Author: aweinsoff@channelchek.com

Release – Bowlero Announces Fourth Quarter and Full Year Results For Fiscal Year 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BOWL

09/11/2023

Record Full Year 2023 with $1,059 million of Revenue. 16.1% Revenue Growth over FY22 and 57.5% Revenue Growth over FY19

RICHMOND, Va.–(BUSINESS WIRE)– Bowlero Corp. (NYSE: BOWL) (“Bowlero” or the “Company”), the world’s largest owner and operator of bowling centers, today provided financial results for the fourth quarter and the full 2023 Fiscal Year, which ended on July 2, 2023. Fourth quarter 2022 and Fiscal Year 2022 had an extra week of results compared to Fourth quarter 2023 and Fiscal Year 2023.

Fourth Quarter Highlights:

  • Revenue was $239.4 million, down $28.3 million or (10.6)% from $267.7 million in the prior year, in which out-of-period Service Revenue and the 53rd week & related calendar shift totaled $29.7 million. Revenue was up 54.0% versus Fourth quarter Fiscal Year 2019
  • Total Bowling Center Revenue grew $5.4 million or 2.4% versus prior year and 54.1% versus Fourth quarter Fiscal Year 2019
  • Normalized Calendar Same Store Revenue decline of (2.6)% versus prior year and growth of 29.3% versus Fourth quarter Fiscal Year 2019
  • Net income of $146.2 million
  • Adjusted EBITDA of $64.5 million
  • Total centers in operation as of July 2, 2023 were 328

Fiscal Year 2023 Highlights:

  • Revenue was $1,058.8 million, up $147.1 million or 16.1% versus $911.7 million in the prior year, which included revenue from the 53rd week & related calendar shift totaling $20.7 million. Revenue was up 57.5% versus Fiscal Year 2019
  • Total Bowling Center Revenue grew $165.2 million or 19.4% versus prior year and 57.8% versus Fiscal Year 2019
  • Normalized Calendar Same Store Revenue growth of 12.8% versus prior year and 31.9% versus Fiscal Year 2019
  • Net income of $82.0 million
  • Adjusted EBITDA of $354.3 million
  • 16 new centers added to the portfolio

“We finished Fiscal Year 2023 with 16% growth over Fiscal Year 2022 and 58% over Fiscal Year 2019. The same-store comp against a strong fourth quarter in Fiscal 2022 was down low-single digits in one of our seasonally smallest quarters. While April began with a decline versus the prior year, we saw an improving trend over the course of the quarter in conjunction with innovating our offerings to encourage more retail spend in our centers. We are in the early stages of pioneering new ways to increase wallet share from our vast customer base, and these changes are resonating with our guests,” said Tom Shannon, Founder, Chief Executive Officer and President. “The capital deployment opportunities are significant. Fiscal Year 2024 will be an investment year to drive top and bottom line growth. We remain confident in the upcoming fiscal year in which we have several exciting initiatives underway, including the acquisition of Lucky Strike, a robust M&A pipeline, new build activity in marquee markets, accelerated center conversions, and the continued rollout of initiatives to enhance the customer experience and increase wallet share. Additionally, as we anniversary the second year of our go-public transaction and 27th since our first center acquisition, we are excited to provide Fiscal Year 2024 guidance.”

Remediation of Material Weaknesses

In our Fiscal Year 2022 Form 10-K, material weaknesses were identified in controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, related to certain financial reporting processes. Throughout fiscal year 2023, management implemented measures designed to remediate the identified material weaknesses. Management has determined that the material weaknesses identified in the prior year have been remediated as of July 2, 2023.

Share Repurchase Program

During the quarter, the Company repurchased 6.4 million shares of Class A common stock at an average price of $12.64, bringing the total shares acquired under the program to 11.3 million and the average purchase price to $11.90. Pro forma for additional Class A common stock repurchased subsequent to quarter end, the total Class A and Class B shares outstanding as of August 30, 2023 are 160.2 million. On September 6, 2023, the Board authorized an increase to the share repurchase program to $200 million.

Fiscal Year 2024 Guidance

Today, the Company provided financial guidance for fiscal year 2024. We expect Revenue to be up 10% to 15% excluding the $21 million of Service Revenue, which equates to $1.14 billion to $1.19 billion of Revenue. Adjusted EBITDA margin is expected to be 32% to 34%, which equates to Adjusted EBITDA of $365 million to $405 million. We expect to heavily reinvest in the business in fiscal year 2024, with more than $160 million allocated to acquisitions, $40 million to new builds, and $75 million to conversions.

Investor Webcast Information

Listeners may access an investor webcast hosted by Bowlero. The webcast and results presentation will be accessible at 10:00 AM ET on September 11, 2023 in the Events & Presentations section of the Bowlero Investor Relations website at https://ir.bowlerocorp.com/overview/default.aspx.

About Bowlero Corp.

Bowlero Corp. is the worldwide leader in bowling entertainment. With 328 bowling centers across North America, Bowlero Corp. serves nearly 30 million guests each year through a family of brands that includes Bowlero and AMF. Bowlero Corp. is also home to the Professional Bowlers Association, which boasts thousands of members and millions of fans across the globe. For more information on Bowlero Corp., please visit BowleroCorp.com.

Forward Looking Statements

Some of the statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risk, assumptions and uncertainties, such as statements of our plans, objectives, expectations, intentions and forecasts. These forward-looking statements are generally identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “confident,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on our management’s current expectations, estimates, forecasts, projections, assumptions, beliefs and information. Although management believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will prove to have been correct. All such forward-looking statements are subject to risks and uncertainties, many of which are outside of our control, and could cause future events or results to be materially different from those stated or implied in this document. It is not possible to predict or identify all such risks. These risks include, but are not limited to: our ability to design and execute our business strategy; changes in consumer preferences and buying patterns; our ability to compete in our markets; the occurrence of unfavorable publicity; risks associated with long-term non-cancellable leases for our centers; our ability to retain key managers; risks associated with our substantial indebtedness and limitations on future sources of liquidity; our ability to carry out our expansion plans; our ability to successfully defend litigation brought against us; our ability to adequately obtain, maintain, protect and enforce our intellectual property and proprietary rights and claims of intellectual property and proprietary right infringement, misappropriation or other violation by competitors and third parties; failure to hire and retain qualified employees and personnel; the cost and availability of commodities and other products we need to operate our business; cybersecurity breaches, cyber-attacks and other interruptions to our and our third-party service providers’ technological and physical infrastructures; catastrophic events, including war, terrorism and other conflicts; public health emergencies and pandemics, such as COVID-19 pandemic, or natural catastrophes and accidents; changes in the regulatory atmosphere and related private sector initiatives; fluctuations in our operating results; economic conditions, including the impact of increasing interest rates, inflation and recession; and other factors described under the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) by the Company on September 11, 2023, as well as other filings that the Company will make, or has made, with the SEC, such as Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this press release and in other filings. We expressly disclaim any obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by applicable law.

Non-GAAP Financial Measures

To provide investors with information in addition to our results as determined under Generally Accepted Accounting Principles (“GAAP”), we disclose Total Bowling Center Revenue, Normalized Calendar Same Store Revenue and Adjusted EBITDA as “non-GAAP measures”, which management believes provide useful information to investors because each measure assists both investors and management in analyzing and benchmarking the performance and value of our business. Accordingly, management believes that these measurements are useful for comparing general operating performance from period to period, and management relies on these measures for planning and forecasting of future periods. Additionally, these measures allow management to compare our results with those of other companies that have different financing and capital structures. These measures are not financial measures calculated in accordance with GAAP and should not be considered as a substitute for revenue, net income, or any other operating performance or liquidity measure calculated in accordance with GAAP, and may not be comparable to a similarly titled measure reported by other companies.

Total Bowling Center Revenue represents Total Revenue less Non-Center Related Revenue, Revenue from Closed Centers (as defined below), Service Revenue, and Revenue from the 53rd Week and associated Calendar Shift, if applicable. Normalized Calendar Same Store Revenue represents Total Revenue less Non-Center Related Revenue, Revenue from Closed Centers, Service Revenue, Revenue from the 53rd Week and associated Calendar Shift, if applicable, and Acquired Revenue. Adjusted EBITDA represents Net Income (Loss) before Interest, Income Taxes, Depreciation and Amortization, Share-based Compensation, EBITDA from Closed Centers, Foreign Currency Exchange Loss (Gain), Asset Disposition Loss (Gain), Transactional and other advisory costs, changes in the value of earnouts and warrants and settlement costs, and other.

The Company considers Total Bowling Center Revenue as an important financial measure because it provides a financial measure of revenue directly associated with bowling center operations. The Company also considers Normalized Calendar Same Store Revenue as an important financial measure because it provides comparable revenue for centers open for the entire duration of both the current and comparable measurement periods, and removes the impact of the 53rd week and associated calendar shift that are non-recurring in nature.

The Company considers Adjusted EBITDA as an important financial measure because it provides a financial measure of the quality of the Company’s earnings. Other companies may calculate Adjusted EBITDA differently than we do, which might limit its usefulness as a comparative measure. Adjusted EBITDA is used by management in addition to and in conjunction with the results presented in accordance with GAAP. We have presented Adjusted EBITDA solely as a supplemental disclosure because we believe it allows for a more complete analysis of results of operations and assists investors and analysts in comparing our operating performance across reporting periods on a consistent basis by excluding items that we do not believe are indicative of our core operating performance. Adjusted EBITDA has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. Some of these limitations are that Adjusted EBITDA:

  • do not reflect every expenditure, future requirements for capital expenditures or contractual commitments;
  • do not reflect changes in our working capital needs;
  • do not reflect the interest expense, or the amounts necessary to service interest or principal payments, on our outstanding debt;
  • do not reflect income tax (benefit) expense, and because the payment of taxes is part of our operations, tax expense is a necessary element of our costs and ability to operate;
  • do not reflect non-cash equity compensation, which will remain a key element of our overall equity based compensation package; and
  • do not reflect the impact of earnings or charges resulting from matters we consider not to be indicative of our ongoing operations.

GAAP Financial Information

 Bowlero Corp.
 Condensed Consolidated Balance Sheets
 (Amounts in thousands, except share and per share amounts)
 (Unaudited)
 July 2, 2023 July 3, 2022
Assets   
Current assets:   
Cash and cash equivalents$195,633  $132,236 
Accounts and notes receivable, net of allowance for doubtful accounts of $551 and $504, respectively3,0925,227
Inventories, net 11,470   10,310 
Prepaid expenses and other current assets 18,395   12,732 
Assets held-for-sale 2,069   8,789 
Total current assets 230,659   169,294 
    
Property and equipment, net 697,850   534,721 
Internal use software, net 17,914   11,423 
Property and equipment under capital leases, net —   262,703 
Operating lease right of use assets, net 449,085   — 
Finance lease right of use assets, net 515,339   — 
Intangible assets, net 90,986   92,593 
Goodwill 753,538   742,669 
Deferred income tax asset 73,807   — 
Other assets 12,096   41,022 
Total assets$2,841,274  $1,854,425 
    
Liabilities, Temporary Equity and Stockholders’ Equity (Deficit)   
Current liabilities:   
Accounts payable and accrued expenses$121,226  $101,071 
Current maturities of long-term debt 9,338   4,966 
Current obligations of operating lease liabilities 23,866   — 
Other current liabilities 14,281   13,123 
Total current liabilities 168,711   119,160 
    
Long-term debt, net 1,138,687   865,090 
Long-term obligations under capital leases —   397,603 
Long-term obligations of operating lease liabilities 431,295   — 
Long-term obligations of financing lease liabilities 652,450   — 
Earnout liability 112,041   210,952 
Other long-term liabilities 34,380   54,418 
Deferred income tax liabilities 4,160   14,882 
Total liabilities 2,541,724   1,662,105 
    
Commitments and Contingencies   
    
Temporary Equity   
Series A preferred stock$144,329  $206,002 
    
Stockholders’ Equity (Deficit)   
Class A common stock 11   11 
Class B common stock 6   6 
Additional paid-in capital 506,112   335,015 
Treasury stock, at cost (135,401)  (34,557)
Accumulated deficit (219,659)  (312,851)
Accumulated other comprehensive income (loss) 4,152   (1,306)
Total stockholders’ equity (deficit) 155,221   (13,682)
Total liabilities, temporary equity and stockholders’ equity (deficit)$2,841,274  $1,854,425 
 Bowlero Corp.
 Condensed Consolidated Statements of Operations
 (Amounts in thousands)
 (Unaudited)
 Three Months Ended Twelve Months Ended
 July 2, 2 023 July 3, 2 022 July 2, 2 023 July 3, 2 022
Revenues$239,420  $267,717  $1,058,790  $911,705 
Costs of revenues 182,172   185,229   716,384   609,971 
Gross profit 57,248   82,488   342,406   301,734 
        
Operating (income) expenses:       
Selling, general and administrative expenses 35,082   35,689   137,919   180,702 
Asset impairment 1,028   1,548   1,601   1,548 
Gain on sale of assets (70)  (2,354)  (2,240)  (4,109)
Other operating expense 1,701   1,260   4,326   6,968 
Total operating expense 37,741   36,143   141,606   185,109 
        
Operating profit 19,507   46,345   200,800   116,625 
        
Other expenses (income):       
Interest expense, net 30,785   25,359   110,851   94,460 
Change in fair value of earnout liability (73,406)  2,564   85,352   25,800 
Change in fair value of warrant liability —   6,092   —   26,840 
Other expense 1,436   (12)  6,792   149 
Total other (income) expense (41,185)  34,003   202,995   147,249 
        
Income (loss) before income tax benefit 60,692   12,342   (2,195)  (30,624)
        
Income tax (benefit) Expense (85,528)  5,399   (84,243)  (690)
Net income (loss) 146,220   6,943   82,048   (29,934)
 Bowlero Corp.
 Condensed Consolidated Statements of Cash Flows
 (Amounts in thousands)
 (Unaudited)
 Three Months Ended Twelve Months Ended
 July 2, 2 023 July 3, 2 022 July 2, 2 023 July 3, 2 022
Net cash provided by operating activities$8,985  $34,809  $217,787  $177,670 
Net cash used in investing activities (65,269)  (41,601)  (253,218)  (220,345)
Net cash provided by (used in) financing activities 90,993   (33,888)  98,957   (12,136)
Effect of exchange rate changes on cash (120)  (61)  (129)  (46)
Net increase (decrease) in cash, cash equivalents and restricted cash 34,589   (40,741)  63,397   (54,857)
        
Cash, cash equivalents and restricted cash at beginning of period 161,044   172,977   132,236   187,093 
        
Cash, cash equivalents and restricted cash at end of period$195,633  $132,236  $195,633  $132,236 

GAAP to non-GAAP Reconciliations

  Same Store Reconciliation – FY23 vs. FY19 Same Store Reconciliation – FY23 vs. FY22 
(in thousands) 4Q FY19 4Q FY23 FY19 FY23 4Q FY22 4Q FY23 FY22 FY23
 Total Revenue – Reported $155,494  $239,420  $672,175  $1,058,790  $267,717  $239,420  $911,705  $1,058,790 
less: Non-Center Related     
(including Closed Centers)  (6,344)  (5,545)  (28,387)  (21,613)  (7,868)  (5,545)  (25,287)  (21,613)
less: Service Revenue  —   (4,088)  —   (21,019)  (14,796)  (4,088)  (14,796)  (21,019)
less: 53rd Week / Calendar Shift  —   —   —   —   (20,663)  —   (20,663)  — 
Total Bowling Center Revenue $149,150  $229,787  $643,788  $1,016,158  $224,390  $229,787  $850,959  $1,016,158 
                 
less: Acquired Revenue  (1,382)  (38,729)  (17,419)  (189,715)  (168)  (11,406)  (47,168)  (109,737)
                 
Normalized Calendar Same Store Revenue $147,768  $191,058  $626,369  $826,443  $224,222  $218,381  $803,791  $906,421 
                 
% Year-over-Year Change                
 
Total Revenue – Reported    54.0%    57.5%    (10.6)%    16.1%
Total Bowling Center Revenue    54.1%    57.8%    2.4%    19.4%
Normalized Calendar Same Store Revenue    29.3%    31.9%    (2.6)%    12.8%
  Adjusted EBITDA Reconciliation 
  Three Months Ended Twelve Months Ended
(in thousands) July 2, 2023 July 3, 2022 July 2, 2023 July 3, 2022
Consolidated        
Revenue $239,420 $267,717 $1,058,790 $911,705
Net income (loss) – GAAP  $146,220  $6,943 $82,048  $(29,934)
Net income (loss) margin 61.1% 2.6% 7.7% (3.3)%
Adjustments:        
Interest expense 32,095 25,359 112,160 94,460
Income tax (benefit) expense (85,528) 5,399 (84,243) (690)
Depreciation, amortization and impairment charges 31,693 30,018 117,281 108,505
Share-based compensation 3,851 3,860 15,742 50,236
Closed center EBITDA (1) 1,692 51 3,319 1,480
Foreign currency exchange (gain) loss (128) (26) (53) 5
Asset disposition gain (70) (2,355) (2,240) (4,109)
Transactional and other advisory costs (2) 6,804 2,762 23,635 43,512
Changes in the value of earnouts and warrants (3) (73,406) 8,644 85,352 52,789
Other, net (4) 1,270 1,737 1,343 121
Adjusted EBITDA  $64,493  $82,392 $354,344  $316,375 
Adjusted EBITDA Margin 26.9% 30.8% 33.5% 34.7%
(1) The closed center adjustment is to remove EBITDA for closed centers. Closed centers are those centers that are closed for a variety of reasons, including permanent closure, newly acquired or built centers prior to opening, centers closed for renovation or rebranding and conversion. If a center is not open on the last day of the reporting period, it will be considered closed for that reporting period. If the center is closed on the first day of the reporting period for permanent closure, the center will be considered closed for that reporting period.
(2) The adjustment for transaction costs and other advisory costs is to remove charges incurred in connection with any transaction, including mergers, acquisitions, refinancing, amendment or modification to indebtedness, dispositions and costs in connection with an initial public offering, in each case, regardless of whether consummated.
(3) The adjustment for changes in the value of earnouts and warrants is to remove of the impact of the revaluation of the earnouts and warrants. As a result of the Business Combination, the Company recorded liabilities for earnouts and warrants. Changes in the fair value of the earnout and warrant liabilities are recognized in the statement of operations. Decreases in the liability will have a favorable impact on the statement of operations and increases in the liability will have an unfavorable impact. The adjustment also includes realized costs associated with the settlement of warrants during past reporting periods.
(4) Other includes the following related to transactions that do not represent ongoing or frequently recurring activities as part of the Company’s operations: (i) non-routine expenses, net of recoveries for matters outside the normal course of business and (ii) other individually de minimis expenses. Certain prior year amounts have been reclassified to conform to current year presentation.

For Media:
Bowlero Corp. Public Relations
PR@BowleroCorp.com

For Investors:
Bowlero Corp. Investor Relations
IRSupport@BowleroCorp.com

Ashley DeSimone
Ashley.DeSimone@icrinc.com

Source: Bowlero Corp

Release – ISG Women in Digital Award Winners Named for Americas

Posted on by aweinsoff@channelchek.com

Research News and Market Data on III

9/8/2023

Leaders with Johnson Controls, Kaiser Permanente, LTIMindtree, McKesson and the National Renewable Energy Laboratory named winners in five award categories

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced the winners of the second annual ISG Women in Digital Awards program for the Americas, recognizing women and their achievements in the digital world.

At a live, virtual award ceremony the evening of September 7, leaders with Johnson Controls, Kaiser Permanente, LTIMindtree, McKesson and the National Renewable Energy Laboratory were honored as winners in five categories, as selected by a panel of industry judges.

“The ISG Women in Digital Awards program received an overwhelming response in our second year, reflecting the large and growing pool of talented women in digital roles,” said Lois Coatney, ISG partner and president, and executive sponsor of the ISG Women in Digital program. “The women chosen as winners have made impressive, impactful and important contributions to the digital industry as a whole. We celebrate their accomplishments.”

An independent panel of judges, comprised of Nidhi Alexander, chief marketing officer, Hexaware; Shannon Bjerregaard, senior vice president and CIO of medical surgical at McKesson; Chris Putur, retired CIO of REI and member of the board of directors of ISG and RealTruck; Sarah Urbanowicz, senior vice president and CIO, AECOM, and Mary Rivard, partner, ISG technology modernization, evaluated the nominations and selected the following winners:

  • Rising Star: for demonstrating exceptional and continuous growth, with increasing levels of leadership, responsibility and sphere of impact:
    Gold Winner: Melissa Rojo Salazar, U.S. senior director of consulting, co-lead of product services and innovation, LTIMindtree
    Silver Winner: Bernice Wong, senior design manager, Albertsons
    Bronze Winner: Devon Reilly, senior business process lead, PVH Corp.
  • Women’s Advocate: for playing an active role guiding women to succeed in the digital world:
    Gold Winner: Diane Schwarz, vice president and CIO, Johnson Controls
    Silver Winner: Shatabdi Sharma, vice president, Global Application Services, PVH Corp.
    Bronze Winner: Heather Bunyard, customer success officer, Birlasoft
  • Digital Innovator: for making a significant impact on an organization, business or client through creative use of digital solutions:
    Gold Winner: Bridget Karlin, senior vice president of IT, Kaiser Permanente
    Silver Winner: Richa Agarwal, senior director of digital go-to-market, PVH Corp.
    Bronze Winner: Ellen Trager, chief digital and information officer, Carrier
  • Rock Star Leader: for leading a major transformation with significant business impact and demonstrating exceptional leadership skills:
    Gold Winner: Nancy Avila, executive vice president, chief information officer and chief technology officer, McKesson
    Silver Winner: Sruti Patnaik, chief information officer, Camping World
    Bronze Winner: Giao Carrico, senior partner, consulting practice leader for data technology and AI, Genpact

Dr. Annabelle Pratt, principal engineer, National Renewable Energy Laboratory, was chosen by the judges as the Digital Titan of the Year for the Americas from the entire pool of regional nominees, recognizing her as the most outstanding woman in digital for 2023.

The awards program, launched in the Americas in 2022, was expanded for 2023 to the Europe, Middle East and Africa (EMEA) and Asia Pacific regions, including India. The global program received a total of 327 nominees, who are listed in an online ISG Women in Digital eBook. Awards for Asia Pacific and India will be presented October 11, at 6 p.m., AEDT, and awards for EMEA will be presented October 26, at 6 p.m., GMT.

“Women are breaking barriers and making lasting, positive changes in digital and technology leadership roles,” said Kimberly Tobias, ISG director and head of the ISG Women in Digital program. “We are delighted to recognize the success of each person nominated and to offer our sincere congratulations to our 2023 winners.”

Created in 2018, the ISG Women in Digital community provides a platform to exchange practical advice and innovative ideas on diversity and advancement in the workplace. The community hosts a LinkedIn page, an ongoing ISG Digital Dish podcast series, and regular events for ISG employees and the greater IT and business services industry.

For more information about the ISG Women in Digital Awards, contact ISG.

About ISG

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 900 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,600 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.

Source: Information Services Group, Inc.

Release – Baudax Bio to Participate in the H.C. Wainwright Global Investment Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on BXRX

 Download as PDF

September 07, 2023 8:00am EDT

MALVERN, Pa., Sept. 07, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that that the Company’s management will be participating in the 25th Annual H.C. Wainwright Global Investment Conference, to be held September 11-13, 2023 in New York, NY.

Gerri Henwood, President & Chief Executive Officer of Baudax Bio, will give a pre-recorded presentation highlighting the Company’s cellular therapy programs, which will be available on-demand by clicking here for the duration of the conference. Ms. Henwood will also be available for one-on-one meetings.

About Baudax Bio

Baudax Bio/TeraImmune is a biotech company focused on innovative products for certain auto-immune conditions, of which many but not all, are orphan drug conditions as well as acute care and related settings. The combined company will further the development of Treg therapy specific to HA (pipeline candidate TI-168). TI-168 is a next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitor. By combining the patented Treg culture method and TeraImmune designed FVIII-specific TCR, the Company has successfully demonstrated the therapeutic concept of FVIII TCR-Treg therapy in controlling of FVIII ADA in a hemophilic animal model. The lead program TI-168 has shown encouraging pre-clinical data and the FDA has cleared an IND to commence a Phase 1/2a clinical trial for the treatment of Hemophilia A with inhibition.

In addition, over time, the combined company will advance the development of TeraImmune’s innovative immune-cell therapies, leveraging a dual Treg manufacturing platform consisting of both natural regulatory Tregs isolated from patients and induced Tregs converted from a patient’s T-effector (“Teff”) cells. This Treg platform technology is designed for conditions that suppress unwanted immune reactions and includes the allogenic, or off-the-shelf, Tregs obtained from Umbilical Cord Blood for the treatment of skin diseases such as Atopic Dermatitis. For more information, please visit www.baudaxbio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio, are intended to identify such forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Baudax Bio’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, clinical results and other future conditions. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Baudax Bio’s most recent Annual Report on Form 10-K filed with the SEC and its subsequent filings with the SEC. Any forward looking statement speaks only as of the date on which it was made. Neither Baudax Bio, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Baudax Bio’s views as of any date subsequent to the date hereof.

Investor Relations Contact:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Source: Baudax Bio

Released September 7, 2023

Release – Alvopetro Announces August 2023 Sales Volumes and an Operational Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ALVOF

Sep 07, 2023

CALGARY, AB, Sept. 7, 2023 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces August 2023 sales volumes and an operational update.

August 2023 Sales Volumes

August sales volumes averaged 1,852 boepd, including natural gas sales of 10.6 MMcfpd, associated natural gas liquids sales (“NGLs”) from condensate of 84 bopd, and oil sales of 8 bopd, based on field estimates. Of the total natural gas sales of 10.6 MMcfpd, 9.9 MMcfpd was from our Caburé field, with 0.7 MMcfpd from our Murucututu field. Natural gas production from our Murucututu field declined from 0.9 MMcfpd in July to 0.7 MMcfpd in August and we are evaluating alternatives to improve the productive capability of the field.

 Natural gas, NGLs and crude oil sales: August 2023July 2023Q2 2023
Natural gas (Mcfpd), by field:
      Caburé9,89110,69710,759
      Murucututu665872510
      Total Company natural gas (Mcfpd)10,55611,56811,269
      NGLs (bopd)849092
      Oil (bopd)8–5
Total Company (boepd)1,8522,0181,975

In connection with a temporary reduction in end user consumption, our offtaker, Bahiagás, has provided notice to reduce natural gas nominations for the remainder of September to approximately 8.5 MMcfpd, and as such, we are expecting a reduction in September natural gas sales. 

Operational Update

In July we spud our 183-A3 well on our Murucututu natural gas field. Alvopetro initially drilled to a total measured depth of 1,614 metres but encountered hole stability problems drilling the intermediate section within the Pojuca Formation in the intermediate 12 1/4″ hole section. We were able to successfully recover the directional drilling assembly and return it to surface and we then initiated a sidetrack from 800 metres. We completed drilling this sidetracked intermediate section to 1,707 metres and we are in the process of cementing this section in place. Our plan is to drill the well to 3,600 metres and we now expect to complete drilling operations in October.

On our Bom Lugar field, following an extended maintenance program on our contracted completions rig, we have now initiated completion operations of our BL-06 well. We expect to have the well on production later this month.

Corporate Presentation

Alvopetro’s updated corporate presentation is available on our website at:http://www.alvopetro.com/corporate-presentation. 

Social Media

Follow Alvopetro on our social media channels at the following links:          Twitter – https://twitter.com/AlvopetroEnergy          Instagram – https://www.instagram.com/alvopetro/          LinkedIn – https://www.linkedin.com/company/alvopetro-energy-ltd          YouTube –https://www.youtube.com/channel/UCgDn_igrQgdlj-maR6fWB0w

Alvopetro Energy Ltd.’s vision is to become a leading independent upstream and midstream operator in Brazil. Our strategy is to unlock the on-shore natural gas potential in the state of Bahia in Brazil, building off the development of our Caburé natural gas field and our strategic midstream infrastructure.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

All amounts contained in this new release are in United States dollars, unless otherwise stated and all tabular amounts are in thousands of United States dollars, except as otherwise noted.

Abbreviations:

bbls=        barrels
boepd=        barrels of oil equivalent (“boe”) per day
bopd =        barrels of oil and/or natural gas liquids (condensate) per day
BRL=        Brazilian real
m3 =        cubic metre
MMBtu =        million British thermal units
Mcf =        thousand cubic feet
Mcfpd =        thousand cubic feet per day
MMcf =        million cubic feet
MMcfpd=        million cubic feet per day
Q2 2023=        three months ended June 30, 2023

BOE Disclosure. The term barrels of oil equivalent (“boe”) may be misleading, particularly if used in isolation. A boe conversion ratio of six thousand cubic feet per barrel (6Mcf/bbl) of natural gas to barrels of oil equivalence is based on an energy equivalency conversion method primarily applicable at the burner tip and does not represent a value equivalency at the wellhead. All boe conversions in this news release are derived from converting gas to oil in the ratio mix of six thousand cubic feet of gas to one barrel of oil.

Forward-Looking Statements and Cautionary Language. This news release contains “forward-looking information” within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward‐looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning the expected timing of certain of Alvopetro’s testing and operational activities including the expected timing of drilling the 183-A3 well and testing the BL-06 well, expected timing of production commencement from the BL-06 well, exploration and development prospects of Alvopetro, and expected natural gas sales and gas deliveries under the Company’s long-term gas sales agreement. The forward‐looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to expectations and assumptions concerning testing results of the BL-06 well, equipment availability, the timing of regulatory licenses and approvals, the success of future drilling, completion, testing, recompletion and development activities, the outlook for commodity markets and ability to access capital markets, the impact of global pandemics and other significant worldwide events, the performance of producing wells and reservoirs, well development and operating performance, foreign exchange rates, general economic and business conditions, weather and access to drilling locations, the availability and cost of labour and services, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, expectations regarding Alvopetro’s working interest and the outcome of any redeterminations, the regulatory and legal environment and other risks associated with oil and gas operations. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided herein as a result of numerous known and unknown risks and uncertainties and other factors. Although Alvopetro believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Alvopetro can give no assurance that it will prove to be correct. Readers are cautioned that the foregoing list of factors is not exhaustive. Additional information on factors that could affect the operations or financial results of Alvopetro are included in our annual information form which may be accessed on Alvopetro’s SEDAR+ profile at www.sedarplus.ca. The forward-looking information contained in this news release is made as of the date hereof and Alvopetro undertakes no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.

SOURCE Alvopetro Energy Ltd.

Release – Fazoli’s Makes Highly Anticipated Return to Orlando

Posted on by aweinsoff@channelchek.com

Research News and Market Data on FAT

SEPTEMBER 07, 2023

 DOWNLOAD PDFPDF FORMAT (OPENS IN NEW WINDOW)

Fans Celebrate Arrival of Favorite Fast Casual Italian

LOS ANGELES, Sept. 07, 2023 (GLOBE NEWSWIRE) — Fazoli’s, America’s favorite fast and fresh Italian chain, is officially open in Orlando. Located at 4201 E. Colonial Dr., the location is owned by local operator Keys Restaurants Inc., and is now serving up its beloved hot and buttery breadsticks and signature Italian dishes including pasta, subs, salads, pizzas and more. 

“We couldn’t be happier to reintroduce our mouthwatering, freshly made food back into the Orlando market,” said Doug Bostick, President at Fazoli’s. “We’ve been humbled by the nonstop excitement from fans and have spent countless hours preparing for the large crowds we expect at our drive-thru and can confidently say, we are ready!” 

“We are excited to have fulfilled our promise to return Fazoli’s to Orlando,” said Keys Restaurants Inc. CEO Rodney Keys. “We have a long history of excellence building franchises and local businesses in the Orlando area and are more committed than ever to our customers. When they walk into a Keys Restaurant Inc. location, they know they can expect nothing but the best.” 

The Orlando Fazoli’s is located at 4201 E. Colonial Dr., Orlando, FL. 32803. The drive-thru and dine-in is open 10:30 a.m. to 10 p.m., Sunday-Thursday, and 10:30 a.m. to 11 p.m. Friday-Saturday. For more information, visit Fazolis.com. 

About FAT (Fresh. Authentic. Tasty.) Brands

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. For more information on FAT Brands, please visit fatbrands.com. 

About Fazoli’s

Fast. Fresh. Italian. Founded in 1988 in Lexington, Ky., Fazoli’s owns and operates nearly 220 restaurants in 27 states, making it the largest QSR Italian chain in America. Fazoli’s prides itself on serving quality Italian food, fast, fresh and friendly. Menu offerings include freshly prepared pasta entrees, sub sandwiches, salads, pizza and desserts – along with its unlimited signature breadsticks. For more information, visit www.Fazolis.com.

MEDIA CONTACT:
Ali Lloyd, FAT Brands
alloyd@fatbrands.com
435-760-6168 

# # # 

Source: FAT Brands Inc.

Release – Century Lithium Obtains Provisional Patent

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CYDVF

September 7, 2023 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (Century Lithium or the Company) is pleased to report it has obtained a provisional patent with the U.S. Patent and Trademark Office, U.S. Department of Commerce. The provisional patent is titled System and Method for Extracting Lithium from Clay and Other Materials in a Chloride Solution Using Individualized Pretreatments. The patent pending process encompasses the Company’s flowsheet, as developed at its Lithium Extraction Facility (“Pilot Plant”) in Amargosa Valley, Nevada, USA and protects the Company’s intellectual property (IP) pertaining to the handling of solutions derived from the treatment of solid materials including clays from the Company’s Clayton Valley Lithium Project (Project) in Nevada.

“Through the excellent work of Century Lithium’s team, we have developed a system for lithium extraction which is proprietary to the Company” said Bill Willoughby, President, and CEO of Century Lithium. “Our system incorporates innovations made during our team’s work at the Pilot Plant. The provisional patent provides protection of our system and its IP as we move forward with our Feasibility Study.”

The Company’s patent pending system is based on the extraction of lithium from solids using both products of a chlor-alkali process; hydrochloric acid and sodium hydroxide. Under the provisional patent, the Company’s protected IP includes the method of treating lithium-bearing solids with chloride solution and the handling of solutions, precipitates, and residues, exclusive of a lithium recovery stage (Direct Lithium Extraction) a component process proprietary to Koch Technology Solutions. 

Key steps of the provisional patent include:

  • Conditioning solids prior to leaching; this step uses recycled process solution and sodium hydroxide, a by-product of the process, which acts as a dispersant and chemical reactant with clay-sized particles
  • Leaching slurried pulp in a hydrochloric acid solution; this step includes capture of carbon dioxide which is used for the precipitation of calcium and magnesium later in the process
  • Method of treating the post-leach slurry to remove iron and aluminum in a manner that allows pressure filtration of the solids and minimizes the use of flocculants and counter-current decantation
  • Treatment of post-DLE spent solution to provide feed stock of sodium chloride solution to a chlor-alkali plant and recycle solution to the conditioning step

Qualified Person

Todd Fayram, MMSA-QP is the qualified persons as defined by National Instrument 43-101 and have approved the technical information in this release.

About Century Lithium Corp.

Century Lithium Corp. (formerly Cypress Development Corp.) is an advanced stage lithium company, focused on developing its 100%-owned Clayton Valley Lithium Project in west-central Nevada, USA. Century Lithium is currently in the pilot stage of testing on material from its lithium-bearing claystone deposit at its Lithium Extraction Facility in Amargosa Valley, Nevada and progressing towards completing a Feasibility Study and permitting, with the goal of becoming a domestic producer of lithium for the growing electric vehicle and battery storage market.

ON BEHALF OF CENTURY LITHIUM CORP.
WILLIAM WILLOUGHBY, PhD., PE
President & Chief Executive Officer

For further information, please contact:
Spiros Cacos | Vice President, Investor Relations
Direct: +1 604 764 1851
Toll Free: 1 800 567 8181
scacos@centurylithium.com 
centurylithium.com  

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.

Cautionary Note Regarding Forward-Looking Statements

This release includes certain statements that may be deemed to be “forward-looking statements”. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects,” “estimates,” “projects,” “anticipates,” “believes,” “could,” “scheduled,” and other similar words. All statements in this release, other than statements of historical facts, that address events or developments that management of the Company expects, are forward-looking statements. Although management believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results or developments may differ materially from those in the forward-looking statements. The Company undertakes no obligation to update these forward-looking statements if management’s beliefs, estimates or opinions, or other factors, should change. Factors that could cause actual results to differ materially from those in forward-looking statements, include market prices, exploration, and development successes, continued availability of capital and financing, and general economic, market or business conditions. Please see the public filings of the Company at www.sedar.com for further information.

Release – Kelly to Participate in the 16th Annual Barrington Research Virtual Fall Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on KELYA

September 7, 2023

TROY, Mich., Sept. 7, 2023 /PRNewswire/ — Kelly (Nasdaq: KELYA, KELYB), a leading global specialty talent solutions provider, today announced it will participate in the 16th Annual Barrington Research Virtual Fall Investment Conference on Thursday, September 14, 2023.

Peter Quigley, president and chief executive officer, Olivier Thirot, executive vice president and chief financial officer, and Scott Thomas, investor relations, will participate in virtual one-on-one meetings. Kelly’s investor presentation is available on the company’s website.

About Kelly®

Kelly Services, Inc. (Nasdaq: KELYA, KELYB) helps companies recruit and manage skilled workers and helps job seekers find great work. Since inventing the staffing industry in 1946, we have become experts in the many industries and local and global markets we serve. With a network of suppliers and partners around the world, we connect more than 450,000 people with work every year. Our suite of outsourcing and consulting services ensures companies have the people they need, when and where they are needed most. Headquartered in Troy, Michigan, we empower businesses and individuals to access limitless opportunities in industries such as science, engineering, technology, education, manufacturing, retail, finance, and energy. Revenue in 2022 was $5.0 billion. Learn more at kellyservices.com.

KLYA-FIN

ANALYST & MEDIA CONTACT:
Scott Thomas
(248) 251-7264  
scott.thomas@kellyservices.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/kelly-to-participate-in-the-16th-annual-barrington-research-virtual-fall-conference-301919882.html

SOURCE Kelly Services, Inc.

Release – PDS Biotech to Participate at the H.C. Wainwright 25th Annual Global Investment Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech, will participate and present an overview of the company and its programs at the H.C. Wainwright 25th Annual Global Investment Conference.

H.C. Wainwright 25th Annual Global Investment Conference
Date: September 11, 2023
Event: On-Demand Presentation
Time: 7:00 AM EDT
Investors can register for the webcast here

Following the presentation, a webcast replay will be available on the Investor section of the company’s website.

For more information about the conference or to schedule one-on-one meetings, please contact your H.C. Wainwright 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 Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. 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 the Company’s 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. 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 other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. 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® and Infectimune® are registered trademarks of PDS Biotechnology. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Release – PDS0202 Universal Influenza Preclinical Ferret Data to be Presented in Oral Lecture at 9th ESWI Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, today announced that data from preclinical studies in ferrets of PDS0202, the company’s universal influenza vaccine utilizing proprietary COBRA (computationally optimized broadly reactive antigen) hemagglutinin (HA) flu proteins, will be featured in an oral lecture at the European Scientific Working Group on Influenza (ESWI) Conference. ESWI is being held September 17-20, 2023, in Valencia, Spain.

Abstract Title: Influenza pre-immune ferrets vaccinated with computationally optimized recombinant HA proteins generate sero-protective antibody responses against H1N1 and H3N2 viruses from the last decade.
Presenting Author: James Allen, PhD, Cleveland Clinic, United States of America
Session Title: Future vaccination strategies SCS09
Lecture: Tuesday 19 September; Time 14:10-15:45 (CET)

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 Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce and shrink tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. 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 Infectimune®
Infectimune® is a novel investigational immune activating platform that generates broad and robust antibody and T cell responses that provide durable protection against infectious disease. Infectimune® based vaccines are given by intramuscular injection and generate robust and durable protection against infectious agents in preclinical studies. Infectimune® based vaccines have demonstrated safety in preclinical studies and appear to provide more robust and longer-lasting protection against infectious disease.

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 the Company’s 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. 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 other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. 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® and Infectimune® are registered trademarks of PDS Biotechnology. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Release – Onconova Therapeutics To Participate At The H.C. Wainwright 25th Annual Global Investment Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ONTX

Sep 06, 2023

PDF Version

NEWTOWN, Pa., Sept. 06, 2023 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven Fruchtman, M.D., President & CEO, will participate in the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023.

Presentation Details

Date/Time:Monday, September 11, 2023, available on-line beginning at 7:00 AM ET
Speaker:Steven Fruchtman, M.D., President & CEO
Investor Access:Webcast Link
1X1 meetingsThe Onconova Management Team will be available for 1X1 meetings during the conference. Those interested in requesting a meeting should contact their H.C. Wainwright representative.

The presentation can be viewed here or on the “Corporate Events and Presentations” section of the Onconova website and will be archived for 90 days.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company’s product candidates include proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in a Phase 1/2 combination trial with the estrogen blocker, letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications.

Onconova’s product candidate rigosertib is being studied in multiple investigator-sponsored studies, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).

For more information, please visit www.onconova.com.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

Release – Alliance Resource Partners, L.P. Announces $25 Million Strategic Investment in Ascend Elements

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ARLP

Company Release – 9/6/2023 7:36 AM ET

TULSA, Okla.–(BUSINESS WIRE)– Alliance Resource Partners, L.P. (NASDAQ: ARLP) (“ARLP” or the “Partnership”) announced today that it has invested $25 million in Ascend Elements, Inc. (“Ascend Elements”), a U.S.-based manufacturer and recycler of sustainable, engineered battery materials for electric vehicles, as part of its $460 million Series D funding round. This capital, combined with $480 million in total grants awarded by the Department of Energy, will advance construction of North America’s first commercial-scale manufacturing facility, located near Hopkinsville, Kentucky, producing cathode materials for electric vehicle batteries.

“We are excited about our strategic investment in Ascend Elements, which has become a proven leader in the rapidly growing battery and critical material sector supporting electrification of transportation,” said Joseph W. Craft III, ARLP’s Chairman, President, and Chief Executive Officer. “We see a significant need for recycling solutions outside of China and U.S.-based production of cathode materials to address the growing demand for critical battery materials. Ascend Elements’ experienced management team, proprietary technology, and recent commercial success with high-quality OEMs give us the confidence they are well positioned to meet these growing needs while delivering attractive risk-adjusted returns.”

In close proximity to ARLP’s western Kentucky operations, when complete, the 1-million-square-foot manufacturing facility will produce enough cathode materials for 750,000 electric vehicles per year. Underpinning the financing and initial capacity of its operation, Ascend Elements signed a $1 billion contract earlier this year to supply cathode materials in the fourth quarter of 2024 with options to expand the multi-year contract to a larger volume valued up to $5 billion.

Mr. Craft closed, “Beyond this initial investment, we look forward to exploring more strategic opportunities with Ascend Elements to expand our investment in the battery recycling industry and leverage our unique operational expertise, geographic footprint, and strategic relationships in Kentucky and the surrounding battery-belt states to further unlock value and growth for both companies.”

About Alliance Resource Partners, L.P.

ARLP is a diversified energy company that is currently the largest coal producer in the eastern United States, supplying reliable, affordable energy domestically and internationally to major utilities, metallurgical and industrial users. ARLP also generates operating and royalty income from mineral interests it owns in strategic coal and oil & gas producing regions in the United States. In addition, ARLP is evolving and positioning itself as a reliable energy partner for the future by pursuing opportunities that support the advancement of energy and related infrastructure.

News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission (“SEC”), are available at www.arlp.com. For more information, contact the investor relations department of ARLP at (918) 295-7673 or via e-mail at investorrelations@arlp.com.

About Ascend Elements, Inc

Based in Westborough, Mass., Ascend Elements is the leading provider of sustainable, closed-loop battery materials solutions. From EV battery recycling to commercial-scale production of lithium-ion battery precursor (“pCAM”) and cathode active materials (“CAM”), Ascend Elements is revolutionizing the production of sustainable lithium-ion battery materials. Its proprietary Hydro-to-Cathode® direct precursor synthesis technology produces new pCAM from spent lithium-ion cells more efficiently than traditional methods, resulting in reduced cost, improved performance, and lowered GHG emissions. With fewer batteries going to landfill and a cleaner manufacturing process, Ascend Elements is taking the lithium-ion battery industry to a higher level of sustainability.

Cary P. Marshall
Senior Vice President and Chief Financial Officer
918-295-7673
investorrelations@arlp.com

Source: Alliance Resource Partners, L.P.

Release – Tonix Pharmaceuticals Announces Commitment to Supply Tosymra® (sumatriptan Nasal Spray) 10 mg for Treatment of Acute Migraine to Meet Potential Increased Demand Following GSK’s Planned Discontinuation of Imitrex® (sumatriptan) Nasal Spray After January 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

September 06, 2023 7:00am EDTDownload as PDF

Tosymra Nasal Spray 10 mg is a Proprietary Acute Migraine Treatment Approved Under the 505(b)2 Pathway Based on Bioequivalence to Imitrex (sumatriptan) Injection 4 mg

GlaxoSmithKline Recently Notified FDA that it will Discontinue Imitrex Nasal Spray 5 mg and 20 mg Products after January 2024

CHATHAM, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it is committed to meeting potential increased demand for Tosymra® (sumatriptan) nasal spray 10 mg after GlaxoSmithKline’s (GSK) planned discontinuation of Imitrex (sumatriptan) nasal spray 5 mg and 20 mg products after January, 2024.

On August 8, 2023, GSK informed the U.S. Food and Drug Administration (FDA) of its plan to discontinue Imitrex nasal spray 5 mg and 20 mg doses after January 31, 2024. The notification is posted on the FDA Drug Shortages website.1 Tonix is preparing for potential increased demand for Tosymra (sumatriptan nasal spray) 10 mg to help avoid possible drug shortages for patients who suffer from migraines. Tosymra nasal spray is approved on the basis of bioequivalence to Imitrex injection 4 mg.

Drug shortages have presented an ongoing challenge for the U.S. healthcare system, reaching near-record levels2 in recent months, causing treatment delays and rationing. Tonix is ready to step in to alleviate potential shortages in sumatriptan, a widely used treatment option for acute migraine.

“In response to FDA outreach, we have confirmed our commitment to meet potential increased demand for sumatriptan nasal spray from patients who suffer from migraines,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “While Tosymra nasal spray and Imitrex nasal spray are not substitutable at the pharmacy, we plan to alert providers to the possibility of prescribing Tosymra for patients who may benefit from a nasal spray formulation of sumatriptan.”

The American Headache Society Consensus Statement on migraine treatments recommends that “a non-oral formulation should be used in patients whose attacks are associated with severe nausea or vomiting, who do not respond well to traditional oral treatments, or who have trouble swallowing orally administered medications.”3 Approximately 73% of migraine patients have been reported to experience nausea with or without vomiting during their attacks.4

“Intranasal sumatriptan is an important therapy for those who suffer from migraines. We believe Tosymra is differentiated from other intranasal formulations of sumatriptan, which are generic equivalents to Imitrex nasal spray because of its proprietary Intravail® absorption enhancer technology,” said James Hunter, Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines. “Intravail technology helps the medication absorb into the bloodstream so it can work quickly, providing migraine pain relief in as little as 10 minutes for some patients.”5,6,7

About Migraine

Nearly 40 million people in the United States suffer from migraine8 and it has been recognized as the second leading cause of disability in the world.9 Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia).

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead development CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia, having completed enrollment of a potentially confirmatory Phase 3 study in the third quarter of 2023, with topline data expected in the fourth quarter of 2023. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition. Enrollment in a Phase 2 proof-of-concept study has been completed, and topline results were reported in the third quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily oral formulation being developed as a treatment for major depressive disorder (MDD), that completed enrollment in a Phase 2 proof-of-concept study in the third quarter of 2023, with topline results expected in the fourth quarter of 2023. TNX-4300 (estianeptine) is a single isomer version of TNX-601, small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease. Relative to tianeptine, estianeptine lacks activity on the µ-opioid receptor while maintaining activity in the rat Novel Object Recognition test in vivo and the ability to activate PPAR-β/δ and neuroplasticity in tissue culture. TNX-1900 (intranasal potentiated oxytocin), is in development for preventing headaches in chronic migraine, and has completed enrollment in a Phase 2 proof-of-concept study with topline data expected in the fourth quarter of 2023. TNX-1900 is also being studied in binge eating disorder, pediatric obesity and social anxiety disorder by academic collaborators under investigator-initiated INDs. 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 third quarter of 2023. Tonix’s rare disease development 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 development 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 rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

1FDA Drug Shortage, accessed Aug 24, 2023 – https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Sumatriptan+Nasal+Spray&st=d&tab=tabs-2
2CNN, accessed September 1, 2023 – https://www.cnn.com/2023/08/10/health/drug-shortage-pharmacist-survey/index.html
3Ailani J, et al. Headache. 2021. 61: 1021–1039
4Newman LC. Headache. 2013. 53 Suppl 1:11-6
5Tosymra [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC: 2021
6Mathew NT, et al. Arch Neurol. 1992. 49(12):1271-6
7Wendt J, et al. Clinical Therapeutics. 2006. 28(4):517-526
8Burch RC, et al. Neurol Clin. 2019. 37(4):631-649
9Steiner TJ, et al. J Headache Pain. 2020. 21(1): 137

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. Intravail is a registered trademark of Aegis Therapeutics, LLC, a wholly owned subsidiary of Neurelis, Inc. All other marks are property of their respective owners.

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; risks related to the failure to successfully market any of our products; 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Tosymra® (sumatriptan nasal spray): IMPORTANT SAFETY INFORMATION

Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop Tosymra and get emergency medical help if you have any signs of heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Tosymra is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.

Do not use Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your healthcare provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider if you are not sure if your medicine is listed above.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any ingredient in Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Tosymra include: tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Tosymra. For more information, ask your provider.

This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE
Tosymra is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Tosymra is not used to treat other types of headaches such as hemiplegic or basilar migraines or cluster headaches.

Tosymra is not used to prevent migraines. It is not known if Tosymra is safe and effective in children under 18 years of age.

Zembrace® SymTouch® (sumatriptan Injection):   IMPORTANT SAFETY INFORMATION

Zembrace SymTouch (Zembrace) can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Zembrace is not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Zembrace if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, dihydroergotamine.
  • are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Zembrace can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Zembrace may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Zembrace include: pain and redness at injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace. For more information, ask your provider.

This is the most important information to know about Zembrace but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATION AND USAGE

Zembrace is a prescription medicine used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.

Zembrace is not used to prevent migraines. It is not known if it is safe and effective in children under 18 years of age.

Source: Tonix Pharmaceuticals Holding Corp.

Released September 6, 2023

Release – MustGrow and Janssen PMP, a division of Janssen Pharmaceutica NV, Announce Significant Project Expansion

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MGROF

  • Exclusive agreement with Janssen PMP to now include postharvest potatoes and bananas globally, a significant strengthening of existing partnership.
  • Janssen PMP postharvest research, development, and commercialization capabilities have driven expansion.
  • Janssen PMP will continue to fund and complete all application testing and development work.

SASKATOON, Saskatchewan, Canada, Sep. 6, 2023 – MustGrow Biologics Corp. (TSXV: MGRO) (OTC: MGROF) (FRA: 0C0) (the “Company” or “MustGrow”), and Janssen PMP, a division of Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (“Janssen PMP”) are pleased to announce a significant expansion to their existing Exclusive Evaluation and Option Agreement (the “Agreement“) to test and develop MustGrow’s biological mustard plant-based technologies for certain postharvest food preservation storage applications globally. The Agreement will now also include postharvest potatoes and bananas globally.

Under the Agreement, the initial evaluation work excluded postharvest potatoes and bananas. However, with 15 months of postharvest evaluation work completed utilizing MustGrow’s technology, Janssen PMP and MustGrow have produced very encouraging and efficacious results, supporting the decision to add postharvest potatoes and bananas to Janssen PMP’s exclusive evaluation work. 

“The postharvest banana market is one of our historical markets where the need for natural fungicides is growing. Also, developing a natural technology acting as an anti-sprouting and as a fungicide for stored potatoes is a major opportunity for Janssen PMP and for the industry.” says Geoffroy de Chabot-Tramecourt, Director R&D and Business Development at Janssen PMP.

“Food storage and preservation continues to be a critical global issue. Our current partnership with Janssen PMP on the postharvest food preservation side has produced positive results with our natural technology that continues to open up new market areas and opportunities”, adds MustGrow COO Colin Bletsky.  “Janssen PMP brings more than 50 years of relevant postharvest development and market experience, and it is expected that adding these two key storage applications will help accelerate the commercialization pathway by levering the knowledge generated from testing other fruits and vegetables as well.” 

Janssen PMP is a world leader in postharvest product development and has proven aptitude in pace of work, knowledge, and market scope. This additional postharvest market area to Janssen PMP is expected to accelerate MustGrow’s development timeline, levering the current project work and technical/marketing expertise of Janssen PMP’s postharvest professionals.

Janssen PMP will continue to fund and drive all application testing and development work.

Postharvest Protection for Global Food Security

Potatoes, the world’s fourth most important food crop in terms of human consumption after maize, wheat and rice,(1) is a US$4 billion industry in the US, with as much as 33% of yield lost per year due to postharvest issues – approximately US$1.3 billion in lost revenue.(2) The Food and Agriculture Organization (FAO) has strongly endorsed potatoes as a food security crop.  Potatoes require up to nine months of storage and become waste without proper sprout suppression management, making postharvest sprout suppression a key element of potato storage.

The environment within storage and during particular stages of storage are most conducive to the spread of diseases. Controlling diseases in storage is difficult since the majority of chemical treatments have been either banned or are ineffective. For example, the leading agrochemical product for sprout suppression, CIPC, was banned by the European Union on Oct. 8, 2020.  For over 60 years, CIPC had long been the major global sprout suppressant, widely applied to stored potatoes.  With this ban in effect, potato growers must now refrigerate produce, with the additional capital expenditure and refrigeration energy consumption making this temporary approach unsustainable.  Although the ban was anticipated, no effective treatment alternatives have emerged – creating a major problem for existing potato storage sites.

Fruit and vegetable crops play a critical role in global food nutrition. More than one-third of produce (worth approximately US$1 trillion in value) is lost or wasted in postharvest operations,(3) which includes loss attributed to fungal and bacterial diseases. Fresh vegetables are highly perishable living tissues that are particularly susceptible. Postharvest fungal and bacterial diseases can cause annual vegetable crop losses of 40–60%.(4) Reducing postharvest losses could increase food availability, reducing pressure on the mounting food supply shortage and global inflationary pressures with respect to food prices. In addition, food production could be more environmentally sustainable with less waste.

Sources:

(1) https://www.intechopen.com/chapters/78618
(2) https://vegetablegrowersnews.com/news/help-to-reduce-huge-losses-in-potato-industry-seen-in-biochemistry/
(3) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5296677/
(4) https://www.intechopen.com/online-first/79995

About JANSSEN PMP

Janssen PMP (https://www.janssenpmp.com/) is a division of Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

Janssen PMP is a long-established world leader in the development and formulation of new and highly effective active substances and end-use products for the protection of materials and food, especially fruits and vegetables. With more than 50 years’ experience in Post-Harvest treatments and Plant Protection, Janssen PMP has developed strong technical and commercial expertise. Through protection of our surroundings, we aim to protect the health and well-being of the people in the environment in which our products are being used.

ON BEHALF OF JANSSEN PMP

Geoffroy de Chabot-Tramecourt
Director R&D and Business Development
Turnhoutseweg 30, 2340 Beerse, Belgium
Tel: +32 14 60 28 57
Mobile: +32 471 80 82 09
Email: gdchabot@its.jnj.com

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About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol, soil amendment and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world.  MustGrow and its leading global partners — Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals.  Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its technology in the soil amendment and biofertility markets.  Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements.  Pending regulatory approval, MustGrow’s patented liquid products could be applied through injection, standard drip or spray equipment, improving functionality and performance features.  Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation, to soil amendment and biofertility.  MustGrow has approximately 49.7 million basic common shares issued and outstanding and 55.6 million shares fully diluted.  For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson
Director & CEO
Phone: +1-306-668-2652
info@mustgrow.ca

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”.  Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: (i) the timing and results of any evaluation work on postharvest potatoes and bananas by Janssen PMP; (ii) the potential acceleration of MustGrow’s development timeline by transferring the additional postharvest market area to Janssen PMP;  (iii) the potential of MustGrow technology to extend shelf life of fruits and vegetables; (iv) the ability of the Company’s technology as a postharvest treatment to help secure a safe, environmentally sustainable food supply, with less waste; and (v) the ability to increase food availability and reduce pressure on the food supply shortage and global inflationary pressures with respect to food prices, by reducing postharvest losses.  

Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow.  Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) the preferences and choices of agricultural regulators with respect to product approval timelines; (ii) the ability of MustGrow’s partners to meet obligations under their respective agreements; and (iii) other risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2021 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com.  Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2023 MustGrow Biologics Corp. All rights reserved.