The Significance of Databases for PAH - MD Magazine

The Significance of Databases for PAH - MD Magazine


The Significance of Databases for PAH - MD Magazine

Posted: 30 May 2019 05:30 AM PDT

Patients who present with symptoms of pulmonary arterial hypertension could land on any spot of a spectrum which indicates minimal to significant risk of comorbidities, and even mortality. The uncommon, burdensome condition often requires that patients are receiving optimized therapy early and aggressively following diagnosis.

That puts pressure on investigators to broaden their access to clinical data. In an interview with MD Magazine®, Rich Channick, MD, director of the Acute and Thromboembolic Disease Program at the UCLA Medical Center, and Prof. Sean Gaine, director of the National Pulmonary Hypertension Unit in Ireland, explained the utility of national, international registries of PAH patients, and how it influences their ability to identify low- and high-risk patients.

MD Mag: How critical are broad database in assessing care of patients with a rare, chronic condition such as PAH?

Channick: Yeah, I mean there's a lot of creative ways to get data. A lot of people are using claims data, insurance claims, instead of getting a big data. You can find a lot of patience. And now with coding, diagnostic codes, you look at pulmonary hypertension as a code for an insurance claim.

Obviously, there's a lot of different insurance companies. It's different in other countries, but you can really then look at different testing that has been done, what drugs are getting used, and patterns of use. You often can't get very granular, as we say, a higher view. But you can look at it a lot of patients.

Gaine: Yeah, in fact, we saw it at our session today, that we were presenting the GRIPHON data from the VA (Veterans Affairs). So the VA is an enormous database, and patients who attend VA have pulmonary hypertension—some of them—and you can gather data from there. So there are those are national registries that we pour through, not just registries from drug trials and seeing how patients are using them, but the national registries. And we learn a lot from them.

We've learned in the last few years that PAH as a disease seems to be sort of shifting—or at least what we're seeing is older patients that we wouldn't have seen previously. So we have to reset where to look for the disease. We used to say, "Oh, this is a disease of idiopathaty from the arterial hypertension." Formerly, primary pulmonary hypertension was a disease in young women in their mid-30s. So you knew where to look, in the sense of when a young woman arrived in breathless. You thought, this is unusual, maybe it's primary pulmonary hypertension, maybe it's idiopathic pulmonary hypertension.

Now we've learned from these registries that it's not necessarily always the case. You may have a 55 year old person who comes in says, "I'm breathless." You're thinking, well you're not doing any exercise, that's why you're breathless. But, in fact—normal pulmonary function, normal chest, X-ray, ECG. They need to go for an echo, and the echo is the number 1 screening tool to see if a person has problems with the right ventricle. So again, in primary care, someone comes in and it just doesn't fit, think of an echo as a really valuable screening tool.

Channick: Yeah, the last thing I'd say about registries—especially all the registries in Europe and elsewhere—is they have allowed us to start to look at things like risk stratification. One of the big mantras in pulmonary hypertension is determining what risk category are patients in, based on composite parameters—coming up with scores where we can actually profile a patient.

And when you treat a patient with these therapies, they determine whether they are into what we call the low-risk category, meaning they'll have a good prognosis. We quantify that. So, these registries have really allowed us both to develop some of these scores, and then validate them to show that it actually are predictive.

And that's really how we're treating. We have the GRIPHON subgroup to really look at the ability of the agent to lower risk, to put people into a low-risk category—that's really important in our treatment.

Bellerophon Therapeutics Inc. (BLPH)'s Financial Results Comparing With Cleveland BioLabs Inc. (NASDAQ:CBLI) - The EN Herald

Posted: 22 May 2019 05:50 AM PDT

We will be contrasting the differences between Bellerophon Therapeutics Inc. (NASDAQ:BLPH) and Cleveland BioLabs Inc. (NASDAQ:CBLI) as far as dividends, analyst recommendations, profitability, risk, earnings and valuation, institutional ownership are concerned. The two businesses are rivals in the Biotechnology industry.

Earnings and Valuation

Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio
Bellerophon Therapeutics Inc. N/A 0.00 2.08M -0.41 0.00
Cleveland BioLabs Inc. 1.11M 15.29 3.26M -0.39 0.00

We can see in table 1 the earnings per share, gross revenue and valuation of Bellerophon Therapeutics Inc. and Cleveland BioLabs Inc.

Profitability

Table 2 shows Bellerophon Therapeutics Inc. and Cleveland BioLabs Inc.'s return on assets, return on equity and net margins.

Net Margins Return on Equity Return on Assets
Bellerophon Therapeutics Inc. 0.00% 0% -64.8%
Cleveland BioLabs Inc. -293.69% -734.3% -56.6%

Volatility and Risk

Bellerophon Therapeutics Inc. has a beta of -0.04 and its 104.00% less volatile than Standard and Poor's 500. In other hand, Cleveland BioLabs Inc. has beta of 0.79 which is 21.00% less volatile than Standard and Poor's 500.

Liquidity

Bellerophon Therapeutics Inc. has a Current Ratio of 2.5 and a Quick Ratio of 2.5. Competitively, Cleveland BioLabs Inc.'s Current Ratio is 3.5 and has 3.5 Quick Ratio. Cleveland BioLabs Inc.'s better ability to pay short and long-term obligations than Bellerophon Therapeutics Inc.

Analyst Recommendations

The next table highlights the given recommendations and ratings for Bellerophon Therapeutics Inc. and Cleveland BioLabs Inc.

Sell Ratings Hold Ratings Buy Ratings Rating Score
Bellerophon Therapeutics Inc. 0 0 1 3.00
Cleveland BioLabs Inc. 0 0 0 0.00

The upside potential is 385.36% for Bellerophon Therapeutics Inc. with consensus target price of $3.

Institutional & Insider Ownership

The shares of both Bellerophon Therapeutics Inc. and Cleveland BioLabs Inc. are owned by institutional investors at 50.6% and 5.5% respectively. 7.8% are Bellerophon Therapeutics Inc.'s share held by insiders. Comparatively, Cleveland BioLabs Inc. has 58.15% of it's share held by insiders.

Performance

Here are the Weekly, Monthly, Quarterly, Half Yearly, Yearly and YTD Performance of both pretenders.

Performance (W) Performance (M) Performance (Q) Performance (HY) Performance (Y) Performance (YTD)
Bellerophon Therapeutics Inc. -2.42% -8.49% -27.52% -20.98% -61.88% -19.14%
Cleveland BioLabs Inc. -3.24% -22.36% -24.7% -36.55% -63.34% 23.76%

For the past year Bellerophon Therapeutics Inc. had bearish trend while Cleveland BioLabs Inc. had bullish trend.

Summary

On 6 of the 10 factors Cleveland BioLabs Inc. beats Bellerophon Therapeutics Inc.

Bellerophon Therapeutics, Inc., a clinical-stage therapeutics company, focuses on the development of products at the intersection of drugs and devices that address unmet medical needs in the treatment of cardiopulmonary diseases. Its product candidates are INOpulse, a pulsatile nitric oxide delivery device, which is in Phase III clinical trials for the treatment of pulmonary arterial hypertension; and in Phase II clinical trials to treat pulmonary hypertension associated with chronic obstructive pulmonary diseases and pulmonary hypertension associated with idiopathic pulmonary fibrosis. Bellerophon Therapeutics, Inc. was founded in 2009 and is headquartered in Warren, New Jersey.

Cleveland BioLabs, Inc., a biopharmaceutical company, develops novel approaches to activate the immune system and address various medical needs in the United States and the Russian Federation. The companyÂ's advanced product candidate is entolimod, a Toll-like receptor 5 (TLR5) agonist that is used to prevent death from acute radiation syndrome, and as an oncology drug. It is also developing CBLB612, a pharmacologically optimized synthetic molecule that structurally mimics naturally occurring lipopeptides of Mycoplasma, and activates NF-kB pro-survival and immunoregulatory signaling pathways; and Mobilan, a recombinant non-replicating adenovirus that directs expression of TLR5 and its agonistic ligand. In addition, the company develops CBL0137, a small molecule with a multi-targeted mechanism of action used for the treatment of various types of cancer. Cleveland BioLabs, Inc. has strategic partnerships with The Cleveland Clinic and Roswell Park Cancer Institute. The company was founded in 2003 and is headquartered in Buffalo, New York.

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