BioCardia Inc (BCDA)

[realfast95]

Ticker back to BCDA from BCDAD

[realfast95]

The trade case here is that BCDA will apply for listing on the Nasdaq soon. They have the independent directors already.

CardiAMP should push for RMAT, regenerative, FDA designation.

The competitor Vericel (VCEL) ixCELL-DCM already has RMAT.
However the FDA stopped them from getting approval for the product until they run a Phase 3 trial. They said they can't without a partner to pay for it. I comes down to the 6 minute walk test.
ixCELL-DCM failed to achieve it in Phase 2. It's the primary endpoint for CardiAMP in this Phase 3 trial.

[Bona Vista]

FROM THE WAY BCDAD HAS BEEN TRADING BEFORE AND AFTER THE R/S, I DON'T HAVE MUCH CONFIDENCE THAT THIS COMPANY WILL BE A SUCCESS STORY.

IT APPEARS AS THOUGH INVESTORS HAVE LOST THEIR EXCITEMENT AND HAVE MOVED ON, CAN'T REALLY BLAME THEM AS I TOO SHOULD HAVE SOLD EARLIER.

[Quintessence]

Yeah, bummer. I still have hope things could turn around at some point...

[Bona Vista]

MEAN TIME THE SHARE PRICE CONTINUES TO DECLINE MAKING NEW LOWS EVERY DAY, LOOKS AS IF THOSE THAT SOLD WELL BEFORE REVERSE SPLIT WERE THE SMART ONES.

[realfast95]

Earnings 11/10

SAN CARLOS, Calif.--(BUSINESS WIRE)--BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results and provided a corporate update for the third quarter ended September 30, 2017.

“These financial results demonstrate BioCardia’s efficiency in its use of capital while conducting the CardiAMP HF Trial. The trial has received Investigational Device Exemption (IDE) Category B reimbursement designation from the Centers for Medicare and Medicaid Services. This significantly reduces the overall development cost of the program.”
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BioCardia reported a net loss of $3.0 million for the third quarter of 2017, which compares to a net loss of $3.3 million for the third quarter of 2016. Research and development expenses were $1.7 million for the third quarter of 2017, compared to $684,000 in the third quarter of 2016, primarily due to expenses incurred for the pivotal CardiAMP Heart Failure Trial (CardiAMP HF Trial). Selling, general and administrative expenses were $1.3 million for the third quarter of 2017, compared to $919,000 in the third quarter of 2016, primarily due to additional costs for the organizational structure needed to support the CardiAMP HF Trial and operations as a public company.

BioCardia CEO Peter Altman, PhD, stated, “These financial results demonstrate BioCardia’s efficiency in its use of capital while conducting the CardiAMP HF Trial. The trial has received Investigational Device Exemption (IDE) Category B reimbursement designation from the Centers for Medicare and Medicaid Services. This significantly reduces the overall development cost of the program.”

Recent accomplishments include:

Successful data safety monitoring board review of the roll-in cohort in the CardiAMP HF Trial,
Activation of five world-class cardiovascular centers enrolling patients in the trial today,
Launch of the patient recruitment website, www.CardiAMP.com,
Appointment of Ian McNiece, PhD, as Chief Scientific Officer,
Publication of the positive Phase II results from our co-sponsored TRIDENT trial evaluating allogeneic mesenchymal stem cells in heart failure in Circulation Research, and
Issuance of US Patent No. 9,301,975 relating to a method of producing mesenchymal stem cells from bone marrow cells, and US Patent No. 9,775,963 related to steerable devices.

BioCardia Chief Medical Officer Dr. Eric Duckers, MD, PhD, said, “The ongoing CardiAMP pivotal trial in ischemic heart failure and the anticipated submission of CardiAMP in the related indication of chronic myocardial ischemia are supported by our CardiAMP Phase I open-label TABMMI ischemic heart failure trial and the Phase 2 randomized placebo-controlled TACHFT-BMC ischemic heart failure trial. In both trials, patients who received cells experienced clinically meaningful and statistically significant improvements in established endpoints of exercise tolerance, while also demonstrating positive changes to their heart geometries. These results are also supported by a recent meta-analysis of 21 randomized controlled trials of bone marrow-derived cells for treating ischemic heart disease, which showed a significant reduction in mortality at long term follow-up in patients who received cells when compared to those who did not receive cells.”

Looking forward, the Company anticipates submitting an IDE supplement to enable an interim analysis on efficacy at the end of 2018, and having top line data available at the end of 2019. The Company also anticipates filing a second IDE with the FDA for a CardiAMP Chronic Myocardial Ischemia Trial in 2017.





September 30,
2017


December 31,
2016

Assets:
Cash, cash equivalents and short-term investments $ 15,125 $ 21,352

[realfast95]

30 days of purgatory BCDAD

[Renee]

BCDA one for 12 reverse split:

http://otce.finra.org/DLSymbolNameChanges

[davidsson10]

In effect tomorrow; BCDAD.

[Quintessence]

Reverse Split has occurred. Looks like no symbol change, which is unusual. My broker's BCDA quotes are pretty messed up today, showing a bid of .41 and an ask of $10. No volume so far.

http://www.nasdaq.com/article/biocardia-effects-1-for-12-reverse-stock-split-cm870298

[judypudy]

Noticed BCDA has a OTC Market Verified Share Structure. Anyone here know why Held at DTC is larger than float? TIA
http://www.otcmarkets.com/stock/BCDA/profile

[realfast95]

(definitive) (def 14c) filed for reverse stock split 12-1

[realfast95]

The reverse stock split should be followed by an up listing.
NTRP did pretty fast.

[realfast95]

FDA sticks it to VCEL. BCDA your stand-alone

VCEL PR
During the presentation the Company also announced that it had met with the U.S. Food and Drug Administration (FDA) on September 29, 2017 for a scheduled Type B meeting to discuss the potential for an accelerated approval pathway for ixmyelocel-T for the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM) utilizing existing Phase 2 clinical trial data. Ixmyelocel-T has received orphan drug, fast track development and regenerative medicine advanced therapy designation from the FDA in this indication. The FDA indicated that the Company should plan to conduct at least one additional adequate and well-controlled clinical study to support a Biologics License Application for ixmyelocel-T. Consistent with its previously disclosed strategy to focus investments on its high-growth commercial business, the Company does not plan to conduct any additional clinical studies for ixmyelocel-T unless fully funded by a partner.

[Quintessence]

But they do have some good news out. Hmm...

https://www.otcmarkets.com/stock/BCDA/news/BioCardia-Announces-Successful-Interim-Safety-Analysis-in-Its-Phase-3-Clinical-Trial-of-CardiAMP-Stem-Cell-Therapy-for-Heart-Failure?id=170908&b=y

[Bona Vista]

NOT A GOOD THING, IF YOU ASK ME

[Quintessence]

12:1 Reverse Split coming...

[miles2go]

https://blog.bulletproof.com/fda-crackdown-stem-cells-means/

[realfast95]

it appears yes, that the S-3 they had advertising through filings finally went active (in effect), $50m worth of shares. So somewhere around 108m shares.

As of April 30, 2017, there were 457,682,784 shares of common stock outstanding, held of record by 330 stockholders.

So my guess is that it is now roughly 566 million

[Quintessence]

Can anyone make sense of this S-3? Did they issue more shares?

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
NOTICE OF EFFECTIVENESS
Effective Date: September 01, 2017
Form: S-3
CIK: 0000925741
Company Name: BioCardia, Inc.
File Number: 333-218124

https://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=12265526

[striker66]

Looks like we are going to go higher, I wonder why!

[joepcf]

Looking like somebody wants back in, large block buying today so far.

[Bona Vista]

FROM THIS ARTICLE IT APPEARS AS IF BCDA IS DEAD IN THE WATER FOR THE NEXT 6 MONTHS TO ONE YEAR, I SUPPOSE SELLING WILL CONTINUE BRINGING SHARE PRICE BACK TO .40s IF NOT LOWER.

NO ONE, WILL BE BUYING AT THIS TIME IN MY OPINION.

[realfast95]

SAN CARLOS, Calif.--(BUSINESS WIRE)--BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced completion of treatment for the 10-patient roll-in cohort for the pivotal Phase III CardiAMP Heart Failure Trial. A pre-specified review of the 30-day outcomes in this cohort by the Data Safety Monitoring Board is anticipated in the third quarter of 2017.

“The company anticipates filing an investigational device exemption (IDE) supplement to add an interim efficacy readout in the fourth quarter of 2018 and expects top line data in the fourth quarter of 2019.”
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The investigational CardiAMP cell therapy system is designed to deliver a high dose of a patient’s own bone marrow cells directly to the region of cardiac dysfunction to stimulate the body’s natural healing mechanism after a heart attack. Patients are selected for the investigational treatment, in part, based on biomarkers in their bone marrow that are anticipated to maximize the potential for patient benefit.

“Leading clinical sites are actively screening patients for the randomized phase of our Phase III trial, and we are onboarding additional clinical sites in the United States,” stated BioCardia Chief Medical Officer Eric Duckers, MD, PhD, FESC. “The company anticipates filing an investigational device exemption (IDE) supplement to add an interim efficacy readout in the fourth quarter of 2018 and expects top line data in the fourth quarter of 2019.”

The CardiAMP Heart Failure Trial is a Phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 260 patients at 40 centers nationwide, which includes a 10-patient roll-in cohort. The trial’s primary endpoint is an improvement in six minute walking distance at 12 months post-treatment. In addition, the primary endpoint analysis incorporates the impact of major adverse cardiac events and other clinically meaningful events.

The company reaffirms guidance on its IDE submission in calendar year 2017 for a new CardiAMP indication to treat patients post-myocardial infarction. In addition, the company anticipates submitting an investigational new drug (IND) application in calendar year 2018 for CardiALLO cell therapy, which utilizes bone marrow-derived mesenchymal cells from a donor to treat heart failure.

http://www.businesswire.com/news/home/20170726005489/en/BioCardia-Completes-Roll-in-Cohort-Pivotal-Phase-III

[dshade]

or perhaps a retrace to .50? with this low vol at this support area it may want to set up there.

[Bona Vista]

PERSONALLY, I BELIEVE BCDA WILL RUN UP INTO THE .80s BEFORE PULLING BACK SOMEWHAT, THEN IT WILL BREAK INTO THE $$$$$.

[dshade]

maybe .70s coming

[realfast95]

OT: $OPK Dr Frost keeps pounding the table with open market buys.
his name came up on Stocktwits. spending 391k on Monday.

The downside to insider buying, is that no material news is occuring soon. I think 30 days.

[realfast95]

never mind. I found what I wanted in the 10K

https://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=11966159

Our FDA accepted Phase III pivotal trial is designed to provide the primary support for the safety and efficacy of CardiAMP. The primary endpoint is functional capacity, as measured by the six minute walk test. Based on the results achieved in the Phase II trial, our Phase III pivotal trial is designed to have more than 90% probability of achieving a positive result with statistical significance. Statistical significance denotes the mathematical likelihood that the results observed are real and not due to chance.

[realfast95]

I'm not a medical person, so bear with me. It appears CardiAMP competes with $VCEL product ixmyelocel-T.

$VCEL completed the Phase 2 last year and had primary endpoint success with the Heart (left side) therapeutic. But did not meet the secondary endpoint Walk Test (no difference than control). $VCEL investors think they can get FDA approval without Phase 3. But I don't see how with CardiAMP in Phase 3.

I can't find any information on CardiAMP Phase 2.
And I believe the CardiAMP Phase 3, Primary endpoint is the Walk.

Can anyone provide me with more clarity? Thanks.

[Kicko]

https://www.forbes.com/sites/schifrin/2017/01/03/the-buffett-of-biotechs-portfolio/#8dc6ed03a4a3

[joepcf]

Moving up looking for a close over .60 today.

[joepcf]

I've been buying

[Bona Vista]

EXACTLY, TIME TO SELL!!!!!!!!!

[joepcf]

Looking to me like they want to move this again, volume picking up and hitting the ask

[atotalbum]

awesome day yesterday then right back where we started lol

[atotalbum]

.34 is key support..has been right at the 200 day MA, and close to the 50..nice to see it hold again but would be nice to see some buyers come in...patience and stage 3 trials the time is slowly on on our side maybe..jmho

[atotalbum]

yes...LAFC finally backed off..hoping he's done selling, he has been relentless for weeks..

jmho

[joepcf]

Decent day today interested to see if we get follow through tomorrow

[atotalbum]

LAFC mm has been selling for months never seen anything like it...fk back off a bit dick lol

jmho

[atotalbum]

DR Frost owns lotta shares in both companies

[UHD]

Only Frost

[Quintessence]

What is the connection between BCDA and SVON?

[atotalbum]

no idea

[bb money]

Is market cap under $10 million still?

[atotalbum]

says SVON uplist and name change going to nasdaq this one going higher i think

[atotalbum]

not sure im holding

[bb money]

Nice! Now wonder where it goes from here.

[atotalbum]

http://www.otcmarkets.com/stock/SVON/news/Sevion-Therapeutics-Inc--and-Eloxx-Pharmaceuticals-Ltd-Announce-the-Entering-into-of-an-Acquisition-Transaction?id=160897&b=y

[bb money]

Trying to find it do you have it? I just see it is up 50%.