AIM ImmunoTech Inc. (AIM)

AIM ImmunoTech Inc. is an immuno-pharma company primarily engaged in developing therapeutics for various significant diseases, including multiple types of cancers, immune disorders, and viral infections like COVID-19. The company's flagship product, Ampligen® (rintatolimod), is an immune-modulator under development for various indications. It's notable for its broad-spectrum activity and is currently involved in numerous clinical studies aimed at demonstrating its efficacy across multiple high-value disease areas, including oncology and chronic viral diseases.

Unicycive Therapeutics, Inc. (UNCY)

Unicycive Therapeutics is a cutting-edge biopharmaceutical company dedicated to developing innovative treatments for kidney-related diseases. Their lead program involves Oxylanthanum Carbonate (OLC)*, a novel phosphate binder for treating hyperphosphatemia in chronic kidney disease (CKD) patients undergoing dialysis.

Acurx Pharmaceuticals, Inc. (ACXP)

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP). To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com

Aethlon Medical, Inc. (AEMD)

Aethlon Medical develops immunotherapeutic technologies to combat cancer and infectious disease. The Aethlon Hemopurifier® is a first-in-class technology designed for the rapid depletion of cancer-promoting exosomes and circulating viruses. The United States Food and Drug Administration (FDA) has designated the Hemopurifier® as a “Breakthrough Device” for 1) the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease; and 2) life-threatening viruses that are not addressed with approved therapies.

Aethlon Medical is currently conducting a clinical trial in Sars-CoV-2 in India and are in the process of launching an oncology clinical trial in Australia.

Alterity Therapeutics Limited (ATHE)

Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company’s lead asset, ATH434, has the potential to treat various forms of Parkinsonian disorders. Alterity also has a broad drug discovery platform generating patentable chemical to intercede in disease processes. Alterity is located in Melbourne, Australia and San Francisco, California, USA. The Company is listed on the Australian Securities Exchange (ASX: ATH) and NASDAQ (NASDAQ: ATHE).

Alzamend Neuro, Inc. (ALZN)

Alzamend Neuro® , Inc., (“Alzamend® ”), a Delaware corporation with its headquarters in Atlanta, Georgia, is a clinical-stage, biopharmaceutical company. At Alzamend, we are committed to “Making Alzheimer’s Just a Memory™ ” as well as developing effective treatments for psychiatric disorders which affect over 600 million people globally. Our mission is to rapidly develop and market safe and effective treatments. We are driven by the belief that strong support of research is the foundation for true innovation and uniquely position us to understand and effectively address the unmet needs of the patients we serve. Alzamend strives to provide hope through the commercialization of existing patented intellectual properties and know-how while simultaneously funding future treatments for other neurodegenerative diseases and psychiatric disorders, through advanced research and development.

Our current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate, and ALZN002 – a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

Our lead product candidate (AL001) that we have licensed and have begun clinical development in humans for the treatment of Alzheimer’s, bipolar disorder, MDD and PTSD. Our preclinical data for AL001 treatment showed prevention of cognitive deficits, depression and irritability in APPSWE/PS1dE9 mice, and is superior in improving associative learning, memory, and irritability, compared with lithium carbonate treatments.  On September 11, 2021, a first-in-human Phase I six-month clinical trial for AL001 commenced with the first patients dosed. Topline data for AL001 was reported on December 17, 2021, and the full data set was released in March 2022. The data affirmed that dose-adjusted relative bioavailability analyses of the rate and extent of lithium absorption in plasma indicate that AL001 at 150 mg dosage is bioequivalent to the marketed 300 mg lithium carbonate product and the shapes of the lithium plasma concentration versus time curves are similar. AL001 salicylate plasma concentrations were observed to be well-tolerated and consistently within safe limits and the safety profiles of both AL001 and the marketed lithium carbonate capsule were benign. In May 2022 we initiated our Phase II multiple-ascending dose study in Alzheimer’s patients and completed the clinical portion of the trial in March 2023. Topline data was announced in June 2023. In July 2022 we received written response from the U.S. Food and Drug Administration (the “FDA”) regarding our meeting request relating to its Type B Pre-Investigational New Drug (“IND”) application. The FDA’s response provides a path for Alzamend’s planned clinical development of AL001 for the treatment of Bipolar Disorder, MDD and PTSD. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized, potentially mitigating the regulatory burden for safety data.

ALZN002 is a proprietary “active” immunotherapy product, which means it is produced by each patient’s immune system. It consists of autologous dendritic cells (“DCs”), which are activated white blood cells taken from each individual patient that are then engineered outside of the body to attack Alzheimer’s-related amyloid-beta proteins. These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed to bolster the ability of the patient’s immune system to combat Alzheimer’s; the goal of this treatment approach is to foster tolerance to treatment for safety purposes while stimulating the immune system to reduce the brain’s beta-amyloid protein burden, resulting in reduced Alzheimer’s signs and symptoms. In October 2022 we received a “Study May Proceed” letter from the U.S. Food and Drug Administration (“FDA”) for a phase I/IIA clinical trial under its Investigational New Drug (“IND”) application for an immunotherapy (ALZN002) to treat mild to moderate dementia of the Alzheimer’s type. We initiated the Phase I/IIA clinical trial in March 2023.

Applied DNA Sciences, Inc. (APDN)

Using our large scale polymerase chain reaction (PCR) based manufacturing platform, we manufacture large quantities of linear DNA for various markets. Whether for supply chain security, brand protection, law enforcement or drug candidate or biologic applications, it is our goal to help establish secure flourishing environments that foster quality, integrity and success.

Artelo Biosciences, Inc. (ARTL)

Artelo Biosciences is a clinical stage company using cutting-edge science to improve patient care.

We were founded in 2017 on the promise of therapeutic development based on lipid-signaling modification, including targeting the receptors of the endocannabinoid system.

Our mission is to alter the course of treatment for those with a diagnosis of cancer and other serious conditions.

Aprea Therapeutics, Inc. (NasdaqCM APRE)

Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered in Doylestown, Pennsylvania, focused on developing and commercializing novel cancer therapeutics that target DNA damage response pathways. The Company’s lead program is ATRN-119, a Phase 1-ready small molecule ATR inhibitor being developed for solid tumor indications.

Assertio Holdings, Inc. (ASRT)

Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients and has a robust portfolio of branded prescription products in neurology, oncology, hospital and pain and inflammation. The Company has grown through business development including licensing, mergers, and acquisitions and is interested in products across all therapeutic areas, including our current focus. 

Autonomix Medical, Inc. (AMIX)

Atai Life Sciences (ATAI)

Atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders.

We founded atai in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, as well as the emergence of therapies that previously may have been overlooked or underused, including psychedelic compounds and digital therapeutics.

Avenue Therapeutics (ATXI)

Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. The Company is currently developing three assets including AJ201, a first-in-class asset for spinal and bulbar muscular atrophy, BAER-101, an oral small molecule selective GABA-A α2/3 receptor positive allosteric modulator for CNS diseases, and IV Tramadol, which is in Phase 3 clinical development for the management of moderate-to-moderately-severe pain in adults in a medically supervised healthcare setting. Avenue is headquartered in Miami, FL and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.avenuetx.com.

Aytu BioPharma, Inc. (AYTU)

Aytu BioPharma is a pharmaceutical company developing and commercializing novel therapeutics. Our company’s evolution has been driven by strategic in-licensing and acquisition-based transactions and organic product growth. As we continue this trajectory, we are also building a complementary novel therapeutic development pipeline addressing significant unmet needs in rare and complex diseases.

Azitra, Inc. (NYSEAM AZTR)

Azitra is a pioneer in genetically engineered bacteria and proteins for therapeutic use in dermatology. Azitra leverages proprietary platforms and an internal microbial library to create new therapeutics that are either engineered living organisms or engineered proteins or peptides to treat skin diseases. Azitra has built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that can be screened for unique therapeutic characteristics. The platform is augmented by an artificial intelligence and machine learning technology that analyzes, predicts, and helps screen Azitra’s library of strains for drug like molecules. The platform also utilizes a licensed genetic engineering technology, which can enable the transformation of previously genetically intractable strains. Azitra’s initial focus is on the development of genetically engineered strains of Staphylococcus epidermidis. Azitra’s lead therapeutic candidates are ATR-12, a genetically modified strain of S. epidermidis for treating the orphan disease Netherton syndrome, and ATR-04, a genetically modified strain of S. epidermidis for treating the papulopustular rash experienced by cancer patients undergoing epidermal growth factor receptor inhibitor, or EGFRi, targeted therapy.

Belite Bio, Inc. (NasdaqCM: BLTE)

bioAffinity Technologies, Inc. (BIAF)

bioAffinity Technologies addresses the urgent need for noninvasive, early-stage cancer diagnosis and targeted cancer treatment. Our first product, CyPath^® Lung, accurately diagnoses early-stage lung cancer, the leading cause of cancer-related deaths, with the potential to dramatically increase overall diagnostic accuracy of lung cancer leading to increased survival, fewer unnecessary invasive procedures, reduced patient anxiety, and lower medical costs.

Bionomics Limited (BNOX)

Bionomics (NASDAQ:BNOX, OTCQB:BNOEF) Bionomics is currently based in Australia and the US and trades in the US on NASDAQ Global Market (NASDAQ) under the ticker “BNOX”.

BioRestorative Therapies, Inc. (BRTX)

BioRestorative Therapies was founded by scientists and researchers committed to developing stem cell therapies to address unmet needs in patients with highly prevalent conditions.

Our advances in stem cell biology and delivery protocols harbor great promise in conditioning our bodies’ own regenerative potential to treat major diseases more effectively than current interventions.

Brainstorm Cell Therapeutics Inc. (BCLI)

BrainStorm (NASDAQ:BCLI) is a biotechnology company developing innovative, autologous stem cell therapies for highly debilitating neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Multiple Sclerosis (MS) and Alzheimer’s Disease (AD).

Chemomab Therapeutics Ltd. (CMMB)

Chemomab 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 the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody that neutralizes CCL24 activity. In clinical and preclinical studies, CM-101 appears safe and has demonstrated the potential to treat multiple severe and life-threatening fibro-inflammatory diseases.

Chemomab has reported positive results from three clinical trials of CM-101 completed to date. A Phase 2 trial in the rare liver disease primary sclerosing cholangitis (PSC) has completed patient enrollment, with topline data expected midyear 2024.

Citius Pharmaceuticals, Inc. (CTXR)

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class critical care products, with a pipeline of anti-infectives in oncology, adjunct cancer care, stem cell therapy and unique prescription products.

Clene Inc. (CLNN)

Clene is a clinical-stage biopharmaceutical company dedicated to revolutionizing the treatment of neurodegenerative diseases to restore and protect neuronal health and function. Our nanotherapeutics target cellular energy impairments that are common to many diseases.

CNS Pharmaceuticals, Inc. (CNSP)

We are single-minded in our pursuit of a cure for Glioblastoma Multiforme (GBM), and invite you to explore our Investor Relations page to understand the financial promise that aligns with our life-changing mission.

Context Therapeutics Inc. (NasdaqCM CNTX)

Context is dedicated to developing the next generation of T cell engaging (TCE) bispecific antibody therapies to treat solid tumors. We are building an innovative portfolio of clinical-stage T cell engaging bispecific therapeutics, including CTIM-76, a selective Claudin 6 (CLDN6) x CD3 bispecific antibody, CT-95, a potential first-in-class mesothelin (MSLN) x CD3 bispecific antibody, and CT-202, a potential best-in-class Nectin-4 x CD3 bispecific antibody.

Daxor Corporation (DXR)

Daxor Corporation (Nasdaq: DXR) is the global leader in blood volume measurement technology focused on blood volume testing innovation. We developed and market the BVA-100™ (Blood Volume Analyzer), the first diagnostic blood test cleared by the FDA to provide safe, accurate, objective quantification of blood volume status and composition compared to patient-specific norms. The BVA technology enhances hospital performance metrics in a broad range of surgical and medical conditions, including heart failure and critical care, by informing treatment strategies, resulting in significantly improved multiple measures of patient outcomes. Daxor’s mission is to advance healthcare by enabling optimal fluid management with blood volume analysis. Daxor’s vision is optimal blood volume for all.

Dermata Therapeutics, Inc. (DRMA)

electroCore, Inc. (ECOR)

In 2005, we were founded on a unified belief that neuromodulation could be used in novel ways to help patients break free from treatments they aren’t happy with. Because different modalities of neuromodulation had previously proven to be effective and safe, we recognized an opportunity to be the leader in this new frontier of medicine and embraced it.

Femasys Inc. (FEMY)

Femasys Inc. is a biomedical company aiming to meet women's needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health.

Fennec Pharmaceuticals (FENC)

Fennec Pharmaceuticals Inc., (NASDAQ: FENC; TSX: FRX) is a commercial stage specialty pharmaceutical company focused on the development of PEDMARK® (sodium thiosulfate injection). PEDMARK is the first and only FDA-approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors. In October 2022, Fennec commercially launched PEDMARK in the United States.

PEDMARK received Orphan Drug designation by the FDA in 2004. The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA).

FibroBiologics, Inc. (FBLG)

FibroBiologics is a cell therapy, regenerative medicine company developing a pipeline of treatments and potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 150+ US and internationally issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, psoriasis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy.

Gain Therapeutics, Inc. (GANX)

Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate, GT-02287 is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma exposure in the projected therapeutic range, CNS exposure, and target engagement and modulation of GCase enzyme. Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function.

Deploying its highly advanced Magellan™ platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology.”

Genelux Corporation (GNLX)

Genelux is a Phase 3 biopharmaceutical company developing powerful therapeutics for patients suffering from difficult-to-treat cancers. The Company is focused on the development of next-generation oncolytic viral immunotherapies that are designed to generate a personalized multi-prong attack to overwhelm a tumor’s sophisticated defense mechanisms.

Genenta Science S.p.A. (GNTA)

IceCure Medical Ltd (ICCM)

IceCure is transforming healthcare by bringing the choice of advanced minimally invasive cryoablation treatment options for benign and malignant tumors to women's health and interventional oncology.

Immuron Limited (IMRN)

Immuron Limited is a commercial and clinical stage publicly listed Australian biopharmaceutical company with a proprietary technology platform focused on the development and commercialization of a novel class of specifically targeted polyclonal antibodies that we believe can address significant unmet medical needs. The company was incorporated under the laws of Australia in 1994 and has been listed on the Australian Securities Exchange (ASX), since April 30, 1999 and our ordinary shares trade under the symbol “IMC.”. Immuron completed an initial public offering on the NADAQ Capital Market in June 2017 and our American Depositary Shares and warrants are listed on NASDAQ under the symbols “IMRN” and “IMRNW”, respectively. Each ADS represents 40 of our ordinary shares, no par value.

Our validated technology platform can produce orally active polyclonal antibodies which offer targeted delivery within the gastrointestinal (“GI”) tract and essentially do not cross into the bloodstream. We believe that our lead drug candidates, currently in clinical development, have the potential to transform the existing treatment paradigms for moderate to severe Campylobacteriosis, Clostridiodes difficile infections, Enterotoxigenic Escherichia coli (ETEC) infections and travelers’ diarrhea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce.

We currently market our flagship commercial products Travelan® and Protectyn® in Australia, where both products are listed medicines on the Australian Register for Therapeutic Goods. Travelan® (AUST L 106709) is an over-the-counter orally administered passive immunotherapeutic product indicated to reduce the risk of travelers’ diarrhea, reduce the risk of minor gastro-intestinal disorders and is antimicrobial. It is sold in pharmacies throughout Australia. Protectyn® (AUST L 231001) is currently sold in practitioners’ offices and is marketed as an immune supplement to help maintain a healthy digestive function and liver. We also market Travelan® in Canada (NPN 80046016) where it is licensed as a natural health product indicated to reduce the risk of travelers’ diarrhea, and presently market Travelan® in the U.S. as a dietary supplement for digestive tract protection.

Indaptus Therapeutics, Inc.(INDP)

Inhibikase Therapeutics, Inc. (IKT)

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease ("PD"), Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, The Company’s pipeline includes multiple product candidates developed from its proprietary RAMP drug innovation and prodrug technology engines, using the same clinically validated kinase target. The Company is headquartered in Atlanta with additional offices in Lexington, Massachusetts.

INmune Bio, Inc. (INMB)

INmune Bio Inc. is a clinical stage biotechnology company focused on restoring function in the innate immune system to fight disease.

Our pipeline consists of first in class therapies designed to maximize benefit without compromising safety.

These innovative treatments are currently being developed for neurologic disease and certain forms of cancer.

Learn more about our Science and current clinical trials.

Iterum Therapeutics plc (ITRM)

Iterum Therapeutics plc is an Ireland-based clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives. These products are aimed at combating the global crisis of multi-drug resistant (MDR) pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum’s first product is a novel anti-infective compound that has demonstrated potent in-vitro activity vs. a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.

Kairos Pharma, Ltd. (KAPA)

Kairos Pharma is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies designed to overcome drug resistance and immune suppression in cancer patients. Our lead candidate, ENV105, is an antibody that targets CD105—a protein identified as a key driver of resistance to various cancer treatments. By inhibiting CD105 on cancer cell surfaces, ENV105 aims to reverse drug resistance and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV105 is in Phase 2 clinical trials for prostate cancer and Phase 1 trials for lung cancer, addressing significant unmet medical needs.

Kazia Therapeutics Limited (KZIA)

At Kazia, we believe that the best thing we can do for our investors is to deliver high-quality science that makes a substantial impact on the lives of patients.

Kiora Pharmaceuticals, Inc. (NasdaqCM:KPRX)

Kiora Pharmaceuticals, Inc. (Kiora) is an ophthalmic specialty pharmaceutical company that develops therapies for the treatment of orphan retinal diseases. Publicly traded on the NASDAQ under KPRX, our mission is to help patients restore vision.

Lexaria Bioscience Corp (LEXX)

Lineage Cell Therapeutics, Inc.(NYSEAM LCTX)

Lineage’s programs are based on the Company’s proprietary cell-based therapy platform and associated development and manufacturing capabilities. With our platform we develop and manufacture specialized, terminally-differentiated human cells from our pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury, or administered as a means of helping the body mount an effective immune response to cancer.

Lipella Pharmaceuticals Inc. (LIPO)

Lipella Pharmaceuticals (Nasdaq: LIPO) is a Pittsburgh-based clinical-stage biotechnology company focused on developing treatments for serious diseases with significant unmet needs. The company has a broad portfolio of three promising IND-approved assets and operates an in-house manufacturing facility. Lipella’s proprietary drug delivery platform utilizes liposomal formulations of tacrolimus, enabling localized treatment with minimal systemic exposure. The company is advancing two lead assets in Phase 2 clinical trials: LP-10, targeting hemorrhagic cystitis, and LP-310, an oral rinse for Oral Lichen Planus. Both programs leverage the 505(b)(2) regulatory pathway to expedite development and reduce costs. With pivotal clinical milestones expected over the next 18 months, Lipella is well-positioned for potential partnerships and licensing agreements.

Lucid Diagnostics Inc. (LUCD)

Lucid Diagnostics Inc., markets the first and only commercial tools for widespread early detection of esophageal precancer and cancer – the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device.

Medicus Pharma Ltd. (MDCX)

Medicus Pharma Ltd. (TSXV:MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutic assets.

Through our diverse experience and extensive industry network, we are building Medicus into a leading pharmaceutical company, committed to delivering better treatment outcomes and alleviate pain and suffering.

Utilizing a thesis driven collaborative process, we identify, acquire and advance relatively de-risked clinical stage assets through clinical development and commercialization.

We look into opportunities across all therapeutics areas where an unmet need exists for improved patient safety and efficacy.

Medicus is opportunistically exploring to expand its drug development pipeline through qualified and accretive acquisitions and partnerships.

Medivir AB (MVIR)

Medivir is a pharmaceutical company focusing on the development and commercialization of innovative treatments for cancer.

MediWound Ltd. (MDWD)

MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The Company specializes in the development, production and commercialization of rapid and effective biologics that improve existing standards of care and patient experiences, while reducing costs and unnecessary surgeries.

Mesoblast Limited (MESO)

Mesoblast is using its proprietary technology platform to develop and commercialize innovative allogeneic cellular medicines to treat complex diseases resistant to conventional standard of care and where inflammation plays a central role.

The Company’s portfolio of Phase 3 product candidates comprises remestemcel-L for the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD), and for moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection; REVASCOR^® for advanced chronic heart failure; and MPC-06-ID for chronic low back pain due to degenerative disc disease.

Milestone Scientific Inc. (MLSS)

Milestone Scientific Inc. (MLSS) is a leading medical research and development company that designs and patents innovative injection technology. Milestone’s computer-controlled systems make injections precise, efficient, and virtually painless.

Moleculin Biotech, Inc. (MBRX)

Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

The Company is initiating the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial, a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards approval for Annamycin for the treatment of AML.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of viruses, as well as certain cancer indications.

Myomo, Inc. (MYO)

Based on patented technology developed at MIT, Harvard Medical School and by the Company, Myomo develops and markets the MyoPro® product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in the paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord or nerve injury such as brachial plexus injury, or other neuro-muscular disabilities. It is the only device that, sensing a patient’s own neurological signals through non-invasive sensors on the arm, can restore their ability to use their arms and hands so that they can return to work, live independently and reduce their cost of care.  Published clinical research shows a clinically significant instantaneous reduction in upper extremity impairment through the use of MyoPro.  MyoPro is referred for patients at leading rehabilitation facilities, including Mayo Clinic, Cleveland Clinic, Massachusetts General Hospital, Kennedy Krieger Institute, Loma Linda Medical Center and twenty VA hospitals, among others.  It is fitted and delivered through a nationwide network of orthotics and prosthetics practices, and over 600 have been used by patients.  Myomo is headquartered in Boston, Massachusetts, with sales and clinical professionals across the U.S.
 

NeuroBo Pharmaceuticals, Inc. (NRBO)

NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Type 2 Diabetes Mellitus (T2DM), and is developing DA-1726 for the treatment of obesity. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In preclinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists.

NEXGEL, Inc. (NXGL)

NEXGEL is a leading provider of ultra-gentle, high-water-content hydrogels for healthcare and consumer applications. Based in Langhorne, Pa., the Company has developed and manufactured electron-beam, cross-linked hydrogels for over two decades. Alongside its strategic partners, NEXGEL has formulated more than 200 different combinations to bring natural ingredients to gentle skin patches that can be worn for long periods of time with little to no irritation.

Numinus Wellness Inc. (TSE: NUMI)

Numinus is an integrated mental health company creating an ecosystem of health solutions to research, develop, and deliver safe, evidence-based, accessible psychedelic-assisted psychotherapy.

Nutex Health Inc. (NUTX)

Nutex Health Inc. is a technology-enabled healthcare services company with two divisions: a Hospital Division and a Population Health Management Division.

The Hospital Division implements and operates innovative health care models, including micro-hospitals, specialty hospitals, and hospital outpatient departments (HOPDs). This division owns and operates 21 facilities in 8 states.

The Population Health Management Division owns and operates provider networks such as Independent Physician Associations (IPAs). Our Management Services Organizations (MSOs) provide management, administrative, and other support services to our affiliated hospitals and physician groups. Our cloud-based proprietary technology platform aggregates data across multiple information systems, settings, and sources to create a holistic view of each patient and provider, allowing us to deliver greater quality care more efficiently.

Ocugen, Inc. (NasdaqCM:OCGN)

Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs.

Oncolytics Biotech Inc. (ONCY)

Oncolytics is focused on obtaining regulatory approval for pelareorep for metastatic breast cancer and pancreatic cancer, indications with continued and considerable unmet needs. Based on very compelling data, Oncolytics believes that advancing pelareorep through late-stage clinical testing, submission and registration in these indications present the highest chance of success with the greatest commercial opportunity.

Oragenics, Inc. (OGEN)

Oragenics, Inc. is a development-stage company dedicated to fighting infectious diseases including coronaviruses and multidrug-resistant organisms. Its lead product is Terra CoV-2, an intranasal vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The Terra CoV-2 program leverages coronavirus spike protein research licensed from the NIH and the NRC with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration. Its lantibiotics program features a novel class of antibiotics against bacteria that have developed resistance to commercial antibiotics. In October of 2023, Oragenics announced the signing of a definitive agreement with Odyssey Health, Inc. to acquire assets related to their proprietary neurological drug therapies, including their proprietary formulation and nasal delivery system. The assets include drug candidates for treating mild traumatic brain injury, also known as concussion, and for treating Niemann Pick Disease Type C.

OS Therapies Incorporated (OSTX)

OS Therapies (OST) is a clinical stage therapeutic company focused on the identification, development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OS Therapies was launched to meet significant unmet need for new treatments in cancers of the bone in kids and adults. Osteosarcoma is an extremely challenging and often aggressive cancer that has particular treatment challenges due to location, changing genotypes, and high recurrence rates. At OST, we are trying to answer the calls for new treatments, considering there have been no new treatments for OS in over 30 years. OST has expanded the pipeline beyond Osteosarcoma with OST-HER2 into other solid tumors with the same recurrence mechanism of action, including Breast, Esophageal and Lung cancer. With the addition of OST-TDC, considered a next generation Antibody Drug Conjugate (ADC) platform technology, we will be targeting Ovarian, Lung and Pancreatic cancer.

Our goal is to identify lead candidates in the treatment of Osteosarcoma and other solid tumors for clinical development, regulatory approval and commercialization. Starting with the most common genetic mutation found in Osteosarcoma, OS Therapies has identified a lead candidate in HER-2 Osteosarcoma with a goal of rapid clinical and regulatory analysis and review. This will be immediately followed in parallel with the OST-TDC development.

Palisade Bio, Inc. (PALI)

Palisade Bio is a biopharmaceutical company dedicated to advancing next-generation precision therapies for immune, inflammatory, and fibrotic diseases. These conditions represent a significant unmet need, leading to chronic organ dysfunction, damage and even failure due to abnormal immune responses and persistent inflammation.

Our lead program, PALI-2108, is a microbiota-activated PDE4 inhibitor prodrug in development for the treatment of moderate-to-severe ulcerative colitis. Ulcerative colitis represents a significant challenge for patients, who are in need of therapies that provide effective remission rates, are non-immunosuppressive and have improved safety.

Quince Therapeutics, Inc. (QNCX)

Quince Therapeutics is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases.

Our Phase 3 lead asset, EryDex, is the first product in development that leverages our proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient’s own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince’s AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response.

EryDex is composed of dexamethasone sodium phosphate (DSP) encapsulated in autologous red blood cells targeted to treat a rare pediatric neurodegenerative disease called Ataxia-Telangiectasia, or A-T. DSP is a corticosteroid well known for its anti-inflammatory properties, as well as its dose-limiting toxicity due to adrenal suppression. EryDex is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic corticosteroid treatment.

We are currently enrolling the pivotal Phase 3 NEAT study, which is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the neurological effects of EryDex in patients with A-T. The Phase 3 NEAT trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), and we expect to report topline results in the fourth quarter of 2025 with a potential New Drug Application (NDA) submission to the FDA and a Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) in 2026, assuming positive study results. Additionally, Quince was granted Fast Track designation by the FDA for the company’s EryDex System for the treatment of patients with A-T based on the potential for EryDex to address a high unmet medical need in A-T.

Quoin Pharmaceuticals, Ltd. (NasdaqCM:QNRX)

Rare diseases are only rare if you don’t live with one.™

Quoin is a clinical stage specialty pharmaceutical company focused on the development of therapeutic products for rare and orphan diseases.

We are dedicated to supporting underserved patients and their families, communities, and care teams around the world.

Rani Therapeutics Holdings, Inc. (RANI)

Rani is a clinical stage biotherapeutics company advancing technologies to enable the development of orally administered biologics, which we believe will have the potential to transform medicine and improve patient outcomes. We have developed the RaniPill capsule, which is our novel, proprietary and patented platform technology, intended to replace subcutaneous or IV injection of biologics with oral dosing. The RaniPill capsule is an orally ingestible pill approximately the size of a “000” capsule (or similar to the size of a standard fish oil or calcium pill) that is designed to automatically administer a precise therapeutic dose of medication upon deployment in the small intestine. To date, we have successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using the RaniPill capsule. Our development efforts have enabled us to construct an extensive intellectual property portfolio that we believe provides us a competitive advantage. 

Reviva Pharmaceuticals Holdings Inc (RVPH)

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) is a clinical-stage pharmaceutical company that discovers, develops and seeks to commercialize next-generation therapeutics for diseases representing significant unmet medical needs in the areas of central nervous system (CNS), cardiovascular, metabolic, and inflammatory diseases.

Reviva uses a chemical genomics driven technology platform and proprietary chemistry to develop new medicines. Reviva’s pipeline currently has two drug candidates, RP5063 (Brilaroxazine) and RP1208. Both are new chemical entities discovered in-house.

Rezolute, Inc. (NasdaqCM:RZLT)

We are a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs. The patient is at the core of every decision we make—from how we develop medicines, to the team we build that brings them to fruition—and we are resolved in our commitment to make a difference.

Hypoglycemia as a result of hyperinsulinism can strike in many forms. From infants with inherited disease to adults battling late-stage cancer, we are driven to empower individuals to restore balance within their lives, and we will continue to work with our partners around the world to fight hyperinsulinism in all its forms.

scPharmaceuticals Inc. (SCPH)

scPharmaceuticals is a clinical-stage pharmaceutical company focused on developing and commercializing products that, through our proprietary platform, are designed to enable the subcutaneous administration of therapies previously limited to intravenous (IV) delivery — with the goal of transforming infused therapies, advancing patient care and reducing healthcare costs.

SCYNEXIS, Inc. (SCYX)

All around the world, millions of people suffer from pernicious fungal diseases.

At SCYNEXIS, we are bringing a ground-breaking class of drugs to the battle by developing innovative products that have the strength, safety and versatility to defeat even the most insidious fungal diseases.

We are committed to positively impacting the lives of patients suffering from fungal infections — from the most common to the difficult-to-treat and deadliest.

SeaStar Medical Holding Corporation (ICU)

With our simple approach to addressing a key source of a dysregulated immune response, SeaStar Medical is advancing the science of cell-directed extracorporeal therapy to prevent the devastation of hyperinflammation

SELLAS Life Sciences Group, Inc. (SLS)

We are a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. Our product candidates currently include galinpepimut-S, or GPS, a cancer immunotherapeutic agent that targets the Wilms tumor 1, or WT1, protein, and SLS009, a highly selective small molecule cyclin-dependent kinase 9, or CDK9, inhibitor.

STRATA Skin Sciences, Inc. (SSKN)

STRATA Skin Sciences is a medical technology company focused on the therapeutic and aesthetic dermatology market. Its products include the XTRAC® laser and VTRAC® excimer lamp systems utilized in the treatment of psoriasis, vitiligo and various other skin conditions.

Talphera, Inc. (TLPH)

Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.

Tenon Medical, Inc. (TNON)

Delivering the latest innovation in sacroiliac joint surgical solutions, Tenon Medical is uniquely positioned to introduce a refined surgical option for patients with chronic sacroiliac joint pain that fail conservative care. The Catamaran™ SIJ Fusion System offers a patented new surgical solution that places a single implant directly into the SI joint. Tenon Medical is led by a powerful team with years of cumulative experience in designing and launching innovative surgical solutions that deliver a pathway to improved quality of life for thousands of patients.

Tivic Health Systems, Inc. (TIVC)

Tivic Health Systems, Inc. is a commercial-stage bioelectronic medicine company focused on treating diseases and conditions by modulating the electrical signals carried along various nerve pathways.

Our first FDA-approved product, ClearUP® Sinus Pain Relief (“ClearUP”), is a patented handheld device that uses ultra-low current electrical waves to relieve sinus pain and congestion, common symptoms of sinus and nasal inflammation. These symptoms are often associated with nasal allergies, sinus infections, chronic sinusitis, cold and flu, a $9.9 billion U.S. market currently dominated by pharmaceutical companies. ClearUP, a non-invasive bioelectronic therapy, can safely and comfortably deliver therapeutic benefits with no significant side effects.

ClearUP is a US FDA Class II and EU Class IIa medical device that has received three regulatory clearances: (US FDA 510(k) number K182025, US FDA De Novo number DEN200006 and EU CE Mark Certificate number CE 704687). ClearUP is available on Amazon, Best Buy, Walgreens, Walmart and other major e-commerce websites.

TriSalus Life Sciences, Inc. (TLSI)

TriSalus Life Sciences® is an oncology focused medical technology business providing disruptive drug delivery technology with the goal of improving therapeutics delivery to liver and pancreatic tumors. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach to deliver a range of therapeutics: the TriNav® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via PEDD may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by PEDD are commonly present as well. Nelitolimod delivered by PEDD will be studied across several indications in an effort to address immune dysfunction and overcome drug delivery barriers in the liver and pancreas.

TuHURA Biosciences (Private)

Vivani Medical, Inc. (VANI)

Vivani Medical is an emerging biopharmaceutical company developing a pipeline of miniature, long-term drug implants with its proprietary NanoPortal™ platform technology for obesity/weight management and other chronic diseases.

Vivani’s lead drug implant candidates are designed to improve medication adherence and deliver smooth consistent therapeutic levels of GLP-1 – the same class of active pharmaceutical ingredients in Ozempic®, Trulicity® and Wegovy® – for six months or longer with a single administration. NPM-115 and NPM-119, are miniature, six-month, GLP-1 (exenatide) implants under development for obesity/chronic weight management and the treatment of type 2 diabetes, respectively.

As a result of positive preclinical weight loss data comparing NPM-115 to Ozempic/Wegovy and the transformational change in the obesity market, Vivani has decided to prioritize development of its obesity portfolio moving forward which also includes NPM-139 (semaglutide implant) with the potential for once-yearly dosing.

Vivani continues to proceed towards initiating LIBERATE-1, a First-in-Human (FIH) study assessing the exenatide implant’s safety and pharmacokinetic profile in obese and overweight individuals. In addition to an active control arm with Bydureon BCise®, LIBERATE-1 will also include a second active control arm with Wegovy (semaglutide injection).

NanoPortal™ has broad potential application across a range of molecule types including peptide therapeutics.

Zevra Therapeutics, Inc. (NasdaqGS: ZVRA)

Zevra is a rare disease therapeutics company driven by science, data and patient need to create transformational therapies for diseases with limited or no treatment options. (Source: Company Website 1.12.24)