Arvinas Reports First Quarter 2021 Financial Results and Provides Corporate Update

NEW HAVEN, Conn., May 04, 2021 (GLOBE NEWSWIRE) — Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported financial results for the first quarter ended March 31, 2021 and provided a corporate update.

“Last quarter we reinforced our leadership position in the targeted protein degradation space by sharing the discovery and chemical structures of ARV-110 and ARV-471 at the American Association for Cancer Research (AACR) Annual Meeting, the first such disclosure of our clinical-stage PROTAC degraders,” said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. “We look forward to further demonstrating the potential of our PROTAC platform to change the lives of patients with few or no therapeutic options.”

Business Highlights and Recent Developments

  • Presented preclinical data describing the discovery of Arvinas’ two clinical-stage PROTAC degraders, ARV-110 and ARV-471, including the first disclosures of their structures at AACR

Anticipated Milestones and Expectations

ARV-471

  • Completion of the Phase 1 dose escalation (1H21)
  • Presentation of completed Phase 1 dose escalation data (2H21)
  • Interim review of safety and dose finding data from the Phase 1b trial in combination with Ibrance® (palbociclib) (2H21)
  • Initiation of a window of opportunity study in early breast cancer (2H21)
  • Initiation of a combination trial of ARV-471 and another targeted therapy in 2L/3L metastatic breast cancer (2H21)

ARV-110

  • Completion of the Phase 1 dose escalation (1H21)
  • Presentation of completed Phase 1 dose escalation data (2H21)
  • Presentation of interim data from the ARDENT Phase 2 dose expansion at 420 mg (2H21)
  • Initiation of combination trial(s) with standard(s)-of-care (2021)

Other Clinical Milestones

  • Initiation of first-in-human study of ARV-766, an androgen receptor (AR) degrader with a differentiated profile from ARV-110, in patients with metastatic castration-resistant prostate cancer (1H21)

Financial Guidance

Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned operating expenses and capital expenditures into 2024.

First Quarter Financial Results

Cash, Cash Equivalents and Marketable Securities Position: As of March 31, 2021, cash, cash equivalents and marketable securities were $651.3 million as compared with $688.5 million as of December 31, 2020. The decrease primarily related to cash used to fund operations of $43.9 million, cash used to purchase fixed assets and leasehold improvements of $1.0 million and unrealized losses of $0.8 million, partially off-set by proceeds from two collaborators of $4.0 million and proceeds from the exercise of stock options of $4.5 million.

Research and Development Expenses: Research and development expenses were $34.9 million for the quarter ended March 31, 2021 as compared with $21.7 million for the quarter ended March 31, 2020. The increase in research and development expenses for the quarter of $13.2 million primarily related to Arvinas’ continued investment in its platform, exploratory and lead optimization programs of $8.3 million, its AR program of $1.5 million and estrogen receptor program (ER) of $3.4 million.

General and Administrative Expenses: General and administrative expenses were $12.3 million for the quarter ended March 31, 2021 as compared with $7.9 million for the quarter ended March 31, 2020. The increase in general and administrative expenses for the quarter of $4.4 million related to an increase of $3.6 million in personnel and facility related costs, including $1.8 million related to stock compensation expense, and insurance, taxes and professional fees of $0.8 million.

Revenues: Revenues were $5.5 million for the quarter ended March 31, 2021 as compared with $6.2 million for the quarter ended March 31, 2020 and was generated from the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017. The decrease in collaboration revenue of $0.7 million for the quarter was primarily related to a collaborator adding new targets that extended the period of revenue recognition for that collaboration agreement.   

Net Loss: Net loss was $41.0 million for the quarter ended March 31, 2021 as compared with $21.7 million for the quarter ended March 31, 2020. The increase in net loss for the quarter ended March 31, 2021 of $19.3 million primarily related to Arvinas’ continued investment in its platform, exploratory and lead optimization programs, its AR program, its ER program, and an increase in general and administrative costs.

About ARV-110

ARV-110 is an investigational orally bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

About ARV-471

ARV-471 is an investigational orally bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.

About ARV-766

ARV-766 is an investigational orally bioavailable PROTAC® protein degrader designed to selectively target and degrade AR. In preclinical studies, ARV-766 degraded all resistance-driving point mutations of AR, including L702H, a mutation associated with treatment with abiraterone and other AR-pathway therapies.

ARV-766 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer, and ARV-766 may also have applicability in other AR-driven diseases both in and outside oncology. ARV-766 has demonstrated activity in preclinical models of resistance to currently available AR-targeted therapies.

About Arvinas

Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and “undruggable” targets, the company has two clinical-stage programs: ARV-110 for the treatment of men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, including the timing of data from our clinical trials for ARV-110 and ARV-471, the potential advantages and therapeutic potential of our product candidates and the sufficiency of cash resources. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1/2 clinical trials for ARV-110 and ARV-471 or conduct a Phase 1 clinical trial for ARV-766, complete our clinical trials for our other product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline and other important factors discussed in the “Risk Factors” sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

Contacts for Arvinas

Investors

Will O’Connor, Stern Investor Relations
[email protected]

Media

Kirsten Owens, Arvinas Communications
[email protected]

Arvinas, Inc.
Consolidated Statement of Operations (Unaudited)
     
  Three Months Ended March 31,
    2021       2020  
Revenue $ 5,539,365     $ 6,239,628  
Operating expenses:              
Research and development   34,866,882       21,726,686  
General and administrative   12,318,713       7,925,005  
Total operating expenses   47,185,595       29,651,691  
Loss from operations   (41,646,230 )     (23,412,063 )
Interest and other income   681,939       1,672,892  
Net loss   (40,964,291 )     (21,739,171 )
Net loss per common share, basic and diluted   (0.84 )     (0.56 )
Weighted average common shares outstanding, basic and diluted   48,621,663       38,548,483  
     

Arvinas, Inc.
Consolidated Balance Sheet (Unaudited)
       
  March 31,
    2021       2020  
               
Assets      
Current assets:      
Cash and cash equivalents $ 346,068,406     $ 588,373,232  
Marketable securities   305,203,086       100,157,618  
Account receivable         1,000,000  
Other receivables   5,175,378       7,443,654  
Prepaid expenses and other current assets   8,209,888       6,113,122  
Total current assets   664,656,758       703,087,626  
Property, equipment and leasehold improvements, net   12,210,324       12,259,515  
Operating lease right of use assets   4,876,584       1,992,669  
Other assets   28,777       28,777  
Total assets $ 681,772,443     $ 717,368,587  
Liabilities and stockholders’ equity      
Current liabilities:      
Accounts payable $ 9,002,938     $ 7,121,879  
Accrued expenses   8,001,201       18,859,840  
Deferred revenue   22,150,861       22,150,861  
Current portion of operating lease liabilities   1,216,914       952,840  
Total current liabilities   40,371,914       49,085,420  
Deferred revenue   20,400,518       22,938,233  
Long term debt, net of current portion   2,000,000       2,000,000  
Operating lease liabilities   3,701,991       1,087,422  
Total liabilities   66,474,423       75,111,075  
Commitments and contingencies      
Stockholders’ equity:      
Common stock, $0.001 par value, 48,785,692 and 48,455,741 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively   48,786       48,455  
Accumulated deficit   (532,853,201 )     (491,888,910 )
Additional paid-in capital   1,148,345,190       1,133,537,171  
Accumulated other comprehensive income   (242,755 )     560,796  
Total stockholders’ equity   615,298,020       642,257,512  
Total liabilities and stockholders’ equity $ 681,772,443     $ 717,368,587  
       



Resgreen Group (OTCPINK: RGGI) Announces Testing of Nimble Messaging System for Wanda SD Fleets to Call Home

Clinton Township, Michigan, May 04, 2021 (GLOBE NEWSWIRE) — Resgreen Group International (OTCPINK: RGGI), a leading mobile robot company, announces testing of an enhanced service to monitor Wanda SD fleets by implementing Open Source MQTT (Message Queuing Telemetry Transport) Broker.

MQTT is an open source publish-subscribe messaging software capable of communicating large amounts of data quickly and efficiently between client devices in a low bandwidth environment. The result is elimination of ques and lag time, making communication instantaneous and a lot more efficient.

The MQTT Broker will add enhanced monitoring efforts between publishers and subscribers on the network regarding all functions of the mobile robot. The software will be essential in validation of UVC-Ozone lamp operations, which is a key component of Wanda SD.

“The MQTT implementation enables Wanda SD to provide nimble messaging reliably to customers with fragile and low bandwidth networks. The message featuring minimized data packets will reach its destination in real-time due to its size, structure, and intelligent use of the network stack.” said Parsh Patel, CEO of RGGI.

Amazon Web Services (AWS) provides heavy support of MQTT with its IoT (Internet of Things) Core. AWS IoT Core works mutually with MQTT’s software to create and facilitate a secure and reliable collection and transfer of data within a network.

MQTT’s abilities to increase security of client connections, ease of scalability between multitude of devices, and reduction in strain on network resources will enhance the efficiency and effectiveness of Wanda SD fleets.


About Resgreen Group International, Inc. (RGGI)

RGGI is a leading developer of Artificial Intelligence Robotics (AIRs), Autonomous Mobile Robots (AMRs), and Automatic Guided Vehicles (AGVs). RGGI’s highly skilled engineers have years of experience in the material handling and robotics industries, which has led to significant intellectual property for the company.

RGGI also provides consulting services including backend operational oversight, material handling assessment, work-flow analysis, and steady state yield management using artificial intelligence, technology and management systems. For more information visit http://resgreenint.com.



Sarah Carlson
[email protected]
248.755.7680

or

ResGreen Group International, Inc.
Parashar (Parsh) Patel, President and CEO
[email protected]

Tekcapital Plc (“Tekcapital”, the “Company” or the “Group”) Portfolio Company Update: Guident Ltd (“Guident”)

LONDON, UNITED KINGDOM, May 04, 2021 (GLOBE NEWSWIRE) — Tekcapital Plc (AIM: TEK), (OTCQB: TEKCF), the UK intellectual property investment group focused on creating valuable products from investing in university technologies that can improve quality of life, is pleased to announce that portfolio company Guident has demonstrated its low-latency, vehicle control software to power its Remote Monitoring and Control Center.

Guident Ltd, the developer of software for improving the safety of autonomous vehicles (AVs) and delivery robots, announces the successful demonstration of its remote-control technology. This will be used in its first remote monitoring and control center (RMCC) for AVs, to be launched later this year in Boca Raton, Florida. The RMCC will be able to monitor multiple vehicles from a remote, secure monitoring centre, akin to air traffic control.

Also known as teleoperations, the remote-control robotics software leverages a secure, low-latency connection. The RMCC’s goal is to rapidly track the location, monitor the surroundings and when necessary, take over control of AVs in the event of an accident or mishap. Guident believes this center will provide last mile delivery fleet operators with an additional level of safety, whilst complying with Florida law, which requires a remote monitoring and control centre for AV’s that do not have drivers or safety operators within the vehicles.

The company has unveiled its new capabilities via a video demonstration. Guident’s RMCC is covered by six U.S. patents several with foreign counterparts and proprietary software designed to enhance the safety of autonomous deliveries.

The Market

According to Triton Market Researchthe last mile AV delivery market autonomous vehicle market is expected to reach $41.7 billion by 2028 with a CAGR of 19%. Contactless or “touch-free” delivery is in high-demand since the COVID-19 pandemic and Guident believes this increased demand will accelerate the roll-out of land-based delivery drones for food and medicines to improve their availability and reduce the costs of these deliveries.

“We are incredibly pleased to announce the successful introduction of our secure software platform designed to power our RMCC. This system is device-agnostic, works with any 5G public mobile or private LTE network and has reduced signal latency when compared with traditional telemetric video monitoring and control systems,” says Harald Braun, Chairman & CEO of Guident Ltd.

“Its exciting to see the significant and rapid progress of
Guident,” said Dr Clifford M. Gross, Executive Chairman of Tekcapital.

About Guident

Guident commercializes new technology to enhance the safety, efficiency and utility of autonomous vehicles and ground-based drones using its proprietary IP & software apps for remote monitoring and control. To learn more please visit www.guident.co

About Tekcapital plc

Tekcapital creates value from investing in new, university-developed intellectual properties and provides a range of IP investment services to make it easy for organisations to commercialise university-developed technology. Tekcapital is quoted on the AIM market of the London Stock Exchange (AIM: symbol TEK) and is headquartered in Oxford, in the UK. For more information, please visit www.tekcapital.com

LEI: 213800GOJTOV19FIFZ85

Tekcapital owns 100% of the share capital of Guident Ltd.

Guident Ltd’s RMCC in Boca Raton, FL

Forward Looking Statements
This press release is for informational purposes only. The information herein does not constitute investment advice nor an offer to invest and may contain statements related to our future business and financial performance and future events or developments involving Guident or Tekcapital that may constitute forward-looking statements. These statements may be identified by words such as “expect,” “look forward to,” “anticipate” “intend,” “plan,” “believe,” “seek,” “estimate,” “will,” “project” or words of similar meaning. We may also make forward-looking statements in other reports, in presentations, in material delivered to customers, stakeholders and in press releases. In addition, our representatives may from time to time make oral forward-looking statements. Such statements may be based on the current expectations and certain assumptions of Guident’ and/or Tekcapital’s management. Please note that these are subject to a number of risks, uncertainties and factors, including, but not limited to those described in various disclosures. Should one or more of these risks or uncertainties materialise, or should underlying expectations not occur or assumptions prove incorrect, actual results, performance or achievements of Guident or Tekcapital may vary materially from those described explicitly or implicitly in the relevant forward-looking statement. Neither Guident nor Tekcapital intends, nor assumes any obligation, to update or revise these forward-looking statements in light of developments which differ from those anticipated.

Guident Ltd’s RMCC in Boca Raton, FL

Thank you!Create reply with Thank you!That works for me.Create reply with That works for me.Perfect, thank you!Create reply with Perfect, thank you!

Are the suggestions above helpful?



Tekcapital Plc Via Flagstaff IR
Clifford M. Gross, Ph.D.

SP Angel Corporate Finance LLP
(Nominated Adviser and Joint Broker)
+44 (0) 20 3470 0470
Richard Morrison / Charlie Bouverat (Corporate Finance)
Abigail Wayne (Corporate Broking)

Flagstaff Strategic and Investor Communications 
+44 (0)207 129 1474
Tim Thompson/Andrea Seymour/Fergus Mellon

Skyline Corporate Communications Group, LLC (U.S.)
+1 646 893 5835
Lisa Gray/Scott Powell 

Beasley Broadcast Group Reports First Quarter Net Revenue of $48.2 Million

  Conference Call and Webcast

Today, May 4, 2021 at 11:00 a.m. ET

334-323-0501, conference ID 7158599 orwww.bbgi.com 
 
     
  Replay information provided below  

NAPLES, Fla., May 04, 2021 (GLOBE NEWSWIRE) — Beasley Broadcast Group, Inc. (Nasdaq: BBGI) (“Beasley” or the “Company”), a multi-platform media company, today announced operating results for the three-month period ended March 31, 2021.

Summary of First Quarter Results

In millions, except per share data Three Months Ended

March 31,
    2021   2020
Net revenue $48.2   $57.7  
Operating loss $(2.5)   $(7.1 )
Net loss attributable to BBGI stockholders 1 $(10.6)   $(8.8 )
Net loss per diluted share 1 $(0.36)   $(0.32 )
Station operating income (SOI – non-GAAP) $5.2   $6.7  
  1. Operating loss, net loss attributable to BBGI stockholders and net loss per diluted share reflect $1.1 million in other operating expenses in the three months ended March 31, 2021. Net loss attributable to BBGI stockholders and net loss per diluted share reflect a $5.0 million loss on extinguishment of long-term debt in the three months ended March 31, 2021. Operating loss, net loss attributable to BBGI stockholders and net loss per diluted share reflect $6.8 million of non-cash impairment losses in the three months ended March 31, 2020.

Net revenue during the three months ended March 31, 2021 reflects a year-over-year decrease in commercial advertising revenue and a lack of non-traditional revenue (“NTR”) and event revenue primarily related to the impact of the COVID-19 pandemic, in addition to lower cyclical political advertising revenue, partially offset by a year-over-year increase in digital revenue.

Beasley reported an operating loss of $2.5 million in the first quarter of 2021 compared to an operating loss of $7.1 million in the first quarter of 2020, which included a $6.8 million non-cash impairment charge in the first quarter of 2020 resulting from the impact of the COVID-19 pandemic. In addition, the first quarter of 2021 had lower corporate and operating expenses, partially offset by higher depreciation and amortization expense, and $1.1 million in other operating expenses.

Beasley reported a net loss attributable to BBGI stockholders of $10.6 million, or $0.36 per diluted share, in the three months ended March 31, 2021, compared to a net loss attributable to BBGI stockholders of $8.8 million, or $0.32 per diluted share, in the three months ended March 31, 2020. The year-over-year increase is primarily due to lower revenue, higher interest expense and the loss on extinguishment of long-term debt resulting from the issuance of secured notes on February 2, 2021 and the use of proceeds to repay existing debt.

SOI decreased $1.5 million in the first quarter of 2021 compared to the first quarter of 2020. The year-over-year decrease is primarily attributable to lower commercial advertising revenue and the lack of NTR and event revenue in the first quarter of 2021 related to the impact of the COVID-19 pandemic, as well as the year-over-year decline in political revenue.

Please refer to the “Calculation of SOI” and “Reconciliation of Net Loss to SOI” tables at the end of this announcement for a discussion regarding SOI calculations.

Commenting on the financial results, Caroline Beasley, Chief Executive Officer, said, “Beasley reported 2021 first quarter financial results consistent with the expectations we outlined when we reported the 2020 fourth quarter, as our strong revenue growth in the first two months of the comparable 2020 period, prior to the onset of the pandemic, created a difficult year-over-year comparison. Though we continued to experience challenges related to the COVID-19 pandemic during the first quarter, I am pleased to report that we began to see a strong recovery. As a result, we expect Beasley to return to top-line revenue growth beginning in the second quarter of 2021.

“During the first quarter, we continued to advance our digital transformation and revenue diversification initiatives across the Company. In this regard, Beasley generated digital revenue growth of approximately 10% on a year-over-year basis, with digital accounting for approximately 12% of total first quarter revenue, compared to 9.3% of total revenue in the prior year period. Consumer demand for digital audio content remains strong and with our ongoing emphasis on digital innovation, Beasley continues attracting new business by successfully targeting the sale of non-radio products to non-radio advertisers. With the continued strong growth of our digital business, Beasley will report digital revenue as a separate segment going forward. We believe this milestone represents an important inflection point in the ongoing evolution of our operating model and clearly highlights the value of our revenue diversification strategies.

“The actions we have taken over the last year to realign our cost structure and improve efficiencies across the organization drove a year-over-year reduction in first quarter operating and corporate expenses of 15.6% and 13.5%, respectively. We believe our ability to extract meaningful expense savings out of the business provided us with the ability to make strategic investments in our commercial sales infrastructure, which will enable us to maintain our market competitiveness so we are best positioned to deliver on our revenue goals as we move deeper into the recovery phase of the pandemic.

“In addition to our expense reduction and revenue diversification initiatives, Beasley also remained committed to enhancing financial flexibility through capital structure improvements. In the first quarter, we completed our offering of $300.0 million in aggregate principal amount of 8.625% senior secured notes due 2026. The net proceeds of the offering were used to repay in full existing indebtedness under the Company’s senior secured credit facilities and other debt, with the remaining proceeds added to our balance sheet for general corporate purposes. In addition, and due to future economic uncertainty, in early February we applied for and were subsequently approved for a $10 million Paycheck Protection Program loan. Together, these transactions improve our liquidity profile, while providing growth capital to support the continued investment in our business.

“In summary, we believe our first quarter financial performance demonstrates that our digital transformation continues to gain momentum and our recent capital structure initiatives have positioned us to further leverage the highest growth areas of our business and capitalize on the many synergies between our broadcast, digital and e-sports divisions, which we believe will drive increased and more diversified cash flows in future periods. Looking ahead, our strategic priorities remain focused on delivering exceptional content and services to our listeners, advertisers, online users and esports fans, while diversifying our revenue, growing our cash flow and maintaining a solid and flexible balance sheet with liquidity at current or higher levels. We believe that this approach, positions Beasley well for near- and long-term success and the enhancement of stockholder value.”

Conference Call and Webcast Information
The Company will host a conference call and webcast today, May 4, 2021, at 11:00 a.m. ET to discuss its financial results and operations. To access the conference call, interested parties may dial 334-323-0501, conference ID 7158599 (domestic and international callers). Participants can also listen to a live webcast of the call at the Company’s website at www.bbgi.com. Please allow 15 minutes to register and download and install any necessary software. Following its completion, a replay of the webcast can be accessed for five days on the Company’s website, www.bbgi.com.

Questions from analysts, institutional investors and debt holders may be e-mailed to [email protected] at any time up until 9:00 a.m. ET on Tuesday, May 4, 2021. Management will answer as many questions as possible during the conference call and webcast (provided the questions are not addressed in their prepared remarks).

About Beasley Broadcast Group

Celebrating its 60th anniversary this year, the Company was founded in 1961 by George G. Beasley, who remains the Company’s Chairman of the Board. The Company owns and operates 62 stations (47 FM and 15 AM) in 15 large- and mid-size markets in the United States. Approximately 20 million consumers listen to the Company’s radio stations weekly over-the-air, online and on smartphones and tablets, and millions regularly engage with the Company’s brands and personalities through digital platforms such as Facebook, Twitter, text, apps and email. The Company recently acquired a majority interest in the Overwatch League’s Houston Outlaws esports team and owns BeasleyXP, a national esports content hub. For more information, please visit www.bbgi.com

Definitions

Station Operating Income (SOI) consists of net revenue less station operating expenses. We define station operating expenses as cost of services and selling, general and administrative expenses.

Free Cash Flow (FCF) consists of SOI less corporate expenses, interest expense, current income tax expense and capital expenditures plus stock-based compensation expense, net proceeds from dispositions, amortization of debt issuance costs and interest income.

SOI and FCF are measures widely used in the radio broadcast industry. The Company recognizes that because SOI and FCF are not calculated in accordance with GAAP, they are not necessarily comparable to similarly titled measures employed by other companies. However, management believes that SOI and FCF provide meaningful information to investors because they are important measures of how effectively we operate our business (i.e., operate radio stations) and assist investors in comparing our operating performance with that of other radio companies.

Note Regarding Forward-Looking Statements

Statements in this release that are “forward-looking statements” are based upon current expectations and assumptions, and involve certain risks and uncertainties within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Words or expressions such as “intends,” “believes,” “expects,” “seek,” “we remain optimistic that” or variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Key risks are described in the Company’s reports filed with the Securities and Exchange Commission (“SEC”) including its annual report on Form 10-K and quarterly reports on Form 10-Q. Readers should note that forward-looking statements are subject to change and to inherent risks and uncertainties and may be impacted by several factors, including:

  • the effects of the COVID-19 pandemic, including its potential effects on the economic environment and our results of operations, liquidity and financial condition, and the increased risk of impairments of our Federal Communications Commission (“FCC”) licenses and/or goodwill, as well as any changes to federal, state or local government laws, regulations or orders in connection with the pandemic;
  • external economic forces that could have a material adverse impact on our advertising revenues and results of operations;
  • the ability of our radio stations to compete effectively in their respective markets for advertising revenues;
  • our ability to develop compelling and differentiated digital content, products and services;
  • audience acceptance of our content, particularly our radio programs;
  • our ability to respond to changes in technology, standards and services that affect the radio industry;
  • our dependence on federally issued licenses subject to extensive federal regulation;
  • actions by the FCC or new legislation affecting the radio industry;
  • our dependence on selected market clusters of radio stations for a material portion of our net revenue;
  • credit risk on our accounts receivable;
  • the risk that our FCC licenses and/or goodwill could become impaired;
  • our substantial debt levels and the potential effect of restrictive debt covenants on our operational flexibility and ability to pay dividends;
  • the potential effects of hurricanes on our corporate offices and radio stations;
  • the failure or destruction of the internet, satellite systems and transmitter facilities that we depend upon to distribute our programming;
  • disruptions or security breaches of our information technology infrastructure;
  • the loss of key personnel;
  • our ability to integrate acquired businesses and achieve fully the strategic and financial objectives related thereto and their impact on our financial condition and results of operations;
  • the fact that we are controlled by the Beasley family, which creates difficulties for any attempt to gain control of the Company; and
  • other economic, business, competitive, and regulatory factors affecting the businesses of the Company, including those set forth in the Company’s filings with the SEC.

Our actual performance and results could differ materially because of these factors and other factors discussed in our SEC filings, including but not limited to our annual reports on Form 10-K or quarterly reports on Form 10-Q, copies of which can be obtained from the SEC, www.sec.gov, or our website, www.bbgi.com. All information in this release is as of May 4, 2021, and we undertake no obligation to update the information contained herein to actual results or changes to our expectations.

-tables follow-

 
BEASLEY BROADCAST GROUP, INC.

Consolidated Statements of Operations (Unaudited)
   
  Three months ended
  March 31,
    2021     2020  
Net revenue $ 48,212,040   $ 57,650,426  
Operating expenses:            
Operating expenses (including stock-based compensation and excluding            
depreciation and amortization shown separately below)   42,967,871     50,900,477  
Corporate expenses (including stock-based compensation)   3,905,289     4,513,092  
Other operating expenses   1,100,000      
Depreciation and amortization   2,951,901     2,576,475  
Impairment losses       6,804,412  
Gain on dispositions   (191,988 )    
Total operating expenses   50,733,073     64,794,456  
Operating loss   (2,521,033 )   (7,144,030 )
Non-operating income (expense):            
Interest expense   (5,778,071 )   (4,184,811 )
Loss on extinguishment of long term debt   (4,996,731 )    
Other income (expense), net   38,413     26,425  
Loss before income taxes   (13,257,422 )   (11,302,416 )
Income tax benefit   (2,602,886 )   (2,417,780 )
Loss before equity in earnings of unconsolidated affiliates   (10,654,536 )   (8,884,636 )
Equity in earnings of unconsolidated affiliates, net of tax   (30,105 )   (61,527 )
Net loss   (10,684,641 )   (8,946,163 )
Earnings attributable to noncontrolling interest   129,249     109,602  
Net loss attributable to BBGI stockholders $ (10,555,392 ) $ (8,836,561 )
     
Basic and diluted net loss per share $ (0.36 ) $ (0.32 )
Basic common shares outstanding   29,302,799     27,947,577  
Diluted common shares outstanding   29,302,799     27,947,577  

Selected Balance Sheet Data – Unaudited

(in thousands)
     
  March 31,


  December 31,


  2021   2020
Cash and cash equivalents $ 56,211   $ 20,759
Working capital   64,216     37,065
Total assets   762,099     738,614
Long term debt, net of unamortized debt issuance costs   302,649     258,345
Stockholders’ equity $ 252,740   $ 267,727

Selected Statement of Cash Flows Data – Unaudited
 
  Three months ended
  March 31,
    2021     2020  
Net cash provided by operating activities $ 2,354,007   $ 1,953,723  
Net cash used in investing activities   (666,768 )   (4,193,430 )
Net cash provided by financing activities   33,763,934     2,070,737  
Net increase (decrease) in cash and cash equivalents $ 35,451,173   $ (168,970 )

Calculation of SOI – Unaudited
     
  Three months ended
  March 31,
    2021     2020  
Net revenue $ 48,212,040   $ 57,650,426  
Operating expenses   (42,967,871 )   (50,900,477 )
SOI $ 5,244,169   $ 6,749,949  

Reconciliation of Net Loss Attributable to BBGI Stockholders to SOI
             
    2021     2020  
Net loss attributable to BBGI stockholders   (10,555,392 ) $ (8,836,561 )
Corporate expenses   3,905,289     4,513,092  
Other operating expenses   1,100,000      
Depreciation and amortization   2,951,901     2,576,475  
Impairment losses       6,804,412  
Gain on dispositions   (191,988 )    
Interest expense   5,778,071     4,184,811  
Loss on extinguishment of long-term debt   4,996,731      
Other income (expense), net   (38,413 )   (26,425 )
Income tax benefit   (2,602,886 )   (2,417,780 )
Equity in earnings of unconsolidated affiliates, net of tax   30,105     61,527  
Earnings attributable to noncontrolling interest   (129,249 )   (109,602 )
   SOI $ 5,244,169   $ 6,749,949  

Reconciliation of Net Revenue to FCF
   
  Three months ended
  March 31,
    2021     2020  
Net revenue $ 48,212,040   $ 57,650,426  
Operating expenses   (42,967,871 )   (50,900,477 )
Corporate expenses   (3,905,289 )   (4,513,092 )
Net proceeds from dispositions   362,500      
Stock-based compensation expense   520,801     266,439  
Interest expense   (5,778,071 )   (4,184,811 )
Amortization of debt issuance costs   411,363     483,983  
Interest income   2,589     15,947  
Current income tax expense        
Capital expenditures   (1,029,268 )   (3,443,430 )
FCF $ (4,171,206 ) $ (4,625,015 )

CONTACT:  
B. Caroline Beasley                                                
Chief Executive Officer                                             
Beasley Broadcast Group, Inc.  
239/263-5000 or [email protected]    
Joseph Jaffoni, Jennifer Neuman
JCIR
212/835-8500 or [email protected] 



Silence Therapeutics Launches New Video Game to Support International Thalassemia Day and Raise Disease Awareness

Silence Therapeutics Launches New Video Game to Support International Thalassemia Day and Raise Disease Awareness


  • Play the free online game and share your score on social #BloodRunBeta

  • Silence partners with Thalassaemia International Federation (TIF) to support May 8th awareness day activities – join the conversation on social media #ITD2021

4 May 2021

LONDON, Silence Therapeutics plc, AIM:SLN and Nasdaq: SLN (“Silence” or “the Company”), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, today announced the launch of a new, retro-inspired, online game to raise awareness of the rare blood disorder, thalassemia, ahead of International Thalassemia Day on Saturday May 8th 2021.

‘Blood Run Beta’ (www.bloodrunbeta.game) is a free game now available for people of all ages to play and learn more about the daily impact of thalassemia and one of its most common symptoms – fatigue. The aim of the game is to get as far as possible without the energy meter reaching zero, avoiding everyday obstacles that consume energy and ‘powering up’ by finding blood drops. The latter represent blood transfusions – one of the main treatment options for people with more severe forms of the disease. Everyone is encouraged to post their scores on social media using the hashtag #BloodRunBeta. By sharing the game on social media, Silence aims to draw public attention to this underrecognized community with high unmet need.

In addition, Silence is proud to be sponsoring the Thalassaemia International Federation (TIF)’s International Thalassemia Day (ITD) activities. ITD is a global event which takes place on May 8th each year, organized by TIF. It marks an opportunity for patient advocacy groups, charities, healthcare professionals, pharma/biotech companies and individuals around the world to unite in raising awareness of the condition through a variety of activities. The theme for this year is “Addressing Health Inequalities Across the Global Thalassemia Community” and the public can join in and show their support largely through social media, using the hashtag #ITD2021.

Giles Campion, MD, EVP, Head of R&D and Chief Medical Officer of Silence Therapeutics said:Thalassemia is a central focus of our research and while great strides have been made in recent years to raise awareness of the condition, there is still more that can be done. The burden of the disease and current treatment options that can be highly disruptive to daily life for patients and their families are often underrecognized. We are proud to partner with the thalassemia community and support better understanding of this often overlooked condition.”

Dr Androulla Eleftheriou (TIF Executive Director) of Thalassaemia International Federation said:
“International Thalassemia Day allows us to commemorate those who are no longer with us and to strengthen the efforts as well as commend those fighting for the right to a better quality of life and equal care across the globe. Increasing public awareness of the condition in new and creative ways is important as we expand our advocacy reach and put thalassemia on the health policy agenda of countries around the world. We are grateful to have partners like Silence who help us further our mission to support affected families on a global scale.”

Enquiries:

Silence Therapeutics plc

Gem Hopkins, Head of IR and Corporate Communications
[email protected]
Tel:  +1 (646) 637-3208
European PR

Consilium Strategic Communications

Mary-Jane Elliott/ Angela Gray / Chris Welsh
[email protected]

 

Tel: +44 (0) 20 3709 5700

About Thalassemia

Thalassemia is an inherited condition which prevents a person’s bone marrow from producing enough healthy red blood cells. Red blood cells carry oxygen from the lungs to all of the cells in the body to help them work normally. There are a number of different types of thalassemia, such as beta-thalassemia. The types vary from a very mild form to a severe disease that can be life-threatening if untreated. Current treatments can usually keep the symptoms under control do not treat the underlying cause of thalassemia or prevent it from progressing. Treatment to manage symptoms often requires regular hospital appointments that can disrupt normal life. More information about Thalassemia including quotes from patients about what it is like to live with the condition can be found here.

About Silence Therapeutics

Silence Therapeutics is developing a new generation of medicines by harnessing the body’s natural mechanism of RNA interference, or RNAi, to inhibit the expression of specific target genes thought to play a role in the pathology of diseases with significant unmet medical need. Silence’s proprietary mRNAi GOLD™ platform can be used to create siRNAs that precisely target and silence disease-associated genes in the liver, which represents a substantial opportunity. Silence’s wholly owned product candidates include SLN360 designed to address the high and prevalent unmet medical need in reducing cardiovascular risk in people born with high levels of lipoprotein(a) and SLN124 designed to address iron loading anemias. Silence also maintains ongoing research and development collaborations with AstraZeneca, Mallinckrodt Pharmaceuticals, and Takeda, among others. For more information, please visit https://www.silence-therapeutics.com/.

About TIF

The Thalassaemia International Federation (TIF) is a non-profit, non-governmental organization founded in 1986 by a small group of patients and parents. Its vision is to ensure equal access to quality health care for every patient with thalassemia and other hemoglobin disorders across the world, with a mission is to promote and implement national control programs for the prevention and treatment of thalassemia and other hemoglobin disorders in every affected country. TIF has a wealth of resources and provides links to local organizations around the world, to help patients or family members find support in their own country.  

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements, including with respect to the Company’s clinical development timeline and commercial prospects. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions.  Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements, including the potential impact of COVID-19 on the Company’s clinical development and regulatory timelines and plans. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.



VBL Therapeutics to Report First Quarter Financial Results on May 11

TEL AVIV, Israel, May 04, 2021 (GLOBE NEWSWIRE) — VBL Therapeutics (Nasdaq: VBLT) will release its first quarter financial results for the period ended March 31, 2021 on Tuesday, May 11, 2021 before market open. Professor Dror Harats, M.D, Chief Executive Officer and Amos Ron, Chief Financial Officer, will host a conference call at 8:30am EDT the same day to discuss the results and provide a corporate update.

Conference Call:

Tuesday, May 11, 2021 at 8:30am EDT

Conference ID: 13719410
US: 1 877 407 9208
Israel Local: 1 809 406 247
International: 1 201 493 6784
Webcast: https://edge.media-server.com/mmc/p/w794ban7

About VBL

Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for areas of unmet need in cancer and immune/inflammatory indications. VBL has developed three platform technologies: a gene-therapy based technology for targeting newly formed blood vessels with focus on cancer, an antibody-based technology targeting MOSPD2 for anti-inflammatory and immuno-oncology applications, and the Lecinoxoids, a family of small-molecules for immune-related indications. VBL’s lead oncology product candidate, ofranergene obadenovec (VB-111), is an investigational, first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is currently being studied in a VBL-sponsored Phase 3 registration enabling trial for platinum-resistant ovarian cancer.

CONTACT:

Burns McClellan for VBL Therapeutics

Lee Roth (investors) / Ryo Imai (media)
[email protected] / [email protected]
+1-212-213-0006



ProQR Therapeutics and Yarrow Biotechnology, an RTW Investments, LP Incubated Company, Announce Exclusive Worldwide License and Discovery Collaboration for Undisclosed Target

  • Yarrow
    Biotech
    nology, Inc.
    , a newly formed biotech
    nology
    company backed by RTW
    Investments, LP
    ,
    will
    lead development
    of
    the
    program
  • ProQR
    Therapeutics
    is eligible to receive
    upfront and milestone
    payments of up to $115 million
    plus
    royalties on future sales
    by
    Yarrow for an exclusive worldwide license and discovery collaboration on a non-ophthalmology target

NEW YORK, New York, LEIDEN, Netherlands & CAMBRIDGE, Mass., May 04, 2021 (GLOBE NEWSWIRE) —  RTW Investments, LP (“RTW”), a global, full life-cycle investment firm that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors, and ProQR Therapeutics N.V. (Nasdaq: PRQR) (ProQR), a company dedicated to changing lives through the creation of transformative RNA therapies for genetic eye diseases, today announced that Yarrow Biotechnology, Inc. (“Yarrow”) , a company newly created by RTW, has in-licensed exclusive rights to ProQR’s antisense oligonucleotide technology (ASO) to develop and commercialize potential therapies for an undisclosed non-ophthalmic target. Yarrow is focused on developing ASO-based therapeutics for disorders with high unmet need.

Roderick Wong, MD, Managing Partner and Chief Investment Officer of RTW, said: “We believe RNA-based therapies hold great promise to treat genetically-defined diseases. We are excited to partner with ProQR to in-license the first target to be developed in Yarrow’s pipeline.”

Under the terms of the agreement, ProQR is eligible to receive up to $115 million of upfront and milestone payments, plus single digit percentage royalties on the net sales of any resulting products during the royalty term. ProQR will also have the right to receive an undisclosed percentage of equity in the form of shares of common stock of Yarrow. ProQR will be responsible for certain preclinical activities with reimbursement for the research costs by Yarrow, while Yarrow will be responsible for continuing development of the program and commercialization activities.

Gerard Platenburg, Chief Innovation Officer at ProQR, will join Yarrow’s board of directors.

Peter Fong, PhD, Head of Company Creation at RTW, said: “Our partnership with ProQR fits perfectly into Yarrow’s mission to develop first-in-class ASO-based therapies for genetically-defined diseases. We look forward to a long and productive partnership.”

Daniel A. De Boer, Founder and CEO of ProQR, said: “As we focus ProQR on our core genetic eye disease strategy, we are pleased to partner with Yarrow to advance our technology in applications outside the eye, while generating value from this partnership and the broad applicability of our platform.”

About
RTW
Investments, LP

RTW Investments, LP (“RTW”) is a New York-based, global, full life-cycle investment firm that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to support emerging medical therapies and the companies and academics developing them.

About
Yarrow
Biotechnology, Inc.

Yarrow Biotechnology, Inc. (“Yarrow”) is a newly formed biotechnology company developing antisense oligonucleotide-based therapeutics for disorders with high unmet need. Yarrow has established a proprietary target discovery engine leveraging large-scale human genetics studies to uncover novel targets where there is a significant unmet need.

Yarrow is the latest new company created and backed by RTW Investments, LP.

About ProQR

ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA therapies for the treatment of severe genetic rare diseases such as Leber congenital amaurosis 10, Usher syndrome and retinitis pigmentosa. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind. Learn more about ProQR at www.proqr.com.

Forward Looking Statements f
or ProQR

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Such forward-looking statements include, but are not limited to, statements regarding the collaboration with RTW and Yarrow and the intended benefits thereof, including milestone and royalty payments from commercial product sales, if any, from the products covered by the collaboration and the issuance of equity in Yarrow to ProQR, as well as the potential of our technologies and product candidates. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors in our filings made with the Securities and Exchange Commission, including certain sections of our annual report filed on Form 20-F. These risks and uncertainties include, among others, the cost, timing and results of preclinical studies and clinical trials and other development activities by us and our collaborative partners whose operations and activities may be slowed or halted by the COVID-19 pandemic; the likelihood of our clinical programs being executed on timelines provided and reliance on our contract research organizations and predictability of timely enrollment of subjects and patients to advance our clinical trials and maintain their own operations; our reliance on contract manufacturers to supply materials for research and development and the risk of supply interruption from a contract manufacturer; the potential for future data to alter initial and preliminary results of early-stage clinical trials; the unpredictability of the duration and results of the regulatory review of applications or clearances that are necessary to initiate and continue to advance and progress our clinical programs; the ability to secure, maintain and realize the intended benefits of collaborations with partners; the possible impairment of, inability to obtain, and costs to obtain intellectual property rights; possible safety or efficacy concerns that could emerge as new data are generated in research and development; and general business, operational, financial and accounting risks, and risks related to litigation and disputes with third parties. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

For
ProQR Therapeutics N.V.

Investor Contact:

Sarah Kiely
ProQR Therapeutics N.V.
T: +1 617 599 6228
[email protected]
or
Hans Vitzthum
LifeSci Advisors
T: +1 617 430 7578
[email protected]

Media Contact:

Cherilyn Cecchini, MD
LifeSci Communications
T: +1 646 876 5196
[email protected]

 



Sentient Energy® Adds 4X the Monitoring Capacity With New UM3+ Distribution Line Sensor for Underground Circuits, Now Able to Monitor up to Twelve Primary Power Cables

New multi-position UM3+ enables utilities with large underground grids to increase monitoring for greater visibility and control, while maximizing savings and efficiencies

FRISCO, Texas, May 04, 2021 (GLOBE NEWSWIRE) — Sentient Energy Inc., a Koch Engineered Solutions company and the leading provider of advanced grid monitoring and analytics for electric utilities, today announced the expansion of its UM3+ underground line sensor platform to support monitoring for up to four positions and twelve phases in a switchgear by simply adding an incremental plug-and-play component. This new modular design means utilities can monitor three, six, nine or twelve primary power cables with a single communications and processing unit, dramatically increasing efficiencies and savings while extending visibility and control to more lines at the grid edge.

Utilities often use a branching strategy for multiple primary cables within their underground cable system. Collecting performance data for monitoring and analyzing any faults or irregularities in these lines is essential for improving segmentation and reducing outage duration times. In these branched circuit scenarios, Sentient Energy’s multi-position UM3+ can monitor more than three and up to twelve phases to provide remote indication of which branch saw the fault, enabling faster repair and restoration.

The new multi-position UM3+ sensor installs inside a switchgear and collects data, which is then sent to the Sentient Energy platform where advanced grid analytics are performed to detect anomalies. In parallel, the data can also be sent to SCADA/DMS/OMS at the utilities’ control center. Utilizing one high-capacity sensor in each padmounted transformer, operators reduce the space required for sensors inside the transformer box. And remote indication of faults means operators can rest assured they will be restored faster, and the frequency and duration of outages will be minimized.

“Large utilities that have multiple branches in their distribution network need greater visibility and control of each line at the grid edge,” said Monika Murugesan, VP of Product Management at Sentient Energy. “With the new multi-position UM3+, operators can confidently monitor more lines from a single integrated sensor that detects, captures, analyzes, and alerts them about faults and non-fault disturbances. This increased capacity saves time, expense and adds efficiency to managing large networks of underground lines.”

Sentient Energy’s multi-position UM3+ is capable of cellular communication via most major cellular carriers. The solution also supports RF mesh network, or hybrid communications extending the reach of distribution line monitoring to include remote or rural areas.

About Sentient Energy

Sentient Energy, a Koch Engineered Solutions company, is the premier provider of intelligent sensing, data analytics, optimization, and control technologies for the distribution grid. Sentient Energy’s hardware and software solutions help electric utilities make data-driven decisions to enhance the delivery of reliable, safe, and efficient power. With the industry’s only Grid Analytics System that covers the entire distribution network, Sentient Energy leads the global market with the largest network of line sensor deployments in North America, gathering rich data in real time for predictive insights and strategic grid management. Sentient Energy’s Grid Edge ControlTM solutions enable utilities to reduce energy costs at the grid edge through Volt-VAR optimization, conservation voltage reduction, and peak demand reduction. Sentient Energy partners with leading communications network providers. For more information, visit www.sentient-energy.com.

Sentient Energy Media Contact:         
Andrea Cousens
[email protected]
310-270-8903 



Oncotelic Joins Chopra Foundation and Heart Foundation of India to Provide Relief for India’s Explosive 2nd Wave of Covid.

AGOURA HILLS, California, May 04, 2021 (GLOBE NEWSWIRE) — Oncotelic Therapeutics, Inc. (OTCQB:OTLC) (“Oncotelic”), a leading developer of TGF-β therapeutics for oncology and infectious disease and respiratory health will be working with Chopra Foundation and Heart Care Foundation to provide COVID-19 relief for India, including medicines and oxygen concentrators.

Medicines will include PulmoHeal, created by Oncotelic and our Indian partner – Windlas Biotech Pvt. Ltd. PulmoHeal is already available over-the-counter (OTC) in India on e-commerce platforms and pharmacies. PulmoHeal has been shown to improve long term respiratory recovery from COVID-19 and possibly from overuse of supplement oxygen- an area of unmet medical needs.

The deployment of PulmoHeal on a large scale will also enable the use of its Post Marketing Survey platform (PMS), which includes the cough artificial intelligence (AI) platform. Put together, PulmoHeal will enable the collection of data on the progression of patients’ response to COVID with its use, as well as other COVID medications. India is caught in a ferocious second wave of the coronavirus pandemic, with the Indian authorities reporting in excess of 400,000 new COVID-19 cases per day. Every one of these patients are participating in an uncontrolled clinical experimentation since there is no proven treatment protocol for COVID-19, except for dexamethasone. It is our objective to leverage our crowd source PMS platform to gather performance data across the multitude of experimental therapeutics being deployed on the Indian community such as Ivermectin, Vitamins, and Ayurvedic drugs. The goal is to arrive at definitive answer as to what is working and what is not working.

“Heart Care Foundation of India has been involved in providing free oxygen concentrators to those patients whose oxygen levels are dropping and who are not able to find a bed or resource in hospitals. This humanitarian deployment of PulmoHeal, together with oxygen, should be synergistic in both the immediate and long-term recovery of COVID-19 patients in India.” Said Saran Saund, Chief Business Officer, Oncotelic.

About the Chopra Foundation

The Chopra Foundation is a 501 (c) (3) organization dedicated to improving health and well-being, cultivating spiritual knowledge, expanding consciousness, and promoting world peace to all members of the human family. The mission of the Chopra Foundation is to advance the cause of mind/body spiritual healing, education, and research through fundraising for selected projects. https://www.choprafoundation.org/

Chopra Foundation is using the Go Fund Me platform to raise donations which will be deployed to the non-profit Heart Care Foundation of India (HCFI) to donate supplies like oxygen tanks and concentrators as well as medicine therapies to citizens in need. For more information, please go to: https://gofund.me/7706fe54

About Heart Care Foundation:

The Heart Care Foundation of India has been actively involved in literary activities as well as patient care since its inception and our efforts particularly gained pace during the Covid 19 pandemic as the need to educate and help more and more people was felt more than ever.

Dr KK Aggarwal, President Heart Care Foundation of India, undertook a mission to educate more than 1% of the population on digital platforms. More than 30 million viewers have been sensitized on COVID in 2021 alone through various social media channels. The Heart Care Foundation is running a 12hr free OPD on Zoom, with the meeting ID – 84290921517. We have a team of covid educators and doctors offering free consultation to almost 1000 patients daily for free. Over 1000 school principals and teachers have been trained as COVID guides. The Heart Care Foundation also trained 1000 health educators in 2020.

Regular update sessions are conducted on zoom to address the problems faced by patients daily as well by different experts. Heart Care Foundation of India has been involved in providing free oxygen concentrators to those patients whose oxygen levels are dropping and who are not able to find a bed or resource in hospitals. These oxygen concentrators are provided along with the treatment protocol which can be followed under the home management guidelines. The Heart Care Foundation is proud to announce this initiative saves- countless lives last year. This new wave of Covid 19 has been more deadly and dangerous and Heart Care Foundation of India has been on its toes to increase their resources to help the society at large

About
ARTIVeda



/
PulmoHeal


The product, ARTIVeda / PulmoHeal is a formulated plant extract of the indigenous plant Artemisia, known in Sanskrit texts as Damanaka. ARTIVeda / PulmoHeal is the first Ayurvedic drug against COVID-19 through TGF-β inhibition. ARTIVeda / PulmoHeal is expected to be effective through the entire infection cycle. The active component of ARTIVeda / PulmoHeal™ has been identified as artemisinin. Through proprietary GMP quality extraction and manufacturing processes, the Artemisia extract was rendered active against COVID-19 with robust Safety Index (SI) greater than 100 (ratio of nonspecific cell kill versus viral kill). Other extracts have SI <10. Testing was performed at the US NIAID core viral laboratory. ARTIVeda / PulmoHeal is protected by a patent portfolio of over 15 international patents by Oncotelic’s R&D. The mechanism of action against COVID-19 has been confirmed in 5 key peer reviewed international scientific/medical publications. ARTIVeda / PulmoHeal is designed to target multiple viral threats including COVID-19 by suppressing both viral replication and clinical symptoms that arise from viral infection. We have a product to be a cost effective prophylactic suitable for global deployment. For more information please visit www.pulmoheal.com.

About
Oncotelic

Oncotelic (formerly known as Mateon Therapeutics, Inc.) was created by the 2019 reverse merger with Oncotelic, which became a wholly owned subsidiary of Oncotelic, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Oncotelic, is a first-in-class anti-TGF-βRNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. OT-101 also has shown activity against SARS-CoV-2 and COVID-19. Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Oncotelic has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi4503). For more information, please visit www.oncotelic.com and www.Oncotelic.com.

Oncotelic
‘s
Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as “may”, “expect”, “anticipate” “hope”, “vision”, “optimism”, “design”, “exciting”, “promising”, “will”, “conviction”, “estimate,” “intend,” “believe”, “quest for a cure of cancer”, “innovation-driven”, “paradigm-shift”, “high scientific merit”, “impact potential” and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company’s product candidates and the potential use of the company’s product candidates to treat various cancer indications. Each of these forward-looking statements involves risks and uncertainties and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the company’s annual report on Form 10-K filed with the SEC on April 10, 2019 and in the company’s other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.

Contact Information:

For Oncotelic Therapeutics, Inc.:
Amit Shah
[email protected]



Checkmate Pharmaceuticals Announces Initiation of Patient Dosing in Potential Registration Trial of Vidutolimod (CMP-001) in Patients with Anti-PD-1 Refractory Advanced Melanoma

CAMBRIDGE, Mass., May 04, 2021 (GLOBE NEWSWIRE) — Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) (“Checkmate”), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced that patient dosing was initiated in a Phase 2 trial intended to assess the efficacy and safety of vidutolimod (CMP-001) in combination with nivolumab for the treatment of patients with anti-PD-1 refractory advanced melanoma. Vidutolimod is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component. Checkmate previously announced initiation of dosing in patients in an additional trial which is evaluating the efficacy and safety of vidutolimod in combination with nivolumab compared to nivolumab monotherapy in patients with first-line metastatic or unresectable melanoma. The data from these two trials are intended to support a biologics license application for the treatment of patients with anti-PD-1 refractory advanced melanoma.

“Initiation of dosing in this pivotal trial is an important milestone as we move towards potential registration of vidutolimod in melanoma,” said Barry Labinger, President and Chief Executive Officer of Checkmate. “Melanoma is estimated to be the fifth most diagnosed cancer in the United States, with more than 100,000 new cases and 7,000 deaths per year. There is a significant unmet medical need for patients who have progressed following treatment with anti-PD-1 therapy since there is no well-established standard of care.”

Checkmate previously announced initiation of patient dosing in a Phase 2 trial of vidutolimod in combination with pembrolizumab to evaluate safety and efficacy in patients with first-line head and neck cancer.

Additional information about the Phase 2 anti-PD-1 refractory melanoma trial and the Phase 2/3 melanoma study, including participating investigative sites, can be found here: https://checkmatepharma.com/pipeline/clinical-trials/melanoma/.

Information about Checkmate’s HNSCC trial can be found here: https://checkmatepharma.com/pipeline/clinical-trials/head-and-neck-squamous-cell-carcinoma/.

About Checkmate Pharmaceuticals

Checkmate Pharmaceuticals is a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer. Checkmate Pharmaceuticals’ product candidate, vidutolimod (CMP-001), is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component, designed to trigger the body’s innate immune system to attack tumors in combination with other therapies. Information regarding Checkmate Pharmaceuticals is available at www.checkmatepharma.com.

Availability of Other Information About Checkmate Pharmaceuticals

Investors and others should note that we communicate with our investors and the public using our website (www.checkmatepharma.com), our investor relations website (ir.checkmatepharma.com), and on social media (Twitter and LinkedIn), including but not limited to: investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Checkmate Pharmaceuticals posts on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward Looking Statements

Various statements in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. These statements include those regarding our product candidate, including its development and therapeutic potential and the advancement of our clinical and preclinical pipeline; expectations regarding the results and analysis of data; and expectations regarding the timing, initiation, implementation and success of its planned and ongoing clinical trials for vidutolimod (CMP-001), and the benefits and related implications of current and future partnerships and/or collaborations. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. These forward-looking statements are subject to risks and uncertainties, including those related to the development of our product candidate, including any delays in our ongoing or planned preclinical or clinical trials, the results from clinical trials, including the fact that positive results from a trial may not necessarily be predictive of the results of future or ongoing clinical trials, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and obtaining, maintaining and protecting our intellectual property. These and additional risks are discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ending December 31, 2020, as filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act 1933, as amended, which is available on the Securities and Exchange Commission’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in Checkmate’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Checkmate undertakes no duty to update this information unless required by law.



Investor Contact
Rob Dolski
Chief Financial Officer
[email protected]

Media Contact
Karen Sharma
MacDougall
781-235-3060
[email protected]