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    1x1 Meetings with Stern IR
    Clients in SF

    January 13-16, 2020

Stern IR will be scheduling and hosting meetings for many of our clients around the 2019 J.P. Morgan Healthcare Conference, being held January 13-16th in San Francisco.

This year we'll be coordinating schedules for around 60 of our top-tier companies, listed here below with brief descriptions. To request specific meetings, please select those companies and fill out the short contact information form with your availability, and a member of our team will follow up shortly for scheduling.

Many of our companies will be hosting meetings in Stern IR suites at The Marker Hotel (501 Geary Street, b/t Jones & Taylor), just 2 blocks away from the conference location at the Westin St. Francis. See you in SF!

Save the Date

When
Begins on Monday, January 13th, 2020.
Ends on Thursday, January 16th, 2020.

Need Further Assistance?

For help or to schedule a meeting over the phone, contact us at:

Offering meeting opportunities with more than 60 of our top-tier companies over the course of 4 days.

1x1 Meeting Registration Form

Companies I'm Interested In

Check all that apply.
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    Clinical-stage oncology-focused biotech company pioneering the development of a robust pipeline of highly potent and targeted ADCs for patients suffering from hematological malignancies and solid tumors. ADCT-402 and ADCT-301, the company's two lead programs, have demonstrated significant clinical activity while maintaining manageable tolerability profiles in heavily pre-treated patients. Enrollment in the 145-patient pivotal Phase 2 clinical trial of ADCT-402 in relapsed or refractory DLBCL is complete and a BLA submission is anticipated in 2H20. ADCT-301 is being evaluated in a 100-patient pivotal Phase 2 clinical trial in relapsed or refractory Hodgkin lymphoma, which is intended to support a BLA submission in 1H22.

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    Clinical-stage biotechnology company focused on the development and commercialization of transformative treatments for patients with serious metabolic disease with high unmet medical need. Akero's lead program, AKR-001, currently being evaluated in a Phase 2a clinical trial for patients with NASH (non-alcoholic steatohepatitis), is an Fc-FGF21 fusion protein that has been engineered to mimic the biological activity profile of native FGF21, an endogenous hormone that regulates lipid and energy metabolism.

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    Late-stage biopharmaceutical company developing first-in-class, oral enzyme therapeutics for rare and severe metabolic and kidney disorders. Currently evaluating lead candidate reloxaliase in pivotal Phase 3 URIROX program in patients with enteric hyperoxaluria (EH), with topline data from URIROX-1 expected in 4Q19 and from URIROX-2 in 2H21. Also evaluating reloxaliase in Study 206, a Phase 2 basket study in patients with EH or primary hyperoxaluria (PH) with advanced chronic kidney disease (CKD) and elevated plasma oxalate, with topline data expected in 4Q19. Second product candidate, ALLN-346, is being developed for hyperuricemia in patients with gout in the setting of advanced CKD, with an IND filing expected in 4Q19 and initiation of the first clinical trial in 1H20.

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    Biopharmaceutical company developing treatments designed to halt the progression of diseases, with initial focus on recurrent platinum-resistant ovarian cancer. Aravive is currently enrolling the expansion cohort in an ongoing Phase 1b portion of its Phase 1b/2 study for its lead product candidate AVB-500, an ultra-high affinity decoy protein that starves the GAS6/AXL signaling pathway, an important driver of cell migration and invasion in cancer and fibrosis.

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    Developing deep pipeline of differentiated antibody-based therapies, built by proprietary technology suite and sustained by accessing novel targets from leading academic labs. FcRn antagonist Efgartigimod (ARGX-113) is currently being tested in one Phase 3 clinical trial in myasthenia gravis (MG) with topline data expected in 2H20 and one Phase 2 clinical trial in pemphigus vulgaris (PV) with data expected in 1H20.  Phase 3 program in primary immune thrombocytopenia (ITP) is expected to start in second half of 2019, and Phase 2 in chronic inflammatory demyelinating polyneuropathy (CIDP) clinical trial on track to start in second half of 2019.  ARGX-117 is still in preclinical development, expected to file Clinical Trial Application (CTA) by end of 2019 with first-in-human trial expected to start in first quarter of 2020. Oncology candidate Cusatuzumab (ARGX-110) targets CD70 and is expected to start Phase 2 and registration-directed clinical trial in AML on track to start in second half of 2019. 

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    Clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis-targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company's initial clinical program, ARV-110 for the treatment of patients with metastatic castrate-resistant prostate cancer, began a Phase 1 clinical trial in the first quarter of 2019. A Phase 1 clinical study of ARV-471, in development for the treatment of patients with locally advanced or metastatic ER positive / HER2 negative breast cancer, began in in the third quarter of 2019.

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    Focused on restoring and repairing neurodegeneration across several diseases of large unmet need. Based on a novel small molecule approach that enhances a natural growth factor, NDX-1017 recently demonstrated promising clinical data in Alzheimer's patients where they showed a rapid improvement of working memory as measured by a task related event which has been selected for an oral presentation at CTAD on Dec 4th. Athira has spent considerable time identifying a key biomarker that has correlated efficacy both preclinically and clinically and shown rapid target engagement and brain penetration, giving the Company a strong knowledge of their therapeutic dose to use in upcoming phase 2 trials in both Parkinson's and Alzheimer's. Athira's second molecule, NDX-1094, is being prepared for an IND in a separate CNS indication. The Company has a strong management team with a successful track record in CNS approvals and drug development.

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    Designing and developing AXA Candidates, compositions of endogenous metabolic modulators, or EMMs, engineered in distinct ratios, designed to target and maximize the fundamental role that EMMs play in regulating multiple metabolic functions. Axcella's AXA Candidates are generated from its proprietary, human-focused AXA Development Platform. Axcella believes its expertise and capabilities in EMMs position it to become a preeminent biotechnology company reprogramming metabolism to address a diverse set of complex diseases and support health. Axcella's AXA Development Platform has already produced a pipeline of product candidates in programs targeting liver, muscle and blood.

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    Clinical stage biopharmaceutical company pioneering novel science focused on the interaction between the brain and the gut to mitigate the causes and symptoms of CNS and other gut-derived diseases. The Company has built a pipeline of novel small-molecules and live biotherapeutics with lead programs to address the significant unmet patient needs associated with Parkinson's Disease and Autism Spectrum Disorder.

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    Clinical-stage, private biopharmaceutical company, broadly developing best-in-class gamma secretase inhibitors as targeted cancer therapies for people living with genetically defined cancers. Ayala's lead product candidate, AL101, is currently in a Phase 2 clinical trial in patients with adenoid cystic carcinoma (ACC) and Notch activating mutations. Recently published poster at ESMO showed encouraging initial results from the ongoing study with clear biological activity of AL101 with favorable safety profile. AL102, is an oral small molecule, which is partnered with Novartis to evaluate in combination with its B-cell maturating antigen (BCMA) therapies in patients with multiple myeloma and is currently under development. Additional clinical studies for triple negative breast cancer (TNBC), T-cell acute lymphoblastic leukemia (T-ALL) and desmoid tumors are planned to be initiated in 2020. Ayala has raised a total of $47M to-date.

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    Advanced clinical-stage biopharmaceutical company developing novel therapies to fundamentally change neurodegenerative diseases by targeting neuroinflammation and the innate immune system. Lead program, ALZT-OP1 is currently being evaluated in a fully enrolled Phase 3 clinical trial in early Alzheimer's disease under a Special Protocol Assessment with FDA. Broad pipeline includes candidates for the treatment of ALS and post-ischemic stroke cognitive impairment. The Company is pursuing a crossover/ mezzanine financing and strategic partnerships to support pre-commercialization activities.

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    Biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous transfusion. Bio-Path's lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for the treatment of blood cancers and is in the process of filing an IND for a Phase 1 clinical trial for solid tumors. The Company is also developing BP1002, which targets the Bcl-2 protein and is expected to be evaluated for the treatment of lymphoma and solid tumors. In addition, BP1003, a novel liposomeincorporated STAT3 antisense oligodeoxynucleotide developed by Bio-Path as a specific inhibitor of STAT3, is expected to enter Phase 1 studies in 2020.

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    Private biotech company harnessing the power of the innate immune system to address key unmet needs in cancer. Bolt is developing Boltbody™ Immune Stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics that address tumors resistant to current therapies and promise improved clinical durability via establishing immunologic memory and epitope spreading to tumor neoantigens. Bolt's platform technology is applicable to a broad spectrum of antibodies targeting tumor antigens expressed on all types of cancer. Lead candidate, BDC-1001, indicated for HER2 refractory, HER2 low, and gastric cancers, to enter Phase 1 study in 1Q20.

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    Clinical-stage biotech developing and commercializing therapies designed to alleviate pruritus by targeting peripheral kappa opioid receptors (KORs). Lead candidate KORSUVA injection met its primary endpoint and all secondary endpoints in the KALM-1 pivotal Phase 3 trial in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP), with KALM-2 Phase 3 global trial ongoing and NDA filing expected in 2H20. Oral KORSUVA is being evaluated in a Phase 2 trial in non-hemodialysis patients with CKD-aP, with topline data expected in 4Q19, as well as in two ongoing Phase 2 trials in atopic dermatitis and chronic liver disease-associated pruritus (CLD-aP), with topline data expected in 2020.

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    Development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. Dociparstat sodium is an investigational product targeting multiple proteins involved in cancer cell resistance to chemotherapy under development for the treatment of acute myeloid leukemia and other hematologic malignancies. Brincidofovir (BCV, CMX001) is an anti-viral drug candidate in development as a medical countermeasure for smallpox.

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    Developing CPI-0610, a potential best-in-class BET inhibitor for the treatment of myelofibrosis, which has demonstrated potential disease-modifying activity based on preliminary results from the open-label Phase 2 monotherapy and combination MANIFEST trial, with updated data to be presented at the ASH Annual Meeting in December. EZH2 inhibitor CPI-1205 has shown deep and durable reductions in prostate-specific antigen levels, in subsets of advanced metastatic castration-resistant prostate cancer patients in combination with either abiraterone or enzalutamide, and is currently being tested in the Phase 2 PROSTAR study. CPI-0209, a second-generation and potentially best-in-class EZH2 inhibitor, recently began a Phase 1/2 clinical trial in advanced, relapsed solid tumors and could address additional patient populations beyond those targeted by first-generation EZH2 inhibitors.

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    Clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections. Lead product candidate exebacase (CF-301) has completed a positive Phase 2 clinical trial for the treatment of Staphylococcus aureus (Staph aureus) bacteremia, including endocarditis. The company plans to initiate a Phase 3 trial of exebacase by the end of 2019.

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    Clinical-stage biotech focused on the development of first-in-class and innovative therapeutics for the treatment of cancer, with data readouts for each of Curis' three programs expected in 4Q19. Fimepinostat, an oral, small molecule HDAC/PI3K targeted suppressor of MYC, is in an ongoing Phase 1 trial in combination with venetoclax in patients with MYC-altered diffuse large B-cell lymphoma (DLBCL). CA-4948, an oral, small molecule IRAK4 suppressor of the toll like receptor pathway, is in an ongoing Phase 1 trial in patients with non-Hodgkin's lymphoma, including those with MYD88 alterations. CA-170, an oral, small molecule VISTA/PD-L1 antagonist, is in an ongoing Phase 1 trial in patients with mesothelioma (high VISTA expressors).

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    Clinical stage life science company dedicated to unlocking the transformative therapeutic potential of serotonin 2A receptor (5-HT2A) agonists for the treatment of inflammation and mental illness.  Recent findings have highlighted the potential of these therapeutics as game changing anti-inflammatories and psychotherapies.  Pipeline includes lead candidate ELE-02 for Diabetic Macular Edema (DME), entering Phase II trials, and a proprietary care delivery prototype for psychoactive drug therapy, entering Phase II trials for Anorexia.

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    Clinical-stage biotechnology company developing orally delivered, systemically acting biologics. Advancing EDP1815 and EDP1066 for inflammatory diseases and EDP1503 for cancer; recently announced positive data from Phase 1b studies of EDP1815 and EDP1066 in psoriasis, and plans to advance EDP1815 into Phase 2 in psoriasis in early 2020. Additional clinical data evaluating 5x dose of EDP1815 in psoriasis expected in 4Q19. Data from new formulation of EDP1815 in psoriasis and atopic dermatitis, for new formulation of EDP1066 in atopic dermatitis, and for EDP1015 in various oncology indications expected throughout 1H2020.

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    Clinical-stage biotechnology company developing a new class of therapeutic oligonucleotides for immuno-oncology, inflammatory diseases and neurological disorders based on a proprietary Spherical Nucleic Acid, or SNA, technology. SNAs are dense, radial arrangements of synthetic nucleic acids that drive better cell uptake and stability, allowing for multi-gene targeting and localized delivery. Lead compound AST-008 is a TLR9 agonist currently in Phase 1b/2 clinical development for the treatment of solid tumors with preliminary results anticipated in 2019. Expecting to announce a new therapeutic candidate for the treatment of genetic disorders by year-end. Completed a $63.3M common stock offering lead by Abingworth and Tybourne Capital and up-listed to NASDAQ in August 2019.

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    Clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders.

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    Clinical-stage biopharmaceutical company developing novel therapies for inflammatory diseases, with initial focus on IBD. Lead asset, niclosamide, has demonstrated strong results with topical formulation in Phase 2a ulcerative colitis (UC) trial, and has the potential to replace current standard-of-care (ASAs) and treat full spectrum of IBD patient segments. Advancing both topical and oral formulations for mild-to-moderate UC, with plans to expand into Crohn's disease and moderate-to-severe IBD.

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    Private biopharma based in Watertown, MA, focused on developing breakthrough medicines for patients with rare hematologic disease and cancers. Following 10 years of research heritage and $900M in non-dilutive partnership investments, the company has recently been transformed with a new leadership team and a wholly-owned pipeline of novel, next-generation oral molecules with first/best-in-class potential, in proven platforms, with near-term data readouts, including PKR agonist FT-4202 to treat Sickle Cell Disease, IDH1m inhibitor Olutasidenib to treat Glioma and AML and FT-7051, CBP/p300 to treat AR-v7 mCRPC.

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    Clinical-stage company developing macrophage-directed therapies for oncology and transplant indications. Lead program, magrolimab (formerly 5F9), is an anti-CD47 antibody in development for a variety of tumors, with potential paths to accelerated approval in myelodysplastic syndrome and diffuse large B cell lymphoma. Also developing FSI-174, an anti-cKIT antibody, and FSI-189, an anti-SIRPα antibody, both expected to enter clinical testing in 2020.

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    Clinical-stage biotech focused on discovering and developing small molecule therapies to regulate gene expression in genetically-defined rare diseases. Leverages a proprietary approach to target identification through its product engine and robust preclinical data generation to rapidly advance drug candidates into the clinic. Recently initiated Phase 2b trial and announced Phase 1 results of lead candidate, losmapimod, which downregulates expression of DUX4 to treat the root cause of FSH Muscular Dystrophy (FSHD). Fulcrum has the only clinical program in FSHD, a disease more prevalent than DMD, for which are no approved treatments.  Phase 2b trial results expected in Q3 2020.  Most advanced pre-clinical program, FTX-6058, is a small molecule which substantially upregulates HbF and is being investigated for the treatment of sickle cell disease and beta-thalassemia with an anticipated IND filing in mid-2020. Other diseases of focus include: DMD, Friedreich Ataxia, Myotonic Dystrophy 1, and α‑Synucleinopathies with 6 additional screens planned for 2020.

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    Delivering advanced cell therapies with the potential to cure cancer and serious, rare hematologic diseases. Proprietary cell expansion technology is designed to enhance the number and functionality of donor cells in culture to potentially improve treatment outcomes from donor-derived therapies. Wholly-owned pipeline includes lead candidate, omidubicel, in Phase 3 development as a potential life-saving treatment option for patients in need of bone marrow transplant, with topline data anticipated in first half of 2020, and GDA-201, an investigational, natural killer (NK) cell-based cancer immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma and multiple myeloma.

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    Biopharmaceutical company discovering and developing therapies that modulate novel targets in the innate immune system as next-generation treatments for cancer, autoimmunity and inflammatory disorders. IFM places each program, or set of related programs, in its own dedicated, independently finances R&D-focused subsidiary company, which is supported by the common infrastructure, management team and resources of the IFM enterprise. Since its founding, IFM has executed three major deals with large pharmaceuticals companies for an aggregate value of more than $4.8B, including two transactions with Novartis in 2019: the acquisition of IFM Tre (NLRP3) and the collaboration and exclusive option agreement for IFM Due (cGAS/STING).

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    Clinical-stage biopharmaceutical company leveraging a proprietary drug delivery platform, DPX, that generates cancer-targeted T cells. DPX-Survivac is a first of a novel class of immunotherapy and targets survivin, an antigen present in more than 20 solid and hematological tumor types. DPX-Survivac is being evaluated in three ongoing Phase 2 studies: (1) as a single regimen in advanced ovarian cancer, and in combination regimen with Keytruda in (2) r/r DLBCL and (3) multiple solid tumors. Data to date have exhibited a favorable safety profile and encouraging signs of anti-tumor activity, including T cell responses that correlate with treatment and durable PFS; readouts from all three studies anticipated between 4Q19 and 1H20.

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    Developing drugs based on proprietary Accordion Pill (AP) platform technology, an oral drug delivery system that is designed to improve the efficacy and safety of drugs by utilizing an efficient gastric retention and specific release mechanism. Two product candidates in clinical trials: Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, in late Phase 3 development for the treatment of severe symptoms in advanced Parkinson's disease patients and AP-cannabinoids in Phase 1 development for various pain indications. Additional feasibility agreement with Novartis Pharmaceuticals for development of custom-designed AP and an ongoing research collaboration with Merck & Co.

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    Leading genome editing company employing a full-spectrum strategy that applies its modular CRISPR/Cas9-based platform across its in vivo and ex vivo efforts. The company has produced a robust set of preclinical data supporting the ability to selectively knock-out disease-causing transgenes of interest and introduce targeted insertion of DNA in vivo, and to engineer therapeutic lymphocytes that retain normal cell physiology. On track to submit an IND for its first in vivo candidate, NTLA-2001, for the treatment of transthyretin amyloidosis (ATTR) in mid-2020 and to declare its first engineered cell therapy candidate for the treatment of acute myeloid leukemia (AML) by the end of 2019.

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    Clinical-stage biotechnology company pioneering a new immune-based approach to treating cancer by creating high quality antigen from patients' own tumors to improve recognition by the immune system.  The Company's proprietary DfuseRxSM technology platform identifies novel drug formulations that contain cell penetration enhancers and anti-cancer agents.  Following direct intratumoral injection cancer cells die in situ eliciting an adaptive immune response. Lead drug candidate, INT230-6, has been designated for Fast Track by FDA and is being evaluated in a Phase 1/2 study for the treatment of solid tumors.  In 45 patients having a variety of cancers the drug has been well-tolerated with evidence of clinical benefit in several patients having multiple tumor types. Intensity has a clinical collaboration with Merck to study INT230-6 in combination with pembrolizumab; this cohort is enrolling.

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    Privately-held, clinical-stage biopharmaceutical company developing strong pipeline with differentiated assets targeting key mechanisms of immunosuppression in the tumor microenvironment. The Company's most advanced program, EOS100850, is a potential best-in-class adenosine A2A receptor antagonist currently in a Phase 1/1b study, followed by EOS884448, a fully human ADCC-enabling anti-TIGIT antibody expected to enter the clinic in the second half of 2019. Initial data for EOS100850 is expected in 2020. Two preclinical programs target immune-metabolism and immunosuppressive cells.

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    Clinical-stage immunotherapy company focused on a biomarker-driven approach to treating cancers with a focus on specific cell type targets within the human tumor microenvironment through the use of its Translational Science Platform. Jounce is developing two clinical-stage programs as well as advancing and building out its broad and wholly-owned discovery pipeline of immuno-oncology targets. Lead asset, vopratelimab, is a monoclonal antibody that binds to and activates ICOS and is currently being assessed in a Phase 2 clinical trial with preliminary efficacy data expected in 2020 and the second asset, JTX-4014, is a PD-1 inhibitor which has completed enrollment in the Phase 1 clinical trial. In July 2019, Jounce licensed the rights to its first macrophage program, JTX-8064, to Celgene.

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    Commercial-stage ophthalmology company developing and commercializing therapeutics using the proprietary AMPPLIFYTM mucus penetrating particle technology. First product INVELTYSTM, launched in January 2019, is the first post-surgical topical steroid with twice-daily dosing. Second product candidate KPI-121 0.25% for temporary relief of dry eye disease has completed one Phase 2 and two Phase 3 studies. A third Phase 3 trial of KPI-121 0.25%, STRIDE 3, is currently ongoing, with data expected by the end of 2019 and resubmission of an NDA to the FDA targeted for the first half of 2020.

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    Privately-held biotech company developing next generation gut microbiome-based therapies harnessing the utility of single strain bacteria to modulate clinically relevant pathways in multiple disease states. LNC01, the company's lead program, is an orally available strain of Christensenella minuta being evaluated in obesity and metabolic disorders and is expected to enter the clinic in 2020. Additional drug candidates are in preclinical development for high impact diseases with unmet needs.

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    Clinical-stage biopharmaceutical company using its differentiated and proprietary ADC platforms to develop highly targeted drugs with increased tolerability and expanded opportunities to deliver meaningful clinical benefit to patients. Lead candidate XMT-1536 is a, first-in-class ADC built on the Dolaflexin platform targeting NaPi2b. The NaPi2b antigen is broadly expressed in non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian cancer. XMT-1536 is in Phase 1 clinical trial with dose escalation and expansion cohorts in patients with ovarian cancer and NSCLC adenocarcinoma. In addition, multiple partners are using Mersana's platform to advance their ADC pipelines.

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    Leading late-stage biopharmaceutical company primarily focused on orphan endocrine diseases with three key assets, including lead program livoletide, a potential first-in-class, pivotal-stage asset for Prader-Willi syndrome, currently in Phase 2b/3 development, with topline results expected in 1H20. Broader pipeline includes nevanimibe in a Phase 2b trial for the treatment of congenital adrenal hyperplasia, and MLE-301, an NK3R antagonist in preclinical development for vasomotor symptoms in menopausal women.

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    Biotech company leveraging a validated innovative scientific platform to discover and develop novel therapeutics purposefully designed to treat rare, immune-mediated diseases. Pipeline includes nipocalimab, a fully human anti-FcRn aglycosylated IgG1 mAb, with two ongoing Phase 2 trials in MG and HDFN and an adaptive Phase 2/3 trial in wAIHA; M254, a hypersialylated human immunoglobulin designed as a high potency alternative for IVIg, currently in a Phase 1/2 trial in ITP; and M230 (CSL730), a potential first-in-class novel recombinant Fc multimer being developed in collaboration with CSL, currently in a Phase 1 trial. Top-line, proof-of-concept data are expected from nipocalimab in MG in 2-3Q2020 and M254 in ITP in 1H2020, with readouts from the wAIHA and HDFN studies anticipated in 2021.

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    Clinical-stage biopharmaceutical company pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious cardiovascular diseases. Initial focus on the development of small molecule therapeutics aimed at muscle proteins of the heart that target causal factors underlying certain types of systolic and diastolic dysfunction.  Pipeline of product candidates directed at diseases driven by excessive contraction, impaired relaxation, or insufficient contraction including: mavacamten in EXPLORER-HCM Phase 3 clinical trial (topline data expected in 2Q20) and MAVERICK-HCM Phase 2 clinical trial (data expected in 4Q19), both for hypertrophic cardiomyopathies (HCM); MYK-491 in Phase 2 for patients with dilated cardiomyopathy (topline data expected in 4Q19); and MYK-224, in Phase 1 development for HCM.

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    Clinical-stage immuno-oncology company and a leader in the field of neoantigen-targeted therapies, dedicated to transforming the treatment of cancer by directing the immune system towards neoantigens. Neon is using its neoantigen platform to develop both vaccine and T cell therapies, including NEO-PV-01, a clinical-stage neoantigen vaccine for the treatment of metastatic melanoma, non-small cell lung cancer, and bladder cancer; NEO-PTC-01, a neoantigen T cell therapy for the treatment of solid tumors; and NEO-SV-01, a neoantigen vaccine for the treatment of subset of hormone receptor-positive (HR+) breast cancer.

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    Commercial-stage pharmaceutical company that develops, manufactures and commercializes CNS-focused products. Neos has three marketed ADHD products with substantial growth runway; Adzenys XR-ODT ®, Cotempla XR-ODT® and Adzenys-ER®. IND-enabling studies are ongoing for development candidate, NT0502, a NCE for the treatment of sialorrhea/excessive drooling, with the anticipated initiation of a Phase 1 clinical trial in 1H 2020.

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    Clinical-stage biopharmaceutical company historically focused on targeting oncology indications with limited treatment options. September 30, 2019, NewLink announced its intent to merge with Lumos Pharma, a private clinical-stage biopharma company targeting rare and neglected diseases. Combined company would focus initially on Lumos Pharma's lead product candidate, LUM-201 (ibutamoren), an oral growth hormone secretagogue targeting pediatric growth hormone deficiency (PGHD) and other rare endocrine disorders. If approved, LUM-201 would represent the first orally administered growth hormone stimulating therapy for PGHD, an established sizable market where daily recombinant human growth hormone injections represent current standard-of-care therapy. Phase 2b trial initiation for LUM-201 in PGHD patients meeting certain Predictive Enrichment Markers (PEMs) is anticipated in mid-2020. Pro forma financial position expected to be sufficient to support combined company's clinical programs through readout of Phase 2b trial. Other indications being evaluated for LUM-201 clinical development include Turner Syndrome and children born Small for Gestational Age (SGA).

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    Privately-held, clinical-stage biopharmaceutical company developing ST266, a first-of-its-kind platform biologic. ST266 is a novel multi-targeted secretome containing hundreds of biologically active proteins and other factors crucial to neuroprotection, the modulation of inflammation, cell recovery and healing. ST266's development is currently focused on various ophthalmologic neurologic, dermatologic, gastrointestinal and pulmonary indications. To date, Noveome has raised $164M in capital from private equity investors and non-dilutive capital from the U.S. Department of Defense and the Commonwealth of Pennsylvania and Allegheny County.

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    Clinical-stage biopharmaceutical company developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer using its immunotherapy platform, TAVO (tavokinogene telseplasmid) which enables the intratumoral delivery of DNA-based interleukin-12 by employing electroporation to produce a controlled, localized expression of IL-12 in the tumor microenvironment. Pipeline includes TAVO in combination with pembrolizumab for the treatment of melanoma and TAVO monotherapy for triple negative breast cancer.

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    Genetic medicines company developing a portfolio of life-transforming AAV-delivered therapeutics for the treatment of rare monogenic CNS diseases. IND-enabling preclinical work is done under a research, collaboration and license agreement with U.Penn and its Gene Therapy Program and Passage Bio conducts all clinical development, regulatory strategy and commercialization activities. The company has a development portfolio of 6 product candidates, with the option to license 6 more, with lead programs in GM1 gangliosidosis, frontotemporal dementia and Krabbe disease, all of which are planned to be in the clinic in 2020. Since launching the company in early 2019, Passage Bio has raised $225.5M.

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    French biopharmaceutical company with late-stage pipeline of next-gen compounds for neurodegenerative diseases, including both orphan and common diseases. Pharnext's PLEOTHERAPY platform utilizes genomic data and AI to identify and develop synergistic combinations of repositioned drugs at low doses, resulting in a faster, safer, more efficient and affordable drug development process. Lead candidate PXT3003 completed an international Phase 3 trial with positive topline results for the treatment of Charcot-Marie-Tooth disease type 1A (CMT1A), with an additional Phase 3 study to be conducted to support an NDA filing. Second drug candidate, PXT864, has generated encouraging Phase 2a results in Alzheimer's disease.

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    International biopharmaceutical company developing innovative drugs for chronic metabolic diseases, with three clinical-stage programs targeting cellular energy. It's lead drug candidate, Imeglimin, targets mitochondrial dysfunction for the treatment of type 2 diabetes and has produced positive Phase 3 results in Japan with partner Sumitomo Dianippon Pharma (JNDA expected in 2020) and Roivant's subsidiary Metavant is expected to initiate a Phase 3 program in type 2 diabetes CKD 3b/4 patients in the US, pending a FDA meeting. PXL065, deuterium-stabilized R-pioglitazone, is a mitochondrial pyruvate carrier (MPC) inhibitor in development for NASH with Phase 1b results expected 4Q19. PXL065 has the potential for expediated development using the 505(b)(2) regulatory pathway. PXL770, an adenosine monophosphate-activated protein kinase (AMPK) activator, is in development for NASH with PK/PD results expected 4Q19 and Phase 2a results expected 2Q20. Poxel is listed on Euronext Paris and headquartered in Lyon, France with subsidiaries in Boston, MA, and Tokyo, Japan.

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    Leveraging breakthroughs in human genetics to develop disease-modifying AAV-based gene therapies to slow or stop the progression of genetically-defined neurodegenerative diseases. Lead candidate, PR001, a single-dose AAV9-based gene therapy, is entering a Phase 1/2 clinical trial for patients with Parkinson's disease with a GBA1 mutation (PD-GBA).  PR001 is also in development for neuronopathic Gaucher disease, and the company plans to initiate a Phase 1/2 clinical trial in the first half of 2020. Broader pipeline includes PR006 for patients with frontotemporal dementia with a GRN mutation (FTD-GRN) and PR004 for patients with certain synucleinopathies.

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    Clinical-stage biopharmaceutical company developing innovative medicines that target the biology of aging to prevent or treat aging-related diseases. resTORbio's lead program, RTB101, is an oral, selective, and potent TORC1 inhibitor currently being evaluated in two Phase 3 PROTECTOR trials for treatment of clinically symptomatic respiratory illness. resTORbio expects results from PROTECTOR 1 in Q1/2020 and from PROTECTOR 2 in mid-2020.

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    Biopharmaceutical company developing and commercializing therapeutics to transform the care of people living with rare genetic disorders of obesity. Lead candidate setmelanotide met primary and all key secondary endpoints for weight loss and reduction in hunger in pivotal Phase 3 studies for POMC and LEPR deficiency obesities in August 2019, with an NDA submission expected in 4Q19-1Q20. Currently evaluating setmelanotide in a pivotal Phase 3 study in Bardet-Biedl Syndrome (BBS) and Alström Syndrome with topline data expected in 2020. Recently expanded Phase 2 basket study into four new MC4R pathway indications, with additional data from this study expected in 2020. Setmelanotide has been granted both Breakthrough Therapy and PRIME Designations for POMC, LEPR, BBS and Alström Syndrome.

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    Proprietary platform targeting growth factor signaling in the disease microenvironment with pipeline focused on neuromuscular disorders, cancer, fibrosis and anemia. Lead product candidate SRK-015 is a highly selective inhibitor of myostatin activation currently in a Phase 2 trial for the treatment of SMA, in three distinct Type 2 and Type 3 patient populations. Lead cancer immunotherapy candidate SRK-181 is a highly specific inhibitor of TGFβ1 being developed to overcome primary resistance to checkpoint blockade therapies that will enter Phase 1 clinical testing in 2020. Scholar Rock is partnered with Gilead to develop highly specific inhibitors of TGFβ for the treatment of fibrotic diseases.

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    Late-stage biotech focused on developing novel cancer immunotherapies for a broad range of cancers. Expects to initiate a Phase 3 study of lead product candidate galinpepimut-S (GPS), a WT1 peptide vaccine, in AML in 4Q19. Currently evaluating GPS in combination with pembrolizumab in a Phase 1/2 open-label trial in patients with selected WT1-positive advanced cancers, with initial data expected in 1Q20. Second product candidate nelipepimut-S (NPS), a HER-2 peptide vaccine, demonstrated positive Phase 2b results in combination with trastuzumab in triple negative breast cancer (TNBC) and is also being evaluated in a Phase 2 trial in women with ductal carcinoma in situ (DCIS) of the breast, with initial data expected by the end of 2019.

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    Pioneering differentiated cancer immunotherapies for patients with high unmet need using a multi-platform approach.  Sensei Bio has previously reported positive Phase 1, proof-of-concept data from its lead product, SNS-301, a phage-based immune activating agent that targets ASPH.  ASPH is a first-in-human, novel antigen expressed in 20+ cancer types, including solid tumors and hematological malignancies.  SNS-301 is currently in several phase 2 studies, including patients with head and neck cancer and myelodysplastic syndrome.  A next generation cell therapy program and a novel checkpoint inhibitor program is underway.

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    Leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the state of bacterial diversity and function is imbalanced. Seres' SER-287 program has obtained Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres' SER-109 program has obtained Breakthrough Therapy and Orphan Drug designations from the FDA and is in Phase 3 development for recurrent C. difficile infection. Seres is also developing SER-401 in a Phase 1b study in patients with metastatic melanoma.

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    A multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections and rare disease. The company's lead candidate, SPR994, an oral carbapenem, is currently in a Phase 3 pivotal trial entitled ADAPT-PO for the treatment of complicated urinary tract infections with top-line data expected in 3Q20.  An independent review committee recently issued a positive recommendation following its evaluation of interim pharmacokinetic data from the ADAPT-PO trial that the trial continue as planned.  Spero's pipeline includes SPR720, a novel oral therapy candidate being developed for the treatment of non-tuberculous mycobacterial (NTM) lung infections, and its Potentiator Platform, including SPR206 and SPR741, to treat MDR Gram-negative infections in the hospital setting.

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    Clinical-stage biotechnology company focused on the discovery, development and commercialization of novel mitochondrial medicines. Lead product candidate, elamipretide, is being studied in a Phase 3 trial for primary mitochondrial myopathy, with data expected in early 2020, and a Phase 2 trial for geographic atrophy associated with dry AMD, expected to complete enrollment in early 2020. Elamipretide has also been evaluated in a Phase 2/3 study in Barth syndrome, for which regulatory discussions toward potential approval are ongoing, and a Phase 2 study for Leber's hereditary optic neuropathy, for which a Phase 3 protocol will be submitted to FDA by year-end. Additional pipeline candidates include SBT-272, expected to begin first-in-human safety studies by end of 2019 and showing promise in a preclinical model of neurodegenerative disease, and SBT-20 and SBT-259, both being evaluated for rare peripheral neuropathies.

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    Biotechnology company pioneering a new way to treat underlying causes of severe genetic diseases by precisely upregulating protein expression to restore target protein to near-normal levels. Proprietary TANGO platform has potential across a broad spectrum of genetic diseases characterized by the presence of one healthy copy, and one mutated copy, of a gene (autosomal dominant haploinsufficiencies).  Lead program STK-001 in development for Dravet syndrome; expect to initiate Phase 1/2 trial in 1H2020, with preliminary efficacy data in 2021. Plan to nominate second candidate to treat additional genetic disease by 1H2020.

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    Clinical-stage biotechnology company using its proprietary, first-of-its-kind Expanded Genetic Alphabet platform technology to create optimized biologics. These biologics, referred to as Synthorins, are proteins optimized through the incorporation of novel amino acids encoded by a new DNA base pair that enables site-specific modifications, enhancing the pharmacological properties of these therapeutics. The company's lead product candidate, THOR-707, a variant of IL-2, is currently in Phase 1 trials in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor. In addition, Synthorx has a second IL-2 program focused on autoimmune disorders as well as additional IL-15 and IL-10 cytokine programs for immune-oncology indications.

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    Clinical-stage biotechnology company redefining the power of small molecules to control the expression of genes.  Currently advancing SY-1425, a selective RARα agonist in a Phase 2 clinical trial for genomically defined subsets of patients with AML, with proof of concept data expected in 2020. Syros has a portfolio of highly selective, potent inhibitors of CDK7 for multiple patient populations with difficult-to-treat solid tumors, and a broader preclinical and discovery pipeline that includes additional programs in oncology and sickle cell disease.

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    Late-stage biopharmaceutical company leveraging a measles vector (MV)-based delivery platform for infectious diseases and cancer. Lead product candidate, a vaccine against the Chikungunya virus, demonstrated strong safety and immunogenicity, as well as single-dose potential in a Phase 2 study, and is expected to launch a pivotal Phase 3 study by YE19. Early-stage infectious disease pipeline includes Phase 1 programs for Zika and Lassa Fever, a high-value Merck collaboration for undisclosed programs and other early-stage programs. For immuno-oncology, the Company is developing oncolytic viruses with a battery of therapy-enhancing payloads; vast preclinical support for this mechanism, with a Phase 1 study in colorectal cancer expected to launch in 1H20 and multiple tumor-killing antigens in development.

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    Clinical-stage biopharmaceutical company focused on developing curative T cell therapies to treat hematological and solid tumor cancers using proprietary, novel T cell technologies; Antibody-Coupled T cell Receptor (ACTR), an autologous engineered T cell therapy designed to direct and amplify T cell response and Bolt-On Chimeric Receptor (BOXR), designed to incorporate novel “bolt-on” transgenes with ACTR or other immunotherapy approaches, to improve intrinsic T cell functionality in the solid tumor microenvironment. Pipeline currently includes four programs in Lymphoma (ACTR707), Multiple Myeloma (ACTR087), HER2+ cancers (ACTR707) and GPC3+ cancers (BOXR1030, including recently disclosed GOT2 transgene as part of BOXR1030).

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    Clinical-stage biopharmaceutical company advancing a diverse portfolio of engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases. Over a dozen candidates with Xencor's XmAb® protein engineering technology are in clinical development internally and with partners. Internal focus is on a growing pipeline of bispecific antibodies for oncology, such as tumor microenvironment activators (dual checkpoint/co-stim) and CD3 T cell engagers, and engineered cytokines. Partners include Alexion (Ultomiris), Morphosys (MOR208/tafasitamab), Novartis, Genentech and Amgen. Have guided to initial Phase 1 dose-escalation data for XmAb13676 (CD20xCD3) in NHL/CLL by YE 2019; for XmAb18087 (SSTR2xCD3) in neuroendocrine tumors and for XmAb20717 (PD1xCTLA4) in advanced solid tumors in 1H2020.

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