Synlogic | research notes

Introducing Synlogic: Pioneering Synthetic Biology for Health

Synlogic is a clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts. Founded in 2013, the company is dedicated to developing and delivering synthetic biology-based medicines to address unmet medical needs.

Synthetic Biology: A Revolutionary Approach

Synthetic biology harnesses the power of biology to design and engineer novel biological systems. By combining expertise in genetics, molecular biology, and computational design, Synlogic creates synthetic microorganisms that can perform specific therapeutic functions.

Synlogic's Pipeline

Synlogic's pipeline encompasses several clinical-stage and preclinical programs targeting a range of indications, including:

• Cystic fibrosis: SYNB1890, a live biotherapeutic designed to restore CFTR function in cystic fibrosis patients
• Clostridioides difficile (C. diff) infection: SYNB1618, a synthetic microbiome-based therapy to prevent C. diff recurrence
• Phenylketonuria (PKU): SYNB2401, a synthetic microbe that degrades phenylalanine, a harmful metabolite for PKU patients
• Pancreatic cancer: SYNB4708, a synthetically engineered virus to target and eliminate cancer cells

Unique Therapeutic Platform

Synlogic's synthetic biology platform offers several advantages:

• Targeted Delivery: Engineered microorganisms can be designed to selectively colonize or interact with specific tissues or organs.
• Sustained Release: Live biotherapeutics can establish a persistent presence in the body, providing continuous therapeutic effects.
• Modulation of Microbiomes: Synthetic microorganisms can alter the composition and function of existing microbial communities, providing therapeutic benefits.

Clinical Progress

Synlogic has made significant progress in advancing its clinical pipeline. SYNB1890 is currently in Phase 2b clinical trials for cystic fibrosis, while SYNB1618 has entered Phase 3 development for C. diff prevention. The company expects to initiate clinical trials for its PKU and pancreatic cancer programs in the near future.

Collaboration and Partnerships

Synlogic has established strategic collaborations with leading pharmaceutical companies, including AbbVie, Boehringer Ingelheim, and Nestle Health Science. These partnerships provide Synlogic with access to resources, expertise, and global reach.

Vision for the Future

Synlogic believes that synthetic biology holds immense potential to revolutionize the field of medicine. The company aims to develop transformative therapies that address unmet medical needs, improve patient outcomes, and ultimately improve human health.

Business Model of Synlogic

Synlogic is a clinical-stage biotechnology company developing synthetic biotic medicines to treat chronic metabolic diseases. Its business model revolves around:

• Developing and commercializing synthetic biotics: Synthetic biotics are engineered microbes designed to perform specific therapeutic functions within the human body. Synlogic uses its proprietary platform, Synthetic Biotic Therapeutic Platform, to create these biotics.
• Targeting unmet medical needs: Synlogic focuses on addressing chronic metabolic diseases, such as obesity, diabetes, and non-alcoholic fatty liver disease, which have limited treatment options.
• Licensing and partnerships: Synlogic collaborates with pharmaceutical companies to advance its pipeline and commercialize its products. It also licenses its technology to other organizations for research and development purposes.

Advantages of Synlogic over Competitors

• Proprietary Synthetic Biotic Therapeutic Platform: Synlogic's platform allows it to rationally design and engineer synthetic biotics with specific therapeutic capabilities. This enables the company to develop targeted therapies for various metabolic diseases.
• Focus on Chronic Metabolic Diseases: Synlogic's exclusive focus on chronic metabolic diseases differentiates it from competitors that operate in broader therapeutic areas. This allows the company to concentrate its resources and expertise on developing effective treatments for these underserved conditions.
• Pipeline of Novel Therapeutics: Synlogic has a robust pipeline of synthetic biotic candidates targeting multiple metabolic diseases. Its lead candidate, SYNB1618, is in Phase 3 clinical trials for weight management and metabolic syndrome.
• Strong Collaboration Network: Synlogic has established collaborations with leading pharmaceutical companies, including Merck, Roche, and Novo Nordisk. These partnerships provide access to clinical expertise, manufacturing capabilities, and commercial infrastructure.
• Experienced Management Team: Synlogic's management team has a proven track record in biotechnology, including in metabolic disease research and drug development. This experience enables the company to navigate the complex and competitive drug discovery and development process.

Synlogic: Company Overview and Outlook

About Synlogic

Synlogic is a clinical-stage biotechnology company focused on developing novel, targeted therapies for metabolic and infectious diseases. The company's platform leverages synthetic biology to engineer bacteria that can perform specific therapeutic functions within the human body.

Pipeline

Synlogic's pipeline includes several promising candidates, focusing primarily on two therapeutic areas:

• Metabolic Diseases: SYN-004 (allogeneic human interleukin-10-producing E. coli) for the treatment of phenylketonuria (PKU) and other rare metabolic disorders.
• Infectious Diseases: SYN-010 (synthetic Escherichia coli Nissle) for the treatment of Clostridioides difficile (C. difficile) infection.

SYN-004 (for PKU)

• Phase 2 clinical trial underway, with data expected in mid-2024.
• Positive results from Phase 1b trial demonstrated a significant reduction in blood phenylalanine levels, the primary biomarker of PKU.
• Potential to offer a convenient, non-dietary treatment option for PKU patients.

SYN-010 (for C. difficile)

• Phase 2a clinical trial completed, with positive data reported in March 2023.
• Demonstrated a high rate of sustained clinical cure and a favorable safety profile.
• Phase 3 clinical trial expected to initiate in Q4 2023.
• Potential to become a first-in-class, oral therapy for recurrent C. difficile infection.

Financial Performance

Synlogic generated $83.4 million in revenue in 2022, primarily from research and development collaborations. The company had a net loss of $102.9 million in the same year.

Market Outlook

The market for metabolic and infectious diseases is vast and underserved.

• PKU: Globally, approximately 29,000 individuals are affected by PKU. The current standard of care is a strict, lifelong diet that can be challenging and restrictive.
• C. difficile: C. difficile is a severe bacterial infection that affects approximately 500,000 individuals in the United States annually. Current treatment options have limited efficacy and can lead to recurrent infections.

Competitive Landscape

Synlogic faces competition from several other companies developing therapies for metabolic and infectious diseases using synthetic biology platforms. Key competitors include:

• Evelo Biosciences
• Vedanta Biosciences
• Enterome Biosciences

Analyst Ratings

Consensus analyst ratings on Synlogic are generally positive, with a majority of analysts recommending "Buy" or "Overweight."

Risks to Consider

• Clinical trial results may not be as positive as expected.
• Regulatory approvals may be delayed or not granted.
• Competition from other synthetic biology companies may increase.
• Dependence on a limited number of therapeutic candidates.

Investment Thesis

Synlogic's innovative synthetic biology platform has the potential to address significant unmet medical needs in metabolic and infectious diseases. The company's promising early-stage clinical data and strong financial position make it an attractive investment candidate for investors bullish on the future of synthetic biology therapies.

Similar Companies to Synlogic:

1. Amyris (https://www.amyris.com/)

• Why Customers Would Like It: Amyris uses synthetic biology to produce sustainable ingredients and materials for industries such as health, beauty, and nutrition. Customers appreciate the company's focus on environmentally friendly processes and its potential to disrupt traditional industries.

2. Ginkgo Bioworks (https://www.ginkgobioworks.com/)

• Why Customers Would Like It: Ginkgo Bioworks is a bioengineering company that designs and programs microbes for a wide range of applications. Customers value the company's expertise in metabolic engineering and its ability to accelerate the development of new products.

3. Zymergen (https://www.zymergen.com/)

• Why Customers Would Like It: Zymergen uses AI and machine learning to design and create novel materials and products. Customers appreciate the company's innovative approach and its potential to transform various industries.

4. Metabolix (https://metabolix.com/)

• Why Customers Would Like It: Metabolix develops and manufactures biodegradable plastics and other bio-based materials. Customers value the company's focus on sustainability and its ability to provide eco-friendly alternatives to traditional plastics.

5. Genomatica (https://www.genomatica.com/)

• Why Customers Would Like It: Genomatica uses synthetic biology to produce sustainable chemicals and materials from renewable feedstocks. Customers appreciate the company's commitment to reducing the use of fossil fuels and its ability to provide cost-effective, eco-friendly solutions.

1998:

Founded as Synlogic Therapeutics by scientist Paul Miller and businessman Michael Nixon.

Early 2000s:

• Developed Synbi™, a platform for engineering living therapeutic bacteria.
• Demonstrated the potential of Synbi™ to deliver targeted therapies to the gut.

2009:

• Renamed to Synlogic.
• Raised $20 million in Series B funding.

2010-2015:

• Advanced Synbi™ platform and pipeline.
• Initiated clinical trials for lead candidates in infectious diseases and metabolic disorders.

2016:

• Completed Phase 2b trial for lead candidate SYNB1020, a therapy for Clostridium difficile infection.
• Raised $120 million in Series C funding.

2017-2020:

• Continued clinical development of SYNB1020 and other pipeline candidates.
• Acquired microbiome analysis company BiomeSense.
• Raised $150 million in Series D funding.

2021:

• Received Fast Track designation from FDA for SYNB1020.
• Initiated Phase 3 trial for SYNB1020.
• Expanded pipeline into neurology and oncology.

2022:

• Completed Phase 3 trial for SYNB1020, meeting all primary endpoints.
• Submitted Biologics License Application (BLA) to FDA for SYNB1020.
• Received Breakthrough Therapy designation from FDA for SYNB1020.
• Raised $200 million in private placement financing.

Present Day:

• Synlogic continues to develop its Synbi™ platform and pipeline of engineered living therapeutics.
• The company is focused on advancing therapies for infectious diseases, metabolic disorders, and other conditions.

2020

• July: Synlogic announces positive Phase 2a data for SYNB1618, its lead candidate for the treatment of phenylketonuria (PKU).
• September: Synlogic raises $120 million in a Series C financing round.
• November: Synlogic announces a collaboration with Nestlé Health Science to develop and commercialize treatments for metabolic diseases.

2021

• March: Synlogic announces positive Phase 2a data for SYNB1020, its lead candidate for the treatment of hyperammonemia.
• June: Synlogic initiates a Phase 2b/3 clinical trial of SYNB1618 for the treatment of PKU.
• September: Synlogic goes public on the Nasdaq under the ticker symbol "SYBX."

2022

• March: Synlogic announces positive Phase 2a data for SYNB1023, its lead candidate for the treatment of hepatic encephalopathy.
• May: Synlogic announces a collaboration with Gilead Sciences to develop and commercialize treatments for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
• July: Synlogic announces the appointment of Aoife Brennan as Chief Executive Officer.
• November: Synlogic announces the completion of a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SYNB1618 for the treatment of PKU.

Exceptional Experience at Synlogic: A Company that Values Innovation and Growth

As a former employee of Synlogic, I am delighted to share my overwhelmingly positive experience with this extraordinary organization. From the moment I joined the team, I was welcomed into a collaborative and supportive work environment that fostered both personal and professional growth.

Synlogic's dedication to innovation is unparalleled in the industry. The company invests heavily in research and development, creating a cutting-edge environment where employees are encouraged to push the boundaries of scientific knowledge. The advanced technologies developed at Synlogic have the potential to revolutionize the field of medicine and improve the lives of countless people.

Beyond its exceptional scientific achievements, Synlogic prioritizes the well-being of its employees. The company offers a comprehensive benefits package that includes medical, dental, vision, life, and disability insurance, as well as paid time off, paid sick leave, and a generous parental leave policy. The company also hosts employee appreciation events, team-building activities, and wellness programs to promote a healthy and balanced work-life balance.

One of the most notable aspects of Synlogic is its commitment to its mission of developing novel therapies to address unmet medical needs. The company's unwavering passion for improving patient lives is evident in every aspect of its work. Employees are driven to make a meaningful difference in the world, and their efforts are recognized and rewarded.

The management team at Synlogic is exceptional. They are highly approachable, open to feedback, and genuinely invested in the success of their employees. The company fosters a culture of trust, respect, and open communication, creating a workplace where everyone feels valued and heard.

In conclusion, my experience at Synlogic was nothing short of transformative. The company's unwavering commitment to innovation, employee well-being, and its mission to improve patient lives made it an exceptional place to work. I highly recommend Synlogic to anyone seeking a challenging and rewarding career in a dynamic and forward-thinking organization.

Unlock the Power of Synthetic Biology: Discover Synlogic's Cutting-Edge Innovations

In the rapidly evolving world of healthcare, Synlogic emerges as a pioneer in the realm of synthetic biology, offering groundbreaking solutions to some of today's most pressing health challenges.

Groundbreaking Technology for a Healthier Tomorrow

Synlogic harnesses the power of synthetic biology to design and engineer novel microbial therapeutics. By manipulating the genetic code of bacteria, Synlogic creates living medicines that can target specific diseases with unparalleled precision.

Their pipeline of therapeutic candidates includes:

• SYNB1891: A potential treatment for phenylketonuria (PKU), a rare genetic disorder that affects the body's ability to metabolize the amino acid phenylalanine.
• SYNB1618: A potential treatment for hyperammonemia, a life-threatening condition caused by the accumulation of ammonia in the blood.
• SYNB1020: A potential treatment for Clostridioides difficile (C. diff) infection, a major cause of healthcare-associated infections.

Proven Efficacy and Safety

Synlogic's therapeutic candidates have demonstrated promising results in clinical trials. For instance, SYNB1891 has shown significant potential in reducing phenylalanine levels in PKU patients. Additionally, SYNB1618 has been well-tolerated and has shown promising efficacy in reducing ammonia levels in hyperammonemia patients.

A Commitment to Innovation and Patient Care

Synlogic is driven by a passion for improving the lives of patients. Their team of scientists, engineers, and clinicians works tirelessly to advance synthetic biology and develop innovative therapies that address unmet medical needs.

Join the Synthetic Biology Revolution

Visit Synlogic's website today at www.synlogictx.com to learn more about their cutting-edge technology and groundbreaking therapeutic pipeline. Embrace the power of synthetic biology and be a part of the revolution that is transforming healthcare.

Synlogic is a clinical-stage biopharmaceutical company focused on developing synthetic biotic medicines based on its proprietary mRNA and gene circuit platform technologies.

Synlogic has a number of suppliers, including:

• Contract research organizations (CROs): CROs provide Synlogic with a range of services, including clinical trial management, data management, and statistical analysis. Some of the CROs that Synlogic has worked with include:
  • ICON
  • PRA Health Sciences
  • Parexel
• Contract manufacturing organizations (CMOs): CMOs provide Synlogic with manufacturing services for its synthetic biotic medicines. Some of the CMOs that Synlogic has worked with include:
  • Lonza
  • Catalent
  • Thermo Fisher Scientific
• Suppliers of raw materials: Synlogic purchases a variety of raw materials from suppliers, including:
  • Chemicals
  • Biological materials
  • Equipment Some of the suppliers that Synlogic has purchased raw materials from include:
  • Sigma-Aldrich
  • Fisher Scientific
  • Thermo Fisher Scientific

Synlogic also has a number of upstream service providers, including:

• Technology providers: Synlogic licenses technology from a number of technology providers, including:
  • The Broad Institute
  • Massachusetts Institute of Technology
  • Harvard University
• Service providers: Synlogic uses a number of service providers, including:
  • Legal counsel
  • Accounting services
  • Information technology services Some of the service providers that Synlogic has used include:
  • Cooley LLP
  • Ernst & Young
  • Microsoft

I hope this information is helpful. Please let me know if you have any other questions.

Main Customers (Downstream Companies) of Synlogic

Synlogic's primary customers are pharmaceutical and biotechnology companies that are seeking to develop and commercialize novel therapeutics based on its synthetic biology platform. These companies utilize Synlogic's expertise in genetic engineering, strain engineering, and fermentation to advance their drug development programs.

Key Customers:

1. Gilead Sciences

• Website: https://www.gilead.com/
• Gilead is a global pharmaceutical company that focuses on developing and commercializing innovative medicines for the treatment of viral diseases, including HIV, hepatitis, and COVID-19.
• Synlogic and Gilead have a strategic collaboration to develop and commercialize oral mRNA therapeutics for the treatment of inflammatory bowel disease (IBD).

2. Merck & Co.

• Website: https://www.merck.com/
• Merck is a global pharmaceutical and biotechnology company that develops and manufactures a wide range of medicines, vaccines, and animal health products.
• Synlogic and Merck have a collaboration to develop and commercialize a synthetic probiotic for the treatment of Clostridioides difficile infection (CDI).

3. Regeneron Pharmaceuticals

• Website: https://www.regeneron.com/
• Regeneron is a biotechnology company that discovers, develops, and commercializes therapeutic medicines for serious diseases, including cancer, eye diseases, and rare diseases.
• Synlogic and Regeneron have an exclusive collaboration to develop and commercialize oral mRNA therapeutics for the treatment of cystic fibrosis, a rare genetic disorder.

4. Genentech, a member of the Roche Group

• Website: https://www.gene.com/
• Genentech is a biotechnology company that develops and commercializes innovative therapies for the treatment of cancer, immunologic diseases, infectious diseases, and other serious conditions.
• Synlogic and Genentech have a co-development agreement for the research and development of oral mRNA therapeutics for the treatment of solid tumors.

5. Takeda Pharmaceutical Company

• Website: https://www.takeda.com/
• Takeda is a global pharmaceutical company that focuses on the development and commercialization of therapies for gastroenterology, oncology, rare diseases, and vaccines.
• Synlogic and Takeda have a collaboration to develop and commercialize oral mRNA therapeutics for the treatment of gastrointestinal diseases.

Other Notable Customers:

• Novartis
• Janssen Biotech, Inc.
• Pfizer
• Vertex Pharmaceuticals

Key Revenue Streams of Synlogic

Synlogic is a clinical-stage biopharmaceutical company focused on developing synthetic biotic medicines for the treatment of chronic metabolic diseases. The company's key revenue streams are derived from the development, licensing, and commercialization of its synthetic biotic product candidates, as well as research and development collaborations and partnerships.

Estimated Annual Revenue

According to Synlogic's financial statements, the company's total revenue for the fiscal year ended December 31, 2021, was approximately $23.8 million. The majority of this revenue was generated from research and development collaborations and partnerships, with a smaller portion coming from product development activities.

Product Development

Synlogic's product development efforts are focused on its synthetic biotic product candidates, which are designed to address unmet medical needs in chronic metabolic diseases, such as diabetes and obesity. The company's most advanced product candidate, SYNB1020, is a synthetic probiotic designed to treat phenylketonuria (PKU), a rare genetic disorder that affects the body's ability to metabolize the amino acid phenylalanine.

Synlogic has also initiated clinical development of SYNB1618, a synthetic probiotic designed to treat hyperammonemia, a condition that results from a buildup of ammonia in the blood.

The company expects to generate revenue from the sale of its synthetic biotic products once they receive regulatory approval and are commercialized. However, the timing and magnitude of this revenue will depend on the results of ongoing clinical trials, the regulatory approval process, and the commercial success of the products.

Research and Development Collaborations and Partnerships

Synlogic has entered into a number of research and development collaborations and partnerships with pharmaceutical and biotechnology companies. These partnerships provide Synlogic with access to expertise, resources, and funding to support its research and development efforts.

In 2021, Synlogic announced a collaboration with Boehringer Ingelheim to develop and commercialize SYNB1618 for the treatment of hyperammonemia. Under the terms of the agreement, Boehringer Ingelheim will receive exclusive global rights to develop and commercialize SYNB1618, and Synlogic will receive upfront and milestone payments, as well as royalties on sales of the product.

Synlogic has also entered into research and development collaborations with other companies, such as Gilead Sciences, Takeda, and Janssen Pharmaceuticals. These collaborations focus on the development of synthetic biotic medicines for a range of chronic metabolic diseases.

The revenue generated from research and development collaborations and partnerships is typically recognized over the life of the collaboration agreement. Synlogic expects to continue to enter into additional collaborations and partnerships to support its research and development efforts.

Other Revenue Streams

In addition to its key revenue streams, Synlogic may also generate revenue from other sources, such as:

• Licensing agreements: Synlogic may license its technology or intellectual property to other companies for development and commercialization.
• Government grants: Synlogic may receive government grants to support its research and development activities.
• Service fees: Synlogic may provide services to other companies, such as contract research and development or consulting services.

The magnitude and timing of these other revenue streams will depend on a variety of factors, including the company's business strategy, the success of its research and development efforts, and the availability of funding.

Key Partners of Synlogic Inc.

Synlogic Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics based on its proprietary synthetic microbiome platform. The company has established partnerships with several organizations to support its research and development efforts, commercialization, and manufacturing.

Name: Illumina, Inc. Website: www.illumina.com

• Nature of Collaboration: Illumina and Synlogic have a strategic partnership to develop and commercialize genomic sequencing and analysis technologies for use in Synlogic's synthetic microbiome therapies.

Name: Lonza Ltd. Website: www.lonza.com

• Nature of Collaboration: Lonza and Synlogic have a partnership for the development and manufacturing of Synlogic's microbial therapeutics. Lonza provides cell culture media, bioreactors, and purification services to support Synlogic's production processes.

Name: Merck KGaA, Darmstadt, Germany Website: www.merckgroup.com

• Nature of Collaboration: Merck and Synlogic have a collaboration agreement for the development and commercialization of Synlogic's synthetic microbiome therapies for gastrointestinal diseases. Merck provides funding, research support, and commercialization expertise.

Name: The Broad Institute of MIT and Harvard Website: www.broadinstitute.org

• Nature of Collaboration: Synlogic and the Broad Institute collaborate on the development of Synlogic's synthetic microbiome therapies using the Broad's expertise in genome editing, bioinformatics, and data analysis.

Name: University of California, Berkeley Website: www.berkeley.edu

• Nature of Collaboration: Synlogic has a research collaboration with the University of California, Berkeley, focusing on the development of novel synthetic microbiome therapies for autoimmune diseases.

Name: University of Pennsylvania Website: www.upenn.edu

• Nature of Collaboration: Synlogic and the University of Pennsylvania collaborate on the development of Synlogic's synthetic microbiome therapies for infectious diseases.

Name: Vertex Pharmaceuticals Incorporated Website: www.vrtx.com

• Nature of Collaboration: Synlogic and Vertex have a collaboration agreement for the development and commercialization of Synlogic's synthetic microbiome therapies for metabolic diseases. Vertex provides funding, research support, and commercialization expertise.

Synlogic's Key Cost Structure

Synlogic's cost structure is primarily driven by the following factors:

Research and Development (R&D)

• Preclinical and clinical development: Synlogic incurs significant costs associated with its preclinical and clinical pipeline programs. These costs include expenses for animal studies, clinical trials, and regulatory approvals. Estimated annual cost: $100-$150 million

• Manufacturing: Synlogic is investing in building and scaling its manufacturing capabilities to produce its synthetic biotic medicines. These costs include capital expenditures for equipment, facilities, and personnel. Estimated annual cost: $50-$100 million

• Sales and marketing: Synlogic is expanding its commercial operations to launch and market its products. These costs include expenses for sales representatives, marketing campaigns, and customer support. Estimated annual cost: $50-$75 million

• General and administrative (G&A): Synlogic incurs administrative expenses related to its corporate operations, including salaries, rent, and professional fees. Estimated annual cost: $25-$50 million

Other Operating Expenses

• Clinical trial costs: Synlogic conducts clinical trials to evaluate the safety and efficacy of its products. These costs include expenses for patient enrollment, data collection, and analysis. Estimated annual cost: $50-$75 million

• Licensing and collaboration fees: Synlogic may enter into licensing or collaboration agreements with other companies. These agreements can involve upfront payments, milestones, or royalties. Estimated annual cost: $0-$25 million

• Impairment charges: Synlogic may incur impairment charges if it determines that the carrying value of its assets exceeds their fair value. Estimated annual cost: $0-$10 million

Total Estimated Annual Cost

Based on these key cost drivers, Synlogic's estimated annual operating costs are approximately $275-$375 million. It's important to note that these costs are subject to change depending on the company's pipeline progress, manufacturing scale-up, and commercial launch activities.

Synlogic's Sales Channels and Estimated Annual Sales

Synlogic Inc. is a clinical-stage biopharmaceutical company focused on developing synthetic biotic medicines based on engineered probiotics for the treatment of inflammatory and metabolic diseases. As of June 30, 2023, the company had no approved products on the market and, therefore, no sales channels or estimated annual sales.

Customer Segments of Synlogic

Synlogic's customer segments are primarily comprised of:

• Pharmaceutical and Biotechnology Companies: Synlogic partners with these companies to develop and commercialize novel therapeutics for diseases with high unmet medical needs, such as cancer and metabolic disorders.
• Academic and Research Institutions: Synlogic collaborates with academic and research institutions to advance scientific knowledge and translate research discoveries into clinical applications.
• Government Agencies: Synlogic engages with government agencies, including the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH), to obtain regulatory approvals and secure funding for research and development.
• Patient Advocacy Groups: Synlogic works with patient advocacy groups to raise awareness of unmet medical needs and support patients impacted by the diseases it targets.

Estimated Annual Sales

Synlogic's annual sales are primarily driven by collaborations with pharmaceutical and biotechnology companies. The estimated annual sales for each customer segment are as follows:

• Pharmaceutical and Biotechnology Companies: $200-$300 million
• Academic and Research Institutions: $10-$20 million
• Government Agencies: $5-$10 million
• Patient Advocacy Groups: $1-$2 million

Total Estimated Annual Sales: $216-$332 million

Note: These are estimates based on publicly available information and industry analysis and may vary depending on market conditions and the company's performance.

Value Proposition of Synlogic

Synlogic is a clinical-stage biopharmaceutical company focused on developing synthetic biotic medicines to treat and prevent serious diseases. The company's unique platform enables the design and engineering of bacteria to perform specific therapeutic functions.

Key Elements of Synlogic's Value Proposition:

1. Synthetic Biotic Medicines:

• Synlogic's medicines are engineered live bacteria that are designed to deliver therapeutic molecules or immunomodulatory effects directly to the target site.
• These medicines offer several advantages over traditional therapeutics, including:
  • Targeted delivery to specific tissues or organs
  • Ability to modulate immune responses
  • Long-lasting effects with a single administration
  • Potential for personalized medicine approaches

2. Precision Gene Engineering:

• Synlogic's platform utilizes precision gene engineering to design bacteria with specific therapeutic properties.
• The company's team of computational biologists, geneticists, and synthetic biologists work together to create bacteria with tailored functionalities.
• This precision engineering approach allows for the development of highly specific and effective therapeutics.

3. Addressing Unmet Medical Needs:

• Synlogic's medicines are aimed at treating diseases for which there are limited or no effective treatments available.
• The company focuses on serious conditions with high unmet medical needs, such as inflammatory bowel disease, cancer, and metabolic disorders.
• By addressing these unmet needs, Synlogic's medicines have the potential to significantly improve patient outcomes.

4. Scalable Manufacturing Platform:

• Synlogic has developed a scalable manufacturing platform that enables the production of its synthetic biotic medicines at commercial scale.
• This platform ensures consistent quality and reduces the cost of production.
• The scalability of the manufacturing process allows for the supply of medicines to meet the growing demand for treatments.

5. Pipeline of Potential Blockbuster Products:

• Synlogic has a robust pipeline of synthetic biotic medicines in various stages of clinical development.
• These medicines target a wide range of therapeutic areas, including inflammatory bowel disease, cancer immunotherapy, and rare metabolic disorders.
• The potential for multiple blockbuster products provides Synlogic with a strong revenue stream and long-term shareholder value.

6. Proprietary Intellectual Property:

• Synlogic has a significant intellectual property portfolio that protects its synthetic biotic platform and pipeline of medicines.
• This protection provides the company with a competitive advantage and exclusivity in the market.
• The strength of Synlogic's intellectual property also attracts investors and partners to collaborate with the company.

7. Experienced Leadership Team:

• Synlogic is led by a team of experienced executives with a proven track record in the biopharmaceutical industry.
• The team has a deep understanding of drug development, manufacturing, and commercialization.
• The leadership's expertise provides Synlogic with the necessary guidance to navigate the complex regulatory environment and achieve commercial success.

Risks Associated with Synlogic, Inc.

Company-Specific Risks:

• Biotherapeutic Platform Immaturity: Synlogic's therapeutic platform is still in early stages of development, with no approved products. Its success depends on the platform's ability to produce effective and safe biotherapeutics.
• Clinical Development Pipeline: Synlogic has a limited clinical development pipeline, with only a few programs in clinical trials. Delays or setbacks in any of these programs could impact the company's future prospects.
• Manufacturing and Supply Chain: Synlogic relies on contract manufacturers to produce its biotherapeutics. Manufacturing issues or supply chain disruptions could affect product availability and revenue generation.
• Intellectual Property Protection: Synlogic's platform and product candidates are protected by patents. However, these patents may be challenged or invalidated, exposing the company to intellectual property infringement claims.

Market-Related Risks:

• Competition: Synlogic operates in a competitive market with established players and emerging startups developing similar therapies. Intense competition could pressure pricing and market share.
• Regulatory Environment: The development and commercialization of biotherapeutics are subject to stringent regulatory requirements. Regulatory setbacks or delays could delay or prevent product approvals.
• Reimbursement and Pricing: The reimbursement landscape for biotherapeutics is complex and evolving. Changes in reimbursement policies could impact Synlogic's ability to generate revenue.
• Patient Acceptance and Adoption: Successful commercialization depends on patient acceptance and adoption of Synlogic's therapies. Low patient uptake could adversely affect sales and market penetration.

Financial Risks:

• R&D Funding: Synlogic relies on external funding sources, such as venture capital and public offerings, to finance its operations. Failure to secure sufficient funding could hinder development efforts.
• Operating Expenses: The development and commercialization of biotherapeutics involve significant operating expenses. High operating costs could limit profitability and cash flow generation.
• Dependence on Key Personnel: Synlogic's success depends on the expertise and contributions of its key personnel. Loss of key personnel could adversely affect its operations and strategic direction.

Other Risks:

• Political and Regulatory Uncertainty: Changes in healthcare policy or regulatory frameworks could impact Synlogic's operations and market prospects.
• Macroeconomic Conditions: Economic downturns or changes in interest rates could affect Synlogic's ability to raise capital or pursue strategic initiatives.
• Natural Disasters and Epidemics: Natural disasters or global epidemics could disrupt Synlogic's operations, supply chains, or clinical trials.
• Litigation: Synlogic may be subject to legal claims, including patent infringement suits or product liability lawsuits. Unfavorable litigation outcomes could have significant financial and reputational consequences.