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  • Serpin Pharma

  • Serpin Pharma, 9501 Discovery Blvd, Manassas, VA 20109, USA
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Serpin Pharma · SP16 Platform

SP16: First-in-Class LRP1 Agonist

A proprietary short peptide derived from Alpha-1 Antitrypsin (A1AT) that activates LRP1 — a master regulator of inflammation and cell repair. Controls disease-driving pathways without immunosuppression.
Patent-protected through 2042+ Three Phase 2 trials — Q2 2026 $50B–$80B+ market opportunity
SP16: A New Standard of Care
A synthetic short peptide that activates LRP1 to control critical disease-driving pathways, modulate harmful immune responses without immunosuppression, and promote cellular and tissue repair simultaneously.
SP16's Unique Mechanism
✓  Controls critical disease-driving pathways
✓  Modulates harmful immune responses — without immunosuppression
✓  Promotes cellular and tissue repair simultaneously
Acute Myocardial Infarction
Reperfusion Injury
• Phase 2 planned Q2 2026
• POC data in STEMI
Acute Kidney Injury
Cardiac Surgery Associated
• Phase 2 planned Q2 2026
• Renal protection focused
Cancer Pain (CIPN)
Chemo-Induced Neuropathy
• Licensed to Dogwood Therapeutics
• Phase 1b funded by NCI
Platform Expansion
Oral Analogs + Metabolic
• CKD, Heart Failure, Obesity
• Extending to chronic disease

The Problem: The Immunosuppression Trap

Current steroids and biologics often disable the immune system — leaving patients vulnerable to infection, opportunistic disease, and poor long-term outcomes. SP16 takes a completely new approach.
The Solution
SP16 —a synthetic 17 amino acid peptide derived from Alpha-1 Antitrypsin that activates LRP1, a master regulator of immune homeostasis.
Dual-Action Mechanism
Simultaneously inhibits pro-inflammatory NFκB signaling while activating Akt/ERK repair pathways —reducing harmful mediators while promoting healing.
Non-Immunosuppressive
Rebalances immune responses while preserving the body's natural ability to fight infection. No immunosuppression, no immunogenicity risk.
Universal Platform
SP16 is cell-type agnostic and injury-type agnostic —the same molecule works across AMI, AKI, neuropathic pain, skin disease, obesity, and more.
SP16 Platform

$50B – $80B+

Annual market opportunity across all acute, chronic & new indications
Acute & Chronic Indications (existing)
$9.7B
Acute kidney injury
No approved therapy exists
$9B
Heart failure
Chronic inflammation driver
$8B+
Chronic kidney disease
Massive global prevalence
$0.6B
Acute myocardial infarction
Acute cardioprotection
Autoimmune & Systemic — Oral
$30B+
Rheumatoid arthritis
Oral SP16 analog; systemic inflammation
$4B+
Lupus (SLE)
Oral SP16 analog; immune dysregulation
$22B+
Multiple sclerosis
Oral SP16 analog; neuroinflammation
Dermatology — Topical / Oral
$40B+
Psoriasis
Topical & oral SP16; inflammatory skin plaques
Allergy / Hypersensitivity — Inhaled / Oral / Topical
$22B+
Asthma
Type 2 & non-type 2 airway inflammation
$5B+
Eosinophilic esophagitis
Validated in Rothenberg / Cincinnati data
$13B+
Eczema (atopic dermatitis)
Topical & systemic; allergic inflammation
Musculoskeletal — Intra-Articular Injection
$15B+
Osteoarthritis
Intra-articular SP16; synovial inflammation & cartilage repair
mRNA-encoded SP16 patents also filed for chronic joint inflammation — enabling sustained intra-articular delivery without repeated injections.
SP16 = pipeline-within-a-product across acute, chronic & new indications
$50B – $80B+ TAM

Platform Highlights

First-in-Class
Only LRP1 agonist — no approved competing therapy exists.
17B–$30B+ TAM
Across AKI, Heart Failure, CKD, AMI, Obesity, AATD and more.
De-Risked
Phase 1 complete · Phase 2 trials launching Q2 2026.
Validated
Estée Lauder · Dogwood · Boehringer Ingelheim · NIH.
Protected
13 issued patents across 5 families through 2042.
Scalable
Synthetic peptide — unlimited supply at low COGS.
Serpin Pharma is defining the future of inflammation.
Actively seeking global and regional partners to expand SP16's reach across inflammation-driven diseases.
Cohava Gelber, PhD, MBA — CEO & Chairperson of the Board
cgelber@serpinpharma.com  ·  +1 (703) 343-3258  ·  serpinpharma.com
9501 Discovery Blvd. Suite #120 · Manassas, VA 20109
Watch the video to learn more

OG World-Class Leadership Team

A proven track record in anti-inflammatory drug development, backed by scientific advisors from Stanford, Cincinnati Children's, Yale, Johns Hopkins and more.
Cohava Gelber
Cohava Gelber, PhD, MBA
Founder, President & CEO
Larry Altstiel
Larry Altstiel, MD, PhD
Acting CMO & SAB Member
Dana Austin
Dana Austin, PhD
VP Research & Development
Mark Spear
Mark Spear, PhD
VP Discovery Research
Amit Hyzjyhu
Amit Hyzjyhu
VP Pharmaceutical Engineering
Dan Aitkens
Dan Aitkens, CPA
Acting CFO
Scientific Advisory Board
Antonio Gotto — Weill Cornell Lawrence Steinman — Stanford Marc Rothenberg — Cincinnati Children's Wendy Campana — UC San Diego Jack Arbiser — Emory / MetroDerm Jonathan Zenilman — Johns Hopkins Jerome Zeldis Alexander (Zan) Fleming Gordon Smith — VCU
Board of Directors
Cohava Gelber, PhD, MBA — CEO Denise Barbut, MD — Cornell University Alexander (Zan) Fleming, MD — FDA, Kinexum Lawrence Steinman, MD — Stanford William B. Johns, MBA — Healthcare Capital Corp.

Published Manuscripts

Peer-reviewed publications covering Serpin Pharma's technology — from foundational LRP1 biology to first-in-human clinical data.
Low-Density Lipoprotein Receptor–Related Protein-1 Is a Therapeutic Target in Acute Myocardial Infarction
JACC: Basic to Translational Science · October 2017
Low Density Lipoprotein Receptor-Related Protein-1 in Cardiac Inflammation and Infarct Healing
Frontiers in Cardiovascular Medicine · April 2019
A Phase 1 Clinical Trial of SP16, a First-in-Class Anti-Inflammatory LRP1 Agonist, in Healthy Volunteers
PLOS ONE · May 2021
α1-Antitrypsin Derived SP16 Peptide Demonstrates Efficacy in Rodent Models of Acute and Neuropathic Pain
The FASEB Journal · November 2022
Safety, Tolerability and Effects of a Single Subcutaneous Administration of SP16
Journal of Cardiovascular Pharmacology · July 2022
Anti-Inflammatory Therapy for Acute Coronary Syndromes
Journal of Cardiovascular Pharmacology · July 2022
Serpin-Derived Small Peptide (SP16) as a Potential Therapeutic Agent Against HIV-Induced Inflammation and Viral Replication in the CNS
Cells (MDPI) · February 2023

Mechanism of Action — LRP1 Agonism

• No other approved therapy targets the LRP1 pathway.
• Endocytic function clears DAMPs/PAMPs from the cell environment — upstream inflammasome regulation.
• Reduces harmful inflammatory mediators (IL-6, TNFα, IL-8, IL-1β).
• Increases resolving mediators (IL-10), cell survival and tissue regeneration.
SP16 Signaling Cascade
SP16 Binds LRP1 Receptor
▼
↓ NFκB Signaling  +  ↑ p-Akt / pERK
▼
↓ IL-6, TNFα, IL-8, IL-1β (pro-inflammatory)
▼
↑ IL-10 · Cell Survival · Tissue Regeneration
▼
Immune Balance Restored — Without Immunosuppression
SP16 LRP1 signaling diagram

Discovery of SP16

Discovery of SP16 as a Breakthrough in LRP1 agonism to safely target a root cause of inflammatory diseases
LRP1 binding domain of A1AT
Natural A1AT motif → modified SP16 pharmacophore
SP16 17 amino acid peptide
SP16 — 17 aa peptide

SP16 Wins Every Comparison

trophy InhibRx acquired by Sanofi for $2.2B (2024) — same target
Feature SP16 Platform Plasma-Derived A1AT Recombinant A1AT-Fc (InhibRx)
Potency 300x higher than natural A1AT Standard / compromised structure Complex size & structure
Administration Self-injected SC + oral/topical/mucosal (in dev.) 1–2 hour clinic infusion 1–2 hour infusion only
Administration Time Instantaneous (subcutaneous injection) Long (1–2 hours in clinic) 1–2 hours
Supply / COGS Unlimited synthetic supply, low cost Scarce — extracted from plasma High complexity; yield TBD
Safety No immunosuppression risk Risks from plasma-derived products Immunogenicity (Fc portion)
IP Position Patented through 2042 Off patent Patented
Mfg. Complexity Low High High

Proof of Concept Already In Hand

Phase 1 — Healthy Volunteers
Published in PLOS ONE (2021) — First-in-Class LRP1 Agonist
✓ Safe and well-tolerated at all dose levels
✓ No serious adverse events at any dose
✓ Favorable pharmacokinetic profile
✓ Dose-dependent plasma exposure confirmed
Cleared — Phase 2 Ready Across Multiple Indications
Phase 2 — STEMI / AMI Trial
n=10 SP16 vs. n=28 historical placebo control
• Significantly lowered CRP (p=0.0147)
• Reduced CK-MB (infarct-size surrogate)
• Preserved LV ejection fraction at 1 year
• Significant reduction in heart-failure events
0%
SP16 hospitalization rate
26%
Placebo hospitalization rate

SP16 Prevents Diet-Induced Cardiac Dysfunction (HFpEF/HFrEF)

In collaboration with Drs. Antonio Abbate and Stefano Toldo (VCU Health) — SP16 demonstrated strong cardioprotection in obese mouse models.
Study Design
Western Diet (high fat/sugar) for 4 weeks → glucose intolerance & obesity
Then 4 additional weeks: WD alone, WD + SP16 (4µg/mouse), or WD + scrambled control (SP34)
Endpoints: body weight, fasting glucose, oral glucose tolerance, echocardiography
AMI induced: infarct size measured after 30 min ischemia + 24h reperfusion
Cardiac Function Rescued
SP16 reversed obesity-induced worsening of ejection fraction, myocardial performance index, and isovolumetric relaxation time. Scrambled control (SP34) was ineffective.
Infarct Size Reduced
Chronic low-dose SP16 significantly reduced infarct size in obese mice. Acute high-dose SP16 at reperfusion also effective. SP34 showed no protective effect.
HFpEF & HFrEF Relevance
Addresses unmet need where current therapies show limited benefit. SP16's dual anti-inflammatory + regenerative mechanism uniquely targets both HFpEF and HFrEF populations.
Key Insight: LRP1 agonists uniquely target both inflammation and tissue repair — positioning SP16 as a novel therapy for HFpEF and HFrEF populations.
Emerging Opportunity
SP16 in Obesity & Metabolic Disease
Boehringer Ingelheim scientists independently validated SP16 as a novel GIP receptor agonist with broad metabolic benefits — opening an entirely new strategic dimension for the platform.
Novel GIPR Agonist
SP16 drives lipolysis via cAMP in human adipocytes, increasing free fatty acids. Boosts mitochondrial oxygen consumption via β-oxidation, improving energy expenditure.
Proven in Obese Mice
A single SC dose of SP16 in diet-induced obese (DIO) mice improved glucose clearance dose-dependently. Significantly reduced glucose AUC, elevated FFAs, and reduced leptin.
Complements GLP-1
While GLP-1/GIP drugs suppress appetite, SP16 restores adipocyte metabolic function and reduces chronic adipose inflammation — a differentiated, synergistic mechanism.
Dual Pathway Action
Targets both metabolic inflexibility (cAMP↑, lipolysis↑, glucose tolerance↑) AND chronic adipose inflammation via LRP1-mediated resolution signaling.
bioRxiv 2025 — Boehringer Ingelheim Research · doi:10.1101/2025.06.17.660082

Alpha-1-Antitrypsin Deficiency (AATD) — An Emerging Indication

AATD is a genetic disorder where a nonfunctional, toxic variant of A1AT accumulates in the liver — causing cell damage and loss of lung-protective function. Over 40% of AATD patients develop COPD.
The Problem in AATD
A1AT is not produced in sufficient amounts, resulting in unchecked neutrophil elastase (NE) activity. This drives chronic inflammation, tissue damage, and loss of lung function.
SP16 Does NOT Need Protease Activity
SP16 and LRP1-derived analogs don't retain A1AT's protease-inhibitor activity — but are far more potent anti-inflammatory molecules via direct LRP1 agonism.
Preclinical Data Confirms
In OVA-challenged mice and human esophageal epithelial cells, SP16 and LRP1 agonist peptides significantly reduced inflammatory cytokines (TSLP, IL-1α) — protease inhibition not required.
Oral Delivery Advantage
Oral LRP1 agonist dosage forms are in development, avoiding the invasive weekly IV infusions required by current A1AT replacement therapies (Baxter, Grifols, CSL Behring).
  A1AT Replacement Therapy LRP1 Agonist (SP16)
Route Intravenous (weekly–monthly) Oral (daily) — in development
LRP1-Binding Indirect (NE:A1AT complex) Direct — far more potent
Inflammation ↓ (modest) ↓↓↓ (highly potent)
Tissue Repair ↑ (limited) ↑↑↑ (strong regenerative effect)

RL-Series: Next-Generation Orally Available Analogs

Optimized design for chronic disease — shorter peptides retaining the active LRP1-binding pharmacophore with improved potency, stability, and oral bioavailability.
20–50x Increased Potency
SP16 analogs show dramatically improved NFκB inhibition in reporter assays. Best analogs (RL5B, RL2-5) have IC50 of 1.17–1.46 μg/mL vs SP16 at 47.1 μg/mL.
Oral Bioavailability ≥7%
Lead cyclic and linear analogs demonstrate oral bioavailability exceeding bioactivity thresholds — enabling daily oral dosing for chronic indications.
Zero Toxicity
A1AT-derived analogs mimic SP16's anti-inflammatory activity across monocytic and microglial cells with no cytotoxicity at tested concentrations.
Format Flexibility
Short 8–10 mer peptides maintain the precise LRP1 pharmacophore. Improved solubility enables broad formulation options: oral, topical, injectable.
Selected Analog IC50 Comparison (NFκB inhibition — lower = more potent)
47.1 μg/mL
 
SP16 (Parent)
1.46 μg/mL
 
RL2-5 (Cyclic)
1.17 μg/mL
 
RL5B (Linear)
5.05 μg/mL
 
RL1-15 (Cyclic)
1.41 μg/mL
 
RL5A (Linear)
3.77 μg/mL
 
RL3-14 (Cyclic)

Validated Across Independent Premier Institutions

Therapeutic activity of SP16 has been demonstrated across multiple disease models by independent researchers — because inflammation is at the core of so many diseases, and SP16 is agnostic to injury and cell type.
Inflammation is at the core of many different diseases
SP16 targets natural pathways of inflammatory diseases
Agnostic to injury or cell type — a universal solution
The scientific basis of SP16 activity is strong
University of Virginia UC San Diego Cincinnati Children's Yale University Uniklinikum Erlangen Florida International University Virginia Tech
  • Investment Type: BioTech
  • Offering Type: Reg D 506c
  • Funding Goal: $20,000,000
  • Initial Amount Raised: $0
  • Minimum Investment Amount: $25,000
CAPITAL STACK

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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.
 

Project Title Document Title Action
Serpin Pharma Serpin Pharma Corp PPP-Aug 23 2024 View
Serpin Pharma Stock Restriction Agreement View
Serpin Pharma Estée Lauder partnership Serpin Pharma View

A Broad & De-Risked Pipeline

SP16 is a pipeline-within-a-product: one molecule advancing across acute, chronic, and consumer-health indications, supported by academic, clinical and commercial partners.
Program Indication Format Stage Partner
SP16 Acute Kidney Injury (AKI) Injectable Peptide PHASE 2 FAU Erlangen-Nürnberg
SP16 Acute Myocardial Infarction (AMI) Injectable Peptide PHASE 2 BIRD / Sheba Medical Center
SP16 Cancer Pain — CIPN Injectable (IV) LICENSED Dogwood Therapeutics + NCI
SP16 Severe Skin Disease Topical / Injectable PHASE 2 READY MetroDerm
RL-Series CKD, Heart Failure Oral Cyclic Peptide Analogs PRECLINICAL Open for Partnering
AT3 Skincare / Anti-Aging Natural Peptide LICENSED Estée Lauder Companies

Marquee Partners Validate the Platform

Partnerships provide external validation of the technology, non-dilutive capital to fund clinical programs, and proven operational expertise.
Exclusive License
Estée Lauder
Consumer Health
Exclusive partnership to develop anti-aging and regenerative skincare using Serpin's natural AT3 peptide portfolio. Serpin received an upfront cash payment plus eligibility for future milestone payments.
Licensed + NCI Funded
Dogwood Therapeutics
Therapeutics
Full upfront payment in unrestricted DWTX stock for the SP16 IV license in CIPN. Phase 1b funded by NCI launching Q2 2026. Dogwood brings a proven regulatory and clinical execution track record.
Active Trials
Academic & Clinical Network
Independent validation
FAU Erlangen-Nürnberg (AKI) · Sheba Medical Center (AMI) · MetroDerm (Skin) · University of Virginia · Yale · UC San Diego · Cincinnati Children's · Virginia Tech.

Fortified Intellectual Property Portfolio

13
Patents Issued
16
Total Applications
5
Patent Families
2042
Longest Patent Life
SP16 (AT3) — Natural Sequence · Filed 2011 & 2022
Foundation patents on the natural A1AT amino-acid motif and its anti-inflammatory uses. Wholly owned by Serpin Pharma.
SP16-3M — Modified LRP1 Agonist · First expiry 2035
Core pharmaceutical asset with enhanced LRP1-affinity modifications — 300x potency vs natural A1AT.
RL-Series — Next-Gen Oral Analogs · First expiry 2042
Shorter cyclic and linear analogs with extensive modifications outside the binding motif. Oral bioavailability ≥7%; 20–50x potency increase.
mRNA-Encoded SP16 & Topicals · Expansion
Long-lasting SP16 expression for osteoarthritis and chronic conditions; plus SP16-impregnated patches, films and wound dressings (partnered with MetroDerm).
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TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL SERPIN AND ITS SERVICE PROVIDERS, LICENSORS OR SUPPLIERS BE LIABLE FOR ANY DIRECT, INDIRECT, PUNITIVE, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY OR OTHER TYPE OF DAMAGES, INCLUDING WITHOUT LIMITATION DAMAGES FOR COVER OR LOSS OF USE, DATA, REVENUE OR PROFITS, ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OR PERFORMANCE OF THE SITE, WITH THE DELAY OR INABILITY TO USE THE SITE, OR FOR ANY CONTENT, OR OTHERWISE ARISING OUT OF THE USE OF THE SITE, WHETHER BASED ON CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, THE FAILURE OF ANY LIMITED REMEDY TO ACHIEVE ITS ESSENTIAL PURPOSE, OR OTHERWISE, EVEN IF SERPIN OR ANY OF SERPIN?S SUPPLIERS HAS BEEN ADVISED OF THE POSSIBILITY OF DAMAGES. BECAUSE SOME STATES/JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY TO YOU.

IF, NOTWITHSTANDING THE OTHER TERMS OF THIS AGREEMENT, SERPIN IS DETERMINED TO HAVE ANY LIABILITY TO YOU OR ANY THIRD PARTY FOR ANY LOSS, HARM OR DAMAGE, YOU AGREE THAT THE AGGREGATE LIABILITY OF SERPIN AND ITS OFFICERS, DIRECTORS, MANAGERS, EMPLOYEES, AFFILIATES, AGENTS, CONTRACTORS, SERVICE PROVIDERS, LICENSORS OR SUPPLIERS SHALL IN ALL CASES BE LIMITED TO ONE HUNDRED US DOLLARS.

FOR PURPOSES OF DISCLAIMER AND LIMITATION OF LIABILITY SECTIONS, ?SERPIN? SHALL INCLUDE ITS DIVISIONS, SUBSIDIARIES, SUCCESSORS, AND THEIR EMPLOYEES, PARTNERS, PRINCIPALS, AGENTS AND REPRESENTATIVES, AND ANY THIRD-PARTY PROVIDERS OR SOURCES OF INFORMATION OR DATA.

8. INDEMNIFICATION

You understand and agree that you are personally responsible for your behavior on the website. You agree to indemnify, defend and hold harmless Serpin, its parent companies, subsidiaries, affiliated companies, joint venturers, business partners, licensors, employees, agents, and any third-party information providers from and against all claims, losses, expenses, damages and costs (including, but not limited to, direct, incidental, consequential, exemplary and indirect damages), and reasonable attorneys? fees, resulting from or arising out of your use, misuse, or inability to use the Site or the Content, or any violation by you of these Terms of Use.

9. ADDITIONAL TERMS OF SERVICE

If you are a customer of Serpin or an employee, representative or agent of a Serpin customer, your purchase and use of Serpin products and services are subject to separate written agreements.

10. GENERAL PROVISIONS

  • Entire Agreement/No Waiver. These Terms of Use constitute the entire agreement of the parties with respect to the subject matter hereof. No waiver by Serpin of any breach or default hereunder shall be deemed to be a waiver of any preceding or subsequent breach or default.
  • Correction of Errors and Inaccuracies. The Content may contain errors and may not be complete or current. Serpin reserves the right, but assumes no duty, to correct any errors, inaccuracies or omissions or to update the Content at any time. Serpin does not warrant that any errors, inaccuracies or omissions will be corrected.
  • Enforcement/ Choice of Law/ Choice of Forum. If any part of these Terms of Use is determined by a court of competent jurisdiction to be invalid or unenforceable, it will not impact any other provision of these Terms of Use, all of which will remain in full force and effect. Any and all disputes relating to these Terms of Use, Serpin?s Privacy Notice, your use of the Site, any other Serpin website or the Content are governed by, and will be interpreted in accordance with, the laws of the Commonwealth of Virginia, without regard to any conflict of laws provisions. You agree to the sole and exclusive jurisdiction and venue of the federal or state courts in the Commonwealth of Virginia in the event of any dispute of any kind

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$269,000 raised of $20,000,000 goal

Investment Summary

  • Deal Type: Investment
  • Sponsor: Serpin Pharma
  • Hold Period: 4 YR.
  • Investor Yield: 12
  • Funding Goal:$20,000,000
  • Investment Type: BioTech
  • Min. Investment: $25,000

  • Offering Memorandum Document

  • Video Gallery

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