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Quick Facts

It is projected that as many as 70 million people could die of tuberculosis over the next 3 decades.

Mission and Milestones

Mission: To develop and commercialize new more effective therapeutics for serious or life-threatening infectious diseases.




2013

Paige MacDonald, CPA, joins Sequella Board

Sequella acquires from Pfizer exclusive worldwide development and commercialization rights for all indications to new oxazolidinone, sutezolid, currently in clinical development for tuberculosis.

SQ641 selected as development lead for therapy of Clostridium. difficile infections from NIH/UVa/Sequella collaboration

First Patient dosed with SQ109 as part of multi-arm, multi-stage (MAMS) phase 2B clinical trial for drug sensitive TB in Africa

Lisa Beth Ferstenberg joins Sequella as Medical Director

Open-label clinical trial of SQ109 in Helicobacter pylori infections demonstrates reduction biomarker of infection, Urea Breath Test, in 14 days


2012

Kenneth R. Lynn, JD, joins Sequella Board
Closed $1,250,000 equity raise through the 2012 Maryland
   Biotechnology Tax Credit Program
Received NIH grants to:
    • evaluate SQ109 combinations with bedaquiline, a novel TB drug
      in development by J&J
    • develop B-SMART™ for TB
    • clinically evaluate SQ109 in H. pylori infections
Patents issue:
    • three U.S. patents on SQ109 methods and composition
    • two China patents on SQ109 methods and composition
    • three Japanese patents on SQ641 methods and composition
    • SQ609 patents on methods and composition in Eurasia and India
Initiated Phase 2a open-label study to evaluate SQ109
   in H. pylori infections
Licensed U.S. rights to B-SMART™ for rapid diagnosis of TB drug resistance
   to LabCorp (NYSE: LH)
Infectex, Sequella’s Russian corporate partner, enrolls first patients
   in pivotal clinical trial of SQ109 for MDR-TB
Sequella R&D collaborator, J&J, receives FDA accelerated approval
   for new MDR-TB drug bedaquiline
Cowen & Company estimates peak annual value of a new MDR-TB drug
   at $500 million

2011

John Friedman joins Board
Completed Phase 2A trial for SQ109
Raised $3.4 million in private capital
Infectex licenses SQ109 for Commercialization in Russia

Received $3.8 million NIH grant for C. difficile program

Manufactured clinical supply of SQ109
Thompson Reuters names SQ109 one of the most promising drugs
  entering phase 2


2010

Awarded $600k grant from NIH for development of SQ109 in MDR TB
Completed Phase 1 trial for SQ109
Initiated Phase 2 trial for SQ109 in tuberculosis
$2.2 million in private capital raised

Received FDA Go-Ahead for Phase 2 trial of SQ109 in H. pylori-associated
  Duodenal Ulcer Disease in Company's Second IND


2009

SQ109 Phase 1b clinical trial initiated
Awarded ARRA stimulus grant for finalization of manufacturing process for SQ109
Awarded $600k grant from NIH for investigation of SQ641 in non-TB indications
Raised $1.8M from equity sales in private placement financing



2008

Awarded $2.3M grant from NIH for development of lead capuramycin drug candidate, SQ641
Raised $2.5M from equity sales in private placement financing



2007

FDA grants Fast-Track designation to SQ109
SQ109 Phase 1a clinical trial completed
SQ109 receives European Union Orphan Product designation
TB STAT-PAK, a rapid lateral-flow serological test for TB for veterinary applications that Sequella licensed for Chembio Diagnostic Systems, is approved for marketing
U.S. Orphan Drug Status granted for SQ109
European Medicines Agency (EMEA) Orphan Drug Status granted for SQ109
Total Institutional and other investments including Maryland Department of Economic Development total $7.0M



2006

Hires VP of Finance, Marty Zug, MBA
Hires Chief Medical Officer and Head Regulatory Affairs, Gary Horwith, M.D.
NIH grants exclusive world-wide commercialization license to Sequella for SQ109 and related compounds
Raises $4.1 million from equity sales in private placement financing
Files first Investigational New Drug (IND) application with U.S. FDA for new diamine antibiotic SQ109



2005

Receives U.S. patent for TB Patch Diagnostic, and also granted nine ex-US country Patch patents
Receives U.S. patent for Therapeutic Diamine Anti-Infective Compounds(SQ109)
Raises $2.5 million in equity sales in private placement financing
Licenses out veterinary TB diagnostic to ChemBio, Inc.



2004

Sankyo Co., Ltd. grants exclusive worldwide license to commercialize new antibiotics
Initiation of clinical trials in South Africa for Patch diagnostic using recombinant protein



2003

Receives first (of 4) NIH Small Business Innovation Research Phase II grant ($1.0 million)
Receives first NIH U01 Biodefense Research grant ($1.6 million)
Hires EVP Business Development, Alan Klein, MBA



2001

Receive support from NCI/NIAID for development of novel second-generation drugs for Tuberculosis



2000

Awarded $1.2 million NIH Challenge Grant for discovery of new TB drugs
Japan BCG Laboratory grants exclusive world-wide license (excl. Japan) to diagnostic Patch Test for Active TB
Raises $400,000 in equity sales in private placement financing



1999

Carol A. Nacy, Ph.D., named CEO
Awarded first NIH Small Business Innovation Research Phase I grant
Signed CRADA with NIH to discover new TB drugs



1998

Hires first employee, Leo Einck, Ph.D., President
First Angel financing ($960,000)



1997

Incorporation in Delaware
First sale of common stock, Founders ($560,000)