Houston brain health co. secures $6.5M for rare disease study

neuro funding

Goldenrod Therapeutics plans to study how its enzyme inhibitor can treat Friedreich’s ataxia. Photo via Unsplash

Houston-based Goldenrod Therapeutics, part of Fannin Partners' portfolio, has announced the initial close of a $6.5 million series seed preferred stock round.

The round was led by Ataxia Ventures and an affiliate of Fannin, according to a news release.

Goldenrod Therapeutics plans to use the funding to support manufacturing, formulation optimization, IND-enabling studies and a Phase I study of its drug to treat brain inflammation, known as 11h.

The study will consider how 11h, which blocks the enzyme PDE4, could treat Friedreich’s ataxia (FA), a rare genetic disease that affects movement, speech and balance. To date, other PDE4 inhibitors have proven to regulate neuroinflammation and neuronal signaling, but have had adverse gastrointestinal side effects or have not reached enough of the central nervous system, according to Goldenrod.

The company says its 11h is expected to have "broad applicability" with limited emetric side effects.

“Our 11h program is a next-generation, orally bioavailable, brain-penetrant PDE4 inhibitor, where researchers overcame longstanding limitations associated with earlier PDE4 inhibitors," Dr. Dev Chatterjee, CEO of Goldenrod, said in the news release. "We believe this creates the potential for a best-in-class therapy for Friedreich’s Ataxia and a potential foundation for development across multiple neurodegenerative and neuroinflammatory disorders.”

11h was first developed at the University of Nebraska Medical Center (UNeMed). Houston-based Fannin Partners in-licensed the product 2020 and landed SBIR Phase I funding to support its initial development for opioid use disorder soon after.

Goldenrod has also received funding to study 11h's effectiveness for multiple sclerosis, methamphetamine addiction and cocaine addiction.

Goldenrod says it is developing 11h to target a variety of neurological and inflammatory conditions, including Alzheimer's disease, multiple sclerosis, ALS, substance use disorders, Batten disease, pain and traumatic brain injury.

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Nexalin develops non-invasive devices that help reset networks in the brain associated with symptoms of anxiety and insomnia. Photo via Getty Images.

How a Houston company is fighting anxiety, insomnia & Alzheimer’s through waveforms

mental health

A Houston-based company is taking a medicine-free approach to target brain neurologically associated with mental illness.

Nexalin Technology’s patented, FDA-cleared frequency-based waveform targets key centers of the midbrain to support the normalization of neurochemicals through a process known as Transcranial Alternating Current Stimulation (tACS). Delivered via a non-invasive device, the treatment gently stimulates the hypothalamus and midbrain, helping to “reset networks associated with symptoms” of anxiety and insomnia. Early clinical evidence suggests this approach can promote healthier brain function and improved sleep.

Through its recently appointed scientific advisory board (SAB), Nexalin also aims to target Alzheimer’s disease with a clinical development pipeline supported by published data and internal data from studies involving its proprietary DIFS technology. Nexalin’s Gen-2 SYNC and Gen-3 Halo headset delivers the DIFS, which is a waveform that can penetrate deep brain structures implicated in cognitive decline and mental illness.

The board includes experts in neurology, neuroimaging and neurodegenerative diseases with Dr. Mingxiong Huang, Dr. David Owens, and Dr. Abe Scheer coming on board. Nexalin plans to initiate new Alzheimer’s-focused clinical studies in the Q3 2025 by incorporating cognitive testing, imaging biomarkers, and guided metrics to assess treatment efficacy and neural activation.

“I am excited to work alongside Nexalin’s leadership and fellow SAB members to help guide the next generation of non-invasive neuromodulation therapies,” Huang said in a news release. “The intersection of neuroimaging, brain stimulation, and clinical science holds enormous potential for treating neurodegenerative disease.”

Recently, Nexalin’s proprietary neurostimulation device moved forward with a clinical trial that evaluated its treatment of anxiety disorders and chronic insomnia in Brazil. The first of Nexalin’s Gen-2 15-milliamp neurostimulation devices was shipped to São Paulo, Brazil, and the study will be conducted at the Instituto de Psiquiatria University Hospital (IPq-HCFMUSP). The shipments aim to support the launch of a Phase II clinical trial in adult patients suffering from anxiety and insomnia. The Nexalin Gen-2 15-milliamp neurostimulation device has also been approved in China, Brazil and Oman. Its Gen 1 device first received FDA clearance in 2003, according to the company's website.

The company also enrolled the first patients in its clinical trial at the University of California, San Diego, in collaboration with the VA San Diego Healthcare System for its Nexalin HALO, which looks to treat mild traumatic brain injury and post-traumatic stress disorder in military personnel and the civilian population.

Nexalin previously raised $5 million through a public stock offering.
FibroBiologics has opened a new 10,000-square-foot Houston lab to scale up research efforts and pave the way for in-house manufacturing. Photo via Fibrobiologics.com

Houston regenerative medicine company expands lab for future trials

new digs

A Houston regenerative medicine company has unveiled new laboratory space with the goal of expanding its pioneering science.

FibroBiologics uses fibroblasts, the body’s most common type of cell, rather than stem cells, to help grow new cells. Fibroblasts are the primary variety of cells that compose connective tissue. FibroBiologics has found in studies that fibroblasts can be even more powerful than stem cells when it comes to both regeneration and immune modulation, meaning they could be a more versatile way forward in those fields.

In 2023, FibroBiologics moved into new lab space in the UH Technology Bridge. Now, with its new space, the publicly traded company, which has more than 240 patents issued or pending, will be even better equipped to power forward with its research.

The new space includes more than 10,000 square feet of space devoted to both labs and offices. The location is large enough to also house manufacturing drug product candidates that will be used in upcoming trials. Additionally, the company reports that it plans to hire additional researchers to help staff the facility.

“This expansion marks a transformative step forward for our company and our mission,” Pete O’Heeron, FibroBiologics founder and CEO, said in a news release. “By significantly increasing the size of our lab, we are creating the space and infrastructure needed to foster greater innovation and accelerate scientific breakthroughs.”

The streamlined, in-house manufacturing process will reduce the company’s reliance on external partners and make the supply chain simpler, O’Heeron added in the release.

Hamid Khoja, the chief scientific officer for FibroBiologics, also chimed in.

“To date, our progress in developing potentially transformative therapeutic candidates for chronic diseases using fibroblasts has been remarkable,” he added in the release. “This new laboratory facility will enable further expansion and acceleration of our research and development efforts. Additionally, the expansive new space will enable us to bring in-house currently outsourced projects, expand our science team and further contribute to the increased efficiency of our R&D efforts.”

This news arrives shortly after a milestone for the company in its research about neurodegenerative disease. Last month, fibroblast treatments in an animal model study demonstrated a notable regeneration of the myelin sheath, the layer that insulates nerves and is worn down by disease.

“Confirming remyelination in a second validated animal model is an important step in our research and development efforts, offering fresh hope for patients with demyelinating diseases, including multiple sclerosis,” O’Heeron added in a separate release. “These findings advance our mission to develop transformative fibroblast-based therapies that address the root causes of chronic disease, not just their symptoms, and reflect our dedication to pushing the frontiers of regenerative medicine."
Daniel Barvin has a neurodegenerative disease in his near future. He joined Houston-based Coya Therapeutics to help fight for a cure to the aggressively deadly ALS. Photo via Getty Images

How this Houston innovator is using his personal connection to ALS fuel his fight for a cure

guest column

We can never predict how our lives will turn out, but then maybe some of us can. Genetic testing showed that I, like my grandfather, aunt, uncle and father before me, would most likely die of amyotrophic lateral sclerosis, more commonly known as ALS, and/or frontotemporal degeneration (FTD) in my 40s.

Being 36, it’s possible that fear could have overtaken my life, but instead I chose to fight for every chance to change not only my life, but the lives of millions who are suffering or may one day suffer from neurodegenerative disease.

ALS is a rare disease that robs one of their ability to control their muscles, leading them to lose their ability to walk, talk and eventually breathe. Eighty percent of cases are sporadic (of unknown origin) and 20 percent have known genetic causes.

When I learned that I carried the C9ORF72 genetic variant, a causative genetic variant for ALS/FTD) my first instincts were to help others understand their status and where they could turn for help. I saw a vacuum for resources and understanding in the genetic ALS space and I knew that thousands were suffering in darkness.

Through the efforts of many, we created the first ever nonprofit – Genetic ALS & FTD: End the Legacy – focused on fighting for the genetic ALS and FTD communities. After making great strides to fight for our rights and access to care, I was asked if I could help my current CEO, Howard Berman, commercialize Dr. Stanley Appel’s regulatory T Cell (Treg) therapy for ALS.

I joined Coya Therapeutics in 2021 as the first employee, working to build a company that would one day bring life changing therapies to patients. Coya’s therapies are based on Dr. Appel’s discovery that neurodegenerative diseases drive an inflammatory response. As inflammation rises, it damages regulatory T cells, and when Tregs are damaged, inflammation becomes a persistent condition driving degeneration and eventually death.

It was at that point that my life changed from the advocacy world to the therapeutic world. Now over three years later, we are closer than ever to making a paradigm change for how patients with ALS and other neurodegenerative diseases are treated.

At Coya, we believe that combination biologics are the future of treating neurodegenerative diseases. COYA 302 is our lead asset, which has shown promising results in a proof-of-concept study released in March of 2023. We are currently working towards a double-blind, placebo-controlled trial for COYA 302 in ALS set to kick off later this year.

I never wanted to live a life so damned by disease, but when put between a rock and a hard place, the only choice is to fight. I don’t know how my life will end, but I hope that my children will know that I faced a great challenge head on with pride and resilience.

In the end, it is the combination of both the worlds I work in that lead to better outcomes for patients, raising awareness and lifesaving research. This ALS Awareness Month, please join us and our partners like the ALS Association, End the Legacy, and I AM ALS in raising awareness about these conditions, their risks, and treatment options.

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Daniel Barvin is the vice president of operations and patient advocacy at Coya Therapeutics.

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Eli Lilly breaks ground on $6.5B pharmaceutical factory in Houston

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Leading pharmaceutical company Eli Lilly broke ground today, Sept. 21, on its $6.5 billion manufacturing site at Houston's Generation Park.

The 236-acre, state-of-the art factory is expected to come online in 2030 and will manufacture Foundayo, the company's first synthetic oral GLP-1 medication, as well as other advanced therapeutics.

"We are thrilled to break ground on our latest ‘medicines made in America’ site in the great state of Texas," David Ricks, Lilly chair and CEO, said in a prepared statement. "This $6.5 billion investment will help change the game for tens of millions of people suffering from overweight, obesity and its consequences like diabetes. We will make and ship Lilly’s latest products from Texas to people here at home and around the world.”

Houston was up against more than 300 locations in the U.S. for the factory, as part of Lilly’s $50 billion investment in domestic medicine production that has launched 10 manufacturing sites since 2020. Lilly first announced Houston had been selected for the site last September.

Photo via gov.texas.gov

As Abbott mentioned, the site is expected to create hundreds of jobs, and will hire engineers, scientists, operations personnel and lab technicians once up and running. It will create 4,000 construction jobs while being built.

In an effort to support workforce development, Lilly also announced a $12.5 million commitment to Houston's San Jacinto College in addition to a $2.5 million charitable donation to the San Jacinto College Foundation. The funding will go toward hands-on training, equipment and facilities to support future technicians, operators, maintenance professionals, and other manufacturing talent, according to Lilly. The charitable donation will fund scholarships for students.

"This relationship will build a strong, sustainable talent pipeline for Lilly while creating meaningful, high-demand career opportunities across our region,” Brenda Hellyer, chancellor of San Jacinto College, said in the release.

"When you invest in a place like Houston, you invest in its people first," Edgardo Hernandez, executive vice president and president of Lilly Manufacturing Operations, added. "This facility will run on the talent of this community, powered by our relationship with San Jacinto College. We're hiring across the greater Houston area to help residents build careers close to home."

Rendering courtesy Eli Lilly

Lilly previously said it chose Generation Park, a 4,300-acre, master-planned commercial district near Lake Houston, because of factors such as financial incentives, access to utilities and transportation and the region’s business-friendly environment. Generation Park is home to campuses for San Jacinto College and Lone Star College.

Since Lilly first announced plans for the site, another fellow pharma giant has made plans to move into Generation Park. Bristol Myers Squibb Co. announced last month that it would build a $2.3 billion factory in the district. The site is expected to manufacture small molecule, biologic and antibody-drug conjugates and will also come online around 2030. Read more here.

UH Health names leader of new digital health institute

new exec

Recently launched UH Health has named the first-ever executive director of its new Institute for Digital Healthcare Transformation at the University of Houston.

Beto López has been tapped to lead the new initiative that aims to help develop and commercialize health care technologies centered around university research.

Launched in August, the Institute for Digital Healthcare Transformation leans on experts from UH’s engineering, medicine, business, law and other departments and will connect with industry partners. It will initially focus on mobile health applications, sensors, wearables and artificial intelligence, according to UH.

“Most digital health initiatives and commercialization efforts start with the technology and hope adoption follows. But the translation gap isn't a science problem — it’s a scaffolding problem between researchers, the community and the market,” López said in a news release. “I've spent the past 10 years building that scaffolding in places that weren’t wired for it, and I'm looking forward to building it here at UH to help ensure new health care technologies reach the people and communities that can benefit from them most.”

López previously spent 10 years at San Francisco-based innovation consultancy company IDEO, where he led over 100 projects for Fortune 500 companies and public agencies. He co-founded and served as managing director of the Design Institute for Health at UT Austin’s Dell Medical School; and also co-founded a social venture studio/venture capital fund focused on health care innovation. He worked alongside Houston’s Legacy Community Health during the COVID-19 pandemic.

“Beto understands that breakthrough technology alone doesn't transform health care — it has to be designed around the needs of patients, providers and communities and have a clear path into practice,” Jonathan McCullers, vice president for health affairs at UH, added in the news release. “His experience spanning academic health care and venture capital equips him to bring together researchers, health care organizations, entrepreneurs and investors. This makes him uniquely suited to lead this institute and help turn the university's innovation into solutions that improve people's lives.”

The University of Houston launched UH Health, its new cross-disciplinary academic venture, in July. It aims to bring together the university's health-related education, research and community impact under one umbrella.

ExxonMobil gets approval for $5B Texas Gulf Coast carbon capture project

CCS Expansion

Spring-based ExxonMobil has won approval from the Texas Railroad Commission for a $5 billion carbon capture and storage project in East Texas.

Dominic Genetti, senior vice president of CCS at ExxonMobil, told The Financial Times, which broke the news, that the Railroad Commission’s action is a “major milestone” that lets the company keep expanding along the Gulf Coast. In a 2-1 vote, commissioners authorized a carbon sequestration permit for the project.

“The Railroad Commission clearly recognizes the important role carbon capture and storage can play in meeting growing global demand for lower-carbon products while supporting new jobs and economic growth,” Genetti said.

The U.S. Environmental Protection Agency (EPA) approved ExxonMobil’s Rose CCS project last year.

The project will enable the company to inject about 53 metric tons of industrial customers’ carbon emissions into three underground wells it drilled in the Beaumont-Port Arthur area. Over a 13-year period, ExxonMobil plans to inject about 4 million metric tons per year into the Fleming and Upper Frio rock formations, according to Carbon Herald.

ExxonMobil says it owns the world’s first and largest CCS system, comprising 1,300 miles of CO2 pipeline and secure storage sites. Seventy percent of the pipelines are along the Gulf Coast.

The company ramped up its CCS business in 2023 with the $4.9 billion purchase of Denbury, which owned about 1,000 miles of CO2 pipelines.

“Our expertise, combined with Denbury’s talent and CO2 pipeline network, expands our low-carbon leadership and best positions us to meet the decarbonization needs of industrial customers while also reducing emissions in our own operations,” ExxonMobil Chairman and CEO Darren Woods said when the deal closed.

In January, Genetti wrote in a post on ExxonMobil’s website that the company is committed to CCS “for the long haul.”

“CCS is not new technology, but it’s flown relatively under the radar compared with the attention that production of hydrocarbons commands,” he wrote. “Now, as the world becomes more aware of the need to reduce emissions, CCS finally has a brighter spotlight and a broader runway to scale up.”

The company also announced this week that it has begun CCS operations at a direct reduced iron facility in Convent, Louisiana. The project will capture, transport and store up to 800,000 metric tons of CO2 per year, according to the company.

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This article first appeared on EnergyCapitalHTX.com.

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