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Kalos Therapeutics Inc

Kalos Therapeutics Inc

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The investment opportunities below are not an offer to the general public to purchase any form of securities. Every investment opportunity below should be considered to be a very high risk investment and the investor must be comfortable in accepting and bearing the very high level of risk associated with any of the investment opportunities listed on this site. The information contained in these investment opportunities is proprietary and strictly confidential. It is intended to be reviewed only by accredited investors in order to evaluate the investment opportunities and should not be used for any other reason or made available to any other person or entity without the prior written consent of The OCMX (P2P Financial Inc.). The technology and process used on this website is protected by existing or pending patents owned by The OCMX. Nothing on this site including any related communication is intended to provide specific financial, investment, tax, legal, accounting or other advice to you, and should not be acted or relied upon in that regard without seeking the advice of a professional. In all circumstances, you should seek guidance from your current advisor as your advisor can help to ensure that your own circumstances have been properly considered and any action is taken on the latest available information.

 

 

 

 

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Kalos Therapeutics Inc

Location: Phoenix, AZ

Sector: Life Sciences.

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Kalos Therapeutics, Inc. is a biomedical company developing a class of therapeutic peptides to fight cancer.  These peptides have already shown significant clinical activity in cardiovascular, cancer and veterinary indications. Kalos’ drugs replicate a natural, anti-proliferative activity by disrupting tubulin activity.

Our lead drug candidate, KTH-222, is a safe, non-toxic drug which may be used as 1) a front-line therapy, 2) a long-term maintenance therapy or 3) a co-therapy which reduces time to chemo resistance and minimizes chemo side-effects.  KTH-222 reduces tumor size while addressing complications, such as metastasis, thereby, allowing the patient to maintain a quality of life not seen with chemo therapy treatments alone.

Initial cancer markets include:  pancreatic, ovarian, prostate, lung and liver.  An animal division will develop drugs for the treatment of cancer and renal disease, congestive heart failure and epistaxis.

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MG cp Summary

KTH-222 – Human Cancer

Breakthrough technology – Novel therapeutic for unmet medical need in pancreatic cancer and associated complications like metastases.

 

Orphan Drug Designation – U.S. Orphan designation qualifies the sponsor to a seven-year period of market exclusivity upon approval of the drug. Sponsor may apply for FDA orphan research grants, a waiver of Prescription Drug User Fee Act filing fees andtax credits for clinical research costs.

 

Low to no toxicity, well tolerated and limited to no side effects – Our drug could be used as a lead therapy, a second line active therapy or potentially the first long-term maintenance therapy for many cancers.  Based on its low/no toxicity, there is little risk of resistance and when used in combination, chemo amounts can be reduced with an improved quality of life for the patient.

 

KTH-222/variants – Canine Cancer

Pet owners are reluctant to subject their pets to chemotherapy based on Quality of Life (QOL), costs, and outcomes. KTH-222 is well tolerated, fewer, if any side effects, reduces primary tumor, address complications like metastases, improves QOL and can be used in combination with chemo should the owner desire.

 

KTH-222/variant – Retinal disease

Ease of delivery – Kalos has explored delivery of this therapy in retinal disease as a topical, delivered as a viscous drop, or applied to film. The goal is to eliminate or reduce injections into the eye as site fatigue is a problem and compliance of patients is difficult. This approach can be adapted in multiple eye diseases and KTH-222 should follow the pathway of testing previously completed with the parent peptide where vision was restored in AMD simulated animal models.

 

KTV-111 – Animal Epistaxis, Equine athletes

Focused on fluid removal to reduce bleeding in Equine Athletes – A well tolerated, potassium sparing approach to fluid removal to stop bleeding, additive benefits: regeneration of microtubules, and improvement of compromised heart function providing therapeutic benefits to the horses, while being compliant with regulations in each sport or event.

Quality-of-Life Safer, less toxic approach to slowing cancer with fewer side effects.

 

Safety/Toxicity Well tolerated. It is similar to amino acids found in the heart.

 

Addresses metastasis Our drug recognizes the metastasis and attacks these as small tumors.  This is not being addressed by other therapies, and can lead to a long-term maintenance therapy and increased survival.

 

Synergistic Can be used in conjunction with existing therapies to provide a better quality-of-life and progression free survival.

 

Reduction of drug resistance When used synergistically with chemo, the amount of chemo used can be reduced thereby allowing a longer treatment cycle.

George Colberg, Co-Founder, CEO, Chairman

Mr. Colberg is a seasoned corporate finance and management executive. He was CEO of Primary Inc., a company where he pioneered the plan for acquisitions and the business model initiating early efforts in personalized medicine, electronic medical record meshed with patient data and billing and the advanced use of diagnostics. Prior to Primary Care he was a Vice President at the Financial Group managing syndications and equity investment research while raising in excess of $100 million.

 

Mr. Colberg developed the corporate philosophy of Kalos, identified and shaped the strategy behind the primary products, and the commercialization plan for Kalos. He raised the seed round, series A and B rounds and grant financing totaling $3.5 million. He recruited the executive team and scientific advisory board and oversees the clinical development plan.  Mr. Colberg set the strategy for securing US and EU IP patents and the Orphan Drug Designation.

 

Mr. Colberg completed his Bachelor of Science from San Diego State University and attended University California, Berkeley  for a Certification as a Biomedical Executive.

 

Jay Merritt, MD, President and Chief Medical Officer

Dr. Merritt is a medical oncologist with over 20 years’ experience as a biotechnology executive. He most recently served as President and Chief Medical Officer at Adventrx Pharmaceuticals.  He was founding CEO of Imagine Pharmaceuticals, a venture stage company with a small molecule approach to facilitate drug uptake across the blood brain barrier.

 

He began his industrial career at the Upjohn Company leading early stage oncology and infectious diseases clinical research and he played a key role in launching Upjohn’s HIV research program. He subsequently held senior management positions at IDEC Pharmaceuticals (now Biogen Idec), Viagene Inc. and Introgen Therapeutics, successfully advancing ground-breaking biological modalities such as therapeutic monoclonal antibodies for cancer and rheumatologic diseases, and retroviral and adenoviral gene transfer technologies for cancer and HIV.

 

Dr. Merritt graduated from Johns Hopkins University and received an M.D. from the University of Vermont. He trained in Internal Medicine and Medical Oncology at the University of Wisconsin where he was also appointed Assistant Scientist in the Biophysics Laboratory.

 

Michael Kozlowski, PhD, Chief Science Officer

Dr. Michael Kozlowski is an Associate Professor at the Arizona College of Optometry (AZCOPT) at Midwestern University and CSO at Kalos therapeutics. Prior to Kalos, Dr. Kozlowski spent over 25 years in drug discovery and development for several clinical applications including cancer, age-related macular degeneration, and CNS disorders, and has over 40 peer-reviewed publications and over a dozen issued US patents.

 

He has worked with large pharmaceutical (Pfizer, BMS) and biotechnology companies (Geron, Telik, Axiom, Kreido Laboratories).  Dr. Kozlowski has held positions ranging from Research Scientist to Chief Scientific Officer.

 

Dr. Kozlowski holds a BS in Biology from Caltech, a PhD in Neuroscience from the University of California at Irvine, and an OD from the New England College of Optometry.


ThermaGenix Inc

ThermaGenix Inc

Marketplace

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The investment opportunities below are not an offer to the general public to purchase any form of securities. Every investment opportunity below should be considered to be a very high risk investment and the investor must be comfortable in accepting and bearing the very high level of risk associated with any of the investment opportunities listed on this site. The information contained in these investment opportunities is proprietary and strictly confidential. It is intended to be reviewed only by accredited investors in order to evaluate the investment opportunities and should not be used for any other reason or made available to any other person or entity without the prior written consent of The OCMX (P2P Financial Inc.). The technology and process used on this website is protected by existing or pending patents owned by The OCMX. Nothing on this site including any related communication is intended to provide specific financial, investment, tax, legal, accounting or other advice to you, and should not be acted or relied upon in that regard without seeking the advice of a professional. In all circumstances, you should seek guidance from your current advisor as your advisor can help to ensure that your own circumstances have been properly considered and any action is taken on the latest available information.
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ThermaGenix Inc

Location: Natick, MA

Sector: Life Sciences.

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ThermaGenix is committed to empowering scientists all over the world with the highest performing Polymerase Chain Reaction (PCR) additives. Our innovative and universal PCR additives ThermaStop™, ThermaGo™ and ThermaStop-RT™ augment polymerase specificity and fidelity, enhancing quantitative end-point data accuracy and analysis and achieving more homogeneous amplicons for downstream applications.

 

These technologies significantly enhance analysis of RNA substrates as well as DNA substrates. From genotyping to Gibson assembly, next generation sequencing sample preparation to diagnostics, ThermaGenix technology will maximize PCR and RT-PCR performance.

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MG cp Summary

ThermaStop™, ThermaGo™ and ThermaStop-RT™ prevent DNA Polymerases and Reverse Transcriptases from acting outside of  precise temperature ranges, thereby minimizing spurious side reactions and off-target activity. TGX is the first company to offer patented molecular reagents that control the key enzymes in very specific temperature ranges- which results in High-Precision PCR.

 

Key Features of ThermaStop:

• Replaces Hot-Start, cheaper & more effective – benefit for all forms of PCR

• Stabilizes Taq Polymerase for Extended Periods of Time- benefit for PCR

• Prevents mis-priming during reverse transcription of RNA

• Enhances Multiplexing – benefit for PCR

• Acts as a Cold Stop – benefit for NGS

• First Hot-Start for RT-PCR – benefit for NGS

 

Key Features of ThermaGo:

• First reagent to suppress product-product interactions during amplification

• Works with both antibody hot start and chemical hot start

• Enhances End-Point Genotyping using Symmetric PCR

• Suppresses chimera formation – benefit for NGS and Gibson assembly

 

Key Features of ThermaStop-RT:

• Provides Superior Hot-Start for RT-PCR

• Significantly improves Sensitivity and Specificity in RT-PCR

• Provides for Significant Increase in RNA Yields as reported and far better One-Step or Two-Step RT-PCR results

Entry into Global PCR Marketplace:

VERY Large and Growing Global Markets. ThermaGenix products are unique and value-adding for all aspects of PCR marketplace.

 

Entry in Global Next-Gen Sequencing (NGS) Markets:

VERY Large and Growing Global Markets. ThermaGenix products are unique and value-adding for all aspects of NGS marketplace. It is estimated that use addition of ThermaGenix reagents in NGS Product and Library preparation that approx.. 25% of NGS costs can by eliminated- saving over $100M annually.

 

Entry into VERY Large and Expanding Liquid Biopsy Marketplace:

ThermaGenix represents an “Intel-Inside” like opportunity to have an investment into the largest growth opportunity to come to Life Science/Cancer Diagnostics in the last decade, and for years to come.

Peter J Coassin – President and CEO

Mr Coassin is an experienced and successful inventor, entrepreneur and leader.  Since graduation Mr. Coassin has invented technologies and worked with leading academic scientists (Hubert Koester, Edwin Southern, John Fenn, Roger Tsien, Ron Davis and most recently Lawrence Wangh) to bring to market many different technologies including DNA Synthesizers, Peptide Synthesizers, DNA Arrays, Capillary Electrophoresis based DNA sequencing, cellular technologies and miniaturization, advanced microscopy and now, truly revolutionary additives to improve critical biotechnology enzyme processes.

 

Mr Coassin has worked within large Fortune 500 companies to produce products (Millipore, Beckman-Coulter, Vertex Pharmaceuticals) as well as a range of startups including CoWest Instruments – Sold to Millipore 1985, Aurora Biosciences –   Sold to Vertex in 2001, Aurora Discovery – sold to Beckman in 2006, Aurora Biotechnologies – merged to Nexus 2009 and sold to Brooks Automation 2011.

 

 

Lawrence J Wangh, Founder and CSO

Professor Lawrence, received his undergraduate degree in biology at Brandeis University in 1968 and his Ph.D. in biochemistry from The Rockefeller University in 1973.  He then went to England as a Helen Hay Whitney Fellow and work at the Medical Research Council laboratories in Cambridge and London.  In 1977 he returned to the Biology Department of Brandeis University to teach courses in developmental biology, reproductive biology, and evolution.  In parallel he established a laboratory aimed at doing basic research in those same fields.  In the course of that work he and his laboratory colleagues invented a novel method for non-symmetric amplification of very small amounts of DNA.

 

From 1997 through 2016, with approximately 10 million dollars of support from grants and biotechnology companies, he and his team invented a suite of synergistic technologies that enhanced their new PCR method and its use in many fields, including quantitative measurements of DNA and RNA in single cell, highly informative single-tube diagnosis of cancer gene targets, and detection of numerous infectious diseases – including extensively drug resistant tuberculosis.

 

After nearly forty years on the Brandeis faculty, Professor Wangh and his team: Aquiles Sanchez, Ph.D., John Rice M.S., and Kenneth Pierce, Ph.D. launched ThermaGenix, Inc. in 2017 in order to commercialize their revolutionary PCR reagents and methods. ThermaGenix is committed to enhancing the quality of life by selling its technologies for high precision analysis of very small quantities of nucleic acids to researchers, biotechnologists, and medical professionals worldwide.

 

 

Charles Powell, Chief Commercial Officer

Mr. Powell has spent the majority of his professional career in a variety of Life Science Sales and Marketing roles and assignments starting out as a field-sales representative with Beckman Instruments. Mr. Powell joined Aurora Discovery in May 2004 as Vice President, Sales and Marketing- eventually becoming Chief Commercial Officer and Director.

 

Aurora evolved over 7 years – merging with Nexus Biosystems in 2009 before being bought by Brooks Automation in 2011. In October 2015 Mr. Powell bought the Aurora Business back from Brooks Automation. In January 2017 Mr. Powell joined Thermagenix as Chief Commercial Officer.


Sequella Inc.

Sequella Inc.

Marketplace

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The investment opportunities below are not an offer to the general public to purchase any form of securities. Every investment opportunity below should be considered to be a very high risk investment and the investor must be comfortable in accepting and bearing the very high level of risk associated with any of the investment opportunities listed on this site. The information contained in these investment opportunities is proprietary and strictly confidential. It is intended to be reviewed only by accredited investors in order to evaluate the investment opportunities and should not be used for any other reason or made available to any other person or entity without the prior written consent of The OCMX (P2P Financial Inc.). The technology and process used on this website is protected by existing or pending patents owned by The OCMX. Nothing on this site including any related communication is intended to provide specific financial, investment, tax, legal, accounting or other advice to you, and should not be acted or relied upon in that regard without seeking the advice of a professional. In all circumstances, you should seek guidance from your current advisor as your advisor can help to ensure that your own circumstances have been properly considered and any action is taken on the latest available information.
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Sequella Inc.

Location: Rockville, MD

Sector: Life Sciences .

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Sequella is a private, clinical stage pharmaceutical company that addresses the challenge of antibiotic resistant bacterial diseases by discovery and development of first in class antibiotics with novel mechanisms of action.

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MG cp Summary

The clinical stage drugs produced by Sequella Inc. are SQ109 and sutezolid: both are being independently advanced for the treatment of drug resistant tuberculosis (MDR-TB).

SQ109 completed a successful MDR-TB registration trial in Russia: application for commercial approval will be filed and Sequella will receive product royalties. Both SQ109 and sutezolid are ready to enter pivotal trials in the US/EU that, if successful, will lead to NDA filing for accelerated registration in both territories. Registration in the U.S. of SQ109 for MDR-TB will provide Sequella with a priority review voucher (PRV) that can be monetized as part of a financing or at receipt: average sales price of PRV since inception is $178M. SQ109 has also been evaluated in an early stage clinical trial for treatment of gastritis (Helicobacter pylori in-fections).

SQ641 is in late pre-clinical development for the treatment of Clostridium difficile induced diarrhea, a deadly healthcare and community acquired infectious disease. Sequella also has a large chemical library of small molecule compounds created around active pharmacophores that can be screened on other important antibiotic resistant bacteria.

Late-stage products (reduced risk) – One drug, SQ109, has successfully completed a registration trial in Russia, meeting both safety and efficacy endpoints; sutezolid has completed a successful Phase 2a study in TB patients, with excellent early bactericidal activity

 

Drugs that address drug-resistant bacterial infections with novel mechanisms of action – Few companies are developing drugs for antibiotic resistant infections, despite clear need: in particular, few companies have or are developing new drugs for TB and no companies are developing drugs for H. pylori, which our drugs address

 

TB will always be treated with ≥ 3 drugs because of resistance development – Companies that are developing new TB drugs are looking for other compatible drugs with which to pair their drugs and make a new safer and more effective drug regimen, so all companies are collaborators, not competitors

 

Drugs in development are either new or improved versions of existing drugs – SQ109 is a new drug that acts in multiple ways to kill TB, no other drugs in clinical development kill TB in the same way. Sutezolid is an improved version of Zyvox (linezolid) and is expected to have similar efficacy and a better safety profile that allows for long term dosing. SQ641 is from a whole new class of antibiotics never before commercialized.

Carol A. Nacy, Chief Executive Officer Dr. Nacy is an accomplished scientist and businesswoman, with 20 years of basic science research and science management in academic settings (Fellow of the American Academy of Microbiology) and an additional 25 years of starting companies and leading science for product development in three U.S.-based biotechnology companies. She and the management team took her first company public on NASDAQ and her second company was acquired by a large biotechnology company. Her passion is in understanding and devising ways to prevent or treat infectious diseases that are global health threats, especially antibiotic resistant bacteria. She co-founded Sequella in 1997 and has led her team to discover and develop several novel antibiotics now in clinical trials that address diseases that infect billions of people worldwide, kill millions of people annually, and are underserved by pharmaceutical and biotechnology companies.

 

Mark Rampy, Chief Business Officer  Dr. Rampy has over twenty years of experience in the biotechnology and pharmaceutical sectors, including leadership roles at early stage and venture-backed companies, and mid-large cap public pharmaceutical/biotechnology companies.  His areas of expertise include business/corporate strategy, business development, structure, negotiation and closing of complex licensing transactions and strategic alliances, as well as technology and product development.  Prior to Sequella, he was CEO of several start-ups (Theraly Pharmaceuticals, and CohBar, Inc), VP Business Development Biologics and Specialty Products, Teva Pharmaceuticals, Founder and Chief Business Officer of CoGenesys, Inc. a company which was acquired by Teva. Prior to CoGenesys, he was with Human Genome Sciences, Inc. for eleven years, in positions of increasing responsibility in R&D and Business Development, the most senior of which was Head of Business Development.​

 

David Mc Neeley, MD, Chief Medical Officer Dr, Mc Neeley is an MD and specialist in pediatric infectious diseases, public health and tropical medicine. He was on the faculty of Weill Cornell Medical Center in the Division of Pediatric Infectious Diseases, working primarily in HIV and TB clinics, as well as general pediatric infectious disease clinic and in-hospital consultations, including rotations through Memorial Sloan-Kettering Medical Center. He has worked extensively in international health settings, including serving as medical director of an all-service hospital and an extensive community health program serving nearly 250,000 people. He conducted clinical and field research in bacterial infections, tuberculosis, human immunodeficiency virus infection and parasitic diseases such as schistosomiasis and filariasis. For the past 14 years, Dr. Mc Neeley has worked in anti-infective drug development (antibiotics, antivirals, and anti-parasitic drugs). For the past 14 years, Dr. Mc Neeley has worked in anti-infective drug development (antibiotics, antivirals, and anti-parasitic drugs) in large pharmaceutical companies (Johnson & Johnson, Novartis) and brought the first new TB drug, bedaquiline, through the clinic and to worldwide registration for J&J.

 

Leo Einck, VP Industry Affairs Dr. Einck has been building companies for the last 33 years: he was the 1st employee of Hemispherix and built out manufacturing facilities and executed clinical trials; he was the 8th employee of EntreMed and managed the relationship with a Harvard research group whose technology enabled the company to have an initial public offering; and he founded Sequella and Sequella Global TB Foundation with Dr. Nacy and has participated in all aspects of growing the company. His current role includes managing the GMP manufacturing and testing of Sequella’s antibiotics and research on TB diagnostics.


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Wellesley Pharmaceuticals

Wellesley Pharmaceuticals

Marketplace

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The investment opportunities below are not an offer to the general public to purchase any form of securities. Every investment opportunity below should be considered to be a very high risk investment and the investor must be comfortable in accepting and bearing the very high level of risk associated with any of the investment opportunities listed on this site. The information contained in these investment opportunities is proprietary and strictly confidential. It is intended to be reviewed only by accredited investors in order to evaluate the investment opportunities and should not be used for any other reason or made available to any other person or entity without the prior written consent of The OCMX (P2P Financial Inc.). The technology and process used on this website is protected by existing or pending patents owned by The OCMX. Nothing on this site including any related communication is intended to provide specific financial, investment, tax, legal, accounting or other advice to you, and should not be acted or relied upon in that regard without seeking the advice of a professional. In all circumstances, you should seek guidance from your current advisor as your advisor can help to ensure that your own circumstances have been properly considered and any action is taken on the latest available information.

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Wellesley Pharmaceuticals

Location: Newtown, PA

Sector: Life Sciences

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Wellesley Pharmaceuticals, LLC was founded to ensure that the ability of Nocturol™ to reduce and sometimes eliminate nocturia symptoms can be disseminated to help the hundreds of millions of people who can benefit from it.   Nocturol is a drug to treat nocturia, the frequent need to urinate at night.  This sometimes-deadly condition afflicts 2.4 billion people and causes insomnia, fatigue, depression, lower quality of life, higher rates of heart disease, stroke, long term brain damage, and deadly falls.

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MG cp Summary

Huge unmet medical need – 2.4 billion people suffer from nocturia, which causes insomnia, fatigue, depression, lower quality of life, higher rates of heart disease, stroke, long term brain damage and deadly falls.

 

No viable competition – There is one FDA approved drug to treat nocturia and it demonstrated a 0.2 void/night benefit compared to the placebo.  Our result was 4.5 times better than that. Their drug has a black box warning about the dangers of hyponatremia.  We had zero side effects reported even among patients using 2 or 3 times the recommended dose.

 

Strong patent portfolio – Our patent lawyer had been named one of the top 1000 patent lawyers in the world six years in a row.  Dr. Ping Wang has never had a patent even challenged, much less overturned.  Our patents include doses ranging from 5mg (which is useless) to 2000mg (which could be deadly).  We believe we have a huge wall of IP around our invention.

Instant efficacy – Our drug is to be taken 30 minutes before bedtime since it is effective in 30 minutes.

 

Lack of side effects – We are using about 20% of the recommended daily dose of the two component drugs for a 10-year-old child.  If it is safe for a 10-year-old to take 5 times per day, we think it should be very safe for most adults to take once per night.

 

Superior efficacy – Compared to placebo, our clinical trial demonstrated 4.5 times higher efficacy than the only FDA approved drug for nocturia.

 

High profit margins – As an LLC, we pay no corporate income tax.  As a virtual corporation, we have almost no overhead expenses.  We have only one full time employee.  We expect net income margins to approach 95% of revenue.

David A. Dill, CEO and President

David Dill is the inventor of Nocturol and the founder of Wellesley Pharmaceuticals, LLC.  Nine years ago he made six changes in his life and since then has over 100 inventions.  When he realized that one of them could have a major impact on the world, he left his CFO position to focus fulltime on nocturia, which killed his father-in-law and leads to thousands of deaths per day.   He graduated summa cum laude from Princeton University in 1973 with a degree in economics.  He graduated from MIT’s Sloan School of Management in 1975 with a Master’s degree in finance and marketing.   He spent 19 years at IBM rising to CFO of a $2 billion business unit.  Since then he was VP Finance at General Instrument and CFO at 7 venture backed companies in 7 different industries, including Worldgate Communications, PlasticsNet, StorageApps, Digital 5, Telewares, Orchestria, and Undertone.   Key Career Milestones Achieved: One IPO (Worldgate Communications in 1999), one sale of a company for $350 million (StorageApps sold to HP in 2001), over 100 inventions in the last 9 years.