Virtual Investor Conferences, the leading proprietary investor conference series, today announced the agenda for the upcoming Life Sciences Virtual Investor Conference to be held on September 15 th .
Individual investors, institutional investors, advisors, and analysts are invited to attend this virtual event showcasing live executive presentations from companies addressing worldwide opportunities in the life sciences.
REGISTER NOW AT : https://bit.ly/3KPH82S
It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates. There is no cost to log-in, attend live presentations and schedule 1x1 meetings with management.
"We are excited to highlight today's innovators from the life science sector," said Jason Paltrowitz, Executive Vice President of Corporate Services at OTC Markets Group. "Our Virtual Investor Conferences continue to provide an efficient platform for these companies to engage and broaden their investor base."
September 15 th
| Eastern Time (ET) | Presentation | Ticker(s) |
| 10:00 AM | Starpharma Holdings Limited | OTCQX: SPHRY | ASX: SPL |
| 10:30 AM | VolitionRx Limited | NYSE: VNRX |
| 11:00 AM | aTyr Pharma, Inc. | Nasdaq: LIFE |
| 11:30 AM | Cloud DX Inc. | OTCQB: CDXFF | TSX-V: CDX |
| 12:00 PM | Cytonics Corporation | Private |
| 12:30 PM | BioHarvest Sciences Inc. | OTCQB: CNVCF | CSE: BHSC |
| 1:00 PM | NovaBay Pharmaceuticals, Inc. | NYSE American: NBY |
| 1:30 PM | Psycheceutical Bioscience, Inc. | OTC Pink: BWVI |
| 2:00 PM | Aethlon Medical, Inc. | Nasdaq: AEMD |
| 2:30 PM | Caladrius Biosciences, Inc. | Nasdaq: CLBS |
| 3:00 PM | HealthBeacon PLC | OTCQX: HBCNF | Euronext Dublin: HBCN |
| 3:30 PM | Else Nutrition Holdings Inc | OTCQX: BABYF | TSX: BABY |
To facilitate investor relations scheduling and to view a complete calendar of Virtual Investor Conferences, please visit www.virtualinvestorconferences.com .
About Virtual Investor Conferences ®
Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly traded companies to seamlessly present directly to investors.
Providing a real-time investor engagement solution, VIC is specifically designed to offer companies more efficient investor access. Replicating the components of an on-site investor conference, VIC offers companies enhanced capabilities to connect with investors, schedule targeted one-on-one meetings and enhance their presentations with dynamic video content. Accelerating the next level of investor engagement, Virtual Investor Conferences delivers leading investor communications to a global network of retail and institutional investors.
Media Contact:
OTC Markets Group Inc. +1 (212) 896-4428, media@otcmarkets.com
Virtual Investor Conferences Contact:
John M. Viglotti
SVP Corporate Services, Investor Access
OTC Markets Group
(212) 220-2221
johnv@otcmarkets.com
News Provided by GlobeNewswire via QuoteMedia
Company invites individual and institutional investors, as well as advisors and analysts, to attend real-time, interactive presentations on VirtualInvestorConferences.com
BioHarvest Sciences Inc. (CSE: BHSC) (OTCQB: CNVCF) (FSE:8MV), a biotechnology company focused on growing plant cells without the plant via its patented CELLicitation platform, today announced that Ilan Sobel, Chief Executive Officer, will present live at VirtualInvestorConferences.com on September 15, 2022.
DATE: September 15, 2022
TIME: 12:30 PM ET
LINK: https://bit.ly/3StcgIH
Available for 1x1 meetings: September 16, 19, 20
This will be a live, interactive online event where investors are invited to ask the company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.
It is recommended that investors pre-register and run the online system check to expedite participation and receive event updates.
Learn more about the event at www.virtualinvestorconferences.com .
Recent BioHarvest Sciences Highlights
About BioHarvest Sciences Inc.
BioHarvest Sciences Inc. (CSE: BHSC) is a fast-growing Biotech firm listed on the Canadian Securities Exchange. BioHarvest has developed a patented bio-cell growth platform technology capable of growing the active and beneficial ingredients in fruit and plants, at industrial scale, without the need to grow the plant itself. This technology is economical, ensures consistency, and avoids the negative environmental impacts associated with traditional agriculture. BioHarvest is currently focused on nutraceuticals and the medicinal cannabis markets. Visit: www.bioharvest.com
About Virtual Investor Conferences ®
Virtual Investor Conferences (VIC) is the leading proprietary investor conference series that provides an interactive forum for publicly traded companies to seamlessly present directly to investors.
Providing a real-time investor engagement solution, VIC is specifically designed to offer companies more efficient investor access. Replicating the components of an on-site investor conference, VIC offers companies enhanced capabilities to connect with investors, schedule targeted one-on-one meetings and enhance their presentations with dynamic video content. Accelerating the next level of investor engagement, Virtual Investor Conferences delivers leading investor communications to a global network of retail and institutional investors.
CONTACTS:
BioHarvest Sciences
Justin Meiklem
Investor Relations
778.686.3855
justin@bioharvest.com
Virtual Investor Conferences
John M. Viglotti
SVP Corporate Services, Investor Access
OTC Markets Group
(212) 220-2221
johnv@otcmarkets.com
News Provided by GlobeNewswire via QuoteMedia
Figure 1
To view an enhanced version of this graphic, please visit:
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The Business Intelligence Group has named BioHarvest Sciences (CSE: BHSC) (OTCQB: CNVCF) (FSE: 8MV) as a winner of its 2022 Sustainability Leadership Award. The Business Intelligence Group seeks out and rewards those with vision, creativity and persistence, all hallmarks found in the world's leading companies and individuals across the globe. The awards programs rely on industry leaders who volunteer to read, score and judge nominations.
"By delivering the benefits of plants using a fraction of the energy, water, and land that agriculture would, we see the potential for conserving valuable global resources at a game-changing scale," said BioHarvest CEO Ilan Sobel. "We are gratified to have our sustainability efforts recognized and we are honoured to be among a distinguished list of multiple industries' leaders."
Sustainability is inherent to BioHarvest's Plant CELLicitation platform technology. For example, when applied to indoor Cannabis cultivation, BioHarvest's process delivers the following unrivaled results (based on estimated internal benchmarking at scale versus New Frontiers Data Set for indoor Cannabis operations):
BioHarvest's sustainability achievements for its platform Bio Plant CELLicitation technology have been accomplished by a diverse Research and Development team comprised of five Israeli female scientists with Ph.D. degrees and led by Dr. Yochi Hagay, the co-founder and CTO of the Company.
"My team and I are so proud that we have developed a technology platform that has the ability to not only deliver critical plant metabolites that the human body needs, without growing the plant, but it does so in a way that protects the planet for many generations to come," stated Dr. Hagay.
"We are proud to reward and recognize BioHarvest Sciences for their sustainability efforts," said Maria Jimenez, Chief Nominations Officer of the Business Intelligence Group. "It was clear to our judges that their vision and strategy will continue to deliver results toward a cleaner, more sustainable world. Congratulations!"
Earlier this year, the company announced its ability to produce full-spectrum cannabis in its industrial scale bioreactors, while using approximately 95% less land than agriculture would use to achieve comparable output. This breakthrough in the cannabis industry also combats the two biggest challenges in growth: product consistency and cleanliness.
As part of its long-term sustainability vision, BioHarvest also has its eyes on space. Recently bringing on astronaut Chris Hadfield as an advisor, the company also has a formal partnership with SpaceTango to explore the effects of micro gravity on plant cells and to explore the potential role of its technology supporting space travel and human settlements in space.
About BioHarvest Sciences Inc.
BioHarvest Sciences Inc. (CSE: BHSC) is a fast-growing Biotech firm listed on the Canadian Securities Exchange. BioHarvest has developed a patented bio-cell growth platform technology capable of growing the active and beneficial ingredients in fruit and plants, at industrial scale, without the need to grow the plant itself. This technology is economical, ensures consistency, and avoids the negative environmental impacts associated with traditional agriculture. BioHarvest is currently focused on nutraceuticals and the medicinal cannabis markets. Visit: www.bioharvest.com.
About Business Intelligence Group
The Business Intelligence Group was founded with the mission of recognizing true talent and superior performance in the business world. Unlike other industry award programs, business executives-those with experience and knowledge-judge the programs. The organization's proprietary and unique scoring system selectively measures performance across multiple business domains and then rewards those companies whose achievements stand above those of their peers.
For further information, please contact:
Maria Jimenez
Chief Nominations Officer
Business Intelligence Group
1 909-529-2737
jmaria@bintelligence.co
BioHarvest Sciences Inc.
Ilan Sobel, Chief Executive Officer
Dave Ryan, VP Investor Relations & Director Phone: 1 (604) 622-1186
Email: dave@bioharvest.com
Twitter: https://twitter.com/bioharvestbhsc
Facebook: https://www.facebook.com/BioHarvestSciences
LinkedIn: https://www.linkedin.com/company/bioharvestsciences/
YouTube: https://www.youtube.com/channel/UCGRJWztmLoycsLFWqwXAzAw
Forward-Looking Statements
Information set forth in this news release includes forward-looking statements that are based on management's current estimates, beliefs, intentions, and expectations, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Investors should note that the Sustainability benchmarks cited in this release are based on industry averages for indoor cannabis cultivation as reported by New Frontiers Data reporting (to 2021) as compared to internal measurements conducted by the BioHarvest Sciences team, which have not been validated by a 3rd party.
All forward-looking statements are inherently uncertain and actual results may be affected by a number of material factors beyond our control. Readers should not place undue reliance on forward-looking statements. BHSC does not intend to update forward-looking statement disclosures other than through our regular management discussion and analysis disclosures.
Neither the Canadian Securities Exchange nor its Regulation Services Provider accept responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/136029
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BioHarvest Sciences Inc. (CSE: BHSC) (OTCQB: CNVCF) (FSE: 8MV) ("BioHarvest" or "the Company") has announced the first multimedia campaign for VINIAâ„¢ in the USA, Phase 1. The company is scaling up its US marketing in line with a 2022 growth plan that aims for significant growth in sales orders following commercial entry in 2021.
"We are delighted to launch our first integrated marketing campaign aimed at expanding our loyal customer base here in the USA," said CEO Ilan Sobel, in New York for the launch. "Bringing our new 20 Ton production facility online was integral to scaling global VINIAâ„¢ supply, so this marketing launch is testament to the entire VINIAâ„¢ team's coordinated dedication to making it happen."
The initial phase will include TV and online advertising with a special focus on Christian programming, which includes TBN (Trinity Broadcasting Network, the world's largest religious-based television network). As part of the sponsorship agreement with TBN, Sobel will appear on the network's flagship shows hosted by Eric Metaxas and Mike Huckabee, with all content to be supported by advertising and educational online content.
New 60-second VINIAâ„¢ commercials were created specifically for the TBN campaign, to start Aug 15, 2022 (View example here)
The campaign underscores VINIA's concept of "Cellular Nutrition" and the benefits of increased blood flow, bringing in Sobel and members of his own family.
"I am inspired every day to hear from our customer community on ways that VINIAâ„¢ is improving their health," Sobel said. "We measure our success by our ability to make significant positive impact to people's lives, and as such our products' efficacy is proven not only in the clinical trials but also on a daily basis with VINIA's users."
See this link for a review of the impact on three generations of the Sobel family.
About BioHarvest Sciences Inc.
BioHarvest Sciences Inc. (CSE: BHSC) is a fast-growing Biotech firm listed on the Canadian Securities Exchange. BioHarvest has developed a patented bio-cell growth platform technology capable of growing the active and beneficial ingredients in fruit and plants, at industrial scale, without the need to grow the plant itself. This technology is economical, ensures consistency, and avoids the negative environmental impacts associated with traditional agriculture. BioHarvest is currently focused on nutraceuticals and the medicinal cannabis markets. Visit: www.bioharvest.com.
BioHarvest Sciences Inc.
Ilan Sobel, Chief Executive Officer
For further information, please contact:
Dave Ryan, VP Investor Relations & Director Phone: 1 (604) 622-1186
Email: dave@bioharvest.com
Twitter: https://twitter.com/bioharvestbhsc
Facebook: https://www.facebook.com/BioHarvestSciences
LinkedIn: https://www.linkedin.com/company/bioharvestsciences/
YouTube: https://www.youtube.com/channel/UCGRJWztmLoycsLFWqwXAzAw
Forward-Looking Statements
Information set forth in this news release includes forward-looking statements that are based on management's current estimates, beliefs, intentions, and expectations, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. There is no assurance that strong sales metrics experienced to date will result in future demand or that proposed additional marketing expenditures will result in increased sales. There is no assurance that the company will achieve significant growth in sales orders as this would require that the marketing campaign is successful which is subject to uncertainty, particularly the response of target audiences to the campaign. Markets for nutraceuticals are unpredictable and subject to changes in consumer tastes and trends as well as economic factors beyond our control. Delays and cost overruns may result in delays achieving our objectives obtaining market acceptance, and regulatory approvals for geographic expansion are subject to risk and cannot be guaranteed.
All forward-looking statements are inherently uncertain and actual results may be affected by a number of material factors beyond our control. Readers should not place undue reliance on forward-looking statements. BHSC does not intend to update forward-looking statement disclosures other than through our regular management discussion and analysis disclosures.
Neither the Canadian Securities Exchange nor its Regulation Services Provider accept responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/134209
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BioHarvest Sciences Inc. (CSE: BHSC) (OTCQB: CNVCF) (FSE: 8MV) ("BioHarvest" or "the Company") ") is pleased to announce that its common shares are now trading on the OTCQB® Venture Market under the ticker symbol "CNVCF".
"Admission to the OTCQB® market is an important step to increase US investor access to BioHarvest Sciences, and it provides US investors an additional level of transparency as we expand both our investor base and our customer base in North America." Stated CEO Ilan Sobel. "We will continue to work on expanding our global visibility to investors to match the commercial entry of our products into new markets."
The BioHarvest Sciences Executive team holds regular online meetings to maintain close ties with the US investment community. All interested media and investors are invited to contact info@bioharvest.com for information on the Company's next interactive event. For more detail on 2022 progress, the July 7, Q2 Shareholder Update focuses on the Company's scale-up plans in the US for its VINIA product, and the market entry strategy for the Company's cannabis products. The recording of that event is available here: https://bioharvest.com/investors/
About the OTCQB Market
The OTCQB® Venture Market is for early-stage and developing U.S. and international companies. To be eligible, companies must be current in their financial reporting and undergo an annual verification and management certification process. The OTCQB® quality standards provide a strong baseline of transparency, as well as the technology and regulation to improve the information and trading experience for investors.
Investors can find current financial disclosure and quotes for the company on https://www.otcmarkets.com/stock/CNVCF.
BioHarvest Sciences will continue to trade on the Canadian Securities Exchange (CSE) as "BHSC" and on Frankfurt as "8MV".
About BioHarvest Sciences Inc.
BioHarvest Sciences Inc. (CSE: BHSC) is a fast-growing Biotech firm listed on the Canadian Securities Exchange. BioHarvest has developed a patented bio-cell growth platform technology capable of growing the active and beneficial ingredients in fruit and plants, at industrial scale, without the need to grow the plant itself. This technology is economical, ensures consistency, and avoids the negative environmental impacts associated with traditional agriculture. BioHarvest is currently focused on nutraceuticals and the medicinal cannabis markets. Visit: www.bioharvest.com.
BioHarvest Sciences Inc.
Ilan Sobel, Chief Executive Officer
For further information, please contact:
Dave Ryan, VP Investor Relations & DirectorÂ
Phone: 1 (604) 622-1186
Email: dave@bioharvest.com
Forward-Looking Statements
Information set forth in this news release includes forward-looking statements that are based on management's current estimates, beliefs, intentions, and expectations, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. There is no assurance that strong sales metrics experienced to date will result in future demand or that proposed additional marketing expenditures will result in increased sales. Markets for nutraceuticals are unpredictable and subject to changes in consumer tastes and trends as well as economic factors beyond our control. Delays and cost overruns may result in delays achieving our objectives obtaining market acceptance, and regulatory approvals for geographic expansion are subject to risk and cannot be guaranteed. Projected sales of BioHarvest products will require the Company to obtain production and/or export licensing which cannot be assured.
All forward-looking statements are inherently uncertain and actual results may be affected by a number of material factors beyond our control. Readers should not place undue reliance on forward-looking statements. BHSC does not intend to update forward-looking statement disclosures other than through our regular management discussion and analysis disclosures.
Neither the Canadian Securities Exchange nor its Regulation Services Provider accept responsibility for the adequacy or accuracy of this release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/131117
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Network Aims to Advance Collaboration Across Industry and Academia to Accelerate Treatment Development for Patients
Inaugural Scientific Summit Prioritized Advancing Translational Research, Pharmacodynamic Readouts and Innovative Biomarker-Driven Programs
Amgen (NASDAQ:AMGN) today announced the launch of Amgen Partners of Choice, a new network that brings together Amgen's oncology research and development experts and world-class clinical leaders at eight research centers across the globe. As part of Amgen's mission to improve care through partnerships across the healthcare ecosystem, the network fosters academic collaboration to advance new treatment options for patients with the greatest unmet needs. The member institutions are:
-Â Asan Medical Center ( Seoul, South Korea )
-Â Dana-Farber Cancer Institute ( Boston )
-Â West German Cancer Center at University Hospital Essen ( Essen, Germany )
- Gustave Roussy ( Paris )
-Â Memorial Sloan Kettering Cancer Center ( New York )
-Â Peter MacCallum Cancer Centre ( Melbourne, Australia )
-Â University Health Network's Princess Margaret Cancer Centre ( Toronto )
-Â Vall d'Hebron Institute of Oncology ( Barcelona, Spain )
"We have a big goal – to make profound differences in changing the standard of cancer care – and we are committed to doing that through collaboration," said Jean-Charles Soria , M.D., Ph.D., senior vice president, Research and Development at Amgen. "Through Amgen Partners of Choice, we hope to foster earlier, deeper and more frequent academic collaboration to fuel quicker progress for patients facing complex, difficult-to-treat cancers."
The network aims to create multiple collaboration channels globally with the goal of expediting the transition of new, transformational programs to leaders in the clinic. Current Amgen Partners of Choice projects are focused on select disease areas and tumor types including thoracic, gastrointestinal and genitourinary cancers.
"We are entering an extraordinary new era in biotechnology, a moment where both the need for innovation and our ability to innovate are expanding exponentially," said Professor Fabrice Barlesi , General Director of Gustave Roussy , Paris Saclay Cancer Cluster, Grand Paris. "As a member of Amgen Partners of Choice, we look forward to collaborating closely with Amgen and other member institutions to catalyze the next wave of innovation in the fight against cancer."
The Amgen Partners of Choice network will convene bi-annual scientific summits where participants will discuss emerging oncology topics and advise on improving clinical trials to foster better outcomes for patients. In June, Amgen hosted the inaugural scientific summit at its headquarters, bringing together Amgen Partners of Choice members for the official launch of the new academic network. During the two-day event, Amgen leaders and network members discussed priority projects and key areas that the network will focus on and how to bring these transformational programs to patients. The next network-wide scientific summit will take place virtually later this year.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best Companies" by TIME.
For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn , Instagram , TikTok , YouTube and Threads .
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd., Kyowa-Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, the Teneobio, Inc. acquisition, the ChemoCentryx, Inc. acquisition, or the proposed acquisition of Horizon Therapeutics plc (including the potential outcome of any litigation with the Federal Trade Commission, prospective performance and outlook of Horizon's business, performance and opportunities and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not obtain regulatory clearance to acquire Horizon or be able to successfully integrate Horizon, and such acquisition or integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Jessica Akopyan , 805-440-5721 (media)
Justin Claeys , 805-313-9775 (investors)
View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-launches-partners-of-choice-network-of-eight-leading-oncology-academic-centers-301932359.html
SOURCE Amgen
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Amgen (NASDAQ:AMGN) will present at the Bank of America Merrill Lynch Global Healthcare Conference at 11:40 a.m. BST on Thursday Sept. 14, 2023. Peter H. Griffith executive vice president and chief financial officer at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek and one of "America's Climate Leaders" by USA Today.
For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn , Instagram , TikTok , YouTube and Threads .
CONTACT: Amgen, Thousand Oaks
Jessica Akopyan , 805-440-5721 (media)
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (investors)
View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-to-present-at-the-bank-of-america-merrill-lynch-global-healthcare-conference-301923661.html
SOURCE Amgen
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In Phase 1b Study, Patients Treated in First-Line Demonstrated a Confirmed Objective Response Rate of 65%
Amgen (NASDAQ:AMGN) today announced exciting data from a study arm of the CodeBreaK 101 clinical trial, a Phase 1b study evaluating LUMAKRAS ® (sotorasib) with carboplatin and pemetrexed in adult patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). These results were featured in an oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) in Singapore on Sunday, September 10 .
In patients treated in the first-line setting (n=20), the confirmed objective response rate (ORR) was 65%, with a 100% disease control rate (DCR) (95% CI: 83.2, 100). In assessable patients in the second-line setting (n=13), the ORR was 54%, with a DCR of 85% (95% CI: 54.6, 98.1). Among patients with protein ligand-1 (PD-L1) expression less than 1%, the ORR was 62% in the first-line setting and 50% in the second-line setting. With a median follow-up of 3.0 months, preliminary rapid and durable responses were observed. Progression-free survival (PFS) and overall survival (OS) were immature.
"We are delighted to see the positive data from the global CodeBreaK 101 trial further validate our approach to move LUMAKRAS earlier within the treatment paradigm through novel therapeutic combinations," said David M. Reese , M.D., executive vice president of Research and Development at Amgen. "Notably, these results follow and further expand upon the Phase 2 investigator-led data demonstrating favorable efficacy and safety of LUMAKRAS plus carboplatin and pemetrexed in the first-line treatment of patients with KRAS G12C-mutated NSCLC."
The LUMAKRAS plus chemotherapy combination reported treatment-related adverse events (TRAEs) consistent with LUMAKRAS and other platinum doublet-based approaches. The most common TRAEs were neutropenia/neutrophil count decrease (53%), anemia (39%) and thrombocytopenia/platelet count decrease (37%). No fatal adverse events occurred.
"Combination treatment is an important approach to prevent or delay the onset of drug resistance and improve the depth and durability of targeted response in KRAS G12C ÂÂ -mutated NSCLC," said Jeffrey M. Clarke , M.D., oncologist and associate professor of medicine, Duke Cancer Institute at Duke University . "The CodeBreaK 101 results show exciting efficacy with sotorasib plus chemotherapy and, importantly for a combination treatment, a safety profile consistent with the individual therapies. These data warrant continued investigation in larger trials."
Based on these results, Amgen has initiated a Phase 3 study of LUMAKRAS plus carboplatin and pemetrexed in first-line KRAS G12C-mutant and negative for programmed cell death PD-L1 advanced NSCLC (CodeBreaK 202; NCT05920356), with enrollment expected to start before the end of 2023.
About CodeBreaK 101
CodeBreaK 101 ( NCT04185883 ) is a global Phase 1b /2 clinical trial evaluating the safety, tolerability, pharmacokinetics, and efficacy of sotorasib in combination with other anticancer therapies in patients with advanced solid tumors and the KRAS G12C mutation. Subprotocol F of the Phase 1b trial is assessing the safety, tolerability, pharmacokinetics, and efficacy of sotorasib in combination with carboplatin and pemetrexed with or without pembrolizumab maintenance, with docetaxel, or with carboplatin and paclitaxel in patients with KRAS G12C-mutated NSCLC. 1
About LUMAKRAS ® /LUMYKRAS ® (sotorasib)
Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS/LUMYKRAS, a KRAS G12C inhibitor. 2 LUMAKRAS/LUMYKRAS has demonstrated a positive benefit-risk profile with rapid, deep, and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation. 3
Amgen is progressing the largest and broadest global KRAS G12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, with clinical trial sites spanning five continents. To date, over 6,500 patients around the world have received LUMAKRAS/LUMYKRAS through the clinical development program and commercial use.
In May 2021 , LUMAKRAS was the first KRAS G12C inhibitor to receive regulatory approval with its approval in the U.S., under accelerated approval. LUMAKRAS/LUMYKRAS is also approved in the European Union, Japan , United Arab Emirates , South Korea , Hong Kong , Switzerland , Taiwan , Turkey , Thailand , Qatar , Australia , Argentina , Brazil , Canada , Great Britain , Kuwait , Macao , Singapore , Mexico , Israel , Bulgaria , Hungary , Romania , and Russia . Additionally, Amgen has submitted MAAs in Colombia , Malaysia and Saudi Arabia .
LUMAKRAS/LUMYKRAS is also being studied in multiple other solid tumors. 4
About Advanced Non-Small Cell Lung Cancer and the KRAS G12C Mutation
Lung cancer is the leading cause of cancer-related deaths worldwide, and it accounts for more deaths worldwide than colon cancer, breast cancer and prostate cancer combined. 5 Overall survival rates for NSCLC are improving but remain poor for patients with advanced disease, and 5-year survival is only 9% for those with metastatic disease. 6
KRAS G12C is the most common KRAS mutation in NSCLC. 7 About 13% of patients with non-squamous NSCLC harbor the KRAS G12C mutation. 8 Unmet medical need remains high and treatment options are limited for NSCLC patients with the KRAS G12C mutation whose first-line treatment has failed to work or has stopped working. The outcomes with other approved therapies are suboptimal, with a median progression-free survival of approximately four months following second-line treatment of KRAS G12C-mutated NSCLC. 9
LUMAKRAS ® (sotorasib) U.S. Indication
LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
LUMAKRAS ® (sotorasib) Important U.S. Safety Information
Hepatotoxicity
Interstitial Lung Disease (ILD)/Pneumonitis
Most Common Adverse Reactions
Drug Interactions
Please see LUMAKRAS full Prescribing Information .
About Amgen Oncology
At Amgen Oncology, our mission to serve patients drives all that we do. That's why we're relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.
For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.
For more information, follow us on www.twitter.com/amgenoncology .
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2022, Amgen was named one of the "World's Best Employers" by Forbes and one of "America's 100 Most Sustainable Companies" by Barron's .
For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn , Instagram , TikTok , YouTube and Threads .
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. [Further,] any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Jessica Akopyan , 805-440-5721 (media)
Justin Claeys , 805-559-0072 (investors)
1 ClinicalTrials.gov. CodeBreaK 101. 2023. Available at: https://classic.clinicaltrials.gov/ct2/show/NCT04185883 . Accessed on July 27, 2023 .
2 Canon J, et al. Nature . 2019;575: 217–223.
3 Skoulidis F, et al. N Engl J Med . 2021;384:2371-2381.
4 Hong DS, et al. N Engl J Med . 2020;383:1207-1217.
5 Sung H, et al. CA Cancer J Clin . 2021;71:209-249.
6 American Cancer Society. Lung Cancer Survival Rates. 2023. Available at: https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html . Accessed on July 27, 2023.
7 Arbour KC, et al. Clin Cancer Res . 2018;24:334-340.
8 Nassar AF, et al. N Engl J. Med . 2021;384:185-187.
9 Spira Al, et al. Lung Cancer . 2021;159:1-9.
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briacell therapeutics corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, today announces the completion of patient enrollment in its Phase 2 clinical study and reports clinical data showing strong patient survival benefit and clinical benefit in advanced metastatic breast cancer patients.
"The promising survival data of BriaCell's combination regimen suggests the potential for an industry-shaping leap in advanced metastatic breast cancer treatment," stated Carmen Calfa, M.D., of the Sylvester Comprehensive Cancer Center at the University of Miami, Associate Professor of Clinical Medicine, and Principal Clinical Investigator of the Phase 2 Bria-IMTâ„¢ plus check point inhibitors study. "The overall safety profile and survival data in advanced metastatic breast cancer is extremely encouraging in this heavily pre-treated patient population."
"We are forging a new path for advanced metastatic breast cancer, a terminal disease with a very limited life expectancy of 6.7 to 9.8 months," stated Dr. William V. Williams, BriaCell's President and CEO. "The impressive survival benefit and tolerability of the Bria-IMTâ„¢ regimen highlights the importance of this treatment option for patients in which all other therapies have failed."
Phase 2 Combination Study of Bria-IMTâ„¢ with Immune Check Point Inhibitor
Tolerability: The tolerability of the treatment regimen remains excellent with no dose limiting toxicities.
Survival Update:
The survival findings support BriaCell's hypothesis of additive and/or synergistic effects of immune check point inhibitors with Bria-IMTâ„¢ and support using this combination regimen for our upcoming pivotal study in advanced breast cancer.
About briacell therapeutics corp.
BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/ .
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This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements, including statements relating to the survival benefit and tolerability of the Bria-IMTâ„¢ regimen in advanced metastatic breast cancer patients and the additive and/or synergistic effects of immune check point inhibitors with Bria-IMTâ„¢. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BriaCell's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading "Risks and Uncertainties" in the Company's most recent Management's Discussion and Analysis, under the heading "Risk Factors" in the Company's most recent Annual Information Form, and under "Risks and Uncertainties" in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR at www.sedar.com and on EDGAR at www.sec.gov . Forward-looking statements contained in this announcement are made as of this date, and briacell therapeutics corp. undertakes no duty to update such information except as required under applicable law.
Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.
Contact Information
Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com
Media Relations:
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Director of Public Relations
CORE IR
917-885-7378
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Investor Relations Contact:
CORE IR
investors@briacell.com
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Amgen (NASDAQ:AMGN) will present at the Morgan Stanley Global Healthcare Conference at 8:50 a.m. ET on Tuesday, Sept. 12, 2023 . Robert A. Bradway chairman and chief executive officer at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek and one of "America's Climate Leaders" by USA Today.
For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn , Instagram , TikTok , YouTube and Threads .
CONTACT: Amgen, Thousand Oaks
Jessica Akopyan , 805-440-5721 (media)
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (investors)
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Amgen (NASDAQ:AMGN) will present at the 2023 Wells Fargo Healthcare Conference at 9:30 a.m. ET on Wednesday Sept. 6, 2023. Amgen will also present at the Citi Global Healthcare Conference at 1:00 p.m. ET on Thursday Sept. 7, 2023. Peter H. Griffith executive vice president and chief financial officer at Amgen, and Murdo Gordon executive vice president of global commercial operations at Amgen will present at both conferences. The webcasts from these events will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcasts, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek and one of "America's Climate Leaders" by USA Today.
For more information, visit Amgen.com and follow us on Twitter , LinkedIn , Instagram , TikTok , YouTube and Threads .
CONTACT: Amgen, Thousand Oaks
Jessica Akopyan , 805-440-5721 (media)
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (investors)
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