Investors

Given the Increasing Societal and Fiscal Burden of Treating HF, GP531 has Exceptionally Favorable Market Characteristics:

  • Total Addressable Market – $20 billion to $40 billion annually in the US and other developed countries for chronic HF and ADHF;
  • Serviceable Market in US alone – ADHF – ~$5 billion annually for therapeutic treatment alone;
  • Projected $1 billion to $3 billion in annual revenues within 5-7 years of FDA approval for ADHF and a considerably higher revenue for an indication that includes chronic HF;
  • Global market potential – HF is a worldwide public health crisis.

Partnering with ViCardia Presents a Major Opportunity to Bring GP531 to Fruition

From the perspective of the hospital, physician, care-giver and the payor, the reduced number of hospitalizations and re-hospitalizations would have a positive benefit by reducing the overall cost of medical care.

Heart Failure is a Major Public Health Problem

  • Heart failure affects more than 5 million patients in the United States, and is the only category of cardiovascular diseases for which the prevalence, incidence, hospitalization rate, total burden of mortality have increased in the past 30 years.
  • Costs of treating heart failure patients have risen dramatically in the U.S. to more than $46 billion in 2019, approximately 70% of these costs are associated with CHF hospitalizations.
  • Hospitalization for acute heart failure (AHF) has risen dramatically having increased 170% from 400,000 in 1979 to nearly 1.2 million in in 2019. The in_hospital mortality of AHF is similar to that of an acute myocardial infarction, but the post_discharge mortality of a patient admitted for AHF is approximately five_fold higher. In addition, nearly 50% of acute heart failure patients will be readmitted to a hospital within three months.
  • Treatment strategies for AHF have been largely empirical, and limited by an incomplete understanding of its pathophysiology. Standard treatment regimens include diuretics, vasodilators, and inotropic agents to improve symptoms (dyspnea and fluid retention), but no treatment has been shown to improve outcomes (mortality and rehospitalization) of these patients. In fact, these therapies may contribute to a worsened prognosis.
  • Multiple pathways of myocardial injury appear to be implicated in a worsened prognosis for acute heart failure patients. Elevated serum troponin levels have been shown to correlate with a poor prognosis. Cellular hypoxia and activation of the renin_angiotensin, adrenergic, cytokine, and nitric oxide systems lead to cell death via both apoptosis and necrosis. Thus, limiting or preventing myocardial injury in these patients may improve long-term outcomes.

  • Adenosine, synthesized continually de novo in human and animal cells, is of fundamental importance not only as a nucleic acid (DNA, RNA) building block, but also as the backbone for the energy storage‐and‐use system of living cells (ATP) and as a regulator of biologic function, modulating adrenergic stimulation and inflammation. These latter effects are critical to the body’s natural defense against tissue oxygen‐deprivation damage or ischemia, leading to adenosine’s designation as the “retaliatory metabolite.”

Costs

HF hospitalizations remain the single most important driver of the estimated total direct and indirect cost of HF in the United States, amounting to an estimated $45.2 billion in 2019.
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Patient Diagnosed with Heart Failure

Initial Hospitalization

  • Hospital Stay: 6 Days
  • Mortality Rate: 4.1%

Hospital Readmission

  • Hospital Readmission at 30 Days: 20%
  • Hospital Readmission at 180 Days: 50%

Long-Term Mortality

  • Mortality at 30 Days: 11.6%
  • Mortality at One Year: 33.1%

Economic Burden

  • Direct and Indirect Costs in the United States (2019): $45.2 Billion
The staggering burden and severity of HF in spite of advanced medication and treatment options.

GP531 is a first-in-class treatment for heart failure addressing mitochondrial dysfunction, the underlying pathology in almost all cases of heart failure. Owing to this unique mechanism of action, GP531 will be the first heart failure therapy that may reverse progression of the disease, thus leading to improved life expectancy and lower hospital readmission rates.
Treating the Underlying Cause of Heart Failure
© ViCardia