Release – Engine Gaming’s Stream Hatchet Releases Its Third Quarter 2022 Report, Highlighting Video Game Live Streaming Viewership Above Peak Pandemic Levels

Research, News, and Market Data on GAME

11/08/2022

Report offers unparalleled insights into audience consumption of gaming and esports content, which continues to attract the most difficult demographic for companies to access

Insights highlight unique, untapped media activation opportunities as engagement continues to increase within the industry

NEW YORK, NY / ACCESSWIRE / November 8, 2022 / Video gaming and esports live streaming analytics company, Stream Hatchet, a wholly-owned subsidiary of Engine Gaming and Media, Inc. (GAME) (“Engine” or the “Company”) (NASDAQ:GAME)(TSXV:GAME), today announced that it has published its Video Game Streaming Trends Third Quarter 2022 Report. This essential read provides an in-depth study on the current state of the live streaming and video games industry, offering unparalleled insights into the performance of the industry, as well as top performing creators, games, releases and more. Importantly, these insights highlight the opportunity to tap into an audience increasingly hard to reach for brands.

The Stream Hatchet team works with a consortium of industry-leading analysts and business leaders to understand and report on key trends related to the impact of live streaming audiences on gaming creators, esports and the broader video games industry.

Key findings include:

  • Viewership is nearly double pre-pandemic levels. Additionally, esports viewership is up 40% year-over-year compared to Q3 2021 last year; the industry has seen consistent growth over the last 4 years.
  • Facebook Gaming lost meaningful marketing share in Q3 ‘22, dropping from 14% in Q3 ‘21 to 5%. Amazon-owned Twitch continues to increase its market share to 72%, holding a steady command of the streaming landscape, while YouTube Gaming grew modestly to 15%, reclaiming its second largest market share position.
  • VTubers (Virtual YouTubers), a term to describe virtual avatars that stream content on platforms like YouTube and Twitch, continue to grow in live streaming now representing 50% of the top female streaming creators in Q3. The top 10 VTubers grew an average of 30% in Q3 2022 as compared to Q2 2022.
  • Gambling live streaming viewership on Twitch hit its peak in Q3 2022. Since, the platform announced a ban on streaming unlicensed gambling sites in the U.S. The ban went into effect in October, and Stream Hatchet will continue to monitor the impact into Q4 2022.

“The collection of this data is extremely valuable as it not only illustrates Stream Hatchet’s ability to provide market leading data across the video game and live-streaming landscape, but also offers marketers, researchers, and analyst actionable insights on how best to reach the 18- to 35-year-old demographic, which continues to be increasingly difficult to reach,” said Eduard Monstserrat, CEO at Stream Hatchet. “As brands strategize on how to connect with this hard-to-reach demographic, they are able to leverage our insights to better understand the top performing streamers and media properties. We power insightful, informed decisions leading to innovation and growth through the aggregation of dynamic, granular data.”

The Video Game Streaming Trends 2022 Third Quarter Report is free to download from: Q3 2022 Live Streaming Report (streamhatchet.com)

About Stream Hatchet
Stream Hatchet is the market leader in live-streaming viewership data analytics for the world’s leading video game streaming platforms. Stream Hatchet provides deep insights to leading brands, creator networks, esports leagues, game publishers, and other businesses measuring the impact of video game live streaming. Stream Hatchet is a wholly-owned subsidiary of Engine Gaming and Media.

About Engine Gaming and Media, Inc.
Engine Gaming and Media, Inc. (NASDAQ:GAME) (TSXV:GAME) provides unparalleled live streaming data and social analytics, influencer relationship management and monetization, and programmatic advertising to support the world’s largest video gaming companies, brand marketers, ecommerce companies, media publishers and agencies to drive new streams of revenue. The company’s subsidiaries include Stream Hatchet, the global leader in gaming video distribution analytics; Sideqik, a social influencer marketing discovery, analytics, and activation platform; and Frankly Media, a digital publishing platform used to create, distribute, and monetize content across all digital channels. Engine generates revenue through a combination of software-as-a-service subscription fees, managed services, and programmatic advertising. For more information, please visit www.enginegaming.com.

Company Contact:
Lou Schwartz
647-725-7765

Stream Hatchet PR:
Amanda Brooks
Stream Hatchet
[email protected]

Investor Relations Contact:
Shannon Devine
MZ North America
Main: 203-741-8811
[email protected]

SOURCE: Engine Gaming & Media Holdings, Inc.



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Release – Ocugen Provides Business Update & Third Quarter 2022 Financial Results

Research, News, and Market Data on OCGN

November 8, 2022

Conference Call and Webcast Today at 8:30 a.m. ET

  • Initiated dosing in the third and final cohort of U.S. Phase 1/2 OCU400 gene therapy clinical trial
  • Expanded product pipeline with OCU500—Ocugen’s mucosal COVID-19 vaccine and OCU410ST for Stargardt disease
  • Completed enrollment of U.S. Phase 2/3 COVAXIN (BBV152) clinical trial

MALVERN, Pa., Nov. 08, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today reported financial results for the quarter ended September 30, 2022, and provided a general business update.

“We achieved several important milestones in the third quarter of 2022,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “We expanded our vaccines pipeline by adding a second asset to combat COVID-19, OCU500, through our exclusive license agreement with Washington University to develop, manufacture, and commercialize a mucosal vaccine in the United States, Europe, and Japan.”

“Our modifier gene therapy platform has significant potential to address multiple blindness diseases,” said Dr. Musunuri. “The OCU400 clinical trial is on track, and we are also pleased to announce the addition of OCU410ST to our pipeline as a potential therapy for Stargardt disease—an orphan disease.”

“We continue to deliver on our near-term commitments as we advance our longer-term strategy and goal of bringing solutions to patients with debilitating diseases for whom no appropriate treatment options exist. We are passionate about this goal and anticipate achieving multiple milestones across our programs next year,” Dr. Musunuri concluded.

Business Updates

Vaccines

  • COVAXIN™ – enrollment was completed, and dosing continues, in the Phase 2/3 immuno-bridging and broadening clinical trial. No safety concerns have been identified to date and efficacy is being continuously monitored. Top line data is expected in early 2023.
  • OCU500 – a novel adenovirus-vectored mucosal vaccine, specifically designed to block COVID-19 infection at the portal of virus entry and that could prevent transmission as well as provide protection against new variants. This approach represents a potential universal booster, regardless of previous COVID-19 vaccination. Obtaining mucosal immunity has been published as a potential way to prevent infection and transmission, thus limiting the origin of new variants. Mucosal vaccines similar to the Company’s approach are already authorized in China and India. Ocugen intends to work closely with government agencies tasked with pandemic preparedness and response to initiate clinical trials.

Gene Therapies

  • OCU400
    • Dosing of subjects with NR2E3 and RHO-related retinitis pigmentosa in Cohort 2 was completed. Based on a review of safety data by the independent Data and Safety Monitoring Board for the clinical trial, dosing has begun in Cohort 3, and enrollment is expected to be completed by the end of the year.
    • The current clinical trial will also start enrolling patients with Leber congenital amaurosis associated with CEP290 mutations.

  • OCU410 and OCU410ST – Filings of Investigational New Drug (IND) applications for both dry age-related macular degeneration and Stargardt disease are planned for Q2 2023.

Biologicals

  • OCU200 – Ocugen is currently executing IND-enabling studies. The filing of an IND application targeting DME is planned for Q1 2023.

Cell Therapies

  • NeoCart® – Ocugen continues to work with the U.S. Food and Drug Administration to finalize the Phase 3 protocol necessary for the clinical development program of NeoCart®. Ocugen is building its own manufacturing suites to prepare for a NeoCart® clinical trial and as part of an overall research and development expansion.

Third Quarter 2022 Financial Results

  • The Company’s cash, cash equivalents, and restricted cash totaled $101.6 million as of September 30, 2022, compared to $95.1 million as of December 31, 2021. The Company believes that its current cash and cash equivalents balance will enable it to fund its operations into Q4 2023. The Company had 216.7 million shares of common stock outstanding as of September 30, 2022.
  • Research and development expenses for the three months ended September 30, 2022, were $15.6 million compared to $6.3 million for the three months ended September 30, 2021. General and administrative expenses for the three months ended September 30, 2022, were $7.5 million compared to $4.5 million for the three months ended September 30, 2021.
  • Ocugen reported a $0.10 net loss per share for the three months ended September 30, 2022, compared to a $0.05 net loss per share for the three months ended September 30, 2021.

Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call or webcast using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers

Conference ID: 3481499

Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. 
Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
[email protected]

Release – Engine Gaming & Media, Inc. Announces Timing of Fiscal Fourth Quarter 2022 and Fiscal Year 2022 Earnings Release and Conference Call

Research, News, and Market Data on GAME

11/07/2022

NEW YORK, NY / ACCESSWIRE / November 7, 2022 / Engine Gaming and Media, Inc. (“Engine” or the “Company”) (NASDAQ:GAME)(TSXV:GAME),a data-driven, gaming, media and influencer marketing platform company, today announced that it will issue a press release promptly after the market close on Tuesday, November 29, 2022, summarizing its financial results for the fiscal fourth quarter of 2022 ended August 31, 2022. The Company will also host a conference call the same day at 4:30 p.m. Eastern Time to discuss its financial results in further detail. The call will conclude with Q&A from participants.

Date:Tuesday, November 29, 2022
Time:4:30 p.m. Eastern time
Dial-in:1-877-407-0784
International Dial-in:1-201-689-8560
Conference Code:13733976
Webcast:GAME Conference Call

Please dial in at least 10 minutes before the start of the call to ensure timely participation.

A playback of the call will be available through December 6, 2022, on Engine Gaming and Media, Inc.’s Investor Relations website at ir.enginemediainc.com

About Engine Gaming and Media, Inc.

Engine Gaming and Media, Inc. (NASDAQ:GAME)(TSXV:GAME) provides unparalleled live streaming data and social analytics, influencer relationship management and monetization, and programmatic advertising to support the world’s largest video gaming companies, brand marketers, ecommerce companies, media publishers and agencies to drive new streams of revenue. The company’s subsidiaries include Stream Hatchet, the global leader in gaming video distribution analytics; Sideqik, a social influencer marketing discovery, analytics, and activation platform; and Frankly Media, a digital publishing platform used to create, distribute, and monetize content across all digital channels. Engine generates revenue through a combination of software-as-a-service subscription fees, managed services, and programmatic advertising. For more information, please visit www.enginegaming.com.

Cautionary Statement on Forward-Looking Information

This news release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Engine to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. In respect of the forward-looking information contained herein, Engine has provided such statements and information in reliance on certain assumptions that management believed to be reasonable at the time. Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Actual results could differ materially from those currently anticipated due to a number of factors and risks. Accordingly, readers should not place undue reliance on forward-looking information contained in this news release.

The forward-looking statements contained in this news release are made as of the date of this release and, accordingly, are subject to change after such date. Engine does not assume any obligation to update or revise any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf, except as required by applicable law.

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

Company Contact:

Lou Schwartz
647-725-7765

Investor Relations Contact:

Shannon Devine
MZ North America
Main: 203-741-8811
[email protected]

SOURCE: Engine Gaming & Media Holdings, Inc.



View source version on accesswire.com:
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Release – Alvopetro Announces Initial 183-B1 Test Results, October 2022 Sales Volumes and Q3 2022 Results Webcast

Research, News, and Market Data on ALVOF

Nov 07, 2022

CALGARY, AB, Nov. 7, 2022 /CNW/ – Alvopetro Energy Ltd. (TSXV: ALV) (OTCQX: ALVOF) announces initial results from the first interval tested in our 183-B1 well on our 100% owned and operated Block 183 and October 2022 sales volumes.

In July 2022, we completed drilling the 183-B1 exploration well to a total measured depth (“MD”) of 2,917 metres. Based on open-hole wireline logs and fluid samples confirming hydrocarbons, the well discovered hydrocarbons in multiple formations with a total of 34.3 metres of potential net hydrocarbon pay, with an average porosity of 10.6% and average water saturation of 29.0% using a 6% porosity cut-off, 50% Vshale cut-off and 50% water saturation cut-off.

Alvopetro has completed the 183-B1 formation test in the Sergi formation, the deepest of three formations with hydrocarbons shows during drilling of the well. We perforated a total of 26.5 metres in the Sergi formation at various intervals between 2,811 metres MD and 2,886 metres MD. We initially swabbed 63 bbls of oil and 7 bbls of completions fluid during the initially clean-up period. After a short shut-in we then initiated the production test. Cumulatively, over the duration of the 72-hour production test, we recovered 59 bbls of 43°API oil, 7 bbls of water identified as completion fluid, and 0.28 MMcf of associated gas. The daily oil rate recovered during swabbing operations averaged 20 bopd.

The 183-B1 well has now been shut-in to measure reservoir pressure and obtain pressure build‑up data to undertake a pressure transient analysis, which will help predict productivity of this first zone. After completing the pressure build-up test, the first interval will be suspended temporarily with a bridge plug and the test will proceed up-hole to test the Agua Grande formation.

October Sales Volumes

October sales volumes averaged 2,720 boepd, including natural gas sales of 15.6 MMcfpd and associated natural gas liquids sales from condensate of 124 bopd, based on field estimates, an increase of 3% over our average daily sales volumes in the third quarter. October sales volumes include initial sales volumes from our 183(1) well on our Murucututu project where we commenced production in mid-October following completion of the commissioning of field production facility. Our team continues to optimize the field production facility at the wellsite. Since coming on production, the well has averaged approximately 0.42 MMcfpd based on field estimates.

Q3 2022 Results Webcast

Alvopetro anticipates announcing Q3 2022 results on November 15, 2022 after markets close and will host a live webcast to discuss the results at 9:00 am Mountain time on November 16, 2022. Details for joining the event are as follows:

Date: November 16, 2022 Time: 9:00 a.m. Mountain/11:00  a.m. EasternLinkhttps://us06web.zoom.us/j/83084021752Dial-in Numbershttps://us06web.zoom.us/u/kgefFrJiJWebinar ID: 830 8402 1752

The webcast will include a question-and-answer period. Online participants will be able to ask questions through the Zoom portal. Dial-in participants can email questions directly to [email protected].

Corporate Presentation

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

SocialMedia

Follow Alvopetro on our social media channels at the following links:

Twitter – https://twitter.com/AlvopetroEnergyInstagram – https://www.instagram.com/alvopetro/LinkedIn – https://www.linkedin.com/company/alvopetro-energy-ltdYouTube – https://www.youtube.com/channel/UCgDn_igrQgdlj-maR6fWB0w

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

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

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

Abbreviations:

API                         =             American Petroleum Institute
°API                         =             an indication of the specific gravity of crude oil measured on the API gravity scale.
bbls                         =             barrels
boepd                     =             barrels of oil equivalent (“boe”) per day
bopd                       =             barrels of oil and/or natural gas liquids (condensate) per day
MMcf                     =             million cubic feet
MMcfpd                 =             million cubic feet per day

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

Testing and Well Results. Data obtained from the 183-B1 well identified in this press release, including hydrocarbon shows, open-hole logging, net pay and porosities and initial testing data, should be considered to be preliminary until detailed pressure transient and other analysis and interpretation has been completed. Hydrocarbon shows can be seen during the drilling of a well in numerous circumstances and do not necessarily indicate a commercial discovery or the presence of commercial hydrocarbons in a well. There is no representation by Alvopetro that the data relating to the 183-B1 well contained in this press release is necessarily indicative of long-term performance or ultimate recovery. The reader is cautioned not to unduly rely on such data as such data may not be indicative of future performance of the well or of expected production or operational results for Alvopetro in the future.

Forward-Looking Statements and Cautionary Language. This news release contains “forward-looking information” within the meaning of applicable securities laws. The use of any of the words “will”, “expect”, “intend” and other similar words or expressions are intended to identify forward-looking information. Forward‐looking statements involve significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to vary significantly from the expectations discussed in the forward-looking statements. These forward-looking statements reflect current assumptions and expectations regarding future events. Accordingly, when relying on forward-looking statements to make decisions, Alvopetro cautions readers not to place undue reliance on these statements, as forward-looking statements involve significant risks and uncertainties. More particularly and without limitation, this news release contains forward-looking information concerning potential hydrocarbon pay in the 183-B1 well, anticipated production from our Murucututu project, exploration and development prospects of Alvopetro and the expected timing of certain of Alvopetro’s testing and operational activities. The forward‐looking statements are based on certain key expectations and assumptions made by Alvopetro, including but not limited to expectations and assumptions concerning testing results of the 183-B1 well and the 182-C2 well, equipment availability, the timing of regulatory licenses and approvals, the success of future drilling, completion, testing, recompletion and development activities, the outlook for commodity markets and ability to access capital markets, the impact of the COVID-19 pandemic, the performance of producing wells and reservoirs, well development and operating performance, foreign exchange rates, general economic and business conditions, weather and access to drilling locations, the availability and cost of labour and services, environmental regulation, including regulation relating to hydraulic fracturing and stimulation, the ability to monetize hydrocarbons discovered, expectations regarding Alvopetro’s working interest and the outcome of any redeterminations, the regulatory and legal environment and other risks associated with oil and gas operations. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be incorrect. Actual results achieved during the forecast period will vary from the information provided herein as a result of numerous known and unknown risks and uncertainties and other factors. Although Alvopetro believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Alvopetro can give no assurance that it will prove to be correct. Readers are cautioned that the foregoing list of factors is not exhaustive. Additional information on factors that could affect the operations or financial results of Alvopetro are included in our annual information form which may be accessed on Alvopetro’s SEDAR profile at www.sedar.com. The forward-looking information contained in this news release is made as of the date hereof and Alvopetro undertakes no obligation to update publicly or revise any forward-looking information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.

www.alvopetro.com

SOURCE Alvopetro Energy Ltd.

Release – Onconova Therapeutics to Provide Corporate Update And Announce Third Quarter Financial Results On November 14, 2022

Research, News, and Market Data on ONTX

Company to host conference call and webcast at 4:30 p.m. Eastern Time on Monday, November 14, 2022

NEWTOWN, Pa., Nov. 07, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company intends to release its third quarter 2022 financial results on Monday, November 14, 2022. Management plans to host a conference call and live webcast at 4:30 p.m. ET on the same day to discuss these results and provide an update on its pipeline programs.

Conference Call and Webcast Information

Interested parties who wish to participate in the conference call may do so by dialing (800) 715-9871 for domestic and (646) 307-1963 for international callers and using conference ID 6078502.

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the Company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.

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

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

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

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680
[email protected]
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
[email protected]

Release – Motorsport Games Announces Content Update for Rfactor 2

Research, News, and Market Data on MSGM

NOVEMBER 7, 2022

UPDATE BRINGS NEW CARS AND TRACKS TO THE PLATFORM, MARKING FIRST TIME CIRCUITS HAVE BEEN LASER-SCANNED INTO A COMMERCIAL SIM RACING PRODUCT

MIAMI, Nov. 07, 2022 (GLOBE NEWSWIRE) — Motorsport Games Inc. (NASDAQ: MSGM) (“Motorsport Games”), a leading racing game developer, publisher and esports ecosystem provider of official motorsport racing series throughout the world, announced today a content update to rFactor 2, one of the most authentic sim racing platforms available to racers around the world.

This quarter’s content update contains new cars for users to experience behind the wheel. Following the partnership between the British Touring Car Championship (BTCC), Motorsport Games and Studio 397, a fifth real world car will be part of the roster – the BMW 330i M Sport NGTC BTCC (trailer here). The rear- wheel drive car – developed by West Surrey Racing – marks the manufacturer’s official entry into the BTCC. Further, the Vanwall Vandervell LMH (trailer here) will be added, built to Le Mans Hypercar specifications and created with data derived from the real car and the same engineering team.

New tracks will be added into the platform as well, all of which mark the first time any of them have been laser (LIDAR) scanned into a commercially available product. British circuits Thruxton (Hampshire) and Croft (North Yorkshire) have been laser-scanned into rFactor 2, alongside the ExCeL London Circuit, featuring an innovative indoor/outdoor layout. Adding to the British circuits, the Bahrain International Circuit will make its debut in rFactor 2 and will feature a full day/night cycle and four distinct track layouts. More information about each track can be found here:

  • Thruxton – The fastest circuit in the United Kingdom, home to the daunting Church Corner. Founded in 1968, it is used by leading real-world national motorsport championships. This year, the BTCC visited the circuit twice and it will return in 2023, June 3rd and 4th. It first held a round at the venue 43 years ago. Trailer found here: https://youtu.be/-AV4IpCGx44
  • Croft Circuit – The only permanent national-level circuit in the Northeast of England. It is known for its mix of high-speed curves and a tight final sector, culminating in one of the slowest corners in UK motorsport – in direct contrast to Thruxton. Trailer found here: https://youtu.be/hPMVA0lmooA
  • ExCeL London Circuit – First created and used by Formula E in 2021, the world-first venue in London mixes tight hairpins and narrow confines within an indoor section. It debuted virtually during the Formula E: Accelerate esports competition in July 2022, won by Frede Rasmussen. Trailer found here: https://www.youtube.com/watch?v=Jv2zrOCOXFE
  • Bahrain International Circuit – The venue used for series such as Formula 1 and the FIA World Endurance Series made its rFactor 2 debut within the opening 2022-23 Le Mans Virtual Series round in September 2022, won by Floyd Vanwall-Burst (LMP) and Oracle Red Bull Racing (GTE). Four layouts are included: Grand Prix, Endurance, Outer and Paddock. Trailer found here: https://youtu.be/hvOFlUO5YpY

“As rFactor 2 continues to expand and define what top simulation platforms should look like, we are excited for our fans to get behind the wheel and race with new cars and on new tracks with this update,” said Zach Griffin, Director of Technology at Motorsport Games. “Through our partnership with the BTCC and by being the official esports partner of Formula E, as well as rFactor 2 being the official simulation platform of Formula E, we are able to bring to life the elements of real-world racing into the simulation and provide an authentic experience for all. The new laser-scanned tracks, the first time they have been implemented into a product to this scale, also marks a new chapter for sim racing and we are proud to be at the forefront of this innovation.”

Several quality-of-life updates to rFactor 2 will be launching today as well, including:

  • Thoroughly revised AI performance (smoother and more naturalistic)
  • Track limit system updates
  • Increased virtual reality (VR) exposure
  • User interface tweaks (increased navigation speed)
  • Increased package installation speed
  • Headlight pulse option

The new content and changes follow the addition of a native in-game store, which removed the need to exit the platform, showcasing bundle offers and previously purchased content which was implemented in October 2022.

Fans have already gotten a taste of the latest BTCC content to be added at the four race activations this year (Snetterton, Thruxton, Silverstone National and Brands Hatch GP). The latest car and track additions to rFactor 2 bring the totals to six layouts and five car types respectively from the BTCC represented in the simulation, including the two Brands Hatch layouts.

The pricing breakdown for the newly released content is as follows:

  • Q4 pack: approximate price = €27.99 (31.5% Off)
    • Includes: BMW 330i M Sport BTCC, Vanwall Vandervell LMH, Bahrain International Circuit, Croft Circuit, Thruxton Circuit, ExCeL London Circuit
  • British Track Pack: approximate price = €19.99 (37.5% off)
    • Croft Circuit, Brands Hatch, Donington Park, Thruxton Circuit
  • Individual Items
    • Vanwall Vandervell LMH – €4.99
    • BMW 330i M Sport BTCC – €4.99
    • Vauxhall Astra BTCC – €4.99
    • Croft Circuit – €6.99
    • Thruxton Circuit – €6.99
    • ExCeL London Circuit – €7.99
    • Bahrain International Circuit – €8.99

About Motorsport Games:
Motorsport Games, a Motorsport Network company, is a leading racing game developer, publisher and esports ecosystem provider of official motorsport racing series throughout the world. Combining innovative and engaging video games with exciting esports competitions and content for racing fans and gamers, Motorsport Games strives to make the joy of racing accessible to everyone. The Company is the officially licensed video game developer and publisher for iconic motorsport racing series across PC, PlayStation, Xbox, Nintendo Switch and mobile, including NASCAR, INDYCAR, 24 Hours of Le Mans and the British Touring Car Championship (“BTCC”), as well as the industry leading rFactor 2 and KartKraft simulations. rFactor 2 also serves as the official sim racing platform of Formula E, while also powering F1 Arcade through a partnership with Kindred Concepts. Motorsport Games is an award-winning esports partner of choice for 24 Hours of Le Mans, Formula E, BTCC, the FIA World Rallycross Championship and the eNASCAR Heat Pro League, among others. Motorsport Games is building a virtual racing ecosystem where each product drives excitement, every esports event is an adventure and every story inspires.

Forward-Looking Statements:
Certain statements in this press release which are not historical facts are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are provided pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected benefits of the content updates to rFactor 2, related products and features and the positive attributes of the platform, such as the Company’s belief that rFactor 2 is one of the most authentic sim racing platforms available to racers around the world. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Motorsport Games and are difficult to predict. Examples of such risks and uncertainties include, without limitation: difficulties, delays in or unanticipated events that may impact the timing and expected benefits of the rFactor 2 updates and/or related products and features, such as due to unexpected release delays. Factors other than those referred to above could also cause Motorsport Games’ results to differ materially from expected results. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in Motorsport Games’ filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, its Quarterly Reports on Form 10-Q filed with the SEC during 2022, as well as in its subsequent filings with the SEC. Motorsport Games anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Motorsport Games assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law. Forward-looking statements speak only as of the date they are made and should not be relied upon as representing Motorsport Games’ plans and expectations as of any subsequent date. Additionally, the business and financial materials and any other statement or disclosure on, or made available through, Motorsport Games’ website or other websites referenced or linked to this press release shall not be incorporated by reference into this press release.

Website and Social Media Disclosure:
Investors and others should note that we announce material financial information to our investors using our investor relations website (ir.motorsportgames.com), SEC filings, press releases, public conference calls and webcasts. We use these channels, as well as social media and blogs, to communicate with our investors and the public about our company and our products. It is possible that the information we post on our websites, social media and blogs could be deemed to be material information. Therefore, we encourage investors, the media and others interested in our company to review the information we post on the websites, social media channels and blogs, including the following (which list we will update from time to time on our investor relations website):

WebsitesSocial Media
motorsportgames.comTwitter: @msportgames & @traxiongg
traxion.ggInstagram: msportgames traxiongg
motorsport.comFacebook: Motorsport Games traxiongg
 LinkedIn: Motorsport Games
 Twitch: traxiongg
 Reddit: traxiongg

The contents of these websites and social media channels are not part of, nor will they be incorporated by reference into, this press release.

Press:
ASTRSK PR
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/287f4dad-b23b-4377-ab0f-d11d26c5defa 

Release – PDS Biotech Announces Presentation of Preliminary PDS0101 Efficacy, Safety, and Immunology Data at Society for Immunotherapy of Cancer (SITC 2022)

Research, News, and Market Data on PDSB

Patients with high-risk, locally advanced cervical cancer on IMMUNOCERV demonstrated increased tumor-infiltrating polyfunctional CD8+ (killer) T cells, and 1-year overall survival of 100%

Data from study across several checkpoint inhibitor refractory HPV-positive cancers demonstrate an increase in HPV-specific T cells following treatment with PDS0101-based triple combination

FLORHAM PARK, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced upcoming poster presentations of clinical data from two Phase 2 clinical trials of PDS0101 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2022) being held November 8-12, 2022 in Boston. PDS0101 is PDS Biotech’s lead candidate being developed as a potential treatment for HPV-positive cancers.

The first abstract accepted for presentation, titled, “IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers,” highlights data from The University of Texas MD Anderson Cancer Center-led IMMUNOCERV Phase 2 clinical trial (NCT04580771). The study is investigating PDS0101 in combination with standard-of-care chemoradiotherapy (CRT) for the potential treatment of cervical cancer in patients with large tumors over 5cm in size and/or cancer that has spread to the lymph nodes (lymph node metastasis). Highlights from the study being presented at SITC 2022 include:

  • 17 patients have been enrolled in the trial.
  • 8 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer.
  • 87.5% (7/8) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease.
  • In comparison, 74.1% (40/54) of locally advanced patients who received CRT alone and were monitored at The University of Texas MD Anderson Cancer Center on a prospective protocol independent of IMMUNOCERV had a CR on PET CT at Day 170.   
  • The 1-year overall survival is 100% (8/8) in patients treated with the combination of PDS0101 and CRT.
  • The observed 1-year disease-free survival rate for IMMUNOCERV patients is 87.5% (7/8).
  • Patients treated with the combination of PDS0101 and CRT had a 71% increase in multi-cytokine-inducing (polyfunctional) killer (CD8+) T cells within the tumors from baseline to end of treatment (38% to 65%). This increase in activated T cells was not seen in patients receiving standard-of-care CRT.
  • Toxicity of PDS0101 was limited to low-grade local injection site reactions.

The second abstract, titled “Immune Correlates Associated with Clinical Benefit in Patients with Checkpoint Refractory HPV-Associated Malignancies Treated with Triple Combination Immunotherapy,” reports data from the Phase 2 triple combination trial (NCT04287868), which is being led by the Center for Cancer Research at the National Cancer Institute (NCI), part of the National Institutes of Health. The study is investigating PDS0101 in combination with two investigational immune-modulating agents: M9241, a tumor-targeting IL-12 (immunocytokine), and bintrafusp alfa, a bifunctional checkpoint inhibitor (PD-L1/ TGF-β). The triple combination is being studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy. For most patients who are CPI refractory, there is no effective therapy. The immune correlates before and after treatment in the CPI refractory patient population were studied. Highlights from the study being presented at SITC 2022 include:

  • A more than two-fold increase in HPV16-specific T cells in the blood of 79% (11/14 tested) of the evaluated patients.
  • Immune responses were associated with increases in natural killer cells, soluble granzyme B (associated with active killer T cells), IFN-γ, TNF-α, etc., two weeks after the first treatment cycle thus signaling a pro-inflammatory response.
  • These immunogenicity findings highlight the potential role of the combination in altering immune suppressive forces, and support previously announced results documenting promising clinical outcomes in the CPI-refractory population receiving the triple combination.

“We are very pleased that research describing PDS0101’s therapeutic potential will be highlighted in two poster presentations at SITC 2022, including encouraging preliminary efficacy results from the ongoing IMMUNOCERV Phase 2 clinical trial,” said Dr. Frank Bedu-Addo, CEO of PDS Biotech. “Taken together, the data being presented at SITC 2022 demonstrate the potential ability of PDS0101 to elicit in patients the right type and quality of therapeutic immune response. This seems to allow PDS0101 to work in combination with a variety of therapeutic agents to generate clinical responses that appear to exceed current standards of care and allow for improved outcomes in patients with HPV-positive cancers. We look forward to continued progression of our Phase 2 clinical trials evaluating the efficacy, safety and tolerability of PDS0101 in combination with other therapies.”

Details of the posters being presented at SITC 2022 are as follows:

Abstract Number: 674
Abstract Title: IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers
Presenting Author: Dr. Ann Klopp, The University of Texas MD Anderson Cancer Center
Session Date: Friday, Nov. 11

Abstract Number: 695
Abstract Title:  Immune correlates associated with clinical benefit in patients with checkpoint refractory HPV-associated malignancies treated with triple combination immunotherapy
Presenting Author: Dr. Meg Goswami, National Cancer Institute
Session Date: Thursday, Nov. 10 

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A National Cancer Institute-supported Phase 2 clinical study of PDS0101 in a triple combination therapy is also being conducted in checkpoint inhibitor refractory patients with multiple advanced HPV-associated cancers. A third Phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being led by The University of Texas MD Anderson Cancer Center. A final Phase 2 clinical trial of PDS0101 monotherapy in first line treatment of newly diagnosed patients HPV16+ head and neck cancer patients is being conducted at the Mayo Clinic.

KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: [email protected]

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: [email protected]

Media Contact:
Bill Borden/Dave Schemelia
Tiberend Strategic Advisors, Inc.
Phone: +1 (732) 910-1620/+1 (609) 468-9325
Email: [email protected] /[email protected]

Release – Digital Direct Holdings’ Orange142 Names Scott Schult to Newly Created Role as Head of Strategy

Research, News, and Market Data on DRCT

November 07, 2022 8:00am EST

Tourism Marketing Leader to Drive Growth for Orange142 & Its Brand Clients

HOUSTON, TX (November 7, 2022) – Direct Digital Holdings, a leading advertising and marketing technology platform, announced today that Scott Schult will be joining Orange142, a demand generation and digital advertising company, in the newly created role of Head of Strategy. Schult will help Orange142’s sales, account management, and marketing teams construct a more strategic approach to client outreach, retention, and production innovation. Schult comes to Orange142 from the Nashville Convention and Visitors Corporation, where he served as Chief Marketing Officer.   

Before leading marketing at the Nashville Convention and Visitors Corporation, Schult worked as Executive Vice President and Chief Marketing Officer for the Myrtle Beach Area Chamber of Commerce. Earlier in his career, he held key roles at the St. Petersburg/Clearwater Area Convention and Visitors Bureau, Primco Capital Management, Sierra Health Services, and Marriott Hotels.

“Scott brings unparalleled experience and innovative thought leadership in the travel and tourism industry, along with years of insights and relationships that will serve us well in helping Orange142 grow marketshare and market our services to a broad reach of industries,” said Mark Walker, CEO, Direct Digital Holdings. 

“Orange142 is a high-performance digital media company that successfully delivers unmatched value and transparency to its clients,” said Schult. “Their solutions are a big win for the travel and tourism brands I know well, as well as for a range of marketers looking for significant ROI from a team that understand the needs of mid-market businesses.” 

Schult holds a B.S. in Hospitality & Tourism Management and an M.S. in Marketing, both from Purdue University.

About Direct Digital Holdings

Direct Digital Holdings (Nasdaq: DRCT), owner of operating companies Colossus SSP, Huddled Masses and Orange 142, brings state-of-the-art sell- and buy-side advertising platforms together under one umbrella company. Direct Digital Holdings’ sell-side platform, Colossus SSP, offers advertisers of all sizes extensive reach within general market and multicultural media properties. The company’s subsidiaries Huddled Masses and Orange142 deliver significant ROI for middle market advertisers by providing data-optimized programmatic solutions at scale for businesses in sectors that range from energy to healthcare to travel to financial services. Direct Digital Holdings’ sell- and buy-side solutions manage approximately 90,000 clients monthly, generating over 100 billion impressions per month across display, CTV, in-app and other media channels. The company has been named a top minority-owned business by The Houston Business Journal.

About Orange142

Part of Direct Digital Holdings, Inc. (Nasdaq: DRCT), Orange142, LLC combines demand-side technology with real-time intelligence and data-driven strategy to support omnichannel marketing. Based in Austin, Texas, Orange142, LLC specializes in driving strong results for mid-market clients in CPG, higher education, government, travel/tourism, and wellness/beauty. For more information, visit www.orange142.com

Media Contact:
Laura Goldberg
LBG Public Relations for Direct Digital Holdings
[email protected]
+1-347-683-1859

Released November 7, 2022

Release – Tonix Pharmaceuticals Reports Third Quarter 2022 Financial Results and Operational HighlightsRelease

Research, News, and Market Data on TNXP

November 07, 2022 7:00am EST

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Five Potentially Pivotal Phase 2 or 3 Studies for CNS Programs Expected to be in the Clinic by First Quarter 2023

Data from Planned Interim Analyses of TNX-102 SL in Phase 3 Fibromyalgia Study and Phase 2 Long COVID Study Expected Second Quarter 2023

Advanced Development Center in Dartmouth, Mass. and Infectious Disease Research and Development Facility in Frederick, Md. Operational

Cash and Cash Equivalents Totaled Approximately $140 Million at September 30, 2022

CHATHAM, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the third quarter ended September 30, 2022, and provided an overview of recent operational highlights.

“Tonix continues to make meaningful progress in the development of multiple programs within its robust pipeline, having already commenced a confirmatory Phase 3 study for fibromyalgia in the second quarter of this year and a potentially pivotal Phase 2 study for Long COVID in the third quarter of this year,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “We look forward to the interim data from both of these TNX-102 SL studies in the second quarter of 2023. Additionally, we look forward to advancing our other central nervous system or CNS product candidates including TNX-102 SL for PTSD, TNX-1900 for chronic migraine, TNX-1300 for cocaine intoxication, and TNX-601 ER for depression, all of which we expect to be in the clinic by first quarter 2023. Finally, we continue to make strides in immunology with TNX-1500 for preventing organ transplant rejection expected to enter into a Phase 1 study in the first half of 2023, as well as in infectious diseases with TNX-801, a vaccine to prevent smallpox and monkeypox, expected to enter into a Phase 1 study also in the first half of next year.”

Recent Highlights—Key Product Candidates*

Central Nervous System (CNS) Pipeline

TNX-102 SL (cyclobenzaprine HCl sublingual tablet): small molecule for the management of fibromyalgia (FM)

  • Enrollment continues in the RESILIENT study, a double-blind, randomized, placebo-controlled, potentially pivotal confirmatory Phase 3 study of TNX-102 SL for the management of fibromyalgia. Results from a planned interim analysis are expected in the second quarter of 2023.

TNX-102 SL for the treatment of Long COVID, also known as Post-Acute Sequelae of COVID-19 (PASC)

  • Enrollment continues in the PREVAIL study, a potentially pivotal Phase 2 study of TNX-102 SL for Long COVID. Results from a planned interim analysis are currently anticipated in the second quarter of 2023.
  • Tonix presented data from a previously announced retrospective observational database study in patients with Long COVID at the International Association for the Study of Pain (IASP) 2022 World Congress on Pain. The poster presentation titled, “Retrospective Observational Database Study of Patients with Long COVID with Multi-site Pain, Fatigue, and Insomnia: A Real-World Analysis of Symptomatology and Opioid Use,” included data showing that approximately 40% of patients had fibromyalgia-like multi-site pain, the rate of opioid use in Long COVID patients with multi-site pain was 34%, which increased to approximately 50% when sleep disturbance was also present. These findings support the feasibility of the currently enrolling Phase 2 study for patients with Long COVID whose symptoms overlap with fibromyalgia.

TNX-102 SL for the treatment of Posttraumatic Stress Disorder (PTSD)

  • Tonix expects to begin enrolling a Phase 2 study of TNX-102 SL in police in Kenya in the fourth quarter of 2022.

TNX-1300 (recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication

  • Tonix expects to initiate a new, potentially pivotal, Phase 2 clinical study of TNX-1300 for the treatment of cocaine intoxication in the first quarter of 2023, pending agreement with the U.S. Food and Drug Administration (FDA).
  • In August 2022, Tonix received a Cooperative Agreement grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support development of TNX-1300.
  • TNX-1300 has been granted Breakthrough Therapy designation by the FDA.

TNX-1900 (intranasal potentiated oxytocin): small peptide for migraine, craniofacial pain, insulin resistance and related disorders, and obesity associated binge eating disorder

  • The Company expects to begin enrollment in a Phase 2 study of TNX-1900 for the prevention of migraine headache in chronic migraineurs in the fourth quarter of 2022.
  • Tonix announced that U.S. Patent 11,389,473 issued in July 2022. The patent, entitled “Magnesium-Containing Oxytocin Formulations and Methods of Use” claims methods and compositions for treating pain, including migraine headaches, using intranasal magnesium-containing oxytocin formulations. This patent, excluding possible patent term extensions, is expected to provide Tonix with U.S. market exclusivity until January 2036.

TNX-601 ER (tianeptine hemioxalate extended-release tablets): a once-daily small molecule for the treatment of major depressive disorder (MDD), PTSD, and neurocognitive dysfunction associated with corticosteroid use.

  • In October 2022, Tonix announced that the FDA has cleared the Investigational New Drug (IND) application to support a Phase 2 study of TNX-601 ER for the treatment of MDD, which the Company expects to initiate in the first quarter of 2023.
  • TNX-601 ER is being developed as a monotherapy and first-line treatment for MDD. No tianeptine-containing product has been approved by the FDA.

Rare Disease Pipeline

TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)

  • In July 2022, Tonix delivered a presentation titled, “TNX-2900 (Intranasal Oxytocin + Magnesium) in Development for the Treatment of Hyperphagia in Adolescents and Young Adults with Prader-Willi Syndrome” at the World Orphan Drug Congress USA.
  • TNX-2900 has been granted Orphan Drug designation from the FDA for the treatment of PWS.

Immunology Pipeline

TNX-1500 (anti-CD40L monoclonal antibody): third generation monoclonal antibody for prophylaxis of organ transplant rejection and treatment of autoimmune disorders.

  • Tonix announced data from three oral presentations at the 29th International Congress of The Transplantation Society (TTS 2022) by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital for TNX-1500 targeting CD40-ligand (CD40L), which is also known as CD154.
  • The presentations titled, “Long-Term Rejection Free Renal Allograft Survival with Fc-Modified Anti-CD154 Antibody Monotherapy in Nonhuman Primates,” and “Monotherapy with TNX-1500, a Fc-Modified Anti-CD154mAb, Prolongs Cardiac Allograft Survival in Cynomolgus Monkeys,” include data demonstrating that TNX-1500 treatment showed activity in preventing organ rejection and was well tolerated in non-human primates. These presentations suggested that blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity in non-human primate cardiac and kidney allograft models without clinical thrombosis
  • The presentation titled, “Long-term (>1 year) Rejection-Free Survival of Kidney Xenografts with Triple Xenoantigen Knockout and Multiple Human Transgenes in NonHuman Primates,” includes data demonstrating that TNX-1500 treatment showed activity in preventing xenograft kidney rejection and was well tolerated in non-human primates. These presentations suggested that blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic xenoimmunity in non-human primate kidney xenograft models without clinical thrombosis.
  • A Phase 1 study of TNX-1500 is expected to start in the first half of 2023.

Infectious Disease Pipeline

TNX-801 (live horsepox virus vaccine for percutaneous administration): vaccine against smallpox and monkeypox designed as a single-administration vaccine to elicit T cell immunity

  • As previously mentioned, Tonix announced a collaboration with the Kenya Medical Research Institute (KEMRI) to plan, seek regulatory approval for and conduct a Phase 1 clinical study in Kenya to develop TNX-801 as a vaccine to protect against monkeypox and smallpox. The study is expected to start in the first half of 2023.
  • Tonix presented data from a research collaboration with The University of Alberta in a poster presentation at the 4th Symposium of the Canadian Society for Virology on June 5, 2022. The poster titled, “Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox,” describes data from animals vaccinated with TNX-801 to protect against monkeypox. The poster presentation reports that all animals (n=8) vaccinated with TNX-801 were fully protected with sterilizing immunity from a challenge with intra-tracheal monkeypox. The vaccinations with TNX-801 were well tolerated. Synthetic horsepox virus is the basis for the Company’s TNX-801 vaccine in development to protect against monkeypox and smallpox and for the Company’s Recombinant Pox Virus (RPV) platform to protect against other pathogens, including SARS-CoV-2.

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

      Recent Highlights–Financial

As of September 30, 2022, Tonix had $140.0 million of cash and cash equivalents, compared to $178.7 million as of December 31, 2021.

In October 2022, Tonix issued 1,400,000 shares of Series A convertible redeemable preferred stock and 100,000 shares of Series B convertible redeemable preferred stock to certain institutional investors in a private placement for gross proceeds of $15.0 million. The Company expects to use the proceeds to redeem the preferred stock.

Cash used in operations was approximately $23.5 million for the three months ended September 30, 2022, compared to $12.9 million for the same period in 2021. The increase in cash outlays was primarily due to an increase in research and development activities. Capital expenditures were approximately $8.8 million for the three months ending September 30, 2022 compared to $7.8 million for the same period in 2021. The increase was primarily due to the continued buildout of the ADC in North Dartmouth, Mass.

Third Quarter 2022 Financial Results

Research and development (R&D) expenses for the three months ended September 30, 2022 were $22.2 million, compared to $13.1 million for the same period in 2021. The increase is predominately due to increased clinical, manufacturing, non-clinical, employee-related and laboratory expenses. The Company continues to expect R&D expenses to increase throughout the remainder of 2022 as it moves its clinical development programs forward and invests in its development pipeline.

General and administrative (G&A) expenses for the three months ended September 30, 2022 were $7.4 million, compared to $5.5 million for the same period in 2021. The increase is primarily due to increased employee-related and financial reporting expenses.

Net loss available to common stockholders was $29.0 million, or $0.69 per share, basic and diluted, for the three months ended September 30, 2022, compared to net loss of $18.5 million, or $1.60 per share, basic and diluted, for the same period in 2021. The basic and diluted weighted average common shares outstanding for the three months ended September 30, 2022 was 41,944,289 compared to 11,581,367 shares for the same period in 2021.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute-COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the second quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

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

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.



TONIX PHARMACEUTICALS HOLDING CORP.
 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Amounts)
(unaudited)

                
                
 Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
 2022  2021  2022  2021 
COSTS AND EXPENSES:               
Research and development$22,201  $13,082  $57,202  $46,542 
General and administrative 7,390   5,453   22,161   16,291 
  29,591   18,535   79,363   62,833 
                
Operating loss (29,591)  (18,535)  (79,363)  (62,833)
                
Interest income, net 610   7   825   99 
                
Net loss (28,981)  (18,528)  (78,538)  (62,734)
                
Preferred stock deemed dividend       4,255    
                
Net loss available to common stockholders$(28,981) $(18,528) $(82,793) $(62,734)
                
Net loss per common share, basic and diluted$(0.69) $(1.60) $(3.06) $(6.02)
                
Weighted average common shares outstanding, basic and diluted 41,944,289   11,581,367   27,066,489   10,429,028 



TONIX PHARMACEUTICALS HOLDING CORP.

CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands)
(Unaudited)

 September 30, 2022 December 31, 20211
Assets  
Cash and cash equivalents$ 139,978 $ 178,660
Prepaid expenses and other          11,161 10,389
Total current assets151,139 189,049
Other non-current assets91,507 51 ,851
Total assets$ 242,646 $ 240,900
   
Liabilities and stockholders’ equity  
Total liabilities$ 13,722 $ 22,183
Stockholders’ equity228,924 218,717
Total liabilities and stockholders’ equity$ 242,646 $ 240,900

1The condensed consolidated balance sheet for the year ended December 31, 2021 has been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
[email protected] 
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
[email protected] 
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
[email protected] 
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released November 7, 2022

Release – FAT Brands Announces Withdrawal of Proposed Common Stock Offering

Research, News, and Market Data on FAT

NOVEMBER 07, 2022

Los Angeles, CA, Nov. 07, 2022 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty) Brands Inc. (Nasdaq: FAT) today announced that it has withdrawn its previously announced proposed registered public offering of shares of its Class A Common Stock as a result of market conditions.

Andy Wiederhorn, the Company’s Chief Executive Officer, said, “This transaction was opportunistic in nature. While we appreciate the significant interest in the proposed offering, we have concluded that the current terms and conditions available in the market were not sufficiently attractive for us to move forward with a transaction at this time. We will continue to monitor market conditions and evaluate whether to pursue another offering in the future.”

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

About FAT (Fresh. Authentic. Tasty.) Brands

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to significant business, economic and competitive risks, uncertainties and contingencies including, but not limited to, uncertainties surrounding the severity, duration and effects of the COVID-19 pandemic, many of which are difficult to predict and beyond our control, which could cause our actual results to differ materially from the results expressed or implied in such forward-looking statements. We refer you to the documents we file from time to time with the Securities and Exchange Commission, such as our reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these and other risks, uncertainties and contingencies. We undertake no obligation to update any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

Investor Relations:
ICR
Michelle Michalski
[email protected]
646-277-1224

Media Relations:
Erin Mandzik
[email protected]
860-212-6509

Release – Energy Fuels Announces Q3-2022 Results, Including Continued Robust Balance Sheet and Market-Leading U.S. Uranium & Rare Earth PositionsRelease

Research, News, and Market Data on UUUU

Webcast on November 8, 2022

LAKEWOOD, Colo., Nov. 4, 2022 /CNW/ – Energy Fuels Inc. (NYSE American: UUUU) (TSX: EFR) (“Energy Fuels” or the “Company”) today reported its financial results for the quarter ended September 30, 2022. The Company’s quarterly report on Form 10-Q has been filed with the U.S. Securities and Exchange Commission (“SEC“) and may be viewed on the Electronic Document Gathering and Retrieval System (“EDGAR“) at www.sec.gov/edgar.shtml, on the System for Electronic Document Analysis and Retrieval (“SEDAR“) at www.sedar.com, and on the Company’s website at www.energyfuels.com. Unless noted otherwise, all dollar amounts are in U.S. dollars.

Highlights:

  • At September 30, 2022, the Company had a robust balance sheet with $122.3 million of working capital, including $77.1 million of cash and cash equivalents, $11.6 million of marketable securities, $27.3 million of inventory, and no short term (or long term) debt. At current commodity prices, the Company’s product inventory has a value of $44.1 million.
  • During the quarter ended September 30, 2022, the Company incurred a net loss of $9.3 million, which includes increases in development, permitting and land holding costs and selling, general and administration costs associated with the Company’s efforts to enhance its business processes and operational readiness for the current and future growth and activity in our uranium and rare earth element (“REE“) operations.
  • With recent uranium market strength and having secured three long-term uranium contracts with major U.S. utilities earlier this year, the Company has hired over 20 new employees and is beginning to perform the work needed to recommence production at one or more of our mines and ISR facilities, starting as soon as 2023. Until such time when the Company has ramped back up to commercial uranium production, we can rely on our significant uranium inventories to fulfill our new contract requirements.
  • In June 2022, the U.S. Department of Energy (“DOE“) issued a Request for Proposals (“RFP“) to purchase uranium (“U3O8“) for the new U.S. Uranium Reserve Program. The DOE states that they expect to purchase up to 1 million pounds of U3O8 inventory from up to four (4) qualified U.S. uranium producers with individual awards ranging from 100,000 pounds to 500,000 pounds. The uranium must be physically located at Honeywell’s Metropolis Works conversion facility (the “U.S. Converter“). Energy Fuels believes it meets all qualifications to supply the Reserve, and the Company currently holds about 610,000 pounds of U3O8 at the U.S. Converter. The Company has submitted a bid to sell U3O8 to the Reserve, taking into consideration our long-term contract commitments and current and expected market conditions. There are no guarantees the DOE will purchase uranium from the Company under this RFP. Assuming the bid review process is not extended by DOE, the Company expects the DOE to issue the awards by mid-November 2022, with deliveries expected to occur by the end of 2022 or early 2023.
  • During the first nine months of 2022, the Company produced approximately 205 tonnes of mixed partially separated carbonate (“RE Carbonate“), containing approximately 95 tonnes of total rare earth oxides (“TREO“). Energy Fuels’ partially separated RE Carbonate contains a higher concentration of valuable NdPr, roughly 32% – 34% NdPr, compared to our previously produced non-separated RE Concentrate which contained approximately 22% NdPr, and is the most advanced REE material being produced in the U.S. today. During Q4-2022, the Company expects to receive approximately 640 tonnes of monazite, which will be processed into partially separated RE Carbonate during Q4-2022 and Q1-2023.
  • In May 2022, the Company announced it had entered into agreements to acquire a 58 square mile rare earth land position in Brazil (the “Bahia Project“). The Bahia Project is a well-known heavy mineral sand (“HMS“) deposit that has the potential to feed the Company’s White Mesa Mill with REE and uranium-bearing monazite sand for decades. Due diligence on the Bahia Project was completed at the end of August, at which time the Company advised the sellers that it intended to proceed with the purchases and was ready to commence closing procedures. After completion of a number of administrative logistics required in both the U.S. and Brazil, the mineral transfers were initiated in mid-October, and closing is currently expected to occur in late 2022 or early 2023 upon approval of the Brazilian governmental authorities reviewing the pending transfers. Upon acquisition, the Company plans to conduct an extensive exploration program to better define the HMS and monazite resource, including comprehensive sonic drilling (for a total phase 1 program of 2,250 meters) and geophysical mapping, with the intent to undertake an Initial Assessment under SK-1300 (U.S.) and a Technical Report under NI 43-101 (Canada) during Q4-2023, to be completed in early Q1-2024.
  • The Company is currently in active discussions with several additional sources of natural monazite sands around the world to significantly increase the supply of feed for our growing REE initiative.
  • The Company continues to make excellent progress toward installing full REE separation capabilities at the Mill to produce both “light” and “heavy” separated REE oxides in the coming years. The Company plans to initially install a “light” REE separation circuit within the existing Mill facilities in the next 12-18 months with the expected ability to produce between 2,500 – 5,000 tonnes TREO (500 – 1,000 tonnes NdPr oxide or oxalates) per year. As this circuit would be constructed within existing Mill facilities, capital expenditures are expected to be low. The Company is also proceeding with the design, engineering and permitting of a separate crack and leach circuit and a second larger “light” and “heavy” separations circuit with capacity in the order of 10,000 – 15,000 tonnes TREO per year to provide additional REE processing capacity at the Mill in the coming years.
  • During the first nine months of 2022, the Company sold approximately 642,000 pounds of existing inventory of vanadium (“V2O5“) (as ferrovanadium, “FeV“), for an average weighted net price of $13.69 per pound of V2O5. Vanadium markets have dropped in recent months. Therefore, the Company has halted sales of its inventory which currently stands at approximately 987,000 pounds of V2O5. However, the Company expects to resume sales as markets may improve in the future. The Company is evaluating the potential to resume vanadium recovery at the Mill in the future as market conditions may warrant for future sale and to replace sold inventory, where its tailings pond solutions contain an estimated additional 1.0 to 3.0 million recoverable pounds of V2O5.

Mark S. Chalmers, Energy Fuels’ President and CEO, stated:

“Energy Fuels continues to strengthen our U.S. market leading position in uranium and rare earth elements, which are both critical to the clean energy transition. Energy Fuels has ‘one-of-a-kind’ competencies that are critical to uranium, rare earth elements, medical isotopes, and vanadium markets; namely our ability to process feedstocks that are naturally radioactive and recover critical materials needed for the clean energy transition. No other company in the U.S. can do the things Energy Fuels does. We are committed to advancing each of these initiatives in a disciplined manner, while working toward profitability and sustained cash flow.

“Uranium is the fuel for carbon-free nuclear energy, and nations around the world are embracing nuclear, as it provides reliable, carbon-free, baseload electricity. Governments in numerous countries, including the U.S., are supporting both existing and new nuclear to help solve national security, energy security, and carbon reduction challenges. We are saddened by the continuing atrocities being committed by Russian forces in Ukraine, and we stand by our partners in the U.S. nuclear industry and the U.S. government to shift away from Russian uranium and nuclear fuel imports as soon as practicable. As previously disclosed, Energy Fuels has signed new long-term uranium sales contracts with major U.S. nuclear utilities, with sales – and sales revenues – beginning in 2023. We are also excited to announce that we are making significant investments in a number of our existing mines and production facilities, including hiring people, with an eye toward resuming large-scale uranium production very soon. We have been the only U.S. company to continue to produce uranium over the past several years, while maintaining several of our projects on standby status, which provides an excellent foundation from which we can build our production in the coming years. We look forward to maintaining our position as the largest U.S. uranium producer and being a long-term supplier of secure and responsibly sourced U.S. uranium that is insulated from geopolitical, transport, and other supply chain issues. We are also pleased to have been able to submit a bid to sell uranium to the U.S. government under the new U.S. Uranium Reserve, a program that resulted from the Company’s 2018 Section 232 Petition, and we eagerly await the results of that bidding process.

“We also continue to make spectacular progress on rare earth elements. Indeed, we are pleased to announce that we plan to install a commercial-scale “light” rare earth separation circuit within the existing footprint of our White Mesa Mill in Utah that we expect to be operational in the next 12 – 18 months. We are already producing the most advanced rare earth product in the U.S. today, a high-purity, partially separated mixed rare earth carbonate. We expect to go one step further by producing up to 500 – 1,000 tonnes of NdPr oxide (or oxalates) per year by late-2023 or early-2024. If successful, we hope to be the ‘first to market’ in the U.S. for this high-value, advanced material. We anticipate selling our separated NdPr oxide (or oxalate) to major electric vehicle manufacturers in the U.S. and Europe, with a goal to significantly increase this capacity in coming years. This should position Energy Fuels as one of the ‘go to’ suppliers of advanced rare earth materials in the U.S. and one of the first companies that electric vehicle (EV) and other clean technology manufacturers look to for the raw materials they need. Ultimately, we plan to install the capacity to produce over 3,000 tonnes of NdPr oxide, plus 250 tonnes of dysprosium oxide and 100 tonnes of terbium oxide per year, in the next 3-4 years, subject to licensing, commissioning, financing, offtake, market conditions, and sufficient monazite feedstock.

“On the monazite feedstock front, we continue to make excellent progress. With regard to our Bahia Project in Brazil, we continue to move diligently toward closing. The mineral transfers were initiated in mid-October after a number of administrative logistics required for closing were completed in both the U.S. and Brazil. Closing is scheduled to occur as soon as the transfers have been approved by the Brazilian governmental authorities reviewing the pending transfers, which we expect by the end of 2022 or in early 2023. Upon acquisition, the Company plans to conduct an initial phase of exploration drilling on the properties, totaling 2,250 meters, in order to maintain expected production timelines. In addition, we continue discussions with a number of monazite suppliers from around the world interested in partnering with Energy Fuels, and we are confident in our ability to secure monazite supply deals that ensure a ‘win-win’ for both Energy Fuels and our partners.

“Finally, we continue to make progress on medical isotopes with major players in the space. If we can successfully recover radioactive isotopes needed for emerging cancer treatments from our existing process streams, we will have secured yet another opportunity to generate significant cash flows in the next 5 to 10 years. We also continue to track vanadium markets to determine when to resume sales of our existing inventories and when to resume production.”

Webcast at 4:00 pm ET on November 8, 2022:

Energy Fuels will be hosting a video webcast on November 8, 2022 at 4:00 pm ET (2:00 pm MT) to discuss its Q3-2022 financial results, the outlook for 2022, uranium, rare earths, vanadium, and medical isotopes. To join the webcast and access the presentation and viewer-controlled webcast slides, please click on the link below:

Webcast Link

If you would like to participate in the webcast and ask questions, please dial in to 1-888-664-6392 (toll free in the U.S. and Canada).

A link to a recorded version of the proceedings will be available on the Company’s website shortly after the webcast by calling 1-888-390-0541 (toll free in the U.S. and Canada) and by entering the code 619525#. The recording will be available until November 22, 2022.

Financial Discussion:

At September 30, 2022, the Company had $122.3 million of working capital, including $88.7 million of cash and cash equivalents and marketable securities and $27.3 million of inventory, including approximately 692,000 pounds of uranium and 987,000 pounds of high-purity vanadium, both in the form of immediately marketable product. The current spot price of U3O8, according to TradeTech, is $52.50 per pound, and the current mid-point spot price of V2O5, according to Metal Bulletin, is $7.80 per pound. Based on those spot prices, the Company’s uranium and vanadium inventories have a current market value of $36.3 million and $7.7 million, respectively, totaling $44.0 million. The Company also holds RE Carbonate inventory with a current value of $0.1 million, for total product inventory of $44.1 million at current commodity prices.

During the quarter ended September 30, 2022, the Company incurred a net loss of $9.3 million, compared to a net loss of $8.0 million for the third quarter of 2021, and a net loss of $42.0 million for the nine months ended September 30, 2022 compared to a net loss of $29.7 million during the first nine months of 2021. The increased net losses in 2022 are due primarily to a non-cash mark-to-market decrease in the value of investments accounted for at fair value of $13.7 million for the nine months ended September 30, 2022.

Operations Update and Outlook for 2022:

Overview

The Company continues to believe that uranium supply and demand fundamentals point to higher sustained uranium prices in the future. In addition, Russia’s recent invasion of Ukraine and the recent entry into the uranium market by financial entities purchasing uranium on the spot market to hold for the long-term has the potential to result in higher sustained spot and term prices and, perhaps, induce utilities to enter into more long-term contracts with non-Russian producers like Energy Fuels to ensure security of supply and more certain pricing. Having recently secured three long-term uranium contracts with major U.S. utilities, the Company is beginning to perform the work needed to recommence production at one or more of its mines and ISR facilities, starting as soon as 2023. Until such time when the Company has ramped back up to commercial uranium production, it can rely on its significant uranium inventories to fulfill its new contract requirements. To that end, the Company purchased an additional 68,552 pounds of U. S. origin U3O8 on the spot market in October 2022. The Company also continues to evaluate selling a portion of its inventories on the spot market in response to future upside price volatility, into the newly created U.S. Uranium Reserve Program, or for delivery into additional long-term supply contracts if procured. During the nine months ended September 30, 2022, the Company also sold a portion of its vanadium inventory into then strengthening markets.

The Company will also continue to seek new sources of revenue, including through its emerging REE business, as well as new sources of Alternate Feed Materials and new fee processing opportunities at the Mill that can be processed without reliance on current uranium sales prices. The Company is also seeking new sources of natural monazite sands (in addition to the pending acquisition of the Bahia Project) for its emerging REE business, is evaluating the potential to recover radioisotopes for use in the development of targeted alpha therapy medical isotopes for the treatment of cancer, and continues its support of U.S. governmental activities to assist the U.S. uranium mining industry, including the new U.S. Uranium Reserve Program and other efforts to restore domestic nuclear fuel capabilities.

Extraction and Recovery Activities Overview

During 2022, the Company plans to recover 130,000 to 140,000 pounds of uranium, which is an increase over our previous guidance of 100,000 to 120,000 pounds of uranium in 2022. This increased uranium production in 2022, combined with other factors, has resulted in a delayed start of our second REE processing campaign in 2022, which is now expected to commence in November 2022 and carry over into Q1 2023. As a result, the Company now expects to produce approximately 205 tonnes of partially separated RE Carbonate in 2022 containing approximately 95 tonnes of high-value partially separated TREO, with the remaining production from the second 2022 REE processing campaign of approximately 410 tonnes of partially separated RE Carbonate containing approximately 200 tonnes of high-value partially separated TREO being packaged in and attributable to Q1 2023. The total expected production from this second 2022 campaign plus production to date in 2022 is equivalent to approximately 831 tons of non-separated RE Carbonate containing approximately 400 tonnes of non-separated TREO, which falls within our 2022 guidance of 650-1,000 tons of non-separated RE Carbonate containing 300-650 tonnes of non-separated TREO, although a portion of that total expected production will carry over into 2023.

No vanadium production is currently planned during 2022, though the Company sold some of its existing vanadium inventory into recent strong markets and is evaluating the potential to recommence vanadium production in 2023 or later years as market conditions may warrant for future sale and to replace sold inventory.

The Company secured three new long-term sales contracts with U.S. nuclear utilities in May 2022 and is continuing to strategically pursue additional uranium sales commitments with pricing expected to have both fixed and market-related components. The Company believes that recent price increases, volatility and focus on security of supply in light of Russia’s ongoing invasion of Ukraine have increased the potential for the Company to make uranium sales and procure additional term sales contracts with utilities at pricing that sustains production and covers corporate overhead. Therefore, existing inventories may increase from 760,000 pounds of U3O8 (692,000 pounds as of September 30, 2022 plus 68,552 pounds acquired after quarter end) to 890,000 to 900,000 pounds of U3O8 at year-end 2022 or may increase to a lesser extent, or be reduced, in the event the Company sells a portion of its inventory on the spot market, to the U.S. Uranium Reserve Program, or pursuant to term contracts in 2022.

ISR Activities

The Company expects to produce insignificant quantities of U3O8 in the year ending December 31, 2022 from Nichols Ranch. Until such time when market conditions improve sufficiently, suitable term sales contracts can be procured, or the U.S. Uranium Reserve Program is expanded, the Company expects to maintain the Nichols Ranch Project on standby and defer development of further wellfields and header houses. The Company currently holds 34 fully permitted, undeveloped wellfields at Nichols Ranch, including four additional wellfields at the Nichols Ranch wellfields, 22 wellfields at the adjacent Jane Dough wellfields, and eight wellfields at the Hank Project, which is fully permitted to be constructed as a satellite facility to the Nichols Ranch Plant. The Company expects to continue to keep the Alta Mesa Project on standby until such time that market conditions improve sufficiently, suitable term sales contracts can be procured, or the U.S. Uranium Reserve Program is expanded.

Conventional Activities

Conventional Extraction and Recovery Activities

During the nine months ended September 30, 2022, the Mill did not package any material quantities of U3O8, focusing instead on developing its REE recovery business. During the nine months ended September 30, 2022, the Mill produced approximately 205 tonnes of partially separated RE Carbonate, containing approximately 95 tonnes of high value partially separated TREO. The Mill recovered small quantities of uranium during the Quarter, which were retained in circuit. During 2022, the Company expects to recover 130,000 to 140,000 pounds of uranium at the Mill as finished product. The Company expects to recover approximately 205 tonnes of partially separated RE Carbonate (equivalent to approximately 277 tonnes of non-separated RE Carbonate) containing approximately 95 tonnes of high value partially separated TREO (equivalent to approximately 128 tonnes of non-separated TREO) at the Mill during 2022. The Company expects to sell all or a portion of its mixed RE Carbonate to Neo Performance Materials (“Neo“) or other global separation facilities and/or to stockpile it for future production of separated REE oxides at the Mill or elsewhere. The Company is in advanced discussions with several sources of natural monazite sands (in addition to the Bahia Project) to secure additional supplies of monazite sands, which if successful, would be expected to allow the Company to increase RE Carbonate production.

In addition to its 760,000 pounds of finished uranium inventories currently located at North American conversion facilities and at the Mill (692,000 pounds as of September 30, 2022 plus 68,552 pounds acquired after quarter end) and the 130,000 to 140,000 pounds of U3O8 expected to be produced in 2022, the Company has approximately 170,000 pounds of U3O8 contained in stockpiled Alternate Feed Materials and other ore inventory at the Mill that can be recovered relatively quickly in the future, as general market conditions may warrant (totaling about 1,060,000 to 1,070,000 pounds of U3O8 of total uranium inventory). The Company is also seeking to acquire additional ore inventory from third party mine cleanup activities that can be recovered relatively quickly in the future.

The Company currently holds approximately 987,000 pounds of V2O5 in inventory, and there remains an estimated 1.0 to 3.0 million pounds of additional solubilized recoverable V2O5 remaining in tailings solutions awaiting future recovery, as market conditions may warrant.

Conventional Standby, Permitting and Evaluation Activities

During the nine months ended September 30, 2022, standby and environmental compliance activities continued at the fully permitted and substantially developed Pinyon Plain Project (uranium and, potentially, copper) and the fully permitted and developed La Sal Complex (uranium and vanadium). The Company increased its number of employees, and continued carrying out engineering, procurement and construction management activities, at its Pinyon Plain Project during the Quarter. The timing of the Company’s plans to extract and process mineralized materials from these projects will be based on sustained improvements in general market conditions, procurement of suitable sales contracts and/or the expansion of the U.S. Uranium Reserve Program.

The Company is selectively advancing certain permits at its other major conventional uranium projects, such as the Roca Honda Project, which is a large, high-grade conventional project in New Mexico. The Company is also continuing to maintain required permits at its conventional projects, including the Whirlwind Project, which is now in the process of recommencing mining operations, and the Sheep Mountain Project. In addition, the Company will continue to evaluate the Bullfrog Project. Expenditures for certain of these projects have been adjusted to coincide with expected dates of price recoveries based on the Company’s forecasts. All of these projects serve as important pipeline assets for the Company’s future conventional production capabilities, as market conditions may warrant.

Uranium Sales

During the three months ended September 30, 2022, the Company did not enter into any new uranium sales contracts, having just recently entered into three uranium sale and purchase agreements with major U.S. utilities in May 2022, constituting its first new long-term supply contracts since 2018. Having observed a marked uptick in interest from nuclear utilities seeking long-term uranium supply, the Company remains actively engaged in pursuing additional selective long-term uranium sales contracts. The Company submitted an offer to sell a portion of its inventories currently located at the ConverDyn conversion facility to the DOE’s newly created U.S. Uranium Reserve Program. If the offer is accepted, the Company may complete some sales of uranium during 2022.

Vanadium Sales

As a result of strengthening vanadium markets, during the nine months ended September 30, 2022, the Company sold approximately 642,000 pounds of the Company’s existing inventory of V2O5 (as FeV) at a net weighted average price of $13.69 per pound of V2O5. The Company expects to sell its remaining finished vanadium product when justified into the metallurgical industry, as well as other markets that demand a higher purity product, including the aerospace, chemical, and potentially the vanadium battery industries. The Company expects to sell to a diverse group of customers in order to maximize revenues and profits. The vanadium produced in the 2018/19 Pond Return campaign was a high-purity vanadium product of 99.6%-99.7% V2O5. The Company believes there may be opportunities to sell certain quantities of this high-purity material at a premium to reported spot prices. The Company may also retain vanadium product in inventory for future sale, depending on vanadium spot prices and general market conditions.

RE Carbonate Sales

The Company commenced its ramp-up to commercial production of a mixed RE Carbonate in March 2021 and has shipped all of its RE Carbonate produced to-date to Neo’s Silmet facility in Estonia, where it is currently being fed into their separation process. All RE Carbonate produced at the Mill in 2022 is expected to be sold to Neo for separation at Silmet. Until such time as the Company expects to permit and construct its own separation circuits at the Mill, production in future years is expected to be sold to Neo for separation at Silmet and, potentially, to other REE separation facilities outside of the U.S. To the extent not sold, the Company expects to stockpile mixed RE Carbonate at the Mill for future separation and other downstream REE processing at the Mill or elsewhere. During the quarter ended September 30, 2022, the Company sold approximately 89,000 kilograms of TREO at an average price of $25.03 per kilogram of TREO.

While the Company continues to ramp up its mixed RE Carbonate production and additional funds are spent on process enhancements, improving recoveries, product quality and other optimization, profits from this initiative are expected to be minimal until such time when monazite throughput rates are increased and optimized. However, even at the current throughput rates, the Company is recovering most of its direct costs of this growing initiative, with the other costs associated with ramping up production, process enhancements and evaluating future separation capabilities at the Mill being expensed as underutilized capacity production costs applicable to RE Carbonate and development expenditures. Throughout this process, the Company is gaining important knowledge, experience and technical information, all of which will be valuable for current and future mixed RE Carbonate production and expected future production of separated REE oxides and other advanced REE materials at the Mill. As discussed above, the Company is planning to install a “light” separation circuit within existing Mill facilities and is evaluating installing a separate crack and leach circuit and full separation circuit at the Mill to produce both “light” and “heavy” separated REE oxides in the coming years, subject to successful licensing, financing, and commissioning and continued strong market conditions.

About Energy Fuels: Energy Fuels is a leading U.S.-based uranium mining company, supplying U3O8 to major nuclear utilities. The Company also produces vanadium from certain of its projects, as market conditions warrant, and is ramping up to full commercial-scale production of RE Carbonate. Its corporate offices are in Lakewood, Colorado near Denver, and all its assets and employees are in the United States. Energy Fuels holds three of America’s key uranium production centers: the White Mesa Mill in Utah, the Nichols Ranch ISR Project in Wyoming, and the Alta Mesa ISR Project in Texas. The White Mesa Mill is the only conventional uranium mill operating in the U.S. today, has a licensed capacity of over 8 million pounds of U3O8 per year, and has the ability to produce vanadium when market conditions warrant, as well as RE Carbonate from various uranium-bearing ores. The Nichols Ranch ISR Project is currently on standby and has a licensed capacity of 2 million pounds of U3O8 per year. The Alta Mesa ISR Project is also currently on standby and has a licensed capacity of 1.5 million pounds of U3Oper year. In addition to the above production facilities, Energy Fuels also has one of the largest S-K 1300 and NI 43-101 compliant uranium resource portfolios in the U.S. and several uranium and uranium/vanadium mining projects on standby and in various stages of permitting and development. The primary trading market for Energy Fuels’ common shares is the NYSE American under the trading symbol “UUUU,” and the Company’s common shares are also listed on the Toronto Stock Exchange under the trading symbol “EFR.” Energy Fuels’ website is www.energyfuels.com.

Cautionary Note Regarding Forward-Looking Statements: This news release contains certain “Forward Looking Information” and “Forward Looking Statements” within the meaning of applicable United States and Canadian securities legislation, which may include, but are not limited to, statements with respect to: production and sales forecasts; costs of production; any expectation that the Company will be awarded any sales under the U.S. Uranium Reserve; scalability, and the Company’s ability and readiness to re-start, expand or deploy any of its existing projects or capacity to respond to any improvements in uranium market conditions or in response to the Uranium Reserve; any expectation as to future uranium, vanadium, RE Carbonate or REE market fundamentals or sales; any expectation as to recommencement of production at any of the Company’s uranium mines or the timing thereof; any expectation regarding any remaining dissolved vanadium in the Mill’s tailings facility solutions or the ability of the Company to recover any such vanadium at acceptable costs or at all; any expectation as to the ability of the Company to secure any new sources of Alternate Feed Materials or other processing opportunities at the Mill; any expectation as to timelines for the permitting and development of projects; any expectation as to longer term fundamentals in the market and price projections; any expectation as to the implications of the current Russian invasion of Ukraine on uranium, vanadium or other commodity markets; any expectation that the Company will maintain its position as a leading uranium company in the United States; any expectation with respect to timelines to production; any expectation that the Mill will be successful in producing RE Carbonate on a full-scale commercial basis; any expectation that Neo will be successful in separating the Mill’s RE Carbonate on a commercial basis; any expectation that Energy Fuels will be successful in developing U.S. separation, or other value-added U.S. REE production capabilities at the Mill, or otherwise, including the timing of any such initiatives and the expected production capacity or capital and operating costs associated with any such production capabilities; any expectation that the Company will restore U.S. rare earth separation capabilities in the coming years; any expectation with respect to the future demand for REEs; any expectation with respect to the quantities of monazite sands to be acquired by Energy Fuels, the quantities of RE Carbonate to be produced by the Mill or the quantities of contained TREO in the Mill’s RE Carbonate; any expectation that any additional supplies of monazite sands will result in sufficient throughput at the Mill to reduce underutilized capacity production costs and allow the Company to realize its expected margins on a continuous basis; any expectation that the Company may sell its separated NdPr oxide (or oxalate) to major electric vehicle manufacturers in the U.S. and Europe or that the Company may position itself as one of the “go to” suppliers of advanced rare earth materials in the U.S.; any expectation that the Bahia Project has the potential to feed the Mill with REE and uranium-bearing monazite sand for decades; any expectation that the Company will complete comprehensive sonic drilling and geophysical mapping at the Bahia Project or complete an Initial Assessment under SK-1300 (U.S.) and a Technical Report Technical Report under NI 43-101 (Canada) during Q4-2023 or Q1-2024, or otherwise; any expectation that the Company’s evaluation of thorium and radium recovery at the Mill will be successful; any expectation that the potential recovery of medical isotopes from any thorium or radium recovered at the Mill will be feasible; any expectation that any thorium, radium or other isotopes can be recovered at the Mill and sold on a commercial basis; any expectation as to the quantities to be delivered under existing uranium sales contracts, or that such contracts may help underpin the Company’s uranium business for many years to come; any expectation that the Company will be successful in completing any additional contracts for the sale of uranium to U.S. utilities; any expectation that any existing or potential future uranium sales contracts will be at prices and quantities that provide an appropriate rate of return or sustain production and cover corporate overhead; any expectation that the value of the Company’s investments accounted for at fair value may improve in future periods; and any expectation that the Company will generate net income in future periods. Generally, these forward-looking statements can be identified by the use of forward-looking terminology such as “plans,” “expects,” “does not expect,” “is expected,” “is likely,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates,” “does not anticipate,” or “believes,” or variations of such words and phrases, or state that certain actions, events or results “may,” “could,” “would,” “might” or “will be taken,” “occur,” “be achieved” or “have the potential to.” All statements, other than statements of historical fact, herein are considered to be forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements express or implied by the forward-looking statements. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements include risks associated with: commodity prices and price fluctuations; processing and mining difficulties, upsets and delays; permitting and licensing requirements and delays; changes to regulatory requirements; legal challenges; the availability of sources of Alternate Feed Materials and other feed sources for the Mill; competition from other producers; public opinion; government and political actions; available supplies of monazite sands; the ability of the Mill to produce RE Carbonate to meet commercial specifications on a commercial scale at acceptable costs; the ability of Neo to separate the RE Carbonate produced by the Mill to meet commercial specifications on a commercial scale at acceptable costs; market factors, including future demand for REEs; the ability of the Mill to be able to separate radium or other radioisotopes at reasonable costs or at all; market prices and demand for medical isotopes; and the other factors described under the caption “Risk Factors” in the Company’s most recently filed Annual Report on Form 10-K, which is available for review on EDGAR at www.sec.gov/edgar.shtml, on SEDAR at www.sedar.com, and on the Company’s website at www.energyfuels.com. Forward-looking statements contained herein are made as of the date of this news release, and the Company disclaims, other than as required by law, any obligation to update any forward-looking statements whether as a result of new information, results, future events, circumstances, or if management’s estimates or opinions should change, or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements. The Company assumes no obligation to update the information in this communication, except as otherwise required by law.

SOURCE Energy Fuels Inc.

For further information: Investor Inquiries: Energy Fuels Inc., Curtis Moore, VP – Marketing and Corporate Development, (303) 974-2140 or Toll free: (888) 864-2125, [email protected], www.energyfuels.com

Release – ISG Acquires Change 4 GrowthRelease

Research, News, and Market Data on III

11/3/2022

Acquisition creates a global powerhouse in change management

STAMFORD, Conn., November 3, 2022 ― Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced it has acquired Change 4 Growth, an award-winning company specializing in transformational change for enterprises.

Founded in 2017, Change 4 Growth offers market-leading change solutions and expertise to support large-scale business transformations involving people, process and technology. Last year it was named a top 10 change management company in the U.S. by Manage HR magazine.

“The combination of Change 4 Growth and our existing ISG Enterprise Change business creates a global powerhouse in change management at a time when demand for such services is expected to grow significantly,” said Michael P. Connors, chairman and CEO of ISG. “Enterprises are in a state of continuous transformation, as they adjust to new technologies, new competitors, and ever-changing market forces. To be successful, they need a highly adaptable, change-ready workforce.”

The combined business will go to market as ISG Enterprise Change with capabilities in organizational change management (OCM), communications, training development and delivery, leadership development, mentoring, Diversity, Equity and Inclusion (DEI) programs, executive coaching and culture change.

“Transformational change is a complex journey best undertaken with a strong and knowledgeable partner,” said Beth Thomas, CEO and founder of Change 4 Growth, who has been named partner and co-leader of ISG Enterprise Change. “Together, we will offer unrivalled expertise, methodologies and tools to help our clients build and sustain change-capable organizations. We could not be more excited to be joining ISG and expanding the reach of both firms’ industry-leading solutions.”

Among those solutions is ATLAS™, a transformational change platform developed by Change 4 Growth that provides access to OCM templates and tools for greater efficiency and gives clients real-time visibility via dashboards into the progress and health of their business transformations. ISG Enterprise Change intends to offer this new solution to its clients immediately.

Change 4 Growth and ISG Enterprise Change together have successfully conducted more than 1,000 change management engagements involving more than 5 million employees. The two businesses have served more than 300 clients in industries including retail, automotive, manufacturing, banking and financial services, insurance, utilities and healthcare.

For more information about ISG’s OCM services, visit the ISG website.

About ISG

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 800 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,300 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.

Release – Information Services Group Announces Third-Quarter 2022 Results and Acquisition of Change 4 GrowthRelease

Research, News, and Market Data on III

11/3/2022

  • Reports third-quarter GAAP revenues of $69 million, reflecting negative FX impact of $4 million
  • Reports net income of $6 million, GAAP EPS of $0.11 and adjusted EPS of $0.14
  • Reports adjusted EBITDA of $11 million
  • Achieves record year-to-date results: GAAP revenues of $212 million, up 6% in constant currency; net income of $15 million, up 29%; adjusted EBITDA of $32 million, up 12%; GAAP EPS of $0.30, up 30%; adjusted EPS of $0.40, up 18%
  • Returns $7 million to shareholders in the form of share repurchases and dividends in Q3
  • Declares fourth-quarter dividend of $0.04 per share, payable December 19 to record holders as of December 5
  • Acquires Change 4 Growth; bolt-on strengthens enterprise change capabilities
  • Sets fourth-quarter guidance for achieving record full-year revenue and EBITDA performance: revenues between $70 million and $72 million and adjusted EBITDA between $10 million and $11 million

STAMFORD, Conn.–(BUSINESS WIRE)– Information Services Group (ISG) (Nasdaq: III), a leading global technology research and advisory firm, today announced financial results for the third quarter ended September 30, 2022.

“ISG remains on track to deliver record full-year revenue and profitability after another solid operating performance in Q3,” said Michael P. Connors, chairman and CEO. “Despite macroeconomic headwinds, in the third quarter we delivered double-digit growth in recurring revenues, as well as in Europe, on an operating basis. Our product mix of higher-margin digital advisory, research and platform services drove the expansion of our adjusted EBITDA margin to 16 percent, our highest-ever quarterly margin.”

Change 4 Growth Acquisition

ISG said today it has acquired Change 4 Growth, a business specializing in transformational change for enterprises. Founded in 2017, Change 4 Growth offers market-leading change solutions and expertise to support large-scale business transformations involving people, process and technology.

“The combination of Change 4 Growth and our existing ISG Enterprise Change business creates a global powerhouse in change management at a time when demand for such services is expected to grow significantly,” said Connors.

ISG estimates demand for organizational change management (OCM) services will grow at a compound annual rate of more than 15 percent over the next five years, as companies continuously adjust to new technologies, new competitors, and ever-changing market forces.

With the acquisition, Connors noted that ISG adds a new platform solution, ATLAS™, that provides access to OCM templates and tools for greater engagement efficiency and gives clients real-time visibility via dashboards into the progress and health of their business transformations.

Third-Quarter 2022 Results

Reported revenues for the third quarter were $68.8 million, down 3 percent from $71.1 million in the prior year, and up 2 percent in constant currency. Currency translation negatively impacted reported revenues by $4.0 million versus the prior year. Reported revenues were $42.2 million in the Americas, down 2 percent versus the prior year, impacted by the completion of a large Automation engagement; $19.3 million in Europe, down 4 percent versus the prior year on a reported basis and up 13 percent in constant currency, and $7.3 million in Asia Pacific, down 10 percent versus the prior year on a reported basis and down 3 percent in constant currency.

ISG reported third-quarter operating income of $7.4 million, up 2 percent from $7.3 million in the third quarter of 2021. Reported third-quarter net income was $5.6 million, up 26 percent, compared with net income of $4.4 million in the prior year. Fully diluted earnings per share was $0.11, compared with $0.09 per fully diluted share in the prior year. Net income margin (calculated by dividing net income by reported revenues) increased to 8.1 percent, from 6.2 percent in the third quarter of 2021.

Adjusted net income (a non-GAAP measure defined below under “Non-GAAP Financial Measures”) for the third quarter was $7.2 million, or $0.14 per share on a fully diluted basis, compared with adjusted net income of $5.9 million, or $0.12 per share on a fully diluted basis, in the prior year’s third quarter.

Third-quarter adjusted EBITDA (a non-GAAP measure defined below under “Non-GAAP Financial Measures”) was $10.7 million, up 5 percent from the third quarter last year. Adjusted EBITDA margin (a non-GAAP measure calculated by dividing adjusted EBITDA by reported revenues) was 16 percent, up 120 basis points from the prior year.

Nine-Month Year-to-Date Results

Reported revenues for the first nine months were a record $212.1 million, up 2 percent versus the prior-year period, and up 6 percent in constant currency. Currency translation negatively impacted reported revenues for the nine-month period by $9.5 million versus the prior year. Reported revenues were $123.1 million in the Americas, up 1 percent versus the prior year; $66.0 million in Europe, down 1 percent versus the prior year on a reported basis and up 11 percent in constant currency, and $23.0 million in Asia Pacific, up 13 percent versus the prior year on a reported basis and up 20 percent in constant currency.

ISG reported year-to-date operating income of $22.3 million, up 23 percent from $18.1 million in the first nine months of 2021. The firm also reported record year-to-date net income and fully diluted earnings per share of $15.4 million and $0.30, respectively, versus net income of $12.0 million and earnings per share of $0.23 in the prior year. Net income margin (calculated by dividing net income by reported revenues) increased to 7.3 percent, from 5.7 percent in the same period last year.

Adjusted net income (a non-GAAP measure defined below under “Non-GAAP Financial Measures”) for the first nine months was $20.4 million, or $0.40 per share on a fully diluted basis, compared with adjusted net income of $17.7 million, or $0.34 per share on a fully diluted basis, in the prior-year period.

Year-to-date adjusted EBITDA (a non-GAAP measure defined below under “Non-GAAP Financial Measures”) reached a record $32.1 million, up 12 percent from same period last year. Adjusted EBITDA margin (a non-GAAP measure calculated by dividing adjusted EBITDA by reported revenues) was 15 percent, up more than 140 basis points from the prior year.

Other Financial and Operating Highlights

The firm’s cash balance totaled $19.7 million at September 30, 2022, down from $31.5 million at June 30, 2022. During the third quarter, ISG repurchased $4.8 million of shares, paid dividends of $2.0 million, paid $1.0 million in a final earnout associated with the 2020 Neuralify acquisition, and paid down $1.1 million of debt. As of September 30, 2022, ISG had $71.3 million in debt outstanding, compared with $75.6 million at the end of the third quarter last year. At 1.7 times, the firm’s gross-debt-to-adjusted-EBITDA ratio (a non-GAAP measure calculated by dividing outstanding debt by adjusted EBITDA) was at a record low as of September 30, 2022.

2022 Fourth-Quarter Revenue and Adjusted EBITDA Guidance

“Based on achieving our fourth-quarter guidance, ISG will deliver record revenues and profitability for the full year,” said Connors. “For the fourth quarter, ISG is targeting revenues of between $70 million and $72 million and adjusted EBITDA of between $10 million and $11 million. We will continue to monitor the macroeconomic environment, including the impact of FX, inflation and other factors, and adjust our business plans accordingly.”

Quarterly Dividend

The ISG Board of Directors declared a fourth-quarter dividend of $0.04 per share, payable on December 19, 2022, to shareholders of record on December 5, 2022.

Conference Call

ISG has scheduled a call for 9 a.m., U.S. Eastern Time, Friday, November 4, 2022, to discuss the company’s third-quarter results. The call can be accessed by dialing 1-833-927-1758; or, for international callers, by dialing +1 929-526-1599. The access code is 121223. A recording of the conference call will be accessible on ISG’s website (www.isg-one.com) for approximately four weeks following the call.

Forward-Looking Statements

This communication contains “forward-looking statements” which represent the current expectations and beliefs of management of ISG concerning future events and their potential effects. Statements contained herein including words such as “anticipate,” “believe,” “contemplate,” “plan,” “estimate,” “target,” “expect,” “intend,” “will,” “continue,” “should,” “may,” and other similar expressions, are “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not guarantees of future results and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated. Those risks relate to inherent business, economic and competitive uncertainties and contingencies relating to the businesses of ISG and its subsidiaries including without limitation: (1) failure to secure new engagements or loss of important clients; (2) ability to hire and retain enough qualified employees to support operations; (3) ability to maintain or increase billing and utilization rates; (4) management of growth; (5) success of expansion internationally; (6) competition; (7) ability to move the product mix into higher margin businesses; (8) general political and social conditions such as war, political unrest and terrorism; (9) healthcare and benefit cost management; (10) ability to protect ISG and its subsidiaries’ intellectual property or data and the intellectual property or data of others; (11) currency fluctuations and exchange rate adjustments; (12) ability to successfully consummate or integrate strategic acquisitions; (13) outbreaks of diseases, including coronavirus, or similar public health threats or fear of such an event; and (14) engagements may be terminated, delayed or reduced in scope by clients. Certain of these and other applicable risks, cautionary statements and factors that could cause actual results to differ from ISG’s forward-looking statements are included in ISG’s filings with the U.S. Securities and Exchange Commission. ISG undertakes no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.

Non-GAAP Financial Measures

ISG reports all financial information required in accordance with U.S. generally accepted accounting principles (GAAP). In this release, ISG has presented both GAAP financial results as well as non-GAAP information for the three and nine months ended September 30, 2022, and September 30, 2021. ISG believes that evaluating its ongoing operating results will be enhanced if it discloses certain non-GAAP information. These non-GAAP financial measures exclude non-cash and certain other special charges that many investors believe may obscure the user’s overall understanding of ISG’s current financial performance and the Company’s prospects for the future. ISG believes that these non-GAAP measures provide useful information to investors because they improve the comparability of the financial results between periods and provide for greater transparency of key measures used to evaluate the Company’s performance.

ISG provides adjusted EBITDA (defined as net income plus interest, taxes, depreciation and amortization, foreign currency transaction gains/losses, non-cash stock compensation, interest accretion associated with contingent consideration, acquisition-related costs, and severance, integration and other expense), adjusted net income (defined as net income plus amortization of intangible assets, non-cash stock compensation, foreign currency transaction gains/losses, interest accretion associated with contingent consideration, acquisition-related costs, and severance, integration and other expense, on a tax-adjusted basis), adjusted net income per diluted share, adjusted EBITDA margin, gross-debt-to-adjusted-EBITDA ratio and selected financial data on a constant currency basis which are non-GAAP measures that the Company believes provide useful information to both management and investors by excluding certain expenses and financial implications of foreign currency translations, which management believes are not indicative of ISG’s core operations. These non-GAAP measures are used by ISG to evaluate the Company’s business strategies and management’s performance.

We evaluate our results of operations on both an as reported and a constant currency basis. The constant currency presentation, which is a non-GAAP financial measure, excludes the impact of year-over-year fluctuations in foreign currency exchange rates. We believe providing constant currency information provides valuable supplemental information regarding our results of operations, thereby facilitating period-to-period comparisons of our business performance and is consistent with how management evaluates the Company’s performance. We calculate constant currency percentages by converting our current and prior-periods local currency financial results using the same point in time exchange rates and then compare the adjusted current and prior period results. This calculation may differ from similarly titled measures used by others and, accordingly, the constant currency presentation is not meant to be a substitution for recorded amounts presented in conformity with GAAP, nor should such amounts be considered in isolation.

Management believes this information facilitates comparison of underlying results over time. Non-GAAP financial measures, when presented, are reconciled to the most closely applicable GAAP measure. Non-GAAP measures are provided as additional information and should not be considered in isolation or as a substitute for results prepared in accordance with GAAP. A reconciliation of the forward-looking non-GAAP estimates contained herein to the corresponding GAAP measures is not being provided, due to the unreasonable efforts required to prepare it.

About ISG

ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 800 clients, including 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,300 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For more information, visit www.isg-one.com.

 
Information Services Group, Inc.
Condensed Consolidated Statement of Income and Comprehensive Income
(unaudited)
(in thousands, except per share amounts)
 
 
Three Months Ended September 30,Nine Months Ended September 30,
 2022   2021   2022   2021 
 
Revenues$68,836 $71,095 $212,100 $208,263 
Operating expenses
Direct costs and expenses for advisors 39,786  43,249  125,111  127,412 
Selling, general and administrative 20,334  19,236  60,806  58,768 
Depreciation and amortization 1,286  1,347  3,872  3,962 
Operating income 7,430  7,263  22,311  18,121 
Interest income 37  65  126  196 
Interest expense (824) (538) (1,997) (1,794)
Foreign currency transaction gain (loss) 131  1  248  (2)
 
Income before taxes 6,774  6,791  20,688  16,521 
Income tax provision 1,218  2,370  5,245  4,570 
Net income$5,556 $4,421 $15,443 $11,951 
 
Weighted average shares outstanding:
Basic 47,888  48,751  48,191  48,521 
Diluted 49,844  51,510  50,637  51,713 
 
Earnings per share:
Basic$0.12 $0.09 $0.32 $0.25 
Diluted$0.11 $0.09 $0.30 $0.23 
 
Information Services Group, Inc.
Reconciliation from GAAP to Non-GAAP
(unaudited)
(in thousands, except per share amounts)
 
 
 
Three Months Ended September 30,Nine Months Ended September 30,
 2022  2021  2022  2021 
 
Net income$5,556 $4,421 $15,443 $11,951 
Plus:
Interest expense (net of interest income) 787  473  1,871  1,598 
Income taxes 1,218  2,370  5,245  4,570 
Depreciation and amortization 1,286  1,347  3,872  3,962 
Interest accretion associated with contingent consideration   47  8  113 
Acquisition-related costs (1) 25  18  41  (14)
Severance, integration and other expense 8  41  458  1,341 
Foreign currency transaction (gain) loss (131) (1) (248) 2 
Non-cash stock compensation 1,987  1,499  5,432  5,075 
Adjusted EBITDA$10,736 $10,215 $32,122 $28,598 
 
Net income$5,556 $4,421 $15,443 $11,951 
Plus:
Non-cash stock compensation 1,987  1,499  5,432  5,075 
Intangible amortization 525  643  1,580  2,001 
Interest accretion associated with contingent consideration   47  8  113 
Acquisition-related costs (1) 25  18  41  (14)
Severance, integration and other expense 8  41  458  1,341 
Foreign currency transaction (gain) loss (131) (1) (248) 2 
Tax effect (2) (772) (719) (2,327) (2,726)
Adjusted net income$7,198 $5,949 $20,387 $17,743 
 
Weighted average shares outstanding:
Basic 47,888  48,751  48,191  48,521 
Diluted 49,844  51,510  50,637  51,713 
 
Adjusted earnings per share:
Basic$0.15 $0.12 $0.42 $0.37 
Diluted$0.14 $0.12 $0.40 $0.34 
 
(1)Consists of expenses from acquisition-related costs and non-cash fair value adjustments on pre-acquisition contract liabilities.
(2)Marginal tax rate of 32%, reflecting U.S. federal income tax rate of 21% plus 11% attributable to U.S. states and foreign jurisdictions.
 
Information Services Group, Inc.
Selected Financial Data
Constant Currency Comparison
 
Three MonthsThree Months
Three MonthsConstantEndedThree MonthsConstantEnded
EndedcurrencySeptember 30, 2022EndedcurrencySeptember 30, 2021
September 30, 2022impactAdjustedSeptember 30, 2021impactAdjusted
Revenue$68,836$3,843$72,679$71,095$(165)$70,930
Operating income$7,430$353$7,783$7,263$(36)$7,227
Adjusted EBITDA$10,736$399$11,135$10,215$(44)$10,171
 
Nine MonthsNine Months
Nine MonthsConstantEndedNine MonthsConstantEnded
EndedcurrencySeptember 30, 2022EndedcurrencySeptember 30, 2021
September 30, 2022impactAdjustedSeptember 30, 2021impactAdjusted
Revenue$212,100$7,745$219,845$208,263$(1,714)$206,549
Operating income$22,311$973$23,284$18,121$(701)$17,420
Adjusted EBITDA$32,122$1,080$33,202$28,598$(724)$27,874

Source: Information Services Group, Inc.