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$6.00 just printed
BestGrowthStocks.Com Issues Comprehensive Analysis on C3is Inc.
(via NewsDirect)
NEW YORK, NY / NewsDirect / November 17th, 2023 / Best Growth Stocks, a leading independent equity research and corporate access firm focused on finding and reporting on the best growth stocks utilizing exclusive ai-assisted research recently issued a comprehensive analysis on C3is Inc. a ship-owning company providing dry bulk seaborne transportation services.
C3is Inc. (Nasdaq: CISS) recently announced their third quarter and nine months 2023 financial and operating results. These results have garnered a lot of investor attention.
Best Growth Stock's full report breaks through the noise and offers an extensive comprehensive analysis of C3is operations, recent news events, growth strategy, financials and more.
Access this full Analysis: https://bestgrowthstocks.com/access-ciss-analysis/
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ABOUT C3IS INC.
C3is Inc. is a ship-owning company providing dry bulk and crude oil seaborne transportation services. The Company owns three vessels, two handysize dry bulk carriers with a total capacity of 64,000 deadweight tons (dwt) and an Aframax oil tanker with a cargo carrying capacity of approximately 115,800 dwt, resulting with a fleet total capacity of 179,800 dwt. C3is Inc.’s shares of common stock are listed on the Nasdaq Capital Market and trade under the symbol “CISS”.
About Best Growth Stocks
Best Growth Stocks is a leading independent equity research and corporate access firm focused on finding and reporting on the best growth stocks utilizing our exclusive ai-assisted research. BGS is also a financial news provider, focused on giving investors direct access to CEOs of promising, publicly-traded companies, and market experts. Our CEO interviews aim to answer the questions that rest on the minds of current and future shareholders. This is not to be construed as financial advice. Please consult with a licensed financial advisor before making any investment decisions.
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SOURCE: BestGrowthStocks.Com
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PUMP BABY
$5.83 hod
I agree. At least they got their NASDAQ compliance back after that run. Earnings were excellent. Just keeping it on the watch list
Nothing. Better luck tomorrow with something else imho
WaveDancer Announces Merger Agreement with Firefly Neuroscience
– Merger to create NASDAQ-listed, commercial-stage AI-Enabled medical technology company focused on bringing FDA-cleared Brain Network Analytics platform to NASDAQ Capital Markets
FAIRFAX, Va., Nov. 16, 2023 (GLOBE NEWSWIRE) -- WaveDancer, Inc. (“WaveDancer”) (NASDAQ: WAVD) today announced that it has entered into a definitive merger agreement with privately held, commercial-stage, medical technology company, Firefly Neuroscience, Inc. (“Firefly”), to combine the companies in an all-stock transaction. The combined company will focus on continuing to develop and commercialize Firefly’s Artificial Intelligence driven Brain Network Analytics (BNA™) platform, which was previously cleared by the U.S. Food and Drug Administration (“FDA”). Upon closing, which is currently expected in Q1-2024, the combined company is expected to operate under the name Firefly Neuroscience, Inc., and trade on the Nasdaq Capital Market.
“This transaction comes at an important time for Firefly as we accelerate the commercialization of our BNA™ platform,” said Jon Olsen, Chief Executive Officer of Firefly. “Based on the world’s largest medical-grade standardized database of electroencephalogram recordings, BNA™ is the first practical and feasible way for front-line clinicians to objectively measure brain function. As such, we believe the platform has the potential to improve patient management and develop biomarkers and companion diagnostics that will enable drug developers to bring more efficacious therapies to market faster and at a reduced clinical development cost. As a publicly traded company, we can continue to drive innovation and bolster our commercialization efforts while providing existing and new shareholders with the opportunity to participate in our growth story.”
Jamie Benoit, Chief Executive Officer and Chairman of WaveDancer, commented, “Following a strategic review and analysis of our long-term prospects as a publicly-traded company, the Board determined that this merger is in the best interests of WaveDancer’s stockholders and an attractive opportunity to realize significant value as Firefly pursues multiple market opportunities for its BNA™ platform. Firefly has emerged from the rigorous FDA approval process and its BNA™ platform has been subjected to comprehensive academic peer-review. We believe these factors contribute to a competitive advantage for Firefly and position it as a unique public company.”
About Firefly’s Brain Network Analytics (BNA™) platform
BNA™ is an FDA-cleared, cloud-based, AI-powered platform used to objectively assess brain function by comparing patient electroencephalograms (EEGs) with a proprietary database of standardized, high-definition EEGs and behavioral data. BNA™ is used by psychiatrists and neurologists in the United States to support the diagnosis of mental illnesses and cognitive disorders; optimize treatment care pathways; and improve patient compliance to therapy. Real-world clinical use has shown that when BNA™ is used as part of patient management, patients showed improved response rates; enhanced therapy compliance; and reduced non-responder rates and need for medication switching.1
Biotechnology and pharmaceutical companies use BNA™ to support drug development decisions, including selecting an optimal dose and measuring cognitive effect.
The economic burden of people suffering from depression alone in the United States was estimated at $326.2 billion for the year 2020.2 In addition, CNS drug development is costly (the cost of developing a new drug is typically US$10—15 billion3), with the lowest success rate of all other drug categories4.
Clinical use of BNA™ is currently offered on a cost-per-use basis; clinics can use established EEG reimbursement codes to perform a BNA™ assessment.
About the Proposed Transaction, Management and Organization
Under the terms of the merger agreement, each share of Firefly common stock issued and outstanding will be converted into common stock of WaveDancer based on a fixed exchange ratio, with any resulting fractional shares to be rounded to the nearest whole share. At the effective time of the merger, securityholders of Firefly will own approximately 92% of the combined company and securityholders of WaveDancer will own approximately 8% of the combined company, on a fully diluted basis. WaveDancer’s ownership may increase if it raises capital in excess of the minimum detailed in the Definitive Merger Agreement. The closing of the transaction is subject to customary closing conditions, including the effectiveness of the registration statement on Form S-4 to be filed by WaveDancer, and the receipt of required stockholder approvals from Firefly and WaveDancer stockholders.
Following the merger, WaveDancer, Inc. will be renamed “Firefly Neuroscience, Inc.” and the corporate headquarters will be located in Toronto, Ontario. The combined company’s Board of Directors after the Merger will consist of five members, one of whom will be designated by WaveDancer, and will continue to be chaired by Arun Menawat, Ph.D., who is currently CEO and Chairman of Profound Medical Corp. (“Profound”), a publicly traded, commercial-stage medical device company.
The combined company will be led by Jon Olsen, who joined Firefly as Chief Executive Officer in September 2020. Mr. Olsen has an accomplished history of executive management success in the global medical technology industry, building out commercial capabilities, leading marketing and sales teams, planning and executing transformative organizational changes, and cultivating strong thought leader relationships across multiple specialties. His 25 years of healthcare experience includes progressive leadership positions at two of the world’s leading global medical technology companies, Smith & Nephew and Medtronic.
“We are thrilled that Jon has agreed to lead the combined company,” said Dr. Menawat. “It has already been captivating to watch the scale, scope and speed with which leading clinicians and drug developers have begun to show interest in BNA™, and Jon’s extensive and demonstrable record of accomplishment in helping to commercialize new medical technologies will continue to be invaluable as we execute the next stages of our growth strategy.”
The transaction has been approved by the Board of Directors of both companies and is expected to close in Q1 2024, subject to customary closing conditions, including the approvals by the stockholders of each company. WaveDancer’s operating subsidiary Tellenger, Inc., a provider of modernization services to the federal government, will be divested through a transaction closing simultaneous to the Firefly merger.
B. Riley Securities is serving as advisor and Greenberg Traurig, LLP is serving as legal counsel to WaveDancer. Haynes and Boone, LLP is serving as legal counsel to Firefly.
References:
Alivation Health. (2023). Improving Patient Outcomes in Psychiatric Care by Objectively Addressing Cognitive Functional Impairment [White Paper]. Retrieved August 23, 2023, from https://www.linkedin.com/feed/update/urn:li:activity:7098357195787927552/.
Greenberg, P. E., Fournier, A.-A., Sisitsky, T., Simes, M., Berman, R., Koenigsberg, S. H., & Kessler, R. C. (2021). The economic burden of adults with major depressive disorder in the United States (2010 and 2018). PharmacoEconomics, 39(6), 653–665. https://doi.org/10.1007/s40273-021-01019-4
Rabiner, E. (2019, May 30). Advances in CNS drug development. Research Outreach. https://researchoutreach.org/articles/cns-drug-development/
Gribkoff, V. K., & Kaczmarek, L. K. (2017). The need for new approaches in CNS drug discovery: Why drugs have failed, and what can be done to improve outcomes. Neuropharmacology, 120, 11-19. https://www.sciencedirect.com/science/article/abs/pii/S0028390816300934
About WaveDancer
WaveDancer, based in Fairfax, VA, has been servicing federal and commercial customers since 1979. WaveDancer is in the business of developing and maintaining information technology (“IT”) systems, modernizing client information systems, and performing other IT-related professional services to government and commercial organizations. https://wavedancer.com/
About Firefly Neuroscience
Firefly is a pioneering AI company developing innovative neuroscientific solutions that improve outcomes for patients with mental illnesses and neurological disorders. BNATM is a scalable cloud-based platform built on the company's extensive proprietary database of standardized, high-definition EEG recordings, including behavioral data. Firefly's biomarker discovery AI platform further exploits the database to discover useful biomarkers for clinicians and pharmaceutical companies. With a focus on developing state-of-the-art technologies that bridge the gap between neuroscience and clinical practice, Firefly is dedicated to transforming brain health by advancing diagnostic and treatment approaches. https://fireflyneuro.com/
Forward-Looking Statements
Certain statements in this press release and the information incorporated herein by reference may constitute “forward-looking statements” for purposes of the federal securities laws concerning WaveDancer, Firefly, the proposed transaction, and other matters. These forward-looking statements include express or implied statements relating to WaveDancer’s management team’s expectations, hopes, beliefs, intentions, or strategies regarding the future. 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,” “could,” “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 are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting WaveDancer, Firefly or the proposed transaction will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond WaveDancer’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the conditions to the closing of the proposed transaction are not satisfied, including the failure to obtain stockholder approval for the transaction; uncertainties as to the timing of the consummation of the proposed transaction and the ability of each of WaveDancer and Firefly to consummate the proposed transaction; risks related to WaveDancer’s continued listing on the Nasdaq Stock Market until closing of the proposed transaction; risks related to WaveDancer’s and Firefly’s ability to correctly estimate their respective operating expenses and expenses associated with the proposed transaction, as well as uncertainties regarding the impact any delay in the closing would have on the anticipated cash resources of the combined company upon closing and other events and unanticipated spending and costs that could reduce the combined company’s cash resources; the
Thanks for posting that info.
$5.75 hod
INSANE!
It's a travesty of a mockery of a sham of a mockery of two mockeries of a sham.
Company is a front for a paper press
Could bounce over $1.00 again today. Forget about this POS tomorrow.
Remember once a dog always a dog. Thousands of other stocks to play ")
Its a dog with fleas
Same dog but different fleas
Chemomab Therapeutics Receives FDA Fast Track Designation for CM-101 for the Treatment of Primary Sclerosing Cholangitis
—CM-101's Unique Dual Anti-Fibrotic and Anti-Inflammatory Activity Has Disease Modifying Potential in this Poorly Treated Condition—
—CM-101's Phase 2 SPRING Trial in PSC is Advancing Towards Completion of Enrollment with Top-line Readout Expected in 2H 2024—
TEL AVIV, Israel, Nov. 15, 2023 /PRNewswire/ -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted CM-101 Fast Track designation for the treatment in adult patients of primary sclerosing cholangitis (PSC), a fibrotic liver disease that can result in liver transplant, cancer and early death.
Fast Track is a process developed by the FDA to facilitate and expedite the development of new treatments that demonstrate a potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and more frequent interactions with the FDA during the clinical development process. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.
"This FDA Fast Track designation is an important validation of CM-101's potential to have a major impact on this devastating disease that attacks people in their prime years and lacks any approved treatments," said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. "We designed the CM-101 Phase 2 SPRING trial to be supportive of a registrational trial in patients with PSC, and we welcome the enhanced opportunities for working closely with the FDA and for acceleration of the development and review process provided by Fast Track status."
There are no FDA-approved treatments for PSC. CM-101 is a first-in-class monoclonal antibody that neutralizes the soluble protein CCL24, which in preclinical and clinical studies has been associated with key pathways underlying PSC pathophysiology. CM-101's dual anti-inflammatory and anti-fibrotic activity, which is designed to break the vicious cycle driving these pathways, has demonstrated the potential for disease modifying activity in preclinical and early clinical studies of PSC-related processes.
Chemomab Chief Medical Officer Matt Frankel, MD, added, "Promising biomarker and elastography results from our Phase 2a liver fibrosis study in nonalcoholic steatohepatitis (NASH) patients reported earlier this year reinforced our optimism about the therapeutic potential of CM-101. There are common fibrosis pathways in NASH and PSC, and CM-101's relevance to PSC is supported by extensive preclinical and patient sample studies. We also are encouraged by robust patient enrollment in the SPRING trial, which speaks to the high unmet need experienced by these patients. We look forward to continuing our work with PSC patients, their clinicians and the FDA to expedite advancement of CM-101 as a potential treatment for this terrible disease."
Chemomab's Phase 2 SPRING trial (NCT04595825) is a double-blind, placebo-controlled study assessing the safety and tolerability of CM-101 in PSC patients. The trial is also measuring a wide range of relevant biomarkers and physiological parameters. Patient enrollment in the trial is advancing towards completion and Chemomab anticipates reporting a top-line readout in the second half of 2024.
About CM-101
CM-101 is a monoclonal antibody that neutralizes CCL24, a soluble protein that helps drive the inflammatory and fibrotic pathways central to many fibro-inflammatory diseases. CCL24's role as a therapeutic target has been validated in extensive preclinical studies and Chemomab researchers have demonstrated preclinical proof-of-concept for CM-101 in multiple animal and patient sample studies. CM-101 was safe and well tolerated in Phase 1 and Phase 2 clinical trials to date. In a Phase 1b study it improved liver biomarkers, decreased liver stiffness and demonstrated a favorable PK and target engagement profile in patients with nonalcoholic fatty liver disease (NAFLD). Data from a completed Phase 2a liver fibrosis trial in NASH patients (NCT05824156) reported earlier this year showed consistent, positive improvements in key inflammatory and fibrogenesis-related biomarkers, including several that may serve as a potential bridge to activity in PSC. CM-101 has Orphan Drug designation from the FDA and Europe's EMA and is currently being evaluated in PSC patients in the Phase 2 SPRING trial.
About Primary Sclerosing Cholangitis
PSC is a rare, progressive liver disease, characterized by inflammation and fibrosis (scarring) of the bile ducts. Eventually, it can lead to cirrhosis of the liver and liver failure. PSC also increases the risk of various cancers, which account for about half of PSC deaths. PSC affects an estimated 30,000 patients in the U.S. and about 80,000 worldwide. The disease can occur in all ages, genders and races, but is more common in men and is typically diagnosed in patients in their 40s. The underlying cause of PSC is unknown, but about 75% of individuals with PSC also have inflammatory bowel disease. Currently there are no FDA or EMA-approved therapies for patients with PSC. Liver transplant is common in advanced cases, but even then, PSC re-occurs in about 20% of transplanted patients. There is a high unmet need for therapeutic options to address the symptoms and modify the progression of this devastating illness.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These forward-looking statements include, among other things, statements regarding the clinical development pathway for CM-101; the length, duration and impact of the war in Israel on Chemomab's business and operations; the future operations of Chemomab and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones; the nature, strategy and focus of Chemomab; the development and commercial potential and potential benefits of any product candidates of Chemomab; and that the product candidates have the potential to address high unmet needs of patients with serious fibrosis-related diseases and conditions. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Chemomab's current expectations. Forward-looking statements involve risks and uncertainties. Because such statements deal with future events and are based on Chemomab's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Chemomab could differ materially from those described in or implied by the statements in this presentation, including those found under the caption "Risk Factors" and elsewhere in Chemomab's filings and reports with the SEC. Chemomab expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Chemomab's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based, except as required by law.
About Chemomab Therapeutics Ltd.
Chemomab is a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need. Based on the unique and pivotal role of CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody designed to neutralize CCL24 activity. In preclinical and clinical studies, CM-101 appears safe, with the potential to treat multiple severe and life-threatening fibro-inflammatory diseases. Chemomab has reported encouraging results from three clinical trials of CM-101 in patients, including a Phase 1b trial in NAFLD patients, a Phase 2a liver fibrosis trial in NASH patients and an investigator-initiated study in patients with severe lung injury. The CM-101 program for the treatment of systemic sclerosis is Phase 2-ready and a Phase 2 trial in primary sclerosing cholangitis patients is ongoing, with top-line data expected in the second half of 2024. For more information about Chemomab, visit chemomab.com.
Contacts:
Media and Investors:
Barbara Lindheim
Consulting Vice President, Investor & Public Relations,
Strategic CommunicationsPhone: +1 917-355-9234
barbara.lindheim@chemomab.com
IR@chemomab.com
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SOURCE Chemomab Therapeutics, Ltd.
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olid Biosciences Announces IND Clearance by FDA for Duchenne Muscular Dystrophy Gene Therapy Candidate SGT-003
– Planning to initiate Phase 1/2 trial in pediatric DMD Patients –
– First cohort to study patients 4 to < 6 years of age –
CHARLESTOWN, Mass., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it has received U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SGT-003, the company’s next-generation Duchenne Muscular Dystrophy (Duchenne) gene therapy candidate.
“We are pleased to have the FDA’s clearance to proceed into the clinic with SGT-003, a new, innovative gene therapy candidate for Duchenne,” said Bo Cumbo, President and CEO at Solid Biosciences. “SGT-003 combines our differentiated microdystrophin transgene with a next generation muscle-tropic capsid and a transient transfection manufacturing process that may help address the unmet needs for the Duchenne community.” Jessie Hanrahan Ph.D. Chief Regulatory Officer added “We appreciate the FDA’s review of the IND and look forward to continuing to work in collaboration with the agency when we initiate dosing of DMD patients.”
SGT-003 uses a proprietary, rationally designed capsid (AAV-SLB101) to deliver a DNA sequence encoding a shortened form of the dystrophin protein (microdystrophin), containing the R16 and R17 nNos binding protein domains. Preclinical data suggests this may be important for both muscular function and durability of benefit in patients.
“IND clearance for SGT-003 is a critical step in bringing a potential next generation gene therapy to the clinic and making a meaningful impact on the lives of those living with Duchenne. We are working closely with clinical sites to dose the first participants, driven by the belief that better therapies are urgently required to treat this devastating disease,” said Gabriel Brooks, M.D., Chief Medical Officer at Solid Biosciences.
Based on the clearance, Solid plans to move expeditiously to submit the study for IRB approval at the clinical trial sites and expects to commence patient screening shortly thereafter. The planned Phase 1/2 trial, SGT-003-101, is a first in human, open-label, multicenter trial to determine the safety and tolerability of SGT-003 in pediatric patients with DMD at a dose of 1E14vg/kg. SGT-003 will be administered as a one-time intravenous infusion to patients in two cohorts with a minimum of three patients each, with the potential for cohort expansion. Cohort 1 will study patients aged 4 to < 6 years of age with DMD. Long-term safety and efficacy will be evaluated for a total of 5 years following treatment.
In an mdx mouse model of Duchenne, SGT-003 demonstrated rapid transduction, showing robust microdystrophin expression levels in the heart, quadriceps, and diaphragm by day 4 post-gene therapy treatment. SGT-003 in nonhuman primates was shown to increase biodistribution to cardiac and skeletal muscle including the diaphragm versus AAV9. These studies suggest increased transgene expression and an improved safety profile compared to first generation microdystrophin gene therapies.
About DMD
Duchenne is a genetic muscle-wasting disease predominantly affecting boys, with symptoms usually appearing between three and five years of age. Duchenne is a progressive, irreversible, and ultimately fatal disease that affects approximately one in every 3,500 to 5,000 live male births and has an estimated prevalence of 5,000 to 15,000 cases in the United States alone.
About Solid Biosciences
Solid Biosciences is a life sciences company focused on advancing a portfolio of gene therapy candidates and neuromuscular and cardiac programs, including SGT-003, for the treatment of Duchenne muscular dystrophy (Duchenne), SGT-501 for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT), AVB-401 for the treatment of BAG3-mediated dilated cardiomyopathy, AVB-202-TT for the treatment of Friedreich’s ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid is advancing its diverse pipeline across rare neuromuscular and cardiac diseases, bringing together experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases. For more information, please visit www.solidbio.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future expectations, plans and prospects for the company; the ability to successfully achieve and execute on the company’s priorities and achieve key clinical milestones; the company’s SGT-003 program, including expectations for working closely with the FDA and clinical sites, initiating dosing, increasing durability and expression, improving safety, developing an innovative therapy and meeting unmet need; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the ability to recognize the anticipated benefits of Solid’s acquisition of AavantiBio; the company’s ability to advance SGT-003, SGT-501, AVB-401, AVB-202-TT and other preclinical programs and capsid libraries on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies of the company’s product candidates; obtain, maintain or protect intellectual property rights related to its product candidates; compete successfully with other companies that are seeking to develop Duchenne and other neuromuscular and cardiac treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-003, SGT-501, AVB-401, AVB-202-TT and other candidates, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of
HeartSciences’ MyoVista® wavECGTM Selected for Heart Screening of Irish Garda National Police Officers
Southlake, Texas, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an AI-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that its MyoVista® wavECGTM has been selected by Cardiact Ltd (“Cardiact”) to be used in its heart screening program of members of the Association of Garda Sergeants and Inspectors (“AGSI”). In addition to the purchase of a MyoVista® device, Cardiact has placed an initial supplies order covering 2,400 patient tests.
Cardiact is rolling out a newly established heart screening program for the AGSI, which represents sergeants and inspectors of the Garda Síochána national police service of Ireland (“Garda”), to be conducted across Ireland and is due to commence on November 27, 2023. Cardiact has also established a new referral pathway directly to cardiology as part of the program.
Andrew Simpson, Chief Executive Officer of HeartSciences, commented, “We are delighted that the MyoVista® wavECG™ has been chosen for use in this heart screening program of Irish Garda officers. AI-ECG is beginning to see mainstream acceptance and we are excited to see this new screening program which further validates the enormous commercial opportunity for the MyoVista® and the role of AI-ECG in preventative testing.” Mr. Simpson added, “This latest announcement follows a number of recent positive developments which we believe fundamentally transform and de-risk HeartSciences. This includes our agreements with Icahn School of Medicine at Mount Sinai, which provides HeartSciences with what we believe is the largest AI-based ECG algorithm portfolio of any commercial organization. In addition, the AI-ECG industry continues to make exciting progress, with the recent creation of a new FDA product classification for AI-ECG algorithms which we expect to make clearance more structured and quicker under the 510(k) process. We believe AI-based ECG algorithms are the bridge that will finally allow front-line healthcare professionals to close the diagnostic gap and detect heart disease much earlier and at a lower cost."
About HeartSciences
Heron Therapeutics Announces Third Quarter 2023 Financial Results and Updates Financial Guidance
Heron is increasing full-year 2023 Net Product Sales guidance for the oncology care franchise to a range of $104 million to $106 million from a prior range of $99 million to $103 million
We anticipate full-year 2023 Net Product Sales to be in the range of $123 million to $125 million and full-year 2024 Net Product Sales to be in the range of $138 million to $158 million
Full-year 2024 EBITDA (excluding stock compensation) expected to be in the range of ($22 million) to $3 million
Cost reduction plan implemented decreasing operating expenses (excluding stock compensation and depreciation and amortization) by 26% in 2023 compared to 2022 and full-year 2024 operating expenses (excluding stock compensation and depreciation and amortization) are expected to be in the range of $108 million to $116 million
SAN DIEGO, Nov. 14, 2023 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care, today announced financial results for the three and nine months ended September 30, 2023 and highlighted recent corporate updates.
Craig Collard, Chief Executive Officer, commented, "In just six months of initiating our corporate restructuring plan, I am pleased to announce its near completion. The enhanced clarity in our sales projections and operational visibility brings optimism for our path to profitability. I am delighted to offer this quarterly update on our expectations for the fourth quarter and to unveil our 2024 guidance. Heron is now strategically positioned to deliver substantial value in the coming years, boasting a robust balance sheet, a dedicated management team, and a steadfast commitment to operational excellence."
Corporate Updates
Guidance for 2023 and 2024:
The Company is updating guidance for the remainder of 2023 and establishing guidance for the full year 2024 that reflects the growth potential of the product portfolio and the output of our continual operational improvements. Based on our current operational plan, we expect the Company to have sufficient capital to achieve profitability:Full-year 2023 net product sales are expected to be in the range of $123 million to $125 million.Full-year 2023 net product sales guidance for the oncology care franchise is being increased to a range of $104 million to $106 million from a prior range of $99 million to $103 million.EBITDA (excluding stock compensation) expected in the range of ($10 million) to ($6 million) in the fourth quarter of 2023.Full-year 2024 net product sales are expected to be in the range of $138 million to $158 million, with our oncology care franchise growing 3% to 5% in 2024 over 2023. and the acute care franchise growing in excess of 48% year-over-year.Full-year 2024 operating expenses (excluding stock compensation, depreciation and amortization) are expected to be in the range of $108 million to $116 millionFull-year 2024 EBITDA (excluding stock compensation) expected to be in the range of ($22 million) to $3 million.Positive EBITDA (excluding stock compensation) is expected during the fourth quarter of 2024.Expected year-end 2023 cash, cash equivalents, and short-term investments to exceed $65 million with additional access to $25 million from our working capital facility.Gross margin is expected to improve from 41% in 2023 to 69% in 2024, and to over 75% in 2025 and beyond.
Adjustments during Third Quarter 2023:Inventory write-offs during the quarter totaled $7.5 million as a reflection of our reforecast of the ZYNRELEF® product launch. Had we not incurred the write-offs, gross profit for the quarter would have been $20.7 million, or a gross margin of approximately 66%. We do not currently anticipate additional inventory write-offs in the future.One-time expenses during the quarter were $4.1 million, consisting of reorganization costs and severance charges.Loss from operations was $24.9 million for the quarter. Excluding inventory write-offs and one-time expenses, loss from operations would have been $13.3 million.
Financings:In July 2023, Heron completed a private placement equity financing with net proceeds from the sale of Company's common stock and pre-funded warrants of $29.8 million.In August 2023, Heron entered into a working capital facility, providing for an aggregate gross principal amount of up to $50.0 million in working capital for the Company, subject to certain terms and conditions, with $24.4 million in net proceeds drawn at closing.
Product Development: The Vial Access Needle ("VAN") program remains on track for a Prior Approval Supplement ("PAS") submission in early 2024 and an anticipated launch in the third quarter of 2024.
Acute Care Franchise
Acute Care Franchise Net Product Sales: For the three and nine months ended September 30, 2023, acute care franchise net product sales were $4.7 million and $12.9 million, respectively, which increased from $2.7 million and $6.3 million, respectively, for the same periods in 2022.
ZYNRELEF Net Product Sales and PDUFA Date:Net product sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and nine months ended September 30, 2023 were $4.4 million and $12.0 million, respectively, which increased from $2.7 million and $6.3 million, respectively, for the same periods in 2022.The Prescription Drug User Fee Act ("PDUFA") action date for the supplemental New Drug Application ("sNDA") for the ZYNRELEF expanded label is on track for January 23, 2024.
APONVIE® Net Product Sales: Net product sales of APONVIE for the three and nine months ended September 30, 2023 were $0.3 million and $0.9 million, respectively, with no sales in the comparable prior year periods. APONVIE became commercially available in the U.S. on March 6, 2023.
Oncology Care Franchise
Oncology Care Franchise Net Product Sales: For the three and nine months ended September 30, 2023, oncology care franchise net product sales were $26.7 million and $79.9 million, respectively, which increased from $23.9 million and $71.3 million, respectively, for the same periods in 2022.
CINVANTI® Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2023 were $23.3 million and $70.6 million, respectively, which increased from $21.2 million and $64.2 million, respectively, for the same periods in 2022.
CINVANTI ANDA Litigation: Heron had a favorable outcome at the Markman hearing in the pending Hatch-Waxman Abbreviated New Drug Application litigation against Fresenius Kabi to enforce our CINVANTI patents. We are pleased with the outcome and will continue to vigorously enforce and defend our patent portfolio.
SUSTOL® Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2023 were $3.4 million and $9.3 million, respectively, which increased from $2.7 million and $7.1 million, respectively, for the same periods in 2022.
Conference Call and Webcast
Heron will host a conference call and webcast on November 14, 2023 at 4:30 p.m. ET. The conference call can be accessed by dialing (646) 307-1963 for domestic callers and (800) 715-9871 for international callers. Please provide the operator with the passcode 5940799 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron's website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron's website for 60 days following the call.
About ZYNRELEF for Postoperative Pain
ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the U.S. Food and Drug Administration (the "FDA") in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication. In December 2022, we submitted an sNDA to support the proposed indication for greatly expanded use of ZYNRELEF in soft tissue and orthopedic surgical procedures. On July 31, 2023, the FDA notified Heron of an extension of the PDUFA approval goal date by three months to provide for a full review of the submission. The FDA has set a new extended PDUFA approval goal date of January 23, 2024. ZYNRELEF is now indicated in the U.S. in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. ZYNRELEF was granted a marketing authorization by the European Commission in September 2020 and by the United Kingdom Regulatory Authority in January 2021. In August 2023, we cancelled the ZYNRELEF U.K. marketing authorization and, in October 2023, we cancelled the ZYNRELEF European Union (EU) marketing authorization, as we do not plan to commercially launch ZYNRELEF in the U.K. or the EU.
Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.
About APONVIE for Postoperative Nausea and Vomiting (PONV)
APONVIE is a substance NK1 Receptor Antagonist (RA), indicated for the prevention of PONV in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023.
Please see full prescribing information at www.APONVIE.com.
About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention
CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.
Please see full prescribing information at www.CINVANTI.com.
About SUSTOL for CINV Prevention
SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL's efficacy and safety in more than 2,000 patients with cancer. SUSTOL's efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).
Please see full prescribing information at www.SUSTOL.com.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.
Forward-looking Statements
MGO Global Announces Third Quarter 2023 Financial Results
Total Revenues Climb 948% and 1017% for Comparable Three and Nine Months Ended September 30, 2023
MIAMI, FL, LONDON, ENGLAND, and NEW YORK, NY / ACCESSWIRE / November 14, 2023 / MGO Global Inc. (NASDAQ:MGOL), a digitally-native, lifestyle brand portfolio company, ("MGO" or the "Company" or "MGO Global"), today announced its financial results for the three and nine months ended September 30, 2023.
Third Quarter 2023 Financial Highlights
Total revenues for the three months ended September 30, 2023 and 2022 rose 948% to $1,469,802, up from $140,191, respectively.Revenues from The Messi Store climbed 197% to $415,641 compared to $140,191 for the three months ended September 30, 2023 and 2022, respectively. Sales of Stand Flagpoles products totaled $1,054,161 for the three months ended September 30,2023, compared to $0 for the same three months in the previous year due to the fact that the Company did not license the brand until March 2023.
For the comparable nine-month reporting periods, total revenues increased 1071% to $3,755,441 from $336,103.Sales of products sold through The Messi Store nearly tripled to $931,840 compared to $336,103 and total revenues from the sale of Stand Flagpoles products totaled $2,822,601 compared to $0 for the nine months ended September 30, 2023 and 2022 respectively.
For the comparable three-month reporting periods, net loss increased 307% to $2,552,113, or $0.17 loss per share, from a net loss of $627,331, or $0.06 loss per share, respectively. For the nine months ended September 30, 2023, net loss totaled $5,170,443, or $0.36 loss per share, representing a 178% increase from a net loss of $1,859,061, or $0.17 loss per share, for the first nine months of 2022.
As of September 30, 2023, cash totaled $1,721,050; working capital totaled $2,421,371; there was zero long-term debt and total stockholders' equity was $2,630,974.
Maximiliano Ojeda, Co-Founder, Chairman and CEO of MGO Global, stated, "I am very proud of the commitment and exceptional execution by our team in their collective efforts to continuing scaling our brands, particularly given the challenging economic backdrop that is taking its toll on consumers. While we anticipate the macroeconomic environment to remain challenging through the remainder of the year, we have every intention to continue to focus on creating value for our fellow shareholders by maintaining operational excellence in our day-to-day business activities and implementing growth strategies designed to expand both our portfolio of distinctive brands and categories of high quality product offerings to our customers."
For more detailed information on MGO's third quarter 2023 financial performance, please refer to the Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission and accessible at www.sec.gov or on MGO's website at www.mgoglobalinc.com.
As a reminder, MGO's management team will host a public webcast this afternoon beginning at 4:30 PM Eastern Time to discuss the Company's third quarter 2023 results. To access the webcast, please go to https://www.webcaster4.com/Webcast/Page/2957/49420. The webcast will be broadcast live and available for replay through the same link.
About MGO Global Inc.
MGO Global is actively engaged in building a portfolio of independent, digitally native, lifestyle brands, which are unique and differentiated, yet all defined by distinctive, high-quality products and a shared commitment to delivering high-touch customer experiences across its ecommerce and wholesale channels. MGO is currently comprised of three business units: MGOTeam1 which operates the The Messi Store, offering a premium line of functional and sporty casual wear, accessories and homewares inspired by legendary pro soccer player Leo Messi and created by Ginny Hilfiger, our co-founder and chief design officer; Americana Liberty, which markets a growing, high-end line of thoughtfully curated home and outdoor products on Stand; and MGO Digital, which leverages data analytics, advanced technology-enabled marketing and our leadership's industry relationships and expertise to identify, incubate and introduce to market new, authentic lifestyle brand concepts. For more information on MGO Global, please visit www.mgoglobalinc.com.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the Company's ability to grow its businesses, The Messi Store and Stand Flagpoles, other statements that are not historical facts, including statements which may be accompanied by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including without limitation, the Company's ability to achieve profitable operations, customer acceptance of new products, and future measures taken by authorities in the countries wherein the Company has supply chain partners, the demand for the Company's products and the Company's customers' economic condition, the impact of competitive products and pricing, successfully managing and perpetuating the Company's licensing rights with Leo Messi Management, general economic conditions and other risk factors detailed in the Company's filings with the United States Securities and Exchange Commission. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake any responsibility to update the forward-looking statements in this release, except in accordance with applicable law.
CONTACT INFORMATION:
FOR MEDIA AND INVESTOR RELATIONS
MGO Global Inc.
Dodi Handy, Director of Communications
Phone: +1 407-960-4636
Email: ir@mgoteam.com
SOURCE: MGO Global
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1847 Reports 29.8% Increase in Revenue to $18.8 Million for Q3 2023
Gross profit increases 64.9% compared to the same period last year
NEW YORK, NY / ACCESSWIRE / November 14, 2023 / 1847 Holdings LLC ("1847" or the "Company") (NYSE American:EFSH), a unique holding company that combines the attractive attributes of owning private, lower-middle market businesses with the liquidity and transparency of a publicly traded company, today provided a business update and reported financial results for the three months ended September 30, 2023.
Q3 2023 Highlights and Subsequent Events
Total revenue was $18.8M for Q3 2023 compared to $14.5M in Q3 2022, a 29.8% year-over-year increase
Gross profit was $8.0M in Q3 2023 compared to $4.9M in Q3 2022, a 64.9% year-over-year increase
1847 Cabinets expanded relationship with one of the nation's leading home builders
Regained compliance with NYSE American continued listing standards
Completed refinancing and upsizing of $15 million revolving credit facility for its subsidiary, ICU Eyewear
Expanded its subsidiary, Wolo Manufacturing Corp, into India through supply chain diversification program
Restructured promissory notes to non-dilutive debt instruments
Mr. Ellery W. Roberts, CEO of 1847 Holdings, commented, "I am pleased to report that revenues for the third quarter of 2023 increased by 29.8% and our gross profit increased 64.9% over the same period last year. We attribute this performance to the strength of our platform and our ability to support the growth of our portfolio companies, while at the same time improving their profitability. During the quarter, we successfully restructured convertible notes to eliminate the potential equity dilution, and recently Egan-Jones affirmed their BB+ rating on our senior credit facility, which further illustrates the strength of our balance sheet. Importantly, our cash flow continues to improve and based on our current trajectory, we expect to achieve over 50% revenue growth in 2023. Heading into 2024, we expect to continue our strong revenue growth, which should significantly enhance our profitability as we leverage our fixed costs and benefit from economies of scale. We also believe that the intrinsic value of the business has not been recognized by the public market, and, as a result, we continue to explore a variety of strategic options which could include spinoffs of subsidiaries or privatization of the Company to maximize value for our shareholders."
Q3 2023 Financial Highlights
Total revenues were $18,777,921 for the three months ended September 30, 2023, as compared to $14,472,361 for the three months ended September 30, 2022.
Revenues from the retail and appliances segment decreased by $513,697, or 17.5%, to $2,421,008 for the three months ended September 30, 2023, from $2,934,705 for the three months ended September 30, 2022. The decline in revenues was primarily attributed to ongoing supply chain delays and decreased customer demand.
Revenues for the retail and eyewear segment were $4,243,254 for the three months ended September 30, 2023.
Revenues from the construction segment increased by $1,182,633, or 11.8%, to $11,230,579 for the three months ended September 30, 2023, from $10,047,946 for the three months ended September 30, 2022. The increase in revenues was primarily attributed to an increase in new multi-family projects and an increase in the average customer contract value.
Revenues from the automotive supplies segment decreased by $606,630, or 40.7%, to $883,080 for the three months ended September 30, 2023, from $1,489,710 for the three months ended September 30, 2022. The decline in revenues was primarily attributed to ongoing supply chain delays with manufacturers and decreased customer demand.
Total cost of revenues was $10,737,174 for the three months ended September 30, 2023, as compared to $9,596,387 for the three months ended September 30, 2022.
Cost of revenues for the retail and appliances segment decreased by $207,941, or 9.5%, to $1,976,031 for the three months ended September 30, 2023, from $2,183,972 for the three months ended September 30, 2022.
Cost of revenues for the retail and eyewear segment was $2,662,586, or 62.7% of retail and eyewear revenues, for the three months ended September 30, 2023.
Cost of revenues for the construction segment decreased by $1,072,127, or 16.4%, to $5,472,716 for the three months ended September 30, 2023, from $6,544,843 for the three months ended September 30, 2022.
Cost of revenues for the automotive supplies segment decreased by $241,731, or 27.9%, to $625,841 for the three months ended September 30, 2023, from $867,572 for the three months ended September 30, 2022.
Total general and administrative expenses were $4,195,261 for the three months ended September 30, 2023, as compared to $2,505,571 for the three months ended September 30, 2022.
Net loss from continuing operations was $5,859,072 for the three months ended September 30, 2023, as compared to a net loss of $4,472,622 for the three months ended September 30, 2022. Such change was primarily due to interest expense of $5,074,169 and other expense of $187,200. Excluding this, the Company's net loss from continuing operations for the three months ended September 30, 2023 would have been $597,703.
Nine Month 2023 Financial Highlights
Total revenues were $53,572,198 for the nine months ended September 30, 2023, as compared to $39,437,482 for the nine months ended September 30, 2022.
Revenues from the retail and appliances segment decreased by $1,434,911, or 17.2%, to $6,887,589 for the nine months ended September 30, 2023, from $8,322,500 for the nine months ended September 30, 2022.
Revenues for the retail and eyewear segment were $11,530,027 for the period from February 9, 2023 (date of acquisition) to September 30, 2023.
Revenues from the construction segment increased by $5,646,972, or 21.7%, to $31,647,199 for the nine months ended September 30, 2023, from $26,000,227 for the nine months ended September 30, 2022.
Revenues from the automotive supplies segment decreased by $1,607,372, or 31.4%, to $3,507,383 for the nine months ended September 30, 2023 from $5,114,755 for the nine months ended September 30, 2022.
Total cost of revenues was $32,774,377 for the nine months ended September 30, 2023, as compared to $25,109,863 for the nine months ended September 30, 2022.
Cost of revenues for the retail and appliances segment decreased by $784,127, or 12.6%, to $5,461,866 for the nine months ended September 30, 2023, from $6,245,993 for the nine months ended September 30, 2022.
Cost of revenues for the retail and eyewear segment was $7,102,908, or 61.6% of retail and eyewear revenues, for the period from February 9, 2023 (date of acquisition) to September 30, 2023.
Cost of revenues for the construction segment increased by $2,212,564, or 14.0%, to $18,048,394 for the nine months ended September 30, 2023, from $15,835,830 for the nine months ended September 30, 2022.
Cost of revenues for the automotive supplies segment decreased by $866,831, or 28.6%, to $2,161,209 for the nine months ended September 30, 2023, from $3,028,040 for the nine months ended September 30, 2022.
Total general and administrative expenses were $10,715,638 for the nine months ended September 30, 2023, as compared to $6,737,782 for the nine months ended September 30, 2022.
Net loss from continuing operations was $8,781,627 for the nine months ended September 30, 2023, as compared to a net loss of $5,547,498 for the nine months ended September 30, 2022. Such change was primarily due to interest expense of $9,747,299 and other expense of $135,232. Excluding this, the Company's net income from continuing operations for the nine months ended September 30, 2023 would have been $1,100,904.
About 1847 Holdings LLC
1847 Holdings LLC (NYSE American: EFSH), a publicly traded diversified acquisition holding company, was founded by Ellery W. Roberts, a former partner of Parallel Investment Partners, Saunders Karp & Megrue, and Principal of Lazard Freres Strategic Realty Investors. 1847 Holdings' investment thesis is that capital market inefficiencies have left the founders and/or stakeholders of many small business enterprises or lower-middle market businesses with limited exit options despite the intrinsic value of their business. Given this dynamic, 1847 Holdings can consistently acquire businesses it views as "solid" for reasonable multiples of cash flow and then deploy resources to strengthen the infrastructure and systems of those businesses in order to improve operations. These improvements may lead to a sale or IPO of an operating subsidiary at higher valuations than the purchase price and/or alternatively, an operating subsidiary may be held in perpetuity and contribute to 1847 Holdings' ability to pay regular and special dividends to shareholders. For more information, visit www.1847holdings.com.
For the latest insights, follow 1847 on Twitter.
Forward-Looking Statements
This press release may contain information about 1847 Holdings' view of its future expectations, plans and prospects that constitute forward-looking statements. All forward-looking statements are based on our management's beliefs, assumptions and expectations of our future economic performance, taking into account the information currently available to it. These statements are not statements of historical fact. Forward-looking statements are subject to a number of factors, risks and uncertainties, some of which are not currently known to us, that may cause our actual results, performance or financial condition to be materially different from the expectations of future results, performance or financial position. Our actual results may differ materially from the results discussed in forward-looking statements. Factors that might cause such a difference include but are not limited to the risks set forth in "Risk Factors" included in our SEC filings.
Contact:
Crescendo Communications, LLC
Tel: +1 (212) 671-1020
Email: EFSH@crescendo-ir.com
SOURCE: 1847 Holdings LLC
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BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure
SUNNYVALE, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the Food and Drug Administration (FDA) approval of its Phase III clinical trial of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure.
BioCardia announces that the Food and Drug Administration (FDA) has approved its proposed CardiAMP Heart Failure II study protocol. The currently ongoing CardiAMP Heart Failure trial has completed enrollment and it is anticipated that the final data analyses will be reported in Q4 2024. In an interim analysis of available data to date for study patients followed up through two years, those having N-terminal pro B-type natriuretic peptide (NT-proBNP) levels consistent as demarcating heart failure (>500 pg/ml) at screening-baseline showed meaningful clinical improvements over controls, including a 59% relative risk reduction in heart death and a 54% relative risk reduction of Major Adverse Cardiovascular or Cerebrovascular events (MACCE). Further, all clinical outcome measures evaluated at follow-up for this interim subset favored cell therapy over guideline directed medical therapy, including having improved quality-of-life as measured using the Minnesota Living with Heart Failure Questionnaire, reduced NT-proBNP levels, greater walk distance as measured using the 6-minute walk distance test, and improved cardiac measures such as left ventricular ejection fraction and left ventricular end systolic and end diastolic volumes. Statistical significance (p<0.05) was noted for both the reduced heart death equivalents measure (p=0.028) and the improved quality of life measure (p=0.016).
The FDA has approved the proposed CardiAMP Heart Failure II study which includes an eligibility requirement that patients demonstrate a pre-specified NT-proBNP level at baseline. The proposed primary efficacy endpoint is also modified from that in the currently ongoing study. The CardiAMP Heart Failure II endpoint is a similar hierarchical composite assessment but consists of all-cause death, the cardiac death equivalents of heart transplant and left ventricular assist device (LVAD) implantation, heart failure hospitalizations, worsening heart failure events treated as an outpatient, and change in quality-of-life, with a follow-up duration ranging from a minimum of 12 to a maximum of 24 months. Statistical power calculations using the interim data analyses support a modestly sized clinical trial would demonstrate efficacy if the interim data it is based on is representative of future study patients enrolled into the trial. Additional modifications from the ongoing trial include enhancements to simplify clinical site logistics and reduce costs of the study. Medicare’s reimbursement support for the trial currently in place for both the control and treatment arms is anticipated to significantly offset clinical costs of the trial.
“CardiAMP Heart Failure II has strong support from our clinical investigators who have reviewed the interim trial results in detail and have first-hand knowledge of this great unmet clinical need,” said Peter Altman, PhD., BioCardia’s President and Chief Executive Officer. “We expect that we can perform this study efficiently at world class clinical centers based on the extensive experience of the ongoing trial and its positive clinical outcomes.”
About the CardiAMP Cell Therapy Program
CardiAMP Cell Therapy – FDA designated as a Breakthrough therapy – uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. The CardiAMP Heart Failure II Trial builds on positive clinical experience with this autologous cell therapy in almost 200 patients and has potential to provide the primary evidence to support FDA approval and marketing registration. The trial is supported by the Maryland Stem Cell Research Fund and the Centers for Medicare and Medicaid Services. CAUTION - Limited by United States law to investigational use.
About BioCardia®
BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP™ autologous and NK1R+ allogeneic cell therapies are the Company’s biotherapeutic platforms that enable four product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information visit: www.BioCardia.com.
Forward Looking Statements:
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements relating to completing follow-up in the CardiAMP Heart Failure Trial, the probability of success of the CardiAMP Heart Failure I and II trials, ability to offset clinical costs utilizing established Medicare reimbursement, anticipated milestones and events, and the ultimate success of our clinical cell therapy programs. These forward-looking statements are made as of the date of this press release.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Treasure Global Inc Announces Major Shareholder Lock-up Agreement
NEW YORK and KUALA LUMPUR, Malaysia, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Treasure Global Inc (NASDAQ: TGL) (“TGL” or the “Company”), a leading innovative technology solutions provider, announced today the execution of a Lock-up Agreement with major shareholders, collectively holding 9,983,416 shares, which accounts for 36.40% of the Company’s outstanding shares. This strategic move underscores the Company’s unwavering commitment to stabilizing stock prices and enhancing investor confidence.
The Lock-up Agreement was endorsed by key stakeholders, including Loke Chee Wai, a director of AI Lab Martech Sdn Bhd, Lim Kok Seng, a Director of Tophill Holdings Sdn. Bhd., Wan Zainuddin Bin Wan Ibrahim, a Director of The Evolutionary Zeal Sdn Bhd, and Chong Chan “Sam” Teo, Chief Executive Officer of Treasure Global Inc, with the primary objective of fortifying long-term stock value and fostering market stability.
According to the terms of the agreement, the signatories have pledged to refrain from any disposition of common stock or securities convertible into shares of Treasure Global Inc for a duration of one year, starting from November 10, 2023. The agreement allows for certain exceptions, permitting specific transactions such as gifts, family transfers and inclusion in employee benefit plans.
“We view this Lock-up Agreement as a testament to our unwavering commitment to fostering a resilient and sustainable investment climate for our valued shareholders,” stated Chong Chan “Sam” Teo, Chief Executive Officer of Treasure Global Inc. “We are confident that this initiative, covering a substantial portion of our outstanding shares, will strengthen investor confidence and pave the way for the Company’s sustained growth and success.”
About Treasure Global Inc
Treasure Global is a Malaysian solutions provider developing innovative technology platforms. Treasure Global has developed two technology solutions: the ZCITY App, a unique digital ecosystem that transforms and simplifies the e-payment experience for consumers, while simultaneously allowing them to earn rewards; and TAZTE, a digital F&B management system providing merchants with a one-stop management and automated solution to digitalize their businesses. Treasure Global also acts as a master franchiser in Southeast Asia for popular restaurant chains, while providing them with the TAZTE solution. As of November 6, 2023, ZCITY had over 2,660,000 registered users.
For more information, please visit https://treasureglobal.co/.
Forward Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are characterized by future or conditional verbs such as “may,” “will,” “expect,” “intend,” “anticipate,” “believe,” “estimate” and “continue” or similar words. You should read statements that contain these words carefully because they discuss future expectations and plans, which contain projections of future results of operations or financial condition or state other forward-looking information. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2023 and subsequent filings filed with the Securities Exchange Commission (“SEC”). Copies of these documents are available on the SEC’s website, www.sec.gov. These forward-looking statements cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
For further information, please contact:
U.S. Investor Contact
Phill Carlson
KCSA Strategic Communications
ir_us@treasuregroup.co
Malaysian Investor Contacts
ir_my@treasuregroup.co
Media Contact
Sue Chuah, Chief Marketing Officer
Treasure Global Inc
mediacontact@treasuregroup.co
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Almirall and Absci announce AI drug discovery partnership to rapidly develop novel treatments for dermatological diseases
The collaboration expands Absci’s de novo AI drug creation portfolio into dermatology and accelerates discovery for broader chronic inflammatory diseases
BARCELONA, Spain & VANCOUVER, Wash.--(BUSINESS WIRE)-- Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on medical dermatology, and Absci Corporation (Nasdaq: ABSI), a generative AI drug creation company, today announced a drug discovery partnership aimed to develop and commercialize AI-designed therapeutics to fight chronic and debilitating dermatological diseases. The partnership combines Absci’s Integrated Drug Creation™ platform with Almirall’s dermatological expertise with the goal of delivering life-changing medicines to patients, marking another step forward in AI drug creation.
The partnership represents Almirall’s first de novo AI drug collaboration, and it comes only months after Absci announced it could design and validate de novo therapeutic antibodies using its ‘zero-shot’ generative AI. Under the terms of the partnership, Absci will apply its de novo generative AI technology to create and commercialize therapeutic candidates for two dermatological targets. In addition to product royalties, Absci is eligible to receive up to approximately $650 million in upfront fees, R&D, and post-approval milestone payments across the two programs if all milestones are successfully completed.
“Almirall chose Absci because their de novo platform brings truly novel innovation in solving the industry’s most challenging targets facing high unmet medical need,” said Almirall Executive VP of R&D and CSO Dr. Karl Ziegelbauer. “Our partnership underlines Almirall’s commitment to target innovative approaches to help patients suffering from severe skin diseases to achieve their dream of leading a healthy life.”
“Our partnership with Almirall marks an important leap forward for dermatologic drug development and is poised to transform the lives of millions managing skin conditions,” said Absci Founder and CEO Sean McClain. “We believe the collaboration will generate tremendous scientific and technical insights for using AI drug creation to treat chronic inflammatory diseases more broadly. Working with a global leader and visionary in skin disease on this ambitious project will accelerate our journey in creating better biologics for a broad range of diseases affecting millions daily.”
About Almirall
Almirall is a global biopharmaceutical company focused on medical dermatology. We collaborate with scientists and healthcare professionals to address patients' needs through science to improve their lives. Our Noble Purpose is at the core of our work: "Transform the patients' world by helping them realize their hopes and dreams for a healthy life". We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.
The company, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has focused intensely on patients' needs. Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenue in 2022 was €878.5 MM.
For more information, please visit almirall.com
Almirall’s legal warning
This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are "forward-looking statements". These statements are based on the information currently available and the best estimates and assumptions that the company considers reasonable. These statements involve risks and uncertainties beyond the control of the company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events or circumstances on which such forward-looking statements are based, unless required by the applicable law.
About Absci
Absci is a generative AI drug creation company that combines AI with scalable wet lab technologies to create better biologics for patients, faster. Our Integrated Drug Creation™ platform unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimizing multiple drug characteristics important to both development and therapeutic benefit. With the data to learn, the AI to create, and the wet lab to validate, Absci can screen billions of cells per week, allowing it to go from AI-designed antibodies to wet lab-validated candidates in as little as six weeks. Absci’s vision is to deliver breakthrough therapeutics at the click of a button, for everyone. Absci's
Earnings out. = INVO Reports Record Third Quarter 2023 Financial Results
Company Expects to Host Conference Call Shortly After November 20, 2023 Following the Progress of Certain Closing Conditions Pertaining to the Announced Merger Agreement with NAYA Biosciences
SARASOTA, Fla., Nov. 13, 2023 /PRNewswire/ -- INVO Bioscience, Inc. (Nasdaq: INVO) ("INVO" or the "Company"), a healthcare services fertility company focused on expanding access to advanced treatment worldwide with its INVOcell® medical device and the intravaginal culture ("IVC") procedure it enables, today announced financial results for the third quarter ended September 30, 2023 and provided a business update.
Q3 2023 Financial Highlights (all metrics compared to Q3 2022 unless otherwise noted)
Revenues of $974,894 increased 314% compared to $235,321.
Q3 2023 included only a partial quarter contribution from the recently acquired Wisconsin Fertility Institute (WFI). Pro forma revenue for Q3 2023, assuming a full quarter of WFI, would have been approximately $1.5 million.
Adjusted EBITDA was $(0.6) million compared to $(2.0) million. Pro forma adjusted EBITDA, assuming a full quarter contribution from WFI, would have been $(0.3) million and the Company is on a progression towards positive earnings and operating cashflows.
Clinic revenue increased 437% to $947,891, compared to $176,395. All reported clinic revenue is derived from the Company's INVO Centers in Atlanta, Georgia, and WFI (partial quarter) which are consolidated in the Company's financial statements.
Revenue from all clinics, inclusive of both those accounted for as consolidated and under the equity method, was $1,352,881, an increase of 169% compared to $502,993.
Total operating costs were approximately $1.9 million, a $0.9 million decrease compared to $2.8 million.
Net loss was $(1.2) million compared to $(2.5) million. Pro forma net loss, assuming a full quarter contribution from WFI, would have been $(1.0) million.
Exclusive of corporate overhead, the clinics generated positive net income in the period.
Recent Operational and Strategic Highlights
On August 10, 2023, INVO acquired WFI, a profitable Madison-based fertility center.
Implemented certain corporate expense reductions as part of go-forward plan to focus on its healthcare service strategy and a near-term path to profitability.
On October 23, 2023, INVO and NAYA Biosciences Inc., a company dedicated to increasing patient access to breakthrough treatments in oncology and regenerative medicine, jointly announced that they had entered into a definitive merger agreement for INVO to acquire NAYA Biosciences, Inc. ("NAYA") in an all-stock transaction.
Management Commentary
"The results of the quarter highlight the transformation of INVO into a growing, innovative healthcare services company leveraging our INVO Centers to drive IVC volume and obtain a greater share of the total fertility cycle revenue," commented Steve Shum, CEO of INVO. "When you look at the pro forma results for the quarter inclusive of a full quarter contribution from WFI our adjusted EBITDA would have been $(0.3) million, a significant improvement compared to ($2.0) million in the year ago quarter. Equally notable was the fact that our clinics, exclusive of our corporate costs, generated positive net income in the period. With the potential for continued growth from our family of INVO Centers, and more rationalized corporate operating expenses, achieving our stated goal of profitability in 2024 becomes increasingly visible. We look forward to maintaining our focus on driving growth and efficiencies in the business moving forward."
Definitive Merger Agreement
On October 23, 2023, INVO and NAYA, a company dedicated to increasing patient access to breakthrough treatments in oncology and regenerative medicine, jointly announced that they had entered into a definitive merger agreement (the "Merger") for INVO to acquire NAYA Biosciences in an all-stock transaction. Under the terms of the agreement, NAYA Biosciences' shareholders will receive 7.3333 shares of INVO for each share of NAYA Biosciences at closing, for a total of approximately 18,150,000 shares of INVO. Following the closing of the Merger, the combined company is expected to operate under the name "NAYA Biosciences".
As described in greater detail in the Company's SEC filings and press releases, the Merger remains subject to certain closing conditions including shareholder approval, an estimated $5 million or more (at NAYA's discretion) in interim private financing in INVO at a premium of INVO's market price at time of financing ("Interim PIPE"), and a private offering by the combined company at a target price of $5.00 per common share of INVO. At this time, there are no further updates on the satisfaction of the closing conditions.
"We are excited by the opportunity to merge INVO and NAYA and having the financial resources to advance both the fertility and newly acquired oncology operations," commented Shum. "We believe this combination provides the benefit of bringing our existing, revenue-generating operations from our fertility business with an ability to further grow these activities, along with the significant upside potential of innovative cancer therapeutics."
Financial Results
Only partial quarter results from WFI, which INVO acquired on August 10, 2023, are included in the results for the three months ended September 30, 2023. Where applicable, pro forma results are provided as if the acquisition closed on July 1, 2023 and therefore would have been included for the entire quarter.
Revenue for the three months ended September 30, 2023, was $974,894 compared to $235,321 for the three months ended September 30, 2023, an increase of 314%. Pro forma revenue for Q3 2023, assuming a full quarter of WFI, would have been $1,492,520, an increase of 534%.
Clinic revenue from the Company's consolidated INVO Centers was $947,891 during the third quarter of 2023, an increase of 437% compared to $176,395 for the three months ended September 30, 2022. Revenue from all INVO Centers combined was $1,352,881, an increase of 201% compared to the year-ago period.
Selling, general and administrative expenses for the three months ended September 30, 2023, were approximately $1.3 million compared to approximately $2.3 million for the three months ended September 30, 2022. The decrease of approximately $1.0 million, or approximately 46%, was primarily the result of approximately $1.1 million in decreased personnel expenses and approximately $0.2 million in decreased marketing expenses, and was partially offset by a $0.1 million increase in professional fees and a $0.1 million increase in operational expenses related to WFI.
R&D expenses were approximately $0.0 million and $0.2 million for the three months ended September 30, 2023, and September 30, 2022, respectively. The decrease is a result of the Company receiving FDA clearance in June 2023 for its 510(k) application.
Total operating costs were $1.9 million and $2. 8 million for the three months ended September 30, 2023, and September 30, 2022, respectively.
Net loss was $(1.2) million and $(2.5) million for the three months ended September 30, 2023, and September 30, 2022, respectively. Pro forma net loss, assuming a full quarter contribution from WFI, would have been approximately $(1.0) million.
Adjusted EBITDA (see Adjusted EBITDA Table) for the three months ended September 30, 2023, was $(0.6) million, compared to adjusted EBITDA of $(2.0) million for the quarter ended September 30, 2022. Pro forma adjusted EBITDA, assuming a full quarter contribution from WFI, would have been approximately $(0.3) million.
As of September 30, 2023, the Company had approximately $1.1 million in cash.
Use of Non-GAAP Measure
Adjusted EBITDA is a non-GAAP measure. This measure is not intended to be a substitute for those financial measures reported in accordance with GAAP. Adjusted EBITDA has been included because management believes that, when considered together with the GAAP figures, it provides meaningful information related to our operating performance and liquidity and can enhance an overall understanding of financial results and trends. Adjusted EBITDA may be calculated by us differently than other companies that disclose measures with the same or similar terms. See our attached financials for a reconciliation of this non-GAAP measure to the nearest GAAP measure.
Conference Call Details
INVO will announce details for a conference call in a future press release. The conference call is expected to be held after November 20, 2023, and following the progress of certain closing conditions pertaining to the Merger.
About INVO Bioscience
We are a healthcare services fertility company dedicated to expanding the assisted reproductive technology ("ART") marketplace by making fertility care accessible and inclusive to people around the world. Our commercialization strategy is focused on the opening of dedicated "INVO Centers" offering the INVOcell® and IVC procedure (with three centers in North America now operational), the acquisition of US-based, profitable in vitro fertilization ("IVF") clinics and the sale and distribution of our technology solution into existing fertility clinics. Our proprietary technology, INVOcell®, is a revolutionary medical device that allows fertilization and early embryo development to take place in vivo within the woman's body. This treatment solution is the world's first intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early embryo development. This technique, designated as "IVC", provides patients a more natural, intimate, and more affordable experience in comparison to other ART treatments. We believe the IVC procedure can deliver comparable results at a fraction of the cost of traditional IVF and is a significantly more effective treatment than intrauterine insemination ("IUI"). For more information, please visit www.invobio.com.
Safe Harbor Statement
This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results t
Yup. back to $3.50
Back over $3.00 now
Now $5.23
Been a nice rally going on here.Stock just under 02
Nice earnings report. Stock desperately needs awareness! https://www.accesswire.com/viewarticle.aspx?id=802581
Direct Digital Holdings Ranked Number 108th Fastest-Growing Company in North America on the 2023 Deloitte Technology Fast 500™
HOUSTON, Nov. 13, 2023 /PRNewswire/ -- Direct Digital Holdings, Inc. (Nasdaq: DRCT) ("Direct Digital Holdings" or the "Company"), a leading advertising and marketing technology platform operating through its companies Colossus Media, LLC ("Colossus SSP"), Huddled Masses LLC ("Huddled Masses") and Orange142, LLC ("Orange142"), today announced the Company has placed 108th on the Deloitte Technology Fast 500™, a ranking of the 500 fastest-growing technology, media, telecommunications, life sciences, fintech and energy tech companies in North America, now in its 29th year. During the measurement period, Direct Digital Holdings grew 1,325%, making it the 8th ranked company in Deloitte's Digital Content / Media / Entertainment division. The Company placed among the top 20% of all companies on the list and was ranked #6 in Texas.
"We are honored to be included on this prestigious list of fellow industry-leading companies, and I would personally like to thank Deloitte for recognizing our company," said Mark D. Walker, Chairman and Chief Executive Officer of Direct Digital Holdings. "This recognition is a testament to the strength and effectiveness of our business model as well as our technological capabilities and highly diversified customer base. We remain committed to providing best-in-class advertising solutions to our partners as our number of clients, average client-size and total impressions per month all continue to increase."
The Company attributes its significant growth to current market dynamics benefitting its technology-driven and differentiated approach to advertising solutions. On November 9, 2023, the Company reported its third quarter earnings ended September 30, 2023. Direct Digital Holdings' sell-side advertising segment revenue grew to $51.6 million or 174% growth over the $18.9 million of sell-side revenue in the same period of 2022. The Company's buy-side advertising segment revenue grew to $7.9 million or 10% growth over the $7.1 million of buy-side revenue in the same period of 2022.
Direct Digital Holdings' subsidiaries bring distinct offerings to the ecosystem, contributing to the Company's advancement. Colossus SSP is focused on connecting brands of all sizes with a full range of diverse and multicultural audiences, as well as the general market, serving as a one-stop-shop for media inventory needs. On the buy-side, with Huddled Masses and Orange142, the Company provides data-driven digital marketing solutions to businesses in the underserved SMB and middle market landscape. Those two buy-side companies also work seamlessly with Colossus SSP to bring the benefits of its inclusive marketplace and approach to SMB and middle market clients – with significant results.
"We are pleased that the recent strategic and operational investments in our technology stack have resulted in industry-leading growth across our sell-side advertising platforms," said Anu Pillai, Direct Digital Holdings' Chief Technology Officer. "As we also continue to capitalize on the shift in media spend from traditional to digital, as well as the growing media spend targeted at the middle market, the result has been advertising solutions that are utilized by businesses across all industries due to the strength of our technology stack and our proven, differentiated approach. We are proud to collaborate with fellow leaders in the industry such as Amazon Publisher Services, FreeWheel's Beeswax and HPE GreenLake, and look forward to continuing to offer the high-quality advertising solutions we have become known and trusted to provide."
Statements from Deloitte
"Each year, I look forward to reviewing the progress and innovations of our Technology Fast 500 winners as these companies truly demonstrate how important new ideas are to progressing our society and the world, especially during difficult times," said Paul Silverglate, Vice Chair, Deloitte LLP and U.S. Technology Sector Leader. "While software and services and life sciences continue to dominate the top 10, I am encouraged to see other categories making their mark. Congratulations to all the winners who show us how creativity, hard work and perseverance can lead to success."
"As a growing company, it's always rewarding to be recognized for the ongoing commitment it takes to navigate obstacles, transform when necessary and ultimately create a thriving business," said Christie Simons, partner, Deloitte & Touche LLP and industry leader for technology, media and telecommunications within Deloitte's audit and assurance practice. "Over the nearly 30 years we've been compiling the Technology Fast 500 we've seen new categories emerge, growth rates explode, and certain regional markets shine from the bright talent they attract. We are proud of all the winners for achieving this well-deserved honor."
About Direct Digital Holdings
Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses, and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings' sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The Company's subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings' sell- and buy-side solutions manage on average over 125,000 clients monthly, generating over 300 billion impressions per month across display, CTV, in-app and other media channels.
About the 2023 Deloitte Technology Fast 500
Now in its 29th year, the Deloitte Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies — both public and private — in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2019 to 2022.
In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company's operating revenues. Companies must have base-year operating revenues of at least US$50,000, and current-year operating revenues of at least US$5 million. Additionally, companies must be in business for a minimum of four years and be headquartered within North America.
Contacts:
Investors:
Brett Milotte, ICR
Brett.Milotte@icrinc.com
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SenesTech Announces Third Quarter 2023 Financial Results
Revenue Growth Up 44%; Net Loss Improved by Almost $700,000
Company to Begin Shipments of Evolve Soft Bait Next Week
Expected to Be a Key Driver of Revenue Growth
PHOENIX, Nov. 9, 2023 /PRNewswire/ -- SenesTech, Inc. (NASDAQ: SNES, "SenesTech" or the "Company"), (www.senestech.com) the leader in fertility control to manage animal pest populations, today announced financial results for the third quarter of 2023.
"We accelerated our growth trajectory during the third quarter with strong 44% year-over-year growth in revenues driven by the initiatives we have undertaken to drive sales, improve our product quality, and expand our product options," commented Joel Fruendt, SenesTech's President and Chief Executive Officer. "We expect this growth to further accelerate as we launch our Evolve Soft Bait, the first and only soft bait developed to control pest populations using a breakthrough technology that targets the rat population where it starts, by restricting fertility through nonlethal methods. We have received pre-orders and expect to start shipping product next week."
Sales growth during the third quarter was led by increases in nearly every key market segment, including agribusiness, zoos and sanctuaries, and commercial. The Company also continued to experience sequential revenue growth and an improvement of its return on marketing investment within its e-commerce platform following the successful reconfiguration of those operations earlier this year. Overall, the various initiatives led to an improvement of nearly $700,000 in its net loss and Adjusted EBITDA loss compared to the year-ago period.
Fruendt continued, "We have made several operational improvements to drive revenue growth more efficiently, with an objective of reaching profitability in the near future."
The launch of the Evolve Soft Bait is expected to be a significant step in expanding SenesTech's reach within key market verticals, including 'big box' retailers, key e-commerce channels, and pest management professionals. Evolve is highly palatable to rats, easy to deploy, and offers diverse placement in many different and complex environments, including municipalities, parks, recreation facilities, sports venues, food processing facilities, correctional facilities, subways, medical facilities, agribusiness, zoos, and residential locations. Importantly, Evolve is priced competitively to currently available rodenticide alternatives.
"Our initial focus will be on the commercial market and key industry distributors. In addition, we have established our vendor account with Amazon and are pursuing the process of selling through their portal, as well as other e-commerce providers. Finally, we are initiating discussions with key big box retailers to offer Evolve on their shelves," added Fruendt.
The introduction of Evolve continues SenesTech's recent string of innovative product offerings designed to provide customers with the effectiveness of fertility control in the format that fits their needs. In July 2023, the Isolate Bait System was launched as a more efficient and easier-to-use liquid bait system, which integrates both the tank and tray as a single unit. In October, Isolate represented over a third of all unit sales. Last year, the Company introduced Elevate, an easily deployed system for mounting in the rafters of barns, granaries, attics, lofts, and storage and manufacturing facilities. Year-to-date, nearly 5,500 Elevate systems have been deployed in various agricultural settings.
"Product innovation is key to our future success. Building upon the recent introductions of the Isolate and Elevate bait systems for ContraPest, Evolve was developed to offer customers a soft bait product that has similar efficacy to ContraPest, but in a format that is easier to deploy and in a format they can use daily in their integrated pest management programs," Fruendt continued. "A key differentiating feature for Evolve is the opportunity to distribute through key big box retailers and e-commerce providers. We are in active negotiations, with a goal to develop partnerships that will dramatically increase the adoption of the Evolve solution and to set SenesTech up for tremendous success in the future."
Q3 2023 Highlights
Revenue during Q3 2023 was $360,000 compared to $250,000 in Q3 2022, an increase of 44%.
Gross profit during Q3 2023 was $176,000, for a gross profit margin of 49%, compared to $122,000, or a gross profit margin of 49%, in Q3 2022.
Net loss during Q3 2023 was $1.9 million, compared with a net loss of $2.6 million for Q3 2022.
Adjusted EBITDA loss, which is a non-GAAP measure of operating performance, for Q3 2023 was $1.7 million compared to $2.4 million in Q3 2022.
Cash at the end of September 2023 was $2.1 million.
Use of Non-GAAP Measure
Adjusted EBITDA is a non-GAAP measure. However, this measure is not intended to substitute for those financial measures reported in accordance with GAAP. Adjusted EBITDA has been included because management believes that, when considered together with the GAAP figures, it provides meaningful information related to our operating performance and liquidity and can enhance an overall understanding of financial results and trends. Adjusted EBITDA may be calculated by us differently than other companies that disclose measures with the same or similar term. See our attached financials for a reconciliation of this non-GAAP measure to the nearest GAAP measure.
Conference Call Details
Date and Time: Thursday, November 9, 2023, at 5:00 pm ET
Call-in Information: Interested parties can access the conference call by dialing (844) 308-3351 or (412) 317-5407.
Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available in the Investor Relations section of the Company's website at http://senestech.investorroom.com/ or https://app.webinar.net/J3D79bAZjVx.
Replay: A teleconference replay of the call will be available for seven days at (877) 344-7529 or (412) 317-0088, replay access code 6400460. A webcast replay will be available in the Investor Relations section of the Company's website at http://senestech.investorroom.com for 90 days or https://app.webinar.net/J3D79bAZjVx.
About SenesTech
We are committed to improving the health of the world by humanely managing animal pest populations through fertility control. We are experts in fertility control to manage animal pest populations. We invented ContraPest, the only U.S. EPA-registered contraceptive for male and female rats, and Evolve, an EPA-designated minimum risk contraceptive currently offered for rats. ContraPest and Evolve fit seamlessly into all integrated pest management programs, significantly improving the overall goal of effective pest management. We strive for clean cities, efficient businesses and happy households – with a product designed to be humane, effective and sustainable.
For more information visit https://senestech.com/ and https://contrapeststore.com.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of federal securities laws, and we intend that such forward-looking statements be subject to the safe harbor created thereby. Such forward-looking statements include, among others, our expectation that the Evolve Soft Bait solution will be a key driver to revenue growth; our expectation that our growth will further accelerate into the future as we launch our Evolve Soft Bait solution; our expectation that we will start shipping Evolve Soft Bait product next week; our objective to drive the business towards profitability; our expectation that the launch of the Evolve Soft Bait solution will be a significant step in expanding our reach within key market verticals, including 'big box' retailers, key e-commerce channels, and leading industry pest management professionals; our belief that product innovation is key to our future success; and our goal to develop partnerships that will dramatically increase the adoption of the Evolve solution and set us up for tremendous success in the future. Forward-looking statements may describe future expectations, plans, results, or strategies and are often, but not always, made through the use of words such as "believe," "may," "future," "plan," "will," "should," "expect," "anticipate," "eventually," "project," "estimate," "continuing," "intend" and similar words or phrases. You are cautioned that such statements are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those reflected by such forward-looking statements. Such factors include, among others, the successful commercialization of our products; market acceptance of our products; our financial performance, including our ability to fund operations; our ability to maintain compliance with Nasdaq's continued listing requirements; and regulatory approval and regulation of our products and other factors and risks identified from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
Nice A>H push $4.45 to close $4.42 up 69.3%. Monday will be interesting for sure
Here (below) is the reason for the selloff. It's been pure panic selling when no panic is needed. I'm loading
The Special Meeting of Stockholders of Tenon Medical, Inc. (“Tenon” or the “Company”) will be held virtually via live webcast on Monday, December 18, 2023 at 10:30 a.m. Pacific Time for the following purposes:
(1) to consider and vote on a proposal to approve, for purposes of Nasdaq Listing Rule 5635(d), the issuance of the maximum number of shares of our common stock issuable under the terms of Series A Preferred Stock and Warrants to be issued by the Company to investors;
(2) to consider and vote on a proposal to approve an amendment (the “Certificate of Amendment”) to the Company’s Second Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), which amends and restates Article IV of the Certificate of Incorporation to (i) authorize the issuance of 150,000,000 shares of capital stock, of which 130,000,000 shall be shares of Common Stock and 20,000,0000 shares of which shall be preferred stock, (ii) expressly vest in the Board of Directors of the Company the authority to issue the preferred stock with powers, designations, preferences and relative, participating, optional or other rights, if any, or the qualifications, limitations or restrictions thereof as the Board of Directors of the Company (the “Board”) may determine and only if the Board determines in its discretion to include the following provision in the Certificate of Amendment (iii) provide for a reverse stock split (the “Reverse Stock Split”) of the Common Stock, that will be at a ratio ranging from one for two (1:2) to one for fifty (1:50) (the “Split Ratio Range”), the final determination of which shall be determined by the Board; and
(3) to consider and vote on the proposal to adjourn the Special Meeting, if necessary or appropriate, to solicit additional proxies.
Altamira Therapeutics Announces European Patent Office Decision to Grant for Patent Application Covering Intranasal Betahistine
Hamilton, Bermuda, Nov. 10, 2023 (GLOBE NEWSWIRE) --
November 10, 2023 -- Altamira Therapeutics Ltd. ("Altamira" or the "Company") (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that it has received an “Intention to Grant” notice from the European Patent Office (EPO) for its patent application titled “Intranasal Composition Comprising Betahistine” (designated as European Patent 3698791).
The application is a continuation of the previously granted European Patent 3474850 and upon issuance, is expected to remain valid until February 2038. Combined, these two patents will provide key intellectual property protection for the Company's intranasal betahistine program (AM-125) in Europe. To date, the patent has been granted in around 50 countries worldwide, including key markets in North America and Europe. The allowed claims cover the composition of matter and methods of use for formulations of betahistine dihydrochloride for intranasal delivery.
“We are very pleased with the continued expansion of our patent portfolio covering the intranasal betahistine program,” commented Thomas Meyer, Altamira Therapeutics’ founder, Chairman and CEO. “Securing our intellectual property is pivotal as we strategically position our Company around our RNA delivery platform. With considerable interest from various parties, we anticipate collaborating with the appropriate partners to bring the AM-125 program to patients worldwide who are suffering from dizziness.”
About Betahistine
Betahistine, a small molecule structural analog of histamine, acts as an agonist at the H1 histamine receptor and as an antagonist at the H3 histamine receptor. Unlike histamine, it crosses the blood-brain-barrier. Betahistine is known to increase the release of histamine, acetylcholine, dopamine and norepinephrine in the brain. It increases cochlear, vestibular and cerebral blood flow and facilitates vestibular compensation and inhibits neuronal firing in the vestibular nuclei. Betahistine for oral administration is approved in about 115 countries (with the U.S. being a notable exception) for the treatment of vertigo and Meniere’s disease. Despite its good safety profile, the clinical utility of orally administered Betahistine is limited due to poor bioavailability.
About AM-125
AM-125 is an intranasal formulation of betahistine. Because of its ability to circumvent first-pass metabolism, AM-125 has been shown to have 5-to-29 times higher bioavailability than orally administered betahistine. Altamira is developing AM-125 for the treatment of acute vestibular syndrome which may be triggered by a variety of causes including trauma, infection, or inner ear fluid disturbances. With its incidence and prevalence increasing with age, vestibular dysfunction affects more than one third of the U.S. population 40 years of age and older.
About Altamira Therapeutics
Altamira (Nasdaq:CYTO) is dedicated to developing RNA-based therapeutics for extrahepatic tar-gets (OligoPhore™ / SemaPhore™ delivery platforms). The Company currently has two flagship siRNA programs in preclinical development beyond in vivo proof of concept: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis. The versatile delivery platform is also suited for mRNA and other types of RNA therapeutics and is planned to be leveraged via out-licensing to pharma or biotech companies. In addition, Altamira is in the process of divesting and/or out-licensing its legacy assets in allergology and viral infection (Bentrio® OTC nasal spray; commercial) and inner ear therapeutics (AM-125 nasal spray for vertigo; post Phase 2; Keyzilen® and Sonsuvi® for tinnitus and hearing loss; Phase 3). Founded in 2003, Altamira is headquartered in Hamilton, Bermuda, with its main operations in Basel, Switzerland. For more information, visit: https://altamiratherapeutics.com/
Forward-Looking Statements
Of course, there is! :)