“I look forward to sharing the company’s incredible progress and dynamic drug development strategies with potential investors and partners in San Francisco. Dignify continues to advance its two lead drug programs to the clinic, fueled by over $20 million in non-dilutive funding. In the muti-billion-dollar market of bladder and bowel disorders, these programs represent novel therapies for severely underserved patient populations. Our novel development approach is rapid, de-risked and capital efficient” stated Mr. DiTonno.

As a serial entrepreneur, Mr. DiTonno has more than 25 years of senior leadership experience spanning the pharmaceutical, biotechnology, and medical device industries. He has a long record of success in launching startups in the pharmaceutical and medical technology industries, extensive experience in raising capital and securing commercial and corporate partnerships, and strong product launch background in some of the most competitive and strictly regulated markets.

The BIO Investor Forum is an annual conference focused on accelerating the progress of new therapeutics technologies into commercialization. As one of the premier forums for facilitating interactions between entrepreneurs and investors, it also features presentations from industry experts and panel discussion focused on emerging trends in the life sciences.

About Dignify Therapeutics
Founded by a team of serial entrepreneurs who are internationally recognized scientists and clinicians, Dignify’s mission is to provide safe, effective, practical and convenient, “on-demand” pharmaceutical agents to treat bladder and bowel voiding dysfunctions. The company has been funded by RA Capital Management, Eshelman Ventures, the North Carolina Biotechnology Center, NIDDK, NINDS, NICHD, NIA, US Defense Department, and the One NC Small Business Program. Dignify is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

PRESS CONTACT

Dignify Therapeutics
Anthony DiTonno, CEO
2 Davis Drive
Research Triangle Park, NC 27709
Phone: 919-371-8138
ditonno@dignifytherapeutics.com
dignifytherapeutics.com

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Dr. Karl Thor, Chief Scientific Officer and patent co-inventor stated “This is an important accomplishment for the company as we expand our portfolio of treatments for individuals with voiding disorders.  This patent helps solidify our mission to restore voluntary “on demand” bladder and bowel voiding to those patients that are unable to voluntarily void or voluntarily control bladder or bowel activity.”  Dr. Aura Kullmann is also a co-inventor.

Many individuals with spinal cord injury, multiple sclerosis, spina bifida, Parkinson’s disease, diabetes as well as many elderly people cannot completely or efficiently empty their bladder or bowel without the assistance of bladder catheters or bowel programs.  Dignify’s US Patent No. 10,086,034 describes a method of drug-induced voiding that could potentially replace bladder catheters and bowel programs, thus improving the standard of care and quality of life for individuals that experience voiding dysfunction.

About Dignify Therapeutics LLC

Founded by a team of serial entrepreneurs who are internationally-recognized scientists and clinicians, Dignify Therapeutics’ mission is to provide safe, effective, practical and convenient, treatments for bladder and bowel voiding dysfunction. The Company has been funded by RA Capital Management, Eshelman Ventures, the North Carolina Biotechnology Center, NIDDK, NINDS, NICHD, NIA and the One NC Small Business Program. Dignify, a member of the Blackstone Entrepreneur Network, is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

PRESS CONTACT
Dignify Therapeutics
Ed Burgard, President
P.O. Box 13169 – 2 Davis Drive
Research Triangle Park, NC  27709
Phone: 919-371-8138
Email:  eburgard@dignifytherapeutics.com
Website:  https://dignifytherapeutics.com

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RESEARCH TRIANGLE PARK, NC and SAN JOSE, CA (September 13, 2023) – Dignify Therapeutics (Dignify), a pharmaceutical and medical device development company focused on restoring bowel and bladder control for elderly and neurologically impaired individuals, today announced that it has entered into a licensing agreement with Aayam Therapeutics (Aayam) to develop compound ATX-003 and related proprietary molecules for on-demand defecation.

“This agreement provides Dignify with a novel treatment to add to its expanding therapeutic pipeline for bowel and bladder disorders” said company President Dr. Ed Burgard. “ATX-003 is a significantly de-risked therapeutic that will extend Dignify’s patent protection as well as provide therapeutic benefit for individuals with constipation and functional bowel disorders”.

Dr. Sundeep Dugar, President of Aayam, added “Constipation and functional bowel disorders are serious issues that patients face and seriously affects their Quality of Life. There are no real therapies available for these patients. We are excited to work with Dignify to advance a safe and effective therapy for this serious and unmet need “

About Dignify Therapeutics
Founded by a team of serial entrepreneurs who are internationally-recognized scientists and clinicians, Dignify Therapeutics’ mission is to provide safe, effective, practical and convenient, treatments for bladder and bowel voiding dysfunctions, primarily using a repositioning strategy of drug discovery that the team has successfully implemented multiple times over the last 20 years in the fields of urology and gastroenterology.
The Company is funded by founders, venture capital (RA Capital Mgmt and Eshelman Ventures), the North Carolina Biotechnology Center, the One NC Small Business Program, and the NIH SBIR/STTR program (18 awards, approximately $18 million). Dignify Therapeutics is located in the First Flight Venture Center in Research Triangle Park, North Carolina.

About Aayam Therapeutics
Aayam is a drug discovery and development company that utilizes LADR4, a unique drug development technology platform that can help significantly reduce the failure rate of drugs in development, cost of novel therapies, and overall time to market. LADR4 is a first of its kind approach that allows New Chemical Entities to be developed under a 505(b)(2) development path, and facilitates the repurposing, repositioning, reprofiling, and rescuing of generic and proprietary drugs.

PRESS CONTACT
Dignify Therapeutics
Ed Burgard, PhD
2 Davis Drive
Research Triangle Park, NC 27709
Phone: 919-371-8138
Email: eburgard@dignifytherapeutics.com
Website: https://dignifytherapeutics.com

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RESEARCH TRIANGLE PARK, NC (February 27, 2023) – Dignify Therapeutics LLC, a pharmaceutical and medical device development company focused on restoring bladder and bowel control for people with spinal injury, multiple sclerosis, diabetes, and the elderly, was awarded the prestigious Blueprint Neurotherapeutics Network grant from the National Institutes of Health (NIH). This 4-year award provides over $4 million in funding to support preclinical and clinical development of the Company’s lead drug candidate, DTI-117, to treat bladder and bowel dysfunction.

“This new award exemplifies the foresight of, and commitment from, the NIH to develop treatments for bladder and bowel dysfunction in people suffering from these conditions” said company President and Principal Investigator, Dr. Ed Burgard. “This award will provide funds for an IND submission and a subsequent clinical trial for DTI-117”.

Dignify is developing novel drug and device therapies for bladder and bowel dysfunction to eliminate or reduce the need for life-long, multiple-daily catheterization of the bladder and difficult and time-consuming manual bowel programs. Worldwide bladder catheter sales total $3 billion/year, while health care expenditures associated with voiding dysfunction cost $7 billion/year in the US alone. Success of Dignify’s development programs will not only improve the quality of life for individuals with voiding dysfunction but will also reduce health care costs.

About Dignify Therapeutics LLC

Founded by a team of serial entrepreneurs who are internationally-recognized scientists and clinicians, Dignify Therapeutics’ mission is to provide safe, effective, practical and convenient, treatments for bladder and bowel voiding dysfunctions, primarily using a repositioning strategy of drug discovery that the team has successfully implemented multiple times over the last 20 years in the fields of urology and gastroenterology. The Company is funded through venture capital (RA Capital Mgmt and Eshelman Ventures), angel investors, the NIH, the North Carolina Biotechnology Center and the One NC Small Business Program. Dignify Therapeutics is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

This content is solely the responsibility of Dignify Therapeutics and does not necessarily represent the official views of the NIH.

PRESS CONTACT

Dignify Therapeutics

Ed Burgard

P.O. Box 13169

2 Davis Drive

Research Triangle Park, NC 27709

Phone: 919-371-8138

Email: eburgard@dignifytherapeutics.com

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RESEARCH TRIANGLE PARK, NC (RTP) – June 27, 2022 – Dignify Therapeutics (Dignify), developers of novel treatments for bladder and bowel disorders, is pleased to announce that Anthony DiTonno has joined Dignify Therapeutics as Executive Chairman of the Board of Directors, where he will be integral in guiding Dignify’s future drug development and partnering strategies.

Mr. DiTonno is a veteran pharmaceutical executive, with over 25 years of senior leadership experience spanning the pharmaceutical, biotechnology and medical device industries. He most recently served as CEO of Tenax Therapeutics (TENX), Avantis Medical Systems, and NeurogesX (NGSX). He successfully completed one IPO, raised over $200M for previous companies, and secured multiple commercial and corporate partnerships.

Dr. Ed Burgard, President of Dignify, stated, “Tony brings a wealth of corporate development and growth experience to Dignify. As Dignify transitions to a multidimensional therapeutics company with a diverse pipeline of drugs and medical devices, Tony’s guidance will ensure that the company secures the capital and partnerships necessary to advance our novel treatments to patients.”

Mr. DiTonno responded, “I am excited to work with the Dignify team to move these important products forward. The team at Dignify have a wealth of experience in discovery and development of novel bowel and bladder therapies and I am honored to join their Board of Directors.”

About Dignify Therapeutics LLC

Founded by a team of serial entrepreneurs who are internationally-recognized scientists and clinicians, Dignify Therapeutics’ mission is to provide safe, effective, practical and convenient, treatments for bladder and bowel voiding dysfunctions, primarily using a repositioning strategy of drug discovery that the team has successfully implemented multiple times over the last 20 years in the fields of urology and gastroenterology. The Company is funded through venture capital (RA Capital Mgmt and Eshelman Ventures), angel investors, the NIH, the North Carolina Biotechnology Center and the One NC Small Business Program. Dignify Therapeutics is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

This content is solely the responsibility of Dignify Therapeutics and does not necessarily represent the official views of the NIH.

PRESS CONTACT

Dignify Therapeutics

Ed Burgard

P.O. Box 13169

2 Davis Drive

Research Triangle Park, NC 27709

Phone: 919-371-8138

Email: eburgard@dignifytherapeutics.com

Website: https://dignifytherapeutics.com

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RESEARCH TRIANGLE PARK, NC (September 28, 2020) – Dignify Therapeutics LLC, a drug and medical device development company focused on restoring bladder and bowel control for people with spinal injury, multiple sclerosis, diabetes, and the elderly, has been awarded five new National Institutes of Health (NIH) awards in 2019-2020. These grants provide over $2.5 million in additional funding for Dignify to support development of novel drugs and medical devices. Dignify has received 16 separate grants from the NIH totaling approximately $15 million over the past seven years.

“These new awards from the NIH will further Dignify’s mission of restoring voluntary control of bladder and bowel function in people suffering from urinary and bowel retention and incontinence” said company Vice President and Principal Investigator, Dr. Lesley Marson. “Our pipeline of diverse therapeutic programs continues to expand to reach additional patient populations”.

Dignify is developing novel drug and device therapies for bladder and bowel dysfunction to eliminate or reduce the need for life-long, multiple-daily catheterization of the bladder and difficult and time-consuming manual bowel programs. Worldwide bladder catheter sales total $3 billion/year, while health care expenditures associated with voiding dysfunction cost $7 billion/year in the US alone. Success of Dignify’s development programs will not only improve the quality of life for individuals with voiding dysfunction but will also reduce health care costs.

Individual grants include: R43NS115169, R43NS115215, R41NS117205 and R44NS115169 from the National Institute of Neurological Disorders and Stroke (NINDS), and R43DK125131 from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

About Dignify Therapeutics LLC

Founded by a team of serial entrepreneurs who are internationally-recognized scientists and clinicians, Dignify Therapeutics’ mission is to provide safe, effective, practical and convenient, treatments for bladder and bowel voiding dysfunctions, primarily using a repositioning strategy of drug discovery that the team has successfully implemented multiple times over the last 20 years in the fields of urology and gastroenterology. The Company is funded through venture capital (RA Capital Mgmt and Eshelman Ventures), angel investors, the NIH, the North Carolina Biotechnology Center and the One NC Small Business Program. Dignify Therapeutics is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

This content is solely the responsibility of Dignify Therapeutics and does not necessarily represent the official views of the NIH.

PRESS CONTACT

Dignify Therapeutics

Ed Burgard

P.O. Box 13169

2 Davis Drive

Research Triangle Park, NC 27709

Phone: 919-371-8138

Email: eburgard@dignifytherapeutics.com

Website: https://dignifytherapeutics.com

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Dignify Therapeutics and friends (Team Dignify) joined a worldwide walk on September 22^nd to support colleagues who are on a journey from Canada to Key West in support of increasing awareness of the impacts of climate change on people with disabilities.

Canada to Key West, a 2,500-mile journey to raise awareness about the impact of extreme weather events on people with disabilities. Canada to Key West co-founders, Drs. Marcalee and Craig Alexander, will travel the 2,500-mile route making stops at rehabilitation hospitals and other locations along the way. Such as Boston, New York City, Philadelphia, Washington D.C., Richmond and Charleston. To engage with academic partners about the need for more effective mechanisms and planning. To help people with disabilities during extreme weather events, such as hurricanes, floods, polar vortices and heat waves. https://www.canadatokeywest.org/ctk2019

Day for Tomorrow  Persons with spinal cord disorders cannot control their body temperature and are forced to stay indoors during extreme heat or cold. During disasters, persons with disabilities and the elderly are most vulnerable, being unable to go to shelters with wheelchairs or personal care assistants. As a result of climate change, extreme weather events including hurricanes, severe rainstorms, and heat waves are becoming more frequent and more severe. It is critical that emergency preparedness efforts account for the needs of everyone, including the estimated one billion people around the world who live with self-disclosed disabilities. https://www.canadatokeywest.org/the-day-for-tomorrow

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RESEARCH TRIANGLE PARK, NC (February 5, 2019) – Dignify Therapeutics LLC, a drug development company focused on restoring bladder and bowel control for people with spinal injury, multiple sclerosis, diabetes, and the elderly, has been awarded CREATE Bio award U44NS106685 by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health. This grant provides $3.6 million and 3 years of potential milestone-driven support for Dignify’s lead drug development program in preparation for a future Phase I clinical study.

Dignify is developing a novel, on-demand, drug-induced voiding therapy for bladder and bowel dysfunction to eliminate or reduce the need for life-long, multiple-daily catheterization of the bladder and manual bowel programs. Worldwide catheter sales total $3 billion/year, while health care expenditures associated with voiding dysfunction cost $7 billion/year in the US alone. Thus, success of Dignify’s lead drug development program will not only improve the quality of life for individuals with voiding dysfunction, it will also substantially reduce health care costs.

“This award from NINDS offers further validation of our scientific and drug development expertise” said Principal Investigator and company President, Dr. Ed Burgard. “In the past five years, Dignify has received 11 grants from National Institutes of Health Agencies including NINDS, NIDDK, NIA and NICHD that have provided the company with over $8 million in funding for development of novel bladder and bowel therapies. With this new award, we will continue to develop new treatments for individuals in desperate need”.

About Dignify Therapeutics LLC
Founded by a team of serial entrepreneurs who are internationally-recognized scientists and clinicians, Dignify Therapeutics’ mission is to provide safe, effective, practical and convenient, pharmaceutical agents to treat bladder and bowel voiding dysfunctions, using a repositioning strategy of drug discovery that the team has successfully implemented multiple times over the last 20 years in the fields of urology and gastroenterology. The Company is funded through venture capital (RA Capital Mgmt and Eshelman Ventures), angel investors, the National Institutes of Health, the North Carolina Biotechnology Center and the One NC Small Business Program. Dignify Therapeutics is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

This content is solely the responsibility of Dignify Therapeutics and does not necessarily represent the official views of the National Institutes of Health.

PRESS CONTACT
Dignify Therapeutics
Ed Burgard
P.O. Box 13169
2 Davis Drive
Research Triangle Park, NC 27709
Phone: 919-371-8138
Email: eburgard@dignifytherapeutics.com
Website: https://dignifytherapeutics.com

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Dr. Karl Thor, Chief Scientific Officer and patent co-inventor stated “This is an important accomplishment for the company as we expand our portfolio of treatments for individuals with voiding disorders. This patent helps solidify our mission to restore voluntary “on demand” bladder and bowel voiding to those patients that are unable to voluntarily void or voluntarily control bladder or bowel activity.” Dr. Aura Kullmann is also a co-inventor.

Many individuals with spinal cord injury, multiple sclerosis, spina bifida, Parkinson’s disease, diabetes as well as many elderly people cannot completely or efficiently empty their bladder or bowel without the assistance of bladder catheters or bowel programs. Dignify’s US Patent No. 10,086,034 describes a method of drug-induced voiding that could potentially replace bladder catheters and bowel programs, thus improving the standard of care and quality of life for individuals that experience voiding dysfunction.

About Dignify Therapeutics LLC

Founded by a team of serial entrepreneurs who are internationally-recognized scientists and clinicians, Dignify Therapeutics’ mission is to provide safe, effective, practical and convenient, treatments for bladder and bowel voiding dysfunction. The Company has been funded by RA Capital Management, Eshelman Ventures, the North Carolina Biotechnology Center, NIDDK, NINDS, NICHD, NIA and the One NC Small Business Program. Dignify, a member of the Blackstone Entrepreneur Network, is located at the First Flight Venture Center in Research Triangle Park, North Carolina.

PRESS CONTACT
Dignify Therapeutics
Ed Burgard, President
P.O. Box 13169 – 2 Davis Drive
Research Triangle Park, NC 27709
Phone: 919-371-8138
Email: eburgard@dignifytherapeutics.com
Website: https://dignifytherapeutics.com

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Thank you for joining Dignify Therapeutics’ journey to restore voluntary control of bodily functions to individuals who have spinal cord damage. I assume you are aware of how spinal cord damage from an accident, or from a disease such as multiple sclerosis, can result in the loss of voluntary control over bladder and bowel function.  (If not, please download our white paper.)  The current procedures for voiding urine and feces require arduous and unpleasant daily routines that often require a caregiver’s assistance and are associated with medical complications.

Way back in 1977, when I started my PhD training in pharmacology, I was highly interested in how spinal cord functions were impacted, when control from the brain is lost. Loss of voluntary control of the arms and legs is obviously important, but I was drawn to loss of voluntary control of bladder and bowel because I felt that a clinically practical solution could be achieved in my lifetime. Furthermore, bladder and bowel dysfunction present a much higher degree of clinically significant morbidity and mortality compared to the inability to walk. Thus many of my first publications were aimed at restoring bladder and bowel function.

Unfortunately, my 25 year career in the pharmaceutical industry did not allow me to study bladder and bowel function in spinal cord injured individuals because the population (about 250,000 in the US) was not large enough compared to other unmet medical needs such as urinary incontinence and “overactive bladder” (about 20,000,000 in the US) to warrant industry interest.

Now however, novel drugs and novel drug delivery techniques that provide a practical clinical development path have emerged. In response to this opportunity, I have assembled a highly accomplished team of professionals that are uniquely positioned to develop compounds that not only restore voluntary control of bladder and bowel function and improve individuals’ quality of life, but also reduce overall medical costs associated with spinal cord injury. Because of the high costs to society, as well as the prevalence of spinal cord injuries among our wounded military men and women, Dignify anticipates that the National Institutes of Health and Department of Defense will join us in this journey and provide substantial resources.

I feel blessed to be in a position where I can focus the last chapter of my career on helping spinal cord injured individuals. While the path forward is likely to contain unforeseen obstacles, at the moment I see no obstacles that cannot be overcome.

Please continue on this journey with us by learning more about the condition and by sharing any personal stories you may have regarding the impact of spinal cord injury on your life or that of someone you know. Please contact me if you have any questions or comments.

Thank you so much!

Best regards,

Karl B. Thor, PhD

Letter from the Chief Scientific Officer

Dignify Therapeutics LLC

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