Post by tatshensini on Mar 17, 2017 17:24:40 GMT
I also read the BioTech section on stockgumshoe.com, and thought many here would want to know about BioStage....
This was posted by Cleveland last week:
Cleveland
www.stockgumshoe.com/2017/02/the-rest-of-the-12-biotechs-of-christmas/comment-page-14/#comment-4925019
BioStage $BSTG
I was asked to review $BSTG.by SoGiAm/Ben.
From a financial standpoint this one is extremely interesting and positive. See Below—.I went ahead and did a full review.
1) Platform Technology
2) bioengineered organ implants to treat cancer and other life threatening conditions using patient STEM CELLS and a medical device scaffold
3) As Dr. KSS mentioned on conference call: key Biostage person is Dr. Saverio La Francesca—2,000 heart transplants and 200 lung transplants—Trained under famous Heart Transplant surgeon Dr. Denton Cooley Texas Heart
(http://www.texasheart.org/AboutUs/History/cooley.cfm)
4) Biostage Tech is rapid regeneration
5) Have demonstrated successful esophagus regeneration on 39 large animals with partner MAYO CLINIC—average 220 POUNDS—some it has been over 1 year since surgery
6) Company believes potentially “De-Risked” based upon discussions with FDA
About Biostage
“Biostage is a biotechnology company developing bioengineered organ implants based on the company’s new Cellframe™ technology which combines a proprietary biocompatible scaffold with a patient’s own stem cells to create Cellspan™ organ implants. Cellspan implants are being developed to treat life-threatening conditions of the esophagus, bronchus or trachea with the hope of dramatically improving the treatment paradigm for patients. Based on its preclinical data, Biostage has selected life-threatening conditions of the esophagus as the initial clinical application of its technology.
Cellspan implants are currently being advanced and tested in collaborative preclinical studies. Preclinical, large-animal safety studies, conducted in compliance with the FDA Good Laboratory Practice (GLP) regulations, for the Company’s Cellspan Esophageal Implant product candidate are ongoing, in support of Biostage’s goal of filing an Investigational New Drug (IND) application with the U.S. FDA in the third quarter of 2017. The IND will seek approval to initiate clinical trials for its esophageal implant product candidate in humans.
Biostage, Inc., formerly Harvard Apparatus Regenerative Technology, Inc. (“Biostage” or the “Company”) is a biotechnology company developing bioengineered organ implants based on our novel Cellframe TM technology. Our Cellframe technology is comprised of a biocompatible scaffold that is seeded with the recipient’s own stem cells.
We believe that this technology may prove to be effective for treating patients across a number of life-threatening medical indications who currently have unmet medical needs.
We are currently developing our Cellframe technology to treat life-threatening conditions of the esophagus, bronchus or trachea with the objective of dramatically improving the treatment paradigm for those patients.”
Website www.biostage.com/
Key March 9, 2017 Press Release
ir.biostage.com/2017-03-09-Biostage-Reports-2016-Financial-Results-and-Provides-Business-Update
Summary points for quick review
1) Shares Outstanding after 2/10/17 $ 8 million private placement at $ .40 share plus 5 year warrants —37 million shares outstanding or a Market Cap of $ 13.3 million —
2) Have approximately $ 10 million cash which should last into fourth quarter 2017—
3) Burns about $ 2 million a quarter—
4) 4th quarter 2017 commence first-in-human study—
5) 5/16 2.9 million shares and 2/15 2.1 million shares private placements raises at $ 1.75-$1.76.
6) Insiders own 14.7% of shares (will be higher as includes only vested stock options)–OK
7) Balance Sheet Note: $ 10 million cash raise 2/17
Looks Fine !! 9/30/16 Form 10-Q Cash $6 million Total Assets $ 7.2 million
Current Liabilities (ignore warrant liability) $ 1.56 million Shareholder Equity $ 4.8 million
8) 52 week High $ 2.86 Low .29 Near 52 week lows
9) Received Orphan Drug Designation (ODD) for Cellspan™ Esophageal Implant from U.S. Food and Drug Administration (FDA);
10) Note Mayo Clinic involvement–Submitted peer-reviewed manuscript for publication with Mayo Clinic on esophageal regeneration data;
11) Advanced collaborative preclinical studies with Connecticut Children’s Medical Center for pediatric esophageal atresia;
12) Additional preclinical studies with partner Mayo Clinic on esophagus and bronchus program;
13) Following the Company’s pre-IND meeting with the FDA in October 2016, the Company received valuable feedback and greater clarity with respect to the FDA’s expectations and Biostage’s requirements for a successful filing of its IND for the esophageal implant program.
14) In November 2016, the Company’s Cellspan™ Esophageal Implant was granted Orphan Drug Designation by the FDA to restore the structure and function of the esophagus subsequent to esophageal damage due to cancer, injury or congenital abnormalities.
15) Biostage remains on track to file its IND application with the FDA for adult esophageal cancer in the third quarter of 2017 and commence its first-in-human studies for its Cellspan esophageal implant before the end of 2017.
16) In addition to developing its Cellspan esophageal implant for use in adults with esophageal cancer, the Company is evaluating its Cellspan esophageal implant for use to treat pediatric esophageal atresia (EA). EA is a rare birth defect in which a baby is born with a gap between the upper and lower esophagus, which effects about 1 in 2,500 babies in the U.S. Biostage remains extremely encouraged with its EA co-development efforts with Connecticut Children’s Medical Center. The Company is also evaluating additional partnerships with children’s hospitals showing strong interest in this program.
17) Successful development of the Company’s Cellframe™ technology in EA opens the opportunity for a pediatric voucher. Under Section 529 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. Under this program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product. The recently enacted 21st Century Cures Act reauthorized the rare pediatric disease priority review voucher along with additional favorable incentives to regenerative medicine companies..
18) Best BioStage presentation in my opinion-much more insight than 3/9/17 presentation—Discusses FDA in some detail
Jim McGorry CEO, will be presenting at the 9th Annual Biotech Showcase conference being held in San Francisco, CA on Monday, January 9, 2017 at 2:30 p.m. PT.78
ir.biostage.com/2017-Biotech-Showcase
19) Key Conference Call and Webcast Details—This is a good review of what lies ahead in 2017
Date and Time: March 9, 2017 replay: ir.biostage.com/2016-Financial-Results
Telephone replay: 877-660-6853 U.S. or 201-612-7415 Int’l Access ID #13656760
Cellspan Esophageal Program Overview
“We believe that a tremendous opportunity lies ahead for Biostage with our ability to provide a solution for underserved patients facing life-threatening diseases. We’ve built and advanced the operational and developmental foundation of our technology over the course of 2016. This progress makes 2017 an extremely important year as we make the transformational pivot to a clinical-stage company. We understand even better the need for transparency with all of our stakeholders during this important time and are committed to communicating our progress regularly. We look forward to continuing the advancement of our Cellspan esophageal implants and providing our breakthrough technology to esophageal cancer patients and children suffering from pediatric esophageal atresia, all of which we believe has the potential to drive shareholder value in the near and long term,” concluded Mr. McGorry
This was posted by Cleveland last week:
Cleveland
www.stockgumshoe.com/2017/02/the-rest-of-the-12-biotechs-of-christmas/comment-page-14/#comment-4925019
BioStage $BSTG
I was asked to review $BSTG.by SoGiAm/Ben.
From a financial standpoint this one is extremely interesting and positive. See Below—.I went ahead and did a full review.
1) Platform Technology
2) bioengineered organ implants to treat cancer and other life threatening conditions using patient STEM CELLS and a medical device scaffold
3) As Dr. KSS mentioned on conference call: key Biostage person is Dr. Saverio La Francesca—2,000 heart transplants and 200 lung transplants—Trained under famous Heart Transplant surgeon Dr. Denton Cooley Texas Heart
(http://www.texasheart.org/AboutUs/History/cooley.cfm)
4) Biostage Tech is rapid regeneration
5) Have demonstrated successful esophagus regeneration on 39 large animals with partner MAYO CLINIC—average 220 POUNDS—some it has been over 1 year since surgery
6) Company believes potentially “De-Risked” based upon discussions with FDA
About Biostage
“Biostage is a biotechnology company developing bioengineered organ implants based on the company’s new Cellframe™ technology which combines a proprietary biocompatible scaffold with a patient’s own stem cells to create Cellspan™ organ implants. Cellspan implants are being developed to treat life-threatening conditions of the esophagus, bronchus or trachea with the hope of dramatically improving the treatment paradigm for patients. Based on its preclinical data, Biostage has selected life-threatening conditions of the esophagus as the initial clinical application of its technology.
Cellspan implants are currently being advanced and tested in collaborative preclinical studies. Preclinical, large-animal safety studies, conducted in compliance with the FDA Good Laboratory Practice (GLP) regulations, for the Company’s Cellspan Esophageal Implant product candidate are ongoing, in support of Biostage’s goal of filing an Investigational New Drug (IND) application with the U.S. FDA in the third quarter of 2017. The IND will seek approval to initiate clinical trials for its esophageal implant product candidate in humans.
Biostage, Inc., formerly Harvard Apparatus Regenerative Technology, Inc. (“Biostage” or the “Company”) is a biotechnology company developing bioengineered organ implants based on our novel Cellframe TM technology. Our Cellframe technology is comprised of a biocompatible scaffold that is seeded with the recipient’s own stem cells.
We believe that this technology may prove to be effective for treating patients across a number of life-threatening medical indications who currently have unmet medical needs.
We are currently developing our Cellframe technology to treat life-threatening conditions of the esophagus, bronchus or trachea with the objective of dramatically improving the treatment paradigm for those patients.”
Website www.biostage.com/
Key March 9, 2017 Press Release
ir.biostage.com/2017-03-09-Biostage-Reports-2016-Financial-Results-and-Provides-Business-Update
Summary points for quick review
1) Shares Outstanding after 2/10/17 $ 8 million private placement at $ .40 share plus 5 year warrants —37 million shares outstanding or a Market Cap of $ 13.3 million —
2) Have approximately $ 10 million cash which should last into fourth quarter 2017—
3) Burns about $ 2 million a quarter—
4) 4th quarter 2017 commence first-in-human study—
5) 5/16 2.9 million shares and 2/15 2.1 million shares private placements raises at $ 1.75-$1.76.
6) Insiders own 14.7% of shares (will be higher as includes only vested stock options)–OK
7) Balance Sheet Note: $ 10 million cash raise 2/17
Looks Fine !! 9/30/16 Form 10-Q Cash $6 million Total Assets $ 7.2 million
Current Liabilities (ignore warrant liability) $ 1.56 million Shareholder Equity $ 4.8 million
8) 52 week High $ 2.86 Low .29 Near 52 week lows
9) Received Orphan Drug Designation (ODD) for Cellspan™ Esophageal Implant from U.S. Food and Drug Administration (FDA);
10) Note Mayo Clinic involvement–Submitted peer-reviewed manuscript for publication with Mayo Clinic on esophageal regeneration data;
11) Advanced collaborative preclinical studies with Connecticut Children’s Medical Center for pediatric esophageal atresia;
12) Additional preclinical studies with partner Mayo Clinic on esophagus and bronchus program;
13) Following the Company’s pre-IND meeting with the FDA in October 2016, the Company received valuable feedback and greater clarity with respect to the FDA’s expectations and Biostage’s requirements for a successful filing of its IND for the esophageal implant program.
14) In November 2016, the Company’s Cellspan™ Esophageal Implant was granted Orphan Drug Designation by the FDA to restore the structure and function of the esophagus subsequent to esophageal damage due to cancer, injury or congenital abnormalities.
15) Biostage remains on track to file its IND application with the FDA for adult esophageal cancer in the third quarter of 2017 and commence its first-in-human studies for its Cellspan esophageal implant before the end of 2017.
16) In addition to developing its Cellspan esophageal implant for use in adults with esophageal cancer, the Company is evaluating its Cellspan esophageal implant for use to treat pediatric esophageal atresia (EA). EA is a rare birth defect in which a baby is born with a gap between the upper and lower esophagus, which effects about 1 in 2,500 babies in the U.S. Biostage remains extremely encouraged with its EA co-development efforts with Connecticut Children’s Medical Center. The Company is also evaluating additional partnerships with children’s hospitals showing strong interest in this program.
17) Successful development of the Company’s Cellframe™ technology in EA opens the opportunity for a pediatric voucher. Under Section 529 to the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA will award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. Under this program, a sponsor who receives an approval for a drug or biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product. The recently enacted 21st Century Cures Act reauthorized the rare pediatric disease priority review voucher along with additional favorable incentives to regenerative medicine companies..
18) Best BioStage presentation in my opinion-much more insight than 3/9/17 presentation—Discusses FDA in some detail
Jim McGorry CEO, will be presenting at the 9th Annual Biotech Showcase conference being held in San Francisco, CA on Monday, January 9, 2017 at 2:30 p.m. PT.78
ir.biostage.com/2017-Biotech-Showcase
19) Key Conference Call and Webcast Details—This is a good review of what lies ahead in 2017
Date and Time: March 9, 2017 replay: ir.biostage.com/2016-Financial-Results
Telephone replay: 877-660-6853 U.S. or 201-612-7415 Int’l Access ID #13656760
Cellspan Esophageal Program Overview
“We believe that a tremendous opportunity lies ahead for Biostage with our ability to provide a solution for underserved patients facing life-threatening diseases. We’ve built and advanced the operational and developmental foundation of our technology over the course of 2016. This progress makes 2017 an extremely important year as we make the transformational pivot to a clinical-stage company. We understand even better the need for transparency with all of our stakeholders during this important time and are committed to communicating our progress regularly. We look forward to continuing the advancement of our Cellspan esophageal implants and providing our breakthrough technology to esophageal cancer patients and children suffering from pediatric esophageal atresia, all of which we believe has the potential to drive shareholder value in the near and long term,” concluded Mr. McGorry