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JAGX: 0.103
52w: 0.1005 - 1.8850
Jaguar Health Provides Updates on Presentation at the World Congress of Gastroenterology About Crofelemer for Pediatric Short Bowel Syndrome (SBS) and Congenital Diarrheal Disorders (CDD) by Third-Party Investigator
aguar is also supporting a third-party investigator evaluating crofelemer for eosinophilic colitis, another rare pediatric gastrointestinal condition
Proof-of-concept data for the use of crofelemer for pediatric orphan or rare disorders is expected to provide additional support for the potential for expanded patient access to crofelemer through programs in Europe in late 2023
SAN FRANCISCO, CA / ACCESSWIRE / December 19, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX) and Napo Therapeutics, the corporation established by Jaguar in Italy in 2021 that focuses on expanding crofelemer access for orphan and rare diseases in Europe, today announced that an update regarding a third-party clinical investigation of crofelemer for pediatric short bowel syndrome (SBS) and congenital diarrheal disorders (CCD) was presented at the World Congress of Gastroenterology, a global GI conference that took place December 12-14, 2023 in Dubai in the United Arab Emirates (UAE). This update was provided by the clinical investigator, Dr. Mohamad Miqdady, Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City in the UAE.
Dr. Miqdady is also expected to make a presentation about this trial in May 2023 at the Annual Elite Ped-GI Congress in Abu Dhabi in the UAE.
"The update at the Annual Elite Ped-GI Congress is part of a series of planned presentations in the first half of 2023 on investigator-initiated proof-of-concept clinical studies of crofelemer for pediatric gastrointestinal orphan or rare diseases which remain a significant unmet medical need," said Lisa Conte, Jaguar's president and CEO. "Clinical studies of crofelemer for addressing pediatric SBS and CDD conditions are expected to be conducted throughout 2023. In accordance with the guidelines of specific EU countries, published data from such clinical investigations could support early patient access of crofelemer for pediatric SBS or CDD, especially for patients with intestinal failure requiring parenteral support, by late 2023 through programs in Europe for these debilitating conditions. Participation in Early Access Programs in some EU countries provides an opportunity for reimbursement while impacting the morbidity and high cost of care for these chronic unmet needs. SBS affects approximately 10,000 to 20,000 people in the EU and similar prevalence is reported for the U.S. Despite limited treatment options, the global adult and pediatric SBS market alone exceeded $568 million in 2019 and is expected to reach $4.6 billion by 2027, according to a report by Vision Research Reports."
As previously announced, the European Medicines Agency (EMA) granted Orphan Drug Designation (ODD) for crofelemer for SBS as well as microvillus inclusion disease (MVID), a rare pediatric CDD condition. The recognition of ODD in Europe for crofelemer for SBS and MVID are key Napo Therapeutics milestones under the company's exclusive crofelemer license agreement with Jaguar, and receipt of these ODDs supports opportunities for accelerated regulatory pathways.
Crofelemer received ODD in the U.S. for SBS from the U.S. Food and Drug Administration (FDA) in 2017, and Jaguar is awaiting a response from the FDA regarding the ODD application the company submitted to the FDA for crofelemer for MVID in the U.S.
Jaguar is also partially supporting a third-party clinical investigation evaluating crofelemer for a patient with eosinophilic colitis (EC), a rare pediatric diarrheal condition.
About Crofelemer
Crofelemer is a novel, oral plant-based medicine purified from the red bark sap, also referred to as "dragon's blood," of the medicinal Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities.
About Jaguar Health, Napo Pharmaceuticals, Napo Therapeutics & Jaguar Animal Health
Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe. Jaguar Animal Health is a tradename of Jaguar Health.
For more information about Jaguar Health, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com.
JAGX: 0.103
52w: 0.1005 - 1.8850
Jaguar Health Provides Updates on Presentation at the World Congress of Gastroenterology About Crofelemer for Pediatric Short Bowel Syndrome (SBS) and Congenital Diarrheal Disorders (CDD) by Third-Party Investigator
aguar is also supporting a third-party investigator evaluating crofelemer for eosinophilic colitis, another rare pediatric gastrointestinal condition
Proof-of-concept data for the use of crofelemer for pediatric orphan or rare disorders is expected to provide additional support for the potential for expanded patient access to crofelemer through programs in Europe in late 2023
SAN FRANCISCO, CA / ACCESSWIRE / December 19, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX) and Napo Therapeutics, the corporation established by Jaguar in Italy in 2021 that focuses on expanding crofelemer access for orphan and rare diseases in Europe, today announced that an update regarding a third-party clinical investigation of crofelemer for pediatric short bowel syndrome (SBS) and congenital diarrheal disorders (CCD) was presented at the World Congress of Gastroenterology, a global GI conference that took place December 12-14, 2023 in Dubai in the United Arab Emirates (UAE). This update was provided by the clinical investigator, Dr. Mohamad Miqdady, Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City in the UAE.
Dr. Miqdady is also expected to make a presentation about this trial in May 2023 at the Annual Elite Ped-GI Congress in Abu Dhabi in the UAE.
"The update at the Annual Elite Ped-GI Congress is part of a series of planned presentations in the first half of 2023 on investigator-initiated proof-of-concept clinical studies of crofelemer for pediatric gastrointestinal orphan or rare diseases which remain a significant unmet medical need," said Lisa Conte, Jaguar's president and CEO. "Clinical studies of crofelemer for addressing pediatric SBS and CDD conditions are expected to be conducted throughout 2023. In accordance with the guidelines of specific EU countries, published data from such clinical investigations could support early patient access of crofelemer for pediatric SBS or CDD, especially for patients with intestinal failure requiring parenteral support, by late 2023 through programs in Europe for these debilitating conditions. Participation in Early Access Programs in some EU countries provides an opportunity for reimbursement while impacting the morbidity and high cost of care for these chronic unmet needs. SBS affects approximately 10,000 to 20,000 people in the EU and similar prevalence is reported for the U.S. Despite limited treatment options, the global adult and pediatric SBS market alone exceeded $568 million in 2019 and is expected to reach $4.6 billion by 2027, according to a report by Vision Research Reports."
As previously announced, the European Medicines Agency (EMA) granted Orphan Drug Designation (ODD) for crofelemer for SBS as well as microvillus inclusion disease (MVID), a rare pediatric CDD condition. The recognition of ODD in Europe for crofelemer for SBS and MVID are key Napo Therapeutics milestones under the company's exclusive crofelemer license agreement with Jaguar, and receipt of these ODDs supports opportunities for accelerated regulatory pathways.
Crofelemer received ODD in the U.S. for SBS from the U.S. Food and Drug Administration (FDA) in 2017, and Jaguar is awaiting a response from the FDA regarding the ODD application the company submitted to the FDA for crofelemer for MVID in the U.S.
Jaguar is also partially supporting a third-party clinical investigation evaluating crofelemer for a patient with eosinophilic colitis (EC), a rare pediatric diarrheal condition.
About Crofelemer
Crofelemer is a novel, oral plant-based medicine purified from the red bark sap, also referred to as "dragon's blood," of the medicinal Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities.
About Jaguar Health, Napo Pharmaceuticals, Napo Therapeutics & Jaguar Animal Health
Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe. Jaguar Animal Health is a tradename of Jaguar Health.
For more information about Jaguar Health, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com.
Quince Therapeutics, Inc. (QNCX) : 0.66
52 Week Range 0.6120 - 14.6000
September 30, 2022
Cash and cash equivalents $ 31,809
Short term investments 62,534
Prepaid expenses and other current assets 3,933
Total current assets 98,276
Property and equipment, net 375
Operating lease right-of-use assets, net 208
Long term investments 5,001
Intangible asset 5,900
Other assets 17
Total assets $ 109,777
Current liabilities:
Accounts payable $ 1,181
Accrued expenses and other current liabilities 3,764
Total current liabilities 4,945
Long-term financing lease liabilities 19
Long-term operating lease liabilities 34
Deferred tax liabilities 248
Total liabilities 5,246
As of November 24, 2022, the registrant had 36,130,306 shares of common stock
Total assets $ 109,777 - Total liabilities 5,246 : 36,130,306 shares of common stock = 2.894/ share.
Quince Therapeutics, Inc., a biopharmaceutical company, focuses on advancing precision therapeutics for debilitating and rare diseases. The company has discovered a broad bone-targeting drug platform to precisely deliver small molecules, peptides, or large molecules directly to the site of bone fracture and disease. Its lead compound is NOV004, an anabolic peptide engineered to precisely target and concentrate at the bone fracture site The company was formerly known as Cortexyme, Inc. and changed its name to Quince Therapeutics, Inc. in August 2022. Quince Therapeutics, Inc. was incorporated in 2012 and is headquartered in South San Francisco, California.
Quince Therapeutics, Inc. (QNCX) : 0.66
52 Week Range 0.6120 - 14.6000
September 30, 2022
Cash and cash equivalents $ 31,809
Short term investments 62,534
Prepaid expenses and other current assets 3,933
Total current assets 98,276
Property and equipment, net 375
Operating lease right-of-use assets, net 208
Long term investments 5,001
Intangible asset 5,900
Other assets 17
Total assets $ 109,777
Current liabilities:
Accounts payable $ 1,181
Accrued expenses and other current liabilities 3,764
Total current liabilities 4,945
Long-term financing lease liabilities 19
Long-term operating lease liabilities 34
Deferred tax liabilities 248
Total liabilities 5,246
As of November 24, 2022, the registrant had 36,130,306 shares of common stock
Total assets $ 109,777 - Total liabilities 5,246 : 36,130,306 shares of common stock = 2.894/ share.
Quince Therapeutics, Inc., a biopharmaceutical company, focuses on advancing precision therapeutics for debilitating and rare diseases. The company has discovered a broad bone-targeting drug platform to precisely deliver small molecules, peptides, or large molecules directly to the site of bone fracture and disease. Its lead compound is NOV004, an anabolic peptide engineered to precisely target and concentrate at the bone fracture site The company was formerly known as Cortexyme, Inc. and changed its name to Quince Therapeutics, Inc. in August 2022. Quince Therapeutics, Inc. was incorporated in 2012 and is headquartered in South San Francisco, California.
LANNETT (LCI) : 0.668 +2.56%
52w: 0.385 - 1.91
* LANNETT COMPANY INC - ON DECEMBER 15, AUTHORIZED A
RESTRUCTURING
AND COST SAVINGS PLAN TO STREAMLINE AND REALIGN OUR OPERATIONS
* LANNETT COMPANY INC - THE ACTIONS WILL RESULT IN REDUCTION
TO
WORKFORCE BY 64 POSITIONS, EQUAL TO ABOUT 11% OF CO'S TOTAL
NUMBER OF EMPLOYEES
* LANNETT COMPANY INC - WORKFORCE REDUCTION WILL BE
IMPLEMENTED IN
SEVERAL PHASES THROUGHOUT REMAINDER OF COMPANY'S CURRENT FISCAL
YEAR
* LANNETT COMPANY INC - ANTICIPATES EXITING STATE ROAD AND
TORRESDALE FACILITIES IN PHILADELPHIA, PENNSYLVANIA BY END OF
CURRENT FISCAL YEAR
* LANNETT COMPANY INC - ESTIMATES THAT IT WILL INCUR ABOUT
$3.0
MILLION IN SEVERANCE-RELATED COSTS IN CONNECTION WITH 2022
RESTRUCTURING PLAN
* LANNETT COMPANY INC - 2022 RESTRUCTURING PLAN INCLUDES
OPERATIONAL IMPROVEMENTS AND COST EFFICIENCIES
* LANNETT- 2022 RESTRUCTURING PLAN INCLUDES ENGAGEMENT WITH
MORE
EXTERNAL PARTNERS & TECHNOLOGY PROVIDERS, GLOBALLY, TO EXECUTE
ON RESEARCH AND DEVELOPMENT PLANS, OPERATIONS
LANNETT (LCI) : 0.668 +2.56%
52w: 0.385 - 1.91
* LANNETT COMPANY INC - ON DECEMBER 15, AUTHORIZED A
RESTRUCTURING
AND COST SAVINGS PLAN TO STREAMLINE AND REALIGN OUR OPERATIONS
* LANNETT COMPANY INC - THE ACTIONS WILL RESULT IN REDUCTION
TO
WORKFORCE BY 64 POSITIONS, EQUAL TO ABOUT 11% OF CO'S TOTAL
NUMBER OF EMPLOYEES
* LANNETT COMPANY INC - WORKFORCE REDUCTION WILL BE
IMPLEMENTED IN
SEVERAL PHASES THROUGHOUT REMAINDER OF COMPANY'S CURRENT FISCAL
YEAR
* LANNETT COMPANY INC - ANTICIPATES EXITING STATE ROAD AND
TORRESDALE FACILITIES IN PHILADELPHIA, PENNSYLVANIA BY END OF
CURRENT FISCAL YEAR
* LANNETT COMPANY INC - ESTIMATES THAT IT WILL INCUR ABOUT
$3.0
MILLION IN SEVERANCE-RELATED COSTS IN CONNECTION WITH 2022
RESTRUCTURING PLAN
* LANNETT COMPANY INC - 2022 RESTRUCTURING PLAN INCLUDES
OPERATIONAL IMPROVEMENTS AND COST EFFICIENCIES
* LANNETT- 2022 RESTRUCTURING PLAN INCLUDES ENGAGEMENT WITH
MORE
EXTERNAL PARTNERS & TECHNOLOGY PROVIDERS, GLOBALLY, TO EXECUTE
ON RESEARCH AND DEVELOPMENT PLANS, OPERATIONS
AMC Entertainment Holdings, Inc. (APE) :0.7297-0.0814 (-10.04%)
Pre-Market: 0.7800 +0.05 (+7.08%)
AMC Entertainment Holdings, Inc. Raises $162 Million Through Sales of AMC Preferred Equity Units ("APE") Since Launching Its At-The-Market Program and Provides Business Update
nhances liquidity by raising more than $162 million of equity capital since the inception of the APE At-The-Market program.
Strengthens balance sheet by repurchasing approximately $36 million in principal amount of debt at an average discount of approximately 61%, taking total principal debt reduction for the fourth quarter to approximately $107 million and the total principal debt reduction for 2022 to approximately $180 million after considering the previously announced Odeon debt refinancing.
Expects liquidity as of December 31, 2022 to be between $725 million and $825 million, including $211.2 million of undrawn capacity under the Company’s revolving credit facility and after taking into consideration debt repurchases. This implies an improvement in the net decrease in cash and cash equivalents and restricted cash of between $110 million and $210 million compared to the third quarter of 2022.
Announces the acquisition of yet another former Arclight theatre in the Boston, Massachusetts market and further potential industry consolidation opportunities.
LEAWOOD, Kansas, December 19, 2022--(BUSINESS WIRE)--AMC Entertainment Holdings, Inc. (NYSE: AMC and APE) ("AMC" or "the Company") today provided a business update for the fourth quarter ending December 31, 2022.
As of December 19, 2022, since the inception of its APE At-The-Market Program ("ATM") offering, AMC has strengthened its liquidity position by raising approximately $162.4 million of gross cash proceeds before fees and commissions, through the sale of 125.9 million AMC Preferred Equity Units. During the fourth quarter of 2022 to date, AMC has raised approximately $153.2 million of gross cash proceeds before fees and commissions, through the sale of 123.2 million AMC Preferred Equity Units.
During the fourth quarter of 2022, AMC used a portion of the net proceeds from its ATM to repurchase approximately $30.7 million principal amount of its 10% Second Lien Debt due 2026 at an average discount of approximately 60% and approximately $5.25 million principal amount of its 6.125% Senior Subordinated Notes due 2027 at an average discount of 70%.
During the fourth quarter of 2022, as a result of the debt repurchases and the previously announced Odeon debt refinancing, AMC reduced the principal amounts of its debt by approximately $107 million, bringing the total principal debt reduction during 2022 to approximately $180 million.
Based on the success of AMC’s ATM program, its operating performance to date, and its effective cash management efforts, AMC’s liquidity position (cash, cash equivalents and undrawn revolving credit facility capacity) as of December 31, 2022 is currently estimated to be between $725 and $825 million, after debt repurchases and including $211.2 million of undrawn capacity under the Company’s revolving credit facility, subject to operating performance during the remainder of the holiday period in 2022 and the timing of landlord concessions. This implies an improvement in the net decrease in cash and cash equivalents and restricted cash of between $110 million and $210 million compared to the third quarter of 2022.
AMC is announcing the acquisition of the 13-screen former Arclight Cinemas theatre located at The Hub on Causeway, the large-scale mixed-use development at North Station, in Boston, Massachusetts. This theatre is brand new, having opened in December 2019 and closed only three months later due to COVID-19.
Adam Aron, Chairman and CEO of AMC Entertainment commented, "Even though the APE units and our common shares are economically equivalent, it is disappointing that the APE units have since inception consistently traded at a significant discount to the AMC common shares. While the trading prices of the two securities seem to reflect distinct market and trading dynamics, the APEs are serving precisely the purpose originally intended for them. At a time when one or more of our competitors have been facing potentially devastating liquidity challenges, by contrast during the past 90 days, AMC has been able to raise $162 million of additional cash through the sale of equity thereby improving our own liquidity position markedly. In addition, AMC reduced debt for the third time this year, including most recently by buying back debt at a substantial 61% discount and is able to contemplate various opportunities to add theatres to our fleet including just having successfully secured for AMC the attractive former Arclight Boston."
Aron added, "Our outlook for the industry is positive as we expect the box office will be larger in 2023 than in 2022. Our liquidity position is strong, as we continue to demonstrate our ability to raise cash, thereby strengthening our balance sheet. We also continue to enhance our footprint by acquiring superb theatres without significant capital outlays while at the same time exiting under-performing locations. For so many reasons, we believe the future remains bright for AMC."
About AMC Entertainment Holdings, Inc.
AMC is the largest movie exhibition company in the United States, the largest in Europe and the largest throughout the world with approximately 940 theatres and 10,500 screens across the globe. AMC has propelled innovation in the exhibition industry by: deploying its Signature power-recliner seats; delivering enhanced food and beverage choices; generating greater guest engagement through its loyalty and subscription programs, web site and mobile apps; offering premium large format experiences and playing a wide variety of content including the latest Hollywood releases and independent programming. For more information, visit www.amctheatres.com.
On the Strength of AVATAR: THE WAY OF WATER and Premium Formats, AMC Theatres® Way Outpaces the Same Weekend in Pre-pandemic 2019 on Admissions Revenue and Food & Beverage Revenue – Domestically and Internationally
Powered by AVATAR: THE WAY OF WATER, AMC’s U.S. and global admissions revenue and food & beverage revenue finish significantly higher than the same weekend in pre-pandemic 2019, which was led by the opening JUMANJI: THE NEXT LEVEL
Premium formats were exceptionally popular this weekend as more than 70 percent of all admissions revenue for AVATAR: THE WAY OF WATER came from a premium experience like 3D, IMAX at AMC, Dolby Cinema at AMC and PRIME at AMC
Internationally, ODEON Cinemas on Saturday recorded its highest single-day admissions and food and beverage revenue in 2022
LEAWOOD, Kan., December 19, 2022--(BUSINESS WIRE)--AMC Theatres® (NYSE:AMC and APE), the largest theatrical exhibitor in the United States and the world, today announced that based on the strength of premium formats, and a great desire by moviegoers to return to Pandora via AVATAR: THE WAY OF WATER, the Company finished materially ahead on U.S. and global admissions revenue and food & beverage revenue versus the same weekend in pre-pandemic 2019, which was led by the opening of JUMANJI: THE NEXT LEVEL.
The groundbreaking, mesmerizing 3D experience led to AVATAR: THE WAY OF WATER being a huge hit in premium formats in the United States. Tickets sold in RealD 3D and Premium Large Formats like Dolby Cinema at AMC, IMAX at AMC, and PRIME at AMC made up more than 70% of all box office gross to the movie at AMC.
Overseas, the movie played strong all weekend, but particularly on Saturday, when Saturday, AMC’s ODEON Cinemas enjoyed its highest admissions revenue and food & beverage revenue for a single day in 2022.
AMC Chairman and CEO Adam Aron Commented:
"At AMC, we’re greatly encouraged to see our revenues soar on the opening weekend of AVATAR: THE WAY OF WATER. James Cameron has done it again with a masterpiece of a film that generated revenues at AMC and ODEON Cinemas that were materially ahead of pre-pandemic 2019. AVATAR: THE WAY OF WATER demands to be seen on the biggest screens, with the loudest sounds in the most comfortable seats imaginable. Not only that, but I’d recommend seeing it in one of our premium formats like IMAX at AMC, Dolby at AMC or PRIME at AMC, Laser at AMC, and seeing it in the visually stunning 3D. The film is unlike anything I’ve ever experienced. All of us at AMC and Odeon extend our eternal thanks to James Cameron for the brilliance of his vision, and to all our friends at Disney for their tireless efforts to make this remarkable and immersive film. I’ve already seen it twice this past weekend, and I can’t wait to go see it again."
Tickets for AVATAR: THE WAY OF WATER are on sale through the holidays at all AMC locations in the United States. Moviegoers can visit amctheatres.com or use the AMC mobile app to see showtimes and purchase tickets.
About AMC Entertainment Holdings, Inc.
AMC is the largest movie exhibition company in the United States, the largest in Europe and the largest throughout the world with approximately 950 theatres and 10,500 screens across the globe. AMC has propelled innovation in the exhibition industry by: deploying its Signature power-recliner seats; delivering enhanced food and beverage choices; generating greater guest engagement through its loyalty and subscription programs, web site and mobile apps; offering premium large format experiences and playing a wide variety of content including the latest Hollywood releases and independent programming. For more information, visit www.amctheatres.com.
AMC Entertainment Holdings, Inc. (APE) :0.7297-0.0814 (-10.04%)
Pre-Market: 0.7800 +0.05 (+7.08%)
AMC Entertainment Holdings, Inc. Raises $162 Million Through Sales of AMC Preferred Equity Units ("APE") Since Launching Its At-The-Market Program and Provides Business Update
nhances liquidity by raising more than $162 million of equity capital since the inception of the APE At-The-Market program.
Strengthens balance sheet by repurchasing approximately $36 million in principal amount of debt at an average discount of approximately 61%, taking total principal debt reduction for the fourth quarter to approximately $107 million and the total principal debt reduction for 2022 to approximately $180 million after considering the previously announced Odeon debt refinancing.
Expects liquidity as of December 31, 2022 to be between $725 million and $825 million, including $211.2 million of undrawn capacity under the Company’s revolving credit facility and after taking into consideration debt repurchases. This implies an improvement in the net decrease in cash and cash equivalents and restricted cash of between $110 million and $210 million compared to the third quarter of 2022.
Announces the acquisition of yet another former Arclight theatre in the Boston, Massachusetts market and further potential industry consolidation opportunities.
LEAWOOD, Kansas, December 19, 2022--(BUSINESS WIRE)--AMC Entertainment Holdings, Inc. (NYSE: AMC and APE) ("AMC" or "the Company") today provided a business update for the fourth quarter ending December 31, 2022.
As of December 19, 2022, since the inception of its APE At-The-Market Program ("ATM") offering, AMC has strengthened its liquidity position by raising approximately $162.4 million of gross cash proceeds before fees and commissions, through the sale of 125.9 million AMC Preferred Equity Units. During the fourth quarter of 2022 to date, AMC has raised approximately $153.2 million of gross cash proceeds before fees and commissions, through the sale of 123.2 million AMC Preferred Equity Units.
During the fourth quarter of 2022, AMC used a portion of the net proceeds from its ATM to repurchase approximately $30.7 million principal amount of its 10% Second Lien Debt due 2026 at an average discount of approximately 60% and approximately $5.25 million principal amount of its 6.125% Senior Subordinated Notes due 2027 at an average discount of 70%.
During the fourth quarter of 2022, as a result of the debt repurchases and the previously announced Odeon debt refinancing, AMC reduced the principal amounts of its debt by approximately $107 million, bringing the total principal debt reduction during 2022 to approximately $180 million.
Based on the success of AMC’s ATM program, its operating performance to date, and its effective cash management efforts, AMC’s liquidity position (cash, cash equivalents and undrawn revolving credit facility capacity) as of December 31, 2022 is currently estimated to be between $725 and $825 million, after debt repurchases and including $211.2 million of undrawn capacity under the Company’s revolving credit facility, subject to operating performance during the remainder of the holiday period in 2022 and the timing of landlord concessions. This implies an improvement in the net decrease in cash and cash equivalents and restricted cash of between $110 million and $210 million compared to the third quarter of 2022.
AMC is announcing the acquisition of the 13-screen former Arclight Cinemas theatre located at The Hub on Causeway, the large-scale mixed-use development at North Station, in Boston, Massachusetts. This theatre is brand new, having opened in December 2019 and closed only three months later due to COVID-19.
Adam Aron, Chairman and CEO of AMC Entertainment commented, "Even though the APE units and our common shares are economically equivalent, it is disappointing that the APE units have since inception consistently traded at a significant discount to the AMC common shares. While the trading prices of the two securities seem to reflect distinct market and trading dynamics, the APEs are serving precisely the purpose originally intended for them. At a time when one or more of our competitors have been facing potentially devastating liquidity challenges, by contrast during the past 90 days, AMC has been able to raise $162 million of additional cash through the sale of equity thereby improving our own liquidity position markedly. In addition, AMC reduced debt for the third time this year, including most recently by buying back debt at a substantial 61% discount and is able to contemplate various opportunities to add theatres to our fleet including just having successfully secured for AMC the attractive former Arclight Boston."
Aron added, "Our outlook for the industry is positive as we expect the box office will be larger in 2023 than in 2022. Our liquidity position is strong, as we continue to demonstrate our ability to raise cash, thereby strengthening our balance sheet. We also continue to enhance our footprint by acquiring superb theatres without significant capital outlays while at the same time exiting under-performing locations. For so many reasons, we believe the future remains bright for AMC."
About AMC Entertainment Holdings, Inc.
AMC is the largest movie exhibition company in the United States, the largest in Europe and the largest throughout the world with approximately 940 theatres and 10,500 screens across the globe. AMC has propelled innovation in the exhibition industry by: deploying its Signature power-recliner seats; delivering enhanced food and beverage choices; generating greater guest engagement through its loyalty and subscription programs, web site and mobile apps; offering premium large format experiences and playing a wide variety of content including the latest Hollywood releases and independent programming. For more information, visit www.amctheatres.com.
On the Strength of AVATAR: THE WAY OF WATER and Premium Formats, AMC Theatres® Way Outpaces the Same Weekend in Pre-pandemic 2019 on Admissions Revenue and Food & Beverage Revenue – Domestically and Internationally
Powered by AVATAR: THE WAY OF WATER, AMC’s U.S. and global admissions revenue and food & beverage revenue finish significantly higher than the same weekend in pre-pandemic 2019, which was led by the opening JUMANJI: THE NEXT LEVEL
Premium formats were exceptionally popular this weekend as more than 70 percent of all admissions revenue for AVATAR: THE WAY OF WATER came from a premium experience like 3D, IMAX at AMC, Dolby Cinema at AMC and PRIME at AMC
Internationally, ODEON Cinemas on Saturday recorded its highest single-day admissions and food and beverage revenue in 2022
LEAWOOD, Kan., December 19, 2022--(BUSINESS WIRE)--AMC Theatres® (NYSE:AMC and APE), the largest theatrical exhibitor in the United States and the world, today announced that based on the strength of premium formats, and a great desire by moviegoers to return to Pandora via AVATAR: THE WAY OF WATER, the Company finished materially ahead on U.S. and global admissions revenue and food & beverage revenue versus the same weekend in pre-pandemic 2019, which was led by the opening of JUMANJI: THE NEXT LEVEL.
The groundbreaking, mesmerizing 3D experience led to AVATAR: THE WAY OF WATER being a huge hit in premium formats in the United States. Tickets sold in RealD 3D and Premium Large Formats like Dolby Cinema at AMC, IMAX at AMC, and PRIME at AMC made up more than 70% of all box office gross to the movie at AMC.
Overseas, the movie played strong all weekend, but particularly on Saturday, when Saturday, AMC’s ODEON Cinemas enjoyed its highest admissions revenue and food & beverage revenue for a single day in 2022.
AMC Chairman and CEO Adam Aron Commented:
"At AMC, we’re greatly encouraged to see our revenues soar on the opening weekend of AVATAR: THE WAY OF WATER. James Cameron has done it again with a masterpiece of a film that generated revenues at AMC and ODEON Cinemas that were materially ahead of pre-pandemic 2019. AVATAR: THE WAY OF WATER demands to be seen on the biggest screens, with the loudest sounds in the most comfortable seats imaginable. Not only that, but I’d recommend seeing it in one of our premium formats like IMAX at AMC, Dolby at AMC or PRIME at AMC, Laser at AMC, and seeing it in the visually stunning 3D. The film is unlike anything I’ve ever experienced. All of us at AMC and Odeon extend our eternal thanks to James Cameron for the brilliance of his vision, and to all our friends at Disney for their tireless efforts to make this remarkable and immersive film. I’ve already seen it twice this past weekend, and I can’t wait to go see it again."
Tickets for AVATAR: THE WAY OF WATER are on sale through the holidays at all AMC locations in the United States. Moviegoers can visit amctheatres.com or use the AMC mobile app to see showtimes and purchase tickets.
About AMC Entertainment Holdings, Inc.
AMC is the largest movie exhibition company in the United States, the largest in Europe and the largest throughout the world with approximately 950 theatres and 10,500 screens across the globe. AMC has propelled innovation in the exhibition industry by: deploying its Signature power-recliner seats; delivering enhanced food and beverage choices; generating greater guest engagement through its loyalty and subscription programs, web site and mobile apps; offering premium large format experiences and playing a wide variety of content including the latest Hollywood releases and independent programming. For more information, visit www.amctheatres.com.
Quince Therapeutics, Inc. (QNCX) : 0.6427
52 Week Range 0.6120 - 14.6000
September 30, 2022
Cash and cash equivalents $ 31,809
Short term investments 62,534
Prepaid expenses and other current assets 3,933
Total current assets 98,276
Property and equipment, net 375
Operating lease right-of-use assets, net 208
Long term investments 5,001
Intangible asset 5,900
Other assets 17
Total assets $ 109,777
Current liabilities:
Accounts payable $ 1,181
Accrued expenses and other current liabilities 3,764
Total current liabilities 4,945
Long-term financing lease liabilities 19
Long-term operating lease liabilities 34
Deferred tax liabilities 248
Total liabilities 5,246
As of November 24, 2022, the registrant had 36,130,306 shares of common stock
Total assets $ 109,777 - Total liabilities 5,246 : 36,130,306 shares of common stock = 2.894/ share.
Quince Therapeutics, Inc., a biopharmaceutical company, focuses on advancing precision therapeutics for debilitating and rare diseases. The company has discovered a broad bone-targeting drug platform to precisely deliver small molecules, peptides, or large molecules directly to the site of bone fracture and disease. Its lead compound is NOV004, an anabolic peptide engineered to precisely target and concentrate at the bone fracture site The company was formerly known as Cortexyme, Inc. and changed its name to Quince Therapeutics, Inc. in August 2022. Quince Therapeutics, Inc. was incorporated in 2012 and is headquartered in South San Francisco, California.
Quince Therapeutics, Inc. (QNCX) : 0.6427
52 Week Range 0.6120 - 14.6000
September 30, 2022
Cash and cash equivalents $ 31,809
Short term investments 62,534
Prepaid expenses and other current assets 3,933
Total current assets 98,276
Property and equipment, net 375
Operating lease right-of-use assets, net 208
Long term investments 5,001
Intangible asset 5,900
Other assets 17
Total assets $ 109,777
Current liabilities:
Accounts payable $ 1,181
Accrued expenses and other current liabilities 3,764
Total current liabilities 4,945
Long-term financing lease liabilities 19
Long-term operating lease liabilities 34
Deferred tax liabilities 248
Total liabilities 5,246
As of November 24, 2022, the registrant had 36,130,306 shares of common stock
Total assets $ 109,777 - Total liabilities 5,246 : 36,130,306 shares of common stock = 2.894/ share.
Quince Therapeutics, Inc., a biopharmaceutical company, focuses on advancing precision therapeutics for debilitating and rare diseases. The company has discovered a broad bone-targeting drug platform to precisely deliver small molecules, peptides, or large molecules directly to the site of bone fracture and disease. Its lead compound is NOV004, an anabolic peptide engineered to precisely target and concentrate at the bone fracture site The company was formerly known as Cortexyme, Inc. and changed its name to Quince Therapeutics, Inc. in August 2022. Quince Therapeutics, Inc. was incorporated in 2012 and is headquartered in South San Francisco, California.
CarSmartt, Inc.
https://smarttholdings.com/
CRSM: 0,0033 + 26.92%
https://www.otcmarkets.com/stock/CRSM/disclosure
Big news is coming
Our share structure has remained the same since last year.
As of 08/30/2021, the number of shares outstanding of our Common Stock was:
595,304,566
11/02/2022
Outstanding Shares
595,304,566
11/02/2022
Float
175,117,101
11/02/2022
= less than 0.6 million in the free float.
no dilution so room for a big rebound
Feb 23, 2022 0.0060
Jan 19, 2022 0.0084
Oct 25, 2021 0.0120
Sep 27, 2021 0.0169
Aug 23, 2021 0.0290
Jul 26, 2021 0.0550
https://smarttholdings.com/category/news/
They want to do more acquisitions : https://smarttholdings.com/careers/
https://blackbrickconstruction.com/
In June, we acquired Black Brick Construction, which specializes in ground up construction. The company has over $100K in positive cash flow and three new projects with potential for more growth.
https://smarttholdings.com/#
https://smarttholdings.com/real-estate/
https://smarttholdings.com/projects/
Smartt Inc. has purchased shares of Coinbase, netflix, fubotv, palantir and tqqq
Smartt Inc., (OTC Pink: CRSM), is pleased to announce the acquisition of Immobilfin S.P.A., a Real Estate company with an asset value of $47.6 Million and generates approximately $1.5 Million per year in revenues.
https://sec.report/Document/0001393905-21-000362/
Smartt Inc., (OTC Pink: CRSM), is pleased to announce the acquisition of Costrade S.P.A., a Construction company founded in 1951 with a track record of approximately $1 Billion in executed projects during the years of operation.
https://www.otcmarkets.com/stock/CRSM/news/Smartt-Inc-FKA-Carsmartt-Inc-Acquires-Costrade-SPA-Over-1-Billion-in-Executed-Projects?id=317575
CarSmartt entered in to an agreement with Archer Robotics, LLC., to establish a project and implementation plan to provide an autonomous vehicle platform for CarSmartt, focused on Parcels delivery with driverless cars.
Exciting things to look forward to:
– News on New Strategic Acquisitions
– News on NFTs and Cryptocurrency.
"We are excited to reveal with our Shareholders the new direction of the company, and we are ready to bring exponential shareholder value. Our commitment is to our shareholders, and we are confident that we won't let you down as we embark on this new exciting chapter."
to the moon:
https://www.barchart.com/stocks/quotes/CRSM/technical-chart?plot=CANDLE&volume=total&data=DO&density=X&pricesOn=1&asPctChange=0&logscale=0&indicators=ACCUM;HLMA(10,8);SMA(20);BBANDS(20,2);RSI(14,100);STOSL(14,3);SMACD(12,26,9);MOMENT(20);MFI(14,100);SMA(20)&sym=CRSM&grid=1
CarSmartt, Inc.
https://smarttholdings.com/
CRSM: 0,0033 + 26.92%
https://www.otcmarkets.com/stock/CRSM/disclosure
Big news is coming
Our share structure has remained the same since last year.
As of 08/30/2021, the number of shares outstanding of our Common Stock was:
595,304,566
11/02/2022
Outstanding Shares
595,304,566
11/02/2022
Float
175,117,101
11/02/2022
= less than 0.6 million in the free float.
no dilution so room for a big rebound
Feb 23, 2022 0.0060
Jan 19, 2022 0.0084
Oct 25, 2021 0.0120
Sep 27, 2021 0.0169
Aug 23, 2021 0.0290
Jul 26, 2021 0.0550
https://smarttholdings.com/category/news/
They want to do more acquisitions : https://smarttholdings.com/careers/
https://blackbrickconstruction.com/
In June, we acquired Black Brick Construction, which specializes in ground up construction. The company has over $100K in positive cash flow and three new projects with potential for more growth.
https://smarttholdings.com/#
https://smarttholdings.com/real-estate/
https://smarttholdings.com/projects/
Smartt Inc. has purchased shares of Coinbase, netflix, fubotv, palantir and tqqq
Smartt Inc., (OTC Pink: CRSM), is pleased to announce the acquisition of Immobilfin S.P.A., a Real Estate company with an asset value of $47.6 Million and generates approximately $1.5 Million per year in revenues.
https://sec.report/Document/0001393905-21-000362/
Smartt Inc., (OTC Pink: CRSM), is pleased to announce the acquisition of Costrade S.P.A., a Construction company founded in 1951 with a track record of approximately $1 Billion in executed projects during the years of operation.
https://www.otcmarkets.com/stock/CRSM/news/Smartt-Inc-FKA-Carsmartt-Inc-Acquires-Costrade-SPA-Over-1-Billion-in-Executed-Projects?id=317575
CarSmartt entered in to an agreement with Archer Robotics, LLC., to establish a project and implementation plan to provide an autonomous vehicle platform for CarSmartt, focused on Parcels delivery with driverless cars.
Exciting things to look forward to:
– News on New Strategic Acquisitions
– News on NFTs and Cryptocurrency.
"We are excited to reveal with our Shareholders the new direction of the company, and we are ready to bring exponential shareholder value. Our commitment is to our shareholders, and we are confident that we won't let you down as we embark on this new exciting chapter."
to the moon:
https://www.barchart.com/stocks/quotes/CRSM/technical-chart?plot=CANDLE&volume=total&data=DO&density=X&pricesOn=1&asPctChange=0&logscale=0&indicators=ACCUM;HLMA(10,8);SMA(20);BBANDS(20,2);RSI(14,100);STOSL(14,3);SMACD(12,26,9);MOMENT(20);MFI(14,100);SMA(20)&sym=CRSM&grid=1
Opgen OPGN: premarket $0.2865 + 0.1615 (+ 129.21%)
Pre-Market Volume 9,729,441
OpGen Announces Positive Top Line Data from Clinical Trial for Unyvero Urinary Tract Infection Panel
Study has enrolled over 1,800 patient samples at 4 U.S. clinical trial sites
Primary endpoint for Unyvero UTI for urinary tract infection shows overall weighted average sensitivity of 96.4% and overall weighted average specificity of 97.4% in preliminary analysis
Clinical performance results will be used to prepare submission package for FDA De Novo request
ROCKVILLE, Md., Dec. 13, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced top line data from its successfully completed Unyvero UTI clinical trial. OpGen’s Unyvero UTI Panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers directly from urine specimens. The test aims at quantitative detection of microorganisms.
The trial was designed to compare the performance of the Unyvero UTI Panel for detecting urinary tract infections (UTI), using clean-catch or catheter related urine samples. Preliminary analysis of all prospectively enrolled samples showed that the primary study endpoint was successfully met by demonstrating an overall weighted average sensitivity of 96.4% and overall weighted average specificity of 97.4% when compared against each trial site’s standard of care microbiology results. These findings are also in line with the interim analysis performed during the first part of the trial.
The trial included a total of 1,858 prospective and archived samples and has run over 3,300 Unyvero cartridges, including controls and reproducibility tests performed at the different trial sites. In addition to local microbiology laboratory results and additional standardized central microbiology data from an independent reference laboratory, OpGen is currently generating next-generation sequencing (NGS) data at its Rockville, MD, lab facility to also allow genotypic correlation of antibiotic resistance markers detected during the study. Based on the results of the unblinded data set, testing of additional contrived samples with well-characterized pathogen strains will complement and provide additional data points for low prevalence strains and antibiotic resistance markers. Based on all the data generated and analyzed, OpGen will now start preparing a De Novo request package for submission to the U.S. FDA in due course.
“Having completed the study as planned, we have successfully generated a large and very comprehensive study data set with multiple reference methods. We’d like to thank our study sites for their contributions in generating these data.”, said Johannes Bacher, Chief Operating Officer of OpGen. “Now that we have unblinded the results, we are excited to proceed with our in-depth analysis and compile the data submission to the FDA over the next few months.”
"Urinary tract infections represent a major healthcare burden, and diagnosing complicated UTI remains challenging. Microbiological cultures take several days to provide definitive results. Pathogenic microbial species may not be detected due to prolonged exposure to antibiotics, and complex polymicrobial infections may be difficult to elucidate. The Unyvero UTI Panel is a new and promising multiplex molecular test for the rapid detection of a comprehensive range of pathogenic bacteria, fungi, and their associated resistance markers directly from urine in under five hours. Rapid results enable early diagnosis and effective antibiotic therapy to help prevent serious complications in UTI patients," said Dr. Christopher Emery, Associate Director of Clinical Microbiology, Indiana University Health Pathology Laboratory (IUHPL), Indianapolis, IN.
OpGen intends to present data from the study at a future conference as well as to submit for a peer reviewed publication.
Disclaimer
Caution - Investigational Device, Limited by Federal (or United States) law to investigational use. The information contained in this communication does not constitute or imply an offer to sell or transfer any product. Performance characteristics for this device have not yet been established and the U.S. FDA has not yet cleared the panel.
About OpGen, Inc.
OpGen, Inc. (Rockville, MD, U.S.A.) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with our subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s current product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction including ARESiss, ARESid, and AREScloud, as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.
Opgen OPGN: premarket $0.2865 + 0.1615 (+ 129.21%)
Pre-Market Volume 9,729,441
OpGen Announces Positive Top Line Data from Clinical Trial for Unyvero Urinary Tract Infection Panel
Study has enrolled over 1,800 patient samples at 4 U.S. clinical trial sites
Primary endpoint for Unyvero UTI for urinary tract infection shows overall weighted average sensitivity of 96.4% and overall weighted average specificity of 97.4% in preliminary analysis
Clinical performance results will be used to prepare submission package for FDA De Novo request
ROCKVILLE, Md., Dec. 13, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced top line data from its successfully completed Unyvero UTI clinical trial. OpGen’s Unyvero UTI Panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers directly from urine specimens. The test aims at quantitative detection of microorganisms.
The trial was designed to compare the performance of the Unyvero UTI Panel for detecting urinary tract infections (UTI), using clean-catch or catheter related urine samples. Preliminary analysis of all prospectively enrolled samples showed that the primary study endpoint was successfully met by demonstrating an overall weighted average sensitivity of 96.4% and overall weighted average specificity of 97.4% when compared against each trial site’s standard of care microbiology results. These findings are also in line with the interim analysis performed during the first part of the trial.
The trial included a total of 1,858 prospective and archived samples and has run over 3,300 Unyvero cartridges, including controls and reproducibility tests performed at the different trial sites. In addition to local microbiology laboratory results and additional standardized central microbiology data from an independent reference laboratory, OpGen is currently generating next-generation sequencing (NGS) data at its Rockville, MD, lab facility to also allow genotypic correlation of antibiotic resistance markers detected during the study. Based on the results of the unblinded data set, testing of additional contrived samples with well-characterized pathogen strains will complement and provide additional data points for low prevalence strains and antibiotic resistance markers. Based on all the data generated and analyzed, OpGen will now start preparing a De Novo request package for submission to the U.S. FDA in due course.
“Having completed the study as planned, we have successfully generated a large and very comprehensive study data set with multiple reference methods. We’d like to thank our study sites for their contributions in generating these data.”, said Johannes Bacher, Chief Operating Officer of OpGen. “Now that we have unblinded the results, we are excited to proceed with our in-depth analysis and compile the data submission to the FDA over the next few months.”
"Urinary tract infections represent a major healthcare burden, and diagnosing complicated UTI remains challenging. Microbiological cultures take several days to provide definitive results. Pathogenic microbial species may not be detected due to prolonged exposure to antibiotics, and complex polymicrobial infections may be difficult to elucidate. The Unyvero UTI Panel is a new and promising multiplex molecular test for the rapid detection of a comprehensive range of pathogenic bacteria, fungi, and their associated resistance markers directly from urine in under five hours. Rapid results enable early diagnosis and effective antibiotic therapy to help prevent serious complications in UTI patients," said Dr. Christopher Emery, Associate Director of Clinical Microbiology, Indiana University Health Pathology Laboratory (IUHPL), Indianapolis, IN.
OpGen intends to present data from the study at a future conference as well as to submit for a peer reviewed publication.
Disclaimer
Caution - Investigational Device, Limited by Federal (or United States) law to investigational use. The information contained in this communication does not constitute or imply an offer to sell or transfer any product. Performance characteristics for this device have not yet been established and the U.S. FDA has not yet cleared the panel.
About OpGen, Inc.
OpGen, Inc. (Rockville, MD, U.S.A.) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with our subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s current product portfolio includes Unyvero, Acuitas AMR Gene Panel, and the ARES Technology Platform including ARESdb, NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction including ARESiss, ARESid, and AREScloud, as well as the Curetis CE-IVD-marked PCR-based SARS-CoV-2 test kit.
TREVENA (TRVN) : 1.98
1.98 - 18.99
Dec 09, 2022 2.3200
Dec 08, 2022 2.5400
Dec 07, 2022 2.6500
Dec 06, 2022 3.1400
Dec 05, 2022 3.4200
Cash, cash equivalents and marketable securities totaled $40.4 million as of September 30, 2022, which the Company believes will be sufficient to fund the Company’s operating expenses and capital expenditure requirements into the third quarter of 2023.
Shares Outstanding 6.95M
Total Cash (mrq) 40.39M
Total Cash Per Share (mrq) 5.81
Market Cap (intraday) 13.76M
Trevena Announces Poster Presentations of TRV045 Nonclinical Epilepsy Data, and OLINVYK Clinical Neurocognitive and GI Data, at Recent Medical Meetings
Thu, December 8, 2022 at 1:00 PM
TRV045 data reflected reduced seizure burden in nonclinical models of acute epilepsy presented at American College of Neuropsychopharmacology (ACNP) Annual Meeting
OLINVYK poster presentation on reduced effect on neurocognitive function in humans compared to morphine presented at ACNP Annual Meeting
OLINVYK comparison analysis versus other opioid treatments showed reduced gastrointestinal adverse effects presented at American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting
CHESTERBROOK, Pa., Dec. 08, 2022 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that three abstracts related to the Company’s commercial and clinical pipeline were presented at medical meetings in December. Each of the posters are available on the publications page of the Company’s website at https://www.trevena.com/publications.
TRV045 Epilepsy Poster Title: TRV045, a Novel, Selective SIP Receptor Subtype-1 Modulator that Does Not Cause Lymphopenia is Efficacious in Acute and Chronic Rodent Epilepsy Models
Summary of conclusions: Efficacy data from three nonclinical epilepsy models, in conjunction with evidence of an anti-inflammatory mechanism, suggest that selective modulation of S1P1 receptors by TRV045 may provide a new therapeutic option for the treatment of epilepsy.
OLINVYK Neurocognitive Poster Title: Oliceridine Demonstrates a Reduced Effect on Neurocognitive Function in Humans, Compared to Morphine: A Phase 1, Randomized, Placebo-Controlled, Dose-ranging, Partial Block, Cross-over Study
Summary of conclusions: OLINVYK has a reduced impact on several clinically relevant measures of cognitive performance, compared to IV morphine, including measures of sedation, motor performance, and eye-hand coordination.
OLINVYK GI Poster Title: Gastrointestinal Adverse Effects Associated with the Use of Intravenous Oliceridine Compared to Intravenous Hydromorphone or Fentanyl in Acute Pain Management Utilizing Indirect Treatment Comparison Methods
Summary of conclusions: When AEs were compared in an indirect treatment comparison (ITC) analysis using morphine as the common comparator, OLINVYK was found to significantly reduce the incidence of nausea and/or vomiting or the need for antiemetics in orthopedic surgical procedures compared to hydromorphone or fentanyl. Results in plastic surgery were not significantly different.
“We are pleased to advance the clinical understanding of the potential differentiated effect of OLINVYK versus traditional IV opioids. These data demonstrate that, compared to IV morphine, OLINVYK shows a statistically significant reduced impact on saccadic eye movement peak velocity, a sensitive measure of the sedating action of medications,” said Mark Demitrack, Senior Vice President and Chief Medical Officer of Trevena. “We are also excited by recent nonclinical results for our novel S1P1 receptor modulator, TRV045, which shows efficacy in three different acute and chronic animal models for epilepsy. We are encouraged by these data, given our recent announcement of positive topline results from our first-in-human Phase 1 study with TRV045.”
About TRV045
TRV045 is a novel, selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as a potential treatment for epilepsy.
S1P receptors are located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability.
Trevena's discovery efforts have identified a family of compounds that are highly selective for the S1P1 receptor. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. TRV045 was not associated with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical studies. TRV045 is an investigational drug and has not been approved by the FDA.
About OLINVYK® (oliceridine) injection
OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, an opioid, which is a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.
IMPORTANT SAFETY INFORMATION
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE – OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing OLINVYK, and monitor all patients regularly for the development of behaviors or conditions.
LIFE-THREATENING RESPIRATORY DEPRESSION – Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose increase.
NEONATAL OPIOID WITHDRAWAL SYNDROME – Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS – Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
INDICATIONS AND USAGE
OLINVYK is an opioid agonist indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated.
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation.
CONTRAINDICATIONS
OLINVYK is contraindicated in patients with:
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Known hypersensitivity to oliceridine (e.g., anaphylaxis)
WARNINGS AND PRECAUTIONS
OLINVYK contains oliceridine, a Schedule II controlled substance, that exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OLINVYK. Assess risk, counsel, and monitor all patients receiving opioids.
Serious, life-threatening respiratory depression has been reported with the use of opioids, even when used as recommended, especially in patients with chronic pulmonary disease, or in elderly, cachectic and debilitated patients. The risk is greatest during initiation of OLINVYK therapy, following a dose increase, or when used with other drugs that depress respiration. Proper dosing of OLINVYK is essential, especially when converting patients from another opioid product to avoid overdose. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status.
Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia with risk increasing in a dose-dependent fashion. In patients who present with CSA, consider decreasing the dose of opioid using best practices for opioid taper.
Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that may be life-threatening. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using OLINVYK for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of OLINVYK with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, or alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate, prescribe the lowest effective dose, and minimize the duration.
OLINVYK was shown to have mild QTc interval prolongation in thorough QT studies where patients were dosed up to 27 mg. Total cumulative daily doses exceeding 27 mg per day were not studied and may increase the risk for QTc interval prolongation. Therefore, the cumulative total daily dose of OLINVYK should not exceed 27 mg.
Increased plasma concentrations of OLINVYK may occur in patients with decreased Cytochrome P450 (CYP) 2D6 function or normal metabolizers taking moderate or strong CYP2D6 inhibitors; also in patients taking a moderate or strong CYP3A4 inhibitor, in patients with decreased CYP2D6 function who are also receiving a moderate or strong CYP3A4 inhibitor, or with discontinuation of a CYP3A4 inducer. These patients may require less frequent dosing and should be closely monitored for respiratory depression and sedation at frequent intervals. Concomitant use of OLINVYK with CYP3A4 inducers or discontinuation of a moderate or strong CYP3A4 inhibitor can lower the expected concentration, which may decrease efficacy, and may require supplemental doses.
Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month). Presentation and symptoms may be nonspecific and include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If confirmed, treat with physiologic replacement doses of corticosteroids and wean patient from the opioid.
OLINVYK may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension. In patients with circulatory shock, avoid the use of OLINVYK as it may cause vasodilation that can further reduce cardiac output and blood pressure.
Avoid the use of OLINVYK in patients with impaired consciousness or coma. OLINVYK should be used with caution in patients who may be susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or brain tumors, as a reduction in respiratory drive and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy.
As with all opioids, OLINVYK may cause spasm of the sphincter of Oddi, and may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
OLINVYK may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures in vulnerable patients. Monitor patients with a history of seizure disorders for worsened seizure control.
Do not abruptly discontinue OLINVYK in a patient physically dependent on opioids. Gradually taper the dosage to avoid a withdrawal syndrome and return of pain. Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving OLINVYK, as they may reduce the analgesic effect and/or precipitate withdrawal symptoms.
OLINVYK may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
Although self-administration of opioids by patient-controlled analgesia (PCA) may allow each patient to individually titrate to an acceptable level of analgesia, PCA administration has resulted in adverse outcomes and episodes of respiratory depression. Health care providers and family members monitoring patients receiving PCA analgesia should be instructed in the need for appropriate monitoring for excessive sedation, respiratory depression, or other adverse effects of opioid medications.
ADVERSE REACTIONS
Adverse reactions are described in greater detail in the Prescribing Information.
The most common (incidence ≥10%) adverse reactions in Phase 3 controlled clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.
MEDICAL INFORMATION
For medical inquiries or to report an adverse event, other safety-related information or product complaints for a company product, please contact the Trevena Medical Information Contact Center at 1-844-465-4686 or email MedInfo@Trevena.com.
You are encouraged to report suspected adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed Warning.
About Trevena
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK® (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company’s novel pipeline is based on Nobel Prize winning research and includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.
For more information, please visit www.Trevena.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of discussions with FDA; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates and approved product; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.
TREVENA (TRVN) : 1.98
1.98 - 18.99
Dec 09, 2022 2.3200
Dec 08, 2022 2.5400
Dec 07, 2022 2.6500
Dec 06, 2022 3.1400
Dec 05, 2022 3.4200
Cash, cash equivalents and marketable securities totaled $40.4 million as of September 30, 2022, which the Company believes will be sufficient to fund the Company’s operating expenses and capital expenditure requirements into the third quarter of 2023.
Shares Outstanding 6.95M
Total Cash (mrq) 40.39M
Total Cash Per Share (mrq) 5.81
Market Cap (intraday) 13.76M
Trevena Announces Poster Presentations of TRV045 Nonclinical Epilepsy Data, and OLINVYK Clinical Neurocognitive and GI Data, at Recent Medical Meetings
Thu, December 8, 2022 at 1:00 PM
TRV045 data reflected reduced seizure burden in nonclinical models of acute epilepsy presented at American College of Neuropsychopharmacology (ACNP) Annual Meeting
OLINVYK poster presentation on reduced effect on neurocognitive function in humans compared to morphine presented at ACNP Annual Meeting
OLINVYK comparison analysis versus other opioid treatments showed reduced gastrointestinal adverse effects presented at American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting
CHESTERBROOK, Pa., Dec. 08, 2022 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that three abstracts related to the Company’s commercial and clinical pipeline were presented at medical meetings in December. Each of the posters are available on the publications page of the Company’s website at https://www.trevena.com/publications.
TRV045 Epilepsy Poster Title: TRV045, a Novel, Selective SIP Receptor Subtype-1 Modulator that Does Not Cause Lymphopenia is Efficacious in Acute and Chronic Rodent Epilepsy Models
Summary of conclusions: Efficacy data from three nonclinical epilepsy models, in conjunction with evidence of an anti-inflammatory mechanism, suggest that selective modulation of S1P1 receptors by TRV045 may provide a new therapeutic option for the treatment of epilepsy.
OLINVYK Neurocognitive Poster Title: Oliceridine Demonstrates a Reduced Effect on Neurocognitive Function in Humans, Compared to Morphine: A Phase 1, Randomized, Placebo-Controlled, Dose-ranging, Partial Block, Cross-over Study
Summary of conclusions: OLINVYK has a reduced impact on several clinically relevant measures of cognitive performance, compared to IV morphine, including measures of sedation, motor performance, and eye-hand coordination.
OLINVYK GI Poster Title: Gastrointestinal Adverse Effects Associated with the Use of Intravenous Oliceridine Compared to Intravenous Hydromorphone or Fentanyl in Acute Pain Management Utilizing Indirect Treatment Comparison Methods
Summary of conclusions: When AEs were compared in an indirect treatment comparison (ITC) analysis using morphine as the common comparator, OLINVYK was found to significantly reduce the incidence of nausea and/or vomiting or the need for antiemetics in orthopedic surgical procedures compared to hydromorphone or fentanyl. Results in plastic surgery were not significantly different.
“We are pleased to advance the clinical understanding of the potential differentiated effect of OLINVYK versus traditional IV opioids. These data demonstrate that, compared to IV morphine, OLINVYK shows a statistically significant reduced impact on saccadic eye movement peak velocity, a sensitive measure of the sedating action of medications,” said Mark Demitrack, Senior Vice President and Chief Medical Officer of Trevena. “We are also excited by recent nonclinical results for our novel S1P1 receptor modulator, TRV045, which shows efficacy in three different acute and chronic animal models for epilepsy. We are encouraged by these data, given our recent announcement of positive topline results from our first-in-human Phase 1 study with TRV045.”
About TRV045
TRV045 is a novel, selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as a potential treatment for epilepsy.
S1P receptors are located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability.
Trevena's discovery efforts have identified a family of compounds that are highly selective for the S1P1 receptor. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. TRV045 was not associated with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical studies. TRV045 is an investigational drug and has not been approved by the FDA.
About OLINVYK® (oliceridine) injection
OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, an opioid, which is a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.
IMPORTANT SAFETY INFORMATION
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE – OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing OLINVYK, and monitor all patients regularly for the development of behaviors or conditions.
LIFE-THREATENING RESPIRATORY DEPRESSION – Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose increase.
NEONATAL OPIOID WITHDRAWAL SYNDROME – Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS – Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
INDICATIONS AND USAGE
OLINVYK is an opioid agonist indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated.
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation.
CONTRAINDICATIONS
OLINVYK is contraindicated in patients with:
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Known hypersensitivity to oliceridine (e.g., anaphylaxis)
WARNINGS AND PRECAUTIONS
OLINVYK contains oliceridine, a Schedule II controlled substance, that exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OLINVYK. Assess risk, counsel, and monitor all patients receiving opioids.
Serious, life-threatening respiratory depression has been reported with the use of opioids, even when used as recommended, especially in patients with chronic pulmonary disease, or in elderly, cachectic and debilitated patients. The risk is greatest during initiation of OLINVYK therapy, following a dose increase, or when used with other drugs that depress respiration. Proper dosing of OLINVYK is essential, especially when converting patients from another opioid product to avoid overdose. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status.
Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia with risk increasing in a dose-dependent fashion. In patients who present with CSA, consider decreasing the dose of opioid using best practices for opioid taper.
Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that may be life-threatening. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using OLINVYK for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of OLINVYK with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, or alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate, prescribe the lowest effective dose, and minimize the duration.
OLINVYK was shown to have mild QTc interval prolongation in thorough QT studies where patients were dosed up to 27 mg. Total cumulative daily doses exceeding 27 mg per day were not studied and may increase the risk for QTc interval prolongation. Therefore, the cumulative total daily dose of OLINVYK should not exceed 27 mg.
Increased plasma concentrations of OLINVYK may occur in patients with decreased Cytochrome P450 (CYP) 2D6 function or normal metabolizers taking moderate or strong CYP2D6 inhibitors; also in patients taking a moderate or strong CYP3A4 inhibitor, in patients with decreased CYP2D6 function who are also receiving a moderate or strong CYP3A4 inhibitor, or with discontinuation of a CYP3A4 inducer. These patients may require less frequent dosing and should be closely monitored for respiratory depression and sedation at frequent intervals. Concomitant use of OLINVYK with CYP3A4 inducers or discontinuation of a moderate or strong CYP3A4 inhibitor can lower the expected concentration, which may decrease efficacy, and may require supplemental doses.
Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month). Presentation and symptoms may be nonspecific and include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If confirmed, treat with physiologic replacement doses of corticosteroids and wean patient from the opioid.
OLINVYK may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension. In patients with circulatory shock, avoid the use of OLINVYK as it may cause vasodilation that can further reduce cardiac output and blood pressure.
Avoid the use of OLINVYK in patients with impaired consciousness or coma. OLINVYK should be used with caution in patients who may be susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or brain tumors, as a reduction in respiratory drive and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy.
As with all opioids, OLINVYK may cause spasm of the sphincter of Oddi, and may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
OLINVYK may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures in vulnerable patients. Monitor patients with a history of seizure disorders for worsened seizure control.
Do not abruptly discontinue OLINVYK in a patient physically dependent on opioids. Gradually taper the dosage to avoid a withdrawal syndrome and return of pain. Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving OLINVYK, as they may reduce the analgesic effect and/or precipitate withdrawal symptoms.
OLINVYK may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
Although self-administration of opioids by patient-controlled analgesia (PCA) may allow each patient to individually titrate to an acceptable level of analgesia, PCA administration has resulted in adverse outcomes and episodes of respiratory depression. Health care providers and family members monitoring patients receiving PCA analgesia should be instructed in the need for appropriate monitoring for excessive sedation, respiratory depression, or other adverse effects of opioid medications.
ADVERSE REACTIONS
Adverse reactions are described in greater detail in the Prescribing Information.
The most common (incidence ≥10%) adverse reactions in Phase 3 controlled clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.
MEDICAL INFORMATION
For medical inquiries or to report an adverse event, other safety-related information or product complaints for a company product, please contact the Trevena Medical Information Contact Center at 1-844-465-4686 or email MedInfo@Trevena.com.
You are encouraged to report suspected adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed Warning.
About Trevena
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK® (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company’s novel pipeline is based on Nobel Prize winning research and includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.
For more information, please visit www.Trevena.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of discussions with FDA; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates and approved product; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.
Vascular Biogenics Ltd. (VBLT):
0.1323
52w: 0.1080 - 2.2898
https://ir.vblrx.com/static-files/0b08ff67-0438-4e8a-a832-7f6877f75613
Continued progress on previously announced strategic process to maximize shareholder value
BL Therapeutics (Nasdaq: VBLT), a clinical stage biotechnology company developing targeted medicines for immune-inflammatory diseases, announced financial results for the third quarter ended September 30, 2022, and provided a corporate update.
“VBL’s management team and board continue to make good progress on the evaluation of strategic options for the company’s assets, including the GMP manufacturing facility and VB-601 program, with the goal of maximizing shareholder value,” said Dror Harats, M.D., Chief Executive Officer of VBL. “We recently submitted our regulatory filings for a first-in-human clinical trial for the VB-601 program, and expect to initiate this trial in the first quarter of 2023, subject to the outcome of our strategic process.”
Third Quarter Highlights
Filed a regulatory submission to the Israel Ministry of Health and institutional review board to conduct a Phase 1 first-in-human trial for its lead immunology product candidate,VB-601, a targeted antibody for immune-inflammatory applications.
Retained Chardan Capital to act as financial advisor to explore and evaluate strategic options for maximizing shareholder value.
Took steps to preserve capital, including the workforce reduction and ceasing internal development of ofra-vec.
Financial Results for the Third Quarter of 2022
At September 30, 2022, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $27.7 million. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures for at least twelve months. VBL’s ongoing review of its strategic options and any transactions resulting from such review may impact this projection.
About VBL Therapeutics
VBL Therapeutics (Nasdaq: VBLT) is developing targeted therapies for immune-inflammatory diseases. VBL’s lead immunology product candidate VB-601 is a targeted antibody for immune-inflammatory applications that has shown disease-modifying activity across multiple preclinical models including multiple sclerosis, rheumatoid arthritis and inflammatory bowel disease. At present, VBL is evaluating options for development of its assets, which may include partnering and other strategic options. To learn more about VBL, please visit vblrx.com or follow VBL on LinkedIn, Twitter, YouTube or Facebook.
Vascular Biogenics Ltd. (VBLT):
0.1323
52w: 0.1080 - 2.2898
https://ir.vblrx.com/static-files/0b08ff67-0438-4e8a-a832-7f6877f75613
Continued progress on previously announced strategic process to maximize shareholder value
BL Therapeutics (Nasdaq: VBLT), a clinical stage biotechnology company developing targeted medicines for immune-inflammatory diseases, announced financial results for the third quarter ended September 30, 2022, and provided a corporate update.
“VBL’s management team and board continue to make good progress on the evaluation of strategic options for the company’s assets, including the GMP manufacturing facility and VB-601 program, with the goal of maximizing shareholder value,” said Dror Harats, M.D., Chief Executive Officer of VBL. “We recently submitted our regulatory filings for a first-in-human clinical trial for the VB-601 program, and expect to initiate this trial in the first quarter of 2023, subject to the outcome of our strategic process.”
Third Quarter Highlights
Filed a regulatory submission to the Israel Ministry of Health and institutional review board to conduct a Phase 1 first-in-human trial for its lead immunology product candidate,VB-601, a targeted antibody for immune-inflammatory applications.
Retained Chardan Capital to act as financial advisor to explore and evaluate strategic options for maximizing shareholder value.
Took steps to preserve capital, including the workforce reduction and ceasing internal development of ofra-vec.
Financial Results for the Third Quarter of 2022
At September 30, 2022, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $27.7 million. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures for at least twelve months. VBL’s ongoing review of its strategic options and any transactions resulting from such review may impact this projection.
About VBL Therapeutics
VBL Therapeutics (Nasdaq: VBLT) is developing targeted therapies for immune-inflammatory diseases. VBL’s lead immunology product candidate VB-601 is a targeted antibody for immune-inflammatory applications that has shown disease-modifying activity across multiple preclinical models including multiple sclerosis, rheumatoid arthritis and inflammatory bowel disease. At present, VBL is evaluating options for development of its assets, which may include partnering and other strategic options. To learn more about VBL, please visit vblrx.com or follow VBL on LinkedIn, Twitter, YouTube or Facebook.
ONVO: 1.76
52w 1.50 - 5.60
5year high: 41.80
As of November 1, 2022, a total of 8,713,268 shares of the registrant’s Common Stock, $0.001 par value, were outstanding.
September 30
Cash and cash equivalents $ 13,265 = 1.53/ share
total assets $ 27,910 = 3.21/ share
https://ir.organovo.com/static-files/eecfb975-d2f1-4fb9-babd-a5c3ab1346b7
https://organovo.com/
About Organovo
Organovo is an early-stage biotechnology company that is developing and utilizing highly customized 3D human tissues as dynamic models of healthy and diseased human biology for drug development. The company’s proprietary technology is being used to build functional 3D human tissues that mimic key aspects of native human tissue composition, architecture, function and disease. Organovo’s advances include cell type-specific compartments, prevalent intercellular tight junctions, and the formation of microvascular structures. Management believes these attributes can enable critical complex, multicellular disease models that can be used to develop clinically effective drugs for selected therapeutic areas.
SAN DIEGO, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), a three-dimensional biology (3D biology) company focused on delivering scientific and medical breakthroughs using novel technologies including 3D bioprinting, today announced that it has successfully advanced the use of its first inflammatory bowel disease (IBD) model and has achieved the next milestone, target validation. The company announced in May 2022 that it had achieved a successful Crohn’s disease model that demonstrates key aspects of patient biology that differ from a non-diseased state and that the model would be used to find and characterize therapeutics. The Crohn’s disease model has since been utilized to understand the biology of disease and identify specific gene targets. Treating some of those targets, by introducing a compound directly to the 3D tissue model that affects the target, has now been shown to reproducibly reduce disease. Multiple targets are now considered validated, and they represent specific druggable opportunities that the company plans to leverage. Organovo plans to advance at least one target program to medicinal chemistry by the end of 2022 to build a proprietary new drug for Crohn’s disease.
“The Organovo team has successfully identified disease regulated genes from our Crohn's disease model and importantly, identified a subset that are disease-driver genes,” said Jeff Miner, Ph.D., Organovo’s Chief Scientific Officer. “These disease-drivers directly affect the disease when modulated and represent superb therapeutic targets” he added.
Organovo Executive Chairman Keith Murphy commented, “Organovo’s progress towards our goal has been driven by a strong, dedicated scientific team that has continued to rapidly advance our programs. We are pleased to have this step completed earlier than expected, and plan to continue to meet or exceed stockholder expectations as we move therapeutics to the clinic to meet unmet medical needs.”
In September 2020, Organovo announced that it had updated its business model to capitalize on its human 3D tissue technologies in drug discovery, building disease models to find effective therapies that are more likely to succeed in the clinic than drugs discovered using animal models. We have focused on the creation of three-dimensional intestinal disease models to discover therapeutic opportunities that leverage the insights possible from the truer human biology achievable in 3D human disease models.
More than 1 million people in North America suffer from Crohn’s and its prevalence is increasing globally. Because of its progressive nature, more than 70% will require at least one surgical intervention to relieve symptoms. Current drugs can slow progression in about 50% of patients, but none are curative. Defects in the intestinal lining and inflammation can lead to abdominal pain, severe diarrhea, fatigue, weight loss, malnutrition, and lower quality of life. Chronic inflammation leads to ulcers, fistulas and bowel obstructions caused by fibrosis. Organovo believes that its 3D tissue technologies are well suited to drug and target discovery in IBD because they contain a functional intestinal epithelium that is affected by disease and a stromal layer demonstrating disease-dependent fibrosis, key targets for therapy.
The drug discovery process using 3D tissues consists of several stages. Two early steps that are uniquely important in Organovo’s approach to drug discovery are creation of a disease model followed by target discovery and validation. The steps involved in each require groundbreaking science that involves the application of tools specific to our approach. We believe the achievement of these goals represents a strong step forward and lowering of risk. The remaining steps after validation of a target are typical pharma development steps to advance a drug to Phase 1 clinical trials. The next phase will be medicinal chemistry, the creation and evaluation of new chemical entities to pick the best drug candidate. Organovo plans to do this work through an outside contract research organization. Organovo is on track to have its medicinal chemistry program result in an investigative new drug (IND) application by 2025 in alignment with our previously communicated objective to have multiple INDs by that time.
Medicinal chemistry, preclinical safety studies, and other common tasks that follow consist of common practices across pharmaceutical development, and are not unique to 3D drug discovery, but can benefit greatly from the additional insights that can be provided by testing candidates in human tissue 3D models as the candidates are screened and developed. Since these steps are more typical, the risk profile is similar to traditional pharmaceutical development at these stages. However, upon entering the clinic and seeking evidence of efficacy in humans, we believe that our use of human 3D disease models to select drug candidates will result in significantly higher probability of success.
Organovo is working on additional IBD disease models representing different aspects of disease, each of which can represent a significant advancement over previous tools. We will also seek to leverage validated targets and scientific knowledge from these disease models into business development deals and partnerships with pharmaceutical companies.
ONVO: 1.76
52w 1.50 - 5.60
5year high: 41.80
As of November 1, 2022, a total of 8,713,268 shares of the registrant’s Common Stock, $0.001 par value, were outstanding.
September 30
Cash and cash equivalents $ 13,265 = 1.53/ share
total assets $ 27,910 = 3.21/ share
https://ir.organovo.com/static-files/eecfb975-d2f1-4fb9-babd-a5c3ab1346b7
https://organovo.com/
About Organovo
Organovo is an early-stage biotechnology company that is developing and utilizing highly customized 3D human tissues as dynamic models of healthy and diseased human biology for drug development. The company’s proprietary technology is being used to build functional 3D human tissues that mimic key aspects of native human tissue composition, architecture, function and disease. Organovo’s advances include cell type-specific compartments, prevalent intercellular tight junctions, and the formation of microvascular structures. Management believes these attributes can enable critical complex, multicellular disease models that can be used to develop clinically effective drugs for selected therapeutic areas.
SAN DIEGO, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), a three-dimensional biology (3D biology) company focused on delivering scientific and medical breakthroughs using novel technologies including 3D bioprinting, today announced that it has successfully advanced the use of its first inflammatory bowel disease (IBD) model and has achieved the next milestone, target validation. The company announced in May 2022 that it had achieved a successful Crohn’s disease model that demonstrates key aspects of patient biology that differ from a non-diseased state and that the model would be used to find and characterize therapeutics. The Crohn’s disease model has since been utilized to understand the biology of disease and identify specific gene targets. Treating some of those targets, by introducing a compound directly to the 3D tissue model that affects the target, has now been shown to reproducibly reduce disease. Multiple targets are now considered validated, and they represent specific druggable opportunities that the company plans to leverage. Organovo plans to advance at least one target program to medicinal chemistry by the end of 2022 to build a proprietary new drug for Crohn’s disease.
“The Organovo team has successfully identified disease regulated genes from our Crohn's disease model and importantly, identified a subset that are disease-driver genes,” said Jeff Miner, Ph.D., Organovo’s Chief Scientific Officer. “These disease-drivers directly affect the disease when modulated and represent superb therapeutic targets” he added.
Organovo Executive Chairman Keith Murphy commented, “Organovo’s progress towards our goal has been driven by a strong, dedicated scientific team that has continued to rapidly advance our programs. We are pleased to have this step completed earlier than expected, and plan to continue to meet or exceed stockholder expectations as we move therapeutics to the clinic to meet unmet medical needs.”
In September 2020, Organovo announced that it had updated its business model to capitalize on its human 3D tissue technologies in drug discovery, building disease models to find effective therapies that are more likely to succeed in the clinic than drugs discovered using animal models. We have focused on the creation of three-dimensional intestinal disease models to discover therapeutic opportunities that leverage the insights possible from the truer human biology achievable in 3D human disease models.
More than 1 million people in North America suffer from Crohn’s and its prevalence is increasing globally. Because of its progressive nature, more than 70% will require at least one surgical intervention to relieve symptoms. Current drugs can slow progression in about 50% of patients, but none are curative. Defects in the intestinal lining and inflammation can lead to abdominal pain, severe diarrhea, fatigue, weight loss, malnutrition, and lower quality of life. Chronic inflammation leads to ulcers, fistulas and bowel obstructions caused by fibrosis. Organovo believes that its 3D tissue technologies are well suited to drug and target discovery in IBD because they contain a functional intestinal epithelium that is affected by disease and a stromal layer demonstrating disease-dependent fibrosis, key targets for therapy.
The drug discovery process using 3D tissues consists of several stages. Two early steps that are uniquely important in Organovo’s approach to drug discovery are creation of a disease model followed by target discovery and validation. The steps involved in each require groundbreaking science that involves the application of tools specific to our approach. We believe the achievement of these goals represents a strong step forward and lowering of risk. The remaining steps after validation of a target are typical pharma development steps to advance a drug to Phase 1 clinical trials. The next phase will be medicinal chemistry, the creation and evaluation of new chemical entities to pick the best drug candidate. Organovo plans to do this work through an outside contract research organization. Organovo is on track to have its medicinal chemistry program result in an investigative new drug (IND) application by 2025 in alignment with our previously communicated objective to have multiple INDs by that time.
Medicinal chemistry, preclinical safety studies, and other common tasks that follow consist of common practices across pharmaceutical development, and are not unique to 3D drug discovery, but can benefit greatly from the additional insights that can be provided by testing candidates in human tissue 3D models as the candidates are screened and developed. Since these steps are more typical, the risk profile is similar to traditional pharmaceutical development at these stages. However, upon entering the clinic and seeking evidence of efficacy in humans, we believe that our use of human 3D disease models to select drug candidates will result in significantly higher probability of success.
Organovo is working on additional IBD disease models representing different aspects of disease, each of which can represent a significant advancement over previous tools. We will also seek to leverage validated targets and scientific knowledge from these disease models into business development deals and partnerships with pharmaceutical companies.
Vascular Biogenics Ltd. (VBLT):
0.1279 + 1.59%
52w: 0.1080 - 2.2898
Continued progress on previously announced strategic process to maximize shareholder value
BL Therapeutics (Nasdaq: VBLT), a clinical stage biotechnology company developing targeted medicines for immune-inflammatory diseases, announced financial results for the third quarter ended September 30, 2022, and provided a corporate update.
“VBL’s management team and board continue to make good progress on the evaluation of strategic options for the company’s assets, including the GMP manufacturing facility and VB-601 program, with the goal of maximizing shareholder value,” said Dror Harats, M.D., Chief Executive Officer of VBL. “We recently submitted our regulatory filings for a first-in-human clinical trial for the VB-601 program, and expect to initiate this trial in the first quarter of 2023, subject to the outcome of our strategic process.”
Third Quarter Highlights
Filed a regulatory submission to the Israel Ministry of Health and institutional review board to conduct a Phase 1 first-in-human trial for its lead immunology product candidate,VB-601, a targeted antibody for immune-inflammatory applications.
Retained Chardan Capital to act as financial advisor to explore and evaluate strategic options for maximizing shareholder value.
Took steps to preserve capital, including the workforce reduction and ceasing internal development of ofra-vec.
Financial Results for the Third Quarter of 2022
At September 30, 2022, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $27.7 million. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures for at least twelve months. VBL’s ongoing review of its strategic options and any transactions resulting from such review may impact this projection.
About VBL Therapeutics
VBL Therapeutics (Nasdaq: VBLT) is developing targeted therapies for immune-inflammatory diseases. VBL’s lead immunology product candidate VB-601 is a targeted antibody for immune-inflammatory applications that has shown disease-modifying activity across multiple preclinical models including multiple sclerosis, rheumatoid arthritis and inflammatory bowel disease. At present, VBL is evaluating options for development of its assets, which may include partnering and other strategic options. To learn more about VBL, please visit vblrx.com or follow VBL on LinkedIn, Twitter, YouTube or Facebook.
Vascular Biogenics Ltd. (VBLT):
0.1279 + 1.59%
52w: 0.1080 - 2.2898
Continued progress on previously announced strategic process to maximize shareholder value
BL Therapeutics (Nasdaq: VBLT), a clinical stage biotechnology company developing targeted medicines for immune-inflammatory diseases, announced financial results for the third quarter ended September 30, 2022, and provided a corporate update.
“VBL’s management team and board continue to make good progress on the evaluation of strategic options for the company’s assets, including the GMP manufacturing facility and VB-601 program, with the goal of maximizing shareholder value,” said Dror Harats, M.D., Chief Executive Officer of VBL. “We recently submitted our regulatory filings for a first-in-human clinical trial for the VB-601 program, and expect to initiate this trial in the first quarter of 2023, subject to the outcome of our strategic process.”
Third Quarter Highlights
Filed a regulatory submission to the Israel Ministry of Health and institutional review board to conduct a Phase 1 first-in-human trial for its lead immunology product candidate,VB-601, a targeted antibody for immune-inflammatory applications.
Retained Chardan Capital to act as financial advisor to explore and evaluate strategic options for maximizing shareholder value.
Took steps to preserve capital, including the workforce reduction and ceasing internal development of ofra-vec.
Financial Results for the Third Quarter of 2022
At September 30, 2022, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $27.7 million. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures for at least twelve months. VBL’s ongoing review of its strategic options and any transactions resulting from such review may impact this projection.
About VBL Therapeutics
VBL Therapeutics (Nasdaq: VBLT) is developing targeted therapies for immune-inflammatory diseases. VBL’s lead immunology product candidate VB-601 is a targeted antibody for immune-inflammatory applications that has shown disease-modifying activity across multiple preclinical models including multiple sclerosis, rheumatoid arthritis and inflammatory bowel disease. At present, VBL is evaluating options for development of its assets, which may include partnering and other strategic options. To learn more about VBL, please visit vblrx.com or follow VBL on LinkedIn, Twitter, YouTube or Facebook.
RECON TECHNOLOGY LTD RCON 0,99 +7,32%
BEIJING, Dec. 8, 2022 /PRNewswire/ -- Recon Technology, Ltd (NASDAQ: RCON) ("Recon" or the "Company"), a China-based independent solutions integrator in the oilfield service and environmental protection, electric power and coal chemical industries, today announced that a mainland China variable interest entity's subsidiary, Huang Hua BHD Petroleum Equipment Manufacturing Co. Ltd. ("HH BHD") was awarded a RMB3.97 million ($0.57 million) contract to provide high efficiency heating furnaces equipment for a leading China oil and gas company. In total, HH BHD has generated RMB6.68 million ($0.96 million) in revenue from awarded bids and contracts in the past fiscal quarters.
Pursuant to the recently awarded contract, the equipment HH BHD will supply include insulation devices, automatic alcohol injection device for oil and gas wells and pipelines, large tank extraction skids for processing equipment, splitters and sewage tanks. HH BHD will also provide repair and maintenance services for heating furnaces at the oil and gas client's oil transmission center. All equipment to be supplied under the contract have a two-year quality guarantee.
Management Statement
Mr. Shenping Yin, Founder and CEO of Recon commented: "These contracts affirm our commitment to our customers to continuously provide first-in-class solutions and services they need to outpace their competition and succeed. The enduring usage and high-quality of our products could be applied in various forms, serving a variety of industries that shall help bolster our overall business performance in the coming year."
About Recon Technology, Ltd ("RCON")
Recon Technology, Ltd (NASDAQ: RCON) is the People's Republic of China's first NASDAQ-listed non-state owned oil and gas field service company. Recon supplies China's largest oil exploration companies, Sinopec (NYSE: SNP) and The China National Petroleum Corporation ("CNPC"), with advanced automated technologies, efficient gathering and transportation equipment and reservoir stimulation measure for increasing petroleum extraction levels, reducing impurities and lowering production costs. Through the years, RCON has taken leading positions within several segmented markets of the oil and gas filed service industry. RCON also has developed stable long-term cooperation relationship with its major clients. For additional information please visit: http://www.recon.cn/.
Forward-Looking Statements
Recon includes "forward-looking statements" within the meaning of the federal securities laws throughout this press release. A reader can identify forward-looking statements because they are not limited to historical fact or they use words such as "scheduled," "may," "will," "could," "should," "would," "expect," "believe," "anticipate," "project," "plan," "estimate," "forecast," "goal," "objective," "committed," "intend," "continue," or "will likely result," and similar expressions that concern Recon's strategy, plans, intentions or beliefs about future occurrences or results. Forward-looking statements are subject to risks, uncertainties and other factors that may change at any time and may cause actual results to differ materially from those that Recon expected. Many of these statements are derived from Recon's operating budgets and forecasts, which are based on many detailed assumptions that Recon believes are reasonable, or are based on various assumptions about certain plans, activities or events which we expect will or may occur in the future. However, it is very difficult to predict the effect of known factors, and Recon cannot anticipate all factors that could affect actual results that may be important to an investor. All forward-looking information should be evaluated in the context of these risks, uncertainties and other factors, including those factors disclosed under "Risk Factors" in Recon's most recent Annual Report on Form 20-F and any subsequent half-year financial filings on Form 6-K filed with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by the cautionary statements that Recon makes from time to time in its SEC filings and public communications. Recon cannot assure the reader that it will realize the results or developments Recon anticipates, or, even if substantially realized, that they will result in the consequences or affect Recon or its operations in the way Recon expects. Forward-looking statements speak only as of the date made. Recon undertakes no obligation to update or revise any forward-looking statements to reflect events or circumstances arising after the date on which they were made, except as otherwise required by law. As a result of these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements included herein or that may be made elsewhere from time to time by, or on behalf of, Recon.
For more information, please contact:
Company
Ms. Liu Jia
Chief Financial Officer
Recon Technology, Ltd
Phone: +86 (10) 8494-5799
Email: info@recon.cn
Investor Relations
Janice Wang
Wealth Financial Services LLC
Phone: +86 13811768559
+1 628 283 9214
Email: services@wealthfsllc.com
RECON TECHNOLOGY LTD RCON 0,99 +7,32%
BEIJING, Dec. 8, 2022 /PRNewswire/ -- Recon Technology, Ltd (NASDAQ: RCON) ("Recon" or the "Company"), a China-based independent solutions integrator in the oilfield service and environmental protection, electric power and coal chemical industries, today announced that a mainland China variable interest entity's subsidiary, Huang Hua BHD Petroleum Equipment Manufacturing Co. Ltd. ("HH BHD") was awarded a RMB3.97 million ($0.57 million) contract to provide high efficiency heating furnaces equipment for a leading China oil and gas company. In total, HH BHD has generated RMB6.68 million ($0.96 million) in revenue from awarded bids and contracts in the past fiscal quarters.
Pursuant to the recently awarded contract, the equipment HH BHD will supply include insulation devices, automatic alcohol injection device for oil and gas wells and pipelines, large tank extraction skids for processing equipment, splitters and sewage tanks. HH BHD will also provide repair and maintenance services for heating furnaces at the oil and gas client's oil transmission center. All equipment to be supplied under the contract have a two-year quality guarantee.
Management Statement
Mr. Shenping Yin, Founder and CEO of Recon commented: "These contracts affirm our commitment to our customers to continuously provide first-in-class solutions and services they need to outpace their competition and succeed. The enduring usage and high-quality of our products could be applied in various forms, serving a variety of industries that shall help bolster our overall business performance in the coming year."
About Recon Technology, Ltd ("RCON")
Recon Technology, Ltd (NASDAQ: RCON) is the People's Republic of China's first NASDAQ-listed non-state owned oil and gas field service company. Recon supplies China's largest oil exploration companies, Sinopec (NYSE: SNP) and The China National Petroleum Corporation ("CNPC"), with advanced automated technologies, efficient gathering and transportation equipment and reservoir stimulation measure for increasing petroleum extraction levels, reducing impurities and lowering production costs. Through the years, RCON has taken leading positions within several segmented markets of the oil and gas filed service industry. RCON also has developed stable long-term cooperation relationship with its major clients. For additional information please visit: http://www.recon.cn/.
Forward-Looking Statements
Recon includes "forward-looking statements" within the meaning of the federal securities laws throughout this press release. A reader can identify forward-looking statements because they are not limited to historical fact or they use words such as "scheduled," "may," "will," "could," "should," "would," "expect," "believe," "anticipate," "project," "plan," "estimate," "forecast," "goal," "objective," "committed," "intend," "continue," or "will likely result," and similar expressions that concern Recon's strategy, plans, intentions or beliefs about future occurrences or results. Forward-looking statements are subject to risks, uncertainties and other factors that may change at any time and may cause actual results to differ materially from those that Recon expected. Many of these statements are derived from Recon's operating budgets and forecasts, which are based on many detailed assumptions that Recon believes are reasonable, or are based on various assumptions about certain plans, activities or events which we expect will or may occur in the future. However, it is very difficult to predict the effect of known factors, and Recon cannot anticipate all factors that could affect actual results that may be important to an investor. All forward-looking information should be evaluated in the context of these risks, uncertainties and other factors, including those factors disclosed under "Risk Factors" in Recon's most recent Annual Report on Form 20-F and any subsequent half-year financial filings on Form 6-K filed with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by the cautionary statements that Recon makes from time to time in its SEC filings and public communications. Recon cannot assure the reader that it will realize the results or developments Recon anticipates, or, even if substantially realized, that they will result in the consequences or affect Recon or its operations in the way Recon expects. Forward-looking statements speak only as of the date made. Recon undertakes no obligation to update or revise any forward-looking statements to reflect events or circumstances arising after the date on which they were made, except as otherwise required by law. As a result of these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements included herein or that may be made elsewhere from time to time by, or on behalf of, Recon.
For more information, please contact:
Company
Ms. Liu Jia
Chief Financial Officer
Recon Technology, Ltd
Phone: +86 (10) 8494-5799
Email: info@recon.cn
Investor Relations
Janice Wang
Wealth Financial Services LLC
Phone: +86 13811768559
+1 628 283 9214
Email: services@wealthfsllc.com
All time low
QUINCE THERAPEUTICS (QNCX): 0.6132 -11.83%
52w: 0.6118 – 14.600
Total Cash (mrq) 94.34M
Total Cash Per Share (mrq) 2.61
Total Debt (mrq) 420k
Book Value Per Share (mrq) 2.89
Shares Outstanding 36.13M
Float 27.61M
Shares Short (Nov 14, 2022) 4 3.38M
Quince Therapeutics, Inc., a biopharmaceutical company, focuses on advancing precision therapeutics for debilitating and rare diseases. The company has discovered a broad bone-targeting drug platform to precisely deliver small molecules, peptides, or large molecules directly to the site of bone fracture and disease. Its lead compound is NOV004, an anabolic peptide engineered to precisely target and concentrate at the bone fracture site The company was formerly known as Cortexyme, Inc. and changed its name to Quince Therapeutics, Inc. in August 2022. Quince Therapeutics, Inc. was incorporated in 2012 and is headquartered in South San Francisco, California.
All time low
QUINCE THERAPEUTICS (QNCX): 0.6132 -11.83%
52w: 0.6118 – 14.600
Total Cash (mrq) 94.34M
Total Cash Per Share (mrq) 2.61
Total Debt (mrq) 420k
Book Value Per Share (mrq) 2.89
Shares Outstanding 36.13M
Float 27.61M
Shares Short (Nov 14, 2022) 4 3.38M
Quince Therapeutics, Inc., a biopharmaceutical company, focuses on advancing precision therapeutics for debilitating and rare diseases. The company has discovered a broad bone-targeting drug platform to precisely deliver small molecules, peptides, or large molecules directly to the site of bone fracture and disease. Its lead compound is NOV004, an anabolic peptide engineered to precisely target and concentrate at the bone fracture site The company was formerly known as Cortexyme, Inc. and changed its name to Quince Therapeutics, Inc. in August 2022. Quince Therapeutics, Inc. was incorporated in 2012 and is headquartered in South San Francisco, California.
TREVENA (TRVN) : 2.26
2.26 - 18.99
Trevena Announces Poster Presentations of TRV045 Nonclinical Epilepsy Data, and OLINVYK Clinical Neurocognitive and GI Data, at Recent Medical Meetings
Thu, December 8, 2022 at 1:00 PM
TRV045 data reflected reduced seizure burden in nonclinical models of acute epilepsy presented at American College of Neuropsychopharmacology (ACNP) Annual Meeting
OLINVYK poster presentation on reduced effect on neurocognitive function in humans compared to morphine presented at ACNP Annual Meeting
OLINVYK comparison analysis versus other opioid treatments showed reduced gastrointestinal adverse effects presented at American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting
CHESTERBROOK, Pa., Dec. 08, 2022 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that three abstracts related to the Company’s commercial and clinical pipeline were presented at medical meetings in December. Each of the posters are available on the publications page of the Company’s website at https://www.trevena.com/publications.
TRV045 Epilepsy Poster Title: TRV045, a Novel, Selective SIP Receptor Subtype-1 Modulator that Does Not Cause Lymphopenia is Efficacious in Acute and Chronic Rodent Epilepsy Models
Summary of conclusions: Efficacy data from three nonclinical epilepsy models, in conjunction with evidence of an anti-inflammatory mechanism, suggest that selective modulation of S1P1 receptors by TRV045 may provide a new therapeutic option for the treatment of epilepsy.
OLINVYK Neurocognitive Poster Title: Oliceridine Demonstrates a Reduced Effect on Neurocognitive Function in Humans, Compared to Morphine: A Phase 1, Randomized, Placebo-Controlled, Dose-ranging, Partial Block, Cross-over Study
Summary of conclusions: OLINVYK has a reduced impact on several clinically relevant measures of cognitive performance, compared to IV morphine, including measures of sedation, motor performance, and eye-hand coordination.
OLINVYK GI Poster Title: Gastrointestinal Adverse Effects Associated with the Use of Intravenous Oliceridine Compared to Intravenous Hydromorphone or Fentanyl in Acute Pain Management Utilizing Indirect Treatment Comparison Methods
Summary of conclusions: When AEs were compared in an indirect treatment comparison (ITC) analysis using morphine as the common comparator, OLINVYK was found to significantly reduce the incidence of nausea and/or vomiting or the need for antiemetics in orthopedic surgical procedures compared to hydromorphone or fentanyl. Results in plastic surgery were not significantly different.
“We are pleased to advance the clinical understanding of the potential differentiated effect of OLINVYK versus traditional IV opioids. These data demonstrate that, compared to IV morphine, OLINVYK shows a statistically significant reduced impact on saccadic eye movement peak velocity, a sensitive measure of the sedating action of medications,” said Mark Demitrack, Senior Vice President and Chief Medical Officer of Trevena. “We are also excited by recent nonclinical results for our novel S1P1 receptor modulator, TRV045, which shows efficacy in three different acute and chronic animal models for epilepsy. We are encouraged by these data, given our recent announcement of positive topline results from our first-in-human Phase 1 study with TRV045.”
About TRV045
TRV045 is a novel, selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as a potential treatment for epilepsy.
S1P receptors are located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability.
Trevena's discovery efforts have identified a family of compounds that are highly selective for the S1P1 receptor. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. TRV045 was not associated with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical studies. TRV045 is an investigational drug and has not been approved by the FDA.
About OLINVYK® (oliceridine) injection
OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, an opioid, which is a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.
IMPORTANT SAFETY INFORMATION
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE – OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing OLINVYK, and monitor all patients regularly for the development of behaviors or conditions.
LIFE-THREATENING RESPIRATORY DEPRESSION – Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose increase.
NEONATAL OPIOID WITHDRAWAL SYNDROME – Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS – Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
INDICATIONS AND USAGE
OLINVYK is an opioid agonist indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated.
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation.
CONTRAINDICATIONS
OLINVYK is contraindicated in patients with:
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Known hypersensitivity to oliceridine (e.g., anaphylaxis)
WARNINGS AND PRECAUTIONS
OLINVYK contains oliceridine, a Schedule II controlled substance, that exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OLINVYK. Assess risk, counsel, and monitor all patients receiving opioids.
Serious, life-threatening respiratory depression has been reported with the use of opioids, even when used as recommended, especially in patients with chronic pulmonary disease, or in elderly, cachectic and debilitated patients. The risk is greatest during initiation of OLINVYK therapy, following a dose increase, or when used with other drugs that depress respiration. Proper dosing of OLINVYK is essential, especially when converting patients from another opioid product to avoid overdose. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status.
Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia with risk increasing in a dose-dependent fashion. In patients who present with CSA, consider decreasing the dose of opioid using best practices for opioid taper.
Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that may be life-threatening. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using OLINVYK for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of OLINVYK with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, or alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate, prescribe the lowest effective dose, and minimize the duration.
OLINVYK was shown to have mild QTc interval prolongation in thorough QT studies where patients were dosed up to 27 mg. Total cumulative daily doses exceeding 27 mg per day were not studied and may increase the risk for QTc interval prolongation. Therefore, the cumulative total daily dose of OLINVYK should not exceed 27 mg.
Increased plasma concentrations of OLINVYK may occur in patients with decreased Cytochrome P450 (CYP) 2D6 function or normal metabolizers taking moderate or strong CYP2D6 inhibitors; also in patients taking a moderate or strong CYP3A4 inhibitor, in patients with decreased CYP2D6 function who are also receiving a moderate or strong CYP3A4 inhibitor, or with discontinuation of a CYP3A4 inducer. These patients may require less frequent dosing and should be closely monitored for respiratory depression and sedation at frequent intervals. Concomitant use of OLINVYK with CYP3A4 inducers or discontinuation of a moderate or strong CYP3A4 inhibitor can lower the expected concentration, which may decrease efficacy, and may require supplemental doses.
Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month). Presentation and symptoms may be nonspecific and include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If confirmed, treat with physiologic replacement doses of corticosteroids and wean patient from the opioid.
OLINVYK may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension. In patients with circulatory shock, avoid the use of OLINVYK as it may cause vasodilation that can further reduce cardiac output and blood pressure.
Avoid the use of OLINVYK in patients with impaired consciousness or coma. OLINVYK should be used with caution in patients who may be susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or brain tumors, as a reduction in respiratory drive and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy.
As with all opioids, OLINVYK may cause spasm of the sphincter of Oddi, and may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
OLINVYK may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures in vulnerable patients. Monitor patients with a history of seizure disorders for worsened seizure control.
Do not abruptly discontinue OLINVYK in a patient physically dependent on opioids. Gradually taper the dosage to avoid a withdrawal syndrome and return of pain. Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving OLINVYK, as they may reduce the analgesic effect and/or precipitate withdrawal symptoms.
OLINVYK may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
Although self-administration of opioids by patient-controlled analgesia (PCA) may allow each patient to individually titrate to an acceptable level of analgesia, PCA administration has resulted in adverse outcomes and episodes of respiratory depression. Health care providers and family members monitoring patients receiving PCA analgesia should be instructed in the need for appropriate monitoring for excessive sedation, respiratory depression, or other adverse effects of opioid medications.
ADVERSE REACTIONS
Adverse reactions are described in greater detail in the Prescribing Information.
The most common (incidence ≥10%) adverse reactions in Phase 3 controlled clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.
MEDICAL INFORMATION
For medical inquiries or to report an adverse event, other safety-related information or product complaints for a company product, please contact the Trevena Medical Information Contact Center at 1-844-465-4686 or email MedInfo@Trevena.com.
You are encouraged to report suspected adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed Warning.
About Trevena
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK® (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company’s novel pipeline is based on Nobel Prize winning research and includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.
For more information, please visit www.Trevena.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of discussions with FDA; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates and approved product; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.
TREVENA (TRVN) : 2.26
2.26 - 18.99
Trevena Announces Poster Presentations of TRV045 Nonclinical Epilepsy Data, and OLINVYK Clinical Neurocognitive and GI Data, at Recent Medical Meetings
Thu, December 8, 2022 at 1:00 PM
TRV045 data reflected reduced seizure burden in nonclinical models of acute epilepsy presented at American College of Neuropsychopharmacology (ACNP) Annual Meeting
OLINVYK poster presentation on reduced effect on neurocognitive function in humans compared to morphine presented at ACNP Annual Meeting
OLINVYK comparison analysis versus other opioid treatments showed reduced gastrointestinal adverse effects presented at American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting
CHESTERBROOK, Pa., Dec. 08, 2022 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that three abstracts related to the Company’s commercial and clinical pipeline were presented at medical meetings in December. Each of the posters are available on the publications page of the Company’s website at https://www.trevena.com/publications.
TRV045 Epilepsy Poster Title: TRV045, a Novel, Selective SIP Receptor Subtype-1 Modulator that Does Not Cause Lymphopenia is Efficacious in Acute and Chronic Rodent Epilepsy Models
Summary of conclusions: Efficacy data from three nonclinical epilepsy models, in conjunction with evidence of an anti-inflammatory mechanism, suggest that selective modulation of S1P1 receptors by TRV045 may provide a new therapeutic option for the treatment of epilepsy.
OLINVYK Neurocognitive Poster Title: Oliceridine Demonstrates a Reduced Effect on Neurocognitive Function in Humans, Compared to Morphine: A Phase 1, Randomized, Placebo-Controlled, Dose-ranging, Partial Block, Cross-over Study
Summary of conclusions: OLINVYK has a reduced impact on several clinically relevant measures of cognitive performance, compared to IV morphine, including measures of sedation, motor performance, and eye-hand coordination.
OLINVYK GI Poster Title: Gastrointestinal Adverse Effects Associated with the Use of Intravenous Oliceridine Compared to Intravenous Hydromorphone or Fentanyl in Acute Pain Management Utilizing Indirect Treatment Comparison Methods
Summary of conclusions: When AEs were compared in an indirect treatment comparison (ITC) analysis using morphine as the common comparator, OLINVYK was found to significantly reduce the incidence of nausea and/or vomiting or the need for antiemetics in orthopedic surgical procedures compared to hydromorphone or fentanyl. Results in plastic surgery were not significantly different.
“We are pleased to advance the clinical understanding of the potential differentiated effect of OLINVYK versus traditional IV opioids. These data demonstrate that, compared to IV morphine, OLINVYK shows a statistically significant reduced impact on saccadic eye movement peak velocity, a sensitive measure of the sedating action of medications,” said Mark Demitrack, Senior Vice President and Chief Medical Officer of Trevena. “We are also excited by recent nonclinical results for our novel S1P1 receptor modulator, TRV045, which shows efficacy in three different acute and chronic animal models for epilepsy. We are encouraged by these data, given our recent announcement of positive topline results from our first-in-human Phase 1 study with TRV045.”
About TRV045
TRV045 is a novel, selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as a potential treatment for epilepsy.
S1P receptors are located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability.
Trevena's discovery efforts have identified a family of compounds that are highly selective for the S1P1 receptor. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. TRV045 was not associated with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical studies. TRV045 is an investigational drug and has not been approved by the FDA.
About OLINVYK® (oliceridine) injection
OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, an opioid, which is a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.
IMPORTANT SAFETY INFORMATION
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE – OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing OLINVYK, and monitor all patients regularly for the development of behaviors or conditions.
LIFE-THREATENING RESPIRATORY DEPRESSION – Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose increase.
NEONATAL OPIOID WITHDRAWAL SYNDROME – Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS – Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
INDICATIONS AND USAGE
OLINVYK is an opioid agonist indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated.
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation.
CONTRAINDICATIONS
OLINVYK is contraindicated in patients with:
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Known hypersensitivity to oliceridine (e.g., anaphylaxis)
WARNINGS AND PRECAUTIONS
OLINVYK contains oliceridine, a Schedule II controlled substance, that exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OLINVYK. Assess risk, counsel, and monitor all patients receiving opioids.
Serious, life-threatening respiratory depression has been reported with the use of opioids, even when used as recommended, especially in patients with chronic pulmonary disease, or in elderly, cachectic and debilitated patients. The risk is greatest during initiation of OLINVYK therapy, following a dose increase, or when used with other drugs that depress respiration. Proper dosing of OLINVYK is essential, especially when converting patients from another opioid product to avoid overdose. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status.
Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia with risk increasing in a dose-dependent fashion. In patients who present with CSA, consider decreasing the dose of opioid using best practices for opioid taper.
Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that may be life-threatening. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using OLINVYK for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of OLINVYK with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, or alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate, prescribe the lowest effective dose, and minimize the duration.
OLINVYK was shown to have mild QTc interval prolongation in thorough QT studies where patients were dosed up to 27 mg. Total cumulative daily doses exceeding 27 mg per day were not studied and may increase the risk for QTc interval prolongation. Therefore, the cumulative total daily dose of OLINVYK should not exceed 27 mg.
Increased plasma concentrations of OLINVYK may occur in patients with decreased Cytochrome P450 (CYP) 2D6 function or normal metabolizers taking moderate or strong CYP2D6 inhibitors; also in patients taking a moderate or strong CYP3A4 inhibitor, in patients with decreased CYP2D6 function who are also receiving a moderate or strong CYP3A4 inhibitor, or with discontinuation of a CYP3A4 inducer. These patients may require less frequent dosing and should be closely monitored for respiratory depression and sedation at frequent intervals. Concomitant use of OLINVYK with CYP3A4 inducers or discontinuation of a moderate or strong CYP3A4 inhibitor can lower the expected concentration, which may decrease efficacy, and may require supplemental doses.
Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month). Presentation and symptoms may be nonspecific and include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If confirmed, treat with physiologic replacement doses of corticosteroids and wean patient from the opioid.
OLINVYK may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension. In patients with circulatory shock, avoid the use of OLINVYK as it may cause vasodilation that can further reduce cardiac output and blood pressure.
Avoid the use of OLINVYK in patients with impaired consciousness or coma. OLINVYK should be used with caution in patients who may be susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or brain tumors, as a reduction in respiratory drive and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy.
As with all opioids, OLINVYK may cause spasm of the sphincter of Oddi, and may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
OLINVYK may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures in vulnerable patients. Monitor patients with a history of seizure disorders for worsened seizure control.
Do not abruptly discontinue OLINVYK in a patient physically dependent on opioids. Gradually taper the dosage to avoid a withdrawal syndrome and return of pain. Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving OLINVYK, as they may reduce the analgesic effect and/or precipitate withdrawal symptoms.
OLINVYK may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
Although self-administration of opioids by patient-controlled analgesia (PCA) may allow each patient to individually titrate to an acceptable level of analgesia, PCA administration has resulted in adverse outcomes and episodes of respiratory depression. Health care providers and family members monitoring patients receiving PCA analgesia should be instructed in the need for appropriate monitoring for excessive sedation, respiratory depression, or other adverse effects of opioid medications.
ADVERSE REACTIONS
Adverse reactions are described in greater detail in the Prescribing Information.
The most common (incidence ≥10%) adverse reactions in Phase 3 controlled clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.
MEDICAL INFORMATION
For medical inquiries or to report an adverse event, other safety-related information or product complaints for a company product, please contact the Trevena Medical Information Contact Center at 1-844-465-4686 or email MedInfo@Trevena.com.
You are encouraged to report suspected adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed Warning.
About Trevena
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK® (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company’s novel pipeline is based on Nobel Prize winning research and includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.
For more information, please visit www.Trevena.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of discussions with FDA; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates and approved product; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.
APRE: 0,544 +13,36%
Volume :133.317
Time for a strong rebound??
H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating on Aprea Therapeutics (APRE - Research Report) and set a price target of $3.00.
APRE: 0,544 +13,36%
Volume :133.317
Time for a strong rebound??
H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating on Aprea Therapeutics (APRE - Research Report) and set a price target of $3.00.
OpGen, Inc. (OPGN) 0.1596+0.0124 (+8.42%)
Back to 0.20?
Nov 28, 2022 0.1830 0.2000 0.1430 0.1500 0.1500 2,804,400
Nov 21, 2022 0.2200 0.2200 0.1800 0.1800 0.1800 589,400
Nov 14, 2022 0.2090 0.2320 0.1900 0.2190 0.2190 1,146,800
Nov 07, 2022 0.1830 0.2070 0.1700 0.2030 0.2030 1,757,700
Oct 30, 2022 0.2040 0.2040 0.1730 0.1820 0.1820 1,496,800
Oct 23, 2022 0.1900 0.2140 0.1610 0.1880 0.1880 2,533,600
Oct 16, 2022 0.1900 0.2170 0.1800 0.1860 0.1860 2,078,800
Oct 09, 2022 0.2580 0.2580 0.1870 0.1900 0.1900 2,729,100
Oct 02, 2022 0.2970 0.3300 0.2430 0.2510 0.2510 1,903,300
Sep 25, 2022 0.4100 0.4100 0.2700 0.2860 0.2860 1,752,900
Sep 18, 2022 0.4130 0.4480 0.3700 0.3870 0.3870 831,500
Sep 11, 2022 0.4500 0.4800 0.3900 0.4190 0.4190 2,307,600
OpGen, Inc. (OPGN) 0.1596+0.0124 (+8.42%)
Back to 0.20?
Nov 28, 2022 0.1830 0.2000 0.1430 0.1500 0.1500 2,804,400
Nov 21, 2022 0.2200 0.2200 0.1800 0.1800 0.1800 589,400
Nov 14, 2022 0.2090 0.2320 0.1900 0.2190 0.2190 1,146,800
Nov 07, 2022 0.1830 0.2070 0.1700 0.2030 0.2030 1,757,700
Oct 30, 2022 0.2040 0.2040 0.1730 0.1820 0.1820 1,496,800
Oct 23, 2022 0.1900 0.2140 0.1610 0.1880 0.1880 2,533,600
Oct 16, 2022 0.1900 0.2170 0.1800 0.1860 0.1860 2,078,800
Oct 09, 2022 0.2580 0.2580 0.1870 0.1900 0.1900 2,729,100
Oct 02, 2022 0.2970 0.3300 0.2430 0.2510 0.2510 1,903,300
Sep 25, 2022 0.4100 0.4100 0.2700 0.2860 0.2860 1,752,900
Sep 18, 2022 0.4130 0.4480 0.3700 0.3870 0.3870 831,500
Sep 11, 2022 0.4500 0.4800 0.3900 0.4190 0.4190 2,307,600
OpGen, Inc. (OPGN) : 0.1501
52 Week Range 0.1427 - 1.4700
recent news:
https://www.globenewswire.com/news-release/2022/10/25/2540712/35690/en/OpGen-Subsidiary-Curetis-and-BioVersys-Sign-Collaboration-Agreement-for-Clinical-Trial-Support.html
Oct. 03, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or the “Company”), today announced that it has closed its previously announced registered direct offering with a single institutional investor for the purchase and sale of 9,660,000 shares of the Company’s common stock at a purchase price of $0.35 per share of common stock.
Total Cash (mrq) 10.28M
Shares Outstanding 53.7M
Float 48.18M
Total Cash Per Share (mrq) 0.19
Book Value Per Share (mrq) 0.29
Total assets September 30, 2022 $32,959,167 $ : 53.7M = 0.614/share
OpGen, Inc., a precision medicine company, engages in developing and commercializing molecular microbiology solutions in the United States and internationally. Its product portfolio includes Acuitas AMR Gene Panel, an in vitro diagnostic (IVD) test for the detection and identification of various bacterial nucleic acids and genetic determinants of antimicrobial resistance (AMR) from bacterial colonies isolated from any specimen, as well as Curetis CE-IVD-marked polymerase chain reaction-based SARS-CoV-2 test kits. The company's products also comprise ARES Technology Platform, including ARES reference database on antimicrobial resistance using next generation sequencing technology and artificial intelligence powered bioinformatics solutions for antibiotic response prediction; and Unyvero Platform, an automated sample-to-answer molecular diagnostics platform that integrates automated sample preparation, analysis, and identification of disease relevant pathogens and antibiotic resistance markers. The company utilizes molecular diagnostics and informatics to help combat infectious diseases. It also helps clinicians with information about life threatening infections to enhance patient outcomes, and to decrease the spread of infections caused by multidrug-resistant microorganisms. OpGen, Inc. has a collaboration with the New York State Department of Health and ILÚM Health Solutions, LLC to develop a research program to detect, track, and manage antimicrobial-resistant infections at healthcare institutions. The company was incorporated in 2001 and is headquartered in Rockville, Maryland.
https://www.opgen.com/
OpGen, Inc. (OPGN) : 0.1501
52 Week Range 0.1427 - 1.4700
recent news:
https://www.globenewswire.com/news-release/2022/10/25/2540712/35690/en/OpGen-Subsidiary-Curetis-and-BioVersys-Sign-Collaboration-Agreement-for-Clinical-Trial-Support.html
Oct. 03, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or the “Company”), today announced that it has closed its previously announced registered direct offering with a single institutional investor for the purchase and sale of 9,660,000 shares of the Company’s common stock at a purchase price of $0.35 per share of common stock.
Total Cash (mrq) 10.28M
Shares Outstanding 53.7M
Float 48.18M
Total Cash Per Share (mrq) 0.19
Book Value Per Share (mrq) 0.29
Total assets September 30, 2022 $32,959,167 $ : 53.7M = 0.614/share
OpGen, Inc., a precision medicine company, engages in developing and commercializing molecular microbiology solutions in the United States and internationally. Its product portfolio includes Acuitas AMR Gene Panel, an in vitro diagnostic (IVD) test for the detection and identification of various bacterial nucleic acids and genetic determinants of antimicrobial resistance (AMR) from bacterial colonies isolated from any specimen, as well as Curetis CE-IVD-marked polymerase chain reaction-based SARS-CoV-2 test kits. The company's products also comprise ARES Technology Platform, including ARES reference database on antimicrobial resistance using next generation sequencing technology and artificial intelligence powered bioinformatics solutions for antibiotic response prediction; and Unyvero Platform, an automated sample-to-answer molecular diagnostics platform that integrates automated sample preparation, analysis, and identification of disease relevant pathogens and antibiotic resistance markers. The company utilizes molecular diagnostics and informatics to help combat infectious diseases. It also helps clinicians with information about life threatening infections to enhance patient outcomes, and to decrease the spread of infections caused by multidrug-resistant microorganisms. OpGen, Inc. has a collaboration with the New York State Department of Health and ILÚM Health Solutions, LLC to develop a research program to detect, track, and manage antimicrobial-resistant infections at healthcare institutions. The company was incorporated in 2001 and is headquartered in Rockville, Maryland.
https://www.opgen.com/
APREA THERAPEUTICS INC APRE: 0,48
52w: 0.3310 - 4.7
https://ir.aprea.com/static-files/30f4a16e-335b-4fa5-83d1-592b0aade43f
H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating on Aprea Therapeutics (APRE - Research Report) and set a price target of $3.00.
Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which is focused on developing and commercializing novel cancer therapeutics that reactivate mutant protein 53 (p53) tumor suppressor protein. The Company's lead product candidate, APR-246, or eprenetapopt, is a small molecule p53 reactivator that is in clinical development for hematologic malignancies, including myelodysplastic syndromes, or myelodysplastic syndromes (MDS), and acute myeloid leukemia (AML). The Company's APR-548 is a second generation p53 reactivator that is a unique analog of eprenetapopt and therefore a pro-drug of MQ. APR-548 exhibits high oral bioavailability in preclinical testing and is being developed in an oral dosage form. The Company has initiated a Phase I clinical trial testing APR-548 in relapsed/refractory MDS and AML. Its solid tumor program includes its clinical trial evaluating eprenetapopt with anti-PD-1 therapy in advanced solid tumors.
Total Cash (mrq) 33.11M
Total Cash Per Share (mrq) 0.62
Total Debt (mrq) 110.55k
Shares Outstanding 53M
% Held by Insiders 24.17%
Sep 30, 2022 0.8380
Jun 30, 2022 1.2900
Apr 30, 2022 1.5500
Mar 31, 2022 2.0400
Jan 01, 2022 3.2100
Dec 01, 2021 4.7000
Sep 30, 2021 5.6700
May 31, 2021 7.8000
Dec 01, 2020 30.9910
APREA THERAPEUTICS INC APRE: 0,48
52w: 0.3310 - 4.7
https://ir.aprea.com/static-files/30f4a16e-335b-4fa5-83d1-592b0aade43f
H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating on Aprea Therapeutics (APRE - Research Report) and set a price target of $3.00.
Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which is focused on developing and commercializing novel cancer therapeutics that reactivate mutant protein 53 (p53) tumor suppressor protein. The Company's lead product candidate, APR-246, or eprenetapopt, is a small molecule p53 reactivator that is in clinical development for hematologic malignancies, including myelodysplastic syndromes, or myelodysplastic syndromes (MDS), and acute myeloid leukemia (AML). The Company's APR-548 is a second generation p53 reactivator that is a unique analog of eprenetapopt and therefore a pro-drug of MQ. APR-548 exhibits high oral bioavailability in preclinical testing and is being developed in an oral dosage form. The Company has initiated a Phase I clinical trial testing APR-548 in relapsed/refractory MDS and AML. Its solid tumor program includes its clinical trial evaluating eprenetapopt with anti-PD-1 therapy in advanced solid tumors.
Total Cash (mrq) 33.11M
Total Cash Per Share (mrq) 0.62
Total Debt (mrq) 110.55k
Shares Outstanding 53M
% Held by Insiders 24.17%
Sep 30, 2022 0.8380
Jun 30, 2022 1.2900
Apr 30, 2022 1.5500
Mar 31, 2022 2.0400
Jan 01, 2022 3.2100
Dec 01, 2021 4.7000
Sep 30, 2021 5.6700
May 31, 2021 7.8000
Dec 01, 2020 30.9910
OpGen, Inc. (OPGN) : 0.1501
52 Week Range 0.1427 - 1.4700
recent news:
https://www.globenewswire.com/news-release/2022/10/25/2540712/35690/en/OpGen-Subsidiary-Curetis-and-BioVersys-Sign-Collaboration-Agreement-for-Clinical-Trial-Support.html
Oct. 03, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or the “Company”), today announced that it has closed its previously announced registered direct offering with a single institutional investor for the purchase and sale of 9,660,000 shares of the Company’s common stock at a purchase price of $0.35 per share of common stock.
Total Cash (mrq) 10.28M
Shares Outstanding 5 53.7M
Float 48.18M
Total Cash Per Share (mrq) 0.19
Book Value Per Share (mrq) 0.29
Total assets September 30, 2022 $32,959,167 $
OpGen, Inc., a precision medicine company, engages in developing and commercializing molecular microbiology solutions in the United States and internationally. Its product portfolio includes Acuitas AMR Gene Panel, an in vitro diagnostic (IVD) test for the detection and identification of various bacterial nucleic acids and genetic determinants of antimicrobial resistance (AMR) from bacterial colonies isolated from any specimen, as well as Curetis CE-IVD-marked polymerase chain reaction-based SARS-CoV-2 test kits. The company's products also comprise ARES Technology Platform, including ARES reference database on antimicrobial resistance using next generation sequencing technology and artificial intelligence powered bioinformatics solutions for antibiotic response prediction; and Unyvero Platform, an automated sample-to-answer molecular diagnostics platform that integrates automated sample preparation, analysis, and identification of disease relevant pathogens and antibiotic resistance markers. The company utilizes molecular diagnostics and informatics to help combat infectious diseases. It also helps clinicians with information about life threatening infections to enhance patient outcomes, and to decrease the spread of infections caused by multidrug-resistant microorganisms. OpGen, Inc. has a collaboration with the New York State Department of Health and ILÚM Health Solutions, LLC to develop a research program to detect, track, and manage antimicrobial-resistant infections at healthcare institutions. The company was incorporated in 2001 and is headquartered in Rockville, Maryland.
https://www.opgen.com/
OpGen, Inc. (OPGN) : 0.1501
52 Week Range 0.1427 - 1.4700
recent news:
https://www.globenewswire.com/news-release/2022/10/25/2540712/35690/en/OpGen-Subsidiary-Curetis-and-BioVersys-Sign-Collaboration-Agreement-for-Clinical-Trial-Support.html
Oct. 03, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or the “Company”), today announced that it has closed its previously announced registered direct offering with a single institutional investor for the purchase and sale of 9,660,000 shares of the Company’s common stock at a purchase price of $0.35 per share of common stock.
Total Cash (mrq) 10.28M
Shares Outstanding 5 53.7M
Float 48.18M
Total Cash Per Share (mrq) 0.19
Book Value Per Share (mrq) 0.29
Total assets September 30, 2022 $32,959,167 $
OpGen, Inc., a precision medicine company, engages in developing and commercializing molecular microbiology solutions in the United States and internationally. Its product portfolio includes Acuitas AMR Gene Panel, an in vitro diagnostic (IVD) test for the detection and identification of various bacterial nucleic acids and genetic determinants of antimicrobial resistance (AMR) from bacterial colonies isolated from any specimen, as well as Curetis CE-IVD-marked polymerase chain reaction-based SARS-CoV-2 test kits. The company's products also comprise ARES Technology Platform, including ARES reference database on antimicrobial resistance using next generation sequencing technology and artificial intelligence powered bioinformatics solutions for antibiotic response prediction; and Unyvero Platform, an automated sample-to-answer molecular diagnostics platform that integrates automated sample preparation, analysis, and identification of disease relevant pathogens and antibiotic resistance markers. The company utilizes molecular diagnostics and informatics to help combat infectious diseases. It also helps clinicians with information about life threatening infections to enhance patient outcomes, and to decrease the spread of infections caused by multidrug-resistant microorganisms. OpGen, Inc. has a collaboration with the New York State Department of Health and ILÚM Health Solutions, LLC to develop a research program to detect, track, and manage antimicrobial-resistant infections at healthcare institutions. The company was incorporated in 2001 and is headquartered in Rockville, Maryland.
https://www.opgen.com/
APREA THERAPEUTICS INC APRE: 0,4799 +18,00%
52w: 0.3310 - 4.7
https://ir.aprea.com/static-files/30f4a16e-335b-4fa5-83d1-592b0aade43f
Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which is focused on developing and commercializing novel cancer therapeutics that reactivate mutant protein 53 (p53) tumor suppressor protein. The Company's lead product candidate, APR-246, or eprenetapopt, is a small molecule p53 reactivator that is in clinical development for hematologic malignancies, including myelodysplastic syndromes, or myelodysplastic syndromes (MDS), and acute myeloid leukemia (AML). The Company's APR-548 is a second generation p53 reactivator that is a unique analog of eprenetapopt and therefore a pro-drug of MQ. APR-548 exhibits high oral bioavailability in preclinical testing and is being developed in an oral dosage form. The Company has initiated a Phase I clinical trial testing APR-548 in relapsed/refractory MDS and AML. Its solid tumor program includes its clinical trial evaluating eprenetapopt with anti-PD-1 therapy in advanced solid tumors.
Total Cash (mrq) 33.11M
Total Cash Per Share (mrq) 0.62
Total Debt (mrq) 110.55k
Shares Outstanding 53M
% Held by Insiders 1 24.17%
APREA THERAPEUTICS INC APRE: 0,4799 +18,00%
52w: 0.3310 - 4.7
https://ir.aprea.com/static-files/30f4a16e-335b-4fa5-83d1-592b0aade43f
Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which is focused on developing and commercializing novel cancer therapeutics that reactivate mutant protein 53 (p53) tumor suppressor protein. The Company's lead product candidate, APR-246, or eprenetapopt, is a small molecule p53 reactivator that is in clinical development for hematologic malignancies, including myelodysplastic syndromes, or myelodysplastic syndromes (MDS), and acute myeloid leukemia (AML). The Company's APR-548 is a second generation p53 reactivator that is a unique analog of eprenetapopt and therefore a pro-drug of MQ. APR-548 exhibits high oral bioavailability in preclinical testing and is being developed in an oral dosage form. The Company has initiated a Phase I clinical trial testing APR-548 in relapsed/refractory MDS and AML. Its solid tumor program includes its clinical trial evaluating eprenetapopt with anti-PD-1 therapy in advanced solid tumors.
Total Cash (mrq) 33.11M
Total Cash Per Share (mrq) 0.62
Total Debt (mrq) 110.55k
Shares Outstanding 53M
% Held by Insiders 1 24.17%