Bellicum and MD Anderson Announce Additional License Agreement for Use of CaspaCIDe® Safety Switch

HOUSTON, Sept. 01, 2021 (GLOBE NEWSWIRE) — Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, and The University of Texas MD Anderson Cancer Center today announced a global option and license agreement covering certain intellectual property and technology rights regarding Bellicum’s CaspaCIDe® (inducible caspase-9, or iC9) safety switch and related technologies, and the use of rimiducid, an agent used to activate the safety switch. Under this agreement, MD Anderson will have the option to incorporate CaspaCIDe into certain cellular therapy programs.

Bellicum’s CaspaCIDe safety switch may facilitate the use of cell therapies where cytokine release syndrome and neurotoxicities have been observed, in pursuit of novel targets with on-target/off-tumor safety concerns, and in conjunction with next-generation higher potency cell therapy constructs.

“We are excited to expand our CaspaCIDe agreement with MD Anderson to include a broader set of programs to benefit cancer patients,” said Rick Fair, President and CEO of Bellicum Pharmaceuticals. “We believe that our switch technology may enhance the benefit/risk profile of cell therapies. We intend to continue to pursue opportunities to expand its use via external collaborations with other leaders in the field.”

Upon exercise of each option – typically expected to be upon out-license of an MD Anderson program that incorporates iC9 – Bellicum will receive an upfront payment and will be entitled to a percentage of certain consideration paid to MD Anderson by the third party. Bellicum also will receive a single-digit-percent royalty on global sales of the product. Additional details of the financial arrangements are not disclosed. Bellicum and MD Anderson have agreed on the first two programs for development concurrent with the execution of the agreement. This agreement expands upon a previous one, which covers the use of CaspaCIDe in a specific MD Anderson cell therapy program.

“The unique inducible caspase-9 technology covered by this agreement has the potential to reduce the risk of serious adverse events associated with cellular therapies and to improve patient outcomes,” said Katy Rezvani, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson. “We have successfully applied the technology to existing cell therapies, and we look forward to the potential future applications made possible by this agreement.”

About CaspaCIDe

®

CaspaCIDe (inducible caspase-9, or iC9) is Bellicum’s chemical induction of dimerization (CID) safety switch technology designated to eliminate cells in the event of toxicity. The CaspaCIDe switch consists of the CID-binding domain coupled to the signaling domain of caspase-9, an enzyme that is part of the apoptotic pathway. Infusion of rimiducid is designed to trigger activation of this domain of caspase-9, which in turn leads to selective apoptosis of the CaspaCIDe-containing cells. In clinical studies, use of CaspaCIDe has resulted in clinical improvement in most patients as early as 24 hours after rimiducid administration. Further, because CaspaCIDe is designed to be permanently incorporated into Bellicum’s cellular therapies, the safety switch has the potential to be available for use when needed long after the initial therapy is delivered.

About Bellicum Pharmaceuticals

Bellicum is a clinical stage biopharmaceutical company striving to deliver cures through controllable cell therapies. The company’s next-generation product candidates are differentiated by powerful cell signaling technologies designed to produce more effective CAR-T cell therapies. Bellicum’s GoCAR-T® product candidates, BPX-601 and BPX-603, are designed to be more efficacious CAR-T cell products capable of overriding key immune inhibitory mechanisms. More information about Bellicum can be found at www.bellicum.com.

About MD Anderson

The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world’s most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 51 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is No. 1 for cancer in U.S. News & World Report’s “Best Hospitals” rankings. It has been named one of the nation’s top two hospitals for cancer since the rankings began in 1990 and has ranked first 16 times in the last 19 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Bellicum may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “designed,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential for Bellicum’s safety switch technology to improve the benefit/risk profile of cell therapies; the potential for expanded beneficial impact of the CaspaCIDe technology on patients enabled by the license agreement; the potential for Bellicum to earn future milestones or royalties under CaspaCID license agreements; Bellicum’s plans to make our technology more broadly available via external collaborations; and the potential useful life of the CaspaCIDe safety switch. Various factors may cause differences between Bellicum’s expectations and actual results as discussed in greater detail under the heading “Risk Factors” in Bellicum’s filings with the Securities and Exchange Commission, including without limitation Bellicum’s quarterly report on Form 10-Q for the three months ended June 30, 2021 and Bellicum’s annual report on Form 10-K the year ended December 31, 2020. Any forward-looking statements that Bellicum makes in this press release speak only as of the date of this press release. Bellicum assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Source: Bellicum Pharmaceuticals & The University of Texas MD Anderson Cancer Center

Contacts:
Bellicum
Robert H. Uhl
Managing Director
Westwicke ICR
858-356-5932
[email protected]

MD Anderson
Clayton Boldt, Ph.D.
Public Relations
713-792-9518
[email protected]



Vision Marine Technologies Shatters Its Own Speed Record with its Bruce 22, Powered by Its Groundbreaking E-Motion™ Powertrain at Lake of the Ozarks Shootout 2021

First on-water event to showcase the Company’s disruptive and uniquely powerful E-Motion™ 180 hp fully electric outboard motor

MONTREAL, Sept. 01, 2021 (GLOBE NEWSWIRE) — Vision Marine Technologies, Inc. (Nasdaq: VMAR) (“Vision Marine” or the “Company”), a global leader in the electric recreational boating industry serving both OEMs and consumers, is proud to announce its Bruce22 electric boat powered by its 180 hp fully electric E-Motion™ outboard motor set a new category speed record at the Lake of the Ozarks Shootout, the largest unsanctioned boat race in the US, which took place August 28-29, 2021.

“We believe that our fully electric technology provided a clear glimpse into the very near future,” said Xavier Montagne, CTO of Vision Marine Technologies. “We envision electric boats and outboard motors quickly becoming mainstream within the consumer markets, and the Lake of the Ozarks Shootout presented an exciting opportunity for Vision Marine to debut its E-Motion™ outboard motor.”

Electric boats made their debut at the Shootout in 2018, with a 25-mph run by Randy Vance in Calypso. In 2021, despite experiencing unusually warm temperatures, Vision Marine was able to achieve a speed of 49 mph, shattering its own record of 31 mph set in 2019, as the world’s fastest production electric boat. The Bruce 22, powered by our E-Motion™ electric outboard motor, achieved this milestone with Vision Marine co-founder and COO Patrick Bobby at the helm.

With a focus on power, speed and performance, Vision Marine is well positioned to take advantage of growing demand and an accelerating demand by OEMs and consumers to shift to environmentally friendly electric technology. The move toward more powerful engines with increased torque, and the expanded availability of pure electric optionality, is projected to increase the addressable market for electric outboard motors almost threefold, from US$4.5 billion in 2018 to US$12.3 billion in 2027. 

Key Features of Vision Marine’s Proprietary E-Motion™ Technology:

  • Dramatic increase in efficiency, torque, power, and consumer experience.
  • Exceptionally fast charging capabilities.
  • Noiseless engine with minimal vibration.
  • Sustainable solution with zero emission.
  • E-Motion™ delivers an exhilarating experience due to its high torque to horsepower ratio
  • 90% reduction in fuel and maintenance cost versus traditional ICE powered boats

“We are absolutely thrilled with the performance of our Bruce 22 powered by our E-Motion™ electric powertrain at the Lake of the Ozarks Shootout,” said Alexandre Mongeon, CEO of Vision Marine Technologies. “One of the largest boating events in the nation, the Shootout provided a tremendous platform to showcase our electric technology to the boating community.”

Named one of the nation’s eight “must-see” boating events according to Powerboat Magazine, the Shootout took place for the ninth year at Captain Ron’s Bar & Grill in Sunrise Beach. The event, now in its 33rd year, raises funds for eight Lake area rescue teams and numerous other charitable organizations.


About Vision Marine Technologies, Inc.

Vision Marine Technologies, Inc. (Nasdaq: VMAR), strives to be a guiding force for change and an ongoing driving factor in fighting the problems associated with waterway pollution by disrupting the traditional boating industry with electric power, in turn directly contributing to zero pollution, zero emission and a noiseless environment. Our flagship outboard powertrain (“E-Motion™”) is the first fully electric purpose-built outboard powertrain system that combines an advanced battery pack, inverter, and high efficiency motor with proprietary union assembly between the transmission and the electric motor design utilizing extensive control software. Our E-Motion™ and related technologies used in this powertrain system are uniquely designed to improve the efficiency of the outboard powertrain and, as a result, enhance both range and performance. Vision Marine continues to design, innovate, manufacture, and sell handcrafted, high performance, environmentally friendly, electric recreational power boats to customers. The design and technology applied to our boats results in far greater enhanced performance in general, higher speeds, and longer range. Simply stated, a smoother ride than a traditional internal combustion engine (ICE) motorboat.


Forward-Looking Statements


Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, actual results may differ materially from these expectations due to changes in global, regional, or local economic, business, competitive, market, regulatory and other factors, many of which are outside of Vision Marine’s control. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Vision Marine’s Annual Report on Form 20-F, filed with the U.S. Securities and Exchange Commission (SEC) for the year ended August 31, 2020, as such factors may be updated from time to time in Vision Marine’s periodic filings with the SEC. Any forward-looking statement in this press release speaks only as of the date of this release. Vision Marine undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.


https://visionmarinetechnologies.com


.

Investor and Company Contact:

Bruce Nurse
Vision Marine Technologies, Inc.
(800) 871-4274
[email protected] 

Dave Gentry
RedChip Companies Inc.
800-RED-CHIP (733-2447) or 407-491-4498
[email protected]

 



Nephros Appoints Wes Lobo to Chief Commercial Officer

SOUTH ORANGE, NJ, Sept. 01, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Nephros, Inc.(Nasdaq: NEPH), a leading water technology company providing innovative filtration and pathogen detection solutions to healthcare and commercial markets, today announced the appointment of Wes Lobo to the role of Chief Commercial Officer.

Mr. Lobo first joined Nephros in February 2021 as Chief Marketing Officer. In the expanded role of Chief Commercial Officer, he will be responsible for all commercial strategy and operations including sales, marketing, business development, product management, and customer service.

“As a growth-focused business, Nephros requires a unified commercial organization built on consistent strategy, messaging, and relationship management that focuses on the unique needs of our partners and end-customers,” said Andy Astor, Chief Executive Officer. “In a very short time, Wes has become a key leader in the company, adding significant strategic and operational value to our decision making, while establishing a scalable marketing infrastructure. We are excited to widen Wes’s scope of responsibility to include all commercial activities across our business.”

“I joined Nephros hoping that the promise of the opportunity would match the reality,” said Mr. Lobo. “I can now confidently say that my enthusiasm and passion have only increased, both for the Nephros team and for the company’s growth opportunity. I am humbled and honored to be part of the Nephros family and to lead our efforts at being a trusted resource to our partners and customers for their water quality needs.”

About Nephros

Nephros, Inc. is a leading water technology company focused on improving the human relationship with water. We provide innovative filtration and pathogen detection as part of an integrated approach to water safety that combines science, solutions, and support services. Nephros products serve the needs of customers within the healthcare and commercial markets, offering both proactive and emergency responses for water management.

For more information about Nephros, please visit www.nephros.com.

Forward-Looking Statements

This release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the benefits expected from Nephros’s new Chief Commercial Officer and other statements that are not historical facts, including statements accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, the impact of the COVID-19 pandemic, and the availability of financing or other capital when needed. These and other risks and uncertainties are detailed in Nephros’s reports filed with the U.S. Securities and Exchange Commission. Nephros does not undertake any responsibility to update the forward-looking statements in this release.

Investor Relations Contacts:

Kirin Smith, President

PCG Advisory, Inc.

(646) 823-8656

[email protected]

Andy Astor, CEO

Nephros, Inc.

(201) 345-0824

[email protected]



Daktronics, Inc. Announces First Quarter Fiscal 2022 Results

BROOKINGS, S.D., Sept. 01, 2021 (GLOBE NEWSWIRE) — Daktronics, Inc. (NASDAQ – DAKT) today reported results for fiscal 2022 first quarter which ended July 31, 2021.

Q1 FY2022 financial highlights:

  • Net sales of $144.7 million were similar to Q1 FY2021 net sales of $143.6 million.
  • Operating income of $5.7 million was lower than Q1 FY2021 operating income of $9.5 million due to inflation in materials and freight costs, increased personnel spend compared to prior year during the pandemic, and due to sales mix difference between the two quarters. Operating income as a percent of sales for Q1 FY2022 was 3.9 percent as compared to 6.6 percent in Q1 FY2021.
  • Net income of $3.7 million, and earnings per diluted share of $0.08 compared to net income of $7.5 million, and $0.17 earnings per diluted share, for Q1 FY2021.
  • First quarter orders of $181.7 million, grew 48.8% year-over-year, driven by increased market activity as the pandemic restrictions eased and large project bookings.
  • Product order backlog of $285 million compared to $192 million a year earlier.(1) The increase was driven by strong order volume offset by muted conversion to sales due to supply chain challenges.
  • Balance sheet remains strong. There were no advances under the loan portion of the line of credit compared to $15 million borrowed at the end of Q1 FY2021.

Reece Kurtenbach, chairman, president and chief executive officer stated, “Late last fiscal year, order and quoting activities began to recover as the pandemic impacts subsided. Strong market conditions and recovery continued through the first quarter and orders increased in all business units. At the same time, material, labor, and freight availability constraints are creating headwinds in lead times and inflationary pressures. We expect these headwinds to persist through this calendar year with some impacts continuing into next calendar year. Our teams are performing well to keep up with the robust demand and working through the dynamic supply chain conditions.”

Outlook
Kurtenbach added, “Our solid backlog and strong pipeline of opportunities positions us for a successful year. However, as we work through supply chain challenges, we expect volatility in our revenue cycles and production costs. Over the long-term, we believe the fundamentals of the audiovisual industry are strong and are poised for growth. We are actively investing in capacity and in new technologies and markets to meet that expected demand with world-leading solutions and value. We look forward to the continued global economic recovery and long-term profitable growth.”

First Quarter Results
Orders for the first quarter of fiscal 2022 increased 48.8 percent as compared to the first quarter of fiscal 2021. Each business unit’s order volume was higher in the first quarter of fiscal 2022 reflecting the recovery from the impact of the global pandemic among our customers. High School Park and Recreation performed well throughout the pandemic and continues to perform well as we emerge from the pandemic driven by the adoption of video displays at the high school level. The increase also was created by several multimillion-dollar orders (“large orders”). During the quarter, we were awarded a number of arena and stadium projects in both International and Live Events and had increased activity in the Commercial and International digital billboard markets. Large orders create volatility in comparisons between quarters.

Net sales increased by 0.8 percent in the first quarter of fiscal 2022 as compared to the first quarter of fiscal 2021. Net sales increased in our International business unit, and decreased in the Commercial, High School Park and Recreation, and Transportation business units. Net sales were flat in our Live Events business unit. Material supply shortages are creating an increase in lead times and extending the timing of converting some orders to sales in the near-term. This has created a larger than typical backlog, which we expect to fulfill in future quarters. 

Gross profit as a percentage of net sales was 22.2 percent for the first quarter of fiscal 2022 as compared to 24.9 percent a year earlier. The decrease in gross profit is primarily related to increased input costs including material, freight, and tariff costs and increased personnel spend compared to prior year during the pandemic. During the first quarter of fiscal 2022 we had more large project sales which generally have lower gross profit because of the competitive nature of large projects and less service revenue as a percentage of sales.

Operating expenses for the first quarter of fiscal 2022 were $26.5 million, compared to $26.2 million for the first quarter of fiscal 2021, or an increase of 1.1 percent. Operating income as a percent of sales for the quarter was 3.9 percent as compared to an operating income as a percent of sales of 6.6 percent during the first quarter of fiscal 2021.

The effective tax rate expense for the first quarter of fiscal 2022 was 25.2 percent compared to an effective tax rate expense of 16.4 percent for the first quarter of fiscal 2021. The difference in rates is primarily driven by estimated tax credits and other permanent items proportionate to estimated pre-tax earnings in fiscal 2022 compared to lower estimated pre-tax earnings in fiscal 2021. 

Cash, restricted cash, and marketable securities at the end of the first quarter of fiscal 2022 were $77.2 million, which compares to $45.9 million at the end of the first quarter of fiscal 2021 and $80.4 million at the end of fiscal 2021. There were no advances under the loan portion of the line of credit compared to $15 million borrowed at the end of the first quarter of fiscal 2021. Free cash flow, defined as cash provided from or used in operating activities less net investment in property and equipment, was a negative $2.2 million for the first quarter fiscal 2022, as compared to a positive free cash flow of $5.5 million for fiscal 2021. Cash provided from or used in operating activities differed as compared to last year due to an increase in accounts receivable and inventory required to support the increased order volume. Net investment in property and equipment was $1.1 million for fiscal 2022, as compared to $3.1 million for fiscal 2021. During fiscal 2021, the share repurchase and dividend programs were suspended with no related cash outflows during either period presented. These programs will be suspended for the foreseeable future. 

(1) Backlog is not a measure defined by accounting principles generally accepted in the United States of America (“GAAP”), and our methodology for determining backlog may vary from the methodology used by other companies in determining their backlog amounts. For more information related to backlog, see Part I, Item 1. Business of our Annual Report on Form 10-K for the fiscal year ended May 1, 2021. 

About Daktronics
Daktronics has strong leadership positions in, and is the world’s largest supplier of, large-screen video displays, electronic scoreboards, LED text and graphics displays, and related control systems. The company excels in the control of display systems, including those that require integration of multiple complex displays showing real-time information, graphics, animation, and video. Daktronics designs, manufactures, markets and services display systems for customers around the world in four domestic business units: Live Events, Commercial, High School Park and Recreation, and Transportation, and one International business unit. For more information, visit the company’s website at: www.daktronics.com, email the company at [email protected], call (605) 692-0200 or toll-free (800) 843-5843 in the United States, or write to the company at 201 Daktronics Dr., P.O. Box 5128, Brookings, S.D. 57006-5128.

Safe Harbor Statement

Cautionary Notice: In addition to statements of historical fact, this news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and is intended to enjoy the protection of that Act. These forward-looking statements reflect the Company’s expectations or beliefs concerning future events. The Company cautions that these and similar statements involve risk and uncertainties which could cause actual results to differ materially from our expectations, including, but not limited to, changes in economic and market conditions, management of growth, timing and magnitude of future contracts and orders, fluctuations in margins, the introduction of new products and technology, the impact of adverse weather conditions, increased regulation and other risks described in the company’s SEC filings, including its Annual Report on Form 10-K for its 2021 fiscal year. Forward-looking statements are made in the context of information available as of the date stated. The Company undertakes no obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur.

For more information contact:    
INVESTOR RELATIONS:    
Sheila M. Anderson, Chief Financial Officer    
Tel (605) 692-0200    

[email protected]
   

Daktronics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
 
  Three Months Ended  
  July 31,     August 1,  
  2021     2020  
Net sales $ 144,732     $ 143,644  
Cost of sales   112,544       107,883  
Gross profit   32,188       35,761  
               
Operating expenses:              
Selling   11,795       11,556  
General and administrative   7,571       7,124  
Product design and development   7,162       7,532  
    26,528       26,212  
Operating income   5,660       9,549  
               
Nonoperating (expense) income:              
Interest income   153       85  
Interest expense   (16 )     (73 )
Other (expense) income, net   (868 )     (627 )
               
Income before income taxes   4,929       8,934  
Income tax expense   1,244       1,467  
Net income $ 3,685     $ 7,467  
               
Weighted average shares outstanding:              
Basic   45,139       44,654  
Diluted   45,419       44,751  
               
Earnings per share:              
Basic $ 0.08     $ 0.17  
Diluted $ 0.08     $ 0.17  
               

Daktronics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands)
 
  July 31,     May 1,  
  2021     2021  
  (unaudited)          
ASSETS              
CURRENT ASSETS:              
Cash and cash equivalents $ 74,658     $ 77,590  
Restricted cash   2,541       2,812  
Accounts receivable, net   78,497       67,808  
Inventories   84,514       74,356  
Contract assets   38,133       32,799  
Current maturities of long-term receivables   1,756       1,462  
Prepaid expenses and other current assets   9,821       7,445  
Income tax receivables   635       731  
Total current assets   290,555       265,003  
               
Property and equipment, net   56,208       58,682  
Long-term receivables, less current maturities   1,390       1,635  
Goodwill   8,311       8,414  
Intangibles, net   1,780       2,083  
Investment in affiliates and other assets   26,271       27,403  
Deferred income taxes   11,941       11,944  
Total non-current assets   105,901       110,161  
TOTAL ASSETS $ 396,456     $ 375,164  
               

Daktronics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets (continued)
(in thousands)
 
  July 31,     May 1,  
  2021     2021  
  (unaudited)          
LIABILITIES AND SHAREHOLDERS’ EQUITY              
CURRENT LIABILITIES:              
Accounts payable $ 57,775     $ 40,251  
Contract liabilities   67,507       64,495  
Accrued expenses   27,650       30,672  
Warranty obligations   9,986       10,464  
Income taxes payable   496       738  
Total current liabilities   163,414       146,620  
               
Long-term warranty obligations   15,395       15,496  
Long-term contract liabilities   10,586       10,720  
Other long-term obligations   7,848       7,816  
Long-term income taxes payable   654       548  
Deferred income taxes   378       410  
Total long-term liabilities   34,861       34,990  
TOTAL LIABILITIES   198,275       181,610  
               
SHAREHOLDERS’ EQUITY:              
Common stock   61,172       60,575  
Additional paid-in capital   47,117       46,595  
Retained earnings   99,701       96,016  
Treasury stock, at cost   (7,101 )     (7,297 )
Accumulated other comprehensive loss   (2,708 )     (2,335 )
TOTAL SHAREHOLDERS’ EQUITY   198,181       193,554  
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 396,456     $ 375,164  

 

Daktronics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
 
  Three Months Ended  
  July 31,     August 1,  
  2021     2020  
CASH FLOWS FROM OPERATING ACTIVITIES:              
Net income $ 3,685     $ 7,467  
Adjustments to reconcile net income to net cash (used in) provided by operating activities:              
Depreciation and amortization   4,052       4,337  
Gain on sale of property, equipment and other assets   (106 )     (53 )
Share-based compensation   518       539  
Equity in loss of affiliates   746       529  
Provision for doubtful accounts   (421 )     1  
Deferred income taxes, net   (32 )     (4 )
Change in operating assets and liabilities   (9,461 )     (4,271 )
Net cash (used in) provided by operating activities   (1,019 )     8,545  
               
CASH FLOWS FROM INVESTING ACTIVITIES:              
Purchases of property and equipment   (1,283 )     (3,155 )
Proceeds from sales of property, equipment and other assets   149       86  
Purchases of and loans to equity investment   (718 )     (492 )
Net cash used in investing activities   (1,852 )     (3,561 )
               
CASH FLOWS FROM FINANCING ACTIVITIES:              
Principal payments on long-term obligations   (200 )     (210 )
Net cash used in financing activities   (200 )     (210 )
               
EFFECT OF EXCHANGE RATE CHANGES ON CASH   (132 )     (481 )
NET (DECREASE) INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH   (3,203 )     4,293  
               
CASH, CASH EQUIVALENTS AND RESTRICTED CASH:              
Beginning of period   80,402       40,412  
End of period $ 77,199     $ 44,705  

Daktronics, Inc. and Subsidiaries
Net Sales and Orders by Business Unit
(in thousands)
(unaudited)
 
  Three Months Ended  
  July 31,     August 1,     Dollar     Percent  
  2021     2020     Change     Change  
Net Sales:                              
Commercial $ 32,781     $ 34,506     $ (1,725 )     (5.0 )%
Live Events   52,387       51,474       913       1.8  
High School Park and Recreation   27,894       28,943       (1,049 )     (3.6 )
Transportation   12,558       14,498       (1,940 )     (13.4 )
International   19,112       14,223       4,889       34.4  
  $ 144,732     $ 143,644     $ 1,088       0.8 %
Orders:                              
Commercial $ 38,329     $ 25,533     $ 12,796       50.1 %
Live Events   49,686       41,860       7,826       18.7  
High School Park and Recreation   45,711       28,099       17,612       62.7  
Transportation   21,345       13,089       8,256       63.1  
International   26,675       13,572       13,103       96.5  
  $ 181,746     $ 122,153     $ 59,593       48.8 %

Reconciliation of Free Cash Flow
*
(in thousands)
(unaudited)
 
  Three Months Ended  
  July 31,     August 1,  
  2021     2020  
Net cash (used in) provided by operating activities $ (1,019 )   $ 8,545  
Purchases of property and equipment   (1,283 )     (3,155 )
Proceeds from sales of property and equipment   149       86  
Free cash flow $ (2,153 )   $ 5,476  

*In evaluating its business, Daktronics considers and uses free cash flow as a key measure of its operating performance. The term free cash flow is not defined under accounting principles generally accepted in the United States of America (“GAAP”) and is not a measure of operating income, cash flows from operating activities or other GAAP figures and should not be considered alternatives to those computations. Free cash flow is intended to provide information that may be useful for investors when assessing period to period results.

 



Xeris Pharmaceuticals Completes Enrollment of Its Phase 1 Study of Levothyroxine (XP-8121)

Xeris Pharmaceuticals Completes Enrollment of Its Phase 1 Study of Levothyroxine (XP-8121)

All participants received initial dose

Preliminary results anticipated in Q1 2022

Compelling pre-clinical data show potential for subcutaneous administration

CHICAGO–(BUSINESS WIRE)–
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that the company has completed enrollment and successfully dosed all participants in a Phase 1 study of levothyroxine (XP-8121) to evaluate the pharmacokinetics, safety and tolerability, and potential for weekly dosing of the investigational, novel, subcutaneous (SC) injection for the treatment of hypothyroidism.

XP-8121 is a novel formulation that could potentially mitigate many of the challenges associated with oral formulations, such as identification of an ideal dose due to absorption variation and medication adherence for patients who have difficulty maintaining a stable, therapeutic serum level. Preclinical studies of SC XP-8121 showed a sustained plasma exposure profile and similar maximum plasma concentration (Cmax) when compared with equivalent doses of the oral formulation.

The Phase 1 clinical study of levothyroxine (XP-8121) is a single ascending dose crossover design in 30 healthy participants to compare matching doses of oral levothyroxine (Synthroid®) and subcutaneous (SC) XP-8121. The primary endpoints of the study are to characterize the absorption and elimination kinetics of XP-8121 and compare bioavailability of XP-8121 to oral levothyroxine. Secondary endpoints are safety and tolerability of XP-8121. The study is being conducted in partnership with Dr. Danielle Armas and Celerion, a leading contract research organization with extensive experience performing first-in-human studies.

“The potential for a once weekly subcutaneous injection of levothyroxine would represent a promising novel approach in treating patients with hypothyroidism. Drug non-compliance, resistant hypothyroidism, and limited GI absorption are some of the major reasons for treatment failure or suboptimal treatment with oral levothyroxine. These challenges could be mitigated by XP-8121 and translate into the long-term health benefit of achieving a euthyroid state for patients,” said Dr. Armas, Senior Principal Investigator, Celerion.

“Because our levothyroxine formulation enables a small volume SC injection, as an injectable maintenance therapy, it may facilitate less frequent dosing. This may provide clinical advantages over the established oral daily route, by providing predictable bioavailability, comparable safety, and ease of use,” said Dr. Ken Johnson, Xeris’ Senior Vice President of Global Development and Medical Affairs.

About Levothyroxine and Hypothyroidism

The thyroid gland is responsible for the synthesis, storage, and release of metabolic hormones including thyroxine (T4) and triiodothyronine (T3) [Colucci et al, 2013]. These hormones are crucial in the regulation of critical metabolic processes and are vital for normal growth and development during fetal life, infancy, and childhood.

Therapeutically, levothyroxine is administered when the body is deficient in the endogenous hormone. The goal of therapy is restoration of the euthyroid state which can reverse the clinical manifestations of hypothyroidism and significantly improve quality of life [Winther et al, 2016]. The treatment of choice for correction of hypothyroidism is levothyroxine, which is the mainstay of thyroid hormone replacement therapy. It is one of the most widely prescribed drug products in the United States, but the complexity of maintaining biochemical and clinical euthyroidism in patients undergoing treatment with oral levothyroxine cannot be underestimated. It has been reported that nearly 40% of patients undergoing treatment with oral levothyroxine are either over- or under-treated [Laurent et al, 2018] due to factors that include, but are not limited to, drug formulation, use of the drug with food, adherence to the drug, use of concomitant medications, and pre-existing medical conditions. Many patients failing to reach target TSH levels are generally managed by simply increasing their levothyroxine daily dose [Chiovato et al, 2019]. However, levothyroxine is a drug with a narrow therapeutic index [Vita et al, 2014], meaning that relatively small deviations from the proper dose can cause a clinically meaningful shift in pharmacological effects when administered to a patient; thus, the titration of levothyroxine oral drug may be a tailored and incremental process.

About Xeris Pharmaceuticals, Inc.

Xeris (Nasdaq: XERS) is a pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world.

With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable drug, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke® in the U.S. Its proprietary XeriSol™ and XeriJect™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system.

Xeris is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on Twitter, LinkedIn or Instagram.

About Celerion

A recognized global leader in early clinical research services, Celerion “translates science into medicine” through scientific excellence, medical expertise, and broad clinical operations experience.

For fifty years Celerion has been providing industry leadership in the execution of safety/tolerability, pharmacokinetic and pharmacodynamics studies in highly controlled clinical environments such as first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism and excretion, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function.

Celerion enhances this with superior data management, biostatistics, clinical monitoring, and bioanalytical services. Our enduring mission is to help clients get their drugs to market in a timely fashion that benefits people in need the world over. For more information, please visit www.celerion.com.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Xeris Pharmaceuticals, Inc., including statements regarding the market and therapeutic potential of its products and product candidates, expectations regarding clinical data or results from planned clinical trials, the timing or likelihood of regulatory approval and commercialization of its product candidates, the timing and likelihood of the consummation of the Strongbridge Biopharma acquisition, the timing or likelihood of expansion into additional markets, the timing or likelihood of identifying potential development and commercialization partnerships, the potential utility of its formulation platforms and other statements containing the words “will,” “would,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, without limitation, the impact of COVID-19 on its business operations, its reliance on third-party suppliers for Gvoke® and Ogluo®, the regulatory approval of its product candidates, its ability to market and sell its products, if approved, and other factors discussed in the “Risk Factors” section of the most recently filed Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”), as well as discussions of potential risks, uncertainties, and other important factors in Xeris’ subsequent filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Xeris expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

Investor Contact

Allison Wey

Senior Vice President, Investor Relations and Corporate Communications

[email protected]

312-736-1237

KEYWORDS: United States North America Illinois

INDUSTRY KEYWORDS: Biotechnology General Health Health Pharmaceutical Clinical Trials

MEDIA:

The Beachbody Company to Participate in the Cowen 2nd Annual Health, Wellness & Beauty Summit

The Beachbody Company to Participate in the Cowen 2nd Annual Health, Wellness & Beauty Summit

SANTA MONICA, Calif.–(BUSINESS WIRE)–
The Beachbody Company, Inc. (NYSE: BODY) (“Beachbody” or the “Company”), a leading subscription health and wellness company, today announced that Beachbody’s management team is participating in the Cowen 2nd Annual Health, Wellness & Beauty Summit on Monday, September 13, 2021.

Beachbody’s Co-Founder, Chairman and Chief Executive Officer, Carl Daikeler, and President and Chief Financial Officer, Sue Collyns are scheduled to present at 10:50 a.m. Eastern Time. A live webcast of the presentation will be available at https://thebeachbodycompany.com/investors.

About The Beachbody Company, Inc.

Headquartered in Southern California, Beachbody is a worldwide leading digital fitness and nutrition subscription company with over two decades of creating innovative content and powerful brands. The Beachbody Company is the parent company of the Beachbody On Demand streaming platform (BOD), the Openfit live digital streaming platform and MYXfitness, the company’s connected fitness brand. For more information, please visit TheBeachbodyCompany.com.

Source: The Beachbody Company, Inc.

Media

ICR

[email protected]

Investor Relations

Edward Plank

[email protected]

ICR

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Technology Internet Fitness & Nutrition Health

MEDIA:

Aramark Announces Participation in Upcoming Investor Conferences

Aramark Announces Participation in Upcoming Investor Conferences

PHILADELPHIA–(BUSINESS WIRE)–
Aramark (NYSE:ARMK), a global leader in food, facilities management and uniforms, announced that members of its management team will participate in featured fireside chat sessions at the following upcoming investor conferences:

  • Goldman Sachs Global Retailing Conference – On Friday, September 10, 2021, John Zillmer, Aramark’s Chief Executive Officer, and Tom Ondrof, Aramark’s Chief Financial Officer, will participate in a fireside chat beginning at 7:30 a.m. ET.
  • Bernstein Strategic Decisions Conference – On Thursday, September 23, 2021, John Zillmer, Aramark’s Chief Executive Officer, will take part in a fireside chat beginning at 8:30 a.m. ET.

A live webcast and replay of the fireside chat sessions will be available through the Investor Relations section of the Aramark website at www.aramark.com.

About Aramark

Aramark (NYSE: ARMK) proudly serves the world’s leading educational institutions, Fortune 500 companies, world champion sports teams, prominent healthcare providers, iconic destinations and cultural attractions, and numerous municipalities in 19 countries around the world with food, facilities, and uniform services. Because our culture is rooted in service, our employees strive to do great things for each other, our partners, our communities, and our planet. Aramark has been named to DiversityInc’s “Top 50 Companies for Diversity” list, the Forbes list of “America’s Best Employers for Diversity,” the Human Rights Campaign Foundation’s “Best Place to Work for LGBTQ Equality” and scored 100% on the Disability Equality Index. Learn more at www.aramark.com and connect with us on Facebook, Twitter, and LinkedIn.

Inquiries

Felise Kissell (215) 409-7287

[email protected]

Scott Sullivan (215) 238-3953

[email protected]

KEYWORDS: Pennsylvania United States North America

INDUSTRY KEYWORDS: Food/Beverage Retail

MEDIA:

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Arrowhead Pharmaceuticals to Participate in Upcoming September 2021 Conferences

Arrowhead Pharmaceuticals to Participate in Upcoming September 2021 Conferences

PASADENA, Calif.–(BUSINESS WIRE)–
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it is scheduled to participate in the following upcoming events:

Citi’s 16th Annual BioPharma Virtual Conference – September 8-10, 2021

September 9, 2021 – Arrowhead management will host a day of virtual investor meetings

HC Wainwright 23rd Annual Global Investment Conference – September 13-15, 2021

September 13, 2021 – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

Baird’s 2021 Global Healthcare Conference – September 14-15, 2021

September 14, 2021, 4:55 p.m. ET – Vince Anzalone, CFA, Arrowhead’s vice president of investor relations, will participate in a fireside chat presentation

2021 Cantor Virtual Global Healthcare Conference – September 27-30, 2021

September 29, 2021, 9:20 a.m. ET – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

A copy of the presentation materials and/or live webcast links may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

For more information, please visit www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” or “continue” are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

Source: Arrowhead Pharmaceuticals, Inc.

Arrowhead Pharmaceuticals, Inc.

Vince Anzalone, CFA

626-304-3400

[email protected]

Investors:

LifeSci Advisors, LLC

Brian Ritchie

212-915-2578

[email protected]

www.lifesciadvisors.com

Media:

LifeSci Communications, LLC

Josephine Belluardo, Ph.D.

646-751-4361

[email protected]

www.lifescicommunications.com

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Finance Health Professional Services Genetics

MEDIA:

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Cyteir Therapeutics to Participate in the 19th Annual Morgan Stanley Global Healthcare Conference

Cyteir Therapeutics to Participate in the 19th Annual Morgan Stanley Global Healthcare Conference

LEXINGTON, Mass.–(BUSINESS WIRE)–
Cyteir Therapeutics, Inc. (“Cyteir”) (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, announced that its President and Chief Executive Officer Markus Renschler, MD will participate in a fireside chat at the 19th Annual Morgan Stanley Global Healthcare Conference, being held virtually on September 10, 2021, at 11:45am ET.

A live webcast of the fireside chat will be available in the Investors & Media section of the Cyteir website at www.cyteir.com. A webcast replay will also be available on the website shortly after conclusion of the event for 30 days.

About Cyteir Therapeutics, Inc.

Cyteir is a clinical-stage oncology company that is focused on the discovery and development of next-generation synthetically lethal therapies to treat cancer. The company is using its expertise in DNA damage response biology to advance a pipeline of novel drug candidates that selectively target key cancer vulnerabilities. Cyteir’s wholly owned lead compound, CYT-0851, is a potent and selective, oral investigational drug that was designed to inhibit RAD51-mediated homologous recombination and the repair of double-strand DNA breaks.

INVESTOR CONTACT:

Lisa Hayes

Vice President, Investor Relations and Corporate Communications

908-868-8926

[email protected]

MEDIA CONTACT:

Michele Parisi

925-429-1850

[email protected]

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Biotechnology Health Genetics Pharmaceutical Oncology

MEDIA:

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Chemomab to Participate in Upcoming September Investor Conferences

PR Newswire

TEL AVIV, Israel, Sept. 1, 2021 /PRNewswire/ — Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrosis-related diseases with high unmet need, today announced that the Company will participate in the following upcoming investor conferences in September:

  • Citi 16th Annual BioPharma Virtual Conference

    Format: Available for 1-on-1 meetings
    Date: September 8-10, 2021
    Registration Link
  • H.C. Wainwright 23rd Annual Global Investment Conference (virtual)
    Format: On demand presentation and available for 1-on-1 meetings
    Date: September 13-15, 2021
    Registration Link
  • Oppenheimer Fall Healthcare Life Sciences and MedTech Summit (virtual)
    Format: Live presentation webcast and available for 1-on-1 meetings
    Presentation: September 22, 8:15 am ET
    Webcast Link
  • Cantor Fitzgerald Virtual Global Healthcare Conference

    Format: Fireside chat and available for 1-on-1 meetings
    Fireside Chat: September 30, 11:20 am ET  
    Webcast Link

 

The presentations and archived webcasts will also be accessible in the News and Events section of the Chemomab website.

About Chemomab Therapeutics Ltd.

Chemomab is a clinical-stage biotech company focusing on the discovery and development of innovative therapeutics for fibrosis-related diseases with high unmet need. Based on the unique and pivotal role of the soluble protein CCL24 in promoting fibrosis and inflammation, Chemomab developed CM-101, a monoclonal antibody designed to bind and block CCL24 activity. CM-101 has potential to treat multiple severe and life-threatening inflammatory and fibrotic diseases and is currently in Phase 2 clinical development for the orphan diseases primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).

For more information on Chemomab, please visit www.chemomab.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. These forward-looking statements include, among other things, statements regarding the clinical development pathway for CM-101; the future operations of Chemomab and its ability to successfully initiate and complete clinical trials and achieve regulatory milestones; the nature, strategy and focus of Chemomab; the development and commercial potential and potential benefits of any product candidates of Chemomab; and that the product candidates have the potential to address high unmet needs of patients with serious fibrosis-related diseases and conditions. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Chemomab’s current expectations. Forward-looking statements involve risks and uncertainties. Because such statements deal with future events and are based on Chemomab’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Chemomab could differ materially from those described in or implied by the statements in this presentation, including: the uncertain and time-consuming regulatory approval process; risks related to Chemomab’s ability to correctly manage its operating expenses and its expenses; Chemomab’s plans to develop and commercialize its product candidates, focusing on  CM-101; the timing of initiation of Chemomab’s planned clinical trials; the timing of the availability of data from Chemomab’s clinical trials; the timing of any planned investigational new drug application or new drug application; Chemomab’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Chemomab’s product candidates; Chemomab’s commercialization, marketing and manufacturing capabilities and strategy; Chemomab’s ability to protect its intellectual property position; and the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all. Additional risks and uncertainties relating to Chemomab’s and its business can be found under the caption “Risk Factors” and elsewhere in Chemomab’s filings and reports with the SEC. Chemomab expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Chemomab’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Contact:

Investor Relations:

Irina Koffler

LifeSci Advisors, LLC
Phone: +1-917-734-7387
[email protected]

Chemomab Therapeutics:

Sharon Elkobi
VP, Business Development
Phone: +972773310156
[email protected]

 

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SOURCE ChemomAb Ltd.