Global Restaurant Franchising Company HiresExperienced C-Suite Growth Leader to Drive Expansion Efforts
LOS ANGELES, Nov. 14, 2022 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc., announces the hiring of its first Chief Growth Officer, Jeremy Theisen. Theisen joins FAT Brands with over 20 years of experience in significantly increasing the revenue stream for high-growth start-ups in the restaurant sector and will be focused on spearheading the growth of the development pipeline across the FAT Brands portfolio. This includes bringing new franchisees into the system and driving multi-unit expansion with existing franchisees.
Prior to joining FAT Brands, Theisen served as Chief Revenue Officer of PathSpot, a hygiene management system geared towards the foodservice industry, where he not only grew the company’s contracted revenue by 15 times in 24 months, but also, was key in their overseas expansion in Europe and Australia. Theisen also served as Chief Sales Officer of Punchh, the restaurant industry leader in loyalty and engagement programs, where he saw the company through its launch to generating $50 million in revenue prior to being acquired by Par Technology Corporation several years later. Other experiences include Google and Truaxis, a loyalty rewards and personalized statement solutions company owned by MasterCard.
“Over the last several years, FAT Brands continues to reach new heights from a growth perspective,” said FAT Brands CEO Andy Wiederhorn. “While our acquisition strategy has been a key mechanism for growth, we have also been heavily invested in building out our deep, organic pipeline. This year has already been record-breaking from an opening standpoint, and we are just getting started. Jeremy is a great addition to our team to drive this growth forward exponentially in the years to come. His experience of quickly scaling companies from start-ups to industry leaders aligns with our fast-paced growth mentality.”
“I am excited for the new journey ahead at FAT Brands,” said Jeremy Theisen. “I have had the pleasure of working with the company while at my other ventures and have been amazed at the growth they have achieved. What was once Fatburger has now transformed into a 17-concept portfolio with a strong worldwide presence. I look forward to adding to the already strong growth trajectory of the company and forging new relationships with new and existing franchisees.”
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide.
HOUSTON, Nov. 14, 2022 /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 that the Company will be participating in the ROTH 11th Annual Technology Event taking place on November 16, 2022 at The Yale Club in New York, NY.
Keith Smith, President of Direct Digital Holdings, and Susan Echard, Chief Financial Officer of Direct Digital Holdings, will be attending on behalf of the Company and available for meetings during the conference. For more information, or to schedule a meeting with management, please reach out to your ROTH representative.
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 approximately 90,000 clients monthly, generating over 100 billion impressions per month across display, CTV, in-app and other media channels. The company has been named a top minority-owned business by The Houston Business Journal.
Completed enrollment in the Phase 1 study with novel, broad-spectrum antiviral PB2 candidate CC-42344 for the treatment of pandemic and seasonal influenza A; remains on track to report topline results in 2022
Announced oral presentation of CC-42344 Phase 1 influenza A data at the World Antiviral Congress 2022 being held in December
Selected novel antiviral candidate CDI-988 for clinical development as an oral treatment for SARS-CoV-2 with Phase 1 study expected to begin in the first quarter of 2023
BOTHELL, Wash., Nov. 14, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) reports financial results for the three and nine months ended September 30, 2022, and provides updates on its antiviral pipeline, upcoming milestones and business activities.
“We are reporting continued progress in advancing our highly promising antiviral portfolio,” said Sam Lee, Ph.D., President and co-interim CEO of Cocrystal. “With enrollment completed in our CC-42344 Phase 1 study for the treatment of pandemic and seasonal influenza A, we are on track to report topline safety and pharmacokinetic (PK) results later this year. The full trial results will be a key component of UK regulatory agency submission for our influenza A Phase 2a human challenge study. Subject to the agency’s review and clearance of our submission, we expect Phase 2a study initiation in the second half of 2023.
“We advanced our oral COVID-19 program with the selected the novel, broad-spectrum protease inhibitor CDI-988 as our lead development candidate,” he added. “We are conducting IND-enabling toxicology studies with CDI-988 and plan to file for regulatory clearance to begin a first-in-human trial in Australia in the first quarter of 2023. Preclinical development activities are ongoing in our norovirus program with plans to select a lead candidate in the first half of 2023.”
“The recent increase in patients hospitalized with viral disease particularly among the pediatric population underscores the need for effective, broad-spectrum antivirals and provides rationale for our approach in developing candidates with barriers to drug resistance,” said James Martin, CFO and co-interim CEO. “We continue to be well positioned to execute on our clinical and regulatory goals given our clean capital structure, cost-efficient business model and a cash balance we believe is sufficient to fund planned operations for the next three years. That said, we continue to pursue non-dilutive funding to further support development of our promising antiviral programs.”
Antiviral Product Pipeline Overview
Many commercial antiviral drugs are only effective against certain strains of a virus and are less effective or not effective at all against other strains or variants. Cocrystal is developing novel drug candidates that specifically target proteins involved in viral replication. Despite the numerous strains that may exist or emerge, these targeted enzymes are required for viral replication and are essentially similar (highly conserved) across all strains. By targeting these highly conserved regions of the replication enzymes, our antiviral compounds are designed to be effective against major virus strains.
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.
During 2022 Cocrystal entered into two agreements with the National Institute of Allergy and Infectious Diseases (NIAID) for exploratory preclinical studies to evaluate our 3CL protease inhibitors for the treatment of COVID-19. The NIAID collaboration announced in April 2022 for in vitro and in vivo studies evaluating the antiviral activity of our compounds has been successfully completed. In June 2022 we expanded our collaboration with the NIAID with a second agreement in which we provided our proprietary process chemistry information for oral 3CL protease inhibitors to the NIAID to support scale-up synthesis of a key intermediate of these compounds. This collaboration is ongoing.
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 exhibits 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.
We plan to initiate a Phase 1 study in the first quarter of 2023. We believe the FDA’s guidance for further development of our antiviral candidate CDI-45205 (described below) 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 COVID-19 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.
InfluenzaPrograms Influenza is a severe respiratory illness caused by either the influenza A or B virus that results in outbreaks of disease mainly during the winter months.
Pandemic and Seasonal Influenza A
A novel 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®. CC-42344 also has favorable PK and drug-resistance profiles.
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 PK profile in the first two cohorts administered single ascending doses of CC-42344 at 100 mg and 200 mg.
In July 2022 we reported PK results from the single ascending dose of the study supporting once-daily dosing.
In November 2022 we announced the Phase 1 study had reached full enrollment and reiterated our expectation to report topline results in 2022.
We entered into an agreement with a UK-based clinical research organization to conduct a human challenge Phase 2a 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 and ensure subjects are infected with influenza A.
We expect to submit an application with the United Kingdom Medicines and Healthcare Products Regulatory Agency in early 2023 to conduct a human challenge Phase 2a study. Pending clearance by the agency, we expect to initiate the study in the second half of 2023.
Pandemic and Seasonal Influenza A/B Program
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, and continues development activities with the compounds discovered under this agreement.
In April 2022 Merck indicated it was continuing development of the compounds discovered under this agreement.
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 a 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 infections.
Third Quarter Financial Results
Research and development (R&D) expenses for the third quarter of 2022 were $3.9 million compared with $2.1 million for the third quarter of 2021, with the increase primarily due to the ongoing influenza A Phase 1 trial and advancement of the preclinical COVID-19 program. The Company anticipates higher R&D spending during the remainder of 2022 in preparation for additional clinical trials. General and administrative (G&A) expenses were $1.8 million for the third quarters of both 2022 and 2021.
The net loss for the third quarter of 2022 was $5.7 million, or $0.70 per share, compared with the net loss for the third quarter of 2021 of $3.9 million, or $0.48 per share.
Nine Month Financial Results
R&D expenses for the first nine months of 2022 were $9.1 million compared with $6.1 million for the first nine months of 2021. G&A expenses were $4.5 million for the first nine months of both 2022 and 2021.
The net loss for the first nine months of 2022 was $34.3 million, or $4.23 per share, and included the items described above. The net loss for the first nine months of 2021 was $10.5 million, or $1.44 per share.
Cocrystal reported unrestricted cash of $42.1 million as of September 30, 2022 compared with $58.7 million as of December 31, 2021. Net cash used in operating activities for the first nine months of 2022 was $16.5 million. The Company reported working capital of $43.3 million with 8.1 million common shares outstanding as of September 30, 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 goals of initiating a Phase 1 study for our CDI-988 candidate in the first quarter of 2023, our expectations of reporting data from the Phase 1 clinical study of our CC-42344 candidate later in 2022 and timeline for filing with the UK regulatory agency and commencing a Phase 2a study in 2023, our plans to select a lead candidate for our norovirus program in the first half of 2023, the viability and efficacy of potential treatments for coronavirus and other diseases, expectations for the global market for therapeutics, our attempts to discover replication inhibitors, our ability to execute our clinical and regulatory goals, our expectations concerning R&D expenses, the expected sufficiency of our cash balance to fund our planned operations, our liquidity 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 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 national and global economy, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including and 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, 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, 2021. 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.
Announced preliminary PDS0101 efficacy and safety data for Phase 2 clinical studies led by The University of Texas MD Anderson Cancer Center (IMMUNOCERV) and The National Cancer Institute at SITC 2022
Announced successful end-of-Phase 2 meeting with FDA for VERSATILE-002, allowing preparation for a registrational trial
Company to host conference call and webcast today at 8:00 AM EST
FLORHAM PARK, N.J., Nov. 14, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, will discuss its financial results for the quarter ended September 30, 2022 and provide a business update on its conference call today.
Recent Business Highlights:
PDS0101 Lead Drug Candidate
VERSATILE-002 Phase 2 Clinical Trial
Hosted a key opinion leader roundtable discussion on current treatment of head and neck cancer, and how PDS0101 might fit into the treatment paradigm.
Announced a successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), allowing progression to a registrational trial for VERSATILE-002.
IMMUNOCERV Phase 2 Clinical Trial
Presented preliminary data on the clinical efficacy and safety of the combination of PDS0101 and chemoradiotherapy, as well as immunological correlates in the IMMUNOCERV Phase 2 trial being conducted at The University of Texas MD Anderson Cancer Center in locally, advanced cervical cancer at the Society for Immunotherapy of Cancer Conference (SITC) 2022.
NCI-led Triple Combination Phase 2 Clinical Trial
Presented data on immunological correlates associated with clinical benefit in patients with HPV-positive checkpoint inhibitor (CPI) refractory cancer treated with the PDS0101-based triple combination in the National Cancer Institute (NCI)-led Phase 2 clinical trial at the Society for Immunotherapy of Cancer Conference (SITC) 2022.
Reported expanded interim data for the Phase 2 PDS0101 based triple combination trial led by the NCI targeting advanced HPV-positive cancers.
Announced completion of recruitment into the NCI-led PDS0101-based triple combination Phase 2 trial, and also reported selection of the CPI refractory arm as the preferred patient group to target in a registrational study with the triple combination.
PDS0102 and PDS0103 Drug Candidates
Presented preclinical data on both PDS0102 and PDS0103, demonstrating the versatility of the Versamune® platform and generation of TARP and MUC1 specific polyfunctional CD8+ T cells presented at the American Association of Cancer Research (AACR) Special Conference: Tumor Immunology and Immunotherapy 2022.
PDS0202 Universal Flu Candidate
Presented data from the preclinical universal flu vaccine program at the American Society of Virology meeting, demonstrating the potential ability of PDS0202 to neutralize multiple strains of influenza in animals.
Financing
Entered into a venture loan and security agreement with Horizon Technology Finance Corporation, which provides PDS Biotech with up to $35 million in term loans.
“The third quarter has been monumental for PDS Biotech, and we continue to make strides towards commercialization of our lead candidate, PDS0101,” stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. We’ve remained focused on progressing our four Phase 2 clinical programs, most recently, announcing data from our IMMUNOCERV trial in locally, advanced cervical cancer. 100% (9/9) of patients had a clinical response with tumor shrinkage of over 60% at the midpoint evaluation, and 89% (8/9) of patients had a complete response with no evidence of disease at day 170, when treated with a combination of PDS0101 and chemotherapy. Furthermore, we released expanded interim data from our NCI-led PDS0101-based triple combination trial demonstrating 66% (19/29) survival at median follow up of 16 months in checkpoint inhibitor refractory HPV-positive cancer patients that appears to show signs of clinical efficacy, durability, and safety, consistent with the data presented at the American Society for Clinical Oncology 2022. And, with VERSATILE-002 in which PDS0101 is combined with KEYTRUDA®, we are preparing for a registrational trial after our successful end-of-Phase 2 meeting with the FDA. To date, we have presented PDS0101 Phase 2 efficacy data in over 60 patients and safety data in over 100 patients.”
Matthew Hill, Chief Financial Officer of PDS Biotech, stated, “We are excited about the progress we have made in our development programs, and we have strengthened the balance sheet to support our ongoing efforts. This August, we increased our cash position by entering into a loan agreement with Horizon Technology Finance Corporation, where we received an initial tranche of $25 million in term loans. This financing provides PDS Biotech with the financial resources and runway needed to prepare for a registrational trial for our lead candidate, PDS0101, and to advance our preclinical pipeline.”
Third Quarter 2022 Financial Results Net loss for the three months ended September 30, 2022 was approximately $7.4 million, or $0.26 per basic share and diluted share, compared to a net loss of approximately $7.0 million, or $0.24 per basic and diluted share, for the three months ended September 30, 2021. The higher net loss reported for the three months ended September 2022 is primarily due to additional costs for expansion of the Company’s research and development, including costs associated with our ongoing clinical trials and additional general and administrative costs.
Research and development expenses increased to $4.4 million for the three months ended September 30, 2022 from $3.7 million for the three months ended September 30, 2021. The increase of $0.7 million in 2022 was primarily attributable to an increase of $0.2 million in clinical study and research costs, $0.3 million in personnel costs and $0.4 million in manufacturing services partially offset by a decrease of $0.2 million in professional fees and facilities.
General and administrative expenses decreased to $2.9 million for the three months ended September 30, 2022 from $3.3 million for the three months ended September 30, 2021. The decrease of $0.4 million is primarily attributable to a decrease of $0.5 million in personnel an increase of $0.2 million in professional fees partially offset by a decrease of $0.1 million in facilities costs.
Total operating expenses were approximately $7.3 million for the three months ended September 30, 2022, from approximately $7.0 million for the three months ended September 30, 2021.
PDS Biotech’s cash balance as of September 30, 2022 was approximately $71.6 million.
Conference Call and Webcast The conference call is scheduled to begin at 8:00 AM EST today, November 14, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13733006. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.
About PDS0101 PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-positive cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A Phase 2 clinical study is also being conducted in both second- and third-line treatment of multiple advanced HPV-positive cancers in partnership with the National Cancer Institute (NCI). A third Phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center. A final Phase 2 clinical trial of PDS0101 monotherapy in first line treatment of newly diagnosed patients HPV16-positive head and neck cancer patients is being conducted at the Mayo Clinic.
KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials. 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.
Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including record inflation, unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19 and the ongoing military conflict between Russia and Ukraine. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.
89% (8/9) had no evidence of disease (complete response) on day 170
Data Presented at Society for Immunotherapy of Cancer (SITC 2022)
FLORHAM PARK, N.J., Nov. 14, 2022 (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 updated clinical data from the ongoing IMMUNOCERV Phase 2 clinical trial was presented during a poster session on November 11 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2022). These data expand upon results detailed in the abstract submitted to SITC 2022 that was released to the public on November 7.
The enhanced data was presented in the poster titled, “IMMUNOCERV, an Ongoing Phase II Trial Combining PDS0101, an HPV-Specific T Cell Immunotherapy, with Chemotherapy and Radiation for Treatment of Locally Advanced Cervical Cancers,” which highlights key findings from The University of Texas MD Anderson Cancer Center-led IMMUNOCERV Phase 2 clinical trial (NCT04580771). The study is investigating PDS0101 in combination with standard-of-care chemoradiotherapy (CRT) for the potential treatment of cervical cancer in patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes (lymph node metastasis). New data from the study presented at SITC 2022 include:
9 of the 17 patients have now completed a day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of their cancer. This includes 78% (7/9) of treated patients with advanced cervical cancer (FIGO stage III or IV).
100% (9/9) of patients treated with the combination of PDS0101 and CRT had a clinical response with tumor shrinkage >60% at mid-point evaluation by MRI.
89% (8/9) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease. One patient who had a CR died from an event unrelated to either their underlying disease or treatment.
1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of PDS0101 and CRT.
As previously reported, data confirm PDS0101 treatment activates HPV16-specific CD8+ T cells. This increase was not seen in patients who did not receive PDS0101. The increase in HPV16-specific T cells generated by the treatment is positively correlated with tumor cell death, suggesting cytotoxic CD8+ T cells are important mediators of antigen-specific immunity.
The data affirm that PDS0101 activates Type 1 interferon pathway in humans, mimicking the mechanism previously demonstrated in preclinical studies in animal models.
Toxicity of PDS0101 remains limited to low-grade local injection site reactions.
“The updated data from the ongoing IMMUNOCERV Phase 2 clinical trial presented during SITC 2022 add to the encouraging results observed thus far and suggest that the combination of PDS0101 and CRT may hold promise as a potential first-line treatment for advanced, localized cervical cancer,” said Dr. Frank Bedu-Addo, CEO of PDS Biotech. “Importantly, 100% of patients responded to treatment with the combination of PDS0101 and CRT. We believe this study also provides further confirmation that PDS0101 induces the right type, quality, and potency of killer T cells in humans that may translate to effective treatment of cervical cancer. We look forward to the continued advancement of the IMMUNOCERV Phase 2 clinical trial and the opportunity to report updated data during 2023.”
In addition, a second poster titled “Immune Correlates Associated with Clinical Benefit in Patients with Checkpoint Refractory HPV-Associated Malignancies Treated with Triple Combination Immunotherapy,” was presented at SITC 2022 and reported data from the Phase 2 triple combination trial being led by the Center for Cancer Research at the National Cancer Institute (NCI), part of the National Institutes of Health. The study is investigating PDS0101 in combination with two investigational immune-modulating agents: M9241, a tumor-targeting IL-12 (immunocytokine), and bintrafusp alfa, a bifunctional checkpoint inhibitor (PD-L1/ TGF-β). The triple combination is being studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy. For most patients who are CPI refractory, there is no effective therapy. The immune correlates before and after treatment in the CPI refractory patient population were studied. Highlights from the study presented at SITC 2022 included:
A more than two-fold increase in HPV16-specific T cells in the blood of 79% (11/14 tested) of the evaluated patients.
Increases on day 15 in several monitored immune correlates, such as granzyme B and interferon-gamma (IFN-γ), were associated with a clinical response.
Immune responses were associated with increases in natural killer cells, soluble granzyme B (associated with active killer T cells), IFN-γ, tumor necrosis factor-alpha (TNF-α), etc., two weeks after the first treatment cycle thus signaling a pro-inflammatory response.
These immunogenicity findings highlight the potential role of the combination in altering immune suppressive forces, and support previously announced results documenting promising clinical outcomes in the CPI-refractory population receiving the triple combination.
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® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor-specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. 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.
About PDS0101 PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second-line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A National Cancer Institute-supported Phase 2 clinical study of PDS0101 in a triple combination therapy is also being conducted in checkpoint inhibitor refractory patients with multiple advanced HPV-associated cancers. A third Phase 2 clinical trial in first-line treatment of locally advanced cervical cancer is being led by The University of Texas MD Anderson Cancer Center. A final Phase 2 clinical trial of PDS0101 monotherapy in first-line treatment of newly diagnosed patients HPV16+ head and neck cancer patients is being conducted at the Mayo Clinic.
KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Forward Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.
Non-dilutive sale of asset expected to materially enhance Energy Fuels’ balance sheet and help to fund the rapid advancement and expansion of near-term U.S. uranium and rare earth production
LAKEWOOD, Colo., Nov. 14, 2022 /CNW/ – Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR) (“Energy Fuels” or the “Company”), a leading U.S. producer of uranium and rare earth elements (“REE“), is pleased to announce that it has entered into a definitive agreement to sell three wholly-owned subsidiaries that together hold Energy Fuels’ Alta Mesa ISR Project (“Alta Mesa“) to enCore Energy (“enCore“) for total consideration of $120 million (the “Transaction“). The Transaction is expected to close by the end of 2022 or early 2023.
The Transaction is significant for the Company, as the cash received is expected to fully finance much of the Company’s uranium, REE, vanadium and medical isotope business plans for the next two to three years without diluting shareholders. These plans may include:
Ramping-up uranium production at one or more of the White Mesa Mill, the Nichols Ranch ISR Project, the Pinyon Plain mine, the La Sal Complex, and/or the Whirlwind mine which total up to two (2) million pounds of U3O8 per year of near-term, lower cost U.S. production capacity in order to fulfill commitments under existing and future long-term uranium supply agreements and as market conditions may warrant;
Accelerating the licensing and development of the Company’s larger-scale uranium mines, including the Sheep Mountain, Roca Honda, and/or Bullfrog projects, which together will add over five (5) million pounds of production capacity in the next several years;
Establishing an “ore purchasing” program to secure additional feed to the White Mesa Mill, from others in the region as uranium mining picks up in the region, thereby maximizing the facility’s existing eight (8) million pounds per year licensed uranium production capacity and having sole ownership of this production;
Financing the construction of “first to market” in the U.S. “Phase 1” REE separation infrastructure (up to 2,500 – 5,000 MT per year TREO capacity, including 500 – 1,000 MT per year of NdPr oxide or oxalate expected) at the White Mesa Mill;
Advancing the design, engineering and permitting of a planned, large “world significant” “Phase 2” crack-and-leach and “light” and “heavy” REE separation facility (up to 15,000 mT per year TREO capacity).
Developing the Company’s Bahia heavy mineral sand and REE project in Brazil upon successful acquisition of the project; and
Acquiring additional monazite supply to feed the Company’s rapidly growing REE business.
The $120 million of total consideration will be paid by enCore to Energy Fuels as follows:
$60 million cash at closing; and
$60 million in a secured convertible note (the “Note”), payable in two years from the closing, bearing annual interest of eight percent (8%). The Note will be convertible at Energy Fuels’ election into enCore shares at a 20% premium to the 10-day volume-weighted average price of enCore shares ending the day before the closing. enCore is currently traded on the TSXV and has applied for a listing on the NASDAQ. The Note will be guaranteed by enCore Energy Corp., will be fully secured by Alta Mesa, and enCore will not be permitted to further encumber Alta Mesa with any third-party indebtedness, royalty or stream while the Note is outstanding. Unless a block trade or similar distribution is executed by Energy Fuels to sell the enCore common shares underlying the Note, Energy Fuels will be limited to converting the Note into a maximum of $10 million principal amount of the Note per thirty (30) day period.
Furthermore, enCore will assume all reclamation liabilities associated with Alta Mesa (approximately $10.3 million) and pay Energy Fuels the cash collateral on the existing reclamation bonds (approximately $3.6 million). Once the reclamation liabilities are transferred to enCore, Energy Fuels will be nearly 60% collateralized on its remaining reclamation obligations. The Company also estimates that the sale of Alta Mesa will reduce Energy Fuels’ cash burn by approximately $2 million per year.
Energy Fuels acquired Alta Mesa in 2016 for approximately $13.6 million of shares, and currently carries this project on its balance sheet at $8.2 million. The Transaction represents an exceptional return on investment for Energy Fuels, and the value metrics of the Transaction compare favorably against precedent transactions within the uranium sector. Energy Fuels expects to replace the expected uranium production from Alta Mesa through permitting and production from its existing larger mining projects, ore purchases, toll milling arrangements, additional alternate feed and clean-up material, and potentially other transactions as market conditions may warrant.
Mark S. Chalmers, President and CEO of Energy Fuels stated: “This is a unique transaction for Energy Fuels. Not only does it allow us to monetize the Alta Mesa Project for $120 million, it allows our company to focus and accelerate our higher priority uranium and rare earth projects without dilution to our shareholders. This non-dilutive transaction will add cash to Energy Fuels’ significant working capital position, which was $122 million at September 30, 2022. Energy Fuels will also retain some exposure to short-term market upside and optionality at Alta Mesa and enCore through the convertible note.
“With recent uranium market strength and having secured new long-term uranium contracts with major U.S. nuclear utilities earlier this year, the Company is beginning to perform the work needed to recommence production at one or more of our projects, with production expected to start as soon as 2023. We have already hired about 20 people, and the cash we receive from the Alta Mesa transaction will help further fund this ramp-up. On top of this, the Company plans to establish an “ore purchasing” program from future uranium mining from others that maximizes the underutilized uranium production capacity of the White Mesa Mill with the uranium produced going 100% to our account in a way that others cannot. Energy Fuels absolutely intends to retain our position as the leading producer of uranium in the U.S. through our remaining outstanding portfolio of ISR and conventional uranium assets, and this transaction with enCore helps to both finance and focus our plans in this regard without dilution associated with equity financings.
“This cash also helps facilitate our plans to install rare earth separation infrastructure at our White Mesa Mill, including the expected capacity to produce approximately 500 – 1,000 tonnes per annum of separated ‘light’ rare earth oxides (or oxalates) by the end of 2023 or early 2024. We are also working on a number of fronts to secure additional monazite supply to feed our new rare earth infrastructure, and we expect this cash to significantly help finance purchases of monazite, fund our Bahia project in Brazil upon successful completion of that acquisition, and otherwise help in this regard. If we are successful with our rare earth initiatives, we have the potential to be the ‘first-to-market’ in the U.S. for the sale of commercial quantities of separated NdPr oxides (or oxalates), a raw material for rare earth permanent magnets used in electric vehicle drivetrains, wind energy systems, and defense applications. For reference, high-efficiency EVs each require about one to two kilograms of NdPr oxide. Therefore, in the next 12-18 months, if we are successful in constructing our Phase 1 rare earth separation capabilities, Energy Fuels could be domestically producing enough magnet material for 250,000 to 1 million EV drivetrains per year.
“I also believe this Transaction represents an important step forward for enCore Energy. Alta Mesa is a fully permitted and developed U.S. uranium project, and enCore’s President and CEO, Paul Goranson, knows it well, having constructed and operated it himself about ten years ago. To us, this appears to be a value creative transaction for both Energy Fuels and enCore.”
The closing of the Transaction is expected to occur by December 31, 2022. If the Transaction is not completed due to certain circumstances, enCore is required to pay to Energy Fuels a $6 million break fee.
Cantor Fitzgerald Canada Corporation is acting as Energy Fuels’ financial advisor and Dorsey & Whitney LLP and Dentons are acting as Energy Fuels’ legal advisors in connection with the Transaction.
About Energy Fuels: Energy Fuels is a leading U.S.-based uranium mining company, supplying U3O8 to major nuclear utilities. The Company also produces vanadium from certain of its projects, as market conditions warrant, and is ramping up to full commercial-scale production of RE Carbonate. Its corporate offices are in Lakewood, Colorado near Denver, and all its assets and employees are in the United States. Energy Fuels holds three of America’s key uranium production centers: the White Mesa Mill in Utah, the Nichols Ranch ISR Project in Wyoming, and the Alta Mesa ISR Project in Texas. The White Mesa Mill is the only conventional uranium mill operating in the U.S. today, has a licensed capacity of over 8 million pounds of U3O8 per year, and has the ability to produce vanadium when market conditions warrant, as well as RE Carbonate from various uranium-bearing ores. The Nichols Ranch ISR Project is currently on standby and has a licensed capacity of 2 million pounds of U3O8 per year. The Alta Mesa ISR Project is also currently on standby and has a licensed capacity of 1.5 million pounds of U3O8 per year. In addition to the above production facilities, Energy Fuels also has one of the largest S-K 1300 and NI 43-101 compliant uranium resource portfolios in the U.S. and several uranium and uranium/vanadium mining projects on standby and in various stages of permitting and development. The primary trading market for Energy Fuels’ common shares is the NYSE American under the trading symbol “UUUU,” and the Company’s common shares are also listed on the Toronto Stock Exchange under the trading symbol “EFR.” Energy Fuels’ website is www.energyfuels.com.
Cautionary Note Regarding Forward-Looking Statements: This news release contains certain “Forward Looking Information” and “Forward Looking Statements” within the meaning of applicable United States and Canadian securities legislation, which may include, but are not limited to, statements with respect to: production and sales forecasts; the ability of the Company to accelerate uranium and rare earth production; scalability, and the Company’s ability and readiness to re-start, expand or deploy any of its existing projects or capacity to respond to any improvements in uranium market conditions;; any expectation as to the timing of the closing of the Transaction or whether the closing will in fact occur; any expectation that the Transaction may fully finance much of the Company’s uranium, rare earth, vanadium, and medical isotope business plans for the next two to three years; any expectation that the Company may license and eventually produce uranium from its Sheep Mountain, Roca Honda and/or Bullfrog projects; any expectation as to recommencement of production at any of the Company’s uranium mines or the timing thereof; any expectation as to the ability of the Company to secure any new sources of ore or other processing opportunities at the Mill through an ore purchasing program; any expectation as to timelines for the permitting and development of projects; any expectation that the Company will maintain its position as a leading uranium company in the United States; any expectation with respect to timelines to production; any expectation that the Mill will be successful in producing RE Carbonate and/or separated REE oxides or oxalates on a full-scale commercial basis; any expectation that Energy Fuels will be successful in developing U.S. separation, or other value-added U.S. REE production capabilities at the Mill, or otherwise, including the timing of any such initiatives and the expected production capacity or capital and operating costs associated with any such production capabilities; any expectation with respect to the quantities of monazite sands to be acquired by Energy Fuels, the quantities of RE Carbonate to be produced by the Mill or the quantities of contained TREO in the Mill’s RE Carbonate; any expectation that the Company may sell its separated NdPr oxide (or oxalate) to major electric vehicle manufacturers in the U.S. and Europe; any expectation that the Bahia Project has the potential to feed the Mill with REE and uranium-bearing monazite sand for decades; any expectation as to the quantities to be delivered under existing uranium sales contracts, or that such contracts may help underpin the Company’s uranium business for many years to come; and any expectation that the Company will generate net income in future periods. Generally, these forward-looking statements can be identified by the use of forward-looking terminology such as “plans,” “expects,” “does not expect,” “is expected,” “is likely,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates,” “does not anticipate,” or “believes,” or variations of such words and phrases, or state that certain actions, events or results “may,” “could,” “would,” “might” or “will be taken,” “occur,” “be achieved” or “have the potential to.” All statements, other than statements of historical fact, herein are considered to be forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements express or implied by the forward-looking statements. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements include risks associated with: commodity prices and price fluctuations; processing and mining difficulties, upsets and delays; permitting and licensing requirements and delays; changes to regulatory requirements; legal challenges; the availability of sources of Alternate Feed Materials and other feed sources for the Mill; competition from other producers; public opinion; government and political actions; available supplies of monazite sands; the ability of the Mill to produce RE Carbonate to meet commercial specifications on a commercial scale at acceptable costs; the ability of Neo to separate the RE Carbonate produced by the Mill to meet commercial specifications on a commercial scale at acceptable costs; market factors, including future demand for REEs; the ability of the Mill to be able to separate radium or other radioisotopes at reasonable costs or at all; market prices and demand for medical isotopes; and the other factors described under the caption “Risk Factors” in the Company’s most recently filed Annual Report on Form 10-K, which is available for review on EDGAR at www.sec.gov/edgar.shtml, on SEDAR at www.sedar.com, and on the Company’s website at www.energyfuels.com. Forward-looking statements contained herein are made as of the date of this news release, and the Company disclaims, other than as required by law, any obligation to update any forward-looking statements whether as a result of new information, results, future events, circumstances, or if management’s estimates or opinions should change, or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements. The Company assumes no obligation to update the information in this communication, except as otherwise required by law.
SOURCE Energy Fuels Inc.
For further information: Investor Inquiries: Energy Fuels Inc., Curtis Moore, VP – Marketing and Corporate Development, (303) 974-2140 or Toll free: (888) 864-2125, investorinfo@energyfuels.com, www.energyfuels.com
TORONTO–(BUSINESS WIRE)– Sierra Metals Inc. (TSX: SMT) (BVL:SMT) (NYSE American: SMTS) (“Sierra Metals” or the “Company”) confirms that it has received further correspondence from Compania Minera Kolpa S.A. (“Kolpa”) and Arias Resource Capital Management LP (“ARC”) regarding their previously announced unsolicited, non-binding letter of intent.
The Company has been diligently and expeditiously pursuing both short-term financing opportunities and the strategic review process announced in Sierra’s press release dated October 18, 2022. As previously announced, CIBC Capital Markets has been engaged as financial advisor to review strategic options.
Kolpa, ARC and other parties that have already expressed interest, among others, will be invited to participate and submit proposals so that they can be considered in the context of the strategic review process that is reasonably and fairly structured to be in the best interests of Sierra and all of its stakeholders. The process will give proper consideration to all viable options, not only the proposed Kolpa transaction.
The Company has not refused to engage nor rejected any proposals and welcomes and encourages participation of all interested parties. The Company is working diligently and expeditiously with full recognition of the timing considerations applicable in the current situation.
About Sierra Metals
Sierra Metals is a diversified Canadian mining company with Green Metal exposure including copper production and base metal production with precious metals byproduct credits, focused on the production and development of its Yauricocha Mine in Peru, and Bolivar and Cusi Mines in Mexico. The Company is focused on increasing production volume and growing mineral resources. The Company also has large land packages at all three mines with several prospective regional targets providing longer-term exploration upside and mineral resource growth potential.
For further information regarding Sierra Metals, please visit www.sierrametals.com or contact:
This press release contains forward-looking information within the meaning of Canadian and United States securities legislation, including the course of action, if any, to be pursued in response to the Kolpa non-binding letter of intent. Forward-looking information relates to future events or the anticipated performance of Sierra Metals and reflect management’s expectations or beliefs regarding such future events and anticipated performance based on an assumed set of economic conditions and courses of action. In certain cases, statements that contain forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “believes” or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, or “will be taken”, “occur” or “be achieved” or the negative of these words or comparable terminology. By its very nature forward-looking information involves known and unknown risks, uncertainness and other factors that may cause actual performance of Sierra Metals to be materially different from any anticipated performance expressed or implied by such forward-looking information. The Company has made certain assumptions regarding, among other things, the strategic alternatives that may be available to it. By its very nature forward-looking information involves known and unknown risks, uncertainties and other factors that may cause actual performance of Sierra Metals to be materially different from any anticipated performance expressed or implied by such forward-looking information.
Forward-looking information is subject to a variety of risks and uncertainties, which could cause actual events or results to differ from those reflected in the forward-looking information, including, without limitation, the risks described under the heading “Risk Factors” in the Company’s annual information form dated March 16, 2022 for its fiscal year ended December 31, 2021 and other risks identified in the Company’s filings with Canadian securities regulators and the United States Securities and Exchange Commission, which filings are available at www.sedar.com and www.sec.gov, respectively.
The risk factors referred to above are not an exhaustive list of the factors that may affect any of the Company’s forward-looking information. Forward-looking information includes statements about the future and is inherently uncertain, and the Company’s actual achievements or other future events or conditions may differ materially from those reflected in the forward-looking information due to a variety of risks, uncertainties and other factors. The Company’s statements containing forward-looking information are based on the beliefs, expectations, and opinions of management on the date the statements are made, and the Company does not assume any obligation to update such forward-looking information if circumstances or management’s beliefs, expectations or opinions should change, other than as required by applicable law. For the reasons set forth above, one should not place undue reliance on forward-looking information.
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.
Filament Made Significant Progress In 3Q22. Filament Health Reported a 3Q22 loss of C$(1.3) million or C$(0.01) per share. The company continued to advance programs in several areas, including patient dosing in clinical trials, new product development, receiving three new patents, and raising C$2.5 million in a private placement. Cash on hand at the end of the quarter was C$3.5 million.
Clinical Trial Are Making Progress. During the quarter, the company announced the first dosing of PEX010, 25mg oral psilocybin, in an FDA-approved clinical trial. This trial will also test PEX020, oral psilocin, and PEX030, sublingual psilocin. Filament also announced that ATMA Journey Centers completed dosing of 14 patients using the psilocybin it had supplied through a collaborative agreement.
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.
Voyager Digital Ltd.’s (TSX: VOYG) (OTCQX: VYGVF) (FRA: UCD2) US subsidiary, Voyager Digital, LLC, is a fast-growing cryptocurrency platform in the United States founded in 2018 to bring choice, transparency, and cost-efficiency to the marketplace. Voyager offers a secure way to trade over 100 different crypto assets using its easy-to-use mobile application. Through its subsidiary Coinify ApS, Voyager provides crypto payment solutions for both consumers and merchants around the globe. To learn more about the company, please visit https://www.investvoyager.com.
Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
The Collapse of FTX. As widely reported, on Friday cryptocurrency exchange FTX filed for Chapter 11 bankruptcy protection in the U.S. Included in the filing is subsidiary FTX US, the entity that had won the auction process for Voyager.
The Old Deal. Recall, back in October, the Bankruptcy Court approved Voyager’s entry into an asset purchase agreement between FTX US and Voyager. FTX US’s bid was valued at approximately $1.422 billion. Voyager’s claims against Three Arrows Capital would have remained with the bankruptcy estate and any recovery on account of the 3AC claims would have been available for additional distribution to Voyager creditors.
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.
TAAL Distributed Information Technologies Inc. delivers value-added blockchain services, providing professional-grade, highly scalable blockchain infrastructure and transactional platforms to support businesses building solutions and applications upon the BitcoinSV platform, and developing, operating, and managing distributed computing systems for enterprise users.
Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
3Q 2022 Results. Revenue totaled CAD$4.4 million for the quarter (all figures in CAD), or a decrease from the prior year’s $12.3 million, and is down sequentially from $7.3 million the previous quarter. The decrease from the prior year and quarter is due to the continuation of the macro trend in cryptocurrency with decreasing prices. Net loss for TAAL was $4.9 million, or diluted EPS of ($0.14), compared to net income of $2.1 million last year, or $0.05. We would note TAAL still does not have an auditor so all statements were prepared solely by management.
Continued Challenging Environment. The Company noted the continued volatility of the cryptocurrency prices, including the Company’s main coins, Bitcoin Core (“BTC”), BitcoinSV (“BSV”) and Bitcoin Cash (“BCH”). For BSV, the price of the coin was approximately $67 on September 30, 2022, and is now $52 as of November 10, 2022.
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.
Mark Reichman, Senior Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Maple Gold site visit. The company recently hosted a site visit for sell-side analysts and institutional investors. Mr. Matthew Hornor, CEO, and Mr. Fred Speidel, V.P. of Exploration provided a corporate update, including the company’s strategic priorities and an overview of the drilling program. The visit provided an opportunity to tour the property and core shack where participants were able to examine core samples and view technologies employed, including handheld/portable X-ray fluorescent (XRF) equipment.
Up to five rigs operating into 2023. Maple Gold recently secured a third drill rig to begin a 5,000-meter Phase III drill program at its 100%-controlled Eagle Mine property to follow up on the first two phases and test additional targets. Two rigs are deployed for the deep drilling program beneath and adjacent to historic underground mine workings in the Telbel area at the Joutel project, which is held in the company’s joint venture with Agnico Eagle Mines Limited. A 10,000-meter deep drilling program at Douay will commence in November with the deployment of a fourth rig. Management indicated that a fifth rig could be deployed at Douay.
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.
Kelly (Nasdaq: KELYA, KELYB) connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 350,000 people around the world and connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice. Revenue in 2021 was $4.9 billion. Visit kellyservices.com and let us help with what’s next for you.
Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
3Q22. Revenue of $1.17 billion was down 2.3% year-over-year (up 0.3% in constant currency). Consensus was $1.22 billion and we were at $1.23 billion. Kelly took a $30.7 million asset impairment charge related to its RocketPower acquisition during the quarter. As a result, GAAP EPS loss was $0.43 compared to net income EPS of $0.88 in 3Q21. Adjusted EPS for the third quarter was $0.25 versus $0.26 last year. We had projected adjusted EPS of $0.24.
GP Rate Continues to Improve. Management continues to drive gross profit rate. GP rate for the quarter was 20.6%, up 140 basis points y-o-y, with all segments once again reporting increased gross profit rate. The improvement has come from a combination of steps to improve organic GP and the addition of higher margin specialty business through recent acquisitions. We believe GP rate can continue to increase.
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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.
EuroDry Ltd. was formed on January 8, 2018 under the laws of the Republic of the Marshall Islands to consolidate the drybulk fleet of Euroseas Ltd. into a separate listed public company. EuroDry was spun-off from Euroseas Ltd. on May 30, 2018; it trades on the NASDAQ Capital Market under the ticker EDRY. EuroDry operates in the dry cargo, drybulk shipping market. EuroDry’s operations are managed by Eurobulk Ltd., an ISO 9001:2008 and ISO 14001:2004 certified affiliated ship management company and Eurobulk (Far East) Ltd. Inc., which are responsible for the day- to-day commercial and technical management and operations of the vessels. EuroDry employs its vessels on spot and period charters and under pool agreements.
Michael Heim, CFA, Senior Research Analyst, Noble Capital Markets, Inc.
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EuroDry reported 2022-3Q revenues, EBITDA and net income below comparable periods and our estimates. Net revenues of $15.8 million were below that of the same period last year ($19.5 million), the 2022-2Q ($21.0 million) and our estimate ($19.5 million). Results reflect a decline in TCE rates to $20,637 and a reduction in voyage days due to 92 scheduled off days. Adjusted ebitda was $9.5 million as the $4-5 million revenue shortfall versus previous periods and our estimate carried down to the ebitda line. Adjusted net income was $5.7 million, or $1.93 per share, well below our $9.5 million or $3.27 per share estimate.
The company’s sensitivity to shipping rates is apparent as it locks in rates at lower prices. EuroDry has locked in 53% of 2022-4Q shipping days but virtually no days beyond 2022. Shipping contracts agreed in recent months have largely been below $15,000 reflecting a 35-50% drop in pricing since the second quarter. Management remains confident shipping rates will eventually improve as global economic conditions improve but near-term comps will be tough. As such, this quarter’s decision to schedule off days for repairs and ship improvements while rates are low seems logical.
This 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.
