata Pharmaceuticals, Inc. RETA (after the close)
• Viatris Inc. VTRS (before the market open)
• ACADIA Pharmaceuticals Inc. ACAD (after the close)
• Invitae Corporation NVTA (after the close)
• Mirati Therapeutics, Inc. MRTX (after the close)
• Nevro Corp. NVRO (after the close)
• ShockWave Medical, Inc. SWAV (after the close)

Tuesday

• Vericel Corporation VCEL (before the market open)
• Intra-Cellular Therapies, Inc. TCI (before the market open)
• Haemonetics Corporation HAE (before the market open)
• Epizyme, Inc. EPZM (before the market open)
• BioNTech (before the market open)
• Biohaven Pharmaceutical Holding Company Ltd. BHVN (before the market open)
• Cardiovascular Systems, Inc. CSII (before the market open)
• ChemoCentryx, Inc. CCXI (after the close)
• FibroGen, Inc. FGEN (after the close)
• Fulgent Genetics, Inc. FLGT (after the close)
• Inovio Pharmaceuticals, Inc. INO (after the close)
• Jazz Pharmaceuticals plc JAZZ (after the close)
• Ligand Pharmaceuticals Incorporated LGND (after the close)
• Silk Road Medical, Inc SILK (after the close)

Wednesday

• Sotera Health Company SHC (before the market open)
• 23andMe Holding Co. ME (after the close)
• Maravai LifeSciences Holdings, Inc. MRVI (after the close)
• Friday
• AstraZeneca PLC AZN (before the market open)

IPOs

IPO Pricing

Dallas, Texas-based Vaxxinity VAXX, a biotech company having a proprietary platform designed to harness the immune system to convert the body into its own drug factory, has filed for offering 6.7 million shares of its Class A common stock in an initial public offering, The offering is expected to be priced between $14 and $16. The company has applied for listing its shares on the Nasdaq under the ticker symbol "VAXX."

IPO Quiet Period Expiry

• Bone Biologics Corporation BBLG
• Lucid Diagnostics Inc. LUCD
• MiNK Therapeutics, Inc. INKT

Related Link: Attention Biotech Investors: Mark Your Calendar For November PDUFA Dates