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Serpin Pharma
Serpin Pharma, 9501 Discovery Blvd, Manassas, VA 20109, USA

Overview
Science
Our Story
Our Team
Pipeline
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Terms

By selectively isolating a key portion of a natural SERPIN protein, our targeted therapeutic, known as SP16, restores balance to harmful inflammatory environments, creating an entirely new class of therapeutics for unmet medical needs.

Targeted

SP16 uses a selective and precise mechanism to restore inflammatory equilibrium, with no known adverse effects.

Potent

In AMI, a single SP16 injection preserved heart function, reduced infarcts, and decreased biomarkers of cardiac injury.

Balancing

SP16 targets a receptor that restores homeostatic balance to cells experiencing inflammation.

Serpin Pharma’s patent estate includes 14 patent applications

13 patents out of 14 patent applications have been approved

IP covers Composition of Matter as well as the Use of SERPIN Peptide Drug and Analogs
SP16 is a fragment of a natural molecule (currently a plasma derived generic drug) with a ⁣modification to the sequence that yielded an enhanced affinity to the LRP1 receptor (expiration 2041)
SP16 analogs are shorter peptide drugs molded on SP16 with extensive modifications outside of the binding motif

Global Anti-Inflammatory Therapeutics Market to Reach $130.9 Billion by 2026

“One of the most important medical discoveries of the past two decades has been the realization that the immune system and inflammatory processes are involved in not just a few select disorders, but a wide variety of mental and physical health problems that dominate present-day morbidity and mortality worldwide.”

Team

Management and Board

Cohava Gelber, PhD, MBA

Founder, Executive Chairperson, & CEO

Larry Douglas Altstiel, MD, PhD

Acting CMO

David Dove, MD, MBA

Board Member

John H Abeles, MD

Acting CMO

Guy Yachin, MBA

Board Member

Alexander Fleming, MD

Board Member

Dan Aitkens, CPA

Acting CFO

Scientific Advisory Board

Alexander Fleming, MD

Chair of Scientific Advisory Board

Larry Douglas Altstiel, MD, PhD

Scientific Advisory Board Member

Wendy Campana, PhD

Scientific Advisory Board Member

Antonio Gotto, MD, PhD

Scientific Advisory Board Member

Marc Rothenberg, MD, PhD

Scientific Advisory Board Member

Gordon Smith MD

Scientific Advisory Board Member

Lawrence Steinmann, MD

Scientific Advisory Board Member

Jerome (“Jerry) Zeldis, MD, PhD

Scientific Advisory Board Member

Jonathan Zenilman, MD

Scientific Advisory Board Member

Emanuel Petricoin III, PhD

Scientific Advisory Board Member

Science

Introducing a targeted, potent, immune-balancing therapeutic.

The Science

By isolating the active portion of AAT, we’ve created a small, selective, and highly-potent therapeutic called SP16. When SP16 activates LRP1, it resolves inflammation in three important ways:

1. Harmful inflammatory triggers are removed from the cell surface.

2. Key survival pathways such as ERK and AKT become activated, increasing cell resilience.

3. And pro-inflammatory pathways like NFkB become deactivated, thereby balancing cytokine output.

What Makes SP16 a Breakthrough Solution?

When the body’s immune response is activated due to disease or injury, inflammation is produced to eliminate the threat. However, too much inflammation can harm the body’s own cells, inducing further damage and distress. Current therapies (including cytokine blockers and steroids) focus on reducing this inflammation, yet in doing so they inhibit the body’s natural immune response, which is essential for complete healing.

Serpin Pharma identified the need for an anti-inflammatory therapeutic that works with, not against, the body’s innate immune response.

By improving on a naturally occurring immunomodulatory protein and targeting a receptor that restores homeostasis to the cell, Serpin Pharma has created a therapeutic that is targeted, potent, and immune balancing.

Our therapeutic, known as SP16, stimulates the body’s innate mechanism for inflammation management. When SP16 binds to the homeostatic receptor LRP1, harmful molecules and pathogens are cleared from the cell surface, and pathways associated with inflammation and cell death become less active. As a result, treatment with SP16 reduces the progression of inflammation before it can reach dangerous levels, such as the “cytokine storm” that has been observed in critical COVID-19 patients. Not only does SP16 prevent cell death, but it actively works towards cell and tissue repair by promoting key proliferative/protective pathways (such as ERK/AKT). In this way, SP16 represents a new class of therapeutics for the treatment of inflammatory diseases.

Our Research Story

In the past few decades, scientists have grown increasingly interested in the therapeutic potential of Serine Protease Inhibitors (SERPINs). Most studies have focused on their anti-protease activity. However, at Serpin Pharma, we were uniquely interested in the SERPINs’ anti-inflammatory and immunoregulatory properties.

We developed SP16 from a classic SERPIN protein called AAT, which is known to be involved in reducing inflammation as well as promoting wound healing and tissue repair. To improve on AAT’s anti-inflammatory activity, we selectively removed portions of the molecule responsible for protease inhibition, as well as those involved in promoting inflammation.

The result? A small, highly selective, peptide therapeutic that is 300 times more potent than its natural counterpart.

Other advantages of SP16 are its safety; moreover, it is not isolated from plasma, which also makes it highly cost-effective to produce. Clinical trials thus far have shown no off-target effects associated with SP16 treatment.

Serpin Pharma currently holds thirteen strong patents concerning the Composition of Matter and Method of Use for its pipeline technologies.

Financial Snapshot

CAPITAL STACK

Total

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Documents

Project Title	Document Title	Action
Serpin Pharma	Corporate PPP 2024	View
Serpin Pharma	Stock Restriction Agreement	View
Serpin Pharma	Estée Lauder partnership Serpin Pharma	View

Pipeline

A revolutionary therapeutic to enhance the body’s natural immune response.

Pipeline: Target Indications for SP16

Clinical Programs

Acute Kidney Injury following cardiac surgery
Chemotherapy-Induced Peripheral Neuropathy
Inflammatory Skin Diseases (Atopic Dermatitis, Shingles, Alopecia Areata, Pemphigus Vulgaris)

Proceeding with strategic partnership

Acute Myocardial Infarction (AMI)
Acute Lung Injury
Eosinophilic Esophagitis (EoE)

Inflammatory diseases are affecting close to 60 million individuals in the U.S. alone. SP16 is positioned as the next generation therapeutic to address this unmet need.

Unlike existing treatments, which suppress the immune response, SP16 enhances the body’s innate mechanism for resolving inflammation. Our therapeutic restores immune balance by targeting a receptor that plays a key role in mitigating inflammation. This platform technology has the potential to treat a wide range of inflammatory diseases.

Orphan indications

Eosinophilic Esophagitis (EoE)

Eosinophilic Esophagitis (EoE) results from allergen-induced inflammation of the throat. It is an orphan indication with limited treatment options. In the U.S., an estimated 150,000 patients (largely children) suffer from this disorder.

In preclinical models, SP16 was shown to:

Control clinically significant drivers of allergic inflammation, including TSLP and TH2 associated cytokines
Significantly reduce eosinophil infiltration at the site of injury
Mediate clinically validated cell signaling pathways (JAK/STAT)
Provide a convenient delivery method

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare disorder characterized by inflammation of the nerves, leading to chronic pain, weakness, numbness, and loss of function in the affected area(s). Current treatments have negative side effects and are not ideal for long-term use. The CIPD market value is anticipated to reach 3.9 billion USD by 2023.

In preclinical models, SP16 was shown to:

Alleviate neuropathic pain
Reduce inflammation at the site of nerve injury
Improve nerve survival, growth, and regenerative signaling

Pemphigus Vulgaris

Pemphigus vulgaris and pemphigoid skin diseases are rare, life-threatening autoimmune disorders characterized by painful blistering of the body’s mucous membranes, including those in the nose, mouth, and throat. The current standards of care often fail to control pain and cause adverse effects with long-term use. By 2026, the inflammatory skin disease treatment market is estimated at 23 billion USD.

Well-aligned with currently understood driving forces of the disease, SP16 has the potential to:

Reduce acute inflammation and pain
Provide a treatment option with little to no side effects
Prevent secondary infections of blisters (a common and serious complication)
Accelerate healing, potentially minimizing the blister associated with tissue damage

Acute indications

Acute Myocardial Infarction (AMI)

Acute myocardial infarction (AMI), also known as a heart attack, invokes an intense inflammatory response which increases heart damage and prolongs recovery. High levels of cardiac inflammation are associated with severe complications, including heart failure. The heart failure market is expected to grow to $22.1 billion by 2028 at a compound annual growth rate of 19.5%.

In a Phase 2a clinical trial, a single dose of SP16 was shown to:

Reduce biomarkers of infarct size
Reduce overall inflammation
Improve long-term heart function (one-year post-treatment)

Acute Lung Injury

Acute Lung Injury (ALI) and acute respiratory distress syndrome (ARDS) are life-threatening respiratory disorders associated with an uncontrolled inflammatory response. Severe respiratory inflammation is a critical hallmark of COVID-19 infection.

In preclinical models, SP16 was shown to:

Increase survival and reduce cytokine levels (comparable to the corticosteroid dexamethasone)
Have bioavailability in the lung following parenteral administration
Reduce key mediators needed for viral entry and spread
Have broad-spectrum of anti-viral effects (including SARS-CoV-2, the virus that causes COVID-19, and other emerging infectious diseases)

Clinical trials to determine the safety and ability of SP16 to lower inflammation in hospitalized patients with COVID-19 are currently underway.

Acute Kidney Injury

Acute Kidney Injury (AKI) is defined as loss of kidney function and is a large risk factor of heart surgery. Cardiac-surgery-associated AKI is further associated with other adverse outcomes, including chronic kidney disease (CKD) and death. The AKI market is projected to reach US $31.6 billion by 2025.

In preclinical models, SP16 was shown to:

Protect kidney cells from hypoxic induced damage
Reduce inflammatory mediated cellular responses in kidney cells

Chronic Indications

Atopic Dermatitis

Atopic Dermatitis (AD), also known as eczema, is the most prevalent inflammatory skin disease in humans. Although mild cases can be managed by current treatment options, advanced AD is only treated by medications with severe side effects.

In preclinical models, SP16 was shown to:

Inhibit the specific immune responses that activate the inflammatory cascade in the skin
Reduce mediators that cause pruritis (itchy skin) (TSLP)
Significantly reduce eosinophil infiltration in the skin
Provide a convenient topical delivery option
Accelerate the healing of damaged skin as shown in cutaneous wound model

Alopecia Areata

Alopecia Areata (AA) is an autoimmune disease that targets the body’s hair follicles, resulting in hair loss. There are currently no FDA-approved treatments for moderate to severe disease states. The market size for AA treatment is estimated at approximately $1.7 billion USD by 2028.

Well-aligned with currently understood driving forces of the disease, SP16 has the potential to:

Realign TH1/TH2 immune imbalances and increase levels of crucial anti-inflammatory cytokines
Mediate clinically significant signaling pathways in epithelial cells
Promote pathways that play a crucial role in de novo hair follicle regeneration

Our Story

Our journey:
Changing the future of inflammatory diseases

Our Story

Our story began with a team of scientists and visionaries looking to tackle one of healthcare’s greatest unmet needs: inflammatory diseases. When we recognized the potential for SERPIN proteins to mitigate these conditions, we committed to developing a first-in-class therapeutic to restore immune balance to harmful inflammatory environments.

Our therapeutic, now known as SP16, is currently undergoing pre-clinical and clinical trials for a broad span of orphan, chronic, and acute indications. We are currently collaborating with leaders across diverse fields of research to deliver our technology to the patients who need it most.

We believe that Serpin Pharma’s therapeutics are poised to shift the inflammatory disease landscape and provide lifelong solutions for a broad patient population.

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Investment Summary

Deal Type: Investment
Sponsor: Serpin Pharma
Hold Period: 4 YR.
Funding Goal:$20,000,000
Investment Type: BioTech
Min. Investment: $8,410
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Documents

Corporate PPP 2024

Stock Restriction Agreement

Estée Lauder partnership Serpin Pharma

Contact Investor Relations