Plakous

Contact: Robert Boyce, CEO
Address: 755 Highland Oaks Dr, Suite 103, Winston-Salem, NC 27103
Phone: 908-625-3295
Email: [email protected]
Website: plakoustherapeutics.com

Management

Robert Boyce, CEO, J&J, Third Start-up (MTI, Imago Systems)

Scott Washburn, MD, Founder, CMO, Lyndhurst Gynecologic, Founder Birth Tissue Recovery

Juliana Blum, PhD, COO, Founder and CCO Humacyte

Key Advisors/Board Members

Bill Carey, MD, Neonatologist, Head of Research Mayo Clinic

Peter Johnson, MD, Board Member

James Kalinovich, Board Member

Alison London Brown, Board Member

Cami Martin, MD, Neonatologist, Head of Neonatology Cornell Weill

Lucas Neff, MD, Pediatric Surgeon Wake Forest

Industry

Life Sciences-Biotechnology

Year Founded

2016

Number of Employees

FT: 3
PT: 2
Contractors: 4

Bank

PNC, SVB

Law Firm

Kilpatrick, Townsend, Stockton

Current Investors

$4.5M in convertible notes

Mayo Clinic Ventures, HNW Private Investors, and Personal Funds.

$2.0M in non-dilutive grant funding from NIH

Monthly Burn Rate

$60K

Financing Sought

$10.0M

Use of Funds

30% Research & Development
50% Manufacturing
10% Salaries and SG&A
10% Regulatory/Legal/Other

Business Description

Plakous Therapeutics is a pre-clinical stage biotech company developing a patented biotherapeutic for the prevention of the rare pediatric disease, Necrotizing Enterocolitis (NEC), a devastating, runaway inflammatory disease of the bowel and a follow-on indication for osteoarthritis (OA). We have generated compelling preclinical data for both conditions, but the unmet medical need and the regulatory efficiencies of NEC as a rare pediatric disease have led us to prioritize the NEC development effort.

Company Background

Plakous was founded by Dr. Scott Washburn, an Ob/Gyn physician in Winston-Salem who formerly founded a birth tissue bank and conceived of the human placental extract product as a byproduct of the portion of birth tissue that was unutilized by his client base. Realizing the untapped potential of placental tissue, he spun Plakous out of Birth Tissue Recovery along with all his IP.

Problem/Solution

Severely premature babies lose their exposure to life giving amniotic fluid before their gastrointestinal systems have had a chance to fully develop. Every year 50,000 Very Low Birth Weight babies are born. 3,000 of these babies go on to develop NEC. One in three of these babies will die. Plakous can change that. Our patented product provides these babies with the regenerative proteins that were supplied by amniotic fluid during pregnancy. Our product will allow their bowel development to continue and eliminate the risk of developing NEC. Aside from saving these precious lives, Plakous can save Neonatal Intensive Care Units (NICU) and hospitals $4 billion in NICU and NEC related costs.

Products/Services

The placenta orchestrates and sustains the transformation of a fertilized egg into a baby during pregnancy. After birth, Plakous extracts the placenta’s active proteins and is developing cell free biotherapeutics for tissue healing and regeneration. Our placental derived platform product is Protego-PD™. The consistent, high concentrations of growth factors, scalable manufacturing, high yields per tissue, and no ethical concerns with tissue collection give Protego-PD advantages over other biologics in development and clinical use. Protego-PD will be a terminally sterilized, shelf-stable crystalline powder allowing seamless integration into NICU standard of care.

Markets
After completing clinical trials and receiving FDA approval to market, we will focus on treating the 50,000 at risk severely premature babies born annually in the US. We will then pursue approvals to market in the rest of the world.
Competition

There are currently no FDA approved products for NEC. We are aware of two companies developing potential treatments. One is a probiotic which is a controversial therapy, and the other is cell derived and has manufacturing/scaling and cost challenges.

Business Model and Distribution Channels

We will leverage our clinical data and labeling to market our product to NICU facilities. Given the limited number of hospitals and a shelf stable product Plakous will hope to sell direct to hospitals. The strong health economic story supports rapid and comprehensive reimbursement coverage.