AIM ImmunoTech Inc.

AIM ImmunoTech Inc. (NYSE American: AIM)  is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.

Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either 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. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.

NLS Pharmaceutics Ltd.

NLS Pharmaceutics Ltd. is a global development-stage biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system, or CNS, disorders, who have unmet medical needs. For more information, please visit www.nlspharma.com.

Numinus Wellness Inc.

Numinus Wellness (TSX: NUMI, OTCQX: NUMIF) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model - including psychedelic production, research and clinic care - is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at www.numinus.com and www.investors.numinus.com.

Altimmune, Inc.

Altimmune is a clinical-stage biopharmaceutical company focused on the development of novel peptide-based therapeutics for the treatment of obesity and liver diseases. The company’s lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell™, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B.

Vivani Medical, Inc.

Vivani Medical (Nasdaq: VANI) is an innovative, near-clinical stage biopharmaceutical company that develops miniature, subdermal drug implants utilizing its proprietary NanoPortal™ technology. Vivani is advancing a pipeline of novel, long-term drug implants, including lead investigational product, NPM-119.  NPM-119 is a six-month, GLP-1 receptor agonist implant under development for the treatment of patients with type 2 diabetes and obesity.

The company’s novel NPM-119 drug implant is designed to optimize GLP-1 therapy by addressing two main barriers to achieving maximum therapeutic benefit, medication non-adherence and fluctuating drug plasma levels which can be associated with poor GI tolerability. Vivani’s NanoPortal implants employ finely tuned nanotubes that require no moving parts which, in turn, allow for a miniaturized implant and a controlled, smooth delivery of drug over the life of the implant.

Our first clinical trial, LIBERATE-1, a Phase 2, randomized, 12-week study in patients with type 2 diabetes to assess the safety and full pharmacokinetic profile of NPM-119, is planned to begin in 2023. In addition to an active control arm with Bydureon BCise®, LIBERATE-1 will also measure the effect of NPM-119 on glycemic control and weight in patients previously prescribed an alternative GLP-1 agonist.
Vivani’s foundational NanoPortal technology has broad potential application across a variety of molecular types including small molecules and peptide therapeutics. The company’s emerging portfolio involves both unpartnered implant candidates and feasibility programs with large pharmaceutical partners.

Vivani has approximately 40 employees and is located in Emeryville, CA, USA. 

Aytu BioPharma, Inc.

Aytu BioPharma is a pharmaceutical company commercializing a portfolio of commercial prescription therapeutics and consumer health products generating approximately $100M in net revenue for the 12 months ending 3/31/23. The company's prescription products include Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of attention deficit hyperactivity disorder (ADHD), as well as Karbinal® ER (carbinoxamine maleate), an extended-release antihistamine suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines available in various formulations for infants and children with fluoride deficiency. Aytu's consumer health segment markets a range of over-the-counter medicines addressing a range of common conditions including diabetes, allergy, hair regrowth, and gastrointestinal conditions.

Cingulate Inc.

Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR™ drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information visit Cingulate.com.

Kiora Pharmaceuticals, Inc.

Kiora Pharmaceuticals, Inc. (Kiora) is an ophthalmic specialty pharmaceutical company that develops therapies for the treatment of different types of eye diseases. Publicly traded on the NASDAQ under KPRX, our mission is to help patients improve their ocular health and restore vision.

Virpax Pharmaceuticals, Inc.

Virpax® Pharmaceuticals Inc., (Nasdaq: VRPX) is a publicly held specialty pharmaceutical company located in Berwyn, PA and is focused on advancing the development and worldwide commercialization of its non-addictive pain and neurological disorder pipeline.

Virpax’s transforming drug-delivery platforms and their targeted drug-releasing capabilities have been developed to enhance compliance and to optimize the efficacy of our non-addictive pain management pipeline and our Central Nervous System (CNS) disorder pipeline.

NEXGEL, INC

NEXGEL Advanced Hydrogel Solutions is your skin-friendly patch company! Our ultra-gentle, high-water content hydrogels are an excellent transdermal drug delivery system for a broad range of OTC and Cosmetic ingredients. Our hydrogels are more gentle because we don’t chemical cross-linking agents, instead, we use a unique electron-beam cross-linking process to create the bond. Additionally, our hydrogels are more skin-friendly than many adhesive patches on the market, since we don’t use chemical adhesives to deliver our ingredients. All of this means that you can rest assured that you have one of the gentlest transdermal delivery systems on the market!

Capricor Therapeutics, Inc.

Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives. Capricor is focused on the development of biologics, primarily cell and exosome-based technologies to treat or prevent a broad range of diseases. Our lead product is a cell therapy designed to treat Duchenne muscular dystrophy (DMD), the most severe form of muscular dystrophy, which results in muscle degeneration and premature death. Capricor’s innovative exosome technology is focusing on engineering exosomes to treat or prevent diseases with high unmet medical needs. Our translational approach to product development is based on the strong research foundation provided by our academic partnerships with leading scientists at top-tier research institutions.

Genenta Science

Genenta (www.genenta.com) 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.

electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets. For more information go to www.electrocore.com

SeaStar Medical

SeaStar Medical (Nasdaq: ICU) is a medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The Company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses.

Biocept, Inc.

Biocept, Inc. (Nasdaq: BIOC)  is a molecular diagnostics company with commercialized assays for patients with carcinomas or melanomas. Our experts have spent years working to change the way physicians look at cerebrospinal fluid in cancer patients. Biocept has developed a unique, patented methodology to isolate cancer material that is shed from the primary tumor, such as CSF tumor cells (CSF-TCs) and cell-free DNA (cfDNA). As such, Biocept is a leading commercial provider of testing services designed to enable clinicians to rapidly detect and monitor cancer biomarkers from a cerebrospinal fluid sample.

Myomo Inc.

Myomo, Inc. is a wearable medical robotics company that offers improved arm and hand function for those suffering from neurological disorders and upper-limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper-limb orthosis designed to support the arm and restore function to the weakened or paralyzed arms of certain patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS or other neuromuscular disease or injury. It is currently the only marketed device that, sensing a patient’s own EMG signals through non-invasive sensors on the arm, can restore an individual’s ability to perform activities of daily living, including feeding themselves, carrying objects and doing household tasks. Many are able to return to work, live independently and reduce their cost of care. Myomo is headquartered in Boston, Massachusetts, with sales and clinical professionals across the U.S. and representatives internationally. For more information, please visit www.myomo.com.

IceCure Medical Ltd.

IceCure Medical Ltd. (Nasdaq:ICCM; TASE:ICCM) develops and markets ProSense®, a minimally invasive cryoablation technology that ablates (destroys) tumors, both malignant and benign, by freezing them - which IceCure believes reduces risk, generally results in fewer side effects, shorter downtime, and reduces the cost of care. The worldwide tumor ablation market is projected to grow to $2.4 billion by 2028.

ProSense is marketed and sold worldwide for various clinical indications that have regulatory clearance to date, including by the U.S. FDA for general minimally-invasive cryoablation applications, CE approval in Europe, and NMPA approval in China (for IceSense3). The company is focused on bringing breast cancer cryoablation to the US market, having filed for marketing authorization with the U.S. FDA based on its ICE3 clinical trial interim analysis for the indication of early-stage low-risk breast cancer in patients who are at high risk to surgery (not suitable for surgical alternatives). For patients treated with ProSense in ICE3, the largest trial of its kind, interim results demonstrated 96.91% were recurrence-free. 100% of patients and physicians reported satisfaction with the cosmetic results as there is no excision made and there is little to no change to the size or shape of the breast with cryoablation.

HCW Biologics, Inc.

HCW Biologics Inc. is a clinical-stage company that has developed proprietary, patented immunotherapeutic treatments for age-related diseases promoted by chronic inflammation, a condition called “inflammaging.”  The Company believes it has created category-defining immunotherapeutics and methods to treat age-related diseases and enhance healthspan.

The induction and retention of low-grade inflammation in an aging human body is mainly the result of the accumulation of non-proliferative but metabolically active senescent cells and the proinflammatory factors they secrete, known as SASP factors.  The Company is based on the primary premise that rejuvenating the immune system creates a systemic change that reduces senescence and SASP factors.  It has invented over 30 molecules using its proprietary TOBI^TM discovery platform.  Two lead product candidates have been identified.  The Company is licensing other molecules and signed its first license with Wugen in 2020.  The upfront payment for the Wugen license included a 5% equity ownership position in Wugen.

The Company projects that it has 18 months of operating capital.  Recently, the Company obtained $26.25 million in project financing that will be used to complete the buildout of new headquarters, including upgrade laboratory space, vivarium, and a world-class biologics manufacturing facility.

Milestones expected through 2024 include: 

• Complete Phase 1/1b clinical trials in cancer indications in 2023  

• Initiate at least one Phase 2 clinical trial in a cancer indication in 2023  

• Identify expanded indications for HCW9218 in 2024

• File IND application for HCW9302 in an autoimmune disorder by the end of 2023  

• Open new headquarters and manufacturing facility in 2024

Alzamend Neuro, Inc.

Alzamend Neuro® is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease, Bipolar disorder, Major Depressive Disorder (“MDD”) and Post-Traumatic Stress Disorder (“PTSD”). Our mission is to rapidly develop and market safe and effective treatments to bring aid to the 43+ Million Americans suffering from these debilitating diseases. 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.

Cutera

Cutera is a leading provider of aesthetic and dermatology solutions for practitioners worldwide. Since 1998, Cutera has been developing innovative, easy-to-use products that harness the power of science and nature to enable medical practitioners to offer safe and effective treatments to their patients.

Nuwellis, Inc.

Nuwellis is a medical technology company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. Our Aquadex SmartFlow® System gently and precisely removes excess fluid build-up in the body, which, when left untreated, can exacerbate symptoms of heart failure and increase length of hospitalization for critical care and pediatric patients.

The efficacy of ultrafiltration therapy using Aquadex SmartFlow is supported by an extensive body of clinical literature, including randomized, controlled clinical trials specific to Aquadex. It is fully commercialized, and the company is executing a growth strategy to expand access to the therapy. As Nuwellis looks to the future, the company is focused on building a novel product pipeline to meet the needs of patients suffering from both heart failure and other cardio-renal diseases.

For more information, please visit www.nuwellis.com

Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes early-stage 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.

Aprea Therapeutics

Aprea Therapeutics (NASDAQ: APRE) is a biopharmaceutical company headquartered in Doylestown, Pennsylvania, focused on developing and commercializing novel synthetic lethality-based cancer therapeutics targeting a critical pathway and some of the most central targets in DDR and cancer progression. The Company’s lead program is ATRN-119, a clinical-stage small molecule ATR inhibitor being developed for solid tumor indications. Our WEE1inhibitor is being advanced to IND submission.

VolitionRx Ltd

Volition is a multi-national epigenetics company powered by Nu.Q®, its proprietary nucleosome quantification platform. Through its subsidiaries, Volition is developing simple, easy to use, cost effective blood tests to help diagnose and monitor a range of life-altering diseases including certain cancers and diseases associated with NETosis such as sepsis and COVID-19. Early diagnosis and monitoring have the potential to not only prolong the life of patients but also improve their quality of life. The tests are based on the science of Nucleosomics™, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid—since changes in these parameters are an indication that disease is present.

Volition's research, product development and manufacturing activities are centered in Belgium, with innovation and U.S. operations in California, and additional offices in Nevada, London and Singapore.

Palisade Bio.

Palisade Bio is a biopharmaceutical company focused on developing therapeutics that protect the integrity of the intestinal barrier. The Company utilizes over three decades of research and established science that links the role of intestinal barrier biology with human disease to advance novel therapeutics that target and improve the integrity of the intestinal barrier. The Company’s lead program, LB1148, is a broad-spectrum serine protease inhibitor that acts to neutralize digestive enzymes, potentially reducing intestinal damage. In prior clinical studies, LB1148 has demonstrated positive results in reducing the incidence and severity of post-surgical abdominal adhesions and potentially reducing the time to return of postoperative bowel function. LB1148’s current U.S. Phase 2 study is evaluating its effectiveness in reducing intra-abdominal adhesions, accelerating return of gastrointestinal function, and the prevention of post-operative ileus in subjects undergoing elective bowel resection (PROFILE).The Company believes that addressing the disruption of the intestinal barrier can fundamentally change the way diseases are treated and establish new standards of patient care.

Moleculin Biotech, Inc.

Moleculin Biotech, Inc. (NASDAQ:MBRX) is a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses. The Company’s lead program, Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

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, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of COVID-19 and other viruses, as well as cancer indications including brain tumors, pancreatic and other cancers.

GRI Bio, Inc.

GRI Bio (NASDAQ:GRI) is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of NKT cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I invariant NKT (“iNKT”) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 NKT agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline.

Clene Inc.

Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. 

Neurodegenerative diseases present unique challenges that must be addressed in novel ways. Decades of research in neurology and the neuroscience fields have shown that many neurodegenerative diseases share a common underlying mechanism: a decline in the cell’s ability to produce energy.  Clene’s revolutionary nanotherapeutics have unleashed the extraordinary catalytic activity of elemental nanocrystals to improve cellular energy production in the setting of disease-related stress resulting in neuroprotection, neurorepair, and remyelination. In this way, nanotherapeutics may have broad applicability to disease states for which energy depletion or dysfunction are fundamental.

Our nanotherapeutics are produced utilizing a patented electro-crystal-chemistry process that results in highly-faceted, clean-surfaced nanocrystals of pure transition elements. This process is optimized to control three critical characteristics: size, shape (highly faceted crystal structure) and surfaces (contaminant free) to ensure consistently high catalytic activity for enhanced therapeutic benefit.

Our lead asset, CNM-Au8®, is potentially a first-in-class, orally-delivered, aqueous suspension of catalytically active, gold nanocrystals that improve cellular energy production and utilization.  We are currently investigating the clinical potential of CNM-Au8® for the treatment of Amyotrophic Lateral Scierosis (“ALS”), Multiple Scierosis (“MS”) and Parkinson’s Disease (“PD”).

Quoin Pharmaceuticals, Ltd.

Quoin Pharmaceuticals Ltd. is a clinical stage specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products that treat rare and orphan diseases for which there are currently no approved treatments. Quoin’s lead product, QRX003, is a once daily, topical lotion to treat Netherton Syndrome, a rare hereditary skin disease. Clinical testing of QRX003 is currently being tested in two clinical studies under an open IND in Netherton patients.