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Anybody knows what’s going on right now?
News: $BCDA BioCardia Announces the Appointment of Two New Board Members
SAN CARLOS, Calif., Oct. 02, 2019 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the appointment of experienced CEOs Jim Allen and Andrew Blank to its Board of Directors, eff...
Got this from BCDA - BioCardia Announces the Appointment of Two New Board Members
News: $BCDA BioCardia Initiates Commercial Release of AVANCE Steerable Introducer Designed to Enhance Physician Control for Complex Cardiac Procedures
SAN CARLOS, Calif., Oct. 01, 2019 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. commercial availability of its AVANCE™ Bi-Directional Steerable Introd...
Read the whole news BCDA - BioCardia Initiates Commercial Release of AVANCE Steerable Introducer Designed to Enhance Physician Control for Complex Cardiac Procedures
They hired a patent guy
That means they are probably going to get ready to patent the new therapy
13G 8.5% - Luis M de la Fuente, his wife and child are the stockholders of Sabiah Ltd. and share voting and dispositive power over the shares held by Sabiah Ltd. The shares include (i) 417,270 shares of common stock, and (ii) 166,667 shares of common stock issuable upon exercise of warrants.
Trial due dates from 4/2019 10k
We have enrolled 32 patients in the trial to date and enrollment is anticipated to begin accelerating due to additional compelling data presented from the
roll in cohort, the addition of world class centers to the trial, and the completion of competitive clinical programs. We anticipate a first interim readout
from the trial in Q3 2019, a second interim readout in Q3 2020, that trial enrollment will be completed in Q3 2020 and that top line data will be available
in Q3 2021.
======================
This is a big trial delay compared what they wrote in the 2018 10K (1.5 years later)
DEAD MONEY
This looks promising
24$ target
5.9mil float
BCDA moved to the Nasdaq from the OTC:
https://otce.finra.org/otce/dailyList?viewType=Deletions
approved for listing on the big boards.
As a result
Price
$14.00
Day's Change
3.45 (32.70%)
Bid
12.50
Ask
14.50
B/A Size
100x100
Day's High
14.19
Day's Low
10.51
Volume(Heavy Day)
3,365
BCDA one for 9 reverse split. **PPS closed up 22 cents to $1.24, hmmmmm.
https://otce.finra.org/otce/dailyList?viewType=Symbol%2FName%20Changes
RS Effective/Ex Date/Time 06/06/2019 00:00:00
Subject to Corporate Action CD
Offering Type No Restrictions
Daily List Comment
Daily List Event Code DA
Forward Split Ratio
Reverse Split Ratio 1:9
Dividend Type Reverse Split
To our fellow shareholders,
Another year is completed and I remain optimistic about the strength of our therapeutic programs and the progress we are making. There is intense effort being put forth by the entire BioCardia team, and our clinical partners are getting closer to the rate of patient recruitment required to complete the Phase III CardiAMP™ Heart Failure Trial.
I wanted to take a moment to lay out our progress across our product pipeline in recent months and share some thoughts about our efforts to build long-term financial health for the company.
The Big Picture
Our primary objective today is to deliver positive CardiAMP Cell Therapy trial data that enables the therapy to be approved by the FDA as a treatment for heart failure. This requires not only full enrollment of the trial, but also persuasive outcomes. The CardiAMP Heart Failure trial was designed based on positive outcomes from the Phase II trial to have greater than 95% power, or a very high probability of meeting the primary endpoint. To be successful, we must also deliver the safety profile we have seen in our trials to date. CardiAMP cell therapy is the primary focus of the company because of its potential to meaningfully improve lives and do so cost-effectively. Our innovative approach to rapidly processing a patient’s own cells at the point of care, rather than sending them out for expensive and time consuming lab manipulation, is intended to make the therapy dramatically less expensive for patients and the healthcare system as a whole, and make it more accessible to more patients when compared to other cell therapies.
CardiAMP Early Phase III Pivotal Trial Results are Promising
Compelling data from the 10-patient roll-in cohort were presented at last November’s American Heart Association Scientific Sessions, showing meaningful improvements in the primary endpoint of exercise capacity, with eight of the 10 patients experiencing exercise improvement. This improvement is more than triple the average improvement over baseline reported in the CardiAMP Phase II trial, and greater than the average improvement seen in a number of pivotal trials for implantable cardiac resynchronization therapy (CRT) to treat heart failure. It’s notable that these CRT therapies were approved by the FDA with substantially the same clinical endpoint. Moreover, the early CardiAMP data showed that there were no treatment emergent major adverse cardiac events at 30 days, and all patients were alive and out of the hospital at one year.
? 125 Shoreway Road, Suite B San Carlos, CA 94070 ? Ph: 650-226-0120 ? Fax: 650-631-3731 ? www.biocardia.com
Patients in this cohort also showed improvement in a key measure of heart function and in quality of life. In earlier clinical trials, CardiAMP showed the potential to not simply slow or stop disease progression, but actually improve heart function, and it is very encouraging that the early Phase III results suggest the same. If the data continues in this fashion, CardiAMP cell therapy could be the first therapy developed in the last 20 years to improve intrinsic heart muscle function in chronic heart failure, resulting in improved quality of life and exercise performance in patients suffering from this life-threatening disease. This goal drives us as BioCardians daily as we continue the development of this potentially first-in-class therapeutic option for patients.
CardiAMP Enrollment is Full Speed Ahead
Thirty-five patients have been treated in the CardiAMP HF Trial to date. We are pleased to see a continuation of the strong safety profile in addition to positive initial improvements in patients’ functional capacity achieved in the roll-in cohort. While enrollment has been slower than originally anticipated, it is now accelerating, and we expect this trend to continue.
There are several reasons for the slow start, and we have addressed many of them:
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Our cell potency assay is one of the unique elements of CardiAMP therapy and the best data in the field suggests that identifying patients with high quality bone marrow will maximize the probability of the trial’s success. This means that we intentionally exclude a group of patients in screening, although that number is currently somewhat higher than we anticipate it will ultimately be.
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Implementation of our Medicare reimbursement within each center has been new for many clinical research groups and has required a learning curve. Additionally, the coverage excludes patients who are ineligible for Medicare and whose insurers do not follow Medicare’s reimbursement guidelines for investigational therapies, thereby affecting enrollment. However, it’s important to note that obtaining Medicare reimbursement for the trial was a very positive achievement and greatly reduces our expense of running the trial.
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Until the end of 2018, we were competing with two other trials for the same patient population and for the attention of several leading centers. Those studies are now completed and these centers are now joining our trial.
We are grateful to our strong clinical partners for working with us to resolve these issues.
Whereas we began 2018 with 7 centers participating, we now have 21 active world-class centers in the CardiAMP Heart Failure Trial and continue to add other sites. We thank those centers that are delivering on their enrollment commitments and are working closely with others as they aim to do better.
CardiALLO™ Gets to the FDA
While CardiAMP remains our primary focus, we feel it is important to offer an alternative for patients who do not qualify for the rigorous requirements of the autologous cell therapy. With that in mind, we recently filed an IND with the FDA for our second cell therapy candidate – CardiALLO – which, once accepted, will enable us to begin an investigational study when we believe the time is right for the business. The CardiALLO trial is specifically designed for patients with low bone marrow cell potency, as determined by our proprietary CardiAMP assay.
CardiALLO is a culture-expanded “off the shelf” mesenchymal cell therapy for the treatment of ischemic heart failure using allogenic cells, or those from a separate donor. The therapy uses NK1R+ mesenchymal stem cells, which are believed to be activated by Substance P, a chemical that has been shown to facilitate healing and minimize damage within the body. We are excited about the potential of CardiALLO to give us two complementary therapies to help heart failure patients who do not have good options today.
Additionally, we see an opportunity to leverage our work with this proprietary cell population for other clinical indications, in order to generate greater value for both patients and shareholders without significant additional expense to BioCardia. For example, there is interesting clinical data in the literature that has been generated in stroke, diabetes, rheumatoid arthritis and Crohn’s disease, and my sense is that our CardiALLO cells have the potential to offer superiority to other therapies currently in development.
Enabling Products Enhance Our Therapeutic Mission
Part of our success to date with CardiAMP is the enabling technologies that enhance successful delivery of the therapy. While they don’t get as much attention, they are important tools in our arsenal and are being leveraged beyond our own needs. Our Helix™ Biotherapeutic Delivery System has been chosen for use in a total of 12 cell therapy trials to date (including our own ongoing CardiAMP Heart Failure Trial, approved CardiAMP Chronic Myocardial Ischemia Trial, and recently submitted CardiALLO Heart Failure Trial). In September 2018, the presentation of the clinical safety experience encompassing 300 procedures in these trials showed that the Helix system presents the lowest risk to patients for cell and gene delivery to the heart, when compared to all other delivery systems in the scientific literature for which data is available. This builds on previous data from 2017 which showed that the system is also the most efficient for our lead cell therapy program. Each delivery procedure utilizing the Helix system relies on our Morph™ steerable guide catheter technology, which has been used in more than 10,000 patients aged two months to 96 years to help treat a broad variety of serious vascular diseases.
Continuous improvement in our enabling technologies enhances our therapeutic programs and those of our partners, and underlies our potential for revenue growth even while we conduct our therapeutic trials. Enhancements to the Helix system have been made or are underway to further de-risk the cell therapy clinical programs. One of these is being made to significantly upgrade our Morph steerable guide platform with what we call “DNA” technology, which we have shown is able to eliminate “whip” when navigating curved anatomy, provides for bidirectional control, is more durable, and should be less expensive to manufacture in volume than our current Morph device.
By making this slight reconfiguration of the Morph platform we have opened up a new product opportunity for the technology. In the fourth quarter of 2018, we submitted a 510(k) to the FDA for the AVANCE™ steerable introducer, based on this Morph “DNA” technology. AVANCE is intended to address the large and growing market for transseptal access, which enables entry via the left side of the heart through the interatrial septum. The global transseptal access systems market is currently estimated at $550 million and is extremely competitive. The physicians we train to perform the CardiAMP cell therapy procedures are among those who may use AVANCE in their normal practice and they have provided extensive input in its development. We intend to submit a 510(k) for another Morph steerable guide product which also incorporates “DNA” technology by the end of this year.
Building Long-Term Financial Health
We are building BioCardia for long-term success and are taking financial actions now that will enable the company to thrive over time. As you may know from our SEC filings, the Board and a majority of shareholders recently voted to move forward with a reverse stock split. When companies make this move, it can sometimes be perceived negatively. However, I want to outline for you why this move is a positive development, based on our careful consideration.
The split should not be taken on its own. It is one piece of a larger strategy. It is a step we must take as part of qualifying to uplist to a major exchange – either NASDAQ or NYSE. To qualify for an uplist, we must bring the share price above $3 per share for at least 30 days, which, for us, requires the split. We anticipate that uplisting will make our stock more accessible to investment funds and analyst coverage, which has the potential to attract new investors, increasing liquidity, access to capital and shareholder value over time. Over the long term, we believe an uplisting will open up opportunities for us as a company and for you, our fellow shareholders.
The Path Ahead
We believe the steps we are taking should also help to secure the financing necessary to complete the CardiAMP Heart Failure Trial. Completion of the trial and analysis of the 12-month results will enable us to file for FDA approval, assuming the results are as positive as we anticipate. Additional financing is expected to also allow us to make progress on other initiatives, including further development of CardiALLO and the Helix system, and commercial availability of AVANCE and Morph “DNA” products. Having multiple platform products where we can succeed de-risks the Company and increases its attractiveness to investors and partners. But make no mistake, CardiAMP is still at the heart of our efforts.
I thank you for your continued support and ask that you remain with us on this journey to bring better options to patients, their families and physicians dealing with cardiovascular disease.
Sincerely,
Peter Altman, PhD
Chief Executive Officer
BioCardia, Inc.
April 22, 2019
the Company received written consents from holders of 21,926,585 shares of voting securities representing approximately 50.3% of the 43,631,684 shares of the total issued and outstanding shares of voting stock of the Company (the “Majority Stockholders”) to approve a reverse stock split of our issued and outstanding shares of Common Stock at a ratio between one-for-seven (1:7) and one-for-ten (1:10) (the “Reverse Stock Split”), which ratio is to be finally determined by the members of management prior to the filing of the Certificate of Amendment with the Secretary of State of the State of Delaware, a form of which is attached to this Information Statement as Annex A (the “ Certificate of Amendment ”) and which filing is to be effected at the sole discretion of our Board.
Trial due dates from last year's 10K
The CardiAMP Heart Failure Trial was initiated in Q4 2016, and the first patient treated in Q1 2017. The Data Safety Monitoring Board (DSMB) safety review of the 10 patient roll in cohort treated at three clinical sites was completed successfully in Q3 2017, and the trial is actively enrolling today at 10 clinical sites. Efficacy data from the primary endpoint in the open label roll in cohort are anticipated in second half of 2018. We anticipate that trial enrollment will be completed in the first half of 2019 and expect top line data will be available in the first half of 2020.
BioCardia and CellProThera Partner for Clinical Trial and Marketing in Singapore of Early Stem Cell Therapy for Patients Following Myocardial Infarction
Press Release | 10/30/2018
CellProThera® and BioCardia® [OTC: BCDA] today announced an agreement to expand their current collaboration to the SIngXpand Clinical Trial in Singapore. The study will evaluate the safety and efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process and delivered via BioCardia’s Helix™ Biotherapeutic Delivery System for the treatment of patients soon after a heart attack.
Under the terms of the agreement, CellProThera will fund completion of all regulatory and clinical activities undertaken by both firms for the clinical investigation. If the study results in regulatory approval of the product, CellProThera will have exclusive commercial rights in Singapore to the Helix Biotherapeutic Delivery System for the delivery of culture expanded CD34+ cells to treat patients who have suffered a recent heart attack. BioCardia will receive double-digit royalty payments on future sales of the combination product.
Published data has shown that delivery of stem cell therapy to the heart using the Helix system resulted in superior cell retention and fewer treatment emergent major adverse cardiac events than either percutaneous intra-coronary infusion or direct injection using a straight needle.1,2 In addition, peer reviewed literature on clinical trials of CD34+ cells have noted minimal adverse events, with potential benefit in the treatment of cardiac conditions. The published results of the pilot study conducted by CellProThera have shown meaningful improvement in cardiac functions after injection of CD34+ stem cells into the myocardium following heart attack.3,4
About CellProThera®
so stat sig in 6MWD and NYHA and trend in MLHFQ? only limited patients but definitely supports their theory. will be exciting to see what happens.
it appears so. But I'm not a doctor.
The paper reports for the first time on the results from the first 10 patients in the open-label Roll-In Phase of the CardiAMP-HF Trial treated with CardiAMP therapy. Treated patients showed improvements in Six Minute Walk Distance (+47.8m ± 19.6, 20.5% relative improvement; p=0.01), improvements in New York Heart Association Heart Failure Class (40% of patients improving one class, p=0.037), and a positive trend in MLHFQ Score (-10.2 ± 7.9, 31% relative improvement, p=0.21) at six months when compared to their baseline values. The magnitude of these improvements is greater than those seen in the trial's predecessor, the double blind, Phase II Transendocardial Autologous Cell Therapy in Heart Failure Trial, which demonstrated statistical significance in functional capacity as measured by six-minute walk and quality of life as measured by the Minnesota Living with Heart Failure Questionnaire.
$BCDA top-line Phase III data out. Looks good to me.
http://www.biocardia.com/investors/press-releases/id/1037?pressReleaseId=42
5% Stockholders:
Entities affiliated with Stertzer Family Trust(2)
3,632,195 9.1%
Sabiah Ltd.(3)
2,255,429 5.7%
Frost Gamma Investments Trust(4)
10,875,319 27.3%
OPKO Health, Inc.
2,178,180 5.5%
Entities affiliated with Gerald P. Peters(5)
2,344,272 5.9%
Named Executive Officers and Directors:
Richard Thomas Allen
129,504 *
Peter Altman, Ph.D.(6)
1,548,304 3.9
%
Henricus Duckers
122,021 *
Fernando L. Fernandez
5,111 *
Richard Krasno
5,111 *
David McClung
97,106 *
Jay M. Moyes(7)
28,831 *
Phil Pesta
134,862 *
Richard C. Pfenniger, Jr.
55,111 *
Thomas Quertermous, M.D.
116,204 *
Simon H. Stertzer, M.D.(8)
3,632,195 9.1
%
Allan R. Tessler(9)
833,292 2.1
%
All directors and executive officers as a group (13 people)
6,707,652 16.9
%
33
*
Represents beneficial ownership of less than 1%.
(1)
Where applicable, share numbers have been adjusted to reflect the Company's reverse stock split, which became effective on November 2, 2017.
(2)
Consists of (i) 2,586,608 shares of Common Stock held by the Stertzer Family Trust, (ii) 409,680 shares of our Common Stock held by Windrock Enterprises L.L.C., (iii) 104,910 shares of our Common Stock held by the Stertzer Gamma Trust, (iv) 448,895 shares our Common Stock held by Stertzer Holdings LLC, and (v) 82,102 shares subject to options that are vested and exercisable within 60 days of February 28, 2018, held by Dr. Stertzer. Dr. Stertzer and his spouse are co-trustees of the Stertzer Family Trust, and sole members and managers of Windrock Enterprises L.L.C., and share voting and dispositive control over the shares held by the Stertzer Family Trust and Windrock Enterprises L.L.C. Dr. Stertzer is the grantor of the Stertzer Gamma Trust and may be deemed to have voting and dispositive control over the shares held by the Stertzer Gamma Trust. Dr. Stertzer may be deemed to have voting and dispositive control over the shares held by Stertzer Holdings LLC.
(3)
Luis M de la Fuente, his wife and child are the stockholders of Sabiah Ltd. and share voting and dispositive control over the shares held by Sabiah Ltd. The address for this entity is P.O. Box 438, Road Town, Tortola, British Virgin Islands.
(4)
Dr. Phillip Frost is the trustee and Frost Gamma Limited Partnership is the sole and exclusive beneficiary of Frost Gamma Investments Trust. Dr. Frost is one of two limited partners of Frost Gamma Limited Partnership. The general partner of Frost Gamma Limited Partnership is Frost Gamma, Inc. and the sole shareholder of Frost Gamma, Inc. is Frost-Nevada Corporation. Dr. Frost is also the sole shareholder of Frost-Nevada Corporation. The address for these entities is 4400 Biscayne Boulevard, Suite 1500, Miami, Florida 33137.
(5)
Consists of (i) 774 shares of our Common Stock held by Gerald P. Peters, (ii) 805,385 shares of our Common Stock held by The Peters Corporation, (iii) 301,112 shares of our Common Stock held by the Peters Family Art Foundation, (iv) 481,500 shares of our Common Stock held in the Kathleen K. Peters & Gerald P. Peters III Revocable Trust UTA dtd. Sept. 29, 2008, (v) 690,836 shares of our Common Stock held in an account for the benefit of Mr. Peters, and (vi) 64,665 shares of our Common Stock held in an account for the benefit of his spouse. Gerald P. Peters, President, Chief Executive Officer and Financial & Fiscal Officer of the Peters Family Art Foundation may be deemed to have voting and dispositive control over the shares held by the Peters Family Art Foundation. The address for the Peters Family Art Foundation is P.O. Box 2437, Santa Fe, NM 87504. Mr. Peters may be deemed to have voting and dispositive control over the shares held by The Peters Corporation.
(6)
Consists of 694,842 shares of our Common Stock held by Dr. Altman and 853,462 shares subject to options vested and exercisable within 60 days of February 28, 2018.
(7)
Consists of 3,312 shares of our Common Stock and 25,519 shares subject to options held by Mr. Moyes that are vested and exercisable within 60 days of February 28, 2018.
(8)
Consists of (i) 2,586,608 shares of Common Stock held by the Stertzer Family Trust, (ii) 409,680 shares of our Common Stock held by Windrock Enterprises L.L.C., (iii) 104,910 shares of our Common Stock held by the Stertzer Gamma Trust, (iv) 448,895 shares our Common Stock held by Stertzer Holdings LLC, and (v) 82,102 shares subject to options, held by Dr. Stertzer that are vested and exercisable within 60 days of February 28, 2018. Dr. Stertzer and his spouse are co-trustees of the Stertzer Family Trust, and sole members and managers of Windrock Enterprises L.L.C., and share voting and dispositive control over the shares held by the Stertzer Family Trust and Windrock Enterprises L.L.C. Dr. Stertzer is the grantor of the Stertzer Gamma Trust and may be deemed to have voting and dispositive control over the shares held by the Stertzer Gamma Trust. Dr. Stertzer may be deemed to have voting and dispositive control over the shares held by Stertzer Holdings LLC.
(9)
Consists of (i) 5,111 shares of Common Stock held by Mr. Tessler, (ii) 13,578 shares subject to options held by Mr. Tessler that are exercisable within 60 days of February 28, 2018, (iii) 580,425 shares of our Common Stock held by ART/FGT Family Limited Partnership, (iv) 117,089 shares of our Common Stock held by International Financial Group, and (v) 117,089 shares of our Common Stock held by The Tessler Family Limited Partnership. Mr. Tessler and his spouse are limited partners of the ART/FGT Family Limited Partnership and share voting and dispositive control over the shares held by the ART/FGT Family Limited Partnership. The address for the ART/FGT Family Limited Partnership is 2500 Moose Wilson Road, Wilson, Wyoming 83014. Mr. Tessler may be deemed to have voting and dispositive control over the shares held by the Tessler Family Limited Partnership and International Financial Group.
34
RELATED PERSON TRANSACTIONS
Policies and Procedures for Related Party Transactions
We have adopted a formal policy that our executive officers, directors, holders of more than 5% of any class of our voting securities, and any member of the immediate family of and any entity affiliated with any of the foregoing persons, are not permitted to enter into a related party transaction with us without the prior consent of our audit committee, or other independent members of our board of directors if it is inappropriate for our audit committee to review such transaction due to a conflict of interest. Any request for us to enter into a transaction with an executive officer, director, principal stockholder, or any of their immediate family members or affiliates, in which the amount involved exceeds $120,000 must first be presented to our audit committee for review, consideration and approval. In approving or rejecting any such proposal, our audit committee is to consider the relevant facts and circumstances available and deemed relevant to the audit committee, including, but not limited to, whether the transaction is on terms no less favorable than terms generally available to an unaffiliated third party under the same or similar circumstances and the extent of the related party's interest in the transaction. All of the transactions described above were entered into prior to the adoption of this policy.
Related Party Transactions
We describe below transactions and series of similar transactions, since the beginning of our last fiscal year, to which we were a party or will be a party, in which:
•
the amounts involved exceeded or will exceed $120,000; and
•
any of our directors, nominees for director, executive officers or holders of more than 5% of our outstanding capital stock, or any immediate family member of, or person sharing the household with, any of these individuals or entities, had or will have a direct or indirect material interest.
Other than as described below, there has not been, nor is there any currently proposed, transactions or series of similar transactions to which we have been or will be a party.
Other Transactions
We have granted stock options to our named executive officers and certain of our directors. See the section titled "Executive Compensation-Outstanding Equity Awards at 2017 Year-End" for a description of these stock options.
We have entered into change of control and severance agreements with certain of our executive officers that provides for certain severance and change in control benefits. See the section titled "Executive Compensation-Potential Payments upon Termination or Change of Control."
Indemnification Agreements
We have entered into indemnification agreements with each of our directors and executive officers. The indemnification agreements, our amended and restated certificate of incorporation and our amended and restated bylaws require us to indemnify our directors to the fullest extent permitted by Delaware law.
35
OTHER MATTERS
Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Exchange Act requires that our executive officers and directors, and persons who own more than 10% of our common stock, file reports of ownership and changes of ownership with the SEC. Such directors, executive officers and 10% stockholders are required by SEC regulation to furnish us with copies of all Section 16(a) forms they file.
SEC regulations require us to identify in this proxy statement anyone who filed a required report late during the most recent fiscal year. Based on our review of forms we received, or written representations from reporting persons stating that they were not required to file these forms, we believe that during our fiscal year ended December 31, 2017, all Section 16(a) filing requirements were satisfied on a timely basis, except with respect to the following failures to timely file: (i) a Form 4 for Peter Altman (filed with the SEC on March 22, 2018), (ii) a Form 4 for David McClung (filed with the SEC on March 22, 2018), (iii) a Form 4 for Henricus Duckers (filed with the SEC on March 22, 2018), (iv) a Form 4 for Richard Thomas Allen (filed with the SEC on March 22, 2018) and (v) a Form 4 for Phil Pesta (filed with the SEC on March 22, 2018).
Fiscal Year 2017 Annual Report and SEC Filings
Our financial statements for our fiscal year ended December 31, 2017 are included in our Annual Report on Form 10-K, which we will make available to stockholders at the same time as this proxy statement. This proxy statement and our annual report are posted on the Financials & Filings portion of our website at investors.biocardia.com and are available from the SEC at its website at http://www.sec.gov. You may also obtain a copy of our annual report without charge by sending a written request to BioCardia, Inc., Attention: Secretary, 125 Shoreway Road, Suite B, San Carlos, California 94070.
* * *
The board of directors does not know of any other matters to be presented at the Annual Meeting. If any additional matters are properly presented at the Annual Meeting, the persons named in the enclosed proxy card will have discretion to vote the shares of our common stock they represent in accordance with their own judgment on such matters.
It is important that your shares of our common stock be represented at the Annual Meeting, regardless of the number of shares that you hold. You are, therefore, urged to vote by telephone or by using the Internet as instructed on the enclosed proxy card or execute and return, at your earliest convenience, the enclosed proxy card in the envelope that has also been provided.
THE BOARD OF DIRECTORS
San Carlos, California
April 27, 2018
36
?
Honestly if you are invested in this stock, you should know better that they are in phase III trials and it takes about 1.5 years to complete. This stock will get moving again at the end of 2018, beginning 2019. It's a long-term hold. Good entry now that everyone sold and joined the crypto world instead.
JUST A MATTER OF TIME BEFORE BCDA IS BACK INTO THE PENNY RANGE,
NEVER SHOULD HAVE HAD THAT R/S AS IT DID ABSOLUTELY NOTHING.
TIME TO UNLOAD AND LOOK FOR A MORE SUCCESSFUL COMPANY, BCDA HAS FAILED.
It does appear that Frost was scammed on the purchase of that company BioReference at $OPK.
All the more reason for BCDA to uplist to the Nasdaq.
IS THAT GOING TO MAKE THE PRICE MOVE UP I DOUBT THAT, BCDA HASN'T BEEN LOOKING GOOD FOR MONTHS.
I DON'T BELIEVE THERE WILL BE ANY TYPE OF POSITIVE TRADING FOR MANY MORE MONTHS TO COME, AND FROST'S OTHER COMPANY'S ARE NOT DOING WELL.
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.
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.
Yeah, bummer. I still have hope things could turn around at some point...
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.
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
30 days of purgatory BCDAD
BCDA one for 12 reverse split:
http://otce.finra.org/DLSymbolNameChanges
In effect tomorrow; BCDAD.
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
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
(definitive) (def 14c) filed for reverse stock split 12-1
The reverse stock split should be followed by an up listing.
NTRP did pretty fast.
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.
NOT A GOOD THING, IF YOU ASK ME
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
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
Looks like we are going to go higher, I wonder why!
Looking like somebody wants back in, large block buying today so far.
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.
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
or perhaps a retrace to .50? with this low vol at this support area it may want to set up there.
PERSONALLY, I BELIEVE BCDA WILL RUN UP INTO THE .80s BEFORE PULLING BACK SOMEWHAT, THEN IT WILL BREAK INTO THE $$$$$.
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