Silo Pharma, Inc. | December 02, 2022
Silo Pharma, Inc. a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today issued a letter to shareholders highlighting the Company’s progress and potential for its portfolio of novel, IP-protected technologies and assets developed in collaboration with world-class medical research partners. The letter, in its entirety, is reprinted below.
Dear fellow Silo Pharma shareholders,
The healthcare market continues to build momentum as science and technology lead to new developments for therapeutics. Nowhere is this more evident than in the growing body of scientific research supporting the therapeutic potential of psychedelics. More than ever, alternative new therapies for numerous diseases and mental health disorders are needed to address the health challenges of today.
Our Company, Silo Pharma, Inc. is working diligently to make further advances in the medical and psychedelic space. To date, the research conducted has shown encouraging promise in the delivery, efficacy, and safety of our pipeline therapeutics and technologies.
This has been an exciting year where we have achieved numerous milestones and anticipate upcoming updates as our pipeline progresses. The purpose of this letter is to provide shareholders with an update on our current business. With over $12 million in cash, we are prepared to advance our pipeline, and believe, with our strong balance sheet, no debt, and recent listing on Nasdaq, that we are in a position to further advance the Company and create shareholder value.
Valuable Intellectual Property and Collaboration
We are focused on advancing traditional therapeutics with psychedelic research to treat underserved large markets. We believe that our novel IP-protected technologies and assets, developed in collaboration with world-class medical research partners, offer disruptive market potential.
The unique assets in our portfolio are well protected with issued and numerous provisional patents pending. We obtained these assets through exclusive drug development collaborations, including a joint venture with Zylö Therapeutics, Inc.; a license and option agreement and an investigator-sponsored study agreement with the University of Maryland, Baltimore; a sponsored study agreement and a licensing option agreement with Columbia University; and a sponsored research agreement with the University of California, San Francisco.
Ketamine is an FDA-approved fast-acting general anesthetic administered through intravenous injection or nasal spray. Scientific research has shown that ketamine’s interactions with certain brain chemicals may be connected to its pain management, anti-inflammatory, and antidepressant effects. Since 2000, increasing research on ketamine has demonstrated significant results as a treatment for pain conditions including chronic neuro-inflammatory disorders and for mood disorders including depression, PTSD, and anxiety.
Considered a serotonergic hallucinogen, this substance is an active ingredient in some species of mushrooms. While classified as a Schedule I controlled substance under the Controlled Substances Act there is an accumulating body of evidence that psilocybin may have beneficial effects on depression and other mental health conditions. The U.S. Food and Drug Administration and the U.S. Drug Enforcement Agency have permitted the use of psilocybin in clinical studies for a range of psychiatric conditions.
About Silo Pharma
Silo Pharma. Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s disease, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the healthcare industry.
BUSINESS INSIGHTS, PHARMACY MARKET
Xeris Pharmaceuticals, Inc. | January 31, 2023
On January 30, 2023, Xeris Biopharma Holdings, Inc., a leading biopharmaceutical company, announced that the Food and Drug Administration (FDA) granted orphan-drug exclusivity (ODE) to its subsidiary Xeris Pharmaceuticals, Inc. for Recorlev® (levoketoconazole) a cortisol synthesis inhibitor for the treatment of endogenous Cushing's syndrome in adult patients for whom surgery is not viable or has not been effective.
levoketoconazole (Recorlev) being the first FDA-approved therapeutic for the treatment of endogenous hypercortisolemia, Xeris Pharmaceutical is permitted to have seven years of orphan-drug market exclusivity beginning from December 30, 2021. The FDA's Orphan Drug Designation program intends to accelerate the development of medications that treat a disease that affects 200,000 or fewer people in the United States each year. This regulatory exclusivity with the patent exclusivity under Xeris' U.S. patents for Recorlev is valid until at least March 2040.
To serve and assist this community, Xeris is dedicated to ensuring that everyone who needs access to their medications receives them. Xeris has developed Xeris CareConnection™ to provide patients and caregivers with a comprehensive program that includes financial support, one-on-one assistance, and educational materials throughout the treatment journey. Additionally, Xeris CareConnection assists healthcare providers and their teams with education on access and reimbursement.
About Xeris Pharmaceuticals, Inc.
Founded in 2005, Xeris is a growth-oriented biopharmaceutical firm dedicated to improving patients' lives via the development and commercialization of novel products in a range of therapies. Its unique technology makes medicines easier to use for patients & caregivers. The company has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for treating severe hypoglycemia (very low blood sugar); Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous hypercortisolemia. In addition, it has an increasingly broad pipeline of research and partnered projects utilizing its unique formulation technology platforms, XeriSol™ and XeriJect™, bringing forward innovative products for the firm and its partners.
BUSINESS INSIGHTS, PHARMACY MARKET
Caris Life Sciences and Xencor | January 06, 2023
Caris Life Sciences®, a molecular science and technology company, and Xencor, Inc., a clinical-stage biopharmaceutical company, have announced that they will work more closely together to research, develop, and sell new bispecific and multispecific XmAb® antibodies.
This expanded relationship will boost the number of targets and cancer types that Caris will investigate with Caris Discovery, a proprietary multi-omics discovery engine platform. The foundation for drug candidate development on Xencor's XmAb platform will be novel targets and their accompanying validation packages.
Under the terms of the new contract, Xencor will receive worldwide commercial rights to study, develop, and market products aimed at up to three targets discovered through collaboration. In addition, Caris will get an upfront payment and may receive up to $187 million in commercial milestone payments and development. The company will also be eligible for royalties on the net sales of products commercialized as a result of the agreement, as well as future rights for molecular profiling and companion diagnostics.
Caris Discovery leverages the collective force of its unmatched platform by combining the data generated from the primary patient tissues' molecular interrogation using ADAPT™, which integrates the company's extensive catalog of molecular and clinical data.
About Caris Life Sciences
Caris Life Sciences® is a Texas-based molecular science firm revolutionizing healthcare. Its market-leading molecular profiling products analyze DNA, RNA, and proteins to produce a molecular blueprint. This plan shows how patients, doctors, and researchers can use the information to improve outcomes and save lives. The company also uses cutting-edge algorithms for artificial intelligence (AI) and machine learning (ML) to improve precision medicine.
Xencor develops modified antibodies and cytokines for cancer and autoimmune illnesses. More than 20 XmAb® candidates are in clinical development while three are sold by partners. The company’s XmAb technology modifies protein structures to create new therapeutic pathways.