• Scout Bio’s research was selected for presentation at the American College of Veterinary Internal Medicine (ACVIM) Forum
• Three lectures will present Scout Bio’s technology, new areas of research, and positive clinical results from first successful pilot clinical study with SB-001 for feline anemia
• First time a large multi-center study applying gene therapy to treat a chronic disease will be presented at a veterinary conference

Philadelphia, PA JUNE 14, 2022 – Scout Bio, a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies and monoclonal antibodies for major chronic pet health conditions, today announced that Scout Bio team members and clinical study investigators will provide presentations including information on Scout Bio’s veterinary gene therapies at the American College of Veterinary Internal Medicine Forum (ACVIM) 2022, which is taking place June 23-25 in Austin, Texas.

The presentations will discuss the benefits of single-injection adeno-associated viral vectors (AAVs), an emerging modality in veterinary medicine, and review Scout Bio’s AAV programs in development, including in the areas of feline anemia, feline and canine osteoarthritis pain, and feline and canine diabetes.

Lead author and clinical investigator in Scout Bio’s CKD-associated anemia clinical study, Dr. Shelly Vaden, will share positive data from the newly completed feline pilot study with SB-001, a product that has successfully shown proof of concept in this condition with significant unmet medical need.

With the potential of long-term efficacy from years to a lifetime after a single dose, AAV gene therapy may deliver an order of magnitude greater convenience and compliance for the management of chronic conditions in pets. “AAV is a platform that we believe will revolutionize the delivery of therapeutic proteins in chronic diseases in veterinary medicine and has the potential to change the way we will manage these diseases in our pets” says Scout Bio’s Chief Development Officer, Dr Anne Traas. “We are honored that the ACVIM has selected our research to present in a number of lectures at the conference, enabling us to share the potential for this platform to a wide audience of veterinary professionals, key opinion and industry leaders”.

The sessions featuring Scout Bio’s work at the ACVIM Forum include:

Adeno-associated Virus Vectors as a Delivery System for Treatment of Chronic Disease
Wednesday, June 22, 2022; 2:00 PM CT
Presenters: Cynthia R. Ward, VMD, PhD, DACVIM (University of Georgia) and Anne Traas, DVM, MS, DACT (Scout Bio)

Anemia of Chronic Kidney Disease, Pathogenesis and Potentials for Gene Therapy
Thursday, June 23, 2022; 3:00 PM CT
Presenter: Shelly L. Vaden, DVM, DACVIM (SAIM), PhD – (North Carolina State University College of Veterinary Medicine)

Novel Treatment for CKD Associated Anemia in Cats
Saturday, June 25, 2022; 10:20 AM CT
Presenters: Dr. Shelly L. Vaden

*Times are subject to change. The full agenda for the Forum can be viewed here.

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies and monoclonal antibodies for major chronic pet health conditions. Scout Bio’s therapies are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio has a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
fran.gaconnier@scoutbio.co

• Leading veterinary biopharma innovators, experts, and investors in gene therapy technologies, including Aaron Schacht and Mark Heffernan, to present opportunities for therapeutic innovation in rapidly growing market

PHILADELPHIA, June 09, 2022 (GLOBE NEWSWIRE) — Scout Bio, a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies and monoclonal antibodies for major chronic pet health conditions, today announced that it will feature at Morgan Stanley Animal Health Biopharma Global KOL Summit in New York City on June 10, 2022.

Chief Executive Officer Mark Heffernan, Ph.D., will present on the company’s background and strategy for delivering a new standard in care for chronic conditions in pets. “The veterinary therapeutics market has experienced strong growth in recent years. Innovation and dramatic increases in pet ownership seen during the pandemic are driving the forecasted growth acceleration,” said Dr. Heffernan. “Within this context, Scout Bio is uniquely poised to deliver that innovation through a diverse pipeline of novel biologic therapies, including AAV-based gene therapies designed to provide long-lasting efficacy for major conditions such as diabetes, pain, allergy and anemia.”

Scout Bio board member Aaron Schacht will provide industry-level context for the emergence of specialty biopharmaceuticals as a key growth area for veterinary therapeutics. Mr. Schacht is CEO of BiomEdit, a standalone venture recently formed through the carve-out of Elanco’s microbiome R&D platform and pipeline combined with the biology capabilities of Ginkgo Bioworks focusing on novel animal health product innovation. Elanco is the second largest animal health company in the world with over 10,000 employees and customers in over 90 countries, where Mr. Schacht formerly served as Executive Vice President with responsibilities over time including oversight of global research and development, regulatory affairs and business development.

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies and monoclonal antibodies for major chronic pet health conditions. Scout Bio’s therapies are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio has a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
fran.gaconnier@scoutbio.co

• Brings experience in managing global innovation portfolios and business development to Scout Bio
• Executive leadership experience across both animal and human health

PHILADELPHIA, February 18, 2022 – Scout Bio, a biotechnology company developing therapeutic proteins and one-time AAV gene therapies for major chronic pet health conditions announced it had appointed Aaron Schacht to its Board of Directors. Mr. Schacht is a deeply experienced life sciences executive with management expertise across a wide range of functions and will work with Scout Bio to execute its strategic development as a veterinary biopharma pioneer.

“Scout Bio’s approach to the innovation and delivery of entirely new biologic therapies for animals is truly unique. Their science is highly validated and has remarkable potential to deliver breakthrough treatments for chronic conditions in pets,” said Mr. Schacht. “I look forward to working with the entire Scout Bio team to support the advancement of the company’s business and rich pipeline.”

“I am pleased to welcome Aaron to Scout Bio during an exciting period where his expertise will add significant value to our corporate strategy,” said Mark Heffernan, Ph.D., chief executive officer of Scout Bio. “We are nearing several inflection points in 2022, including a number of significant clinical milestones for multiple programs. Aaron’s global product development experience will be invaluable in shaping our portfolio and supporting our mission to transform the treatment of major conditions with biologic therapies that will integrate seamlessly into veterinary care.”

Mr. Schacht was until recently an Executive Vice President at Elanco (NYSE: ELAN), with a number of responsibilities over time including oversight of global research and development and innovation as well as regulatory affairs and business development. Elanco is the second largest animal health company in the world with over 10,000 employees and customers in over 90 countries. Mr. Schacht currently serves as President and CEO of MBRD, a new company created to transform Elanco’s microbiome R&D platform and pipeline into a standalone venture.

During his time at Elanco, Mr. Schacht transformed Elanco’s innovation model, building and integrating internal and external innovation strategies that position Elanco as a leading independent animal health company. Aaron led the strategic acquisitions of Bayer Animal Health, Aratana Therapeutics, and Kindred Biosciences. His R&D teams delivered more than a dozen new products to the market during his tenure, while integrating the R&D capabilities and pipelines of Novartis Animal Health, Boehringer Ingelheim pet vaccines, Bayer Animal Health, Aratana, Prevtec and Kindred. Aaron was a member of the founding executive team that completed the carve out from parent Eli Lilly and Company, taking Elanco public in 2018. Schacht began his career at Lilly in 1990 as a medicinal chemist. He holds a Bachelors of Science degree from the University of Illinois.

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies for major chronic pet health conditions. Scout Bio’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio has a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
fran.gaconnier@scoutbio.co

PHILADELPHIA, February 15, 2022 – Scout Bio, a biotechnology company developing therapeutic proteins and one-time AAV gene therapies for major chronic pet health conditions, today announced that it will present at two conferences in February 2022. They include:

• Animal Health, Nutrition and Technology Innovation Europe (In-person). Scout Bio is a sponsor of the event, and management will host a technical insights session reviewing the company’s platform and pipeline on February 22 at 3:15 p.m. GMT.
• Bank of America Securities Animal Health Summit (Virtual). Scout Bio Chief Executive Officer Mark Heffernan, Ph.D., will provide a corporate overview on Thursday, February 25, 2022 at 10:50-11:30 a.m. EST.

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies for major chronic pet health conditions. Scout Bio’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio has a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
fran.gaconnier@scoutbio.co

• Partnership agreement includes exclusive rights in animal health to novel viral vector capsid and expands additional option rights to novel capsids
• Next-generation novel adeno-associated viral (AAV) vector capsid promises enhanced manufacturability
• Expanded partnership with Penn’s Gene Therapy Program continues to strengthen Scout Bio’s long-term leadership position in companion animal gene therapy

Philadelphia, PA December 7, 2021 – Scout Bio, a biotechnology company focused on one-time AAV gene therapies for major chronic pet health conditions, today announced the expansion of their foundational collaboration agreement with the Gene Therapy Program (GTP) at the University of Pennsylvania (Penn) to grant Scout Bio exclusive rights in the field of animal health to an emerging viral vector capsid technology for use in animal gene therapy, as well as extended option terms to other next-generation AAV vector technologies.

Scout Bio has undertaken a thorough evaluation of this new capsid, which is now the basis of several of Scout Bio’s programs undergoing in-species veterinary clinical trials. This capsid has been optimized for enhanced manufacturability to significantly increase yield per production batch. The next generation capsid may also deliver enhanced targeting of muscle cells, further supporting Scout Bio’s focus on gene therapy treatments that emphasize convenience for owners and ease of administration and integration into veterinary practice.

The collaboration expansion, which includes additional rights to novel capsids, leverages world leading AAV capsid discovery, development, and engineering programs under the direction of James M. Wilson, Director of the Gene Therapy Program at Penn and a co-founder of Scout Bio.

“This expanded collaboration supports Scout Bio’s continued scientific leadership in pet gene therapy and supports the manufacturing and commercial planning for our portfolio – which is already delivering meaningful clinical outcomes. We are proud to leverage the world’s leading AAV technologies to complement our in-house expertise in preclinical R&D, manufacturing, and clinical execution,” said Mark Heffernan, Ph.D., Chief Executive Officer at Scout Bio.

“Scout Bio’s complementary expertise means our partnership is ideally suited to deliver an entirely new paradigm to veterinary medicine and see transformational benefits in complex chronic diseases in companion animals,” Wilson said. “Scout Bio’s progress in veterinary patients is now showing significant potential of the AAV gene therapy platform for more expanded applications across multiple species.”

With three AAV product candidates in clinical development and the ability to move from concept to the clinic rapidly, Dr Heffernan said, “Scout Bio has built a discovery and development engine designed to meet the major needs in pet chronic disease with affordable, convenient, and durable one-time gene therapies.”

About AAV Vector-Based Gene Therapies For Pets
Scout Bio is the leading developer of gene therapies for pets. Each gene therapy candidate is a single injection designed to induce long-term expression of a therapeutic protein to treat a particular serious chronic veterinary disease or condition. Scout Bio uses a highly validated technology for the delivery of therapeutic genes called adeno-associated viral (AAV) vectors.

A ‘vector’ is a transporter for genetic material. AAV vectors are the most commonly used and studied delivery technology in gene therapy today. The exclusive rights covered in the collaboration agreement with Penn cover animal health applications of a new type of AAV vector capsid, which is the protein shell that mediates delivery of a vector’s payload to target cells. Capsid engineering can bring a range of additional benefits. For example, Scout Bio’s novel AAV vector capsids have delivered dramatic improvements in the manufacturability of the vector.

Scout Bio focuses on intramuscular delivery of gene therapies for pets to maximize convenience and integration into veterinary practice. The company’s data suggests that intramuscular delivery may deliver superior durability of therapeutic effect and mitigate any dampening effect of natural antibodies against AAV vectors. Scout Bio’s candidates are therefore optimized to specifically deliver therapeutic genes to muscle cells.

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies for major chronic pet health conditions. Scout Bio’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio has a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

University of Pennsylvania Financial Disclosure
Dr. Wilson is a Penn faculty member, scientific collaborator, key advisor, and co-founder of Scout Bio. As such, he holds an equity stake in the Company, his laboratory at Penn receives sponsored research funding from Scout Bio, and as an inventor of the licensed technology he may receive additional future financial benefits under licenses granted by Penn to Scout Bio. The University of Pennsylvania also holds equity and licensing interests in Scout Bio.

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
fran.gaconnier@scoutbio.co

IHS Markit recognizes Scout Bio for pioneering therapies in companion animal medicine

PHILADELPHIA, November 08, 2021 — Scout Bio, a biotechnology company focused on one-time AAV gene therapies for major chronic pet health conditions, received top honors as the Best Start-up 2021 from the IHS Markit Animal Health Awards. Judged by an independent panel of industry experts, the awards honor a firm’s ability to innovate, attract investment, and execute exciting R&D achievements within the animal health sector during a calendar year.

Joseph Harvey, Head of Animal Health at IHS Markit, said: “Scout Bio’s progress has really stood out in 2021. It has a team of proven innovators that are again showing momentum in the companion animal therapeutics segment. This year, the start-up has shown significant development with both clinical trials and fundraising. The judging panel believe Scout Bio will be a key innovator of the future.”

Over the last twelve months, Scout Bio has accomplished a number of animal health industry firsts including the:

• First gene therapy in clinical development to successfully treat feline patients with an acquired non-monogenic disease (chronic kidney disease associated anemia)
• First to clinically advance a novel GLP-1 analog expressed via adeno-associated virus (AAV) gene therapy for feline diabetes in companion animal patients
• First vectorized monoclonal antibody to be studied in feline chronic pain when delivered by AAV gene therapy

“This award is welcomed recognition acknowledging our team’s innovative work in achieving a number of industry firsts amidst a year of COVID-related challenges,” said Mark Heffernan, Ph.D., Chief Executive Officer at Scout Bio. “I couldn’t be more proud of our team and key collaborators for their commitment to advancing gene therapy innovation in pet patients in a number of chronic diseases over this past year. In addition to these groundbreaking pipeline milestones, we are strongly positioned to continue to advance Scout Bio’s portfolio of AAV delivered therapeutic proteins for companion animal diseases thanks to the recent closing of additional financing.”

A spin-out company from the University of Pennsylvania (Penn) and the laboratory of Dr. Jim Wilson at Penn’s Gene Therapy Program (GTP), Scout Bio is uniquely able to leverage the expertise of GTP to accelerate discovery and development efforts in this exciting new field of companion animal medicine. “Scout Bio is on target to significantly disrupt the field by showing that AAV gene therapy can deliver therapeutic proteins as a single-injection alternative to weekly or monthly injectable proteins,” Wilson said. “Scout Bio’s progress in veterinary patients is now showing significant potential of the AAV gene therapy platform for more expanded applications in a multitude of species.”

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies for major chronic pet health conditions. Scout Bio’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio has a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

University of Pennsylvania Financial Disclosure
Dr. Wilson is a Penn faculty member, scientific collaborator, key advisor, and co-founder of Scout Bio. As such, he holds an equity stake in the Company, his laboratory at Penn receives sponsored research funding from Scout Bio, and as an inventor of the licensed technology he may receive additional future financial benefits under licenses granted by Penn to Scout Bio. The University of Pennsylvania also holds equity and licensing interests in Scout Bio.

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
Fran.gaconnier@scoutbio.co

– First vectorized antibody gene therapy to be studied in pets

– Strong initial in-species data support therapeutic profile of one-time gene therapy designed for long-term pain management

– Novel monthly pain management antibody therapy also assessed as part of study design

– Topline data expected in Q3 2022

PHILADELPHIA, October 28, 2021 – Scout Bio, a biotechnology company focused on revolutionizing pet medicine by delivering a pipeline of one-time therapeutics for major chronic pet health conditions, today announced the initiation of a clinical study to evaluate the safety and efficacy of SB-007, the company’s one-time AAV gene therapy for chronic arthritis pain in cats. After a single injection, SB-007 is designed to trigger consistent long-term production of an antibody that inhibits a pain-promoting protein called nerve growth factor (NGF) in cats. The study will also assess SB-011, which is the anti-NGF antibody encoded by SB-007, in parallel development as a monthly injection.

“Pet owners and veterinarians are looking for ways to relieve chronic pain and restore quality of life in the most convenient, long-lasting way, which is the promise of one-time gene therapies like SB-007,” said Mark Heffernan, Ph.D., Chief Executive Officer of Scout Bio. “Emerging anti-NGF antibody therapies have validated the potential of this approach, and as the leaders in pet gene therapy Scout Bio has a clear opportunity to significantly improve treatment options in this major therapeutic area, as we are also doing in anemia, diabetes and atopic dermatitis.”

The study is a multi-center placebo-controlled pilot clinical study that will target enrollment of 132 client-owned (pet) cats in veterinary clinics throughout the United States. The study will include an evaluation of the SB-011 antibody given monthly; or two combination groups where one dose of SB-011 is followed two weeks later by one of two dosages of the SB-007 gene therapy. The transition enables the direct assessment of anti-NGF activity and clinical outcomes delivered by a monthly antibody versus a one-time gene therapy. Endpoints will include validated owner-assessment tools for pain and mobility in cats. Topline data from the study is expected in the third quarter of 2022.

Both SB-007 and SB-011 target feline NGF which has been shown to play an important role in the production of pain signals and inflammation in diseases like degenerative joint disease (DJD). Inhibition of NGF is intended to dramatically reduce or eliminate pain, improving a cat’s quality of life and mobility.

“Our anti-NGF candidates represent another major innovation to emerge from our proprietary research and AAV development platform. This study expands our work in vectorized antibodies, a gene therapy approach that allows patients to produce their own therapeutic antibodies after a single, intramuscular dose of gene therapy,” said Matt Wilson, Scout Bio’s VP of Product Discovery and External Innovation. “Anti-NGF antibodies are only the first of many antibodies that may be vectorized through a design process where we have specialist expertise based on our foundational partnership with the University of Pennsylvania’s Gene Therapy Program. In addition to feline anti-NGF vectorized antibodies, we are also advancing a canine anti-NGF and an anti-IL-31 antibody program for the major area of atopic dermatitis.”

Data highlights from completed studies of SB-011 and SB-007 to-date include:

• SB-011: This monoclonal antibody (mAb) candidate has demonstrated potent neutralizing activity and repeat dosing in healthy cats has been shown to achieve a serum concentration with potential for therapeutic effect. SB-011 has also demonstrated favorable safety following multiple repeated subcutaneous injections. No immunogenicity has been observed.
• SB-007: Our gene therapy program to express our SB-011 monoclonal antibody has demonstrated the ability to produce sustained plasma levels of the monoclonal antibody within a target therapeutic concentration for over a year after a single injection. The animals in this pre-clinical study continue to be followed long-term.
• No drug related adverse events have been observed with either product.

About Feline Chronic Pain and Degenerative Joint Disease (DJD)
Degenerative joint disease, also known as osteoarthritis or degenerative arthritis, is one of the most significant and under-diagnosed diseases of cats. It involves the destruction of cartilage and supportive tissue which causes pain. 90% of cats over age 12 have radiographic evidence of joint disease. It is difficult for owners to recognize clinical symptoms of arthritis in a cat, as they often conceal their pain. Nearly 40% of all cats have clinical signs of DJD which are often mistaken for normal signs of aging. They include limping, difficulty with stairs, stiffness upon rising, pain when petted, and inability to jump.

Veterinarians spend considerable time educating their clients about chronic diseases such as DJD. Clients and patients – particularly cats – struggle with the need for regular treatments to manage chronic disease or pain. A pet’s limited ability to clearly communicate when they are experiencing early symptoms of their chronic conditions can prevent early intervention. These factors often result in both poor compliance and patient outcomes for chronic diseases. Scout Bio’s proprietary market data strongly supports the eagerness of veterinarians for one-time therapies that can effectively answer these challenges.

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies for major chronic pet health conditions. Scout Bio’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio has a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co.

For further information, please contact:

Fran Gaconnier
Scout Bio
214.417.4142
fran.gaconnier@scoutbio.co

– Proceeds to support advancing single injection Adeno-Associated Viral (AAV) vector therapeutics targeting chronic companion animal diseases including diabetes, pain, and anemia associated with chronic kidney disease (CKD)

– New investors to the syndicate include leading healthcare investment firm OrbiMed

Philadelphia, PA – October 19, 2021 – Scout Bio, a biotechnology company focused on revolutionizing pet medicine by delivering a pipeline of one-time AAV gene therapies for major chronic pet health conditions, today announced the closing of a Series B2 financing, which raised a total of $33.0 million. This financing round included new investors, including OrbiMed and a major animal health company, along with existing Series B1 investors: Digitalis Ventures, Frazier Healthcare Partners, RiverVest Venture Partners, Greenspring Associates, Adage Capital Management and Correlation Ventures. Proceeds from the financing will advance the clinical development of Scout Bio’s lead product candidates targeting diabetes, feline pain associated with osteoarthritis and CKD-associated anemia, in addition to research efforts in further indications.

“We are pleased to welcome the validating support of world-class investors who share our excitement for innovation in veterinary medicine.  The financial commitment from our broadened investor base will enable us to further deliver on the clinical development of our programs in a number of conditions, such as diabetes and chronic pain,” said Mark Heffernan Ph.D., Chief Executive Officer at Scout Bio. “We are very excited to have recently generated meaningful clinical data in patients with CKD-associated anemia, proving that AAV gene therapy can be efficacious in client owned animals with chronic diseases. Scout Bio is on target to deliver on our platform over the next twelve months, making single-shot therapies expressing validated protein therapeutics a reality in veterinary medicine.”

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies for major chronic pet health conditions. Scout Bio’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio has a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

About OrbiMed
OrbiMed is a leading healthcare investment firm, with $19 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, utilizing a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed maintains offices in New York City, San Francisco, Shanghai, Hong Kong, Mumbai and Herzliya. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and global team resources and support to help build world-class healthcare companies.

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
fran.gaconnier@scoutbio.co

PHILADELPHIA, Oct. 04, 2021 (GLOBE NEWSWIRE) — Scout Bio, a biotechnology company focused on revolutionizing pet medicine by delivering a pipeline of one-time AAV gene therapies for major chronic pet health conditions, today announced that Mark Heffernan, Chief Executive Officer, will present at two upcoming investor conferences.

• Chardan 5th Annual Genetic Medicines Conference (Virtual) on Monday, October 4, 2021 at 5:00 p.m. ET
• Jefferies Gene Therapy/Editing Summit (Virtual) on Thursday, October 28, 2021 at 2:00 p.m. ET

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies for major chronic pet health conditions. Scout Bio’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio has a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
Fran.gaconnier@scoutbio.co

PHILADELPHIA, September 9, 2021 — Scout Bio today announced the successful completion of a CKD-associated anemia study in client owned cats treated with SB-001, an AAV expressing feline erythropoietin (fEPO). The study demonstrated a prolonged therapeutic effect with statistically significant increases in red blood cells after a single injection. SB-001 is the first gene therapy to successfully treat feline patients with an acquired non-monogenic disease. These results pave the way for Scout Bio’s portfolio of AAV delivered therapeutic proteins for companion animal diseases.

Clinical Study Highlights:

• Studies compared the change in Packed Cell Volume (PCV), an indicator of increased hematocrit or red blood cell number, from baseline in twenty-three client owned cats with kidney disease;
• All cats received therapy and success was defined as an increase in PCV into the normal range or ≥5 percentage points above their pre-treatment PCV;
• A single dose has now been selected that significantly increased PCV (p<0.05), 87% of cats met success criteria by showing clinically relevant increases in PCV;
• A study published by Boyd in 2008 determined that 95% of Stage 4 CKD cats will die by 99 days after diagnosis. In the Scout Bio study, 44% of treated Stage 4 cats lived longer than 99 days, with one cat living to 339 days post-treatment;
• The single injection AAV treatment is expected to last the rest of the cat’s life, therefore offering a significant compliance and convenience advantage over current intervention (i.e., off-label human EPO or blood transfusions) or future approaches; and
• No immune response to fEPO was observed with SB-001 treatment in any feline patient. In contrast, off-label use of human drugs in cats is reported to carry a high risk of a life-threatening immune reaction to the drug.

“In this study we have successfully shown that SB-001 has the ability to increase PCV into the normal range, thereby reducing or eliminating the clinical effects of anemia associated with CKD.” said Mark Heffernan, Ph.D., CEO of Scout Bio. “These exciting results reinforce the potential for Scout Bio’s gene therapy platform to advance treatments for other acquired chronic diseases such as diabetes, chronic pain and atopic dermatitis.”

There are no FDA-approved treatments available for CKD-associated anemia in cats. The single injection treatment of SB-001 presents an enormous advantage in convenience, improved compliance, and potentially allows owners more quality time with their pets. “A new option for cats with kidney disease and anemia is urgently needed. These cats come into the veterinary clinic with weakness, lethargy, breathing difficulties, and overall feeling very unwell. SB-001’s ability to increase the PCV can make a huge difference for many of these cats that would otherwise face euthanasia,” said Anne Traas, DVM, MS, DACT, Chief Development Officer for Scout Bio and head of the clinical team leading the study. “It was very rewarding to hear from owners participating in the study, who expressed their deep gratitude for the additional time SB-001 was able to provide their beloved pets.”

James M. Wilson, MD, PhD, Director of the Gene Therapy Program at the University of Pennsylvania and a co-founder of Scout Bio, commented, “Scout Bio’s focus in companion animals with chronic diseases has resulted in this successful demonstration that AAV gene therapy can be an effective alternative to frequent injections with therapeutic proteins and result in the improvement of feline patient lives. These results provide validation that Scout Bio’s platform can be used to successfully deliver therapeutic proteins to treat chronic diseases in companion animals.”

Scout Bio intends to progress key manufacturing activities and safety studies that will be necessary to apply for Expanded Conditional Approval under FDA guidelines.

About SB-001
SB-001 has a unique and innovative adeno-associated viral (AAV) vector, containing the gene for feline EPO, for delivery into the muscle cell nucleus which will continually produce therapeutic levels of the hormone. The expressed feline EPO stimulates erythropoiesis, or red blood cell production. The U.S. Food and Drug Administration (FDA) CVM has confirmed that SB-001 is eligible for Expanded Conditional Approval, potentially shortening the time until this product could be approved and made available.

About Chronic Kidney Disease (CKD)-Associated Anemia
Anemia associated with chronic kidney disease (CKD) in cats is a disease of high unmet medical need, with no FDA-approved therapies currently available. CKD is one of the most common diseases in senior cats and is an end-of-life disease that creates quality of life issues for cats and their owners. Up to 21% of cats with CKD have anemia and the only currently available therapeutic options are multiple blood transfusions or repeated injections of off-label human drugs. Compared to the off-label use of human EPO drugs, SB-001 is expected to have a superior safety profile with respect to immune reactions and incidence of pure red cell aplasia (PRCA), a serious life-threatening condition.

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies for major chronic pet health conditions. Scout Bio’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio has a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

University of Pennsylvania Financial Disclosure
Dr. Wilson is a Penn faculty member, scientific collaborator, key advisor, and co-founder of Scout Bio. As such, he holds an equity stake in the Company, his laboratory at Penn receives sponsored research funding from Scout Bio, and as an inventor of the licensed technology he may receive additional future financial benefits under licenses granted by Penn to Scout Bio. The University of Pennsylvania also holds equity and licensing interests in Scout Bio.

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
Fran.gaconnier@scoutbio.co