Roth Capital Partners is pleased to invite you to our Roth Healthcare Opportunities Conference to be held at the The Yale Club in New York City, NY on October 12th, 2023. This event will consist of 10 minute Company Presentations introduced by Roth Research Analysts as well as 1-on-1/ small group meetings. This format will provide an opportunity for C-level executives representing public healthcare companies in the Biotechnology, Pharmaceuticals, Medical Technologies, Oncology and Mental Health Therapeutics to tell their stories to investors.
- Beyond Air, Inc.
- Biofrontera Inc.
- BioRestorative Therapies, Inc.
- Chemomab Therapeutics Ltd.
- Delcath Systems, Inc.
- First Wave BioPharma, Inc.
- Fortress Biotech, Inc.
- Genenta Science S.p.A.
- Helius Medical Technologies, Inc.
- Imugene Ltd
- Monopar Therapeutics Inc.
- Nuvectis Pharma, Inc.
Beyond Air, Inc. (NASDAQ: XAIR)
Beyond Air, Inc. (NASDAQ: XAIR) is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors. The Company has received FDA approval for its first system, LungFit® PH for the treatment of term and near-term neonates with hypoxic respiratory failure. Beyond Air is currently advancing its other LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19), and nontuberculous mycobacteria (NTM). The Company has also partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of Autism Spectrum disorder (ADS) and other neurological disorders. Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit the company's website at: www.beyondair.net
Biofrontera Inc. (NASDAQ: BFRI)
Biofrontera Inc. (NASDAQ: BFRI) is a U.S.-based biopharmaceutical company commercializing a portfolio of products for the treatment of dermatologic conditions with a focus on photodynamic therapy (PDT) and topical antibiotics. The Company's licensed products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. For more information, visit the company's website at: www.biofrontera-us.com
BioRestorative Therapies, Inc. (NASDAQ: BRTX)
BioRestorative Therapies, Inc. (NASDAQ: BRTX ) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Their two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: • Disc/Spine Program (brtxDISC™): Their lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person's own) cultured mesenchymal stem cells collected from the patient's bone marrow. They intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. The BRTX-100 production process utilizes proprietary technology and involves collecting a patient's bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patient's damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. They have commenced a Phase 2 clinical trial using BRTX-100 to treat chronic lower back pain arising from chronic lumbar disc disease. They are also investigating the expansion of the clinical application of BRTX-100 to other indications within the body. • Metabolic Program (ThermoStem®): They are developing a cell-based therapy candidate to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue ("BAT"). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes. For more information, visit the company's website at: www.biorestorative.com
Chemomab Therapeutics Ltd. (NASDAQ: CMMB)
Chemomab Therapeutics Ltd. (NASDAQ: CMMB) is a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique and pivotal role of CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody designed to neutralize CCL24 activity. In preclinical and clinical studies, CM-101 appears safe, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported encouraging results from three clinical trials of CM-101 in patients, including a Phase 2 liver fibrosis trial and an investigator-initiated study in patients with severe lung injury. A Phase 2 trial in primary sclerosing cholangitis patients is ongoing, with topline data expected in the second half of 2024. For more information, visit the company's website at: www.chemomab.com
Delcath Systems, Inc. (NASDAQ: DCTH)
Delcath Systems, Inc. (NASDAQ: DCTH) is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company's proprietary products, HEPZATO KIT (melphalan for Injection/Hepatic Delivery System), approved for use in the United States by FDA, and CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), designated under the medical device regulation for use in Europe and the United Kingdom, are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. For more information, visit the company's website at: delcath.com
First Wave BioPharma, Inc. (NASDAQ: FWBI)
First Wave BioPharma, Inc. (NASDAQ: FWBI) is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company is currently advancing a therapeutic development pipeline with multiple Phase 2 clinical stage programs built around three proprietary technologies – Capeserod, a selective 5-HT4 receptor partial agonist which First Wave will pursue for gastrointestinal (GI) indications; the biologic adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency; and niclosamide, an oral small molecule with anti-inflammatory properties for patients with inflammatory bowel diseases such as ulcerative colitis and Crohn's disease. First Wave BioPharma is headquartered in Boca Raton, Florida. For more information, visit the company's website at: www.firstwavebio.com
Fortress Biotech, Inc. (NASDAQ: FBIO)
Fortress Biotech, Inc. (NASDAQ: FBIO) is an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates. The company has eight marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company's portfolio of product opportunities. Fortress has established partnerships with some of the world's leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, St. Jude Children's Research Hospital, Nationwide Children's Hospital and Sentynl. For more information, visit the company's website at: www.fortressbiotech.com
Genenta Science S.p.A. (NASDAQ: GNTA)
Genenta Science S.p.A. (NASDAQ: GNTA) is a clinical-stage biotechnology company engaged in the development of a proprietary hematopoietic stem cell therapy for the treatment of a variety of solid tumor cancers. Temferon™ is based on ex-vivo gene transfer into autologous Tie2+ hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs). Temferon, which is under investigation in a phase 1/2a clinical trial in newly diagnosed Glioblastoma Multiforme patients who have an unmethylated MGMT gene promoter (uMGMT-GBM), is designed to reach solid tumors, induce a durable immune response not restricted to pre-selected tumor antigens nor type, and avoid systemic toxicity, which are some of the main unresolved challenges in immuno-oncology. For more information, visit the company's website at: www.genenta.com
Helius Medical Technologies, Inc. (NASDAQ: HSDT)
Helius Medical Technologies, Inc. (NASDAQ: HSDT) is a leading neurotech company in the medical device field focused on neurologic deficits using orally applied technology platform that amplifies the brain's ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company's first commercial product is the Portable Neuromodulation Stimulator (PoNS®) device. For more information, visit the company's website at: www.heliusmedical.com
Imugene Ltd (ASX: IMU) (OTC: IUGNF)
Imugene Ltd (ASX: IMU) (OTC: IUGNF) is a clinical stage immuno- oncology company, today announced the first patient dosed in the combination cohort of the IMPRINTER study, a clinical trial to evaluate the safety and efficacy of Imugenes PD1-Vaxx, a B-cell activating immunotherapy alone or in combination with atezolizumab (Tecentriq®), an immune checkpoint inhibitor targeting PD-L1 from Roche, in patients with non-small cell lung cancer (NSCLC). For more information, visit the company's website at: www.imugene.com
Inventiva (NASDAQ: IVA)
Inventiva (NASDAQ: IVA) is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with NASH, mucopolysaccharidoses ("MPS") and other diseases with significant unmet medical needs. The Company benefits from a strong expertise and experience in the field of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently advancing one clinical candidate, has a pipeline of two preclinical programs and continues to explore other development opportunities to add to its pipeline. For more information, visit the company's website at: inventivapharma.com
Monopar Therapeutics Inc. (NASDAQ: MNPR)
Monopar Therapeutics Inc. (NASDAQ: MNPR) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients. Monopar's pipeline consists of camsirubicin (Phase 1b) for the treatment of advanced soft tissue sarcoma; MNPR-101, a late-stage preclinical antibody for radiopharmaceutical use in advanced cancers; and MNPR-202, an early-stage camsirubicin analog for various cancers. For more information, visit the company's website at: www.monopartx.com
Nuvectis Pharma, Inc. (NASDAQ: NVCT)
Nuvectis Pharma, Inc. (NASDAQ: NVCT) is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company is currently developing two drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule currently in a Phase 1b clinical trial investigating the activity of NXP800 as a potential treatment for platinum resistant, ARID1a-mutated ovarian carcinoma. The U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to the NXP800 development program in platinum resistant, ARID1a-mutated ovarian carcinoma, and Orphan Drug Designation for the treatment of cholangiocarcinoma. NXP900 is a novel, small molecule SRC/YES1 kinase inhibitor. The NXP900 Investigational New Drug Application has been cleared by the FDA and a Phase 1a dose escalation study is expected to begin in Q3 2023. For more information, visit the company's website at: nuvectis.com
Oryzon (BME: ORY)
Oryzon (BME: ORY) is a clinical stage biopharmaceutical company and the European leader in epigenetics, with a strong focus on personalized medicine in CNS disorders and oncology. Oryzon's team is composed of highly qualified professionals from the pharma industry located in Barcelona, Boston, NYC and San Diego. Oryzon has an advanced clinical portfolio with two LSD1 inhibitors, vafidemstat in CNS and iadademstat in oncology, in several Phase II clinical trials. The company has other pipeline assets directed against other epigenetic targets. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. For more information, visit the company's website at: www.oryzon.com
Procaps Group, S.A. (NASDAQ: PROC)
Procaps Group, S.A. (NASDAQ: PROC) is a leading developer of pharmaceutical and nutraceutical solutions, medicines, and hospital supplies that reach more than 50 countries on five continents. Procaps has a direct presence in 13 countries in the Americas and more than 5,500 employees working under a sustainable model. Procaps develops, manufactures, and markets over-the-counter (OTC) pharmaceutical products, prescription pharmaceutical drugs (Rx), nutritional supplements, and high-potency clinical solutions. For more information, visit the company's website at: www.procapsgroup.com
ProSomnus, Inc. (NASDAQ: OSA)
ProSomnus, Inc. (NASDAQ: OSA) is a leading CPAP alternative for the treatment of Obstructive Sleep Apnea, a serious medical disease affecting over 1 billion people worldwide, that is associated with comorbidities including heart failure, stroke, hypertension, morbid obesity, and type 2 diabetes. ProSomnus intraoral medical devices are engineered to precisely track the treatment plan and anatomy for each patient. Non-invasive, patient preferred and easy to use, ProSomnus devices have demonstrated excellent efficacy, safety, adherence, and overall outcomes in a growing body of clinical investigations. ProSomnus precision intraoral devices are FDA-cleared, patented, and covered by commercial medical insurance, Medicare, TRICARE and many Government sponsored healthcare plans around the world, representing over 200 million covered lives. For more information, visit the company's website at: www.ProSomnus.com
RenovoRx, Inc. (NASDAQ: RNXT)
RenovoRx, Inc. (NASDAQ: RNXT) is a clinical-stage biopharmaceutical company developing targeted combination therapies for high unmet medical needs. The Company's proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed to bypass traditional systemic delivery methods and ensure precise therapeutic delivery to a target tissue, while minimizing a therapy's systemic toxicities. RenovoRx's unique approach to drug-delivery offers the potential for increased treatment safety, tolerance, and wider therapeutic windows. The Company's lead product candidate, RenovoGem™ combines gemcitabine with the company's patented delivery system and is regulated by FDA under the IND 21 CFR 312 pathway. RenovoGem is currently in a Phase III clinical trial (TIGeR-PaC) for the treatment of locally advanced pancreatic cancer, where it observed a 6-month median Overall Survival benefit, 8-month progression-free survival (PFS) and 65% reduction in adverse events at its interim analysis. RenovoRx is committed to transforming the lives of patients by delivering innovative solutions to change the current paradigm of cancer care. RenovoGem is currently under investigation for TAMP therapeutic delivery of gemcitabine and has not been approved for commercial sale. For more information, visit the company's website at: www.renovorx.com
Revelation Biosciences Inc. (NASDAQ: REVB)
Revelation Biosciences Inc. (NASDAQ: REVB) is a life sciences company focused on the development of immunologic-based therapies for the prevention and treatment of disease. Revelation has multiple product candidates in development that are based on the well-established biology of phosphorylated hexaacyl disaccharide (PHAD) and its effect on the innate immune system. REVTx‑300 is being developed as a potential therapy for the treatment of acute and chronic organ disease including CKD, AKI and myocarditis. REVTx‑100 is being developed as a prevention and treatment of infection. REVTx‑200 is being developed as an intranasal immunomodulator adjunct to be used in combination with an intramuscular vaccination for more complete immunity. REVTx‑99b is being developed as a treatment for food allergies. For more information, visit the company's website at: www.RevBiosciences.com
Sensus Healthcare, Inc. (NASDAQ: SRTS)
Sensus Healthcare, Inc. (NASDAQ: SRTS) is a medical device company specializing in highly effective, non-invasive, minimally invasive and cost-effective treatments for both oncological and non-oncological conditions. Sensus offers its proprietary low-energy X-ray technology known as superficial radiation therapy (SRT), which is the culmination of more than a decade of research and development, to treat non-melanoma skin cancers and keloids with its SRT-100™, SRT-100+™ and SRT-100 Vision™ systems. With its portfolio of innovative medical device products, including aesthetic lasers and its needleless TransDermal Infusion System™, Sensus provides revolutionary treatment options to enhance the quality of life of patients around the world. For more information, visit the company's website at: www.sensushealthcare.com
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP)
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The company's versatile TFF technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, or for topical delivery to the eyes, nose and topically to the skin. TFF Pharmaceuticals has two lead drug candidates in the clinic: TFF VORI (Voriconazole Inhalation Powder) and TFF TAC (Tacrolimus Inhalation Powder). The Company continues collaborations with a broad array of pharmaceutical companies, academic institutions, and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by 120+ patents issued or pending in the U.S. and internationally. For more information, visit the company's website at: tffpharma.com
Unicycive Therapeutics, Inc. (NASDAQ: UNCY)
Unicycive Therapeutics, Inc. (NASDAQ: UNCY) is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, visit the company's website at: www.unicycive.com