Engineers at MIT and the University of Massachusetts Medical School have designed a new type of nanoparticle that can be administered to the lungs, where it can deliver messenger RNA encoding useful proteins.
With further development, these particles could offer an inhalable treatment for cystic fibrosis and other diseases of the lung, the researchers say.
“This is the first demonstration of highly efficient delivery of RNA to the lungs in mice. We are hopeful that it can be used to treat or repair a range of genetic diseases, including cystic fibrosis,” says Daniel Anderson, a professor in MIT’s Department of Chemical Engineering and a member of MIT’s Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science (IMES).
In a study of mice, Anderson and his colleagues used the particles to deliver mRNA encoding the machinery needed for CRISPR/Cas9 gene editing. That could open the door to designing therapeutic nanoparticles that can snip out and replace disease-causing genes.
The senior authors of the study, which appears today in Nature Biotechnology, are Anderson; Robert Langer, the David H. Koch Institute Professor at MIT; and Wen Xue, an associate professor at the UMass Medical School RNA Therapeutics Institute. Bowen Li, a former MIT postdoc who is now an assistant professor at the University of Toronto; Rajith Singh Manan, an MIT postdoc; and Shun-Qing Liang, a postdoc at UMass Medical School, are paper’s lead authors.
Targeting the Lungs
Messenger RNA holds great potential as a therapeutic for treating a variety of diseases caused by faulty genes. One obstacle to its deployment thus far has been difficulty in delivering it to the right part of the body, without off-target effects. Injected nanoparticles often accumulate in the liver, so several clinical trials evaluating potential mRNA treatments for diseases of the liver are now underway. RNA-based Covid-19 vaccines, which are injected directly into muscle tissue, have also proven effective. In many of those cases, mRNA is encapsulated in a lipid nanoparticle — a fatty sphere that protects mRNA from being broken down prematurely and helps it enter target cells.
Several years ago, Anderson’s lab set out to design particles that would be better able to transfect the epithelial cells that make up most of the lining of the lungs. In 2019, his lab created nanoparticles that could deliver mRNA encoding a bioluminescent protein to lung cells. Those particles were made from polymers instead of lipids, which made them easier to aerosolize for inhalation into the lungs. However, more work is needed on those particles to increase their potency and maximize their usefulness.
In their new study, the researchers set out to develop lipid nanoparticles that could target the lungs. The particles are made up of molecules that contain two parts: a positively charged headgroup and a long lipid tail. The positive charge of the headgroup helps the particles to interact with negatively charged mRNA, and it also help mRNA to escape from the cellular structures that engulf the particles once they enter cells.
The lipid tail structure, meanwhile, helps the particles to pass through the cell membrane. The researchers came up with 10 different chemical structures for the lipid tails, along with 72 different headgroups. By screening different combinations of these structures in mice, the researchers were able to identify those that were most likely to reach the lungs.
Efficient Delivery
In further tests in mice, the researchers showed that they could use the particles to deliver mRNA encoding CRISPR/Cas9 components designed to cut out a stop signal that was genetically encoded into the animals’ lung cells. When that stop signal is removed, a gene for a fluorescent protein turns on. Measuring this fluorescent signal allows the researchers to determine what percentage of the cells successfully expressed the mRNA.
After one dose of mRNA, about 40 percent of lung epithelial cells were transfected, the researchers found. Two doses brought the level to more than 50 percent, and three doses up to 60 percent. The most important targets for treating lung disease are two types of epithelial cells called club cells and ciliated cells, and each of these was transfected at about 15 percent.
“This means that the cells we were able to edit are really the cells of interest for lung disease,” Li says. “This lipid can enable us to deliver mRNA to the lung much more efficiently than any other delivery system that has been reported so far.”
The new particles also break down quickly, allowing them to be cleared from the lung within a few days and reducing the risk of inflammation. The particles could also be delivered multiple times to the same patient if repeat doses are needed. This gives them an advantage over another approach to delivering mRNA, which uses a modified version of harmless adenoviruses. Those viruses are very effective at delivering RNA but can’t be given repeatedly because they induce an immune response in the host.
“This achievement paves the way for promising therapeutic lung gene delivery applications for various lung diseases,” says Dan Peer, director of the Laboratory of Precision NanoMedicine at Tel Aviv University, who was not involved in the study. “This platform holds several advantages compared to conventional vaccines and therapies, including that it’s cell-free, enables rapid manufacturing, and has high versatility and a favorable safety profile.”
To deliver the particles in this study, the researchers used a method called intratracheal instillation, which is often used as a way to model delivery of medication to the lungs. They are now working on making their nanoparticles more stable, so they could be aerosolized and inhaled using a nebulizer.
The researchers also plan to test the particles to deliver mRNA that could correct the genetic mutation found in the gene that causes cystic fibrosis, in a mouse model of the disease. They also hope to develop treatments for other lung diseases, such as idiopathic pulmonary fibrosis, as well as mRNA vaccines that could be delivered directly to the lungs.
The research was funded by Translate Bio, the National Institutes of Health, the Leslie Dan Faculty of Pharmacy startup fund, a PRiME Postdoctoral Fellowship from the University of Toronto, the American Cancer Society, and the Cystic Fibrosis Foundation.
MALVERN, Pa., March 31, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the Company’s Chief Scientific Officer, Arun Upadhyay, PhD, will present at the World Vaccine Congress being held April 3 – 6 in Washington D.C.
“Current COVID-19 vaccines are limited by a lack of durability and inability to stop infection and transmission,” said Dr. Upadhyay. “Inhaled vaccines have the potential to generate rapid mucosal immunity in respiratory pathways, limiting infection and transmission. I look forward to discussing Ocugen’s inhaled vaccine technology—to address COVID-19 and flu—during the World Vaccine Congress.”
Ocugen is currently developing a novel mucosal vaccine platform that includes OCU500, a bivalent COVID-19 inhaled vaccine; OCU510, a seasonal quadrivalent flu inhaled vaccine; and OCU520, a combination quadrivalent seasonal flu and bivalent COVID-19 inhaled vaccine. The OCU500 series grants Ocugen a distinct product candidate profile status that could significantly impact major global health obstacles and maximize the Company’s opportunity to serve broader patient markets. For the 2022 to 2023 flu season, in the United States alone, more than 50% of the population above six months of age received a seasonal flu shot, representing a market size of more than 170 million doses.
Details on Dr. Upadhyay’s participation are as follows:
PresentationTitle: “A next generation inhalation-based mucosal vaccine for COVID-19 and Flu: Potential approach to reduce infection and transmission” Date: Wednesday, April 5, 2023 Time: 5:40 p.m. ET Location: Walter E. Washington Convention Center, Washington D.C. – Level 2, Room 203AB
Roundtable DiscussionTitle: “Going beyond existing limitations – Why mucosal vaccines are essential for respiratory diseases” Date: Tuesday, April 4, 2023 Time: 11:40 – 12:20 p.m. ET (rotation 1); 12:30 – 1:10 p.m. ET (rotation 2) Location: Walter E. Washington Convention Center, Washington D.C. – Room 203B
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Contact: Tiffany Hamilton Head of Communications IR@ocugen.com
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
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Financial Results. Maia Biotechnology reported a 4Q22 loss of $5.1 million or $(0.47) per share and a FY2022 loss of $15.7 million or $(1.75) per share. The Phase 2 THIO-101 trial continues to enroll and treat patients at its clinical sites, with several clinical milestone ahead during FY2023. The company ended FY2022 with $10.9 million in cash.
THIO-101 Reached Expected Milestones During 4Q22. MAIA began patient treatment in the THIO-101 trial in NSCLC (non-small cell lung cancer) in July 2022. The first patients were treated in Australia, with European country approvals announced in December 2022. These approvals allow opening clinical sites in Hungary, Poland, and Bulgaria to support European approval. MAIA reported that two European patients have been begun treatment.
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Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
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4Q22 Reported. Axcella Health reported a 4Q22 loss of $23.0 million or $(0.33) per share and a FY2022 loss of $81.2 million or $(1.49) per share. The 4Q loss included restructuring and impairment charges of $4.2 million. Since the restructuring, Axcella has made significant progress transforming AXA1125 from Phase 2a data into an approved IND for a Phase 2b/3 clinical trial. The company ended FY2023 with $17.1 million in cash.
Long COVID Trial Is “Phase 2b/3 Ready”. In February 2023, Axcella announced the FDA accepted its IND for a Phase 2b/3 pivotal study testing AXA1125 in Long COVID. The design of the study was based on the results of its Phase 2a placebo-controlled trial in Long COVID announced in August 2022. The Phase 2a data showed statistically significant results in mental and physical fatigue scores. Although an experimental biomarker endpoint in muscle recovery was not met, the FDA accepted the IND for a Phase 2b/3 trial.
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Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.
Joe Gomes, Managing Director – Generalist Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
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4Q22 Results. Revenue was $40.1 million, up 51.4% y-o-y from $26.5 million. Adjusted EBITDA was $13.3 million, or 33.1% of revenue in the quarter, up from $7.5 million, or 28.3%, a year ago. Schwazze reported a net loss to common shareholders of $29.8 million, or a loss of $0.53/sh in the quarter, versus $5.5 million of net income, or $0.12/sh. last year. Both periods were impacted by one-time items.
Key Metrics. For the eighth consecutive quarter, Schwazze outpaced the Colorado industry, this time by 11%, but, once again, ongoing weakness in the Colorado market resulted in declines in key performance metrics. Colorado two year stacked IDs for same store sales in the fourth quarter were down 6%, and down 9% for the one year period. The same measurements for New Mexico were up 57% and 43%, respectively. Average basket size fell 11.8% in New Mexico but was up 1.5% in Colorado. Customer visits declined 10.5% in Colorado and were up 61.7% in New Mexico.
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Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Financial Results. Cocrystal reported a 4Q loss of $4.5 million or $(0.55) per share and a FY2022 loss of $38.8 million or $(4.77) per share. The full-year results included a non-cash charge of $19.1 million for the impairment of goodwill in 2Q22. Excluding the charge, expenses levels for Research and Development and General and Administrative expense were close to expectations. The company ended FY2022 with $37.1 million in cash.
Influenza Clinical Trial Expected To Begin In 2H2023. In December 2022, Cocrystal reported preliminary safety and tolerability results from its dose-ranging Phase 1 study for orally administered CC-42344 for influenza. A Phase 2a study has been designed to challenge healthy human volunteers with pharmaceutically-produced influenza A virus, then treat with CC-42344. An application to start trials in the UK is planned for 1H2023, with enrollment beginning in 2H23. Preclinical development of an inhaled formulation of CC-42344 continues.
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BOTHELL, Wash., March 29, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) reports financial results for the 12 months ended December 31, 2022, and provides updates on its antiviral pipeline, upcoming milestones and business activities.
“This is an eventful time for Cocrystal with multiple near-term milestones with our highly promising antiviral programs,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “Preparations are ongoing with a UK regulatory filing to begin an influenza A Phase 2a human challenge study with our novel oral PB2 inhibitor CC-42344. Pending regulatory clearance, we expect patient enrollment to begin in the second half of this year.
“We are also preparing to file with the Australian regulatory agency to begin a first-in-human trial in our oral COVID-19 program with our novel, broad-spectrum protease inhibitor CDI-988. This trial is also slated to begin in the first half of 2023, subject to regulatory clearance,” he added. “In our norovirus program, preclinical development activities are ongoing and we plan to select a lead oral candidate by mid-2023.”
“We made significant progress over the past year that put us on pace to initiate two clinical trials during 2023,” said James Martin, CFO and co-CEO. “We expect our cash will be sufficient to fund operating activities for the coming year as we tightly manage our financial resources under our cost-efficient operating model. We also intend to pursue non-dilutive funding to further support development of our promising antiviral programs.”
Antiviral Product Pipeline Overview
We are developing antiviral therapeutics that inhibit the essential viral replication function of RNA viruses that cause acute and chronic viral diseases. Our drug discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level. It differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes. In designing drug candidates, we seek to anticipate and avert potential viral mutations leading to resistance. By designing and selecting drug candidates that interrupt the viral replication process and have specific binding characteristics, we seek to develop drugs that not only are effective against both the virus and possible mutants of the virus, but also have reduced off-target interactions that may cause undesirable clinical side effects. We will continue developing preclinical and clinical drug candidates using our proprietary drug discovery technology.
Influenza Programs
Influenza is a severe respiratory illness caused by either the influenza A or B virus that results in disease outbreaks mainly during the winter months. The global seasonal influenza market was valued at $6.5 billion in 2021 and is projected to reach up to $27.95 billion by 2029, according to Data Bridge Market Research.
Pandemic and Seasonal Influenza A
Our novel oral PB2 inhibitor, CC-42344, has shown excellent antiviral activity against influenza A strains including pandemic and seasonal strains, as well as strains resistant to Tamiflu® and Xofluza®.
In March 2022 we initiated enrollment in our randomized, double-controlled, dose-escalating Phase 1 study to evaluate the safety, tolerability and pharmacokinetics of orally administered CC-42344 in healthy adults.
In April 2022 we announced preliminary Phase 1 study data demonstrating a favorable safety and pharmacokinetic (PK) profile in the first two cohorts in the single-ascending dose portion of the study.
In July 2022 we reported PK results from the single-ascending dose of the study supporting once-daily dosing.
In December 2022 we reported favorable safety and tolerability results from the Phase 1 study with CC-42344 for influenza A.
We entered into an agreement with a UK-based clinical research organization to conduct a Phase 2a human challenge study evaluating safety, viral and clinical measures of orally administered CC-42344 in influenza A-infected subjects. Under the human challenge model, healthy adults will be infected with the influenza A virus under carefully controlled conditions, which we believe will hasten trial enrollment.
We expect to submit an application with the United Kingdom Medicines and Healthcare Products Regulatory Agency in the first half of 2023 to conduct this study. Pending clearance by the agency, we expect to initiate the study in the second half of 2023.
Preclinical development is underway with an inhaled formulation of CC-42344 as a treatment and prophylaxis for influenza A.
Pandemic and Seasonal Influenza A/B Program
Merck recently notified the Company that they continue development activities with the compounds discovered under this agreement and that they have filed on behalf of both companies multiple U.S. and international patent applications associated with these compounds. Merck continues to be responsible for managing the patents.
In January 2019 we entered into an Exclusive License and Research Collaboration Agreement with Merck Sharp & Dohme Corp. (Merck) to discover and develop certain proprietary influenza antiviral agents that are effective against both influenza A and B strains. This agreement includes milestone payments of up to $156 million plus royalties on sales of products discovered under the agreement.
In January 2021 we announced completion of all research obligations under the agreement. Merck is now solely responsible for further preclinical and clinical development of compounds discovered under this agreement.
COVID-19 and Other Coronavirus Programs
By targeting viral replication enzymes and protease, we believe it is possible to develop an effective treatment for all coronavirus diseases including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Our main SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses that cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis.
Oral Protease Inhibitor CDI-988
We selected CDI-988 as our lead candidate for development as a potential oral treatment for SARS-CoV-2. CDI-988, which was designed and developed using our proprietary structure-based drug discovery platform technology, targets a highly conserved region in the active site of SARS-CoV-2 3CL (main) protease required for viral RNA replication.
CDI-988 exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against current variants of concern, and demonstrated a safety profile and PK properties that are supportive of daily dosing.
We are currently conducting good laboratory practice (GLP) toxicology studies in preparation for a Phase 1 study.
Preparations are underway to submit an application to the Australian regulatory authority for a planned randomized, double-blind, placebo-controlled Phase 1 study. Pending regulatory clearance, we expect to initiate the study in the first half of 2023. We believe the FDA’s guidance for further development of our antiviral candidate CDI-45205 (described below) also provides us with a clearer pathway for our planned Phase 1 study with CDI-988, as well as directives for designing a subsequent Phase 2 study.
Intranasal/Pulmonary Protease Inhibitor CDI-45205
An IND-enabling study is ongoing with CDI-45205, our novel SARS-CoV-2 3CL (main) protease inhibitor being developed as a potential treatment for SARS-CoV-2 and its variants.
We received guidance from the FDA regarding further preclinical and clinical development of CDI-45205 that provides a clearer pathway for future clinical development.
CDI-45205 and several analogs showed potent in vitro activity against the main SARS-CoV-2 variants to date including the Omicron variant, surpassing the activity observed with the original Wuhan strain.
CDI-45205 demonstrated good bioavailability in mouse and rat PK studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. CDI-45205 also demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir.
CDI-45205 was among the broad-spectrum viral protease inhibitors we obtained from Kansas State University Research Foundation (KSURF) under an exclusive license agreement announced in April 2020. We believe the protease inhibitors obtained from KSURF have the ability to inhibit the inactive SARS-CoV-2 polymerase replication enzymes into an active form.
Replication Inhibitors
We are using our proprietary structure-based drug discovery platform technology to discover replication inhibitors for orally administered therapeutic and prophylactic treatments for SARS-CoV-2. Replication inhibitors hold potential to work with protease inhibitors in a combination therapy regimen.
Norovirus Program
We are developing certain proprietary broad-spectrum, non-nucleoside polymerases for the treatment of human norovirus infections using our proprietary structure-based drug design technology platform. We also hold exclusive rights to norovirus protease inhibitors for use in humans under the KSURF license.
We are targeting the selection of an oral preclinical lead in the first half of 2023.
Norovirus is a global public health problem responsible for nearly 90% of epidemic, non-bacterial outbreaks of gastroenteritis around the world.
Hepatitis C Program
We are seeking a partner to advance the development of CC-31244 following the successful completion of a Phase 2a study. This compound has shown favorable safety and preliminary efficacy in a triple-regimen Phase 2a study in combination with Epclusa (sofosbuvir/velpatasvir) for the ultra-short duration treatment of individuals infected with the hepatitis C virus (HCV).
HCV is a viral infection of the liver that causes both acute and chronic infection. In June 2022 the World Health Organization estimates that 58 million people worldwide have chronic HCV infection.
2022Financial Results
Research and development expenses for 2022 were $12.4 million compared with $8.8 million for 2021, with the increase primarily due to advancing our influenza lead candidate CC-42344 through a Phase 1 trial and preparation for a Phase 2a clinical trial planned for 2023, as well as advancing our lead COVID-19 clinical oral candidate CDI-988 in preparation for a Phase 1 clinical trial planned for 2023. General and administrative expenses for 2022 were $5.7 million compared with $5.4 million for 2021, with the increase primarily due to professional fees and litigation expenses.
The Company’s litigation with an insurer resulted in the insurance company obtaining a summary judgment during the second quarter of 2022 and accounted for a potential $1.6 million adverse award. The Company filed an appeal in July 2022. Pending the outcome of the appeal, the Company paid $1.6 million into the registry of the court, which stayed execution of the judgment. The United States Court of Appeals for the Third Circuit held oral argument on the appeal on March 8, 2023, and the parties are still awaiting a ruling on the appeal.
The net loss for 2022 was $38.8 million, or $4.77 per share, compared with the net loss for 2021 of $14.2 million, or $0.16 per share. This increase was primarily due to a $19.1 million non-cash impairment-loss of goodwill and an increase in R&D expenses as we continue to advance CC-42344, CDI-988 and other product candidates.
Cocrystal reported unrestricted cash of $37.1 million as of December 31, 2022 compared with $58.7 million as of December 31, 2021. Net cash used in operating activities for 2022 was $21.4 million. The Company reported working capital of $39.0 million and 8.1 million common shares outstanding as of December 31, 2022.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical drug candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value driving milestones in our programs, including, preparation, commencement and advancement of clinical studies for certain product candidates in 2023, the viability and efficacy of potential treatments for coronavirus and other diseases, expectations for the markets for certain therapeutics, our ability to execute our clinical and regulatory goals and deploy regulatory guidance towards future studies, the expected sufficiency of our cash balance to fund our planned operations, our liquidity and planned cost-efficient management of our financial resources, and our continued pursuit of non-dilutive funding. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the impact of COVID-19 (including long-term and pervasive effects of the virus), inflation, interest rate increases and the Ukraine war on our Company, our collaboration partners, and on the U.S., U.K., Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current Contract Research Organization (CRO) and any future CROs and Contract Manufacturing Organizations, the results of the studies for CC-42344 and CDI-988, the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and the outcome of our appeal of the summary judgment. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
FLORHAM PARK, N.J., March 29, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that Dr. Frank Bedu-Addo, President and Chief Executive Officer, will participate in Cantor’s Future of Oncology Virtual Symposium being held on April 3-5, 2023.
Cantor Symposium Presentation Date: Tuesday, April 4, 2023 Time: 3:00 PM ET
For more information about the conference, please contact your Cantor representative directly.
About PDS Biotechnology PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead clinical candidate, PDS0101, has demonstrated the ability to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
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FY2022 Reported With Clinical Progress Updates. PDS Biotech reported a 4Q22 loss of $19.1 million or $(0.61) per share and a FY2022 loss of $40.9 million or $(1.43) per share. The loss included $10 million in licensing fees for PDS0301, paid with $5 million in cash and $5 million in stock. Management updated its plans for Phase 3 trials for PDS0101 and PDS0301 during 2023. Cash on hand on December 31, 2022 was $73.8 million, which is expected to fund operations through 3Q24.
PDS Expects To Begin VERSATILE-003 In 4Q23. The Phase 2 VERSATILE-002 trial has reported strong results testing PDS0101 with Keytruda (pembrolizumab, a checkpoint inhibitor) for recurrent or metastatic head and neck cancer. Based on this data, PDS has received FDA guidance for the Phase 3 VERSATILE-003 trial. The trial protocols are being finalized with an IND submission expected in 2H23 and start of enrollment in 4Q23.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.
Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
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All patients met Good or Excellent intubating conditions. In the 2nd interim pre-planned analyis released Monday, March 27th, 41 patients from 4 cohorts (at least 10 from each) met Good or Excellent intubating conditions, with 40 patients intubated at 60 seconds and 1 patient at 90 seconds. Treatments were generally well tolerated, and while there were no serious events, one patient experienced a treatment-emergent adverse event that could possibly be related to treatment. Based on the analysis, none of the four cohorts (3 different dose groups of BX1000, and a standard dose group of rocuronium) are expected to be dropped nor is the full 80-patient trial enrollment number expected to be adjusted.
Results similar to the 1st interim analysis. In late January, Baudax Bio released the 1st interim analysis that showed the 20 patients (5 patients from each of the four cohorts) met the criteria for Good or Excellent intubating conditions with no adverse events. As a reminder, the primary endpoints assess the time frame needed to reach intubation conditions (time frame is within 2 minutes of administration) and also assess, using a standardized scale (Poor, Good, Excellent), the proportion of patients meeting Good or Excellent conditions. Secondary endpoints assess the safety and tolerability profile of BX1000.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
U.S. Food & Drug Administration (FDA) approves enrolling pediatric patients in the ongoing OCU400 Phase 1/2 trial who have: 1) RP associated with NR2E3 and RHO mutations and 2) LCA associated with CEP290 gene mutations
Ocugen has completed enrollment of adult RP patients with NR2E3 and RHO mutations in the Phase 1/2 trial and expanded enrollment in LCA patients with CEP290 mutations
MALVERN, Pa., March 27, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the FDA approved enrolling pediatric patients in the ongoing OCU400 Phase 1/2 trial.
“This approval moves us one step closer in our efforts to bring OCU400, a novel gene-agnostic modifier gene therapy, to market as a potential life-changing treatment for children afflicted with inherited retinal diseases, such as RP and LCA,” noted Arun Upadhyay, PhD, Ocugen’s Chief Scientific Officer. “This approval further demonstrates the consistent, positive, and timely progress we are making with the Phase 1/2 trial in adult patients. Since a significant number of individuals in the pediatric age group are diagnosed with RP and LCA, it is very important for us to cover this age group in our clinical trials.”
Enrollment of adult RP patients in the Phase 1/2 trial is complete—per protocol—and enrollment continues among patients with LCA. The Company plans to initiate the Phase 3 trial near the end of 2023.
Unlike single-gene replacement therapies, which only target one genetic mutation, Ocugen believes that its modifier gene therapy platform, through its use of Nuclear Hormone Receptors (NHRs), represents a novel approach that has the potential to address multiple retinal diseases caused by mutations in multiple genes with one product, and potentially address complex diseases that are caused by imbalances in multiple gene-networks. While single-gene replacement therapies have shown tremendous promise in rare retinal diseases, they are highly specific and cannot improve a multitude of disease-causing genetic defects. For example, RP and LCA are associated with mutations in more than 100 and in more than 25 genes, respectively. Ocugen is the only company with a gene-agnostic modifier platform that aims to alter this single-gene therapy paradigm through the introduction of a functional gene to modify the expression of multiple genes and gene-networks. We believe that patient prevalence in the United States alone would provide significant long-term value, with RP and LCA affecting 110,000 and 15,000 people, respectively.
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its diverse functionality, OCU400 resets altered/affected cellular gene-networks and establishes homeostasis—a state of balance, which has the potential to improve retinal health and function in patients with inherited retinal diseases.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Contact: Tiffany Hamilton Head of Communications IR@ocugen.com
CHATHAM, N.J., March 27, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that Zeil Rosenberg, M.D., M.P.H., Executive Vice President, Medical and Farooq Nasar, Ph.D., Senior Principal Investigator, both of Tonix Pharmaceuticals, will deliver oral presentations at the World Vaccine Congress, which will be held in Washington D.C., April 3 – 6, 2023. Copies of the Company’s presentations will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the World Vaccine Congress website here.
In addition, Sina Bavari, Ph.D., Executive Vice President, Infectious Disease Research and Development of Tonix Pharmaceuticals will be moderating a panel of key opinion leaders discussing Mpox and the challenges and opportunities in vaccine development.
A Live Attenuated Orthopoxvirus (Horsepox) Vaccine for Mpox and Smallpox
Location:
Walter E. Washington Convention Center, Washington D.C.
Date:
Wednesday April 5, 2023
Time:
12:25 p.m. ET
Oral Presentation Details
Presenter:
Farooq Nasar, Ph.D. (Tonix Pharmaceuticals)
Title:
The Development of Horsepox Virus as a Vaccine Platform: Evaluation of TNX-1800 as a SARS-CoV-2 Vaccine
Location:
Walter E. Washington Convention Center, Washington D.C.
Date:
Thursday April 6, 2023
Time:
10:10 a.m. ET
Panel Details
Title:
Mpox – Challenges and Opportunities in Vaccine Development
Panel:
Sina Bavari, Ph.D. (Tonix Pharmaceuticals); David Evans, Ph.D. (University of Alberta); Jose Esparza, M.D., Ph.D. (University of Maryland); Deborah Birx, M.D. (BGR Group); Michael Merchlinsky, Ph.D. (HHS/BARDA)
Location:
Walter E. Washington Convention Center, Washington D.C.
Date:
Thursday April 6, 2023
Time:
11:30 a.m. ET
Tonix Pharmaceuticals Holding Corp.*
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition, for which a Phase 2 study was initiated in the third quarter of 2022. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is currently enrolling with interim data expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets), a once-daily formulation of tianeptine being developed as a treatment for major depressive disorder (MDD), is also currently enrolling with interim data expected in the fourth quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox, for which a Phase 1 study is expected to be initiated in the second half of 2023. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease portfolio also includes TNX-3900, a class of broad-spectrum small molecule oral antivirals.
*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
DENVER, March 24, 2023 /CNW/ – Medicine Man Technologies Inc. operating as Schwazze, (OTCQX: SHWZ); (NEO: SHWZ) (“Schwazze” or the “Company”), today announced the appointment of Mr. Bradley Stewart to the Board of Directors of Schwazze. The Company also reports that Mr. Sal Wahdan has resigned as a Director of Schwazze.
Mr. Stewart is a Private Equity-backed CEO, board member and advisor, where he specializes in building technology and services companies with a focus on strategic transformation, balance sheet restructuring and M&A. He currently, serves as Senior Advisor at Sixth Street, as Chairman at Perch and as an independent board member at Private Medical and Semper Paratus (Nasdaq: LGSTU).
Previously, Mr. Stewart was CEO at Fair Technologies, a fintech / marketplace backed by SoftBank Group. Prior to Fair, he was Chairman and CEO at XOJet, the largest on-demand private jet services company in North America, backed by TPG and Mubadala, where he led the company’s turnaround. In concurrence with XOJet, he was a Senior Advisor at TPG, a leading private equity firm, where he served on the board of directors for multiple TPG portfolio companies. Prior to his tenure at XOJet and TPG, he was a Vice President at Parthenon Capital, a leading mid-market private equity firm, and formerly an Engagement Manager at McKinsey & Company. He received an MBA from Columbia Business School, a BSB in Corporate Finance from the University of Minnesota’s Carlson School of Management and a Lower Division Completion Certificate from the University of Minnesota’s College of Science & Engineering.
Justin Dye, CEO of Schwazze stated, “We look forward to Brad’s participation on the Board of Directors of Schwazze as his strong experience and skills will be an excellent addition to our Board and the Company. We also would like to thank Sal for his valuable contributions to the Board and wish him well in his future endeavours.”
About Schwazze Schwazze (OTCQX: SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high- performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices. Medicine Man Technologies, Inc. was Schwazze’s former operating trade name. The corporate entity continues to be named Medicine Man Technologies, Inc. Schwazze derives its name from the pruning technique of a cannabis plant to enhance plant structure and promote healthy growth.
Forward-Looking Statements This press release contains “forward-looking statements.” Such statements may be preceded by the words “plan,” “will,” “may,” “continue,” “predicts,” or similar words. Forward-looking statements include the guidance provided regarding the Company’s Q4 2022 performance and annual capital spending. Forward-looking statements are not guarantees of future events or performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. Consequently, actual events and results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our products and product candidates on a commercial scale on our own or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; (v) difficulties in securing regulatory approval to market our products and product candidates; (vi) our ability to successfully execute our growth strategy in Colorado and outside the state, (vii) our ability to identify and consummate future acquisitions that meet our criteria, (viii) our ability to successfully integrate acquired businesses and realize synergies therefrom, (ix) the ongoing COVID-19 pandemic, * the timing and extent of governmental stimulus programs, (xi) the uncertainty in the application of federal, state and local laws to our business, and any changes in such laws, and (xii) our ability to achieve the target metrics, including our annualized revenue and EBIDTA run rates set out in our Q4 2022 guidance. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.
