Read coverage about our Series A funding, which will help us advance our pipeline of off-this-shelf stem cell therapies for pets.

From Brakke Consulting 
<a href="https://brakkeconsulting.com/animal-health-news-notes-for-january-12-2024/" target="_blank">Animal Health News & Notes</a>

Brakke Consulting: Animal Health News & Notes

Read coverage from Today's Veterinary Business breaking news section, which will help us advance our pipeline of off-this-shelf stem cell therapies for pets.

From Today's Veterinary Business 
<a href="https://todaysveterinarybusiness.com/veterinary-breaking-news-011124/" target="_blank">Gallant Closes $15 Million Funding Round</a>

Today's Veterinary Business: Gallant Closes $15 Million Funding Round

Read Longevity Today's coverage about our Series A funding, which will help us advance our pipeline of off-this-shelf stem cell therapies for pets.

From Longevity Technology 
<a href="https://longevity.technology/news/gallant-raises-15m-to-advance-stem-cell-therapies-for-pets/" target="_blank">Gallant Raises $15m to Advance Stem Cell Therapies for Pets</a>

Longevity Technology: Gallant Raises $15m to Advance Stem Cell Therapies for Pets

Read coverage from Pulse 2.0 about our Series A funding, which will help us advance our pipeline of off-this-shelf stem cell therapies for pets.

From Pulse 2.0 
<a href="https://pulse2.com/gallant-therapeutics-animal-health-biotech-company-secures-over-15-million/" target="_blank">Gallant Therapeutics: Animal Health Biotech Company Secures Over $15 Million</a>

Pulse 2.0: Gallant Therapeutics: Animal Health Biotech Company Secures Over $15 Million

Read FinSME's coverage of our Series A funding, which will help us advance our pipeline of off-this-shelf stem cell therapies for pets.

From FinSMEs 
<a href="https://www.finsmes.com/2024/01/gallant-therapeutics-raises-over-15m-in-series-a-funding.html" target="_blank">Gallant Therapeutics Raises Over $15M in Series A Funding</a>

FinSME: Gallant Therapeutics Raises Over $15M in Series A Funding

Read Veterinary Practice New's coverage of our Series A funding, which will help us advance our pipeline of off-this-shelf stem cell therapies for pets.

From Veterinary Practice News 
<a href="https://www.veterinarypracticenews.com/gallant-therapeutics-funding/" target="_blank">$15M Funding Aims to Advance Stem Cell Therapies for Pets</a>

Veterinary Practice News: $15M funding aims to advance stem cell therapies for pets

Check out BioSpace's coverage of our recent round of funding, which will help us advance our pipeline of off-this-shelf stem cell therapies for pets.

From BioSpace 
<a href="https://www.biospace.com/article/releases/gallant-therapeutics-raises-over-15-million-in-series-a-funding-to-advance-pipeline-of-off-the-shelf-stem-cell-therapies-for-pets" target="_blank">Gallant Therapeutics Raises Over $15 Million in Series A Funding to Advance Pipeline of "Off-the-Shelf" Stem Cell Therapies for Pets</a>

BioSpace: Gallant Therapeutics Raises Over $15 Million in Series A Funding to Advance Pipeline of "Off-the-Shelf" Stem Cell Therapies for Pets

Read coverage from BNN Breaking about our appointment of Aaron Schacht to Gallant's Board of Directors

From BNN Breaking 
<a href="https://bnnbreaking.com/breaking-news/health/gallant-therapeutics-appoints-industry-veteran-aaron-schacht-to-board" target="_blank" rel="noopener">Gallant Therapeutics Appoints Industry Veteran Aaron Schacht to Board</a>

BNN Breaking: Gallant Therapeutics Appoints Industry Veteran Aaron Schacht to Board

Read what BioSpace had to say about our <a href="https://www.gallant.com/fcgs">pivotal study</a> of allogeneic stem cell therapy targeting feline chronic gingivostomatitis (FCGS), a painful and debilitating disease in cats.

From Biospace 
<a href="https://www.biospace.com/article/releases/gallant-therapeutics-announces-launch-of-jedi-pivotal-study-for-first-allogeneic-stem-cell-therapy-targeting-feline-chronic-gingivostomatitis/" target="_blank" rel="noopener">Gallant Therapeutics Announces Launch of JEDI Pivotal Study for First Allogeneic Stem Cell Therapy Targeting Feline Chronic Gingivostomatitis</a>

BioSpace: Gallant Therapeutics Announces Launch of JEDI Pivotal Study for First Allogeneic Stem Cell Therapy Targeting Feline Chronic Gingivostomatitis

BNN Breaking discusses the lifespan of large breed dogs and how companies like Gallant are working to extend the duration and quality of life for large breeds

From BNN Breaking 
<a href="https://bnnbreaking.com/breaking-news/health/revolutionary-drugs-poised-to-extend-large-breed-canine-lifespans" target="_blank" rel="noopener">Revolutionary Drugs Poised to Extend Large Breed Canine Lifespans</a>

BNN Breaking: Revolutionary Drugs Poised to Extend Large Breed Canine Lifespans

Read coverage from BioSphere about Aaron Schacht's appointment to Gallant's Board of Directors

From BioSphere 
<a href="https://www.biospace.com/article/releases/gallant-therapeutics-adds-animal-health-executive-aaron-schacht-to-board-of-directors/" target="_blank" rel="noopener">Gallant Therapeutics Adds Animal Health Executive Aaron Schacht to Board of Directors</a>

BioSpace: Gallant Therapeutics Adds Animal Health Executive Aaron Schacht to Board of Directors

Read coverage from dvm360 about Aaron Schacht's appointment to our Board of Directors.

From dvm360 
<a href="https://www.dvm360.com/view/paws-and-profits-highlighting-new-promotions-in-veterinary-business" target="_blank" rel="noopener">Paws and profits: Highlighting new promotions in veterinary business</a>

dvm360: Paws and profits: Highlighting new promotions in veterinary business

Veterinary Practice covered our <a href="https://www.gallant.com/fcgs">pivotal study</a> of allogeneic stem cell therapy targeting feline chronic gingivostomatitis (FCGS) as its February 2024 Innovation Feature .

From Veterinary Practice 
<a href="https://www.veterinary-practice.com/article/stem-cell-therapy-refractory-feline-chronic-gingivostomatitis" target="_blank" rel="noopener">Breakthroughs in Stem Cell Therapy for Refractory Feline Chronic Gingivostomatitis and Beyond</a>

Veterinary Practice: Breakthroughs in Stem Cell Therapy for Refractory Feline Chronic Gingivostomatitis and Beyond

Read coverage from the San Diego Business Journal about our <a href="https://www.gallant.com/fcgs">pivotal study</a> of allogeneic stem cell therapy targeting feline chronic gingivostomatitis (FCGS), a painful and debilitating disease in cats.

From the San Diego Business Journal (requires subscription) 
<a href="https://www.sdbj.com/life-sciences/biotech-life-sciences/gallant-advances-stem-cell-therapy-for-cats" target="_blank" rel="noopener">Gallant Advances Stem Cell Therapy for Cats</a>

San Diego Business Journal: Gallant Advances Stem Cell Therapy for Cats

Read coverage from StemCell Science News about our <a href="https://www.gallant.com/fcgs">pivotal study</a> of allogeneic stem cell therapy targeting feline chronic gingivostomatitis (FCGS), a painful and debilitating disease in cats.

From StemCell Science News 
<a href="https://www.stemcellsciencenews.com/newsletter/218609/" target="_blank" rel="noopener">Gallant Therapeutics Announces Launch of JEDI Pivotal Study for First Allogeneic Stem Cell Therapy Targeting Feline Chronic Gingivostomatitis</a>

StemCell Science News: Gallant Therapeutics Announces Launch of JEDI Pivotal Study for First Allogeneic Stem Cell Therapy Targeting Feline Chronic Gingivostomatitis

Read coverage from PharmaShots about our <a href="https://www.gallant.com/fcgs">pivotal study</a> of allogeneic stem cell therapy targeting feline chronic gingivostomatitis (FCGS), a painful and debilitating disease in cats.

From PharmaShots 
<a href="https://pharmashots.com/16508/gallant-therapeutics-to-commence-jedi-study-of-first-allogeneic" target="_blank" rel="noopener">Gallant Therapeutics to Commence JEDI Study of First Allogeneic Stem Cell Therapy for Feline Chronic Gingivostomatitis (FCGS) in Cats</a>

PharmaShots: Gallant Therapeutics to Commence JEDI Study of First Allogeneic Stem Cell Therapy for Feline Chronic Gingivostomatitis (FCGS) in Cats

Read coverage from Veterinary Practice News about our <a href="https://www.gallant.com/fcgs">pivotal study</a> of allogeneic stem cell therapy targeting feline chronic gingivostomatitis (FCGS), a painful and debilitating disease in cats.

From Veterinary Practice News 
<a href="https://www.veterinarypracticenews.com/gallant-therapeutics-announces-study-for-feline-stem-cell-therapy/" target="_blank" rel="noopener">Gallant Therapeutics Announces Study for Feline Stem Cell Therapy</a>

Veterinary Practice News: Gallant Therapeutics Announces Study for Feline Stem Cell Therapy

Gallant Therapeutics, an animal health biotechnology company pioneering off-the-shelf stem cell therapies for pets, today announced the successful completion of its Series A financing, securing over $15 million. The financing round, led by BOLD Capital and joined by new investors Digitalis Ventures and Hill Creek Partners, positions Gallant for a transformative phase of growth as they advance towards conditional FDA approval of their leading therapeutic candidate for Feline Chronic Gingivostomatitis (FCGS). Cindy Cole of Digitalis Ventures will join as a board observer alongside a new independent director who will join existing board members Teymour Boutros-Ghali, Linda Black, Richard Jennings, Darryl Rawlings, and James Ratigan Sr.

The successful funding round will enable Gallant to accelerate the development of its pipeline of potentially first-in-class allogeneic stem cell therapeutics, focusing on achieving conditional FDA approval for its leading therapeutic candidate targeting FCGS, a deadly disease with a high unmet medical need. Beyond FCGS, Gallant is advancing a pipeline that targets osteoarthritis (OA), chronic kidney disease (CKD), and atopic dermatitis— all chronic diseases with a high burden of care in dogs and cats.

“Gallant’s team has demonstrated a fierce vision backed by great progress toward the goal of bringing a new class of transformational therapies to animal health,” said Teymour Boutros-Ghali, Ph.D., Managing Partner BOLD Capital. “We’re excited to support the mission to pioneer innovative solutions for our pets’ greatest health challenges.”

Gallant is building first-in-class technologies around the promise of delivering the regenerative potential of stem cell therapeutics to veterinary medicine. The company’s novel approach of addressing the root cause of disease with mesenchymal stem cells (MSCs) is strengthened by positive results from multiple pilot studies and the notable launch of their JEDI Pivotal Study, a critical phase in the development of the first allogeneic stem cell therapy targeting FCGS.

“Gallant has an impressive track record of early successes. Bringing a new class of therapies to the market is exciting and requires exceptional talent, technology, and manufacturing capabilities,” said Cindy Cole, DVM, Ph.D., Technical Partner at Digitalis Ventures. “Gallant has all of that. We look forward to partnering with them to realize the broad clinical potential of their validated technologies and redefine standards in veterinary care.”

As Gallant advances its pipeline, the anticipated conditional FDA approval of its leading candidate will mark an important step in derisking its core platform and accelerating market access for other pipeline programs, contributing more broadly to its long-term goal of making accessible ready-to-use doses of stem cell therapeutics for today’s most common conditions in pets.

“We have made unprecedented progress this past year, hitting significant clinical, regulatory, and manufacturing milestones,” said Linda Black, DVM, Ph.D., CEO of Gallant Therapeutics. "This investment allows us to leverage our early-stage successes, extending beyond FCGS, to bring a diverse range of therapies to the broader pet market.”

Backed by scalable onsite manufacturing, early-stage commercialization capabilities, and an experienced team of pioneers in cell therapy product development, Gallant remains committed to pushing the boundaries of veterinary care. This series A funding represents a crucial step toward Gallant’s vision of bringing "off-the-shelf" stem cell therapies to veterinary clinics worldwide. The company looks forward to the continued support of its investors, partners, and the broader community as it advances its therapeutic pipeline and strives to redefine the future of pet healthcare.

<h3>About Gallant Therapeutics</h3>

Gallant Therapeutics is a clinical-stage biotechnology company setting a new standard in animal health by delivering a pipeline of off-the-shelf stem cell therapies that target the root cause of major diseases in pets. Gallant is led by industry pioneers in veterinary regenerative medicine with deep expertise in development, manufacturing and early commercialization. To learn more about the potential of Gallant’s stem cell therapies, visit GallantTherapeutics.com.

<h3>About BOLD Capital</h3>

BOLD is a venture capital firm that seeks entrepreneurs and companies who share a fierce vision for a brighter tomorrow. We are particularly interested in two transformative areas: health and life sciences, and deep tech and productivity. We identify emerging science and technologies that will disrupt and democratize massive markets, creating innovative solutions to humanity’s greatest challenges. BOLD is headquartered in Santa Monica, California.

<h3>About Digitalis Ventures</h3>

Digitalis Ventures backs founders solving critical problems in health. The firm invests in early-stage companies across life sciences, health technology & services, and animal health with the goal of supporting them through multiple rounds of financing. Digitalis is headquartered in New York City.

<h3>Media Contact</h3>
 Adam Silverstein
 Adam@ScientPR.com

Gallant Raises Over $15 Million in Series A Funding

Gallant Therapeutics, an animal health biotechnology company pioneering off-the-shelf stem cell therapies for pets, today announced the launch of a pivotal study to evaluate the safety and efficacy of its novel allogeneic stem cell therapy candidate to support FDA conditional approval in cats with refractory feline chronic gingivostomatitis (FCGS), the JEDI study.

FCGS is a debilitating disease affecting about 2 million domestic cats, resulting in reduced quality of life, and painful mucosal lesions, often resulting in the death of affected cats. Current therapies include long-term immunosuppressive therapy and dental extraction. More than 50% of these cats do not respond to therapy (are refractory) and are euthanized or die. In pilot studies1, Gallant’s investigational stem cell therapy has been demonstrated effective for refractory FCGS, improving painful lesions and quality of life, allowing these cats to live longer and healthier lives.

The multicenter pivotal JEDI study includes veterinary dental specialist sites across the United States and is currently enrolling cats under an FDA-concurred protocol.

“We have seen the power of stem cells to promote healing and save pet’s lives,” said Linda Black, DVM, Ph.D., CEO of Gallant Therapeutics, “and the launch of our JEDI study is an exciting clinical milestone to fast-track our mission to bring regenerative medicine to all pets and their families.”

The JEDI Study builds on multiple pilot studies demonstrating the efficacy of MSCs in improving clinical status and lesion scores in cats with refractory FCGS.1,2,3

The product’s ready-to-use formulation is a critical factor in ensuring its success as a first-in-class treatment in veterinary medicine. “It's not just about creating a therapy that treats the root cause of FCGS and other immune-mediated or inflammatory conditions; it's about ensuring compliance and ease of use in a busy practice setting,” said Valentine Williams, DVM, MS, SVP of Clinical Development and Regulatory at Gallant Therapeutics.

The name of the JEDI study embodies the idea of a noble order of protectors unified in their ability to channel the power of the force for healing and aligns with Gallant's mission to harness the power of regenerative medicine for all pets.

<h3>More Information About the JEDI Study</h3>

Cats with the following symptoms may have FCGS: excessive licking, drooling, decreased grooming, anorexia, weight loss, reduced socialization, vocalization, bleeding gums, and painful sores in the mouth. If a diagnosed cat has already undergone medical treatment and dental extraction and is still showing clinical signs of disease, they are considered refractory and have limited to no currently available treatment options.
 
For JEDI eligibility and other criteria, please visit https://www.gallant.com/fcgs

<h3>About Gallant Therapeutics</h3>

Gallant Therapeutics is a clinical-stage animal health biotechnology company setting a new standard in animal health by harnessing the power of stem cell therapy to treat the root cause of diseases in dogs and cats. Gallant’s pipeline of off-the-shelf mesenchymal stem cell (MSC) therapies has the potential to treat a broad range of diseases, including canine and feline osteoarthritis (OA), feline chronic kidney disease (CKD), and others. The first product, based on our uterine-derived MSC platform for feline chronic gingivostomatitis (FCGS), is on track for FDA conditional approval in 2025. United by a love of and commitment to animals, Gallant’s team includes industry pioneers in veterinary regenerative medicine with deep experience in cell therapy product development, manufacturing, and commercialization. To learn more about the potential of our stem cell therapies, visit GallantTherapeutics.com.

<h3>Media Contact</h3>
 
Adam Silverstein
 
Adam@ScientPR.com

1 Taechangam et. al. 2023. Pilot Efficacy of Feline Uterine-Derived MSCs for the Treatment of Refractory FCGS. NAVRMA, Kona, Hawaii (Sept, 21st).

2 Soltero-Rivera M, Hart S, Blandino A, Vapniarsky N, Arzi B. Mesenchymal stromal cell therapy for feline chronic gingivostomatitis: Long term experience. Frontiers in Veterinary Science. 2023;10. doi:10.3389/fvets.2023.1171922

3 Arzi B, Clark KC, Sundaram A, et al. Therapeutic efficacy of fresh, allogeneic mesenchymal stem cells for severe refractory feline chronic gingivostomatitis. Stem Cells Translational Medicine. 2017;6(8):1710-1722. doi:10.1002/sctm.17-0035

Gallant Announces JEDI Pivotal Study Targeting FCGS

The Simons are a Pug family. When their family pug, Walter, was two years old, the Simons noticed that for a few months, Walter wasn’t himself; he was less interactive and often confused. One day, he had a sudden onset of severe seizures. Within 24 hours, Walter was diagnosed with pug dog encephalitis (PDE), a common name for necrotizing meningoencephalitis (NME) because it occurs most commonly in that breed. Despite aggressive therapy with steroids, immunosuppressants, and anti-seizure medications, Walter died within 24 hours of his diagnosis.

NME is a devastating and often fatal autoimmune disease of the brain. Although most pugs exhibit symptoms including lethargy, behavioral changes, seizures, circling, and visual deficits, between the ages of 1.5 and 2.5 years old, they are usually asymptomatic until advanced inflammation has already developed within the brain, limiting effective treatment options. Pugs may appear normal then be severely affected within days. Even with aggressive treatment with steroids and auto-immune medicines, most pugs with NME won’t live longer than 6 months from the time of diagnosis.

The Simons’ experience with Walter is a devastatingly common reality for families whose pugs have NME, as common signs of early NME often go undetected until the disease has progressed. Ethos Discovery, a nonprofit organization developing innovative medical treatments and tests that benefit pets and humans, and Gallant Therapeutics, an animal health biotechnology company pioneering off-the-shelf stem cell therapies for pets, today announced their collaboration on the third study of an ongoing clinical trials program designed to investigate Gallant's stem cell therapy as an effective and safe product to help pugs with NME.

Ethos Discovery previously identified an early form of NME characterized by a combination of symptoms including neck and back pain, reduced visual processing on one side, and reduced paw placement (usually on the same side as the reduced visual processing).

In this current phase of the clinical program, Gallant Mesenchymal Stem Cells (MSCs) will be used to treat pugs with early-stage NME with the goal of preventing further brain damage, improving clinical signs and minimizing disease progression. MSCs are well known to have immunomodulatory and anti-inflammatory properties,1,2 targeting the root cause of disease, and thereby potentially altering the abnormalities that lead to the severe brain inflammation associated with NME.

Based on their experience with Walter, the Simons had their other two pugs screened for signs of early NME, and one of these Pugs, Mary Katherine, was determined to be genetically high risk. She also had some of the symptoms of early NME including a dull demeanor, spinal pain, reduced paw placement, reduced vision, and loss of balance. Mary Katherine was treated with stem cells, and after 24 hours, her spinal pain and neurological deficits improved, and the Simons owners noticed an increase in her energy level and playfulness.

“Ethos Discovery and Gallant Therapeutics are natural partners in this type of clinical research, as we both believe that evidence is paramount to advancing innovation,” said Chand Khanna, DVM, PhD, DACVIM (Onc), DACVP (Hon), Ethos Discovery Board Chair. “We are very glad to have Gallant Therapeutics as a partner because of this shared priority, as well as Gallant’s scientific rigor in developing stem cell therapies.”

“Like millions of dogs and cats with inflammatory or immune-mediated diseases, current treatment options for NME only address the symptoms, and most pugs with advanced disease die despite these therapies. If we can change their underlying immune dysfunction with stem cells, we have a chance of saving more pugs,” said Linda Black, DVM, PhD, CEO of Gallant Therapeutics. “We are thrilled to collaborate with Ethos Discovery to evaluate the use of MSCs to help prevent the most devastating outcomes of NME.”

Ethos Discovery is conducting these trials in collaboration with human research groups who seek to use the data to support similar clinical trials in humans with diseases that behave similarly to NME, such as multiple sclerosis.

<h3>More about the Ethos Discovery Clinical Program of NME in Pugs</h3>
 

The overarching goals of this clinical program are to identify symptoms in pugs that are high risk for NME that could be used to diagnose the disease earlier, and to identify new treatment options that will provide improved clinical signs and long-term survival times. In two earlier ‘pug clinics’ hosted by Ethos Discovery, clinicians conducted neurological, blood, and genetic testing for NME, and identified a possible early clinical phenotype (i.e., combination of symptoms) of NME that may allow for the disease to be diagnosed and treated at an earlier stage. In this third study in the program, Ethos Discovery and Gallant Therapeutics are investigating treatment with Gallant’s MSCs in pugs previously screened for NME. To learn more about enrolling your pug in the study, please visit: https://www.ethosdiscovery.org/clinical-study/necrotizing-meningoencephalitis-study-for-pugs-seep-steep/.

<h3>About Ethos Discovery</h3>
 
Ethos Discovery is a 501(c)3 nonprofit organization devoted to developing innovative medical treatments and tests that benefit both pets and humans. Through targeted research, clinical trials, and the delivery of advanced veterinary care, we seek to address unmet clinical needs to improve health outcomes for humans and animals with complex medical problems.

Ethos Discovery is uniquely positioned, with the support of Ethos Veterinary Health, to reach patients and doctors nationally and to partner with key international leaders in their field. This flexibility provides us the opportunity to pursue impactful research that will make a difference where it is most important, within clinical hospitals and for patients and families. Our scientific portfolio is currently focused on: Oncology, Neurology, Emergency and Critical Care, Innovations in Surgery, Internal Medicine, Anesthesia and Drug Repurposing. For more information, visit EthosDiscovery.org.

<h3>About Gallant Therapeutics</h3>
 

Gallant Therapeutics is a clinical-stage animal health biotechnology company setting a new standard in animal health by harnessing the power of stem cell therapy to treat the root cause of diseases in dogs and cats. Gallant’s pipeline of off-the-shelf mesenchymal stem cell (MSC) therapies has the potential to treat a broad range of diseases, including canine and feline osteoarthritis (OA), feline chronic kidney disease (CKD) and others. The first product based on our uterine-derived platform, for feline chronic gingivostomatitis (FCGS), is on track for conditional approval by the FDA in 2025. United by a love of and commitment to animals, Gallant’s team includes industry leaders in veterinary regenerative medicine with deep experience in cell therapy product development, manufacturing and commercialization. To learn more about the potential of our stem cell therapies, visit GallantTherapeutics.com.

<h3>Media Contacts</h3>
 
Gallant Therapeutics
 
Adam Silverstein
 
Adam@ScientPR.com

<h3>Ethos Discovery</h3>
 
Tina Rice
 
Executive Director
 
trice@ethosvet.com

<h3>Clinical Trial Contact</h3>
 
Rebecca Windsor, DVM, DACVIM
 
Veterinary Neurologist
 
WRAHNeurology@wrah.com
 
720-213-2720

1 Carrade DD, Borjesson DL. Immunomodulation by mesenchymal stem cells in veterinary species. Comp Med. 2013 Jun;63(3):207-17. PMID: 23759523; PMCID: PMC3690426.

2 Wu, X., Jiang, J., Gu, Z. et al. Mesenchymal stromal cell therapies: immunomodulatory properties and clinical progress. Stem Cell Res Ther 11, 345 (2020). https://doi.org/10.1186/s13287-020-01855-9.

JEDI Pivotal Study Article from PharmaShots