SOURCE: Mount Tam Biotechnologies, Inc.

Mount Tam Biotechnologies, Inc.

June 03, 2016 13:00 ET

Mount Tam Biotechnologies, Inc. Letter to Stockholders

NOVATO, CA--(Marketwired - Jun 3, 2016) - Mount Tam Biotechnologies, Inc. ("Mount Tam") (OTC PINK: MNTM)

Dear Stockholder:
It is with a great sense of excitement that I am writing this, Mount Tam's first stockholder letter. In 2016 we have made great strides to develop and refine our corporate strategy, build our team, and lay the groundwork so that the company may be in a position to execute on key milestones, and to enable our lead compound, TAM-01, to move to Investigational New Drug ("IND") filing with the FDA, and first-in-man clinical studies.

Management Update
A key step forward this year has been the expansion and strengthening of the Mount Tam management team. Our new team brings together the expertise and experience necessary to move Mount Tam's lead program and discovery efforts forward, and to achieve the best outcomes for stockholders.

Richard Marshak, VMD MBA, joined the company in March as CEO, bringing a wealth of pharmaceutical development, commercialization and business development experience. In a series of leadership roles at Abbott Laboratories Pharmaceutical Products Group (now Abbvie) and as a strategic consultant to leaders in biotech, Dr. Marshak has demonstrated the ability to guide programs and organizations to success and is excited to lead Mount Tam's programs in mTOR modulation with the goal of bringing novel medications to patients in areas of high unmet need.

Tim Powers, PhD, returns to his role as Chief Scientific Officer (CSO), where he will lead medicinal chemistry, CMC and pre-clinical development efforts for both lead compound TAM-01 and for Mount Tam's product development platform. Dr. Powers has been engaged in all aspects of drug discovery and development for more than 20 years at both small and large biotechnology and pharmaceutical companies. Prior to joining Mount Tam, Dr. Powers held the position of Scientific Director of Medicinal Chemistry at Amgen where he provided scientific and executive leadership to the teams that were responsible for the discovery and development of Amgen's first b-secretase small-molecule clinical candidate for Alzheimer's disease. Prior to joining Amgen, he was Director of Medicinal Chemistry at Alantos Pharmaceuticals, overseeing all aspects of the company's discovery research activities which led to the clinical development of the company's two flagship programs in the areas of type-II diabetes and osteoarthritis.

Jim Stapleton, MBA, joined the company on May 2, 2016 as the CFO, and brings over 25 years of public company CFO experience across a wide range of industries. Specific to Mt. Tam, Mr. Stapleton was the CFO of Bionovo, a clinical state drug discovery and development company from 2005 through 2007, and was the CFO of a biotech device company, Biotech Solutions and is responsible for raising more than $100M from institutional investors while serving as CFO for both companies.

With our new team in place, Mount Tam is confident that we have the combination of leadership, expertise and experience necessary to move our critical programs forward all while maximizing shareholder value.

Pipeline Update

Mount Tam's lead program, TAM-01 for systemic lupus erythematosus (SLE), is ready for execution of cGMP manufacturing and GLP Tox studies, the final steps before filing an IND and entering clinical studies in man. cGMP manufacturing is ready to begin within 60 days, with GLP tox studies commencing as soon as cGMP product is available.

This novel rapalog has demonstrated, through extensive pre-clinical testing, a profile that is expected to deliver a superior combination of efficacy and safety vs. rapamycin, and to provide an important new therapeutic option for patients suffering with SLE. With its multi-modal mechanism of action, rapamycin has proven effective at treating refractory SLE in one open-label study (David Fernandez et. al. Arthritis & Rheumatism (2006) 54 (9), 2983) but with a side effect profile that includes dyslipemia, dysregulation of glucose metabolism and decreased reticulocyte counts,we believe that rapamycin is not an optimal candidate for chronic therapy in SLE, particularly given the increased risk of cardiovascular morbidity and mortality seen in these patients. TAM-01 has shown > efficacy vs. rapamycin in standard SLE models without the adverse event profile that limits rapamycin's utility in these patients.

The SLE market represents an area of high unmet need and rapid sales growth, with a recent Decision Resources Group (DRG) report indicating that DRG expects this market to grow from its current size of < $1B to more than $4B by 2022, driven by novel therapeutics taking the place of older drugs that are the standard of care today. We believe that TAM-01 will fill an important role in this dynamic market.

Other Pipeline
Beyond TAM-01, we are excited by the broader potential for our pipeline. Along with TAM-02, with its strong pre-clinical profile for the treatment of multiple sclerosis, we are particularly excited by our proprietary platform for the discovery and pre-clinical evaluation of novel rapalogs across a range of indications. Combining the ability to generate novel rapalogs in a rapid and cost-effective manner with our ability to rapidly screen for mTORC1 and mTORC2 activity, we are in a position to become the leader in discovering and developing mTOR modulation based therapeutics.

Our understanding of the potential benefit of mTOR modulation across a range of disease states has greatly increased in the last decade, along with our understanding of how disease-modifying therapeutics might benefit patients across a broad range of disease states including cancer, cognitive disorders, muscular dystrophies and a variety of auto-immune and neurodegenerative diseases. At Mount Tam, we intend to use our unique approach to drug discovery to bring forward medications that can have a lasting, positive impact on patients' lives.

Financial Update
Mount Tam is pleased to have executed a Secured Promissory Note in March 2016 whereby Mount Tam may borrow up to one million dollars ($1,000,000) with the agreement of the holder of the Note. Recently the holder of the Note has agreed to increase the total amount available on this Note to $2,000,000. This Note has a mandatory conversion provision whereby the principal will be converted to equity, at a 20% discount, upon the completion of a Qualified Financing of > two million dollars ($2,000,000). The successful execution of this Note has allowed Mount Tam to focus on quickly securing the financing necessary to move our core programs forward.

In conclusion, we are confident that Mount Tam is in a stronger position than at any time in its history, poised to move forward and to deliver on the promise of becoming a leader in discovering and developing novel mTOR modulators. The combination of our lead compound for SLE and our broader pipeline focused across a range of indications where recent research has demonstrated the potential for mTOR modulation to deliver meaningful benefit is an exciting combination, and one that puts Mount Tam in an advantageous position to become a leader in this exciting area.

We appreciate your support as we work to advance our proprietary science and technology platform and are excited by our future prospects. 

About Mount Tam Biotechnologies, Inc.

Mount Tam Biotechnologies, Inc. was established to develop, optimize and bring to market leading medical compounds to better the health and well being of millions of people who have been affected by autoimmune diseases. The organization's most advanced product focuses on the treatment of systemic lupus erythematosus (SLE).

Mount Tam has partnered with the world-renowned Buck Institute for Research on Aging through a worldwide exclusive licensing and collaboration agreement. The assets, which are focused on autoimmune diseases, are highly target-specific polyketides -- a class of compounds with an extremely successful track record with the FDA drug approval process. The assets are supported by intellectual property consisting of over 45 worldwide issued patents and patent applications, including composition of matter, manufacturing and therapeutic area applications.

Mount Tam intends to apply its first and most advanced asset, TAM-01, to the Investigational New Drug (IND) application phase of the FDA. It has already completed non-GLP pre-clinical development. The primary focus is to develop TAM-01 for the treatment of systemic lupus erythematosus (SLE) in an expanding orphan drug market. Mount Tam will use the R&D conducted on TAM-01 as the core science for additional assets, including its second product known as TAM-02, which is currently focused on multiple sclerosis (MS).

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