Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced topline study results showing a survival benefit in the Healey ALS Platform trial of CNM-Au8®, an investigational gold nanocrystal suspension, in participants with amyotrophic lateral sclerosis (ALS).
The primary endpoint of slope of change in ALS Functional Rating Scale Revised (ALSFRS-R) scores adjusted for mortality was not significant (2% slowing, 95% CI: -20% to +19%) at 24 weeks. Secondary endpoints of Combined Assessment of Function and Survival (CAFS) and slow vital capacity (SVC) were also not met at 24 weeks across the combined 30 mg and 60 mg CNM-Au8 doses.
The prespecified exploratory analyses of the secondary survival endpoint demonstrated a >90% reduction in risk of death alone or in risk of death/permanently assisted ventilation at 24 weeks, when adjusted for baseline imbalances in risk (p=0.028 to p=0.075, unadjusted for multiple comparisons) with the CNM-Au8 30 mg dose. These survival results were statistically consistent for the 30 mg dose between the regimen only and full analysis sets, which included shared placebo from other regimens participating in the Healey ALS Platform trial (Regimens A, B, and D). This survival signal is consistent with results previously reported by Clene in the Phase 2 RESCUE-ALS trial with CNM-Au8.
The full analyses, including data on biomarkers of neurodegeneration and exploratory efficacy results, are expected later in 2022. The open-label extension will continue to follow participants and provide data updates in the future. Clene is in discussions with the Healey & AMG ALS Center to offer a broader EAP of CNM-Au8 30 mg for eligible participants of closed regimens and others.
Based on these topline findings, Clene has selected the CNM-Au8 30 mg dose for continued development in ALS. The CNM-Au8 60 mg dose did not demonstrate a survival benefit. CNM-Au8 was well-tolerated, and there were no drug-related serious adverse events or significant safety findings reported.
"There remains a high unmet medical need for treatments for people living with ALS. The potential survival benefit with CNM-Au8 at 30 mg is encouraging. Additional pre-specified exploratory analyses of both the RCT and open-label extension part of the study will be shared once available," said Merit Cudkowicz, M.D., MSc, principal investigator and sponsor of the Healey ALS Platform Trial, director of the Sean M. Healey & AMG Center for ALS, chief of the Department of Neurology at Massachusetts General Hospital, and the Julieanne Dorn Professor of Neurology at Harvard Medical School. "We are thankful to the many people who participated in this study. We will learn from these results and continue to use these data to inform future advances in ALS trial design," she concluded.
Robert Glanzman, M.D., FAAN, Clene's Chief Medical Officer, said, "We are very pleased to see a survival benefit in a broad population of people who had already been living with ALS for up to three years. Importantly, this is the second Phase 2 study demonstrating a survival benefit following CNM-Au8 treatment. CNM-Au8's mechanism of enabling energy metabolism and efficiency may not be reflected in the slope of ALSFRS-R change after only 24 weeks of treatment. These Healey ALS Platform Trial results support advancement of the CNM-Au8 30 mg dose. We look forward to discussions with U.S. regulatory authorities at an End of Phase 2 meeting for our CNM-Au8 development program in ALS."
Rob Etherington, Clene's President and CEO, added, "The survival results from this trial together with the consistent benefit seen in the open-label extension of the Phase 2 RESCUE-ALS trial, based on up to 31.5 months of long-term follow-up, support the rationale for treating neuronal and glial energetic failure with CNM-Au8. We have now completed multiple Phase 2 studies in ALS and MS, building a body of evidence demonstrating that CNM-Au8 supports cellular energy production, improving myelination and neuronal viability. We believe supporting brain energetic capacity translates to patient benefit, including survival. We will work closely with regulatory health authorities, ALS experts, and patient representatives to determine the proper path for FDA and EMA approval. Clene remains committed to advancing CNM-Au8 clinical programs to the ultimate goal of FDA approval. To support this effort, Clene is pursuing paths, including strategic partnerships, and is in dialogue with various potential partners."
Michael Hotchkin, Clene's Chief Development Officer, concluded, "We thank the ALS community for its support of the Healey ALS Platform trial. Furthermore, we thank the site investigators for their research excellence and dedication to patients, and we thank Dr. Cudkowicz and the team at the Healey & AMG ALS center for their leadership and for the development of the platform trial. Most importantly, we thank people living with ALS who participated in the study and their families for their effort and willingness to engage in clinical research."
Conference Call and Webcast Information
Clene will host a conference call and webcast at 8:30 am EDT to discuss the Healey ALS Platform trial topline results for CNM-Au8. Members of Clene's executive team will lead the discussion.
Time and Date: 8:30 a.m. EDT on Oct. 3, 2022 Investors: 1 (888) 660-6179 (toll-free) or 1 (929) 203-1946 (toll) Conference ID: 5318408 Press *1 to ask or withdraw a question, or *0 for operator assistance .
To access the live webcast, please register online at this link . Participants are requested to register at a minimum 15 minutes before the start of the call. A replay of the call will be available two hours after the call and archived on the same web page for six months. A live audio webcast of the call will be available on the Investors section of the Company's website Events page. An archived webcast will be available on the Company's website approximately two hours after the event. About the Healey ALS Platform Trial The Healey ALS Platform Trial is a perpetual multi-center, randomized, double-blind, placebo-controlled program designed to evaluate the efficacy and safety of multiple investigational products utilizing a shared placebo group in people living with amyotrophic lateral sclerosis (ALS). In the CNM-Au8 regimen, 161 participants were randomized to 30 mg CNM-Au8, 60 mg CNM-Au8, or placebo as adjunct to standard of care for a 24-week treatment period. Active drug was offered to all participants who were eligible and elected to continue into the open-label extension. The primary outcome of the trial was the change in disease severity over time as measured by ALSFRS-R through 24 weeks accounting for mortality (analyzed using a Bayesian shared parameter model). Prespecified secondary efficacy endpoints included the Combined Assessment of Function and Survival joint rank test (CAFS), change in respiratory function as measured by slow vital capacity (SVC), and overall survival. For more information, please see ClinicalTrials.gov Identifier: NCT04297683 .
About CNM-Au8® CNM-Au8 is Clene's lead asset in mid- and late-stage clinical development for the treatment of multiple sclerosis and amyotrophic lateral sclerosis. An oral suspension of gold nanocrystals, CNM-Au8 was developed to protect neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.
About Clene Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter , LinkedIn and Facebook.
Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the "safe harbor" provisions created by those laws. Clene's forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would," and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; uncertainty regarding whether potential strategic partnerships will result in any agreements or transactions, or, if completed, any agreements or transactions will be successful or on attractive terms; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in "Risk Factors" in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.
News Provided by GlobeNewswire via QuoteMedia
Clene Inc. (NASDAQ: CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced that it will report topline results of the CNM-Au8® regimen of the HEALEY ALS Platform Trial on Monday, Oct. 3. Clene's management team will host a conference call and webcast to discuss the results.
Conference Call and Webcast Details Time and Date: 8:30 a.m. EDT on Oct. 3, 2022 Investors: 1 (888) 660-6179 (toll-free) or 1 (929) 203-1946 (toll) Conference ID: 5318408 Webcast Link
A live audio webcast can be accessed by visiting the Investors section of the Company's website on the Events page . An archived webcast will be available on the website approximately two hours after the event.
About CNM-Au8® CNM-Au8 is Clene's lead asset in mid- and late-stage clinical development for the treatment of multiple sclerosis and amyotrophic lateral sclerosis. An oral suspension of gold nanocrystals, CNM-Au8 was developed to protect neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.
About Clene Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter , LinkedIn and Facebook.
Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the "safe harbor" provisions created by those laws. Clene's forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would," and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in "Risk Factors" in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.
News Provided by GlobeNewswire via QuoteMedia
Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced presentation of updated survival results from the Phase 2 RESCUE-ALS trial open-label extension (OLE) at the 2022 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Clinical & Scientific Conference, taking place September 21-24 in Nashville, Tennessee.
The poster titled, " Evidence for a Potential Survival Benefit in Amyotrophic Lateral Sclerosis with CNM-Au8 Treatment: Interim Results from the RESCUE-ALS trial Long-Term Open Label Extension ," provides ongoing evidence supporting the clinical benefits of Clene's lead drug candidate, CNM-Au8 ® , a catalytically active gold nanocrystal suspension that holds promise as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS). Specifically, the poster evaluated the survival benefit associated with long-term CNM-Au8 treatment. Updated interim analyses of all-cause mortality with up to 137 weeks of follow-up from randomization comparing participants originally randomized to CNM-Au8 to participants originally randomized to placebo demonstrated a significant survival benefit with CNM-Au8 treatment, resulting in approximately a 70% decreased risk of death (HR = 0.29, p=0.01). Sensitivity analyses of observed survival compared to predicted median survival derived from the published ENCALS prediction model based on each participant's baseline study characteristics, with a data cutoff of August 31, 2022, also demonstrated a significant survival benefit with CNM-Au8 treatment (HR = 0.36, p=0.003). CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported during the OLE .
"These clinical and survival data from RESCUE-ALS contribute to the growing body of evidence supporting the potential for CNM-Au8 as a disease-modifying therapy for amyotrophic lateral sclerosis (ALS)," said Robert Glanzman, MD, FAAN, Clene's Chief Medical Officer.
Rob Etherington, Clene's CEO, added, "The impressive ALS survival benefits seen with CNM-Au8 treatment corroborate our thesis – energetic support of neurons may protect CNS health and slow neurodegenerative disease progression. We look forward to upcoming results from the HEALEY ALS Platform Trial and advancing CNM-Au8 development in ALS and other neurodegenerative diseases, including multiple sclerosis and Parkinson's."
About Rescue-ALS RESCUE-ALS, a Phase 2 multi-center, randomized, double-blind, parallel-group, placebo-controlled trial, examined the efficacy, safety, pharmacokinetics and pharmacodynamics of CNM-Au8 in 45 participants (73% limb onset, 27% bulbar onset) with early ALS over a 36-week treatment period. The primary endpoint was the percent change in the summated motor unit index (MUNIX) scores to week 36.
The primary blinded comparative period was followed by an open-label extension (OLE) in which all participants received 30 mg of CNM-Au8 once-daily, with 90% (36/45 patients) entering the OLE. The primary endpoint was not significant, driven by limited MUNIX decline in bulbar-onset participants. However, in a prespecified analyses of limb-onset participants who demonstrated the expected decline in MUNIX scores, there was a strong trend for reducing MUNIX scores (p=0.074). There was a significant reduction in ALS disease progression evident in CNM-Au8 treated participants at week 36 (p=0.0125), and the risk of experiencing significant (≥ 6-point) decline in ALSFRSR was significantly reduced in the CNM-Au8 treated patients (p=0.035). Furthermore, CNMAu8 treated participants demonstrated improved quality of life on the ALSSQOL-SF (p=0.018). Importantly, there were no significant CNM-Au8 related adverse effects reported.
About CNM-Au8 ® CNM-Au8 is Clene's lead asset in mid- and late-stage clinical development for the treatment of multiple sclerosis and amyotrophic lateral sclerosis. An oral suspension of gold nanocrystals, CNM-Au8 was developed to protect neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8 ® is a federally registered trademark of Clene Nanomedicine, Inc.
About Clene Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter , LinkedIn and Facebook.
This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the "safe harbor" provisions created by those laws. Clene's forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would," and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in "Risk Factors" in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.
News Provided by GlobeNewswire via QuoteMedia
Clene Inc. (NASDAQ: CLNN) along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced that it will participate in the following investor conferences in September:
Citi's 17 th Annual BioPharma Conference Date: September 8, 2022 Location: Four Seasons Hotel, Boston, MA Format: 1x1 meetings
H.C. Wainwright 24 th Annual Global Investment Conference Dates: September 12-13, 2022 Location: Lotte New York Palace Hotel, New York, NY Date, Time and Location of Presentation: September 13, 2022, at 12:00 ET (Kennedy I) Format: Corporate Presentation and 1x1 meetings
About CNM-Au8 ® CNM-Au8 is Clene's lead asset in mid- and late-stage clinical development for the treatment of multiple sclerosis and amyotrophic lateral sclerosis. An oral suspension of gold nanocrystals, CNM-Au8 was developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8 ® is a federally registered trademark of Clene Nanomedicine, Inc.
About Clene Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter , LinkedIn and Facebook .
Media Contact Ignacio Guerrero-Ros, Ph.D., or David Schull Russo Partners, LLC Ignacio.guerrero-ros@russopartnersllc.com David.schull@russopartnersllc.com (858) 717-2310
Investor Contact Kevin Gardner LifeSci Advisors kgardner@lifesciadvisors.com 617-283-2856
News Provided by GlobeNewswire via QuoteMedia
Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today reported its second quarter 2022 and recent operating highlights.
"We are on the cusp of a transformative period for the Company as we await a key data readout in ALS for our lead asset, CNM-Au8 ® ," said Rob Etherington, President and CEO of Clene. "The ALS patient population is desperate for new treatments to help mitigate the disease course and following the statistically significant survival benefits demonstrated in our open label trial, we are hopeful that we can deliver an effective therapy for people living with ALS."
Second Quarter 2022 and Recent Operating Highlights
CNM-Au8 ® , a gold nanocrystal suspension, for the treatment of amyotrophic lateral sclerosis (ALS)
CNM-Au8 for the treatment of multiple sclerosis (MS)
CNM-ZnAg for the treatment of COVID-19
Clene's cash, cash equivalents and marketable investments securities totaled $26.3 million as of June 30, 2022, compared to $50.3 million as of December 31, 2021.
Research and development expenses were $9.2 million for the quarter ended June 30, 2022, compared to $6.5 million for the same period in 2021. The year-over-year increase is primarily attributable to the development of CNM-Au8 and CNM-ZnAg (including the rapid completion of the COVID study due to a viral wave leading to increased patient recruitment), rent expense for the newly-leased facility in Elkton, Maryland, and personnel expenses due to increased headcount as a result primarily of increased manufacturing hours, partially offset by decreased stock-based compensation expense.
General and administrative expenses were $4.5 million for the quarter ended June 30, 2022, compared to $6.9 million for the same period in 2021. The year-over-year decrease is primarily attributable to a decrease in directors' and officers' insurance costs, stock-based compensation expense and other general and administrative costs, including decreases in investor relations, accounting and consulting fees. These decreases were offset by increases in personnel compensation due to increased headcount as well as increases on other miscellaneous general and administrative expenses.
Clene reported a net loss of $4.5 million, or $0.07 per share, for the quarter ended June 30, 2022, compared to a net loss of $3.4 million, or $0.05 per share, for the same period in 2021. Included in net loss for the quarter ended June 30, 2022, is an unrealized gain from the change in fair value of contingent earn-out liabilities of $9.4 million, compared to an unrealized gain of $9.9 million in the prior year period.
About Clene Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter , LinkedIn and Facebook.
About CNM-Au8 ® CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8 ® is a federally registered trademark of Clene Nanomedicine, Inc.
About CNM-ZnAg CNM-ZnAg, a proprietary zinc-silver ionic solution, has demonstrated broad antiviral and antimicrobial activity.
Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the "safe harbor" provisions created by those laws. Clene's forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would," and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in "Risk Factors" in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.
Clene Inc. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (In thousands, except share and per share amounts) (Unaudited)
Clene Inc. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) (Unaudited)
News Provided by GlobeNewswire via QuoteMedia
Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced positive topline results from the Phase 2 VISIONARY-MS trial of CNM-Au8 ® an investigational gold nanocrystal suspension, in participants with stable relapsing remitting multiple sclerosis (RRMS).
VISIONARY-MS was a Phase 2 proof-of-concept, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of CNM-Au8 (15 mg or 30 mg daily) as adjunctive therapy to currently available disease-modifying therapies (DMTs) versus placebo over 48 weeks in stable RRMS participants with chronic optic neuropathy.
As announced in February 2022, the trial was stopped prematurely due to COVID-19 pandemic operational challenges, limiting enrollment to 73 out of the 150 planned participants. Due to the limited enrollment, the threshold for significance was pre-specified at p=0.10 prior to database lock. The primary analysis was conducted in a modified intent to treat (mITT) population, which censored invalid data. The mITT population excluded data from a single site (n=9) with LCLA testing execution errors and the timed 25-foot walk data from one subject with a change in mobility assist device. The ITT results were directionally consistent with the mITT results, although the ITT results were not significant.
"These data are very encouraging to us in the MS research and treatment community as we work to address functional improvement in patients," said Benjamin Greenberg, MD, MHS, FANA, FAAN, CRND Professor of Neurology and one of the trial's clinical advisors. "The MS community has been successful at limiting relapses, but we need therapies to address progression independent of relapse activity (PIRA). This study was designed as a proof-of-concept evaluation to establish that treatment of neuronal and glial energetic failure can support remyelination and neuroprotection in people living with MS. I am pleased to see the potential effectiveness of CNM-Au8 demonstrated in this trial."
Primary and secondary results from Baseline to Week 48 were:
Consistent improvements favoring CNM-Au8 were observed across multiple paraclinical biomarkers, including multifocal visual evoked potentials (mfVEP) amplitude and latency, optical coherence tomography (OCT), and MRI endpoints, including magnetization transfer ratio and diffusion tensor imaging metrics. Placebo treated patients, in contrast, generally worsened as expected across these measures during the 48-week period. These data provide independently assessed quantitative physiological evidence that supports the potential neuroprotective and remyelinating effects of CNM-Au8. The full dataset will be reported at an upcoming scientific congress.
CNM-Au8 was well-tolerated, and there were no significant safety findings reported.
Robert Glanzman, MD, FAAN, Clene's Chief Medical Officer, said, "In this study, CNM-Au8 demonstrated neurological improvements in people with stable relapsing MS as adjunctive therapy to immunomodulatory DMTs. I am very impressed by the consistency of structural and functional improvements demonstrated by CNM-Au8 throughout the neuraxis. With these data, Clene looks forward to initiating a Phase 3 clinical program in people with MS who are experiencing progression independent of relapse activity, the most urgent unmet medical need in MS today. We look forward to the next phase of clinical development."
Rob Etherington, Clene's Chief Executive Officer and President, added, "These results further demonstrate the potential of CNM-Au8 to drive neuronal cellular energy production in patients struggling with MS and other neurodegenerative diseases. We also await additional evidence of clinical efficacy from the HEALEY ALS Platform Trial, which is expected to report topline data later in this quarter. Clene will continue to work tirelessly to further CNM-Au8's development to treat neurodegenerative diseases."
Conference Call and Webcast Information Clene will host a conference call and webcast at 7:30 am EDT to discuss the VISIONARY-MS topline results.
Toll free: 1 (888) 770-7152 Conference ID: 5318408 Press *1 to ask or withdraw a question, or *0 for operator assistance .
To access the live webcast, please register online at this link . Participants are requested to register at a minimum 15 minutes before the start of the call. A replay of the call will be available two hours after the call and archived on the same web page for six months. A live audio webcast of the call will be available on the Investors section of the Company's website Presentation page . An archived webcast will be available on the Company's website approximately two hours after the event.
About VISIONARY-MS VISIONARY-MS was a Phase 2 multi-center, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of CNM-Au8 in participants with stable relapsing remitting multiple sclerosis (RRMS) with a history of chronic visual impairment who are allowed disease-modifying therapy (DMT). Enrolled subjects were randomized 1:1:1 to CNM-Au8 15 mg/day, 30 mg/day, or placebo. As announced in February 2022, the trial was stopped prematurely due to COVID-19 pandemic operational challenges, enrolling 73 out of the 150 planned participants. Due to limited enrollment, the threshold for significance was pre-specified at p=0.10 prior to database lock. The primary endpoint was the change in best corrected-low contrast letter acuity (BC-LCLA) from baseline to week 48 in the clinically affected eye. Key secondary efficacy outcomes assessed neurological function by the modified MS Functional Composite (mMSFC) including 25-Foot Timed Walk, Symbol Digit Modalities Test, 9-Hole Peg Test (dominant and non-dominant hands), and LCLA (affected and fellow eye) from baseline through Week 48. For more information, see ClinicalTrials.gov . Identifier: NCT03536559 . The open label extension of VISIONARY-MS is ongoing.
About CNM-Au8 ® CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8 ® is a federally registered trademark of Clene Nanomedicine, Inc.
About Clene Clene is a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease by targeting energetic failure, an underlying cause of many neurological diseases. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on Twitter , LinkedIn and Facebook .
This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the "safe harbor" provisions created by those laws. Clene's forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would," and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in "Risk Factors" in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.
News Provided by GlobeNewswire via QuoteMedia
-- Cybin strengthens its intellectual property library with more than 20 active patent filings across six patent families, and multiple license agreements that provide access to over 35 patents and applications --
Cybin Inc. ( NEO:CYBN ) (NYSE AMERICAN:CYBN) (" Cybin " or the " Company "), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics ® , is pleased to provide an update on its intellectual property ("IP") progress in support of its research and development strategy. The Company continues to prioritize the development of in-house IP and licensing opportunities that support its active development programs and future novel drug candidates.
Cybin currently has more than 20 active patent filings - 14 of which were filed this year alone - across 6 patent families. Additionally, the Company has entered into multiple licensing agreements that provide Cybin with additional access to IP from over 15 more patents or patent applications. Collectively, Cybin has access to more than 35 patents and applications through a combination of internal filings and licensing arrangements.
"Securing and maintaining a robust IP portfolio is an important component of our approach to successful drug development," said Doug Drysdale, Chief Executive Officer of Cybin. "We are focused on adding targeted IP that we believe complements our research and development strategy, supports our position as an innovator in the psychedelic therapeutics space, and will continue to build shareholder value."
Cybin's three-pillar strategy leverages the Company's core competencies in preclinical innovation and clinical development toward the creation of intellectual property focused on developing the Company's platform technology, the progression of clinical development programs including CYB003, a deuterated psilocybin analog, CYB004, a deuterated dimethyltryptamine (DMT), CYB005, phenethylamine derivatives, and an expansive list of preclinical molecules to facilitate future development opportunities.
"Supplemented by our agreements with multiple licensors, our IP extends across six patent families, and we have an expansive number of preclinical compounds to explore that have the potential to strengthen our R&D pipeline and support our mission of bringing important new therapeutic options to treating multiple mental health disorders," concluded Drysdale.
Cybin's wholly owned subsidiary Cybin IRL Limited recently entered into licensing agreements that collectively provide the Company with access to a broad range of preclinical molecule combinations for its library of psychedelic derivative drug development candidates. These agreements include the acquisition of an exclusive license to a targeted class of tryptamine-based molecules from Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) as announced by the Company in September 2022.
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
Cautionary Notes and Forward-Looking Statements
Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin's future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words "believe", "expect", "aim", "intend", "plan", "continue", "will", "may", "would", "anticipate", "estimate", "forecast", "predict", "project", "seek", "should" or similar expressions or the negative thereof, are forward-looking statements. Forward looking statements in this news release include statements regarding the Company's plan to engineer proprietary drug development platforms, innovative drug delivery systems, novel formulation approaches, potential treatment regimens for psychiatric disorders and development of medicinal psychedelics to address unmet medical needs.
These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company's operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company's management's discussion and analysis for the three months ended June 30, 2022 and the Company's annual information form for the year ended March 31, 2022, which are available under the Company's profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov . Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations.
Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved nor disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221006005305/en/
Investors & Media: Leah Gibson Vice President, Investor Relations & Strategic Communications Cybin Inc. irteam@cybin.com - or - media@cybin.com Gabriel Fahel Chief Legal Officer Cybin Inc. 1-866-292-4601
News Provided by Business Wire via QuoteMedia
Researchers from Boston's GreenLight Biosciences and the Queensland University of Technology (QUT) in Brisbane, Australia, have announced an agreement to develop a solution to fall armyworm, which causes more than US$2 billion in annual global crop loss.
The partnership includes an Australian government grant to QUT of more than AUD$400,000 from the Australian Research Council. It brings together the teams of two preeminent researchers, Dr. Julia Bally and Professor Peter Waterhouse from the QUT Centre for Agriculture and the Bioeconomy , and GreenLight's Plant Health research and development team.
The partnership aims to develop a solution for fall armyworm, a pest of national priority in Australia. It is also a point of emphasis that the project delivers environmentally-friendly crop protection tools against fall armyworm.
GreenLight's plant health division is working on producing RNA-based solutions for a variety of fungi and insects that cause massive food loss and crop damage annually. In lab tests and field trials, GreenLight's RNA-based solutions leave low or no residues.
Dr. Bally said previous collaboration on fall armyworm with GreenLight had been important to securing the grant from the Australian Research Council this year.
"We are excited to work with GreenLight Biosciences on this solution to armyworm," she said. "We believe furthering our partnership will generate comprehensive new technologies to fight against one of the most damaging global crop pests and greatly improve Australian agritech capacity and strengthen international collaborations."
GreenLight's Vice President of Plant Health R&D Ron Flannagan said: "Fall armyworm has recently invaded Australia and devastates many crops, including sorghum and cotton. Our RNA platform allows us to develop solutions faster and more efficiently than was previously possible. So we are delighted to partner with QUT to accelerate our work targeting the fall armyworm with a sustainable solution."
The project will begin with lab studies and advance to greenhouse and field trials.
"We believe this research will provide significant benefits, such as added security for Australia's most important agricultural crops and regions and global food production," Dr. Bally said.
GreenLight Biosciences aims to address some of the world's biggest problems by delivering on the full potential of RNA for human health and agriculture. Our RNA platform allows us to research, design, and manufacture for human, animal, and plant health. In human health, this includes messenger RNA vaccines and therapeutics. In agriculture , this includes RNA to protect honeybees and a range of crops. The company's platform is protected by numerous patents. GreenLight's human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. GreenLight is a public benefit corporation that trades under the ticker GRNA on Nasdaq. For more information, visit https://www.greenlightbiosciences.com/
David Pesci Head of Media Relations dpesci@greenlightbio.com
For press, email: press@greenlightbio.com
For investors, email: investors@greenlightbio.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/90b3b271-5f43-4894-8e95-f6a9ec97b1ea
News Provided by GlobeNewswire via QuoteMedia
Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company") a drug discovery company developing novel, optimized, next-generation psychedelic and non-psychedelic medications to treat neuropsychiatric and neurological disorders with unmet medical needs, today announced that after extensive preclinical screening studies, a lead psychedelic drug clinical candidate, MSP-2020, and a second back-up drug candidate, MSP-2003, have been selected from its Family 2 program in collaboration with The McQuade Center for Strategic Research and Development, LLC (MSRD), a member of the global Otsuka family of pharmaceutical companies, to advance to IND enabling studies.
MSP-2020 and MSP-2003 are both novel and patentable compounds. They are covered under Mindset's United States Patent and Trademark Office (USPTO) patent number 17/387,864, titled "3-Pyrrolidine-Indole Derivatives as Serotonergic Psychedelic Agents for the Treatment of CNS Disorders." Mindset has received a notice of allowance from the USPTO for this application.
In side-by-side comparisons to psilocybin and psilocin, the two drug candidates elicit in vitro and behavioral responses consistent with a stronger and shorter acting psychedelic effect than psilocybin and a significantly reduced half-life. The drug candidates are CNS penetrant and exhibit high oral bioavailability in different species. They are being developed as optimized next-generation psychedelic drug candidates for the treatment of mental health disorders with IND enabling studies to be initiated by a leading global CRO in late 2022.
"Through a world class scientific collaboration among the Mindset, MSRD and Otsuka Pharmaceuticals teams, Mindset has successfully moved its Family 2 program forward. After extensively screening multiple drug candidates in preclinical studies, we were able to identify not one, but two novel drug candidates to potentially advance to clinical human trials. We are delighted to have reached this major milestone in our program's development," said James Lanthier, CEO of Mindset Pharma. "These candidates, when compared to psilocin and psilocybin, showed the potential to be stronger and faster acting. The preclinical results continue to support our belief that next-generation psychedelic drug compounds have the potential to be superior treatment options for mental health. Our teams continue to advance our collaboration to bring this innovative therapeutic into first-in-human clinical development and ultimately to patients in medical need as rapidly as possible."
To watch a video of Mindset's CEO and CSO discussing the announcement in greater detail, please visit: https://youtu.be/fEDe8nwkupI
About Mindset Pharma Inc. Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next-generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin in addition to its own proprietary compounds. The company has a co-development agreement with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies, for its short-duration compounds, Mindset Families 2 & 4.
For further information on Mindset, please visit our website at www.mindsetpharma.com .
For more information, please contact:
Investor Contact: Allison Soss KCSA Strategic Communications Email: MindSet@kcsa.com Phone: 212-896-1267
Media Contact: McKenna Miller KCSA Strategic Communications Email: MindSet@kcsa.com Phone: 949-606-6585
Company Contact: James Lanthier, CEO Email: jlanthier@mindsetpharma.com
Jason Atkinson, VP, Corporate Development Email: jatkinson@mindsetpharma.com Phone: 416-479-4094
Forward-Looking Information This news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate", "may", "will", "would", "potential", "proposed" and other similar words, or statements that certain events or conditions "may" or "will" occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company's business are contained under the heading "Risk Factors" in the Company's annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
News Provided by GlobeNewswire via QuoteMedia
Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced the tuck-in acquisition of Circularis, a biotechnology company with a proprietary circular RNA and promoter screening platform. When circularized, RNA is much longer-lived in cells, improving its robustness as a potential therapeutic modality. The Circularis platform also allows ultra-high-throughput screening of promoters and other enhancers. Ginkgo is excited to welcome the Circularis team and platform to enable new solutions across bioproduction, RNA therapeutics, cell therapy, and gene therapy partnerships.
In recent years, Ginkgo has significantly expanded its work in cell and gene therapy, including a program to improve adeno-associated virus (AAV) manufacturing in partnership with Biogen , and a program to develop AAV capsids with altered tropism and immunogenicity in partnership with Selecta Biosciences . The field of nucleic acid therapeutics is a promising novel therapeutic modality, and Ginkgo has worked on programs across the space, including with Moderna and Aldevron , and is actively engaged in improving circular RNA efficacy and manufacturing yields.
The Circularis platform strengthens Ginkgo's platform for development of cell and gene therapies, providing the capability to rapidly identify novel promoters with appropriate strength and tissue-specificity designed into customer specific delivery modalities. Leveraging Ginkgo's ability to explore large numbers of genetic designs, these promoter libraries can be explored in combination with modified therapeutic payloads and capsids to provide gene therapy developers a solution that works across any range of cell or organism models. Similarly, the Circularis platform will give Ginkgo the ability to rapidly identify context-specific promoters for cell therapy applications, such as those that modulate gene expression in the tumor microenvironment.
"Circularis has built an exceptional platform to screen gene expression regulatory elements, a need across the cell and gene therapy space," said Narendra Maheshri, Head of Mammalian Foundry at Ginkgo Bioworks. "We are excited to leverage the strong expertise of the Circularis team to further develop circular RNA methods for therapeutic use, and can't wait to incorporate this technology into existing and upcoming cell programs across therapeutic applications as well as more broadly."
"Circularis was founded because we saw a need for better tools to control gene regulation in a range of species. Our team is incredibly proud of what we've built, and the opportunity to scale it on the Ginkgo platform means we're a major step closer to realizing this technology's potential," said Mat Falkowski, Chief Executive Officer at Circularis. "We are excited to bring the power of the Ginkgo platform to both Circularis' already existing customer base and future partners."
Circularis has been using the power of circRNA to control cells for the past eight years. Our novel biology has enabled new scales of experimental methods to help customers make advancements in gene therapy and treatment of rare diseases. Our advanced understanding of circular RNA across multiple cell types and organisms has guided our design towards a range of novel circular RNA materials for use in the growing field of RNA therapeutics.
Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit www.ginkgobioworks.com .
This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential success of the acquisition and Ginkgo's cell programming platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.
GINKGO BIOWORKS INVESTOR CONTACT: investors@ginkgobioworks.com
GINKGO BIOWORKS MEDIA CONTACT: press@ginkgobioworks.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/ginkgo-bioworks-acquires-circularis-to-strengthen-capabilities-in-cell-and-gene-therapy-301639685.html
News Provided by PR Newswire via QuoteMedia
Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, today announced the tuck-in acquisition of Altar, a French biotechnology company that has developed a proprietary adaptive evolution platform. A fleet of Altar's automated adaptive laboratory evolution (ALE) instruments will be integrated into Ginkgo's Foundry to serve customers across food and beverage, biofuels, biomaterials, cosmetics, animal health and human health applications, among others. Ginkgo has successfully collaborated with Altar on customer programs historically and is excited to welcome them to the team.
Despite the immense progress in rational genome editing and high-throughput testing of engineered strains over the last decade, it often remains challenging to engineer microorganisms that meet target specifications under industrially relevant conditions due to the complexity and unknowns of the underlying genetics. For the development of certain phenotypes, such as those based on improved growth under normally unfavorable conditions, ALE can be a powerful approach to address this challenge. By incorporating Altar's ALE platform to Ginkgo's existing strain engineering capabilities, Ginkgo expects to be able to routinely engineer those target phenotypes that can be selected for based on their improved growth properties under defined process conditions, such as in the presence of otherwise inhibitory concentrations of a target end product or prohibitively high temperatures. Selected strains coming out of these ALE-based selections will then be characterized and further validated by Ginkgo's existing suite of test workflows.
"As the range of programs we work on continues to expand, it is imperative that we have the best tools in rational design as well as the ability to leverage the inherent diversity and creativity that emerges from evolutionary processes," said Nikos Reppas , Senior Director, Foundry Technology at Ginkgo Bioworks. "We're excited to welcome the Altar team to Ginkgo and look forward to integrating the Altar technology into Ginkgo's suite of offerings so we can better serve existing and future customers."
"We founded Altar to increase the feasibility and reduce time-to-market for bio-manufactured products," said Simon Trancart, CEO of Altar. "We've been working with Ginkgo for a few years now, and are thrilled to join the Ginkgo platform as we work to accomplish our mission at an even greater scale by collectively using biology to drive innovation across industries."
Altar is specialized in the development of microorganisms for industrial applications. Altar's technology, which was developed in collaboration with the French Alternative Energies and Atomic Energy Commission (CEA), automates Adaptive Laboratory Evolution and offers a unique capability to adapt microorganisms to the conditions required by industrial companies for their competitive utilization at commercial scale. Altar benefited from the support of the European Commission through the EIC Accelerator Pilot financing program. For more information, visit https://www.altar.bio/ .
Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. For more information, visit www.ginkgobioworks.com .
This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential success of the acquisition and Ginkgo's cell programming platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) the effect of Ginkgo's business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, (vi) the risk of downturns in demand for products using synthetic biology, (vii) the unpredictability of the duration of the COVID-19 pandemic and the demand for COVID-19 testing and the commercial viability of our COVID-19 testing business, (viii) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, and (ix) our ability to close and realize the expected benefits of pending merger and acquisition transactions. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2022 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.
GINKGO BIOWORKS INVESTOR CONTACT: investors@ginkgobioworks.com
GINKGO BIOWORKS MEDIA CONTACT: press@ginkgobioworks.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/ginkgo-bioworks-acquires-adaptive-laboratory-evolution-company-altar-301639661.html
News Provided by PR Newswire via QuoteMedia
Provides access to large catalog of compounds complementary to Company's preclinical assets –
– Strengthens drug discovery and development platform to build future potential novel drug candidates –
– Supports broad intellectual property portfolio of innovative psychedelic-based molecules –
Cybin Inc. ( NEO:CYBN ) (NYSE AMERICAN:CYBN) ("Cybin" or the "Company"), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics™, is pleased to announce that, through its wholly-owned subsidiary Cybin IRL Limited, it has entered into an agreement with Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (" Mindset ") to acquire an exclusive license to an extensive targeted class of tryptamine-based molecules from Mindset (the " Agreement ").
Pursuant to the Agreement, Cybin has paid Mindset a one-time license fee of US $500,000 with additional milestones payable upon the successful completion of certain future milestones. Notably, the Agreement:
"This exclusive license bolsters the breadth of Cybin's IP holdings while adding a significant number of compounds to our growing library of psychedelic derivative drug development candidates," said Doug Drysdale, Cybin's Chief Executive Officer. "In addition to the value created from progressing our clinical stage programs for CYB003 and CYB004, our discovery and development engine will continue to be an asset for the Company as we leverage strategic M&A opportunities, including this one, to strengthen our competitive advantage and support our goal of developing new and innovative psychedelic treatments for mental health conditions and other areas of high unmet need. We are pleased to work with Mindset who, like Cybin, has a deep-rooted understanding of psychedelic science."
The Agreement includes an initial license fee payment by Cybin to Mindset of US $500,000 as well as additional clinical development milestone payments (the " Milestone Payments ") payable only upon the successful completion of certain milestones contemplated in the Agreement (the " Milestones "). The Milestone Payments could total up to US $9,500,000, with the first Milestone Payment, in the amount of US $500,000, payable upon completion of a Phase 1 clinical trial. At the sole discretion of Cybin, the Milestone Payments may be payable in cash or in common shares in the capital of Cybin, or a combination thereof, subject to the approval of the Neo Exchange Inc. (the "NEO") and upon the successful completion of the Milestones, including the approval and commercialization of the first drug candidate. The Agreement also contemplates a sales royalty of approximately 2% for all commercialized licensed products within the scope of the Agreement, which is customary for drug licensing agreements of this nature.
Cybin is a leading ethical biotechnology company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
Cautionary Notes and Forward-Looking Statements
Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin's future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words "believe," "expect," "aim," "intend," "plan," "continue," "will," "may," "would," "anticipate," "estimate," "forecast," "predict," "project," "seek," "should" or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Cybin's proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders; the completion of any of the Milestones; the payment of any of the Milestone Payments; and Cybin's expectation that the Agreement will expand Cybin's R&D pipeline of potential treatments for mental health disorders and potentially other areas of high unmet needs.
These forward-looking statements are based on reasonable assumptions and estimates of management of Cybin and Mindset at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Cybin to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where Cybin operates; and the risk factors set out in Cybin's management's discussion and analysis for the three months ended June 30, 2022 and Cybin's annual information form for the year ending March 31, 2022, which are available under the Company's profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov . Although the forward-looking statements contained in this news release are based upon what management believes, or believed at the time, to be reasonable assumptions, Cybin cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Cybin assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations.
Neither the NEO nor the NYSE American LLC stock exchange have approved nor disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220926005858/en/
Investors & Media: Leah Gibson Vice President, Investor Relations & Strategic Communications Cybin Inc. irteam@cybin.com – or – media@cybin.com
Gabriel Fahel Chief Legal Officer Cybin Inc. 1-866-292-4601
News Provided by Business Wire via QuoteMedia
Investing News Network websites or approved third-party tools use cookies. Please refer to the cookie policy for collected data, privacy and GDPR compliance. By continuing to browse the site, you agree to our use of cookies.